Exhibit B

Post 24: 24 March 2006

2006-03-24T07:50:00.000Z

Links are given to online full text resources, all other materials can be obtained via the Fade Library, just mail your request to library.services@fade.nhs.uk

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Latest Systematic Reviews

Bias in published cost effectiveness studies: systematic review
Chaim M Bell, David R Urbach, Joel G Ray, Ahmed Bayoumi, Allison B Rosen, Dan Greenberg, Peter J Neumann
BMJ 2006;332:699-703, doi:10.1136/bmj.38737.607558.80

Objective To investigate if published studies tend to reportfavourable cost effectiveness ratios (below $20 000, $50 000,and $100 000 per quality adjusted life year (QALY) gained) andevaluate study characteristics associated with this phenomenon.

Design Systematic review.

Studies reviewed 494 English language studies measuring healtheffects in QALYs published up to December 2001 identified usingMedline, HealthSTAR, CancerLit, Current Content, and EconLitdatabases.

Main outcome measures Incremental cost effectiveness ratiosmeasured in dollars set to the year of publication.

Results Approximately half the reported incremental cost effectivenessratios (712 of 1433) were below $20 000/QALY. Studies fundedby industry were more likely to report cost effectiveness ratiosbelow $20 000/QALY (adjusted odds ratio 2.1, 95% confidenceinterval 1.3 to 3.3), $50 000/QALY (3.2, 1.8 to 5.7), and $100000/QALY (3.3, 1.6 to 6.8). Studies of higher methodologicalquality (adjusted odds ratio 0.58, 0.37 to 0.91) and those conductedin Europe (0.59, 0.33 to 1.1) and the United States (0.44, 0.26to 0.76) rather than elsewhere were less likely to report ratiosbelow $20 000/QALY.

Conclusion Most published analyses report favourable incrementalcost effectiveness ratios. Studies funded by industry were morelikely to report ratios below the three thresholds. Studiesof higher methodological quality and those conducted in Europeand the US rather than elsewhere were less likely to reportratios below $20 000/QALY

Latest Guidelines

Irritable bowel syndrome in adults: prevention, diagnosis and management of irritable bowel syndrome in primary care

NICE has issued a draft scope on “Irritable bowel syndrome in adults: prevention, diagnosis and management of irritable bowel syndrome in primary care” for consultation

In terms of clinical management, areas that will be covered are:
• Diagnosis of IBS in primary care. This will include patient history, clinical examination and diagnostic tests using the ROME II criteria.
• Patient self-management, including exercise and dietary changes, and self-medication.
• Drug treatments, including bulking agents, anti-motility agents, antispasmodics and anti-depressants. Note that guideline recommendations will normally fall within licensed indications; exceptionally, and only where clearly supported by evidence, use outside of a licensed indication may be recommended. The guideline will assume that prescribers will use the Summary of Product Characteristics to inform their decisions for individual patients.
• Non-pharmacological treatments, including a range of therapeutic treatments such as cognitive behavioural therapy, acupuncture, Chinese herbal medicine, hypnotherapy, meditation, reflexology and aromatherapy.

The development of the guideline recommendations will begin in May 2006.

Tuburculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control

NICE has published guidelines on clinical diagnosis and management of tuberculosis, and measures for its prevention and control. The clinical guideline covers:
• diagnosing and treating active and latent TB in adults and children
• preventing the spread of TB, for example by offering tests to people at high risk, and by vaccination.
• the guideline does not explain TB or its treatments in detail.

In terms of the management of active TB, the following recommendations have been identified as priorities for implementation (taken directly from the guideline):
• A 6-month, four-drug initial regimen (6 months of isoniazid and rifampicin supplemented in the first 2 months with pyrazinamide and ethambutol) should be used to treat active respiratory TB in:
- adults not known to be HIV-positive
- adults who are HIV-positive
- children.
• Patients with active meningeal TB should be offered:
- a treatment regimen, initially lasting for 12 months, comprising isoniazid,
pyrazinamide, rifampicin and a fourth drug (for example, ethambutol) for the first 2 months, followed by isoniazid and rifampicin for the rest of the treatment period
- a glucocorticoid at the normal dose range: adults – equivalent to prednisolone 20–40mg if on rifampicin, otherwise 10–20 mg; children - equivalent to prednisolone 1–2 mg/kg, maximum 40mg with gradual withdrawal of the glucocorticoid considered, starting within 2–3 weeks of initiation.

Final Appraisal Determination (FAD) on erythropoietin for anaemia induced by cancer treatment.

NICE has issued a Final Appraisal Determination (FAD) on erythropoietin for anaemia induced by cancer treatment.

The guidance does not cover the use of erythropoietin (epoetin alfa, epoetin beta and darbepoetin alfa) in the management of cancer-related anaemia that is not induced by cancer treatment (chemotherapy or radiotherapy). The preliminary recommendations are as follows:

• Erythropoietin is recommended for use in the management of anaemia only as part of ongoing or new clinical trials that are constructed to generate robust and relevant data in order to address the gaps in the currently available evidence.

• Patients currently receiving erythropoietin could experience loss of well-being if treatment is discontinued at a time they did not anticipate. Because of this, patients should have the option to continue therapy until they and their consultants consider it appropriate to stop.

The appeal period for this appraisal will close on 31 March 2006.

Improving outcomes for people with sarcoma

The National Institute for Health and Clinical Excellence (NICE) and the National Collaborating Centre for Cancer (NCCC) have issued guidance for the NHS in England and Wales on how to improve the care of all patients with bone sarcomas and adults with soft tissue sarcomas. The guidance provides advice to those who develop and deliver cancer services on the planning, commissioning and configuration of those services.

Improving Outcomes for People with Skin Tumours including Melanoma

The NICE clinical guideline on skin tumours outlines how healthcare services for people with skin tumours should be organised. The key recommendations are:
- Cancer networks should establish two levels of multidisciplinary teams to care for patients. - Patients with a precancerous lesion should either be treated by their GP or referred. - The care of patients with low-risk basal cell carcinoma may be managed by doctors in the community or at a local hospital. - Patients who need specialist diagnosis should be referred to a doctor trained to diagnose skin cancer. - Skin cancer teams should work to agreed protocols. - Protocols should cover the management of care for people in high-risk or special groups. - Follow-up care should be agreed. - All patients and carers should have access to high quality information. - Information should be collected. - More research should be done.

Nutrition support in adults: oral nutrition support, enteral tube feeding and parenteral nutrition

The NICE clinical guideline on nutrition support in adults covers the care of patients with malnutrition or at risk of malnutrition, whether they are in hospital or at home. It doesn't cover malnutrition or its treatments in detail.

Latest Reports

Moving beyond effectiveness in evidence synthesis: Methodological issues in the synthesis of diverse sources of evidence
Popay J
National Institute for Health and Clinical Excellence
Imprint: London : NICE, 2006
120p.

Between 2000 and 2005 the Health Development Agency (HDA) carried out a programme of work to develop the evidence base in public health. As part of that work there was an underpinning methodological workstream. The contents of this volume arose from one of the activities within that workstream. In 2003 a group of researchers and methodologists held a seminar to consider the question of evidence synthesis when that evidence is derived from diverse sources and from a variety of methodological traditions. This document consists of reworked versions of the papers presented at that meeting.

Essence of care: promoting health
Department of Health
Imprint: London : DoH, 2006
14p.

Essence of care: promoting health is a new benchmark that provides a framework for shifting the focus from treating ill health to the promotion of healthier life choices in all good patient care. The benchmarking process outlined in the 2003 edition of Essence of care helps practitioners to take a structured approach to sharing and comparing practice, enabling them to identify the best examples and to develop action plans to remedy poor practice.

Independent Advisory Group on Sexual Health and HIV: Annual repoort 2004/2005
Gould J
Independent Advisory Group on Sexual Health and HIV
Imprint: London : DoH, 2005
32p.

The third annual report of the Independent Advisory Group on Sexual Health and HIV made recommendations in four main areas: delivering improved services; developing new services; enhancing professional skills; and promoting sexual health and wellbeing in the 21st century.

Independent Advisory Group on Sexual Health and HIV: DH response to the third annual report published October 2005: 15 March 2006
Department of Health
Imprint: London : DoH, 2006
5p.

NHS foundation trusts: nine-month report for period 1 April 2005 to 31 December 2005
Monitor
Imprint: London : Monitor, 2006
4p.
Monitor has published NHS foundation trusts: nine-month report for period 1 April 2005 to 31 December 2005 together with a technical annex, which outlines the financial performance of the 32 FTs between April and December 2005. Some of the main findings are:

The aggregate deficit of the 32 FTs was £9m on total income of £5,000m;

Excluding the performance of one FT (University College London Hospitals), the remaining 31 FTs generated a £20m surplus, considerably ahead of their planned position of an £11m surplus;

The performance of University College London Hospitals (UCLH) NHS FT remains a significant concern. At quarter 3 it had a deficit of £29.4m (quarter 2 £17.4m). The Board of UCLH, overseen by Monitor, is implementing a detailed plan for financial recovery. The Board of UCLH has been invited to present its recovery plan at a meeting with the Board of Monitor on 15 March;

Three FTs which recorded significant net deficits in 2004/05 (Bradford, Peterborough and Royal Devon & Exeter) have been implementing turnaround plans, with the support of Monitor. The 2004/05 aggregate deficit of £23m has been reduced to £0.4m at quarter 3. Bradford has now reverted to quarterly, rather than monthly, monitoring;

Performance in quarter 4 may not be as strong as in the nine months to quarter 3. A number of FTs are reporting concerns about the ability and willingness of PCTs to pay for contracted activity. It is possible FTs will be forced to make provision for potential non-payment for some activity, resulting in a weaker full-year position.

Creating the future: Modernising careers for salaried dentists in primary care: Stakeholder consultation: Response report
NHS Partners
Imprint: London : DoH, 2006
49p.

This is the outcome of the consultation on modernising careers for salaried dentists in England. 'Creating the future: modernising careers for salaried dentists in primary care: stakeholder consultation: response report' provides an analysis of consultation responses, key findings, participant profile and an analysis of quantitative data. The Department of Health has also published its response to the consultation.

Creating the future: Modernising careers for salaried dentists in primary care: Department of Health response
Department of Health
Imprint: London : DoH, 2006
3p.

This is the response the consultation on modernising careers for salaried dentists in England, 'Creating the future: modernising careers for salaried dentists in primary care: stakeholder consultation: response report'.

Learning from the Implementation Co-ordination Group
Primary Care Contracting
Imprint: London : Primary Care Contracting, 2006
8p.

The Implementation Coordination Group (ICG) was first established as an interim arrangement to deal with problems during the implementation phase of the new GMS contract. It was re-established in response to calls from LMCs for involvement from the GPC and the Department of Health in local disagreements with PCOs that could not be resolved locally and which were inappropriate for formal dispute resolution procedures. The ICG meets monthly and comprises of a negotiator from the three National negotiating parties – Richard Armstrong (Department of Health), Philip Grant (NHS Employers Organisation) and Hamish Meldrum (GPC). The ICG deals with both local and national problems arising from the interpretation of the GMS contract regulations and guidance and provides a final recommendation on matters raised.

This document shares learning from recent decisions to allow learning from these cases across the wider NHS.

Getting equal: Proposals to outlaw sexual orientation discrimination in the provision of goods and services
Walker F
Department of Trade and Industry
Imprint: London : DTI, 2006
84p.

The Equality Act 2006 included a power that allows the Government to prohibit discrimination on the grounds of sexual orientation in the provision of goods, facilities and services, in education and in the exercise of public functions. The Government intends to use this power to make regulations that take effect in October 2006. This consultation paper describes the approach proposed for the regulations. They are intended to bring protection from sexual orientation discrimination into line with existing legislation that prohibits discrimination on the grounds of race, sex and for reasons related to disability.

Survey of employers’ policies, practices and preferences relating to age: A report of research carried out by the National Institute of Economic and Social Research (NIESR) in conjunction with the British Market Research Bureau (BMRB) on behalf of the Department for Work and Pensions and the Department of Trade and Industry
Metcalf H
Co-Meadows P
National Institute of Economic and Social Research; British Market Research Bureau
Imprint: DWP, 2006
240p.
Series: (Research Report No 325: DTI Employment Relations Research Series No 49)

This survey was designed to establish, prior to the implementation of the Employment Equality (Age) Regulations 2006, the extent to which current employment policies and practices have an age dimension. It provides a baseline measure for evaluating the effectiveness of the regulations. The study was based on a representative survey of 2,087 employment establishments in Great Britain with at least five employees.

New deal for disabled people evaluation: Survey of eligible population, wave three
Pires R
Co-Kazimirski A; Shaw A; Sainsbury R; Meah A
National Centre for Social Research; Social Policy Research Unit
Imprint: London : DWP, 2006
140p.
Series: (Research Report No 324)

The New Deal for Disabled People (NDDP) is the major employment programme for people on incapacity benefits. It is a voluntary programme that aims to help people with a disability or health condition move into sustained employment. Over 65 job brokers, who are a mix of public, private and voluntary sector organisations, have delivered the programme. As part of a comprehensive evaluation, the survey of the eligible population has been conducted to obtain information about people who were eligible and invited to take part in NDDP. The survey aims to establish the characteristics of this population, their work aspirations and their awareness of, attitudes to and involvement with NDDP.

Choice of scan: Phase 2: Guidance
Department of Health
Imprint: London : DoH, 2006
10p.

The Department of Health has published updated guidance for phase 2 of the Choice of Scan initiative. Choice of Scan: phase 2 - guidance has been developed with NHS stakeholders at trust, PCT and SHA levels. From April 2006, Choice of Scan, phase 2 will go live. This will mean that hospitals will offer patients waiting longer for all diagnostic imaging tests who do not have an appointment within 20 weeks, the choice of having their scan at another provider within a maximum of 20 weeks from their original referral.

National survey of NHS staff 2005: Summary of key findings
Healthcare Commission
Imprint: London : Healthcare Commission, 2006
39p.

The annual NHS staff survey has been published by the Healthcare Commission. The Commission states that the survey shows the first significant sign of a trend towards fewer staff facing physical attacks, bullying and harassment from patients or their relatives. 28% of respondents said they had experienced either violence or abuse in the previous 12 months, compared with 31% in 2004 and 32% in 2003. But the Commission said it was too early to say whether the trend would carry on and urged NHS trusts to continue their efforts to tackle the problem.

On errors and incidents, 40% of respondents reported seeing at least one potentially harmful error, near miss or incident that could have hurt either staff or patients in the previous month . However, this is a fall from 47% in 2003.

The survey suggests that trusts could do more to reduce the spread of hospital-acquired infection. One in four staff said that their trust does not do enough to promote the importance of hand cleaning to staff, patients and visitors. Only 61% reported that hot water, soap and paper towels, and alcohol rubs were always available when needed. But a further 28% did report that they were available most of the time.

The survey also suggests that NHS employment is becoming more family friendly. Thirty-eight per cent of staff reported access to a childcare co-ordinator in 2005 compared to 32% in 2003. Staff reporting access to subsidised childcare also increased from 17% to 24% over the three years.

The survey also covers areas such as whistle-blowing, work-related stress and equal opportunities

Department of Health draft simplification plan
Department of Health
Imprint: London : DoH, 2006
3p.

The Department of Health has published a draft plan setting out its commitment to reduce policy and administrative costs by more than £750 million. This responds to the requirement set by Government following the Better Regulation Task Force report, Less is More, to develop a rolling simplification plan.

The draft plan includes:

the reconfiguration of DH's arms length bodies

the wider review of health and social care regulations aiming to balance patient safety with reducing administrative burdens,

and initiatives being introduced to streamline data gathering and dissemination and reduce bureaucracy on the NHS.

Accessibility planning and the NHS: Improving patient access to health services
National Institute of Health and Clinical Excellence
Imprint: London : NICE, 2006
16p.

This briefing provides an overview of accessibility planning, highlights the role of the NHS and describes some examples of current approaches. It is aimed at:

NHS managers and board members dealing with service reconfiguration, the location of services, the Local Improvement Finance Trust (LIFT), and health service planning in general

Local authority transport planning and health policy officers and elected members, especially those concerned with the health aspects of accessibility planning and the local transport plan process

Practitioners working to reduce health inequalities and/or enhance social cohesion and inclusion.

Evidence from Journals

Bischoff-Ferrari HA, et al. Effect of cholecalciferol plus calcium on falling in ambulatory older men and women: a 3-year randomized controlled trial. Arch Intern Med. 2006 Feb 27;166(4):424-30

BACKGROUND: A recent meta-analysis found that cholecalciferol (vitamin D) should reduce falls by more than 20%. However, little is known about whether supplemental cholecalciferol plus calcium citrate malate will lower the long-term risk of falling in men, active older individuals, and older individuals with higher 25-hydroxyvitamin D levels.

METHODS: We studied the effect of 3-year supplementation with cholecalciferol-calcium on the risk of falling at least once in 199 men and 246 women 65 years or older and living at home. Individuals received 700 IU of cholecalciferol plus 500 mg of calcium citrate malate per day or placebo in a randomized double-blind manner. Subjects were classified as less physically active if physical activity was below the median level. Low 25-hydroxyvitamin D levels were classified as those below 32 ng/mL (<80 style="font-weight: bold;">RESULTS: In 3 years, 55% of women and 45% of men reported at least 1 fall. Mean +/- SD baseline 25-hydroxyvitamin D levels were 26.6 +/- 12.7 ng/mL (66.4 +/- 31.7 nmol/L) in women and 33.2 +/- 14.2 ng/mL (82.9 +/- 34.9) in men. Cholecalciferol-calcium significantly reduced the odds of falling in women (odds ratio [OR], 0.54; 95% confidence interval [CI], 0.30-0.97), but not in men (OR, 0.93; 95% CI, 0.50-1.72). Fall reduction was most pronounced in less active women (OR, 0.35; 95% CI, 0.15-0.81). Baseline 25-hydroxyvitamin D level did not modulate the treatment effect.

CONCLUSIONS: Long-term dietary cholecalciferol-calcium supplementation reduces the odds of falling in ambulatory older women by 46%, and especially in less active women by 65%. Supplementation had a neutral effect in men independent of their physical activity level.

Effectiveness of educational interventions in improving detection and management of dementia in primary care: cluster randomised controlled study
Murna Downs, Stephen Turner, Michelle Bryans, Jane Wilcock, John Keady, Enid Levin, Ronan O'Carroll, Kate Howie, Steve Iliffe
BMJ 2006;332:692-696, doi:10.1136/bmj.332.7543.692

Objective To test the effectiveness of educational interventionsin improving detection rates and management of dementia in primarycare.

Design Unblinded, cluster randomised, before and after controlledstudy.

Setting General practices in the United Kingdom (central Scotlandand London) between 1999 and 2002.

Interventions Three educational interventions: an electronictutorial carried on a CD Rom; decision support software builtinto the electronic medical record; and practice based workshops.

Participants 36 practices participated in the study. Eight practiceswere randomly assigned to the electronic tutorial; eight todecision support software; 10 to practice based workshops; and10 to control. Electronic and manual searches yielded 450 validand usable medical records.

Main outcome measures Rates of detection of dementia and theextent to which medical records showed evidence of improvedconcordance with guidelines regarding diagnosis and management.

Results Decision support software (P = 0.01) and practice basedworkshops (P = 0.01) both significantly improved rates of detectioncompared with control. There were no significant differencesby intervention in the measures of concordance with guidelines.

Conclusions Decision support systems and practice based workshopsare effective educational approaches in improving detectionrates in dementia.

Therapeutics

The Bug Buster kit was better than single dose pediculicides for head lice

Dawes

Evid Based Med.2006; 11: 17

Pulmonary vein isolation was better than antiarrhythmic drugs for symptomatic atrial...

George Wyse

Evid Based Med.2006; 11: 16

Vitamin E did not prevent cardiovascular disease and cancer in healthy women

Rees Willett

Evid Based Med.2006; 11: 11

Using exhaled NO concentrations to adjust inhaled corticosteroid dose maintained...

Rees

Evid Based Med.2006; 11: 20

Review: viscosupplementation for knee osteoarthritis reduces pain and improves function

Shoor

Evid Based Med.2006; 11: 12

Review: vitamin D plus calcium, but not vitamin D alone, prevents osteoporotic fractures...

Johnell

Evid Based Med.2006; 11: 13

Low dose aspirin did not prevent cancer in healthy women

Cook NR

Evid Based Med. 2006;11:10

Diagnosis

Review: IgA endomyseal and transglutaminase antibodies had high specificity for...

Gibson

Evid Based Med.2006; 11: 25

EBM Notebook

An emerging consensus on grading recommendations?

Guyatt et al.

Evid Based Med.2006; 11: 2-4

Latest Questions to the Primary Care Question Answering Service

Assessment and Diagnosis

Can you recommend an assessment tool or depression scale for the assessment of severity of depression?

What were the main findings of the million women's health study?

Please could you let me know if it is better to clean a wound before taking a swab for culture and sensitivity - and the rational behind it - thank you

I’ve heard about a new medical encyclopaedia that doctors can edit – any ideas?

Cancer

In the treatment of ganglions, what is the evidence for different treatment methods? In particular, how does aspiration compare with surgical excision?

Cardiovascular disease

Is there any available patient information for children/young adults with precordial catch?

What extra degree of protection from further cardiovascular events is gained by reducing total cholesterol target from 5 mmol/L to 4 mmol/L for a population receiving sec prevention management after a CV event

In patient with PH of IHD and recent episode fast AF, what is evidence base for adding Clopidogrel to Aspirin antiplatelet therapy?

Causes Risks and Prevention

In a patient taking stontium for osteoporosis is their a link with memory loss and fits?

What is the safest antidepressant to use in pregnancy at 22 weeks?

Infectious disease

If you have a IUD user with suspected chlamydia, who you plan to treat, would you remove the IUD?

Obesity

Is there any evidence that metformin causes weight loss in non diabetic patients

Palliative care

What standards or good practice guidelines are there for terminal care/end of life care in cottage hospitals? I am particularly interested around privacy and dignity issues.

Renal & urogenital

What is the best treatment for persistant hyponatraemia in an elderly woman?

Hitting the Headlines - Evidence Behind the Press Stories

'Spinal manipulation doesn't work'

There is no evidence that spinal manipulation works, reported three newspapers on 22 March 2006. The newspaper articles are based on a systematic review of systematic reviews. Insufficient outcome data, uncertain methodology of the included reviews, and uncertain quality of the original studies limits interpretation.

Three newspapers (1-3) reported that there was no evidence that spinal manipulation works, although one newspaper (1) noted that spinal manipulation was as effective as conventional treatments for the relief of back pain. In addition, two of the newspapers (1,2) reported that spinal manipulation was associated with minor adverse events, and more rarely with serious complications.
The newspaper articles are based on a systematic review (4) of sixteen systematic reviews concerned with spinal manipulation for any medical condition. The review concluded that there is no evidence that spinal manipulation is effective for any condition, except back pain, where it is no better than conventional treatment.
The main message from the research that there is little evidence to support the practice of spinal manipulation was correctly reflected in all the newspapers. No data on adverse events were presented in the review, although an association was referred to in the press release (5) and in the authors' conclusions. The uncertain methodology of the original reviews and uncertain quality of the original studies makes it difficult to judge the validity of the authors' conclusions.

Evaluation of the evidence base for spinal manipulation for any medical condition

Where does the evidence come from?

The research was led by Professor Edzard Ernst, based at the Penisular Medical School, Exeter, UK.

What were the authors' objectives?

To determine the effectiveness of spinal manipulation for any medical problem.

What was the nature of the evidence?

The study was a systematic review of sixteen systematic reviews published between 2000 and May 2005. A total of 239 studies, assessing spinal manipulation in a variety of medical conditions (back pain, neck pain, non-spinal pain, primary and secondary dysmenorroea, infantile colic, asthma, allergy, cervicogenic dizziness, and any medical problem) were included. Four electronic databases were used to identify relevant systematic reviews, unrestricted by language. Reviews were required to have explicit and repeatable search strategies, inclusion and exclusion criteria, as well as include evidence from at least two controlled trials to be eligible for inclusion.

What interventions were examined in the research?

The reviews included any type of spinal manipulation, spinal manipulation and mobilization, chiropractic spinal manipulation, physiotherapy and/or spinal manipulation, or manual therapy.

What were the findings?

The authors presented excerpts from the conclusions made in each of the included studies. The majority of the reviews concluded that there was no evidence that spinal manipulation is effective, or that spinal manipulation is more effective than other treatments. However, one review showed that spinal manipulation is better than sham therapy for low back pain, and another concluded that when combined with exercise, spinal manipulation can be effective in reducing back pain, but is not as effective as a single treatment. Another review concluded that spinal manipulation is better than massage, and produces an effect similar to that of prophylactic drugs for headache, and another concluded that spinal manipulation and/or mobilisation are possible treatment options for low back and neck pain. None of the reviews found conclusive evidence that spinal manipulation is ineffective.

What were the authors' conclusions?

The authors concluded that there is no evidence that spinal manipulation is effective for any of the conditions examined, except for back pain where it was superior to sham manipulation but no better than conventional treatment. The authors state that, given the possibility of adverse effects, the review does not support the use of spinal manipulation.

How reliable are the conclusions?

While this systematic review appears to have been well conducted, insufficient details of the methodological robustness of the reviews included in the systematic review were provided. In addition, few details relating to the quality or the results of the primary studies included in the original reviews were reported. As a consequence, the reliability of the authors' conclusions cannot be fully assessed.

Systematic reviews

Information staff at CRD searched for systematic reviews relevant to this topic. Systematic reviews are valuable sources of evidence as they locate, appraise and synthesize all available evidence on a particular topic.

There was one related systematic review identified on the Cochrane Database of Systematic Reviews (CDSR) (5). There were three related reviews identified on the Database of Abstracts of Reviews of Effects (DARE) (6-8).

References and resources

1. Chiropractors are offering 'worthless' form of treatment. The Times, 22 March 2006, p11.

2. Back treatments 'that cause more harm than good'. Daily Mail, 22 March 2006, p19.

3. Quack-ache. The Sun, 22 March 2006, p13.

4. Ernst E, Canter PH. A systematic review of systematic reviews of spinal manipulation. Journal of the Royal Society of Medicine 2006;100:189-193.

5. French SD, Grant WD, Green S, Walker B. Chiropractic interventions for low-back pain. (Protocol). The Cochrane Database of Systematic Reviews 2005, Issue 3. Art. No.: CD005427. DOI: 10.1002/14651858.CD005427.

6. Ernst E. Massage therapy for low back pain: a systematic review. Journal of Pain and Symptom Management 1999;17(1):65-69. [DARE Abstract]

7. Koes B W, Assendelft W J, van der Heijden G J, Bouter L M. Spinal manipulation for low back pain: an updated systematic review of randomized clinical trials. Spine 1996;21(24):2860-2871. [DARE Abstract]

8. Evans G, Richards S. Low back pain: an evaluation of therapeutic interventions. Bristol: University of Bristol, Department of Social Medicine, Health Care Evaluation Unit 1996:176. [DARE Abstract]

Consumer information

British Chiropractic Association

General Chiropractic Council

NHS Direct - Complementary therapies

Previous Hitting the Headlines summaries on this topic

Can chiropractic maim and kill? Hitting the Headlines archive, 12th July 2001.

Document of the Week from the National Library for Health

"Better reporting of harms in randomized trials: an extension of the CONSORT statement."

Annals of Internal Medicine present the CONSORT checklist with 10 new recommendations about how to report issues relating to harm.

The authors of this paper also include examples or proper reporting.

Post 23: 17 March 2006

2006-03-16T08:47:00.000Z

Links are given to online full text resources, all other materials can be obtained via the Fade Library, just mail your request to library.services@fade.nhs.uk

Navigation
Latest Systematic Reviews
Latest Reports
Evidence from Journals
Latest Questions to the Primary Care Question Answering Service
Hitting the Headlines - Evidence Behind the Press Stories
Document of the Week from the National Library for Health
What's New from the National Library for Health

Latest Systematic Reviews

Shipman SA, et al. Screening for developmental dysplasia of the hip: a systematic literature review for the US Preventive Services Task Force. Pediatrics. 2006 Mar;117(3):e557-76.

BACKGROUND: Developmental dysplasia of the hip (DDH) represents a spectrum of anatomic abnormalities that can result in permanent disability.

OBJECTIVE: We sought to gather and synthesize the published evidence regarding screening for DDH by primary care providers.

METHODS: We performed a systematic review of the literature by using a best-evidence approach as used by the US Preventive Services Task Force. The review focused on screening relevant to primary care in infants from birth to 6 months of age and on interventions used in infants before 1 year of age.

RESULTS: The literature on screening and interventions for DDH suffers from significant methodologic shortcomings. No published trials directly link screening to improved functional outcomes. Clinical examination and ultrasound identify somewhat different groups of newborns who are at risk for DDH. A significant proportion of hip abnormalities identified through clinical examination or ultrasound in the newborn period will spontaneously resolve. Very few studies examine the functional outcomes of patients who have undergone therapy for DDH. Because of the high rate and unpredictable nature of spontaneous resolution of DDH and the absence of rigorous comparative studies, the effectiveness of interventions is not known. All surgical and nonsurgical interventions have been associated with avascular necrosis of the femoral head, the most common and most severe harm associated with all treatments of DDH.

CONCLUSIONS: Screening with clinical examination or ultrasound can identify newborns at increased risk for DDH, but because of the high rate of spontaneous resolution of neonatal hip instability and dysplasia and the lack of evidence of the effectiveness of intervention on functional outcomes, the net benefits of screening are not clear.

Latest Reports

Creating the future: Modernising careers for salaried dentists in primary care: Stakeholder consultation response report
Department of Health; NHS Partners
London : Department of Health, 2006
49p.

This is the outcome of the consultation on modernising careers for salaried dentists in England. The report provides an analysis of consultation responses, key findings and an analysis of quantitative data. The Department of Health's response to the consultation is also available.

Developing the annual health check in 2006-07 : Have your say
Healthcare Commission
London : Healthcare Commission, 2006
80p.

The Healthcare Commission undertakes independent and patient-centred assessments of the performance of healthcare organisations, within a framework of national standards and targets set by Government. On March 31 2005, it launched the annual health check, an entirely new approach to assessing the performance of NHS organisations. The annual health check replaces the previous system of 'star' ratings and will provide a much richer picture of health and healthcare in England. This consultation document sets out its proposals for assessing the performance of healthcare organisations in England in 2006-07 and asks for comments on the different aspects of our approach.

Reducing crime: an overview analysis
Home Office, Strategic Policy Team
London : Home Office, 2006
41p.

This is a high-level summary of the types of offences and offender responsible for the majority of crime levels.

Partial regulatory impact assessment: Our health, our care, our say white paper
Department of Health
London : DoH, 2006
64p.

This partial regulatory impact assessment provides the Government's considered early
assessment of the likely impact of the policy initiatives set out in the 'Our Health, Our Care, Our
Say: A new direction for community services' white paper, published on 30 January 2005.

Final declaration: Important information for trusts
Healthcare Commission
London : Healthcare Commission, 2006
31p.

This document provides important information to help NHS trusts to prepare for the submission of final declarations by 4 May 2006. In particular, it provides new guidance on the Healthcare
Commission's assessment and scoring, and clarifies key aspects of previous guidance.

Mixing private and public service providers and specialization
Gersbach H
Co-Halonen-Akatwijuka M
University of Bristol, Centre for Market and Public Organisation
Bristol : CMPO, 2006
41p.
(Working Paper No. 05/131)

We analyze the reform of public sector welfare services such as education. In this paper we compare a mix of private and a public service provider with full privatization. In both cases the suppliers specialize in serving particular customer types. In the mixed institution the government sets the public fee such that service quality does not deteriorate and the price of the private supplier is anchored at comparatively low level. Under full privatization, however, prices escalate to the highest possible level. As a consequence, consumer welfare is higher with a mixed institution – unless the proportion of low-cost customers is high. The mixed institution can also accommodate wealth constraints of customers to some extent.

Caring for people after they have had a stroke: A follow-up survey of patients
Healthcare Commission; Picker Institute Europe
London : Healthcare Commission, 2006
56p.
(Survey of patients 2006)

The HC has published a survey of stroke patients, 'Caring for people after they have had a
stroke', which shows the satisfaction that patients feel about the care they receive following a
stroke declines after leaving hospital. This survey is the latest in a series of HC assessments of
stroke care, which included a survey of patients in hospital and a clinical audit covering all English hospitals. Together, these studies show that while more people are gaining access to specialist stroke care, more still needs to be done to improve rehabilitation outside hospital and access to specialist units. Over 850 stroke patients took part in the survey, which has enabled the HC to follow the experience of stroke patients from hospital through to their return home.

Making a difference: safe and secure data sharing between health and adult social care
staff
Department of Health; Cabinet Office, Better Regulation Executive
London : DoH, 2006
24p.

Produced detailing a joint project by the Cabinet Office’s Better Regulation Executive and the
Department of Health (DH), recommending practical changes that reduce or remove unnecessary burdens on frontline staff caused by the way information is shared across the healthcare sector. It intends to streamline current processes while not relaxing existing controls over the security and confidentiality of patient information. A number of outcomes to be implemented over the next year are specified:

The Law Society, the Association of British Insurers and the Association of Personal Injury
Lawyers will work with their members to reduce the number of requests for patient records in
support of personal injury claims below £10,000, aiming to reduce annual requests by up to
300,000.

By December, a single information sharing protocol will be developed that reduces the amount of legislation and guidance, enabling health and social care staff to exchange information more
appropriately and effectively.

By September, the DH will issue guidance promoting consistent interpretation of legislation on

Mental Capacity Act code of practice
Department for Constitutional Affairs
London : DCA, 2006
32p.

The Mental Capacity Act 2005 (the Act) provides a statutory framework for acting and making
decisions on behalf of individuals who lack the mental capacity to do so for themselves. The Act
specifies the principles that must be applied by everyone who is working with or caring for adults who lack capacity. It also provides options for those who may choose to plan and make provision for a future time when they may lack capacity. Whilst the Act sets out the legal framework, the Code of Practice (the Code) provides guidance and information for those acting under its terms and applying its provisions on a daily basis. As there are many situations that can arise when caring or working with those who may lack capacity, the Code incorporates good practice along with the flexibility to apply the principles to the particular circumstances of the situation.

Mental Capacity Act draft code of practice
Department for Constitutional Affairs
London : DCA, 2006
184p.

The Mental Capacity Act 2005 (the Act) provides a statutory framework for acting and making
decisions on behalf of individuals who lack the mental capacity to do so for themselves. The Act
specifies the principles that must be applied by everyone who is working with or caring for adults who lack capacity. It also provides options for those who may choose to plan and make provision for a future time when they may lack capacity. Whilst the Act sets out the legal framework, the Code of Practice (the Code) provides guidance and information for those acting under its terms and applying its provisions on a daily basis. As there are many situations that can arise when caring or working with those who may lack capacity, the Code incorporates good practice along with the flexibility to apply the principles to the particular circumstances of the situation.

Modelling poverty by not modelling poverty: An application of a simultaneous hazards
approach to the UK
Aassve A
Co-Burgess S; Dickson M; Propper C
London School of Economics, Centre for Analysis of Social Exclusion
London : CASE, 2006
70p.
(CASEpaper 106)

Pursues an economic approach to analysing poverty. This requires a focus on the variables that
individuals can influence, such as forming or dissolving a union or having children. The paper
argues that this indirect approach to modelling poverty is the right way to bring economic tools to bear on the issue. In the implementation of this approach, the report has a focus on endogenous demographic and employment transitions as the driving forces behind changes in poverty. It constructs a dataset covering event histories over a long window and estimate five simultaneous hazards with unrestricted correlated heterogeneity. The model fits the demographic and poverty data reasonably well. It investigates the important parameters and processes for differences in individuals’ poverty likelihood. Employment, and particularly employment of disadvantaged women with children, is important.

Dynamics of school attainment of England's ethnic minorities
Wilson D
Co-Burgess S; Briggs A
London School of Economics, Centre for Analysis of Social Exclusion
London : CASE, 2006
64p.
(CASEpaper 105)

Exploits a universe dataset of state school students in England with linked test score records to
document the evolution of attainment through school for different ethnic groups. The analysis
yields a number of striking findings. First, shows that, controlling for personal characteristics, all
minority groups make greater progress than white students over secondary schooling. Second,
much of this improvement occurs in the high-stakes exams at the end of compulsory schooling.
Third, shows that for most ethnic groups, this gain is pervasive, happening in almost all schools in which these students are found. Addresses some of the usual factors invoked to explain
attainment gaps: poverty, language, school quality, and teacher influence. Concludes that our
findings are more consistent with the importance of factors like aspirations and attitudes.

Choice: Will more choice improve outcomes in education and health care? The evidence from economic research
Burgess S
Co-Propper C; Wilson D
University of Bristol, Centre for Market and Public Organisation
Bristol : CMPO, 2005
40p.

Extending choice in public services is currently a popular policy. For education it is proposed by both Labour and the Conservatives. For health care it is proposed in some form by all parties. In this report,we provide a summary of the evidence from economic research on whether more choice will improve outcomes in these two key public services.

Building and managing facilities for public services
Bennett J
Co-Iossa I
University of Bristol, Centre for Market and Public Organisation
Bristol : CMPO, 2005
32p.
(CMPO Working Paper Series No. 05/137)

We model alternative institutional arrangements for building and managing facilities for provision of public services, including the use of the Private Finance Initiative (PFI), by exploring the effects on innovative investment activity by providers. The desirability of bundling the building and management operations is analyzed, and it is considered whether it is optimal to allocate ownership to the public or the private sector. We also examine how the case for PFI is affected by the (voluntary or automatic) transfer of ownership from the private to the public sector when the contract expires. Asset specificity and service-demand risk play critical roles.

Extending choice in English health care: The implications of the economic evidence
Propper C
Co-Wilson D; Burgess S
University of Bristol, Centre for Market and Public Organisation
Bristol : CMPO, 2005
22p.
(CMPO Working Paper Series No. 05/133)

Extending choice in health care is currently popular amongst English, and other, politicians. Those promoting choice make an appeal to a simple economic argument. Competitive pressure helps make private firms more efficient and consumer choice acts as a major driver for efficiency. Giving service users the ability to choose applies competitive pressure to health care providers and, analogously with private markets, they will raise their game to attract business. The paper subjects this assumption to the scrutiny provided by a review of the theoretical and empirical economic evidence on choice in health care. The review considers several interlocking aspects of the current English choice policy: competition between hospitals, the responsiveness of patients to greater choice, the provision of information and the use of fixed prices. The paper concludes that there is neither strong theoretical nor empirical support for competition, but that there are cases where competition has improved outcomes. The paper ends with a discussion of the implications of this literature for policies to promote competition in the English NHS.

Health supplier quality and the distribution of child health
Propper C
Co-Rigg J; Burgess S
ALSPAC Study Team; University of Bristol, Centre For Market and Public Organisation
Bristol : CMPO, 2005
46p.
(CASE Working Paper No.102, CMPO Working Paper No. 05/123)

There is emerging evidence to suggest that initial differentials between the health of poor and more affluent children in the UK do not widen over early childhood. One reason may be that through the universal public funded health care system all children have access to equally effective primary care providers. This paper examines this explanation. The analysis has two components. It first examines whether children from poorer families have access to general practitioners of a similar quality to children from richer families. It then examines whether the quality of primary care to which a child has access has an impact on their health at birth and on their health during early childhood. The results suggest that children from poor families do not have access to markedly worse quality primary care, and further, that the quality of primary care does not appear to have a large effect on differentials in child health in early childhood.

Hidden Harm: Responding to the needs of children of problem drug users: Executive
summary of the report of an Inquiry by the Advisory Council on the Misuse of Drugs
Home Office, Advisory Council on the Misuse of Drugs
London : Home Office, 2005
16p.

This inquiry by the Advisory Council on the Misuse of Drugs focused on parents or guardians
whose drug use had serious negative consequences for their children. The summary estimates
the scale of the problem and makes rcommendations.

Hidden Harm: Responding to the needs of children of problem drug users
Home Office, Advisory Council on the Misuse of Drugs
London : Home Office, 2005
92p.

This inquiry by the Advisory Council on the Misuse of Drugs focused on parents or guardians
whose drug use had serious negative consequences for their children.

http://www.fade.nhs.uk/pit/questionnaire-text.pdf

Government's response to Hidden harm report on parental drug misuse
Department for Education and Skills
London : DfES, 2005
40p.

This inquiry by the Advisory Council on the Misuse of Drugs focused on parents or guardians
whose drug use had serious negative consequences for their children.

Labour market disadvantage amongst disabled people: A longitudinal perspective
Rigg JA
London School of Economics, Centre for Analysis of Social Exclusion
London : CASE, 2005
38p.
(CASEPaper 103)

Considerable cross-sectional evidence has highlighted the lower employment rates and earnings
amongst disabled people in Britain. But very little is known about the progression of disabled
people in employment. This study uses data from the Labour Force Survey (LFS) to examine the labour market progression of disabled people in Britain along several dimensions: earnings
growth, lowpay transition probabilities, changes in labour market participation, the rate of training and the rate of upward occupational mobility. The analysis also explores the extent of
heterogeneity in the labour market progression of disabled people with respect to differences in
age, education, occupation and disability severity.

The evidence indicates that the earnings trajectories of disabled people lag behind those for non-
disabled people, especially for men. The median annual change in earnings is 1.4 percent lower
for disabled men and 0.6 percent lower for disabled women compared to non-disabled men and
women respectively. Moreover, disabled people are approximately three times more likely to exit work than their non-disabled counterparts, a difference that increases markedly for more-severely disabled people. The evidence highlights the need for policy to tackle the barriers that disabled people face in the workplace, not merely in access to jobs.

Parallel lives? Ethnic segregation in schools and neighbourhoods
Burgess S
Co-Wilson D; Lupton R
London School of Economics, Centre for Analysis of Social Exclusion
London : CASE, 2005
48p.

Provides evidence on the extent of ethnic segregation experienced by children across secondary
schools and neighbourhoods (wards). Using 2001 Schools Census and Population Census data
we employ the indices of dissimilarity and isolation and compare patterns of segregation across
nine ethnic groups, and across Local Education Authorities in England. Looking at both schools
and neighbourhoods, the report finds high levels of segregation for the different groups, along
with considerable variation across England. Finds consistently higher segregation for South Asian
pupils than for Black pupils. For most ethnic groups children are more segregated at school than
in their neighbourhood. Analyses the relative degree of segregation and show that high
population density is associated with high relative school segregation.

Non-residential fatherhood and child involvement: Evidence from the millennium cohort
study
Kiernan KA
London School of Economics, Centre for Analysis of Social Exclusion
London : CASE, 2005
22p.
(CASEPaper 100)

Fifteen per cent of British babies are now born to parents who are neither cohabiting nor married. Little is known about non-residential fatherhood that commences with the birth of a child. Here, we use the Millennium Cohort Study to examine a number of aspects of this form of fatherhood. Firstly, considers the extent to which these fathers were involved with or acknowledged their child at the time of the birth. Secondly, identifies the characteristics that differentiate parents who continue to live apart from those who move in together. Thirdly, for the fathers who moved in with the mother and their child the reprt enquires whether they differ in the extent of their engagement in family life compared with fathers who have been living with the mother since birth. Finally, for fathers who were living apart from their child when the child was 9 months old the report assesses the extent to which they were in contact, contributed to their maintenance and were involved in their child’s life at this time.

Parental investment in childhood and later adult well-being: Can more involved parents
offset the effects of socioeconomic disadvantage?
Hango D
London School of Economics, Centre for Analysis of Social Exclusion
London : CASE, 2005
34p.
(CASEReport 98)

Parental involvement in their children’s lives can have a lasting impact on wellbeing. More
involved parents convey to their children that they are interested in their development, and this in turn signals to the child that their future is valued. However, what happens in socio-economically disadvantaged homes? Can the social capital produced by greater parental involvement counteract some of the harmful effects of less financial capital? These questions are examined on the National Child Development Study; a longitudinal study of children born in Britain in 1958. Results on a sample of children raised in two parent families suggest that parental involvement does matter, but that it depends on when it and poverty are measured, as well as the type of involvement and the gender of the parent. Father interest in education has the strongest impact on earlier poverty, especially at age 11. Meanwhile, both father and mother interest in school at age 16 have the largest direct impact on education. The frequency of outings with mother at age 11 also has a larger direct impact on education than outings with father, however, neither compare with the reduction in the poverty effect as a result of father interest in school.

Evidence from Journals

Choi-Kwon S, et al. Fluoxetine treatment in poststroke depression, emotional incontinence, and anger proneness: a double-blind, placebo-controlled study. Stroke. 2006 Jan;37(1):156-61. Epub 2005 Nov 23.

BACKGROUND AND PURPOSE: The efficacy and safety of the selective serotonin reuptake inhibitor fluoxetine have rarely been studied in the treatment of poststroke emotional disturbances.

METHODS: Stroke patients (152) who had poststroke depression (PSD), emotional incontinence (PSEI), or anger proneness (PSAP) were studied. PSD was evaluated by Beck Depression Inventory and Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, PSEI by Kim's criteria, and PSAP was assessed by Spielberger Trait Anger Scale. Subjects were randomly given either fluoxetine 20 mg/day (n=76) or placebo (n=76) for 3 months. Follow-up evaluations were done 1, 3, and 6 months after the beginning of the treatment. The primary outcome measurement was the scores of emotional disturbances at each follow-up assessment. The secondary outcome measurements were the percentage changes of the scores and the subjective responses of the patients.

RESULTS: Although patients in the fluoxetine group more often dropped out because of adverse effects, fluoxetine administration was generally safe. Fluoxetine significantly improved PSEI and PSAP, whereas no definitive improvement of PSD was found. Improvement of PSAP was noted even at 3 months after the discontinuation of the treatment.

CONCLUSIONS: Fluoxetine is efficacious in the treatment of PSEI and PSAP. Its effect on PSD is not solidly confirmed.

Shahinian VB, et al. Risk of the "androgen deprivation syndrome" in men receiving androgen deprivation for prostate cancer. Arch Intern Med. 2006 Feb 27;166(4):465-71.

BACKGROUND: Androgen deprivation therapy for prostate cancer has been associated with a spectrum of adverse effects, such as depression, memory difficulties, and fatigue, termed the androgen deprivation syndrome. Primary care physicians providing follow-up care for men with prostate cancer will be faced with managing these effects. We therefore sought to estimate the incidence of these effects and, by using a control group, ascertain whether these effects were related to androgen deprivation itself.

METHODS: We assessed the risk of physician diagnoses of depression, cognitive impairment, or constitutional symptoms in Medicare data following androgen deprivation using a sample of 50 613 men with incident prostate cancer and 50 476 men without cancer, from 1992 through 1997, in the linked Surveillance, Epidemiology, and End Results-Medicare database. Cox proportional hazards regression was used to adjust for confounding variables.

RESULTS: Of men surviving at least 5 years after diagnosis, 31.3% of those receiving androgen deprivation developed at least 1 depressive, cognitive, or constitutional diagnosis compared with 23.7% in those who did not (P<.001). After adjustment for variables such as comorbidity, tumor characteristics, and age, the risks associated with androgen deprivation were substantially reduced or abolished: relative risk (RR) for depression diagnosis, 1.08 (95% confidence interval [CI], 1.02-1.15); RR for cognitive impairment, 0.99 (95% CI, 0.94-1.04); and RR for constitutional symptoms, 1.17 (95% CI, 1.13-1.22). CONCLUSION: Depressive, cognitive, and constitutional disorders occur more commonly in patients receiving androgen deprivation, but this appears to be primarily because patients receiving androgen deprivation are older and have more comorbid conditions and more advanced cancers.

Latest Questions to the Primary Care Question Answering Service

Assessment and Diagnosis

Do you start aspirin and dipyramidole straight after a TIA or should one wait for a CT scan?

In someone suspected of having a pulmonary embolism should they be given heparin straightaway or wait for a definate diagnosis?

A man of 59 - with moderate symptoms of benign prostatic hypertrophy and a normal PSA in 2004 - has asked me about the effectiveness [ sensitivity and specificity] of a 'new' genetic screening test for carcinoma of the prostate - UPM3. Can you help please?

Cancer

Will co-proxamol still be available for use in palliative care patients, where it can be very useful?

Cardiovascular disease

Are CoQ10 vitamins advised for patients taking statins, as advised in the Daily Mail article yesterday?

Can warfarin increase glucometer readings in diabetic people?

How long before & after a dental extraction should a patient stop clopidogrel or aspirin. What is the evidence base?

Causes Risks and Prevention

In the prison setting we see many patients who have been using Zolpidem and Zopiclone hypnotics illicitly for many months. Is there any need to withdraw these patients from these drugs slowly?

What are the risks of using ibuprofen in pregnancy?

What evidence is there surrounding the efficacity of early pregnancy (ie before 20 weeks gestation) education?

At what corrected age should a pre term infant receive BCG SSI vaccine ?

After an uncomplicated Caesarian Section, how long should a woman wait before trying to conceive again?

Is there a link between having a positive lupus anticoagulant and developing S.L.E. ? A patient of mine had a positive lupus anticoagulant detected on a thrombophilia screen and also suffers generalised arthralgia. What are the chances he will develop S.L.E.?

Child health

Is the appropriate treatment for Molluscum Contagiosum in a 3 year old to do nothing? What are the alternative treatments and are they more likely to produce scarring?

What is the best evidence based practice to treat chilhood obesity for under 5's?

Complementary medicine

Is there any clinical evidence to suggest Matol is effective and safe in the treatment of psoriasis?

Mental health

Is there any evidence that self help techniques, or the use of a support group or organisation can help in the management of cyclothymia? if so could you inform me what resources are available. Many thanks

Musculoskeletal disease

In patients with hip arthritis is intra articular hyalurinidase (hyaluronic acid) effective for pain control or prevention of arthroplasty?

Neurological disease

What evidence based sleep clinic tool / training are there?

Obesity

What is the evidence for dietary aids to aid weight loss? I'm interested in products patients can buy as opposed to prescribable drugs or interventions such as dieting or surgery.

Hitting the Headlines - Evidence Behind the Press Stories

'The drug that could reverse heart disease'

A statin (rosuvastatin) could reverse the build up of fatty deposits in the arteries that can trigger coronary heart disease, reported seven newspapers (14 March 2006). The newspapers accurately reported on an uncontrolled trial which showed promising results. Further research is needed to assess whether the treatment actually saves lives and reduces heart attacks.

Rosuvastatin (Crestor), a cholesterol lowering drug, could reverse the build up of fatty deposits inside the arteries (atherosclerosis) that lead to heart attacks, strokes and coronary heart disease reported seven newspapers, 14 March 2006 (1-7).
The newspaper articles were based on the findings of the ASTEROID study, which assessed the build up of atherosclerosis in 349 patients with moderate heart disease before and after 24 months of treatment with a higher than normal dose of the drug rosuvastatin (8). Treatment with the statin significantly reduced the total build up of fatty deposits, decreased low density lipoprotein cholesterol levels (LDL-C) and increased high density lipoprotein cholesterol levels (HDL-C) over the 24 month treatment period.
The newspapers all reported the findings of the study broadly accurately, and six (1-6) highlighted the fact that further research is needed to assess whether the observed reduction in atheroscelerosis translates into a clinically meaningful reduction in mortality and morbidity from coronary heart disease.

Evaluation of the evidence base for 'the drug that could reverse heart disease'

Where does the evidence come from?

The study was led by Dr S Nissen from the Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, USA on behalf of the ASTEROID Investigators (A Study to Evaluate the Effect of Rosuvastatin on Intravascular Ultrasound-Derived Coronary Atheroma Burden). The study was sponsored by AstraZeneca (the manufacturers of rosuvastatin), who were involved in the design, conduct and analysis of the study in conjunction with the study investigators.

What were the authors' objectives?

The primary objective was to assess whether high dose statin therapy could regress coronary atheroscelerosis as determined by intravascular ultrasound imaging (IVUS). Secondary objectives were to assess the effects on both low and high density lipoprotein cholesterol levels (LDL-C and HDL-C).

What was the nature of the evidence?

The evidence comes from a prospective, open-label pre-post study, the ASTEROID trial, which enrolled 507 people at different centres across the USA, Canada, Australia and Europe. The trial enrolled people who required coronary angiography or abnormal functional studies for a clinical indication, who had no more than three months statin therapy in the previous 12 months, and had at least 20% angiographic luminal diameter narrowing in any coronary vessel. People who had more than 50% luminal narrowing, uncontrolled triglyceride levels or poorly controlled diabetes were not enrolled into the study.

What interventions were examined in the research?

Intravascular ultrasound (IVUS) was used to assess the extent of atherosclerosis in participants at baseline, after which they received 40 mg rosuvastatin daily (most statins are more commonly prescribed in doses of 10mg or 20mg/day) for a treatment period of 24-months. Participants continued to take their usual prescribed medication such as aspirin, angiotensin-converting enzyme inhibitors, organic nitrates or beta-blockers in addition to the statin therapy. At 24 months treatment, all active study participants underwent repeat IVUS examination. Videotapes containing baseline and follow-up information were analysed in a randomised and blinded manner.

What were the findings?

In total, 349 participants completed the study and provided data that were included in the analysis. After two years of treatment, mean LDL-C levels decreased significantly by 53% from 130 mg/dL to 61 mg/dL, and mean HDL-C levels increased significantly by 15% from 43 mg/dL to 49 mg/dL. The overall change in build up of fatty deposits showed a significant median reduction of 6.8%. Adverse events associated with treatment were relatively infrequent and similar to those observed in other statin trials.

What were the authors' conclusions?

The authors' concluded that high dose statin therapy using rosuvastatin in patients with pre existing coronary heart disease, can regress (partially reverse) the build up of fatty deposits in the coronary arteries. Further studies are needed to determine the effect of the observed changes on clinical outcomes.

How reliable are the conclusions?

This study was reasonably well designed and well orchestrated. Overall, whilst the results from this preliminary study look promising, the authors' are right to highlight the need for further randomised controlled trials to determine the effect of the observed changes on clinical outcomes.

The investigators specified a priori the outcome measures of interest and the sample size. The outcome assessments were conducted in a randomised and blinded fashion. In addition, clear inclusion criteria were specified for participant eligibility and concomitant interventions. The handling of withdrawals and drop-outs from the study was explicitly documented and there were no significant baseline differences between participants who completed the study and those who dropped-out. However, this was a pre-post study that may potentially be subject to a number of biases. The use of surrogate outcome measures means that it cannot be ascertained whether the potential reduction in atherosclerosis translates into a clinically meaningful drop in mortality and morbidity from coronary heart disease.

Systematic reviews

There were two related systematic reviews which are currently being completed identified on the Cochrane Database of Systematic Reviews (CDSR) (9-10) and six reviews identified on the Database of Abstracts of Reviews of Effects (DARE) (11-16).

References and resources

1. The drug that could reverse heart disease. Daily Mail, 14 March 2006, p10.

2. Wonder heart drug 'cleans out' arteries. The Sun, 14 March 2006, p4.

3. Heart disease may be reversible. The Independent, 14 March 2006, p5.

4. One pill a day to beat heart disease. The Times, 14 March 2006, p1.

5. Heart drug is found to turn clock back on furred arteries. Daily Telegraph, 14 March 2006, p1.

6. Drug that reverses heart disease. Daily Express, 14 March 2006, p1.

7. Cholesterol treatment boost for AstraZeneca. The Guardian, 14 March 2006, p27.

8. Nissen SE, Nicholls SJ, Sipahi I, Libby P, Raichlen JS, Ballantyne CM et al. Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. JAMA 2006;295:(doi:10.1001/jama.295.13.jpc60002).

9. Girolami B, Calderan A. Statins for acute coronary syndromes. (Protocol). The Cochrane Database of Systematic Reviews 2003, Issue 4. Art. No.: CD004470. DOI: 10.1002/14651858.CD004470.

10. Moore THM, Bartlett C, Burke MA, Davey Smith G, Ebrahim SBJ. Statins for preventing cardiovascular disease. (Protocol). The Cochrane Database of Systematic Reviews 2004, Issue 2. Art. No.: CD004816. DOI: 10.1002/14651858.CD004816.

11. Wilt TJ, Bloomfield HE, MacDonald R, Nelson D, Rutks I, Ho M, Larsen G, McCall A, Pineros S, Sales A. Effectiveness of statin therapy in adults with coronary heart disease. Archives of Internal Medicine 2004;164(13):1427-1436. [DARE Abstract]

12. Kang S, Wu Y, Li X. Effects of statin therapy on the progression of carotid atherosclerosis: a systematic review and meta-analysis. Atherosclerosis 2004;177(2):433-442. [DARE Abstract]

13. Law MR, Wald NJ, Rudnicka AR. Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis. BMJ 2003;326:1423-1427. [DARE Abstract]

14. Vrecer M, Turk S, Drinovec J, Mrhar A. Use of statins in primary and secondary prevention of coronary heart disease and ischemic stroke: meta-analysis of randomized trials. International Journal of Clinical Pharmacology and Therapeutics 2003;41(12):567-557. [DARE Abstract]

15. Amarenco P, Labreuche J, Lavallee P, Touboul PJ. Statins in stroke prevention and carotid atherosclerosis: systematic review and up-to-date meta-analysis. Stroke 2004;35(12):2902-2909. [DARE Provisional Abstract]

16. Briel M, Studer M, Glass TR, Bucher HC. Effects of statins on stroke prevention in patients with and without coronary heart disease: a meta-analysis of randomized controlled trials. American Journal of Medicine 2004;117(8):596-606. [DARE Provisional Abstract]

17. Centre for Reviews and Dissemination. Cholesterol and coronary heart disease: screening and treatment. Effective Health Care Bulletin 1998;4(1):16.

18. Ebrahim S, Davey Smith G, McCabe C, Payne N, Pickin M, Sheldon TA, et al. What role for statins? A review and economic model. Health Technology Assessment 1999;3(19).

Consumer information

British Heart Foundation

NHS Direct: Atherosclerosis

Previous Hitting the Headlines summaries on this topic

New cholesterol treatment can reduce heart attack and strokes. Hitting the Headlines archive, 14th November 2001.

Heart drug could save 10,000 lives every year. Hitting the Headlines archive, 5th July 2002.

Does early statin therapy reduce the death rate of heart attack patients? Hitting the Headlines archive, 31st August 2005.

'Statin drugs could cut heart attacks by third'. Hitting the Headlines archive, 27th September 2005.

Document of the Week from the National Library for Health

Use of opinion leaders may be beneficial, particularly in specialised groups.

Implementation Science published this study into the benefits of recruiting opinion leaders as health care change agents.

The authors found that although the effectiveness of opinion leaders in health care has not been thoroughly tested, opinion leaders could be useful for supporting change in health care delivery, particularly in groups with members of the same specialism.

What's New from the National Library for Health

WWW Conference 2006, 23 -26 May, Edinburgh

The World Wide Web Conference is the global event to bring together the key influencers, decision makers, technologists, businesses and standards bodies shaping the future of the web. Key speakers from the NHS and NICE will be present to discuss the impact of the web on health.

Post 22: 10th March 2006

2006-03-06T10:12:00.000Z

Links are given to online full text resources, all other materials can be obtained via the Fade Library, just mail your request to library.services@fade.nhs.uk

Navigation
Latest Technology Assessments and Appraisals
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Latest Technology Assessments and Appraisals

A systematic review of the effectiveness and cost-effectiveness of neuroimaging assessments used to visualise the seizure focus in people with refractory epilepsy being considered for surgery (Whiting) 250 pages, Volume 10, number 4

This review highlighted the inadequacy of existing data for the effectiveness and cost-effectiveness of imaging techniques in patients with refractory epilepsy being considered for surgery. The need for investigative studies was established and suggestions provided for the conduct of future research.

Compariso
n of conference abstracts and presentations with full-text articles in the health technology assessments of rapidly evolving technologies (Dundar) 162 pages, Volume 10, number 5

Systematic review and evaluation of methods of assessing urinary incontinence (Martin) 132 pages, Volume 10, number 6

Study of methods for diagnosing urinary incontinence finds that a large proportion of women with urodynamic stress incontinence can be correctly diagnosed in primary care from clinical history and urinary diaries. However, more research is needed into this area, particularly on urinary incontinence in men, where there is little information.

Latest Guidelines

Management of patients with dementia: A national clinical guideline
Scottish Intercollegiate Guidelines Network
Edinburgh : SIGN, 2006
57p.
(SIGN Guideline No. 86)

The Scottish Intercollegiate Guidelines Network (SIGN) has updated its guideline on interventions for the management of behavioural and psychological aspects of dementia (SIGN 22), which was published in February 1998.

The guideline examines evidence relating to all aspects of diagnosis and management, including the role of complex psychological assessment, drug treatment, techniques such as reality orientation and interventions for behavioural and psychological problems which develop later in the course of the disease.

Final Appraisal Determination on immunosuppressive therapy for renal transplantation in children and adolescents
National Institute for Health and Clinical Excellence
London : NICE, 2006
45p.

NICE has issued a Final Appraisal Determination on immunosuppressive therapy for renal transplantation in children and adolescents. The guidance considers the use of basiliximab, daclizumab, tacrolimus, mycophenolate (mofetil and sodium) and sirolimus in relation to a standard triple therapy regimen of ciclosporin, azathioprine and a corticosteroid.

The following preliminary recommendations have been made:

Basiliximab or daclizumab, used as part of a ciclosporin-based immunosuppressive regimen, are recommended as options for induction therapy in the prophylaxis of acute organ rejection, irrespective of immunological risk. The induction therapy with the lowest acquisition cost should be used, unless it is contraindicated.

Tacrolimus is recommended as an alternative option to ciclosporin when a calcineurin inhibitor is indicated as part of an initial or a maintenance immunosuppressive regimen. The initial choice of tacrolimus or ciclosporin should be based on the relative importance of their side-effect profiles for the individual patient

Mycophenolate mofetil (MMF) is recommended as an option as part of an immunosuppressive regimen only when:

there is proven intolerance to calcineurin inhibitors, particularly nephrotoxicity which could lead to risk of chronic allograft dysfunction, OR
there is a very high risk of nephrotoxicity necessitating the minimisation or avoidance of a calcineurin inhibitor until the period of high risk has passed.

The use of MMF in corticosteroid reduction or withdrawal strategies is recommended only within the context of RCTs.

Mycophenolate sodium (MPS) is currently not recommended for use as part of an immunosuppressive regimen.

Sirolimus is not recommended unless there is proven intolerance to calcineurin inhibitors (including nephrotoxicity) which necessitates the complete withdrawal of these treatments.

It is noted that as a consequence of following this guidance, some medicines may be prescribed outside the terms of their UK marketing authorisation. The formal consultees for this appraisal have 15 working days to consider whether they wish to appeal against it. The appeal period for this appraisal will end on 24 March 2006.

National service guidelines for developing sexual assault referral centres (SARCs)
Department of Health; National Institute for Mental Health in England (NIMHE); Victims of Violence and Abuse Prevention Programme (VVAPP); Home Office
London : DoH, 2005
38p.

Rape and sexual assault are devastating experiences for any victim. Profound feelings of violation, a sense of continuing danger, shock and numbness can affect the person’s ability to function for a long time after the attack. Failure to address the victim’s immediate and ongoing needs can have a considerable and long-term impact on their emotional well-being and health. It can also cause the victim to disengage from the criminal justice process, reducing the opportunity for offenders to be brought to justice.

Sexual Assault Referral Centres are an important example of how agencies working in partnership have the potential to improve both mental and physical health as well as criminal justice outcomes for victims of rape and sexual assault. Crucially, they provide a holistic service to victims of sexual violence, tailored to their needs and under-pinned by principles of dignity and respect.

Latest Reports

Learning from complaints: Summary of responses to the consultation on changes to the social services complaints procedure for adults
Department of Health
London : DoH, 2006
32p.

This document provides a summary of the responses to the consultation on changes to the social services complaints procedure for adults. The consultation asked for views and comments on the proposed regulations and guidance.

Review of research on the impact of violent computer games on young people
Boyle R
Hibberd M
Department for Culture, Media and Sport
London : DCMS, 2005
45p.

This review examines the academic literature on violent video games and violent behaviour. It ensures that all the key studies examining the relationship between playing violent computer games and real-world violence in young people between 1985 and 2004 are covered, and advises on the quality and reliability of that research.

HIV related stigma and discrimination: Action plan
Department of Health
London : DoH, 2005
25p.

The need for action to tackle the stigma associated with HIV was identified in the National Strategy for Sexual Health and HIV in 2001, and a commitment to publish an HIV stigma action plan was made in the strategy's implementation action plan in 2002. The Department of Health welcomes comments on this action plan especially, from people living with or affected by HIV.

State of the English cities: A research study: Volume 1
State of the English cities: A research study: Volume 2
Parkinson M
Champion T; Simmie J; Turok I; Crookston M; Katz B; Park A; Berube A; Coombes M; Dorling D; Evans R; Glass N; Hutchins M; Kearns A; Martin R; Wood P
Office of the Deputy Prime Minister
London : ODPM, 2006
267p.

In its Urban White Paper of 2000, Towards an Urban Renaissance, the Government made a commitment to commission a report on the progress and performance of English cities in the last five years. This State of the Cities report to government by a consortium of research organisations fulfils that commitment.

This is an independent report to ODPM by a group of city experts led by Professor Michael Parkinson. It provides a comprehensive audit of urban performance in England and a review of the impact of government policies upon cities. The main themes are: social cohestion; demographics; economic competitiveness and performance; liveability, and governance and the impact of policy.

This report is based on a series of reports prepared by the team, which contain a much richer mix of evidence, opinions and analysis than can be contained here. The study draws upon many sources – extensive academic and consultancy literature; case studies in 12 cities; interviews with over 250 policy makers; a review of international experience; analysis of public attitudes to cities and a review of demographic trends. It is underpinned by a new, large set of key indicators of urban performance specifically created for the project – the State of the Cities Database.

The report is intended to be an authoritative statement of the state of English cities, the opportunities and challenges they face in an international context and the policy steps that need to be taken to build upon the progress that has been made in recent years.

Points-based System: Making migration work for Britain
Home Office
London : Home Office, 2006
55p.

This document sets out the Government's proposals for a new points-based approach to managing the flow of migrants coming to the UK to work or study.

Employers' use of migrant labour: Summary report
Dench S
Hurstfield J; Hill D; Akroyd K
Home Office
London : Home Office, 2006
21p.
(Home Office Online Report 03/06)

The Institute for Employment Studies was commissioned by the Home Office to conduct research into the recruitment and employment of migrant workers in the UK. This research formed part of the preparation for change from the current economic migration system to the new points-based system. The focus of the study was on economic migrants - people who come to this country primarily to work, rather than asylum seekers or refugees. Data was collected between April and August 2005.

Chief Nursing Officer's review of mental health nursing: Summary of responses to the consultation
Department of Health
London : DoH, 2006
23p.

Summary of responses to the consultation on the Chief Nursing Officer's review of mental health nursing, published by the Department of Health in July 2005, provides an overview of consultation responses on the questions raised. The aim of the consultation was to gain a clearer understanding of views on how mental health nursing should best contribute to the care of service users in the future and to inform final recommendations to be made by the review.
Chief Nursing Officer's review of mental health nursing: consultation document

Supporting women into the mainstream: Commissioning women-only community day services
Newbigging K
Abel K
London : DoH, 2006
38p.

Best practice guidance intended to support commissioners in delivering Section 6.1 of the implementation guidance Mainstream gender and women's mental health on women-only community day services. It relates to the recommendations set out in the Mental health and social exclusion report specific to day services. The purpose of this guide is:

As a practical guide for commissioners: PCTs, local implementation teams and local authorities.

To support local commissioners to review and develop women-only community day services which promote inclusion and access to mainstream opportunities for women with mental health problems.

To provide further information and support to the previously published "Mainstreaming gender and women’s mental health: implementation guidance"

For local women and other stakeholders who want to get involved in the development of local provision for women.

Direct payments for people with mental health problems: A guide to action
National Institute for Mental Health in England
London : DoH, 2006
28p.

This guide sets out good practice in relation to making direct payments more accessible to people with mental health problems. It is intended to support the efforts that all local authorities, primary care trusts, mental health trusts and non-statutory providers of mental health services and support will wish to make to ensure that direct payments become a standard option within mental health services.

From segregation to inclusion: Commissioning guidance on day services for people with mental health problems
National Institute for Mental Health in England; Department of Health, National Inclusion Programme; Care Services Improvement Partnership
London : DoH, 2006
28p.

Abstract: This guidance is designed to assist commissioners of mental health services in the refocusing of day services for working-age adults with mental health problems. It relates to community-based services but does not address acute day hospitals, crisis services or vocational services.

Informing healthier choices: Information and intelligence for healthy populations
Department of Health
London : DoH, 2006
45p.

This consultation invites comments from all interested parties and stakeholders on the public health information and intelligence strategy, devised as part of the delivery plan for the white paper Choosing health: making healthier choices easier. The strategy supports wider health priorities such as action on health inequalities, health protection and effective commissioning of health and wellbeing. It aims to improve the availability and quality of health information and intelligence across England and to increase its use to support population health improvement, health protection and work on care standards and quality. The deadline for responses to this consultation is 5 May 2006.

National Institute for Health and Clinical Excellence (NICE) selection of topics: consultation paper
Department of Health
London : DoH, 2006
19p.

The Department of Health has launched a consultation on proposals for a new streamlined system of selecting topics for review by NICE. The proposed new system is aimed at reducing the time taken to refer topics to NICE by 3-4 months and encouraging wider representation from the NHS and patient groups in the topic selection process. It covers clinical guidelines, technical appraisals and public health programmes. The three-month consultation will run from 6 March 2006 and ends on 9 June 2006.

Cardiovascular disease and air pollution: A report by the Committee on the Medical Effects of Air Pollutants and appendices
Ayres JG
Company: Department of Health, Committee on the Medical Effects of Air Pollutants
London, DoH
215p., 87p.

Abstract: The main findings of the report are that “outdoor air pollutants are likely to be associated with increased deaths and hospital admissions for cardiovascular related disease. This association is not as large as factors such as family history, smoking and hypertension.” The Committe could not identify the exact mechanisms by which air pollution affects the cardiovascular system, but suggests two possible mechanisms:

Inhalation of particles in the air causes chemical reactions in the body which increase the likelihood of blood to clot and/or atheromatous plaque to rupture, leading to heart attack.

Particles subtly affect the control of heart rhythm.

Changes to primary care trusts: Government response to the Health Committee’s report on changes to primary care trusts
Department of Health
London : TSO, 2006
28p.
(Cm 6760)

This Command Paper sets out the Government’s response to the Health Select Committee’s second report of session 2005–06, Changes to PCTs. It includes discussion on issues surrounding the reconfiguration and sets out in more detail the background to these changes.

HPA weekly national influenza report :Summary of UK surveillance of influenza and other seasonal respiratory illness: 8 March 2006 (Week 10)
Health Protection Agency
London : HPA, 2006
5p.

The Health Protection Agency has issued the weekly national influenza report for week 9, which can be accessed via the link above. It notes that influenza-like illness (ILI) consultation rates continued to decrease from the updated rate of 29.1 per 100,000 in week 08/06 to 24.4 per 100,000 in week 09/06. The rates are below the baseline level of 30 per 100,000 population.

Evidence from Journals

Lee SJ, et al. Development and validation of a prognostic index for 4-year mortality in older adults. JAMA. 2006 Feb 15;295(7):801-8.

CONTEXT: Both comorbid conditions and functional measures predict mortality in older adults, but few prognostic indexes combine both classes of predictors. Combining easily obtained measures into an accurate predictive model could be useful to clinicians advising patients, as well as policy makers and epidemiologists interested in risk adjustment.
OBJECTIVE: To develop and validate a prognostic index for 4-year mortality using information that can be obtained from patient report.
DESIGN, SETTING, AND PARTICIPANTS: Using the 1998 wave of the Health and Retirement Study (HRS), a population-based study of community-dwelling US adults older than 50 years, we developed the prognostic index from 11,701 individuals and validated the index with 8009. Individuals were asked about their demographic characteristics, whether they had specific diseases, and whether they had difficulty with a series of functional measures. We identified variables independently associated with mortality and weighted the variables to create a risk index.
MAIN OUTCOME MEASURE: Death by December 31, 2002.
RESULTS: The overall response rate was 81%. During the 4-year follow-up, there were 1361 deaths (12%) in the development cohort and 1072 deaths (13%) in the validation cohort. Twelve independent predictors of mortality were identified: 2 demographic variables (age: 60-64 years, 1 point; 65-69 years, 2 points; 70-74 years, 3 points; 75-79 years, 4 points; 80-84 years, 5 points, >85 years, 7 points and male sex, 2 points), 6 comorbid conditions (diabetes, 1 point; cancer, 2 points; lung disease, 2 points; heart failure, 2 points; current tobacco use, 2 points; and body mass index <25, style="font-weight: bold;">CONCLUSION: This prognostic index, incorporating age, sex, self-reported comorbid conditions, and functional measures, accurately stratifies community-dwelling older adults into groups at varying risk of mortality.

Winner P, et al. Sumatriptan nasal spray in adolescent migraineurs: a randomized, double-blind, placebo controlled, acute study. Headache. 2006 Feb;46(2):212-22.

Objective.-To compare the efficacy and tolerability of sumatriptan nasal spray (NS) (5, 20 mg) versus placebo in the acute treatment of migraine in adolescent subjects.
Background.-Currently, no triptan is approved in the United States for the treatment of migraine in adolescent subjects (12 to 17 years). In a previous randomized, placebo-controlled study of 510 adolescent subjects, sumatriptan NS at 5, 10, and 20 mg doses was well tolerated. However, the primary efficacy analysis for headache relief with 20 mg at 2 hours did not demonstrate statistical significance (P= .059). A second study was initiated to evaluate the efficacy of sumatriptan NS in this population. Methods.-This was a randomized (1:1:1), placebo-controlled, double-blind, parallel-group study. Overall, 738 adolescent subjects (mean age: 14 years) with >/=6-month history of migraine (with or without aura) self-treated a single attack of moderate or severe migraine. The primary endpoints were headache relief at 1 hour and sustained relief from 1 to 24 hours. Pain-free rates, presence/absence of associated symptoms, headache recurrence, and use of rescue medications were also assessed. Tolerability was based on adverse events (AEs) and vital signs.
Results.-Sumatriptan NS 20 mg provided greater headache relief than placebo at 30 minutes (42% vs. 33%, respectively; P= .046) and 2 hours (68% vs. 58%; P= .025) postdose, but did not reach statistical significance at 1 hour (61% vs. 52%; P= .087) or for sustained headache relief from 1 to 24 hours (P= .061). Significant differences (P < .05) in favor of sumatriptan NS 20 mg over placebo were observed for several secondary efficacy endpoints including sustained relief from 2 to 24 hours. In general, sumatriptan NS 5 mg percentages were slightly higher than placebo but the differences did not reach statistical significance. Both doses of sumatriptan NS were well tolerated. No AEs were serious or led to study withdrawal. The most common event was taste disturbance (2%, placebo; 19%, sumatriptan NS 5 mg; 25%, sumatriptan NS 20 mg). Conclusions.-This study suggests that sumatriptan may be beneficial to some adolescents and is generally well tolerated in the acute treatment of migraine in this population.

Holtmann G, et al. A placebo-controlled trial of itopride in functional dyspepsia. N Engl J Med. 2006 Feb 23;354(8):832-40.

BACKGROUND: The treatment of patients with functional dyspepsia remains unsatisfactory. We assessed the efficacy of itopride, a dopamine D2 antagonist with acetylcholinesterase effects, in patients with functional dyspepsia.
METHODS: Patients with functional dyspepsia were randomly assigned to receive either itopride (50, 100, or 200 mg three times daily) or placebo. After eight weeks of treatment, three primary efficacy end points were analyzed: the change from baseline in the severity of symptoms of functional dyspepsia (as assessed by the Leeds Dyspepsia Questionnaire), patients' global assessment of efficacy (the proportion of patients without symptoms or with marked improvement), and the severity of pain or fullness as rated on a five-grade scale.
RESULTS: We randomly assigned 554 patients; 523 had outcome data and could be included in the analyses. After eight weeks, 41 percent of the patients receiving placebo were symptom-free or had marked improvement, as compared with 57 percent, 59 percent, and 64 percent receiving itopride at a dose of 50, 100, or 200 mg three times daily, respectively (P<0.05 p="0.05)." p="0.04)." style="font-weight: bold;">CONCLUSIONS: Itopride significantly improves symptoms in patients with functional dyspepsia

Kimerling R, et al. Brief report: Utility of a short screening scale for DSM-IV PTSD in primary care. J Gen Intern Med. 2006 Jan;21(1):65-7.

OBJECTIVE: To evaluate Breslau's 7-item screen for posttraumatic stress disorder (PTSD) for use in primary care.
DESIGN: One hundred and thirty-four patients were recruited from primary care clinics at a large medical center. Participants completed the self-administered 7-item PTSD screen. Later, psychologists blinded to the results of the screen-interviewed patients using the Clinician Administered PTSD Scale (CAPS). Sensitivity, specificity, and likelihood ratios (LR) were calculated using the CAPS as the criterion for PTSD.
RESULTS: The screen appears to have test-retest reliability (r=.84), and LRs range from 0.04 to 13.4.
CONCLUSIONS: Screening for PTSD in primary care is time efficient and has the potential to increase the detection of previously unrecognized PTSD.

Jackson RD, et al. Calcium plus vitamin D supplementation and the risk of fractures. N Engl J Med. 2006 Feb 16;354(7):669-83.

BACKGROUND: The efficacy of calcium with vitamin D supplementation for preventing hip and other fractures in healthy postmenopausal women remains equivocal.
METHODS: We recruited 36,282 postmenopausal women, 50 to 79 years of age, who were already enrolled in a Women's Health Initiative (WHI) clinical trial. We randomly assigned participants to receive 1000 mg of elemental calcium as calcium carbonate with 400 IU of vitamin D3 daily or placebo. Fractures were ascertained for an average follow-up period of 7.0 years. Bone density was measured at three WHI centers.
RESULTS: Hip bone density was 1.06 percent higher in the calcium plus vitamin D group than in the placebo group (P<0.01). style="font-weight: bold;">CONCLUSIONS: Among healthy postmenopausal women, calcium with vitamin D supplementation resulted in a small but significant improvement in hip bone density, did not significantly reduce hip fracture, and increased the risk of kidney stones.

Scaccianoce G, et al. Helicobacter pylori eradication with either 7-day or 10-day triple therapies, and with a 10-day sequential regimen. Can J Gastroenterol. 2006 Feb;20(2):113-7.

BACKGROUND: Helicobacter pylori eradication rates achieved by standard seven-day triple therapies are decreasing in several countries, while a novel 10-day sequential regimen has achieved a very high success rate. A longer 10-day triple therapy, similar to the sequential regimen, was tested to see whether it could achieve a better infection cure rate.

METHODS: Patients with nonulcer dyspepsia and H pylori infection were randomly assigned to one of the following three therapies: esomeprazole 20 mg, clarithromycin 500 mg and amoxycillin 1 g for seven days or 10 days, or a 10-day sequential regimen including esomeprazole 20 mg plus amoxycillin 1 g for five days and esomeprazole 20 mg, clarithromycin 500 mg and tinidazole 500 mg for the remaining five days. All drugs were given twice daily. H pylori eradication was checked four to six weeks after treatment by using a 13C-urea breath test. RESULTS: Overall, 213 patients were enrolled. H pylori eradication was achieved in 75.7% and 77.9%, in 81.7% and 84.1%, and in 94.4% and 97.1% of patients following seven-day or 10-day triple therapy and the 10-day sequential regimen, at intention-to-treat and per protocol analyses, respectively. The eradication rate following the sequential regimen was higher than either seven-day (P=0.002) or 10-day triple therapy (P=0.02), while no significant difference emerged between the latter two regimens (P=0.6).

CONCLUSIONS: The 10-day sequential regimen was significantly more effective than both triple regimens, while 10-day triple therapy failed to significantly increase the H pylori eradication rate achieved by the standard seven-day regimen.

Latest Questions to the Primary Care Question Answering Service

Assessment and Diagnosis

What are the current thoughts regarding dipstick testing for UTI in children?

Does an incidental finding of positive parietal antibodies in a patient with a normal full blood count require further investigation.

If CRP is raised in infection and inflamation, would it be usefull to distinguish if the cause of breathlessness in a patient with co-morbidities such as asthma, COPD or heart failure, was due to infection or not?

In the past every child with a first febrile convulsion was admitted but now paediatricians seem less keen to admit. Are there any guidelines or protocols on when to admit? Is it age related?

Do you have any evidence based guidelines for the management of otitis media in primary care? what are the indications for antibiotics?

Do you have any evidence based guidelines for the management of conjunctivitis in primary care?

How useful is carbohydrate deficient transferrin (CDT) as a marker for alcohol abuse? what are its limitations?

What causes a raised ESR and normal CRP?

What evidence is there that too big a cuff will produce erroneous bp readings?

Is unilateral breast enlargement in an otherwise healthy and normally developed 18/12 old child simply a variant of normal or should it be investigated further?

Cancer

What stage is the HPV vaccine at in development, and is it currently available?

Does a patient of 45 years who has a FH of breast cancer in her maternal grandmother in her 40's and her maternal great grandmother need screening early?

1. What is the evidence of increased risk of breast cancer for a 15 year old girl prescribed combined oral contraceptive for svere dysmenorrhoea who has a FH of breast cancer in her mother aged 40? The breast cancer was hormone sensitive.

Which treatment gives the best prognosis: the clearance of axillary lymph nodes or node sampling in a 46 year old with discrete lobular breast cancer 15 mm lower inner quadrant? There is no tumour spread detectable clinically or with ultrasound or mammography. Also, is the treatment of choice lumpectomy (followed by radiotherapy) or mastectomy?

Cardiovascular disease

What are the recommendations for Vit b12 blood level monitoring in those patients receiving long term hydroxcobalamin three monthly?

Where would I find a comprehensive list of drug interactions with warfarin, and warfarin interactions with herbal remedies

For diabetic patients who have had a stroke or MI, is clopidogrel more effective than aspirin at reducing further espisodes of atherothrombotic events?

Can statins or fibrates cause gynaecomastia?

In using beta-blockers for treating hypertension is any particular beta-blocker preferred?

Causes Risks and Prevention

In addition to scheduled immunisations, what is the recommended immunisation/s for a child (aged one year) due to have cochlear implants please?

What evidence is there about the use of one way valve mouth pieces to prevent the spread of infection when used with tools such as peak flow meters and spirometers? Also, how often to change air inlet and outlet filters in nebilisers?

Can you tell me what is known about flushing in elderly men and what options have been tried to treat this? Is there any evidence to support the use of oestrogens for this problem?

Are there any proven interventionsthat improve access to teenage sexual health services, and most importantly reduce adverse events?

What are the criteria for BCG now? I have a family with three children living in an affluent area. They have no UK risks but visit Lebanon twice a year and have grandparents in Ghana, should they have BCG?

Is there any evidence about the longterm effects of omega 3 and 5 supplementation in children (recommended by some for learning difficulties/ADHD/dyspraxia) indeed, is there good evidence for their use with children? If not, is there a view about their likely safety?

32 year old patient complaining of unilateral headache on waking up on most days for 3 years which gets better within 1-2 hrs of waking up. What are the possible causes ? Can it be rebound headache ?

Is there any evidence that vitamin E reduces the incidence of cataracts?

Is it ok to give Depo Provera in the buttock in obese women?

Can saw palmetto be causing a man of 76 to develop abnormal LFTs, and if so how common/likely is this?

Can a 57 year old lady with OA and type 2 DM take glucosamine - are there any contraindications?

Child health

Who can do baby clinics and 6w checks? And as a qualified GP who does not have a paeds exam how can I gain a certificate in CHS if this is necessary.

I recently heard a weaning talk to a group of young parents and wondered what evidence there is for the following: A baby should not be weaned before six month as its gastric juices cannot break down the food adequately.

Complementary medicine

What is the standard daily dose of St john's wort which should be recommended for a patient with mild depression and for how long would it need to be taken before an improvement could be expected?

What is the evidence for magnet therapy in osteoarthritis and how would you 'prescribe' magnet therapy if it was at all appropriate?

Ear nose and throat

A patient has recently read that melatonin can be used for treating his tinnitus - any evidence?

Health informatics

Are you aware of any tools to review web sites (our aim is to review web sites that are specifically for teenagers and would like a tool to support this)

Health management

What is the future role of district nurses in diabetes management changes that will be needed.

Infectious disease

What is current UK stockpile of Tamiflu, if we were to be asked by a member of the public?

What evidence is there that cimetidine helps cure verrucas?

What evidence is there that 5 days antibiotic treatment for chest infections is superior to 3 days.

Learning disabilities

Is there any evidence to support the use of "brain gym" techniques in dyspraxia & related conditions?

Mental health

In anorexics are anti-depressants useful?

Musculoskeletal disease

How often should someone take Folic Acid if on Methotrexate or is it dependent on blood folate levels?

Renal & urogenital

What is the evidence for using allopurinol for hyperuracaemia but without any history of gout?

Respiratory

Patients with > 400 mls salbutamol spirometry reversibility, but who do not reverse to normal lung function - should they be on the asthma or COPD register or both?

Post 21: 3rd March 2006

2006-03-03T12:21:00.000Z

Links are given to online full text resources, all other materials can be obtained via the Fade Library, just mail your request to library.services@fade.nhs.uk

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Latest Systematic Reviews
Latest Reports
Evidence from Journals
Latest Questions to the Primary Care Question Answering Service
Hitting the Headlines - Evidence Behind the Press Stories
Document of the Week from the National Library for Health

Latest Systematic Reviews

Beach J, Rowe BH, Blitz S, Crumley E, Hooton N, Russell K, Spooner C, Klassen T. Evidence
Report/Technology Assessment No. 129. (Prepared by the University of Alberta Evidence-based Practice Center, under Contract No. 290-02-0023.) AHRQ Publication No. 06-E003-2. Rockville, MD: Agency for Healthcare Research and Quality. November 2005.

Latest Reports

Tackling child obesity: First steps: Report by the Comptroller General prepared jointly by the Audit Commission, The Healthcare Commission and the National Audit Office: HC 801 Session 2005-2006
Bourn J
National Audit Office; Audit Commission; Healthcare Commission
London : National Audit Office, 2006
Series: 59p.

The hidden heroes of the NHS: Time to recognise staff grade and associate specialist doctors
Johnson JN
British Medical Association
Imprint: London : BMA, 2006
50p.

Self-sufficiency in blood products in England and Wales: A chronology from 1973 to 1991
Department of Health
London : DoH, 2006
49p.

This report contains a chronology of events and an analysis of the key issues, including: developing understanding of the seriousness of the Hepatitis C virus; the evolving understanding of the viral risks associated with pooled blood products, both domestically produced and imported, and how this influenced policy; and more.

Sausage and mash and sustainability: a different type of food supplement
Purvis A
Department for Environment, Food and Rural Affairs
London : DEFRA, 2006
24p.

Managing personal change workbook
Cheshire and Merseyside SHA; Wellstead Associates
Stockton Heath : Cheshire and Merseyside SHA, 2005
55p.

Screening for breast cancer in England: past and future
Beral V
Advisory Committee on Breast Cancer Screening
Sheffield : NHS Cancer Screening Programmes, 2006
Description: 60p.

The purpose of the report is to review all available evidence on the benefits and risks associated with the NHS Breast Screening Programme and to draw firm conclusions about its effectiveness. The report estimates that the NHS Breast Screening Programme is saving 1,400 lives every year in England. The report also shows that women who attend for screening are not only less likely to die from breast cancer but are also less likely to be treated with a mastectomy than those who are not screened.

NHS Health Technology Assessment programme: Annual report 2005
National Coordinating Centre for Health Technology Assessment
Southampton : NCCHTA, 2006

This report, for clinicians, managers and users of the NHS and others interested in research, gives a brief outline of how the HTA programme works and the progress it has made in the past year. It includes information about the expanded role of the HTA programme in the new NHS R&D strategy, as well as details about the programme's new expert advisory panel on disease prevention.

Evaluating the activities of the Healthcare Commission
Healthcare Commission
London : Healthcare Commission, 2006

This paper sets out a high-level strategy for evaluating the impact of the Healthcare Commission’s activities over the next 12 to 18 months. A subsequent paper will cover other activities up to 2008. The primary aim of the evaluation is to assess the impact that the Healthcare Commission is having on the organisations that it assesses and inspects, and to assess how successful it is being in promoting improvements in healthcare for patients and the public.

Health equity audit: Learning from practice briefing
National Institute for Health and Clinical Excellence
London : NICE, 2006
32p.

The National Institute for Health and Clinical Excellence (NICE) has published Health equity audit : learning from practice briefing. This briefing provides a summary of learning from three workshops on HEA, and examples of completed or near-completed HEAs to illustrate these learning points.

Public service productivity: Health
Office for National Statistics
London : ONS, 2006
48p.

The Office of National Statistics (ONS) has published Public service productivity : health, which builds on the first health productivity publication in October 2004. The article discusses various methodologies and measures of quality improvements in the National Health Service. It estimates the change in productivity associated with public expenditure on health using National Accounts data from 1995 to 2004, in the context of wider information about health spending, output, outcomes and measurement issues. The main publication has a complementary technical article on sources and methods.

Sources and methods for public service productivity: Health

Supporting people with long term conditions to... self care: A guide to developing local strategies and good practice
Department of Health
London : DoH, 2006
56p.

The Department of Health has published a report on Supporting people with long term conditions to self care. The report is a guide for health and social care services to develop local strategies and good practice through an integrated package which includes information, self monitoring devices, self care skills, education and training and self care support networks.

The Intelligent Board
Wells W
Dr Foster Intelligence
London : Dr Foster Intelligence, 2006
46p.

The Intelligent Board proposes a basic set of criteria that Information Boards of acute and mental health trusts should have if they are to provide effective strategic leadership and monitoring of hospital performance.

The report highlights particular information challenges:

Action is required to avoid overloading Boards with excessive detail, and to present clear information on trends in performance and comparisons with others

Under payment by results, trust Boards need to pay much closer attention to cash-flow and the margins between revenues and costs on key areas of hospital activity

Trusts need a far better and more frequently updated understanding of how patients, their families and GPs feel about their experiences of the hospital

Bird flu (avian influenza): Public health advice for those going to or returning from Bird flu-affected areas: disease risk
Department of Health
London : DoH, 2006
4p.

This leaflet provides public health advice for those going to or returning from Bird flu-affected areas. It contaings information on this potentially serious disease and the precautions you should take to help protect yourself.

Travellers should be aware that cases of a severe form of bird flu are occurring in poultry and wild birds in some parts of the world.

Electronic prescription service
NHS Connecting for Health
Leeds : Connecting for Health, 2006
5p.

Connecting for Health (CfH) has published ‘The electronic prescription service’ (EPS), a leaflet which was distributed to healthcare professionals with last week’s Pharmaceutical Journal and Chemist and Druggist.

The leaflet explains the basis of how EPS works and discusses implementation of the system. Further information and resources are available from the link below, including a fact sheet on EPS.

Consultation on The Draft National Health Service (Functions of Strategic Health Authorities and Primary Care Trusts and Administration Arrangements) (England) (Amendment) Regulations 2005: Summary of Responses
Department of Health
London : Department of Health, 2006
6p.

Evidence from Journals

Mihalopoulos C, Kiropoulos L, Shih ST, Gunn J, Blashki G, Meadows G. (2005) Exploratory economic analyses of two primary care mental health projects: implications for sustainability. Med J Aust. 2005 Nov 21;183(10 Suppl):S73-6.

We evaluated an Internet-based psychological intervention supported by either general practitioners or psychologists (Panic Online), and a Primary-care Evidence-based Psychological-interventions (PEP) strategy which involves training GPs to deliver specific psychological interventions.

Economic modelling suggests that Panic Online is cost-effective when supported by either GPs or psychologists.

Threshold analysis of the psychological training of GPs suggests that a modest effect size for clinical benefit would be sufficient to provide an acceptable cost-effectiveness ratio.

The sustainability of these approaches depends on a range of factors, including funding, workforce availability, and acceptability to consumers and health care providers.

Thomas TR Rosemann , Katharina KJ Joest , Thorsten TK Koerner , Marc MH Heiderhoff , Rainer RS Schaefert and Joachim JS Szecsenyi (2006) How can the practice nurse be more involved in the care of the chronically ill? The perspectives of GPs, patients and practice nurses. BMC Family Practice 2006, 7:14

Background: A well established "midlevel" of patient care, such as nurse practitioners and/or physician assistants, exits in many countries like the US, Canada, and Australia. In Germany, however there is only one kind of profession assisting the physician in practices, the practice nurse. Little is known about the present involvement of practice nurses in patients' care in Germany and about the attitudes of GPs, assistants and patients concerning an increased involvement. The aim of our study was to get qualitative information on the extent to which practice nurses are currently involved in the treatment of patients and about possibilities of increased involvement as well as on barriers of increased involvement.

Methods: We performed qualitative, semi-structured interviews with 20 GPs, 20 practice nurses and 20 patients in the Heidelberg area. The interviews were digitally recorded, transcribed and content-analysed with ATLAS.ti.

Results: Practice nurses are only marginally involved in the treatment of patients. GPs as well as patients were very sceptical about increased involvement in care. Patients were sceptical about nurses' professional background and feared a worsening of the patient doctor relationship. GPs also complained about the nurses' deficient education concerning medical knowledge. They feared a lack of time as well as a missing reimbursement for the efforts of an increased involvement. Practice nurses were mostly willing to be more involved, regarding it as an appreciation of their role. Important barriers were lack of time, overload with administrative work, and a lack of professional knowledge.

Conclusions: Practice nurses were only little involved in patient care. GPs were more sceptical then patients regarding an increased involvement. One possible area, accepted by all interviewed groups, was patient education as for instance dietary counselling. New treatment approaches as the chronic care model will require a team approach which currently only marginally exists in the German health care system. Better medical education of practice nurses is indispensable, but also GPs have to accept that they can not fulfil the requirement of future care alone.

Rosemann T, Korner T, Wensing M, Gensichen J, Muth C, Joos S, Szecsenyi J. (2005)
Rationale, design and conduct of a comprehensive evaluation of a primary care based intervention to improve the quality of life of osteoarthritis patients. The PraxArt-project: a cluster randomized controlled trial. BMC Public Health. Jul 19;5:77.

BACKGROUND: Osteoarthritis (OA) has a high prevalence in primary care. Conservative, guideline orientated approaches aiming at improving pain treatment and increasing physical activity, have been proven to be effective in several contexts outside the primary care setting, as for instance the Arthritis Self management Programs (ASMPs). But it remains unclear if these comprehensive evidence based approaches can improve patients' quality of life if they are provided in a primary care setting.

METHODS/DESIGN: PraxArt is a cluster randomised controlled trial with GPs as the unit of randomisation. The aim of the study is to evaluate the impact of a comprehensive evidence based medical education of GPs on individual care and patients' quality of life. 75 GPs were randomised either to intervention group I or II or to a control group. Each GP will include 15 patients suffering from osteoarthritis according to the criteria of ACR.In intervention group I GPs will receive medical education and patient education leaflets including a physical exercise program. In intervention group II the same is provided, but in addition a practice nurse will be trained to monitor via monthly telephone calls adherence to GPs prescriptions and advices and ask about increasing pain and possible side effects of medication.In the control group no intervention will be applied at all. Main outcome measurement for patients' QoL is the GERMAN-AIMS2-SF questionnaire. In addition data about patients' satisfaction (using a modified EUROPEP-tool), medication, health care utilization, comorbidity, physical activity and depression (using PHQ-9) will be retrieved.Measurements (pre data collection) will take place in months I-III, starting in June 2005. Post data collection will be performed after 6 months.

DISCUSSION: Despite the high prevalence and increasing incidence, comprehensive and evidence based treatment approaches for OA in a primary care setting are neither established nor evaluated in Germany. If the evaluation of the presented approach reveals a clear benefit it is planned to provide this GP-centred interventions on a much larger scale.

Zillich AJ, et al. (2005) Hypertension outcomes through blood pressure monitoring and evaluation by pharmacists (HOME study). J Gen Intern Med. Dec;20(12):1091-6.

OBJECTIVE: To evaluate the effectiveness of a community pharmacist-based home blood pressure (BP) monitoring program.

DESIGN: Trial of a high-intensity (HI) versus low-intensity (LI) intervention randomized in 12 community pharmacies. The HI intervention comprised 4 face-to-face visits with a trained pharmacist. Pharmacists provided patient-specific education about hypertension. Following the first and third visits, patients were provided with a home BP monitoring device and instructed to measure their BP at least once daily for the next month. Home BP readings were used by the pharmacists to develop treatment recommendations for the patient's physician. Recommendations were discussed with the physician and, if approved, implemented by the pharmacist. In the LI intervention, pharmacists measured patients BP in the pharmacy and referred them to their physician for evaluation.

PARTICIPANTS: Patients with uncontrolled BP at baseline.

MEASUREMENTS: The main outcomes were the differences in systolic and diastolic BP (SBP and DBP) from baseline to follow-up between the HI and LI patients. RESULTS: The study enrolled 125 patients, 64 in the HI and 61 in the LI group. From baseline, SBP declined 13.4 mmHg in the HI group and 9.0 mmHg in the LI group. At the final visit, the difference in SBP/DBP change between the HI and LI group was -4.5/-3.2 mmHg (P=.12 for SBP and P=.03 for DBP).

CONCLUSIONS: The HI intervention achieved a lower DBP and this model could be a strategy for patients with hypertension.

Irwin, et al. (2006) Comparative meta-analysis of behavioral interventions for insomnia and their efficacy in middle-aged adults and in older adults 55+ years of age. Health Psychol. Jan;25(1):3-14.

Meta-analyses support the effectiveness of behavioral interventions for the treatment of insomnia, although few have systematically evaluated the relative efficacy of different treatment modalities or the relation of old age to sleep outcomes. In this meta-analysis of randomized controlled trials (k = 23), moderate to large effects of behavioral treatments on subjective sleep outcomes were found. Evaluation of the moderating effects of behavioral intervention type (i.e., cognitive-behavioral treatment, relaxation, behavioral only) revealed similar effects for the 3 treatment modalities. Both middle-aged adults and persons older than 55 years of age showed similar robust improvements in sleep quality, sleep latency, and wakening after sleep onset. A research agenda is recommended to examine the mechanisms of action of behavioral treatments on sleep with increased attention to the high prevalence of insomnia in older individuals.

Conen D, et al. (2006) Usefulness of B-type natriuretic Peptide and C-reactive protein in predicting the presence or absence of left ventricular hypertrophy in patients with systemic hypertension. Am J Cardiol. Jan 15;97(2):249-52. Epub 2005 Nov 21.

The diagnosis of left ventricular (LV) hypertrophy, an independent predictor of death and cardiovascular events, is difficult without using echocardiography. This study tested the hypothesis whether C-reactive protein (CRP) and B-type natriuretic peptide (BNP) would be useful to exclude echocardiographic LV hypertrophy. Consecutive hypertensive outpatients were asked to participate. Exclusion criteria were overt heart failure, severe renal insufficiency or any other severe concomitant illness. A venous blood sample was taken to measure plasma CRP and BNP concentrations. Echocardiographic LV hypertrophy was defined as LV mass > or =125 g/m2 for men and > or =110 g/m2 for women. In total, 320 patients were studied, and 37 patients (12%) had echocardiographic LV hypertrophy. Patients with LV hypertrophy were significantly older and had higher CRP and BNP concentrations and higher systolic blood pressure than those without LV hypertrophy. The optimal cut-off points for the diagnosis of LV hypertrophy were 35 pg/ml for BNP (sensitivity 73%, specificity 72%) and 2.5 mg/L for CRP (sensitivity 68%, specificity 59%). Only 1 of 123 patients with values of BNP and CRP less than the optimal cut-off point had echocardiographic LV hypertrophy, resulting in a high negative predictive value of 99% for the 2 blood tests combined to exclude LV hypertrophy. In conclusion, in hypertensive patients, echocardiographic LV hypertrophy can be excluded on the basis of a single blood sample for the determination of BNP and CRP.

Wolfe J, et al. (2006) Formoterol, 24 microg bid, and serious asthma exacerbations: similar rates compared with formoterol, 12 microg bid, with and without extra doses taken on demand, and placebo. Chest. Jan;129(1):27-38.

STUDY OBJECTIVES: The primary objective was to determine whether high-dose formoterol, 24 mug bid, was associated with more asthma exacerbations compared with lower formoterol doses in patients with stable persistent asthma. Serious asthma exacerbations (life threatening or requiring hospitalization) were the primary end point. Secondary end points included significant exacerbations requiring systemic corticosteroids, all exacerbations, and changes in FEV1.

DESIGN: In a multicenter, placebo-controlled, parallel-group study, patients were randomized to 16 weeks of treatment with formoterol, 24 microg bid; formoterol, 12 microg bid, with up to two additional 12-microg doses daily on demand for worsening symptoms (12 microg bid plus on demand); formoterol, 12 microg bid; or placebo. The formoterol 12-microg-bid plus on-demand regimen was administered open label, while the other three regimens were double blind.

SETTING: Outpatient clinics.

PATIENTS: A total of 2,085 patients aged > or = 12 years with stable, persistent asthma were enrolled and treated; 65% (n = 1,347) received regular concomitant antiinflammatory therapy during the study.

MEASUREMENTS AND RESULTS: Nine patients had respiratory-related serious adverse events (SAEs) requiring hospitalization: two patients (0.4%) in the 24-microg-bid group; one patient (0.2%) in the 12-microg-bid plus on-demand group; five patients (0.9%) in the 12-microg-bid group; and one patient (0.2%) in the placebo group. All of these events were asthma related, except for two SAEs in the 12-microg-bid group that were later considered not to be asthma related by independent reviewers who were not associated with the conduct of the study. The proportions of patients with significant asthma exacerbations (requiring systemic corticosteroids) were similar in the 24-microg-bid group (6.3%, 33 of 527 patients), 12-microg-bid group (5.9%, 31 of 527 patients) and placebo group (8.8%, 45 of 514 patients) and lower in the 12-microg-bid plus on-demand group (4.4%, 23 of 517 patients; p = 0.0057 vs placebo). All treatments were well tolerated. All formoterol treatment regimens had a significant effect on FEV1 measured 2 h after dose during the study (p < 0.0001 vs placebo); and on predose trough FEV1 measured at all visits after baseline (p < 0.002 vs placebo).

CONCLUSIONS: Treatment with formoterol, 24 microg bid, was not associated with an increase in serious asthma exacerbations compared with the lower formoterol doses or placebo.

Hindley D, et al. (2006) A randomised study of ``wet wraps`` versus conventional treatment for atopic eczema. Arch Dis Child. 2006 Feb;91(2):164-8. Epub 2005 Nov 24.

AIMS: To compare two treatments in common usage for children with atopic eczema: "wet wrap" bandages versus conventional topically applied ointments. METHODS: A total of 50 children (age 4-27 months) with moderate to severe eczema were randomised to one or other treatment. Two research nurses supervised the study. The first gave advice and support, and the second, blinded to the treatment modality being used, scored the change in eczema severity over a period of four weeks using the SCORAD eczema severity scale.

RESULTS: Both treatments gave a benefit in overall SCORAD scores (mean change for wet wrap group was 53 to 24; for the conventional group, 41 to 17). There was no significant difference between the two groups in terms of overall improvement at four weeks or in the timescale of improvements. The amount of topical of topical steroid used was similar in both groups. The wet wrap group suffered significantly more skin infections requiring antibiotics. Carers reported that wet wraps were less easy to apply than conventional treatment.

Pompeii LA, et al. Physical exertion at work and the risk of preterm delivery and small-for-gestational-age birth. Obstet Gynecol. 2005 Dec;106(6):1279-88.

OBJECTIVE: To assess whether exposure to standing, lifting, night work, or long work hours during 3 periods of pregnancy are associated with an increased risk of preterm or small-for-gestational-age birth.

METHODS: The Pregnancy, Infection and Nutrition study is a prospective cohort with a nested case-control component that was conducted through clinic and hospital settings in Central North Carolina. A total of 1,908 women pregnant with a singleton gestation were recruited during prenatal visits from January 1995 through April 2000 and provided information during telephone and face-to-face interviews about physical exertion for the 2 longest-held jobs during pregnancy.

RESULTS: No significant elevations in preterm delivery were observed among women who lifted repeatedly or stood at least 30 hours per week, with no changes in risk estimates over the course of pregnancy. A 50% elevation in the risk of preterm delivery (relative risk 1.5, 95% confidence interval 1.0-2.0; first trimester) was observed among women who reported working at night (10:00 PM to 7:00 AM), whereas a 40% reduction in risk was observed among women working at least 46 hours per week (relative risk 0.6, 95% confidence interval 0.4-0.9; first trimester), regardless of period of exposure. No elevations in small-for-gestational-age birth were observed among women exposed to any of the 4 types of occupational exertion.

CONCLUSION: Physically demanding work does not seem to be associated with adverse pregnancy outcomes, whereas working at night during pregnancy may increase the risk of preterm delivery. Studies to examine the effect of shift work on uterine activity would help to clarify the possibility of a causal effect on preterm birth.

Hoepffner N, et al. Comparative evaluation of a new bedside faecal occult blood test in a prospective multicentre study. Aliment Pharmacol Ther. 2006 Jan 1;23(1):145-54.

BACKGROUND: Faecal occult blood testing is an established method of colorectal neoplasia screening. Guaiac-based tests are limited by poor patient compliance, low sensitivity, specificity and positive predictive value. Newer immunochemical-based tests, accurate but tedious, require a well-established laboratory set up. There is need for simpler immunochemical tests that can be performed at the out-patient clinic.

AIM: To compare the performance characteristics of a new bedside immunological test strip device with a sensitive Guaiac-based and established immunochemical test for detection of faecal occult blood in patients undergoing colonoscopy.

METHODS: A total of 389 consecutive patients from four centres who were referred for colonoscopy also provided the stool samples for detection of occult blood without dietary restrictions. Stool tests performed were (i) Guaiac-based, (ii) immunochemical enzyme-linked immunosorbent assay and (iii) bedside immunochemical strip test. RESULTS: At the optimal threshold level, the sensitivity and specificity of the beside immunochemical strip test for detection of significant colorectal neoplasia (adenomas >1.0 cm and carcinomas) were 60% and 95%, respectively.

CONCLUSIONS: This bedside immunochemical strip test proved to be a simple, convenient, non-cumbersome and accurate tool with similar performance characteristics for detection of any bleeding lesion including colorectal neoplasia when compared with an established immunochemical faecal occult blood test.

Latest Questions to the Primary Care Question Answering Service

Assessment and Diagnosis

1) Is there any evidence of benefit of using pulse oximeters in the assessment of patients with respiratory disorders (Pleuritic chest pains, asthma) in the general practice setting? 2) Also any evidence of positive or negative predictive values of normal and abnormal oxygen levels (detected by pulse oximetry) in disorders such as Pulm embolism etc?

A 26 year old patient wants to delay starting her family until she is 30 years old. Her mother had menopause at age 40yrs and sister at mid 30s. What is the likelyhood of her having premature menopause?

What causes a raised ESR and normal CRP?

What is the difference between central and peripheral vertigo?

What general factors influence the selection of an antibiotic regime

If a gap occurs between 1st and 2nd doses of Hepatitis B vaccine, at what point should consideration be given to restarting the vaccination course?

What evidence is there that too big a cuff will produce erroneous bp readings?

Is unilateral breast enlargement in an otherwise healthy and normally developed 18/12 old child simply a variant of normal or should it be investigated further?

I would like to ask about monitoring of patients on venlafaxine. When should we be checking BP - I presume we should check before treatment starts but how often during treatment. Also is it necessary to perform an ECG and if so why?

Where can I find predicted peak flow charts for adults and children online?

Cancer

Given that the evidence suggests that people older than 69 stand to significantly benefit from screening for colorectal cancer, why has the government chosen the cut-off 60-60 for the screening programme?

Causes, Risks and Prevention

Is it ok to give Depo Provera in the buttock in obese women?

Can saw palmetto be causing a man of 76 to develop abnormal LFTs, and if so how common/likely is this?

Is there any evidence that corticosteroids injection can cause shingles?

When giving 2 or more vaccinations into the same site, how far apart should they be given?

In a patient ages 38, complaining of severe tingling and pins and needles in her fingers, both feet, lower lip and tip of the tongue for one week, what investigations and management plan would be appropriate?

Does Betnovate RD produce less skin atrophy than Halciderm?

Can a 57 year old lady with OA and type 2 DM take glucosamine - are there any contraindications?

Is there evidence to support the concomitant use of cabergoline or bromocriptine for treating hyperprolactinaemia in patients on risperidone?

Can you prescribe HRT for someone with focal migraines. If not what can be tried for her flushes? Also would HRT be advisable to protect her bones?

Can raised uric acid or gout could cause tinnitus?

Child Health

In acute otitis media but should antibiotics be used in an acutely discharging ear post otitis media in children and if so how long after the discharge starts?

Infections Disease

Does the evidence support a patient's request for long term antibiotics to treat her multiple sclerosis?

Musculoskeletal Disease

Is there evidence that the once a month biphosphanate ibandronate is superior to the currently available daily or once a week currently available preparations in preventing osteoporotic fractures

Hitting the Headlines - Evidence Behind the Press Stories

'Arthritis painkiller could double the risk of heart attack'

The painkiller celecoxib, marketed under the name Celebrex, may double the risk of heart attacks, reported four newspapers on 1 March 2006.(1-4) The generally accurate reports were based on a well-conducted systematic review of randomised controlled trials, the findings of which appear reliable.(5)

The painkiller celecoxib, one of a class of drugs called Cox-2 inhibitors, may double the risk of heart attacks, reported four newspapers on 1 March 2006.(1-4) All the reports included reference to the withdrawal of Vioxx, another Cox-2 inhibitor, from markets in 2004 after researchers found that it increased the risk of heart attacks and strokes.
The newspaper articles were based on a well-conducted systematic review of randomised controlled trials that compared celecoxib with placebo, diclofenac, ibuprofen or paracetamol, involving 12,780 participants.(5)
The review authors concluded that there was an increased risk of myocardial infarction with celecoxib therapy, consistent with a class effect for COX-2 specific inhibitors. The newspapers accurately reported these findings, which appear reliable.

Evaluation of the evidence base for heart attack risk of celecoxib

Where does the evidence come from?

The evidence comes from research conducted at the Medical Research Institute of New Zealand, led by Brent Caldwell. The research was funded by a bequest of the Estate of Beverley Liddington.

What were the authors' objectives?

The objective was to examine the risk of cardiovascular events associated with the use of celecoxib.

What was the nature of the evidence?

The study was a systematic review of double-blind randomised controlled trials of celecoxib compared with placebo, paracetamol or a non-steroidal anti-inflammatory drug (NSAID). Six trials, with a total of 12,780 participants were included in the review.

What interventions were examined in the research?

Studies of at least six weeks' duration that randomised patients to celecoxib or placebo, paracetamol or an NSAID, and reported serious cardiovascular thromboembolic events were eligible for inclusion in the review. Estimates of the odds ratios for risk of cardiovascular events with celecoxib compared with the comparator treatment were calculated. The main outcome measure was myocardial infarction.

What were the findings?

There was a statistically significant increase in the risk of myocardial infarction with celecoxib (1.13% patients) compared with placebo (0.41% patients) based on three studies. There was no statistically significant increase in composite cardiovascular events, cardiovascular deaths or stroke.

There was a statistically significant increase in the risk of myocardial infarction with celecoxib (0.83% patients) compared with placebo, diclofenac, ibuprofen or paracetamol (0.38% patients) based on five studies. There was no statistically significant increase in composite cardiovascular events, cardiovascular deaths or stroke.

It was not possible to investigate the effect of different dosages and duration of treatment owing to the small number of studies included.

What were the authors' conclusions?

The authors concluded that the available data indicate an increased risk of myocardial infarction with celecoxib therapy, consistent with a class effect for COX-2 specific inhibitors.

How reliable are the conclusions?

This was a well conducted systematic review and the conclusions are likely to be reliable.

The inclusion criteria for the review were well defined and a thorough search strategy was used to identify relevant trials, including contacting the manufacturer of celecoxib. Selection of studies and data extraction were carried out independently by two reviewers, which helps reduce the potential for bias and error. The methods used to pool studies appear to have been appropriate. The included studies were primarily designed to determine the efficacy of celecoxib and risk of gastrointestinal adverse events, therefore, each of the individual studies was underpowered to identify the risk of myocardial infarction. The quality of the included studies does not appear to have been systematically assessed, however, only double-blind randomised controlled trials were included.

Systematic reviews

There were no related systematic reviews identified on the Cochrane Database of Systematic Reviews (CDSR) or on the Database of Abstracts of Reviews of Effects (DARE).

References and resources

1. Painkiller 'may double risk of heart attacks'. Daily Telegraph, 1 March 2006, p7.

2. Arthritis painkiller could double the risk of a heart attack. Daily Mail, 1 March 2006, p15.

3. Heart attack risk of painkiller used by 600,000 people. Daily Express, 1 March 2006, p28.

4. Warning over painkiller issued. Independent, 1 March 2006, p8.

5. Caldwell B, Aldington S, Weatherall M, Shirtcliffe P, Beasley R. Risk of cardiovascular events and celecoxib: a systematic review and meta-analysis. Journal of the Royal Society of Medicine 2006;99:132-140.

Consumer information

British Heart Foundation

NHS Direct - Heart attack

Arthritis Research Campaign

Previous Hitting the Headlines summaries on this topic

Anti-inflammatory drugs and risk of heart attack. Hitting the Headlines archive, 16th June 2005.

New pill for arthritis. Hitting the Headlines archive, 20th August 2004.

Ibuprofen may reduce the protective benefits of aspirin on cardiovascular disease. Hitting the Headlines archive, 14th February 2003.

Melatonin for the treatment of tinnitus

Melatonin, a drug used for jet lag, could help sufferers of tinnitus, reported the Daily Mail on 28 February 2006 (1). The report was based on a small uncontrolled trial, whose findings would need to be confirmed in a larger placebo-controlled trial. The newspaper's brief report was generally accurate.

The Daily Mail (1) reported that melatonin, a hormone naturally produced by the pineal gland that helps to control the body's sleep-wake cycle, could help sufferers of tinnitus. However, they also quote the chairman of the British Tinnitus Association as stating that patients probably felt better because they were sleeping better, rather than melatonin actually having a direct effect on the condition itself.
The research (2) was a very small uncontrolled trial involving 20 patients with tinnitus. The authors' conclusions that melatonin use is associated with improvements in tinnitus and sleep would need to be confirmed in a larger, placebo-controlled trial, before any recommendations can be made for its use in the treatment of tinnitus.
The newspaper report was generally accurate, although the headline overstated the improvement in tinnitus symptoms found in the trial, which was not clinically significant.

Evaluation of the evidence base for treatment of tinnitus

Where does the evidence come from?

The evidence comes from research conducted at the Clinical Outcomes Research Office, Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, led by Uchechukwu Megwalu.

What were the authors' objectives?

The objective was to determine whether melatonin improves tinnitus in patients with idiopathic nonpulsatile tinnitus and if the improvement is related to improvement in sleep.

What was the nature of the evidence?

The study was a small uncontrolled trial involving 20 adult patients who had idiopathic, troublesome, unilateral or bilateral, nonpulsatile tinnitus of at least 6 months' duration. Patients had to score 25 or more, out of a possible 100, on the Tinnitus Handicap Inventory to be eligible for inclusion in the study. Patients with tinnitus related to cochlear implantation, retrocochlear lesion or other known anatomic and structural lesions of the ear and temporal bone were not eligible for the study.

What interventions were examined in the research?

Patients were asked to take a 3 mg melatonin pill every night, one to two hours before going to bed, for four weeks, followed by 4 weeks of observation. Patients were asked to complete the Tinnitus Handicap Inventory and the Pittsburgh Sleep Quality Index questionnaires at the beginning of the study and at two weeks, four weeks, six weeks and eight weeks. The authors predefined a drop of 10 points in the Tinnitus Handicap Inventory to be a minimally important difference and a change of 2.5 points, out of a possible 21 points, on the Pittsburgh Sleep Quality Index to be clinically significant.

What were the findings?

Of 20 patients who enrolled in the study, two dropped out after four weeks due to loss of interest. No adverse effects of melatonin were reported by any of the patients.

There was a statistically significant, but not clinically significant, decrease in the Tinnitus Handicap Inventory score between the beginning of the study and the end of treatment (p=0.02) and between the beginning of the study and four weeks after the end of treatment (p=0.006).

There was a statistically significant and clinically significant decrease in the Pittsburgh Sleep Quality Index score between the beginning of the study and the end of treatment (p<0.0001)>

There was a statistically significant association between the change in the Pittsburgh Sleep Quality Index and the change in the Tinnitus Handicap Inventory between the beginning of the study and the end of treatment, but not between the beginning of the study and four weeks after the end of treatment.

What were the authors' conclusions?

The authors concluded that melatonin use is associated with improvement in tinnitus and sleep and that there was an association between the amount of improvement in sleep and tinnitus.

How reliable are the conclusions?

This was a very small, uncontrolled trial. The outcomes measured appear to have been appropriate and the authors used validated tinnitus and sleep quality scales. However, 15% of the included patients had pulsatile tinnitus; the inclusion criteria stated that patients had to have nonpulsatile tinnitus, therefore, these patients did not meet the trial's inclusion criteria. No assessment of patient compliance with medication was made.

The authors' conclusions are supported by the findings of the trial. However, the findings need to be confirmed in a larger, placebo-controlled trial. The authors state that they are currently planning a large prospective randomised placebo-controlled trial to study the therapeutic efficacy of melatonin in the treatment of tinnitus. The authors refer to a previous placebo controlled trial of melatonin for tinnitus which found an improvement in tinnitus with melatonin and with placebo, but no difference in improvement between the two groups (3).

Systematic reviews

There were no related systematic reviews identified on the Cochrane Database of Systematic Reviews (CDSR) or on the Database of Abstracts of Reviews of Effects (DARE).

References and resources

1. Jet-lag drug can end misery of tinnitus. Daily Mail, 28 February 2006, p50.

2. Megwalu UC, Finnell, JE, Piccirillo JF. The effects of melatonin on tinnitus and sleep. Otolaryngology-Head and Neck Surgery 2006;134(2):210-213.

3. Rosenberg SI, Silverstein H, Rowan PT, Olds MJ. Effect of melatonin on tinnitus. Laryngoscope 1998;103(3):305-10.

Consumer information

British Tinnitus Association

Action for Tinnitus Research

NHS Direct Online Health Encyclopaedia - Tinnitus

RNID Information and Resources for Tinnitus

Previous Hitting the Headlines summaries on this topic

Effectiveness of Ginkgo biloba in treating tinnitus. Hitting the Headlines archive, 25 January 2001.

Viagra 'could be a remedy' for Crohn's disease

Viagra could be a remedy for Crohn's disease, reported The Guardian (1). The newspaper accurately reported the findings of a study investigating the causes of Crohn's disease. A clinical trial is needed before the usefulness of Viagra in the treatment of Crohn's disease is known.

Viagra could be used as a treatment for Crohn's disease, reported The Guardian (1).
The story was based on an experimental study which was primarily an investigation into the causes of Crohn's disease (2). Researchers studied the immune response to killed bacteria and acute trauma caused by biopsy of the bowel in individuals with Crohn's disease, ulcerative colitis, and non-inflammatory bowel disease. After injection with killed bacteria, patients with Crohn's disease showed an abnormally low increase in bloodflow at the site of the injection. Ten individuals with Crohn's disease and five healthy individuals were given 50mg Viagra either 24 or 48 hours after bacterial injection. Most patients showed a significant increase in blood flow after taking Viagra. The authors concluded that vasodilatatory drugs such as Viagra may be useful in healing or preventing lesions in Crohn's disease. The results are preliminary and a clinical trial is needed before the effectiveness of Viagra in the treatment of Crohn's disease is known.
The newspaper accurately reported the findings of the study, and noted the researchers' intention to carry out a clinical trial to determine whether Viagra, or a similar drug, could actually aid healing in the gut of people with Crohn's disease.

Systematic reviews

There were no related systematic reviews identified on the Cochrane Database of Systematic Reviews (CDSR) or on the Database of Abstracts of Reviews of Effects (DARE).

"Demonstrating Excellence in Practice-based Teaching for Public Health"

The aim of this report, published by the Association of Schools of Public Health, is to bridge the gap between public health schools and public health practitioners so that public health professionals can improve their knowledge in their working environment.

This document provides the following:

explanation of practice-based teaching
instructions for implementing of practice-based teaching, eg hints and tips for organising and evaluating session
practical examples
suggestions for building links between public health practitioners and professional public health education and training

Post 20: 24th February 2006

2006-02-22T13:44:00.000Z

Links are given to online full text resources, all other materials can be obtained via the Fade Library, just mail your request to library.services@fade.nhs.uk

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Is there any evidence that delivering travel health in a dedicated travel clinic improves health outcomes?

DIABETES

What advice can I give to type 2 diabetics about diet & medication if they develop an acute illness e.g.vomiting

INFECTIOUS DISEASE

Is there any guidance on the screening of relatives of a MRSA patient in hospital?

In adults with non-opthalmic herpes zoster, who should we be giving antivirals to?

MUSCULOSKELETAL DISEASE

When is co-proxamol actually being withdrawn from the market e.g. how long can we continue to prescribe before being available unlicensed only.

NEUROLOGICAL DISEASE

What is the place of donepezil and similar drugs in suspected vascular dementia?

RESPIRATORY

Is there any evidence to suggest that health care assistants are able to perform spirometry on patients in primary care, if so, how would their competency be audited?

Post 19: 17th February 2006

2006-02-16T09:58:00.000Z

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Links are given to online full text resources, all other materials can be obtained via the Fade Library, just mail your request to library.services@fade.nhs.uk

Latest Guidelines

NICE (2006) Postnatal care: second consultation. London: NICE.

A clinical practice guideline on postnatal care is being developed for use in the NHS in England and Wales. Registered stakeholders for the postnatal care guideline are invited to comment on the provisional guideline recommendations.

Department of Health (2006) National Guidelines for Maternity Services Liaison Committees (MSLCs). London: DoH.

These guidelines are for healthcare managers, commissioners, practitioners and others. They provide advice on making local MSLCs work more effectively. They include practice examples and reference details to enable local initiatives to build on the experience of other groups, together with self-assessment tools and detailed guidance on establishing a Committee and making it effective.

Latest Reports

John Appleby and Anthony Harrison (2006)Spending on Healthcare: How much is enough?. London: King's Fund.

Investment in the NHS has increased significantly under the Blair government. Spending will soon reach the EU average, but when we catch up with our European neighbours, what then? Assuming that pressures to spend more will continue, but that marginal health returns on extra investment are likely to diminish, this paper asks the question: how much is enough? In particular, can a limit on health spending be defined, and if so, how? And what evidence is required to inform what is ultimately a political decision?

NHS Confederation (2006) Our health, our care, our say: A new direction for community services. NHS Confederation Briefing Issue 128.

The Government’s white paper on community health and care services – Our health, our care, our say – was launched at the end of January. Drawn up after a consultation process which involved more than 143,000 people, it promises a shift in strategic direction for health services. Over the next five years patients will be able to
expect more joined-up and personalised care delivered in the community or at their homes, if appropriate. This Briefing looks at some of the key policies, as outlined in the white paper, and what they will mean for the health service.

Department of Health (2006) The NHS in England: the operating framework for 2006/7. London: DoH.

This document, addressed to all NHS Chief Executives, sets out the specific business and financial arrangements for the NHS for 2006/7. It describes, amongst other things, the delivery priorities, the payment by results and tariff details and expectations on the development of choice, commissioning and practice-based commissioning. It gives new SHAs the influence to ensure local implementation of the guidance.

Department of Health (2006) ISTC Manual Independent Sector Treatment Centre (ISTC) Programme. London: DoH.

The Independent Sector Treatment Centre (ISTC) Programme is part of a major initiative to create additional capacity within the NHS to reduce waiting times and introduce choice for patients. The purpose of this manual is to explain the background to Wave 1 of the ISTC Programme, the key issues relating to it and the ways in which Wave 1 works in practice.

Lisa Dyson, Mary Renfrew, Alison McFadden, Felicia McCormick, Gill Herbert and James Thomas (2006) Effective action briefing on the initiation and duration of breastfeeding: Effective action recommendations. York: University of York.

The effective action briefing on the initiation and duration of breastfeeding presents draft evidence-based recommendations for promoting the initiation and continuation of breastfeeding, particularly among population groups where breastfeeding rates are low. The report also describes the characteristics of effective programmes for these groups and for different settings as well as strategies for overcoming barriers to change.

Glickman, M., Corbin. T., Tortoriello, M. and Devis, T. (2006) United Kingdom health statistics. London: ONS.

These key indicators are among a wide range of statistics that show noticeable variations in health across the four countries of the UK.

Evidence from Journals

Alper BS, White DS, Ge B. (2005) Physicians answer more clinical questions and change clinical decisions more often with synthesized evidence: a randomized trial in primary care. Ann Fam Med. Nov-Dec;3(6):507-13.

PURPOSE: Clinicians need evidence in a format that rapidly answers their questions. DynaMed is a database of synthesized evidence. We investigated whether primary care clinicians would answer more clinical questions, change clinical decision making, and alter search time using DynaMed in addition to their usual information sources.

METHODS: Fifty-two primary care clinicians naive to DynaMed searched for answers to 698 of their own clinical questions using the Internet. On a per-question basis, participants were randomized to have access to DynaMed (A) or not (N) in addition to their usual information sources. Outcomes included proportions of questions answered, proportions of questions with answers that changed clinical decision making, and median search times. The statistical approach of per-participant analyses of clinicians who asked questions in both A and N states was decided before data collection.

RESULTS: Among 46 clinicians in per-participant analyses, 23 (50%) answered a greater proportion of questions during A than N, and 13 (28.3%) answered more questions during N than A (P = .05). Finding answers that changed clinical decision making occurred more often during A (25 clinicians, 54.3%) than during N (13 clinicians, 28.3%) (P = .01). Search times did not differ significantly. Overall, participants found answers for 263 (75.8%) of 347 A questions and 250 (71.2%) of 351 N questions. Answers changed clinical decision making for 224 (64.6%) of the A questions and 209 (59.5%) of the N questions. CONCLUSIONS: Using DynaMed, primary care clinicians answered more questions and changed clinical decisions more often, without increasing overall search time. Synthesizing results of systematic evidence surveillance is a feasible method for meeting clinical information needs in primary care.

Janosky JE (2005) Use of the single subject design for practice based primary care research. Postgrad Med J. 2005 Sep;81(959):549-51.

The use of a single subject research design is proposed for practice based primary care research. An overview of the rationale of the design, an introduction to the methodology, strengths, limitations, a sample of recent literature citations, a working example, and possible clinical applications are presented.

Arroll B, Macgillivray S, Ogston S, Reid I, Sullivan F, Williams B, Crombie I. (2005) Efficacy and tolerability of tricyclic antidepressants and SSRIs compared with placebo for treatment of depression in primary care: a meta-analysis. Ann Fam Med. Sep-Oct;3(5):449-56.

PURPOSE: Depression is common in primary care. There are no systematic reviews of depression treatment comparing antidepressants with placebo; hence, we do not know whether these medications are effective in primary care.

METHODS: We searched the Cochrane Collaboration Depression, Anxiety and Neurosis Group register of controlled trials, MEDLINE, International Pharmaceutical abstracts, PsycINFO, and EMBASE. Abstracts of potential studies were reviewed independently by 2 authors. Studies needed to include randomized controlled trials of either a tricyclic antidepressant (TCA) or selective serotonin reuptake inhibitor (SSRI), or both, and placebo in a primary care setting. The data and quality of the studies were extracted and assessed by 2 authors blind to the other's choice. Disagreements were resolved by discussion. The main outcome measures were the standardized mean difference and weighted mean difference of the final mean depression scores, the relative risk of improvement, and the number withdrawing because of side effects. Pooling of results was done using Review Manager 4.2.2.
RESULTS: There were 10 studies in which TCAs were compared with placebo, 3 in which SSRIs were compared with placebo, and 2 with both compared with placebo. One half of the studies were of low methodological quality, and nearly all studies were of short duration, typically 6 to 8 weeks. Pooled estimates of efficacy data showed a relative risk of 1.26 (95% CI, 1.12-1.42) for improvement with TCAs compared with placebo; For SSRIs, relative risk was 1.37 (95% CI, 1.21-1.55). Most patients, 56% to 60%, responded well to active treatment compared with 42% to 47% for placebo. The number needed to treat for TCAs was about 4, and for SSRIs it was 6. The numbers needed to harm (for withdrawal caused by side effects) ranged from 5 to 11 for TCAs and 21 to 94 for SSRIs. Low-dose (100 mg or 75 mg) as well as high-dose TCAs were effective.

CONCLUSION: This systematic review is the first comparing antidepressants with placebo for treatment of depression in primary care. Both TCAs and SSRIs are effective. This review is also the first to show that low-dose TCAs are effective in primary care. Prescribing antidepressants in primary care is a more effective clinical activity than prescribing placebo.

Wilson, E.C.F., Rees, J. and Fordham, R.J. (2006) Developing a prioritisation framework in an English Primary Care Trust. Cost Effectiveness and Resource Allocation 2006, 4:3

Background : In the English NHS, Primary Care Trusts (PCTs) are required to commission health services, to maximise the well-being of the population, subject to the available budget. There are numerous techniques employed to make decisions, some more rational and transparent than others. A weighted benefit score can be used to rank options but this does not take into account value for money from investments.

Methods: We developed a weighted benefit score framework for use in an English PCT which ranked options in order of 'cost-value' or 'cost per point of benefit'. Our method differs from existing techniques by explicitly combining cost and a composite weighted benefit score into the cost-value ratio.

Results: The technique proved readily workable, and was able to accommodate a wide variety of data and competing criteria. Participants felt able to assign scores to proposed services, and generate a ranked list, which provides a solid starting point for the PCT Board to discuss and make funding decisions. Limitations included potential for criteria to be neither exhaustive nor mutually exclusive and the lack of an interval property in the benefit score limiting the usefulness of a cost-value ratio.

Conclusions: A technical approach to decision making is insufficient for making prioritisation decisions, however our technique provides a very valuable, structured and informed starting point for PCT decision making.

Dr Foster Intelligence (2006) Keeping people out of hospital : the challenge of reducing emergency admissions. London: Dr Foster Intelligence.

According to the report more than one million emergency admissions every year, via accident and emergency, could be better managed outside hospital - at home or in the community. The findings are based on the first ever analysis of national hospital data to identify the impact of repeat emergency hospital admissions on the NHS, by patients referred to as high-impact users - those who are admitted to accident and emergency at least three times in a year. The report also reveals that there is wide geographical variation in the number of emergency admissions by high-impact users, from fewer than 1,000 in one south east primary care trust to nearly 10,000 in a primary care trust in the Midlands.

Beresford SA, Johnson KC, Ritenbaugh C, Lasser NL, Snetselaar LG, Black HR, Anderson GL, Assaf AR, Bassford T, Bowen D, Brunner RL, Brzyski RG, Caan B, Chlebowski RT, Gass M, Harrigan RC, Hays J, Heber D, Heiss G, Hendrix SL, Howard BV, Hsia J, Hubbell FA, Jackson RD, Kotchen JM, Kuller LH, LaCroix AZ, Lane DS, Langer RD, Lewis CE, Manson JE, Margolis KL, Mossavar-Rahmani Y, Ockene JK, Parker LM, Perri MG, Phillips L, Prentice RL, Robbins J, Rossouw JE, Sarto GE, Stefanick ML, Van Horn L, Vitolins MZ, Wactawski-Wende J, Wallace RB, Whitlock E. (2006) Low-fat dietary pattern and risk of colorectal cancer: the Women's Health Initiative Randomized Controlled Dietary Modification Trial. JAMA. Feb 8;295(6):643-54.

CONTEXT: Observational studies and polyp recurrence trials are not conclusive regarding the effects of a low-fat dietary pattern on risk of colorectal cancer, necessitating a primary prevention trial. OBJECTIVE: To evaluate the effects of a low-fat eating pattern on risk of colorectal cancer in postmenopausal women.

DESIGN, SETTING, AND PARTICIPANTS: The Women's Health Initiative Dietary Modification Trial, a randomized controlled trial conducted in 48,835 postmenopausal women aged 50 to 79 years recruited between 1993 and 1998 from 40 clinical centers throughout the United States.

INTERVENTIONS: Participants were randomly assigned to the dietary modification intervention (n = 19,541; 40%) or the comparison group (n = 29,294; 60%).The intensive behavioral modification program aimed to motivate and support reductions in dietary fat, to increase consumption of vegetables and fruits, and to increase grain servings by using group sessions, self-monitoring techniques, and other tailored and targeted strategies. Women in the comparison group continued their usual eating pattern.

MAIN OUTCOME MEASURE: Invasive colorectal cancer incidence.

RESULTS: A total of 480 incident cases of invasive colorectal cancer occurred during a mean follow-up of 8.1 (SD, 1.7) years. Intervention group participants significantly reduced their percentage of energy from fat by 10.7% more than did the comparison group at 1 year, and this difference between groups was mostly maintained (8.1% at year 6). Statistically significant increases in vegetable, fruit, and grain servings were also made. Despite these dietary changes, there was no evidence that the intervention reduced the risk of invasive colorectal cancer during the follow-up period. There were 201 women with invasive colorectal cancer (0.13% per year) in the intervention group and 279 (0.12% per year) in the comparison group (hazard ratio, 1.08; 95% confidence interval, 0.90-1.29). Secondary analyses suggested potential interactions with baseline aspirin use and combined estrogen-progestin use status (P = .01 for each). Colorectal examination rates, although not protocol defined, were comparable between the intervention and comparison groups. Similar results were seen in analyses adjusting for adherence to the intervention.

CONCLUSION: In this study, a low-fat dietary pattern intervention did not reduce the risk of colorectal cancer in postmenopausal women during 8.1 years of follow-up.

Howard BV, Van Horn L, Hsia J, Manson JE, Stefanick ML, Wassertheil-Smoller S, Kuller LH, LaCroix AZ, Langer RD, Lasser NL, Lewis CE, Limacher MC, Margolis KL, Mysiw WJ, Ockene JK, Parker LM, Perri MG, Phillips L, Prentice RL, Robbins J, Rossouw JE, Sarto GE, Schatz IJ, Snetselaar LG, Stevens VJ, Tinker LF, Trevisan M, Vitolins MZ, Anderson GL, Assaf AR, Bassford T, Beresford SA, Black HR, Brunner RL, Brzyski RG, Caan B, Chlebowski RT, Gass M, Granek I, Greenland P, Hays J, Heber D, Heiss G, Hendrix SL, Hubbell FA, Johnson KC, Kotchen JM. (2006) Low-fat dietary pattern and risk of cardiovascular disease: the Women's Health Initiative Randomized Controlled Dietary Modification Trial. JAMA. Feb 8;295(6):693-5.

CONTEXT: Multiple epidemiologic studies and some trials have linked diet with cardiovascular disease (CVD) prevention, but long-term intervention data are needed.

OBJECTIVE: To test the hypothesis that a dietary intervention, intended to be low in fat and high in vegetables, fruits, and grains to reduce cancer, would reduce CVD risk.

DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial of 48,835 postmenopausal women aged 50 to 79 years, of diverse backgrounds and ethnicities, who participated in the Women's Health Initiative Dietary Modification Trial. Women were randomly assigned to an intervention (19,541 [40%]) or comparison group (29,294 [60%]) in a free-living setting. Study enrollment occurred between 1993 and 1998 in 40 US clinical centers; mean follow-up in this analysis was 8.1 years.

INTERVENTION: Intensive behavior modification in group and individual sessions designed to reduce total fat intake to 20% of calories and increase intakes of vegetables/fruits to 5 servings/d and grains to at least 6 servings/d. The comparison group received diet-related education materials.

MAIN OUTCOME MEASURES: Fatal and nonfatal coronary heart disease (CHD), fatal and nonfatal stroke, and CVD (composite of CHD and stroke).

RESULTS: By year 6, mean fat intake decreased by 8.2% of energy intake in the intervention vs the comparison group, with small decreases in saturated (2.9%), monounsaturated (3.3%), and polyunsaturated (1.5%) fat; increases occurred in intakes of vegetables/fruits (1.1 servings/d) and grains (0.5 serving/d). Low-density lipoprotein cholesterol levels, diastolic blood pressure, and factor VIIc levels were significantly reduced by 3.55 mg/dL, 0.31 mm Hg, and 4.29%, respectively; levels of high-density lipoprotein cholesterol, triglycerides, glucose, and insulin did not significantly differ in the intervention vs comparison groups. The numbers who developed CHD, stroke, and CVD (annualized incidence rates) were 1000 (0.63%), 434 (0.28%), and 1357 (0.86%) in the intervention and 1549 (0.65%), 642 (0.27%), and 2088 (0.88%) in the comparison group. The diet had no significant effects on incidence of CHD (hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.90-1.06), stroke (HR, 1.02; 95% CI, 0.90-1.15), or CVD (HR, 0.98; 95% CI, 0.92-1.05). Excluding participants with baseline CVD (3.4%), the HRs (95% CIs) for CHD and stroke were 0.94 (0.86-1.02) and 1.02 (0.90-1.17), respectively. Trends toward greater reductions in CHD risk were observed in those with lower intakes of saturated fat or trans fat or higher intakes of vegetables/fruits.

CONCLUSIONS: Over a mean of 8.1 years, a dietary intervention that reduced total fat intake and increased intakes of vegetables, fruits, and grains did not significantly reduce the risk of CHD, stroke, or CVD in postmenopausal women and achieved only modest effects on CVD risk factors, suggesting that more focused diet and lifestyle interventions may be needed to improve risk factors and reduce CVD risk.

Videoconferencing enables improved healthcare for cancer patients. Br J of Healthcare Computing & Information Management 2006;23(1) p31.

This case study looks at the videoconferencing system used by the Surrey, West Sussex and Hampshire (SWSH) Cancer Network. A shortage of cancer specialists and palliative care professionals led to the install of the system which is used to maximise the availablility of expert resource for patient treatment and reduce the necessity for travel.

Reisinger KS, Brown ML, Xu J, Sullivan BJ, Marshall GS, Nauert B, Matson DO, Silas PE, Schodel F, Gress JO, Kuter BJ (2006) A combination measles, mumps, rubella, and varicella vaccine (ProQuad) given to 4- to 6-year-old healthy children vaccinated previously with M-M-RII and Varivax. Pediatrics. Feb;117(2):265-72.

BACKGROUND: In the United States, children receive primary doses of M-M-RII (Merck & Co, Inc, West Point, PA) and Varivax (Merck & Co, Inc) beginning at 12 months, often at the same health care visit. Currently a second dose of M-M-RII is given to 4- to 6-year-old children, to increase vaccination rates and to reduce the number of individuals without detectable antibodies. A second dose of a varicella-containing vaccine may result in similar benefits.

OBJECTIVES: To demonstrate that ProQuad (measles, mumps, rubella, and varicella virus vaccine live; Merck & Co, Inc) may be given in place of a second dose of M-M-RII or second doses of M-M-RII and Varivax for 4- to 6-year-old children.

METHODS: Four- to 6-year-old children who had been immunized previously with M-M-RII and Varivax were assigned randomly to receive either ProQuad and placebo (N = 399), M-M-RII and placebo (N = 195), or M-M-RII and Varivax (N = 205) and were then monitored for safety and immunogenicity.

RESULTS: ProQuad was generally well tolerated. Similarity (noninferiority) was demonstrated in postvaccination antibody responses to measles, mumps, and rubella between recipients of ProQuad and all recipients of M-M-RII and in responses to varicella between recipients of ProQuad and recipients of Varivax. Postvaccination seropositivity rates for antibodies against all 4 viruses were nearly 100% in all 3 groups. Small fold increases were observed for measles, mumps, and rubella antibody titers. In contrast, substantial boosts in varicella antibody titers were observed among recipients of a second dose of varicella vaccine, administered as ProQuad or Varivax.

CONCLUSIONS: ProQuad may be used in place of a second dose of M-M-RII or second doses of M-M-RII and Varivax for 4- to 6-year-old children

Francavilla R, Lionetti E, Castellaneta SP, Magista AM, Boscarelli G, Piscitelli D, Amoruso A, Di Leo A, Miniello VL, Francavilla A, Cavallo L, Ierardi E. (2005) Improved efficacy of 10-Day sequential treatment for Helicobacter pylori eradication in children: a randomized trial. Gastroenterology. Nov;129(5):1414-9.

BACKGROUND & AIMS: The currently recommended first-line eradication treatment of Helicobacter pylori in children is usually successful in about 75%. Recently, in adults, a novel 10-day sequential treatment has achieved an eradication rate of 95%. The aim of the study was to assess the H pylori eradication rate of the sequential treatment regimen compared with conventional triple therapy in children.

METHODS: Seventy-eight consecutive children with H pylori infection were randomized to receive either sequential treatment (omeprazole plus amoxicillin for 5 days, followed by omeprazole plus clarithromycin plus tinidazole for another 5 days) (n = 38; 15 boys [39.5%]; median age, 11.0 years [range, 3.3-16 years]) or triple therapy (omeprazole, amoxicillin, and metronidazole) for 1 week (n = 37; 15 boys [40.5%]; median age, 9.9 years [range, 4.3-16 years]). H pylori infection was based on 2 out of 3 positive tests results: 13C-urea breath test, rapid urease test, and histologic analysis. Eradication was assessed by 13C-urea breath test 8 weeks after therapy.

RESULTS: Seventy-four patients completed the study. H pylori eradication was achieved in 36 children receiving sequential treatment (97.3%; 95% confidence interval, 86.2-99.5) and 28 children receiving triple therapy (75.7%; 95% confidence interval, 59.8-86.7) (P < .02). Compliance with therapy was good (>95%) in all.

CONCLUSIONS: Our study shows, for the first time in children, that 10-day sequential treatment achieves a higher eradication rate than standard triple therapy, which is consistent with the results of adult studies.

Therapeutics

Trimethoprim reduced dysuria in women with symptoms of urinary tract infection but...
Leibovici
Evid Based Med.2006; 11: 19

Topical chloramphenicol was not effective in children with acute infective conjunctivitis
Lindbaek
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The Bug Buster kit was better than single dose pediculicides for head lice
Dawes
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Review: cholinesterase inhibitors may be effective in Alzheimer’s disease
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Review: anticholinergics in addition to ß2 agonists improve outcome in children...
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Pulmonary vein isolation was better than antiarrhythmic drugs for symptomatic atrial...
George Wyse
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Using exhaled NO concentrations to adjust inhaled corticosteroid dose maintained...
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Review: vitamin D plus calcium, but not vitamin D alone, prevents osteoporotic fractures...
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Review: viscosupplementation for knee osteoarthritis reduces pain and improves function
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Diagnosis

Review: IgA endomyseal and transglutaminase antibodies had high specificity for...
Gibson
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Multislice computed tomography detected coronary artery disease
Hlatky and Sanders Evid Based Med.2006; 11: 24

Clinical Prediction Guide

A simple risk score predicted 7 day stroke risk after transient ischaemic attack
Hart
Evid Based Med.2006; 11: 27

Trials

Latest Questions to the Primary Care Question Answering Service

ASSESSMENT AND DIAGNOSIS

A 79 year old patient has mild lymphocytosis of 8*10 9 cells. Is it appropriate to continue monitoring or should be be referred? Also, since having this raised lymph he has had a CVA - may they be linked?

In which situations can a bisphosphonate be initiated without performing a DEXA scan?

I need to obtain current UK centile / BMI charts for children and young adults.Can I get printables from net?

What is the latest view on the most appropriate injection site for intramuscular injections?

What features help distinguish flu from the common cold, and how reliable are they at discriminating?

If notes say total abdominal hysterectomy with any histology can we assume that cervix was removed?

How useful is the D-dimer test in diagnosing DVT?

I have a patient who had had long irregular periods since menarche at 13yrs, what is the best treatment option?

Are their any recent guidelines discussing investigation and treatment of erectile dysfunction?

What is the effect of HRT on fibroids?

What investigations are needed in a man who has had 2 proven UTIs in 6 months?

Is there any evidence that Bell's Palsy can resolve within 24 – 48 hours?

What is the significance of ventricular ectopic beats and supra ventricular ectopic beats in a 24 hour ecg. Is there any significance of bigeminy or trigeminy?

1) Is there any evidence of benefit of using pulse oximeters in the assessment of patients with respiratory disorders (Pleuritic chest pains, asthma) in the general practice setting? 2) Also any evidence of positive or negative predictive values of normal and abnormal oxygen levels (detected by pulse oximetry) in disorders such as Pulm embolism etc?

CARDIOVASCULAR DISEASE

How soon after first CVA should prophylactic aspirin be introduced?

What are the risks of using Dianette as an oral contraceptive, over and above the risks associated with a 3rd generation oral contraceptive pill?

If a patient on atenolol 50mg daily has the dose increased to 100mg daily, can the additional risk in terms of metabolic side effects be quantified i.e. diabetogenic effects - particularly if also taking thiazides?

CAUSES, RISKS AND PREVENTION

Is there any evidence that use of zoladex injections used for 6 months for treatment of endometriosis can affect future fertility in a detrimental way?

It is quoted that 20-30% of consultations in primary care is due to musculoskeletal problems. What references are there, in British literature?

By the age of 25, what vaccinations should everyone have had / been offered as a minimum?

Someone, now 19 has had one Meningococcal C vaccine as a child and one acwy vaccine 4 years ago. Should they have another menC now on going to university?

Someone aged 30 is going to university. Should they have Meningococcal C immunisation? should they have any other vaccinations, assuming they had normal childhood immunisations?

Is vomiting a usual side-effect of trimethoprim in children?

OBESITY

Are there any new NICE or other goverment guidelines about when to start Orlistat in obesity and how long can be taken for? Are there any new revision as predicted by Feb 2004 in the NICE guidelines?

COMPLEMENTARY MEDICINE

Are there any complementary therapies/medicines that have proved helpful in rheumatoid arthritis?

CANCER

Should we be doing cervical smears on virgins?

MUSCULOSKELETAL DISEASES

Is there any published evidence on the effectiveness of steroid injection for coccygodynia? Is surgery effective?

If a patient with osteoporosis is unable to take calcium supplements, are bisphosphonates as effective as when a patient is able to take calcium supplements?

In patients who have carpal tunnel syndrome secondary to hypothyroidism, what is the evidence (if any) to suggests that treatment with thyroxine settles the symptoms of the carpal tunnel syndrome.

Hitting the Headlines - Evidence Behind the Press Stories

New drug for stroke patients

A new drug could aid the recovery of stroke patients reported two newspapers on 9 February 2006 (1,2). The Sun (1) provided a brief but accurate report of a large, well-conducted trial, the findings of which appear reliable. However the Daily Express (2) inaccurately stated that the drug increased the chances of survival.

A new drug, NXY-059, could aid the recovery of stroke patients reported two newspapers on 9 February 2006 (1,2).
A multinational trial of NXY-059 versus placebo for the reduction of disability after stroke was the basis for the newspaper reports. The results of the trial showed a twenty percent reduced likelihood of disability after being given NXY-059 compared with being given placebo at 90 days following stroke (3). No improvements were found in neurological functioning and ability to perform tasks independently. Mortality and rates of adverse events were similar in the treatment and placebo groups.
The Sun (1) provided a brief but accurate report of this well-conducted trial. The findings of the trial appear reliable. The Daily Express (2) stated that the new drug increased the chances of survival. However this was not a finding of the trial. Although the headline was overly optimistic in its use of the word 'Miracle', the article did correctly state that the new drug will not be commercially available for some time.

Evaluation of the evidence base for NXY-059 for Acute Ischemic Stroke

Where does the evidence come from?

The evidence comes from the Stroke-Acute Ischemic NXY Treatment (SAINT I) trial and was conducted in 154 hospitals across 24 countries. The research was led by Professor Kennedy R Lees of the Acute Stroke Unit and Cerebrovascular Clinic, University Department of Medicine and Therapeutics, Western Infirmary, Glasgow. The trial was funded by Astra-Zeneca. The academic authors vouch for the veracity and completeness of the data and data analysis.

What were the authors' objectives?

To assess whether the drug NXY-059 would reduce disability in patients following acute ischaemic stroke.

What was the nature of the evidence?

SAINT I was a multicentre randomised double-blind placebo controlled trial. The trial included 1722 patients with acute ischemic stroke. Patients were eligible for inclusion if they were conscious, aged over 18, had a clinical diagnosis of acute stroke, had limb weakness and a score of at least six on the National Institutes of Health Stroke Scale (NIHSS).

What interventions were examined in the research?

Patients were randomised to receive a 72 hour infusion of placebo or intravenous NXY-059 within six hours after the onset of stroke.

The main outcome of interest was disability at 90 days according to the modified Rankin Scale. The scale ranges from 0 (no symptoms) to 5 (severe disability requiring constant care and bedridden). Assessment was made at 24 and 72 hours and at 7, 30 and 90 days. Other outcomes of interest included neurological improvements, measures of independence, mortality and adverse events.

What were the findings?

At 90 days, there was a twenty percent reduced likelihood of disability in those given NXY-059 compared with those given placebo based on the modified Rankin Scale.

No improvements in neurological functioning were noted on the NIHSS or in independence as rated by the Barthel Index. Mortality and rates of serious and non-serious adverse events were similar in the treatment and placebo groups.

What were the authors' conclusions?

The authors concluded that, although NXY-059 administered within six hours of acute ischaemic stroke reduced disability at 90 days according to the modified Rankin scale, further research is needed to determine its potential benefits for stroke patients.

How reliable are the conclusions?

This large multicentre trial appears to have used appropriate methods in its design and analysis, and to have been well conducted. Clear details were given for all participants included in the study indicating that the numbers who withdrew from the trial or were lost to follow-up or received an unassigned treatment were small. The study groups were comparable at baseline. The conclusions are therefore likely to be reliable.

The authors state that a further trial, SAINT II, is under way with the aim of confirming the findings of the present study in a larger sample.

Systematic reviews

There were no related systematic reviews identified on the Cochrane Database of Systematic Reviews (CDSR) or on the Database of Abstracts of Reviews of Effects (DARE).

References and resources

1. Drug bid for stroke. The Sun, 9 February 2006, p15.

2. 'Miracle' drug may save stroke victims. Daily Express, 9 February 2006, p13.

3. Lees KD, Zivin JA, Ashwood T, Davalos A, Davis SM, Diener H, Grotta J, Lyden P, Shuaib A, Hardemark H, Wasiewski WW for the Stroke–Acute Ischemic NXY Treatment (SAINT I) Trial Investigators. NXY-059 for Acute Ischemic Stroke. New England Journal of Medicine, 2006;354(6):588-600.

Consumer information

The Stroke Association

NHS Direct - Stroke

BestTreatments - Stroke, emergency care

Document of the Week from the National Library for Health

Sharing best practice in quality use of medicine

Report on a tool to facilitate sharing best practice in quality use of medicine BMC Health Services Research reports on an online, web-based project database, known as QUMap, which enables researchers to collaborate on research related to improving the use of medicines. One of the issues that was raised in this research, was that much of the research was carried out for the benefits of the health professionals rather than the consumers, and that frequently, consumers were not involved in the process.

Post 18: 10 February 2006

2006-02-09T10:30:00.000Z

Links are given to online full text resources, all other materials can be obtained via the Fade Library, just mail your request to library.services@fade.nhs.uk

Latest Reports

Department of Health (2006) Practice based commissioning: early wins and top tips. London: DoH.

These tips are based on the practical experience of those involved in setting up practice based commissioning. No doubt there will be others as more practices and other professionals develop expertise. Nonetheless they are likely to be a useful "first base" checklist.

European Commission Health and Consumer Protection Directorate-General (2005) Improving the mental health of the population: Towards a strategy on mental health for the European Union. Brussels: EC.

The mental health of the European population is a resource for the attainment of some of the EU’s strategic policy objectives, such as to put Europe back on the path to long-term prosperity, to sustain Europe’s commitment to solidarity and social justice, and to bring tangible practical benefits to the quality of life for European citizens.

NICE (2006)Effective action briefing on breastfeeding - revised in the light of stakeholder comments - for final consultation. London: NICE.

NICE has issued draft evidence-based recommendations for promoting the initiation and continuation of breastfeeding, particularly among population groups where breastfeeding rates are low.

These draft recommendations focus on effective public health interventions that can help increase and maintain breastfeeding rates, and are intended to complement Chapter 5 (Infant Feeding) of the draft clinical guideline on routine postnatal care of recently delivered women and their babies.

Department of Health (2006) NHS Direct Commissioning Framework April 2006–March 2007
Guidance for Primary Care Trusts on Commissioning NHS Direct Services from April 2006. London: DoH.

Latest commissioning framework, which gives further guidance to PCTs in their role as commissioners of NHS Direct services. It covers the period 2006/07 only and replaces the second version of the framework which was published in March 2005.

Bell, D. and Bowes A. (2006) Financial care models in Scotland and the UK. York: Joseph Rowntree Foundation.

The University of Stirling has carried out research into the funding and operation of long-term care policy in Scotland with wider lessons for the UK as a whole, focusing particularly on the policy of free personal and nursing care. Financial care models in Scotland and the UK, published by the Joseph Rowntree Foundation (JRF):

outlines current care policy for older people in the UK, and the development and context of free personal care in Scotland;

explores the Scottish situation, finding that Scotland is a good exemplar for social care policies elsewhere in the UK;

assesses the practical problems encountered introducing the policy in Scotland, from

the point of view of both care providers and older people themselves;
identifies key threats to the sustainability of the Scottish policy.

Commission for Social Care Inspection (2006) Handled with care: managing medication for residents of care homes and children's homes - a follow up study. London: Commission for Social Care Inspection.

Nearly half of all nursing and care homes fail to meet national minimum standards for how they manage residents' medicines, a new report 'Handled with Care' shows today. Often people are given the wrong medication, someone else’s medication, medication in the wrong doses, or no medication at all, the report finds. Staff are poorly trained and records are not kept properly. Over 5,000 out of 11,500 homes for older people and over 3,000 out of nearly 8,000 homes for younger adults fail to meet national minimum standards. Around 210,000 people live in these 8,000 nursing and care homes

The Social Enterprise Coalition (2006) More for your money – a guide to procuring from social enterprises for the NHS has. London: The Social Enterprise Coalition.

The Social Enterprise Coalition (SEC), in partnership with the NHS Purchasing and Supply Agency (PASA), has published More for your money - a guide to procuring from social enterprises for the NHS, a short guide to achieving better outcomes from NHS procurement and how social enterprises can help in achieving this. The guide explains why the NHS should consider buying goods and services from a social enterprise and what it can do to encourage social enterprises to successfully compete for contracts.

King's Fund (2006) Where the Patient was King? A study of patient choice and its effect on five specialist HIV units in London. London: King's Fund.

Patient choice has been central to the government’s recent NHS reforms, along with a new payment system that rewards hospitals that are attractive to patients. But will these reforms make services more responsive? In the treatment of HIV and AIDS, patients have always had a choice of which hospital to go to. This paper explores the impact of patient choice on services in this area.

Audit Commission (2006) Public Interest Report and Referral to the Secretary of State Cheshire West Primary Care Trust. London: Audit Commission.

As external auditors of Cheshire West PCT, it is our professional opinion that the financial standing problems of Cheshire West PCT should be reported to the public under section 8 of the Audit Commission Act 1998.

House of Commons Health Committee ( 2006)NHS Charges: Third Report of Session 2005–06
Volume II: Written evidence. London: TSO.

When the National Health Service was established in July 1948 the principle was to provide healthcare for all based on need, not on the ability to pay, except where regulations provide otherwise. Initially, the prescription charge was introduced in 1952 based on a charge per form. In 1956 a charge per item prescribed was introduced. The charge was abolished in 1965 and re-introduced in 1968. The categories of exemption are fundamentally unchanged since their introduction in 1968.

Audit Commission (2006) NFI matters: An update on the Audit Commission’s National Fraud Initiative. London: Audit Commission.

In 2004/05, we ran a series of pilots to test the benefit of adding specific new data
matching areas to the NFI portfolio. These were payments to creditors, serial insurance claimants, abuse of blue badges and overpayments to care homes. These pilots have brought some great results, including a number of successful prosecutions as well as the recovery of overpayments.

Evidence from Journals

Latest Questions to the Primary Care Question Answering Service

ASSESSMENT AND DIAGNOSIS

What is the likely cause of a lady in mid 20s with fever, headaches, vomiting, general aching, swollen hands and feet who 2-3 days later starts skin peeling?

Is lamotrigine a liver enzyme inducer? ie would a woman on lamotrigine and an combined oral contraceptive pill need a 50 microgram pill?

What is the effect of anaemia on HbA1c? I have read conflicting evidence on this.

How do you estimate CVD risk in people already on antihypertensive and/or lipid lower therapy?

In patients with ulcerative colitis who are on long term mesalazine treatment, should renal function be checked on a regular basis?

Is isolated vertigo a common presentation of stroke in an elderly patient with cardiovascular risk factors? The patient was diagnosed with acute labyrinthitis, should we have been more reluctant to accept a diagnosis of labyrinthitis in such a case?

I am trying to find out some information on how to interpret the results of a Protein Creatinine Index (PCI) to assess proteinuria

CARDIOVASCULAR DISEASE

Is there any evidence that one statin is better than another statin at lowering triglycerides in a patient with high cholesterol (patients cholesterol is now under control but triglycerides remain high)

In people with hypertension will eating 5 fruit and vegetables a day be more effective at reducing blood pressure than taking anti-hypertensives alone?

CAUSES, RISKS AND PREVENTION

What is the recommended regime for routine immunisation af a)adolescents and b) adults whose previous immunisation history is unknown and unobtainable.

What are the causes of a black tongue in a 10 w old baby?

How suitable is Topiramate for Juvenile Myoclonic Epilepsy in a 15yr old girl and if they experience sided effects in the first 3 weeks of taking in it will these subside or are they likely to remain or worsen?

GASTROENTEROLOGY

Are there any other treatment options for intractable pruritus ani for which bland ointments etc have not helped. I once read something about capsaicin cream. Is there any evidence for this?

EAR, NOSE AND THROAT

In a 45 yr old man with post nasal drip, what is the most effective treatment to reduce symptoms? What alternatives are there?

MUSCULOSKELETAL DISEASES

A lady with terrible restless legs and a low ferritin of 7.5 (ref range 12-230) but a normal Hb. is it worth putting her on iron?

Hitting the Headlines - Evidence Behind the Press Stories

Possible new bird flu vaccine

A new vaccine against bird flu has been developed, reported six newspapers (2nd Feb 2006)(1-6). The reports were based on laboratory studies where a new vaccine had provided protection in mice. Two newspaper articles omitted to mention that it may be several years before a vaccine is available for human use (1,2).

Hope that a new bird flu vaccine had been developed was reported in six newspapers (1-6). Four reported that unlike conventional vaccines, this one could be stockpiled (3-6).
The newspaper reports were based on a series of experimental studies which tested a vaccine genetically engineered from the common cold virus (7). The studies were carried out on mice and investigated the ability of the vaccine to protect the mice from three variations of the H5N1 type of avian influenza infection, isolated from people. The researchers also looked at the method of delivery of the vaccine and its ability to produce T cells which fight infections.
The researchers' findings appear to follow from the results of the experiments. However, as stated in four of the newspapers, further development work and eventually trials in human volunteers are required before such a vaccine is made generally available.

Evaluation of the evidence base for adenoviral-vector-based influenza vaccine against H5N1 strains in mice

Where does the evidence come from?

The research was conducted by Mary A Hoelscher and colleagues at the Influenza Branch, Division of Rickettsial and Viral Diseases, Centers for Disease Control and Prevention, Atlanta USA, and the Department of Veterinary Pathobiology, Purdue University, USA.

What were the authors' objectives?

To develop an influenza vaccine and to assess the immunogenicity and efficacy of the vaccine to confer protection in BALB/c mice.

What was the nature of the evidence?

The researchers developed a vaccine by genetically engineering a common cold virus to produce the protein haemugglutinin subtype 5(H5HA), a component of the H5N1 avian influenza virus. Controlled trials of the vaccine were then carried out on mice in a laboratory.

What interventions were examined in the research?

In a series of laboratory experiments, groups of mice were vaccinated with HAd-H5HA, HAd-deltaE1E3, or rH5HA either in the presence or absence of 1% alum adjuvant. The control groups of mice received phosphate-buffered saline. Two doses of vaccine were given four weeks apart. Four weeks later all the mice were infected with a lethal for mice dose of the H5N1 HK/483/97 virus. The mice were monitored for clinical signs and bodyweight changes for 14 days. Further similar experiments were conducted to test more recent strains of the H5N1 virus isolated from people (eg HK/213/03) and investigate the route of immunisation (intramuscular or intranasal). The researchers used a further trial to determine whether the vaccine induced functional CD 8 T cells in mice, as these cells have been shown to contribute to viral clearance.

What were the findings?

HAd-H5HA and rH5HA plus alum produced better protective effect than the interventions used in the other groups against HK/156/97 virus. However, HAd-H5HA was the most effective against the two other virus strains tested. Overall, intramuscular delivery of HAd-H5HA vaccine induced consistently higher responses than intranasal delivery. Mice that received the HAd-H5HA vaccine had a three to eight fold higher frequency of CD8 T cells compared to the other groups.

What were the authors' conclusions?

That BALB/c mice immunised with HAd-H5HA vaccine were effectively protected from H5N1 disease. The authors also said the findings highlight the potential of an Ad-vector-based delivery system which offers stockpiling options for the development of a pandemic influenza vaccine.

How reliable are the conclusions?

As the studies are laboratory studies no formal assessment of the reliability of the authors' conclusions has been made. However, they would appear to be reasonable, given that the authors word their discussion in terms of what the research could 'potentially' lead to. Clearly further development work and eventually trials in human volunteers are required before such a vaccine becomes widely available.

Systematic reviews

There were no related systematic reviews identified on the Cochrane Database of Systematic Reviews (CDSR) or on the Database of Abstracts of Reviews of Effects (DARE).

References and resources

1. GM vaccine raises hopes of beating bird flu. The Guardian, 2 February 2006, p7.

2. Common cold cure for bird flu. Daily Mirror, 2 February 2006, p11.

3. New bird flu vaccine may be key to preventing pandemic. The Times, 2 February 2006, p8.

4. Cold virus link for bird flu vaccine. The Daily Telegraph, 2 February 2006, p13.

5. Vaccine hope on bird flu. The Sun, 2 February 2006, p27.

6. Scientists create a new bird flu vaccine. Daily Mail, 2 February 2006, p35.

7. Hoelscher MA, Garg S, Bangari DS, Belser JA, Lu X, Stephenson I, et al. Development of adenoviral-vector-based pandemic influenza vaccine against antigenically distinct human H5N1 strains in mice. The Lancet, (Early Online Publication).

Consumer information

Health Protection Agency - Influenza

NHS Direct - Avian flu

Science and development network - Bird flu: the facts

Previous Hitting the Headlines summaries on this topic

Antiviral treatment for avian flu. Hitting the Headlines archive, 19 January 2006.

'New drug promises to hit flu where it hurts'. Hitting the Headlines archive, 23 January 2003.

Drug stops flu's spread through families. Hitting the Headlines archive, 14 February 2001.

Post 17: 3rd February 2006

2006-02-02T08:26:00.000Z

Links are given to online full text resources, all other materials can be obtained via the Fade Library, just mail your request to library.services@fade.nhs.uk

Latest Technology Assessments and Appraisals

The clinical effectiveness and cost-effectiveness of computed tomography screening for lung cancer: systematic reviews (Black) 106 pages, Volume 10, number 3

Computed tomography (CT) screening for lung cancer does not currently meet the accepted National Screening Committee criteria, with no randomised controlled trials and no evidence to support its clinical effectiveness or cost-effectiveness.

The clinical and cost-effectiveness of donepezil, rivastigmine, galantamine and memantine for Alzheimer’s disease (Loveman) 176 pages, Volume 10, number 1

To provide an update review of the best quality evidence for the clinical effectiveness and cost-effectiveness of donepezil, rivastigmine and galantamine for mild to moderately severe Alzheimer’s disease (AD) and of memantine for moderately severe to severe AD.

FOOD: a multicentre randomised trial evaluating feeding policies in patients admitted to hospital with a recent stroke (Dennis) 136 pages, Volume 10, number 2

Study findings did not support routine supplementation of hospital diet for unselected stroke patients who are predominantly well nourished on admission nor did they support a policy of early initiation of percutaneous endoscopic gastrostomy (PEG) feeding in dysphagic stroke patients.

Latest Guidelines

NICE (2006) High dose rate brachytherapy for localised prostate cancer - Interventional procedures consultation document. NICE: London.

Prostate cancer is one of the most common cancers in men. It tends to affect older men, with the risk rising with age. It is not a single disease entity but may be indicated form an incidental biopsy finding to presentation with metastatic prostate cancer, which may or may not cause any symptoms or shorten life. Symptoms when they occur include urinary outflow obstruction and features of metastases, such as bone pain. Prognosis with prostate cancer is variable and depends on the grade of the tumour and stage of the diagnosed cancer. Treatment options depend on the stage of the cancer. Brachytherapy is a form of radiotherapy in which delivery of radiation is targeted directly to the prostate gland through the implantation of small radioactive pellets. Brachytherapy may be used in combination with external beam radiation (EBRT) in high dose therapy.

The consultation period ends on 28/02/2006.

Scottish Intercollegiate Guidelines Network (2005) Management of transitional cell carcinoma of the bladder. Edinburgh: Sign.

Transitional cell carcinoma of the bladder is the fifth most common cancer in men and fifteenth in women in Scotland. Seventy five per cent of patients present with superficial tumours and in 10% this will progress to muscle invasive cancer. Invasive cancer is diagnosed in 25% of patients and has a five year survival of less than 50%. Superficial disease recurs in up to 80% of patients. The guidelines cover referral and all aspects of medical and surgical management of superficial and invasive disease. Specific aetiological factors related to lifestyle and occupation are covered and information for discussion with patients and carers is highlighted.

Latest Reports

Department of Health (2006) Our health, our care, our say: a new direction for community services. London: TSO.

The White Paper, Our health, our care, our say: a new direction for community services aims to provide people with more choice and say over the care they receive in the community, and much closer working and coordination between health and social care. New measures outlined in the White Paper include:

Links are given to online full text resources, all other materials can be obtained via the Fade Library, just mail your request to

Shifting expenditure from spending on hospitals to spending on care closer to home and on preventative services

New responsibilities placed on local councils and the NHS to work together to provide joined-up care plans for those who need them

Bringing some specialties out of the hospital nearer to people including dermatology, ENT, orthopaedics and gynaecology

Introducing a new generation of community hospitals that will provide diagnostics, minor surgery, outpatient facilities and access to social services in one location

Pilot a new NHS “Life Check” to assess people's lifestyle risks, the right steps to take, and provide referrals to specialists if needed

Give patients a guarantee of registration onto a GP practice list in their locality and simplifying the system for doing this

Introducing incentives to GP practices to offer opening times that respond to the needs of patients in their area

Increasing the quantity and quality of primary care in under served, deprived areas through nationally supported procurement of new capacity with contracts awarded by PCTs

Supporting people to self care by trebling the investment in the Expert Patient Programme

Developing an “information prescription” for people with long term health and social care needs and for their carers, investing in professional education and skills development

Providing a Personal Health and Social Care Plan as part of an integrated health and social care record

More support for carers including improved emergency respite arrangements and the establishment of a national helpline for carers

Extension of direct payments and piloting of Individual Budgets for social care

Our health, our care, our say: a new direction for community services: A brief guide

Our health, our care, our say: a new direction for community services: Easy Read Version

Change Agent Team (2006)Making Connections, the third and final Annual Report. London: DoH.

This report covers the third year of the health and social care Change Agent Team. It will be their last report as they become part of the new Care Services Improvement Partnership (CSIP). The report reviews the work of the Change Agent Team during 2004/05 and highlights the team's new work areas such as development of Older People's Mental Health Services, Community Hospitals, Telecare and Extra Care Housing

Matrix (2005) Improvement partnership for hospitals: evaluation report. Coventry: NHS Institute for Innovation and Improvement.

This document summarises the lessons learnt from the Improvement Partnership for Hospitals (IPH). It shows that IPH did have an impact, and that people were most likely to adopt clinical systems improvement ideas after training at local and national workshops.

Ofcom (2005) Ofcom own-initiative investigation into the price of making telephone calls to hospital patients:A case closure document issued by the Office of Communications. London: Ofcom.

Ofcom closed its investigation into the price of telephone calls to hospital patients with a recommendation that the Department of Health ('DoH') review all aspects of the installation and operation of bedside telephone and entertainment systems in hospitals

Evidence from Journals

Trials

Latest Questions to the Primary Care Question Answering Service

ASSESSMENT AND DIAGNOSIS

In an otherwise healthy young male who has recurrent haematuria after exercise (jogging for an hour a day) what investigations should be done?

A patient stopped depo 6 months ago and still has no periods, which she wants to initiate, and suggestions?

What is the relative risk for a 14 year old girl travelling on long haul flights of thrombosis if she is on the contraceptive pill?

Are there any significant medical conditions that cause night terrors in a 2 year old child? What advice can I give the mother?

Is there any information on the reliability and validity of wound assessment charts?

Are there any up to date guidelines dealing with burns and scalds?

Can an Indian female vegetarian be suffering fromVitamin D deficiency as a result of her diet?

How high can a testsosterone level be before PCOS is unlikely and more sinister causes should be looked for?

What is the Cockcroft Gault calculation and how is it used?

Is there any guidance on the safety of biopsy of possible squamous cell skin cancer in primary care?

CAUSES, RISKS AND PREVENTION

Is there any evidence that bladder irritants (caffeine, alcohol, nicotine) are directly irritant to the bladder wall or are they deemed irritant by virtue of their diuretic properties? Does avoiding them actually help bladder stability?

Are veterinary workers, and workers at risk of exposure to animal body fluids at risk specifically of hepatitis B? What immunisations should such groups be offered and why?

What harm can result from allowing seizure activity in temporal lobe epilepsy to continue?

When can you start a COC after stopping the most common anti epileptic drugs e.g. Carbamazepine or Lamotrigine?

Are Tampons sterile? Is 'Toxic Shock Syndrom' related to length of time a tampon is left in the vagina or is it completely unrelated and can individuals suffer from this immeditely after a tampon is inserted?

Do pregnant women have to avoid goats as well as sheep?

Parents of a teenager with mumps recently contacted me about having a mumps vaccine. Is there any guidance on vaccinating contacts with mumps cases?

Use of antidepressants in children with depression (ages 5-18)

How suitable are IUDs (non-hormonal) for patients with multiple sclerosis?

Is it safe for a patient with IUDs (non-hormonal) to have a MRI scan?

If someone suffered poliomyelitis as a child, would this render them immune, thus not requiring further immunisation.

Is there any evidence to support not adminstering antipyretics either post vaccination or in fever

CARDIOVASCULAR DISEASE

In the elderly, should statins be started at lower doses e.g. simvastatin 10 or 20mg and titrated upwards?

In patients on multiple lipid lowering agents including a statin a fibrate and ezetimibe is the risk of pancreatitis cumulative with added agents?

What are the side-effects of statins?

Should patients on oral steroids be screened for aortic aneurysm? Is there an association between oral steroids and large blood vessel abnormalities?

INFECTIOUS DISEASES

Is there evidence that melatonin treatment improves symptoms of fatigue in patients with chronic fatigue syndrome?

NEUROLOGICAL DISEASES

Is there any evidence for use of oxygen therapy in the treatment of migraine. If so how should the oxygen be used ?flow rate

HEALTH MANAGEMENT

Do you know what the criteria is for chronic renal disease in the new contract? Will it be based on GFR and if so what is the cut off value.

GASTROENTEROLOGY

1)How long should a patient with ulcerative colitis continue to take oral mesalazine/5' ASA be continued to prevent relapse? 2) How should an acute exacerbation while on oral 5'ASA treatment be managed?

Hitting the Headlines - Evidence Behind the Press Stories

Possible new bird flu vaccine

A new vaccine against bird flu has been developed, reported six newspapers (2nd Feb 2006)(1-6). The reports were based on laboratory studies where a new vaccine had provided protection in mice. Two newspaper articles omitted to mention that it may be several years before a vaccine is available for human use (1,2).

Hope that a new bird flu vaccine had been developed was reported in six newspapers (1-6). Four reported that unlike conventional vaccines, this one could be stockpiled (3-6).
The newspaper reports were based on a series of experimental studies which tested a vaccine genetically engineered from the common cold virus (7). The studies were carried out on mice and investigated the ability of the vaccine to protect the mice from three variations of the H5N1 type of avian influenza infection, isolated from people. The researchers also looked at the method of delivery of the vaccine and its ability to produce T cells which fight infections.
The researchers' findings appear to follow from the results of the experiments. However, as stated in four of the newspapers, further development work and eventually trials in human volunteers are required before such a vaccine is made generally available.

Evaluation of the evidence base for adenoviral-vector-based influenza vaccine against H5N1 strains in mice

Where does the evidence come from?

What were the authors' objectives?

To develop an influenza vaccine and to assess the immunogenicity and efficacy of the vaccine to confer protection in BALB/c mice.

What was the nature of the evidence?

What interventions were examined in the research?

What were the findings?

What were the authors' conclusions?

How reliable are the conclusions?

Systematic reviews

There were no related systematic reviews identified on the Cochrane Database of Systematic Reviews (CDSR) or on the Database of Abstracts of Reviews of Effects (DARE).

References and resources

1. GM vaccine raises hopes of beating bird flu. The Guardian, 2 February 2006, p7.

2. Common cold cure for bird flu. Daily Mirror, 2 February 2006, p11.

3. New bird flu vaccine may be key to preventing pandemic. The Times, 2 February 2006, p8.

4. Cold virus link for bird flu vaccine. The Daily Telegraph, 2 February 2006, p13.

5. Vaccine hope on bird flu. The Sun, 2 February 2006, p27.

6. Scientists create a new bird flu vaccine. Daily Mail, 2 February 2006, p35.

Consumer information

Health Protection Agency - Influenza

NHS Direct - Avian flu

Science and development network - Bird flu: the facts

Previous Hitting the Headlines summaries on this topic

Antiviral treatment for avian flu. Hitting the Headlines archive, 19 January 2006.

'New drug promises to hit flu where it hurts'. Hitting the Headlines archive, 23 January 2003.

Drug stops flu's spread through families. Hitting the Headlines archive, 14 February 2001.

Aricept for dementia

Aricept is effective for people with mild, moderate and severe dementia without increasing NHS costs reported the Daily Mail on 25th January 2006. The newspaper report did not make it clear that cost data from the review did not relate to the UK and comments about the effectiveness in mild dementia may be overstated.

The Daily Mail (1) reported that Aricept is effective for patients with mild, moderate and severe dementia, helping with memory loss and daily living. They reported that Aricept was not more expensive for the NHS compared to placebo or sham, stating that this contradicts the latest guidance from the National Institute for health and Clinical Excellence (NICE).
The newspaper article is based on a systematic review (2) of 23 trials that compared Aricept to placebo. The authors concluded people with mild, moderate and severe dementia due to Alzheimer's disease treated for periods of 12, 24 or 52 weeks with Aricept experienced benefits in cognitive function, activities of daily living and behaviour. They also stated that there is some evidence that Aricept is neither more nor less expensive compared to placebo.
The newspaper article did not make it clear that the information on costs of the drug reported in the review were not specifically related to the UK. Also, most of the studies in the review were only 12 to 24 weeks duration and not all - 'for at least a year' as stated in the paper. The review is of reasonable quality though should be interpreted with some caution. Appropriate processes were not used in the review to reduce error and bias and the review did not specifically investigate the relative effectiveness of the drug in patients with different disease severity.

Evaluation of the evidence base for Aricept for dementia due to Alzheimer's disease.

Where does the evidence come from?

This systematic review was conducted by Jacqueline Birks at the Division of Clinical Geratology at the University of Oxford and Dr Richard Harvey at the University of Melbourne. The study was also supported by Barwon Health, Australia.

What were the authors' objectives?

To assess whether Aricept (donepezil) improves the well-being of patients with dementia due to Alzheimer's disease.

What was the nature of the evidence?

The evidence comes from a Cochrane systematic review of 23 trials, involving 5,272 participants. The review included double-blind randomised controlled trials (RCTs) that compared Aricept to placebo treatment, in patients who had been diagnosed as having probable Alzheimer's disease using accepted criteria. The participants in the studies had mild, moderate and severe dementia, however it is unclear from the review the proportion of patients with each level of severity. The mean Mini Mental State Examination (MMSE) scores ranged from 11-24 in the included studies. The review investigated the effect of Aricept on cognitive function, activities of daily living, global clinical state and quality of life. Side effects and some additional outcomes were also reported.

What interventions were examined in the research?

The trials included in the review compared either 5 or 10mg of Aricept per day to placebo treatment. Treatment duration in the included studies ranged from 12 weeks to 60 weeks, however only three of the included studies were of one year or more.

What were the findings?

Only 14 of the 23 studies reported results in sufficient detail to be included in the analysis.

In general, the trials found that Aricept had a beneficial effect in comparison to placebo for all aspects of Alzheimer's disease. Aricept had a beneficial effect in comparison to placebo in terms of physician assessed global state and cognitive function. There was also evidence from three studies of a benefit in terms of activities of daily living, though no evidence of any benefit in relation to quality of life. Aricept was associated with significantly more adverse events than placebo, particularly so for 10 mg of Aricept per day.

Two studies included in the review reported data on the cost-effectiveness of Aricept compared to placebo in various countries; but not the UK. There were no significant differences between Aricept and placebo, except for the total carer costs which was in favour of placebo.

What were the authors' conclusions?

People with mild, moderate or severe dementia due to Alzheimer's disease treated for periods of 12, 24 or 52 weeks with Aricept experienced benefits in cognitive function, activities of daily living and behaviour. There is some evidence that Aricept is neither more nor less expensive compared to placebo when assessing total health care resource costs. The evidence suggests that the benefits of Aricept at 10 mg once a day are marginally greater than 5 mg per day, however given the better tolerability of Aricept at 5 mg a day, the lower dose may be the better option. The debate of the efficacy of Aricept continues as the treatment effects are small and not always apparent in clinical practice.

How reliable are the conclusions?

The author's conclusions follow from the findings of the review. However, the review has weaknesses which should be considered. Only one reviewer screened the studies for inclusion in the review and extracted data so there is a possibility that bias or error may have been introduced and some potentially relevant studies may have been missed. Additionally, only a small number of studies were available for most of the outcomes. It is unclear what proportion of participants had mild, moderate and severe dementia and the effects of Aricept with regards to these various levels of severity were not investigated. Also, data relating to the cost of Aricept were limited, not quality assessed, and did not relate to the UK.

Systematic reviews

There were no additional related systematic reviews identified on the Cochrane Database of Systematic Reviews (CDSR). Three systematic reviews were identified on the Database of Abstracts of Reviews of Effects (DARE)(3-5).

References and resources

1. Alzheimer's outcry: drug that NHS plans to ration 'can ease suffering'. Daily Mail, 25 January 2006, p18.

2. Birks JS, Harvey R. Donepezil for dementia due to Alzheimer's disease. The Cochrane Database of Systematic Reviews 2003, Issue 3. Art. No.: CD001190. DOI: 10.1002/14651858.CD001190

3. Dooley M, Lamb H M. Donepezil: a review of its use in Alzheimer's disease. Drugs and Aging 2000;16(3):199-226.[DARE Abstract]

4. Wolfson C, Oremus M, Shukla V, Momoli F, Demers L, Perrault A, Moride Y. Donepezil and rivastigmine in the treatment of Alzheimer's disease: a best-evidence synthesis of the published data on their efficacy and cost effectiveness. Clinical Therapeutics 2002;24(6):862-886.[DARE Abstract]

5. Wolfson C, Moride Y, Perrault A, Momoli F, Demers L, Oremus M. Drug treatments for Alzheimers's disease: 1. A comparative analysis of clinical trials. Ottawa, ON, Canada: Canadian Coordinating Office for Health Technology Assessment (CCOHTA) 2000:1-124.[DARE Abstract]

6. Loveman E, Green C, Kirby J, Takeda A, Picot J, Payne E, et al. The clinical and cost-effectiveness of donepezil, rivastigmine, galantamine and memantine for Alzheimer's disease. Health Technology Assessment 2006;10(1).

7. Clegg A, Bryant J, Nicholson T, McIntyre L, De Broe S, Gerard K, et al. Clinical and cost-effectiveness of donepezil, rivastigmine and galantamine for Alzheimer's disease: a rapid and systematic review.Health Technology Assessment 2001;5(1).

Consumer information

Alzheimer's Society

NHS Direct - Alzheimer's disease

Alzheimer's Research Trust

Previous Hitting the Headlines summaries on this topic

'Alzheimer's drug has little real benefit'. Hitting the Headlines archive, 25 June 2004.

Document of the Week from the National Library for Health

Junghans, C., Feder, G., Hemingway, H., Timmis, A. and Jones, M. (2005) Recruiting patients to medical research: double blind randomised trial of "opt-in" versus "opt-out" strategies. BMJ 331:940.

What's New from the National Library for Health

Post 16: 27 January 2006

2006-01-26T11:17:00.000Z

Links are given to online full text resources, all other materials can be obtained via the Fade Library, just mail your request to library.services@fade.nhs.uk

Latest Technology Assessments and Appraisals

Latest Guidelines

NICE (2006) Arrhythmia - implantable cardioverter defibrillators (ICDs) - guidance. London: NICE.

Updated NICE guidance on the use of implantable-cardioverter defibrillators (ICDs) for people at risk of sudden cardiac death (SCD) as a result of cardiac arrhythmias. The guidance, recommends the following categories of patients for an ICD:

primary prevention of SCD in the group of individuals who can be identified as being at high risk of SCD either from a number of clinical factors (e.g. previous history of heart attack, heart failure and results of electrical testing of the heart), or, in the presence of specific cardiac abnormalities known to carry a high risk of SCD including people with familial conditions such as long QT syndrome, and hypertrophic caridomyopathy as well as certain types of congenital heart disease.

secondary prevention of SCD in individuals who have survived (been resuscitated) a sudden cardiac event.

An ICD is a small device, placed beneath the skin of the upper chest below the left shoulder. Leads from the device are passed into the heart to continually sense for a rapid heart rhythm that might cause SCD and deliver a small electric shock to return the rhythm back to normal if necessary.

Parkinson's disease - full guideline, second consultation

A clinical practice guideline on Parkinson’s Disease is being developed for use in the NHS in England and Wales. Registered stakeholders for the guideline are invited to comment on the provisional recommendations during the consultation period, which runs until the 21tst February 2005. Publication of the final guideline is expected in June 2006. Please see the links above to access the guideline.

Latest Reports

Office for National Statistics (2006) Focus on Health. Basingstoke: Palgrave Macmillan.

Describes the health of people living in the UK. The data is based on five key areas : health status, risk factors, ill-health, preventive, curative and long-term care services and mortality. Emphasis is placed on trends over time.

House of Commons Committee of Public Accounts (2006) The NHS Cancer Plan: a
progress report: Twentieth Report of Session 2005–06: Report, together with formal minutes,
oral and written evidence. London: TSO.

The Commons' Public Accounts Committee report on the 10-year Cancer Plan said results were mixed, but that there were major improvements in services. MPs praised the availability of drugs. But criticism came for inequalities in death rates across the UK and lack of effective performance monitoring. The report cited the fact that one in three cancer networks - regional groupings of hospitals, local health managers, councils and the voluntary sector set up to co-ordinate services - had no comprehensive plans in place and monitoring of performance was also said to be "inconsistent". Waiting and staffing targets had been met, the MPs said, but the plan to develop a public awareness campaign about cancer symptoms had not been met. The report also said the Cancer Plan needed to be redrafted because since it was published the NHS has undergone major restructuring with the setting up of 300 primary care trusts, regional strategic health authorities and foundation hospitals.

Department of Health (2005) Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees. London: DoH.

NHS Research Ethics Committees (RECs) are convened to provide independent advice on
the extent to which proposals for research studies to be carried out within the NHS comply
with recognised ethical standards.

The primary purpose of a REC when considering the proposed study is to protect the
rights, safety, dignity and wellbeing of all actual or potential participants. Ethics review is
one of a series of safeguards intended to protect individuals. They are described in the
Research Governance Framework for Health and Social Care. Research governance is
intended to enable relevant research of good quality, as well as to forestall inappropriate
research.

Ethical approval is therefore only one of the r equirements for initiation of a r esearch
proposal. The Advisory Group was asked to report on the operation of NHS R esearch
Ethics Committees and on the inter face with other research approval processes.

Central Office for Research Ethics Committees (2006) Implementing the recommendations of the Ad Hoc Advisory Group: consultation. London: National Patient Safety Agency.

Through its Central Office for Research Ethics Committees (COREC), the National Patient Safety Agency (NPSA) has published its consultation on implementing the recommendations of the Report of the ad hoc advisory group on the operation of NHS research ethics committees, an independent report commissioned by the Department of Health. One of the key proposals in the consultation is to reconfigure the research ethics committee system as a more agile research ethics service. This will include the establishment of a new independent group of National Research Ethics Advisers who will ensure that only appropriate proposals for studies are considered by full committees and who will also be able to take some straightforward decisions on their behalf. The consultation ends on the 21st April 2006.

Department of Health (2006) Best Research for Best Health:A new national health research strategy: The NHS contribution to health research in England. London: DoH.

Best Research for Best Health outlines the direction that NHS research and development (R&D) will take over the next five years to ensure a vibrant, world-class environment for conducting and using NHS health research.

Academy of Medical Sciences (2006) Personal data for public good: using health information in medical research. London: Academy of Medical Sciences.

This report claims that research has been inhibited by confusing regulatory guidance, stifling bureaucracy and unnecessary constraints on researchers’ access to health data. The large numbers treated by the NHS and the use of electronic records should allow the UK to lead the field in analysing health data to allow better understanding and tackling of disease. Instead it has been hidebound by bureaucracy.

Department of Health (2006) Implementing local commissioning for primary care dentistry - understanding the transitional provisions order: factsheet no. 8. London: DoH.

The purpose of this factsheet is to explain how the following groups of dentists will transfer to the new contracts:

dentists who are working within the “old” general dental services (GDS) system (under section 35 of the NHS Act 1977),

dentists with a practice limited to orthodontics, and

dentists working in personal dental services (PDS) pilots (under the Primary Care Act 1997)

Care Services Improvement Partnership (2006) Women at Risk: The mental health of women in contact with the judicial system. London: DoH.

Sets out the key findings and recommendations of the work, and in particular the role of the NHS when responsibility for the health of those in custody is fully transferred to PCTs in April 2006. Two key messages underpinning all the recommendations is the need for partnership working within establishments, between government departments, and between statutory and voluntary organisations in the community, and the need to make interventions at an early stage of a woman’s contact with the criminal justice system. This publication has only just become available, although it was originally published on the 6th January 2006.

Evidence from Journals

Öngür D
About 30% of men with schizophrenia or schizoaffective disorders have obsessive-compulsive symptoms
Evid. Based Ment. Health, Vol.9, No.1, p.28

Grant BF
About 26% of people in the US have an anxiety, mood, impulse control, or substance disorder
Evid. Based Ment. Health, Vol.9, No.1, p.27

Harpaz-Rotem I
Young people admitted with self-injury had more severe psychiatric disorders in 2000 than in 1990
Evid. Based Ment. Health, Vol.9, No.1, p.26

Schmidt N
Suicide ideation and attempts are more prevalent in people aged 25–44 years in Australia but become less prevalent in older people
Evid. Based Ment. Health, Vol.9, No.1, p.25

Links PS
History of psychiatric hospital admission increases the risk of suicide less in the very old than in middle aged people
Evid. Based Ment. Health, Vol.9, No.1, p.24

Foong J
Epilepsy or a family history of epilepsy increases the risk of schizophrenia or schizophrenia-like psychosis
Evid. Based Ment. Health, Vol.9, No.1, p.23

Becker DR & Drake RE
Supported employment interventions are effective for people with severe mental illness
Evid. Based Ment. Health, Vol.9, No.1, p.22

Terman M
Review: light therapy is an effective treatment for seasonal affective disorder
Evid. Based Ment. Health, Vol.9, No.1, p.21

Blacker D
Neither vitamin E nor donepezil delays progression from amnestic mild cognitive impairment to Alzheimer’s disease in the long term
Evid. Based Ment. Health, Vol.9, No.1, p.20

Gilley DW
Review: cholinesterase inhibitors reduce burden and care time for informal carers of people with Alzheimer’s disease
Evid. Based Ment. Health, Vol.9, No.1, p.19

Burgio L
Training nursing home care staff to recognise psychopathology improves their ability to identify depressed residents
Evid. Based Ment. Health, Vol.9, No.1, p.18

Price DJR
A structured activity programme reduces depressive symptoms in moderately depressed older men with coronary heart disease, but not women
Evid. Based Ment. Health, Vol.9, No.1, p.17

Byrne MK
Pharmacotherapy and cognitive behavioural therapy: similarly cost effective compared with community referral for disadvantaged women with major depression
Evid. Based Ment. Health, Vol.9, No.1, p.16

Muzina DJ
Divalproex and lithium are similarly cost effective for adults with bipolar disorder
Evid. Based Ment. Health, Vol.9, No.1, p.15

Bowden CL
Cognitive therapy is more cost effective than standard care alone for bipolar disorder
Evid. Based Ment. Health, Vol.9, No.1, p.14

Overbeek T & Schruers K
Cognitive behavioural therapy reduces nocturnal panic in people with panic disorder
Evid. Based Ment. Health, Vol.9, No.1, p.13

Grilo CM
Cognitive behavioural therapy does not improve outcome in obese women with binge eating disorder receiving a comprehensive very low calorie diet programme
Evid. Based Ment. Health, Vol.9, No.1, p.12

Isaac MT
Individual dietary education reduces olanzapine associated weight gain
Evid. Based Ment. Health, Vol.9, No.1, p.11

Edlinger M, Fleischhacker WW
Review: no evidence to support gradual over abrupt switching of antipsychotics
Evid. Based Ment. Health, Vol.9, No.1, p.10

Leucht DS, Davis JM
Intramuscular haloperidol and olanzapine begin to reduce psychosis within 24 hours
Evid. Based Ment. Health, Vol.9, No.1, p.9

Kazdin AE
Multisystemic therapy reduces long term rearrest compared with usual treatment
Evid. Based Ment. Health, Vol.9, No.1, p.8

Barton J
Atomoxetine improves teacher rated symptoms in children with ADHD more than placebo
Evid. Based Ment. Health, Vol.9, No.1, p.7

Fombonne E
Risperidone improves restricted, repetitive, and stereotyped behaviour in autistic children and adolescents
Evid. Based Ment. Health, Vol.9, No.1, p.6

Larsen TK
Poor social and interpersonal functioning prior to diagnosis predicts poor outcome for people with first episode psychosis
Evid. Based Ment. Health, Vol.9, No.1, p.5

Latest Questions to the Primary Care Question Answering Service

ASSESSMENT AND DIAGNOSIS

A Duke's score is quoted after an exercise ECG test - I know it relates to ST level changes but how is it worked out and what is a 'significant' score?

How should I interpret a 24 hour BP recording. Is the average reading reasonable to use even if the patient has had a number of high recordings during busy parts of the day ie commuting or getting up?

When should I investigate a patient in primary care for phaeochromocytoma?

In any patient with IHD and > 20% CVD risk started on full treatmnet with statins,aspirin,ACE and bblockers what is the new risk of CVD in the next 10yrs ie by how much is the risk lowered in total by all treatments ?

What are the long term complications on renal function of taking Lithium (for say over 20 years)? How, apart from measuring serum creatinine, should renal problems be monitored in such patients?

How often should CHD risk be assessed in patients with diabetes?

We have been asked to diagnose chronic renal failure as part of the new GP contract. Could you give us guidelines as to how to diagnose this and guidelines on how to manage it, given also that the creatinine level acceptable seems to differ with age.

Do women with previuosly normal smear test results who are no longer sexually active need to continue to have smears? and is there a time scale from last sexual activity where by we would consider stopping?

Are there guidelines on interpretation of 24 hr BP results?

CAUSES, RISKS AND PREVENTION

Do you know of any patient education DVD's (non commercial) that would be suitable for playing in the waiting room, eg brief scenarios about asthma, hypertension, diabetes, flu vacs, childcare etc?

What is the incidence of penicillin allergy?

Could you tell me what to suggest in women over 50 who are still taking pop ,how do we establish when it is time to stop contraception?

What is the antibiotic of choice to treat a case of chlamydia in a breast feeding mother? and what side effects could the baby develop?

CHILD HEALTH

What is the antibiotic of choice in a child who has suspected meningitis presenting to general practice, if they are allergic to penicillin? is it iv chloramphenicol?

Is there any evidence to suggest if infantile colic actually exists and if so, are there any effective remedies ?

What is the latest guidance for managing suspected epiglotittis in the community whilst waiting for an ambulance; is there a role for steroid or anitiobiotic use?

NEUROLOGICAL DISEASE

What interventions are appropriate for a patient with PCOS hoping to start a family in the near future?

HEALTH MANAGEMENT

Please define patient care pathways

MUSCOLOSKELETAL DISEASES

Should you automatically give calcium and Vit D to someone newly diagnosed as having osteoporosis that you commence on Alendronate?

GASTROENTEROLOGY

My patients mother has alpha tripsin1 deficiency and her consultant has asked her daughter to attend for advice & screening. What information do I need to give her?

Does increasing fibre have any benefit in people suffering from haemorrhoids?

TREATMENT AND DISEASE MANAGEMENT

Is there any guidance on the management of HRT withdrawal?

CARDIOVASCULAR DISEASE

1) In a patient with AF and previous TIAs on warfarin presenting with suspected angina is aspirin use contraindicated or more beneficial? 2) what is the percentage of haemorrhagic complications with aspirin and warfarin together do the risks outweigh the benefits?

GENITOURINARY - MALE

Can you please advise at which hospitals radical prostatectomies are carried out on the NHS.

RESPIRATORY

Aerochaber or volumatic in asthma patients, any evidence for or against?

Hitting the Headlines - Evidence Behind the Press Stories

Antiviral treatment for avian flu

Antiviral drugs for influenza may not be effective against avian flu, reported three newspapers (19 January 2006). These articles were based on a systematic review, which found that antiviral drugs eased symptoms of influenza but did not prevent infection. There was no evidence for their use or effectiveness in avian flu.

Three newspapers (1-4) reported that there is no evidence that the antiviral drugs Tamiflu and Relenza are effective against avian flu. One of the articles (4) reported that both Tamiflu and Relenza, as well as two additional antiviral drugs, eased the symptoms of influenza but did not prevent infection.
The newspaper articles are based on a report of two systematic reviews (5) of randomised controlled trials comparing the efficacy and safety of antivirals with placebo against influenza and asymptomatic influenza. The review found that both the older (amantadine and rimantidine) and newer antiviral drugs (Tamiflu and Relenza) prevented or eased symptoms of influenza but did not prevent infection. None of the investigated drugs was effective against influenza-like illnesses. The two older drugs, amantadine and rimantidine, also caused side effects such as hallucinations and agitation. The review was unable to provide any evidence specific to avian-derived influenza.
The main message from the research study that none of the available drugs is likely to be sufficiently effective in the event of an avian-flu pandemic was correctly reflected in all the newspapers. However, three of the newspaper articles were brief and perhaps gave the impression that the research was more specific to avian-derived influenza than it actually was.

Evaluation of the evidence base for the efficacy of antiviral drugs for avian flu.

Where does the evidence come from?

The evidence comes from research led by Dr Thomas Jefferson, based at the Cochrane Vaccines Field, Italy. The study was supported by the UK Department of Health, the Cochrane Review Incentive Scheme 2005, and two ASL grants (ASL19 and ASL20).

What were the authors' objectives?

The objective was to assess the efficacy, effectiveness, and safety of registered antivirals against naturally occurring influenza in healthy adults.

What was the nature of the evidence?

This is based on two systematic reviews of randomised controlled trials of antiviral drugs for the prevention and treatment of influenza. Fifty-two trials comparing the effects of four antiviral agents with control (placebo, no intervention, or symptomatic medication) were included in the review. A comprehensive literature search of several electronic databases, reference lists and contact with the manufacturers and authors of identified studies was used to identify relevant trials. The review studied effects on cases of properly diagnosed influenza (symptomatic or asymptomatic); cases of influenza-like illness, pneumonia, and human influenza caused by avian-derived influenza viruses. It also investigated the effects of the drugs on how infectious people were and for how long (duration and concentration of nasal shedding of viruses or persistence in upper airways). Studies from any part of the world were reviewed.

What interventions were examined in the research?

The review included studies that assessed the effects of M2 ion channel blocking drugs (amantadine and rimantadine) and the neuraminidase inhibitors Tamiflu (oseltamivir) and Relenza (zanamivir), used at any dose, preparation or time schedule against influenza and influenza-like illness.

What were the findings?

Amantadine and Rimantadine:

When used to prevent influenza, amantadine was shown to prevent 61% of influenza A cases and 25% of influenza-like illness but it had no effect in preventing asymptomatic cases of influenza. Also, compared with placebo, amantadine was found to increase the odds of side effects (nausea, insomnia and hallucinations) by two-fold. Rimantadine was found to have similar effects.

When used to treat influenza, compared to placebo, amantadine and rimantadine significantly shortened duration of fever by around a day, but did not stop infected patients being infectious. No data were found for the effect of amantadine or rimantadine specifically on avian-derived influenza.

Tamiflu and Relenza (Neuraminidase inhibitors):

When used for the prevention of influenza, compared to placebo, neither Tamiflu (oral) nor Relenza (inhaled) had an effect against asymptomatic influenza or influenza like illness, even at higher doses. The efficacy of Tamiflu 75mg daily against symptomatic influenza was 61% and 73% at 150mg daily. Relenza (10mg daily) was 62% effective.

When used to prevent influenza in people living in households where someone has already been infected Tamiflu was shown to demonstrate a protective efficacy of 58.5% for households and from 68% to 89% in contacts of index cases. When used for the treatment of patients infected with influenza Tamiflu and Relenza were both associated with shorter times for the alleviation of symptoms and patients were less infectious (viral nasal titres were shown to be significantly reduced). However neither drug stopped patients being infectious irrespective of the dose of the drug.

No credible data assessing the effect of Tamiflu on avian-derived influenza were found. Data from previous studies relating to Tamiflu were briefly reported on in the discussion. High dose Tamiflu was shown to be effective in preventing lower respiratory tract complications (bronchitis and pneumonia) in influenza cases but not influenza-like illness.

What were the authors' conclusions?

The evidence does not support the use of amantadine and rimantadine for influenza. It is also suggested that neuraminidase inhibitors should not routinely be used in the control of seasonal influenza, and should only be used in a serious epidemic or pandemic alongside other public health measures.

How reliable are the conclusions?

This was a well conducted review and the authors' conclusions are likely to be reliable. An effort was made to obtain all the relevant information, and when conducting the review appropriate measures were taken to minimise error and bias. The authors were correct to point out that their conclusions are limited by the quality and quantity of the evidence base.

The review was looking at the effects of antiviral drugs against naturally occurring influenza in healthy adults and the results of the review are applicable to such an illness. The review was unable to provide any evidence specific to avian-derived influenza. Therefore it is unknown if the more effective drugs (Tamiflu or Relenza) would be less or equally effective against avian-derived influenza.

Systematic reviews

There were no related systematic reviews identified on the Cochrane Database of Systematic Reviews (CDSR) or on the Database of Abstracts of Reviews of Effects (DARE).

References and resources

1. No evidence flu drugs work-study. The Guardian, 19 January 2006, p1.

2. Flu fight 'waste' . Daily Mirror, 19 January 2006, p8.

3. Flu drug warning. The Times, 19 January 2006, p2.

4. Flu drugs 'will not work' if pandemic strikes. The Guardian, 19 January 2006, p4.

5. Jefferson T, Demicheli V, Rivetti D, Jones M, Di Pietrantonj C, Rivetti A. Antivirals for influenza in healthy adults: systematic review. Lancet Early Online Publication, 19 January 2006 DOI:10.1016/S0140-6736(06)67970-1.

Consumer information

Health Protection Agency - Influenza

NHS Direct - Avian flu

Science & development network - Bird flu: the facts

Previous Hitting the Headlines summaries on this topic

New drug promises to hit flu where it hurts. Hitting the Headlines archive, 23 January 2003.

Drug stops flu's spread through families. Hitting the Headlines archive, 14 February 2001.

Document of the Week from the National Library for Health

Tramer, M.R., Reynolds, D.J.M., Moore, R.A., McQuay H.J. (1997) Impact of covert duplicate publication on meta-analysis: a case study. BMJ 315:635-64.

Objective: To quantify the impact of duplicate data on estimates of efficacy.

Design: Systematic search for published full reports of randomised controlled trials investigating ondansetron's effect on postoperative emesis. Abstracts were not considered.

Data sources: Eighty four trials (11 980 patients receiving ondansetron) published between 1991 and September 1996.

Main outcome measures: Percentage of duplicated trials and patient data. Estimation of antiemetic efficacy (prevention of emesis) of the most duplicated ondansetron regimen. Comparison between the efficacy of non-duplicated and duplicated data.

Results: Data from nine trials had been published in 14 further reports, duplicating data from 3335 patients receiving ondansetron; none used a clear cross reference. Intravenous ondansetron 4 mg versus placebo was investigated in 16 reports not subject to duplicate publication, three reports subject to duplicate publication, and six duplicates of those three reports. The number needed to treat to prevent vomiting within 24 hours was 9.5 (95% confidence interval 6.9 to 15) in the 16 non-duplicated reports and 3.9 (3.3 to 4.8) in the three reports which were duplicated (P<0.00001). n="25)" style="font-weight: bold;">

Conclusions: By searching systematically we found 17% of published full reports of randomised trials and 28% of the patient data were duplicated. Trials reporting greater treatment effect were significantly more likely to be duplicated. Inclusion of duplicated data in meta-analysis led to a 23% overestimation of ondansetron's antiemetic efficacy.

Post 15: 20 January 2006

2006-01-19T08:35:00.000Z

Links are given to online full text resources, all other materials can be obtained via the Fade Library, just mail your request to library.services@fade.nhs.uk

Latest Reports

Department of Health (2006) Measuring Childhood Obesity: Guidance to Primary Care Trusts. London: DoH.

Provides advice to primary care trusts (PCTs) on how to measure the height and weight of children aged between 4 and 11 years. Measuring outlined in this guidance is for the purpose of population monitoring. Local data on childhood obesity are needed for the following purposes:

To inform local planning and targeting of local resources and interventions.

To enable tracking of local progress against the public service agreement target on obesity, and local performance management.

House of Commons, Committee of Public Accounts (2005) Department of Health: Tackling cancer: improving the patient journey: Nineteenth Report of Session 2005–06: Report, together with formal minutes, oral and written evidence. London: TSO.

The report argues that there still needs to be improvement in access to cancer services, particularly for people with prostate cancer.

Department of Health (2006) Responding to domestic abuse: a handbook for health professionals. London: DoH.

Gives practical guidance to healthcare professionals on working with patients who may have experienced, or are experiencing domestic abuse. It provides:

all readers with an insight into domestic abuse and its effects on individuals, the health service and society;

healthcare professionals with practical prompts that they will be able to use in their day-to-day work with women and children;

managers and policy-makers with advice on creating strategies for improving the care given to those who have experienced, or are experiencing domestic abuse.

Health Protection Agency (2006) HPA National Influenza Summary 2005/2006. London: HPA.

Influenza activity remained within baseline levels in United Kingdom during weeks 01/06 and 02/06 (week ending 15/01/06). GP consultations for influenza-like illness remained at similar levels to previous weeks with the slightly higher rates recorded amongst those aged between 45-64 years and in northern and central regions.

Detections of influenza, from specimens collected for routine testing and by sentinel systems, remain at low levels with influenza B representing 80% (N=47) of those positive influenza specimens referred to the Centre for Infections. Influenza B viruses from both the influenza B lineages (B/Yamagata/16/88 lineage and B/Victoria/2/87 lineage), that circulated during the 2004-2005 season, have been detected this season.

As influenza activity remains at low levels a full evaluation of this season’s influenza vaccine composition should not be made until a significant number of influenza isolates have been collected from the older age groups and other high risk groups that receive the vaccine.

During week 01/06 the incidence of influenza-like illness in the Netherlands was 66.5 per 100 000 population, which was two times higher than the incidence in week 52/05 (27.1/100 000). Activity elsewhere in Europe, reported by the European Influenza Surveillance Scheme (EISS), remained at baseline levels during weeks 52/05 and 01/ 06.

Institute for Healthcare Improvement (2006) Saving Accounts; Stories of how health care organisations are saving time, resources, energy and patients’ lives. Cambridge, MA: IHI.

IHI's 2006 Progress Report contains the extraordinary stories of brave health care institutions that have committed to a new level of performance, along with stories of some of the patients whose lives have been affected by these changes.

Evidence from Journals

Pinto BM, Frierson GM, Rabin C, Trunzo JJ, Marcus BH.(2005) Home-based physical activity intervention for breast cancer patients. J Clin Oncol. 2005 May 20;23(15):3577-87.

PURPOSE: The efficacy of a home-based physical activity (PA) intervention for early-stage breast cancer patients was evaluated in a randomized controlled trial.

PATIENTS AND METHODS: Eighty-six sedentary women (mean age, 53.14 years; standard deviation, 9.70 years) who had completed treatment for stage 0 to II breast cancer were randomly assigned to a PA or contact control group. Participants in the PA group received 12 weeks of PA counseling (based on the Transtheoretical Model) delivered via telephone, as well as weekly exercise tip sheets. Assessments were conducted at baseline, after treatment (12 weeks), and 6 and 9 month after baseline follow-ups. The post-treatment outcomes are reported here.
RESULTS: Analyses showed that, after treatment, the PA group reported significantly more total minutes of PA, more minutes of moderate-intensity PA, and higher energy expenditure per week than controls. The PA group also out-performed controls on a field test of fitness. Changes in PA were not reflected in objective activity monitoring. The PA group was more likely than controls to progress in motivational readiness for PA and to meet PA guidelines. No significant group differences were found in body mass index and percent body fat. Post-treatment group comparisons revealed significant improvements in vigor and a reduction in fatigue in the PA group. There was a positive trend in intervention effects on overall mood and body esteem.

CONCLUSION: The intervention successfully increased PA and improved fitness and specific aspects of psychological well-being among early-stage breast cancer patients. The success of a home-based PA intervention has important implications for promoting recovery in this population.

Briel M, Christ-Crain M, Young J, Schuetz P, Huber P, Periat P, Bucher HC, Muller B. (2005) Procalcitonin-guided antibiotic use versus a standard approach for acute respiratory tract infections in primary care: study protocol for a randomised controlled trial and baseline characteristics of participating general practitioners. BMC Fam Pract. 2005 Aug 18;6:34.

Background: Acute respiratory tract infections (ARTI) are among the most frequent reasons for consultations in primary care. Although predominantly viral in origin, ARTI often lead to the prescription of antibiotics for ambulatory patients, mainly because it is difficult to distinguish between viral and bacterial infections. Unnecessary antibiotic use, however, is associated with increased drug expenditure, side effects and antibiotic resistance. A novel approach is to guide antibiotic therapy by procalcitonin (ProCT), since serum levels of ProCT are elevated in bacterial infections but remain lower in viral infections and inflammatory diseases.

The aim of this trial is to compare a ProCT-guided antibiotic therapy with a standard approach based on evidence-based guidelines for patients with ARTI in primary care.

Methods/Design: This is a randomised controlled trial in primary care with an open intervention. Adult patients judged by their general practitioner (GP) to need antibiotics for ARTI are randomised in equal numbers either to standard antibiotic therapy or to ProCT-guided antibiotic therapy. Patients are followed-up after 1 week by their GP and after 2 and 4 weeks by phone interviews carried out by medical students blinded to the goal of the trial.

Exclusion criteria for patients are antibiotic use in the previous 28 days, psychiatric disorders or inability to give written informed consent, not being fluent in German, severe immunosuppression, intravenous drug use, cystic fibrosis, active tuberculosis, or need for immediate hospitalisation.

The primary endpoint is days with restrictions from ARTI within 14 days after randomisation. Secondary outcomes are antibiotic use in terms of antibiotic prescription rate and duration of antibiotic treatment in days, days off work and days with side-effects from medication within 14 days, and relapse rate from the infection within 28 days after randomisation.

Discussion: We aim to include 600 patients from 50 general practices in the Northwest of Switzerland. Data from the registry of the Swiss Medical Association suggests that our recruited GPs are representative of all eligible GPs with respect to age, proportion of female physicians, specialisation, years of postgraduate training and years in private practice.

Moss S, Gray A, Legood R, Vessey M, Patnick J, Kitchener H (2006)Effect of testing for human papillomavirus as a triage during screening for cervical cancer: observational before and after study. BMJ. 2006 Jan 14;332(7533):83-5.

OBJECTIVE: To assess the effect of introducing testing for human papillomavirus combined with liquid based cytology in women with low grade cytological abnormalities. DESIGN: Observational before and after study. SETTING: Three cervical screening laboratories, England.

PARTICIPANTS: 5654 women aged 20-64 with low grade cytological abnormalities found at routine cervical screening in a pilot; 5254 similar women in the period before the pilot.

INTERVENTIONS: Human papillomavirus testing combined with liquid based cytology in the management of women with borderline or mildly dyskaryotic cervical smear results compared with conventional smear tests, with immediate referral to colposcopy of women positive for human papillomavirus.

RESULTS: 57.9% (3187/5506) of women tested in the pilot were positive for human papillomavirus. The rate of repeat smears fell by 74%, but the rate of referral to colposcopy for low grade cytological abnormalities more than doubled. The estimated negative predictive value of human papillomavirus testing varied between 93.8% and 99.7%.

CONCLUSION: The addition of testing for human papillomavirus in women with low grade cytological abnormalities resulted in a reduction in the rate of repeat smears, but an increase in rates of referral to colposcopy.

Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, Raskin P, Zinman B (2005) Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. NEJM 2005 Dec 22;353(25):2643-53.

BACKGROUND: Intensive diabetes therapy aimed at achieving near normoglycemia reduces the risk of microvascular and neurologic complications of type 1 diabetes. We studied whether the use of intensive therapy as compared with conventional therapy during the Diabetes Control and Complications Trial (DCCT) affected the long-term incidence of cardiovascular disease.

METHODS: The DCCT randomly assigned 1441 patients with type 1 diabetes to intensive or conventional therapy, treating them for a mean of 6.5 years between 1983 and 1993. Ninety-three percent were subsequently followed until February 1, 2005, during the observational Epidemiology of Diabetes Interventions and Complications study. Cardiovascular disease (defined as nonfatal myocardial infarction, stroke, death from cardiovascular disease, confirmed angina, or the need for coronary-artery revascularization) was assessed with standardized measures and classified by an independent committee.

RESULTS: During the mean 17 years of follow-up, 46 cardiovascular disease events occurred in 31 patients who had received intensive treatment in the DCCT, as compared with 98 events in 52 patients who had received conventional treatment. Intensive treatment reduced the risk of any cardiovascular disease event by 42 percent (95 percent confidence interval, 9 to 63 percent; P=0.02) and the risk of nonfatal myocardial infarction, stroke, or death from cardiovascular disease by 57 percent (95 percent confidence interval, 12 to 79 percent; P=0.02). The decrease in glycosylated hemoglobin values during the DCCT was significantly associated with most of the positive effects of intensive treatment on the risk of cardiovascular disease. Microalbuminuria and albuminuria were associated with a significant increase in the risk of cardiovascular disease, but differences between treatment groups remained significant (P< or ="0.05)">

CONCLUSIONS: Intensive diabetes therapy has long-term beneficial effects on the risk of cardiovascular disease in patients with type 1 diabetes.

Schwartz RP, Highfield DA, Jaffe JH, Brady JV, Butler CB, Rouse CO, Callaman JM, O'grady KE, Battjes RJ. (2006) A randomized controlled trial of interim methadone maintenance. Arch Gen Psychiatry. Jan;63(1):102-9.

CONTEXT: Effective alternatives to long waiting lists for entry into methadone hydrochloride maintenance treatment are needed to reduce the complications of continuing heroin dependence and to increase methadone treatment entry. OBJECTIVE: To compare the effectiveness of interim methadone maintenance with that of the usual waiting list condition in facilitating methadone treatment entry and reducing heroin and cocaine use and criminal behavior.

DESIGN: Randomized, controlled, clinical trial using 2 conditions, with treatment assignment on a 3:2 basis to interim maintenance-waiting list control.

SETTING: A methadone treatment program in Baltimore.

PARTICIPANTS: A total of 319 individuals meeting the criteria for current heroin dependence and methadone maintenance treatment. INTERVENTIONS: Participants were randomly assigned to either interim methadone maintenance, consisting of an individually determined methadone dose and emergency counseling only for up to 120 days, or referral to community-based methadone treatment programs.

MAIN OUTCOME MEASURES: Entry into comprehensive methadone maintenance therapy at 4 months from baseline; self-reported days of heroin use, cocaine use, and criminal behavior; and number of urine drug test results positive for heroin and cocaine at the follow-up interview conducted at time of entry into comprehensive methadone treatment (or at 4 months from baseline for participants who did not enter regular treatment).

RESULTS: Significantly more participants assigned to the interim methadone maintenance condition entered comprehensive methadone maintenance treatment by the 120th day from baseline (75.9%) than those assigned to the waiting list control condition (20.8%) (P<.001). Overall, in the past 30 days at follow-up, interim participants reported significantly fewer days of heroin use (P<.001), had a significant reduction in heroin-positive drug test results (P<.001), reported spending less money on drugs (P<.001), and received less illegal income (P<.02) than the waiting list participants. CONCLUSION: Interim methadone maintenance results in a substantial increase in the likelihood of entry into comprehensive treatment, and is an effective means of reducing heroin use and criminal behavior among opioid-dependent individuals awaiting entry into a comprehensive methadone treatment program.

Rietveld RP, ter Riet G, Bindels PJ, Bink D, Sloos JH, van Weert HC. (2005) The treatment of acute infectious conjunctivitis with fusidic acid: a randomised controlled trial. J Gen Pract. Dec;55(521):924-30.

BACKGROUND: Acute infectious conjunctivitis is a common disorder in primary care. Despite a lack of evidence regarding the effectiveness of topical antibiotics for the treatment of acute infectious conjunctivitis, most patients presenting in primary care with the condition receive topical antibiotics. In The Netherlands, fusidic acid is most frequently prescribed. AIM: To assess the effectiveness of fusidic acid gel compared to placebo for acute infectious conjunctivitis. DESIGN: Double-blind randomised placebo-controlled trial.

SETTING: Twenty-five Dutch primary care centres. METHOD: Adults presenting with a red eye and either (muco)purulent discharge or glued eyelid(s) were allocated to either one drop of fusidic acid gel 1% or placebo, four times daily during one week. The main outcome measure was the difference in recovery rates at 7 days. Secondary outcome measures were difference in bacterial eradication rates, a survival time analysis of the duration of symptoms, and the difference in recovery rates in culture-positive and culture-negative patients.

RESULTS: One hundred and eighty-one patients were randomised and 163 patients were analysed. Forty-five of the 73 patients in the treatment and 53 of the 90 patients in the placebo group recovered (adjusted risk difference = 5.3% [95% confidence interval {CI} = -11 to 18]). There was no difference between the median duration of symptoms in the two groups. At baseline, the prevalence of a positive bacterial culture was 32% (58/181). The bacterial eradication rate was 76% in the treatment and 41% in the placebo group (risk difference = 35% [95% CI = 9.3 to 60.4]). In culture positive patients, the treatment effect tended to be strong (adjusted risk difference = 23% [95% CI = -6 to 42]).

CONCLUSION: At 7 days, cure rates in the fusidic acid gel and placebo group were similar, but the confidence interval was too wide to clearly demonstrate their equivalence. These findings do not support the current prescription practices of fusidic acid by GPs.

Rosemann T.R., Wensing, M.R., Rueter, G.R. and Szecsenyi .JS. (2006) Referrals from general practice to consultants in Germany: If the GP is the initiator, patients' experiences are more positive. BMC Health Services Research 2006, 6:5.

Background: Referrals of patients from primary care to medical specialist care are an important activity in any health care system. German data show that the number of referrals by GPs have increased since 2004, but detailed insight into the experiences of patients, GPs and consultants regarding referrals is very limited. This study aimed at describing the experiences of consultants, GPs and patients with referrals from primary care to medical specialist care. An additional objective was to examine the impact of purpose regarding the referral and of the referrer on the experiences of GPs and patients.

Methods: Referrals of 25 general practitioners (GPs) from 25 practices in Marbach, a rural region in the south of Germany were studied. All adult patients referred after consulting these GPs in a period of five weeks were eligable for the study. GPs, consultants and patients completed short structured forms to document factual characteristics of each referral and their experiences with the referral. GPs and patients completed forms before and after the referral was made, while the consultants completed forms after the patient had consulted them.

Results: Overall, consultants were very positive about appropriateness of the referral (91%). They were somewhat more critical regarding the information provided on the patients' medical history (61%) and prescriptions (48%). In 258 referrals (63%) GPs perceived clear diagnostic benefits, while in 202 referrals (39%) they perceived clear treatment benefits. GPs' experiences were more positive if the GP's purpose was to reduce diagnostic uncertainty (beta=0.318, p<0.000) or if the purpose was to exclude serious illness (beta=0.143, p<0.010). Other purposes of the referral had no impact on their experiences. Patients' expectations regarding the referrals mostly referred to diagnosis, including increased diagnostic certainty (80%), detailed information about the illness (66%) and exclusion of serious illness (62%). They were overall satisfied with the referral (83%). Their experiences with the referral were more positive if the initiative for the referral came from the physician (beta=0.365, p<0.000).

Conclusions: Patients, GPs and consultants have positive views on the value of referrals from primary care to medical specialists. Patients were most positive if the physician had initiated the referral, which supports the gate keeper role of the GP.

Ruiz-Palacios GM, Perez-Schael I, Velazquez FR, Abate H, Breuer T, Clemens SC, Cheuvart B, Espinoza F, Gillard P, Innis BL, Cervantes Y, Linhares AC, Lopez P, Macias-Parra M, Ortega-Barria E, Richardson V, Rivera-Medina DM, Rivera L, Salinas B, Pavia-Ruz N, Salmeron J, Ruttimann R, Tinoco JC, Rubio P, Nunez E, Guerrero ML, Yarzabal JP, Damaso S, Tornieporth N, Saez-Llorens X, Vergara RF, Vesikari T, Bouckenooghe A, Clemens R, De Vos B, O'Ryan M (2006) Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. Jan 5;354(1):11-22.

BACKGROUND: The safety and efficacy of an attenuated G1P[8] human rotavirus (HRV) vaccine were tested in a randomized, double-blind, phase 3 trial.

METHODS: We studied 63,225 healthy infants from 11 Latin American countries and Finland who received two oral doses of either the HRV vaccine (31,673 infants) or placebo (31,552 infants) at approximately two months and four months of age. Severe gastroenteritis episodes were identified by active surveillance. The severity of disease was graded with the use of the 20-point Vesikari scale. Vaccine efficacy was evaluated in a subgroup of 20,169 infants (10,159 vaccinees and 10,010 placebo recipients).

RESULTS: The efficacy of the vaccine against severe rotavirus gastroenteritis and against rotavirus-associated hospitalization was 85 percent (P<0.001 for the comparison with placebo) and reached 100 percent against more severe rotavirus gastroenteritis. Hospitalization for diarrhea of any cause was reduced by 42 percent (95 percent confidence interval, 29 to 53 percent; P<0.001). During the 31-day window after each dose, six vaccine recipients and seven placebo recipients had definite intussusception (difference in risk, -0.32 per 10,000 infants; 95 percent confidence interval, -2.91 to 2.18; P=0.78).

CONCLUSIONS: Two oral doses of the live attenuated G1P[8] HRV vaccine were highly efficacious in protecting infants against severe rotavirus gastroenteritis, significantly reduced the rate of severe gastroenteritis from any cause, and were not associated with an increased risk of intussusception.

Trials

Latest Questions to the Primary Care Question Answering Service

CAUSES, RISKS AND PREVENTION

Will swimming exacerbate Osgood Schlatter's Disease?

Do you have any dietary advise sheets for people who suffer with gout?

What evidence is there for the efficacy of calcium and vitamin d in the PREVENTION of osteoporosis in those women at risk?

In a child under 2 years old undergoing a thoracotomy and lower lobe lobectomy how common is scoliosis as a complication. How severe or disabling is it usually in these cases. Does the scoliosis in these cases result in long term morbidity?

Can antibiotics cause polyneuritis?

Is the Influenza vaccination given in the UK in 2005 / 2006 identical to the vaccination given in Belgium this year?

In patients taking Methotrexate, why is it advised that they should not drink alcohol?

ASSESSMENT AND DIAGNOSIS

What percentage of smokers will never develop any symptomatic physiological deficit of lung function?

A very high percentage of patients after major operations have subclinical DVTs. Is the d-dimer test therefore useful in excluding a DVT after such operations in a patient complaining of ankle swelling, for instance post-hip replacement?

Is there a standard questionnaire that can be used to gently enquire whether a client is suffering with Erectile Dysfunction?

What test should be carried out on patients taking methotrexate and how often

Is a family history of cerebral vascular disease an increased risk factor for coronary vascular disease. Therefore when calculating a CHD risk percentage would the figure be mutiplied by 1.5% if there is a family hx of cva?

CARDIOVASCULAR DISEASE

Can patients with history of primary cerebral haemorrage ever have regular aspirin for secondary prevention?

Should beta-blockers post MI be lifelong? which beta-blocker is best and what dose?

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In a peri-menopausal woman of 40 (non-smoker), who is anxious not to conceive, what are the differing relative risks from VTE of the combined oral contraceptive pill compared with HRT.

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CANCER

Is there any value in genetic investigation in cases of asymptomatic patients with a family history of stomach carcinoma?

MUSCULOSKELETAL DISEASE

Are there any randomised controlled trials comparing intravenous pamidronate to oral bisphosphonates in the treatment of osteopenia?

COMPLEMENTARY MEDICINE

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Hitting the Headlines - Evidence Behind the Press Stories

Aspirin for the prevention of cardiovascular events

Aspirin lowers the risk of heart problems in men and women in different ways reported two newspapers on 18 January 2006. The newspapers accurately reported the results of a systematic review which should, however, not be regarded as conclusive.
Two newspapers (1-2) reported that aspirin taken regularly significantly reduced the risk of heart problems in men and women (by 14% and 12%, respectively) but in different ways. In men, the risk of heart attacks is reduced by 32%, and in women the risk of stroke is reduced by 17%. Both newspapers also note that aspirin is also associated with an increase in major bleeding.
The newspaper articles were based on a systematic review (3) of six trials involving 95456 people (54% women) without existing cardiovascular disease. After an average of 6.4 years, the risk of cardiovascular events (heart attack, stroke, or death from these causes) was 14% lower in men and 12% lower in women taking aspirin compared to those not receiving the drug. Looking at the three event categories separately, only the risk of heart attack was significantly reduced in men (by 32%) and only the risk of stroke was significantly reduced in women (by 17%). There was no effect on rate of death detected in either men or women. The effects on heart attack and stroke are based on relatively small numbers of events.
The newspapers reported the results of the research accurately. However the front page story in the Daily Express (1) overstated the positive findings of the study by incorrectly saying that the research showed that aspirin could be a 'lifesaver'.
Evaluation of the evidence base for aspirin in the prevention of cardiovascular events in women and men

Where does the evidence come from?

The research was conducted by a team from the USA and Italy led by Dr DL Brown, based at the State University of New York.

What were the authors' objectives?

To determine if the benefits and risks of aspirin in the primary prevention of cardiovascular disease are different in men and women.

What was the nature of the evidence?

This was a systematic review of randomised controlled trials assessing aspirin for the prevention of cardiovascular disease, and reporting cardiovascular death, myocardial infarction and stroke and major bleeding as outcomes. Six trials involving 95456 participants (51342 women and 44114 men) were included in the review. Three trials included only men and one included only women. Three trials were in apparently healthy health care professionals, and 3 included individuals with risk factors for cardiovascular disease.

What interventions were examined in the research?

Aspirin therapy, with dosage ranging from 100 mg every other day to 500 mg daily, was compared with placebo. The mean duration of therapy at follow-up ranged from 3.6 years to 10.1 years.

What were the findings?

Aspirin significantly reduced the odds of major cardiovascular events (cardiovascular death, myocardial infarction or stroke) by 12% in women and 14% in men.
In women, aspirin had no significant effect on the rate of myocardial infarction, but significantly reduced the odds of stroke by 17%. Considering stroke subtypes, there was a significant 24% reduction in the odds of ischemic stroke but no significant effect on hemorrhagic stroke.
In men, aspirin significantly reduced the odds of myocardial infarction by 32%. Although aspirin did not have a significant effect on all strokes or ischemic stroke, it was associated with a significant 69% increase in the odds of hemorrhagic stroke.
In both men and women aspirin had no significant effect on total mortality or deaths from cardiovascular causes.
In both men and women aspirin was associated with significantly increased odds of major bleeding of 70%.

What were the authors' conclusions?

The authors concluded that in both women and men, aspirin therapy reduced the risk of a composite of cardiovascular events. In women this was due to its effect on reducing the risk of ischemic stroke and in men it was due to a reduction in the risk of myocardial infarction. Aspirin significantly increased the risk of bleeding to a similar degree among men and women.

How reliable are the conclusions?

This systematic review appears to have been generally well conducted. However, the statistical power of the analyses may have been limited, particularly those considering the different categories of cardiovascular event. This was because the number of trials included in some of the comparisons was small and also because the outcomes studied (cardiovascular death, myocardial infarction and stroke and major bleeding) are relatively rare. Therefore, the indicated differences in effects in men and women should be considered with caution. Also it is possible that the apparent differences in the effect of aspirin in men and women may mainly reflect the difference in how common myocardial infarction and stroke are in men and women, rather than any real difference in its effect. The authors themselves suggest that further studies are needed to confirm the gender differences.

Systematic reviews

Information staff at CRD searched for systematic reviews relevant to this topic. Systematic reviews are valuable sources of evidence as they locate, appraise and synthesize all available evidence on a particular topic.
There were two related systematic reviews identified on the Cochrane Database of Systematic Reviews (CDSR) (4-5) and three on the Database of Abstracts of Reviews of Effects (DARE) (6-8).

References and resources

1. Miracle aspirin. New proof that it prevents heart attacks and strokes. Daily Express, 18 January 2006, p1,4.
2. Aspirin, the heart tonic for both sexes. Daily Mail, 18 January 2006, p24.
3. Berger JS, Ronacaglioni MC, Avanzini F, Pangrazzi I, Tognoni G, Brown DL. Aspirin for the primary prevention of cardiovascular events in women and men: a sex-specific meta-analysis of randomized controlled trials. JAMA 2006;295(3):306-313.
4. Hankey GJ, Sudlow CLM, Dunbabin DW. Thienopyridine derivatives (ticlopidine, clopidogrel) versus aspirin for preventing stroke and other serious vascular events in high vascular risk patients. The Cochrane Database of Systematic Reviews 2000, Issue 1. Art. No.: CD001246. DOI: 10.1002/14651858.CD001246.
5. Jackson PR, Aarabi M, Wallis JE. Aspirin for primary prevention of coronary heart disease. (Protocol). The Cochrane Database of Systematic Reviews 2004, Issue 1. Art. No.: CD004586. DOI: 10.1002/14651858.CD004586.
6. Eidelman R S, Herbert P R, Wiesman S M, Hennekens C H. An update on aspirin in the primary prevention of cardiovascular disease. Archives of Internal Medicine 2003;163(17):2006-2010. [DARE Abstract]
7. Hayden M, Pignone M, Phillips C, Mulrow C. Summary of the evidence: aspirin for the primary prevention of cardiovascular events. Rockville, MD, USA: Agency for Health Care Policy and Research 2002:33. [DARE Abstract]
8. Boltri J M, Akerson M R, Vogel R L. Aspirin prophylaxis in patients at low risk for cardiovascular disease: a systematic review of all-cause mortality. Journal of Family Practice 2002;51(8):700-704. [DARE Abstract]
Consumer information
British Heart Foundation
NHS Direct - Heart Attack Prevention
Healthy Heart

"Drug meant to stop early birth 'brings it on instead'"

A drug given to pregnant women to prevent premature birth has been found to double the risk, reported five newspapers (13 January 2006). The newspapers were generally accurate in reporting that a well-conducted trial found that metronidazole does not reduce, and may increase early preterm birth in high risk women.

Five newspapers (1-5) reported that metronidazole, an antibiotic given to around one in 200 pregnant women to prevent premature birth, increases the risk of premature birth.

The research (6) was a well-conducted double blind randomised controlled trial, in which 100 pregnant women at high risk of preterm delivery were randomised to receive either metronidazole or placebo for one week. There was no difference in the proportion of women delivering before 30 weeks gestation between the metronidazole and placebo groups. However, significantly more women in the metronidazole treated group delivered before 37 weeks gestation than in the placebo group (62% and 39% respectively). The authors' concluded that metronidazole does not does not reduce and may increase early preterm birth in high risk pregnant women.

The newspapers were generally accurate in their reporting of the trial, however one newspaper reported that the number of premature babies born as a result of the drug was more than 1,000 over the last month (1), whilst the other newspapers reported the figure to be around 1,000 per year (2, 3, 4, 5). This figure was not reported in the research study. Although the authors' conclusion seems to be supported by the research, only 100 women were randomised, therefore, the trial may have been underpowered and unable to detect statistically significant differences in some outcomes between groups.

Evaluation of the evidence base for metronidazole for the prevention of preterm birth in women at high risk.

Where does the evidence come from?

This multi-centre trial was conducted at fourteen UK hospitals, led by Professor Andrew Shennan of the Maternal and Fetal Research Unit at St Thomas' Hospital in London. The study was funded by Tommy's the baby charity, who had no involvement in the study.

What were the authors' objectives?

The objective was to determine whether metronidazole reduces early preterm labour in asymptomatic women with positive vaginal fetal fibronectin (fFN) in the second trimester of pregnancy.

What was the nature of the evidence?

The study was a double blind, randomised placebo controlled trial involving 892 asymptomatic
pregnant women who were at between 23 and 24 weeks of gestation, with a singleton pregnancy, and who were at high risk of pre-term birth (history of previous preterm birth or preterm prelabour rupture of membranes, previous late miscarriage, uterine anatomical abnormality, prior cervical surgery or current cervical cerclage). Gestational age was confirmed by obstetric ultrasound. Women were excluded if they had been prescribed metronidazole within four weeks prior to study recruitment. Randomisation was computer-generated by the trial statistician and sent to a commercial packaging company to pre-package and label the tablets. The tablets were identical, sealed in opaque containers and dispensed by local pharmacies independent of the investigators and attending clinicians. Randomisation was stratified by clinic and week of gestation when the positive fFN result was obtained.
A sample size calculation determined that 420 women with positive fFN tests were required to detect a statistically significant difference between metronidazole and placebo groups. Outcome data were collected from maternity records and hospital computer databases, using trial-specific data collection forms.

What interventions were examined in the research?

Women were screened at 24 weeks and 27 weeks gestation for presence of fFN in cervicovaginal secretions, which is used to predict risk of preterm delivery. One hundred women with a positive result at the 24 or 27-week fFN test were randomised to receive either metronidazole 400mg three times daily for seven days, or indistinguishable placebo. Women were asked to record the time and date that they took each tablet and asked to return the tablet packaging, in order to assess their compliance. The fFN test was repeated at 30 weeks gestation.
The primary outcome measure was delivery prior to 30-week gestation; secondary outcome measures included delivery prior to 37-week gestation and parameters of neonatal outcome. Interim analyses were performed after each 50 women were recruited.

What were the findings?

The study was stopped early due to difficulty in recruitment. 892 women were tested for fFN status and 730 tests were repeated at 27 weeks. 116 pregnancies tested positive on either the 24 or 27-week test and 100 women accepted randomisation. Compliance with medication was good, with 75% of women returning their records; of which only seven missed any dose. Women in the intervention and control groups were comparable, except for number of qualifications; those in the placebo group were statistically significantly more likely to have left school with fewer qualifications.

Following treatment the 30-week fFN test result reverted to negative in 48% women randomised to metronidazole and 50% women randomised to placebo. Antenatal admissions were more frequently recorded in the metronidazole group, however the length of stay was similar between groups.

There was no statistically significant difference in the proportion of women who delivered before 30 weeks gestation between the metronidazole and placebo groups. Statistically significantly more women in the metronidazole treated group delivered before 37 weeks gestation than in the placebo group (62% and 39% respectively). In a subgroup analysis, statistically significantly more women in the metronidazole group had spontaneous onset of labour (rather than indicated delivery) before 37 weeks gestation than in the placebo group (79% and 50% respectively). There were no statistically significant differences in birthweight, 1- and 5-minute Apgar scores, Special Care Baby Unit admissions or survival between the metronidazole and placebo groups.

What were the authors' conclusions?

The authors concluded that metronidazole does not reduce early preterm birth in high risk pregnant women selected by history and a positive vaginal fFN test and that preterm birth may be increased by metronidazole therapy.

How reliable are the conclusions?

The authors' conclusions are supported by the findings of this well conducted trial. Randomisation, concealment of allocation and blinding procedures appear to have been appropriate. There were no significant differences between women assigned to the two treatment groups, other than number of qualifications. Compliance with medication was reported as being good. The outcomes measured were clinically relevant and systematically collected. Statistical analyses appear to have been appropriate. The sample size calculation determined that 420 women with positive fFN tests would be required to detect a statistically significant difference between the metronidazole and placebo groups. However, only 116 women with positive tests were recruited, of which 100 were randomised, therefore, the trial may have been underpowered and unable to detect statistically significant differences in some outcomes between groups.

Systematic reviews

Information staff at CRD searched for systematic reviews relevant to this topic. Systematic reviews are valuable sources of evidence as they locate, appraise and synthesize all available evidence on a particular topic.
There were four related systematic reviews identified on the Cochrane Database of Systematic Reviews (CDSR) (7-10) and four on the Database of Abstracts of Reviews of Effects (DARE) (11-14). However these reviews investigated antibiotics in general, including metronidazole, rather than specifically investigating metronidazole alone.

References and resources

1. Birth-delay drugs that don't work. Daily Express, 13 January 2006, p40.
2. Pregnancy drug 'doubles risk of premature birth'. Daily Mail, 13 January 2006, p9.
3. Labour-delaying drug linked to 1,000 pre-term babies a year. The Guardian, 13 January 2006, p8.
4. Premature baby drug doubles risk. Daily Telegraph, 13 January 2006, p1.
5. Drug meant to stop early birth 'brings it on instead'. The Times, 13 January 2006, p5.
6. Shenan A, Crawshaw S, Briley A, Hawken J, Seed P, Jones G, et al. A randomised controlled trial of metronidazole for the prevention of preterm birth in women positive for cervicovaginal fetal fibronectin: the PREMET Study. BJOG: An International Journal of Obstetrics and Gynaecology 2006;113(1):65-74.
7. King J, Flenady V. Prophylactic antibiotics for inhibiting preterm labour with intact membranes. The Cochrane Database of Systematic Reviews 2002, Issue 4. Art. No.: CD000246. DOI: 10.1002/14651858.CD000246.
8. Thinkhamrop J, Hofmeyr GJ, Adetoro O, Lumbiganon P. Prophylactic antibiotic administration in pregnancy to prevent infectious morbidity and mortality. The Cochrane Database of Systematic Reviews 2002, Issue 4. Art. No.: CD002250. DOI: 10.1002/14651858.CD002250.
9. Kenyon S, Boulvain M, Neilson J. Antibiotics for preterm rupture of membranes. The Cochrane Database of Systematic Reviews 2003, Issue 2. Art. No.: CD001058. DOI: 10.1002/14651858.CD001058.
10. McDonald H, Brocklehurst P, Parsons J. Antibiotics for treating bacterial vaginosis in pregnancy. The Cochrane Database of Systematic Reviews 2005, Issue 1. Art. No.: CD000262. DOI: 10.1002/14651858.CD000262.pub2.
11. Egarter C, Leitich H, Husslein P, Kaider A, Schemper M. Adjunctive antibiotic treatment in preterm labor and neonatal morbidity: a meta-analysis. Obstetrics and Gynecology 1996;88(2):303-309. [DARE Abstract]
12. Koumans E H, Markowitz L E, Hogan V. Indications for therapy and treatment recommendations for bacterial vaginosis in nonpregnant and pregnant women: a synthesis of data. Clinical Infectious Diseases 2002;5(Supplement 2):S152-S172. [DARE Abstract]
13. Leitich H, Brunbauer M, Bodner-Adler B, Kaider A, Egarter C, Husslein P. Antibiotic treatment of bacterial vaginosis in pregnancy: a meta-analysis. American Journal of Obstetrics and Gynecology 2003;188(3):752-758. [DARE Abstract]
14. Riggs M A, Klebanoff M A. Treatment of vaginal infections to prevent preterm birth: a meta-analysis. Clinical Obstetrics and Gynecology 2004;47(4):796-807. [DARE Provisional Abstract]
Consumer information
National Childbirth Trust
Tommy's: the baby charity

"New cervical test 'not any better'

Liquid-based cytology cervical cancer screening method is no better than the conventional Papanicolaou (Pap) smear test, reported two newspapers (13 January 2006). The newspapers reflected the conclusions of the systematic review (3), however, this review has some limitations regarding study quality, potential bias and generalisability.

On 13th January 2006, two newspapers (1,2) reported that the liquid-based cytology screening method for cervical cancer, was no better than the conventional Pap smear test.
The research, published in the Lancet (3), was a systematic review, which included 56 primary studies. The studies examined the results of over a million slides. The results showed that there was no evidence that liquid-based cytology either reduced the proportion of unsatisfactory slides, or had greater accuracy in detecting higher-grade lesions, than conventional cytology.
The newspaper reports generally provided an accurate report of the authors' conclusions. However, the studies included in the main analysis of the review varied greatly, both clinically and statistically. In addition, there were limitations regarding the quality of included studies, potential for publication bias, and the exclusion of studies using automated systems, which may impact on the reliability and generalisability of the results. The authors' conclusion that large randomised controlled trials are needed is supported.

Evaluation of the evidence base for the comparative performance of cervical cytology techniques

Where does the evidence come from?

The systematic review was conducted by researchers from the Screening and Test Evaluation Program, and Victorian Cytology Service in Australia, led by Dr Davey. The research was part funded by the National Health and Medical Research Council of Australia.

What were the authors' objectives?

To compare the performance of liquid-based cytology for screening for cervical cancer, with that of conventional cytology.

What was the nature of the evidence?

The study was a systematic review, which included 56 primary studies. The authors searched two electronic bibliographic databases and the reference lists of included studies and previous reviews for studies published in peer-reviewed journals.

What interventions were examined in the research?

Studies that described a direct comparison between two cytology techniques for screening for cervical cancer; liquid-based cytology and conventional cytology, with results for both being read using manual techniques (and not an automated screening system), were reviewed. Liquid-based cytology and conventional cytology were compared in terms of the proportion of slides classified as unsatisfactory, the proportion of slides classified in each cytology category, and the accuracy of detection of high-grade disease. An overall pooled difference was calculated using a random effects meta-analysis. Further analyses were conducted taking into account study design, quality and setting. The sensitivity and specificity of tests were calculated where possible, to investigate the accuracy of the two techniques.

What were the findings?

The authors classified five studies as high quality, 32 as medium quality and 19 as low quality. None of the studies randomly assigned women to the two techniques evaluated, however the five studies that were considered high quality were paired sample studies.

In the 46 studies that provided information on percentages of unsatisfactory slides, 3,646 of 483,050 (0.75%) of the liquid based cytology slides, and 5,389 of 662,401 (0.81%) of the conventional cytology slides were considered unsatisfactory. The proportional difference in the number of unsatisfactory slides between the two techniques ranged from -10.8 to 8.9%. When results from these studies were pooled, the difference in the number of unsatisfactory slides between the two techniques was -0.14%, and not statistically significant.

Analysis showed that overall there was no statistically significant difference in the median differences in the proportion of unsatisfactory slides, when the studies were stratified according to study design, quality or setting.

Four of the 37 high and medium quality studies provided sufficient data to calculate sensitivity and specificity. None of the studies provided evidence that liquid-based cytology improved accuracy in the detection of high-grade disease.

What were the authors' conclusions?

The authors concluded that there was no evidence that liquid-based cytology reduced the proportion of unsatisfactory slides, or detected more high-grade lesions in high quality studies than conventional cytology. They also stated that large randomised controlled trials are needed.

How reliable are the conclusions?

The review was appropriately conducted with regard to study selection, quality assessment and data extraction, with each of these being carried out in duplicate. Two electronic databases were searched and only studies published in peer-reviewed journals were included, therefore there is a potential for publication bias. The pooling of results in a meta-analysis of studies that varied so much, both clinically and statistically, may not have been appropriate. The results seem to support the conclusion that there is no evidence to suggest that liquid-based cytology reduced the proportion of unsatisfactory slides compared to conventional cytology. However, the limitations regarding the quality of included studies, potential for publication bias, and the exclusion of studies using automated systems should be kept in mind.

Systematic reviews

There was one related systematic review (4) and one review which is currently being completed and will be available in the future (5) identified on the Cochrane Database of Systematic Reviews (CDSR). There were four related reviews identified on the Database of Abstracts of Reviews of Effects (DARE) (6-9).

References and resources

1. New cervical test 'not any better'. Daily Telegraph, 13 January 2006, p2.

2. Doubts over new smear test. The Times, 13 January 2006, p5.

3. Davey E, Barratt A, Irwig L, Chan SF, Macaskill P, Mannes P, Saville AM. Effect of study design and quality on unsatisfactory rates, cytology classifications, and accuracy in liquid-based versus conventional cervical cytology: a systematic review. Lancet 2006;367:122-132.

4. Forbes C, Jepson R, Martin-Hirsch P. Interventions targeted at women to encourage the uptake of cervical screening. The Cochrane Database of Systematic Reviews 1999, Issue 3. Art. No.: CD002834. DOI: 10.1002/14651858.CD002834.

5. Koliopoulos G, Martin-Hirsch P, Paraskevaidis E, Arbyn M. HPV testing versus cervical cytology for screening for cancer of the uterine cervix. (Protocol). The Cochrane Database of Systematic Reviews 2003, Issue 4. Art. No.: CD004709. DOI: 10.1002/14651858.CD004709.

6. Cuzick J, Sasieni P, Davies P, Adams J, Normand C, Frater A, van Ballegooijen M, van den Akker E. A systematic review of the role of human papillomavirus testing within a cervical screening programme. Health Technology Assessment 1999;3(14):1-204. [DARE Abstract]

7. Australian Health Technology Advisory Committee. Review of automated and semi-automated cervical screening devices. Canberra, ACT, Australia: Commonwealth Department of Health and Family Services 1998. [DARE Abstract]

8. Buntinx F, Brouwers M. Relation between sampling device and detection of abnormality in cervical smears: a meta-analysis of randomised and quasi-randomised studies. BMJ 1996;313:1285-1290. [DARE Abstract]

9. Nanda K, McCrory D C, Myers E R, Bastian L A, Hasselblad V, Hickey J D, Matchar D B. Accuracy of the Papanicolaou test in screening for and follow-up of cervical cytologic abnormalities: a systematic review. Annals of Internal Medicine 2000;132(10):810-819. [DARE Abstract]

10. Payne N, Chilcott J, McGoogan E. Liquid-based cytology in cervical screening: a rapid and systematic review. Health Technology Assessment 2000;4(18).

11. Karnon J, Peters J, Platt J, Chilcott J, McGoogan E, Brewer N. Liquid-based cytology in cervical screening: an updated rapid and systematic review and economic analysis. Health Technology Assessment 2004;8(20).

Consumer information

CancerBACUP: Cervical cancer information centre

NHS Direct: Cancer of the cervix

Cancer Research UK

Previous Hitting the Headlines summaries on this topic

'Vaccine for cervical cancer'. Hitting the Headlines archive, 7 October 2005.

Cervical cancer vaccine 'in two years'. Hitting the Headlines archive, 7 April 2005.

'Vaccine for cervical cancer'. Hitting the Headlines archive, 2 February 2005.

'Vaccine hope over cervical cancer'. Hitting the Headlines archive, 12 November 2004.

'Vaccine to beat cervical cancer'. Hitting the Headlines archive, 29 October 2004.

A vaccine for cervical cancer? Hitting the Headlines archive, 20-21 November 2002.

Electric shock and drugs for the treatment of depression

Electric shock therapy and drugs are the best treatment response to depression reported two newspapers (13 January 2006). The newspaper articles were based upon an overview of recent developments and current controversies in the treatment of depression that was not conducted using systematic methodology.

Two newspapers (1,2) (13 January 2006) report that anti-depressants and electroconvulsive therapy (ECT) are still the best way to treat depression, according to a paper in the Lancet.(3) Both newspapers focussed upon the authors statements, as emphasised in the Lancet press release,(4) regarding the effects of ECT and the use of antidepressants.
The article, which was published in the 'Seminar' section of the Lancet, was an overview of recent developments and current controversies in the management of depression. This was not a systematic review of all the evidence regarding the effects of either ECT or antidepressant therapy. Although a number of electronic databases had been searched to identify relevant literature, this was then used, in line with the aims of the review, to illustrate the "recent developments and current controversies in depression".
The newspaper articles accurately summarised the statements made on the effectiveness of ECT and antidepressant therapy and recent public concerns about potential side effects as presented in the Lancet press release. However, neither of the newspapers stated that their articles were based upon an overview written to stimulate debate in the field, rather than a specific piece of research.
There are a number of systematic reviews that have assessed the effects of both ECT and antidepressant therapy in the treatment of depression (see below for details).

Systematic reviews

There were two related systematic reviews identified on the Cochrane Database of Systematic Reviews (CDSR) (5-6) and three related reviews on the Database of Abstracts of Reviews of Effects (DARE) (7-9).

References and resources

1. Electric shock treatment 'best response' to depression. The Guardian, 13 January 2006, p14.

2. Electric shock and drugs 'are best hope for depressives'. The Times, 13 January 2006, p16.

3. Ebmeier KP, Donaghey C, Steele JD. Recent developments and current controversies in depression. Lancet 2006;367:153-167.

4. Antidepressants and electroconvulsive therapy are the best treatment options for depression. Lancet press release, 13 January 2006.

5. Van der Wurff FB, Stek ML, Hoogendijk WL, Beekman ATF. Electroconvulsive therapy for the depressed elderly. The Cochrane Database of Systematic Reviews 2003, Issue 2. Art. No.: CD003593. DOI: 10.1002/14651858.CD003593.

6. Geddes JR, Freemantle N, Mason J, Eccles MP, Boynton J. Selective serotonin reuptake inhibitors (SSRIs) versus other antidepressants for depression. The Cochrane Database of Systematic Reviews 1999, Issue 4. Art. No.: CD001851. DOI: 10.1002/14651858.CD001851.

7. UK ECT Review Group. Efficacy and safety of electroconvulsive therapy in depressive disorders: a systematic review and meta-analysis. Lancet 2003;361:799-808. [DARE Abstract]

8. Kho K H, van Vreeswijk M F, Simpson S, Zwinderman A H. A meta-analysis of electroconvulsive therapy efficacy in depression. Journal of ECT 2003;19(3):139-147. [DARE Abstract]

9. University of Newcastle upon Tyne. Centre for Health Services Research; University of York. Centre for Health Economics. The choice of antidepressants for depression in primary care. Newcastle upon Tyne: University of Newcastle upon Tyne, Centre for Health Services Research 1998:67. [DARE Abstract]

10. Improving the recognition and management of depression in primary care. Effective Health Care 2002;7(5):1-12.

11. Greenhalgh J, Knight C, Hind D, Beverley C, Walters S. Clinical and cost-effectiveness of electroconvulsive therapy for depressive illness, schizophrenia, catatonia and mania: systematic reviews and economic modelling studies. Health Technology Assessment 2005;9(9).

Consumer information

MIND

Mental Health Foundation

Depression Alliance

Previous Hitting the Headlines summaries on this topic

Seroxat and the risk of suicide. Hitting the Headlines archive, 22 August 2005.

'Antidepressants 'little better than placebos'. Hitting the Headlines archive, 21 July 2004.

Antidepressants and the risk of suicide. Hitting the Headlines archive, 21 July 2004.

Therapy beats pills if you are miserable. Hitting the Headlines archive, 3 December 2000.

Added value of a clinical decision support system when combined with a community intervention.

This study in the Journal of the American Medical Association, compared the sole use of a community intervention with the use of the community intervention combined with a clinical decision support system to assist with the prescribing of antimicrobial drugs for acute respiratory tract infections.

The results showed that antimicrobial prescribing decreased with the combined intervention, thus demonstrating that the clinical decision support system added value to the community intervention.

What's New from the National Library for Health

Post 14: 13 January 2006

2006-01-16T11:17:00.000Z

Links are given to online full text resources, all other materials can be obtained via the Fade Library, just mail your request to library.services@fade.nhs.uk

Latest Systematic Reviews

Latest Technology Assessments and Appraisals

Towards evidence-based guidelines for the prevention of venous thromboembolism: systematic reviews of mechanical methods, oral anticoagulation, dextran and regional anaesthesia as thromboprophylaxis (Roderick) 94 pages, Volume 9, number 49

This study showed that graduated compression stockings (and other mechanical compression methods) reduced the risk of deep venous thrombosis and pulmonary embolism in a wide range of surgical patients. Oral anticoagulants (such as warfarin) and infusions of dextran were also effective, although they appeared less protective than heparin-based regimens. In operations where regional anaesthesia is feasible, it resulted in a lower risk of venous thromboembolism than general anaesthesia, thus adding to any benefits from mechanical and pharmacologic methods.

The effectiveness and cost-effectiveness of parent training/education programmes for the treatment of conduct disorder, including oppositional defiant disorder, in children (Dretzke) 250 pages, Volume 9, number 50

Clinical and cost-effectiveness of autologous chondrocyte implantation for cartilage defects in knee joints: systematic review and economic evaluation (Clar) 98 pages, Volume 9, number 47

Systematic review of effectiveness of different treatments for childhood retinoblastoma (McDaid) 162 pages, Volume 9, number 48

Latest Guidelines

NICE (2006) Smoking Cessation Programme Draft Scope. London: NICE.

NICE has issued the draft scope for the optimal provision of smoking cessation services, including the provision of nicotine replacement therapy (NRT), for primary care, pharmacies, local authorities and workplaces with particular reference to manual working groups, pregnant smokers and hard to reach communities.
The document is available for consultation between 9 January and 6 February 2006. The final version of the scope will be available on the NICE website in March 2006 and full guidance is expected be published by August 2007.

Latest Reports

House of Commons Health Committee (2006) Changes to Primary Care Trusts: Second Report of Session 2005–06: Report, together with formal minutes, oral and
written evidence. London: TSO.

NHS Primary Care Trusts (PCTs) were created in 2002, and are currently responsible for controlling some 80% of the NHS’s 76 billion annual budget, which they use to
commission health services for their local populations. In addition, they have responsibility for public health, and many PCTs also provide community-based health services, such as district nursing and community hospitals.

Commissioning a Patient-Led NHS was published on 28 July 2005. It set out proposals to dramatically reduce numbers of PCTs in order to achieve cost savings of £250 million and to improve commissioning. The paper also announced plans to contract out community health services currently provided by PCTs to non-NHS providers by the end of 2008. At the same time, the number of Strategic Health Authorities (SHAs) would also be substantially reduced.

These proposals were received with widespread alarm, and were described by
commentators as ‘incoherent’. Those working in the NHS expressed outrage at the
prospect of a further large scale structural reorganisation only three years after PCTs were created in the last round of restructuring, as well as raising serious doubts as to whether the reforms would achieve their stated aims.

Corrigan, P. (2006) Registering Choice: how primary care should change to meet patient needs. London: Social Market Foundation.

Patients have had the right to choose a GP since 1948. Yet for most of us, this right is little more than hypothetical: GP surgeries with closed lists, restrictions regarding where we can register and GP surgeries offering almost identical services means even those of us lucky enough to have a choice of GP find we have very little to choose between.

The report explains why patient demand must be organised more effectively to trigger new and different forms of primary care, and how supply must be better organised to meet this demand. The implications this will have for the future role of the PCT are explored. Explores how, in a system of patient choice, primary care providers might fail and what the Government should do to deal with them. Finally, it discusses the need for more information to help patients make informed choices in primary care; who will provide this information and whether additional guidance, perhaps in the form of Patient Care Advisers, is a justifiable cost to help the hardest to reach groups in society exercise their right to choice.

Evidence from Journals

Howard L
Atypical antipsychotic use during the first trimester of pregnancy may not increase major malformations
Evid Based Ment Health 2005, 8(4), 115

Hart S
Comorbid pain related somatisation is common in Latin Americans with major depressive disorder
Evid Based Ment Health 2005, 8(4), 116

Crystal S
Prescription of pharmacotherapy for depression in elderly people varies with age, race, gender, and length of care
Evid Based Ment Health 2005, 8(4), 117

Links PS
Suicide risk peaks in first week of psychiatric hospitalisation and post-discharge
Evid Based Ment Health 2005, 8(4), 114

Cipriani A
Forensic database study suggests selective serotonin reuptake inhibitors do not increase the risk of suicide in people taking antidepressants
Evid Based Ment Health 2005, 8(4), 113

Petry NM
Methadone plus contingency management or performance feedback reduces cocaine and opiate use in people with drug addiction.
Evid Based Ment Health 2005, 8(4), 112

Swinson RP
Pharmacotherapy is an effective treatment option for generalised anxiety disorder.
Evid Based Ment Health 2005, 8(4), 111

Kumar DS
Coordinated care consisting of cognitive behavioural therapy plus medication improves panic disorder.
Evid Based Ment Health 2005, 8(4), 110

Bisson JL
Adding hypnosis to cognitive behavioural therapy may reduce some acute stress disorder symptoms
Evid Based Ment Health 2005, 8(4), 109

Carter FA
Postnatal home visits from healthcare professionals show promise for preventing postnatal depression
Evid Based Ment Health 2005, 8(4), 108

Ernst E
St John's wort is at least as effective as paroxetine in reducing severity of depression and is better tolerated.
Evid Based Ment Health 2005, 8(4), 107

Buist-Bouwman MA
Collaborative care management improves physical functioning in older people with depression
Evid Based Ment Health 2005, 8(4), 106

Conn DK
Collaborative care depression management for older adults: level of comorbidity does not affect outcome
Evid Based Ment Health 2005, 8(4), 105

Herrmann N
Some psychosocial therapies may reduce depression, aggression, or apathy in people with dementia
Evid Based Ment Health 2005, 8(4), 104

Charlesworth G
Cognitive behavioural therapy reduces psychological distress in carers of people with Parkinson's disease.
Evid Based Ment Health 2005, 8(4), 103

Lau MA
Adding cognitive therapy to minimal psychiatric care prevents short term, but not long term, relapse in people with bipolar disorder.
Evid Based Ment Health 2005, 8(4), 102

Carlson GA
Bipolar disorder in young people: divalproex sodium no more effective than lithium for maintenance
Evid Based Ment Health 2005, 8(4), 101

Killeen TK
Long acting injectable naltrexone is effective and safe for treating alcohol dependence
Evid Based Ment Health 2005, 8(4), 100

Lowe B
The sentence completion test for depression can distinguish between people with and without major depressive disorder
Evid Based Ment Health 2005, 8(4), 99

Bonomo Y
Early onset of drinking increases alcohol use in adulthood
Evid Based Ment Health 2005, 8(4), 98

Sakinofsky I
Attendance at accident and emergency for deliberate self harm predicts increased risk of suicide, especially in women
Evid Based Ment Health 2005, 8(4), 97

Haw CM
Lifetime risk of suicide in people with schizophrenia lower than commonly reported
Evid Based Ment Health 2005, 8(4), 96

Bourgeois JA
The incidence of delirium in older people with a mood disorder is similar with lithium and valproate
Evid Based Ment Health 2005, 8(4), 95

Kemper, K.J., Gardiner, P., Gobble, J, Mitra, A. and Woods, C. (2005) Randomized Controlled Trial Comparing Four Strategies for Delivering e-Curriculum to Health Care Professionals. BMC Medical Education 2006, 6:2

Background: Internet education is increasingly provided to health professionals, but little is known about the most effective strategies for delivering the content. The purpose of this study is to compare four strategies for delivering an Internet-based (e-) curriculum on clinicians' knowledge (K), confidence (CONF), and communication (COMM) about herbs and other dietary supplements (HDS).

Method: This national randomized 2 X 2 factorial trial included physicians, pharmacists, nurses, nutritionists and trainees in these fields. Participants were randomly assigned to one of four curriculum delivery strategies for 40 brief modules about HDS: a) delivering four (4) modules weekly over ten (10) weeks by email (drip-push); b) modules accessible on web site with 4 reminders weekly for 10 weeks (drip-pull); c) 40 modules delivered within 4 days by email (bolus-push); and d) 40 modules available on the Internet with one email informing participants of availability (bolus-pull).

Results: Of the 1,267 enrollees, 25% were male; the average age was 40 years. The completion rate was 62%, without significant differences between delivery groups. There were statistically significant improvements in K, CONF and COMM scores after the course (P<0.001 style="font-weight: bold;">Conclusion: All delivery strategies tested similarly improved K, CONF, COMM scores about HDS. Educators can use the strategy that is most convenient without diminishing effectiveness. Additional curricula may be necessary to make substantial changes in clinicians' communication practices.

Helping practitioners understand the contribution of qualitative research to evidence-based practice
Mark Newman, Carl Thompson, and Anthony P Roberts
Evid Based Nurs 2006; 9: 4-7.

Reflections on "Helping practitioners understand the contribution of qualitative research to evidence-based practice"
Sally Thorne
Evid Based Nurs 2006; 9: 7-8.

The WHO technique for intramuscular thigh vaccination in infants and toddlers had fewer adverse reactions than 2 other techniques
Linda Diggle (commentator)
Evid Based Nurs 2006; 9: 9.

Liposomal lidocaine improved intravenous cannulation success rates in children
Jeanette Robertson (commentator)
Evid Based Nurs 2006; 9: 10.

Review: children permitted clear fluids <=120 minutes before surgery have similar gastric volumes and pH values as those on standard fasts
Andrew Jull (commentator)
Evid Based Nurs 2006; 9: 11.

Topical chloramphenicol was not effective for acute infective conjunctivitis in children
Gene Elizabeth Harkless (commentator)
Evid Based Nurs 2006; 9: 12.

Nurse home visits did not differ from standard care for prevention of recurrent child abuse
Wendy E Peterson (commentator)
Evid Based Nurs 2006; 9: 13.

Multisystemic therapy improved adherence to blood glucose testing in adolescents with type 1 diabetes
Barbara L Paterson (commentator)
Evid Based Nurs 2006; 9: 14.
A weight maintenance diet reduced bulimic symptoms in adolescent girls
Janet D Allan (commentator)
Evid Based Nurs 2006; 9: 15.

After 3 months, low dose oral contraceptives reduced pain in adolescent girls with moderate to severe dysmenorrhoea
Marjorie MacDonald (commentator)
Evid Based Nurs 2006; 9: 16.

Trimethoprim reduced dysuria in women with symptoms of urinary tract infection but negative urine dipstick test results
M Kay Libbus (commentator)
Evid Based Nurs 2006; 9: 17.

Review: wearing graduated compression stockings during air travel reduces the risk of deep venous thromboembolism
Susan Campbell (commentator)
Evid Based Nurs 2006; 9: 18.

A home based, physical activity intervention increased physical activity, fitness, and vigour and reduced fatigue in sedentary women with early stage breast cancer
Carolyn Ingram (commentator)
Evid Based Nurs 2006; 9: 19.

Glargine dose titration by patients and by physicians were equally effective for preventing severe hypoglycaemia
Randa Fakhry (commentator)
Evid Based Nurs 2006; 9: 20.

Web based care management improved glucose control in patients with poorly controlled diabetes
Anne Phillips (commentator)
Evid Based Nurs 2006; 9: 21.

An educational booklet did not improve adherence or symptoms in patients prescribed thyroxine for primary hypothyroidism
Barbara A Given (commentator)
Evid Based Nurs 2006; 9: 22.

Review: multidisciplinary interventions reduce hospital admission and all cause mortality in heart failure
Simon Stewart (commentator)
Evid Based Nurs 2006; 9: 23.

Review: multivitamins and mineral supplements do not reduce infections in elderly people
Catherine Ford Thomas (commentator)
Evid Based Nurs 2006; 9: 24.

Multivitamin and multimineral supplements did not reduce reported infection days or related use of healthcare services in elderly people
Veronica L Conners (commentator)
Evid Based Nurs 2006; 9: 25.

A simple risk score predicted 7 day stroke risk after transient ischaemic attack
Sandra Ireland (commentator)
Evid Based Nurs 2006; 9: 26.

Mothers’ decisions about MMR vaccination were framed by their children’s vulnerabilities and wider social trends
Francine M Cheater (commentator)
Evid Based Nurs 2006; 9: 27.

UK and US adolescents perceived internet health information to be salient but of questionable credibility
Deborah Finfgeld-Connett (commentator)
Evid Based Nurs 2006; 9: 28.

Young women described the benefits of having advance supplies of emergency contraception but emphasised its use as a "last resort" rather than an alternative form of contraception
Cicely Marston (commentator)
Evid Based Nurs 2006; 9: 29.

Marginalised HIV positive drug users felt that an HIV diagnosis created benefits as well as losses
Irene Goldstone (commentator)
Evid Based Nurs 2006; 9: 30.

Perceived barriers and benefits were factors in decision making about colorectal screening
John Oliffe (commentator)
Evid Based Nurs 2006; 9: 31.

UK palliative care professionals identified service infrastructure, patient and carer attitudes and characteristics, and practice culture as influencing place of death of patients with cancer
Lucille Taylor (commentator)
Evid Based Nurs 2006; 9: 32.

Trials

Latest Questions to the Primary Care Question Answering Service

CAUSES, RISKS AND PREVENTION

How long can alcohol stay in blood?

Once a young man has developed mumps parotitis is there anything we can do to stop him developing orchitis, and if he does is there anything we can do to stop him becoming sterile

Can inhaled steroids in recommended doses stunt growth in asthmatic children?

Should prophylactic antibiotics be prescribed routinely following ingrown toe nail surgery?

Is there any evidence to suggest that bleach or other hair dyes should not be used in pregnancy?

Is tonsillectomy recommended for teenagers presenting with regular episodes of tonsillitis?

ASSESSMENT AND DIAGNOSIS

Is it acceptable to prescribe antibiotics over the telephone for suspected otitis media in a 6 month old?

1) I use 400mcgs salbutamol via spacer for reversibility testing for copd, but was originally taught either 10 puffs or to nebulise, is there evidence that i am adminiistering enough? 2) I also do steroid reversibility if still not sure if Asthma, is there evidence that should do this always?

What is the prevalence of a history of splenectomy?

Barretts' oesophagus and PPIs. What dose PPI should we use and how often should we re-scope. Is there any evidence for or against H pylori eradication?

How should I manage a second UTI in an otherwise well 8yr old?

Who is the most appropriate person to refer to for a patient with McArdle's disease in view of weight loss and diet problems aged 35?

If a patient has a positive chlamydia swab, could you advise what is the max length of time that she may have previously been infected?

Is there any data available on the prevelance of a false diagnosis of an antibiotic "allergy" being recorded on a patients medical record? (If you could be specific for Penicillin this would be ideal)

CARDIOVASCULAR DISEASES

What was the myocardial infarct rate prior to 1910? How did this compare to 1930, 1950 and 1970?

Please can you tell me after a blood transfusion, how long it it is before the body regenerates the bodies blood?

What is the evidence for changing patients from atorvastatin to simvastatin ? Is one better than the other?

What drugs are recommended for the treatment of diastolic dysfunction?

In patients on ACE inhibitors or AR2 blockers, BNF recommends monitoring U+E before and during treatment, is there any evidence that confirms this or suggests any other time frame? Or is it just tradition?

Can I safely prescribe bupropion with someone taking cannabis with no previous history of fits or depression?

1) What is the significance of raised protein C and S levels in relation to venous or arterial thrombosis? 2) Do raised protein C and S levels affect the decision to prescribe statins?

NUTRITION AND METABOLIC DISEASES

An overweight patient with polycystic ovary syndrome is having difficulty losing weight despite serious long term efforts. Is it acceptable to use metformin to aid weight loss?

INFECTIOUS DISEASES

What is the dose of pencillin V in post splenectomy patients?

CANCER

What is the evidence that dairy products have a causative role in the development of malignant and/or benign breast disease?

TREATMENT AND DISEASES MANAGEMENT

Has anyone got any PGD [Patient Group Directions] on reversibility testing for asthma/copd. Drugs include salbutamol, atrovent, combivent. we are still reversing for copd due to qaf points.

What is the evidence for metformin in restoring fertility in women with PCOS?

In patients using depo provera contraception, what should be done if they are late for their next injection in order to ensure safe contraception?

Hitting the Headlines - Evidence Behind the Press Stories

"Prostate cancer test may not cut death rate"

Screening for prostate cancer with the prostate-specific antigen (PSA) test does not reduce the risk of death, reported two newspapers (10 January 2006). The newspapers reflected the overall conclusion of a case-control study, however, this was based on an analysis of 1002 men, only 135 of whom were screened.

On 10th January 2006, two newspapers (1,2) reported that having a PSA test to screen for prostate cancer may not reduce the risk of death in men.
The research(3), was a well-conducted case-control study involving 501 men (cases) aged over 50 who had been diagnosed with and had died of prostate cancer, and 501 living men (controls) aged over 50, and with or without cancer. The study found no significant difference in all-cause mortality, or mortality due to prostate cancer, between men screened and not screened, whether adjusted for age and co-morbidity (the presence of coexisting or additional diseases/conditions).
Although the newspaper reports generally provided an accurate overview of the results of the study, The Guardian (1) incorrectly stated that all the men in the control group had prostate cancer. This type of study cannot provide a definitive answer on the PSA test, and The Times (2) highlights that randomised controlled trials assessing the effectiveness of screening with the PSA test are currently underway in the USA and Europe.

Evaluation of the evidence base for prostate cancer screening not reducing death rate in men

Where does the evidence come from?

The multi-centre study was carried out in the United States, led by Dr Concato from the Department of Veterans Affairs Connecticut Healthcare System, West Haven. Funding was provided by the Department of Veterans Affairs.

What were the authors' objectives?

To evaluate the effectiveness of the PSA test, with or without digital rectal examination (DRE), in reducing mortality.

What was the nature of the evidence?

The study was a multi-centre case-control study, involving a cohort of 71,661 men over the age of 50 who had not been diagnosed with prostate cancer when the study commenced (1991). From this cohort, 501 men who were diagnosed as having prostate cancer in the years 1991 to 1995 and had died by the end of 1999 were identified as cases. The 501 controls were men randomly selected from the same cohort, with or without cancer, who were alive at the time the corresponding case patient had died. Medical records of cases and controls were reviewed to determine whether patients had received screening with PSA or DRE. Researchers abstracting these data were blinded to case or control status. Controls were matched for each case patient based on Veteran Affairs facility and age. Cases included a statistically significant greater number of people who were black and/or had more severe co-morbidity.

How did participants differ on their levels of exposure to the factor of interest?

The factor of interest was whether PSA testing or DRE was performed for screening prior to the diagnosis of prostate cancer among cases. Screening occurred in 70 cases (14%) and 65 controls (13%). There were 54 pairs of men where the cases were screened and the controls were not, and 49 pairs where the controls were screened and the cases were not.

What were the findings?

Results showed no statistically significant difference in all-cause mortality, or mortality due to prostate cancer, between men screened and not screened, whether adjusted for age and co-morbidity or not.

In addition, there were no statistically significant differences in mortality with PSA screening when men with symptoms of benign prostatic hyperplasia were included in the screening, when PSA screening was conducted more frequently, in the subset of men with no or mild co-morbidity, or when the subset of patients aged 72.5 years or younger were analysed.

Black race and co-morbidity were significant predictors of all-cause mortality and mortality from prostate cancer.

What were the authors' conclusions?

The authors concluded that the results do not suggest that screening with PSA is effective in reducing mortality.

How reliable are the conclusions?

On the whole, this was a well-conducted case-control study, with cases and controls sourced from then same population, and information obtained from medical records by researchers blind to case or control status. The imbalance in race, and more particularly co-morbidity, between the cases and controls may have impacted on the observed mortality of these groups, however, the authors performed analyses with and without adjusting for these confounding factors, and the results were similar in both. The authors' conclusions appear valid, but were based on the analysis of 501 matched pairs of which only 135 were screened. This is a small sample size when considering the number and the diversity of men involved in screening programmes, and it is unclear whether results of this sample would be representative of the wider population of men being screened for prostate cancer. However, the authors had performed a calculation to determine the sample size required, which was exceeded in the study.

Systematic reviews

There were no related systematic reviews identified on the Cochrane Database of Systematic Reviews (CDSR), although there is one review which is currently being completed and will be available in the future (5). Three related systematic reviews were identified on the Database of Abstracts of Reviews of Effects (DARE) (6-8).

References and resources

1. Prostate cancer test may not cut death rate. The Guardian, 10 January 2006, p7.

2. Prostate cancer test may leave men even worse off. The Times, 10 January 2006, p11.

3. Concato J, Wells CK, Horwitz RI, Penson D, Fincke G, Berlowitz DR, et al. The effectiveness of screening for prostate cancer: a nested case-control study. Archives of Internal Medicine 2006;166:38-43.

4. Barry MJ. The PSA conundrum [editorial]. Archives of Internal Medicine 2006;166:7-8.

5. Ilic D, Green S, O'Connor D, Wilt T. Screening for prostatic cancer. [Cochrane Protocol] The Cochrane Database of Systematic Reviews 2004, Issue 2. Art. No.: CD004720. DOI: 10.1002/14651858.CD004720.

6. Selley S, Donovan J, Faulkner A, Coast J, Gillatt D. Diagnosis, management and screening of early localised prostate cancer. Health Technology Assessment 1997;1(2):1-96. [DARE Abstract]

7. Hoogendam A, Buntinx F, de Vet H C. The diagnostic value of digital rectal examination in primary care screening for prostate cancer: a meta-analysis. Family Practice 1999;16(6):621-626. [DARE Abstract]

8. Hoffman R M, Clanon D L, Littenberg B, Frank J J, Peirce J C. Using the free-to-total prostate-specific antigen ratio to detect prostate cancer in men with nonspecific elevations of prostate-specific antigen levels. Journal of General Internal Medicine 2000;15(10):739-748. [DARE Abstract]

9. NHS Centre for Reviews and Dissemination. Screening for prostate cancer. Effectiveness Matters 1997;2(2):1-4.

10. Eichler K, Wilby J, Hempel S, Myers L, Kleijnen J. Diagnostic value of systematic prostate biopsy methods in the investigation for prostate cancer: a systematic review. CRD Report 29. York: University of York, 2005.

11. Donovan J, Hamdy F, Neal D, Peters T, Oliver S, Brindle L, et al. Prostate testing for cancer and Treatment (ProtecT) feasibility study. Health Technology Assessment 2003;7(14):1-42.

12. Chamberlain J, Melia J, Moss S, Brown J. The diagnosis, management, treatment and costs of prostate cancer in England and Wales: a review. Health Technology Assessment 1997;1(3):1-53.

Consumer information

The Prostate Cancer Charity

Prostate Cancer UK

NHS Direct – Cancer of the prostate

Previous Hitting the Headlines summaries on this topic

Men's cancer test fails 82% of time. Hitting the Headlines archive, 24 July 2003.

New test for assessing the aggressiveness of prostate cancer. Hitting the Headlines archive, 10 August 2005

Document of the Week from the National Library for Health

Special journal supplement contains key articles on challenges of summarising better health.

The North American Evidence-Based Practice Centers (EPCs) make up a network set up by the Agency for Healthcare Research and Quality (AHRQ) in 1997. By 2004, they had produced more than 100 evidence reports and had learned much from the experience. This experience of methodological challenges that they encompassed, is written up in this special supplement, produced by the Annals of Internal Medicine.

Click on each heading to view the articles. NHS Athens passwords are required to access this resource, and can be obtained from the National Library for Health here

Better Information for Better Health Care: The Evidence-based Practice Center Program and the Agency for Healthcare Research and Quality

Challenges in Systematic Reviews of Complementary and Alternative Medicine Topics

Challenges in Systematic Reviews of Diagnostic Technologies

Challenges in Systematic Reviews of Economic Analyses

Challenges in Systematic Reviews of Educational Intervention Studies

Challenges in Systematic Reviews of Therapeutic Devices and Procedures

Challenges in Systematic Reviews That Assess Treatment Harms

Challenges in Systematic Reviews That Evaluate Drug Efficacy or Effectiveness

Challenges in Systematic Reviews: Synthesis of Topics Related to the Delivery, Organization, and Financing of Health Care

Challenges in Using Nonrandomized Studies in Systematic Reviews of Treatment Interventions

Dissemination of Evidence-based Practice Center Report