Post 20: 24th February 2006

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?

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DIABETES

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

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INFECTIOUS DISEASE

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

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

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When is co-proxamol actually being withdrawn from the market e.g. how long can we continue to prescribe before being available unlicensed only.

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NEUROLOGICAL DISEASE

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

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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?

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Post 19: 17th February 2006

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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

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Latest Guidelines

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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.

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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.

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Latest Reports

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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?

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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.

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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.

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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.

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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.

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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.

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Evidence from Journals

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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

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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.

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Therapeutics

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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
Evid Based Med.2006; 11: 18

The Bug Buster kit was better than single dose pediculicides for head lice
Dawes
Evid Based Med.2006; 11: 17

Review: some evidence shows that self help books based on cognitive behaviour therapy...Primack
Evid Based Med.2006; 11: 8

Review: limited evidence from 2 randomised controlled trials suggests that oral...
Bial
Evid Based Med.2006; 11: 9

Review: cholinesterase inhibitors may be effective in Alzheimer’s disease
Luckmann
Evid Based Med.2006; 11: 23

Review: anticholinergics in addition to ß2 agonists improve outcome in children...
Thien
Evid Based Med.2006; 11: 21

Pulmonary vein isolation was better than antiarrhythmic drugs for symptomatic atrial...
George Wyse
Evid Based Med.2006; 11: 16

Using exhaled NO concentrations to adjust inhaled corticosteroid dose maintained...
Rees
Evid Based Med.2006; 11: 20

Review: vitamin D plus calcium, but not vitamin D alone, prevents osteoporotic fractures...
Johnell
Evid Based Med.2006; 11: 13

Review: viscosupplementation for knee osteoarthritis reduces pain and improves function
Shoor
Evid Based Med.2006; 11: 12

Review: angiotensin converting enzyme inhibitors and angiotensin receptor blockers...
Karthikeyan and Lip
Evid Based Med.2006; 11: 15

Adjunctive treatment with eplerenone reduced 30 day all cause mortality in acute...
Moyer and Berger
Evid Based Med.2006; 11: 14

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Diagnosis

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Review: IgA endomyseal and transglutaminase antibodies had high specificity for...
Gibson
Evid Based Med.2006; 11: 25

Multislice computed tomography detected coronary artery disease
Hlatky and Sanders Evid Based Med.2006; 11: 24

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Clinical Prediction Guide

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

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Trials

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Latest Questions to the Primary Care Question Answering Service

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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?

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

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

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

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

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

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

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

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

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What is the effect of HRT on fibroids?

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

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

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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?

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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?

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CARDIOVASCULAR DISEASE

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How soon after first CVA should prophylactic aspirin be introduced?

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

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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?

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CAUSES, RISKS AND PREVENTION

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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?

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

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

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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?

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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?

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

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OBESITY

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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?

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COMPLEMENTARY MEDICINE

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

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CANCER

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Should we be doing cervical smears on virgins?

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MUSCULOSKELETAL DISEASES

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

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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?

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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.

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Hitting the Headlines - Evidence Behind the Press Stories

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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

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 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

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Document of the Week from the National Library for Health

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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.

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Post 18: 10 February 2006

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 Reports

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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.

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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.

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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.

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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.

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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.

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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

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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.

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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.

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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.

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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.

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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.

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Evidence from Journals

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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?

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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.

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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?

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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)

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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

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

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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

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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

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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

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 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

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

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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.

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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.

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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.

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Latest Guidelines

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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.

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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.

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Latest Reports

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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

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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

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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.

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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

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Evidence from Journals

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Trials

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Latest Questions to the Primary Care Question Answering Service


ASSESSMENT AND DIAGNOSIS

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

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

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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?

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

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

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

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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?

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

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CAUSES, RISKS AND PREVENTION

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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?

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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?

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

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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?

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

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

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

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

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

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

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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?

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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?

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INFECTIOUS DISEASES

---

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

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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

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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.

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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?

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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

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 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.

---

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

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 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.

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Document of the Week from the National Library for Health

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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.

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