Exhibit B

Combining Evidence Based Practice resources into a single source of Current Awareness for the Liverpool PCTs.

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Friday, March 24, 2006

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Latest Systematic Reviews
Latest Guidelines
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

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 report favourable cost effectiveness ratios (below $20 000, $50 000, and $100 000 per quality adjusted life year (QALY) gained) and evaluate study characteristics associated with this phenomenon.

Design Systematic review.

Studies reviewed 494 English language studies measuring health effects in QALYs published up to December 2001 identified using Medline, HealthSTAR, CancerLit, Current Content, and EconLit databases.

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

Results Approximately half the reported incremental cost effectiveness ratios (712 of 1433) were below $20 000/QALY. Studies funded by industry were more likely to report cost effectiveness ratios below $20 000/QALY (adjusted odds ratio 2.1, 95% confidence interval 1.3 to 3.3), $50 000/QALY (3.2, 1.8 to 5.7), and $100 000/QALY (3.3, 1.6 to 6.8). Studies of higher methodological quality (adjusted odds ratio 0.58, 0.37 to 0.91) and those conducted in Europe (0.59, 0.33 to 1.1) and the United States (0.44, 0.26 to 0.76) rather than elsewhere were less likely to report ratios below $20 000/QALY.

Conclusion Most published analyses report favourable incremental cost effectiveness ratios. Studies funded by industry were more likely to report ratios below the three thresholds. Studies of higher methodological quality and those conducted in Europe and the US rather than elsewhere were less likely to report ratios 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 interventions in improving detection rates and management of dementia in primary care.

Design Unblinded, cluster randomised, before and after controlled study.

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

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

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

Main outcome measures Rates of detection of dementia and the extent to which medical records showed evidence of improved concordance with guidelines regarding diagnosis and management.

Results Decision support software (P = 0.01) and practice based workshops (P = 0.01) both significantly improved rates of detection compared with control. There were no significant differences by intervention in the measures of concordance with guidelines.

Conclusions Decision support systems and practice based workshops are effective educational approaches in improving detection rates 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.





posted by Kieran at 7:50 am 0 comments

Thursday, March 16, 2006

Post 23: 17 March 2006

Exhibit B LogoLinks 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

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 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.

posted by Tracy at 8:47 am 0 comments

Monday, March 06, 2006

Post 22: 10th March 2006

Exhibit B LogoLinks 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:
  1. there is proven intolerance to calcineurin inhibitors, particularly nephrotoxicity which could lead to risk of chronic allograft dysfunction, OR
  2. 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?






posted by Tracy at 10:12 am 0 comments

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