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ABSTRACT: Despite the rapid increase in research in China, little is known about the quality of clinical trials conducted there.
A systematic review and critical appraisal of randomised controlled trials (RCTs) conducted in China and published in 2004 was undertaken to describe their characteristics, assess the quality of their reporting, and where possible, the quality of their conduct. Randomised controlled trials in all disease areas and types of interventions, which took place in China and included Chinese citizens were identified using PubMed and hand searching the Journal Series of the Chinese Medical Association. Quality was assessed against a subset of criteria adapted from the CONSORT statement.
Three hundred and seven RCTs were included. One hundred and ninety-nine (64.8%) failed to report methods of randomization and 254 (82.4%) did not mention blinding of either participants or investigators. Reporting of baseline characteristics, primary outcome and length of follow-up was inadequate in a substantial proportion of studies. Fewer than 11% of RCTs mentioned ethical approval and only 18.0% adequately discussed informed consent. However, dropout rates were very favourable with nearly 44% of trials reporting a zero dropout rate.
Reporting of RCTs in China requires substantial improvement to meet the targets of the CONSORT statement. The conduct of Chinese RCTs cannot be directly inferred from the standard of reporting; however without good reporting the methods of the trials cannot be clearly ascertained.
Trials 02/2008; 9:22. · 2.02 Impact Factor
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ABSTRACT: The aim of this study was to examine the effects of age, sex and social deprivation on mortality rates for respiratory infection. An ecological study was undertaken, using official public health mortality data and population census data for the West Midlands health region, UK. Postcodes at the time of death were used to assign Townsend deprivation scores and the resulting deprivation quintile. Poisson regression analysis was used to estimate the association between respiratory mortality, deprivation quintile, age and sex. In most age groups there was a statistically significant trend of increasing mortality with increasing deprivation. The relative risk for the most deprived was highest in the 45-64 year age-group (RR=4.4, 95% CI 4.0, 4.8). However, the absolute risks were greater in those aged 75-84 years (RR=1.3, 95% CI 1.3, 1.4) where the annual death rate was 669 per 100,000. Consistently higher mortality rates were seen in males. These results suggest that the risk of mortality from respiratory infection varies by sex and generally increases with increasing age and deprivation quintile. The identified association between deprivation and mortality from respiratory infections is consistent with the effect of deprivation on many other diseases. Addressing the social determinants of ill health may help to reduce the high burden of respiratory mortality in the UK. However, individual level studies and examination of other areas are needed to explain the mechanisms by which deprivation increases the risk of mortality from respiratory infection, and thereby identify target groups for effective interventions.
Respiratory Medicine 08/2006; 100(7):1282-5. · 2.47 Impact Factor
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ABSTRACT: Influenza causes substantial mortality in high-risk groups despite targeted vaccination programmes. This paper considers whether it is worth vaccinating healthcare workers (HCWs) against influenza to protect high-risk patients in a series of systematic reviews and an economic evaluation. Eighteen studies are included. Vaccination was highly effective in HCWs, with minimal adverse effects. Two trials assessed patient mortality after vaccinating HCWs, both of which showed a reduction. Despite recommendations, less than 25% of HCW in Europe and the UK are vaccinated. Five studies looked at programmes to increase uptake; these produced increases of 5%-45%. Published economic evaluations did not include patient benefit; therefore, an economic evaluation using UK data was undertaken. In the base case, vaccination was cost saving (pounds 12/vaccinee). In the most pessimistic scenario it cost pounds 405/life-year gained. Effective implementation should be a priority.
Vaccine 06/2006; 24(19):4212-21. · 3.77 Impact Factor
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ABSTRACT: We present a systematic review of the effectiveness of vaccinating healthy children to protect others. Primary studies were identified by searching standard electronic databases, internet sites, trials registers and citation lists to January 2004 and subjected to critical appraisal. Eight randomised controlled trials, three community studies and three economic evaluations met the inclusion criteria. The evidence suggests that vaccinating healthy children against influenza has the potential for reducing the impact of influenza epidemics. However, further evidence is needed as limitations of study design or execution mean that the community benefits are difficult to quantify.
Vaccine 03/2006; 24(8):1047-62. · 3.77 Impact Factor
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DPHE Report Number. 01/2005; 53.
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ABSTRACT: Carpal tunnel syndrome (CTS) comprises a complex of symptoms in the hand, including pain and paresthesia and weakness of hand muscles thought to result from compression of the median nerve. Many clinicians either refer patients for electrodiagnostic studies to aid diagnosis or conduct electrodiagnostic studies, which may be useful as an aid to decisions on treatment. The aim of this systematic review is to evaluate the evidence base for the use of electrodiagnostic tests in the diagnosis and management of carpal tunnel syndrome. A systematic search was undertaken for studies that included patients with clinical diagnosis of CT5 who were undergoing electrodiagnostic tests and surgery together with reported outcomes of surgery. A published systematic review found that electrodiagnosis was not a useful diagnostic test in patients with clinical signs of CTS. Seven primary studies of prognosis reporting electrodiagnosis and surgery outcomes were found, however, one of them was subsequently retracted. The remaining six were retrospective case senes of poor quality. Four of these studies reported outcomes of surgery in patients with clinically identified CTS, comparing both positive or negative electrodiagnostic results. No study found any statistical difference in surgical outcome between those who were electrodiagnostic test positive and those who were negative. Despite the limited quality of the evidence, in cases of clear-cut clinical CTS, electrodiagnosis is not warranted either as a diagnostic test, where clinical symptoms are well defined, or as a predictive indicator of surgical outcome. It may still be useful in cases where the clinical diagnosis is not clear.
British Journal of General Practice 09/2002; 52(481):670-3. · 1.83 Impact Factor
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ABSTRACT: To assess the evidence for the effectiveness of increasing numbers of drugs in antiretroviral combination therapy.
Systematic review, meta-analysis, and meta-regression of fully reported randomised controlled trials. All studies included compared quadruple versus triple therapy, triple versus double therapy, double versus monotherapy, or monotherapy versus placebo or no treatment.
Patients with any stage of HIV infection who had not received antiretroviral therapy.
Changes in disease progression or death (clinical outcomes); CD4 count and plasma viral load (surrogate markers). Search strategy: Six electronic databases, including Medline, Embase, and the Cochrane Library, searched up to February 2001.
54 randomised controlled trials, most of good quality, with 66 comparison groups were included in the analysis. For both the clinical outcomes and surrogate markers, combinations with up to and including three (triple therapy) were progressively and significantly more effective. The odds ratio for disease progression or death for triple therapy compared with double therapy was 0.6 (95% confidence interval 0.5 to 0.8). Heterogeneity in effect sizes was present in many outcomes but was largely related to the drugs used and trial quality.
Evidence from randomised controlled trials supports the use of triple therapy. Research is needed on the effectiveness of quadruple therapies and the relative effectiveness of specific combinations of drugs.
BMJ (Clinical research ed.). 04/2002; 324(7340):757.
