[show abstract][hide abstract] 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.
[show abstract][hide abstract] 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. · 2.59 Impact Factor
[show abstract][hide abstract] 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.
[show abstract][hide abstract] 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.
[show abstract][hide abstract] 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
[show abstract][hide abstract] 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.
[show abstract][hide abstract] ABSTRACT: To determine whether the levonorgestrel-releasing intrauterine device (LNG-IUS), licensed at present for contraceptive use, may reduce menstrual blood loss with few side effects. If effective, surgery could be avoided with consequent resource savings.
A systematic review addressing the effectiveness and cost effectiveness of the LNG-IUS for menorrhagia was undertaken.
Five controlled trials and five case series were found which measured menstrual blood loss. Nine studies recorded statistically significant average menstrual blood loss reductions with LNG-IUS (range 74%-97%). Another showed reduction in menstrual disturbance score. The LNG-IUS was more effective than tranexamic acid, but slightly less effective than endometrial resection at reducing menstrual blood loss. In one study, 64% of women cancelled surgery at six months, compared with 14% of control group women. In another, 82% were taken off surgical waiting lists at one year. No cost effectiveness studies were found.
Small studies of moderate quality indicate the LNG-IUS is an effective treatment for menorrhagia. Costs may be less than for tranexamic acid in primary and secondary care. Although its use may reduce surgical waiting lists, cost effectiveness assessment requires longer follow up.
Effectiveness and cost effectiveness relative to other treatments and the effect on surgical waiting lists can only be established in larger trials measuring patient-centred outcomes in women with menorrhagia.
BJOG An International Journal of Obstetrics & Gynaecology 02/2001; 108(1):74-86. · 3.76 Impact Factor
[show abstract][hide abstract] ABSTRACT: This review presents and evaluates the evidence of the effectiveness of laser resurfacing for facial acne scars. Primary studies of all types of design in any language were identified from MEDLINE, EMBASE, the Cochrane database, Science Citation Index and various internet sites. Studies were accepted if they included patients treated by any laser for atrophic or ice-pick acne scars. The quality of the studies was assessed and data extracted by two independent researchers. There were no controlled trials but 14 case series were found which reported the effects of either the carbon dioxide or erbium:YAG laser. All of the studies were of poor quality. The types and severity of scarring were poorly described and there was no standard scale used to measure scar improvement. There was no reliable or validated measure of patient satisfaction; most improvement was based on visual clinical judgement, in many cases without blinded assessment. The inaccurate use of ordinal scales meant that any improvement was impossible to quantify with any validity, although the evidence suggested that laser treatment had some efficacy (a range in individual patients of 25-90% for both the carbon dioxide laser and the erbium:YAG laser). Changes in pigmentation as a side-effect were common (in up to 44% of patients), although lasting only a few weeks. Laser resurfacing technology is increasingly used in clinical practice to treat acne scars. Despite the poor quality evidence, it is plausible that there is some improvement of acne scarring; there is insufficient information, however, for patients to make informed decisions on whether to opt for treatment and there is not enough evidence to compare the two types of laser. There is a particular lack of information about the psychological effects of acne scar improvement. Good quality randomized controlled trials are needed with standardized scarring scales and validated patient outcome measures in order to assess the effectiveness of laser resurfacing in this group of patients.
British Journal of Dermatology 04/2000; 142(3):413-23. · 3.76 Impact Factor
[show abstract][hide abstract] ABSTRACT: Multiple sclerosis (MS) is an important problem both for people with the disease and for society. There is no cure, and alleviation of symptoms forms the cornerstone of care. Excessive fatigue that severely limits activity is experienced by at least two-thirds of the estimated 60,000 people with MS in the UK.
(1) To identify current treatments for fatigue in MS and their evidence-base. (2) To systematically review the evidence for those treatments that have been investigated in more than one rigorous study, in order to determine their effectiveness and cost-effectiveness.
The review was carried out in two stages: a formal scoping review (to assess the range of interventions used by people with MS), and a systematic review for treatments that had been identified as promising and that had been investigated in clinical trials (as identified in the scoping review). A systematic review of research on costs and cost-effectiveness of those interventions identified as promising was also performed. Electronic databases, including MEDLINE and EMBASE, were searched for the period 1991-June 1999 (scoping review) and 1966-December 1999 (systematic review). Reference lists from publications were also searched, and experts were contacted for any additional information not already identified.
Interventions identified for the treatment of fatigue in MS (1) Behavioural advice. This is the main element of initial clinical management and no rigorous research of its effectiveness was identified. (2) Drugs (amantadine, pemoline, potassium-channel blockers and antidepressants). (3) Training, rehabilitation and devices (cooling vests and electromagnetic fields). (4) Alternative therapies (bee venom, cannabis, acupuncture/acupressure and yoga). Only two drugs, amantadine and pemoline, met the criteria for full systematic review. RESULTS - EFFECTIVENESS OF AMANTADINE: One parallel and three crossover trials were found, involving a total of 236 people with MS. All studies were open to bias. All studies showed a pattern in favour of amantadine compared with placebo, but there is considerable uncertainty about the validity and clinical significance of this finding. This pattern of benefit was considerably undermined when different assumptions were used in the sensitivity analysis. RESULTS - EFFECTIVENESS OF PEMOLINE: One parallel and one crossover trial were found involving a total of 126 people with MS. Both studies were open to bias. There was no overall tendency in favour of pemoline over placebo and an excess of reports of adverse effects with pemoline. RESULTS - HEALTH ECONOMIC ANALYSIS: The drug costs of amantadine and pemoline are modest (pound 200 and pound 80 per annum, respectively). No economic evaluations were identified in the systematic review, and available data were insufficient to allow modelling of cost-effectiveness in this rapid review.
There is insufficient evidence to allow people with MS, clinicians or policy makers to make informed decisions on the appropriate use of the many treatments on offer. Only amantadine appears to have some proven ability to alleviate the fatigue in MS, though only a proportion of users will obtain benefit and then only some of these patients will benefit sufficiently to take the drug in the long term. CONCLUSIONS - RECOMMENDATIONS FOR RESEARCH: The frequency, severity and impact of fatigue, the poverty of available research, and the absence of any ongoing research, suggest that new research is an urgent priority. People with MS, clinicians and policy makers should work together to ensure that the evidence required is collected as quickly as possible by encouraging involvement in rigorous research. Research should not be restricted to the two drugs reviewed in depth in this report. All interventions identified in the scoping review (see above) should be considered, as should basic scientific research into the underlying mechanism of fatigue in MS.