Cochrane Collaboration

About: Cochrane Collaboration is a nonprofit organization based out in Oxford, United Kingdom. It is known for research contribution in the topics: Systematic review & Randomized controlled trial. The organization has 1995 authors who have published 3928 publications receiving 382695 citations.

Of mites and men: reference bias in narrative review articles: a systematic review.

Abstract: Background Citations in scientific articles may tend to favor the views presented. We studied whether there is such reference bias in narrative review articles that discuss interventions against house dust mites for people with asthma. Design Systematic review of reviews identified in a Medline search that expressed an opinion about the clinical effects of physical or chemical intervention methods. Main outcome measure Positive bias was judged to have occurred if the reference list contained a higher proportion of trial references with significant results than among all trials available to the authors (published 2 years or more prior to the review). Results Seventy reviews were included, of which 63 (90%) recommended physical interventions. Forty-six reviews had trial references, 4 of these only to chemical interventions. In the remaining 42 reviews, reference bias was detected (P=2 x 10-8). The most quoted trial had only 7 patients per group, its claimed significant result was probably erroneous, and it did not report a clinical outcome. Intervention recommendations were often based on nonrandomized evidence, and the most quoted nonrandomized controlled study had included only 10 patients per group but claimed very positive results. Conclusion The narrative review articles were severely biased, and their positive intervention recommendations are at variance with the systematic Cochrane Review on this topic and a recent very large trial of physical intervention, both of which failed to find an effect.

Efficacy and safety of treatment with dupilumab for severe asthma: A systematic review of the EAACI guidelines-Recommendations on the use of biologicals in severe asthma.

Abstract: Dupilumab, a fully human monoclonal antibody against interleukin-4 receptor α, is approved as add-on maintenance treatment for inadequately controlled type 2 severe asthma. This systematic review evaluated the efficacy, safety and economic impact of dupilumab compared to standard of care for uncontrolled severe asthma. PubMed, EMBASE and Cochrane Library were searched for RCTs and health economic evaluations. Critical and important asthma-related outcomes were evaluated. The risk of bias and the certainty of the evidence were assessed using GRADE. Three RCTs including 2735 subjects >12 years old and 24-52 weeks of follow-up were included. Dupilumab reduced with high certainty severe asthma exacerbations (Incidence rate ratio 0.51; 95% CI 0.45-0.59) and the percentage use of oral corticosteroid use (mean difference (MD) -28.2 mg/d; 95% CI -40.7 to -15.7). Asthma control (ACQ-5), quality of life (AQLQ) and rescue medication use [puffs/d] improved, without reaching the minimal important clinical difference: ACQ-5 MD -0.28 (95% CI -0.39 to -0.17); AQLQ MD +0.28 (95% CI 0.20-0.37); and rescue medication MD -0.35 (95% CI -0.73 to +0.02). FEV1 increased (MD +0.15; 95% CI +0.11 to +0.18) (moderate certainty). There was an increased rate of dupilumab-related adverse events (AEs) (moderate certainty) and of drug-related serious AEs (low certainty). The incremental cost-effectiveness ratio of dupilumab versus standard therapy was 464 000$/QALY (moderate certainty). More data on long-term safety are needed both for children and for adults, together with more efficacy data in the paediatric population.

Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process

Abstract: Introduction Transvaginal mesh devices are approved in the USA by the Food and Drug Administration (FDA), through the 510(k) system. However, there is uncertainty about the benefit to harm balance of mesh approved for pelvic organ prolapse. We, therefore, assessed the evidence at the time of approval for transvaginal mesh products and the impact of safety studies the FDA mandated in 2012 because of emerging harms. Methods We used FDA databases to determine the evidence for approval of transvaginal mesh. To create a ‘family tree’ of device equivalence, we used the 510(k) regulatory approval of the 1985 Mersilene Mesh (Ethicon) and the 1996 ProteGen Sling (Boston Scientific), searched for all subsequently related device approvals, and for the first published randomised trial evidence. We assessed compliance with all FDA 522 orders issued in 2012 requiring postmarketing surveillance studies. Results We found 61 devices whose approval ultimately relied on claimed equivalence to the Mersilene Mesh and the ProteGen Sling. We found no clinical trials evidence for these 61 devices at the time of approval. Publication of randomised clinical trials occurred at a median of 5 years after device approval (range 1–14 years). Analysis of 119 FDA 522 orders revealed that in 79 (66%) the manufacturer ceased market distribution of the device, and in 26 (22%) the manufacturer had changed the indication. Only seven studies (six cohorts and new randomised controlled trial) covering 11 orders were recruiting participants (none had reported outcomes). Conclusions Transvaginal mesh products for pelvic organ prolapse have been approved on the basis of weak evidence over the last 20 years. Devices have inherited approval status from a few products. A publicly accessible registry of licensed invasive devices, with details of marketing status and linked evidence, should be created and maintained at the time of approval.

The controlled clinical trial turns 100 years: Fibiger's trial of serum treatment of diphtheria

Abstract: The British Medical Research Council's trial of streptomycin for pulmonary tuberculosis, published in 1948,1 has been proposed as the first randomised trial in which random numbers were used and allocation of patients was effectively concealed. Before 1948 several randomised trials had been reported,2 but the method of randomisation was either not stated3 or was open to selection bias—for example, randomisation with use of a deck of cards.4 The earliest of these trials was published in 1898.5 It investigated the effect of serum treatment on diphtheria and was conducted by the Danish Nobel laureate, Johannes Fibiger. It was the first clinical trial in which random allocation was used and emphasised as a pivotal methodological principle. This pioneering improvement in methodology, combined with a large number of patients and rigorous planning, conduct, and reporting, makes the trial a milestone in the history of clinical trials. Fibiger's trial was published in Danish and its method of randomisation has often been quoted incorrectly. We have translated central passages into English (available on the BMJ website at www.bmj.com) and discussed its methodological merit. ### Summary points A large randomised clinical trial was performed as early as 1898 Random allocation was emphasised as a central methodological principle Patients were allocated to serum or no serum according to day of admittance, which created two comparable groups The planning, conduct, and reporting of the trial was of high quality The efficacy of serum treatment on diphtheria was shown The trial was the first properly conducted controlled clinical trial Johannes A G Fibiger (1867-1928) was born in Silkeborg, Denmark (figure). After receiving his medical degree in 1890 from the University of Copenhagen he visited Robert Koch and Emil von Behring in Germany. In 1895 Fibiger was awarded a doctoral degree for a thesis on diphtheria from the …

Intimate partner violence: last year prevalence and association with socio-economic factors among women in Madrid, Spain.

Abstract: BACKGROUND: Intimate partner violence (IPV) is a public health problem with significant consequences on women's health. This study estimates the prevalence of intimate partner violence by type among Madrid's female population and assesses the association with socio-economic variables. METHODS: We conducted a cross-sectional study in 2004, 2136 women aged 18-70 years, living in the Madrid region with a partner or who had been in contact with an ex-partner in the previous year, were interviewed by telephone. The questionnaire used to measure past-year intimate partner violence, consisted of a Spanish translation of the psychological and sexual violence module of the French National Survey on Violence against Women, and the physical violence module of the Conflict Tactics Scale-1. To assess the association with socio-economic factors, logistic regression models were fitted. Results: About 10.1% [confidence interval (CI) 8.9-11.5] of the women had suffered some type of IPV in the previous year. 8.6% (CI 7.4-9.8) experienced psychological violence, 2.4% (CI 1.8-3.1) physical violence and 1.1% (CI 0.68-1.6) sexual violence; the prevalence of psychological-only violence (non-physical/non-sexual) was 6.9% (CI 5.8-8.0). Factors associated with psychological-only violence were divorced or separated status and Group III (clerical workers; supervisors of manual workers) or V (unskilled manual workers) occupation. Unemployment and divorced or separated status were associated with physical violence. CONCLUSIONS: Spanish women in our study, experienced past year partner violence at a similar level as in other industrialized countries. Unemployment and low occupational status are associated with physical and psychological-only violence, respectively. Language: en