Are more observational studies being included in Cochrane Reviews?
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ABSTRACT: Background
Increasing the scope of an evidence based approach to areas outside healthcare has renewed the importance of a long-standing discussion on randomised versus observational study designs in evaluating the effectiveness of interventions. We investigate statistically if an increasing recognition of the role of certain nonrandomised studies to support or generalize the results of randomised controlled trials has had an impact on the actual inclusion criteria applied in Cochrane reviews.Methods
We conduct an on-line search of the Cochrane Database of Systematic Reviews (CDSR) and divide all Cochrane reviews according to their design inclusion criterion: (A) RCTs only or (B) RCTs and (some subset of) observational studies. We test statistically whether a shift in the proportion of category B reviews has occurred by comparing reviews published before 2008 with reviews published during 2008/09.Results
We find that the proportion of Cochrane reviews choosing a broader inclusion criterion has increased, although by less than two percentage points. The shift is not statistically significant (P = 0.08).Conclusions
There is currently not sufficient data to support a hypothesis of a significant shift in favour of including observational studies, neither at the aggregate level nor at the level of individual Review Groups within the Cochrane Collaboration.
SUBMITTER: Kongsted HC
PROVIDER: S-EPMC3503546 | biostudies-literature | 2012 Oct
REPOSITORIES: biostudies-literature
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Are more observational studies being included in Cochrane Reviews?
Kongsted Hans Christian HC Konnerup Merete M
BMC research notes 20121016
<h4>Background</h4>Increasing the scope of an evidence based approach to areas outside healthcare has renewed the importance of a long-standing discussion on randomised versus observational study designs in evaluating the effectiveness of interventions. We investigate statistically if an increasing recognition of the role of certain nonrandomised studies to support or generalize the results of randomised controlled trials has had an impact on the actual inclusion criteria applied in Cochrane rev ...[more]
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| S-EPMC4187994 | biostudies-literature
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| S-EPMC6458756 | biostudies-literature
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| S-EPMC4395015 | biostudies-literature
Project description:In 1996, shortly after the founding of The Cochrane Collaboration, leading figures in test evaluation research established a Methods Group to focus on the relatively new and rapidly evolving methods for the systematic review of studies of diagnostic tests. Seven years later, the Collaboration decided it was time to develop a publication format and methodology for Diagnostic Test Accuracy (DTA) reviews, as well as the software needed to implement these reviews in The Cochrane Library. A meeting hosted by the German Cochrane Centre in 2004 brought together key methodologists in the area, many of whom became closely involved in the subsequent development of the methodological framework for DTA reviews. DTA reviews first appeared in The Cochrane Library in 2008 and are now an integral part of the work of the Collaboration.
| S-EPMC3851548 | biostudies-literature
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Project description:BACKGROUND:Nudge interventions are those that seek to modify the social and physical environment to enhance capacity for subconscious behaviours that align with the intrinsic values of an individual, without actively restricting options. This study sought to describe the application and effects of nudge strategies on clinician implementation of health-related guidelines, policies and practices within studies included in relevant Cochrane systematic reviews. METHODS:As there is varied terminology used to describe nudge, this study examined studies within relevant systematic reviews. A two-stage screening process was undertaken where, firstly, all systematic reviews published in the Cochrane Library between 2016 and 2018 were screened to identify reviews that included quantitative studies to improve implementation of guidelines among healthcare providers. Secondly, individual studies within relevant systematic reviews were included if they were (i) randomised controlled trials (RCTs), (ii) included a nudge strategy in at least one intervention arm, and (iii) explicitly aimed to improve clinician implementation behaviour. We categorised nudge strategies into priming, salience and affect, default, incentives, commitment and ego, and norms and messenger based on the Mindspace framework. SYNTHESIS:The number and percentage of trials using each nudge strategy was calculated. Due to substantial heterogeneity, we did not undertake a meta-analysis. Instead, we calculated within-study point estimates and 95% confidence intervals, and used a vote-counting approach to explore effects. RESULTS:Seven reviews including 42 trials reporting on 57 outcomes were included. The most common nudge strategy was priming (69%), then norms and messenger (40%). Of the 57 outcomes, 86% had an effect on clinician behaviour in the hypothesised direction, and 53% of those were statistically significant. For continuous outcomes, the median effect size was 0.39 (0.22, 0.45), while for dichotomous outcomes the median Odds Ratio was 1.62 (1.13, 2.76). CONCLUSIONS:This review of 42 RCTs included in Cochrane systematic reviews found that the impact of nudge strategies on clinician behaviour was at least comparable to other interventions targeting implementation of evidence-based guidelines. While uncertainty remains, the review provides justification for ongoing investigation of the evaluation and application of nudge interventions to support provider behaviour change. TRIAL REGISTRATION:This review was not prospectively registered.
| S-EPMC7329401 | biostudies-literature
Project description:BACKGROUND: Eczema is the most common inflammatory skin disease of childhood, characterized by an itchy red rash that usually involves the face and skin folds. There is currently no curative treatment for eczema, so the reduction of eczema incidence through disease prevention is a desirable goal. Potential interventions for preventing eczema include exclusive breastfeeding, hydrolysed protein formulas and soy formulas when bottle feeding, maternal antigen avoidance, omega oil supplementation, prebiotics and probiotics. OBJECTIVES: This overview of reviews aims to present the current body of data from Cochrane and non-Cochrane reviews to provide the most up-to-date evidence on the efficacy and safety of interventions to prevent eczema in infants and children at different risk levels for developing allergic disease. METHODS: Our pool of Cochrane and non-Cochrane reviews came from the 2010 United Kingdom National Health Service (NHS) Evidence Skin Disorders Annual Evidence Updates Mapping Exercise on Atopic Eczema. This group used a comprehensive search strategy last conducted in August 2010 to identify all systematic reviews on eczema prevention. We identified all reviews that met our pre-specified inclusion criteria, and data were extracted, analysed, compiled into tables and synthesized using quantitative and qualitative methods. MAIN RESULTS: Seven systematic reviews containing 39 relevant trials with 11 897 participants were included in this overview. Overall, there was no clear evidence that any of the main interventions reviewed reduced eczema incidence. In subgroup analyses of infants at high risk of allergic disease, an observational study found that exclusive breastfeeding for at least six months compared with introduction of solids at three to six months decreased the incidence of eczema by 60% (risk ratio (RR): 0.40; 95% confidence interval (CI): 0.21, 0.78), and a randomized controlled trial found that prebiotics compared with no prebiotics decreased incidence by 58% (RR: 0.42; 95% CI: 0.21, 0.84). However, each of these findings was based on the results of a single small trial, and no intervention reduced eczema incidence beyond the first two years of life. Although we pre-specified incidence of atopic eczema (i.e. eczema associated with immunoglobulin E (IgE) sensitization) as a primary outcome, data on whether participants diagnosed with eczema were truly atopic were largely lacking from systematic reviews. Similarly, data on atopy, measured using skin prick tests or specific IgE tests to allergens, were not reported in many reviews. No interventions were found to decrease atopy when reported. Adverse events data were generally lacking, but data from a trial of probiotics versus no probiotics showed significantly more spitting up in the first one (RR: 1.88; 95% CI: 1.03, 3.45) and two (RR: 1.69; 95% CI: 1.02, 2.80) months of life, but no overall increase in risk of gastrointestinal symptoms in the first year. AUTHORS#ENTITYSTARTX02019; CONCLUSIONS: Although there is currently no clear evidence showing that any of the interventions examined in this overview prevent eczema in participants not selected for risk of allergic disease, there is some evidence that exclusive breastfeeding for at least six months and prebiotics might reduce eczema incidence in high-risk participants. However, these conclusions are based on limited evidence with methodological shortcomings. Future research on prevention of eczema is needed and should examine different types of hydrolysed formulas, prebiotics and probiotics, as well as enhancement of the skin barrier and other novel approaches in infants at different risk levels for developing allergic disease.
| S-EPMC3399595 | biostudies-other