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      COSMOS-E: Guidance on conducting systematic reviews and meta-analyses of observational studies of etiology

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          Abstract

          Background

          To our knowledge, no publication providing overarching guidance on the conduct of systematic reviews of observational studies of etiology exists.

          Methods and findings

          Conducting Systematic Reviews and Meta-Analyses of Observational Studies of Etiology (COSMOS-E) provides guidance on all steps in systematic reviews of observational studies of etiology, from shaping the research question, defining exposure and outcomes, to assessing the risk of bias and statistical analysis. The writing group included researchers experienced in meta-analyses and observational studies of etiology. Standard peer-review was performed. While the structure of systematic reviews of observational studies on etiology may be similar to that for systematic reviews of randomised controlled trials, there are specific tasks within each component that differ. Examples include assessment for confounding, selection bias, and information bias. In systematic reviews of observational studies of etiology, combining studies in meta-analysis may lead to more precise estimates, but such greater precision does not automatically remedy potential bias. Thorough exploration of sources of heterogeneity is key when assessing the validity of estimates and causality.

          Conclusion

          As many reviews of observational studies on etiology are being performed, this document may provide researchers with guidance on how to conduct and analyse such reviews.

          Abstract

          In a Guidelines and Guidance article, Olaf Dekkers and colleagues discuss COSMOS-E, in which they aim to provide guidance for those performing systematic reviews and meta-analyses of observational studies addressing etiology.

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          Most cited references52

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          The nuts and bolts of PROSPERO: an international prospective register of systematic reviews

          Background Following publication of the PRISMA statement, the UK Centre for Reviews and Dissemination (CRD) at the University of York in England began to develop an international prospective register of systematic reviews with health-related outcomes. The objectives were to reduce unplanned duplication of reviews and provide transparency in the review process, with the aim of minimizing reporting bias. Methods An international advisory group was formed and a consultation undertaken to establish the key items necessary for inclusion in the register and to gather views on various aspects of functionality. This article describes the development of the register, now called PROSPERO, and the process of registration. Results PROSPERO offers free registration and free public access to a unique prospective register of systematic reviews across all areas of health from all around the world. The dedicated web-based interface is electronically searchable and available to all prospective registrants. At the moment, inclusion in PROSPERO is restricted to systematic reviews of the effects of interventions and strategies to prevent, diagnose, treat, and monitor health conditions, for which there is a health-related outcome. Ideally, registration should take place before the researchers have started formal screening against inclusion criteria but reviews are eligible as long as they have not progressed beyond the point of completing data extraction. The required dataset captures the key attributes of review design as well as the administrative details necessary for registration. Submitted registration forms are checked against the scope for inclusion in PROSPERO and for clarity of content before being made publicly available on the register, rejected, or returned to the applicant for clarification. The public records include an audit trail of major changes to planned methods, details of when the review has been completed, and links to resulting publications when provided by the authors. Conclusions There has been international support and an enthusiastic response to the principle of prospective registration of protocols for systematic reviews and to the development of PROSPERO. In October 2011, PROSPERO contained 200 records of systematic reviews being undertaken in 26 countries around the world on a diverse range of interventions.
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            The hazards of scoring the quality of clinical trials for meta-analysis.

            Although it is widely recommended that clinical trials undergo some type of quality review, the number and variety of quality assessment scales that exist make it unclear how to achieve the best assessment. To determine whether the type of quality assessment scale used affects the conclusions of meta-analytic studies. Meta-analysis of 17 trials comparing low-molecular-weight heparin (LMWH) with standard heparin for prevention of postoperative thrombosis using 25 different scales to identify high-quality trials. The association between treatment effect and summary scores and the association with 3 key domains (concealment of treatment allocation, blinding of outcome assessment, and handling of withdrawals) were examined in regression models. Pooled relative risks of deep vein thrombosis with LMWH vs standard heparin in high-quality vs low-quality trials as determined by 25 quality scales. Pooled relative risks from high-quality trials ranged from 0.63 (95% confidence interval [CI], 0.44-0.90) to 0.90 (95% CI, 0.67-1.21) vs 0.52 (95% CI, 0.24-1.09) to 1.13 (95% CI, 0.70-1.82) for low-quality trials. For 6 scales, relative risks of high-quality trials were close to unity, indicating that LMWH was not significantly superior to standard heparin, whereas low-quality trials showed better protection with LMWH (P<.05). Seven scales showed the opposite: high quality trials showed an effect whereas low quality trials did not. For the remaining 12 scales, effect estimates were similar in the 2 quality strata. In regression analysis, summary quality scores were not significantly associated with treatment effects. There was no significant association of treatment effects with allocation concealment and handling of withdrawals. Open outcome assessment, however, influenced effect size with the effect of LMWH, on average, being exaggerated by 35% (95% CI, 1%-57%; P= .046). Our data indicate that the use of summary scores to identify trials of high quality is problematic. Relevant methodological aspects should be assessed individually and their influence on effect sizes explored.
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              Mendelian randomization: prospects, potentials, and limitations.

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                Author and article information

                Journal
                PLoS Med
                PLoS Med
                plos
                plosmed
                PLoS Medicine
                Public Library of Science (San Francisco, CA USA )
                1549-1277
                1549-1676
                21 February 2019
                February 2019
                : 16
                : 2
                : e1002742
                Affiliations
                [1 ] Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands
                [2 ] Department of Clinical Endocrinology and Metabolism, Leiden University Medical Centre, Leiden, the Netherlands
                [3 ] Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark
                [4 ] Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom
                [5 ] Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland
                [6 ] Manchester Cancer Research Centre, NIHR Manchester Biomedical Research Centre, Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, United Kingdom
                [7 ] Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom
                [8 ] Centre for Infectious Diseases Epidemiology and Research (CIDER), School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa
                Author notes

                I have read the journal's policy and the authors of this manuscript have the following competing interests: AGR has received lecture honoraria from Merck Serona and Janssen-Cilag, and independent research funding and lecture honoraria from Novo Nordisk and Sanofi Pasteur MSD. ME receives a stipend as a Specialty Consulting Editor for PLOS Medicine and serves on the journal's Editorial Board.

                Author information
                http://orcid.org/0000-0002-1333-7580
                http://orcid.org/0000-0002-9115-4405
                http://orcid.org/0000-0001-7462-5132
                Article
                PMEDICINE-D-18-01836
                10.1371/journal.pmed.1002742
                6383865
                30789892
                f5fe89e0-e5dc-4161-8ddc-095f9299a55a
                © 2019 Dekkers et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                Page count
                Figures: 3, Tables: 1, Pages: 24
                Funding
                ME was supported by special project funding (Grant No. 174281) from the Swiss National Science Foundation. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript
                Categories
                Guidelines and Guidance
                Research and Analysis Methods
                Research Design
                Observational Studies
                Research and Analysis Methods
                Research Assessment
                Systematic Reviews
                Research and Analysis Methods
                Mathematical and Statistical Techniques
                Statistical Methods
                Metaanalysis
                Physical Sciences
                Mathematics
                Statistics
                Statistical Methods
                Metaanalysis
                Research and Analysis Methods
                Research Design
                Case-Control Studies
                Medicine and Health Sciences
                Pathology and Laboratory Medicine
                Etiology
                Research and Analysis Methods
                Research Design
                Cohort Studies
                Research and Analysis Methods
                Database and Informatics Methods
                Database Searching
                Medicine and Health Sciences
                Epidemiology
                Medical Risk Factors
                Cancer Risk Factors
                Medicine and Health Sciences
                Oncology
                Cancer Risk Factors

                Medicine
                Medicine

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