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      ROBIS: A new tool to assess risk of bias in systematic reviews was developed

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          Abstract

          Objective

          To develop ROBIS, a new tool for assessing the risk of bias in systematic reviews (rather than in primary studies).

          Study Design and Setting

          We used four-stage approach to develop ROBIS: define the scope, review the evidence base, hold a face-to-face meeting, and refine the tool through piloting.

          Results

          ROBIS is currently aimed at four broad categories of reviews mainly within health care settings: interventions, diagnosis, prognosis, and etiology. The target audience of ROBIS is primarily guideline developers, authors of overviews of systematic reviews (“reviews of reviews”), and review authors who might want to assess or avoid risk of bias in their reviews. The tool is completed in three phases: (1) assess relevance (optional), (2) identify concerns with the review process, and (3) judge risk of bias. Phase 2 covers four domains through which bias may be introduced into a systematic review: study eligibility criteria; identification and selection of studies; data collection and study appraisal; and synthesis and findings. Phase 3 assesses the overall risk of bias in the interpretation of review findings and whether this considered limitations identified in any of the phase 2 domains. Signaling questions are included to help judge concerns with the review process (phase 2) and the overall risk of bias in the review (phase 3); these questions flag aspects of review design related to the potential for bias and aim to help assessors judge risk of bias in the review process, results, and conclusions.

          Conclusions

          ROBIS is the first rigorously developed tool designed specifically to assess the risk of bias in systematic reviews.

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          Most cited references13

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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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            Validation of an index of the quality of review articles.

            The objective of this study was to assess the validity of an index of the scientific quality of research overviews, the Overview Quality Assessment Questionnaire (OQAQ). Thirty-six published review articles were assessed by 9 judges using the OQAQ. Authors reports of what they had done were compared to OQAQ ratings. The sensibility of the OQAQ was assessed using a 13 item questionnaire. Seven a priori hypotheses were used to assess construct validity. The review articles were drawn from three sampling frames: articles highly rated by criteria external to the study, meta-analyses, and a broad spectrum of medical journals. Three categories of judges were used to assess the articles: research assistants, clinicians with research training and experts in research methodology, with 3 judges in each category. The sensibility of the index was assessed by 15 randomly selected faculty members of the Department of Clinical Epidemiology and Biostatistics at McMaster. Authors' reports of their methods related closely to ratings from corresponding OQAQ items: for each criterion, the mean score was significantly higher for articles for which the authors responses indicated that they had used more rigorous methods. For 10 of the 13 questions used to assess sensibility the mean rating was 5 or greater, indicating general satisfaction with the instrument. The primary shortcoming noted was the need for judgement in applying the index. Six of the 7 hypotheses used to test construct validity held true. The OQAQ is a valid measure of the quality of research overviews.
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              No role for quality scores in systematic reviews of diagnostic accuracy studies

              Background There is a lack of consensus regarding the use of quality scores in diagnostic systematic reviews. The objective of this study was to use different methods of weighting items included in a quality assessment tool for diagnostic accuracy studies (QUADAS) to produce an overall quality score, and to examine the effects of incorporating these into a systematic review. Methods We developed five schemes for weighting QUADAS to produce quality scores. We used three methods to investigate the effects of quality scores on test performance. We used a set of 28 studies that assessed the accuracy of ultrasound for the diagnosis of vesico-ureteral reflux in children. Results The different methods of weighting individual items from the same quality assessment tool produced different quality scores. The different scoring schemes ranked different studies in different orders; this was especially evident for the intermediate quality studies. Comparing the results of studies stratified as "high" and "low" quality based on quality scores resulted in different conclusions regarding the effects of quality on estimates of diagnostic accuracy depending on the method used to produce the quality score. A similar effect was observed when quality scores were included in meta-regression analysis as continuous variables, although the differences were less apparent. Conclusion Quality scores should not be incorporated into diagnostic systematic reviews. Incorporation of the results of the quality assessment into the systematic review should involve investigation of the association of individual quality items with estimates of diagnostic accuracy, rather than using a combined quality score.
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                Author and article information

                Contributors
                Journal
                J Clin Epidemiol
                J Clin Epidemiol
                Journal of Clinical Epidemiology
                Elsevier
                0895-4356
                1878-5921
                1 January 2016
                January 2016
                : 69
                : 225-234
                Affiliations
                [a ]School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, UK
                [b ]The National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West at University Hospitals Bristol NHS Foundation Trust, 9th Floor, Whitefriars, Lewins Mead, Bristol BS1 2NT
                [c ]Kleijnen Systematic Reviews Ltd, Unit 6, Escrick Business Park, Riccall Road, Escrick, York YO19 6FD, UK
                [d ]Centre for Reviews and Dissemination, University of York, York YO10 5DD, UK
                [e ]School of Clinical Sciences, University of Bristol, Bristol Royal Infirmary, Level Queen's Building, 69 St Michael's Hill, Bristol BS2 8DZ, UK
                [f ]Community Information and Epidemiological Technologies Institute of Population Health, 1 Stewart Street, Room 319, Ottawa, Ontario, K1N 6N5, Canada
                [g ]School for Public Health and Primary Care (CAPHRI), Maastricht University, PO Box 616, 6200 MD, Maastricht, The Netherlands
                Author notes
                []Corresponding author. Tel.: +44 117 34 212 73. penny.whiting@ 123456bristol.ac.uk
                Article
                S0895-4356(15)00308-X
                10.1016/j.jclinepi.2015.06.005
                4687950
                26092286
                04da2314-69ce-4e57-8c08-57f732217041
                © 2016 The Authors

                This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

                History
                : 5 June 2015
                Categories
                Guidelines

                Public health
                evidence,meta-analysis,quality,risk of bias,systematic review,tool
                Public health
                evidence, meta-analysis, quality, risk of bias, systematic review, tool

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