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      Methodological quality (risk of bias) assessment tools for primary and secondary medical studies: what are they and which is better?

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          Abstract

          Methodological quality (risk of bias) assessment is an important step before study initiation usage. Therefore, accurately judging study type is the first priority, and the choosing proper tool is also important. In this review, we introduced methodological quality assessment tools for randomized controlled trial (including individual and cluster), animal study, non-randomized interventional studies (including follow-up study, controlled before-and-after study, before-after/ pre-post study, uncontrolled longitudinal study, interrupted time series study), cohort study, case-control study, cross-sectional study (including analytical and descriptive), observational case series and case reports, comparative effectiveness research, diagnostic study, health economic evaluation, prediction study (including predictor finding study, prediction model impact study, prognostic prediction model study), qualitative study, outcome measurement instruments (including patient - reported outcome measure development, content validity, structural validity, internal consistency, cross-cultural validity/ measurement invariance, reliability, measurement error, criterion validity, hypotheses testing for construct validity, and responsiveness), systematic review and meta-analysis, and clinical practice guideline. The readers of our review can distinguish the types of medical studies and choose appropriate tools. In one word, comprehensively mastering relevant knowledge and implementing more practices are basic requirements for correctly assessing the methodological quality.

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          Most cited references66

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          AGREE II: advancing guideline development, reporting and evaluation in health care.

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            Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials.

            To determine if inadequate approaches to randomized controlled trial design and execution are associated with evidence of bias in estimating treatment effects. An observational study in which we assessed the methodological quality of 250 controlled trials from 33 meta-analyses and then analyzed, using multiple logistic regression models, the associations between those assessments and estimated treatment effects. Meta-analyses from the Cochrane Pregnancy and Childbirth Database. The associations between estimates of treatment effects and inadequate allocation concealment, exclusions after randomization, and lack of double-blinding. Compared with trials in which authors reported adequately concealed treatment allocation, trials in which concealment was either inadequate or unclear (did not report or incompletely reported a concealment approach) yielded larger estimates of treatment effects (P < .001). Odds ratios were exaggerated by 41% for inadequately concealed trials and by 30% for unclearly concealed trials (adjusted for other aspects of quality). Trials in which participants had been excluded after randomization did not yield larger estimates of effects, but that lack of association may be due to incomplete reporting. Trials that were not double-blind also yielded larger estimates of effects (P = .01), with odds ratios being exaggerated by 17%. This study provides empirical evidence that inadequate methodological approaches in controlled trials, particularly those representing poor allocation concealment, are associated with bias. Readers of trial reports should be wary of these pitfalls, and investigators must improve their design, execution, and reporting of trials.
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              Systematic reviews in health care: Assessing the quality of controlled clinical trials.

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                Author and article information

                Contributors
                13598615285@163.com
                13545027094@163.com
                yangzhihuaxx@126.com
                13163248347@163.com
                wengh92@163.com
                zengxiantao1128@163.com , zengxiantao@whucebtm.com
                Journal
                Mil Med Res
                Mil Med Res
                Military Medical Research
                BioMed Central (London )
                2095-7467
                2054-9369
                29 February 2020
                29 February 2020
                2020
                : 7
                : 7
                Affiliations
                [1 ]GRID grid.49470.3e, ISNI 0000 0001 2331 6153, Center for Evidence-Based and Translational Medicine, Zhongnan Hospital, , Wuhan University, ; 169 Donghu Road, Wuchang District, Wuhan, 430071 Hubei China
                [2 ]GRID grid.49470.3e, ISNI 0000 0001 2331 6153, Department of Evidence-Based Medicine and Clinical Epidemiology, The Second Clinical College, , Wuhan University, ; Wuhan, 430071 China
                [3 ]GRID grid.49470.3e, ISNI 0000 0001 2331 6153, Center for Evidence-Based and Translational Medicine, , Wuhan University, ; Wuhan, 430071 China
                [4 ]GRID grid.49470.3e, ISNI 0000 0001 2331 6153, Global Health Institute, , Wuhan University, ; Wuhan, 430072 China
                Author information
                http://orcid.org/0000-0003-1262-725X
                Article
                238
                10.1186/s40779-020-00238-8
                7049186
                32111253
                190a509e-ecb9-45d3-9925-f353121945b4
                © The Author(s) 2020

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 17 January 2020
                : 18 February 2020
                Funding
                Funded by: Entrusted Project of National commission on health and health of China
                Award ID: No. [2019]099
                Award Recipient :
                Funded by: National Key Research and Development Plan of China
                Award ID: 2016YFC0106300
                Award Recipient :
                Funded by: Nature Science Foundation of Hubei Province
                Award ID: 2019FFB03902
                Award Recipient :
                Categories
                Review
                Custom metadata
                © The Author(s) 2020

                methodological quality,risk of bias,quality assessment,critical appraisal,methodology checklist,appraisal tool,observational study,qualitative study,interventional study,outcome measurement instrument

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