102
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

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

      Read this article at

          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          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.

          Related collections

          Most cited references66

          • Record: found
          • Abstract: not found
          • Article: not found

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

            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            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.
              Bookmark
              • Record: found
              • Abstract: not found
              • Article: not found

              Systematic reviews in health care: Assessing the quality of controlled clinical trials.

                Bookmark

                Author and article information

                Journal
                Mil Med Res
                Military Medical Research
                Springer Science and Business Media LLC
                2054-9369
                2054-9369
                February 29 2020
                : 7
                : 1
                Affiliations
                [1 ] Center for Evidence-Based and Translational Medicine, Zhongnan Hospital, Wuhan University, 169 Donghu Road, Wuchang District, Wuhan, 430071, Hubei, China.
                [2 ] Department of Evidence-Based Medicine and Clinical Epidemiology, The Second Clinical College, Wuhan University, Wuhan, 430071, China.
                [3 ] Center for Evidence-Based and Translational Medicine, Zhongnan Hospital, Wuhan University, 169 Donghu Road, Wuchang District, Wuhan, 430071, Hubei, China. zengxiantao1128@163.com.
                [4 ] Department of Evidence-Based Medicine and Clinical Epidemiology, The Second Clinical College, Wuhan University, Wuhan, 430071, China. zengxiantao1128@163.com.
                [5 ] Center for Evidence-Based and Translational Medicine, Wuhan University, Wuhan, 430071, China. zengxiantao1128@163.com.
                [6 ] Global Health Institute, Wuhan University, Wuhan, 430072, China. zengxiantao1128@163.com.
                Article
                10.1186/s40779-020-00238-8
                10.1186/s40779-020-00238-8
                7049186
                32111253
                190a509e-ecb9-45d3-9925-f353121945b4
                History

                Appraisal tool,Critical appraisal,Interventional study,Methodological quality,Methodology checklist,Observational study,Outcome measurement instrument,Qualitative study,Quality assessment,Risk of bias

                Comments

                Comment on this article