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      PROBAST: A Tool to Assess Risk of Bias and Applicability of Prediction Model Studies: Explanation and Elaboration

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          Abstract

          Prediction models in health care use predictors to estimate for an individual the probability that a condition or disease is already present (diagnostic model) or will occur in the future (prognostic model). Publications on prediction models have become more common in recent years, and competing prediction models frequently exist for the same outcome or target population. Health care providers, guideline developers, and policymakers are often unsure which model to use or recommend, and in which persons or settings. Hence, systematic reviews of these studies are increasingly demanded, required, and performed. A key part of a systematic review of prediction models is examination of risk of bias and applicability to the intended population and setting. To help reviewers with this process, the authors developed PROBAST (Prediction model Risk Of Bias ASsessment Tool) for studies developing, validating, or updating (for example, extending) prediction models, both diagnostic and prognostic. PROBAST was developed through a consensus process involving a group of experts in the field. It includes 20 signaling questions across 4 domains (participants, predictors, outcome, and analysis). This explanation and elaboration document describes the rationale for including each domain and signaling question and guides researchers, reviewers, readers, and guideline developers in how to use them to assess risk of bias and applicability concerns. All concepts are illustrated with published examples across different topics. The latest version of the PROBAST checklist, accompanying documents, and filled-in examples can be downloaded from www.probast.org.

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          Most cited references180

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          Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement.

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            Is Open Access

            The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials

            Flaws in the design, conduct, analysis, and reporting of randomised trials can cause the effect of an intervention to be underestimated or overestimated. The Cochrane Collaboration’s tool for assessing risk of bias aims to make the process clearer and more accurate
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              Is Open Access

              ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions

              Non-randomised studies of the effects of interventions are critical to many areas of healthcare evaluation, but their results may be biased. It is therefore important to understand and appraise their strengths and weaknesses. We developed ROBINS-I (“Risk Of Bias In Non-randomised Studies - of Interventions”), a new tool for evaluating risk of bias in estimates of the comparative effectiveness (harm or benefit) of interventions from studies that did not use randomisation to allocate units (individuals or clusters of individuals) to comparison groups. The tool will be particularly useful to those undertaking systematic reviews that include non-randomised studies.
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                Author and article information

                Journal
                Annals of Internal Medicine
                Ann Intern Med
                American College of Physicians
                0003-4819
                January 01 2019
                January 01 2019
                : 170
                : 1
                : W1
                Affiliations
                [1 ]Julius Center for Health Sciences and Primary Care and Cochrane Netherlands, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.G.M., J.B.R.)
                [2 ]Kleijnen Systematic Reviews, York, United Kingdom (R.F.W., M.W.)
                [3 ]Centre for Prognosis Research, Research Institute for Primary Care and Health Sciences, Keele University, Keele, United Kingdom (R.D.R.)
                [4 ]Bristol Medical School of the University of Bristol and National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West, University Hospitals Bristol National Health Service Foundation Trust, Bristol, United Kingdom (P.F.W.)
                [5 ]Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom (G.S.C.)
                [6 ]Kleijnen Systematic Reviews, York, United Kingdom, and School for Public Health and Primary Care, Maastricht University, Maastricht, the Netherlands (J.K.)
                [7 ]Institute of Applied Health Research, National Institute for Health Research Birmingham Biomedical Research Centre, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom (S.M.)
                Article
                10.7326/M18-1377
                30596876
                b8ccb738-cb03-4c8d-9502-157c5d4ea092
                © 2019
                Product
                Self URI (article page): http://annals.org/article.aspx?doi=10.7326/M18-1377

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