Risk of bias assessment and different tools used to assess systematic review - Pubrica

1. What is the Risk of Bias Assessment and Different Tools used to Assess Systematic Review Dr. Nancy Agens, Head, Technical Operations, Pubrica sales@pubrica.com In Brief The risk of bias is defined as the risk of systematic error or a deviation from reporting the truth or an appropriate evidence finding. It occurs when there is a systematic flaw or limitations in the study design or the conduct of the study. This article describes different assessment tools and the types of study designs for which the tool is applicable along with the flow of how to avoid the risk of bias. I. INTRODUCTION A systematic review guideline will often determine the study design to answer the formulated question, and it is not enough in trusting the evidence of systematic review over observational studies. There are several terms like quality assessment, critical appraisal, or internal validity, which are used for the evaluation of studies supported by the guideline. Whereas in the risk of bias, the bias determines the factor that can affect the observations and findings of the study systematically and report it to be different from the actual conclusion. In other words, a study affected by bias can be inaccurate and thus leads to an inappropriate guideline recommendation. Therefore, inadequate study design or the conduct of the study will give false findings which result in wasting time and resources, and missing opportunity for effective intervention. Quality assessment or risk of bias assessment helps in regulating and establishing transparency of evidence synthesis (data collection methods, search strategies, etc.) and findings and it is often performed for each study in a review; thus the collected evidence eliminate bias in the outcomes. Generally, assessment outside of a systematic review does not require evidence synthesis method; however, it completely depends upon the utilization of evidence synthesis method. The risk of bias assessment can be done by professionals who may be conducted by the guideline development group or requires a methodological expert or by experiences systematic review researchers. Once the evaluation is done, then it can be used for the synthesis of study results and findings and combined into the complete assessment of the evidence. There are certain common factors which can introduce bias in many research areas, that include Selection bias Population comparability in a study Performance bias– The influence of estimate effect (aspects other than the intervention or exposure of interest) Reporting bias– Problems with measurements or classification of outcome (missing information) The risk of bias is assessed frequently by evaluating the study design and the conduct of the study because it is impossible to determine a specific study has been affected by bias or not. II. DIFFERENT TOOLS USED TO ASSESS THE RISK OF BIAS IN THE SYSTEMATIC REVIEW AMSTAR 2 - A MeaSurement Tool to Assess systematic Reviews AHRQ RRB - AHRQ tool for evaluating the Risk of Reporting Bias a quality – Participant or Copyright © 2020 pubrica. All rights reserved 1

2. AHRQ ORB– AHRQ Outcome and analysis Reporting Bias framework GRADE – Recommendations Development and Evaluation GRADE-CERQual Confidence in Evidence from Reviews of Qualitative research SAQAT– Semi-Automated Quality Assessment Tool NMA Quality– Framework for evaluating the quality of evidence from a Network Meta-Analysis NOS - Newcastle-Ottawa Scale AXIS–Appraisal tool for Cross- Sectional Studies QUIPS - QUality In Prognosis Studies tool RoB 1.0–Cochrane Risk of Bias tool for randomized trials RoB 2.0 - Revised tool for Assessing Risk of Bias in randomized trials SYRCLE RoB–SYstematic Review Centre for Laboratory Experimentation Risk of Bias tool SciRAP - Science in Risk Assessment and Policy SIGN - The Scottish Intercollegiate Guidelines Network ROBIS - Risk Of Bias in Systematic Reviews RoBANS - Risk of Bias Assessment Tool for Nonrandomized Studies RoBINS I - Risk of Bias In Non- randomized Studies of Interventions tool ORBIT 1– Outcome Reporting Bias In Trials classification system for benefit outcomes QUADAS 2 - Quality Assessment of Diagnostic Accuracy Studies PROBAST - Prediction model Risk Of Bias ASsessment Tool ORBIT 2 - Outcome Reporting Bias In Trials classification system for harm outcomes Reid– Selective reporting bias algorithm RTI 2012– RTI Item Bank for Assessment of Risk of Bias and Precision for Observational Studies of Interventions or Exposures RTI 2013– RTI Item Bank for Assessing Risk Confounding for Observational Studies of Interventions or Exposures JBI - the Joanna Briggs Institute OHAT - Office of Health Assessment and Translation Downs Black - Downs Black tool Grading Assessment, of – GRADE of Bias and III. HOW TO ASSESS THE RISK OF BIAS 1.Plan your approach 2.Identifying an appropriate risk of bias assessment tool 3.Be aware of related issues 4.Appraise each study 5.Report the assessment process 6.Use your appraisals to inform the guideline IV. DETERMINING AN APPROPRIATE RISK OF BIAS ASSESSMENT TOOL animal Copyright © 2020 pubrica. All rights reserved 2

3. Study type Assessment tools Year Source AMSTAR - 2 2017 https://amstar.ca/Amstar-2.php www.bristol.ac.uk/population-health- sciences/projects/robis/ https://www.sign.ac.uk/checklists-and- notes.html ROBIS 2016 Systematic reviews SIGN checklist 2014 Cochrane RoB 2.0 Tool 2016 www.riskofbias.info Randomized trials https://www.sign.ac.uk/checklists-and- notes.html 2016 www.riskofbias.info https://www.sign.ac.uk/checklists-and- notes.html http://joannabriggs.org/research/critica l-appraisal-tools.html 2014 www.systematic-reviews.com/probast SIGN checklist 2014 ROBINS-I Non-randomised studies of interventions (case-control, cohort, etc.) Prognostic: Prognostic factors Risk modelling Overall prognosis/baseline risk/prevalence/inciden ce SIGN checklist 2014 JBI prevalence studies PROBAST checklist for 2017 prediction https://methods.cochrane.org/prognosi s/welcome QUIPS 2013 https://www.sign.ac.uk/checklists-and- notes.html www.bristol.ac.uk/population-health- sciences/projects/quadas/quadas-2 https://casp-uk.net/wp- content/uploads/2018/01/CASP- Qualitative-Checklist-2018.pdf 2017 https://www.cerqual.org/ http://joannabriggs.org/research/critica l-appraisal-tools.html SIGN checklist 2014 Diagnostic QUADAS-2 2011 CASP Checklist Qualitative 2018 Qualitative GRADE-CERQual JBI Checklist Qualitative Research Navigation risk of bias checklist for 2017 Guide 2018 https://www.cosmin.nl/ Observational studies of exposures epidemiology, wildlife) (human https://ntp.niehs.nih.gov/ntp/ohat/pubs /riskofbiastool_508.pdf OHAT tool 2015 Navigation risk of bias checklist SciRAP tool Guide 2018 https://www.cosmin.nl/ 2018 http://www.scirap.org/ https://ntp.niehs.nih.gov/ntp/ohat/pubs /riskofbiastool_508.pdf www.ecotoxcentre.ch/projects/risk- assessment/cred Systematic Review Laboratory Animal Experimentation https://ntp.niehs.nih.gov/ntp/ohat/pubs /riskofbiastool_508.pdf OHAT tool 2015 In vivo animal studies CRED 2016 Centre for SYRCLE tool 2014 In vitro studies OHAT tool 2015 Obtained from: https://www.nhmrc.gov.au/guidelinesforguidelines/develop/assessing-risk-bias# Copyright © 2020 pubrica. All rights reserved 2

4. In summary, risk of bias assessment is a tool used to regulate findings which are accurate and appropriate, and it is essential to select the risk of bias tool rightly. There are many researches available to help, and it makes things easier to find appropriate tools for assessing the risk of bias. This article describes different assessment tools for a systematic review and the types of study designs for which the tool is applicable along with the flow of how to avoid the risk of bias. REFERENCE 1. Bero, L. A. Why the Cochrane risk of bias tool should include funding source as a standard item. Cochrane Database of Systematic Reviews, 2013. 2. Higgins, J. P., J. Savović, et al., Eds. Revised Cochrane the risk of bias tool for randomized trials, 20 October 2016. 3. Marshall, I. J., A. Noel-Storr, et al. Machine learning for identifying Randomized Controlled Trials: An evaluation and practitioner's guide. Research Synthesis Methods, 2016. 4. Reeves, et al. AMSTAR 2: a critical appraisal tool for systematic reviews that include randomized or non-randomised studies of healthcare interventions, or both. British Medical Journal 358, 2017. 5. Whiting, P., J. Savović, et al. ROBIS: A new tool to assess the risk of bias in systematic reviews was developed. Journal of Clinical Epidemiology 69: 225-234, 2016. Copyright © 2020 pubrica. All rights reserved 2