{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T04:59:46Z","timestamp":1790657986010,"version":"4.1.0"},"reference-count":43,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2026,12,1]],"date-time":"2026-12-01T00:00:00Z","timestamp":1796083200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,12,1]],"date-time":"2026-12-01T00:00:00Z","timestamp":1796083200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T00:00:00Z","timestamp":1788480000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100016145","name":"Ministerio de Sanidad, Consumo y Bienestar Social","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100016145","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","jclinepi.com","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Clinical Epidemiology"],"published-print":{"date-parts":[[2026,12]]},"DOI":"10.1016\/j.jclinepi.2026.112486","type":"journal-article","created":{"date-parts":[[2026,8,30]],"date-time":"2026-08-30T14:29:16Z","timestamp":1788100156000},"page":"112486","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"special_numbering":"C","title":["Risk-of-bias tools for causal inference studies using real-world data: a rapid scoping review"],"prefix":"10.1016","volume":"200","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8012-1520","authenticated-orcid":false,"given":"Wendy","family":"Nieto-Gutierrez","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvia","family":"Moler-Zapata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1549-183X","authenticated-orcid":false,"given":"Sebastian A.","family":"Medina-Ramirez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1303-706X","authenticated-orcid":false,"given":"Soledad","family":"Isern de Val","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"9","key":"10.1016\/j.jclinepi.2026.112486_bib1","doi-asserted-by":"crossref","first-page":"1033","DOI":"10.1002\/pds.4297","article-title":"Good practices for real-world data studies of treatment and\/or comparative effectiveness: recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making","volume":"26","author":"Berger","year":"2017","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"10.1016\/j.jclinepi.2026.112486_bib2","doi-asserted-by":"crossref","first-page":"1123","DOI":"10.2147\/IJGM.S402478","article-title":"Worldwide trends in registering real-world studies at ClinicalTrials.gov: a cross-sectional analysis","volume":"16","author":"Li","year":"2023","journal-title":"Int J Gen Med"},{"key":"10.1016\/j.jclinepi.2026.112486_bib3","doi-asserted-by":"crossref","first-page":"150","DOI":"10.1002\/cpt.2272","article-title":"Understanding use of real-world data and real-world evidence to support regulatory decisions on medical product effectiveness","volume":"111","author":"Mahendraratnam","year":"2022","journal-title":"Clin Pharmacol Ther"},{"key":"10.1016\/j.jclinepi.2026.112486_bib4","series-title":"Programme for the use of real world data in health technology assessment. Potential uses for Real World Data (RWD) in the Spanish HTA network","author":"Mu\u00f1oz Fern\u00e1ndez","year":"2024"},{"issue":"1","key":"10.1016\/j.jclinepi.2026.112486_bib5","doi-asserted-by":"crossref","first-page":"42","DOI":"10.1080\/09332480.2019.1579578","article-title":"A second chance to get causal inference right: a classification of data science tasks","volume":"32","author":"Hern\u00e1n","year":"2019","journal-title":"Chance"},{"key":"10.1016\/j.jclinepi.2026.112486_bib6","doi-asserted-by":"crossref","first-page":"2685","DOI":"10.1093\/aje\/kwae405","article-title":"Causal inference in multi-cohort studies using the target trial framework to identify and minimize sources of bias","volume":"194","author":"Downes","year":"2025","journal-title":"Am J Epidemiol"},{"issue":"1","key":"10.1016\/j.jclinepi.2026.112486_bib7","doi-asserted-by":"crossref","first-page":"12","DOI":"10.11613\/BM.2013.003","article-title":"Bias in research","volume":"23","author":"Simundi\u0107","year":"2013","journal-title":"Biochem Med (Zagreb)"},{"issue":"2","key":"10.1016\/j.jclinepi.2026.112486_bib8","doi-asserted-by":"crossref","first-page":"148","DOI":"10.1159\/000516178","article-title":"The real-world data challenges radar: a review on the challenges and risks regarding the use of real-world data","volume":"5","author":"Grimberg","year":"2021","journal-title":"Digit Biomark"},{"issue":"41","key":"10.1016\/j.jclinepi.2026.112486_bib9","first-page":"664","article-title":"Avoiding bias in observational studies: part 8 in a series of articles on evaluation of scientific publications","volume":"106","author":"Hammer","year":"2009","journal-title":"Dtsch Arztebl Int"},{"issue":"1","key":"10.1016\/j.jclinepi.2026.112486_bib10","doi-asserted-by":"crossref","DOI":"10.1136\/bmjmed-2024-001280","article-title":"Identifying and avoiding design related biases in observational studies using the target trial framework","volume":"5","author":"Hansford","year":"2026","journal-title":"BMJ Med"},{"key":"10.1016\/j.jclinepi.2026.112486_bib11","doi-asserted-by":"crossref","first-page":"209","DOI":"10.1002\/cpt.2364","article-title":"Prevalence of avoidable and bias-inflicting methodological pitfalls in real-world studies of medication safety and effectiveness","volume":"111","author":"Bykov","year":"2022","journal-title":"Clin Pharmacol Ther"},{"issue":"9","key":"10.1016\/j.jclinepi.2026.112486_bib12","doi-asserted-by":"crossref","first-page":"1573","DOI":"10.1007\/s00296-023-05354-x","article-title":"A scoping review on quality assessment tools used in systematic reviews and meta-analysis of real-world studies","volume":"43","author":"Gebrye","year":"2023","journal-title":"Rheumatol Int"},{"issue":"2","key":"10.1016\/j.jclinepi.2026.112486_bib13","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2023-075173","article-title":"Tools for assessing quality of studies investigating health interventions using real-world data: a literature review and content analysis","volume":"14","author":"Jiu","year":"2024","journal-title":"BMJ Open"},{"issue":"10","key":"10.1016\/j.jclinepi.2026.112486_bib14","doi-asserted-by":"crossref","first-page":"1663","DOI":"10.1016\/j.jval.2022.09.001","article-title":"HARmonized protocol template to enhance reproducibility of Hypothesis evaluating real-world evidence studies on treatment effects: a good practices report of a joint ISPE\/ISPOR Task Force","volume":"25","author":"Wang","year":"2022","journal-title":"Value Health"},{"key":"10.1016\/j.jclinepi.2026.112486_bib15","series-title":"NICE real-world evidence framework","year":"2025"},{"key":"10.1016\/j.jclinepi.2026.112486_bib16","doi-asserted-by":"crossref","DOI":"10.1136\/bmj-2023-076335","article-title":"Updated recommendations for the Cochrane rapid review methods guidance for rapid reviews of effectiveness","volume":"384","author":"Garritty","year":"2024","journal-title":"BMJ"},{"key":"10.1016\/j.jclinepi.2026.112486_bib17","doi-asserted-by":"crossref","first-page":"467","DOI":"10.7326\/M18-0850","article-title":"PRISMA extension for scoping reviews (PRISMA-ScR): checklist and explanation","volume":"169","author":"Tricco","year":"2018","journal-title":"Ann Intern Med"},{"key":"10.1016\/j.jclinepi.2026.112486_bib18","series-title":"Tools for assessing risk of bias in real-world studies: a scoping review of the evidence [Internet]","author":"Nieto-Gutierrez","year":"2026"},{"issue":"2","key":"10.1016\/j.jclinepi.2026.112486_bib19","doi-asserted-by":"crossref","first-page":"345","DOI":"10.1177\/1932296819832661","article-title":"The new FDA real-world evidence program to support development of drugs and biologics","volume":"14","author":"Klonoff","year":"2020","journal-title":"J Diabetes Sci Technol"},{"key":"10.1016\/j.jclinepi.2026.112486_bib20","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0138237","article-title":"The role of Google Scholar in evidence reviews and its applicability to grey literature searching","volume":"10","author":"Haddaway","year":"2015","journal-title":"PLoS One"},{"key":"10.1016\/j.jclinepi.2026.112486_bib21","series-title":"Real-world evidence provided by EMA: support for regulatory decision-making [Internet]","year":"2024"},{"key":"10.1016\/j.jclinepi.2026.112486_bib22","doi-asserted-by":"crossref","first-page":"173","DOI":"10.1186\/s12874-017-0451-0","article-title":"The development of CHAMP: a checklist for the appraisal of moderators and predictors","volume":"17","author":"van Hoorn","year":"2017","journal-title":"BMC Med Res Methodol"},{"issue":"7","key":"10.1016\/j.jclinepi.2026.112486_bib23","doi-asserted-by":"crossref","first-page":"1275","DOI":"10.1007\/s00296-024-05595-4","article-title":"Development of quality assessment tool for systematic reviews and meta-analyses of real-world studies: a Delphi consensus survey","volume":"44","author":"Gebrye","year":"2024","journal-title":"Rheumatol Int"},{"issue":"12","key":"10.1016\/j.jclinepi.2026.112486_bib24","doi-asserted-by":"crossref","first-page":"1849","DOI":"10.1016\/j.jval.2025.07.024","article-title":"APPRAISE: a tool for appraising potential for bias in real-world evidence studies on medication effectiveness or safety","volume":"28","author":"Bykov","year":"2025","journal-title":"Value Health"},{"key":"10.1016\/j.jclinepi.2026.112486_bib25","doi-asserted-by":"crossref","first-page":"244","DOI":"10.1016\/j.jclinepi.2021.12.019","article-title":"The GetReal Trial Tool: design, assess and discuss clinical drug trials in light of real world evidence generation","volume":"149","author":"Zuidgeest","year":"2022","journal-title":"J Clin Epidemiol"},{"key":"10.1016\/j.jclinepi.2026.112486_bib26","doi-asserted-by":"crossref","DOI":"10.1016\/j.envint.2024.108602","article-title":"A tool to assess risk of bias in non-randomized follow-up studies of exposure effects (ROBINS-E)","volume":"186","author":"Higgins","year":"2024","journal-title":"Environ Int"},{"key":"10.1016\/j.jclinepi.2026.112486_bib27","article-title":"ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions","volume":"355","author":"Sterne","year":"2016","journal-title":"BMJ"},{"key":"10.1016\/j.jclinepi.2026.112486_bib28","doi-asserted-by":"crossref","first-page":"57","DOI":"10.1016\/j.annepidem.2020.09.014","article-title":"Development, content validation, and reliability of the Assessment of Real-World Observational Studies (ArRoWS) critical appraisal tool","volume":"55","author":"Coles","year":"2021","journal-title":"Ann Epidemiol"},{"key":"10.1016\/j.jclinepi.2026.112486_bib29","series-title":"NICE real-world evidence framework: appendix 2: reporting on methods used to minimise risk of bias [Internet]","year":"2022"},{"issue":"5","key":"10.1016\/j.jclinepi.2026.112486_bib30","doi-asserted-by":"crossref","first-page":"249","DOI":"10.4082\/kjfm.23.0034","article-title":"RoBANS 2: a revised risk of bias assessment tool for nonrandomized studies of interventions","volume":"44","author":"Seo","year":"2023","journal-title":"Korean J Fam Med"},{"issue":"1","key":"10.1016\/j.jclinepi.2026.112486_bib31","doi-asserted-by":"crossref","first-page":"21","DOI":"10.1186\/s13601-019-0256-9","article-title":"The REal Life EVidence AssessmeNt Tool (RELEVANT): development of a novel quality assurance asset to rate observational comparative effectiveness research studies","volume":"9","author":"Campbell","year":"2019","journal-title":"Clin Transl Allergy"},{"key":"10.1016\/j.jclinepi.2026.112486_bib32","doi-asserted-by":"crossref","first-page":"269","DOI":"10.1016\/j.jclinepi.2022.10.005","article-title":"Causal analyses with target trial emulation for real-world evidence removed large self-inflicted biases: systematic bias assessment of ovarian cancer treatment effectiveness","volume":"152","author":"Kuehne","year":"2022","journal-title":"J Clin Epidemiol"},{"key":"10.1016\/j.jclinepi.2026.112486_bib33","doi-asserted-by":"crossref","first-page":"22","DOI":"10.1186\/1471-2288-4-22","article-title":"A systematic review of the content of critical appraisal tools","volume":"4","author":"Katrak","year":"2004","journal-title":"BMC Med Res Methodol"},{"key":"10.1016\/j.jclinepi.2026.112486_bib34","doi-asserted-by":"crossref","first-page":"666","DOI":"10.1093\/ije\/dym018","article-title":"Tools for assessing quality and susceptibility to bias in observational studies in epidemiology: a systematic review and annotated bibliography","volume":"36","author":"Sanderson","year":"2007","journal-title":"Int J Epidemiol"},{"issue":"1","key":"10.1016\/j.jclinepi.2026.112486_bib35","doi-asserted-by":"crossref","first-page":"204","DOI":"10.1186\/s13643-017-0604-6","article-title":"A proposed framework for developing quality assessment tools","volume":"6","author":"Whiting","year":"2017","journal-title":"Syst Rev"},{"key":"10.1016\/j.jclinepi.2026.112486_bib36","doi-asserted-by":"crossref","DOI":"10.1016\/j.jclinepi.2024.111370","article-title":"Common challenges and suggestions for risk of bias tool development: a systematic review of methodological studies","volume":"171","author":"Tomlinson","year":"2024","journal-title":"J Clin Epidemiol"},{"issue":"2","key":"10.1016\/j.jclinepi.2026.112486_bib37","doi-asserted-by":"crossref","first-page":"92","DOI":"10.4103\/picr.picr_12_23","article-title":"Data quality - the foundation of real-world studies","volume":"14","author":"Bhatt","year":"2023","journal-title":"Perspect Clin Res"},{"key":"10.1016\/j.jclinepi.2026.112486_bib38","doi-asserted-by":"crossref","first-page":"1373","DOI":"10.1016\/S0895-4356(96)00236-3","article-title":"A simulation study of the number of events per variable in logistic regression analysis","volume":"49","author":"Peduzzi","year":"1996","journal-title":"J Clin Epidemiol"},{"key":"10.1016\/j.jclinepi.2026.112486_bib39","doi-asserted-by":"crossref","first-page":"2446","DOI":"10.1001\/jama.2022.21383","article-title":"Target trial emulation: a framework for causal inference from observational data","volume":"328","author":"Hern\u00e1n","year":"2022","journal-title":"JAMA"},{"key":"10.1016\/j.jclinepi.2026.112486_bib40","series-title":"NICE real-world evidence framework. Corporate document ECD9 [Internet]","article-title":"Appendix 1: data suitability assessment tool (DataSAT)","year":"2022"},{"key":"10.1016\/j.jclinepi.2026.112486_bib41","doi-asserted-by":"crossref","first-page":"894","DOI":"10.1002\/cpt.3746","article-title":"Navigating the real world: a scoping review of structured frameworks to effectively identify, evaluate, and select real-world data sources for fit-for-purpose studies","volume":"118","author":"Zebachi","year":"2025","journal-title":"Clin Pharmacol Ther"},{"key":"10.1016\/j.jclinepi.2026.112486_bib42","article-title":"STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies","volume":"372","author":"Wang","year":"2021","journal-title":"BMJ"},{"key":"10.1016\/j.jclinepi.2026.112486_bib43","series-title":"Applying quantitative bias analysis to epidemiologic data","author":"Fox","year":"2021"}],"container-title":["Journal of Clinical Epidemiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0895435626003628?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0895435626003628?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T04:49:26Z","timestamp":1790657366000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0895435626003628"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,12]]},"references-count":43,"alternative-id":["S0895435626003628"],"URL":"https:\/\/doi.org\/10.1016\/j.jclinepi.2026.112486","relation":{},"ISSN":["0895-4356"],"issn-type":[{"value":"0895-4356","type":"print"}],"subject":[],"published":{"date-parts":[[2026,12]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Risk-of-bias tools for causal inference studies using real-world data: a rapid scoping review","name":"articletitle","label":"Article Title"},{"value":"Journal of Clinical Epidemiology","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.jclinepi.2026.112486","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 The Authors. Published by Elsevier Inc.","name":"copyright","label":"Copyright"}],"article-number":"112486"}}