{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,16]],"date-time":"2026-05-16T06:08:47Z","timestamp":1778911727027,"version":"3.51.4"},"reference-count":52,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2026,3,15]],"date-time":"2026-03-15T00:00:00Z","timestamp":1773532800000},"content-version":"vor","delay-in-days":14,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,3,1]],"date-time":"2026-03-01T00:00:00Z","timestamp":1772323200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cochrane Evidence Synthesis and Methods"],"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This study aimed to evaluate the feasibility, reliability, and impact of the Research Integrity Assessment (RIA) tool when applied to randomized controlled trials (RCTs) included in systematic reviews. RIA is a structured tool designed to assess retractions, trial registration, ethical approval, authorship, and plausibility of methods and results, thereby identifying RCTs that may not meet basic standards of research integrity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Meta\u2010epidemiological study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We systematically identified Cochrane reviews and non\u2010Cochrane systematic reviews of RCTs investigating interventions for COVID\u201019 and extracted all RCTs. Each RCT was independently assessed by two reviewers (with different expertise in evidence synthesis) using the RIA tool, with disagreements resolved by a senior reviewer. Reliability and feasibility were recorded, and sensitivity analyses examined the impact of excluding studies failing the RIA on meta\u2010analytic results.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Two hundred six RCTs from 23 Cochrane reviews and non\u2010Cochrane systematic reviews were assessed with RIA. Fifty\u2010nine RCTs (29%) were excluded due to integrity concerns, 79 (38%) classified as \u201cawaiting classification\u201d, and 11 (5%) identified as non\u2010randomized studies, leaving 57 RCTs (28%) rated as \u201cno concern.\u201d The most common reason for exclusion was absent or retrospective trial registration, while uncertainties around ethics approval were the main reason for \u201cawaiting classification\u201d.\u00a0Interrater reliability was moderate overall (\u03ba\u2009=\u20090.5), with higher agreement in objective domains and lower in domains requiring interpretive judgment, necessitating senior adjudication in a substantial proportion of assessments. On average, application of RIA required 21\u201327\u2009min per RCT; however, the time required for senior assessor reassessment, conflict resolution, and author correspondence was not systematically recorded and substantially exceeded that of the initial assessments. We received 35 author responses to 165 individual queries. Sensitivity analyses restricted to RCTs passing RIA reduced the median number of eligible RCTs per meta\u2010analysis by 60%. This frequently widened confidence intervals and decreased the certainty of conclusions, although the direction of effect estimates changed only rarely.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>These results demonstrate that integrity checks can be feasibly applied and reveal widespread concerns in COVID\u201019 RCTs, but require expertise, adjudication mechanisms, and adequate resources. Incorporating such assessments into review methodology can strengthen the trustworthiness of clinical evidence and safeguard patient safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Registration<\/jats:title>\n                    <jats:p>\n                      A protocol to this meta\u2010epidemiological study has been registered (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/doi.org\/10.17605\/OSF.IO\/NBRHX\">https:\/\/doi.org\/10.17605\/OSF.IO\/NBRHX<\/jats:ext-link>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cesm.70076","type":"journal-article","created":{"date-parts":[[2026,3,15]],"date-time":"2026-03-15T09:30:19Z","timestamp":1773567019000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Impact of a Research Integrity Assessment (RIA) of Randomized Controlled Trials Included in Interventional COVID\u201019 Systematic Reviews: A Meta\u2010Epidemiological Study"],"prefix":"10.1002","volume":"4","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1900-2535","authenticated-orcid":false,"given":"Stephanie","family":"Weibel","sequence":"first","affiliation":[{"name":"Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine University Hospital W\u00fcrzburg W\u00fcrzburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patrick","family":"Meybohm","sequence":"additional","affiliation":[{"name":"Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine University Hospital W\u00fcrzburg W\u00fcrzburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Annika","family":"Oeser","sequence":"additional","affiliation":[{"name":"Institute of Public Health Faculty of Medicine and University Hospital Cologne, University of Cologne Cologne Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria","family":"Popp","sequence":"additional","affiliation":[{"name":"Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine University Hospital W\u00fcrzburg W\u00fcrzburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tamara","family":"Pscheidl","sequence":"additional","affiliation":[{"name":"Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine University Hospital W\u00fcrzburg W\u00fcrzburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefanie","family":"Reis","sequence":"additional","affiliation":[{"name":"Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine University Hospital W\u00fcrzburg W\u00fcrzburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lena","family":"Saal\u2010Bauernschubert","sequence":"additional","affiliation":[{"name":"Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine University Hospital W\u00fcrzburg W\u00fcrzburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephanie","family":"Stangl","sequence":"additional","affiliation":[{"name":"Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine University Hospital W\u00fcrzburg W\u00fcrzburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1471-4237","authenticated-orcid":false,"given":"Emma","family":"Sydenham","sequence":"additional","affiliation":[{"name":"Cochrane Central Editorial Service London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carina","family":"Wagner","sequence":"additional","affiliation":[{"name":"Institute of Public Health Faculty of Medicine and University Hospital Cologne, University of Cologne Cologne 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