Identifying and Managing Problematic Trials: A Research Integrity Assessment Tool for Randomized Controlled Trials in Evidence Synthesis

Autor/inn/en	Weibel, Stephanie; Popp, Maria; Reis, Stefanie; Skoetz, Nicole; Garner, Paul; Sydenham, Emma
Titel	Identifying and Managing Problematic Trials: A Research Integrity Assessment Tool for Randomized Controlled Trials in Evidence Synthesis
Quelle	In: Research Synthesis Methods, 14 (2023) 3, S.357-369 (13 Seiten)Infoseite zur Zeitschrift PDF als Volltext Verfügbarkeit
Zusatzinformation	ORCID (Weibel, Stephanie)
Sprache	englisch
Dokumenttyp	gedruckt; online; Zeitschriftenaufsatz
ISSN	1759-2879
DOI	10.1002/jrsm.1599
Schlagwörter	Identification; Randomized Controlled Trials; Integrity; Evaluation Methods; Literature Reviews; Research Problems + Suchen Sie Ihr Suchwort? Identifikation; Identifizierung; Integrität; Forschungskritik
Abstract	Evidence synthesis findings depend on the assumption that the included studies follow good clinical practice and results are not fabricated or false. Studies which are problematic due to scientific misconduct, poor research practice, or honest error may distort evidence synthesis findings. Authors of evidence synthesis need transparent mechanisms to identify and manage problematic studies to avoid misleading findings. As evidence synthesis authors of the Cochrane COVID-19 review on ivermectin, we identified many problematic studies in terms of research integrity and regulatory compliance. Through iterative discussion, we developed a research integrity assessment (RIA) tool for randomized controlled trials for the update of this Cochrane review. In this paper, we explain the rationale and application of the RIA tool in this case study. RIA assesses six study criteria: study retraction, prospective trial registration, adequate ethics approval, author group, plausibility of methods (e.g., randomization), and plausibility of study results. RIA was used in the Cochrane review as part of the eligibility check during screening of potentially eligible studies. Problematic studies were excluded and studies with open questions were held in awaiting classification until clarified. RIA decisions were made independently by two authors and reported transparently. Using the RIA tool resulted in the exclusion of >40% of studies in the first update of the review. RIA is a complementary tool prior to assessing "Risk of Bias" aiming to establish the integrity and authenticity of studies. RIA provides a platform for urgent development of a standard approach to identifying and managing problematic studies. (As Provided).
Anmerkungen	Wiley. Available from: John Wiley & Sons, Inc. 111 River Street, Hoboken, NJ 07030. Tel: 800-835-6770; e-mail: cs-journals@wiley.com; Web site: https://www.wiley.com/en-us
Erfasst von	ERIC (Education Resources Information Center), Washington, DC
Update	2024/1/01