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Research integrity in randomized clinical trials: A scoping umbrella review by María Núñez‐Núñez; Marta Maes‐Carballo; Luciano E. Mignini; Patrick F. W. Chien; Yacoub Khalaf; Mohamed Fawzy; Javier Zamora; Khalid S. Khan; Aurora Bueno‐Cavanillas is a Medicine article available to read on EtoBox.

What is Research integrity in randomized clinical trials: A scoping umbrella review about?

Background: Randomized clinical trials (RCTs) are experiencing a crisis of confidence in their trustworthiness. Although a comprehensive literature search yielded several reviews on RCT integrity, an overarching overview is lacking. ## Objectives: The authors undertook a scoping umbrella review of the research integrity literature concerning RCTs. Search strategy and selection criteria: Following prospective registration (https:// osf.io/3ursn), two reviewers independently searched PubMed, Scopus, The Cochrane Library, and Google Scholar, without language or time restrictions, until November 2021. The authors included systematic reviews covering any aspect of research integrity throughout the RCT lifecycle. ## Data collection and analysis: The authors assessed methodological quality using a modified AMSTAR 2 (A Measurement Tool to Assess Systematic Reviews) tool and collated the main findings. Main results: A total of 55 relevant reviews, summarizing 6001 studies (median per review, 63; range, 8-1106) from 1964 to 2021, had an overall critically low quality of 96% (53 reviews). Topics covered included general aspects (15%), design and approval (22%), conduct and monitoring (11%), r

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Author
María Núñez‐Núñez; Marta Maes‐Carballo; Luciano E. Mignini; Patrick F. W. Chien; Yacoub Khalaf; Mohamed Fawzy; Javier Zamora; Khalid S. Khan; Aurora Bueno‐Cavanillas
Publisher
Wiley
Published
2023
Language
EN
Field
Medicine (Health Sciences)

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