@misc{10481/82285,
year = {2023},
url = {https://hdl.handle.net/10481/82285},
abstract = {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 integ-
rity 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 integ-
rity 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%), reporting (38%), postpublication concerns (2%),
and future research (13%). The most common integrity issues covered were ethics
(18%) and transparency (18%).
Conclusions: Low-quality reviews identified various integrity issues across the RCT
lifecycle, emphasizing the importance of high ethical standards and professional-
ism while highlighting gaps in the integrity landscape. Multistakeholder consensus is
needed to develop specific RCT integrity standards.},
organization = {Spanish Government},
organization = {Research institute Carlos III
	CM20/00074},
organization = {Universidad de Granada/CBUA},
publisher = {Wiley},
keywords = {Quality assessmen},
keywords = {Randomized clinical trial},
keywords = {Research integrity},
keywords = {Scoping},
keywords = {Scoping review},
keywords = {Umbrella review},
keywords = {Umbrella review integrity issues},
title = {Research integrity in randomized clinical trials: A scoping umbrella review},
doi = {10.1002/ijgo.14762},
author = {Núñez Núñez, María and Saeed Khan, Khalid and Bueno Cavanillas, Aurora},
}