Research integrity in randomized clinical trials: A scoping umbrella review

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

doi:10.1002/ijgo.14762

Research integrity in randomized clinical trials: A scoping umbrella review

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

^*Corresponding author for this work

Metabolism and Systems Research

Research output: Contribution to journal › Review article › peer-review

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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 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%), 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 professionalism while highlighting gaps in the integrity landscape. Multistakeholder consensus is needed to develop specific RCT integrity standards.

Original language	English
Journal	International Journal of Gynecology and Obstetrics
Early online date	16 Apr 2023
DOIs	https://doi.org/10.1002/ijgo.14762
Publication status	E-pub ahead of print - 16 Apr 2023

Bibliographical note

Funding Information:
KSKis a distinguished investigator at the University of Granada funded by the Beatriz Galindo (senior modality) program of the Spanish Ministry of Education. MNN is in a research training grant program funded by the Research institute Carlos III (Rio Hortega CM20/00074). Funding for the open access charge was received from Universidad de Granada/CBUA.

Publisher Copyright:
© 2023 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.

Keywords

quality assessment
randomized clinical trial
research integrity
scoping
scoping review
umbrella review
umbrella review integrity issues

ASJC Scopus subject areas

Obstetrics and Gynaecology

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Cite this

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title = "Research integrity in randomized clinical trials: A scoping umbrella review",

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 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%), 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 professionalism while highlighting gaps in the integrity landscape. Multistakeholder consensus is needed to develop specific RCT integrity standards.",

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author = "Mar{\'i}a N{\'u}{\~n}ez-N{\'u}{\~n}ez and Marta Maes-Carballo and Mignini, {Luciano E.} and Chien, {Patrick F.W.} and Yacoub Khalaf and Mohamed Fawzy and Javier Zamora and Khan, {Khalid S.} and Aurora Bueno-Cavanillas",

note = "Funding Information: KSKis a distinguished investigator at the University of Granada funded by the Beatriz Galindo (senior modality) program of the Spanish Ministry of Education. MNN is in a research training grant program funded by the Research institute Carlos III (Rio Hortega CM20/00074). Funding for the open access charge was received from Universidad de Granada/CBUA. Publisher Copyright: {\textcopyright} 2023 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.",

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AU - Núñez-Núñez, María

AU - Maes-Carballo, Marta

AU - Mignini, Luciano E.

AU - Chien, Patrick F.W.

AU - Khalaf, Yacoub

AU - Fawzy, Mohamed

AU - Zamora, Javier

AU - Khan, Khalid S.

AU - Bueno-Cavanillas, Aurora

N1 - Funding Information: KSKis a distinguished investigator at the University of Granada funded by the Beatriz Galindo (senior modality) program of the Spanish Ministry of Education. MNN is in a research training grant program funded by the Research institute Carlos III (Rio Hortega CM20/00074). Funding for the open access charge was received from Universidad de Granada/CBUA. Publisher Copyright: © 2023 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.

PY - 2023/4/16

Y1 - 2023/4/16

N2 - 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%), 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 professionalism while highlighting gaps in the integrity landscape. Multistakeholder consensus is needed to develop specific RCT integrity standards.

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Research integrity in randomized clinical trials: A scoping umbrella review

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

Access to Document

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Cite this