<rdf:RDF xmlns:rdf="http://www.openarchives.org/OAI/2.0/rdf/" xmlns:ow="http://www.ontoweb.org/ontology/1#" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:ds="http://dspace.org/ds/elements/1.1/" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:doc="http://www.lyncode.com/xoai" xsi:schemaLocation="http://www.openarchives.org/OAI/2.0/rdf/ http://www.openarchives.org/OAI/2.0/rdf.xsd">
   <ow:Publication rdf:about="oai:digibug.ugr.es:10481/82285">
      <dc:title>Research integrity in randomized clinical trials: A scoping umbrella review</dc:title>
      <dc:creator>Núñez Núñez, María</dc:creator>
      <dc:creator>Saeed Khan, Khalid</dc:creator>
      <dc:creator>Bueno Cavanillas, Aurora</dc:creator>
      <dc:subject>Quality assessmen</dc:subject>
      <dc:subject>Randomized clinical trial</dc:subject>
      <dc:subject>Research integrity</dc:subject>
      <dc:subject>Scoping</dc:subject>
      <dc:subject>Scoping review</dc:subject>
      <dc:subject>Umbrella review</dc:subject>
      <dc:subject>Umbrella review integrity issues</dc:subject>
      <dc:description>Background: Randomized clinical trials (RCTs) are experiencing a crisis of confidence&#xd;
in their trustworthiness. Although a comprehensive literature search yielded several&#xd;
reviews on RCT integrity, an overarching overview is lacking.&#xd;
Objectives: The authors undertook a scoping umbrella review of the research integ-&#xd;
rity literature concerning RCTs.&#xd;
Search strategy and selection criteria: Following prospective registration (https://&#xd;
osf.io/3ursn), two reviewers independently searched PubMed, Scopus, The Cochrane&#xd;
Library, and Google Scholar, without language or time restrictions, until November&#xd;
2021. The authors included systematic reviews covering any aspect of research integ-&#xd;
rity throughout the RCT lifecycle.&#xd;
Data collection and analysis: The authors assessed methodological quality using a&#xd;
modified AMSTAR 2 (A Measurement Tool to Assess Systematic Reviews) tool and&#xd;
collated the main findings.&#xd;
Main results: A total of 55 relevant reviews, summarizing 6001 studies (median per&#xd;
review, 63; range, 8–1106) from 1964 to 2021, had an overall critically low quality of&#xd;
96% (53 reviews). Topics covered included general aspects (15%), design and approval&#xd;
(22%), conduct and monitoring (11%), reporting (38%), postpublication concerns (2%),&#xd;
and future research (13%). The most common integrity issues covered were ethics&#xd;
(18%) and transparency (18%).&#xd;
Conclusions: Low-quality reviews identified various integrity issues across the RCT&#xd;
lifecycle, emphasizing the importance of high ethical standards and professional-&#xd;
ism while highlighting gaps in the integrity landscape. Multistakeholder consensus is&#xd;
needed to develop specific RCT integrity standards.</dc:description>
      <dc:date>2023-06-06T11:10:49Z</dc:date>
      <dc:date>2023-06-06T11:10:49Z</dc:date>
      <dc:date>2023</dc:date>
      <dc:type>journal article</dc:type>
      <dc:identifier>Núñez-Núñez M, Maes-Carballo M, Mignini LE, et al. Research integrity in randomized clinical trials: A scoping umbrella review. Int J Gynecol Obstet. 2023;00:1-17. [doi:10.1002/ijgo.14762]</dc:identifier>
      <dc:identifier>https://hdl.handle.net/10481/82285</dc:identifier>
      <dc:identifier>10.1002/ijgo.14762</dc:identifier>
      <dc:language>eng</dc:language>
      <dc:rights>http://creativecommons.org/licenses/by-nc-nd/4.0/</dc:rights>
      <dc:rights>open access</dc:rights>
      <dc:rights>Attribution-NonCommercial-NoDerivatives 4.0 Internacional</dc:rights>
      <dc:publisher>Wiley</dc:publisher>
   </ow:Publication>
</rdf:RDF>