Publication: Methods used to assess outcome consistency in clinical studies: A literature-based evaluation.
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Identifiers
Date
2020-06-17
Authors
Rogozińska, Ewelina
Gargon, Elizabeth
Olmedo-Requena, Rocío
Asour, Amani
Cooper, Natalie A M
Vale, Claire L
Van't Hooft, Janneke
Advisors
Journal Title
Journal ISSN
Volume Title
Publisher
Public Library of Science
Abstract
Evaluation studies of outcomes used in clinical research and their consistency are appearing more frequently in the literature, as a key part of the core outcome set (COS) development. Current guidance suggests such evaluation studies should use systematic review methodology as their default. We aimed to examine the methods used. We searched the Core Outcome Measures in Effectiveness Trials (COMET) database (up to May 2019) supplementing it with additional resources. We included evaluation studies of outcome consistency in clinical studies across health subjects and used a subset of A MeaSurement Tool to Assess systematic Reviews (AMSTAR) 2 (items 1-9) to assess their methods. Of 93 included evaluation studies of outcome consistency (90 full reports, three summaries), 91% (85/93) reported performing literature searches in at least one bibliographic database, and 79% (73/93) was labelled as a "systematic review". The evaluations varied in terms of satisfying AMSTAR 2 criteria, such that 81/93 (87%) had implemented PICO in the research question, whereas only 5/93 (6%) had included the exclusions list. None of the evaluation studies explained how inconsistency of outcomes was detected, however, 80/90 (88%) concluded inconsistency in individual outcomes (66%, 55/90) or outcome domains (20%, 18/90). Methods used in evaluation studies of outcome consistency in clinical studies differed considerably. Despite frequent being labelled as a "systematic review", adoption of systematic review methodology is selective. While the impact on COS development is unknown, authors of these studies should refrain from labelling them as "systematic review" and focus on ensuring that the methods used to generate the different outcomes and outcome domains are reported transparently.
Description
MeSH Terms
Databases, Bibliographic
Delivery of Health Care
Diagnostic Tests, Routine
Humans
Outcome Assessment, Health Care
Publications
Treatment Outcome
Delivery of Health Care
Diagnostic Tests, Routine
Humans
Outcome Assessment, Health Care
Publications
Treatment Outcome
DeCS Terms
Atención a la salud
Bases de datos bibliográficas
Evaluación de resultado en la atención de salud
Humanos
Pruebas diagnósticas de rutina
Publicaciones
Resultado del tratamiento
Bases de datos bibliográficas
Evaluación de resultado en la atención de salud
Humanos
Pruebas diagnósticas de rutina
Publicaciones
Resultado del tratamiento
CIE Terms
Keywords
Bibliographic Databases, Delivery of Health Care, Diagnostic Tests Routine, Routine, Humans
Citation
Rogozińska E, Gargon E, Olmedo-Requena R, Asour A, Cooper NAM, Vale CL, et al. Methods used to assess outcome consistency in clinical studies: A literature-based evaluation. PLoS One. 2020 Jul 8;15(7):e0235485.