Methods used to assess outcome consistency in clinical studies: A literature-based evaluation
Metadatos
Afficher la notice complèteEditorial
PUBLIC LIBRARY SCIENCE
Date
2020Referencia bibliográfica
Rogozińska E, Gargon E, Olmedo-Requena R, Asour A, Cooper NAM, Vale CL, et al. (2020) Methods used to assess outcome consistency in clinical studies: A literature-based evaluation. PLoS ONE 15(7): e0235485. [https://doi.org/10.1371/journal.pone.0235485]
Patrocinador
Medical Research Council UK (MRC) MC_UU_12023/24Résumé
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.