RESUMO
OBJECTIVES: In 2019, only 7% of Cochrane systematic reviews (SRs) cited a core outcome set (COS) in relation to choosing outcomes, even though a relevant COS existed but was not mentioned (or cited) for a further 29% of SRs. Our objectives for the current work were to (1) examine the extent to which authors are currently considering COS to inform outcome choice in Cochrane protocols and completed SRs, and (2) understand author facilitators and barriers to using COS. STUDY DESIGN AND SETTING: We examined all completed Cochrane SRs published in the last 3 months of 2022 and all Cochrane protocols published in 2022 for the extent to which they: (a) cited a COS, (b) searched for COS, (c) used outcomes from existing COS, and (d) reported outcome inconsistency among included studies and/or noted the need for COS. One investigator extracted information; a second extractor verified all information, discussing discrepancies to achieve consensus. We then conducted an online survey of authors of the included SRs to assess awareness of COS and identify facilitators and barriers to using COS to inform outcome choice. RESULTS: Objective 1: We included 294 SRs of interventions (84 completed SRs and 210 published SR protocols), of which 13% cited specific COS and 5% did not cite but mentioned searching for COS. A median of 83% of core outcomes from cited COS (interquartile range [IQR] 57%-100%) were included in the corresponding SR. We identified a relevant COS for 39% of SRs that did not cite a COS. A median of 50% of core outcomes from noncited COS (IQR 35%-72%) were included in the corresponding SR. Objective 2: Authors of 236 (80%) of the 294 eligible SRs completed our survey. Seventy-seven percent of authors noted being aware of COS before the survey. Fifty-five percent of authors who did not cite COS but were aware of them reported searching for a COS. The most reported facilitators of using COS were author awareness of the existence of COS (59%), author positive perceptions of COS (52%), and recommendation in the Cochrane Handbook regarding COS use (48%). The most reported barriers related to matching of the scope of the COS and the SR: the COS target population was too narrow/broad relative to the SR population (29%) or the COS target intervention was too narrow/broad relative to the SR intervention (21%). Most authors (87%) mentioned that they would consider incorporating missing core outcomes in the SR/update. CONCLUSION: Since 2019, there is increasing consideration and awareness of COS when choosing outcomes for Cochrane SRs of interventions, but uptake remains low and can be improved further. Use of COS in SRs is important to improve outcome standardization, reduce research waste, and improve evidence syntheses of the relevant effects of interventions across health research.
Assuntos
Revisões Sistemáticas como Assunto , Revisões Sistemáticas como Assunto/métodos , Humanos , Avaliação de Resultados em Cuidados de Saúde/métodos , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricosRESUMO
OBJECTIVES: The importance of including patients, carers, and the public in health research is well recognized, including the need to consider outcomes in health care research that reflect the priorities of patients. Core outcome sets (COS) define the minimum set of outcomes that should be measured and reported in research of a given condition, determined through consensus among key stakeholders. The Core Outcome Measures in Effectiveness Trials Initiative undertakes an annual systematic review (SR) to identify newly published COS to update its online database of COS for research. The objective of this study was to assess the impact of patient participation on COS. STUDY DESIGN AND SETTING: SR methods used in previous updates were applied to identify research studies published or indexed in 2020 and 2021 (conducted as separate reviews) that report development of a COS, regardless of any specifications relating to condition, population, intervention, or setting. Studies were assessed according to published standards for COS development, and core outcomes extracted from study publications were categorized according to an outcome taxonomy and added to an existing database of core outcome classifications of all previously published COS. The effect of patient participation on core domains was examined. RESULTS: Searches identified 56 new studies published in 2020 and 54 in 2021. All studies met all four minimum standards for scope, and 42 (75%) of the 2020 studies and 45 (83%) of the 2021 studies met all three standards for stakeholders involved. However, only 19 (34%) of the 2020 studies and 18 (33%) of the 2021 studies met all four standards for the consensus process. COS that involved patients or their representatives are more likely to include life impact outcomes (239, 86%) than COS without patient participation (193, 62%). Physiological/clinical outcomes are almost always specified at a granular level, whereas life impact outcomes are often described at a higher level. CONCLUSION: This study adds to the body of evidence demonstrating the importance and impact of including patients, carers, and the public in COS development, in particular by demonstrating that the impact of interventions on patients' lives is more likely to be represented in COS that involve patients or their representatives. COS developers are encouraged to pay increased attention to methods and reporting relating to the consensus process. Further work is required to understand the appropriateness and rationale for the discrepancy in granularity levels between outcome domains.