Developing core outcome sets for clinical trials: issues to consider

By Paula R. Williamson, Douglas G. Altman, Jane M. Blazeby, Mike Clarke, D. Devane, Elizabeth Gargon, Peter Tugwell. Trials, 2012

1,488 citations recorded by the source corpus.

The selection of appropriate outcomes or domains is crucial when designing clinical trials in order to compare directly the effects of different interventions in ways that minimize bias. If the findings are to influence policy and practice then the chosen outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set, which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for general guidance on the development of core outcome sets. Key issues to consider in the development of a core outcome set include its scope, the stakeholder groups to involve, choice of consensus method and the achievement of a consensus.

Subfields: Economics and Econometrics, Public Health, Environmental and Occupational Health, Sociology and Political Science

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Citations in the corpus

How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” – a practical guideline (2016, neutral): “…biomarkers, clinical rating scales, imaging tests, laboratory tests, patient questionnaires, and performance-based tests) measure the same outcome, causing inconsistencies in reporting and difficulties in comparing and combining the findings in systematic reviews and meta-analyses [2, 3].”
The COMET Handbook: version 1.0 (2017, methodology): “Although some guidance exists for COS developers [21, 46, 47], it is varied in the level of detail and is often unclear regarding the level of evidence available to support particular methodological recommendations.”
Core Outcome Set-STAndards for Development: The COS-STAD recommendations (2017, background): “Core outcome sets (COS) are an agreed standard set of outcomes that should be measured and reported, as a minimum, in all clinical trials in specific areas of health or healthcare [1].”