Journal Article

Developing core outcome sets for clinical trials: issues to consider

Williamson, Paula R, Blazeby, Jane M, Gargon, Elizabeth, Clarke, Mike, Devane, Declan, Tugwell, Peter, Altman, Douglas G

2012

Overview

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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Bias / Biomedicine / Clinical trials / Clinical Trials as Topic - methods / Clinical Trials as Topic - standards / Collaboration / Commentary / Consensus / Core outcome set / Decision making / Endpoint Determination - standards / Evidence-Based Medicine / Feasibility studies / Gastrointestinal surgery / Guideline Adherence / Guidelines as Topic / Health care / Health Sciences / Health services / Humans / Intervention / Medicine / Medicine & Public Health / Methodology / Methods / Obesity / Outcome reporting bias / Patients / Research Design - standards / Rheumatology / Stakeholders / Standardization of outcomes / Statistics for Life Sciences / Systematic review / Treatment Outcome