For example, the most accessed and the top cited Cochrane Reviews in 2009 all describe problems due to inconsistencies in the outcomes reported in trials. Difficulties caused by heterogeneity in outcome measurement are well-known to systematic reviewers. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. 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. Selection of appropriate outcomes or domains is crucial when designing clinical trials to compare directly the effects of different interventions in ways that minimize bias. Outcomes may be specific (for example, progression of loss of eyesight in patients with retinal degeneration) or they may be a broad construct used to demonstrate effects of an intervention on one aspect of health (for example, pain). This is determined by comparing outcomes that are chosen to reflect beneficial and harmful effects. 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.Ĭlinical trials seek to evaluate whether an intervention is effective. Accumulating work in this area has identified the need for general guidance on the development of core outcome sets. 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. 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.
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