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. A recent review of the measurement properties of patient reported outcome measures for rotator cuff disorders revealed a large selection of diverse measures, many with questionable validity, reliability and responsiveness. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set (COS), which should be measured and reported in all trials for a specific clinical area. These sets do not imply that outcomes in a particular trial should be restricted to those in the COS. Rather, there is an expectation that the core outcomes will always be collected and reported, and that researchers will continue to explore other outcomes. The purpose of the present project is to develop a COS for rotator cuff disorders.
ContributorsJoel Gagnier 1-2, Hal Morgenstern 2-4, Mark MacEachern 5
1. Department of Orthopaedic Surgery, University of Michigan; 2. Department of Epidemiology, School of Public Health, University of Michigan; 3. Environmental Health Sciences, School of Public Health, University of Michigan; 4. Department of Urology, University of Michigan; 5. Taubman Health Sciences Library, University of Michigan.
Disease Category: Orthopaedics & trauma
Disease Name: Rotator cuff disease
Age Range: 0 - 100
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Researchers
- COS for clinical trials or clinical research
The methods will include a comprehensive systematic literature review and assessment of the properties of outcome measures, identifying and involving relevant stakeholders, and using consensus based methods to develop a COS.