Objective: To achieve consensus on the most important outcome domains to measure across all clinical trials for shoulder disorders. Methods: We performed an online modified Delphi study with an international, multidisciplinary and multistakeholder panel. A literature review and the OMERACT Filter 2.0 framework was used to generate a list of potential core domains, which were presented to patients, clinicians and researchers in two Delphi rounds. Participants were asked to judge the importance of each potential core domain and provide a rationale for their response. A core domain was defined a priori as a domain that at least 67% of participants considered core. Results: In both rounds, 335 individuals were invited to participate (268 clinicians/researchers and 67 patients); response rates were 27% (n=91) and 29% (n=96), respectively. From a list of 41 potential core domains, four domains met our criteria for inclusion: 'pain', 'physical functioning', 'global assessment of treatment success' and 'health-related quality of life'. Two additional domains, 'sleep functioning' and 'psychological functioning', met the criteria for inclusion by some, but not all stakeholder groups. There was consensus that 'number of deaths' was not a core domain, but insufficient agreement on whether or not several other domains, including 'range of motion' and 'muscle strength', were core domains. Conclusions: Based on international consensus from patients, clinicians and researchers, 'pain', 'physical functioning', 'global assessment of treatment success' and 'health-related quality of life' were considered core outcome domains for shoulder disorder trials. The value of several other domains needs further consideration.
Matthew J Page, Hsiaomin Huang, Arianne P Verhagen, Rachelle Buchbinder, Joel J Gagnier
Disease Category: Orthopaedics & trauma
Disease Name: Shoulder disorders
Age Range: 0 - 100
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Researchers
- COS for clinical trials or clinical research
- Recommendations for outcome measures (measurement/how)
- Delphi process
- Systematic review
- Consensus meeting
The methods for the COS development will include 3 phases: 1. A comprehensive review of the core domains used in shoulder disorder trials; 2. An international Delphi study involving relevant stakeholders (patients, clinicians, scientists) to define which domains should be core; 3. An international focus group informed by the evidence identified in phases 1 and 2, to determine which measurement instruments best measure the core domains and identification of any evidence gaps that require further empiric evidence. Phase 3 will take place at OMERACT 2016 meeting. All phases of these consensus meetings are done in concert with the OMERACT initiative who’s mission statement is “through a data driven multi-stakeholder consensus process, strives to identify and improve health outcome domains, endorsing valid, responsive, feasible health outcome measures in patients with musculoskeletal conditions”. The aim of the current proposal is to convene several meetings of international experts and patients to develop a COS for clinical trials of shoulder disorders and to develop an implementation strategy to ensure rapid uptake of the core set of outcomes in clinical trials.