Identifying a core set of outcome domains to measure in clinical trials for shoulder disorders: a modified Delphi study

Abstract

ObjectiveTo achieve consensus on the most important outcome domains to measure across all clinical trials for shoulder disorders.MethodsWe 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.ResultsIn 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.ConclusionsBased 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.

A Preliminary Core Domain Set for Clinical Trials of Shoulder Disorders: A Report from the OMERACT 2016 Shoulder Core Outcome Set Special Interest Group

“…Our next steps will be to 1) Explore whether participation (recreation and work) should be in the inner core; 2) Perform a review of qualitative studies that had explored the lived experience of having shoulder pain; 3) Conduct a third Delphi round to finalise definitions and wording of domains and reach final endorsement for the domains from Delphi participants; and 4) Determine which instruments can be endorsed after having passed the OMERACT 2.0 Truth Discrimination and Feasibility (TDF) filter [7]. Results of this work will inform the final COS which we plan to present to OMERACT for endorsement.…”

“…At the pre-OMERACT meeting, participants agreed with the inclusion of pain and physical functioning as inner core domains (100% endorsement), in keeping with their endorsement by the Delphi study [7]. Global assessment of treatment success also endorsed by the Delphi study was also included in the inner core (100% endorsement), but changed to 'global perceived effect' in view of the fact that some trials include a usual care or no treatment arm where treatment success may not be a relevant concept.…”

“…Second, we conducted an international Delphi consensus study including 55 shoulder trial experts and/or clinicians and 41 patients from 13 countries to identify the key domains that should be included in a shoulder COS [7]. Four domains met an a priori threshold (at least 67% of all respondents) for inclusion in the core set: pain, physical functioning, global assessment of treatment success and health-related quality of life.…”

“…The patient participants suggested that patient respondents in the Delphi study [7], were likely considering the impact that reduced range of movement and strength have on function when indicating their importance in a COS. Although OMERACT recommends inclusion of resource use as a core domain, it was noted that it was not rated highly in the Delphi study [7], and may not be relevant to all trials. Other than pain, there were also no pathophysiological manifestations 14 included in our preliminary core domain set.…”

“…Figure 1 presents the final preliminary core domain set -each domain and its location in the OMERACT onion received 100% endorsement by SIG participants. Table 1 provides current definitions for each domain [7].…”