A modified Delphi study to identify which items should be evaluated in shoulder instability research: a first step in developing a core outcome set

BACKGROUND: The aim of this study was to identify items that healthcare providers and/or patients consider important to include in a questionnaire for clinical trials and cohort studies in shoulder instability research. This could serve as a basis to develop a core outcome set for shoulder instability research. METHODS: Healthcare providers and patients were included in a panel for a modified Delphi consensus study. The study consisted of three rounds, comprising (1) identifying items, (2) rating the importance of the items, and (3) rating the importance again after seeing a summary of the results of round two. Importance was rated on a 9-point Likert scale. Consensus was defined as ≥ 80% of the panel giving a score of 7 or higher. RESULTS: In total, 44 healthcare providers and 30 patients completed all three rounds. Round one identified 54 items. After round three, the panel reached a consensus on 11 items that should be included in a questionnaire, comprising re-dislocation (99%), instable feeling of the shoulder (96%), limitations during sport (93%), patient satisfaction with the shoulder (93%), fear/anxiety for re-dislocation (91%), range of motion (88%), return to old level of functioning (85%), performing daily activities (85%), return to sport (82%), return to work (82%), and trusting the shoulder (81%). CONCLUSION: Healthcare providers and patients reached a consensus on 11 items that should be included in a questionnaire for shoulder instability research. These items can facilitate design and development of future clinical trials and form the basis for the development of a core outcome set.