Abstract Objective: To describe the development and initial evaluation of a new context-specific patient decision aid for care-seeking patients with subacromial pain syndrome (SAPS) in primary care. Methods: To develop a new contextually relevant decision aid, mixed methods research study with four components was conducted. We adapted a previously tested decision aid using the ADAPT guidance (Activity I) and simultaneously developed new items using the International Patient Decision Aid Standards and the Ottawa Decision Support Framework (Activity II) to inform a prototype of the decision aid. In activity III, we alpha tested the prototype through think-aloud interviews with 10 patients with SAPS and 10 healthcare practitioners of different disciplines. In the interviews, participants were also asked to rate their readiness for the decision-making process using the Preparation for Decision-Making (PrepDM) questionnaire and the face-validity of the prototype was evaluated using the QQ-10 questionnaire. Revisions were made based on the feedback from the participants, the project group and a reference group consisting of 26 individuals including patients and healthcare practitioners. Following this, the new prototype was beta-tested in primary care with 23 care-seeking patients with SAPS. All participants were asked to complete the Shoulder Pain and Disability Index (SPADI), EQ-5D-3L and Decisional Conflict Scale (DCS) before, after and two weeks after introduction to the decision aid. Participants also scored the Decision Regret Scale (DRS) after two weeks. Following beta-testing, 13 interviews were conducted to explore the acceptability and usability of the decision aid, guided by the Standards for UNiversal reporting of Decision Aid Evaluations (SUNDAE) guidelines and Preparation for Decision Making Scale (PrepDM). Results: Based on the two first activities, the prototype decision aid included 10 treatments. Findings from alpha-testing highlighted that the prototype was acceptable and useful in preparing both patients and healthcare practitioners for the treatment decision-making process. Beta-testing showed that after introduction to the decision aid, the DCS decreased from 40 + 18 at baseline to 25 + 18 two weeks after the decision, indicating low levels of decisional conflict. Furthermore, after two weeks the DRS indicated low levels of decisional regret (25 + 9). SPADI and EQ-5D-3L scores were largely similarly across all time-points. Interviews highlighted that both patients and healthcare practitioners felt the decision aid was a valuable tool for clinical practice. Conclusions: Our decision aid is a promising tool for influencing the decision-making process in patients with SAPS in primary care. Further research that compares the offer of the decision aid to patients and healthcare practitioners in primary care with usual care is needed. Implications: Further research is needed to fully evaluate the effects of the decision aid.

The authors have declared no competing interest.

KDL is funded through TrygFonden (ID: 1524959), Danish Association of Physiotherapy and Aalborg University. SCB is funded by through an undergraduate Scholarships from Novo Nordisk Foundation. NEF is funded through an Australian National Health and Medical Research Council (NHMRC) Investigator Grant (ID: 2018182). JRZ is funded through an Australian National Health and Medical Research Council (NHMRC) Investigator Grant (ID: APP1194105).None of the funders were involved in the research. All authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study was conducted in accordance with the Helsinki Declaration and was deemed exempt from full ethical approval by The North Denmark Region Committee on Health Research Ethics (2023-000206).

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All data produced in the present study are available upon reasonable request to the authors.