Development of the FOCUS tool to guide prioritization of clinical guideline recommendations for shared...

While clinical practice guidelines (CPGs) provide general recommendations, their application to individual patients requires consideration of differences in preferences, values, and practical circumstances. Shared decision-making (SDM) can help bridge this gap. To better integrate SDM into CPGs, this study aimed to develop a pragmatic tool to support CPG developers in identifying and prioritizing recommendations for which SDM may be particularly relevant.

The development of our tool, FOCUS (Facilitating priOritization of CPG recommendations to sUpport Shared decision-making), comprised two steps: (1) generating an initial version within the project core team, informed by a scoping review, an interview study, and a modified Delphi study; and (2) refining this version through two iterative testing rounds with an international multidisciplinary group of experts and patient partners, each consisting of a survey followed by a group discussion.

A total of 12 participants from eight countries contributed to the testing and refinement of FOCUS. The final tool comprises five items: (1) multiple options with different benefit-harm profiles, (2) decision with impact, (3) potential discrepancy in values and preferences, (4) treatment burden and financial aspects, and (5) uncertainty of evidence. Across items, participants rated FOCUS with a mean of 3.38 or higher (on a scale ranging from 1 to 5) in terms of understandability, applicability, and usefulness for determining SDM relevance. FOCUS is intended to be applied at the recommendation level within the CPG development process. Patient representatives and healthcare professionals rate each item on a 5-point Likert scale, and a weighted mean score is then calculated so that patient and healthcare professional perspectives each contribute 50% to the final score. Higher scores indicate greater potential relevance of SDM for a given recommendation.

FOCUS offers a preliminary structured approach to better reflect SDM in CPG development by helping to identify and prioritize recommendations for which SDM may be particularly relevant. The next step is to test FOCUS within CPG development processes to assess its applicability, appropriateness, usefulness, and discriminative performance, and to inform further refinement.