Development and Testing of a Tool to Foster Shared Decision-Making between Patients and Healthcare Professionals in Clinical Practice Guidelines: Project Protocol (Preprint)

Abstract

Clinical practice guidelines (CPGs) are designed to assist healthcare professionals in medical decision-making. In the context of preference-sensitive CPG recommendations, shared decision-making (SDM) is advocated as a way of incorporating patients’ values and preferences into the decision-making process. However, existing evidence suggests that CPGs are currently not well suited to facilitate SDM effectively. To address this shortcoming and foster SDM through CPGs, the integration of patient decision aids (PDAs) has been proposed as an important strategy. However, there are currently no methods available for systematically identifying and prioritizing CPG recommendations according to their relevance for SDM.

To develop (1) a tool for CPG developers to systematically identify and prioritize CPG recommendations with high relevance for SDM, and (2) a platform for PDAs.

The project consists of six work packages (WPs). In WP 1, we will conduct a scoping review in bibliographic databases and grey literature sources to identify methods used to foster SDM via PDAs in the context of CPGs. In WP 2, we will conduct semi-structured interviews with CPG experts to better understand the concepts of preference sensitivity and identify strategies for fostering SDM through CPGs. In WP 3, a modified Delphi study, including surveys and focus groups with SDM experts, aims to define and operationalize preference sensitivity. Based on the results of the Delphi study, we will develop a methodology for prioritizing key questions in CPGs. In WP 4, the tool will be developed. A list of relevant items to identify CPG recommendations that are most relevant to SDM is created, tested and iteratively refined, accompanied by the development of a user manual. In WP 5, a platform for creating and digitizing German language PDAs will be developed to support the practical application of SDM during clinical encounters. WP 6 will conclude the project by testing the tool with newly developed and revised CPGs.

The Brandenburg Medical School Ethics Committee approved the qualitative parts of the project (i.e. WP 2 and 3; No. 165122023-ANF). An international multidisciplinary advisory board is involved to guide the tool development on CPGs and SDM. Patient partners are involved throughout the project, considering the essential role of the patient perspective in SDM. As of 20 February 2024, we are currently assessing literature references to determine eligibility for inclusion in the scoping review (WP 1). We expect the project to be completed by 31 December 2026.

The tool will enable CPG developers to systematically incorporate aspects of SDM into CPG development, thereby providing guideline–based support for the patient-practitioner interaction. Together, the tool and the PDA platform will create a systematic link between CPGs, SDM and PDAs, which may facilitate SDM in clinical practice.