Development of a patient decision aid for type 2 diabetes mellitus: a patient-centered approach

Abstract

Background: Patient decision aids (PDAs) have been shown to effectively facilitate shared decision-making (SDM) between patients and healthcare professionals. The International Patient Decision Aid Standards (IPDAS) Collaboration created a model for the systematic development of PDAs, offering guidance to PDA developers. However, the absence of a solid evidence base limits practical recommendations for best practices. For example, uncertainties exist about the most appropriate method for identifying the needs and preferences of patients and healthcare professionals. We aim to provide a comprehensive overview of the development process (including key stakeholders and methodologies employed), using the IPDAS model, for the development of a PDA for type 2 diabetes mellitus (T2DM). Methods: Between September 2020 and February 2023, we systematically developed the PDA for T2DM in the Netherlands. We adopted a patient-centered approach by researching patient considerations and actively collaborating with a multidisciplinary steering group that represented all relevant stakeholders in Dutch diabetes care (e.g., patients with T2DM, healthcare professionals, and patient organizations). The content of the PDA and the development of a prototype were determined by incorporating the needs and preferences of patients, input from the steering group, and available evidence regarding treatment options for T2DM. The research team and steering group iteratively reviewed the PDA prototype. Results: A web-based PDA was developed consisting of five sections: 1) information about T2DM and the available treatment options; 2) comparison of treatment options based on, for example, risk of cardiovascular diseases and effect on daily life; 3) questions to assess patients’ knowledge; 4) value-clarification exercise; and 5) summary of the patient’s journey through the PDA. Before patients use the PDA, healthcare professionals can make a preselection of the most relevant treatment options. Conclusions: Patients and healthcare professionals were involved in the development process of the PDA for T2DM in an early and iterative way. This ensured that the PDA is aligned with the needs and preferences of the end-users. In a future study, we will investigate the effectiveness of the PDA in facilitating shared decision-making in the treatment of T2DM. Trial registration: International Clinical Trials Registry Platform ID: NL8948, date of registration: 05-10-2020

Evaluating the feasibility of study methods for a future trial-based economic evaluation of a multistage shared decision-making program for type 2 diabetes mellitus: protocol for a cluster-randomized controlled pilot study

“…The program was co-created with a multidisciplinary steering group representing all relevant stakeholders in Dutch diabetes care. The development of the PDA for T2DM is described in detail elsewhere [5].…”

“…The multistage SDM program combines an online PDA with a preparatory consultation for patients as well as an interprofessional training in the PDA and SDM for HCPs (Fig 1 was co-created with a multidisciplinary steering group representing all relevant stakeholders in Dutch diabetes care. The development of the PDA for T2DM is described in detail elsewhere [5]. The PDA is available in the online catalog of PatientPlus (https://www.keuzehulp.info/frontpage/keuzehulpen/diabetes-type-2, Dutch only), the largest supplier of PDAs in the Netherlands.…”

“…SDM support is needed to reap the full benefits of person-centered T2DM care. We developed a multistage SDM program for T2DM that combines (1) an online patient decision aid (PDA) with (2) a preparatory consult for patients, and (3) interprofessional training in the PDA and SDM for HCPs [5]. The program was co-created with patients with T2DM, healthcare professionals involved in T2DM care, and patient organizations.…”

“…Recognizing the challenges faced in previous research, small-scale piloting is crucial to address uncertainties around the feasibility of study methods and to improve the study procedures of an economic evaluation [12, 13]. This article outlines the protocol for a cluster-randomized controlled pilot study aimed at evaluating the feasibility of a future trial-based economic evaluation of a multistage SDM program, including a PDA for T2DM in the Netherlands, compared to usual care [5]. The pilot study specifically focuses on sample recruitment and retention, study management, and feasibility of outcome and cost measurements.…”