Development and field testing of a patient decision aid for management of acute Achilles tendon rupture: a study protocol

Abstract

Background Achilles tendon ruptures are common injuries in an otherwise healthy, active population. Several treatment options exist, with both surgical and non-surgical options. Each treatment option has a unique set of risks and harms, which may present patients with decisional conflict. The aim of the proposed study is to develop, alpha test and field test a patient decision aid for patients presenting with acute Achilles tendon ruptures. Methods This is a three-stage study protocol. First, we will assemble a multi-disciplinary steering group including patients, clinicians, educators, and researchers to develop the patient decision aid prototype using the Ottawa Decision Support Framework. Second, we will perform a mixed-methods alpha test of the decision aid prototype with patients and clinicians experienced in acute Achilles tendon ruptures. Outcomes measured will include acceptability and usability of the patient decision aid measured using validated outcome scales and semi-structured interviews. A minimum of three rounds of feedback will be obtained. Results will be analyzed using descriptive statistics, reviewed by the steering group, to guide revisions to decision aid prototype at each round. The third stage will be field testing the revised decision aid prototype in usual clinical care. A pre-/post-study will be performed with patients with acute Achilles tendon ruptures. Patients will be recruited from the emergency department and complete the pre-consultation decision aid prior to a one-week follow up with their surgeon. The primary outcome of field testing will be feasibility of implementing the decision aid in the clinical setting and will be measured with recruitment and completion metrics. Secondary outcomes include acceptability of the decision aid, knowledge, preparedness for decision making, and decisional conflict, measured using validated outcome measures. Statistical analysis will be performed using descriptive analysis for primary outcomes and a student t-test and Wilcoxon Rank-Sum test for secondary outcomes. Discussion This comprehensive study protocol outlines the development, alpha testing, and field testing of a patient decision aid for patients with acute Achilles tendon rupture. Systematic and transparent development and testing of patient decision aids is critical to improve decision aid quality. Trial registration Not Applicable.

Developing a patient decision aid for Achilles tendon rupture management: a mixed-methods study

“…Compared with a 2022 patient decision aid for Achilles tendon ruptures developed by Healthwise,26 our study provided more detail about how feedback was used to guide development, presented numerical estimates of benefits and harms in the decision aid and followed guidance from the IPDAS criteria. A 2021 study outlined a protocol to develop and test a patient decision aid for Achilles tendon rupture management 27. In comparison to their planned development process, our study used the Think-Aloud approach to semi-structured interviews and reviewed the decision aid as new themes emerged, rather than round-by-round.…”

“…A 2021 study outlined a protocol to develop and test a patient decision aid for Achilles tendon rupture management. 27 In comparison to their planned development process, our study used the Think-Aloud approach to semi-structured interviews and reviewed the decision aid as new themes emerged, rather than round-by-round.…”

Making the BEST decision-the BESTa project development, implementation and evaluation of a digital Decision Aid in Swedish cancer screening programmes- a description of a research project

“…5 users found a minimum of 55% problems, 10 users 82% and 20 users 95%. This model was applied in a previous study describing the development of a decision aid for patients with acute Achilles tendon rupture [ 40 ]. Another benchmark is a previous study on the same topic where 25 interviews were needed in the alpha phase, until saturation was reached [ 35 ].…”