A new patient-reported outcome measure for the evaluation of ankle instability: description of the development process and validation protocol
11/09/2024
Spennacchio P, Senorski E.H, Mouton C, Seil R, Cabri J, Karlsson J. A new patient-reported outcome measure for the evaluation of ankle instability: description of the development process and validation protocol. J Orthop Surg Res 19, 557 (2024). https://doi.org/10.1186/s13018-024-05057-4
Background Acute ankle sprains represent one of the most common traumatic injuries to the musculoskeletal
system. Many individuals with these injuries experience unresolved symptoms such as instability and recurrent
sprains, leading to chronic ankle instability (CAI), which affects their ability to maintain an active lifestyle. While
rehabilitation programs focusing on sensorimotor, neuromuscular, strength and balance training are primary
treatments, some patients require surgery when rehabilitation fails. A critical analysis of the patient-reported outcome
tools (PROs) used to assess CAI surgical outcomes raises some concerns about their measurement properties in CAI
patients, which may ultimately affect the quality of evidence supporting current surgical practice. The aim of this
research is to develop and validate a new PRO for the assessment of ankle instability and CAI treatment outcomes,
following recent methodological guidelines, with the implicit aim of contributing to the generation of scientifically
meaningful evidence for clinical practice in patients with ankle instability.
Methods Following the Consensus-based Standards for the selection of Health Measurement Instruments (COSMIN),
an Ankle Instability Treatment Index (AITI) will be developed and validated. The process begins with qualitative
research based on face‒to‒face interviews with CAI individuals to explore the subjective experience of living with
ankle instability. The data from the interviews will be coded following an inductive approach and used to develop
the AITI content. The preliminary version of the scale will be refined through an additional round of face‒to‒face
interviews with a new set of CAI subjects to define the AITI content coverage, relevance and clarity. Once content
validity has been examined, the AITI will be subjected to quantitative analysis of different measurement properties:
construct validity, reliability and responsiveness.
Discussion The development of AITI aims to address the limitations of existing instruments for evaluating surgical
outcomes in patients with CAI. By incorporating patient input and adhering to contemporary standards for validity
and reliability, this tool seeks to provide a reliable and meaningful assessment of treatment effects.