Description

Background and Rationale: Ankle fractures are among the most common lower-limb injuries in orthopedic practice. Patient-reported recovery, including physical function, sleep, mood, and social participation, is not adequately captured by traditional clinician-based outcome measures such as the AOFAS Ankle-Hindfoot Score or the Olerud-Molander Ankle Score. The A-FORM, developed by McPhail et al. (2014), is a 15-item, Rasch-calibrated patient-reported outcome measure designed specifically to evaluate the rehabilitation experience after ankle fracture. No validated Turkish-language version currently exists.

Methodological Framework: The study follows the eight-stage cross-cultural adaptation and validation protocol described by Cruchinho et al. (2024), which incorporates the recommendations of Beaton et al. (2000) and the COSMIN framework (Mokkink et al., 2010). Written permission to translate and use the instrument has been granted by Prof. Steven McPhail (Queensland University of Technology).

Translation and Adaptation: Forward translation is carried out by two independent bilingual translators (one faculty member from the Department of English Language and Literature, providing linguistic expertise; one bilingual orthopedic surgeon, providing clinical content expertise). A reconciliation committee produces a synthesised Turkish version, which is then back-translated by two independent translators blinded to the original. A harmonisation expert committee compares the source, forward, and back versions for semantic, idiomatic, experiential, and conceptual equivalence. The harmonised pre-test version is evaluated through cognitive debriefing interviews with 10 to 15 ankle-fracture patients before field testing.

Field Testing: In the field testing phase, 150 adult patients with a radiographically confirmed unilateral ankle fracture (Weber A, B, or C; treated surgically by open reduction and internal fixation or conservatively with cast, walker boot, or functional brace) are enrolled across three orthopedic centres. Patients between 3 weeks and 12 months post-injury are eligible. The A-FORM-TR is administered together with the AOFAS Ankle-Hindfoot Score and the OMAS-TR. A sub-cohort of approximately 50 patients is re-administered the A-FORM-TR at 7 to 14 days, with a Global Rating of Change item used to identify clinically stable patients for the test-retest reliability analysis.

Statistical Analysis Plan: Developed in consultation with the institutional biostatistics team. Internal consistency is assessed by Cronbach's alpha (target greater than or equal to 0.80). Test-retest reliability is assessed by the intraclass correlation coefficient on stable patients (target greater than or equal to 0.90). Structural validity is assessed by confirmatory factor analysis against the a priori structure established by the original developers. Rasch measurement analysis examines item fit, threshold ordering, person separation reliability, person-item targeting, local independence, unidimensionality, and differential item functioning by sex, age group, treatment modality, recruiting centre, and time since injury. Construct validity is assessed via pre-specified hypotheses about correlation patterns with the AOFAS and OMAS-TR. Content validity is assessed via item-level and scale-level Content Validity Index and the Kappa coefficient from the expert committee. Floor and ceiling effects are reported. Responsiveness is not formally evaluated in this initial validation study and is reserved for a planned subsequent longitudinal study. Analyses use SPSS version 26 or later and R (lavaan, psych, eRm, and TAM packages).

Ethics and Registration: Ethics approval is sought from the Girne University Clinical Research Ethics Committee. An institutional permission letter is obtained from Ankara Bilkent City Hospital. Data are handled in accordance with the Turkish Personal Data Protection Law (KVKK No. 6698): pseudonymised, securely stored, and retained for a maximum of 5 years post-publication.