A systematic review of the patient reported outcome measures utilized in level 1 randomized controlled trials involving achilles tendon ruptures.

Background: Patient Reported Outcome Measures (PROMs) are utilized in level 1 randomized controlled trials involving Achilles tendon ruptures. However, the characteristics of these PROMs and current practices has not yet been reported. We hypothesize that there will be heterogeneous PROM usage in this context.

Methods: A PubMed and Embase systematic review was performed including all dates up to July 27th, 2022, assessing Achilles tendon ruptures in level 1 studies using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines where applicable. Inclusion criteria were all randomized controlled clinical studies involving Achilles tendon injuries. Studies that: (1) were not level 1 evidence (including editorial, commentary, review, or technique articles), (2) omitted outcome data or PROMs, (3) included injuries aside from Achilles tendon ruptures, (4) involved non-human or cadaveric subjects, (5) were not written in English, and (6) were duplicates were excluded. Demographics and outcome measures were assessed in the studies included for final review.

Results: Out of 18,980 initial results, 46 studies were included for final review. The average number of patients per study was 65.5. Mean follow up was 25 months. The most common study design involved comparing two different rehabilitation interventions (48 %). Twenty different outcome measures were reported including the Achilles tendon rupture score (ATRS) (48 %), followed by the American Orthopedic Foot and Ankle score Ankle-Hindfoot score (AOFAS-AH) (46 %), the Leppilahti score (20 %), and the RAND-36/Short Form (SF) - 36/SF-12 scores (20 %). An average of 1.4 measures were reported per study.

Conclusion: Significant heterogeneity exists in PROM usage among level 1 studies involving Achilles tendon ruptures, which prevents meaningful interpretation of these data across multiple studies. We advocate for usage of at least the disease-specific Achilles Tendon Rupture score and a global, quality of life (QOL) survey such as the SF-36/12/RAND-36. Future literature should provide more evidence-based guidelines for PROM usage in this context.

Level Of Evidence: Level IV; Systematic Review.