Inconsistency in use and derivation of clinically meaningful changes in anterior cruciate ligament reconstruction: A systematic review.

Abstract

This study aimed to evaluate the current literature on its use and derivation of clinically meaningful changes (CMC) in patient-reported outcome measures (PROMs) for evaluation of post-treatment outcomes after anterior cruciate ligament (ACL) reconstruction. A systematic search following the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines was conducted using PubMed, Scopus and Web of Science databases from 2008 to 2024. Inclusion criteria included full-text articles in the English language regarding ACL reconstruction that used and described the derivation of CMC metrics in PROMs with a minimum 1-year follow-up. Studies were excluded if they were non-human research, narrative or systematic reviews, case studies, editorials, commentaries, or if CMCs were derived from previous studies. CMC terms included: Minimal Clinically Important Difference (MCID), Patient Acceptable Symptom State (PASS), Minimal Detectable Change (MDC), Substantial Clinical Benefit (SCB), Minimal Important Difference (MID) and Minimal Important Change (MIC). Twenty-two studies met the inclusion criteria with 4852 total patients with a mean age of 24.2 years. The MCID was calculated in 14 studies (63.6%). MCID was calculated using distribution-based methods in 11 studies (50.0%), anchor-based methods in one study (4.5%) and both methods in one study (4.5%). MDC was derived in three studies (13.6%), using distribution-based methods. PASS was derived in six studies (7.3%), SCB was derived in two studies (9.1%), MID was derived in one study (4.5%), and MIC was derived in one study (4.5%), all using anchor-based methods. There is inconsistency in the ACL literature regarding the use and derivation of CMC metrics for the assessment of PROMs. With increased use of PROMs in literature to develop Clinical Practice Guidelines and guide Medicare/Medicaid decisions, standardization of PROM interpretation is necessary. Clear definitions and consistency in the derivation of CMC metrics will help increase standardization in patient outcome assessments. Level IV.