Minimal clinically important difference (MCID), patient-acceptable symptom state (PASS), and substantial clinical benefit (SCB) following surgical knee ligament reconstruction: a systematic review.

Abstract

Introduction: The minimal clinically important difference (MCID), patient-acceptable symptom state (PASS), and substantial clinical benefit (SCB) are designed to prioritise clinically significant outcomes that demonstrate true clinical benefit rather than relying solely on statistical significance. These instruments aid clinicians in understanding the patient's perspective, allowing healthcare professionals to set treatment goals that align with patients' desires and expectations. This systematic review analysed tools to estimate the clinical relevance of the most commonly used PROMs to assess patients following surgical knee ligament reconstruction.

Methods: This study was conducted according to the 2020 PRISMA statement. In January 2024, the following databases were accessed: PubMed, Web of Science, and Embase. No time constraint was set for the search. All the clinical studies investigating tools to assess the clinical relevance of PROMs in knee ligament surgery were accessed. Only studies which evaluated the MCID, PASS, and SCB were eligible. The PROMs of interest were: International Knee Document Committee (IKDC), Knee Injury and Osteoarthritis Outcome Score (KOOS) and its related subscales activity of day living (ADL), pain, quality of life (QoL), sport and recreational, and symptoms (Roos et al. in J Orthop Sports Phys Ther 28:88-96, 1998), Lysholm knee scoring scale, Short Form 12 (SF-12) and its related mental and physical component subscales, Tegner Activity Scale.

Results: Seven non-RCT investigations, three with a prospective and four with a retrospective study design, were selected for inclusion in the present review, including 1,414 patients. The overall risk of bias was low to moderate in 71.4% (5 of 7) and serious in 28.6% (2 of 7) of the studies assessed in the present investigation, indicating a broadly acceptable methodological quality. The IKDC reported an MCID of 13.8/100, the KOOS 8.0/100, the Lysholm 9.9/100, and the Tegner Activity Scale 0.5/10.

Conclusion: This systematic review demonstrated that more dependable scientific data, appropriate study methodology, and adequate reporting of MCID, SCB, and PASS in surgical knee ligament reconstruction is necessary. The IKDC score, the Lysholm score, and the Tegner activity scale were the only instruments with multiple studies reporting values. Level of evidence Level IV, systematic review and meta-analysis.