Minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient-acceptable symptom state (PASS) in patients who have undergone total knee arthroplasty: a systematic review

Migliorini, Filippo; Maffulli, Nicola; Schäfer, Luise; Simeone, Francesco; Bell, Andreas; Hofmann, Ulf Krister

Abstract

Background
The present systematic review investigated the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient-acceptable symptom state (PASS) of several frequent and established PROMs used to assess patients who have undergone TKA. This study was conducted according to the 2020 PRISMA statement.

Methods
In September 2023, PubMed, Web of Science, and Embase were accessed with no time constraint All clinical studies investigating tools to assess the clinical relevance of PROMs used to evaluate patients having received TKA were accessed. Only studies which evaluated the MCID, PASS, or SCB were eligible. The PROMs of interest were the Forgotten Joint Score-12 (FJS-12), the Oxford Knee Score (OKS), the Knee Injury and Osteoarthritis Outcome Score (KOOS) and its related subscales activity of daily living (ADL), pain, quality of life (QoL), sports and recreational activities, and symptoms, the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) score, the Knee Society Score (KSS) and related function score, and the Short Form-12 (SF-12) and Short Form-36 (SF-36).

Results
Data from 29,737 patients were collected. The overall risk of bias was low to moderate. The great variability of thresholds for MCID, SCB and PASS between questionnaires but also between investigated aspects was noted, whereby MCIDs for the SF-36 appear lower than for knee-specific questionnaires.

Conclusion
Despite its critical role from a patient’s perspective, the dimension of SCB is still neglected in the literature. Moreover, thresholds for the different concepts need to be condition-specific. We encourage authors to specifically report such data in future studies and to adhere to previously reported definitions to allow future comparison.
Level of evidence Level IV, systematic review and meta-analysis

Citation

Migliorini, F., Maffulli, N., Schäfer, L., Simeone, F., Bell, A., & Hofmann, U. K. (in press). Minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient-acceptable symptom state (PASS) in patients who have undergone total knee arthroplasty: a systematic review. Knee Surgery & Related Research, 36(1), Article 3. https://doi.org/10.1186/s43019-024-00210-z

• Journal Article Type: Article
• Acceptance Date: Jan 2, 2024
• Online Publication Date: Jan 11, 2024
• Deposit Date: Jan 16, 2024
• Publicly Available Date: Jan 16, 2024
• Journal: Knee Surgery & Related Research
• Print ISSN: 2234-2451
• Publisher: Springer Nature [academic journals on nature.com]
• Peer Reviewed: Peer Reviewed
• Volume: 36
• Issue: 1
• Article Number: 3
• DOI: https://doi.org/10.1186/s43019-024-00210-z
• Keywords: MCID, PROMs, Arthroplasty, PASS, SCB, Knee, Patient-reported outcome measures