Migliorini Filippo, Maffulli Nicola, Jeyaraman Madhan, Schäfer Luise, Rath Björn, Huber Thorsten
Department of Life Sciences, Health, and Health Professions, Link Campus University of Rome, Rome, Italy.
Department of Orthopedics and Trauma Surgery, Academic Hospital of Bolzano (SABES-ASDAA), 39100, Bolzano, Italy.
Eur J Trauma Emerg Surg. 2025 Jan 22;51(1):32. doi: 10.1007/s00068-024-02708-3.
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.
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.
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.
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.
最小临床重要差异（MCID）、患者可接受症状状态（PASS）和显著临床获益（SCB）旨在优先考虑具有真正临床获益的临床显著结果，而非仅仅依赖统计学显著性。这些工具有助于临床医生理解患者的观点，使医疗保健专业人员能够设定与患者愿望和期望相一致的治疗目标。本系统评价分析了用于评估膝关节韧带重建术后患者的最常用患者报告结局量表（PROMs）临床相关性的工具。
本研究按照2020年PRISMA声明进行。2024年1月，检索了以下数据库：PubMed、科学网和Embase。检索无时间限制。纳入了所有调查评估膝关节韧带手术中PROMs临床相关性工具的临床研究。仅纳入评估了MCID、PASS和SCB的研究。感兴趣的PROMs包括：国际膝关节文献委员会（IKDC）、膝关节损伤和骨关节炎结局评分（KOOS）及其相关子量表日常生活活动（ADL）、疼痛、生活质量（QoL）、运动和娱乐以及症状（Roos等人，《矫形运动物理治疗杂志》28:88 - 96，1998）、Lysholm膝关节评分量表、简短健康调查12项量表（SF - 12）及其相关的心理和身体成分子量表、Tegner活动量表。
本综述纳入了7项非随机对照试验研究，其中3项为前瞻性研究设计，4项为回顾性研究设计，共1414例患者。在本研究评估的研究中，71.4%（7项中的5项）的总体偏倚风险为低至中度，28.6%（7项中的2项）为严重，表明方法学质量总体可接受。IKDC报告的MCID为13.8/100，KOOS为8.0/100，Lysholm为9.9/100，Tegner活动量表为0.5/10。
本系统评价表明，在膝关节韧带重建手术中，需要更可靠的科学数据、适当的研究方法以及对MCID、SCB和PASS的充分报告。IKDC评分、Lysholm评分和Tegner活动量表是仅有多项研究报告了相关值的工具。证据级别：IV级，系统评价和荟萃分析。
