使用荟萃分析方法评估非手术干预后膝骨关节炎患者膝关节屈曲的最小临床重要变化。

BACKGROUND: Minimal clinically important change (MCIC) represents the minimum patient-perceived improvement in an outcome after treatment, in an individual or within a group over time. This study aimed to determine MCIC of knee flexion in people with knee OA after non-surgical interventions using a meta-analytical approach. METHODS: Four databases (MEDLINE, Cochrane, Web of Science and CINAHL) were searched for studies of randomised clinical trials of non-surgical interventions with intervention duration of ≤ 3 months that reported change in (Δ) (mean change between baseline and immediately after the intervention) knee flexion with Δ pain or Δ function measured using tools that have established MCIC values. The risk of bias in the included studies was assessed using version 2 of the Cochrane risk-of-bias tool for randomised trials (RoB 2). Bayesian meta-analytic models were used to determine relationships between Δ flexion with Δ pain and Δ function after non-surgical interventions and MCIC of knee flexion. RESULTS: Seventy-two studies (k = 72, n = 5174) were eligible. Meta-analyses included 140 intervention arms (k = 61, n = 4516) that reported Δ flexion with Δ pain using the visual analog scale (pain-VAS) and Δ function using the Western Ontario and McMaster Universities Osteoarthritis Index function subscale (function-WOMAC). Linear relationships between Δ pain at rest-VAS (0-100 mm) with Δ flexion were - 0.29 (- 0.44; - 0.15) (β: posterior median (CrI: credible interval)). Relationships between Δ pain during activity VAS and Δ flexion were - 0.29 (- 0.41, - 0.18), and Δ pain-general VAS and Δ flexion were - 0.33 (- 0.42, - 0.23). The relationship between Δ function-WOMAC (out of 100) and Δ flexion was - 0.15 (- 0.25, - 0.07). Increased Δ flexion was associated with decreased Δ pain-VAS and increased Δ function-WOMAC. The point estimates for MCIC of knee flexion ranged from 3.8 to 6.4°. CONCLUSIONS: The estimated knee flexion MCIC values from this study are the first to be reported using a novel meta-analytical method. The novel meta-analytical method may be useful to estimate MCIC for other measures where anchor questions are problematic. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42022323927.

背景：最小临床重要变化（MCIC）代表个体或群体在一段时间内治疗后，在结局上患者感知到的最小改善。本研究旨在采用荟萃分析方法确定膝关节骨性关节炎患者非手术干预后膝关节屈曲的 MCIC。

方法：在 MEDLINE、Cochrane、Web of Science 和 CINAHL 这四个数据库中检索了非手术干预的随机临床试验研究，干预时间不超过 3 个月，使用已经确定 MCIC 值的工具报告了（Δ）（基线和干预后即刻之间的平均变化）膝关节屈曲的变化，同时报告了Δ疼痛或Δ功能。使用随机试验的 Cochrane 偏倚风险工具（RoB 2）版本 2 评估纳入研究的偏倚风险。使用贝叶斯荟萃分析模型来确定非手术干预后膝关节屈曲与 Δ疼痛和 Δ功能之间的关系，以及膝关节屈曲的 MCIC。

结果：共有 72 项研究（k=72，n=5174）符合条件。荟萃分析包括 140 个干预臂（k=61，n=4516），这些干预臂使用视觉模拟量表（疼痛-VAS）报告了Δ疼痛，使用 Western Ontario 和 McMaster 大学骨关节炎指数功能子量表（功能-WOMAC）报告了Δ功能。在静止状态下，疼痛 VAS（0-100mm）与Δ屈曲之间的线性关系为-0.29（-0.44；-0.15）（β：后中位数（CrI：可信区间））。活动状态下疼痛 VAS 与Δ屈曲之间的关系为-0.29（-0.41，-0.18），一般疼痛 VAS 与Δ屈曲之间的关系为-0.33（-0.42，-0.23）。功能 WOMAC（满分 100 分）与Δ屈曲之间的关系为-0.15（-0.25，-0.07）。增加Δ屈曲与减少疼痛-VAS 和增加功能-WOMAC 相关。膝关节屈曲的 MCIC 估计值范围为 3.8 至 6.4°。

结论：本研究采用新的荟萃分析方法首次报道了膝关节屈曲的 MCIC 值。该新的荟萃分析方法可能有助于在锚定问题存在问题的情况下估计其他指标的 MCIC。

系统综述注册：PROSPERO CRD42022323927。