Department of Hand Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Finnish Centre of Evidence-Based Orthopedics (FICEBO), University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
BMC Med Res Methodol. 2022 Apr 29;22(1):127. doi: 10.1186/s12874-022-01600-1.
The Numerical Rating Scale (NRS) and Patient-rated wrist/hand evaluation (PRWHE) are patient-reported outcomes frequently used for evaluating pain and function of the wrist and hand. The aim of this study was to determine thresholds for minimal important difference (MID) and patient acceptable symptom state (PASS) for NRS pain and PRWHE instruments in patients with base of thumb osteoarthritis.
Fifty-two patients with symptomatic base of thumb osteoarthritis wore a splint for six weeks before undergoing trapeziectomy. NRS pain (0 to 10) and PRWHE (0 to 100) were collected at the time of recruitment (baseline), after splint immobilization prior to surgery, and at 3, 6, 9 and 12 months after surgery. Four anchor-based methods were used to determine MID for NRS pain and PRWHE: the receiver operating characteristics (ROC) curve, the mean difference of change (MDC), the mean change (MC) and the predictive modelling methods. Two approaches were used to determine PASS for NRS pain and PRWHE: the 75 percentile and the ROC curve methods. The anchor question for MID was the change perceived by the patient compared with baseline; the anchor question for PASS was whether the patient would be satisfied if the condition were to stay similar. The correlation between the transition anchor at baseline and the outcome at all time points combined was calculated using the Spearman's rho analysis.
The MID for NRS pain was 2.5 using the ROC curve method, 2.0 using the MDC method, 2.8 using the MC method, and 2.5 using the predictive modelling method. The corresponding MIDs for PRWHE were 22, 24, 10, and 20. The PASS values for NRS pain and PRWHE were 2.5 and 30 using the ROC curve method, and 2.0 and 22 using the 75th percentile method, respectively. The area under curve (AUC) analyses showed excellent discrimination for all measures.
We found credible MID estimates for NRS and PRWHE (including its subscales), although the MID estimates varied depending on the method used. The estimates were 20-30% of the range of scores of the instruments. The cut-offs for MID and PASS showed good or excellent discrimination, lending support for their use in future studies.
This clinimetrics study was approved by the Helsinki University ethical review board (HUS1525/2017).
数字评分量表（NRS）和患者自评腕/手部评估（PRWHE）是常用于评估腕手部疼痛和功能的患者报告结局指标。本研究的目的是确定拇指基底部骨关节炎患者使用 NRS 疼痛和 PRWHE 工具的最小临床重要差异（MID）和可接受症状状态（PASS）的阈值。
52 例有症状的拇指基底部骨关节炎患者在接受腕掌关节切开松解术前行夹板固定 6 周。在招募时（基线）、夹板固定术前、术后 3、6、9 和 12 个月时，收集 NRS 疼痛（0 到 10）和 PRWHE（0 到 100）。使用四种基于锚定的方法来确定 NRS 疼痛和 PRWHE 的 MID：受试者工作特征（ROC）曲线、变化的平均差异（MDC）、平均变化（MC）和预测模型方法。使用两种方法来确定 NRS 疼痛和 PRWHE 的 PASS：75%分位数和 ROC 曲线方法。MID 的锚定问题是患者与基线相比感知到的变化；PASS 的锚定问题是如果病情保持相似，患者是否会满意。使用 Spearman's rho 分析计算基线时的转换锚与所有时间点的综合结果之间的相关性。
ROC 曲线法的 NRS 疼痛 MID 为 2.5，MDC 法为 2.0，MC 法为 2.8，预测模型法为 2.5。PRWHE 的相应 MID 分别为 22、24、10 和 20。ROC 曲线法的 NRS 疼痛和 PRWHE 的 PASS 值分别为 2.5 和 30，75%分位数法的 PASS 值分别为 2.0 和 22。曲线下面积（AUC）分析显示，所有指标的区分度均较好。
我们发现 NRS 和 PRWHE（包括其分量表）有可靠的 MID 估计值，尽管 MID 估计值因使用的方法而异。这些估计值占工具评分范围的 20-30%。MID 和 PASS 的截止值具有良好或极好的区分度，支持在未来的研究中使用。
本临床研究方案经赫尔辛基大学伦理审查委员会（HUS1525/2017）批准。
