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全腹子宫切除术后的最小临床重要差异和患者可接受的症状状态:随机对照试验数据的二次分析

Minimal Clinically Important Difference and Patient Acceptable Symptom State After Total Abdominal Hysterectomy: Secondary Analysis of RCT Data.

作者信息

Pejcic Nada, Kutlesic Marija, Milic Vladimir, Jankovic Radmilo, Zornic Nenad

机构信息

Clinic for Anesthesiology and Intensive Therapy, University Clinical Center Nis, Nis, SRB.

Clinic for Anesthesiology and Intensive Therapy, Clinic for Gynecology and Obstetrics, University Clinical Center Nis, Nis, SRB.

出版信息

Cureus. 2025 Jul 10;17(7):e87703. doi: 10.7759/cureus.87703. eCollection 2025 Jul.

DOI:10.7759/cureus.87703
PMID:40786319
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12335722/
Abstract

Background Modern anesthesia focuses on the patient's perception of achieved pain relief rather than just statistical significance. The minimal clinically important difference (MCID) and the patient acceptable symptom state (PASS) are measures of patient-reported outcomes. MCID in pain scores refers to the minimum reduction in visual analogue scale (VAS) or numeric rating scale (NRS) scores that leads to a perceptible improvement in pain, although it may not necessarily indicate full pain relief. PASS, on the other hand, is the threshold beyond which patients consider themselves to be in an acceptable state of well-being. These patient-centered outcomes reflect the clinical significance of the achieved pain relief from the patient's perspective. Furthermore, these metrics can guide anesthesiologists toward postoperative pain management targets. The purpose of this study was to determine the MCID in NRS scores and PASS after total abdominal hysterectomy (TAH). Methods This study represents a secondary analysis of a double-blind, randomized controlled trial (RCT) evaluating quadratus lumborum block (QLB) in total abdominal hysterectomy. The primary outcome was to determine the distribution-based MCID in NRS scores. The MCID was calculated as the average of three values derived from distinct distribution-based methods: (1) a proportion of the pooled standard deviation (SD), (2) a proportion of the standard error of measurement (SEM) in the control group, and (3) 10% of the scale range. The secondary outcome was to assess PASS. PASS was determined using the "threshold approach," identifying the pain score threshold that most accurately predicted patient satisfaction with pain relief. This was achieved by determining the value that yielded the best sensitivity and specificity in a receiver operating characteristic (ROC) curve analysis. Results The MCID for pain intensity, calculated as the mean value (1.5) derived from three distribution-based methods, represents the threshold for meaningful improvement. Concurrently, an NRS score of ≤3.5 was identified as the PASS threshold, indicating a high probability of patient satisfaction. This value defines the treatment target representing an acceptable level of symptom control. Conclusion Our findings establish an MCID of 1.5 and a PASS of ≤3.5 for NRS pain scores following total abdominal hysterectomy, defining clinically meaningful improvement and treatment targets to support more personalized and effective postoperative pain management.

摘要

背景 现代麻醉侧重于患者对所实现的疼痛缓解的感知,而非仅仅关注统计学意义。最小临床重要差异(MCID)和患者可接受症状状态(PASS)是患者报告结局的衡量指标。疼痛评分中的MCID是指视觉模拟量表(VAS)或数字评分量表(NRS)评分的最小降低幅度,该幅度会使疼痛有可感知的改善,尽管这不一定意味着疼痛完全缓解。另一方面,PASS是指患者认为自己处于可接受的健康状态的阈值。这些以患者为中心的结局从患者角度反映了所实现的疼痛缓解的临床意义。此外,这些指标可指导麻醉医生确定术后疼痛管理目标。本研究的目的是确定全腹子宫切除术(TAH)后NRS评分的MCID和PASS。

方法 本研究是一项双盲、随机对照试验(RCT)的二次分析,该试验评估了全腹子宫切除术中腰方肌阻滞(QLB)的效果。主要结局是确定基于分布的NRS评分MCID。MCID的计算方法是将三种基于不同分布的方法得出的值的平均值:(1)合并标准差(SD)的一定比例,(2)对照组测量标准误(SEM)的一定比例,(3)量表范围的10%。次要结局是评估PASS。PASS采用“阈值法”确定,即确定最能准确预测患者对疼痛缓解满意度的疼痛评分阈值。这是通过在受试者工作特征(ROC)曲线分析中确定产生最佳敏感性和特异性的值来实现的。

结果 基于三种分布方法得出的平均值(1.5)计算出的疼痛强度MCID代表有意义改善的阈值。同时,NRS评分≤3.5被确定为PASS阈值,表明患者满意度较高。该值定义了代表可接受症状控制水平的治疗目标。

结论 我们的研究结果确定了全腹子宫切除术后NRS疼痛评分的MCID为1.5,PASS为≤3.5,定义了具有临床意义的改善和治疗目标,以支持更个性化和有效的术后疼痛管理。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aab2/12335722/65493f29b47b/cureus-0017-00000087703-i02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aab2/12335722/babd81967ccb/cureus-0017-00000087703-i01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aab2/12335722/65493f29b47b/cureus-0017-00000087703-i02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aab2/12335722/babd81967ccb/cureus-0017-00000087703-i01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aab2/12335722/65493f29b47b/cureus-0017-00000087703-i02.jpg

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本文引用的文献

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Quadratus lumborum block for total abdominal hysterectomy: a double-blind, randomized, controlled trial.用于全腹子宫切除术的腰方肌阻滞:一项双盲、随机对照试验。
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Ultrasound-Guided Posterior Quadratus Lumborum Block for Acute Postoperative Analgesia in Adult Patients: A Meta-Analysis of Randomized Controlled Trials.
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Pain relief that matters to patients: systematic review of empirical studies assessing the minimum clinically important difference in acute pain.对患者至关重要的疼痛缓解:评估急性疼痛最小临床重要差异的实证研究的系统评价
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Measuring acute postoperative pain using the visual analog scale: the minimal clinically important difference and patient acceptable symptom state.使用视觉模拟评分法测量急性术后疼痛:最小临床重要差异和患者可接受的症状状态。
Br J Anaesth. 2017 Mar 1;118(3):424-429. doi: 10.1093/bja/aew466.