多种患者报告的术后急性疼痛结局指标的反应性：国际多中心PROMPT NIT-1研究的主要结果
Responsiveness of multiple patient-reported outcome measures for acute postsurgical pain: primary results from the international multi-centre PROMPT NIT-1 study.
作者信息
Vollert Jan, Segelcke Daniel, Weinmann Claudia, Schnabel Kathrin, Fuchtmann Fabian, Rosenberger Daniela C, Komann Marcus, Maessen Timo, Sauer Lena, Kalso Eija, Fletcher Dominique, Lavand'homme Patricia, Kaiser Ulrike, Liedgens Hiltrud, Meissner Winfried, Pogatzki-Zahn Esther M
机构信息
Department of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Muenster, Muenster, Germany; Department of Clinical and Biomedical Sciences, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK.
Department of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Muenster, Muenster, Germany.
出版信息
Br J Anaesth. 2024 Jan;132(1):96-106. doi: 10.1016/j.bja.2023.10.020. Epub 2023 Nov 28.
BACKGROUND
Postsurgical outcome measures are crucial to define the efficacy of perioperative pain management; however, it is unclear which are most appropriate. We conducted a prospective study aiming to assess sensitivity-to-change of patient-reported outcome measures assessing the core outcome set of domains pain intensity (at rest/during activity), physical function, adverse events, and self-efficacy.
METHODS
Patient-reported outcome measures were assessed preoperatively, on day 1 (d1), d3, and d7 after four surgical procedures (total knee replacement, breast surgery, endometriosis-related surgery, and sternotomy). Primary outcomes were sensitivity-to-change of patient-reported outcome measures analysed by correlating their changes (d1-d3) with patients' global impression of change and patients' specific impression of change items as anchor criteria. Secondary outcomes included identification of baseline and patient characteristic variables explaining variance in change for each of the scales and descriptive analysis of various patient-reported outcome measures from different domains and after different surgeries.
RESULTS
Of 3322 patients included (18 hospitals, 10 countries), data from 2661 patients were analysed. All patient-reported outcome measures improved on average over time; the median calculated sensitivity-to-change for all patient-reported outcome measures (overall surgeries) was 0.22 (range: 0.07-0.31, scale: 0-10); all changes were independent of baseline data or patient characteristics and similar between different procedures.
CONCLUSIONS
Pain-related patient-reported outcome measures have low to moderate sensitivity-to-change; those showing higher sensitivity-to-change from the same domain should be considered for inclusion in a core outcome set of patient-reported outcome measures to assess the effectiveness and efficacy of perioperative pain management.
背景
术后结果指标对于确定围手术期疼痛管理的疗效至关重要；然而，目前尚不清楚哪些指标最为合适。我们开展了一项前瞻性研究，旨在评估患者报告结局指标对变化的敏感性，这些指标用于评估疼痛强度（静息/活动时）、身体功能、不良事件和自我效能等核心结局领域。
方法
在四项外科手术（全膝关节置换术、乳房手术、子宫内膜异位症相关手术和胸骨切开术）术前、术后第1天（d1）、d3和d7评估患者报告结局指标。主要结局是通过将患者报告结局指标的变化（d1 - d3）与患者对变化的总体印象以及患者对变化项目的具体印象作为锚定标准进行关联分析，得出患者报告结局指标对变化的敏感性。次要结局包括确定解释各量表变化方差的基线和患者特征变量，以及对来自不同领域和不同手术后的各种患者报告结局指标进行描述性分析。
结果
纳入3322例患者（来自18家医院，10个国家），分析了其中2661例患者的数据。所有患者报告结局指标随时间推移平均有所改善；所有患者报告结局指标（总体手术）计算得出的变化敏感性中位数为0.22（范围：0.07 - 0.31，量表：0 - 10）；所有变化均独立于基线数据或患者特征，且不同手术之间相似。
结论
与疼痛相关的患者报告结局指标对变化的敏感性较低至中等；对于评估围手术期疼痛管理的有效性和疗效，应考虑将来自同一领域且对变化显示出较高敏感性的指标纳入患者报告结局指标的核心结局集中。
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