Minimal clinically important difference in postoperative recovery among patients with gastrointestinal cancer
Minimal clinically important difference in postoperative recovery among patients with gastrointestinal cancer
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DOI：
10.1007/s00520-021-06632-9
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发表时间：
2021-10-26
影响因子：
3.1
通讯作者：
Kakuda，Wataru
中科院分区：
文献类型：
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作者：
Hara，Tsuyoshi;Kogure，Eisuke;Kakuda，Wataru
基于患者报告的结果的最小临床重要差异（MCID）是足以影响管理的最小结果变化，对设计和解释比较有效性试验至关重要。本研究的目的是估计MCID为术后恢复指标在胃肠道cancer patients.MethodsThis是一个三个机构的队列研究。参与者为219例计划接受胃肠道肿瘤择期手术的患者。在术前1-2天（基线）和术后4周评价体重指数（BMI）、等长膝关节伸展扭矩（IKET）、6分钟步行试验（6 MWT）和简明健康调查量表（SF-36）第2版。患者在住院期间接受物理治疗师的术后康复护理。MCID使用基于锚的方法。该锚是一个评分的SF-36身体功能子量表大于或低于平均得分的一般Japanese population.ResultsThe接收器工作曲线表明一个截止值的6 MWT的-7.8米的临床相关下降（曲线下面积[AUC] = 0.67，95%置信区间[CI] = 0.599-0.741）或1.5%的变化。SF-36角色-体格子量表的临床相关下降（AUC = 0.691，95% CI = 0.621-0.761）或下降36.6%的临界值为-34.4。BMI、IKET和锚的变化之间无显著相关性。这些值可以帮助临床试验的解释和观察胃肠道肿瘤手术后的临床过程。
PurposeThe minimal clinically important difference (MCID) based on patient-reported outcomes is the smallest outcome change sufficiently significant to influence management and is crucial to the design and interpretation of comparative effectiveness trials. The purpose of this study was to estimate the MCID for postoperative recovery metrics in gastrointestinal cancer patients.MethodsThis was a three-institutional cohort study. Participants were 219 patients scheduled for gastrointestinal cancer elective surgery. Body mass index (BMI), isometric knee extension torque (IKET), 6-min walk test (6 MWT), and Short-Form 36-Item Health Survey (SF-36) version 2 were evaluated 1–2 days prior to surgery (baseline) and 4 weeks after surgery. Patients received postoperative rehabilitative care from a physical therapist during hospitalization. The MCID used anchor-based methods. The anchor was a score on the SF-36 physical functioning subscale greater or lower than the average score of the general Japanese population.ResultsThe receiver operating curve indicated a cutoff value on the 6 MWT of −7.8 m for clinically relevant decline (area under curve [AUC] = 0.67, 95% confidence interval [CI] = 0.599–0.741) or a 1.5% change. The cutoff value on the SF-36 role-physical subscale was −34.4 for clinically relevant decline (AUC = 0.691, 95% CI = 0.621–0.761) or a 36.6% decrease. No significant correlation was found between changes in BMI, IKET, and anchor.ConclusionPlausible MCIDs are present in patients with gastrointestinal cancer. These values can assist the interpretation of clinical trials and observation of the postoperative clinical course of gastrointestinal cancer surgery.