Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, McGill University Health Centre, Montreal, QC, Canada.
Division of Clinical Epidemiology, McGill University Health Centre, Montreal, QC, Canada.
Surgery. 2014 Aug;156(2):319-27. doi: 10.1016/j.surg.2014.03.005. Epub 2014 Mar 15.
Surgical innovations are introduced to improve "recovery," a complex construct often operationalized by the use of patient-reported outcomes. The minimal clinically important difference (MCID) is the smallest change in an outcome sufficiently important to influence management and is crucial for designing and interpreting comparative effectiveness trials. Our objective was to generate MCID estimates for three postoperative recovery metrics.
Prospectively collected data on two cohorts of 281 and 130 adult patients undergoing abdominal surgery were analyzed. At each of three visits, patients had completed the 36-Item Short Form Survey from the RAND Medical Outcomes Study (SF-36) and either Community Healthy Activities Model Program for Seniors (CHAMPS) or the 6-minute walk test (6MWT). The MCID was estimated with an anchor-based approach with random effects linear regression models. Patients' rating of their own health was used to predict SF-36 domain, CHAMPS, and 6MWT scores. Results are reported as MCID (95% confidence interval).
On the SF-36 domains analyzed, MCIDs were consistently smaller for patients rating their health as "excellent" or "very good" (from 8 [6-9] to 15 [12-18]) compared with those for patients rating their health as "fair" or "poor" (from 15 [12-19] to 32 [28-36]). For CHAMPS, the MCID was 8 kcal/kg/week (7-9), and for the 6MWT, 14 meters (9-18).
Plausible MCIDs and ranges around each estimate are provided. These values should be considered when planning and interpreting abdominal surgery clinical trials where patient-reported outcomes are assessed.
外科创新旨在改善“恢复”，这是一个复杂的结构，通常通过使用患者报告的结果来操作。最小临床重要差异（MCID）是结果中足以影响管理的最小变化，对于设计和解释比较有效性试验至关重要。我们的目标是为三个术后恢复指标生成 MCID 估计值。
分析了 281 名和 130 名成年腹部手术患者的两个队列前瞻性收集的数据。在每三次就诊时，患者都完成了 RAND 医疗成果研究的 36 项简短形式调查（SF-36）和社区健康活动模式计划为老年人（CHAMPS）或 6 分钟步行测试（6MWT）之一。使用基于锚的方法和随机效应线性回归模型估计 MCID。患者对自己健康的评分用于预测 SF-36 域、CHAMPS 和 6MWT 评分。结果以 MCID（95%置信区间）报告。
在分析的 SF-36 域中，对于将自己的健康状况评为“优秀”或“非常好”的患者（从 8 [6-9] 到 15 [12-18]），MCID 始终小于将自己的健康状况评为“一般”或“较差”的患者（从 15 [12-19] 到 32 [28-36]）。对于 CHAMPS，MCID 为 8 kcal/kg/week（7-9），对于 6MWT，MCID 为 14 米（9-18）。
提供了合理的 MCID 和每个估计值的范围。在评估患者报告的结果的腹部手术临床试验中，应考虑这些值来规划和解释。
