基于锚定法和分布法确定乳腺癌患者生活质量量表QLICP-BR（V2.0）的最小临床重要差异
Establishing Minimal Clinically Important Differences for the Quality of Life Instrument in Patients With Breast Cancer QLICP-BR (V2.0) Based on Anchor-Based and Distribution-Based Methods.
作者信息
Li Fei, Liu Yuxi, Wan Chonghua, Zhou Jiali, Tan Jianfeng, Chen Huanwei
机构信息
Research Center for Quality of Life and Applied Psychology, Key Laboratory for Quality of Life and Psychological Assessment and Intervention, School of Humanities and Management, Guangdong Medical University, Dongguan, China.
Central Hospital of Guangdong Nongken, The six wards of Medical Oncology, Zhanjiang, China.
出版信息
Front Oncol. 2022 May 2;12:753729. doi: 10.3389/fonc.2022.753729. eCollection 2022.
OBJECTIVE
To determine the minimal clinically important differences (MCIDs) for the breast cancer scale QLICP-BR (V2.0) among the Quality of Life Instruments system for cancer patients (QLICP), which consist of the general module of 32 items classifying into 4 domains and the specific module of 10 items.
METHODS
According to the scoring rule of QLICP-BR (V2.0), the scores of each domain and the overall scale were calculated. The MCIDs of this scale were established by anchor-based and distribution-based methods. The anchor method used the Q29 item in the EORTC QLQ-C30 scale as anchors and defined the treatment effectiveness of the anchor-based method using criteria A (one level improvement after treatment) and B (at least one level improvement after treatment), while methods of effect size (ES), standard error of measurement (SEM), and reliability change index (RCI) were used in distribution-based methods.
RESULTS
Using the anchor-based method, according to standard A, the MCIDs of the physical domain (PHD), psychological domain (PSD), social domain (SOD), common symptoms and side effect domain (SSD), core/general module (CGD), specific domain (SPD), and the total score (TOT) were 16.24, 11.37, 11.31, 12.07, 11.49, 10.69, and 11.23 respectively; according to standard B, the MCIDs of PHD, PSD, SOD, SSD, CGD, SPD, and TOT were 18.88, 15.14, 14.10, 14.50, 13.93, 12.17, and 14.23 respectively. In the distribution-based MCID study, when ES = 0.8, the MCID values of each domain and the total score of the scale were 9.14, 10.34, 8.34, 10.54, 6.79, 9.73, and 6.96 respectively. The MCIDs calculated when a SEM of 1.96 was used as the intermediary index were 8.38, 11.04, 8.67, 10.00, 7.44, 9.83, and 7.81. The MCIDs calculated when a RCI of 1.96 was used as the intermediary index were 11.84, 15.61, 12.27, 14.14, 10.52, 13.90, and 11.05. Additionally, the MCID value calculated by the two standards of the anchor method was similar to 0.8 ES, 1.96 SEM, and 1.96 RCI.
CONCLUSION
Using the anchor-based method, 0.8ES, 1.96SEM, and 1.96RCI have a better effect on the minimal clinically important difference of breast cancer scale and were recommended to be the preferred methods for establishing MCID.
目的
确定癌症患者生活质量量表体系（QLICP）中乳腺癌量表QLICP - BR（V2.0）的最小临床重要差异（MCID），该量表由32个项目的通用模块（分为4个领域）和10个项目的特定模块组成。
方法
根据QLICP - BR（V2.0）的评分规则，计算每个领域及总量表的得分。该量表的MCID通过基于锚定法和基于分布法确定。锚定法使用欧洲癌症研究与治疗组织生活质量核心问卷（EORTC QLQ - C30）量表中的Q29项作为锚定，并使用标准A（治疗后提高一个等级）和标准B（治疗后至少提高一个等级）来定义基于锚定法的治疗效果，而基于分布法使用效应量（ES）、测量标准误（SEM）和可靠性变化指数（RCI）等方法。
结果
采用基于锚定法，根据标准A，身体领域（PHD）、心理领域（PSD）、社会领域（SOD）、常见症状及副作用领域（SSD）、核心/通用模块（CGD）、特定领域（SPD）及总分（TOT）的MCID分别为16.24、11.37、11.31、12.07、11.49、10.69和11.23；根据标准B，PHD、PSD、SOD、SSD、CGD、SPD及TOT的MCID分别为18.88、15.14、14.10、14.50、13.93、12.17和14.23。在基于分布的MCID研究中，当ES = 0.8时，量表各领域及总分的MCID值分别为9.14、10.34、8.34、10.54、6.79、9.73和6.96。以1.96的SEM作为中介指标计算的MCID分别为(8.38)、(11.04)、(8.67)、(10.00)、(7.44)、(9.83)和(7.81)。以1.96的RCI作为中介指标计算的MCID分别为11.84、15.61、12.27、14.14、10.52、13.90和11.05。此外，基于锚定法的两个标准计算的MCID值与0.8ES、1.96SEM和1.96RCI计算的结果相似。
结论
采用基于锚定法，0.8ES、1.96SEM和1.96RCI对乳腺癌量表最小临床重要差异的效果较好，建议作为确定MCID的首选方法。
Zotero 插件