Department of Public Health, Erasmus Medical Center Rotterdam, Rotterdam, The Netherlands.
The Research Unit, Department of Palliative Medicine, Bispebjerg Hospital, Copenhagen, Denmark; Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
Value Health. 2019 Jan;22(1):92-98. doi: 10.1016/j.jval.2018.07.002. Epub 2018 Aug 20.
There is a need to improve the assessment of emotional functioning (EF). In the international Advance Care Planning: an Innovative Palliative Care Intervention to Improve Quality of Life in Cancer Patients - a Multi-Centre Cluster Randomized Clinical Trial (ACTION) trial involving patients with advanced cancer, EF was assessed by a customized 10-item short form (EF10). The EF10 is based on the European Organisation for Research and Treatment of Cancer (EORTC) EF item bank and has the potential for greater precision than the common EORTC Quality of Life Questionnaire Core 30 four-item scale (EF4). We assessed the relative validity (RV) of EF10 compared with EF4.
Patients from Belgium, Denmark, Italy, the Netherlands, Slovenia, and the United Kingdom completed EF10 and EF4, and provided data on generic quality of life, coping, self-efficacy, and personal characteristics. Based on clinical and sociodemographic variables and questionnaire responses, 53 "known groups" that were expected to differ were formed, for example, females versus males. The EF10 and EF4 were first independently compared within this known group, for example, the EF10 score of females vs the EF10 score of males. When these differences were significant, the RV was calculated for the comparison of the EF10 with the EF4.
A total of 1028 patients (57% lung, 43% colorectal cancer) participated. Forty-five of the 53 known-groups comparisons were significantly different and were used for calculating the RV. In 41 of 45 (91%) comparisons, the RV was more than 1, meaning that EF10 had a higher RV than EF4. The mean RV of EF10 compared with that of EF4 was 1.41, indicating superior statistical power of EF10 to detect differences in EF.
Compared with EF4, EF10 shows superior power, allowing a 20% to 34% smaller sample size without reducing power, when used as a primary outcome measure.
需要改进情感功能（EF）的评估。在国际“预先医疗照护计划：改善癌症患者生活质量的创新姑息治疗干预措施——一项多中心集群随机临床试验（ACTION）”中，涉及晚期癌症患者，EF 通过定制的 10 项简短形式（EF10）进行评估。EF10 基于欧洲癌症研究与治疗组织（EORTC）EF 项目库，与常用的 EORTC 生活质量问卷核心 30 四项量表（EF4）相比，具有更高的精度潜力。我们评估了 EF10 与 EF4 的相对有效性（RV）。
来自比利时、丹麦、意大利、荷兰、斯洛文尼亚和英国的患者完成了 EF10 和 EF4，并提供了关于一般生活质量、应对方式、自我效能和个人特征的数据。根据临床和社会人口统计学变量和问卷回答，形成了 53 个预期会有所不同的“已知组”，例如女性与男性。首先在这个已知组内，独立比较 EF10 和 EF4，例如，女性的 EF10 评分与男性的 EF10 评分。当这些差异具有统计学意义时，计算 EF10 与 EF4 比较的 RV。
共有 1028 名患者（57%为肺癌，43%为结直肠癌）参与。在 53 个已知组比较中，有 45 个比较具有统计学差异，用于计算 RV。在 45 个比较中的 41 个（91%）中，RV 大于 1，这意味着 EF10 的 RV 高于 EF4。EF10 与 EF4 的平均 RV 为 1.41，表明 EF10 在检测 EF 差异方面具有更高的统计能力。
与 EF4 相比，EF10 具有更高的功效，当用作主要结局测量时，允许样本量减少 20%至 34%，而不会降低功效。
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