Department of Health Statistics, School of Public Health, Shanxi Medical University, 56 South XinJian Road, Taiyuan, Shanxi Province 030001, China.
Department of Hematology, Shanxi Cancer Hospital, No. 3 Workers' New Village, Taiyuan, Shanxi Province 030013, China.
Cancer Epidemiol. 2020 Aug;67:101774. doi: 10.1016/j.canep.2020.101774. Epub 2020 Jul 2.
Based the important role of patient-reported outcome in measuring patients' QoL, a general PRO instrument was designed for Chinese patients with cancer.
The instrument was administered in eight hospitals. Based on PRO guidelines, a conceptual framework and item pool were generated after literature review and patients' interviews. Via two-item selection process, the original version of a cancer PRO measure (CA-PROM) was generated. Patients' responsiveness was evaluated in four disease systems by item response theory. The reliability, validity, and feasibility of CA-PROM were assessed. The minimum clinically important differences (MCIDs) and risk thresholds of PRO were calculated.
A total of 2213 valid questionnaires were collected. After expert opinions and cognitive tests, 11 items were deleted. In the pre-survey and formal survey, 19 items were deleted based on six methods of classical test theory. In the respiratory, digestive, hematological, and endocrine systems, four items with poor responsiveness were deleted by item response theory. The final CA-PROM included four domains, 13 subdomains, and 49 items. Reliability coefficients of 13 subdomain was > 0.7. The framework of CA-PROM met required criteria by CFA and OBID. The average response time was 14.2 min, indicating feasibility of CA-PROM. The MCIDs were 5.63, 3.42, 4.16 in the physiological, psychological, social domain, respectively. The risk thresholds of PRO for six subdomains were 71.74, 71.28, 66.29, 65.16, 59.56, 66.60, in that order.
The developed CA-PROM exhibited good reliability, validity, and feasibility, and can be used as an effective evaluation tool in cancer patients.
鉴于患者报告结局在测量患者生活质量方面的重要作用，为中国癌症患者设计了一种通用的患者报告结局工具。
该工具在 8 家医院进行了评估。根据患者报告结局指南，通过文献回顾和患者访谈生成了概念框架和条目池。通过两项条目选择过程，生成了癌症患者报告结局测量量表（CA-PROM）的原始版本。通过项目反应理论评估了四个疾病系统中的患者反应性。评估了 CA-PROM 的信度、效度和可行性。计算了最小临床重要差异（MCID）和患者报告结局的风险阈值。
共收集了 2213 份有效问卷。在专家意见和认知测试后，删除了 11 项条目。在预调查和正式调查中，基于经典测试理论的 6 种方法，删除了 19 项条目。在呼吸、消化、血液和内分泌系统中，通过项目反应理论删除了 4 项反应性较差的条目。最终的 CA-PROM 包括 4 个领域、13 个亚领域和 49 个条目。13 个亚领域的信度系数均>0.7。CA-PROM 的结构通过 CFA 和 OBID 符合要求标准。平均反应时间为 14.2 分钟，表明 CA-PROM 具有可行性。MCID 在生理、心理和社会领域分别为 5.63、3.42、4.16。6 个亚领域的 PRO 风险阈值分别为 71.74、71.28、66.29、65.16、59.56、66.60。
开发的 CA-PROM 具有良好的信度、效度和可行性，可作为癌症患者的有效评估工具。
