School of Nursing, Army Medical University (Third Military Medical University), No. 30 Gaotanyan Street, Shapingba District, Chongqing, 400038, People's Republic of China.
Department of Nephrology, the Key Laboratory for the Prevention and Treatment of Chronic Kidney Disease of Chongqing, Chongqing Clinical Research Center of Kidney and Urology Diseases, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, People's Republic of China.
Int Urol Nephrol. 2024 Feb;56(2):653-665. doi: 10.1007/s11255-023-03702-1. Epub 2023 Jul 15.
The patient-reported outcomes (PROs) measuring patient's experience and perception of disease are important components of approach to care. However, no tools are available to assess the PROs of chronic kidney disease (CKD). This study aims to develop and verify a PROs scale to evaluate clinical outcomes in CKD patients.
The theoretical structure model and original item pool were formed through a literature review, patient interviews and references to relevant scales. The Delphi method, classical test theory methods and item response theory method were used to select items and adjust dimensions to form the final scale. Altogether 360 CKD patients were recruited through convenience sampling. CKD-PROs could be evaluated from four aspects, namely reliability, content validity, construct validity, responsibility, and feasibility.
The CKD-PROs scale covers 4 domains, including the physiological, psychological, social, and therapeutic domain, and 12 dimensions, 54 items. The Cronbach's α is 0.939, the split reliability coefficient is 0.945, and the correlation of the scores each item and domain's coefficients range from 0.413 to 0.669. The results of structure validity, content validity and reactivity showed that the multidimensional measurement of the scale met professional expectations. The recovery rate and effective rate of the scale were over 99%.
The CKD-PROs scale has great reliability, validity, reactivity, acceptability and is capable of being used as one of the evaluation tools for the clinical outcomes of CKD patients.
患者报告的结局（PROs）衡量患者对疾病的体验和感知，是治疗方法的重要组成部分。然而，目前尚无工具可用于评估慢性肾脏病（CKD）患者的 PROs。本研究旨在开发和验证一种 PROs 量表，以评估 CKD 患者的临床结局。
通过文献回顾、患者访谈和参考相关量表，形成理论结构模型和原始条目库。采用德尔菲法、经典测试理论方法和项目反应理论方法选择条目并调整维度，形成最终量表。通过方便抽样共招募 360 名 CKD 患者。CKD-PROs 可从四个方面进行评估，包括可靠性、内容效度、结构效度、责任和可行性。
CKD-PROs 量表涵盖 4 个领域，包括生理、心理、社会和治疗领域，共 12 个维度，54 个条目。Cronbach's α 为 0.939，分半信度系数为 0.945，各条目和维度得分的相关性系数范围为 0.413 至 0.669。结构效度、内容效度和反应度的结果表明，该量表的多维测量符合专业预期。该量表的恢复率和有效率均超过 99%。
CKD-PROs 量表具有良好的信度、效度、反应度、可接受性，可作为评估 CKD 患者临床结局的评价工具之一。
