Development and validation of the patient-reported outcome scale for chronic kidney disease

作者全名："Shi, Yu; Pu, Shi; Peng, Hongmei; Luo, Yu"

作者地址："[Shi, Yu; Pu, Shi; Peng, Hongmei; Luo, Yu] Third Military Med Univ, Army Med Univ, Sch Nursing, 30 Gaotanyan St, Chongqing 400038, Peoples R China; [Shi, Yu; Pu, Shi; Peng, Hongmei] Third Military Med Univ, Army Med Univ, Chongqing Clin Res Ctr Kidney & Urol Dis, Xinqiao Hosp,Dept Nephrol,Key Lab Prevent & Treatm, Chongqing 400037, Peoples R China"

通信作者："Luo, Y (通讯作者)，Third Military Med Univ, Army Med Univ, Sch Nursing, 30 Gaotanyan St, Chongqing 400038, Peoples R China."

来源：INTERNATIONAL UROLOGY AND NEPHROLOGY

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:001030769200001

JCR分区：Q3

影响因子：1.8

年份：2023

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期号：　

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文献类型：Article; Early Access

关键词：Chronic kidney disease; Patient-reported outcomes measures; Scale development; Classical test theory; Item response theory; Reliability; Validity

摘要："PurposeThe 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.MethodsThe 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.ResultsThe CKD-PROs scale covers 4 domains, including the physiological, psychological, social, and therapeutic domain, and 12 dimensions, 54 items. The Cronbach's & alpha; 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%.ConclusionThe 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."

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