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

Purpose: 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.

Methods: 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.

Results: 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%.

Conclusion: 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.