TCM Outcomes Assessment Instrument Based On Patient-Reported Outcomes For CKD-4Patient

BackgroundChronic kidney diseases are difficult to cure completely. Currently the main treatment aims to delay its progression. The curative effect of Chinese medicine in the treatment of chronic disease is extraordinary. A large number of medicine clinical reports show that Chinese medicine can protect the kidney and delay the development of chronic kidney diseases.The aim of the use of Chinese medicine treatment is to alleviate the symptoms of the disease. However, there are many problems in the evaluation of the effectiveness of traditional Chinese medicine. There is still no unified index for the evaluation of treatment effectiveness. ObjectivesPatients report outcomes (PRO) is a method which collects the clinical treatment information from the patients and evaluate the efficacy of the treatment. It stresses the subjective feeling of the patient, in a way similar to Chinese medicine therapy. This research study aims to construct a Chinese medicine PRO assessment instrument which is suitable for CKD-4patient, and to look for new evaluation method of curative effect.MethodsWith the advice from the expert group, by employing methods like literature research, patient record review and patient interview, the item pool was established. After analyzing and processing the item pool, the Chinese medicine PRO assessment instrument for CKD-4patient was constructed. Moderately educated CKD patients are then invited to conduct a language test on the PRO assessment instrument. Result(1) The PRO instrument which is suitable for chronic kidney disease patients does not exist presently. TCM clinical symptoms are missing in the KDQOL-1.3scale and the SF-36scale. The KMQOL scale lack items of mental heal th. They fail to fully reflect the symptom changes of patients.(2) We developed the "TCM outcomes assessment instrument based on Patient-Reported Outcomes for CKD-4patient", according to the item pool which was established by reviewing a large number of patient records, interviewing the patients and collecting other instrument items. The domains of the instrument include physiological symptoms, psychological healthiness, social adaptation and the TCM symptoms.(3) Preliminary language test:"TCM outcomes assessment instrument based on Patient-Reported Outcomes for CKD-4patient is modified by multidisciplinary experts and patients by conducting language test. The language with unclear meaning is clarified.ConelusionAccording to the principle and process which is made by U. S. Food and Drug Administration (FDA), we have developed an CKD-4PRO instrument which include four domains:physiology, psychological, social and the TCM symptoms. It is designed to apply in clinical evaluation after the reliability、validity and responsiveness test.