Development and Assessment of Patient Reported Outcome Assessment Scale for Hemorrhoids
Objective:To provide an objective and standardized measurement tool for the evaluation of the clinical efficacy of TCM hemorrhoidal diseases from the patient's point of view by developing a patient reported outcome(PRO)scale under the guidance of traditional Chinese medicine(TCM)theory.Methods:According to the Guidelines for Diagnosis and Treatment of Common Diseases in Traditional Chinese Medicine Anorectal Medicine,the objectives of the PRO study and the guidelines,and with reference to the methodology of social research,the PRO-based hemorrhoid efficacy assessment scale was formed on the basis of the objective examination by doctors,self-assessment of hemorrhoid patients and psychological questionnaire method,combined with the traditional Chinese medicine(TCM)syndrome differentiation and typing.261 hemorrhoid patients were investigated using statistical methods such as Cronbach's α method,exploratory factor analysis,and discriminant analysis to comprehensively assess the performance of the scale.Results:The Cronbach's α coefficient of the total scale was 0.855;the Spearman-Browm split reliability was 0.691,and the Guttman split reliability was 0.677;the correlation coefficients between the domains ranged from 0.261 to 0.536,and the correlation coefficients between the domains and the total scale ranged from 0.643 to 0.758;a total of six common factors were extracted,and the cumulative variance contribution was 60.118%.Conclusion:The scale with good reliability and validity,can establish discriminant analysis function,which can be used for clinical efficacy evaluation of hemorrhoidal diseases,treatment plan screening and standard optimization.