Design And Validation Of A Comprehensive Neurogenic Lower Urinary Tract Dysfunction Scale

Background:Patients with Neurogenic Lower Urinary Tract Dysfunction(NLUTD)often experience other associated conditions,such as bowel dysfunction,sexual dysfunction,and psychological disorders.To date,there was no instrument for comprehensive evaluation of the symptoms in patients with NLUTD.This study aimed to design and evaluate a comprehensive patient-reported outcome measure for patients diagnosed with NLUTD and presented as a radar chart to better visualize the changes of patient’s symptoms.Methods:1.Based on literature reviews as well as opinions from patients and experts,a draft questionnaire was generated.Using the Delphi method,the scale was evaluated though familiarity,judgment basis,authority degree,importance,and accuracy.After refining the scale based on the experts’ feedback from the first round,the scale was again sent to the experts for evaluation,resulting in a new scale.2.Patients in Qilu hospital of Shandong University and the Second Affiliated Hospital of Shandong University of traditional Chinese medicine were recruited to complete the questionnaire.The critical ratio method was used to assess the program quality.Cronbach’s alpha and test-retest reliability were used to test the reliability of the scale.Exploratory factor analysis was used to test the validity of the questionnaire.Content validity was assessed using the content validity index,the content validity ratio,and kappa statistics.The criterion validity of the scale was assessed by correlation with the Short Form of Health Survey(SF-36).At the same time,the correlation between the dimensions of the scale and the total scale was assessed.To be more intuitive,the questionnaire was presented in the form of a radar chart.Results:Based on the first round of expert evaluation results,the values of familiarity(Cs),judgment basis(Ca)and authority degree(Cr)were 0.806,0.922 and 0.864,respectively.The Kendall W of importance and accuracy were 0.265(P<0.001)and 0.095(P=0.097).At the second round of expert evaluation results,the values of familiarity,judgment basis and authority degree were 0.853,0.968 and 0.912,respectively.The Kendall W of importance and accuracy were 0.235 and 0.223(P<0.001).A Comprehensive Neurogenic Lower Urinary Tract Dysfunction Scale which includes 7 dimensions and 27 items was designed.Ninety patients completed the questionnaire twice.The scale had good discrimination(P<0.05 in item analysis).Cronbach’s a of the total scale was 0.762;Cronbach’s a of others ranged from 0.510 to 0.927;Cronbach’s a of the male and female sexual function dimensions were 0.833 and 0.807 respectively;test-retest reliability value of the total scale was 0.972,and of others were 0.831-0.992.Kaiser-Meyer-Olkin was 0.727 and Bartlett’s sphericity test was 2065.330.The factor loadings for every item were 0.472-0.977.Content validity index≥0.89,content validity ratio≥0.78,and kappa statistics≥0.89.The correlation between the SF-36 and the total scale was-0.354(P<0.05);the correlation between the dimensions of the scale and the total scale was 0.306-0.720(P<0.05).The questionnaire results were presented as a radar chart to allow better visualization of the changes in the patients’ symptoms.Conclusion:The CNLUTDS is a novel patient-reported outcome measure that can be used to comprehensively assess changes in patients’ symptoms with strong reliability,validity and convenience.This instrument can facilitate treatment and follow-up of patients with NLUTD.