Reliability and validity analysis of quantitative diagnostic criteria for hysterosalpingography in clinical trials
10.3969/j.issn.1008-794X.2025.01.009
- VernacularTitle:面向临床试验的子宫输卵管造影量化诊断标准的信度与效度分析
- Author:
Haoyue CHEN
1
;
Jingwen QIU
;
Jingyuan LU
Author Information
1. 210029 江苏南京 南京医科大学第四临床医学院
- Keywords:
clinical trial;
hysterosalpingography;
diagnostic criteria;
reliability;
validity
- From:
Journal of Interventional Radiology
2025;34(1):58-63
- CountryChina
- Language:Chinese
-
Abstract:
Objective To conduct a reliability and validity analysis of the quantitative diagnostic criteria for hysterosalpingography(HSG)in clinical trials.Methods Questionnaire survey method was used for this study.A test questionnaire scale was constructed based on the imaging data of 10 patients who had received HSG.Fifteen medical workers engaged in HSG-related clinical and scientific research work were invited to score the test questionnaire according to quantitative diagnostic criteria.Internal consistency testing,correlation analysis,and exploratory factor analysis were used to evaluate the reliability and validity of the quantified diagnostic criteria.Results The overall Cronbach's α coefficient for this quantitative diagnostic criteria was 0.834.The Cronbach's α coefficients for the three evaluation functions,including tubal patency,tubal adhesion and pelvic adhesion,were 0.722,0.627 and 0.724 respectively.The Spearman-Brown split-half reliability coefficient was 0.859,and the Guttman split-half coefficient was 0.830.The inter-rater reliability measured by the Kendall W coefficient was 0.806(P＜0.05).The analysis indicated that the evaluation function for pelvic adhesion was suitable for factor analysis(KMO value=0.573,Bartlett Spherical test P=0.003).Two common factors were extracted(characteristic root being set at 1),and the cumulative variance interpretation rate was up to 74.74％.These factors were named as"items with low ambiguity"and"items with potential ambiguity"respectively.Conclusion The overall reliability and validity of this quantitative diagnostic criteria are satisfactory,it can meet the requirements of HSG-related clinical trials and has the potential for clinical promotion.
