Development of the First Health-Related Quality of Life Questionnaires in Arabic for Women With Polycystic Ovary Syndrome (Part II): Dual-Center Validation of PCOSQoL-47 and PCOSQoL-42 Questionnaires.

Introduction Validation assesses the acceptability, responsiveness, interpretability, and quality of any questionnaire in any specific population. This is done by correlation matrix evaluation of the proposed test tool with a previously well-validated assessment tool. The study objective is the dual-center assessment of the construct validity of the first health-related quality of life questionnaires for married and unmarried women with polycystic ovary syndrome (PCOS), i.e., PCOSQoL-47 and PCOSQoL-42, respectively. Materials and methods At two centers in Iraq, we enrolled 406 married women and 362 unmarried women with PCOS to test for the construct validity of PCOSQoL-47 and PCOSQoL-42, respectively, from August 2019-August 2020 (after obtaining full results of reliability testing in our previous work). We used the comparable domains from the multiculturally validated questionnaire (World Health Organization Quality of Life [WHOQOL-BREF]) as a comparator to assess the construct validity of the domains of the final highly reliable questionnaire drafts of PCOSQoL-47 and PCOSQoL-42 which were obtained from our previous work. The enrolled women will respond to WHOQOL-BREF and either PCOSQoL-47 or PCOSQoL-42, according to their marital status. Pearson's parametric correlational coefficient compared the total scores of the matched domains in one of our questionnaires and WHOQOL-BREF at p≤0.05. Values more than 0.3 denoted an important correlation between our test questionnaires and the well-validated WHOQOL-BREF questionnaire. The inter-rater reliability between our questionnaires and the comparator was calculated by Cronbach's alpha level, inter-item, and intra-class correlations coefficients matrix. Results We obtained a good respondent-to-item ratio of approximately 9:1 for both questionnaires. We had a good response for the domains of our questionnaires and WHOQOL-BREF. The coping domain at PCOSQoL-42 showed the highest Pearson's coefficient value of (0.708), which indicates a strong and significant correlation between the two constructs at (p<0.001). Other domains of the PCOSQoL-42 showed moderate significant correlation coefficient values. The psychological and emotional status domain of PCOSQoL-47 showed a weak yet significant correlation with its corresponding domain of the WHOHRQOL-BREF. The other domains of the PCOSQoL-47 showed moderate significant correlation coefficient values >0.5. The PCOSQoL-42 and PCOSQoL-47 showed high inter-rater reliability levels in measuring the requested construct or concept when we used Cronbach's alpha and inter-item correlation matrix assessment. Conclusion The individualized PCOSQoL-47 and PCOSQoL-42 for married and unmarried women with PCOS, respectively, represent the first reliable and valid HRQoL assessment tools for assessing the health-related quality of life (HRQoL) in those women with PCOS who use Arabic as a first or native language and address the sexual function as a separate domain.