Development of the First Health-Related Quality of Life Questionnaires in Arabic for Women with Polycystic Ovary Syndrome (Part I): The Creation and Reliability Analysis of PCOSQoL-47 and PCOSQoL-42 Questionnaires.

Background and objective We lack a reliable and validated health-related quality of life (HRQoL) questionnaire to measure the negative impact of polycystic ovary syndrome (PCOS) on the various aspects of the lives of Arabic women, which addresses sexuality in married women only. Hence, we aimed to develop two separate, simple, reliable, validated, and easily interpretable HRQoL questionnaires in Arabic for married and unmarried women with PCOS for effective QoL evaluation. Materials and methods The development and reliability analysis of the Polycystic Ovary Syndrome Quality of Life (PCOSQoL)-47 and PCOSQoL-42 involved two quantitative and qualitative phases. Phase 1 included retrieval of 158 items from 584 PubMed articles, item reduction, Arabic translation, content and face validity testing, creation of a five-domain draft (53 items for married and 45 items for unmarried women), with no sexuality domain for unmarried women. Phase 2 involved test-retest reliability, which involved using the Spearman's correlation, Wilcoxon nonparametric signed-rank, and internal consistency using Cronbach's-alpha, inter-item, and intraclass correlation (ICC) coefficients, as well as creating a second draft (47 items for married and 42 items for unmarried women). Results The content validity indices testing by 26 healthcare experts decreased the item pool to 57 items for married and 45 items for unmarried women. Face validity by another 30 experts and 30 women from each group resulted in a further reduction to 53 items for married and 45 items for unmarried women, to be tested in a pilot study, which included another 30 women from each group. Test-retest reliability analysis by 195 married and 173 unmarried women revealed significantly excellent redundancy, reliability, and stability of items (highly significant Cronbach's alpha and ICC by internal consistency testing), and reduced the item pool to 47 items for married and 42 items for unmarried women. Conclusions Both questionnaires were found to be highly reliable for the HRQoL evaluation among both married and unmarried Arabic women with different phenotypes of PCOS.

Odhaib SA ，Nasiri Amiri F ，Altemimi MT ，Imran HJ ，Alidrisi HA ，Mohammed MJ ，Mansour AA ... -  《Cureus》

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.

Odhaib SA ，Nasiri Amiri F ，Altemimi MT ，Imran HJ ，Alidrisi HA ，Mohammed MJ ，Mansour AA ... -  《-》

Development of the First Health-Related Quality of Life Questionnaires in Arabic for Women With Polycystic Ovary Syndrome (Part III): Scoring System Interpretation.

Our team developed the first highly reliable, validated, easily comprehensible, and self-administered polycystic ovary syndrome quality of life (PCOSQOL)-42 and PCOSQOL-47 questionnaires for unmarried and married women with polycystic ovary syndrome (PCOS), respectively. Using such scales needs a scoring system that covers the responses to each item per domain and overcomes the missing responses. we developed a scoring system for PCOSQOL-42 and PCOSQOL-47 to interpret the items' responses at any similar population. The scoring was inspired by the 5-point Likert scale that was used during the creation of PCOSQOL-42 and PCOSQOL-47, where each item represents the woman's experience in the last two weeks before seeking consultation, i.e., Never=5 or no effect, on the health-related quality of life (HRQOL), (Seldom=4), (Quite often=3), (Very often=2), and (Always=1 or the maximal effect on the QOL). The sum of the total points in each item per domain was evaluated. Then we divided the results by the number of the items that had been scored only to get the final domain score as a (mean ± SD). The ultimate or final score per the questionnaire was gained from the sum of individual domain scores divided by the number of domains that had been evaluated. Ultimately, the first interval values (from 1 to < 3 points) represent marked effects on HRQOL; second interval values (from 3 to < 4 points) represent the marginal effect on HRQOL; third interval values (from 4 to < 5 points) represent the minimal effect on HRQOL; fourth interval (5 points) represents no effect on HRQOL. The lower the score, the greater the negative impact on HRQOL. Although all domains in both questionnaires showed a marked reduction in HRQOL, women in either cohort were more concerned with their body image dissatisfaction and psychological distress induced by PCOS than their reproductive concerns. The mean score calculated for the questionnaire had a greater negative impact than the emotions subscale and was similar to the subscale for infertility. All mean points per item and domain values indicate a marked effect (< 3 points) on QOL using PCOSQOL-42 and PCOSQOL-47. All values referred to a marked reduction in PCOSQOL-47 points, whether item or domain-wise. The current scoring system provides an easy way to interpret the responses in both questionnaires and overcome the missing responses in any item per domain. There was a marked impact on all domains of HRQOL using both questionnaires, with a special impact on body image and psychological concerns. The responses of women in either cohort to the sexual and reproductive items were extremely high, reflecting the scope of this problem in the life of women with PCOS.

Odhaib SA ，Altemimi MT ，Imran HJ 《-》

Translation of the Modified Polycystic Ovary Syndrome Questionnaire (mPCOSQ) and the Polycystic Ovary Syndrome Quality of Life Tool (PCOSQOL) in Dutch and Flemish Women with PCOS.

Jiskoot G ，Somers S ，De Roo C ，Stoop D ，Laven J ... -  《Journal of Clinical Medicine》

The translation and validation of the Arabic Version of the Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (AR-PCOSQ).

Alghadeer S ，Algarawi A ，Abu-Rkybah F ，Alshebly MM ，Alruthia Y ... -  《BMC Womens Health》