Study Design and Participants
A cross-sectional study women using translated and validated questionnaire (AR-PCOSQ) was conducted by interviewing 117 women with PCOS who attended the obstetrics and gynecology clinics at King Khalid University Hospital during the period from November till December 2017. The inclusion criteria: being 18–45 years of age; married; Saudi and not having problems in speaking or listening. Exclusion criteria: having non-classic adrenal hyperplasia, thyroid dysfunction and hyperprolactinemia; previously diagnosed diabetes; took any medication having an effect on insulin levels or hormonal medications, including contraceptive pills, at least two months before participating.
PCOSQ is a self-administered specific HRQL instrument consisting of 26 items grouped into the following five domains; emotions (eight items), body hair (five items), weight concerns (five items), infertility concerns (four items) and menstrual irregularities (four items). Each item is associated with a seven-point Likert scale, where seven represents optimal function and 1 represents the poorest function. The emotions domain contains items concerning feeling depressed, easily tired, worried, moody, low self-esteem, being self-conscious and fear of getting cancer as a result of having PCOS. The body hair domain contains items in concern with visible face hair and excessive amounts of body hair. The weight concerns domain contains items about weight issues such as feelings about being overweight, difficulties maintaining an ideal weight and frustration about trying to lose weight. The infertility concerns domain includes items related to infertility such as fear of not being able to have children, feeling sad or concerned because of infertility. The menstrual irregularities domain includes items regarding menstrual irregularities and physical symptoms associated with menstruation. The mean score of all items in a domain indicates a domain score for each woman. 17
An answer template for the PCOSQ was given to randomly selected participants (30 participants) to take with them for the subsequent telephonic interview for the re-administration of the PCOSQ. The second interview was scheduled at the convenience of the participant no less than five days but no longer than two weeks following the first interview. This interval selected in order to minimize recall bias i.e. patients recalling answers without reading the questionnaire in the second interview.
Permission from the author of the PCOSQ was obtained to translate the questionnaire (copy of the questionnaire and agreement in the attachment). A forward–backward process will apply to translate the English version of the PCOSQ into Arabic. Two bilingual translators (one has a medical background and the other has no medical background) proficiently fluent in English independently translate the complete English version of the PCOSQ, including item content, response options, and instructions, into Arabic. The two forward translations will merge into one version after the expert panel discussions. In backward translation, two translators independently will translate the single forward translation back into English while totally blinded to the original English version of the PCOSQ.
Statistical analysis was carried out using IBM SPSS Statistics. Face and content validity was used to test the validity of the Arabic translated version of PCOSQ. Reliability analysis tests of internal consistency as well as test-retest reliability was performed. Reliability is the ability of a questionnaire to measure outcomes by different individuals or on different occasions in a reproducible manner. Validity is the degree to which the questionnaire measures what it is supposed to measure. It is concerned with the meaning and interpretation of the score.
o Content Validity
An expert panel of 10 specialists in gynecology was asked to comment independently on relevancy in order to calculate the content validity index (CVI) of the items. The relevancy of the items was assessed using a four-point Likert scale: (1) not relevant, (2) somewhat relevant, (3) relevant, (4) very relevant. The value of the CVI is recommended to be 0.80 as the acceptable lower limit for the CVI value.
o Face Validity
It is concerned with how appropriate, relevant and understandable the items on a questionnaire are to the focus or aim of the questionnaire. It is important to be done as it can improve the assistance of respondents completing a questionnaire, identify any ambiguities in the wording of items and identify any inappropriate items. To test face validity, the Ar-PCOSQ was administrated to 30 patients with PCOS to ensure the linguistic and conceptual equivalence of the translation. 18
o Internal Consistency
It relates to a scale homogeneity. The higher the coefficient value, the higher the reliability and the lower the standard error of measurement. The internal consistency was assessed with the Cronbach’s alpha coefficient that ranges from 0 to 1, and values equal to or greater than 0.70 suggest satisfactory internal consistency for a scale. 19
o Test–retest Reliability
Measures stability over time, by applying the same test to the same individuals at two points in time. The test–retest reliability of the scale was estimated by intraclass correlation-coefficient(ICC). The following category was selected to interpret the agreement levels: 00–0.2 as small, 0.21–0.40 as fair, 0.41–0.60 as moderate, 0.61–0.80 as substantial and 0.81–1 as almost perfects.