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.


Introduction
The phenotypic heterogeneity in women with polycystic ovary syndrome (PCOS) is broad and associated with significant adverse effects on their health-related quality of life (HRQoL) [1]. These effects often manifest as psychological and physical distress, and self-esteem misperception, due to the failure to conform to the idealized norms of women's aesthetic and optimal health standards [2].
The symptoms perception related to PCOS is often influenced and characterized by complex cultural systems 1 2 1 1 1 The next step was to test whether the items were essential to be asked in the context of PCOS, through the estimation of content validity ratio (CVR), which must be >0.37 for a total of 26 experts, as per Lawshe [9]. To achieve that, we attached a 3-point Likert scale wherein 1 represented "not necessary", 2 indicated "useful, but not necessary", and 3 stood for "essential or necessary". We counted only the scores of 3 in the CVR estimation.
The number of agreed-on items among the 26 experts, which achieved the required CVI and CVR, were 45 for unmarried women, and 57 for married women.

Distribution of the items in different domains
The resultant items were distributed according to their presumed relation to each other in the two fivedomains questionnaires with a different number of items per domain for the unmarried and married women with PCOS as PCOSQoL-45 and PCOSQoL-57, respectively ( Tables 1, 2). We tried to have uniform and homogenous domains with regard to the item count, which was achieved for PCOSQoL-57, but not for PCOSQoL-45 because the latter did not contain any queries about sexual life. The items across the domains had the same themes regardless of marital status, except for the items included in the sexual and fertility domain for the married women (

Qualitative and quantitative assessment (April-July 2019)
To ensure that the items of the domain were appropriate, relevant, easily comprehensible, and understandable in terms of the focus and aim of the questionnaires for the women with PCOS, and to see whether these items genuinely reflected the presumed assessment for the HRQoL, we performed an initial qualitative, subjective assessment of the item pool through face validity. The purpose was to identify irrelevant items that could distract participants' attention and may result in omissions or faulty responses. Face validity provided a better chance for the future participants to complete the requested tasks, identified any wording ambiguities in any item, and pointed out any unconnected or missed concepts. Face validity is a qualitative and quantitative step to analyze questionnaire reliability [11,12].
To measure the impact score of the preliminary importance of the items as a measure for HRQoL, we attached a 5-point Likert scale for each item. We selected only those responses where the item was frequently perceived as important. The item impact score equals the frequency multiplied by the importance. We accepted all items with an impact score of ≥1.5.

Implementation of Face Validity Through Two Steps
The face validity was implemented through two steps. The first step involved 30 women with already diagnosed PCOS of different phenotypes from each group. We interviewed these women individually to obtain their opinion about the importance of the selected items. Each interview lasted about 15 minutes, and started with the question "What does PCOS mean to you?" or "Do you have any feeling regarding your diagnosis of PCOS?", or "Did PCOS affect your quality of life by any means?". The interviewer registered all those that looked important in the responses to be compared later with our preliminary list to see if it had any added value or new information. Then we gave each woman the specific numbered form and explained how to answer each item separately by encircling the score, which corresponds to its importance. After the completion, the authors asked for any further opinions about the items, to be written down or verbally registered.
The second step involved 30 healthcare professionals. They consisted of 10 adult endocrinologists, seven gynecologists, six endocrine nurses, three dermatologists, a psychiatrist, an internist, a family physician, and a gynecological radiologist. Twenty experts were approached through social media, and 10 experts responded in person. The same method described above was implemented for healthcare experts.
We ensured the anonymity of the responses during the whole process. Each form was encoded as a number that was known only to the first authors.
In conclusion, we excluded four items from the form meant for the married women who did not achieve the required item impact score of ≥1.5. The four excluded items included two items from the emotional and psychological domain (A11 and A12), one item from the body image domain (C12), and one item from the hair and acne domain (D12). No item was excluded from the form for the unmarried women (   The resultant final draft contained 45 items for unmarried women and 53 items for married women. This  step helped us primarily to re-arrange the items in the domains sequentially according to their total mean  score, presumed importance, and necessity, maintaining the same theme of the content. The new codes for  the questionnaires at this stage were PCOSQoL-45 for unmarried, and PCOSQoL-53 for married women with PCOS.

The second draft (Tables 5, 6)
The questionnaires were rearranged in a clear paper-pack format with five domains for each group of women with PCOS. Each item was attached with a 5-point Likert scale, where 1 denoted that the complaint item was "always" present, and (5) denoted that this complaint item was "never" perceived. The item scores in between correspond to the frequency of the women's complaint item in the last two weeks. The response was requested for each item accordingly. The respondent had the right to omit any item that they found irrelevant or embarrassing. On completion of the questionnaire, the overall score and the score for each domain were marked. The interviewer did the marking with anonymous record registration.
The questionnaires would be assessed through a psychometric validation process and statistical tests of reliability, including test-retest, internal consistency, and construct validity, to assess the questionnaire's acceptability, responsiveness, and interpretability in a specific population [12]. And to achieve that, we performed a real-world study of reliability testing.

Initial recruitment in a cross-sectional preliminary pilot study
The inclusion criteria were simple and included all premenopausal women with the diagnosis of PCOS according to the Rotterdam criteria (2003) [1], within the age range of 16-40 years who attended Faiha Specialized Diabetes Endocrine and Metabolism Center (FDEMC) in Basrah, Southern Iraq, for diagnosis and follow-up, and who were able to comprehend the questionnaire individually or with (independent) assistance. Patients with any comorbidity not related to PCOS and pregnant women were excluded.
One of the research team members approached individual women to explain the questionnaire items to help solve any difficulty in understanding them. Participants were made aware that this questionnaire would not be a part of their ongoing care, and declining to participate would not compromise their care level. The participants were asked to sign an informed consent form that was provided and explained by the interviewer before the enrollment. The participants were also told that they could omit the answer for any question they found bothersome or embarrassing. They could exclude themselves from the study at any point in the future according to their will.
Baseline clinical and demographic data were collected from electronic clinical records, with the assigned case numbers for de-identification and confidentiality. The participants were expected to answer the items directly by encircling the most appropriate answer for what they felt during the last two weeks. The exact timing of the response would be calculated. The proposed time was around 15-30 minutes.
This pilot study, which lasted for five days, helped us identify any logistical difficulties in implementing the questionnaire by both the women and the research team. To achieve this goal, we initially enrolled 30 women with PCOS from each group, who agreed to answer the questionnaire according to the previously mentioned instructions. After the conclusion of the pilot study, no change had been made to the structures of the questionnaires. The next step was to measure questionnaires' reliability on a larger scale.

Phase 2: Statistical analysis of reliability
Reliability measures the questionnaire's reproducibility for different individuals or in various situations by measuring the presumed outcome, which should be the same irrespective of the change in respondents [13].

Test-retest reliability
Test-retest reliability is useful to measure the stability of the HRQoL questionnaires on different occasions [13].
The retest evaluation was scheduled within five to seven days from the initial interview (test). We enrolled women with PCOS who attended FDEMC within the next 60 days. The timing between the test and retest was planned to minimize any recall bias, i.e., patients memorizing their initial responses without reading the questionnaire items on retest occasion.
Participants would not receive any treatment intervention that would alter their HRQoL during these five to seven days. The duration between the first and second visits was determined by the women receiving the results of their investigation by the central endocrine laboratory. We enrolled 195 married women and 173 unmarried women with PCOS, who consented to the test-retest reliability evaluation, to answer the PCOSQoL-53 and PCOSQoL-45, respectively.
The Spearman's correlational analysis rho (ρ) and Wilcoxon nonparametric signed-rank test were used to calculating the statistical differences between the two occasions' ordinal scores. We calculated the two-way mixed intraclass correlations (ICC) coefficients to evaluate for any significant relationship (p: ≤0.05) between the scores at the two times and draw a heat map for the items according to their corresponding score. The coefficient values of >0.7 were considered good, >0.8 were optimal, and >0.9 were determined excellent to measure the ICC [14].

Internal consistency
The statistical method used to measure the association of the items within the scale was Cronbach's alpha reliability coefficient, which ranges between zero and one. Scores of >0.7 meant that the questionnaire items were measuring related constructs. Scores that were very close to 1 indicated higher redundancy of the scale of the item. We recalculated the Cronbach's alpha after removing individual domain items with low scores, to make the scale more reliable. If the alpha coefficient score increased after a question was removed, this would mean that the item had no correlation with other items in the domain. This process measured the item-total consistency and internal reliability of the items (Presentation: Gliem JA, Gliem RR. Calculating, interpreting, and reporting Cronbach's alpha reliability coefficient for Likert-type scales. 2003 Midwest Research to Practice Conference in Adult, Continuing and Community Education. Columbus, OH). We also calculated the inter-item correlations for each domain's items, intending to reach a corrected inter-item correlation mean of more than 0.3. The inter-rater reliability analysis was also calculated.
Upon completing these two steps of the test-retest study, which could also be considered an item reduction step, we excluded six items from the PCOSQoL-53 (A10, B9, E1, E2, E4, and E6) to reduce the items to 47, and the questionnaire was renamed as (PCOSQoL-47). We excluded three items from the PCOSQoL-45 (A7, C8, and C9) to bring the items down to 42, and the questionnaire was renamed a (PCOSQoL-42

Gathering of the data sets
For every respondent, there were scores of either PCOSQoL-47 or PCOSQoL-42 and the WHOQOL-BREF. The questionnaires' data were captured directly on an already prepared IBM SPSS Statistics for Windows, Version 26.0. (IBM Corp., Armonk, NY) format by the interviewer. It was then checked and compared by two other research members for consistency and accuracy of the data.
The statistical analysis was done using the same version of SPSS; we performed the nonparametric correlation, bivariate correlation, and reliability construct validity analysis at a two-tailed significance level of ≤0.05.
All the paper forms were sorted and stored according to the first author's registration numbers, and they were kept ready to be retrieved on request from any respondent. All enrolled women were provided with a copy of their responses to ensure transparency in dealing with their data. All women were told that they would be free to withhold their consent at any time during the study till the time of final publication, and this would not affect in any way the level of medical care provided for them in FDEMC. However, none of the women withheld their consent.

Ethical approval
All the study phases which involved interviewing women with PCOS were in accordance with the ethical standards of the Faiha Specialized Diabetes Endocrine and Metabolism Center Research Committee, from which the ethical approval was obtained, and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

Informed consent
Informed consent was obtained from all individual participants included in the study, during all phases of the study.

Phase 1
After the initial steps of item retrieval, the items-reduction phases were pivotal in determining the construct dimensions, questionnaire's items development and format, and questionnaire length. The first draft of the items for the questionnaires in Arabic was created after an exhaustive analysis of content validity. The first draft for unmarried women contained 45 items and was encoded as PCOSQoL-45, while that of married women contained 57 items and was encoded as PCOSQoL-57 (Tables 1-4). The mean CVI and CVR for the PCOSQoL-45 were 0.94 and 0.92, and those for PCOSQoL-57 were 0.92 and 0.93, respectively.
The face validity analysis for both questionnaires, which was done through 30 women with PCOS from each group along with 30 healthcare experts, created the second drafts for the questionnaires. No change was carried out for the PCOSQoL-45, unlike PCOSQoL-57, from which four items were omitted, to be renamed as PCOSQoL-53 (Tables 5, 6).

The pilot study
The resultant draft was used in the five-day pilot study on 30 women with PCOS from each group and was attached to a five-point Likert scale. The score of 1 denoted that the complaint item was always present, and 5 denoted that this complaint item was never perceived in the last two weeks before the presentation ( Tables  5, 6). The pilot study pointed out some logistical difficulties in implementing the questionnaires for women with PCOS. It gave us an idea about the general characteristics of women, which would be considered in the next steps. The general characteristics of women in the pilot study are summarized in Table 9.

Phase 2: test-retest reliability
After the conclusion of the pilot study, we performed test-retest reliability analysis to assess for the questionnaires' stability over time in measuring the given outcome, where we used the same draft of the questionnaire twice for the same woman, to be responded to in the enrollment visit, and after five to seven days.
We enrolled 173 unmarried and 195 married women to respond to PCOSQoL-45 and PCOSQoL-53, respectively. No woman had been excluded or none had defaulted during the test-retest evaluation. Table  10 presents the general characteristics of enrolled women in the test-retest reliability evaluation. The response rate of women with each item is presented in Table 11.    For both PCOSQol-45 and PCOSQoL-53, using the Wilcoxon nonparametric signed-rank test and Spearman's correlation coefficient rho (ρ), the response to the items in the test and retest was similar with significantly related similar mean scores, with statistical significance (p< 0.001), during domain-wise (Table 12) and item by item-wise comparison ( Table 11). The (ρ) for the item by item and per-domain were positively and strongly related at a two-tailed significance level of <0.001. All domains had significantly high (ρ) (>0.9), which indicated high reliability of the use of domain items across the two occasions in both questionnaires.

Variables
To complete the reliability analysis of the questionnaires, we performed further internal consistency analysis of the data by estimation of the Cronbach's alpha, inter-item correlation analysis, and the two-way mixed ICC (total agreement type), within a 95% confidence interval, and a two-tailed significance level of ≤0.05. Table 13 presents the internal consistency reliability analysis steps for both questionnaires in the test-retest evaluation. The overall alpha score for all domains was highly redundant for all items in both questionnaires, i.e., >0.9, which indicates excellent test-retest reliability, and excellent inter-rater reliability. The inter-item correlations and ICC for the items per domain in both questionnaires were >0.9, and indicated excellent internal reliability of the dimensions, and suggested a highly significant relationship between the questionnaires' domains.
We also calculated the inter-item correlations for each domain's items, intending to reach a corrected interitem correlation mean of >0.3.  We could not produce a heat map for the domains in both questionnaires because all domains showed a highly significant inter-item correlation coefficient of >0.9, i.e., showing an excellent strong correlation with each other with no preference. Internal consistency reliability analysis used Cronbach's alpha to aid item reduction. The item would be deleted if the domain's alpha coefficient scored more after its deletion.

Questionnaire
Cronbach's alpha values before and after deletion for each item per domain are presented in Table 14. This step was considered as an item-reduction step through qualitative and quantitative analyses. All items were significantly related to each other, corresponding item with a two-tailed significance level of <0.001. We did not write it in the

Discussion
The spectrum of complaints of women with PCOS is broad and contributes to PCOS phenotypic heterogeneity [1,12], marked psychological and emotional distress, and self-esteem misperception [2], which in turn negatively impacts their HRQoL due to the failure to conform to the idealized feminine aesthetic norms and optimal health standards [1,2].
The two most important questionnaires for HRQoL estimation in women with PCOS have been the 26item PCOS questionnaire (PCOSQ) by Cronin et al. [15] and the most recent PCOSQ-50 by Nasiri-Amiri et al. [16]. The PCOSQ-50 is a 50-item questionnaire for women with PCOS, regardless of their marital status, with some culturally related modifications to suit the Iranian community [16], which is similar in its marital relations, traditions, and norms to the Iraqi community. These two reliable and validated questionnaires were the inspiration and the foundation for our work in developing the first disease-specific questionnaires for Arabic women with PCOS.
In this study, we tried to develop two HRQoL questionnaires, one for unmarried women and the second for married women with PCOS, in which we kept in mind that unmarried women in our conservative community are not sexually active, and the sexual activity is confined to married women; that is why we did not include sexual activity items in the questionnaire for unmarried women.
We used sophisticated qualitative and quantitative analyses for reliability and to create these two questionnaires for women with PCOS, with particular emphasis on the sexual and fertility issues faced frequently by these women. The qualitative and quantitative approaches started earlier at the item pool formation. The items development process lasted about four months, after which we got the final number of well-validated item pools in terms of content and face validity, by adopting the rules of Lawshe [8] and Ayre and Scally [9], to reach the maximally validated scores. We chose the minimal CVI and CVR as ≥0.65 and ≥0.3, respectively, as they corresponded to the 40-item pool concept, which is the maximal number described by the latter [9]. Although we set these two low cut-points as indicators, the minimal CVI and CVR for a given item in our scales were higher, i.e., >0.7.
The choice of having five domains for each questionnaire was determined by the redundancy of the items as frequently encountered by women with PCOS. The retrieved items in both questionnaires covered most of the PCOS aspects as creating a negative impact on HRQoL. We tried to include as many sexuality-related, acne, and hirsutism items as possible, to overcome some of the limitations of PCOSQ and PCOSQ-50.
The CVI and CVR of both questionnaires were around 0.92, which was similar to the 0.92 of the PCOSQ-50 We did not compare PCOSQoL-42 or PCOSQoL-47 to the 26-items PCOSQ of Cronin et al. because of its limited sensitivity, poor content and face validity, and reflectivity of HRQoL in these women with different phenotypes of PCOS [15,17], pertaining to physical symptoms and missing many QoL issues raised by the qualitative literature, such as acne [17].
The negative effect of PCOS on the psychological domains is evident and well-studied. Women with PCOS experience more incidences of neurotic disorders, aggression, and avoidance behavior [2,16,18]. The broad symptomatic spectrum of women with PCOS may affect their sexual function directly, or indirectly by obesity and body image dissatisfaction, which is frequently perceived by women with PCOS due to the associated clinical hyperandrogenic signs like hirsutism, female pattern hair loss, and acne [2,19]. The psychological and sexual domains are interrelated with causal relationships [19].
According to Nasiri-Amiri et al., the ability to tolerate the scope of the symptoms and signs of PCOS is affected by all the health dimensions (physical, mental, emotional, cognitive, social, and even the role functioning dimensions), and evaluating any coping mechanism is pivotal in estimating the HRQoL in any questionnaire [2,16,18].
There were two items related to the acne's effect on the general appearance that were kept in mind during the whole process of questionnaire evaluation. Acne is an important sign, which was frequently overlooked by the previous questionnaires [15,16]. The consideration of acne as a reliable sign of clinical hyperandrogenism in PCOS is controversial, given the previous observations among many women with different acne severities who had an average androgen level, and the lack of significant direct or causal correlation between hyperandrogenemia and acne. The underlying mechanism for this discrepancy might be attributed to the selective sebum production by the pilosebaceous unit in response to different concentrations of local or peripheral androgen in genetically susceptible women with PCOS [20].
The questionnaires' conceptual models were assessed through a psychometric cascade for reliability and validation to assess the questionnaire's framework acceptability, responsiveness, and interpretability in a specific population [11]. There was no consensus on the scale characteristics to measure a requested healthrelated outcome from the patient perspective, especially scale length, item wordiness, or item length [21]. We tried our best to include positive, negative, and mixed wording formats in various items in our scales. This altering response alternative orientation was useful to restrict acquiescence by participants, without altering the scale [22].
Regarding the scale length, we used the 5-point Likert scale in both questionnaires, which was not short or long in scale length, by which the respondents were able to differentiate the intensity and directionality of their responses, with a neutral response in between. Increasing the scale length may have caused the participants to confuse how to translate their opinion into the scale, especially if they were cognitively apathetic or unprepared, leading to chances of resorting to heuristic responses [23].
The response time in the pilot study, the test-retest reliability analysis, and the final step of construct validity evaluation ranged from 15 to 30 minutes for both questionnaires, which is similar to what was primarily proposed by the research group during the item pool formation. Response time elapsed in answering questions is an important variable in the measuring scales, which may provide understanding related to some cognitive points during responding. It can be considered as an indicator of the recall ability that influences responding, for which any latency may indicate faulty design characteristics of the scale [24].
For test-retest reliability analysis, the timeline between the two occasions (five to seven days) was not so short, which helped to avoid recall or reporting bias among the participants that would have led them to memorize their previous responses in the initial test, and not so long during which the health status of the woman might change, as shown in previous reports [13].
The response rate was calculated for respondents who completed all items in a domain with no omission of any items ( Table 10). The response rate of married women to their measuring scale showed no change between the two occasions as per the domain-wise and overall scale-wise patterns. While the response rate of unmarried women was profoundly low domain-wise and overall scale-wise patterns, we have no explanation for this discrepancy in response, given the same venue, interviewer, and logistics on both occasions. Still, the response rate ranged from acceptable to excellent in the two sets.
Our two questionnaires showed higher internal consistency, stability, and ICC during the test-retest reliability analysis compared to those of the PCOSQ-50 and PCOSQ [15,16]. Our questionnaire contained elements that had been overlooked or neglected by other questionnaires, a special domain for hair disorders and acne. A detailed sexual function and fertility domain may lead to higher reliability in assessing PCOSrelated issues.
Hulin et al. had voiced concerns of a very high Cronbach's alpha coefficient during the reliability analysis, which may result from decreased validity due to acquiescence bias, especially in agreement responses. This type of bias, which was mostly seen in nonmotivated women, could not be neglected [22,25]. This was not the case in our questionnaires because there was a fluctuation in the responses and mean scores per domain, which ultimately explained the different item responses.
Our study's main strength lay in the study design, which included sequential analysis by both qualitative and quantitative statistical methods to reach the final scales for assessing the QoL in both married and unmarried women. During the whole study, we came across all PCOS phenotypes in different women, which provided an element of diversity in the responses for different subscales, and made the scales useful in any woman with PCOS regardless of the phenotype. The sexuality items were not selected for unmarried women, which might explain the high response rate across the study. However, the same items were a limiting factor for the married women's responses.
We used simple Arabic language with minimal use of ambiguous and medical terms to make the items more accessible to women from both groups. We also avoided words that might have various meanings and stuck to the use of original, one-meaning words.
Additionally, the PCOSQoL-42 and PCOSQoL-47 have addressed the concept of being sexually active and inactive properly by avoiding the inclusion of sexual themes in the scale described for unmarried women, which makes these two questionnaires applicable for any community with similar sexual norms. The structure of both scales provided the luxury of choosing between the two according to the sexual activity.
Due to its simple language format, these questionnaires can be translated to any language with ease and can be especially useful for communities similar to ours. Still, the measurement properties alone are not indicative of suitability among different populations [11].

Introduction
We represent the study group of FDEMC. We are trying to validate a new questionnaire dealing with the health-related quality of life in sexually active women with polycystic ovary syndrome (PCOS). PCOS is the commonest female endocrinopathy. We want you to participate in this study to help us validate our new questionnaire that uses the Arabic language for the first time, which will be useful for all Arabic-speaking women. You are free to participate or not, and you have all the right to agree or not. You are not obliged to give us consent today, you have all the week-long to study the consent and give us the response in your next visit a week from now, during this period you are free to contact any one of the study group to ask about any aspect you found it peculiar and need discussion. Whatever your decision will be, it will not affect our level of medical services provided to you. Keep in mind that you can withdraw your consent at any time before the complete publication of the study, and you are not obliged to give us any reasons. Again this will not affect our medical decision regarding your management by any means. You may have no questions now, but during the study, you may have questions, feel free to inform us to answer them. Is this understandable to you?

Purpose of the research
PCOS is a common endocrinopathy affecting many women in their reproductive life and affecting their quality of life negatively at different levels. It affects the marital life, conception, childbearing, and body image, and may associate important diseases like hypertension, diabetes mellitus, and metabolic syndrome, in addition to its association with many psychological illnesses. We need to create and validate a questionnaire that may include most of your concerns about PCOS, that many women may consider important. We will try to measure the questionnaire reliability in our community in Basrah as an Arabicspeaking city. Is this understandable to you?

Type of Research Intervention
We will give you a questionnaire in Arabic language containing items concerned with your health-related quality of life and the effect of PCOS on different aspects of your life. The question will try to cover all aspects of your health related-quality of life. These questions were created and carefully selected and located in different domains with the simplest language terms to be self-explainable. You will have around 45 different questions in Arabic, you may read them carefully and answer them by selecting the appropriate scale of its effect on your life. These questions are about your feelings and sensations in the last two weeks. You will have all questions supplied with the same scale of the answer which is called (Likert scale), of five points. Point 1 represents the severe effect on your HRQoL, while point five represents the mildest effect on your HRQoL during that period. Please feel free to ask any of the workgroups about any question you may find ambiguous or difficult to understand. You are not obliged to answer any question you are not comfortable with it, and you are not obliged to give any justification to do that by anyone. And always remember that any answer will not affect our level of services that were planned for you by any means.
This questionnaire may take 12-25 minutes to be answered, you can take your time in a quiet place provided by the study group, where you calmly replied to the questions. You are free to seek help from a partner, or a family, or any of the workgroup, or you answer without help from anyone.
You (may) find another questionnaire attached to the first questionnaire, this will deal with the general aspect of the quality of life that was previously validated by the World Health Organization (WHO). It contains 26 questions in Arabic. Feel free to answer them or not, and you can ask about any question of them. This questionnaire may take 6-10 minutes.
We will use the second questionnaire to validate the first questionnaire through multiple statistical methods, to reach the final form of the questionnaire that represents the main complaints of women with PCOS, and their quality of life.
You are not restricted by any time, but the provider will register the exact timing that the questionnaires were provided to you, to calculate the time elapsed to answer the questions. You are free to leave any question or domain at any time during the questionnaire reading, and you will not be asked for any justification, and will never affect our judgment for your PCOS management. All the data and information provided by you in the questionnaire are confidential, and no one will know about it except the study group, and absolutely no sharing of data by any means will occur, now or later. Do you have any questions?
All the participants will be dealt with as (registration numbers), not by names during the study progress. To keep the data as secrete as possible. All information will be registered as numbers on our datasheet directly with no names, only the registration number at the FDEMC database. The whole study is screening for any effect of the PCOS on your HRQoL and not involve any invasive or noninvasive investigations by any means. Is this understandable to you?

Participant Selection
You are being invited to take part in this research because we feel that your experience with PCOS can contribute much to our understanding and knowledge of local health practices, and may help us to decrease the effect of this syndrome on the quality of life of women. Is this understandable to you?

Voluntary Participation
Your participation in this research is entirely voluntary. It is your choice whether to participate or not. If you choose not to participate, all the services you receive at FDEMC will continue and nothing will change.
If you decide not to take part in this research study, do you know what your options are? Do you know that you do not have to take part in this research study if you do not wish to? Do you have any questions?
You need to know: · We need to participate to help us to enlighten the effect of PCOS on the HRQoL of sexually inactive women (Unmarried), in Basrah first and then to use it in any Arabic-speaking city. You will not be asked about any sexuality issues.

·
You will not be subjected to any discussion group or focus group or any group therapy by any mean, and you will not share your information or data with anyone whether similar to your complaint or not, all the participants are blind to each other, but not to the study group.

·
We will never ask you about any person's beliefs, practices, or stories, that you are not comfortable with sharing.

·
All interviews will take place at FDEMC clinics, by the workgroups exclusively, not anyone else. All the interviews are verbal and not recorded by any means. Only data registration will take place on our datasheet by the first author (Samih Abed Odhaib) exclusively, without name identification, but only registration numbers at FDEMC. And he will be the only person that can access your data.

·
All the questionnaire papers will be kept by the first author with no names on them, only the registration number. All paper-packs will be destroyed by the first author on study completion after publication, with no hard copies to be kept.

Duration
The proposed time of the study is about 20 months, the study will end in August 2020. The data will be available for analysis after that date, and you will be free to participate in the study at any time, given you will fulfill the enrollment criteria at that time. On the other hand, if you accept to participate in the study you can withdraw your participation at any time before the publication of the whole study, i.e. August 2020 will be the deadline for the enrollment not for publication. Do you have any more questions?

Risks
We are asking you to share with us some very personal and confidential information, and you may feel uncomfortable talking about some of the topics. We already Omitted the sexuality items from your copy of the questionnaire. You do not have to answer any question or take part in the discussion/interview/questionnaire if you don't wish to do so, and that is also fine. You do not have to give us any reason for not responding to any question, or for refusing to take part in the interview or questionnaire.

Benefits
There will be no direct benefit to you, but your participation is likely to help us find out more about how to deal with PCOS's effect on the HRQoL in our community.

Reimbursements
You will not be provided any incentive to take part in the research. There will be no monetary reward to you by any kind.
Can you tell me if you have understood correctly the benefits that you will have if you take part in the study? Do you know if the study will pay for your travel costs and time lost, and do you know how much you will be reimbursed? Do you have any other questions?

Confidentiality
The research being done in the community may draw attention and if you participate, you may be asked questions by other people in the community. We will not be sharing information about you with anyone outside of the research team. The information that we collect from this research project will be kept private. Any information about you will have a number on it instead of your name. Only the researchers will know what your number is and we will lock that information up with a lock and key. It will not be shared with or given to anyone except the first author.

Sharing the Results
Nothing that you tell us today will be shared with anybody outside the research team, and nothing will be attributed to you by name. The knowledge that we get from this research will be shared with you before it is published. Each participant will receive a summary of the results in private.

Right to Refuse or Withdraw
You do not have to take part in this research if you do not wish to do so, and choosing to participate will not affect the medical services and your evaluations in any way. You may stop participating in them at any time that you wish without any effect on the level of medical care being affected.

Whom to Contact
If you have any questions, you can ask them now or later. If you wish to ask questions later, you may contact any of the following: I have accurately read out the information sheet to the potential participant, and to the best of my ability made sure that the participant understands that the following will be done: 1. She understands the goal of the study and the different aspects of it.
2.She had all time to ask questions and was free to participate in the study or not.
3.She was aware that all her data are confidential.
I confirm that the participant was given an opportunity to ask questions about the study, and all the questions asked by the participant have been answered correctly and to the best of my ability. I confirm that the individual has not been coerced into giving consent, and the consent has been given freely and voluntarily.
A copy of this informed consent form has been provided to the participant.
Print Name of Researcher/person taking the consent: Signature of Researcher/person taking the consent: Date: Day/month/year B: Informed consent form for married women with polycystic ovary syndrome in Basrah

Introduction
We represent the study group of FDEMC. We are trying to validate a new questionnaire dealing with the health-related quality of life in sexually active women with polycystic ovary syndrome (PCOS). PCOS is the commonest female endocrinopathy. We want you to participate in this study to help us validate our new questionnaire that uses the Arabic language for the first time, which will be useful for all Arabic-speaking women. You are free to participate or not, and you have all the right to agree or not. You are not obliged to give us consent today, you have all the week-long to study the consent and give us the response in your next visit a week from now, during this period you are free to contact any one of the study group to ask about any aspect you found it peculiar and need discussion. Whatever your decision will be, it will not affect our level of medical services provided to you. Keep in mind that you can withdraw your consent at any time before the complete publication of the study, and you are not obliged to give us any reasons. Again this will not affect our medical decision regarding your management by any means. You may have no questions now, but during the study, you may have questions, feel free to inform us to answer them. Is this understandable to you?
Purpose of the research PCOS is a common endocrinopathy affecting many women in their reproductive life and affecting their quality of life negatively at different levels. It affects the marital life, conception, childbearing, and body image, and may associate important diseases like hypertension, diabetes mellitus, and metabolic syndrome, in addition to its association with many psychological illnesses. We need to create and validate a questionnaire that may include most of your concerns about PCOS, that many women may consider important. We will try to measure the questionnaire reliability in our community in Basrah as an Arabicspeaking city. Is this understandable to you?

Type of Research Intervention
We will give you a questionnaire in Arabic language containing items concerned with your health-related quality of life and the effect of PCOS on different aspects of your life. The question will try to cover all aspects of your health related-quality of life. These questions were created and carefully selected and located in different domains with the simplest language terms to be self-explainable. You will have around 45 different questions in Arabic, you may read them carefully and answer them by selecting the appropriate scale of its effect on your life. These questions are about your feelings and sensations in the last two weeks. You will have all questions supplied with the same scale of the answer which is called (Likert scale), of five points. Point 1 represents the severe effect on your HRQoL, while point five represents the mildest effect on your HRQoL during that period. Please feel free to ask any of the workgroups about any question you may find ambiguous or difficult to understand. You are not obliged to answer any question you are not comfortable with it, and you are not obliged to give any justification to do that by anyone. And always remember that any answer will not affect our level of services that were planned for you by any means.
This questionnaire may take 12-25 minutes to be answered, you can take your time in a quiet place provided by the study group, where you calmly replied to the questions. You are free to seek help from a partner, or a family, or any of the workgroup, or you answer without help from anyone.
You (may) find another questionnaire attached to the first questionnaire, this will deal with the general aspect of the quality of life that was previously validated by the World Health Organization (WHO). It contains 26 questions in Arabic. Feel free to answer them or not, and you can ask about any question of them. This questionnaire may take 6-10 minutes.
We will use the second questionnaire to validate the first questionnaire through multiple statistical methods, to reach the final form of the questionnaire that represents the main complaints of women with PCOS, and their quality of life.
You are not restricted by any time, but the provider will register the exact timing that the questionnaires were provided to you, to calculate the time elapsed to answer the questions. You are free to leave any question or domain at any time during the questionnaire reading, and you will not be asked for any justification, and will never affect our judgment for your PCOS management. All the data and information provided by you in the questionnaire are confidential, and no one will know about it except the study group, and absolutely no sharing of data by any means will occur, now or later. Do you have any questions?
All the participants will be dealt with as (registration numbers), not by names during the study progress. To keep the data as secrete as possible. All information will be registered as numbers on our datasheet directly with no names, only the registration number at the FDEMC database. The whole study is screening for any effect of the PCOS on your HRQoL and not involve any invasive or noninvasive investigations by any means. Is this understandable to you?

Participant Selection
You are being invited to take part in this research because we feel that your experience with PCOS can contribute much to our understanding and knowledge of local health practices, and may help us to decrease the effect of this syndrome on the quality of life of women. Is this understandable to you?

Voluntary Participation
Your participation in this research is entirely voluntary. It is your choice whether to participate or not. If you choose not to participate, all the services you receive at FDEMC will continue and nothing will change.
If you decide not to take part in this research study, do you know what your options are? Do you know that you do not have to take part in this research study if you do not wish to? Do you have any questions?
You need to know: · We need to participate to help us to enlighten the effect of PCOS on the HRQoL of sexually active women (Married), in Basrah first and then to use it in any Arabic-speaking city.

·
You will not be subjected to any discussion group or focus group or any group therapy by any mean, and you will not share your information or data with anyone whether similar to your complaint or not, all the participants are blind to each other, but not to the study group.

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We will never ask you about any person's beliefs, practices, or stories, that you are not comfortable with sharing.

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All interviews will take place at FDEMC clinics, by the workgroups exclusively, not anyone else. All the interviews are verbal and not recorded by any means. Only data registration will take place on our datasheet by the first author (Samih Abed Odhaib) exclusively, without name identification, but only registration numbers at FDEMC. And he will be the only person that can access your data.

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All the questionnaire papers will be kept by the first author with no names on them, only the registration number. All papers will be destroyed by the first author on study completion after the proposed date of August, with no copies to be kept.

Duration
The proposed time of the study is about 20 months, the study will end in August 2020. The data will be available for analysis during that period, and you will be free to participate in the study at any time, given you will fulfill the enrollment criteria at that time. On the other hand, if you accept to participate in the study you can withdraw your participation at any time before the publication of the whole study, i.e. August 2020 will be the deadline for the enrollment not for publication. Do you have any more questions?

Risks
We are asking you to share with us some very personal and confidential information, and you may feel uncomfortable talking about some of the topics. You do not have to answer any question or take part in the discussion/interview/questionnaire if you don't wish to do so, and that is also fine. You do not have to give us any reason for not responding to any question, or for refusing to take part in the interview or questionnaire.

Benefits
There will be no direct benefit to you, but your participation is likely to help us find out more about how to deal with PCOS's effect on the HRQoL in our community.

Reimbursements
You will not be provided any incentive to take part in the research. There will be no monetary reward to you by any kind.
Can you tell me if you have understood correctly the benefits that you will have if you take part in the study? Do you know if the study will pay for your travel costs and time lost, and do you know how much you will be reimbursed? Do you have any other questions?

Confidentiality
The research being done in the community may draw attention and if you participate you may be asked