Translation and Psychometric Analysis of Urdu Version of Modified Polycystic Ovary Syndrome Health Related Quality of Life Questionnaire (MPCOSQ-U)

doi:10.21203/rs.3.rs-3323037/v1

Background: Polycystic ovary syndrome is a metabolic disorder prevalent among females of reproductive age. The symptoms of PCOS profoundly affect the quality of life of these females. Outcome measures specific to PCOS are crucial to the management of these patients. The MCPOSQ is a validated tool to measure the health-related quality of life specific to PCOS. The purpose of this study was to translate the modified polycystic ovary syndrome quality of life questionnaire (MPCOSQ) and to determine the reliability and validity of the modified polycystic ovary syndrome quality of life questionnaire Urdu version (MPCOSQ-U).

Methodology: This cross-sectional study was conducted in Islamabad/Rawalpindi. The MPCOSQ was translated to Urdu and validated by expert gynaecologists. The MPCOSQ-U and SF-36 were administered to one hundred eighty females with PCOS. The MPCOSQ-U was evaluated for internal consistency, test-retest reliability, factor analysis, face validity, content validity and construct validity.

Results: The average age (years) of the females was 25.27(1.83). The MPCOSQ-U showed excellent test-retest reliability and internal consistency (ICC_2,1=0.95, Cronbach’s α=0.97). The content validity index (CVI) was 0.92. There was a statistically significant but weak positive correlation between MPCOSQ-U and SF-36 (r=.186, p=.012).

Conclusion: The Urdu version of the modified version of the polycystic ovarian syndrome quality of life questionnaire is a validated and reliable tool to assess the quality of life of Pakistani females with PCOS. This is an important step to cover the language barrier, which influences the outcome assessment in PCOS.

Females

Gynecology

Polycystic Ovary Syndrome

Psychometrics

Quality of Life

Polycystic ovary syndrome (PCOS) is a chronic, heterogeneous, metabolic disorder affecting females of reproductive age. Women with PCOS manifest infertility, reduced insulin sensitivity, obesity, hirsutism, acne, heart problems and various other health-related issues. Polycystic ovary syndrome can have different phenotype presentations based on clinical symptoms, biochemical tests and ultrasound. It has a strong impact on the overall life of females, as it is associated with numerous other comorbidities. (1, 2)

Although the prevalence varies according to the diagnostic criteria, PCOS is the most commonly reported gynecological disorder among premenopausal females, with a prevalence of 55.41% in Karachi, Pakistan. (3, 4)

PCOS perception and its symptoms are embodied in complex cultural systems of beliefs, values, and ideals. The increase in the number of immigrant women contacting infertility clinics in Europe makes a firm analysis of the impact of cultural, social and religious factors on PCOS and how it affects the lifestyle of women. Studies have shown that poor quality of life is related to PCOS and that the assessment of PCOS-related quality of life should be considered. (5, 6)

The influence of polycystic ovary syndrome on the quality of life of females necessitates the need for an HRQOL tool specific for the condition. Therefore, in 1998, Cronin et al. first developed the polycystic ovary syndrome questionnaire (PCOSQ), which consists of 26 items related to PCOS-specific quality of life. These items were grouped into five subscales, i.e., emotions, body hair, weight, infertility, and menstrual problems. All items are scored on a 7-point Likert scale. There are several health-related questionnaires, but the PCOSQ is most accurate in measuring quality of life and perspectives among females and is said to be more adequate to rule out undiagnosed issues related to health. (7)

The PCOSQ was modified in 2007, as the subscale domains were found to be inadequate. Barnard et al. reintroduced the PCOSQ as the MPCOSQ, which consists of 30 items with 6 subscales. An additional acne subscale was added to the other five subscales. Higher scores indicate better quality of life. The MPCOSQ has been translated and validated into many languages, including German, Austrian, Iranian and Chinese. (3, 8, 9, 10)

Since the prevalence of PCOS is on the rise, outcome measures specific to PCOS are widely used in clinical settings and research in Pakistan. Any tool that is valid in one language is not necessarily valid in another. The Urdu-translated version of the MPCOSQ helps overcome the language barrier of the patients and improve their understanding of the questions. The purpose of this study was to translate the modified polycystic ovary syndrome quality of life questionnaire (MPCOSQ) and to determine the reliability and validity of the modified polycystic ovary syndrome quality of life questionnaire Urdu version (MPCOSQ-U).

Study design and participants

This cross-sectional study was conducted from November 2020 to August 2021 after approval from the Ethical Research Committee of Riphah International University (RIPHAH/RCRS/REC/00843). The translation and cultural adaptation of the modified polycystic ovary syndrome quality of life questionnaire (MPCOSQ) was performed after the consent of the developer (8). A sample of 180 females with PCOS was recruited from the Zohra Institute of Health and Sciences and Islamabad Healing Centre. Females aged 18 to 30 years with a diagnosis of PCOS made according to the Rotterdam Criteria (11) were included in the study. The exclusion criteria were: nonadrenal hyperplasia, thyroid dysfunction, hyperprolactinemia, HRT, malignancies, recent fractures or surgery, neurological conditions, and cognitive impairments.

Outcome Measurement

MPCOSQ

The modified polycystic ovary syndrome quality of life questionnaire (MPCOSQ) is an updated and modified form of the PCOSQ. It consists of thirty items and six subscales to assess the quality of life specific to PCOS. The subscales include emotional disturbances, hirsutism, infertility, weight, menstrual problems and acne. All items are measured on a 7-point Likert scale, where “1” indicates maximum impairment and “7” indicates least impairment. MPCSOQ is a validated and reliable measure for the health-related quality of life of women with PCOS. (3)

SF-36

The SF-36 was used to determine construct validity. The short form for HRQOL, the SF-36, is a commonly used measure designed for use across a wide range of conditions. It consists of eight subscales, including physical functioning, role limitations due to physical issues, body pain, general perception of health, social functioning, role limitation due to emotional health, vitality and mental health. The scale is scored on a scale of 0-100, where higher scores indicate better quality of life. (12)

Translation and cross-cultural adaptation

The Modified Polycystic Ovary Syndrome Questionnaire was translated and culturally adapted in Urdu language according to the guidelines of the World Health Organization (WHO) for tool translation. (13)

Two forward translators, one of whom was a linguistic translator (Urdu scholar) and the second of whom was a bilingual medical expert who had command in both Urdu and English, translated the MPCOSQ into Urdu. The two Urdu versions were then combined into one by the primary investigator and the translator to develop a consensus Urdu version. This Urdu version was then tested for face and content validity by ten experts who were gynaecologists with more than ten years of clinical experience. For face validity, a dichotomous scale of Yes and No was used. Items were also assessed on “relevance”, “clarity”, “simplicity”, and “ambiguity” on a Likert scale. These suggested changes were discussed with the Urdu scholar, and hence, the prefinal version of the MPCOSQ of Urdu was developed.

For backwards translation, a bilingual expert, blinded to the original MPCOSQ, was recruited to translate the final Urdu version of the MPCOSQ back to English. The backwards translation along with the original version of the questionnaire were again reviewed by the same experts to develop the final version. The final Urdu version of the MPCOSQ was then applied to a population of 180 females with PCOS for further psychometric analysis. An informed consent was taken from the respondents prior to data collection.

Data Analysis Procedure

The statistical analysis was performed using SPSS version 21.

Internal consistency

The homogeneity of the tool was measured using Cronbach’s alpha. This value ranges from 0 to 1. A higher value indicates better reliability. A Cronbach’s alpha value of ≥0.7 is an acceptable internal consistency

Test-retest reliability

The intraclass correlation coefficient (ICC) was used for test-retest reliability. For this, two measurements were taken on the MPCOSQ-U, which were two weeks apart. The values of ICC can vary from 0 to 1. These ICC values are categorized as 00-0.2 small, 0.21 to 0.4 fair, 0.41-0.6 moderate, 0.61-0.8 substantial and 0.81 -1 high.

Factor analysis

Principal component analysis (PCA) with varimax rotation and an eigenvalue of 1 was used to determine the subscales of the MPCOSQ-U. A KMO value greater than 0.6 and a p value of >.05 were considered significant for Bartlett’s test.

Face validity and content validity

Face validity was assessed on a dichotomous scale of yes and no, for which experts as well as a sample of 10 PCOS females were requested.

For content validity, the content validity index (CVI) was calculated. The acceptable limit for the CVI was set at 0.8.

Construct validity

Construct validity was measured using Pearson’s correlation between the MPCOSQ-U and SF-36. A p value of 0.05 was considered significant. Portnoy and Watkins criteria were used to interpret the correlation, where r<.25 indicates little correlation, r=.25 to.5 indicates fair correlation, r=.5 to.75 indicates moderate correlation and r=.75 to 1 indicates good correlation. (14)

Translation and Cross-Cultural adaptation

The expert panel suggested changes in the two translated versions of the MPCOSQ-U (T1 and T2), and the final version was developed after the revision based on the suggestions of the expert panel (T3). Revisions were suggested for Items 7, 19, 20 and 27 due to cultural differences. For item 22, the term “unsexy” was replaced with “not confident” due to the cultural nuances.

In the pretesting and cognitive interviewing, the participants reported that the questionnaire was easily understandable and included all the relevant items associated with PCOS. Therefore, no changes were made in the MPCOSQ-U after pretesting.

Face and Content Validity

The responses of ten gynaecologists with at least 10 years of clinical experience were collected for face and content validity. The content validity ratio (CVR) of every item was above 0.8, and the content validity index (CVI) for the prefinal version was 0.92. Face Validity was assessed on a dichotomous scale of “Yes” and “No”. For all the items of the MPCOSQ-U, all experts responded with “Yes”.

Test-retest reliability and internal consistency

Two hundred females with polycystic ovarian syndrome (PCOS) were screened on the eligibility criteria. Thirteen patients did not fulfil the eligibility criteria, and seven patients refused to participate. (Figure I)

The average subscale scores and total scores as well as the reliability analysis are shown in Tables 1 and 2. The Urdu version of the MPCOSQ showed good internal consistency for all items (Cronbach’s alpha=.859). All subscales showed high internal consistency (Cronbach’s alpha=.795 to.850). A fair to good correlation was reported between individual items and total scores of the MPCOSQ-U with Spearman’s correlation coefficients of 0.396 to 0.852, which confirms the internal consistency of the MPCOSQ-U.

Table 1: Internal consistency reliability of the MPCOSQ-U

	Internal Consistency (n=180)
	Cronbach’s α	Mean(SD)
Emotions	.795	32.21(9.66)
Hair	.850	22.86(7.26)
Infertility	.818	11.76(6.30)
Acne	.823	18.90(5.70)
Weight	.817	26.63(10.01)
Menstrual problems	.809	24.52(6.30)
MPCOSQ-U Total Score	.845	136.92(34.35)

Test-retest reliability was assessed by taking a second measurement after two weeks of the first from 30 respondents out of 180. The MPCOSQ-U showed excellent test-retest reliability for the total score (ICC_{2, 1}=0.94) and subscales (ICC_{2, 1}=0.93-0.99) (Table 2).

Table 2: Test-retest reliability of the MPCOSQ-U

MPCOSQ-U	Test retest reliability (n=30)
MPCOSQ-U	1^stMeasurement Mean(SD)	2^nd Measurement Mean(SD)	ICC (95% CI)
Emotions	27.86(10.84)	27.96(10.43)	.993*
Hair	20.40(8.84)	21.03(8.02)	.976*
Infertility	8.76(5.44)	9.40(5.16)	.982*
Acne	18.83(6.97)	19.36(7.71)	.987*
Weight	22.53(10.11)	19.37(7.71)	.983*
Menstrual problems	23.90(7.21)	23.70(6.96)	.991*
Total Score	122.30(39.41)	120.26(35.81)	.939*

* p<.05; SD: standard deviation, CI: confidence interval.

Factor Analysis

The results of a Kaiser–Meyer–Olkin (KMO) measure of sampling adequacy showed a satisfactorily high (0.907) KMO value. Bartlett’s test was significant (p ≤.05), which indicates that all items were correlated. A six-factor structure was demonstrated based on an eigenvalue of >1. The PCA revealed six factors for the MPCOSQ-U. The loading factor for all items was greater than 0.4 (Table 3).

Table 3: Principal component analysis of MPCOSQ-U

Items		Subscales
Items		Emotional Disturbance	Acne	Weight	Infertility	Hirsuitism	Menstrual Problems
Q2	Feel depressed as a result of having PCOS	.846
Q17	Feel worried about having PCOS	.836
Q18	Feel self-conscious as a result of having PCOS	.810
Q6	Feel moody as a result of having PCOS	.755
Q11	Experienced low self-esteem as a result of having PCOS	.699
Q23	Feel a lack of control over the situation with PCOS	.669
Q24	Have difficulties staying at your ideal weight		.858
Q10	Had trouble dealing with your weight		.847
Q12	Feel frustration in trying to lose weight		.819
Q3	Feel concerned about being overweight		.760
Q22	Feel like you are not confident because of being overweight		.760
Q4	Tired easily		.437
Q15	Growth of visible hair on your face			.842
Q26	Growth of visible body hair			.814
Q9	Growth of visible hair on your upper lip			.810
Q1	Growth of visible hair on your chin			.793
Q16	Feelings of embarrassment about excessive body hair			.766
Q8	irregular menstrual bleeding				.740
Q7	Headaches				.732
Q20	late menstrual period				.696
Q19	abdominal bloating				.599
Q21	menstrual cramps				.494
Q25	Feel sad because of infertility problems					.779
Q13	Feel afraid of not being able to have children					.767
Q5	Feel concerned about infertility problems					.754
Q14	Feel afraid of getting cancer					.578
Q29	Feel depressed as a result of acne						.746
Q28	Feel unattractive because of acne						.671
Q27	Acne (last 2 weeks)						.600
Q30	Acne in last menstrual period						.575

Table 4: Total Variance Explained

MPCOSQ-U	% of variance
Emotional disturbance	42.38%
Hirsuitism	10.58%
Infertility	7.11%
Acne	5.84%
Weight	4.73%
Menstrual problems	3.64%
Total	74.28%

The eigenvalue for the first factor was 41.01, which explained 42.38% of the variance. The total variance explained by all six factors was 74.28% (Table 4). The six-factor structure is supported by a scree plot that depicts the straightening of the line after the first six factors. (Figure II)

Construct Validity

Pearson’s correlation showed a statistically significant but weak positive correlation between the total scores of the MPCOSQ-U and SF-36 (n=180, r=.186, p=.012).

This is the first study that has translated the MPCOSQ to the Urdu language. The MPCOSQ-U is a valid and reliable tool to determine the quality of life of females with polycystic ovary syndrome. All items of the MPCOSQ-U were culturally relevant to Pakistani females with PCOS. The current study showed that the MPCOSQ-U is easy to understand and can be used in clinical settings in Pakistan. Although the six factors were identified in the Urdu version of the tool, there was a slight difference in the item loading for the emotional and infertility domains. The item “Feel afraid of getting cancer” loaded on the infertility subscale, which was previously in the domain of emotional disturbances.

The results of the current study are comparable to the previous literature. The Arabic version of the modified polycystic ovary syndrome quality of life questionnaire reported a CVI of 0.9 from ten experts, which shows acceptable content validity. Cronbach’s alpha coefficients demonstrated good internal consistency for all items together (α=0.863). The ICC for each subscale ranged from 0.911 to 0.986 (15). The current study also reported a high internal consistency (CVI=0.91) and test-retest reliability (ICC=0.939).

A Chinese version of the MPCOSQ showed 77% overall variance and had an internal consistency of 0.88 and a good test-retest reliability of 0.89, which overall demonstrates its good discriminant validity. There was an addition of another subscale of “Menstrual predictability” to the Chinese version of the MPCOSQ. However, the MPCOSQ-U had the same factor structure as the original MPCOQ. (16)

The MPCOSQ has also been translated into Dutch. The Dutch version of the tool demonstrated excellent internal consistency (α= 0.95) and a high test-retest reliability for all subscales of the mPCOSQ (ICC: 0.88-0.96). The factor analysis, however, did not confirm the six-factor structure, and another domain was added for “coping”. Overall, it was reported to be a reliable and disease-specific measure for women with PCOS. It was recommended that the item “lack of control over situation with PCOS” be moved to the emotional domain. (17) However, contrary to this finding, the current study showed the same item loading on the emotional subscale.

Bazarganipour et al translated the mPCOSQ to the Iranian language. The psychometric analysis was performed on a sample of 200 Iranian females. The Iranian version of the mPCOSQ showed excellent content validity (CVI: 0.96). The scale also showed a six-factor structure on exploratory factor analysis. The item “late menstrual period” was loaded for the menstrual subscale instead of emotional disturbance. The CFA also supported that the six-factor structure was a fit to the model. The internal consistency and intraclass correlation coefficient (ICC) were also satisfactory. All subscales were significantly correlated. (3)

The SF-36 was used as a comparison tool for construct validity. Although this tool is a widely used measure of quality of life related to health, it may still have limitations in capturing the specific aspects of PCOS that measured by the MPCOSQ-U. Using a more disease-specific comparison tool is recommended as it could provide a more robust assessment of construct validity. A weak correlation between MPCOSQ-U and SF-36 (r = 0.186), which could raise concerns regarding the construct validity of the MPCOSQ-U. Further investigations are needed to explore the psychometric properties of MPCOSQ-U by including a diverse group of experts and patients to make sure that it accurately reflects the experiences of Pakistani women with PCOS.

The Urdu version of the modified version of the polycystic ovarian syndrome quality of life questionnaire is a validated and reliable tool to assess the quality of life of Pakistani females with PCOS. This is an important step to cover the language barrier, which influences the outcome assessment in PCOS.

Ethical approval and consent to participate

This study was approved by the institutional review board ethics committee of Riphah College of Rehabilitation, Riphah International University, and Islamabad (Riphah/RCRS/REC/00843).

Consent for Publication: Not applicable

Availability of data and materials: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Competing interests: The authors declare that they have no competing interests

Funding: None

Authors' contributions

Conception and design: R.Z., S.E., A.F.

Collection and assembly of data: R.Z., A.F.

Analysis and interpretation of data: S.E., R.Z.

Drafting of article: S.E., R.Z., J.S.

Critical revision of article for important intellectual content: S.E., S.O.

Statistical expertise: S.O.

Final approval and guarantor of the article: R.Z., S.E., A.F., S.O., J.S.

All authors read and approved the final manuscript.

Acknowledgements: None

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No competing interests reported.

Translation and Psychometric Analysis of Urdu Version of Modified Polycystic Ovary Syndrome Health Related Quality of Life Questionnaire (MPCOSQ-U)

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Abstract

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BACKGROUND

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DISCUSSION

CONCLUSION

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REFERENCES

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