INTRODUCTION
In growing and evolved countries, the most common endocrine disorder in women of childbearing age is polycystic ovarian disease, affecting 5-10% of the population (2). The disorder is associated with a variety of clinical features, including reproductive disorders (infertility, hyperandrogenism, hirsutism), metabolic disorders (insulin resistance, glucose intolerance, type 2 diabetes), risk of cardiovascular events, and affects psychological features (1). The exact pathophysiology of PCOD is complex and largely unknown. PCOD may be misdiagnosed or underdiagnosed due to inconsistent diagnostic criteria, ignorance of medical professionals, and variability in her PCOD phenotype (3). Additionally, many women are unaware that they have PCOD and may not receive proper evaluation and treatment, putting them at risk for PCOD. (1)
The prevalence of PCOD has traditionally been estimated at 4-8% in studies in Greece, Spain, Australia, Asia, and the United States (1). The prevalence of PCOD has increased with the use of different diagnostic criteria and was recently demonstrated to be 18% in the first community-based prevalence study based on current Rotterdam diagnostic criteria (1). The main diagnostic steps to confirm PCOD are an ultrasound scan and a series of blood tests based on hormone levels (3). In addition, key clinical feature-based questionnaires and scales to identify PCOD would be useful in epidemiologic studies of female reproductive health (3). This is because such questionnaires can be distributed to large groups of women without the need for expensive hospital visits or diagnostic blood tests. The purpose of this study is to develop a scale or questionnaire to assess PCOD based on the first symptoms to assist women at risk of PCOD and increase public awareness of PCOD.
OBJECTIVE OF THE STUDY
The purpose of this study is to develop a new PCOD scale or questionnaire to assess patients, focusing on the symptoms of PCOD.
METHODOLOGY
Study design: survey study
Sampling method: purposive sample
Sample size: 277
Sample setting: online platform, via google forms.
MATERIALS AND METHOD
This self-designed questionnaire, employing a Likert scale, comprises five demographic questions, four preliminary questions, and 14 main questions related to PCOD symptoms. The 14 questions were formulated in reference to the Rotterdam criteria and existing PCOD-related questionnaires, covering topics such as irregular periods, weight gain, dermatological conditions, psychological symptoms, daily activities, and infertility, among others (1). The questionnaire underwent a review process by experts in the field of obstetrics and gynaecology at Medical College and Hospital in Bengaluru, India on 19th July 2023. Suggestions provided by the experts were incorporated, and the final questionnaire was transformed into a Google Forms format. It was then distributed via WhatsApp and email to 277 women aged between 18-45 years, from 1st august 2023 to 15th September 2023 ensuring the consent from all participants. Out of this group, 174 women were diagnosed with PCOD, while 103 women were not diagnosed with PCOD. The collected data from the questionnaire were shared with a biostatistician on 16th September 2023 for statistical analysis to assess the reliability, content validity, construct validity, sensitivity and specificity of the self-designed questionnaire.
INCLUSION CRITERIA:
Age between 18 to 44 years
Women diagnosed with PCOD, not diagnosed with PCOD
EXCLUSION CRITERIA:
Age above 45
Post menopause
STATISTICAL ANALYSIS
Regarding the questionnaire instrument, Likert scale was employed. The rating required respondents to determine the level of a variable. The baseline data compares individuals with and without Polycystic OverIan disease (PCOD) across key variables. On average, those with PCOD are younger (mean age 24.017 years) compared to those without PCOD (mean age 24.932 years). PCOD individuals tend to be shorter (average height 146.226 cm) with greater variability, while non-PCOD individuals are taller (mean height 153.177 cm) with less variability. In terms of weight, PCOD individuals weigh more on average (mean weight 59.220 kg) with higher variability, whereas non-PCOD individuals weigh less on average (mean weight 54.068 kg) with lower variability. Age at menarche is also lower on average for PCOD individuals (mean age 13.063 years) compared to non-PCOD individuals (mean age 13.796 years).
Table 1: Showing baseline characteristics of the samples included
Table2:- Baseline
Among individuals with PCOD, 18.4% are married while 81.6% are unmarried, with 10.9% homemakers, 66.7% students, and 22.4% working women. Conversely, in the NO PCOD group, 19.4% are married, 80.6% unmarried, with 8.7% homemakers, 82.5% students, and 8.7% working women. Notably, all PCOD cases have consulted a doctor for menstrual irregularities, while 94.2% in the NO PCOD group have not sought medical advice, and only 5.8% have consulted a doctor. Additionally, all individuals with PCOD have undergone ultrasound scans for diagnosis.
RELIABILITY OF THE TOOL
In this study, a Cronbach's Alpha value of 0.878 suggests good internal consistency among the items, indicating that they reliably measure the same construct
CONSTRUCT VALIDITY
Exploratory factor analysis Result: The Kaiser–Meyer–Olkin measure of sampling adequacy is 0.890, well exceeding the minimum requirements for conducting Exploratory Factor Analysis. Factor loading represents the correlation coefficient between a variable and a factor, indicating the likelihood of variance explained as "not likely (1)," "somewhat likely (2)," and "very likely (3)." The data were subsequently analysed using SPSS 22 through Principal Component Analysis (PCA) to derive meaningful interpretations.
Table 3 Construct Validity
Most questions have factor loadings above 0.5, indicating a good correlation with the factor, except for Q8, which shows moderate correlation. The order of questions with high correlation to the factor is: Q14, Q9, Q4, Q10, Q2, Q13, Q11, Q7, Q3, Q12, Q5, Q1, Q6, and Q8.
CONTENT VALIDITY
Item level content validity index (96%) meet satisfactory level, and thus the scale of questionnaire has achieved satisfactory level of content validity.
Table 4: - content validity
Table: - 5 Area under the curve
The Receiver operating characteristics (ROC) analysis evaluated the "Total score" variable's predictive performance for identifying Polycystic Ovarain disease (PCOD), yielding an Area under the curve (AUC) of 0.909, indicating strong discrimination between PCOD presence and absence. With a standard error of 0.018, this AUC value provides a precise estimate of the variable's predictive ability. The highly significant p-value (p = 0.000) supports the "Total score" variable's statistical significance as a predictor of PCOD. The 95% confidence interval for the AUC is 0.874 to 0.944.
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Figure 1: showing sensitivity and specificity
The sensitivity and specificity values, along with the specified cutoff value, provide additional insights into the performance of the diagnostic test for Polycystic Ovarian disease.
The sensitivity and specificity values, along with the specified cut off value, provide additional insight into the performance of the diagnostic test for PCOD.
Specificity: The specificity of 60.2% signifies that the test correctly identifies 60.2% of individuals who do not have PCOD. While this is relatively lower compared to sensitivity, it still suggests that the test has a moderate ability to correctly rule out PCOD in individuals without the condition.
Cutoff Value: The cutoff value of 15.5 is the threshold used to classify individuals into PCOD-positive or PCOD-negative groups based on the Total _score variable. Individuals with a Total _score above this cutoff is considered positive for PCOD, and those below are considered negative.
RESULT
Reliability of the tool: In this study, Cronbach's Alpha value of 0.878 suggests good internal consistency among the items, indicating that they reliably measure the same construct.
Construct validity: The Kaiser–Meyer– Olkin measure of sampling adequacy was 0.890, which is well above the minimum sampling adequacy requirements for conducting exploratory factor analysis.
Content validity: Item level content validity index (96%) meet satisfactory level, and thus the scale of questionnaire has achieved satisfactory level of content validity.
Sensitivity: The sensitivity value of 99.4% demonstrates the test's ability to accurately identify individuals with PCOD, reflecting a high true positive rate and effectiveness in detecting genuine case
Specificity: With a specificity of 60.2%, the test accurately identifies 60.2% of individuals without PCOD. Although lower than sensitivity, it still indicates a moderate ability to rule out PCOD in those without the condition.
Cut off Value: The cut-off value of 15.5 distinguishes individuals into PCOD-positive or PCOD-negative groups based on the Total score variable. Scores above this threshold indicate PCOD positivity, while scores below signify PCOD negativity.
DISCUSSION
Polycystic Ovarian disease (PCOD) is a highly prevalent disorder, representing the single most common endocrine-metabolic disorder in reproductive-aged women. Polycystic ovarian disease is a highly inherited complex polygenic, multifactorial disorder. Women with PCOD are at increased risk for irregular menstrual cycle, hypertension, subfertility and Obstetric complications like endometrial atypia or carcinoma. (4) The prevalence rate of PCOD is high among Indian women. (5) Because there was no Awareness or knowledge about PCOD in early stage and people are hesitant to disclose about PCOD.As ultrasound scan and Rotterdam criteria are the only two reliable tool for screening Of PCOD which is out of reach for most of the women in India, due to reasons like Socioeconomic status. As physiotherapist we assist women with PCOD diagnosed with their Weight loss exercise and physical activity regimen (6), our aim was to develop a simple self-made questionnaire based on the major clinical symptoms of PCOD for feasible early Screening of PCOD.
This self-made questionnaire made using Likert scale pattern of 5 demographic questions, 4 Preliminary questions and 14 main questions related to PCOD symptoms in the following order irregular period, weight gain, mood swings, dermatological condition, infertility and so on this self-made questionnaire was then circulated among the experts in the field of Obstetrics and gynecology from Dr.B.R. Ambedkar medical College and hospital Bengaluru, India for advice and review of the questionnaire. A few changes suggested by the experts Were made and then with their consent, questionnaire was circulated via Google forms to 277 women between the Age group of 18-45 years according to the inclusion and exclusion criteria, after which the samples were segregated to 174 women who were diagnosed with PCOD and103 women who have not been diagnosed with PCOD further intervention the samples data collected was sent to the biostatistician for analysis of the self-designed questionnaire.
LIMITATION
Women are hesitant to disclose their medical conditions related to fertility and menstruation related problems.
RECOMMENDATION
- Further study can be developed on individual domain of the symptoms determining diagnosis of PCOD.
- A comparative study to detect PCOD in early stages using self-made PCOD questionnaire and ultrasound pelvic scan.
CONCLUSION
The study concludes that in the self-made questionnaire designed for early diagnosis of PCOD, women can achieve a maximum total score of 42. If the total score surpasses the cut-off value of 15.5, determined using the receiver operating curve, it is considered highly likely that the individual is positive for PCOD. In such cases, further medical interventions are recommended.
CONFLICT OF INTEREST
Authors declare no conflict of interest
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