Feasibility and Validation of a Survey-Based Screening Tool with Quality-of-Life Assessment for Polycystic Ovarian Syndrome in Rural India: A Pilot Study

Background: Polycystic ovarian syndrome (PCOS) affects nearly one in five women in India yet remains substantially underdiagnosed especially in rural settings primarily due to limited access to care, menstrual stigma, and low health literacy. This often results in PCOS getting identified often when women seek care for infertility, rendering PCOS largely invisible within rural health systems. Thus, there is a critical need for culturally appropriate, community-based screening approaches that facilitate earlier identification of PCOS-related symptoms. Methods: This dissertation includes two sequential phases to assess the feasibility and validity of a screening tool for PCOS. First, it employed a sequential mixed methods design in three villages of Punjab, India. A Punjabi-language, symptom-based PCOS screening tool was developed and piloted among 35 women during a community health camp to assess feasibility and symptom distribution. Nine months later, qualitative interviews were conducted with three community health workers (CHWs) and two clinicians to explore acceptability, usability, and implementation considerations. Second, the screening tool was validated using a camp-based cross-sectional diagnostic accuracy pilot study. A convenience sample of 70 PCOS and non-PCOS women were recruited for the study across four villages in Punjab. Participants underwent symptom-based screening followed by blinded endocrinologist evaluation using Rotterdam criteria as the reference standard. Diagnostic performance metrics, agreement statistics, and internal consistency were calculated. Quality-of-life (QoL) was assessed using a validated PCOS-specific instrument. Results: In the feasibility study, 88.6% of women screened positive, with hirsutism (87.1%), weight gain (74.2%), and amenorrhea (51.6%) most commonly reported. Qualitative findings demonstrated strong community acceptance and perceived demand, with recommendations for simplified language and visual aids. In the validation study, the screening tool demonstrated high sensitivity (94.1%) and good specificity (80.6%), with substantial agreement with clinician diagnosis (κ = 0.74). Women diagnosed with PCOS reported significantly poorer QoL across physical, emotional, reproductive, appearance, and self-perception domains (p < .001), with psychological and body image-related symptoms associated with the lowest median scores. Conclusion: Findings support the feasibility and preliminary validity of a culturally adapted, CHW-integrated screening approach in low-resource rural settings. The tool captured a broader symptom burden beyond infertility, challenging clinic-based diagnostic paradigms. Community-based PCOS screening linked to structured clinical referral offers a scalable strategy to improve early identification and reduce diagnostic delays in rural India, addressing both biomedical and psychosocial dimensions of PCOS.