Quality of life in women with a human papillomavirus-positive screening test, cervical neoplasia, or cervical cancer in Latin America

Technical Summary: Quality of Life in Women with HPV-Positive Screening, Cervical Neoplasia, or Cervical Cancer in Latin America

Problem Statement
Human papillomavirus (HPV) infection is a primary cause of cervical cancer, a significant burden in Latin America and the Caribbean. While the clinical progression from HPV infection to cervical intraepithelial neoplasia (CIN) and invasive cancer is well-documented, there is a scarcity of region-specific data regarding the impact of these conditions on health-related quality of life (HRQOL). Existing literature often focuses on cervical cancer or specific subdomains (e.g., sexual function) and relies on data from high-income countries. However, the perception of health and the resulting utility values are influenced by socioeconomic, cultural, and healthcare system factors, meaning findings from other regions may not be directly applicable to Latin America. Accurate, locally derived HRQOL estimates are essential for conducting valid cost-effectiveness analyses to inform public health policies and intervention strategies for cervical cancer elimination.

Methodology
This cross-sectional study enrolled 1,073 women aged 18 to 75 years from Bolivia, Colombia, Honduras, Peru, and Uruguay. Participants were recruited from clinical sites between January 2022 and had received a recent diagnosis (within six months) of an HPV-positive test, CIN (stages 1–3), or first-time cervical cancer. Exclusion criteria included ongoing treatment for cervical cancer or comorbidities significantly affecting HRQOL.

Data collection involved structured interviews and chart reviews to gather sociodemographic and clinical data, including diagnosis and FIGO cancer stage. The primary instrument for HRQOL assessment was the EQ-5D-5L questionnaire, which evaluates five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. To calculate EQ-5D index scores, country-specific value sets were applied where available (Peru and Uruguay). For Bolivia, Colombia, and Honduras, a value set corresponding to the non-English Hispanic population in the United States was utilized due to the absence of local valuation studies.

Statistical analysis involved calculating medians and interquartile ranges (IQR) for EQ-5D index and Visual Analogue Scale (VAS) scores. Given the left-skewed distribution of EQ-5D index scores, the authors transformed the data to fit a gamma distribution (calculating "disutility" or HRQOL loss) to perform gamma regression. Models were adjusted for country, diagnosis, age, education, and parity. Pairwise comparisons and trend analyses were conducted to assess differences across diagnoses and countries.

Key Results
The study population had a median age of 43 years. The analysis revealed a clear inverse relationship between disease severity and HRQOL:

• EQ-5D Index Scores: Scores decreased as diagnosis severity increased: HPV-positive test alone (0.906), CIN1 (0.891), CIN2 (0.892), CIN3 (0.870), and cervical cancer (0.737).
• HRQOL Loss: After adjusting for covariates, women with cervical cancer experienced a 3.19-fold higher HRQOL loss compared to women with an HPV-positive test alone or CIN1.
• Country Variations: Significant differences in HRQOL loss were observed across countries. Compared to Bolivia, women in Colombia, Honduras, and Uruguay reported higher HRQOL loss. Similarly, Colombia and Honduras showed higher loss compared to Peru.
• Specific Domains: Anxiety/depression was the most frequently affected domain (58.5% of participants), followed by pain/discomfort (42.0%). The proportion of women reporting problems in at least one domain increased from 64.2% in those with HPV-positive tests/CIN1 to 85.1% in those with cervical cancer.
• Perfect Health: Only 29.6% of respondents reported a state of perfect health (11111). Women with cervical cancer were significantly less likely to report perfect health (OR: 0.24) compared to those with HPV-positive tests or CIN1.

Key Contributions
This study provides the first region-specific EQ-5D-5L utility estimates for a spectrum of HPV-related health states in Latin America, ranging from a positive screening test to invasive cancer. By generating these local utility values, the authors address a critical gap in health economic modeling. The data allows for more accurate cost-effectiveness evaluations of HPV preventive interventions (such as vaccination and screening programs) tailored to the specific health preferences and cultural contexts of Latin American populations. The study also highlights that HRQOL is not uniform across the region, suggesting that a "one-size-fits-all" approach to economic modeling may yield misleading results.

Significance and Claims
The authors assert that their findings are vital for facilitating clinical decision-making and conducting robust health economic evaluations. They emphasize that the observed variations in HRQOL across countries and diagnosis severities are clinically significant, exceeding minimal important difference thresholds established in previous literature. The study concludes that obtaining accurate, locally derived HRQOL estimates is essential for cost-effectiveness modeling. The authors caution that while their study provides aggregate differences between countries, it was not powered to provide precise estimates within every specific diagnostic category for every country. Furthermore, they acknowledge that the use of a combined Hispanic value set for countries without local data may introduce some bias, though they argue it is preferable to using unrelated country value sets. Ultimately, the paper positions these utility measures as foundational tools for public health stakeholders to design efficient strategies for cervical cancer prevention and control in Latin America.