Indicators for monitoring screening programs with primary HPV test

Area of Science:

• Public Health
• Gynecologic Oncology
• Screening Programs

Background:

• Italy's cervical cancer screening programs are transitioning to primary Human Papillomavirus (HPV) testing, replacing cytology, aligning with national and international guidelines.
• Ensuring equity, quality of life, and informed consent are crucial for public health interventions like cervical screening.
• The Italian Cervical Screening Group (GISCi) developed a handbook for monitoring indicators under the new HPV primary screening protocol with cytology triage.

Purpose of the Study:

• To establish a comprehensive monitoring system for Italy's evolving cervical cancer screening program.
• To define key performance indicators for assessing screening process efficiency, test accuracy, and early outcomes.
• To adapt monitoring to the new protocol utilizing primary HPV testing with cytology triage.

Main Methods:

• Developed indicators based on European guidelines and Italian recommendations for HPV-based screening.
• Grouped indicators into baseline, one-year repeat, cumulative, and waiting time categories.
• Defined data sources, calculation formulas, standards, and interpretation for each indicator, referencing NTCC trials and Italian pilot studies.

Main Results:

• Key organizational indicators include invitations, compliance rates (first invitation, one-year repeat, colposcopy referral).
• Test and process accuracy indicators use a cohort approach, tracking women for at least one year.
• Proposed accuracy indicators include positive HPV test, positive triage cytology, and positive predictive values for colposcopy referral and detection rates.

Conclusions:

• Monitoring the new primary HPV testing protocol with cytology triage is more complex than previous methods.
• The updated protocol necessitates a higher number of indicators and a cohort approach for data analysis.
• Increased complexity in monitoring may lead to a delay in obtaining performance data.