NM HOPES PROSPR

Comparative Effectiveness of the Cervical Screening Process:
Past, Present, and Future

Although Pap smear screening has reduced cervical cancer incidence in the United States, cervical cancer continues to be associated with substantial morbidity and mortality, contributes to racial and ethnic disparities, and imposes high economic costs. Advances in cancer epidemiology and medical technology provide a remarkable opportunity to improve upon the effectiveness and efficiency of the cervical cancer screening process. However, critical challenges remain with respect to clinical decision-making and adoption of best practices, pertaining to patient behavior, provider incentives, health systems, and the real-world clinical effectiveness of emerging technologies.

We are employing a decision-analytic approach, adapting an existing modeling framework by leveraging data from clinical provider networks and a state-of-the-art registry of cervical cancer screening information in New Mexico. We will evaluate and weigh the tradeoffs (benefits and harms) of alternative cervical interventions across the continuum of care; explore the uncertainty around their outcomes; incorporate information on patient behavior and real-world practice; and inform timely clinical and policy questions. By achieving our specific aims, we expect to have an impact on:

1. the effectiveness and efficiency of the cervical cancer screening process by investigating the effects of acceptability, delivery, and adoption of best practices;
2. cervical cancer outcomes, including reduced incidence, enhanced quality of life through earlier detection, improved survival, and reduced disparities;
3. the equitable distribution and rationale use of new technology;
4. the financial and economic profile of health care organizations related to cervical cancer control.

While prophylactic vaccination is likely to provide important future health gains, cervical cancer screening will need to be continued for the whole generation of women that is already infected with the HPV types included in vaccines. Potential reductions in cervical cancer screening due to misconceptions about HPV vaccine protection could result in an increase in cervical cancer rather than the anticipated reductions. Many alterations in cervical cancer screening practices per recent clinical guideline recommendations are anticipated both in the near term and over the long-term. Population-based U.S. surveillance is critical to assessing the safety and effectiveness of these changes as well as to address continuing failures in the cervical screening, diagnosis and treatment process. Sustained population-based surveillance enables the assessment of system and practice failures and successes prior to and coincident with a variety of anticipated overlapping changes in cervical cancer prevention programs (e.g. vaccination, lengthened screening intervals and new HPV tests and applications).

Data from our cervical cancer screening surveillance unit, the New Mexico HPV Pap Registry (NMHPVPR) can describe screening, diagnosis and treatment histories of women diagnosed with incident invasive cervical cancer. The NMHPVPR data forms the cornerstone of our PROSPR Screening Process Documentation Unit (SPDU). Through partnerships with the University of New Mexico (UNM) Geospatial and Population Studies (GPS) program and Dr. Dan Goldberg, who is now with Texas A&M Geography Department, we will also identify and evaluate the impact of geographic barriers on failures in screening and prevention practices and invasive cervical cancer outcomes. New Mexico offers a rich opportunity in which this surveillance is conducted among diverse multi-cultural populations suffering a variety of health disparities including those attributable to high levels of poverty and rural living.

Failures to screen, diagnose, and treat women for cervical precancer and cancer are well documented. The current U.S. screening program fails to reach small pockets of populations living mainly in low-resource, medically underserved regions as part of a complex of diseases linked to poverty and/or racial disparities. It is reasonable to suggest that the current cervical cancer prevention program has reached its limits and innovative strategies are needed to overcome these barriers and further reduce the disease burden in underserved populations.

NM-HOPES-PROSPR will fully describe the current cervical screening, diagnostic, and treatment care continuum, and identify areas needing improvement for targeted interventions.

Verna Newman

vnewman@salud.unm.edu

505-280-9469

Nikhil Patel

nipatel@salud.unm.edu

505-277-4673

The New Mexico HPV Outcomes, Practice Effectiveness and Surveillance (NM-HOPES) PROSPR Research Center (NM-HOPES-PROSPR), directed by Dr. Cosette Wheeler forms the cornerstone of an interdisciplinary research program that presents innovations to improve the delivery of cervical cancer screening, diagnosis and treatment. Dr. Wheeler’s expertise spans across the molecular biology and epidemiology of HPV to the implementation of primary and secondary cervical cancer prevention.

Alan Waxman, MD, is the Co-PI of the NM-HOPES-PRC Leadership and Administrative Core and serves as the Head of the Executive Leadership Committee. Dr. Waxman is a Professor of Obstetrics and Gynecology at the UNM School of Medicine. He joined the faculty of UNM in 2000 after completing a 24 year career in the U.S. Public Health Service where he served as the Chief Clinical Consultant for Obstetrics and Gynecology for the Indian Health Service (IHS) from 1994-2000. He has served on national and regional medical advisory boards of the National Breast and Cervical Cancer Early Detection Program and has been nationally recognized as a teacher of colposcopy, regularly lecturing nationally and internationally on cervical cytology screening, HPV and colposcopy. He has been a course director and/or on the faculty of postgraduate courses on colposcopy and cervical cancer screening produced by the American College of Obstetricians and Gynecologists (ACOG) and the ASCCP and he continues to direct the IHS Colposcopy Training Program. He has served on the board of directors of ASCCP intermittently since 1996 and he is currently the society’s treasurer and co-chair of the Assessment and International Education and Humanitarian Outreach committees. He helped establish the Society’s curriculum for colposcopy education and oversees a Colposcopy Mentorship Program for advanced practice nurses and physicians.

Jane Kim, PhD, serves as a member of the NM-HOPES-PROSPR Executive Leadership Committee and is the PI of NM-HOPES-PRC Project 3. She is an Assistant Professor in the Department of Health Policy and Management at the Harvard School of Public Health. Dr. Kim’s research focuses on the development and application of decision-analytic tools to policy questions related to women's health. Dr. Kim has been a leader in the evaluation of the cost-effectiveness of cervical cancer prevention in the U.S. Her methodological expertise includes (1) sophisticated modeling methods (inclusive of Markov, Monte Carlo simulation, dynamic transmission, linear programming modeling); (2) methods of longitudinal data analysis for parameterizing natural history models of cancer progression; (3) empirical calibration methods; and (4) sophisticated approaches to uncertainty analysis. Her disciplinary and applied expertise includes decision science, health policy, public health practice, and comparative effectiveness (inclusive of cost-effectiveness analysis). Her translational experience includes (1) coordinating and leading major collaborations with NCI, ACS, and CDC, involving epidemiologists, clinicians, scientists, and opinion leaders, early in her research to shape key policy debates; (2) working directly with CDC and ACIP to ensure her results on HPV vaccination and screening recommendations in the U.S. would be in a format understandable and useful to decision making (3) leading and executing high-profile analyses for direct requests from U.S. agencies to inform policy recommendations.

Isabel Scarinci, PhD, serves as a member of the NM-HOPES-PROSPR Executive Leadership Committee. She is a Professor of Preventive Medicine at the University of Alabama, Birmingham and a clinical psychologist. Her primary area of interest is cancer prevention and control among low-income, minority and immigrant populations (particularly Latinos and African Americans). She works primarily in the areas of breast and cervical cancer and tobacco control among women. Her expertise is in community-based participatory research (CBPR) and use of mixed methodology (qualitative/quantitative), particularly as it relates to culturally relevant needs/assets assessments. Her goals are directed at the development, implementation, and evaluation of community-based programs that are theoretically based and culturally relevant to these populations, and, consequently, sustainable. The focus of her work is on the application of behavioral science to public health by promoting behavior change at the population level. She has extensive experience in the continuum of cervical cancer prevention, including studies in Mississippi on the acceptability and uptake of self-collection for HPV testing among underserved women who are reluctant to seek curative and preventive care.

Philip Castle, PhD, MPH, serves as a member of the NM-HOPES-PROSPR Executive Leadership Committee. Dr. Castle is an international expert on the clinical and preventive epidemiology of HPV and cervical cancer. He has conducted validations studies and analyses of virtually all commonly used assays for HPV. He has also contributed greatly to the diagnostics of cervical precancer, including studies of the reliability of histopathologic diagnosis, the relationships of cytology to histopathology, and the regressive nature of some precancerous diagnoses, using data from the NCI’s ALTS trial and ongoing collaborations with Kaiser Permanente Northern California. He has extensive knowledge of self-collection and HPV testing for cervical cancer screening, having conducted 2 studies in the Mississippi Delta and 2 studies in China. The latter includes an evaluative study of several low-cost molecular tests, including the AVantage HPV E6 Test, careHPV, and careHPV16/18/45, for screening and triage of screen-positives as well as self-collection and HPV DNA testing for the detection of cervical precancer and cancer in 7,500 women living in rural China. In the U.S., Dr. Castle is serving/has served as member on many national guideline committees for the ACS and ASCCP. For his contributions for cervical cancer prevention, Dr. Castle was awarded the Distinguished Scientific Achievement Award by ASCCP in 2010. Dr. Castle has worked closely with several members of the NM-HOPES-PRC. Dr. Castle has worked with Dr. Wheeler for 10 year and has published more than 30 papers with her. He was founding member of the NMHPVPR and serves as a steering committee member and lead analyst on numerous projects. He has been a long-time collaborator with Dr. Kim, providing data and his knowledge of HPV epidemiology to develop better models for health decision, comparative effectiveness, and cost-effectiveness analyses related to cervical cancer prevention. His expertise and interests span our entire NM-HOPES-PRC from the NMHPV Pap Registry across all Projects.

Jack Cuzick, PhD, serves as a member of the NM-HOPES-PROSPR Executive Leadership Committee. Dr. Cuzick is Professor and Head of Mathematics, Statistics and Epidemiology at the Wolfson Institute of Preventive Medicine, London UK. He has a long-standing role in the UK of analyzing effectiveness of cancer screening. He was responsible for a UK policy statement that lead to introduction of an active call and recall system in the UK. Recently he has been a leader in defining the role of HPV testing in primary cervical screening and he has contributed to understanding the predicted impact of HPV vaccination. His work spans across all three cancers considered by the PROSPR including breast, colorectal and cervical cancer. He has been a standing member of the New Mexico HPV Pap Registry Steering Committee, which represents the cornerstone of the NM-HOPES-PROSPR application and has worked closely with the NM-HOPES-PRC Director, Dr. Wheeler. He will provide input to defining screen-eligible populations who are not attending clinic as without this his view is the US is failing to understand even those who are so-called active clinic populations. He will provide leadership strategies to all three of our Research Projects but in particular he will provide analytic input to Dr. Kim in Project 3 and he will provide input to standardization of data variables and coding for the overall PROSPR consortium. He will assist in the construction of instruments for screening failures as his experience in audits of the UK cervical screening program are extensive.