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Grant Details

Grant Number: 1R01CA169093-01A1 Interpret this number
Primary Investigator: Sawaya, George
Organization: University Of California, San Francisco
Project Title: Using Comparative Effectiveness Analyses to Optimize Cervical Cancer Screening
Fiscal Year: 2013


DESCRIPTION (provided by applicant): With the introduction of tests for oncogenic human papillomavirus (HPV) types and type-specific HPV vaccines, potential strategies for cervical cancer prevention in the US have expanded tremendously over the last decade. With multiple options has come complexity, and determining how best to maximize screening benefits and minimize harms (including resource inputs) has become a great challenge. As an example, preliminary results from randomized trials comparing HPV DNA tests to cytology indicate that HPV testing has a higher sensitivity (detects more cases of cervical neoplasia) than cytology and a lower specificity (at least doubling the number of positive tests). Given that most cervical cancer occurs among never- and inadequately-screened women, the potential preventable burden among screened US women is relatively small (n~5000) compared to the approximately 80 million women at risk per year. While screening benefits can be maximized by apply more sensitive tests at increasingly frequent intervals over a lifetime, harms increase substantially with such strategies, especially among healthy women. Measuring harms is challenging since they can take many forms including false-positive tests that lead to unnecessary interventions with concomitant side effects, life disruptions and other potential decrements in health-related quality of life. To fully capture the magnitude and effect of screening harms, the perspectives and preferences of women are needed. One approach to maximizing benefits and minimizing harms is to personalize screening by individual risk factor assessment. For example, HPV vaccination appears to lower risk of cervical neoplasia; continuing to screen vaccinated women with the same vigilance as unvaccinated women, therefore, may exacerbate screening harms. Further, annual screening of immunocompromised women (e.g., HIV infection) has been recommended for over a decade, though it is unclear if such an approach appropriately balances benefits and harms. Determining how to optimally use new tests (singly or in combination) and whether "personalized" approaches should be considered in subgroups of women (e.g., vaccinated, immunocompromised) will remain difficult, if not impossible, if we are to rely solely on randomized trials. An alternative approach is using decision analytic models and comparative effectiveness analyses to identify novel strategies that provide similar benefits and harms (or an improved benefit/harm balance). Defining a "range of reasonable options" for cervical cancer screening and how these might vary by individual risk factors, would be immediately useful and synthetic to the core goal of comparative effectiveness research as defined by the Institute of Medicine: determining which strategy works best, for whom, and under what circumstances. The current study will address this question for cervical cancer prevention using state-of-the-art methodology.


Effectiveness of 'catch-up' human papillomavirus vaccination to prevent cervical neoplasia in immunosuppressed and non-immunosuppressed women.
Authors: Silverberg M.J. , Leyden W.A. , Lam J.O. , Chao C.R. , Gregorich S.E. , Huchko M.J. , Kulasingam S. , Kuppermann M. , Smith-McCune K.K. , Sawaya G.F. .
Source: Vaccine, 2020-06-15; 38(29), p. 4520-4523.
EPub date: 2020-05-20.
PMID: 32446836
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Estimated Quality of Life and Economic Outcomes Associated With 12 Cervical Cancer Screening Strategies: A Cost-effectiveness Analysis.
Authors: Sawaya G.F. , Sanstead E. , Alarid-Escudero F. , Smith-McCune K. , Gregorich S.E. , Silverberg M.J. , Leyden W. , Huchko M.J. , Kuppermann M. , Kulasingam S. .
Source: JAMA internal medicine, 2019-07-01; 179(7), p. 867-878.
PMID: 31081851
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Cervical Cancer Screening: More Choices in 2019.
Authors: Sawaya G.F. , Smith-McCune K. , Kuppermann M. .
Source: JAMA, 2019-05-28; 321(20), p. 2018-2019.
PMID: 31135834
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Effectiveness of catch-up human papillomavirus vaccination on incident cervical neoplasia in a US health-care setting: a population-based case-control study.
Authors: Silverberg M.J. , Leyden W.A. , Lam J.O. , Gregorich S.E. , Huchko M.J. , Kulasingam S. , Kuppermann M. , Smith-McCune K.K. , Sawaya G.F. .
Source: The Lancet. Child & adolescent health, 2018 Oct; 2(10), p. 707-714.
EPub date: 2018-08-08.
PMID: 30236379
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Cervical Cancer Screening-Moving From the Value of Evidence to the Evidence of Value.
Authors: Sawaya G.F. .
Source: JAMA internal medicine, 2018-10-01; 178(10), p. 1293-1295.
PMID: 30140917
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Recent intrauterine device use and the risk of precancerous cervical lesions and cervical cancer.
Authors: Averbach S. , Silverberg M.J. , Leyden W. , Smith-McCune K. , Raine-Bennett T. , Sawaya G.F. .
Source: Contraception, 2018-04-17; , .
EPub date: 2018-04-17.
PMID: 29673740
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Human Immunodeficiency Virus (HIV)- and Non-HIV-Associated Immunosuppression and Risk of Cervical Neoplasia.
Authors: Silverberg M.J. , Leyden W.A. , Chi A. , Gregorich S. , Huchko M.J. , Kulasingam S. , Kuppermann M. , Seto A. , Smith-McCune K.K. , Sawaya G.F. .
Source: Obstetrics and gynecology, 2018 Jan; 131(1), p. 47-55.
PMID: 29215531
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Effect of professional society recommendations on women's desire for a routine pelvic examination.
Authors: Sawaya G.F. , Smith-McCune K.K. , Gregorich S.E. , Moghadassi M. , Kuppermann M. .
Source: American journal of obstetrics and gynecology, 2017 Sep; 217(3), p. 338.e1-338.e7.
EPub date: 2017-05-18.
PMID: 28528899
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Cervical Cancer Screening.
Authors: Sawaya G.F. , Huchko M.J. .
Source: The Medical clinics of North America, 2017 Jul; 101(4), p. 743-753.
EPub date: 2017-04-21.
PMID: 28577624
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Women's beliefs about the purpose and value of routine pelvic examinations.
Authors: Norrell L.L. , Kuppermann M. , Moghadassi M.N. , Sawaya G.F. .
Source: American journal of obstetrics and gynecology, 2017 Jul; 217(1), p. 86.e1-86.e6.
EPub date: 2016-12-28.
PMID: 28040449
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Cervical cancer screening in women over 65. CON: Reasons for uncertainty.
Authors: Sawaya G.F. .
Source: Gynecologic oncology, 2016 Sep; 142(3), p. 383-4.
PMID: 27545586
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Population-based screening for cancer: hope and hype.
Authors: Shieh Y. , Eklund M. , Sawaya G.F. , Black W.C. , Kramer B.S. , Esserman L.J. .
Source: Nature reviews. Clinical oncology, 2016 Sep; 13(9), p. 550-65.
EPub date: 2016-04-13.
PMID: 27071351
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Cervical Cancer Screening.
Authors: Sawaya G.F. , Smith-McCune K. .
Source: Obstetrics and gynecology, 2016 Mar; 127(3), p. 459-467.
PMID: 26855089
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Obstetrician-gynecologists' beliefs about performing less cervical cancer screening: the pendulum swings.
Authors: Schneider A. , Henderson J.T. , Harper C.C. , Hsu A. , Saraiya M. , Sawaya G.F. .
Source: American journal of obstetrics and gynecology, 2015 Nov; 213(5), p. 744-5.
EPub date: 2015-07-14.
PMID: 26184779
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Re-envisioning the Annual Well-Woman Visit: The Task Forward.
Authors: Sawaya G.F. .
Source: Obstetrics and gynecology, 2015 Oct; 126(4), p. 695-696.
PMID: 26348172
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Identifying a "range of reasonable options" for cervical cancer screening.
Authors: Sawaya G.F. , Kuppermann M. .
Source: Obstetrics and gynecology, 2015 Feb; 125(2), p. 308-310.
PMID: 25569012
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Shared decision-making: easy to evoke, challenging to implement.
Authors: Kuppermann M. , Sawaya G.F. .
Source: JAMA internal medicine, 2015 Feb; 175(2), p. 167-8.
PMID: 25436939
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