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Biomedical subjects

George F Sawaya

Publications and source records attributed to George F Sawaya.

15 recordsLinked to original sources

Cost-effectiveness of extending cervical cancer screening intervals among women with prior normal pap tests.

OBJECTIVE: Annual cervical cancer screening in women with many prior normal Pap tests is common despite limited evidence on the cost-effectiveness of this strategy. We estimated the cost-effectiveness of screening women with 3 or more prior normal tests compared with screening those with no prior tests. METHODS: We used a validated cost-effectiveness model in conjunction with data on the prevalence of biopsy-proven cervical neoplasia in women enrolled in the Centers for Disease Control and Prevention National Breast and Cervical Cancer Early Detection Program. Women were grouped according to age at the final Program Pap test (aged < 30, 30-44, 45-59, and 60-65 years) and by screening history (0, 1, 2, and 3+ consecutive prior normal Program tests) to estimate cost per life-year and quality-adjusted life-year associated with annual, biennial, and triennial screening. RESULTS: For women aged 30-44 years with no prior tests, incremental cost-effectiveness ratios ranged from 20,533 US dollars for screening triennially (compared with no further screening) to 331,837 US dollars for screening annually (compared with biennially) per life-year saved. Among same-aged women with 3 or more prior normal Program tests, incremental cost-effectiveness ratios for the same measures ranged from 60,029 US dollars to 709,067 US dollars per life-year saved. Inclusion of the most conservative utility estimates resulted in incremental cost-effectiveness ratios in excess of 100,000 US dollars per quality-adjusted life-year saved associated with annual screening of same-aged women with 3 or more prior normal tests compared with biennial screening. CONCLUSION: As the number of prior normal Pap tests increases, the costs per life-year saved increase substantially. Resources should be prioritized for screening those never or rarely screened women. LEVEL OF EVIDENCE: II-2.

Adult↗

Effect of Replens gel used with a diaphragm on tests for human papillomavirus and other lower genital tract infections.

OBJECTIVE: Little is known about effects of vaginal lubricants with barrier contraceptives on detection of sexually transmissible infections. We hypothesized that Replens gel used with a diaphragm would neither inhibit human papillomavirus (HPV) detection in cervical samples and chlamydia (CT) and gonorrhea (GC) detection in urine samples, nor affect cervical cytology quality. MATERIALS AND METHODS: After a clinician-collected cervical sample and a self-collected vaginal sample for HPV detection ("pregel" specimens), women placed a diaphragm containing Replens gel into the vagina. Participants (n = 77) removed the diaphragm after 6 hours and performed vaginal HPV self-sampling at several time points thereafter. Clinicians performed cervical cytology sampling and HPV testing ("postgel" specimens) 24 hours after diaphragm removal. Pregel and postgel specimens were analyzed with and without added SiHa cells (source of defined numbers of HPV16 genomes). HPV was detected by polymerase chain reaction using MY09/11 primers. Urine samples were obtained for CT and GC testing. Proportions of samples testing positive were compared using relative risk (RR) regression models. RESULTS: Proportions with detectable HPV in the clinician-collected cervical pregel and postgel samples were not statistically different for samples with added SiHa cells (88.3% vs 93.2%, RR = 1.06, 95% confidence interval = 0.96-1.14) or for native HPV infection (32.9% vs 28.2%, RR = 0.87, 95% confidence interval = 0.71-1.06). In self-collected vaginal postgel samples, there was no trend for decreased HPV detection after gel exposure. Gel affected neither urine tests for CT and GC nor cytological quality. CONCLUSIONS: Recent Replens gel use with a diaphragm does not inhibit cervical HPV testing, urine testing for CT and GC, or cervical cytology quality.

Adolescent↗

Discontinuation of postmenopausal hormone therapy.

Current guidelines recommend that postmenopausal hormone therapy (HT) be used primarily for treatment of vasomotor and urogenital symptoms associated with the menopausal transition and that women use the lowest effective dose for the shortest time necessary. Vasomotor symptoms improve or resolve spontaneously within a few months to a few years of onset in the majority of women, suggesting that most women should be able to discontinue HT within a few years of starting treatment. Approximately 75% of women who try to stop are able to stop HT without major difficulty. However, some women who would like to stop HT are unable to do so, mainly owing to the development of vasomotor symptoms. Troublesome symptoms associated with stopping HT appear to be more common among women who start HT for treatment of symptoms, but they also are reported by women who started HT for other reasons, such as prevention of osteoporosis. Unfortunately, little information is available to guide physicians in helping women who have difficulty stopping HT. Many clinicians recommend slowly tapering HT or adding another drug for treatment of hot flashes, but the effectiveness of these approaches has not been evaluated. For women who cannot tolerate even a slow taper, the value of symptom relief likely outweighs any increased risks due to HT use.

Estrogen Replacement Therapy↗

Current cervical neoplasia screening practices of obstetrician/gynecologists in the US.

OBJECTIVE: The purpose of this study was to determine cervical cancer screening practices of obstetrician/gynecologists in the US after recent revised guidelines. STUDY DESIGN: Questionnaires were mailed to 355 randomly selected US obstetrician/gynecologists. Questions were structured as clinical vignettes. RESULTS: Questionnaires were returned by 60% (213/355) of recipients; 185 were eligible. Seventy-four percent would begin screening virginal girls at age 18. Sixty percent would continue annual screening in a 35-year-old woman with 3 or more normal tests. Frequent screening is common in women after total hysterectomy for symptomatic fibroids and no history of dysplasia, and in 70-year-old women with a 30-year history of previous normal tests. Most (82%) use liquid-based cytology; 78% of female respondents would prefer it for themselves. Most (64%) would not adopt triennial Pap/HPV DNA screening, although 58% of women would choose it for themselves. CONCLUSION: Most US obstetrician/gynecologists screen low-risk women often and indefinitely, despite national guidelines designed to minimize screening harms resulting from overtesting.

Adult↗

Cervical cancer screening continues to limit provision of contraception.

PURPOSE: Balancing needs for contraception and cervical cancer screening is challenging for clinicians. We assessed US obstetrician/gynecologists' practices regarding requirement of Pap testing before prescribing oral contraceptive or emergency contraceptive pills. METHODS: Questionnaires structured as clinical vignettes describing women desiring contraception with different risks of cervical dysplasia were mailed to a national sample of 355 obstetrician/gynecologists. RESULTS: A minority (3%) of the 185 obstetrician/gynecologists who responded would refill 12 months of oral contraceptives without requiring Pap testing. However, most would provide a limited supply of oral contraceptives until Pap testing could be performed. A substantial proportion (11-16%) would refuse to prescribe emergency contraception to women who they felt required Pap testing. Younger physicians, those practicing in academic settings and those who follow American Cancer Society guidelines were more willing to prescribe contraceptives without Pap testing. CONCLUSIONS: Cervical cancer screening continues to limit prescription of routine and emergency contraception by many US obstetrician/gynecologists.

Contraception↗

Risk of cervical cancer associated with extending the interval between cervical-cancer screenings.

BACKGROUND: Although contemporary guidelines suggest that the intervals between Papanicolaou tests can be extended to three years among low-risk women with previous negative tests, the excess risk of cervical cancer associated with less frequent than annual screening is uncertain. METHODS: We determined the prevalence of biopsy-proven cervical neoplasia among 938,576 women younger than 65 years of age, stratified according to the number of previous consecutive negative Papanicolaou tests. Using a Markov model that estimates the rate at which dysplasia will progress to cancer, we estimated the risk of cancer within three years after one or more negative Papanicolaou tests, as well as the number of additional Papanicolaou tests and colposcopic examinations that would be required to avert one case of cancer given a particular interval between screenings. RESULTS: Among 31,728 women 30 to 64 years of age who had had three or more consecutive negative tests, the prevalence of biopsy-proven cervical intraepithelial neoplasia of grade 2 was 0.028 percent and the prevalence of grade 3 neoplasia was 0.019 percent; none of the women had invasive cervical cancer. According to our model, the estimated risk of cancer with annual Papanicolaou tests for three years was 2 in 100,000 among women 30 to 44 years of age, 1 in 100,000 among women 45 to 59 years of age, and 1 in 100,000 among women 60 to 64 years of age; these risks would be 5 in 100,000, 2 in 100,000, and 1 in 100,000, respectively, if screening were performed once three years after the last negative test. To avert one additional case of cancer by screening 100,000 women annually for three years rather than once three years after the last negative test, an average of 69,665 additional Papanicolaou tests and 3861 colposcopic examinations would be needed in women 30 to 44 years of age and an average of 209,324 additional Papanicolaou tests and 11,502 colposcopic examinations in women 45 to 59 years of age. CONCLUSIONS: As compared with annual screening for three years, screening performed once three years after the last negative test in women 30 to 64 years of age who have had three or more consecutive negative Papanicolaou tests is associated with an average excess risk of cervical cancer of approximately 3 in 100,000.

Adolescent↗

Screening interval and risk of invasive squamous cell cervical cancer.

To compare the risks of developing invasive squamous cell cervical cancer associated with screening intervals of 1, 2, and 3 years after a negative cervical smear. We conducted a matched case-control study of invasive squamous cell cervical cancer patients (n = 482) diagnosed between 1983 and 1995 among long-term members of a large health maintenance organization. Controls were matched for age, length of membership, and race (n = 934). Screening interval was time between the last negative cervical smear and the case diagnosis date. The main outcome measure was the relative odds of invasive disease associated with 1-year, 2-year, and 3-year intervals. The odds ratio for a 2-year versus a 1-year interval was 1.72 (95% confidence interval 1.12, 2.64, P =.013) and for a 3-year versus a 1-year interval was 2.06 (95% confidence interval 1.21, 3.50, P =.007). The odds ratio for a 3-year versus a 2-year interval was 1.20 (95% confidence interval 0.65, 2.21, P =.561). Controlling for ever having had an abnormal cervical smear or a previous consecutive negative smear did not substantially change these results. In this large health plan, the relative risks of invasive squamous cell cervical cancer were significantly greater for 2-year and 3-year cervical cancer screening intervals compared with a 1-year interval, but not for a 3-year interval compared with a 2-year interval. Our findings need to be placed in the context of the low absolute risks of developing invasive cervical cancer during the first 3 years after a negative cervical smear before making policy recommendation.

Adult↗

Changes in cervical cancer incidence after three decades of screening US women less than 30 years old.

OBJECTIVE: To examine incidence trends of invasive cervical carcinoma in US women less than 30 years old from 1973 to 1999 by histologic type. METHODS: Incidence rates were obtained from the National Cancer Institute's Surveillance, Epidemiology and End Results (SEER) database and stratified by age and three histologic categories: all histologic types, squamous cell carcinoma, and adenocarcinoma. The estimated annual percent change was calculated by joinpoint regression to measure trends during the entire evaluation period and a recent subperiod (1985-1999). All statistical tests were two-sided. RESULTS: Incidence rates of cervical carcinoma overall and squamous cell carcinoma specifically declined during 1973-1999, with estimated annual percent changes of -0.94% (95% confidence interval [CI] -1.47%, -0.41%) and -1.10% (95% CI -1.59%, -0.62%), respectively. Rates of adenocarcinoma increased (+2.90%; 95% CI 1.34%, 4.49%), though trends have been stable since 1990. All cancers were uncommon: the annual incidence per million women ranged from 8.0 to 14.3 for squamous cell carcinoma and from 0.7 to 2.7 for adenocarcinoma. For women younger than 20 years, no statistically significant changes were observed, but cancers were rare (0-3 per million women annually). CONCLUSIONS: More investigation is necessary to clarify the contribution of screening to declines in the squamous cell carcinoma rate and to determine the etiology of adenocarcinoma rate increases over the last three decades in US women less than 30 years old. Because of the small number of actual observed cases, caution must be exercised in interpreting these trends.

Adenocarcinoma↗

Cervical cancer after multiple negative cytologic tests in long-term members of a prepaid health plan.

OBJECTIVE: To estimate squamous cell cervical cancer incidence within 3.5 years of 1, 2 and > or = 3 consecutive, normal cytologic tests. STUDY DESIGN: Data were from a case-control study of cervical cancer screening efficacy. Long-term members of a prepaid health plan diagnosed with cancer from 1983 to 1995 (the cases) were grouped by number of prior conventional cytologic tests and by time from the last negative screening test to the diagnosis date. Women from the population at risk were estimated by multiplying the timated by multiplying the proportions of women without cancer (the matched controls) in each screening category by the numbers of long-term of the numbers of long-term female members enrolled from male members enrolled from 1983 to 1995. RESULTS: Of an estimated 6,802,641 woman-years of observation, 129 cases were diagnosed within 3.5 years of > or = 21 negative screening test. After > or = 3 consecutive negative tests, incidence per 100,000 woman-years grouped by time from the last negative screening test were: 1.43 (26/1,813,552) 0-18 months later, 4.24 (17/400,584) 19-30 months later and 4.73 (10/211,217) 31- 42 months later. CONCLUSION: The first 18 months after the last negative screening Pap test in women with > or = 3 prior negative tests, cancer incidence increases to an estimated 4-5 per 100,000 woman-years in each of the subsequent 2 years.

Adult↗

Stage at diagnosis and mortality in patients with adenocarcinoma and adenosquamous carcinoma of the uterine cervix diagnosed as a consequence of cytologic screening.

OBJECTIVE: To determine if cytologic screening is associated with early stage at diagnosis of and decreased mortality from invasive adenocarcinoma and adenosquamous carcinoma of the uterine cervix. STUDY DESIGN: We retrospectively reviewed the medical records of all 169 women diagnosed with invasive adenocarcinoma or adenosquamous carcinoma of the cervix in a prepaid health plan during 1988-1994. Differences in stage and survival were assessed in relation to screening history and symptoms. RESULTS: Among the 169 cases, late-stage disease was present in 19/169 women (11.2%) at the time of diagnosis, and 24/269 (14.2%) women died of the disease during the three-year follow-up period. Women whose cancer was screen detected numbered 48/169 (28.4%) and were less likely to present with late-stage disease than non-screen-detected women: 2/48 (4.2%) versus 17/121 (14.0%) (P = .05). A mortality advantage at three years from diagnosis was associated with screen-detected cancers: 1/48 (2.1%) versus 23/121 (19.0%) (P = .002), and this advantage persisted after controlling for stage at diagnosis. CONCLUSION: Invasive adenocarcinomas and adenosquamous carcinomas of the cervix detected by screening are found at an earlier stage and are associated with lower disease-specific mortality than those not detected by screening.

Adenocarcinoma↗