Preferences for surveillance strategies for women treated for high-grade precancerous cervical lesions.

OBJECTIVES: Data are lacking on how women view alternative approaches to surveillance for cervical cancer after treatment of high-grade cervical intraepithelial neoplasia. We measured and compared patient preferences (utilities) for scenarios with varying surveillance strategies and outcomes to inform guidelines and cost-effectiveness analyses of post-treatment surveillance options. METHODS: English- or Spanish-speaking women who had received an abnormal Pap test result within the past 2 years were recruited from general gynecology and colposcopy clinics and newspaper and online advertisements in 2007 and 2008. Participation consisted of one face-to-face interview, during which utilities for 11 different surveillance scenarios and their associated outcomes were elicited using the time tradeoff metric. A sociodemographic questionnaire also was administered. RESULTS: 65 women agreed to participate and successfully completed the preference elicitation exercises. Mean utilities ranged from 0.989 (undergoing only a Pap test, receiving normal results) to 0.666 (invasive cervical cancer treated with radical hysterectomy or radiation and chemotherapy). Undergoing both Pap and HPV tests and receiving normal/negative results had a lower mean utility (0.953) then undergoing only a Pap test and receiving normal results (0.989). Having both tests and receiving normal Pap but positive HPV results was assigned an even lower mean utility (0.909). 15.9% of the respondents gave higher utility scores to the Pap plus HPV testing scenario (with normal/negative results) than to the "Pap test alone" scenario (with normal results), while 17.5% gave the Pap test alone scenario a higher utility score. CONCLUSIONS: Preferences for outcomes ending with normal results but involving alternative surveillance processes differ substantially. The observed differences in utilities have important implications for clinical guidelines and cost-effectiveness analyses.

Vaginal birth after cesarean in California.

OBJECTIVE: To estimate rates at which women were offered and consented to trial of labor in California hospitals with high and low risk-adjusted cesarean delivery rates. METHODS: From 267 nonfederal acute-care hospitals in California that performed more than 678 deliveries in 1992-1993, 51 hospitals were selected in a stratified sample. Hospitals in the sample were categorized as having high, medium, and low risk-adjusted cesarean rates using a logistic regression model based on data from the California Patient Discharge Data System. We reviewed medical records of women with previous cesareans for evidence of counseling regarding trial of labor, other clinical variables, and method of delivery. Differences in proportions between the three groups of hospitals were compared. RESULTS: According to records of 369 women with previous cesareans, after excluding contraindications, 312 were potentially eligible for trial of labor. Hospitals with low risk-adjusted cesarean rates documented counseling women for trial of labor in over 99% of records reviewed, compared with 85% and 79%, respectively, of hospitals with intermediate and high rates (P <.001). Rates of completed vaginal births after cesarean were 71% in hospitals with low risk-adjusted cesarean rates, compared with 39% and 31% in hospitals with intermediate and high rates (P <.05). CONCLUSIONS: California hospitals with high cesarean rates in 1992-1993 had markedly higher rates of repeat elective cesarean delivery without evidence of counseling regarding trial of labor. Informed patient choice is a critical element of the decision for trial of labor or elective repeat cesarean, and lack of documented counseling is cause for concern.

New tests for cervical cancer screening.

The Papanicolaou (Pap) smear has been used to screen women for cervical cancer since 1940. Recently, a number of new technologies have been developed to improve the detection of cervical cancer and its precursors. However, there is substantial controversy about whether the new tests offer meaningful advantages over the conventional Pap smear. Ideally, these new tests will increase the early detection of meaningful Pap smear abnormalities, reduce the number of unsatisfactory smears and provide fewer ambiguous results. It is also hoped that these new screening methods will not increase the number of false-positive results, but will improve the productivity of cytology laboratories without substantially increasing costs. The new tests include liquid-based/thin-layer preparations to improve the quality and adequacy of the Pap smear; computer-assisted screening methods to improve Pap smear interpretation; and new-generation human papillomavirus testing methods that may be useful in triaging patients with atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesions. Evidence on these new tests is reviewed and the advantages and disadvantages of their use are discussed.

Put prevention into practice: a controlled evaluation.

OBJECTIVES: The purpose of this study was to evaluate whether Put Prevention Into Practice (PPIP) materials affected the delivery of 8 clinical preventive services. METHODS: Program materials were provided to a family medicine practice serving a diverse, low-income population. Appropriate use of clinical preventive services was assessed via medical record reviews at baseline, 6 months, 18 months, and 30 months at both intervention and control sites. RESULTS: The delivery rates of 7 clinical preventive services were higher in the intervention site at 6 months. These rates had flattened or decreased by 30 months. CONCLUSIONS: Use of PPIP materials modestly improved delivery of certain clinical preventive services. Sustained improvement will require substantial system changes and ongoing support.

Comparing the use of physician time and health care resources among patients speaking English, Spanish, and Russian.

BACKGROUND AND OBJECTIVES: The number of US residents with limited English proficiency (LEP) is 14 million and rising. The goal of this study was to estimate the effects of LEP on physician time and resource use. DESIGN: This was a prospective, observational study. SETTING AND SUBJECTS: The study included 285 Medicaid patients speaking English (n = 112), Spanish (n = 62), or Russian (n = 111) visiting the General Medicine and Family Practice Clinics at the UC Davis Medical Center in 1996-1997 (participation rate, 85%). Bilingual research assistants administered patient questionnaires, abstracted the medical record, and conducted detailed time and motion studies. MAIN OUTCOME MEASURES: We used seemingly unrelated regression models to evaluate the effect of language on visit time, controlling for patient demographics and health status, physician specialty, visit type, and resident involvement in care. We also estimated the effect of LEP on cross-sectional utilization of health care resources and adherence to follow-up with referral and testing appointments. RESULTS: The 3 language groups differed significantly by age, education, and reason for visit but not gender, number of active medical conditions, physical functioning, or mental health. Physician visit time averaged 38+/-20 minutes (mean+/-SD). Compared with English-speaking patients and after multivariate adjustment, Spanish and Russian speakers averaged 9.1 and 5.6 additional minutes of physician time, respectively (P <0.05). The language effect was confined largely to follow-up visits with resident physicians (house staff). Compared with English speakers, Russian speakers had more referrals (P = 0.003) and Spanish speakers were less likely to follow-up with recommended laboratory studies (P = 0.031). CONCLUSIONS: In these academic primary care clinics, some groups of patients using interpreters required more physician time than those proficient in English Additional reimbursement may be needed to ensure continued access and high-quality care for this special population.

Treatment outcomes for squamous intraepithelial lesions.

OBJECTIVE: To assess the effectiveness of cone biopsy, cryotherapy, laser ablation and the loop electrosurgical procedure in the treatment of squamous intraepithelial lesions. METHOD: Systematic review of randomized controlled trials in subjects who underwent treatment of low- and high-grade squamous intraepithelial lesions with these modalities. Main outcome measures included the following: percent resolution and persistence of a lesion and notable complications for each procedure. RESULT: Pooled rates of resolution for low-grade, high-grade, or combined squamous intraepithelial lesions were similar across the different treatment modalities (range 85.2-94.7%), with substantial overlap among the 95% confidence intervals. Significant hemorrhage occurred most frequently in subjects who received cone biopsy (4.6%) (95% CI: 2.15, 6.99), followed by laser ablation (1.75%) (95% CI: 0.70, 2.81), and LEEP (1.35%) (95% CI: 0.24, 2.47). No hemorrhages were reported among subjects who received cryotherapy. Study sample sizes were relatively small. There were no reported cases of progression to invasive cancer, but duration of follow-up (median follow-up time for all eligible studies = 12 months) was not sufficient to evaluate long-term outcomes. CONCLUSIONS: There were no substantive differences in outcomes regarding persistence and resolution in the treatment of squamous intraepithelial lesions for subjects receiving cone biopsy, cryotherapy, laser ablation, or LEEP.

Do follow-up recommendations for abnormal Papanicolaou smears influence patient adherence?

OBJECTIVE: To compare adherence to follow-up recommendations for colposcopy or repeated Papanicolaou (Pap) smears for women with previously abnormal Pap smear results. DESIGN: Retrospective cohort study. SETTING: Three northern California family planning clinics. PATIENTS: All women with abnormal Pap smear results referred for initial colposcopy and a random sample of those referred for repeated Pap smear. Medical records were located and reviewed for 90 of 107 women referred for colposcopy and 153 of 225 women referred for repeated Pap smears. INTERVENTION: Routine clinic protocols for follow-up--telephone call, letter, or certified letter--were applied without regard to the type of abnormality seen on a Pap smear or recommended examination. MAIN OUTCOME MEASURES: Documented adherence to follow-up within 8 months of an abnormal result. Attempts to contact the patients for follow-up, adherence to follow-up recommendations, and patient characteristics were abstracted from medical records. The probability of adherence to follow-up vs the number of follow-up attempts was modeled with survival analysis. Cox proportional hazards models were used to examine multivariate relationships related to adherence. RESULTS: The rate of overall adherence to follow-up recommendations was 56.0% (136/243). Adherence to a second colposcopy was not significantly different from that to a repeated Pap smear (odds ratio, 1.40; 95% confidence interval, 0.80-2.46). The use of as many as 3 patient reminders substantially improved adherence to follow-up. Women without insurance and women attending 1 of the 3 clinics were less likely to adhere to any follow-up recommendation (hazard ratio for no insurance, 0.43 [95% confidence interval, 0.20-0.93], and for clinic, 0.35 [95% confidence interval, 0.15-0.73]). CONCLUSIONS: Adherence to follow-up was low in this family planning clinic population, no matter what type of follow-up was advised. Adherence was improved by the use of up to 3 reminders. Allocating resources to effective methods for improving adherence to follow-up of abnormal results may be more important than which follow-up procedure is recommended.

Determining costs of health care services for cost-effectiveness analyses: the case of cervical cancer prevention and treatment.

OBJECTIVES: To estimate costs for the prevention and treatment of cervical cancer based on resource utilization and to compare those costs to published estimates and to local charges and reimbursements. DESIGN: Cost estimates for cervical cancer prevention services were based on clinic staff time, use of specialized equipment and supplies, laboratory costs, and clinic overhead. Cost estimates for cervical cancer treatment were based on HMO expenditures for cervical cancer patients and control patients. These costs were adjusted for stage distribution and survival rates. Published cost estimates were obtained from a systematic review of the medical literature between 1990 and 1996. SETTING: Three family planning clinics (for prevention costs) and a staff-model HMO (for treatment costs). PATIENTS: For treatment costs: 98 cervical cancer patients and 133,058 female control patients, matched by age and chronic disease score. MAIN OUTCOME MEASURES: Estimated costs for prevention and treatment of cervical cancer. Cost-to-charge and cost-to-reimbursement ratios. RESULTS: Costs of cervical cancer prevention and treatment services have been determined using a variety of methods. We found substantial variation in these estimates, even for studies with similar methodologies. Detailed resource-based estimation suggests that prevention costs are generally lower than those previously published in the literature, whereas the costs of cervical cancer treatment are generally higher. CONCLUSIONS: It is practical and desirable to employ resource use-based estimates of medical costs in cost-effectiveness analyses. Failure to do so for cervical cancer may affect policy recommendations by understating the relative benefits of prevention programs.

Natural history of cervical squamous intraepithelial lesions: a meta-analysis.

OBJECTIVE: To define the strengths and weaknesses of existing research on the natural history of cervical squamous intraepithelial lesions (SIL) and to estimate rates of progression and regression without treatment. DATA SOURCES: Studies of women whose cervical smears showed squamous atypia or worse and who were observed for a minimum of 6 months were identified by a search of MEDLINE from 1966 to 1996, Current Contents, the Federal Research in Progress database, and references of review articles and identified studies, and by experts in the field. METHODS OF STUDY SELECTION: Fifteen of 81 studies were eligible for data extraction. To be eligible, studies had to report a minimum of 6 months' follow-up without treatment; relate entry cytologic findings to outcomes; and report entry cytologic findings so that the study population could be stratified into categories of atypical cells of undetermined significance (ASCUS), low-grade SIL, or high-grade SIL. Studies published before 1970 were excluded. TABULATION, INTEGRATION, AND RESULTS: Eligible studies, representing 27,929 patients, were stratified according to entry cytologic findings. The following rates of progression to high-grade SIL at 24 months were found: ASCUS, 7.13% (95% confidence interval [CI] 0.8%, 13.5%); low-grade SIL, 20.81% (6.08%, 35.55%); and high-grade SIL, 23.37% (12.82%, 32.92%). The following rates of invasive cancer at 24 months were found: ASCUS, 0.25% (0%, 2.25%); low-grade SIL, 0.15% (0%, 0.71%); and high-grade SIL, 1.44% (0%, 3.95%). The following rates of regression to normal were found: ASCUS, 68.19% (57.51%, 78.86%); low-grade SIL, 47.39% (35.92%, 58.86%); and high-grade SIL, 35.03% (16.57%, 53.49%). Study heterogeneity was not explained by regression analysis of study level variables. CONCLUSION: Our findings for borderline and low-grade abnormal cervical cytologic results suggest a relatively low risk of invasive cervical cancer with observation up to 24 months and support the clinical policy of early colposcopy for high-grade lesions.

Detection of high-grade cervical dysplasia: impact of age and Bethesda system terminology.

Pap smear, colposcopy, and biopsy results were collected from 1988-1993 at a group of family planning clinics. Positive predictive values and likelihood ratios were calculated for diagnosis of high-grade lesions based on age and Pap smear results. One thousand and forty-seven colposcopies were logged; 771 had a biopsy or endocervical curettage. Seventy-nine (10%) were high-grade lesions. If only human papillomavirus (HPV) was reported on the Pap smear, the likelihood of a high-grade biopsy was lowest (positive predictive value, 4.5%; likelihood ratio, 0.4). Women under age 25 were less likely to have high-grade biopsies (positive predictive value, 7.3%; likelihood ratio 0.7). Repeat Pap smears for atypical cells of undetermined significance (ASCUS) and low grade squamous intra-epithelial lesion (LGSIL) showing only HPV in women under age 30 would have reduced the immediate colposcopy rate by 60% and delayed diagnosis by 23% of high-grade lesions. Consideration of patient age and whether HPV is the only Pap smear finding may reduce referral for immediate colposcopy.

Effect of a transportation incentive on compliance with the first prenatal appointment: a randomized trial.

OBJECTIVE: To evaluate the effectiveness of incentives for improving compliance with the first prenatal appointment. METHODS: One hundred four low-income women, intending to enroll for prenatal care in a system of Northern California family planning clinics, were recruited for a randomized trial. Study subjects were assigned randomly to one of three groups, receiving a taxicab voucher or a baby-blanket coupon or an appointment slip (controls). Intention-to-treat analysis was used to compare compliance with the first prenatal appointment between the three groups. RESULTS: Subjects receiving the taxi voucher had a compliance rate of 82% for the first prenatal appointment, 22% higher than mean appointment compliance in the other groups. The odds ratio for missing the first appointment was 0.32 (95% confidence interval 0.12, 0.88) in the taxi voucher group. This was not affected by controlling for possible confounders. Despite better appointment compliance, only one of 34 taxi vouchers distributed was actually used. CONCLUSION: A taxi voucher incentive was effective in improving compliance with the first prenatal appointment, despite the fact that only one subject actually used the voucher.

Cancer prevention and screening in women.

Although there is no recommended screening for ovarian or endometrial cancers, the use of oral contraceptives is a primary prevention maneuver. The prevention of cervical cancer is accomplished best by Pap smear screening every 1 to 3 years. Clinical breast examination and mammography every 1 to 2 years after age 50 years are effective in reducing breast cancer mortality. Screening for BRCA1 and BRCA2 mutations is now available, but the role of these tests is still not clear; extensive patient counseling is required.

Is cervicography a useful diagnostic test? A systematic overview of the literature.

BACKGROUND: The appropriate approach to women with mild dyskaryotic changes on Papanicolaou smear is subject to controversy. Our aim was to assess the usefulness of cervicography as a diagnostic test in detecting cervical cancer or its precursors. METHODS: We undertook an extensive literature search looking for pertinent studies of cervicography published between 1966 and 1996. Eligible studies included those in which the reference standard (colposcopy) was done on all patients. The following information was calculated: sensitivity, specificity, positive predictive value, negative predictive value, disease prevalence, and likelihood ratios. RESULTS: Cervicography has a high false-positive rate. This rate ranged from 8.2 to 61.0 percent (median 42.1 percent) for any dysplasia and 9.8 to 63.4 percent (median 50.6 percent) for high-grade cervical lesions. Likelihood ratios for a positive test result ranged from 1.0 to 10.6. Likelihood ratios for a negative result ranged from 0.02 to 1.0. CONCLUSIONS: The usefulness of cervicography is heavily dependent on the approach used to evaluate abnormal findings on a Papanicolaou smear. If a provider typically offers colposcopy to all patients with low-grade cytologic findings on a Papanicolaou smear, cervicography will decrease colposcopy use and allow for detection of cases of high-grade dysplasia missed by the index Papanicolaou smear. If a provider typically uses watchful waiting with repeat Papanicolaou smears for all patients who have low-grade cytologic findings, cervicography will substantially increase the use of colposcopy. Many of these colposcopies will be done as a result of false-positive cervigrams.

Management choices for patients with "squamous atypia" on Papanicolaou smear. A toss up?

Appropriate management of borderline abnormalities on Papanicolaou (Pap smears is controversial. This decision analysis compared two strategies for management of women with the Pap smear result of "squamous atypia." A policy of immediate colposcopy and biopsy was compared with repeating the cervical smear at 6-month intervals. Relevant probabilities and ranges were extracted from published studies in the English language medical literature from 1966 to 1993. When no relevant studies could be located, probabilities with a plausible range were determined through consensus of a panel of experts. Outcome values were assigned for the analysis to contrast the time period (approximately 2 years) covered by the analysis. Using baseline estimates, either policy resulted in an essentially equivalent probability of invasive cervical cancer. The estimated likelihood of remaining free of invasive cervical cancer was .9974 for follow-up by repeat smear versus .9976 for immediate colposcopy and biopsy. In sensitivity analysis, very high probabilities of progression to invasive cervical cancer favored the policy of immediate colposcopy and biopsy. Follow-up of squamous atypia on cervical smear by repeating the smear at 6-month intervals is unlikely to result in a detectable increase in invasive cervical cancers.

Management of patients with atypical and low-grade Pap smear abnormalities.

Family physicians frequently encounter patients with atypical and low-grade Papanicolaou (Pap) smear findings. While near consensus exists regarding the evaluation and management of patients with high-grade dysplasia and carcinoma detected on Pap smear, the appropriate management of patients with atypical and low-grade abnormalities continues to be controversial. Recent guidelines from the National Cancer Institute propose consideration of a more conservative management approach, with repeat Pap smear as an alternative to immediate colposcopy. Conservative management, as an alternative to an ablative or excisional procedure, has also been proposed for women with histologic evidence of lowgrade dysplasia. It is unlikely that an approach including a conservative diagnostic strategy and careful follow-up will result in an increase in the number of missed cases of cervical cancer. This assumption needs to be assessed by prospective clinical trials.