A Population-Based Intervention to Improve Care Cascades of Patients With Hepatitis C Virus Infection.

Hepatitis C virus (HCV) infection is common in the United States and leads to significant morbidity, mortality, and economic costs. Simplified screening recommendations and highly effective direct-acting antivirals for HCV present an opportunity to eliminate HCV. The objective of this study was to increase testing, linkage to care, treatment, and cure of HCV. This was an observational, prospective, population-based intervention program carried out between September 2014 and September 2018 and performed in three community health centers, three large multiclinic health care systems, and an HCV patient education and advocacy group in King County, WA. There were 232,214 patients included based on criteria of documented HCV-related diagnosis code, positive HCV laboratory test or prescription of HCV medication, and seen at least once at a participating clinical site in the prior year. Electronic health record (EHR) prompts and reports were created. Case management linked patients to care. Primary care providers received training through classroom didactics, an online curriculum, specialty clinic shadowing, and a telemedicine program. The proportion of baby boomer patients with documentation of HCV testing increased from 18% to 54% during the project period. Of 77,577 baby boomer patients screened at 87 partner clinics, 2,401 (3%) were newly identified HCV antibody positive. The number of patients staged for treatment increased by 391%, and those treated increased by 1,263%. Among the 79% of patients tested after treatment, 95% achieved sustained virologic response. Conclusion: A combination of EHR-based health care system interventions, active linkage to care, and clinician training contributed to a tripling in the number of patients screened and a more than 10-fold increase of those treated. The interventions are scalable and foundational to the goal of HCV elimination.

Accuracy and cost-effectiveness of cervical cancer screening by high-risk human papillomavirus DNA testing of self-collected vaginal samples.

OBJECTIVE: Estimate the accuracy and cost-effectiveness of cervical cancer screening strategies based on high-risk human papillomavirus (HPV) DNA testing of self-collected vaginal samples. MATERIALS AND METHODS: A subset of 1,665 women (age range, 18-50 y) participating in a cervical cancer screening study were screened by liquid-based cytology and by high-risk HPV DNA testing of both self-collected vaginal swab samples and clinician-collected cervical samples. Women with positive/abnormal screening test results and a subset of women with negative screening test results were triaged to colposcopy. On the basis of individual and combined test results, 5 screening strategies were defined. Estimates of sensitivity and specificity for cervical intraepithelial neoplasia grade 2 or worse were calculated, and a Markov model was used to estimate the incremental cost-effectiveness ratios for each strategy. RESULTS: Compared with cytology-based screening, high-risk HPV DNA testing of self-collected vaginal samples was more sensitive (68%, 95% CI = 58%-78% vs 85%, 95% CI = 76%-94%) but less specific (89%, 95% CI = 86%-91% vs 73%, 95% CI = 67%-79%). A strategy of high-risk HPV DNA testing of self-collected vaginal samples followed by cytology triage of HPV-positive women was comparably sensitive (75%, 95% CI = 64%-86%) and specific (88%, 95% CI = 85%-92%) to cytology-based screening. In-home self-collection for high-risk HPV DNA detection followed by in-clinic cytology triage had a slightly lower lifetime cost and a slightly higher quality-adjusted life year (QALY) expectancy than did cytology-based screening (incremental cost-effectiveness ratio of triennial screening compared with no screening was $9,871/QALY and $12,878/QALY, respectively). CONCLUSIONS: Triennial screening by high-risk HPV DNA testing of in-home, self-collected vaginal samples followed by in-clinic cytology triage was cost-effective.

Obtaining sensitive data through the Web: an example of design and methods.

Several studies have suggested that the quality of coital data from diaries is superior to that collected by retrospective questionnaires. By collecting data over short intervals of time, diaries can present a more comprehensive picture of exposure, while minimizing the potential for recall bias. Despite these advantages, paper diaries have limited use because of their expense and difficulty of implementation. Web-based data collection offers the opportunity to make improvements to the quality of epidemiologic exposure measurement by providing privacy and convenience to study participants while reducing costs associated with questionnaire administration and allowing for real-time data processing. We adapted coital diaries for Web-based data collection in a study of transmission rates of genital human papillomavirus infection among young adults. University women complete an online sexual behavior questionnaire ("diary") every 2 weeks over a 3-year follow-up period; men complete a single online sexual behavior questionnaire ("journal"). In this paper we describe the design, methodology and implementation issues that emerge in conducting a Web-based epidemiologic study. We also discuss compliance, as well as methods for assuring appropriate security, confidentiality and privacy.

Liquid-based Papanicolaou smears without a transformation zone component: should clinicians worry?

OBJECTIVE: To evaluate whether ThinPrep smears without versus those with a transformation zone component were more likely to have falsely negative cytology findings. METHODS: Women aged 18-50 (N = 4389) attended one of three Planned Parenthood clinics between 1997 and 2001 for screening by ThinPrep Papanicolaou and polymerase chain reaction-based human papillomavirus (HPV) DNA testing. Women with 1) any cytologic abnormality, 2) high-risk HPV types, and 3) a random sample with normal Papanicolaou and negative HPV tests were offered repeat cytology, colposcopy, and biopsy. Cytology and biopsy diagnoses at the colposcopy visit were reviewed according to the presence (n = 3689) or absence (n = 700) of a transformation zone component at screening. RESULTS: Among women with normal cytology at screening, histologic detection of at least cervical intraepithelial neoplasia grade 2 (odds ratio 1.3, 95% confidence interval 0.5, 3.3) at colposcopy did not differ significantly between transformation zone-positive and zone-negative smears. Histologically confirmed cervical intraepithelial neoplasia grade 1 was detected more often among smears lacking a transformation zone component (odds ratio 2.0, confidence interval 1.0, 3.8). Transformation zone-negative smears were more common among older women, current oral contraceptive users, those past the 14th day of their last menstrual period, and those negative for high-risk HPV types. CONCLUSION: Absence of a transformation zone component in a screening ThinPrep Papanicolaou test was not associated with missed high-grade lesions. Based upon our data, we do not recommend repeat screening of reproductive-aged women with negative liquid-based tests and no cytologic evidence of a transformation zone component.

Maternal, delivery, and perinatal characteristics associated with cryptorchidism: a population-based case-control study among births in Washington State.

BACKGROUND: The etiology of cryptorchidism is largely unknown. To identify maternal, perinatal, and delivery characteristics associated with cryptorchidism at birth, we conducted a population-based case-control study using Washington State birth certificates linked to birth hospitalization records. METHODS: We identified 2,395 cases of cryptorchidism among male infants born in Washington State during 1986-1996, and, for comparison, we randomly selected four controls per case (N = 9,580), frequency-matched by year of birth. RESULTS: Infant characteristics associated with cryptorchidism included low birth weight (OR = 1.5; 95% CI = 1.3-1.8), small size for gestational age (OR = 1.9; 95% CI = 1.6-2.2), and breech presentation (OR = 1.7; 95% CI = 1.4-2.1). In addition to cryptorchidism, cases were more likely to have another type of congenital malformation (OR = 3.7; 95% CI = 3.2-4.2), particularly digestive (OR = 6.8; 95% CI = 3.7-12.7) or genitourinary (OR = 4.1; 95% CI = 3.0-5.6). Maternal and pregnancy characteristics associated with cryptorchidism included nulliparity (OR = 1.2; 95% CI = 1.1-1.3), maternal smoking during pregnancy (OR = 1.2; 95% CI = 1.1-1.4), and the following pregnancy complications: oligohydramnios (OR = 1.8; 95% CI = 1.3-2.6), placental abnormality (OR = 1.3; 95% CI = 1.0-1.8), and pregnancy-induced hypertension (OR = 1.6; 95% CI = 1.4-1.9). Odds ratios were similar when the analysis was restricted to term infants. CONCLUSIONS: These findings suggest that factors affecting fetal growth and development may increase the risk of cryptorchidism.