Costs and Projected Effect of a Federally Qualified Health Center-Based Mailed Colorectal Cancer Screening Program in Texas.

Introduction: Mailed stool testing for colorectal cancer (CRC) may improve screening uptake and reduce the incidence and mortality of CRC, especially among patients at federally qualified health centers (FQHCs). To expand screening programs it is important to identify cost-effective approaches. Methods: We developed a decision-analytic model to estimate the cost, effects on screening and patient outcomes (CRCs detected, CRCs prevented, CRC deaths prevented), and cost-effectiveness of implementing a state-wide mailed stool testing program over 5 years among unscreened, age-eligible (aged 50-75 y) patients at FQHCs in Texas. We compared various outreach strategies and organizational structures (centralized, regional, or a hybrid). We used data from our existing regional mailed stool testing program and recent systematic reviews to set parameters for the model. Costs included start-up and ongoing activities and were estimated in 2022 US dollars from the perspective of a hypothetical third-party payer. Cost-effectiveness was assessed by using both incremental and average cost-effectiveness ratios. Results: Using either a statewide centralized or hybrid organizational configuration to mail stool tests to newly eligible FQHC patients and patients who have responded at least once since program inception is likely to result in the best use of resources over 5 years, enabling more than 110,000 additional screens, detecting an incremental 181 to 194 CRCs, preventing 91 to 98 CRCs, and averting 46 to 50 CRC deaths, at a cost of $10 million to $11 million compared with no program. Conclusions: A statewide mailed stool testing program for FQHC patients can be implemented at reasonable cost with considerable effects on CRC screening outcomes, especially when its structure maximizes program efficiency while maintaining effectiveness.

Equitable Implementation of Mailed Stool Test-Based Colorectal Cancer Screening and Patient Navigation in a Safety Net Health System.

BACKGROUND: Mailed stool testing programs increase colorectal cancer (CRC) screening in diverse settings, but whether uptake differs by key demographic characteristics is not well-studied and has health equity implications. OBJECTIVE: To examine the uptake and equity of the first cycle of a mailed stool test program implemented over a 3-year period in a Central Texas Federally Qualified Health Center (FQHC) system. DESIGN: Retrospective cohort study within a single-arm intervention. PARTICIPANTS: Patients in an FQHC aged 50-75 at average CRC risk identified through electronic health records (EHR) as not being up to date with screening. INTERVENTIONS: Mailed outreach in English/Spanish included an introductory letter, free-of-charge fecal immunochemical test (FIT), and lab requisition with postage-paid mailer, simple instructions, and a medical records update postcard. Patients were asked to complete the FIT or postcard reporting recent screening. One text and one letter reminded non-responders. A bilingual patient navigator guided those with positive FIT toward colonoscopy. MAIN MEASURES: Proportions of patients completing mailed FIT in response to initial cycle of outreach and proportion of those with positive FIT completing colonoscopy; comparison of whether proportions varied by demographics and insurance status obtained from the EHR. KEY RESULTS: Over 3 years, 33,606 patients received an initial cycle of outreach. Overall, 19.9% (n = 6672) completed at least one mailed FIT, 5.6% (n = 374) tested positive during that initial cycle, and 72.5% (n = 271 of 374) of those with positive FIT completed a colonoscopy. Hispanic/Latinx, Spanish-speaking, and uninsured patients were more likely to complete mailed FIT compared with white, English-speaking, and commercially insured patients. Spanish-speaking patients were more likely to complete colonoscopy after positive FIT compared with English-speaking patients. CONCLUSIONS: Mailed FIT outreach with patient navigation implemented in an FQHC system was effective in equitably reaching patients not up to date for CRC screening.

Effectiveness and Cost-effectiveness of Mailed FIT in a Safety Net Clinic Population.

BACKGROUND: Mailed fecal immunochemical testing (FIT) can increase colorectal cancer (CRC) screening rates, including for vulnerable patients, but its cost-effectiveness is unclear. OBJECTIVE: We sought to examine the effectiveness and cost-effectiveness of the initial cycle of our mailed FIT program from November 2017 to July 2019 in a federally qualified health center (FQHC) system in Central Texas. DESIGN: Single group intervention and economic analysis PARTICIPANTS: Eligible patients were those ages 50-75 who had been seen recently in a system practice and were not up to date with screening. INTERVENTION: The program mailing packet included an introductory letter in plain language, the FIT itself, easy to read instructions, and a postage-paid lab mailer, supplemented with written and text messaging reminders. MAIN MEASURES: We measured effectiveness based on completion of mailed FIT and cost-effectiveness in terms of cost per person screened. Costs were measured using detailed micro-costing techniques from the perspective of a third-party payer and expressed in 2019 US dollars. Direct costs were based on material supply costs and detailed observations of labor required, valued at the wage rate. KEY RESULTS: Of the 22,838 eligible patients who received program materials, mean age was 59.0, 51.5% were female, and 43.9% were Latino. FIT were successfully completed by 19.2% (4395/22,838) patients at an average direct cost of $5275.70 per 500-patient mailing. Assuming completed tests from the mailed intervention represent incremental screening, the direct cost per patient screened, compared with no intervention, was $54.83. Incorporating start-up and indirect costs increases total costs to $7014.45 and cost per patient screened to $72.90. Alternately, assuming 2.5% and 5% screening without the intervention increased the direct (total) cost per patient screened to $60.03 ($80.80) and $67.05 ($91.47), respectively. CONCLUSIONS: Mailed FIT is an effective and cost-effective population health strategy for CRC screening in vulnerable patients.

Spatial Insights for Understanding Colorectal Cancer Screening in Disproportionately Affected Populations, Central Texas, 2019.

INTRODUCTION: Colorectal cancer (CRC) screening can reduce morbidity and mortality; however, important disparities exist in CRC uptake. Our study examines the associations of distance to care and frequency of using primary care and screening. METHODS: To examine the distribution of screening geographically and according to several demographic features, we used individual patient-level data, dated September 30, 2018, from a large urban safety-net health system in Central Texas. We used spatial cluster analysis and logistic regression adjusted for age, race, sex, socioeconomic status, and health insurance status. RESULTS: We obtained screening status data for 13,079 age-eligible patients from the health system's electronic medical records. Of those eligible, 55.1% were female, and 55.9% identified as Hispanic. Mean age was 58.1 years. Patients residing more than 20 miles from one of the system's primary care clinics was associated with lower screening rates (odds ratio [OR], 0.63; 95% CI, 0.43-0.93). Patients with higher screening rates included those who had a greater number of primary care-related (nonspecialty) visits within 1 year (OR, 6.90; 95% CI, 6.04-7.88) and those who were part of the county-level medical assistance program (OR, 1.61; 95% CI, 1.40-1.84). Spatial analysis identified an area where the level of CRC screening was particularly low. CONCLUSION: Distance to primary care and use of primary care were associated with screening. Priorities in targeted interventions should include identifying and inviting patients with limited care engagements.

Colonoscopy Quality and Adherence to Postpolypectomy Surveillance Guidelines in an Underinsured Clinic System.

BACKGROUND: Delivery of high-quality colonoscopy and adherence to evidence-based surveillance guidelines is essential to a high-quality screening program, especially in safety net systems with limited resources. We sought to assess colonoscopy quality and ensure appropriate surveillance in a network of safety net practices. METHODS: We identified age-eligible patients ages 50-75 within a Federally Qualified Health Center (FQHC) clinic system with evidence of colonoscopy in preceding 10 years. We performed chart reviews to assess key aspects of colonoscopy quality: bowel preparation quality, evidence of cecal intubation, cecal withdrawal time, and the adenoma detection rate. We then utilized established guidelines to assess and revise surveillance colonoscopy intervals, determine whether appropriate surveillance had taken place, and schedule overdue patients as appropriate. RESULTS: Of 26,394 age-eligible patients, a total of 3,970 patients had evidence of prior colonoscopy and 1,709 charts were selected and reviewed. Mean age was 57, 54% identified as women and 51% identified as Hispanic. Of 1709 colonoscopies reviewed, 77% had data on bowel preparation, and of those, 85% had adequate preparation quality. Cecal intubation was documented in 89% of procedures. Adequate cecal withdrawal time was documented in 59% of those with documented cecal intubation. Overall adenoma detection rate was 42%. Initial surveillance interval was clearly stated in 72% (n = 1238) of procedures. Of these, initial recommended intervals were too short in 24.5% (n = 304) and too long in 3.6% (n = 45). A total of 132 patients (10.7%) were overdue for appropriate surveillance and were referred for follow-up colonoscopy. CONCLUSIONS: Overall, the quality of screening colonoscopy was high, but reporting was incomplete. We found fair adherence to evidence-based surveillance guidelines, with significant opportunities to extend surveillance intervals and improve adherence to best practices.

Differences in the Prevalence of Human Papillomavirus (HPV) in Head and Neck Squamous Cell Cancers by Sex, Race, Anatomic Tumor Site, and HPV Detection Method.

IMPORTANCE: Human papillomavirus (HPV) causes an increasing proportion of oropharyngeal squamous cell carcinomas (OPSCCs), particularly in white men. The prevalence of HPV among other demographic groups and other anatomic sites of HNSCC is unclear. OBJECTIVE: To explore the role of HPV tumor status among women and nonwhites with OPSCC and patients with nonoropharyngeal head and neck squamous cell carcinoma (non-OP HNSCC). DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study at 2 tertiary academic centers including cases diagnosed 1995 through 2012, oversampled for minorities and females. A stratified random sample of 863 patients with newly diagnosed SCC of the oral cavity, oropharynx, larynx, or nasopharynx was used. MAIN OUTCOMES AND MEASURES: Outcomes were HPV status as measured by p16 immunohistochemical analysis, HPV16 DNA in situ hybridization (ISH), and high-risk HPV E6/E7 mRNA ISH. RESULTS: Of 863 patients, 551 (63.9%) were male and median age was 58 years (interquartile range, 51-68 years). Among 240 OPSCCs, 144 (60%) were p16 positive (p16+), 115 (48%) were HPV16 DNA ISH positive (ISH16+), and 134 (56%) were positive for any oncogenic HPV type (ISH+). From 1995 to 2012, the proportion of p16+ OPSCC increased significantly among women (from 29% to 77%; P = .005 for trend) and men (36% to 72%; P < .001 for trend), as well as among whites (39% to 86%; P < .001 for trend) and nonwhites (32% to 62%; P = .02 for trend). Similar results were observed for ISH+ OPSCC (P ≤ .01 for all). Among 623 non-OP HNSCCs, a higher proportion were p16+ compared with ISH positive (62 [10%] vs 30 [5%]; P = .001). A high proportion (26 of 62 [42%]) of these p16+ non-OP HNSCCs were found in sites adjacent to the oropharynx. The proportion of p16+ and ISH+ non-OP HNSCCs were similar by sex. Over time, the proportion of non-OP HNSCCs that were p16+ (or ISH+) increased among whites (P = .04 for trend) but not among nonwhites (each P > .51 for trend). Among OPSCCs, p16 had high sensitivity (100%), specificity (91%), and positive (93%) and negative predictive value (100%) for ISH positivity. In non-OP HNSCCs, p16 had lower sensitivity (83%) and positive predictive value (40%) but high specificity (94%) and negative predictive value (99%) for ISH positivity. CONCLUSIONS AND RELEVANCE: During 1995 through 2012, the proportion of OPSCCs caused by HPV has increased significantly. This increase was not restricted to white men but was a consistent trend for women and men, as well as for white and nonwhite racial groups. Few non-OP HNSCCs were HPV related. P16 positivity was a good surrogate for ISH+ tumor status among OPSCC, but not a good surrogate for non-OP HNSCC.

Sex Differences in Risk Factors and Natural History of Oral Human Papillomavirus Infection.

UNLABELLED: Oral human papillomavirus genotype 16 (HPV16) infection causes oropharyngeal squamous cell carcinoma (SCC), and the prevalence of oropharyngeal SCC is higher among men than women in the United States. In a cohort study of oral HPV infection among 409 individuals aged 18-25 years, the risk among men but not among women significantly increased as the number of recent (ie, within the prior 3 months) oral sex partners increased (Pinteraction = .05). In contrast, the risk among women but not among men significantly decreased as the lifetime number of vaginal sex partners increased (Pinteraction = .037). Men were also significantly less likely than women to clear oral HPV infection. Our data contribute to understanding sex differences in risk for HPV-positive oropharyngeal SCC. CLINICAL TRIALS REGISTRATION: NCT00994019.

Oral Human Papillomavirus (HPV) Infection among Unvaccinated High-Risk Young Adults.

Oral HPV infection, the cause of most oropharyngeal cancer in the U.S., is not well studied among high-risk young adults. Men (n = 340) and women (n = 270) aged 18-25 years attending Baltimore County STD clinics were recruited if they declined HPV vaccination. Each participant had a 30-second oral rinse and gargle sample tested for 37 types of HPV DNA, and a risk-factor survey. Factors associated with prevalent infection were explored using log binomial regression. Men had higher prevalence of any oral HPV (15.3% vs. 7.8%, p = 0.004) and vaccine-type oral HPV (i.e., HPV16/18/6/11: 5.0% vs. 1.1%, p = 0.007) infection than women. In multivariate analysis, male gender (aPR = 1.93, 95% CI = 1.10-3.39), number of recent oral sex partners (p-trend = 0.013) and having ever performed oral sex on a woman (aPR = 1.73, 95% CI = 1.06-2.82) were associated with increased oral HPV prevalence. Performing oral sex on a woman may confer higher risk of oral HPV acquisition than performing oral sex on a man.