Strategies to Increase Cervical Cancer Screening With Mailed Human Papillomavirus Self-Sampling Kits: A Randomized Clinical Trial.

Importance: Optimal strategies for increasing cervical cancer screening may differ by patient screening history and health care setting. Mailing human papillomavirus (HPV) self-sampling kits to individuals who are overdue for screening increases adherence; however, offering self-sampling kits to screening-adherent individuals has not been evaluated in the US. Objective: To evaluate the effectiveness of direct-mail and opt-in approaches for offering HPV self-sampling kits to individuals by cervical cancer screening history (screening-adherent and currently due, overdue, or unknown). Design, Setting, and Participants: Randomized clinical trial conducted in Kaiser Permanente Washington, a US integrated health care delivery system. Individuals aged 30 to 64 years with female sex, a primary care clinician, and no hysterectomy were identified through electronic health records (EHRs) and enrolled between November 20, 2020, and January 28, 2022, with follow-up through July 29, 2022. Interventions: Individuals stratified as due (eg, at the time of randomization, these individuals have been previously screened and are due for their next screening in ≤3 months) were randomized to receive usual care (patient reminders and clinician EHR alerts [n = 3671]), education (usual care plus educational materials about screening [n = 3960]), direct mail (usual care plus educational materials and a mailed self-sampling kit [n = 1482]), or to opt in (usual care plus educational materials and the option to request a kit [n = 3956]). Individuals who were overdue for screening were randomized to receive usual care (n = 5488), education (n = 1408), or direct mail (n = 1415). Individuals with unknown history for screening were randomized to receive usual care (n = 2983), education (n = 3486), or to opt in (n = 3506). Main Outcomes and Measures: The primary outcome was screening completion within 6 months. Primary analyses compared direct-mail or opt-in participants with individuals randomized to the education group. Results: The intention-to-treat analyses included 31 355 randomized individuals (mean [SD] age, 45.9 [10.4] years). Among those who were due for screening, compared with receiving education alone (1885 [47.6%]), screening completion was 14.1% (95% CI, 11.2%-16.9%) higher in the direct-mail group (914 [61.7%]) and 3.5% (95% CI, 1.2%-5.7%) higher in the opt-in group (2020 [51.1%]). Among individuals who were overdue, screening completion was 16.9% (95% CI, 13.8%-20.0%) higher in the direct-mail group (505 [35.7%]) compared with education alone (264 [18.8%]). Among those with unknown history, screening was 2.2% (95% CI, 0.5%-3.9%) higher in the opt-in group (634 [18.1%]) compared with education alone (555 [15.9%]). Conclusions and Relevance: Within a US health care system, direct-mail self-sampling increased cervical cancer screening by more than 14% in individuals who were due or overdue for cervical cancer screening. The opt-in approach minimally increased screening. To increase screening adherence, systems implementing HPV self-sampling should prioritize direct-mail outreach for individuals who are due or overdue for screening. For individuals with unknown screening history, testing alternative outreach approaches and additional efforts to document screening history are warranted. Trial Registration: ClinicalTrials.gov Identifier: NCT04679675.

Economic Evaluation of Mailed Home-Based Human Papillomavirus Self-sampling Kits for Cervical Cancer Screening.

Importance: Human papillomavirus (HPV) self-sampling addresses barriers to cervical cancer screening, and mailed self-sampling kits have been reported to increase screening uptake. International research suggests mailed kits are cost-effective in certain settings. However, the cost-effectiveness of mailing HPV self-sampling kits for increasing screening uptake has not been evaluated in the US. Objective: To conduct an economic evaluation of a mailed HPV self-sampling intervention among underscreened women enrolled in an integrated US health care system. Design, Setting, and Participants: This economic evaluation involved a cost-effectiveness analysis of results from a randomized clinical trial of 19 851 women aged 30 to 64 years enrolled in a health plan from Kaiser Permanente Washington (KPWA), a US-based integrated health care system. Women were identified through electronic medical records, and eligible participants were enrolled in a health plan for at least 3 years and 5 months, had a primary care clinician, had not received a Papanicolaou test for at least 3 years and 5 months, and had not received a hysterectomy. Enrollment occurred from February 25, 2014, to August 29, 2016, with follow-up through February 25, 2018. The current economic evaluation was conducted between August 2, 2021, and July 30, 2022. Intervention delivery costs were calculated from both the KPWA and Medicare perspectives and were based on either wellness visit or Papanicolaou test-only visit costs. Intervention: Participants in the control group received usual care, which comprised patient reminders and ad hoc outreach for screening. Participants in the intervention group received usual care plus a mailed HPV self-sampling kit. Main Outcome and Measures: The primary economic outcome was the incremental cost-effectiveness ratio (ICER) for increased screening uptake, defined as the incremental difference in cost (intervention group minus control group) divided by the difference in the number of participants completing screening (intervention group minus control group) within 6 months of randomization. Results: Among 19 851 women (mean [SD] age, 50.1 [9.5] years; 76.7% White), 9960 were randomized to the intervention group, and 9891 were randomized to the control group. Baseline ICERs ranged from $85.84 (95% CI, $85.68-$85.99) using KPWA wellness visits as the cost basis to $146.29 (95% CI, $146.20-$146.38) using Medicare Papanicolaou test-only visits as the cost source. Subgroups of participants aged 50 to 64 years and participants most recently overdue for screening achieved cost-effectiveness at lower levels of willingness to pay for an additional completed screening than other subgroups. Conclusions and Relevance: In this economic evaluation, mailing HPV self-sampling kits to women overdue for cervical cancer screening was cost-effective for increased screening uptake relative to usual care. These results support mailing HPV kits as an efficient outreach strategy for increasing screening rates among eligible women in US health care systems.

Design of a pragmatic randomized controlled trial of home-based human papillomavirus (HPV) self-sampling for increasing cervical cancer screening uptake in a U.S. healthcare system: The STEP trial.

BACKGROUND: Mailing HPV self-sampling kits to overdue individuals increases cervical cancer screening adherence; offering self-sampling to previously adherent individuals has not been evaluated in the U.S. Given heterogeneity of the U.S. health system and population, data are needed to optimize how HPV self-sampling is offered to individuals who are overdue, due after successful past screening, or have an unknown screening history. METHODS: STEP is a pragmatic randomized controlled trial set within a U.S. integrated healthcare delivery system, designed to compare different outreach approaches for offering HPV self-sampling in populations defined by prior screening behavior (previously-adherent, overdue, or unknown screening history). Over 14 months, eligible individuals were identified through electronic medical record (EMR) data and randomized to Usual Care (UC), Education (UC + educational materials about cervical cancer screening), Direct-Mail (UC + Education + a mailed self-sampling kit) or Opt-In (UC + Education + option to request a kit), depending on screening history. The primary objective is to compare screening completion by outreach approach and screening history. Secondary objectives include evaluating incremental cost-effectiveness of outreach approaches, and identifying patient preference for, and satisfaction with, HPV self-screening, and barriers to abnormal results follow-up (measured through interviews and focus groups). CONCLUSIONS: The trial was designed to generate data that U.S. health systems can use to inform primary HPV screening implementation strategies that incorporate HPV self-sampling options to improve screening access, adherence, and patient satisfaction. The objective of this report is to describe the rationale and design of this pragmatic trial.

Causal evaluation of the health effects of light rail line: A Natural Experiment.

BACKGROUND AND OBJECTIVE: No research to date has causally linked built environment data with health care costs derived from clinically assessed health outcomes within the framework of longitudinal intervention design. This study examined the impact of light rail transit (LRT) line intervention on health care costs after controlling for mode-specific objectively assessed moderateto-vigorous physical activity (MVPA), participant-level neighborhood environmental measures, demographics, attitudinal predispositions, and residential choices. DATA AND METHODS: Based on a natural experiment related to a new LRT line in Portland - 282 individuals divided into treatment and control groups were prospectively followed during the pre- and post-intervention periods. For each individual, we harness high-resolution data on Electronic Medical Record (EMR) based health care costs, mode-specific MVPA, survey-based travel behavior, attitudinal/perception information, and objectively assessed built environment measures. Simulation-assisted longitudinal grouped random parameter models are developed to gain more accurate insights into the effects of LRT line intervention. RESULTS: Regarding the "average effect" of the LRT line intervention, no statistically significant reductions in health care costs were observed for the treated individuals over time. However, substantial heterogeneity was observed not only in the magnitude of effects but its direction as well after controlling for the within- and between-individual variations. For a subgroup of treated individuals, the LRT line opening decreased health care costs over time relative to the control group. Further comparative analysis based on the findings of heterogeneity-based models revealed that the effect of LRT intervention for the treated individuals differed by individual characteristics, attitudes/perceptions, and neighborhood level environmental features. CONCLUSIONS: The study revealed the presence of significant effect modifiers and distinct subgroup structures in the data related to the effects of LRT line intervention on health care costs. Severe implications of ignoring unobserved heterogeneity are highlighted. Limitations and potential avenues for future research are discussed.

Health plan-based mailed fecal testing for colorectal cancer screening among dual-eligible Medicaid/Medicare enrollees: Outcomes of 2 program models.

BACKGROUND: Health insurance plans are increasingly offering mailed fecal immunochemical test (FIT) programs for colorectal cancer (CRC) screening, but few studies have compared the outcomes of different program models (eg, invitation strategies). METHODS: This study compares the outcomes of 2 health plan-based mailed FIT program models. In the first program (2016), FIT kits were mailed to all eligible enrollees; in the second program (2018), FIT kits were mailed only to enrollees who opted in after an outreach phone call. Participants in this observational study included dual-eligible Medicaid/Medicare enrollees who were aged 50 to 75 years and were due for CRC screening (1799 in 2016 and 1906 in 2018). Six-month FIT completion rates, implementation outcomes (eg, mailed FITs sent and reminders attempted), and program-related health plan costs for each program are described. RESULTS: All 1799 individuals in 2016 were sent an introductory letter and a FIT kit. In 2018, all 1906 were sent an introductory letter, and 1905 received at least 1 opt-in call attempt, with 410 (21.5%) sent a FIT. The FIT completion rate was 16.2% (292 of 1799 [95% CI, 14.5%-17.9%]) in 2016 and 14.6% (278 of 1906 [95% CI, 13.0%-16.2%]) in 2018 (P = .36). The overall implementation costs were higher in 2016 ($40,156) than 2018 ($34,899), with the cost per completed FIT slightly higher in 2016 ($138) than 2018 ($126). CONCLUSIONS: An opt-in mailed FIT program achieved FIT completion rates similar to those of a program mailing to all dual-eligible Medicaid/Medicare enrollees. LAY SUMMARY: Health insurance plans can use different program models to successfully mail fecal test kits for colorectal cancer screening to dual-eligible Medicaid/Medicare enrollees, with nearly 1 in 6 enrollees completing fecal testing.

A Centralized Program with Stepped Support Increases Adherence to Colorectal Cancer Screening Over 9 Years: a Randomized Trial.

BACKGROUND: Screening over many years is required to optimize colorectal cancer (CRC) outcomes. OBJECTIVE: To evaluate the effect of a CRC screening intervention on adherence to CRC screening over 9 years. DESIGN: Randomized trial. SETTING: Integrated health care system in Washington state. PARTICIPANTS: Between August 2008 and November 2009, 4653 adults in a Washington state integrated health care system aged 50-74 due for CRC screening were randomized to usual care (UC; N =1163) or UC plus study interventions (interventions: N = 3490). INTERVENTIONS: Years 1 and 2: (arm 1) UC or this plus study interventions; (arm 2) mailed fecal tests or information on scheduling colonoscopy; (arm 3) mailings plus brief telephone assistance; or (arm 4) mailings and assistance plus nurse navigation. In year 3, stepped-intensity participants (arms 2, 3, and 4 combined) still eligible for screening were randomized to either stopped or continued interventions in years 3 and 5-9. MAIN MEASURES: Time in adherence to CRC testing over 9 years (covered time, primary outcome), and percent with no CRC testing in participants assigned to any intervention compared to UC only. Poisson regression models estimated incidence rate ratios for covered time, adjusting for patient characteristics and accounting for variable follow-up time. KEY RESULTS: Compared to UC, intervention participants had 21% more covered time over 9 years (57.5% vs. 69.1%; adjusted incidence rate ratio 1.21, 95% confidence interval 1.16-1.25, P<0.001). Fecal testing accounted for almost all additional covered time among intervention patients. Compared to UC, intervention participants were also more likely to have completed at least one CRC screening test over 9 years or until censorship (88.6% vs. 80.6%, P<0.001). CONCLUSIONS: An outreach program that included mailed fecal tests and phone follow-up led to increased adherence to CRC testing and fewer age-eligible individuals without any CRC testing over 9 years. TRIAL REGISTRATION: Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up (SOS), NCT00697047, clinicaltrials.gov/ct2/show/NCT00697047.

Validity of the Exercise Vital Sign Tool to Assess Physical Activity.

INTRODUCTION: Assessment and counseling by healthcare providers can successfully increase physical activity; however, a valid instrument to effectively measure physical activity is needed. This study examines the validity of the Exercise Vital Sign tool by comparing Exercise Vital Sign data collected at Kaiser Permanente Northwest with accelerometry data. METHODS: Participants (n=521) completed accelerometer monitoring and had ≥1 Exercise Vital Sign measurement in their electronic medical record. Using accelerometry as the gold standard, the association between moderate-to-vigorous physical activity minutes per week estimated through Exercise Vital Sign and that estimated through accelerometry was examined using the Spearman correlation coefficient. Comparability of moderate-to-vigorous physical activity categories (inactive, lowly active, moderately active, sufficiently active) was assessed using simple and weighted κ statistics. Sensitivity, specificity, and positive and negative predictive values were calculated. The study was conducted in 2012-2015, with analysis in 2019-2020. RESULTS: Average accelerometry-based moderate-to-vigorous physical activity was 212 minutes per week, and 57% of the participants were considered sufficiently active. Exercise Vital Sign‒based moderate-to-vigorous physical activity averaged 170 minutes per week, and 53% of the participants were active. There was a positive correlation between the moderate-to-vigorous physical activity minutes per week reported through Exercise Vital Sign and that reported through accelerometry (r =0.38, p<0.0001). A fair agreement was observed between Exercise Vital Sign‒ and accelerometry-based moderate-to-vigorous physical activity categories (weighted κ=0.29), with the highest agreement occurring for those with physical activity level ≥150 minutes per week. The positive correlation increased when moderate-to-vigorous physical activity was examined dichotomously (<150 or ≥150 minutes per week, κ=0.34). The sensitivity, specificity, positive predictive value, and negative predictive value for Exercise Vital Sign (when compared with those of accelerometry) were 67%, 68%, 61%, and 73%, respectively. CONCLUSIONS: The Exercise Vital Sign is a useful physical activity assessment tool that correctly identifies the majority of adults who do and do not meet physical activity guidelines.

Dietary Patterns with Healthy and Unhealthy Traits Among Overweight/Obese Hispanic Women with or at High Risk for Type 2 Diabetes.

Hispanic women are at high risk for type 2 diabetes (T2D), with obesity and unhealthy eating being important contributing factors. A cross-sectional design was used in this study to identify dietary patterns and their associations with diabetes risk factors. Participants completed a culturally adapted Food Frequency Questionnaire capturing intake over the prior 3 months. Overweight/obese Hispanic women (n = 191) with or at risk for T2D were recruited from a community clinic into a weight loss intervention. Only baseline data was used for this analysis. Dietary patterns and their association with diabetes risk factors (age, body mass index, abdominal obesity, elevated fasting blood glucose [FBG], and hemoglobin A1c). An exploratory factor analysis of dietary data adjusted for energy intake was used to identify eating patterns, and Pearson correlation coefficient (r) to assess the association of the eating patterns with the diabetes risk factors. Six meaningful patterns with healthful and unhealthful traits emerged: (1) sugar and fat-laden, (2) plant foods and fish, (3) soups and starchy dishes, (4) meats and snacks, (5) beans and grains, and (6) eggs and dairy. Scores for the "sugar and fat-laden" and "meats and snacks" patterns were negatively associated with age (r = - 0.230, p = 0.001 and r = - 0.298, p < 0.001, respectively). Scores for "plant foods and fish" were positively associated with FBG (r = 0.152, p = 0.037). Being younger may be an important risk factor for a diet rich in sugar and fat; this highlights the need to assess dietary patterns among younger Hispanic women to identify traits potentially detrimental for their health.

Costs of Two Health Insurance Plan Programs to Mail Fecal Immunochemical Tests to Medicare and Medicaid Plan Members.

BeneFIT is a 4-year observational study of a mailed fecal immunochemical test (FIT) program in 2 Medicaid/Medicare health plans in Oregon and Washington. In Health Plan Oregon's (HPO) collaborative model, HPO mails FITs that enrollees return to their clinics for processing. In Health Plan Washington's (HPW) centralized model, FITs are mailed directly to enrollees who return them to a centralized laboratory. This paper examines model-specific Year 1 development and implementation costs and estimates costs per screened enrollee. Staff completed activity-based costing spreadsheets. Non-labor costs were from study and external data. Data matched each plan's 2016 development and implementation dates. HPO development costs were $23.0K, primarily administration (eg, clinic recruitment). HPW development costs were $37.3K, 38.8% for FIT selection and mailing/tracking protocols. Year 1 implementation costs were $51.6K for HPO and $139.7K for HPW, reflecting HPW's greater outreach. Labor was 50.4% ($26.0K) of HPO's implementation costs, primarily enrollee eligibility and processing returned FITs, and was shared by HPO ($17.0K) and 6 participating clinics ($9.0K). Labor was 10.5% of HPW's implementation costs, primarily administration and enrollee eligibility. HPO's implementation costs per enrollee were 12.3% higher ($18.36) than for HPW ($16.34). Similar proportions of completed FITs among screening-eligibles produced a 15% lower cost per completed FIT in HPW ($89.75) vs. HPO ($105.79). Implementation costs for HPO only (without clinic costs) were $15.16/mailed introductory letter, $16.09/mailed FIT, and $87.35/completed FIT, comparable to HPW. Results highlight cost implications of different approaches to implementing a mailed FIT program in 2 Medicaid/Medicare health plans.

School-Level Factors Associated with Sun Protection Practices in California Elementary Schools.

BACKGROUND: This study examined implementation of district sun safety policy in schools and tested correlates of implementation in California public school districts. METHODS: Principals (N = 118) and teachers (N = 113) in California public elementary schools (N = 118) were recruited and completed a survey on sun protection policies and practices. The sample contained schools whose districts subscribed to the California School Boards Association and adopted Board Policy 5141.7 for sun safety. Principals and teachers reported on implementation of 10 school practices related to BP 5141.7 indicating which practices were implemented in the school. RESULTS: Years in public education (Exponentiated Score (ES) = 0.51, p < .001), years worked in the current district (ES = 0.49, p < .001), perception that parents should take action to protect children from the sun (ES = 0.43, p < .01), and personal skin phenotype (Low Risk ES = 0.55; High Risk ES = 0.09, p < .05) were associated with number of practices implemented in the school using multiple Poisson regression. CONCLUSIONS: Policy implementation is more likely among schools with experienced faculty, when parents are seen as important partners in student skin cancer prevention, and when school principals and teachers have a lower personal risk phenotype.

Economic Evaluation of a Sun Protection Promotion Program in California Elementary Schools.

BACKGROUND: An economic evaluation of Sun Safe Schools intervention designed to aid California elementary schools with implementing sun safety practices consistent with local board-approved policy. DESIGN: Program cost analysis: intervention delivery and practice implementation. SETTING: California elementary schools (58 interventions and 60 controls). Principals at 52 intervention and 53 control schools provided complete implementation data. PARTICIPANTS: Principals completing pre-/postintervention surveys assessing practice implementation. INTERVENTION: Phone-based 45-minute session with a project coach on practice implementation, follow-up e-mails/phone contacts, $500 mini-grant. Schools chose from a list of 10 practices for implementation: ultraviolet monitoring, clothing, hats, and/or sunscreen recommendations, outdoor shade, class education, staff training and/or modeling, parent outreach, and resource allocation. The duration of intervention was 20 months. Rolling recruitment/intervention: February 2014 to December 2017. MEASURES: Intervention delivery and practice implementation costs. Correlations of school demographics and administrator beliefs with costs. ANALYSIS: Intervention delivery activities micro-costed. Implemented practices assessed using costing template. RESULTS: Intervention schools: 234 implemented practices, control schools: 157. Twenty-month delivery costs: $29 310; $16 653 (per school: $320) for project staff, mostly mini-grants and coaching time. Administrator costs: $12 657 (per school: $243). Per-student delivery costs: $1.01. Costs of implemented practices: $641 843 for intervention schools (per-school mean: $12 343, median: $6 969); $496 365 for controls (per-school mean: $9365, median: $3123). Delivery costs correlated with implemented practices (0.37, P < .01) and total practice costs (0.37, P < .05). Implemented practices correlated with principal beliefs about the importance of skin cancer prevention to student health (0.46, P < .001) and parents (0.45, P < .001). CONCLUSION: Coaching of elementary school personnel can stimulate sun safety practice implementation at a reasonable cost. Findings can assist schools in implementing appropriate sun safety practices.

Economic Evaluation of an Intervention Promoting Adoption of Occupational Sun Protection Policies.

OBJECTIVE: Economic evaluation of an intervention promoting adoption of occupational sun protection actions by Colorado public sector employers. METHODS: Randomized controlled trial with 2-year follow-up conducted during 2010 to 2013. Thirty-three intervention and 30 attention-control worksites in final economic sample. Twenty-four-month intervention of personal contacts, training, and materials. Intervention delivery micro-costed. Costs of implemented actions from employer self-report. RESULTS: Twenty-four-month intervention costs: $121,789, 51.8% incurred by project staff (per-worksite mean=$1,732). Worksite costs: $58,631 (mean = $1,777). Per-employee costs: $118 project staff, $56 worksites. Materials cost: $5990 (mean = $181). Intervention worksites implemented 72 nontraining sun protection actions post-Sun Safe Workplaces (SSW) (mean = 2.18). Control worksites implemented 39 actions (mean = 1.30). Total costs to intervention worksites of implementing the 72 post-SSW actions: $90,645 (mean = $2,747). Control worksite costs: $66,467 (mean = $2,216). Per-employee implementation costs are comparable to other worksite health interventions. CONCLUSION: SSW expanded adoption of sun protection actions at a reasonable per-employee cost.

Financial Incentives to Increase Colorectal Cancer Screening Uptake and Decrease Disparities: A Randomized Clinical Trial.

Importance: Colorectal cancer screening rates are suboptimal, particularly among sociodemographically disadvantaged groups. Objective: To examine whether guaranteed money or probabilistic lottery financial incentives conditional on completion of colorectal cancer screening increase screening uptake, particularly among groups with lower screening rates. Design, Setting, and Participants: This parallel, 3-arm randomized clinical trial was conducted from March 13, 2017, through April 12, 2018, at 21 medical centers in an integrated health care system in western Washington. A total of 838 age-eligible patients overdue for colorectal cancer screening who completed a questionnaire that confirmed eligibility and included sociodemographic and psychosocial questions were enrolled. Interventions: Interventions were (1) mail only (n = 284; up to 3 mailings that included information on the importance of colorectal cancer screening and screening test choices, a fecal immunochemical test [FIT], and a reminder letter if necessary), (2) mail and monetary (n = 270; mailings plus guaranteed $10 on screening completion), or (3) mail and lottery (n = 284; mailings plus a 1 in 10 chance of receiving $50 on screening completion). Main Outcomes and Measures: The primary outcome was completion of any colorectal cancer screening within 6 months of randomization. Secondary outcomes were FIT or colonoscopy completion within 6 months of randomization. Intervention effects were compared across sociodemographic subgroups and self-reported psychosocial measures. Results: A total of 838 participants (mean [SD] age, 59.7 [7.2] years; 546 [65.2%] female; 433 [52.2%] white race and 101 [12.1%] Hispanic ethnicity) were included in the study. Completion of any colorectal screening was not significantly higher for the mail and monetary group (207 of 270 [76.7%]) or the mail and lottery group (212 of 284 [74.6%]) than for the mail only group (203 of 284 [71.5%]) (P = .11). For FIT completion, interventions had a statistically significant effect (P = .04), with a net increase of 7.7% (95% CI, 0.3%-15.1%) in the mail and monetary group and 7.1% (95% CI, -0.2% to 14.3%) in the mail and lottery group compared with the mail only group. For patients with Medicaid insurance, the net increase compared with mail only in FIT completion for the mail and monetary or the mail and lottery group was 37.7% (95% CI, 11.0%-64.3%) (34.2% for the mail and monetary group and 40.4% for the mail and lottery group) compared with a net increase of only 5.6% (95% CI, -0.9% to 12.2%) among those not Medicaid insured (test for interaction P = .03). Conclusions and Relevance: Financial incentives increased FIT uptake but not overall colorectal cancer screening. Financial incentives may decrease screening disparities among some sociodemographically disadvantaged groups. Trial Registration: ClinicalTrials.gov identifier: NCT00697047.

The Health and economic effects of light rail lines: design, methods, and protocol for a natural experiment.

BACKGROUND: The health impacts of community design have been studied extensively over the past two decades. In particular, public transportation use is associated with more walking between transit stops and shops, work, home and other destinations. Change in transit access has been linked with physical activity and obesity but seldom to health outcomes and associated costs, especially within a causal framework. Health related fiscal impacts of transit investment should be a key consideration in major transit investment decisions. METHODS: The Rails & Health study is a natural experiment evaluating changes in clinical measures, health care utilization and health care costs among Kaiser Permanente Northwest (KPNW) members following the opening of a new light rail transit (LRT) line in Portland, Oregon. The study is prospectively following 3036 adults exposed to the new LRT line and a similar cohort of 4386 adults who do not live close to the new line. Individual-level outcomes and covariates are extracted from the electronic medical record at KPNW, including member demographics and comorbidities, blood pressure, body mass index, lipids, glycosylated hemoglobin, and health care utilization and costs. In addition, participants are surveyed about additional demographics, travel patterns, physical activity (PA), and perceived neighborhood walkability. In a subsample of the study population, we are collecting direct measures of travel-related behavior-physical activity (accelerometry), global positioning system (GPS) tracking, and travel diaries-to document mechanisms responsible for observed changes in health outcomes and cost. Comprehensive measures of the built environment at baseline and after rail construction are also collected. Statistical analyses will (1) examine the effects of opening a new LRT line on chronic disease indicators, health care utilization, and health care costs and (2) evaluate the degree to which observed effects of the LRT line on health measures and costs are mediated by changes in total and transportation-associated PA. DISCUSSION: The results of the Rails & Health study will provide urban planners, transportation engineers, health practitioners, developers, and decision makers with critical information needed to document how transit investments impact population health and related costs.

A cost-effectiveness analysis of a colorectal cancer screening program in safety net clinics.

STOP CRC is a cluster-randomized pragmatic study of a colorectal cancer (CRC) screening program within eight federally-qualified health centers (FQHCs) in Oregon and California promoting fecal immunochemical testing (FIT) with appropriate colonoscopy follow-up. Results are presented of a cost-effectiveness analysis of STOP CRC. Organization staff completed activity-based costing spreadsheets, assigning labor hours by intervention activity and job-specific wage rates. Non-labor costs were from study data. Data were collected over February 2014-February 2016; analyses were performed in 2016-2017. Incremental cost-effectiveness ratios (ICERs) using completed FITs adjusted for number of screening-eligible patients (SEPs), as the effectiveness measure were calculated overall and by organization. Intervention delivery costs totaled $305 K across eight organizations (range: $10.2 K-$110 K). Overall delivery cost per SEP was $14.43 (range: $10.37-$19.10). The largest cost category across organizations was implementation, specifically mailing preparation. The overall ICER was $483 per SEP-adjusted completed FIT (range: $96-$1021 among organizations with positive effectiveness). Lagged data accounting for implementation delay produced comparable results. The costs of colonoscopies following abnormal FITs decreased the overall ICER to S409 because usual care clinics generated more such colonoscopies than intervention clinics. Using lagged data, follow-up colonoscopies increase the ICER by 4.3% to $460. Results indicate the complex implications for cost-effectiveness of implementing standard CRC screening within a pragmatic setting involving FQHCs with varied patient populations, clinical structures, and resources. Performance variation across organizations emphasizes the need for future evaluations that inform the introduction of efficient CRC screening to underserved populations.

Implementation of Occupational Sun Safety at a 2-Year Follow-Up in a Randomized Trial: Comparison of Sun Safe Workplaces Policy Intervention to Attention Control.

PURPOSE: Implementation of employer sun safety actions was assessed in a 2-year follow-up to an occupational sun protection policy intervention. DESIGN: Two-year follow-up assessment in a randomized pretest-posttest controlled design. SETTING: Local government organizations with workers in public safety, public works, and parks and recreation. PARTICIPANTS: Sixty-three local government organizations (participation = 64%) and 330 frontline supervisors and 1454 workers. INTERVENTION: Sun Safe Workplaces (SSW) intervention promoting occupational sun safety policy and education. MEASURES: Observations of SSW messages and sun safety items and surveys on organizations' communication and actions on sun safety. ANALYSIS: Comparison between SSW and control groups was conducted using regression models and adjusted for clustering where appropriate, with α criterion set at P = .05 (2-tailed). RESULTS: At intervention worksites, more SSW messages ( P < .001) and sun safety items ( P = .025) were observed; more frontline supervisors reported organizations provided free/reduced price sunscreen ( P = .005) and communicated about sun safety ( P < .001); and more workers recalled receiving sun safety messages ( P < .001) and sun safety training ( P <.001) compared to control organizations. Implementation was greater at larger than smaller intervention organizations for wide-brimmed hats ( P = .009), long work pants ( P = .017), and shade structures ( P = .036). Older workers received the most written messages ( P = .015). CONCLUSIONS: Sun Safe Workplaces appeared to produce actions by organizations to support employee sun safety. Large organizations may have processes, communication channels, and slack resources to achieve more implementation.

Positive predictive values of fecal immunochemical tests used in the STOP CRC pragmatic trial.

Annual fecal immunochemical testing (FIT) is cost-effective for colorectal cancer (CRC) screening. However, FIT positivity rates and positive predictive value (PPV) can vary substantially, with false-positive (FP) results adding to colonoscopy burden without improving cancer detection. Our objective was to describe FIT PPV and the factors associated with FP results among patients undergoing CRC screening. In an ongoing pragmatic clinical trial of mailed-FIT outreach, clinics delivered one of three FIT brands (InSure, OC-Micro, and Hemosure). Patients who had a positive FIT result and a follow-up colonoscopy were included in this analysis (N = 1130). Patients' demographic and medical histories were abstracted from electronic health records (EHR). Associations with a FP result (ie, a positive FIT result with no evidence of advanced neoplasia during follow-up colonoscopy) were evaluated for FIT brand and patient factors using mixed-effects multivariable logistic regression. The mean proportion of FIT-positive results ranged from 8% in centers using the OC-Micro test to 21% for Hemosure. PPVs for advanced neoplasia were 0.30 to 0.17, respectively (P for χ2  = 0.08). In multivariable-adjusted models, use of Hemosure was associated with greater odds of a FP result than OC-Micro (OR = 2.00, 95% CI: 0.47-8.56) or InSure (OR = 1.72, 95% CI: 0.44-6.68). However, only female sex (OR = 1.58, 95% CI: 1.19-2.10) and history of a colorectal condition (OR = 2.17, 95% CI: 1.13-4.15) were significantly associated with FP. In conclusion, FIT positivity varied by brand, and FP results differed by patient factors available through the EHR. These results can be used to minimize the frequency of FP results, reducing patient distress and colonoscopy burden.

Accuracy of Principal and Teacher Knowledge of School District Policies on Sun Protection in California Elementary Schools.

INTRODUCTION: Policy is a key aspect of school-based efforts to prevent skin cancer. We explored the extent and accuracy of knowledge among principals and teachers in California public school districts about the elements specified in their district's written sun safety policy. METHODS: The sample consisted of California public school districts that subscribed to the California School Boards Association, had an elementary school, adopted Board Policy 5141.7 for sun safety, and posted it online. The content of each policy was coded. Principals (n = 118) and teachers (n = 113) in elementary schools were recruited from September 2013 through December 2015 and completed a survey on sun protection policies and practices from January 2014 through April 2016. RESULTS: Only 38 of 117 principals (32.5%) were aware that their school district had a sun protection policy. A smaller percentage of teachers (13 of 109; 11.9%) than principals were aware of the policy (F108 = 12.76, P < .001). We found greater awareness of the policy among principals and teachers who had more years of experience working in public education (odds ratio [OR] = 1.05, F106 = 4.71, P = .03) and worked in schools with more non-Hispanic white students (OR = 7.65, F109 = 8.61, P = .004) and fewer Hispanic students (OR = 0.28, F109 = 4.27, P = .04). CONCLUSION: Policy adoption is an important step in implementing sun safety practices in schools, but districts may need more effective means of informing school principals and teachers of sun safety policies. Implementation will lag without clear understanding of the policy's content by school personnel.

A centralized mailed program with stepped increases of support increases time in compliance with colorectal cancer screening guidelines over 5 years: A randomized trial.

BACKGROUND: Screening over many years is required to optimize reductions in colorectal cancer (CRC) mortality. However, no prior trials have compared strategies for obtaining long-term adherence. METHODS: Systems of Support to Increase Colorectal Cancer Screening and Follow-Up was implemented in an integrated health care organization in Washington State. Between 2008 and 2009, 4675 individuals aged 50 to 74 years were randomized to receive the usual care (UC), which included clinic-based strategies to increase CRC screening (arm 1), or, in years 1 and 2, mailings with a call-in number for colonoscopy and mailed fecal tests (arm 2), mailings plus brief telephone assistance (arm 3), or mailings and assistance plus nurse navigation (arm 4). Active-intervention subjects (those in arms 2, 3, and 4 combined) who were still eligible for CRC screening were randomized to mailings being stopped or continued in years 3 and 5. The time in compliance with CRC screening over 5 years was compared for persons assigned to any intervention and persons assigned to UC. Screening tests contributed time on the basis of national guidelines for screening intervals (fecal tests annually, sigmoidoscopy every 5 years, and colonoscopy every 10 years). RESULTS: All participants contributed data, but they were censored at disenrollment, death, the age of 76 years, or a diagnosis of CRC. Compared with UC participants, intervention participants had 31% more adjusted covered time over 5 years (incidence rate ratio, 1.31; 95% confidence interval, 1.25-1.37; covered time, 47.5% vs 62.1%). Fecal testing accounted for almost all additional covered time. CONCLUSIONS: In a health care organization with clinic-based activities to increase CRC screening, a centralized program led to increased CRC screening adherence over 5 years. Longer term data on screening adherence and its impact on CRC outcomes are needed. Cancer 2017;123:4472-80. © 2017 American Cancer Society.