Socioeconomic status and inequities in treatment initiation and survival among patients with cancer, 2011-2022.

BACKGROUND: Lower neighborhood socioeconomic status (SES) is associated with suboptimal cancer care and reduced survival. Most studies examining cancer inequities across area-level socioeconomic status tend to use less granular or unidimensional measures and pre-date the COVID-19 pandemic. Here, we examined the association of area-level socioeconomic status on real-world treatment initiation and overall survival among adults with 20 common cancers. METHODS: This retrospective cohort study used electronic health record-derived deidentified data (Flatiron Health Research Database, 2011-2022) linked to US Census Bureau data from the American Community Survey (2015-2019). Area-level socioeconomic status quintiles (based on a measure incorporating income, home values, rental costs, poverty, blue-collar employment, unemployment, and education information) were computed from the US population and applied to patients based on their mailing address. Associations were examined using Cox proportional hazards models adjusted for diagnosis year, age, sex, performance status, stage, and cancer type. RESULTS: This cohort included 291 419 patients (47.7% female; median age = 68 years). Patients from low-SES areas were younger and more likely to be Black (21.9% vs 3.3%) or Latinx (8.4% vs 3.0%) than those in high-SES areas. Living in low-SES areas (vs high) was associated with lower treatment rates (hazard ratio = 0.94 [95% confidence interval = 0.93 to 0.95]) and reduced survival (median real-world overall survival = 21.4 vs 29.5 months, hazard ratio = 1.20 [95% confidence interval = 1.18 to 1.22]). Treatment and survival inequities were observed in 9 and 19 cancer types, respectively. Area-level socioeconomic inequities in treatment and survival remained statistically significant in the COVID-19 era (after March 2020). CONCLUSION: To reduce inequities in cancer outcomes, efforts that target marginalized, low-socioeconomic status neighborhoods are necessary.

Natural History of Human Epidermal Growth Factor Receptor 2-Amplified and Human Epidermal Growth Factor Receptor 2 Wild-Type Refractory Metastatic Colorectal Cancer in US Clinical Practice.

PURPOSE: The molecular heterogeneity of metastatic colorectal cancer (mCRC) presents a therapeutic challenge, with few trials focused on patients with human epidermal growth factor receptor 2 amplification (HER2-Amp). Our limited understanding of real-world patterns and outcomes by HER2 status of treatment-refractory patients leaves treatment decisions with little contextual information. We conducted a retrospective cohort study to describe the natural disease history of patients with refractory mCRC using an electronic health record-derived database with oncogenomic information. METHODS: We included patients with stage IV or recurrent mCRC diagnosed from January 2011 through December 2019 from a deidentified clinicogenomic database. Patients with ≥ 2 documented clinic visits, ≥ 2 lines of therapy (LOT) after mCRC diagnosis, and comprehensive genomic profiling were eligible. Patient records defined by treatment-refractory LOT were allocated to the HER2-Amp or HER2 wild-type (WT) cohort on the basis of comprehensive genomic profiling. Index date was defined as the start of any treatment-refractory LOT (≥ 2 LOT; patients could contribute multiple records). Descriptive statistics included demographic and clinical characteristics, treatments, laboratory values, and biomarkers. Overall survival (OS) was calculated as time (in months) from the index date until death from any cause and analyzed using Kaplan-Meier methodology. Sensitivity analyses were conducted to test the robustness of the primary findings. RESULTS: A total of 576 patients were included (1,339 records); 63 (158 records) were HER2-Amp, and 513 (1,181 records) were HER2-WT. Demographics, clinical characteristics, biomarkers, and laboratory values were comparable between HER2 cohorts. OS was similar, with an unadjusted median OS of 11.2 months (95% CI, 8.6 to 15.1) and 9.9 months (95% CI, 8.3 to 10.9) across LOT for HER2-Amp and HER2-WT cohorts, respectively. CONCLUSION: This study showed considerable treatment heterogeneity and poor outcomes among patients with treatment-refractory mCRC, emphasizing a substantial unmet therapeutic need.

ERBB2 Copy Number as a Quantitative Biomarker for Real-World Outcomes to Anti-Human Epidermal Growth Factor Receptor 2 Therapy in Advanced Gastroesophageal Adenocarcinoma.

PURPOSE: Human epidermal growth factor receptor 2 (HER2) overexpression or amplification (ERBB2amp) are biomarkers for approved anti-HER2 therapies. ERBB2amp may better predict response compared with immunohistochemistry or in situ hybridization, and quantitative copy number (CN) may further stratify patients. We characterized ERBB2amp in advanced gastroesophageal adenocarcinomas (GEA) and hypothesized that increased CN was associated with better outcome to trastuzumab. METHODS: Comprehensive genomic profiling, including assessment of ERBB2amp, was performed for 12,905 GEA tissue cases. Clinical outcomes were assessed using a clinicogenomic database linking deidentified electronic health record-derived clinical data to genomic data. Multivariable Cox proportional hazard models were used for real-world progression-free survival (rwPFS) comparisons. RESULTS: ERBB2amp (CN ≥ 5) was detected in 15% (1,934 of 12,905) of GEA; median CN 22 (interquartile range 9-73). Median ERBB2 amplicon size was 0.27 megabase (interquartile range 0.13-0.95), and smaller amplicons were associated with higher CN (P < .001). In the clinicogenomic database, of 101 evaluable first-line trastuzumab-treated patients, ERBB2 CN was a significant predictor of rwPFS as a continuous variable (adjusted hazard ratio = 0.73; 95% CI, 0.60 to 0.89; P = .002), whereas ERBB2 CN was not predictive of rwPFS on chemotherapy (adjusted hazard ratio = 0.93; 95% CI, 0.73 to 1.20; P = .59). Among trastuzumab-treated patients, no significant associations with ERBB2 CN were observed for disease site, age, stage at advanced diagnosis, or most selected coalterations. CONCLUSION: ERBB2amp was detected in 15% of GEA tissue samples, with significant diversity in ERBB2 CN and amplicon focality. ERBB2 CN was predictive of rwPFS as a continuous variable for patients treated with trastuzumab. Further studies exploring the clinical utility of quantitative ERBB2 CN, particularly in the setting of the evolving anti-HER2 landscape and combination therapies, are warranted.

Accounting for Delayed Entry in Analyses of Overall Survival in Clinico-Genomic Databases.

BACKGROUND: Clinico-genomic databases favor inclusion of long-term survivors, leading to potentially biased overall survival (OS) analyses. Risk set adjustments relying on the independent delayed entry assumption may mitigate this bias. We aimed to determine whether this assumption is satisfied in a dataset of patients with advanced non-small cell lung cancer (aNSCLC), and to give guidance for clinico-genomic OS analyses when the assumption is not satisfied. METHODS: We analyzed the association of timing of next-generation sequencing (NGS) testing with real-world OS (rwOS) in patient data from a United States-based nationwide longitudinal deidentified electronic health records-derived database. Estimates of rwOS using risk set adjustment were compared with estimates computed with respect to all patients, regardless of NGS testing. RESULTS: The independent delayed entry assumption was not satisfied in this database, and later sequencing had a negative association with the hazard of death after sequencing. In a model adjusted for relevant characteristics, each month delay in sequencing was associated with a 2% increase in the hazard of death. However, until the median survival time, estimates of OS using risk set adjustment are similar to estimates computed for all patients, regardless of NGS testing. CONCLUSIONS: rwOS analyses in clinico-genomic databases should assess the independent delayed entry assumption. Comparisons versus broader population may be useful to evaluate the rwOS differences between calculations using risk set adjustment and patient cohorts where the bias relates to overrepresentation of long survivors. IMPACT: This study illustrates practices that can increase the interpretability of findings from OS analyses in clinico-genomic databases.

Bayesian additional evidence for decision making under small sample uncertainty.

BACKGROUND: Statistical inference based on small datasets, commonly found in precision oncology, is subject to low power and high uncertainty. In these settings, drawing strong conclusions about future research utility is difficult when using standard inferential measures. It is therefore important to better quantify the uncertainty associated with both significant and non-significant results based on small sample sizes. METHODS: We developed a new method, Bayesian Additional Evidence (BAE), that determines (1) how much additional supportive evidence is needed for a non-significant result to reach Bayesian posterior credibility, or (2) how much additional opposing evidence is needed to render a significant result non-credible. Although based in Bayesian analysis, a prior distribution is not needed; instead, the tipping point output is compared to reasonable effect ranges to draw conclusions. We demonstrate our approach in a comparative effectiveness analysis comparing two treatments in a real world biomarker-defined cohort, and provide guidelines for how to apply BAE in practice. RESULTS: Our initial comparative effectiveness analysis results in a hazard ratio of 0.31 with 95% confidence interval (0.09, 1.1). Applying BAE to this result yields a tipping point of 0.54; thus, an observed hazard ratio of 0.54 or smaller in a replication study would result in posterior credibility for the treatment association. Given that effect sizes in this range are not extreme, and that supportive evidence exists from a similar published study, we conclude that this problem is worthy of further research. CONCLUSIONS: Our proposed method provides a useful framework for interpreting analytic results from small datasets. This can assist researchers in deciding how to interpret and continue their investigations based on an initial analysis that has high uncertainty. Although we illustrated its use in estimating parameters based on time-to-event outcomes, BAE easily applies to any normally-distributed estimator, such as those used for analyzing binary or continuous outcomes.

Real-world association of HER2/ERBB2 concordance with trastuzumab clinical benefit in advanced esophagogastric cancer.

Aim: To assess concordance between HER2 status measured by traditional methods and ERBB2 amplification measured by next-generation sequencing and its association with first-line trastuzumab clinical benefit in patients with advanced esophagogastric cancer. Methods: Retrospective analysis of HER2/ERBB2 concordance using a deidentified USA-based clinicogenomic database. Clinical outcomes were assessed for patients with HER2+ advanced esophagogastric cancer who received first-line trastuzumab. Results: Overall HER2/ERBB2 concordance was 87.5%. Among patients who received first-line trastuzumab, concordant HER2/ERBB2 was associated with longer time to treatment discontinuation (adjusted hazard ratio [aHR]: 0.63; 95% CI: 0.43-0.90) and overall survival (aHR: 0.51; 95% CI: 0.33-0.79). ERBB2 copy number ≥25 (median) was associated with longer time to treatment discontinuation (aHR: 0.56; 95% CI: 0.35-0.88) and overall survival (aHR: 0.52; 95% CI: 0.30-0.91). Conclusion: HER2/ERBB2 concordance and higher ERBB2 copy number predicted clinical benefit from trastuzumab.

Lay abstract Trastuzumab is a drug that has been shown to prolong survival in some patients with advanced esophagogastric cancer whose tumor expresses a protein biomarker called HER2. There are different methods for assessing whether a patient's tumor expresses HER2, including but not limited to traditional methods such as immunohistochemistry and in situ hybridization and novel methods such as next-generation sequencing, which detects alterations in the gene (ERBB2) that encodes the HER2 protein. In our study, we assessed concordance between HER2 status (HER2-positive or HER2-negative) measured by traditional methods and ERBB2 amplification measured by next-generation sequencing, to determine whether there was an association between concordance and clinical benefit in patients with advanced esophagogastric cancer treated with trastuzumab. Our results suggest that, when HER2 positivity is detected through traditional methods, both ERBB2 concordance (i.e., agreement that a patient's tumor had the biomarker) and a higher ERBB2 copy number (the amount of the ERBB2 gene expressed by the tumor) were associated with longer time to treatment discontinuation and overall survival in patients with advanced esophagogastric cancer treated with first-line trastuzumab.

TRK Fusion Cancer: Patient Characteristics and Survival Analysis in the Real-World Setting.

BACKGROUND: Neurotrophic tyrosine receptor kinase (NTRK) gene fusions are oncogenic drivers in various tumor types. While NTRK gene fusions are predictive of benefit from tropomyosin receptor kinase inhibitors regardless of tumor type, the prognostic significance of NTRK gene fusions in a pan-tumor setting remains unclear. OBJECTIVE: This study evaluated the characteristics and prognosis of tropomyosin receptor kinase fusion cancer in the real-world setting. PATIENTS AND METHODS: This retrospective study used a de-identified clinico-genomic database and included patients with cancer who had comprehensive genomic profiling between January 2011 and July 2018. Patients were classified as having cancer with NTRK gene fusions or NTRK wild-type genes. Patients were matched with a 1:4 ratio (NTRK fusion:NTRK wild-type) using the Mahalanobis distance method on demographic and clinical characteristics, including age and Eastern Cooperative Oncology Group performance status. Descriptive analysis of clinical and molecular characteristics was conducted. Kaplan-Meier estimator and Cox regression were used for overall survival analysis. RESULTS: Median overall survival was 12.5 months (95% confidence interval 9.5-not estimable) and 16.5 months (95% confidence interval 12.5-22.5) in the NTRK gene fusion (n = 27) and NTRK wild-type cohorts (n = 107), respectively (hazard ratio 1.44; 95% confidence interval 0.61-3.37; p = 0.648). Co-occurrence of select targetable biomarkers including ALK, BRAF, ERBB2, EGFR, ROS1, and KRAS was lower in cancers with NTRK gene fusions than in NTRK wild-type cancers. CONCLUSIONS: Although the hazard ratio for overall survival suggested a higher risk of death for patients with NTRK gene fusions, the difference was not statistically significant. Co-occurrence of NTRK gene fusions and other actionable biomarkers was uncommon.

RAS Amplification as a Negative Predictor of Benefit from Anti-EGFR-Containing Therapy Regimens in Metastatic Colorectal Cancer.

BACKGROUND: RAS short variant (SV) mutations in colorectal cancer (CRC) are associated with lack of benefit from epidermal growth factor receptor (EGFR) monoclonal antibody (EGFRmAb). However, the clinical implications for RAS amplification (RASa) as a biomarker for anti-EGFR therapy in CRC remain ill defined. METHODS: Genomic analysis was performed using the Foundation Medicine (FM) comprehensive genomic profiling database of 37,233 CRC cases. Clinical outcomes were assessed using two independent cohorts: the City of Hope (COH) cohort of 338 patients with metastatic CRC (mCRC) and the Flatiron Health-FM real-world clinicogenomic database (CGDB) of 3,904 patients with mCRC. RESULTS: RASa was detected in 1.6% (614/37,233) of primarily mCRC. RASa 6-9 (n = 241, 39%), 10-19 (n = 165, 27%), and ≥ 20 (n = 209, 34%) copy number subsets had co-RAS SV/BRAF V600E in 63%/3%, 31%/0.6%, and 4.8%/0% of cases, respectively. In the COH cohort, six patients with RASa (13-54 copies) received EGFRmAb, four of six had progressive disease, two had stable disease, and median time to treatment discontinuation (TTD) was 2.5 months. Of the CGDB EGFRmAb-treated patients, those with RASa (n = 9) had median TTD of 4.7 months and overall survival (OS) of 11.4 months, those with RAS SV (n = 101) had median TTD and OS of 5.3 and 9.4 months, and those with RAS/BRAF wild-type (n = 608) had median TTD and OS of 7.6 and 13.7 months. CONCLUSION: Patients with RASa without RAS mutations (1.1% of mCRC) may have poor outcomes on EGFRmAb, although numbers herein were small, and interpretation is confounded by combination chemotherapy. Larger independent studies are warranted to determine if RASa, including degree of amplification, may act similarly to RAS mutation as a resistance mechanism to EGFRmAb therapies. IMPLICATIONS FOR PRACTICE: Genomic data suggest that RAS amplification occurs as the sole RAS/RAF alteration in >1% of colorectal cancer cases and that degree of amplification inversely correlates with co-occurring MAPK pathway alterations. Preliminary clinical evidence suggests that RAS amplification may function similarly to RAS mutation as a negative predictor of benefit from anti-epidermal growth factor receptor therapies in colorectal cancer. More clinical data are needed, and comprehensive genomic profiling, including detection of RAS amplification, should be used in trial design to inform therapy selection.

Retrospective analysis of real-world data to determine clinical outcomes of patients with advanced non-small cell lung cancer following cell-free circulating tumor DNA genomic profiling.

OBJECTIVES: Liquid biopsy and comprehensive genomic profiling (CGP) of circulating tumor DNA (ctDNA) are increasingly used for detection of targetable genomic alterations (GA) in non-small cell lung cancer (NSCLC). To examine the clinical outcomes for patients following CGP using liquid biopsy versus tissue biopsy, receipt of matched targeted therapy post-CGP and associated outcomes were evaluated in the real-world setting. METHODS: 6491 patients with NSCLC and liquid biopsy (N = 937 tests) and/or tissue (N = 5582 tests) CGP were included in a de-identified commercial clinico-genomic database. Targetable GAs included National Comprehensive Cancer Network NSCLC guideline biomarkers. Clinical characteristics, real-world progression, and real-world response (rwR) were obtained via technology-enabled abstraction of clinician notes and radiology/pathology reports. RESULTS: At the time of liquid biopsy CGP, 53% (496/937) of patients were documented to have received ≥1 line of prior therapy (tissue CGP: 13%, 735/5582). 90% (832/928) of liquid biopsy cases had evidence of ctDNA. A targetable GA was detected in 20% (188/937) of liquid biopsy and 22% (1215/5582) of tissue CGP cases. Use of matched targeted therapy overall was similar post-liquid biopsy or post-tissue CGP but varied considerably across emerging (25%, 79/317) versus standard of care (SOC) (74%, 475/640) GA. Real-world-progression free survival for patients receiving SOC first line matched targeted therapy administered following liquid biopsy (n = 33) and tissue (n = 229) CGP were similar (13.8 vs 10.6 months; aHR = 0.68 [0.36-1.26]). Among patients evaluated for rwR, overall response rate (partial/complete response) to matched targeted therapy post-liquid biopsy CGP was 75% (39/52) versus 66% post-tissue CGP (254/385, P = 0.51). CONCLUSION: Retrospective analysis of real-world clinico-genomic data demonstrated that clinical outcomes on matched targeted therapy were similar following liquid biopsy and tissue CGP in NSCLC, which suggests routine clinical use of liquid biopsy CGP can reliably guide therapy selection.

Clinical and Genomic Characteristics of Small Cell Lung Cancer in Never Smokers: Results From a Retrospective Multicenter Cohort Study.

BACKGROUND: Small cell lung cancer (SCLC) has the strongest association with smoking among lung cancers. The characteristics of never smokers with SCLC is not known. RESEARCH QUESTION: Are the clinical characteristics, prognostic factors, survival, genomic alterations, and tumor mutational burdens of SCLC in patients who have never smoked different from those who have smoked? STUDY DESIGN AND METHODS: A retrospective multicenter cohort study of patients with clinician-confirmed SCLC was performed with the use of a longitudinal and nationally representative electronic medical records database. Smoking history was assessed through technology-enabled abstraction and confirmed for never smokers via chart review. Genomic characteristics of never smoker patients with SCLC were examined with the use of a next-generation sequencing-based gene panel and whole exome sequencing. RESULTS: One hundred of 5,632 patients (1.8%) with SCLC were never smokers. Relative to smokers, never smokers were more likely to be female (66.0% vs 52.4%; P = .009) and present with extensive stage (70.0% vs 62.2%; P = .028). Never smokers had a higher proportion of patients in age groups 35 to 49 years (7.0% vs 3.0%; P = .006) and ≥80 years (17.0% vs 8.2%; P = .006). Known risk factors for lung cancer were found in <20% of never smokers. There were no overall survival differences between never smokers and smokers. Among patients with available genomic data (n = 9), never smoker SCLC were characterized by lower tumor mutational burden, a lower frequency of TP53 mutations, and an absence of mutational signatures related to tobacco exposure. INTERPRETATION: The sex- and age-specific distribution of SCLC among never smokers, along with differences that were identified by genomic analyses, suggests a distinct biology of SCLC in never smokers compared with smokers.

Comparison of Treatment, Cost, and Survival in Patients With Metastatic Colorectal Cancer in Western Washington, United States, and British Columbia, Canada.

PURPOSE: Few studies have directly compared health care utilization, costs, and outcomes between patients treated in the US multipayer health system and Canada's single-payer system. Using cancer registry and claims data, we assessed treatment types, costs, and survival for patients with metastatic colorectal cancer (mCRC) in Western Washington State (WW) and British Columbia (BC). MATERIALS AND METHODS: Patients age ≥ 18 years diagnosed with mCRC in 2010 and later were identified from the BC Cancer database and a regional database linking WW SEER to claims from Medicare and two large commercial insurers. Demographics, treatment characteristics, costs of systemic therapy, and survival data were obtained from these databases and compared between the two regions. RESULTS: A total of 1,592 patients from BC and 901 from WW were included in the study. Median age was similar (BC, 66 years; WW, 63 years), but patients in BC were more likely to be male (57.1% v 51.2%; P ≤ .01) and to have de novo metastatic disease (61.0% v 38.3%; P ≤ .01). The use of radiation therapy was similar between regions (BC, 31.2%; WW, 33.9%; P = .18), but primary tumor resection was more common in BC (74.1% v 66.3%; P ≤ .01) as was hepatic metastasectomy (12.4% v 2.3%; P ≤ .01). Similar percentages of patients received systemic therapy (BC, 68.8%; WW, 67.1%; P = .40), but costs were significantly higher for first-line systemic therapy in WW ($6,226 v $15,792 per patient per month; P ≤ .01). Median overall survival was similar (BC, 16.9 months; WW, 18 months). CONCLUSION: Cost of systemic therapy for mCRC was significantly higher for patients in WW than in BC, but this did not translate to a difference in overall survival.

Outcomes of the Adelante community social marketing campaign for Latino youth.

The authors designed and evaluated an innovative, branded campaign called 'Adelante' to promote positive youth development (PYD) and reduce risk behaviors among Latino youth near Washington, DC. Repeated cross-sectional surveys were conducted in the intervention and a comparison community to evaluate campaign exposure and changes in PYD outcomes. The sample consisted of 1549 Latino and immigrant adolescents surveyed at three time points in intervention and comparison communities. A social marketing campaign was implemented using outdoor advertising, Web, video and social media channels to promote PYD and health outcomes over a 1-year period from 2015 to 2016. Measures included media use; self-reported exposure to campaign promotions; Adelante message receptivity; validated PYD scales; substance use, sexual risk taking, violence-related knowledge, attitudes, beliefs, intentions and risk behavior. Outcomes were regressed first on campaign exposure to examine dose-response effects of the Adelante campaign over time. Second, we compared outcomes between the Adelante and comparison communities. We observed a positive effect of self-reported exposure on multiple outcomes, including improvements in pro-violence and sexual risk outcomes and lower pro-violence attitudes and lower risky attitudes toward sex. Adelante was effective in improving youth risk outcomes and offers a promising model for future health promotion with Latino and immigrant populations.

The Saleema initiative in Sudan to abandon female genital mutilation: Outcomes and dose response effects.

PURPOSE: The overall goal of the Saleema Initiative in Sudan is to promote long-term abandonment of female genital mutilation and cutting (FGM) through a contribution to changing social norms, attitudes, and intentions related to the practice. The initiative aims to create positive cultural associations with a girl remaining uncut, a new social norm. Saleema hypothesizes that branding the alternative to FGM (abandonment) will promote social norms change. In 2014, the lead author designed a monitoring and evaluation framework for Saleema in partnership with UNICEF, the National Council for Child Welfare (NCCW), and local organizations. METHODS: The Saleema evaluation aimed to evaluate the effectiveness of the campaign in reducing pro-FGM social norms. A quasi-experimental design controlled for dosage of campaign messages delivered across the 18 states in Sudan to measure a dose-response effect. We operationalized social norms through a 4-item scale validated in previous research. RESULTS: This paper reports on quantitative evaluation findings based on data gathered in from 2015-2017 and focuses on the dose-response relationship between Saleema exposure and changes in FGM social norms. We found that self-reported exposure was associated with reduced pro-FGM social norms (coeff. = -0.329, p < .001). Additionally, higher doses of Saleema, measured through an exogenous measure of campaign event exposure from an independent monitoring system was associated with reduced pro-FGM social norms (coeff. = -0.146, p < .001). CONCLUSIONS: Saleema was effective in reducing pro-FGM social norms. It is a promising strategy and findings contribute to the growing literature on social norms approaches to behavior change.

The Mediating Effect of Adelante brand equity on Latino Immigrant Positive Youth Development Outcomes.

This paper reports on mediation analysis of effects of the Adelante brand, an innovative program for Latino immigrant adolescents and their families, and positive youth development (PYD) outcomes. Specific objectives were to increase adolescent engagement and participation in a community-based program called Adelante, based on PYD theory, which sought to reduce substance use, sexual risk taking, and interpersonal violence among Latino immigrant youth. A total of 238 parent-child dyads were recruited from a predominantly low-income Latino immigrant community and followed for an average of 22 months. Measures included demographics; acculturation; stress and coping; social support; violence, substance use, and sexual risk attitudes; future expectations; the Adelante brand equity scale; and PYD asset measures. Multiple regression modeling shows that the leadership brand equity construct is associated with decreased proviolence and increased antiviolence attitudes. Additionally, having any program exposure (vs. none) is associated with improved substance abuse attitudes in models adjusting for the loyalty brand equity construct. In mediation analysis, we observed a mediating effect of the leadership brand equity construct on improved antiviolence attitudes among those exposed to the Adelante program. As found in previous research, Adelante brand equity operated as a mediator of program effects on Latino youth PYD outcomes.

Effects of the truth FinishIt brand on tobacco outcomes.

Since 2000, the truth campaign has grown as a social marketing brand. Back then, truth employed branding to compete directly with the tobacco industry. In 2014, the launch of truth FinishIt reflected changes in the brand's strategy, the tobacco control environment, and youth/young adult behavior. Building on a previous validation study, the current study examined brand equity in truth FinishIt, as measured by validated multi-dimensional scales, and tobacco related attitudes, beliefs, and behavior based on two waves of the Truth Longitudinal Cohort data from 2015 and 2016. A fixed effects logistic regression was used to estimate the change in brand equity between panel survey waves 3 and 4 on past 30-day smoking among ever and current smokers. Additional models determined the effects of brand equity predicting tobacco attitudes/use at follow up among the full sample. All analyses controlled for demographic factors. A one-point increase in the brand equity scale between the two waves was associated with a 66% greater chance of not smoking among ever smokers (OR 1.66, CI 1.11-2.48, p < 0.05) and an 80% greater chance of not smoking among current smokers (OR 1.80, CI 1.05-3.10, p < 0.05). Higher overall truth brand equity at wave 3 predicted less smoking at wave 4 and more positive anti-tobacco attitudes. Being male, younger, and non-white predicted some of the tobacco related attitudes. Future research should examine long-term effects of brand equity on tobacco use and how tobacco control can optimize the use of branding in campaigns.

Federally Qualified Health Center Substitution of Local Health Department Services.

INTRODUCTION: Strategic and budgetary considerations have shifted local health departments (LHDs) away from safety net clinical services and toward population-focused services. Federally Qualified Health Centers (FQHCs) play an increasing role in the safety net, and may complement or substitute for LHD clinical services. The authors examined the association between FQHC service levels in communities and the presence of specific LHD clinical services in 2010 and 2013. METHODS: Data from LHD surveys and FQHC service data were merged for 2010 and 2013. Multivariate regression and instrumental variable methods were used to examine FQHC service levels that might predict related LHD service presence or discontinuation from 2010 to 2013. RESULTS: There were modest reductions in LHD service presence and increases in FQHC service volume over the time period. LHD primary care and dental service presence were inversely associated with higher related FQHC service volume. LHD prenatal care service presence, as well as a measure of change in general service approach, were not significantly associated with FQHC service volume. CONCLUSIONS: LHDs were less likely to provide certain clinical services where FQHCs provide a greater volume of services, suggesting a substitution effect. However, certain clinical services, such as prenatal care, may complement the public health mission-and LHDs may be strategically placed to continue to deliver these services.

The Living the Example Social Media Substance Use Prevention Program: A Pilot Evaluation.

BACKGROUND: Adolescent substance use rates in rural areas of the United States, such as upstate New York, have risen substantially in recent years, calling for new intervention approaches in response to this trend. The Mentor Foundation USA conducts the Living the Example (LTE) campaign to engage youth in prevention using an experiential approach. As part of LTE, youth create their own prevention messages following a training curriculum in techniques for effective messaging and then share them via social media. This paper reports on a pilot evaluation of the LTE program. OBJECTIVE: To conduct a pilot test of LTE in two rural high schools in upstate New York. We hypothesized that positive antidrug brand representations could be promoted using social media strategies to complement the Shattering the Myths (STM) in-person, event-based approach (hypothesis 1, H1), and that youth would respond positively and engage with prevention messages disseminated by their peers. We also hypothesized that exposure to the social media prevention messages would be associated with more positive substance use avoidance attitudes and beliefs, reductions in future use intentions, and decreased substance use at posttest (hypothesis 2, H2). METHODS: We adapted a previously published curriculum created by the authors that focuses on branding, messaging, and social media for prevention. The curriculum consisted of five, one-hour sessions. It was delivered to participating youth in five sequential weeks after school at the two high schools in late October and early November 2016. We designed a pre- and posttest pilot implementation study to evaluate the effects of LTE on student uptake of the intervention and short-term substance use and related outcomes. Working at two high schools in upstate New York, we conducted a pilot feasibility evaluation of LTE with 9th-grade students (ie, freshmen) at these high schools. We administered a 125-item questionnaire online to capture data on media use; attitudes toward social media; next 30-day personal drug use intentions; personal reasons to use drugs; reasons participants believe their peers would use drugs; self-reported exposure to the LTE program; and receptivity to the LTE program, among those reporting exposure. We constructed multivariable logistic regression models to analyze the relationship between program receptivity and outcomes. First, in a cross-sectional logistic regression model, we regressed self-reported LTE message receipt on drug use intent and actions related to LTE messaging. Then, for analysis of participants with matched pre- and posttest responses, we used multilevel generalized estimating equation (GEE) techniques to model changes in behavior from baseline to follow-up. RESULTS: Youth reported increased intentions to use marijuana (odds ratio [OR] 2.134, P=.02) between pre- and posttest. However, youth who reported exposure and receptivity to LTE reported a significant decrease in intentions (OR 0.239, P=.008). We observed a similar pattern for sedatives/sleeping pills-an increase in intentions overall (OR 1.886, P=.07), but a decrease among youth who reported exposure and receptivity to LTE (OR 0.210, P=.02). We saw the same pattern for use of any drug-an increase in reported intentions overall (OR 2.141, P=.02), but a decrease among youth who reported exposure and receptivity to LTE (OR 0.111, P=.004). CONCLUSIONS: We observed some evidence of significant LTE program effects. Social media may be an effective strategy for peer-to-peer substance use prevention in the future. These findings point both to the potential of LTE and the social media diffusion model and to the need for more research on a larger scale with an expanded youth population in the future.

Design and Feasibility Testing of the truth FinishIt Tobacco Countermarketing Brand Equity Scale.

The original truth campaign was a branded, national smoking prevention mass media effort focused on at-risk youth ages 12-17. Today the truth brand focuses on the goal of finishing tobacco (truth FinishIt). There have been significant changes in the tobacco control landscape, leading FinishIt to focus on 15- to 21-year-olds. The present article reports on formative research and media monitoring data collected to pilot test a new truth FinishIt brand equity scale. The goals of this study were to (a) content analyze truth FinishIt mass media ads, (b) assess truth's social media and followers' perceptions of truth's digital brand identity, and (c) develop and feasibility test a new version of the truth FinishIt brand equity scale using data from an existing Truth Initiative media monitoring study. Through factor analysis, we identified a brand equity scale, as in previous research, consisting of 4 main constructs: brand loyalty, leadership/satisfaction, personality, and awareness. Targeted truth attitudes and beliefs about social perceptions, acceptability, and industry-related beliefs were regressed on the higher order factor and each of the 4 individual brand equity factors. Ordinary least squares regression models generally showed associations in the expected directions (positive for anti-tobacco and negative for pro-tobacco) between targeted attitudes/beliefs and truth FinishIt brand equity. This study succeeded in developing and validating a new truth FinishIt brand equity scale. The scale may be a valuable metric for future campaign evaluation. Future studies should examine the effects of truth FinishIt brand equity on tobacco use behavioral outcomes over time.

The 5-4-3-2-1 go! Brand to promote nutrition and physical activity: a case of positive behavior change but negative change in beliefs.

In recent years, community-based obesity prevention programs have taken an ecological approach and addressed social determinants of obesity. The branded 5-4-3-2-1 Go! obesity prevention program aims to change obesity risk behaviors in low-income neighborhoods in Chicago with a multilevel approach. This study follows a previous evaluation, which showed 5-4-3-2-1 Go! exposure to be associated with increased fruit and vegetable consumption. The authors examined whether increased positive beliefs about fruit and vegetable consumption were associated with exposure to program messages. Exploratory factor analysis identified a fresh fruit/vegetable availability satisfaction factor. The authors compared outcome measures between baseline and follow-up samples and between exposure and control conditions. Multivariable logistic regression models were estimated to evaluate the effects of program exposure on changes in nutrition beliefs. The study found that participants' (n = 246) beliefs about fruit and vegetable consumption were negatively associated with exposure to the program and that demographic factors, social environment, and physical environment were strongly associated with beliefs about fruit and vegetable consumption. These findings merit further research and may indicate the environmental factors that are associated with attitude formation among those reached by obesity prevention interventions, especially when many participants live in neighborhoods lacking convenient fruit and vegetable shopping options.

Dose-response effects of the text4baby mobile health program: randomized controlled trial.

BACKGROUND: Mobile health (mHealth) is growing rapidly, but more studies are needed on how to optimize programs, including optimal timing of messaging, dose of exposure, and value of interactive features. This study evaluates final outcomes of text4baby (a text message service for pregnant and postpartum women) from a randomized trial performed in a population of pregnant female soldiers and family members. OBJECTIVE: The study aims were to evaluate (1) treatment effects and (2) dose-response effects of text4baby on behavioral outcomes compared to control (no text4baby) condition. METHODS: The study was a randomized trial of text4baby at Madigan Army Medical Center. Female military health beneficiaries who met inclusion criteria were eligible for the study. Participants provided consent, completed a baseline questionnaire, and then were randomized to enroll in text4baby or not. They were followed up at 3 time points thereafter through delivery of their baby. Generalized estimating equation models were used to evaluate outcomes. We examined treatment effects and the effects of higher doses of text4baby messages on outcomes. RESULTS: We report descriptive statistics including dosage of text messages delivered. The main finding was a significant effect of high exposure to text4baby on self-reported alcohol consumption postpartum (OR 0.212, 95% CI 0.046-0.973, P=.046), as measured by the question "Since you found out about your pregnancy, have you consumed alcoholic beverages?" The text4baby participants also reported lower quantities of alcohol consumed postpartum. CONCLUSIONS: Studies of text4baby have helped to build the mHealth evidence base. The effects of text4baby offer lessons for future scalable mHealth programs and suggest the need to study dose-response effects of these interventions.