Financial Incentives for Smoking Cessation Among Socioeconomically Disadvantaged Adults: A Randomized Clinical Trial.

Importance: Socioeconomically disadvantaged individuals (ie, those with low socioeconomic status [SES]) have difficulty quitting smoking and may benefit from incentive-based cessation interventions. Objectives: To evaluate the impact of incentivizing smoking abstinence on smoking cessation among adults with low SES. Design, Setting, and Participants: This study used a 2-group randomized clinical trial design. Data collection occurred between January 30, 2017, and February 7, 2022. Participants included adults with low SES who were willing to undergo smoking cessation treatment. Data were analyzed from April 18, 2023, to April 19, 2024. Interventions: Participants were randomized to usual care (UC) for smoking cessation (counseling plus pharmacotherapy) or UC plus abstinence-contingent financial incentives (UC plus FI). Main Outcomes and Measures: The primary outcome was biochemically verified 7-day point prevalence smoking abstinence (PPA) at 26 weeks after the quit date. Secondary outcomes included biochemically verified 7-day PPA at earlier follow-ups, 30-day PPA at 12 and 26 weeks, repeated 7-day PPA, and continuous abstinence. Multiple approaches were employed to handle missing outcomes at follow-up, including categorizing missing data as smoking (primary), complete case analysis, and multiple imputation. Results: The 320 participants had a mean (SD) age of 48.9 (11.6) and were predominantly female (202 [63.1%]); 82 (25.6%) were Black, 15 (4.7%) were Hispanic, and 200 (62.5%) were White; and 146 (45.6%) participated during the COVID-19 pandemic. Overall, 161 were randomized to UC and 159 were randomized to UC plus FI. After covariate adjustment with missing data treated as smoking, assignment to UC plus FI was associated with a greater likelihood of 7-day PPA at the 4-week (adjusted odds ratio [AOR], 3.11 [95% CI, 1.81-5.34]), 8-week (AOR, 2.93 [95% CI, 1.62-5.31]), and 12-week (AOR, 3.18 [95% CI, 1.70-5.95]) follow-ups, but not at the 26-week follow-up (22 [13.8%] vs 14 [8.7%] abstinent; AOR, 1.79 [95% CI, 0.85-3.80]). However, the association of group assignment with smoking cessation reached statistical significance at all follow-ups, including 26 weeks, with multiple imputation (37.37 [23.5%] in the UC plus FI group vs 19.48 [12.1%] in the UC group were abstinent; AOR, 2.29 [95% CI, 1.14-4.63]). Repeated-measures analyses indicated that participants in the UC plus FI group were significantly more likely to achieve PPA across assessments through 26 weeks with all missing data estimation methods. Other secondary cessation outcomes also showed comparable patterns across estimation methods. Participants earned a mean (SD) of $72 ($90) (of $250 possible) in abstinence-contingent incentives. Participation during the COVID-19 pandemic reduced the likelihood of cessation across assessments. Conclusions and Relevance: In this randomized clinical trial, incentivizing smoking cessation did not increase cessation at 26 weeks when missing data were treated as smoking; however, the UC plus FI group had greater odds of quitting at follow-ups through 12 weeks. Cessation rates were higher for the UC plus FI group at all follow-ups through 26 weeks when multiple imputation was used to estimate missing outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT02737566.

A Comprehensive Assessment of Co-occurring Birth Defects among Infants with Non-Syndromic Anophthalmia or Microphthalmia.

PURPOSE: Infants with anophthalmia or microphthalmia frequently have co-occurring birth defects. Nonetheless, there have been few investigations of birth defect patterns among these children. Such studies may identify novel multiple malformation syndromes, which could inform future research into the developmental processes that lead to anophthalmia/microphthalmia and assist physicians in determining whether further testing is appropriate. METHODS: This study includes cases with anophthalmia/microphthalmia identified by the Texas Birth Defects Registry from 1999 to 2014 without clinical or chromosomal diagnoses of recognized syndromes. We calculated adjusted observed-to-expected ratios for two - through five-way birth defect combinations involving anophthalmia/microphthalmia to estimate whether these combinations co-occur more often than would be expected if they were independent. We report combinations observed in ≥5 cases. RESULTS: We identified 653 eligible cases with anophthalmia/microphthalmia (514 [79%] with co-occurring birth defects), and 111 birth defect combinations, of which 44 were two-way combinations, 61 were three-way combinations, six were four-way combinations and none were five-way combinations. Combinations with the largest observed-to-expected ratios were those involving central nervous system (CNS) defects, head/neck defects, and orofacial clefts. We also observed multiple combinations involving cardiovascular and musculoskeletal defects. CONCLUSION: Consistent with previous reports, we observed that a large proportion of children diagnosed with anophthalmia/microphthalmia have co-occurring birth defects. While some of these defects may be part of a sequence involving anophthalmia/microphthalmia (e.g., CNS defects), other combinations could point to as yet undescribed susceptibility patterns (e.g., musculoskeletal defects). Data from population-based birth defect registries may be useful for accelerating the discovery of previously uncharacterized malformation syndromes.

A novel approach for propensity score matching and stratification for multiple treatments: Application to an electronic health record-derived study.

Currently, methods for conducting multiple treatment propensity scoring in the presence of high-dimensional covariate spaces that result from "big data" are lacking-the most prominent method relies on inverse probability treatment weighting (IPTW). However, IPTW only utilizes one element of the generalized propensity score (GPS) vector, which can lead to a loss of information and inadequate covariate balance in the presence of multiple treatments. This limitation motivates the development of a novel propensity score method that uses the entire GPS vector to establish a scalar balancing score that, when adjusted for, achieves covariate balance in the presence of potentially high-dimensional covariates. Specifically, the generalized propensity score cumulative distribution function (GPS-CDF) method is introduced. A one-parameter power function fits the CDF of the GPS vector and a resulting scalar balancing score is used for matching and/or stratification. Simulation results show superior performance of the new method compared to IPTW both in achieving covariate balance and estimating average treatment effects in the presence of multiple treatments. The proposed approach is applied to a study derived from electronic medical records to determine the causal relationship between three different vasopressors and mortality in patients with non-traumatic aneurysmal subarachnoid hemorrhage. Results suggest that the GPS-CDF method performs well when applied to large observational studies with multiple treatments that have large covariate spaces.

Cost-Effectiveness of Adding Androgen Deprivation Therapy to Radiation Therapy for Men with Advanced Prostate Cancer from a U.S. Payer's Perspective.

BACKGROUND: No study has investigated the cost and effectiveness of androgen deprivation therapy (ADT) and other curative treatment therapies among the Medicare population, and no study has taken into consideration the long-term side effects associated with ADT. OBJECTIVE: To examine if adding ADT was cost-effective when accounting for ADT-related long-term side effects in men with prostate cancer. METHODS: For this cost-utility analysis, we used the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database to estimate and compare patient survival, costs from a health payer's perspective, and cost-effectiveness of 3 treatment modalities for advanced prostate cancer patients, including radiation therapy, radiation plus ADT, and active surveillance. We also estimated quality-adjusted life-years (QALYs) by assigning appropriate health state utility values obtained from the literature for each phase of care and for long-term side effects. Propensity score matching was used to control for bias and confounding that were inherent to the observational study design. RESULTS: Adding ADT to radiation therapy increased median patient survival by 0.71 years. The incremental cost-effectiveness ratio (ICER) for radiation plus ADT versus radiation alone was $63,049 and $295,995 per mean life-year gained for radiation compared with active surveillance, respectively. Treatment-associated adverse side effects substantially reduced QALYs gained. Compared with radiation only, the incremental cost of radiation plus ADT was $127,900 per mean QALY and was nearly 80% cost-effective at a willingness-to-pay threshold of $210,000 per QALY. CONCLUSIONS: Despite ADT-associated costs and long-term side effects, compared with radiation alone, radiation plus ADT was cost-effective at $127,900 per QALY. DISCLOSURES: This research was supported in part by the Cancer Prevention Research Institute of Texas (grant nos. RP130051 and RP170668). The authors declare that there are no conflicts of interest.

Racial, Socioeconomic, and Geographic Disparities in the Receipt, Timing to Initiation, and Duration of Adjuvant Androgen Deprivation Therapy in Men with Prostate Cancer.

OBJECTIVE: This retrospective cohort study aims to examine the receipt, timing to initiation, and duration of androgen deprivation therapy (ADT) in men with prostate cancer by race/ethnicity, socioeconomic status, and geographic location. METHODS: The study population are patients from Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database, who were 66 years or older and newly diagnosed with stage III and IV prostate cancer in 1992-2009 and underwent radiation therapy, where ADT was proven to be highly beneficial and its use was considered as most appropriate (n = 12,170). We use logistic regression to examine the receipt of ADT and linear regression to study factors associated with time to ADT initiation while controlling for baseline characteristics. RESULTS: Overall, 77% of eligible patients received at least one form of ADT in combination with radiation therapy, of which 12% underwent orchiectomy and the rest received ADT, and 77.2% of non-Hispanic white and 80.7% of Hispanic patients received ADT compared to 73.8% of non-Hispanic black. After adjustment for demographic and tumor characteristics, black men and men of other races are less likely to receive ADT compared to white counterparts (OR = 0.64 and 0.74, respectively). The median time from cancer diagnosis to ADT initiation is 2 months. Once initiated, men received a median of seven drug injections. After controlling for covariates, race/ethnicity and geographic location (SEER areas) are associated with early initiation of therapy. White, Hispanic men and men living in the South initiate ADT earlier. CONCLUSION: Significant racial disparities exist in the receipt and use of this highly beneficial therapy, and there are geographic variations in the utilization of this therapy.

Risks of Major Long-Term Side Effects Associated with Androgen-Deprivation Therapy in Men with Prostate Cancer.

STUDY OBJECTIVE: To examine the risks and compare the occurrences of major long-term side effects (sexual dysfunction, bone fractures, diabetes, cardiovascular morbidity, acute myocardial infarction [MI], and dementia) in patients with prostate cancer who received androgen-deprivation therapy (ADT) with those who did not. DESIGN: Propensity score-matched retrospective cohort study using Medicare claims data. DATA SOURCE: National Cancer Institute's Surveillance, Epidemiology, and End Results Program-Medicare linked database. PATIENTS: A total of 201,797 patients 66 years or older who were diagnosed with any stage of prostate cancer between 1992 and 2009; of these, 94,528 patients received ADT; 107,269 patients did not. MEASUREMENTS AND MAIN RESULTS: We identified receipt of ADT and number of claims for ADT, and ascertained the long-term treatment-related side effects that occurred during 19 years of follow-up, from 1992-2010, from Medicare claims data. Cox proportional hazards models were used to estimate the incidences and hazard ratios (HRs) of newly developed side effects. Among all potential long-term side effects, the risk of bone fractures was highest (HR 1.39, 95% confidence interval [CI] 1.35-1.43), followed by diabetes (HR 1.21, 95% CI 1.18-1.24), dementia (HR 1.16, 95% CI 1.13-1.20), coronary heart disease (HR 1.12, 95% CI 1.09-1.14), and acute MI (HR 1.11, 95% CI 1.08-1.15) in those who received ADT compared with those who did not. The HRs for bone fractures and diabetes increased steadily as the number of ADT doses increased, indicating a linear trend in the dose-response relationship. Compared with patients who received active surveillance, ADT was associated with a 12% increased risk of sexual dysfunction (HR 1.12, 95% CI 1.05-1.20). The HR for sexual dysfunction increased to 1.68 (95% CI 1.59-1.77) when ADT was combined with radiation therapy and to 3.54 (95% CI 3.26-3.85) when ADT was combined with radiation and surgery. CONCLUSION: The results of this study demonstrated that in men with prostate cancer, receipt of ADT was associated with higher risks of bone fractures, diabetes, dementia, coronary heart disease, acute MI, and sexual dysfunction than in those who did not receive ADT.

Methods for Early Control of Abdominal Hemorrhage: An Assessment of Potential Benefit.

BACKGROUND: Noncompressible truncal hemorrhage (NCTH) after injury is associated with a mortality increase that is unchanged during the past 20 years. Current treatment consists of rapid transport and emergent intervention. Three early hemorrhage control interventions that may improve survival are placement of a resuscitative endovascular balloon occlusion of the aorta (REBOA), injection of intracavitary self-expanding foam, and application of the Abdominal Aortic Junctional Tourniquet (AAJT™). The goal of this work was to ascertain whether patients with uncontrolled abdominal or pelvic hemorrhage might benefit by the early or prehospital use of one of these interventions. METHODS: This was a single-center retrospective study of patients who received a trauma laparotomy from 2013 to 2015. Operative reports were reviewed. The probable benefit of each hemorrhage control method was evaluated for each patient based on the location(s) of injury and the severity of their physiologic derangement. The potential scope of applicability of each control method was then directly compared. RESULTS: During the study period, 9,608 patients were admitted; 402 patients required an emergent trauma laparotomy. REBOA was potentially beneficial for hemorrhage control in 384 (96%) of patients, foam in 351 (87%), and AAJT in 35 (9%). There was no statistically significant difference in the potential scope of applicability between REBOA and foam (ρ = .022). There was a significant difference between REBOA and AAJT (ρ < .001) and foam and AAJT™ (ρ < .001). The external surface location of signs of injury did not correlate with the internal injury location identified during laparotomy. CONCLUSION: Early use of REBOA and foam potentially benefits the largest number of patients with abdominal or pelvic bleeding and may have widespread applicability for patients in the preoperative, and potentially the prehospital, setting. AAJT may be useful with specific types of injury. The site of bleeding must be considered before the use of any of these tools.

Does Juvenile Detention Impact Health?

Youth involved in the juvenile justice system represent a medically underserved population. Recidivist youth have poorer health outcomes compared to youth detained for the first time. This study determined differences in immunization history, substance use, mental health symptoms, and sexual behavior between recidivist youth and first-time detainees following improvements in intake screenings at a large, urban juvenile detention center in the Southeastern United States. Multivariable logistic regression analysis found that recidivist youth had significantly higher acellular pertussis immunization rates compared with first-time detainees (odds ratio [ OR] = 3.3; p = .02), and recidivist males were less likely to test positive for chlamydia ( OR = 0.6; p = .03) after controlling for age and Black race. There was no significant difference for most other outcomes between recidivist youth and first-time detainees after controlling for age.

Clinical and Economic Evaluation of Treatment Strategies for T1N0 Anal Canal Cancer.

OBJECTIVE: A comparative assessment of treatment alternatives for T1N0 anal canal cancer has never been conducted. We compared the outcomes associated with the treatment alternatives-chemoradiotherapy (CRT), radiotherapy (RT), and surgery or ablation techniques (surgery/ablation)-for T1N0 anal canal cancer. MATERIALS AND METHODS: This retrospective cohort study was conducted using the Surveillance, Epidemiology and End Results (SEER) registries linked with Medicare longitudinal data (SEER-Medicare database). Analysis included 190 patients who were treated for T1N0 anal canal cancer using surgery/ablation (n=44), RT (n=50), or CRT (n=96). The outcomes were reported in terms of survival and hazards ratios using Kaplan-Meier and Cox proportional hazards modeling, respectively; lifetime costs; and cost-effectiveness measured in terms of incremental cost-effectiveness ratio, that is, the ratio of the difference in costs between the 2 alternatives to the difference in effectiveness between the same 2 alternatives. RESULTS: There was no significant difference in the survival duration between the treatment groups as predicted by the Kaplan-Meier curves. After adjusting for patient characteristics and propensity score, the hazard ratio of death for the patients who received CRT compared with surgery/ablation was 1.742 (95% confidence interval, 0.793-3.829) and RT was 2.170 (95% confidence interval, 0.923-5.101); however, the relationship did not reach statistical significance. Surgery/ablation resulted in lower lifetime cost than RT or CRT. The incremental cost-effectiveness ratio associated with CRT compared with surgery/ablation was $142,883 per life year gained. CONCLUSIONS: There was no statistically significant difference in survival among the treatment alternatives for T1N0 anal canal cancer. Given that surgery/ablation costs less than RT or CRT and might be cost-effective compared with RT and CRT, it is crucial to explore this finding further in this era of limited health care resources.

Bayesian variable selection for multistate Markov models with interval-censored data in an ecological momentary assessment study of smoking cessation.

The application of sophisticated analytical methods to intensive longitudinal data, collected with ecological momentary assessments (EMA), has helped researchers better understand smoking behaviors after a quit attempt. Unfortunately, the wealth of information captured with EMAs is typically underutilized in practice. Thus, novel methods are needed to extract this information in exploratory research studies. One of the main objectives of intensive longitudinal data analysis is identifying relations between risk factors and outcomes of interest. Our goal is to develop and apply expectation maximization variable selection for Bayesian multistate Markov models with interval-censored data to generate new insights into the relation between potential risk factors and transitions between smoking states. Through simulation, we demonstrate the effectiveness of our method in identifying associated risk factors and its ability to outperform the LASSO in a special case. Additionally, we use the expectation conditional-maximization algorithm to simplify estimation, a deterministic annealing variant to reduce the algorithm's dependence on starting values, and Louis's method to estimate unknown parameter uncertainty. We then apply our method to intensive longitudinal data collected with EMA to identify risk factors associated with transitions between smoking states after a quit attempt in a cohort of socioeconomically disadvantaged smokers who were interested in quitting.

The Time-Varying Relations Between Risk Factors and Smoking Before and After a Quit Attempt.

Introduction: Intensive longitudinal data (ILD) collected with ecological momentary assessments (EMAs) can provide a rich resource for understanding the relations between risk factors and smoking in the time surrounding a cessation attempt. Methods: Participants (N = 142) were smokers seeking treatment at a safety-net hospital smoking cessation clinic who were randomly assigned to receive standard clinic care (ie, counseling and cessation medications) or standard care plus small financial incentives for biochemically confirmed smoking abstinence. Participants completed EMAs via study provided smartphones several times per day for 14 days (1 week prequit through 1 week postquit). EMAs assessed current contextual factors including environmental (eg, easy access to cigarettes, being around others smoking), cognitive (eg, urge to smoke, stress, coping expectancies, cessation motivation, cessation self-efficacy, restlessness), behavioral (ie, recent smoking and alcohol consumption), and affective variables. Temporal relations between risk factors and smoking were assessed using a logistic time-varying effect model. Results: Participants were primarily female (57.8%) and Black (71.8%), with an annual household income of <$20000 per year (71.8%), who smoked 17.6 cigarettes per day (SD = 8.8). Individuals assigned to the financial incentives group had decreased odds of smoking compared with those assigned to usual care beginning 3 days before the quit attempt and continuing throughout the first week postquit. Environmental, cognitive, affective, and behavioral variables had complex time-varying impacts on smoking before and after the scheduled quit attempt. Conclusions: Knowledge of time-varying effects may facilitate the development of interventions that target specific psychosocial and behavioral variables at critical moments in the weeks surrounding a quit attempt. Implications: Previous research has examined time-varying relations between smoking and negative affect, urge to smoke, smoking dependence, and certain smoking cessation therapies. We extend this work using ILD of unexplored variables in a socioeconomically disadvantaged sample of smokers seeking cessation treatment. These findings could be used to inform ecological momentary interventions that deliver treatment resources (eg, video- or text-based content) to individuals based upon critical variables surrounding their attempt.

Total Lifetime and Cancer-related Costs for Elderly Patients Diagnosed With Anal Cancer in the United States.

OBJECTIVE: To determine the lifetime and phase-specific cost of anal cancer management and the economic burden of anal cancer care in elderly (66 y and older) patients in the United States. PATIENTS AND METHODS: For this study, we used Surveillance Epidemiology and End Results-Medicare linked database (1992 to 2009). We matched newly diagnosed anal cancer patients (by age and sex) to noncancer controls. We estimated survival time from the date of diagnosis until death. Lifetime and average annual cost by stage and age at diagnosis were estimated by combining survival data with Medicare claims. The average lifetime cost, proportion of patients who were elderly, and the number of incident cases were used to estimate the economic burden. RESULTS: The average lifetime cost for patients with anal cancer was US$50,150 (N=2227) (2014 US dollars). The average annual cost in men and women was US$8025 and US$5124, respectively. The overall survival after the diagnosis of cancer was 8.42 years. As the age and stage at diagnosis increased, so did the cost of cancer-related care. The anal cancer-related lifetime economic burden in Medicare patients in the United States was US$112 million. CONCLUSIONS: Although the prevalence of anal cancer among the elderly in the United States is small, its economic burden is considerable.

Reliability of the hospital nutrition environment scan for cafeterias, vending machines, and gift shops.

According to ecological models, the physical environment plays a major role in determining individual health behaviors. As such, researchers have started targeting the consumer nutrition environment of large-scale foodservice operations when implementing obesity-prevention programs. In 2010, the American Hospital Association released a call-to-action encouraging health care facilities to join in this movement and improve their facilities' consumer nutrition environments. The Hospital Nutrition Environment Scan (HNES) for Cafeterias, Vending Machines, and Gift Shops was developed in 2011, and the present study evaluated the inter-rater reliability of this instrument. Two trained raters visited 39 hospitals in southern California and completed the HNES. Percent agreement, kappa statistics, and intraclass correlation coefficients were calculated. Percent agreement between raters ranged from 74.4% to 100% and kappa statistics ranged from 0.458 to 1.0. The intraclass correlation coefficient for the overall nutrition composite scores was 0.961. Given these results, the HNES demonstrated acceptable reliability metrics and can now be disseminated to assess the current state of hospital consumer nutrition environments.

Stochastic search gene suggestion: a Bayesian hierarchical model for gene mapping.

Mapping the genes for a complex disease, such as diabetes or rheumatoid arthritis (RA), involves finding multiple genetic loci that may contribute to the onset of the disease. Pairwise testing of the loci leads to the problem of multiple testing. Looking at haplotypes, or linear sets of loci, avoids multiple tests but results in a contingency table with sparse counts, especially when using marker loci with multiple alleles. We propose a hierarchical Bayesian model for case-parent triad data that uses a conditional logistic regression likelihood to model the probability of transmission to a diseased child. We define hierarchical prior distributions on the allele main effects to model the genetic dependencies present in the human leukocyte antigen (HLA) region of chromosome 6. First, we add a hierarchical level for model selection that accounts for both locus and allele selection. This allows us to cast the problem of identifying genetic loci relevant to the disease into a problem of Bayesian variable selection. Second, we attempt to include linkage disequilibrium as a covariance structure in the prior for model coefficients. We evaluate the performance of the procedure with some simulated examples and then apply our procedure to identifying genetic markers in the HLA region that influence risk for RA. Our software is available on the website http://www.epigenetic.org/Linkage/ssgs-public/.