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PURPOSE Cancer genetic risk assessment (CGRA) is recommended for women with ovarian cancer or high-risk breast cancer, yet fewer than 30% receive recommended genetic services, with the lowest rates among underserved populations. We hypothesized that compared with usual care (UC) and mailed targeted print (TP) education, CGRA uptake would be highest among women receiving a phone-based tailored risk counseling and navigation intervention (TCN). METHODS In this three-arm randomized trial, women with ovarian or high-risk breast cancer were recruited from statewide cancer registries in Colorado, New Jersey, and New Mexico. Participants assigned to TP received a mailed educational brochure. Participants assigned to TCN received the mailed educational brochure, an initial phone-based psychoeducational session with a health coach, a follow-up letter, and a follow-up navigation phone call. RESULTS Participants' average age was 61 years, 25.4% identified as Hispanic, 5.9% identified as non-Hispanic Black, and 17.5% lived in rural areas. At 6 months, more women in TCN received CGRA (18.7%) than those in TP (3%; odds ratio, 7.4; 95% CI, 3.0 to 18.3; P < .0001) or UC (2.5%; odds ratio, 8.9; 95% CI, 3.4 to 23.5; P < .0001). There were no significant differences in CGRA uptake between TP and UC. Commonly cited barriers to genetic counseling were lack of provider referral (33.7%) and cost (26.5%), whereas anticipated difficulty coping with test results (14.0%) and cost (41.2%) were barriers for genetic testing. CONCLUSION TCN increased CGRA uptake in a group of geographically and ethnically diverse high-risk breast and ovarian cancer survivors. Remote personalized interventions that incorporate evidence-based health communication and behavior change strategies may increase CGRA among women recruited from statewide cancer registries.

Continuous positive airway pressure (CPAP) improves sleepiness in patients with obstructive sleep apnea, but some patients remain sleepy. The objective of this study was to identify determinants that are associated with improvements in self-reported sleepiness in patients with obstructive sleep apnea on CPAP therapy.A retrospective cohort study was performed in a clinic-based population to determine which variables contributed to the improvement in the Epworth Sleepiness Scale (ESS) in patients on CPAP therapy for OSA, stratified by baseline ESS score (11 or ≥ 11). Variables associated with ESS scores normalizing with CPAP were also assessed.Patients with a baseline high ESS score showed greater improvements in the ESS with CPAP. When looking at interactions between baseline ESS classification and changes in ESS, we found that a higher apnea-hypopnea index was only associated with improvement in the ESS among patients with a high baseline ESS. Other assessed factors or covariates were not significantly different. When looking at ESS normalization, we found that female sex and lower body mass index were associated with a lower likelihood of ESS normalization. The difference in the rate of ESS normalization between females and males was higher with more days on CPAP.Of all the assessed factors and covariates, only the apnea-hypopnea index was associated with the change in the ESS differently in patients with a high or normal baseline ESS score. ESS normalization rates were lower in females than in males, and this disparity was amplified by more days on CPAP.Scharf MT, Zhang P, Walker NA, et al. Sex differences in Epworth Sleepiness Scale normalization with continuous positive airway pressure.

Acculturation to the mainstream culture and the settlement contexts could shape cognitive function of older immigrants. Guided by ecological theory, this study examines the interaction effect between individual acculturation and ecology of family on cognitive function among older Chinese Americans.Data were derived from the Population Study of Chinese Elderly in Chicago (Older adults in the commanding-conflicted type had the lowest cognitive function. After controlling confounding variables, higher levels of acculturation (Acculturation to the dominant culture is identified as a cultural asset for cognitive function in older Chinese Americans. Social services could protect cognitive function of older immigrants in the commanding-conflicted type through enhancing cultural participation. Future research could test how affective and cognitive aspects of acculturation affect health.

Uptake of breast cancer screening has been decreasing in England since 2007. However, the associated factors are unclear. On the other hand, survival among breast cancer patients have recently increased. We conducted a quasi-experimental analysis to test whether the trend-change in proportional incidence of non-screened cancers coincided with that in five-year net-survival.We extracted population-based proportional incidence and age-standardized five-year net-survival data from Public Health England that included English women with invasive breast cancer diagnosed during 1995-2011 (linked to death certificates, followed through 2016). Piece-wise log-linear models with change-point/joinpoint were used to estimate temporal trends.Among 254,063 women in England with invasive breast cancer diagnosed during 1995-2011, there was downward-to-upward trend-change in proportional incidence of non-screened breast cancers (annual percent change [APC]=5.6 after 2007 versus APC=-3.5 before 2007,There was a downward-to-upward trend-change in proportional incidence of non-screened breast cancers in 2007 that coincided with a steeper upward-trend in age-standardized five-year net survival among English women in 2007. Survival benefits of breast cancer screening decreased during 2007-2011. The data support reduction of breast cancer screening in some patients, but future validation studies are warranted.

Background: The addition of neoadjuvant platinums to standard chemotherapy regimens for triple negative breast cancer (TNBC) improves rates of pathologic complete response (pCR). Our prior trial combining carboplatin (CAR) with liposomal doxorubicin (DOX) for metastatic TNBC showed good response rates with minimal side effects and allows for higher platinum dosing. We hypothesized that the doublet of DOX+CAR is effective and tolerable in the neoadjuvant setting for TNBC and tumor genomics may identify biomarkers of complete response and actionable targets. Methods: A phase II single arm trial was conducted for patients (pts) diagnosed with stage II-III TNBC. Patients received 4 cycles of neoadjuvant carboplatin (AUC 5) and liposomal doxorubicin (30mg/m2) administered every 28 days, then underwent definitive breast surgery followed by 12 weeks of adjuvant paclitaxel 80 mg/m2 administered weekly. Primary and secondary clinical endpoints were rate of pCR and two year recurrence free survival (RFS) and overall survival (OS), respectively. Cardiac safety of the combination was assessed. Fresh residual tumor samples were obtained at time of surgery for generation of patient derived xenografts (PDX). Whole genome sequencing (WGS) and RNA sequencing will be performed to evaluate specific patterns of small-variant mutations and patterns of structural variants to identify which patients are likely to have pCR. Results: From 2/2015 to 6/2021, 62 pts were enrolled, 8 pts withdrew consent either prior to treatment or completion of neoadjuvant therapy and/or surgery. Median age of the cohort was 55.4 years. There was high participation by under-represented groups: 17.0% African American, 20.8% Asian, 13.2% Hispanic. Most histologies were invasive ductal carcinoma, but included apocrine, pleomorphic lobular, and metaplastic subtypes. 53 pts completed all 4 cycles of neoadjuvant DOX+CAR, followed by definitive surgery; 1 pt progressed after 1 cycle and proceeded to surgery thereafter. 30.2% (16) pts achieved pCR, and residual cancer burden (RCB) will be reported in patients with residual disease. Of the 53 pts who completed 4 cycles of treatment, 5 pts progressed (recurrence or death) within two years from time of surgery (4 distant and 1 local recurrence), yielding the 2-year recurrence-free-survival rate of 90.3% (95%CI 81.0%, 99.6%). The most common toxicities during DOX+CAR were grade 1 fatigue in 50 pts (92.6%), grade 1 anemia in 44 pts (81.5%), and grade 3/4 neutropenia in 16 pts (29.6%); these pts received GCSF support with subsequent cycles; febrile neutropenia occurred in 1 pt (1.9%) in this group. Only 10 pts (18.5%) had grade 1 alopecia, 5 pts (9.3%) had grade 2 alopecia, 2 pts (3.7%) had grade 3 thrombocytopenia. There were no delays in treatment due to cardiotoxicity or complications from surgical healing. Of the 37 pts who had residual disease, PDX was attempted in 21 pts, and 16 (76%) PDX were established, including those for 4 patients experiencing recurrence. WGS and RNA sequencing data from pre-treatment and residual disease samples will be analyzed and reported.Conclusion: 4 cycles of neoadjuvant DOX+CAR achieved rate of pCR similar to standard regimens and has good tolerability. Post chemotherapy PDX is feasible and may help identify targeted approaches for patients with resistant disease. These results warrant further evaluation of this combination for early stage TNBC. Citation Format: Nancy Chan, Shou-en Lu, Yue Wang, Gregory M Riedlinger, Coral Omene, Mridula George, Jyoti Malhotra, Maria Kowzun, Firas G Eladoumikdachi, Lindsay B Potdevin, Shicha Kumar, Kant Matsuda, Shruti Desai, Nayana Patel, Deborah L Toppmeyer, Shridar Ganesan, Kim Hirshfield. Neoadjuvant liposomal doxorubicin and carboplatin is effective and tolerable for the treatment of early stage triple negative breast cancer [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P2-12-15.

Background: Triple negative breast cancer (TNBC) is an aggressive subtype accounting for 15% of all breast cancer subtypes. It is characterized by larger tumor size, higher grade, early peak of recurrence, and a worse 5-year overall survival rate compared to other breast cancer subtypes. Treatment with immunotherapy has been shown to be beneficial in PD-L1 positive patients in the metastatic setting. Priming the tumor environment can upregulate PD-L1 expression. Pelareorep, a proprietary isolate of the unmodified replication competent reovirus type 3 Dearing (T3D) strain, a non-enveloped reovirus has been shown to upregulate PD-L1 expression in tumor and inflammatory cells and promote a favorable CD8:regulatory T cell ratio indicating a less immunosuppressive tumor microenvironment. Retifanlimab (INCMGA00012) is PD-1 inhibitor currently in development. A phase 2 study is currently underway studying the combination with the rationale that the administration of pelareorep will prime the tumor microenvironment for enhanced tumor response to PD-1 inhibitor retifanlimab. Trial design: This is a phase II multi-site single-arm clinical trial to study the combination of PD-1 inhibitor retifanlimab and the oncolytic virus pelareorep in patients with metastatic triple negative breast cancer. Eligible patients will receive pelareorep 4.5x1010 TCID50/day, on Days 1, 2, 15 and 16 and retifanlimab 500 mg on day 3 of every 28-day cycle. Patients will be monitored clinically and radiologically for response to treatment. Tumor tissue, stool and blood samples will be collected during treatment to evaluate changes in PD-L1 expression, gut microbiome and inflammatory cells induced by the study drugs. (ClinicalTrials.gov Identifier: NCT04445844) Eligibility criteria: Premenopausal/postmenopausal women with metastatic TNBC who have previously received 1-2 prior lines of chemotherapy in the metastatic setting are eligible for the study. They must have adequate performance status (ECOG PFS 0-2). Specific aims: Primary endpoint will be objective response rate (ORR) and safety, determined by the number, frequency, duration, and severity of AEs using CTCAE v5.0. The Secondary end-points will be progression free survival (PFS), overall survival (OS), duration of response (DOR) and quality of life measures using EORTC QLQ-C30. Statistical methods: Simon’s optimal 2-stage design will be used to calculate sample size. In the first stage, 14 patients will be accrued. If there are 1 or fewer responses in these 14 patients, the study will be stopped. Otherwise, 11 additional patients will be accrued for a total of 25. The null hypothesis will be rejected if 4 or more responses are observed in 25 patients. The first 6 patients will be enrolled in a staggering interval for the safety run-in phase of the study. Accrual: The study is currently enrolling patients at Rutgers Cancer Institute of New Jersey and Ohio State University Comprehensive Cancer Center. There are no safety signals with the combination in patients who have received both drugs to date. Citation Format: Mridula George, Nicole Williams, Coral Omene, Nancy Chan, Shou-En Lu, Danielle Tang, Grey Wilkinson, Shridar Ganesan, Deborah Toppmeyer. Irene study: Phase 2 study of Incmga00012 and the oncolytic virus pelareorep in metastatic triple negative breast cancer [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr OT2-25-01.

Background: Published evidence indicates that individual use of metformin and statin is associated with reduced cancer mortality. However, their differential and joint effects on pancreatic cancer survival are inconclusive.Methods: We identified a large population-based cohort of 12,572 patients ages 65 years or older with primary pancreatic ductal adenocarcinoma (PDAC) diagnosed between 2008 and 2011 from the Surveillance, Epidemiology, and End Results (SEER)-Medicare-linked database. Exposure to metformin and statins was ascertained from Medicare Prescription Drug Event files. Cox proportional hazards models with time-varying covariates adjusted for propensity scores were used to assess the association while controlling for potential confounders.Results: Of 12,572 PDAC patients, 950 (7.56%) had used metformin alone, 4,506 (35.84%) had used statin alone, and 2,445 (19.45%) were dual users. Statin use was significantly associated with improved overall survival [HR, 0.94; 95% confidence interval (CI), 0.90–0.98], and survival was more pronounced in postdiagnosis statin users (HR, 0.69; 95% CI, 0.56–0.86). Metformin use was not significantly associated with overall survival (HR, 1.01; 95% CI, 0.94–1.09). No beneficial effect was observed for dual users (HR, 1.00; 95% CI, 0.95–1.05).Conclusions: Our findings suggest potential benefits of statins on improving survival among elderly PDAC patients; further prospective studies are warranted to corroborate the putative benefit of statin therapy in pancreatic cancer.Impact: Although more studies are needed to confirm our findings, our data add to the body of evidence on potential anticancer effects of statins. Cancer Epidemiol Biomarkers Prev; 26(8); 1225–32. ©2017 AACR.

Introduction Mild Cognitive Impairment (MCI) is defined as a noticeable decline in cognitive abilities that doesn't interfere with daily activities; MCI may be a precursor of Alzheimer’s disease and related dementia. Elevated risk of MCI has been shown in subjects with obstructive sleep apnea (OSA) in a sleep clinic population and in subjects with insomnia in a general population. OSA and Insomnia both have a high prevalence among members of the World Trade Center Health Program General Responders’ Cohort (WTCHP GRC). Previous research indicated they had a high prevalence of MCI but did not examine sleep. We examined the association between MCI with OSA and/or Insomnia in the WTCHP GRC. Methods We assessed MCI by the Montreal Cognitive Assessment (MoCA) in English (n=115) and Spanish (n=27). MoCA < 26 defines MCI. OSA defined by AHI4>=5 or RDI>=15 events/hr, was assessed by home sleep test or in-lab NPSG. A score>7 on the Insomnia Severity Index (ISI) defined insomnia. Education was categorized as < or > bachelor’s (BA/BS) degree; subjects were categorized as Latino or not. Variables were analyzed using linear correlation, t-tests and chi-square tests as appropriate. Results The study population consisted of 142 subjects (80%M/20%F, age 58±8 years, BMI=29.7±5 kg/m2., Non-Latino/White=57%, Latino/any race=35%, < BA/BS=65%). OSA prevalence was 65.5% (mean AHI4=10.8±12.5/hr and RDI=21.42±16/hr). Insomnia prevalence was 48% (ISI=8.8 + 6). 48% (n=68) of subjects were classified as MCI. No correlation was observed between MoCA and OSA severity (r=0.1,p=0.24) or ISI (r=-0.1,p=0.1). Subjects without OSA had higher MCI prevalence (MCI_OSA=21.5% vs MCI_noOSA=37%, p=0.018). Lower educational level, race/ethnicity, and language (Spanish/English) (p< 0.001) were associated with MCI. Conclusion In this heterogenous cohort, we showed an unexpected lower MCI prevalence in OSA subjects. As shown by others, MCI defined by the MoCA was highly impacted by race/ethnicity, language and education. This suggests that our findings may be influenced by differences in the MoCA scoring and MCI cutoffs in Hispanic populations. To understand the relationship between MCI and sleep disorders in the WTC population, future studies should re-assess the cutoffs used in MoCA scoring or use tools to assess MCI less dependent on ethnicity and educational level. Support (if any) NIOSH/CDC U01OH011481, K24HL109156

ImportanceFew evidence-based treatments are available for Gulf War illness (GWI). Behavioral treatments that target factors known to maintain the disability from GWI, such as problem-solving impairment, may be beneficial. Problem-solving treatment (PST) targets problem-solving impairment and is an evidence-based treatment for other conditions.ObjectiveTo examine the efficacy of PST to reduce disability, problem-solving impairment, and physical symptoms in GWI.Design, Setting, and ParticipantsThis multicenter randomized clinical trial conducted in the US Department of Veterans Affairs compared PST with health education in a volunteer sample of 511 Gulf War veterans with GWI and disability (January 1, 2015, to September 1, 2019); outcomes were assessed at 12 weeks and 6 months. Statistical analysis was conducted between January 1, 2019, and December 31, 2020.InterventionsProblem-solving treatment taught skills to improve problem-solving. Health education provided didactic health information. Both were delivered by telephone weekly for 12 weeks.Main Outcomes and MeasuresThe primary outcome was reduction from baseline to 12 weeks in self-report of disability (World Health Organization Disability Assessment Schedule). Secondary outcomes were reductions in self-report of problem-solving impairment and objective problem-solving. Exploratory outcomes were reductions in pain, pain disability, and fatigue.ResultsA total of 268 veterans (mean [SD] age, 52.9 [7.3] years; 88.4% male; 66.8% White) were randomized to PST (n = 135) or health education (n = 133). Most participants completed all 12 sessions of PST (114 of 135 [84.4%]) and health education (120 of 133 [90.2%]). No difference was found between groups in reductions in disability at the end of treatment. Results suggested that PST reduced problem-solving impairment (moderate effect, 0.42; P = .01) and disability at 6 months (moderate effect, 0.39; P = .06) compared with health education.Conclusions and RelevanceIn this randomized clinical trial of the efficacy of PST for GWI, no difference was found between groups in reduction in disability at 12 weeks. Problem-solving treatment had high adherence and reduced problem-solving impairment and potentially reduced disability at 6 months compared with health education. These findings should be confirmed in future studies.Trial RegistrationClinicalTrials.gov Identifier: NCT02161133

Background Increased risk of a second primary malignancy (SPM) before or after diagnosis of anal squamous cell carcinoma (ASCC) has been reported in a previous single‐institution study. We hypothesize that patients diagnosed with ASCC are at increased risk for developing SPMs before or after the diagnosis of ASCC. The primary objective of this study was to identify the diagnoses of cancer most likely to occur as SPMs before or after ASCC. Methods This work employs the Surveillance, Epidemiology, and End Results (SEER) Program registry data to conduct a US‐population‐based study of patients diagnosed with ASCC between 1975 and 2016. In patients diagnosed with ASCC, we evaluated the risk of SPMs and the risk of developing ASCC as an SPM after another cancer using standardized incidence ratios (SIR) for all SPMs by calculating the ratio of observed events in the ASCC cohort compared to expected (O/E) events in a matched reference cohort of the general population. Results A total of 7,594 patients with primary ASCC were included. Patients with ASCC were at increased risk of the diagnosis of an SPM (SIR = 1.45), particularly cancers of the lung, vulva, oropharynx, or colon. Patients with ASCC had an increased rate of previous malignancy (SIR = 1.23), especially Kaposi sarcoma or vulvar cancer. Overall elevated incidence of SPMs was unrelated to prior radiation treatment. Radiation treatment was associated with increased risk for SPMs in the female genital system but appeared protective against prostate cancer as SPMs. Conclusions Our findings support increased surveillance and screening for second malignancies in patients with these diagnoses, as patients with ASCC are often either survivors of a prior cancer diagnosis or are at increased risk of developing later malignancies., Survivors of anal squamous cell carcinoma are at increased risk for particular second malignancies and should be screened for these. Risk of second malignancies is sometimes related to radiation therapy, but radiation can also be protective against second cancers in some cases.

Multivariate failure time data are frequently analyzed using the marginal proportional hazards models and the frailty models. When the sample size is extraordinarily large, using either approach could face computational challenges. In this paper, we focus on the marginal model approach and propose a divide-and-combine method to analyze large-scale multivariate failure time data. Our method is motivated by the Myocardial Infarction Data Acquisition System (MIDAS), a New Jersey statewide database that includes 73,725,160 admissions to nonfederal hospitals and emergency rooms (ERs) from 1995 to 2017. We propose to randomly divide the full data into multiple subsets and propose a weighted method to combine these estimators obtained from individual subsets using three weights. Under mild conditions, we show that the combined estimator is asymptotically equivalent to the estimator obtained from the full data as if the data were analyzed all at once. In addition, to screen out risk factors with weak signals, we propose to perform the regularized estimation on the combined estimator using its combined confidence distribution. Theoretical properties, such as consistency, oracle properties, and asymptotic equivalence between the divide-and-combine approach and the full data approach are studied. Performance of the proposed method is investigated using simulation studies. Our method is applied to the MIDAS data to identify risk factors related to multivariate cardiovascular-related health outcomes.

IntroductionIndividuals with schizophrenia are more likely to smoke and less likely to quit smoking than those without schizophrenia. Because task persistence is lower in smokers with than without schizophrenia, it is possible that lower levels of task persistence may contribute to greater difficulties in quitting smoking observed among smokers with schizophrenia.AimsTo develop a feasible and acceptable intervention for smokers with schizophrenia.MethodsParticipants (N = 24) attended eight weekly individual cognitive behavioral therapy sessions for tobacco use disorder with a focus on increasing task persistence and received 10 weeks of nicotine patch.ResultsIn total, 93.8% of participants rated the intervention as at least a 6 out of 7 regarding how ‘easy to understand’ it was and 81.3% rated the treatment as at least a 6 out of 7 regarding how helpful it was to them. A total of 62.5% attended at least six of the eight sessions and session attendance was positively related to nicotine dependence and age and negatively related to self-efficacy for quitting.DiscussionThis intervention was feasible and acceptable to smokers with schizophrenia. Future research will examine questions appropriate for later stages of therapy development such as initial efficacy of the intervention and task persistence as a mediator of treatment outcome.

Background Pre‐clinical studies suggest that metformin and statins may delay prostate cancer (PCa) metastases; however, data in humans are limited. To the best of our knowledge, this is the first human study aimed to quantify the individual and joint effects of statin and metformin use among patients with high‐risk PCa. Methods This population‐based retrospective cohort study identified patients from the Surveillance, Epidemiology, and End Results (SEER)‐Medicare linked database. Exposure to metformin and statins was ascertained from Medicare Prescription Drug Event files. The association with all‐cause and PCa mortality were evaluated using Cox proportional hazard model with competing causes of death, where propensity scores were used to adjusted imbalances in covariates across groups. Results Based on 12 700 patients with high‐risk PCa, statin alone or in combination with metformin was significantly associated with reduced all‐cause mortality (Hazard Ratio [HR]: 0.89; 95% Confidence Interval [CI]: 0.83, 0.96; and HR: 0.75; 95% CI, 0.67‐0.83, respectively) and PCa mortality (HR, 0.80; 95% CI: 0.69, 0.92) and 0.64; 95% CI, d 0.51‐0.81, respectively. The effects were more pronounced in post‐diagnostic users: combination use of metformin/statins was associated with a 32% reduction in all‐cause mortality (95% CI, 0.57‐0.80), and 54% reduction in PCa mortality (95% CI, 0.30‐0.69). No significant association of metformin alone was observed with either all‐cause mortality or PCa mortality. Conclusions Statin use alone or in combination with metformin was associated with lower all‐cause and PCa mortality among high‐risk patients, particularly in post‐diagnostic settings; further studies are warranted., In this population‐based cohort study of 12 700 high‐risk prostate cancer patients, statin use alone or combined with metformin was significantly associated with lower all‐cause mortality, particularly in post‐diagnostic settings. Randomized clinical trials are warranted to confirm these findings.

Heart rate variability (HRV) and End Tidal CO2 (ETCO2) in relation to treatment response have not been studied in Latino populations or in comorbid asthma and panic disorder (PD). An extension of previously published research, the current study explored psychophysiological variables as possible mediators of treatment response. Latino treatment completers (N = 32) in the Bronx with asthma-PD received either Cognitive-Behavioral Psychophysiological Therapy (CBPT) or Music Relaxation Therapy (MRT). CBPT included HRV-biofeedback (HRVB); in-the-moment heart rate data to help an individual learn to influence his/her own heart rate. The sample was primarily female (93.8%) and Puerto Rican (81.25%). Treatment groups did not differ on demographics, except for less education in CBPT. The Panic Disorder Severity Scale (PDSS) and Asthma Control Questionnaire (ACQ) assessed changes in symptoms. HRV and ETCO2 were measured at four of eight therapy sessions. Baseline ETCO2 and changes in HRV from first to last of psychophysiology sessions were investigated as mediators of change on ACQ and PDSS. Mixed model analyses indicated in the CPBT group, changes in both asthma control and PD severity were not mediated by changes in HRV. In the CBPT and MRT groups combined, changes in PD severity were not mediated by baseline ETCO2. These findings may be due to the brevity of HRVB in CBPT, multiple treatment components, ETCO2 not directly targeted, and/or unique physiological pathways in Latinos with asthma-PD.

New Jersey (NJ) residents in some areas may be exposed to perfluoroalkyl and polyfluoroalkyl substances (PFAS) due to PFAS contamination of public drinking water. This contamination stems from industrial discharges and the use of aqueous film-foaming foams at military bases and commercial airports for drills and locations where fires occurred. Exposure to PFAS has raised significant public health concerns due to its persistence both in the environment and human body. The potential toxicity of these chemicals may pose risks to human health. Statewide biomonitoring data is needed to establish a baseline of exposure and to identify the subpopulations at risk. The NJ Department of Health (NJDOH) conducted a statewide NJ Biomonitoring (NJBM) study for PFAS utilizing a cost-effective sampling approach, i.e. acquiring remnant sera from both clinical laboratories and blood banks across NJ. This convenience sampling approach was adopted as an alternative to a costly and labor-intensive probability-based population sampling. One thousand and thirty human sera were collected from NJ adults between 20 and 74 years of age from 2016 to 2018, with additional information of county, sex, and age. The serum collection was demographically and geographically dispersed across four seasons. Twelve PFAS analytes were measured for the specimens collected. The data were post-stratified by county, sex, and age groups (20–39, 40–59, and 60–74 years old). Stratified individual sample weights were developed and used to estimate population means, compare least-squared mean differences, and examine contributing variables. Geometric means (GMs) and percentiles with 95% confidence intervals (CIs) of the target analytes are presented, providing preliminary baselines of the statewide PFAS exposure for NJ adults. PFOA, PFNA, PFHxS, and PFOS were selected for in-depth analyses because their GMs were greater than 0.5 ng/mL and they were detected over 99% in study population. Subjects from this study had higher serum levels of PFOA, PFNA, and PFHxS compared to the general U.S. population reported by the latest National Health and Nutrition Examination Survey (NHANES in 2015–2016). However, the distributions of PFOA, PFNA, PFHxS, and PFOS across sex and age groups were consistent with the patterns found in NHANES, i.e. all differed by sex and age group. Further sex and age stratification showed significantly lower concentrations of the 4 analytes in younger females (20–59 years old) than in older females (60–74 years old) and males (20–74 years old). Future research is needed to identify PFAS exposure sources and to develop effective intervention strategies. Continuing PFAS biomonitoring using population sampling is recommended for tracking trends and better identifying subpopulations at risk.

The COVID-19 pandemic significantly affected healthcare delivery, shifting focus away from nonurgent care. The aim of this study was to examine the impact of the pandemic on the practice of surgical oncology.A web-based survey of questions about changes in practice during the COVID-19 pandemic was approved by the Society of Surgical Oncology (SSO) Research and Executive Committees and sent by SSO to its members.A total of 121 SSO members completed the survey, 77.7% (94/121) of whom were based in the United States. Breast surgeons were more likely than their peers to refer patients to neoadjuvant therapy (p = 0.000171). Head and neck surgeons were more likely to refer patients to definitive nonoperative treatment (p = 0.044), while melanoma surgeons were less likely to do so (p = 0.029). In all, 79.2% (95/120) of respondents are currently using telemedicine. US surgeons were more likely to use telemedicine (p = 0.004). Surgeons believed telemedicine is useful for long-term/surveillance visits (70.2%, 80/114) but inappropriate (50.4%, 57/113) for new patient visits.COVID-19 pandemic resulted in increased use of neoadjuvant therapy, delays in operative procedures, and increased use of telemedicine. Telemedicine is perceived to be most efficacious for long-term/surveillance visits or postoperative visits.

Background: Everyday people die unnecessarily from opioid overdose-related addiction. Dentists are among the leading prescribers of opioid analgesics. Opioid seeking behaviors have been linked to receipt of initial opioid prescriptions following the common dental procedure of third molar extraction. With each opioid prescription a patient’s risk for opioid misuse or abuse increases. With an estimated 56 million tablets of 5 mg hydrocodone annually prescribed after third molar extractions in the United States, 3.5 million young adults may be unnecessarily exposed to opioids by dentists who are inadvertently increasing their patient’s risk for addiction.Methods: A double blind, stratified randomized, multi-center clinical trial has been designed to evaluate whether a combination of over-the-counter non-opioid containing analgesics is not inferior to the most prescribed opioid analgesic. The impacted 3rd molar extraction model is being used due to the predictable severity of the post-operative pain and generalizability of results. Within each site/clinic and gender type (male/female), patients are randomized to receive either OPIOID (hydrocodone/acetaminophen 5/300 mg) or NON-OPIOID (ibuprofen/acetaminophen 400/500 mg). Outcome data include pain levels, adverse events, overall patient satisfaction, ability to sleep, and ability to perform daily functions. To develop clinical guidelines and a clinical decision making tool, pain management, extraction difficulty and number of tablets taken is being collected enabling an experimental decision making tool to be developed. Discussion: The proposed methods address the short comings of other analgesic studies. Although prior studies have tested short-term effects of single doses of pain medications, patients and their dentists are interested in managing pain for the entire post-operative period, not just the first 12 hours. After surgery, patients expect to be able to perform normal daily functions without feeling nauseous or dizzy and they desire a restful sleep at night. Parents of young people are concerned with the risks of opioid use and misuse, either related to treatments received or to subsequent use of leftover pills. Upon successful completion of this clinical trial, dentists, patients, and their families will be better able to make informed decisions regarding post-operative pain management.Trial registration: ClinicalTrials.gov NCT04452344. Registered on June 20, 2020

Background Everyday people die unnecessarily from opioid overdose-related addiction. Dentists are among the leading prescribers of opioid analgesics. Opioid-seeking behaviors have been linked to receipt of initial opioid prescriptions following the common dental procedure of third molar extraction. With each opioid prescription, a patient’s risk for opioid misuse or abuse increases. With an estimated 56 million tablets of 5 mg hydrocodone annually prescribed after third molar extractions in the USA, 3.5 million young adults may be unnecessarily exposed to opioids by dentists who are inadvertently increasing their patient’s risk for addiction. Methods A double-blind, stratified randomized, multi-center clinical trial has been designed to evaluate whether a combination of over-the-counter non-opioid-containing analgesics is not inferior to the most prescribed opioid analgesic. The impacted 3rd molar extraction model is being used due to the predictable severity of the post-operative pain and generalizability of results. Within each site/clinic and gender type (male/female), patients are randomized to receive either OPIOID (hydrocodone/acetaminophen 5/300 mg) or NON-OPIOID (ibuprofen/acetaminophen 400/500 mg). Outcome data include pain levels, adverse events, overall patient satisfaction, ability to sleep, and ability to perform daily functions. To develop clinical guidelines and a clinical decision-making tool, pain management, extraction difficulty, and the number of tablets taken are being collected, enabling an experimental decision-making tool to be developed. Discussion The proposed methods address the shortcomings of other analgesic studies. Although prior studies have tested short-term effects of single doses of pain medications, patients and their dentists are interested in managing pain for the entire post-operative period, not just the first 12 h. After surgery, patients expect to be able to perform normal daily functions without feeling nauseous or dizzy and they desire a restful sleep at night. Parents of young people are concerned with the risks of opioid use and misuse, related either to treatments received or to subsequent use of leftover pills. Upon successful completion of this clinical trial, dentists, patients, and their families will be better able to make informed decisions regarding post-operative pain management. Trial registration ClinicalTrials.govNCT04452344. Registered on June 20, 2020

A two-stage enrichment design is a type of adaptive design, which extends a stratified design with a futility analysis on the marker negative cohort at the first stage, and the second stage can be either a targeted design with only the marker positive stratum, or still the stratified design with both marker strata, depending on the result of the interim futility analysis. In this paper we consider the situation where the marker assay and the classification rule are possibly subject to error. We derive the sequential tests for the global hypothesis as well as the component tests for the overall cohort and the marker-positive cohort. We discuss the power analysis with the control of the type-I error rate and show the adverse impact of the misclassification on the powers. We also show the enhanced power of the two-stage enrichment over the one-stage design, and illustrate with examples of the recent successful development of immunotherapy in non-small-cell lung cancer.

Background Many respiratory conditions have been attributed to toxic dust and fume exposure in World Trade Center (WTC) rescue and recovery workers, who frequently report symptoms of OSA. We examined the prevalence of new-onset OSA and tested if the prevalence and severity of OSA are related to the presence of chronic rhinosinusitis (CRS). Methods A total of 601 subjects (83% men; age, 33-87 years; BMI, 29.9 ± 5.5 kg/m2) enrolled in the WTC Health Program, excluding those with significant pre-September 11, 2001, snoring or prior CRS, underwent two nights of home sleep testing. OSA was defined as Apnea Hypopnea Index 4% ≥ 5 events/h or respiratory disturbance index of ≥ 15 events/h. CRS was assessed using nasal symptom questionnaires. Results The prevalence of OSA was 75% (25% no OSA, 46% mild OSA, 19% moderate OSA, and 10% severe OSA), and the prevalence of CRS was 43.5%. Compared with no CRS, new and worsening CRS was a significant risk factor for OSA with an OR of 1.80 (95% CI, 1.18-2.73; P = .006) unadjusted and 1.76 (95% CI, 1.08-2.88; P = .02) after adjustment for age, BMI, sex, gastroesophageal reflux disorder, and alcohol use. Conclusions The high prevalence of OSA in WTC responders was not explained fully by obesity and sex. Possible mechanisms for the elevated risk of OSA in subjects with CRS include increased upper airway inflammation and/or elevated nasal/upper airway resistance, but these need confirmation.

BACKGROUND Reducing serious hypoglycemic events is a Federal-wide objective. Despite studies of trends for rates of serious hypoglycemia in existing literature, rigorous evaluation of links between the observed trends and changes in professional guidelines or performance measures for glycemic control is lacking. OBJECTIVE To evaluate whether changes in professional society guidelines and performance measures for glycemic control correspond to changes in rates of serous hypoglycemia. RESEARCH DESIGN This was a retrospective observational study. We merged Veterans Health Administration (VHA) and Medicare patient-level databases of VHA patients and identified those aged 65 years and above and receiving hypoglycemic agents. We derived age-adjusted and sex-adjusted annual rates and constructed piecewise Poisson regression models adjusting for age and sex to assess time trends of the rates. SUBJECTS VHA patients, 2002-2015. MEASURES The main outcome was the annual rates (2004-2015) of serious hypoglycemia, defined as hypoglycemia-related emergency department visits or hospitalizations. Secondary outcomes were annual rates of hemoglobin (Hb) A1c level 9%. Age and sex were additional variables. RESULTS The annual rate for hypoglycemia decreased by 4.8% (rate ratio: 0.952; 95% confidence interval, 0.949-0.956) for 2008-2015 but did not change (1.001; 0.994-1.001) in 2004-2008. In 2008-2015, the annual rate for HbA1c 9%, increased by 7.9% (1.079; 1.076-1.082). CONCLUSION The cooccurrence of decreasing rates for HbA1c

Purpose/Objective(s) Treatment with concurrent chemoradiation and immune checkpoint inhibition (ICI) in patients (pts) with locally advanced or stage III/IV non-small lung cancer (NSCLC) is associated with improved PFS and OS. However, treatment is limited by the development of pneumonitis and esophagitis, toxicities associated with both chemoradiation and ICIs. Materials/Methods We conducted a single center retrospective review of pts with locally advanced or stage III/IV NSCLC who received chemoradiation with concurrent or subsequent ICI. Pts were excluded if the relevant structure contours were missing or if the tumor location was not matched by both groups. Pneumonitis and esophagitis were assessed with CTACE V5. Results From 2015-2020, 49 pts were identified and 25 were included in the analysis. One patient was excluded due absent contours. Ten pts were adapted and 15 were non-adaptive controls. Mean age at onset was 728 years, 12F, 13 M; 13 adenocarcinoma, 9 squamous, 3 poorly differentiated; mean BMI 28.3 6.1, 1 IIB, 9 IIIA, 15 IIIB; 4 T1, 6 T2, 9 T3, 6 T4; 1 LLL, 8 LUL, 4 RLL, 12 RUL. Twenty and 77.7% of pts in the adaptive group had pneumonitis and esophagitis respectively, while 20% and 80% in the non-adapted group had pneumonitis and esophagitis respectively. Due to the number of DVH parameters sampled, bivariate analysis was performed; values with P Conclusion Both the adaptive and non-adaptive groups had statistically equivalent toxicities; however, GTV volumes between the 2 groups were significantly different in size. By using adaptive therapy techniques, pts with large tumor sizes can be treated with an equivalent level of toxicity to patients with smaller tumors treated with traditionally.

Background: Per-and polyfluoroalkyl substances (PFAS), are ubiquitous pollutants associated with adverse health outcomes. High PFAS levels have been demonstrated among career firefighters; less is known about PFAS levels among volunteer firefighters who comprise two-thirds of US firefighters. Methods: Volunteer fire department members completed a survey and provided blood samples. We calculated geometric means and 95% CIs for PFAS reported by the National Health and Nutrition Examination Survey (NHANES). We compared PFAS distribution and levels among non-Hispanic white adult male study participants to those in the 2015–2016 and 2017–2018 NHANES cycles. We assessed associations between PFAS serum levels and years of firefighting controlling demographics and occupation using linear regression. Results: Participant’s average age was 46.6 years (sd. 17.1). Perfluorododecanoic acid (PFDoA) was detected in almost half study but

Aims Gulf War Illness (GWI) is a prevalent and disabling condition characterized by persistent physical symptoms. Clinical practice guidelines recommend self-management to reduce the disability from GWI. This study evaluated which GWI self-management strategies patients currently utilize and view as most effective and ineffective. Materials and methods Data were collected from 267 Veterans during the baseline assessment of a randomized clinical trial for GWI. Respondents answered 3 open-ended questions regarding which self-management strategies they use, view as effective, and view as ineffective. Response themes were coded, and code frequencies were analyzed. Key findings Response frequencies varied across questions (in-use: n = 578; effective: n = 470; ineffective: n = 297). Healthcare use was the most commonly used management strategy (38.6% of 578), followed by lifestyle changes (28.5% of 578), positive coping (13% of 578), and avoidance (13.7% of 578). When asked about effective strategies, healthcare use (25.9% of 470), lifestyle change (35.7% of 470), and positive coping (17.4% of 470) were identified. Avoidance was frequently identified as ineffective (20.2% of 297 codes), as was invalidating experiences (14.1% of 297) and negative coping (10.4% of 297). Significance Patients with GWI use a variety of self-management strategies, many of which are consistent with clinical practice guidelines for treating GWI, including lifestyle change and non-pharmacological strategies. This suggests opportunities for providers to encourage effective self-management approaches that patients want to use.

Rationale: Continuous positive airway pressure (CPAP) adherence is often poor in obstructive sleep apnea (OSA) and may be influenced by nasal resistance. CPAP with a reduction of expiratory pressure (CPAPflex) may reduce discomfort in those with high nasal resistance and improve adherence in this subgroup. Objectives: To evaluate the association of positive airway pressure (PAP) treatment adherence to nasal resistance and examine if CPAPflex improves adherence over CPAP in subjects with high nasal resistance. Methods: A randomized double-blind crossover trial of 4 weeks each of CPAPflex versus CPAP in subjects exposed to World Trade Center dust with OSA stratified by nasal resistance, measured by 4-Phase Rhinomanometry. Results: Three hundred seventeen subjects with OSA (mean, apnea–hypopnea index with 4% O(2) desaturation for hypopnea = 17 ± 14/h) were randomized. Overall, PAP adherence was poor, but adherence to CPAP (n = 239; mean hours per night [95% confidence interval (CI)]), 1.97 h (1.68 to 2.26) was greater than adherence to CPAPflex (n = 249; 1.65 h [1.39 to 1.91]; difference of 0.31 h [0.03; 0.6]; P

Phosphoglycerate dehydrogenase (PHGDH), the first rate-limiting enzyme of serine synthesis, is frequently overexpressed in human cancer. PHGDH overexpression activates serine synthesis to promote cancer progression. Currently, PHGDH regulation in normal cells and cancer is not well understood. Parkin, an E3 ubiquitin ligase involved in Parkinson's disease, is a tumor suppressor. Parkin expression is frequently downregulated in many types of cancer, and its tumor-suppressive mechanism is poorly defined. Here, we show that PHGDH is a substrate for Parkin-mediated ubiquitination and degradation. Parkin interacted with PHGDH and ubiquitinated PHGDH at lysine 330, leading to PHGDH degradation to suppress serine synthesis. Parkin deficiency in cancer cells stabilized PHGDH and activated serine synthesis to promote cell proliferation and tumorigenesis, which was largely abolished by targeting PHGDH with RNA interference, CRISPR/Cas9 KO, or small-molecule PHGDH inhibitors. Furthermore, Parkin expression was inversely correlated with PHGDH expression in human breast cancer and lung cancer. Our results revealed PHGDH ubiquitination by Parkin as a crucial mechanism for PHGDH regulation that contributes to the tumor-suppressive function of Parkin and identified Parkin downregulation as a critical mechanism underlying PHGDH overexpression in cancer.

This study aimed to examine the associations between different types of elder mistreatment, anxiety symptoms, and depressive symptoms among U.S. Chinese older adults.Data were derived from the Population Study of Chinese Elderly (PINE), a study of Chinese older adults aged 60 years and above in the greater Chicago area from 2011-2013. Measurements include elder mistreatment screening tools, Hospital Anxiety and Depression Scale, and Patient Health Questionnaire-9. Negative binomial regressions and logistic regressions were performed.Participants with any mistreatment, psychological mistreatment, physical mistreatment, financial exploitation, and caregiver neglect were more likely to have anxiety symptoms and depressive symptoms. Sexual mistreatment was not associated with symptoms of anxiety and depression.The rate of psychological distress differs based on the types of mistreatment among U.S. Chinese older adults. The findings underline the need for public and community awareness and improved education for health care professionals.

We describe a clinical trial which is seeking to determine the effectiveness and understand implementation outcomes for tele-collaborative specialty care for Veterans with Gulf War Illness (GWI).This study will be a hybrid type 1 randomized effectiveness-implementation trial comparing tele-collaborative specialty care to electronic consultation for Gulf War Veterans with GWI (N = 220). In tele-collaborative specialty care, the specialty provider team will deliver health coaching and problem-solving treatment to Veterans and recommend a plan for analgesic optimization. In electronic consultation, the specialty provider team will make a one-time recommendation to the primary care team for locally delivered health coaching, problem-solving treatment and analgesic optimization. The primary aim will be to determine the effectiveness of tele-collaborative specialty care as compared to electronic consultation to reduce disability related to GWI. Our secondary aim will be to understand implementation outcomes.There is a need to improve care for Veterans with GWI. A potentially useful model to improve care is tele-collaborative specialty care, where the specialists work with the primary care provider to synergistically treat the patients.This is the first clinical trial to prospectively compare different models of care for Veterans with GWI. This responds to multiple calls for research to improve treatment for Veterans with GWI, including from the National Academy of Medicine.

In a secondary analysis of data from a prior study, we calculated the relationships among depression (PHQ-8), anxiety (GAD-7), and measures of asthma in 69 steroid-naïve patients with mild and moderate symptomatic asthma. Average levels of pulmonary function, depression and anxiety tended to be in the normal range, and asthma tended to be well controlled (Asthma Control Test). Nevertheless, PHQ-8 scores were significantly correlated with forced oscillation (FO) measures of airway reactance (AX) and resistance at a low frequency of stimulation (Rrs

To identify clinical parameters that are prognostic for improved overall survival (OS) after yttrium-90 radioembolization (RE) in patients with liver metastases from colorectal cancer (CRC).A total of 131 patients who underwent RE for liver metastases from CRC, treated at 2 academic centers, were reviewed. Twenty-one baseline pretreatment clinical factors were analyzed in relation to OS by the Kaplan-Meier method along with log-rank tests and univariate and multivariate Cox regression analyses.The median OS from first RE procedure was 10.7 months (95% confidence interval [CI], 9.4-12.7 months). Several pretreatment factors, including lower carcinoembryonic antigen (CEA; ≤20 ng/mL), lower aspartate transaminase (AST; ≤40 IU/L), neutrophil-lymphocyte ratio (NLR)5, and absence of extrahepatic disease at baseline were associated with significantly improved OS after RE, compared with high CEA (20 ng/mL), high AST (40 IU/L), NLR ≥5, and extrahepatic metastases (P values of.001,.001, .0001, and .04, respectively). On multivariate analysis, higher CEA, higher AST, NLR ≥5, extrahepatic disease, and larger volume of liver metastases remained independently associated with risk of death (hazard ratios of 1.63, 2.06, 2.22, 1.48, and 1.02, respectively).The prognosis of patients with metastases from CRC is impacted by a complex set of clinical parameters. This analysis of pretreatment factors identified lower AST, lower CEA, lower NLR, and lower tumor burden (intra- or extrahepatic) to be independently associated with higher survival after hepatic RE. Optimal selection of patients with CRC liver metastases may improve survival rates after administration of yttrium-90.

Cure model is a useful model for analyzing failure time data when there is evidence of long-term survivors. In traditional cure models, it is assumed that the cured or uncured status in the censored set cannot be distinguished. However, in many occasions, data of some diagnostic procedures, with some sensitivity and specificity, may have provided partial information about the cured or uncured status in the censored set. Failure to use such data would be wasteful and result in efficiency loss. Wu et al. in 2014 proposed an extended cure model. It incorporates such additional diagnostic information into traditional Proportional Hazards (PH) cure model analysis. In this work, we extended a semi-parametric Accelerated-Failure-Time (AFT) cure model to incorporate the additional diagnostic information because AFT model may be more appropriate than PH models in some applications and it provides intuitive and easy-to-understand interpretation through postulating direct relationship between failure-times and covariates. Through simulations, we showed that the proposed extended semi-parametric AFT cure model provided more efficient and less biased estimations than traditional semi-parametric AFT cure model; higher efficiency and smaller bias were associated with higher sensitivity and specificity of the diagnostic procedures. The proposed method was illustrated using a clinical data example.

There is limited available literature examining factors that predispose patients to the development of LMC after stereotactic radiosurgery (SRS) for brain metastases. We sought to evaluate risk factors that may predispose patients to LMC after SRS treatment in this case-control study of patients with brain metastases who underwent single-fraction SRS between 2011 and 2016. Demographic and clinical information were collected retrospectively for 19 LMC cases and 30 controls out of 413 screened patients with brain metastases. Risk factors of interest were evaluated by univariate and multivariate logistic regression analyses and overall survival rates were evaluated by Kaplan-Meier survival analysis. About 5% of patients with brain metastases treated with SRS developed LMC. Patients with LMC (median 154 days, 95% CI 33-203 days) demonstrated a poorer overall survival than matched controls (median 417 days, 95% CI 121-512 days, p = 0.002). The most common primary tumor histologies that lead to the development of LMC were non-small cell lung cancer (36.8%), breast cancer (26.3%), and melanoma (21.1%). No association was found between the risk of LMC and the location of the brain lesion or total volume of brain metastases. Prior surgical resection of brain metastases before SRS was associated with a 6.5 times higher odds (95% CI 1.45-29.35, p = 0.01) of developing LMC post-radiosurgery compared to those with no prior resections of brain metastases. Additionally, adjuvant WBRT may help to reduce the risk of LMC and can be considered in decision-making for patients who have had brain metastasectomy.

Despite previous findings of therapeutic effects for heart rate variability biofeedback (HRVB) on asthma, it is not known whether HRVB can substitute either for controller or rescue medication, or whether it affects airway inflammation. Sixty-eight paid volunteer steroid naive study participants with mild or moderate asthma were given 3 months of HRVB or a comparison condition consisting of EEG alpha biofeedback with relaxing music and relaxed paced breathing (EEG+), in a two-center trial. All participants received a month of intensive asthma education prior to randomization. Both treatment conditions produced similar significant improvements on the methacholine challenge test (MCT), asthma symptoms, and asthma quality of life (AQOL). MCT effects were of similar size to those of enhanced placebo procedures reported elsewhere, and were 65% of those of a course of a high-potency inhaled steroid budesonide given to a sub-group of participants following biofeedback training. Exhaled nitric oxide decreased significantly only in the HRVB group, 81% of the budesonide effect, but with no significant differences between groups. Participants reported becoming more relaxed during practice of both techniques. Administration of albuterol after biofeedback sessions produced a large improvement in pulmonary function test results, indicating that neither treatment normalized pulmonary function as a potent controller medication would have done. Impulse oscillometry showed increased upper airway (vocal cord) resistance during biofeedback periods in both groups. These data suggest that HRVB should not be considered an alternative to asthma controller medications (e.g., inhaled steroids), although both biofeedback conditions produced some beneficial effects, warranting further research, and suggesting potential complementary effects. Various hypotheses are presented to explain why HRVB effects on asthma appeared smaller in this study than in earlier studies. Clinical Trial Registration NCT02766374.

Introduction Over 85% of opioid-dependent individuals in methadone treatment smoke cigarettes; however, smoking cessation interventions are minimally effective in this population. To better help opioid-dependent individuals quit smoking, we developed and pilot-tested an intervention, based in the Information-Motivation-Behavioral Skills (IMB) model of behavior change, which could be tailored to address individual barriers to smoking cessation in this population. Methods We randomized participants (n = 83) in methadone treatment to the eight-session, IMB model-based, intervention plus nicotine replacement therapy (intervention, n = 41) or a facilitated referral to the state Quitline (control, n = 42). All participants completed assessments at baseline, 3 months, and 6 months. Results Intervention participants completed a median of five sessions (interquartile range [IQR] 3-8) and had significantly higher intervention satisfaction than control participants. Intervention participants reported smoking significantly fewer cigarettes per day at 3 months (median [IQR] = 6 [4-15]) and 6 months (median [IQR] = 8 [4-14]) as compared control participants at 3 months (median [IQR] = 10 [5-20]) and 6 months (median [IQR] = 10 [6-20]). Fifty-six percent of the intervention group and 41% of the control group a made a quit attempt during the study (p = .16). At 3 months, 7% (n = 3) of intervention participants and none of the control participants were abstinent from smoking (p = .23). At 6 months, 2% of participants in both groups were abstinent. Twenty-four percent and 10% of the intervention and control group participants, respectively, reported 20 or more smoke-free days (p = .43). Conclusions An IMB model-based smoking cessation intervention for opioid-dependent smokers is feasible and acceptable in methadone treatment and may help methadone maintained smokers cut down on their smoking. Implications This is the first study of a tailored, IMB Model-based, smoking cessation intervention for opioid dependent smokers. Results showed that opioid dependent smokers are willing and able to participate in an IMB model-based smoking cessation intervention, and this intervention may help this population cut down on their smoking. Also, the Quitline seems less feasible and acceptable for this population than a face-to-face intervention. Further research is needed to determine how to integrate smoking cessation treatment into methadone programs and how to improve interventions so that treatment gains can lead to long-term abstinence in this population.