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Background Though maintaining physical conditioning and a healthy weight are requirements of active military duty, many US veterans lose conditioning and rapidly gain weight after discharge from active duty service. Mobile health (mHealth) interventions using wearable devices are appealing to users and can be effective especially with personalized coaching support. We developed Stay Strong, a mobile app tailored to US veterans, to promote physical activity using a wrist-worn physical activity tracker, a Bluetooth-enabled scale, and an app-based dashboard. We tested whether adding personalized coaching components (Stay Strong+Coaching) would improve physical activity compared to Stay Strong alone. Objective The goal of this study is to compare 12-month outcomes from Stay Strong alone versus Stay Strong+Coaching. Methods Participants (n=357) were recruited from a national random sample of US veterans of recent wars and randomly assigned to the Stay Strong app alone (n=179) or Stay Strong+Coaching (n=178); both programs lasted 12 months. Personalized coaching components for Stay Strong+Coaching comprised of automated in-app motivational messages (3 per week), telephone-based human health coaching (up to 3 calls), and personalized weekly goal setting. All aspects of the enrollment process and program delivery were accomplished virtually for both groups, except for the telephone-based coaching. The primary outcome was change in physical activity at 12 months postbaseline, measured by average weekly Active Minutes, captured by the Fitbit Charge 2 device. Secondary outcomes included changes in step counts, weight, and patient activation. Results The average age of participants was 39.8 (SD 8.7) years, and 25.2% (90/357) were female. Active Minutes decreased from baseline to 12 months for both groups (P Conclusions Adding personalized health coaching comprised of in-app automated messages, up to 3 coaching calls, plus automated weekly personalized goals, did not improve levels of physical activity compared to using a smartphone app alone. Physical activity in both groups decreased over time. Sustaining long-term adherence and engagement in this mHealth intervention proved difficult; approximately two-thirds of the trial’s 357 participants failed to sync their Fitbit device at 12 months and, thus, were lost to follow-up. Trial Registration ClinicalTrials.gov NCT02360293; https://clinicaltrials.gov/ct2/show/NCT02360293 International Registered Report Identifier (IRRID) RR2-10.2196/12526

BACKGROUND Though maintaining physical conditioning and a healthy weight are requirements of active military duty, many US veterans lose conditioning and rapidly gain weight after discharge from active duty service. Mobile health (mHealth) interventions using wearable devices are appealing to users and can be effective especially with personalized coaching support. We developed Stay Strong, a mobile app tailored to US veterans, to promote physical activity using a wrist-worn physical activity tracker, a Bluetooth-enabled scale, and an app-based dashboard. We tested whether adding personalized coaching components (Stay Strong+Coaching) would improve physical activity compared to Stay Strong alone. OBJECTIVE The goal of this study is to compare 12-month outcomes from Stay Strong alone versus Stay Strong+Coaching. METHODS Participants (n=357) were recruited from a national random sample of US veterans of recent wars and randomly assigned to the Stay Strong app alone (n=179) or Stay Strong+Coaching (n=178); both programs lasted 12 months. Personalized coaching components for Stay Strong+Coaching comprised of automated in-app motivational messages (3 per week), telephone-based human health coaching (up to 3 calls), and personalized weekly goal setting. All aspects of the enrollment process and program delivery were accomplished virtually for both groups, except for the telephone-based coaching. The primary outcome was change in physical activity at 12 months postbaseline, measured by average weekly Active Minutes, captured by the Fitbit Charge 2 device. Secondary outcomes included changes in step counts, weight, and patient activation. RESULTS The average age of participants was 39.8 (SD 8.7) years, and 25.2% (90/357) were female. Active Minutes decreased from baseline to 12 months for both groups (PP=.82) or 12 months (P=.98). However, at 12 months, many participants in both groups did not record Active Minutes, leading to missing data in 67.0% (120/179) for Stay Strong and 61.8% (110/178) for Stay Strong+Coaching. Average baseline weight for participants in Stay Strong and Stay Strong+Coaching was 214 lbs and 198 lbs, respectively, with no difference at baseline (P=.54) or at 6 months (P=.28) or 12 months (P=.18) postbaseline based on administrative weights, which had lower rates of missing data. Changes in the number of steps recorded and patient activation also did not differ by arm. CONCLUSIONS Adding personalized health coaching comprised of in-app automated messages, up to 3 coaching calls, plus automated weekly personalized goals, did not improve levels of physical activity compared to using a smartphone app alone. Physical activity in both groups decreased over time. Sustaining long-term adherence and engagement in this mHealth intervention proved difficult; approximately two-thirds of the trial’s 357 participants failed to sync their Fitbit device at 12 months and, thus, were lost to follow-up. CLINICALTRIAL ClinicalTrials.gov NCT02360293; https://clinicaltrials.gov/ct2/show/NCT02360293 INTERNATIONAL REGISTERED REPORT RR2-10.2196/12526

OBJECTIVE: The Centers for Medicare & Medicaid Services’ National Partnership to Improve Dementia Care in Nursing Homes focuses on but is not limited to long-term care (LTC) residents with dementia; the potential impact on residents with other diagnoses is unclear. We sought to determine whether resident subpopulations experienced changes in antipsychotic and mood stabilizer prescribing. DESIGN: Repeated cross-sectional analysis of a 20% Medicare sample, 2011–2014. SETTING AND PARTICIPANT: Fee-for-service Medicare beneficiaries with Part D coverage in LTC (n=562,485) and a secondary analysis limited to persons with depression or bipolar disorder (n=139,071). METHODS: Main outcome was quarterly predicted probability of treatment with an antipsychotic or mood stabilizer. RESULTS: From 2011–2014, the adjusted predicted probability (APP) of antipsychotic treatment fell from 0.120 (95% confidence interval [CI] 0.119–0.121) to 0.100 (95% CI 0.099–0.101; p

Objectives To evaluate national trends in electrocardiogram (EKG) monitoring in Veterans Affairs (VA) beneficiaries prescribed high‐dose citalopram before and after the 2011–12 Food and Drug Administration (FDA) safety warnings. Design Interrupted time‐series analyses. Setting National VA healthcare system data linked to Medicare data for veterans dually eligible for VA and Medicare services. Participants Adult VA outpatients prescribed citalopram or sertraline from February 2010 to September 2013 (N=1,068,816). Measurements EKG monitoring for VA outpatients prescribed high‐dose citalopram (>40 mg/d aged ≤60, >20 mg/d aged >60) or sertraline. Results For individuals prescribed high‐dose citalopram, EKG monitoring increased from 9.0% before the start of the first FDA warning to a peak of 12.6% for individuals aged 18 to 60 and from 14.0% to 19.4% for individuals aged 61 to 100. However, following the second FDA warning in 2012, EKG monitoring declined, returning to prewarning levels in both age groups. EKG monitoring did not increase in individuals with a history of previous cardiac risk factors prescribed high‐dose citalopram in either age group. Conclusions EKG frequency did not significantly change in individuals with cardiac risk factors at greatest potential risk for QT prolongation. Lack of responsiveness to the FDA warnings may be due to many factors, including lack of clarity about which individuals should undergo EKG monitoring, provider substitution of alternative antidepressants for citalopram, conflicting evidence regarding risk for adverse cardiac events with high‐dose citalopram use, and lack of provider knowledge regarding the warnings.

The intestinal immune system is regulated by microbes and their metabolites. The roles of gut microbial metabolites in regulating intestinal inflammation and tumorigenesis are incompletely understood. We systematically studied the roles of short-chain fatty acids (SCFAs) and their receptors (GPR43 or GPR41) in regulating tissue bacterial load, acute versus chronic inflammatory responses, and intestinal cancer development. SCFA receptor-, particularly GPR43-, deficient mice were defective in mounting appropriate acute immune responses to promote barrier immunity, and developed uncontrolled chronic inflammatory responses following epithelial damage. Further, intestinal carcinogenesis was increased in GPR43-deficient mice. Dietary fiber and SCFA administration suppressed intestinal inflammation and cancer in both GPR43-dependent and independent manners. The beneficial effect of GPR43 was not mediated by altered microbiota but by host tissue cells and hematopoietic cells to a lesser degree. We found that inability to suppress commensal bacterial invasion into the colonic tissue is associated with the increased chronic Th17-driven inflammation and carcinogenesis in the intestine of GPR43-deficient mice. In sum, our results reveal the beneficial function of the SCFA-GPR43 axis in suppressing bacterial invasion and associated chronic inflammation and carcinogenesis in the colon.

Fluorescence lifetime sensing has been shown to noninvasively characterize the preimplantation health and viability of engineered tissue constructs. However, current practices to monitor postimplantation construct integration are either qualitative (visual assessment) or destructive (tissue histology). We employed label-free fluorescence lifetime spectroscopy for quantitative, noninvasive optical assessment of engineered tissue constructs that were implanted into a murine model. The portable system was designed to be suitable for intravital measurements and included a handheld probe to precisely and rapidly acquire data at multiple sites per construct. Our model tissue constructs were manufactured from primary human cells to simulate patient variability based on a standard protocol, and half of the manufactured constructs were stressed to create a range of health states. Secreted amounts of three cytokines that relate to cellular viability were measured in vitro to assess preimplantation construct health: interleukin-8 (IL-8), human β-defensin 1 (hBD-1), and vascular endothelial growth factor (VEGF). Preimplantation cytokine secretion ranged from 1.5 to 33.5 pg/mL for IL-8, from 3.4 to 195.0 pg/mL for hBD-1, and from 0.1 to 154.3 pg/mL for VEGF. In vivo optical sensing assessed constructs at 1 and 3 weeks postimplantation. We found that at 1 week postimplantation, in vivo optical parameters correlated with in vitro preimplantation secretion levels of all three cytokines (p

In 2011-2012 the U.S. Food and Drug Administration (FDA) issued safety announcements cautioning providers against prescribing high doses of citalopram given concerns for QT prolongation. The authors evaluated Veterans Affairs (VA) national trends in citalopram use and dose compared with alternative antidepressants after the FDA warnings.Time series analyses estimated the effect of the FDA warnings on citalopram and other antidepressant across three periods: before the first FDA warning in August 2011, after the 2011 FDA warning until the second warning in March 2012, and after the 2012 FDA warning. In a National VA health system, adult VA outpatients prescribed citalopram or alternative antidepressants from February 2010 to September 2013 were studied. Outpatient use of high-dose citalopram (40 or20 mg daily in adults aged 60 years) including the proportion of patients prescribed citalopram and difference between study periods.Between the first and second FDA warnings, among patients aged 18-60, high-dose citalopram use decreased by 2.0% per month (p 0.001) and by 1.9% per month (p 0.001) for older adults. After the second FDA warning in 2012, 30.7% of older patients remained on doses higher than the newly recommended dose of 20 mg. Reductions in overall use of citalopram were accompanied by significant increases in prescriptions of alternative antidepressants, with sertraline most widely prescribed.Although trends in high-dose citalopram use declined after the 2011-2012 FDA warnings, roughly one-third of older adults still remained on higher than recommended doses. Concomitant increases in sertraline and other antidepressant prescriptions suggest potential substitution of these medications for citalopram.

Background Survey-based research is essential for evaluating the outcomes of health care in an era of patient-centered care. However, many such studies are hampered by poor response rates in completion of study questionnaires, thus limiting the generalizability of any findings. The objectives of this analysis were to identify independent variables associated with nonresponse to surveys following breast reconstruction to improve future patient-reported outcomes research. Materials and methods The Mastectomy Reconstruction Outcomes Consortium is a prospective cohort study involving 11 leading medical centers from the United States and Canada. Nonresponse rates for surveys assessing satisfaction with breast, satisfaction with care (BREAST-Q), depression (Patient Health Questionnaire-9), and anxiety (Generalized Anxiety Disorder-7) were measured at 1 y and 2 y postoperatively. Clinical complication rates were compared between responders and nonresponders, and multivariable models were used to assess predictors of nonresponse. Results Among 2856 women in the analytic cohort, 1882 (65.9%) underwent implant-based, 817 (28.6%) received autologous, and 157 (5.5%) underwent latissimus dorsi myocutaneous flap breast reconstructions. Nonresponse rates to surveys at 1 y and 2 y were 27.8% and 34.4%, respectively. Race, ethnicity, and annual household income were associated with nonresponse to surveys. Women who underwent implant-based procedures were less likely to complete long-term surveys. Conclusions As survey-based research plays an increasingly prominent role in evaluating the outcomes of breast reconstruction, we found socioeconomic and procedure-related differences in survey response rates. Investigators must consider systematic differences in response rates among particular groups of women on the generalizability and validity of findings and perform rigorous nonresponse bias analyses.

In postmastectomy reconstruction, procedure choice is heavily influenced by the relative risks of the various options. This study sought to evaluate complications in a large, multicenter patient population.Previous studies have reported widely varying complication rates, but have been limited by their single center designs and inadequate controlling for confounders in their analyses.Eleven sites enrolled women undergoing first time, immediate, or delayed reconstruction following mastectomy for cancer treatment or prophylaxis. Procedures included expander/implant, latissimus dorsi (LD), pedicle transverse rectus abdominis musculocutaneous (PTRAM), free TRAM (FTRAM), and deep inferior epigastric perforator (DIEP) techniques. Data were gathered pre- and postoperatively from medical records. Separate logistic regressions were conducted for all complications and major complications (those requiring rehospitalization and/or reoperation) within 1 year. Odds ratios (ORs) were calculated for procedure type, controlling for site, demographic, and clinical variables.Complication rates for 2234 patients were analyzed. Compared with expander/implant reconstructions, LD (OR) 1.95, P = 0.026), PTRAM (OR 1.89, P = 0.025), FTRAM (OR 1.94, P = 0.011), and DIEP (OR 2.22, P0.001) procedures were associated with higher risks of complications. Significantly higher risks were also associated with older age, higher body mass index (BMI), immediate reconstruction, bilateral procedures, and radiation. For major complications, regression showed significantly greater risks for PTRAM (OR 1.86, P = 0.044) and DIEP (OR 1.75, P = 0.004), than expander/implant reconstructions. Failure rates were relatively low, ranging from 0% for PTRAM to 5.9% for expander/implant reconstructions.In this multicenter analysis, procedure choice and other patient variables were significant predictors of 1-year complications in breast reconstruction. These findings should be considered in counseling patients on reconstructive options.

Acellular dermal matrix has gained widespread acceptance in immediate expander/implant reconstruction because of perceived benefits, including improved expansion dynamics and superior aesthetic results. Although previous investigators have evaluated its risks, few studies have assessed the impact of acellular dermal matrix on other outcomes, including patient-reported measures.The Mastectomy Reconstruction Outcomes Consortium Study used a prospective cohort design to evaluate patients undergoing postmastectomy reconstruction from 10 centers and 58 participating surgeons between 2012 and 2015. The analysis focused on women undergoing immediate tissue expander reconstruction following mastectomies for cancer treatment or prophylaxis. Medical records and patient-reported outcome data, using the BREAST-Q and Numeric Pain Rating Scale instruments, were reviewed. Bivariate analyses and mixed-effects regression models were applied.A total of 1297 patients were evaluated, including 655 (50.5 percent) with acellular dermal matrix and 642 (49.5 percent) without acellular dermal matrix. Controlling for demographic and clinical covariates, no significant differences were seen between acellular dermal matrix and non-acellular dermal matrix cohorts in overall complications (OR, 1.21; p = 0.263), major complications (OR, 1.43; p = 0.052), wound infections (OR, 1.49; p = 0.118), or reconstructive failures (OR, 1.55; p = 0.089) at 2 years after reconstruction. There were also no significant differences between the cohorts in the time to expander/implant exchange (p = 0.78). No significant differences were observed in patient-reported outcome scores, including satisfaction with breasts, psychosocial well-being, sexual well-being, physical well-being, and postoperative pain.In this multicenter, prospective analysis, the authors found no significant acellular dermal matrix effects on complications, time to exchange, or patient-reported outcome in immediate expander/implant breast reconstruction. Further studies are needed to develop criteria for more selective use of acellular dermal matrix in these patients.Therapeutic, II.

Background Frequent premature ventricular complexes (PVCs) have been associated with increased mortality. However, the optimal approach to the risk stratification of these patients is unclear. Objective The purpose of this study was to prospectively assess the use of cardiac magnetic resonance imaging (MRI) and programmed ventricular stimulation to identify patients with PVCs undergoing radiofrequency ablation at risk for adverse long-term outcomes. Methods A total of 321 consecutive patients (52 ± 15 years; 157 men [49%]; left ventricular ejection fraction 51% ± 12%) underwent PVC ablation between 2004 and 2015, preceded by cardiac MRI to assess for structural heart disease (SHD). Programmed stimulation was performed at the time of the ablation procedure. If ventricular tachycardia (VT) was induced in the presence of SHD, an implantable cardioverter-defibrillator (ICD) was implanted. Results SHD was identified by MRI in 64 patients (20%), and sustained monomorphic VT was inducible in 15 patients (5%). Fourteen patients had both SHD and inducible VT, and received an ICD after the procedure. The primary endpoint of VT/ventricular fibrillation or death was met in 15 patients after a median 20 months of follow-up. The combination of SHD by MRI and VT inducibility conferred independently an increased risk of adverse outcome (multivariate hazard ratio 25.73, 95% confidence interval 6.74–98.20; P Conclusion Preablation cardiac MRI and programmed stimulation can be useful for risk stratification in patients with frequent PVCs. Patients with inducible VT in the setting of SHD may benefit from ICD implantation after ablation regardless of left ventricular ejection fraction.

IMPORTANCE: Women undergoing immediate breast reconstruction often require chemotherapy. The effects of chemotherapy on reconstruction are not well described. OBJECTIVE: To evaluate the association of neoadjuvant and adjuvant chemotherapy with complications and patient-reported outcomes (PROs) in immediate reconstruction. DESIGN, SETTING, AND PARTICIPANTS: The Mastectomy Reconstruction Outcomes Consortium Study is a cohort study that prospectively assessed PROs and retrospectively evaluated complications in patients undergoing immediate implant-based or autologous reconstruction at 11 centers from January 1, 2012, to December 31, 2017. Women 18 years or older undergoing immediate reconstruction after mastectomy with 2 years of follow-up were included. Patients were excluded if they had prophylactic mastectomy; delayed reconstruction; mixed-timing reconstruction; mixed reconstruction; a latissimus dorsi, superior gluteal artery perforator, or inferior gluteal artery perforator flap; or both neoadjuvant and adjuvant chemotherapy. Data were analyzed from May 1 to June 30, 2018. MAIN OUTCOMES AND MEASURES: Complications and PROs (satisfaction with breast and physical, psychosocial, and sexual well-being) using the BREAST-Q questionnaire, a validated, condition-specific PRO measure. Baseline patient characteristics were collected. RESULTS: A total of 1881 women were included in the analysis (mean [SD] age, 49.9 [9.9] years). Of these, 1373 (73.0%) underwent implant-based procedures; 508 (27.0%), autologous reconstruction; 200 (10.6%), neoadjuvant chemotherapy; 668 (35.5%), adjuvant chemotherapy; and 1013 (53.9%), no chemotherapy. Patients without chemotherapy were significantly older (mean [SD] age, 51.6 [9.4] years; P

Knowledge of complex arrhythmogenic substrates can help plan ventricular tachycardia (VT) ablation in patients with idiopathic dilated cardiomyopathy (DCM).The purpose of this study was to assess whether preprocedural late gadolinium enhancement magnetic resonance imaging (LGE-MRI) can improve ablation outcomes in DCM.Consecutive patients (N = 96) with idiopathic DCM underwent VT ablation with open-irrigated catheters (2006-2016). Before 2012, LGE-MRI was not performed at our institution in patients with implanted devices, but it has been performed routinely in all patients after implementation of a new MRI protocol in 2012. We retrospectively compared acute and long-term outcomes of initial VT ablation procedures in patients with (n = 41) and those without (n = 55) preprocedural LGE-MRI. Procedural outcome was classified as successful if VT was not inducible postablation.The 2 groups had a similar mean age and ejection fraction, comorbidities, and frequency of epicardial ablation. Preablation LGE-MRI was independently associated with improved procedural success (63% vs 24%) by logistic regression analysis (adjusted odds ratio [OR] 7.86, P.001). This result was consistent even when patients with nondiagnostic MRIs due to artifact were included in the imaging group (OR 4.87, P = .005). Preablation imaging was also associated with improved survival free of the composite endpoint of VT recurrence, heart transplantation, or death, which was met by 11 (27%) and 33 (60%) patients in the imaging and no imaging groups, respectively, after median 7.6 months of follow-up (unadjusted log-rank P = .02). However, there was no association with long-term outcomes after adjustment for other covariates.Preprocedural imaging with LGE-MRI may be associated with improved outcomes of VT ablation in DCM.

Background: Ablation of postinfarction ventricular tachycardia (VT) has been shown to reduce VT recurrence and decrease mortality. However, VT recurrence can occur despite extensive ablation procedures. The lack of inducibility of clinical VTs during ablation procedures remains problematic and may be in part responsible for VT recurrences. In this prospective study, we targeted documented but noninducible clinical VTs based on stored implantable cardioverter-defibrillator (ICD) electrograms. Methods: Radiofrequency ablation was performed in a consecutive group of 66 postinfarction patients (mean age, 67.5±9.2 years; men, 61; mean left ventricular ejection fraction, 25.1±10.8%) in whom clinical VTs were not inducible during an ablation procedure. In the first 33 patients (control group), only inducible VTs were targeted, and in the second 33 patients, noninducible clinical VTs were also targeted by pace-mapping based on stored ICD-electrograms (ICD-electrogram–guided ablation group). Procedural and clinical outcomes were compared at 24 months post-ablation. Results: VT recurred in 5 patients (15%) in whom the ICD-electrogram–guided approach was performed and in 13 patients (39%) in the control group. Freedom from recurrent VT was higher (log-rank P =0.04) in the ICD-electrogram–guided group, but there was no difference in ventricular fibrillation or in total mortality between both groups. Conclusions: Ablation guided by pace-mapping of noninducible postinfarction clinical VTs based on ICD-electrograms is feasible and reduces the risk of recurrent VT.

BACKGROUND: In choosing between implant-based and autologous breast reconstruction, surgeons and patients must weigh relative risks and benefits. However, differences in outcomes across procedure types may vary between unilateral versus bilateral reconstructions. Procedure-related differences in complications and patient-reported outcomes (PROs) were evaluated for unilateral and bilateral reconstruction. METHODS: Complications and PROs were assessed at two years for patients undergoing autologous (TRAM, DIEP, SIEA) or implant-based (TE, DTI) reconstructions. Overall complications and major complications (requiring re-admission and/or re-operation) were recorded, while PROs were measured with BREAST-Q and PROMIS surveys. Stratified regression models compared outcomes between autologous and implant-based reconstructions, separately for unilateral and bilateral cohorts. RESULTS: Among 2125 patients, 917 underwent unilateral (600 implant, 317 autologous) and 1208 underwent bilateral (994 implant, 214 autologous) reconstructions. Controlling for patient characteristics, complication rates were significantly higher in the autologous versus implant-based group with both unilateral (overall: OR 2.50, p

OBJECTIVE: Assess whether neighborhood characteristics predict patient‐reported outcomes for depression. DATA SOURCES: VA electronic medical record data and U.S. census data. STUDY DESIGN: Retrospective longitudinal cohort. DATA EXTRACTION METHODS: Neighborhood and individual characteristics of patients (N = 4,269) with a unipolar depressive disorder diagnosis and an initial Patient Health Questionnaire (PHQ‐9) score ≥10 were used to predict 50 percent improvement in 4‐8‐month PHQ‐9 scores. PRINCIPAL FINDINGS: The proportion of a patient's neighborhood living in poverty (OR = 0.98; 95% CI: 0.97‐.1.00; P = 0.03) was associated with lower likelihood of depression symptom improvement in addition to whether the patient was black (OR = 0.76; 95% CI:0.61‐0.96; P = 0.02) had PTSD (OR = 0.59; 95% CI:0.50‐0.69; P

OBJECTIVE Prescriptions for sedative hypnotics are routinely initiated and renewed to treat insomnia, despite evidence supporting nonpharmacologic treatments as comparable and more favorable over time. We used national Veterans Health Administration data to assess patient characteristics associated with high-dose and long-term zolpidem use. METHOD The study included outpatients with new zolpidem prescriptions (January 1, 2013, to June 3, 2014). We defined high-dose use as use of doses above those recommended in the 2013 FDA safety warning (> 5 mg for women, > 10 mg for men) and defined long-term use as at least 180 days of continued supply. We fit separate logistic regression models by sex to evaluate how patient factors, adjusting for facilities, predicted high-dose and long-term use. RESULTS Of 139,525 new zolpidem users, < 1% of men and 41% of women used high doses within 180 days of initiation, and 20% continued to use zolpidem long-term. Prior-year use of other sleep medications was associated with both high-dose and long-term use. Substance abuse/dependence was associated with high-dose use in women (odds ratio = 1.20, P < .001). Although long-term use was less likely in those over the age of 85 years, about 1 in 5 users aged 65 to 85 continued long-term. In both sexes, individuals of Hispanic ethnicity and nonwhite races were less likely to use long-term, whereas those with ICD-9-CM-defined psychiatric and sleep disorder diagnoses were more likely to use long-term. CONCLUSIONS Zolpidem use at a higher-than-recommended dose was common in women who were new zolpidem users. In both sexes, 1 in 5 users continued to use zolpidem for at least 180 days. Efforts to improve access to effective nonpharmacologic treatment alternatives may benefit from attention to subpopulations with higher risk of high-dose and long-term use.

POLICY POINTS: Engaging and involving underrepresented communities when setting research priorities could make the scientific research agenda more equitable, more just, and more responsive to their needs and values. Groups and individuals from minority and underserved communities strongly prioritized child health and mental health research, often choosing to invest at the highest possible level. Groups consisting of predominantly Native American or Arab American participants invested in culture and beliefs research at the highest level, while many groups did not select it at all. The priority given to culture and beliefs research by these groups illustrates the importance of paying special attention to unique preferences, and not just commonly held views, when getting public input on spending priorities for research. CONTEXT: A major contributor to health disparities is the relative lack of resources—including resources for science—allocated to address the health problems of those with disproportionately greater needs. Engaging and involving underrepresented communities in setting research priorities could make the scientific research agenda more equitable, more just, and more responsive to their needs and values. We engaged minority and underserved communities in informed deliberations and report here their priorities for health research. METHODS: Academic‐community partnerships adapted the simulation exercise CHAT for setting health research priorities. We had participants from minority and medically underserved communities (47 groups, n = 519) throughout Michigan deliberate about health research priorities, and we used surveys and CHAT software to collect the demographic characteristics and priorities selected by individuals and groups. FINDINGS: The participants ranged in age (18 to 88), included more women than men, and were overrepresented by minority groups. Nearly all the deliberating groups selected child health and mental health research (93.6% and 95.7%), and most invested at the highest level. Aging, access, promote health, healthy environment, and what causes disease were also prioritized by groups. Research on mental health and child health were high priorities for individuals both before and after group deliberations. Access was the only category more likely to be selected by individuals after group deliberation (77.0 vs 84.0%, OR = 1.63, p = .005), while improve research, health policy, and culture and beliefs were less likely to be selected after group deliberations (all, p < .001). However, the level of investment in many categories changed after the group deliberations. Participants identifying as Black/African American were less likely to prioritize mental health research, and those of Other race were more likely to prioritize culture and beliefs research. CONCLUSIONS: Minority and medically underserved communities overwhelmingly prioritized mental health and child health research in informed deliberations about spending priorities.

Purpose Obesity disproportionately burdens individuals with serious mental illness (SMI), especially women. This observational study investigated whether there were sex differences in weight loss and program participation among veterans with SMI enrolled in the Veterans Health Administration's (VHA) MOVE! weight management program. Procedures Participants were identified from a national cohort of 148,254 veterans enrolled in MOVE! during fiscal years 2008 through 2012 who attended two or more sessions within 12 months of enrollment. The cohort included those with International Classification of Disease, 9th Edition, Clinical Modification (ICD-9-CM) diagnoses for SMI, age less than 70 years, and weight data at baseline and one or more follow-up timepoints within approximately 1 year of enrollment ( n = 8,943 men; n = 2,245 women). Linear mixed models assessed associations of sex with 6- and 12-month weight change from baseline, adjusting for demographic- and site-level variables. Findings Both sexes averaged 6.4 (standard deviation, 4.6) sessions within 12 months; however, women with and without SMI participated at rates double their respective proportion rates among all VHA users. Participants averaged statistically significant weight loss at 6 months (men, −2.5 lb [95% CI, −2.8 to −2.1]; women, −2.4 lb [95% CI, −3.1 to −1.7]) and 12 months (men, −2.5 lb [95% CI, −2.8 to −2.2]; women, −2.9 lb [95% CI, −3.6 to −2.2]), but no sex-based difference in absolute weight loss at either timepoint. Slightly more women achieved 5% or greater (clinically significant) weight loss at the 12-month follow-up than did men (25.7% vs. 23.0%; p Conclusions Women with SMI participated in MOVE! at rates equivalent to or greater than men with SMI, with comparable weight loss. More women were Black, single, had bipolar and posttraumatic stress disorder, and higher service-connected disability, suggesting areas for program customization.

ObjectiveVarious models of peer support may be implemented in mental health settings. This randomized trial assessed the effectiveness of a telephone-delivered mutual peer support intervention.MethodsA total of 443 patients receiving ongoing depression treatment from the U.S. Department of Veterans Affairs were enrolled in either enhanced usual care (N=243) or the peer support intervention (N=200). Intent-to-treat analyses assessed outcomes at six months postenrollment, excluding 56 patients who experienced an unplanned telephone platform shutdown.ResultsAt baseline, patients had substantial depressive symptoms, functional limitations, and low quality of life. Both groups showed significant clinical improvements at six months, with no significant differences by group.ConclusionsTelephone-delivered mutual peer support for patients with depression did not improve outcomes beyond those observed with enhanced usual care. Other peer support models, with more "professionalized" peers delivering a structured curriculum, may be more effective.

AIMS To examine the characteristics of patients with diabetes who regularly receive help from a supporter in preparing for and attending medical visits, and the association between this help and clinical risk factors for diabetes complications. METHODS We linked survey data about family involvement for patients in the Veterans Health Administration system with poorly controlled Type 2 diabetes (n = 588; mean 67 years; 97% male) with health record data on blood pressure, glycaemic control and prescription-fill gaps. We used multivariable regression to assess whether supporter presence and, among patients with supporters, supporter role (visit preparation, accompaniment to medical visit or no involvement) were associated with concurrent trends in clinical risk factors over 2 years, adjusting for sociodemographic and health characteristics. RESULTS Most patients (78%) had a main health supporter; of these, more had regular support for preparing for appointments (69%) than were regularly accompanied to them (45%). Patients with preparation help only were younger and more educated than accompanied patients. Support presence and type was not significantly associated with clinical risk factors. CONCLUSIONS Family help preparing for appointments was common among these patients with high-risk diabetes. In its current form, family support for medical visits may not affect clinical factors in the short term. Supporters helping patients engage in medical visits may need training and assistance to have an impact on the clinical trajectory of patients with diabetes.

This study examined the effect of a walking intervention on step counts among patients with chronic back pain who report opioid use. Data were collected as part of a randomized trial to reduce back-pain-related disability. Participants (n = 118 usual care, 111 intervention) were Veterans receiving care within one healthcare system. Step counts were collected at baseline, 6 mo, and 12 mo via an uploading pedometer. Self-reported opioid use was collected by survey. More than 40% (n = 99) of participants reported opioid use at baseline. After adjustment, the predicted mean step count for baseline opioid users assigned to the intervention increased by more than 1,200 steps compared with a reduction of nearly 400 steps for those assigned to usual care (between-group difference = 1,625 steps, p = 0.004). Among nonopioid users, there was no change for those in the intervention (-16 steps) and an increase of about 660 steps for those assigned to usual care (between-group difference = 683 steps, p = 0.17). These data show that patients taking opioids may engage in walking to help manage their back pain. This finding emphasizes the importance of encouraging the use of alternative pain management strategies for these patients.

Importance Blood pressure (BP) targets are the main measure of high-quality hypertension care in health systems. However, BP alone does not reflect intensity of pharmacological treatment, which should be carefully managed in older patients. Objectives To develop and validate an electronic health record (EHR) data-only algorithm using pharmacy and BP data to capture intensive hypertension care (IHC), defined as 3 or more BP medications and BP less than 120 mm Hg, and to identify conditions associated with greater IHC, either through greater algorithm false-positive IHC, or by contributing clinically to delivering more IHC. Design, Setting, and Participants This cross-sectional study was conducted among 319 randomly selected patients aged 65 years or older receiving IHC from the Veterans Health Administration (VHA) from July 1, 2011, to June 30, 2013. Data were collected from a total of 3625 primary care visits. Data were analyzed from January 2017 to March 2020. Exposures Calibration and measurement of the algorithm for IHC (algorithm IHC). Main Outcomes and Measures For each primary care visit, the reference standard, clinical IHC, was determined by detailed review of free-text clinical notes. The correlation in BP medication count between the EHR-only algorithm vs the reference standard and the sensitivity and specificity of the algorithm IHC were calculated. In addition, presence vs absence of contributing conditions acting in combination with hypertension management were measured to examine incidence of IHC associated with contributing conditions, including an acute condition that lowered BP (eg, dehydration), another condition requiring a BP target lower than the standard 140 mm Hg (eg, diabetes), or the patient needing a BP-lowering medication for a nonhypertension condition (eg, β-blocker for atrial fibrillation) resulting in low BP. Results Among 319 patients with 3625 visits (mean [SD] age, 75.6 [7.2] years; 3592 [99.1%] men), 911 visits (25.1%) had clinical IHC by the reference standard. The algorithm for determining medication count was highly correlated with the reference standard (r = 0.84). Sensitivity of detecting clinical IHC was 92.2% (95% CI, 89.3%-95.1%), and specificity was 97.2% (95% CI, 96.1%-98.3%), suggesting that clinical IHC can be identified from routinely collected data. Only 75 visits (2.1%) were algorithm IHC false positives, 55 visits (1.5%) involved IHC with contributing conditions, and 125 visits (3.5%) involved either false-positive or IHC with contributing conditions. Among select contributing conditions, congestive heart failure (37 patients [5.2%]) was most associated with a prespecified combined false-positive or IHC with contributing conditions rate higher than 5%. Conclusions and Relevance These findings suggest that health system data can be used reliably to estimate IHC.

BACKGROUND Although maintaining a healthy weight and physical conditioning are requirements of active military duty, many US veterans rapidly gain weight and lose conditioning when they separate from active-duty service. Mobile health (mHealth) interventions that incorporate wearables for activity monitoring have become common, but it is unclear how to optimize engagement over time. Personalized health coaching, either through tailored automated messaging or by individual health coaches, has the potential to increase the efficacy of mHealth programs. In an attempt to preserve conditioning and ward off weight gain, we developed Stay Strong, a mobile app that is tailored to veterans of recent conflicts and tracks physical activity monitored by Fitbit Charge 2 devices and weight measured on a Bluetooth-enabled scale. OBJECTIVE The goal of this study is to determine the effect of activity monitoring plus health coaching compared with activity monitoring alone. METHODS In this randomized controlled trial, with Stay Strong, a mobile app designed specifically for veterans, we plan to enroll 350 veterans to engage in an mHealth lifestyle intervention that combines the use of a wearable physical activity tracker and a Bluetooth-enabled weight scale. The Stay Strong app displays physical activity and weight data trends over time. Enrolled participants are randomized to receive the Stay Strong app (active comparator arm) or Stay Strong + Coaching, an enhanced version of the program that adds coaching features (automated tailored messaging with weekly physical activity goals and up to 3 telephone calls with a health coach—intervention arm) for 1 year. Our primary outcome is change in physical activity at 12 months, with weight, pain, patient activation, and depression serving as secondary outcome measures. All processes related to recruitment, eligibility screening, informed consent, Health Insurance Portability and Accountability Act authorization, baseline assessment, randomization, the bulk of intervention delivery, and outcome assessment will be accomplished via the internet or smartphone app. RESULTS The study recruitment began in September 2017, and data collection is expected to conclude in 2019. A total of 465 participants consented to participate and 357 (357/465, 77%) provided baseline levels of physical activity and were randomized to 1 of the 2 interventions. CONCLUSIONS This novel randomized controlled trial will provide much-needed findings about whether the addition of telephone-based human coaching and other automated supportive-coaching features will improve physical activity compared with using a smartphone app linked to a wearable device alone. CLINICALTRIAL ClinicalTrials.gov NCT02360293; https://clinicaltrials.gov/ct2/show/NCT02360293 (Archived by WebCite at http://www.webcitation.org/75KQeIFwh) INTERNATIONAL REGISTERED REPOR DERR1-10.2196/12526

Proponents of public deliberation suggest that engaging in deliberation increases deliberators’ subsequent participation in other forms of politics. We evaluate this “deliberative participation hypothesis” using data drawn from a deliberative field experiment in which members of medically underserved communities in Michigan deliberated in small groups about the design of that state’s Medicaid program. Participants were randomly assigned to deliberate about the program in a group or to think about the decision individually, and then completed a post-survey that included measures of willingness to engage in a variety of political acts. We measured willingness to engage in common forms of political participation, as well as willingness to participate in particularistic resistance to adverse decisions by insurance bureaucracies. Contrary to the claims of much of the existing literature, we find no impact of deliberation on willingness to engage in political participation. These results suggest that the ability of public deliberation to increase broader political engagement may be limited or may only occur in particularly intensive, directly empowered forms of public deliberation.

Team-based care models, including the patient-centered medical home (PCMH), are increasingly promoted to improve the delivery of primary care. However, evaluation measures are often reported at a clinic or primary care provider (PCP) level, creating challenges in describing and analyzing the use and impact of non-PCP clinician team members. Thus, we aimed to measure clinician-specific care delivery trends and determine whether trends were responsive to systemwide PCMH implementation.Interrupted time-series analysis of 57 million primary care encounters among 5 million veterans at 764 Veterans Health Administration primary care clinics from 2009 to 2013.Retrospective data identified patient encounters attributable to 12 types of clinicians, yielding an encounters-by-clinician metric. Negative binomial regression modeled the monthly clinic-level rates of encounters for each type of clinician, before and during PCMH implementation.Over 5 years, the percentage of encounters by non-PCP clinicians increased from 29% to 35%. Monthly encounter rates for nurses and social workers significantly increased by 0.5% and 1.3%, respectively, after the introduction of PCMH, whereas PCP encounter rates significantly decreased over time. Encounter trends for pharmacists, nutritionists, and behavioral health clinicians did not significantly change.This study demonstrated the feasibility of capturing care delivered by a full complement of team members using routinely collected data. Findings suggest that the proportions of care delivered by non-PCP clinicians were sensitive to a change in care delivery model. As team-based care models expand, availability and use of metrics that account for care by all team members are critical for inferring clinician-related effects on outcomes.

Objectives Mental illness may impact outcomes from structured behavioral weight loss interventions. This secondary analysis investigated the influence of mental health on weight loss among Veterans with prediabetes enrolled in either an in-person diabetes prevention program (DPP) or the usual care weight management program (MOVE!) designed to help patients achieve weight loss through changes in physical activity and diet. Methods Prediabetes was defined by Hemoglobin A1c between 5.7 and 6.4% or Fasting Plasma Glucose 100–125 mg/dL and no use of antiglycemic medications during the past six months. Veterans Health Administrative data were used to assign Veterans into one of three mental health diagnoses: severe mental illness (SMI), affective disorder (AD) without SMI, or No SMI/No AD. The influence of mental health on weight changes at 6 and 12 months was modeled using linear mixed-effects regression. Results On average, Veterans with prediabetes (n = 386) were 59 years old (SD = 10.0 years), with a BMI of 34.8 kg/m2 (SD = 5.3 kg/m2) and A1c of 6.0% (SD = 0.2%). The sample consisted of 12% (n = 47), 39% (n = 150), and 49% (n = 189) diagnosed with SMI, AD and No SMI/No AD, respectively. Across interventions, Veterans with SMI lost less weight than those with AD or No SMI/No AD. From baseline to 6 months, weight loss was significantly less for Veterans with SMI (1.53 kg) compared to Veterans with AD (3.85 kg) or No SMI/No AD (3.73 kg). This weight loss trend by mental health diagnosis continued from baseline to 12 months but was no longer statistically significant at 12 months. Conclusion Weight loss was not clinically or statistically different among Veterans with prediabetes diagnosed with AD or No SMI/No AD. However, Veterans diagnosed with SMI exhibited less weight loss over 6 months than Veterans with AD or No SMI/No AD and though not statistically significant, the trend continued to 12 months, suggesting that SMI may influence weight loss outcomes.

Clinical translation of engineered tissue constructs requires noninvasive methods to assess construct health and viability after implantation in patients. However, current practices to monitor post-implantation construct integration are either qualitative (visual assessment) or destructive (tissue histology). As label-free fluorescence lifetime sensing can noninvasively characterize pre-implantation construct viability, we employed a handheld fluorescence lifetime spectroscopy probe to quantitatively and noninvasively assess tissue constructs that were implanted in a murine model. We designed the system to be suitable for intravital measurements: portability, localization with precise maneuverability, and rapid data acquisition. Our model tissue constructs were manufactured from primary human cells to simulate patient variability and were stressed to create a range of health states. Secreted amounts of three cytokines that relate to cellular viability were measured in vitro to assess pre-implantation construct health. In vivo optical sensing assessed tissue integration of constructs at one-week and three-weeks post-implantation. At one-week post-implantation, optical parameters correlated with in vitro pre-implantation secretion levels of all three cytokines (p < 0.05). This relationship was no longer seen at three-weeks post-implantation, suggesting comparable tissue integration independent of preimplantation health. Histology confirmed re-epithelialization of these constructs independent of pre-implantation health state, supporting the lack of a correlation. These results suggest that clinical optical diagnostic tools based on label-free fluorescence lifetime sensing of endogenous tissue fluorophores could noninvasively monitor post-implantation integration of engineered tissues.

To evaluate national trends in electrocardiogram (EKG) monitoring in Veterans Affairs (VA) beneficiaries prescribed high-dose citalopram before and after the 2011-12 Food and Drug Administration (FDA) safety warnings.Interrupted time-series analyses.National VA healthcare system data linked to Medicare data for veterans dually eligible for VA and Medicare services.Adult VA outpatients prescribed citalopram or sertraline from February 2010 to September 2013 (N=1,068,816).EKG monitoring for VA outpatients prescribed high-dose citalopram (40 mg/d aged ≤60,20 mg/d aged60) or sertraline.For individuals prescribed high-dose citalopram, EKG monitoring increased from 9.0% before the start of the first FDA warning to a peak of 12.6% for individuals aged 18 to 60 and from 14.0% to 19.4% for individuals aged 61 to 100. However, following the second FDA warning in 2012, EKG monitoring declined, returning to prewarning levels in both age groups. EKG monitoring did not increase in individuals with a history of previous cardiac risk factors prescribed high-dose citalopram in either age group.EKG frequency did not significantly change in individuals with cardiac risk factors at greatest potential risk for QT prolongation. Lack of responsiveness to the FDA warnings may be due to many factors, including lack of clarity about which individuals should undergo EKG monitoring, provider substitution of alternative antidepressants for citalopram, conflicting evidence regarding risk for adverse cardiac events with high-dose citalopram use, and lack of provider knowledge regarding the warnings.

Trauma related guilt, a distressing emotion associated with negative cognitions regarding one's actions or inaction during a traumatic event, is common among individuals with posttraumatic stress disorder (PTSD). We hypothesized that trauma related guilt cognitions would partially explain the relationship between PTSD symptom severity and functioning. The sample consisted of 254 combat veterans or active duty military personnel who served in Operation Enduring Freedom, Operation Iraqi Freedom or Operation New Dawn (OEF/OIF/OND) who consented to participate in a larger PTSD treatment study. Results revealed a significant relationship between PTSD severity and guilt cognitions (standardized β = 0.40), as well as PTSD and overall functioning (β = 0.49). Guilt cognitions (β's = 0.13 to 0.32) were significantly associated with nearly all domains of functioning, including overall functioning (β = 0.27), and partially explained the relationship between PTSD and functioning. This study lends support to the addition of guilt as a symptom of PTSD in the DSM-5 as it contributes significantly to functional impairment even when accounting for other symptoms of PTSD, although co-occurring mental health problems may also contribute to functional impairments associated with PTSD. Future studies are needed to investigate whether reductions in traumatic guilt are related to improved functional outcomes in PTSD treatments.

Background Chronic postsurgical pain (CPSP) is a reported risk for women undergoing breast reconstruction, but it remains unclear that such persistent pain is induced by reconstructive surgery. To address this concern, this prospective cohort study examined the prevalence of and risk factors associated with CPSP among women undergoing breast reconstruction. Materials and methods Women (n = 1996) recruited for the Mastectomy Reconstruction Outcomes Consortium (MROC) Study were assessed preoperatively and at two-years postoperatively for relevant medical/.surgical variables, pain experience, body physical well-being, anxiety, depression, and reconstruction procedure type and characteristics. Results Nearly half of the entire sample reported some level of preoperative pain. At two years there were statistically significant but not clinically meaningful increases in both pain intensity and chest/upper body discomfort but a decrease in affective pain rating. Average clinical pain severity was strikingly similar for preoperative and postoperative assessments. Preoperative levels of pain, acute postoperative pain, and (marginally) level of depression held consistent relationship at two-year follow-up with all outcome measures. Autologous flap reconstruction was associated with more severe CPSP compared to TE/I reconstruction. Older age, higher BMI, bilateral reconstruction, and adjuvant radiation and chemotherapy were associated with CPSP and chest/upper body discomfort for at least one outcome measure at two years. Conclusions The substantial rate of preoperative pain and comparable prevalence of preoperative and postoperative pain ratings suggest that persistent pain after breast reconstruction may not necessarily reflect surgery-induced pain. Future research will need to determine those factors that contribute to long-term pain following breast reconstruction.

Sedative hypnotic medications are routinely prescribed for insomnia treatment, but have been associated with significant risks of morning-after impairment. We evaluated responsiveness in the Veterans Health Administration (VHA) facilities to two drug safety warnings recommending against high-dose zolpidem use-a 2007 Veterans Administration Pharmacy Benefits Management Service warning and a 2013 Food and Drug Administration (FDA) warning.We used interrupted time-series design to assess how the two warnings influenced prescribing within the VHA in outpatients from 2005 to 2014. We assessed two outcomes: monthly outpatient use of (1) higher-than-recommended dose of zolpidem among zolpidem users and (2) any-dose zolpidem among all VHA users. In sensitivity analyses, we compared zolpidem prescribing to prescribing other sleep medications not subject to safety warnings.After the 2007 VHA warning, high-dose zolpidem use decreased significantly among both sexes from approximately 10% to 2%. Following the 2013 FDA warning, high-dose zolpidem use declined again; however, approximately half of women Veterans remained on high doses. Overall zolpidem use nearly quadrupled between the 2007 VHA and 2013 FDA warnings, but the overall use declined after the 2013 FDA warning. Increase in sedating antidepressant use was seen after the FDA warning, suggesting potential substitution.Higher than recommended dose use within the VHA decreased after each zolpidem high dose warning. Although overall use also decreased after the FDA warning, almost 50% of high-dose use among women Veterans is concerning. Different strategies to communicate the warnings should be examined.A commentary on this article appears in this issue on page 1093.

Previous studies suggest that immediate reconstruction following mastectomy produces superior results over delayed procedures. However, for medical or oncological reasons, some patients may be poor candidates for immediate reconstruction. We compared complications and patient-reported outcomes between immediate and delayed breast reconstructions in a prospective, multicenter study.1957 patients (1806 immediate, 151 delayed) met eligibility criteria. Demographic data, major complications, infections, and reconstructive failure rates were evaluated. Patient-reported outcomes were assessed with BREAST-Q, PROMIS, and EORTC QLQ-BR23 surveys, pre- and two years post-operatively. Subscale scores were compared across cohorts using mixed-effects regression models, controlling for patient characteristics and hospitals.Complete data were available in 1639 immediate and 147 delayed reconstruction patients. There were significant baseline differences between immediate and delayed cohorts in age, BMI, prevalence of diabetes, lymph node management, use of radiation, and chemotherapy. Controlling for clinical covariates, the delayed group had lower odds of any (OR 0.38, p 0.001) and major (OR 0.52, p = 0.016) complications, compared with immediate patients. Furthermore, delayed reconstruction was associated with a significantly lower failure rates (6% vs. 1.3%, p = 0.032). However, multivariate analyses found no significant differences in patient satisfaction or in psychosocial, sexual, or physical well-being at two years.Compared with immediate techniques, delayed reconstruction following mastectomy was associated with lower rates of overall and major complication, while providing equivalent patient satisfaction and quality of life benefits. Although immediate reconstruction is still the preferred choice of most patients and surgeons, delaying reconstruction does not appear to compromise clinical or patient-reported outcomes.

Emotional and social adaptation is a central challenge for women with recently diagnosed breast cancer [1]. Prevalence rates for anxiety and depressive disorders among a heterogeneous sample of cancer patients are estimated to range from 10 to 40% [2,3], and women with newly diagnosed breast cancer demonstrate comparable rates of affective distress [4]. As a result, breast reconstruction outcome studies routinely assess psychological variables and their influence on various patient-specific outcomes such as aesthetic satisfaction and functional status. While these studies typically include measures of preoperative depression and anxiety as possible predictors of clinical outcomes, relatively little attention has been paid to the identification of suicidal ideation (SI) in this cohort. This may seem surprising given evidence that depression is highly prevalent among cancer patients and, when increasingly severe, presents a primary risk for SI and intention [5]. While numerous studies describe the incidence of suicide among cancer patients in general [6], and women with breast cancer more specifically [7], there is sparse information on the prevalence of suicidal ideation among these populations. The assessment of SI in breast cancer patients presenting for reconstruction is in line with the American College of Surgeons (ACS) Commission on Cancer guidelines for distress screening of all cancer patients by 2015 [8]. We examined the prevalence of preoperative anxiety and depression among women enrolled in an ongoing prospective study of post-mastectomy breast reconstruction procedure outcomes. The prevalence of moderate-to-severe SI challenged the study team to devise an identification and response system to intervene with potential at-risk patients and triage them to appropriate mental health attention. We describe this system and propose its consideration for future surgical outcome studies where depression and SI are of reasonable concern.

Individuals with diabetes mellitus are at an increased risk of developing a diabetic foot ulcer (DFU). This study evaluated the safety and efficacy of Integra Dermal Regeneration Template (IDRT) for the treatment of nonhealing DFUs. The Foot Ulcer New Dermal Replacement Study was a multicenter, randomized, controlled, parallel group clinical trial conducted under an Investigational Device Exemption. Thirty-two sites enrolled and randomized 307 subjects with at least one DFU. Consented patients were entered into the 14-day run-in phase where they were treated with the standard of care (0.9% sodium chloride gel) plus a secondary dressing and an offloading/protective device. Patients with less than 30% reepithelialization of the study ulcer after the run-in phase were randomized into the treatment phase. The subjects were randomized to the control treatment group (0.9% sodium chloride gel; n = 153) or the active treatment group (IDRT, n = 154). The treatment phase was 16 weeks or until confirmation of complete wound closure (100% reepithelialization of the wound surface), whichever occurred first. Following the treatment phase, all subjects were followed for 12 weeks. Complete DFU closure during the treatment phase was significantly greater with IDRT treatment (51%) than control treatment (32%; p = 0.001) at sixteen weeks. The median time to complete DFU closure was 43 days for IDRT subjects and 78 days for control subjects in wounds that healed. The rate of wound size reduction was 7.2% per week for IDRT subjects vs. 4.8% per week for control subjects (p = 0.012). For the treatment of chronic DFUs, IDRT treatment decreased the time to complete wound closure, increased the rate of wound closure, improved components of quality of life and had less adverse events compared with the standard of care treatment. IDRT could greatly enhance the treatment of nonhealing DFUs.

Practical and valid instruments are needed to assess fidelity of coaching for weight loss. The purpose of this study was to develop and validate the ASPIRE Coaching Fidelity Checklist (ACFC). Classical test theory guided ACFC development. Principal component analyses were used to determine item groupings. Psychometric properties, internal consistency, and inter-rater reliability were evaluated for each subscale. Criterion validity was tested by predicting weight loss as a function of coaching fidelity. The final 19-item ACFC consists of two domains (session process and session structure) and five subscales (sets goals and monitor progress, assess and personalize self-regulatory content, manages the session, creates a supportive and empathetic climate, and stays on track). Four of five subscales showed high internal consistency (Cronbach alphas > 0.70) for group-based coaching; only two of five subscales had high internal reliability for phone-based coaching. All five sub-scales were positively and significantly associated with weight loss for group- but not for phone-based coaching. The ACFC is a reliable and valid instrument that can be used to assess fidelity and guide skill-building for weight management interventionists.

Objective To determine whether the presence or severity of pain is predictive of suboptimal weight loss outcomes in behavioral weight management programs. Methods This is a secondary data analysis comparing weight loss among participants with overweight/obesity who participated in a 12-month randomized controlled trial. Of the 481 participants randomized, 394 (81.9%) had available pain data and were categorized by Pain Type (back pain, arthritis pain, both, or neither) and Pain Severity (no pain, moderate pain, or severe pain). Dietary and physical activity outcomes were also explored. Results High rates of moderate and severe (80.2%), and back and arthritis (72.6%), pain were observed. Linear mixed models showed significant differences in % weight loss among Pain Severity, but not Pain Type, groups. Patients with severe pain lost significantly less weight (−0.1 kg, 95% CI = −1.5, −1.2) compared to those with either moderate or no pain (−1.9 kg, 95% CI = −2.5, −1.3; −2.1 kg, 95% CI = −3.3, −1.0, respectively). Patients with arthritis pain lost a significant amount of weight despite only minor improvements in walking distance. Conclusions Pain severity, but not pain type, is predictive of suboptimal weight loss outcomes.

BACKGROUND Low levels of physical activity (PA) are associated with poor outcomes in people with COPD. Interventions to increase PA could improve outcomes. METHODS We tested the efficacy of a novel Internet-mediated, pedometer-based exercise intervention. Veterans with COPD (N = 239) were randomized in a 2:1 ratio to the (1) intervention group (Omron HJ-720 ITC pedometer and Internet-mediated program) or (2) wait-list control group (pedometer). The primary outcome was health-related quality of life (HRQL), assessed by the St. George's Respiratory Questionnaire (SGRQ), at 4 months. We examined the SGRQ total score (SGRQ-TS) and three domain scores: Symptoms, Activities, and Impact. The secondary outcome was daily step counts. Linear regression models assessed the effect of intervention on outcomes. RESULTS Participants had a mean age of 67 ± 9 years, and 94% were men. There was no significant between-group difference in mean 4-month SGRQ-TS (2.3 units, P = .14). Nevertheless, a significantly greater proportion of intervention participants than control subjects had at least a 4-unit improvement in SGRQ-TS, the minimum clinically important difference (53% vs 39%, respectively, P = .05). For domain scores, the intervention group had a lower (reflecting better HRQL) mean than the control group by 4.6 units for Symptoms ( P = .046) and by 3.3 units for Impact ( P = .049). There was no significant difference in Activities score between the two groups. Compared with the control subjects, intervention participants walked 779 more steps per day at 4 months ( P = .005). CONCLUSIONS An Internet-mediated, pedometer-based walking program can improve domains of HRQL and daily step counts at 4 months in people with COPD. TRIAL REGISTRY ClinicalTrials.gov ; No.: NCT01102777; URL: www.clinicaltrials.gov

Hospitalizations for cirrhosis are costly and associated with increased mortality. Disease management outside of clinic, such as the use of interactive voice response (IVR) calls, may identify signs to prevent hospitalization. The aim of this study was to investigate whether IVR monitoring can predict hospitalization and mortality in cirrhosis.One hundred patients with decompensated cirrhosis were enrolled in this observational study, of which 79 patients were included in the final analysis. Participants were followed until death, transplant, or last clinical follow-up (range 7-874 days). Analysis focused on potential predictors identified during the first month of IVR calls: presence of jaundice, abdominal/leg swelling, weakness, paracentesis requirement, medication changes, and weight change. The primary outcome was time to first hospital admission; secondary outcomes included hospitalization and time to death. Potential predictors with a p value0.1 were further analyzed after adjustment for covariates (Model for End-stage Liver Disease score, serum sodium, number of medications).Twenty (25%) patients died, and 49 (62%) were hospitalized at least once. Fifty-six (70%) patients completed80% of their IVR calls. After adjustment for covariates, weakness was associated with an increased risk of first hospitalization (HR 2.14, CI 1.13-4.05, p = 0.02) and hospitalization rate (HR 2.1, CI 1.0-4.3, p = 0.048). Weight change of ≥ five pounds (2.3 kg) in a week increased the rate of hospitalization by 2.7 (CI 1.0-7.1, p = 0.045). No variable predicted death after covariate adjustment.These results suggest IVR calls can be used to predict hospitalization in cirrhosis.

This study reports multicenter outcomes and complications for catheter ablation of premature ventricular complexes (PVCs) and investigates predictors of procedural success, as well as development of PVC-induced cardiomyopathy.Catheter ablation of frequent idiopathic PVCs is used to eliminate symptoms and treat PVC-induced cardiomyopathy. Large-scale multicenter outcomes and complication rates have not been reported.This retrospective cohort study included 1,185 patients (55% female; mean age 52 ± 15 years; mean ejection fraction 55 ± 10%; mean PVC burden 20 ± 13%) who underwent catheter ablation for idiopathic PVCs at 8 centers between 2004 and 2013. The following factors were evaluated: patient demographics, procedural characteristics, complication rates, and clinical outcomes.Acute procedural success was achieved in 84% of patients. In centers at which patients were followed up routinely with post-ablation Holter monitoring, continued success at clinical follow-up without use of antiarrhythmic drugs was 71%. Including the use of antiarrhythmic medications, the success rate at a mean of 1.9 years of follow-up was 85%. In a multivariate analysis, the significant predictors of acute success were PVC location and number of distinct PVC configurations (p 0.03). The only significant predictor of continued success at clinical follow-up was a right ventricular outflow tract PVC location (p 0.01). In 245 patients (21%) with PVC-induced cardiomyopathy, the mean ejection fraction improved from 38% to 50% (p 0.01) after ablation. Independent predictors for development of PVC-induced cardiomyopathy were male gender, PVC burden, lack of symptoms, and epicardial PVC origin (p 0.05). The overall complication rate was 5.2% (2.4% major complications and 2.8% minor complications), and complications were most commonly related to vascular access (2.8%). There was no procedure-related mortality.Catheter ablation of frequent PVCs is a low-risk and often effective treatment strategy to eliminate PVCs and associated symptoms. In patients with PVC-induced cardiomyopathy, cardiac function is frequently restored after successful ablation.

Objective The objective was to determine whether obesity screening and weight management program participation and outcomes are equitable for individuals with serious mental illness (SMI) and depressive disorder (DD) compared to those without SMI/DD in Veterans Health Administration (VHA), the largest integrated US health system, which requires obesity screening and offers weight management to all in need. Methods We used chart-reviewed, clinical and administrative VHA data from fiscal years 2010–2012 to estimate obesity screening and participation in the VHA's weight management program (MOVE!) across groups. Six- and 12-month weight changes in MOVE! participants were estimated using linear mixed models adjusted for confounders. Results Compared to individuals without SMI/DD, individuals with SMI or DD were less frequently screened for obesity (94%–94.7% vs. 95.7%) but had greater participation in MOVE! (10.1%–10.4% vs. 7.4%). MOVE! participants with SMI or DD lost approximately 1 lb less at 6 months. At 12 months, average weight loss for individuals with SMI or neither SMI/DD was comparable (−3.5 and −3.3 lb, respectively), but individuals with DD lost less weight (mean=−2.7 lb). Conclusions Disparities in obesity screening and treatment outcomes across mental health diagnosis groups were modest. However, participation in MOVE! was low for every group, which limits population impact.

Objective To assess for the frequency of binge eating behavior and its association with weight loss in an overweight/obese sample of veterans. Methods This study is a secondary analysis of data from the ASPIRE study, a randomized effectiveness trial of weight loss among veterans. Of the 481 enrolled veterans with overweight/obesity, binge eating frequency was obtained by survey for 392 (82%). Results The majority (77.6%) reported binge eating, and 6.1% reported high-frequency binge eating. Those reporting any binge eating lost 1.4% of body weight, decreased waist circumference by 2.0 cm, and had significantly worse outcomes than those reporting never binge eating who lost about double the weight (2.7%) and reduced waist circumference by twice as much (4.2 cm). The high-frequency binge group gained 1.4% of body weight and increased waist circumference by 0.3 cm. Conclusions High rates of binge eating were observed in an overweight/obese sample of veterans enrolled in weight loss treatment. The presence of binge eating predicted poorer weight loss outcomes. Furthermore, high-frequency binge eating was associated with weight gain. These findings have operational and policy implications for developing effective strategies to address binge eating in the context of behavioral weight loss programs for veterans.

Background Weight-loss trials tend to recruit highly selective, non-representative samples. Effective weight-loss approaches are needed for real-world challenging populations. Purpose To test whether a small-changes intervention, delivered in groups or via telephone, promotes greater weight loss than standard obesity treatment in a predominantly male, high-risk Veteran population. Data were collected in 2010–2012 and analyzed in 2013. Design A three-arm, 12-month randomized pragmatic effectiveness trial. Setting/participants Four-hundred eighty-one overweight/obese participants from two Midwestern Veterans Affairs (VA) Medical Centers were randomly assigned to one of three programs: the 12-month Aspiring to Lifelong Health (ASPIRE) weight-loss program delivered (1) individually over the phone (ASPIRE-Phone) or (2) in-person group sessions (ASPIRE-Group); compared to (3) VA's standard weight-loss program (MOVE!). Intervention Twenty-eight sessions with a non-clinician coach via telephone or in-person groups using a small-changes obesity treatment approach compared to a 15–30-session standard VA program. Main outcome measures Twelve-month change in weight (kilograms). Results Participants in all three arms lost significant ( p ® . ASPIRE-Group resulted in greater improvements in all other anthropometric measures compared to MOVE! at 12 months ( p p p =0.23) compared to ASPIRE-Phone. Conclusions Group-based delivery of the ASPIRE weight management program is more effective than MOVE! and the phone-based version of ASPIRE at promoting sustained weight loss in a predominantly male population with multiple comorbidities. The incremental benefits of group-based ASPIRE over the current MOVE! program could yield significant population-level benefits if implemented on a large scale.