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BACKGROUND/OBJECTIVES Psychotropic and opioid medications are routinely prescribed for symptom management in hospice, but national estimates of prescribing are lacking. Changes in Medicare hospice payment in 2014 provide the first opportunity to examine psychotropic and opioid prescribing among hospice beneficiaries, and the factors associated with use of specific medication classes. DESIGN Cross-sectional analysis of a 20% sample of traditional and managed Medicare with Part D enrolled in hospice, 2014-2016. SETTING Beneficiaries enrolled in the Medicare hospice benefit. PARTICIPANTS Medicare beneficiaries ≥65 newly enrolled in hospice between July 1, 2014 and December 31, 2016 (N = 554,022). MAIN OUTCOME Prevalence of psychotropic and opioid medication prescribing by class and factors associated with prescribing. RESULTS 70.3% of hospice beneficiaries were prescribed a psychotropic and 63.3% were prescribed an opioid. The most common psychotropic classes prescribed were: benzodiazepines (60.6%), antipsychotics (38.3%), antidepressants (18.4%), and antiepileptics (10.2%). Lorazepam (56.4%), morphine (52.8%), and haloperidol (28.6%) were received by the most beneficiaries. Prevalence of any psychotropic and opioid prescription was highest among beneficiaries who were female (76.7%), non-Hispanic white (76.6%), and those with cancer (78.9%). Compared to white beneficiaries, non-Hispanic black beneficiaries were less likely to receive nearly every class of medication, with significantly lower odds of receiving opioids (64.1% vs 57.9%; AOR 0.75, 95% CI 0.72-0.77) and benzodiazepines (61.6% vs 52.2%; AOR 0.66, 95% CI 0.64-0.68). Differences were seen across hospice diagnosis; those with cancer were more likely to receive opioids, benzodiazepines, and antipsychotics but less likely to receive antidepressants and antiepileptics. CONCLUSIONS Psychotropic and opioid medications are frequently prescribed in hospice. Observed variations in prescribing across race and ethnicity may reflect disparities in prescribing as well as patient preferences for care. Further work is important to understand factors driving prescribing given limited studies surrounding medication prescribing in hospice.

Summary Background Although acellular dermal matrix (ADM) is widely used in expander-implant-based breast reconstructions, previous analyses have been unable to demonstrate improvements in patient-reported outcomes (PROs) with this approach over non-ADM procedures. This study aims to develop a more selective, evidence-based approach to the use of ADM in expander-implant-based breast reconstruction by identifying patient subgroups in which ADM improved clinical outcomes and PROs. Study design The Mastectomy Reconstruction Outcomes Consortium Study prospectively evaluated immediate expander-implant reconstructions at 11 centers from 2012 to 2015. Complications (any/overall and major), and PROs (satisfaction, physical, psychosocial, and sexual well-being) were assessed two years postoperatively using medical records and the BREAST-Q, respectively. Using mixed-models accounting for centers and with interaction terms, we analyzed for differential ADM effects across various clinical subgroups, including age, body mass index, radiation timing, and chemotherapy. Results Expander-implant-based breast reconstruction was performed in 1451 patients, 738 with and 713 without ADM. Major complication risk was higher in ADM users vs. nonusers (22.9% vs. 16.4% and p = 0.04). Major complication risk with ADM increased with higher BMI (BMI=30, OR=1.70; BMI=35, OR=2.29, interaction p = 0.02). No significant ADM effects were observed for breast satisfaction, psychosocial, sexual, and physical well-being within any subgroups. Conclusion In immediate expander-implant-based breast reconstruction, ADM was associated with a greater risk of major complications, particularly in high-BMI patients. We were unable to identify patient subgroups where ADM was associated with significant improvements in PROs. Given these findings and the financial costs of ADM, a more critical approach to the use of ADM in expander-implant reconstruction may be warranted.

BACKGROUND: Clinical services provided by pharmacists embedded in practices can improve patient outcomes within the primary care setting. Little is known about whether physician organizations (POs) will retain the services of clinical pharmacists after outside funding for a statewide implementation program is ended. OBJECTIVE: To evaluate a statewide program, Michigan Pharmacists Transforming Care and Quality (MPTCQ), that incorporated pharmacists within 17 POs. METHODS: A descriptive study was conducted using data collected from June 2016 to September 2018 from primary care clinical pharmacist encounters in POs participating in MPTCQ. Process outcomes included the number of participating POs, patient encounters, and average visits per patient. Analyses at the encounter level were stratified by 2 encounter types: disease state management (DSM) or comprehensive medication review (CMR). Separately by encounter type, pharmacist effect was described by the number, type, and reasons for medication changes, as well as medication adherence and cost barriers found and addressed. Clinical outcomes included hemoglobin A1c and blood pressure change. Sustainability and patient satisfaction of pharmacists providing clinical services are reported. RESULTS: Across 17 POs, 27 pharmacists participated in the MPTCQ program. Pharmacists completed 24,523 patient encounters for DSM with 5,942 patients, with an average of 5 visits per patient with diabetes and 2 visits for hypertension. Pharmacists made 15,153 therapeutic medication changes during visits for diabetes and hypertension, with approximately 70% related to efficacy. Pharmacists completed 4,203 CMR visits for 3,092 patients. During CMR visits, 1,296 therapeutic medication changes were recommended. Problems with medication cost were identified in 13% of CMR visits. Blood pressure and A1c levels decreased in patients managed by pharmacists. In 157 patients surveyed, 87% rated their pharmacists' care as excellent. Sixteen POs retained their pharmacists at the end of funding. CONCLUSIONS: A statewide provider-payer partnership successfully integrated and retained primary care pharmacists within POs. Pharmacists in the MPTCQ program contributed to improvements in disease control by changing medications to improve patient clinical outcomes. DISCLOSURES: Support for MPTCQ was provided by Blue Cross and Blue Shield of Michigan (BCBSM) as part of the BCBSM Value Partnerships program. Coe was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under award number KL2TR002241. Although BCBSM and MPTCQ work collaboratively, the opinions, beliefs, and viewpoints expressed by the authors do not necessarily reflect the opinions, beliefs, and viewpoints of BCBSM or any of its employees. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The authors have no conflicts of interest to report.

BACKGROUND The objective of this study was to determine whether women with a history of radiation therapy before mastectomy experience a risk for postoperative complications and patient-reported outcomes similar to those of women undergoing postmastectomy radiation therapy in the setting of immediate implant reconstruction. METHODS The cohort included patients undergoing immediate implant reconstruction at 11 centers across North America. Women were categorized into three groups: prior breast conservation therapy, postmastectomy radiation therapy, and no radiation therapy. Mixed effect logistic regressions were used to analyze the effects of radiation therapy status on complication rates and patient-reported outcomes. RESULTS ONE THOUSAND FIVE HUNDRED NINETY-FOUR: patients were analyzed, including 84 women with prior breast conservation therapy, 329 women who underwent postmastectomy radiation therapy, and 1181 women with no history of radiation therapy. Compared with postmastectomy radiation therapy, breast conservation was associated with lower rates of all complications and major complications (OR, 0.65; 95 percent CI, 0.37 to 1.14; p = 0.13; and OR, 0.61; 95 percent CI, 0.33 to 1.13; p = 0.12). These differences were not statistically significant. Rates of reconstructive failure between the two cohorts were comparable. Before reconstruction, satisfaction with breasts was lowest for women with prior breast conservation therapy (p < 0.001). At 2 years postoperatively, satisfaction with breasts was lower for women with postmastectomy radiation therapy compared with breast conservation patients (p = 0.007). CONCLUSIONS Higher postoperative complication rates were observed in women exposed to radiation therapy regardless of timing. Although women with prior breast conservation experienced greater satisfaction with their breasts and fewer complications when compared to women undergoing postmastectomy radiation therapy, there was a similar risk for reconstruction failure. CLINICAL QUESTION/LEVEL OF EVIDENCE Therapeutic, II.

OBJECTIVE: We sought to evaluate national trends in incident varenicline and nicotine replacement therapy (NRT) prescribing among Veterans Affairs (VA) beneficiaries before and after U.S. Food and Drug Administration (FDA) warnings regarding neuropsychiatric side effects with varenicline use. METHODS: We determined all adult VA patients identified as smokers from 2007–2019 (N=3,600,947) and calculated monthly counts of new varenicline and NRT users. An interrupted times series analysis estimated the effect of the FDA warnings on varenicline and NRT prescribing overall and among Veterans with and without mental health disorders. RESULTS: The incident use rate of varenicline decreased from a peak of 6.2 per 1,000 Veteran smokers in 10/2007 to 1.0 by 6/2009 following the first FDA warning (pre-warning monthly slope = −0.27; p=0.03). New NRT use increased from 10.7 per 1,000 Veteran smokers in 10/2007 to a peak of 12.6 in 7/2009 (slope change = 0.71, p=0.01) suggesting potential substitution. Following removal of the FDA boxed warning in 12/2016, varenicline prescribing increased but did not return to pre-warning levels by 12/2019. Among Veterans with and without mental health disorders, varenicline use decreased 90% and 88%, following the first FDA warning—both groups had comparable rates of new NRT use. CONCLUSIONS: Following the first FDA warning, incident use of varenicline declined significantly both among Veterans with and without mental health disorders. Despite removal of the FDA boxed warning in 12/2016, new use of varenicline had not returned to pre-warning levels 3 years following the removal.

IMPORTANCE: Ventricular tachycardia (VT) is associated with high mortality in patients with cardiac sarcoidosis (CS), and medical management of CS-associated VT is limited by high failure rates. The role of catheter ablation has been investigated in small, single-center studies. OBJECTIVE: To investigate outcomes associated with VT ablation in patients with CS. DESIGN, SETTING, AND PARTICIPANTS: This cohort study from the Cardiac Sarcoidosis Consortium registry (2003-2019) included 16 tertiary referral centers in the US, Europe, and Asia. A total of 158 consecutive patients with CS and VT were included (33% female; mean [SD] age, 52 [11] years; 53% with ejection fraction [EF]

BACKGROUND/OBJECTIVES Hypertension treatment reduces cardiovascular events. However, uncertainty remains about benefits and harms of deintensification or further intensification of antihypertensive medication when systolic blood pressure (SBP) is tightly controlled in older multimorbid patients, because of their frequent exclusion in trials. We assessed the association of hypertension treatment deintensification or intensification with clinical outcomes in older adults with tightly controlled SBP. DESIGN Longitudinal cohort study (2011-2013) with 9-month follow-up. SETTING U.S.-nationwide primary care Veterans Health Administration healthcare system. PARTICIPANTS Veterans aged 65 and older with baseline SBP

Background Previous investigators demonstrated that female patients often prefer female providers. However, these studies have not determined whether there are gender preferences for breast reconstruction surgeons or whether the effects of surgeon gender impacts patient-reported outcomes. Methods Adult women were crowdsourced using Amazon Mechanical Turk to characterize societal preferences for the gender of breast and plastic surgeons in a hypothetical scenario. The authors also used data from the Mastectomy Reconstruction Outcomes Consortium to determine the association between surgeon gender and patient satisfaction after breast reconstruction. The BREAST-Q questionnaire was used to assess patient-reported outcomes at 3 months and 2 years following reconstruction. Regression analyses were performed to investigate the effects of surgeon gender on patient-reported outcomes. Results In total, 1413 surveys were collected. Forty-two percent preferred female plastic surgeons, 5 percent preferred male surgeons, and 53 percent reported no preference. The Mastectomy Reconstruction Outcomes Consortium analysis included 2236 patients of 55 male and nine female plastic surgeons. In this cohort, 1921 patients (82.2 percent) had male surgeons, whereas 415 patients (17.8 percent) had female surgeons. Regression analysis at 2 years revealed no differences in satisfaction with surgeon, outcome, or psychosocial well-being. Only satisfaction with information differed, as patients of female surgeons reported greater satisfaction in this category, with an adjusted mean difference of 2.82 (p = 0.018). Conclusions Although nonpatient women hypothetically prefer female providers, surgeon gender makes little difference in actual patient satisfaction with breast reconstruction. More investigation is needed to determine whether the difference in information delivery is clinically significant and whether it reflects variations in practices between male and female surgeons. Clinical question/level of evidence Therapeutic, III.

Importance Distal radius fractures (DRFs) are common injuries among older adults and can result in substantial disability. Current evidence regarding long-term outcomes in older adults is scarce. Objective To compare outcomes across treatment groups at 24 months among adults with DRFs who participated in the WRIST trial. Design, Setting, and Participants The Wrist and Radius Injury Surgical Trial (WRIST) randomized, international, multicenter trial was conducted from April 1, 2012, through December 31, 2016. Participants were adults aged 60 years or older with isolated, unstable DRFs at 24 health systems in the US, Canada, and Singapore. Data analysis was performed from March 2019 to March 2021. Interventions Participants were randomized to open reduction and volar locking plate system (VLPS), external fixation with or without supplementary pinning (EFP), and percutaneous pinning (CRPP). The remaining participants chose closed reduction and casting. Main Outcomes and Measures The primary outcome was the 24-month Michigan Hand Outcomes Questionnaire (MHQ) summary score. Secondary outcomes were scores on the MHQ subdomains hand strength and wrist motion. Results A total of 304 adults were recruited for the study, and 187 were randomized to undergo surgery, 65 to VLPS, 64 to EFP, and 58 to CRPP; 117 participants opted for closed reduction and casting. Assessments were completed at 24 months for 182 participants (160 women [87.9%]; mean [SD] age, 70.1 [8.5] years). Mean MHQ summary scores at 24 months were 88 (95% CI, 83-92) for VLPS, 83 (95% CI, 78-88) for EFP, 85 (95% CI, 79-90) for CRPP, and 85 (95% CI, 79-90) for casting, with no clinically meaningful difference across groups after adjusting for covariates (χ23 = 1.44; P = .70). Pain scores also did not differ across groups at 24 months (χ23 = 2.64; P = .45). MHQ summary scores changed from 82 (95% CI, 80-85) to 85 (95% CI, 83-88) (P = .12) between 12 and 24 months across groups. The rate of malunion was higher in the casting group (26 participants [59.1%]) than in the other groups (4 participants [8.0%] for VLPS, 8 participants [17.0%] for EFP, and 4 participants [9.8%] for CRPP; χ23 = 43.6; P

Background Whether to irradiate the tissue expander before implant exchange or to defer irradiation until after exchange in immediate, two-stage expander/implant reconstruction remains uncertain. The authors evaluated the effects of irradiation timing on complication rates and patient-reported outcomes in patients undergoing immediate expander/implant reconstruction. Methods Immediate expander/implant reconstruction patients undergoing postmastectomy radiation therapy at 11 Mastectomy Reconstruction Outcomes Consortium sites with demographic, clinical, and complication data were analyzed. Patient-reported outcomes were assessed with BREAST-Q, Patient-Reported Outcomes Measurement Information System, and European Organisation for Research and Treatment of Cancer Breast Cancer-Specific Quality-of-Life Questionnaire surveys preoperatively and 2 years postoperatively. Survey scores and complication rates were analyzed using bivariate comparison and multivariable regressions. Results Of 317 patients who met inclusion criteria, 237 underwent postmastectomy radiation therapy before expander/implant exchange (before-exchange cohort), and 80 did so after exchange (after-exchange cohort). Timing of radiation had no significant effect on risks of overall complications (OR, 1.25; p = 0.46), major complications (OR, 1.18; p = 0.62), or reconstructive failure (OR, 0.72; p = 0.49). Similarly, radiation timing had no significant effect on 2-year patient-reported outcomes measured by the BREAST-Q or the European Organisation for Research and Treatment of Cancer survey. Outcomes measured by the Patient-Reported Outcomes Measurement Information System showed less anxiety, fatigue, and depression in the after-exchange group. Compared with preoperative assessments, 2-year patient-reported outcomes significantly declined in both cohorts for Satisfaction with Breasts, Physical Well-Being, and Sexual Well-Being, but improved for anxiety and depression. Conclusions Radiation timing (before or after exchange) had no significant effect on complication risks or on most patient-reported outcomes in immediate expander/implant reconstruction. Although lower levels of anxiety, depression, and fatigue were observed in the after-exchange group, these differences may not be clinically significant. Clinical question/level of evidence Therapeutic, II.

Objective The primary aim of this study was to compare patient-reported outcomes (PROs) of women who underwent immediate implant-based breast reconstruction (IBBR) after receiving either: (1) nipple-sparing mastectomy (NSM) or (2) simple mastectomy with subsequent nipple reconstruction (SNR). Background The goal of post-mastectomy breast reconstruction is to restore body image and quality-of-life after mastectomy, but removal of the nipple-areolar complex may have its own negative psychosocial consequences. NSM may have increased in popularity due to its perceived oncologic safety in many women and to reports of superior aesthetic results with this technique. Despite the increased utilization of NSM, few studies have evaluated the impact of NSM on PROs and complications in women undergoing immediate IBBR. Methods We performed a secondary analysis of the Mastectomy Reconstruction Outcomes Consortium study, a multicenter, prospective cohort study that recruited patients between February 2012 and July 2015. The primary aim of this study was to compare PROs as measured by BREAST-Q scores between women who underwent IBBR after NSM versus SNR. The secondary aim was to compare complication rates. Mixed-effects regression models controlled for demographic and clinical covariates. Results Of the 600 women in the study, 286 (47.7%) underwent NSM. After controlling for baseline patient characteristics, we found no significant differences in satisfaction with breast, psychosocial well-being, physical well-being or sexual well-being between women undergoing NSM versus SNR. Mastectomy type was not a significant predictor of complications or reconstructive failure. Conclusions Despite reports of superior aesthetics for NSM over simple mastectomy with nipple reconstruction in immediate IBBR, we found no significant differences at 2 years after reconstruction in patient satisfaction, quality-of-life, or complication rates.

Context Engaging underrepresented communities in health research priority setting could make the scientific agenda more equitable and more responsive to their needs. Objective Evaluate democratic deliberations engaging minority and underserved communities in setting health research priorities. Methods Participants from underrepresented communities throughout Michigan (47 groups, n = 519) engaged in structured deliberations about health research priorities in professionally facilitated groups. We evaluated some aspects of the structure, process, and outcomes of deliberations, including representation, equality of participation, participants’ views of deliberations, and the impact of group deliberations on individual participants’ knowledge, attitudes, and points of view. Follow‐up interviews elicited richer descriptions of these and also explored later effects on deliberators. Results Deliberators (age 18‐88 years) overrepresented minority groups. Participation in discussions was well distributed. Deliberators improved their knowledge about disparities, but not about health research. Participants, on average, supported using their group's decision to inform decision makers and would trust a process like this to inform funding decisions. Views of deliberations were the strongest predictor of these outcomes. Follow‐up interviews revealed deliberators were particularly struck by their experience hearing and understanding other points of view, sometimes surprised at the group's ability to reach agreement, and occasionally activated to volunteer or advocate. Conclusions Deliberations using a structured group exercise to engage minority and underserved community members in setting health research priorities met some important criteria for a fair, credible process that could inform policy. Deliberations appeared to change some opinions, improved some knowledge, and were judged by participants worth using to inform policymakers.

BACKGROUND: Guidelines recommend most benzodiazepine (BZD) treatment be short-term, though chronic BZD use is increasing. OBJECTIVE: Determine the rate of BZD discontinuation among chronic users and identify patient- and provider-level factors associated with discontinuation. DESIGN, SETTING, AND PARTICIPANTS: A retrospective cohort study using nationwide insurance claims data from 2014 to 2016 of US adults ≥ 18 years old with chronic BZD use (i.e., > 120 days) during the baseline year. MAIN OUTCOMES AND MEASURES: The primary outcome was BZD discontinuation among chronic users after 1 year of follow-up. A series of multilevel logistic regression models examined the association of BZD discontinuation with patient and provider characteristics. Covariates included patient sociodemographics, medical and psychiatric comorbidity, co-prescribed opioids and other psychotropics, and characteristics of the prescribed BZD. KEY RESULTS: Of 141,008 chronic BZD users, 13.4% discontinued use after 1 year. Females had lower odds of discontinuation (AOR 0.83, 99% CI 0.79–0.87), while African-American patients had higher odds (AOR 1.12, 99% CI 1.03–1.22). Those prescribed a high-potency BZD had lower odds of discontinuation (AOR 0.51, 99% CI 0.47–0.54), as did those prescribed an opioid (AOR 0.94, 99% CI 0.89–0.99). After adjusting for patient- and provider-level factors, differences between providers accounted for 5.8% of variation in BZD discontinuation (p

Background and aims Cost-effectiveness studies in randomized clinical trials have shown that tobacco cessation pharmacotherapy is among the most cost-effective of health-care interventions. Clinical trial eligibility criteria and treatment protocols may not be followed in actual practice. This study aimed to determine whether tobacco cessation pharmacotherapy is cost-effective in real-world settings. Design A retrospective analysis of costs and outcomes. Setting Hospitals and clinics of the US Veterans Health Administration, USA. Participants A total of 589 862 US veterans who screened positive for tobacco use in 2011. Intervention and comparator Tobacco users who initiated smoking cessation pharmacotherapy in the 6 months after screening were compared with those who did not use pharmacotherapy in this period. Pharmacotherapy included nicotine replacement therapy, bupropion (if prescribed at 300 mg per day or specifically for tobacco cessation) or varenicline. Measures Effectiveness was determined from responses to a subsequent tobacco screening conducted between 7 and 18 months after the treatment observation period. Cost of medications and prescribing health-care encounters was determined for the period between initial and follow-up tobacco use screening. Multivariate fixed-effects regression was used to assess the effect of initial treatment status on cost and outcome while controlling for differences in case-mix with propensity weighting to adjust for confounding by indication. Findings Thirteen per cent of participants received tobacco cessation pharmacotherapy within 6 months of initial screening. After an average of an additional 218.1 days' follow-up, those who initially received pharmacotherapy incurred $143.79 in additional treatment cost and had a 3.1% absolute increase in tobacco quit rates compared with those who were not initially treated. This represents an incremental cost-effectiveness ratio of $4705 per quit. The upper limit of the 99.9% confidence region was $5600 per quit. Without propensity adjustment, the cost-effectiveness ratio was $7144 per quit, with the upper limit of the 99.9% confidence region $9500/quit. Conclusions Tobacco cessation pharmacotherapy provided by the US Veterans Health Administration in 2011/12 was cost-effective in this real-world setting, with an incremental cost-effectiveness ratio of $4705 per quit.

Objective Our objectives were to investigate case-mix adjusted hospital variations in 2-year clinical and patient-reported outcomes following immediate breast reconstruction. Background Over the past few decades, variations in medical practice have been viewed as opportunities to promote best practices and high-value care. Methods The Mastectomy Reconstruction Outcomes Consortium Study is an National Cancer Institute-funded longitudinal, prospective cohort study assessing clinical and patient-reported outcomes of immediate breast reconstruction after mastectomy at 11 leading medical centers. Case-mix adjusted comparisons were performed using generalized linear mixed-effects models to assess variation across the centers in any complication, major complications, satisfaction with outcome, and satisfaction with breast. Results Among 2252 women in the analytic cohort, 1605 (71.3%) underwent implant-based and 647 (28.7%) underwent autologous breast reconstruction. There were significant differences in the sociodemographic and clinical characteristics, and distribution of procedure types at the different Mastectomy Reconstruction Outcomes Consortium Study centers. After case-mix adjustments, hospital variations in the rates of any and major postoperative complications were observed. Medical center odds ratios for major complication ranged from 0.58 to 2.13, compared with the average major complication rate across centers. There were also meaningful differences in satisfaction with outcome (from the lowest to highest of -2.79-2.62) and in satisfaction with breast (-2.82-2.07) compared with the average values. Conclusions Two-year postoperative complications varied widely between hospitals following post-mastectomy breast reconstruction. These variations represent an important opportunity to improve care through dissemination of best practices and highlight the limitations of extrapolating single-institution level data and the ongoing challenges of studying hospital-based outcomes for this patient population.

OBJECTIVE: Mood disorders lead to significant functional impairment and are the costliest conditions for health plans. Few individuals with mood disorders have access to evidence-based Collaborative Chronic Care Models (CCMs) because most are seen in small-group practices (

Key Points Question Can the intensity of hypertension treatment by total dose burden for older patients be accurately quantified using only health system administrative pharmacy fill data? Findings In this cross-sectional study, dose intensity measured using pharmacy data in a national health care system was highly correlated with dose intensity documented in clinical notes by using a new algorithm that can be applied to an individual patient on any given day. Meaning This study suggests that intensity of hypertension treatment can be measured using pharmacy data at a more detailed level than using medication counts or blood pressure alone for quality comparison or as a research tool., Importance Simple measures of hypertension treatment, such as achievement of blood pressure (BP) targets, ignore the intensity of treatment once the BP target is met. High-intensity treatment involves increased treatment burden and can be associated with potential adverse effects in older adults. A method was previously developed to identify older patients receiving intense hypertension treatment by low BP and number of BP medications using national Veterans Health Administration and Medicare Part D administrative pharmacy data to evaluate which BP medications a patient is likely taking on any given day. Objective To further develop and validate a method to more precisely quantify dose intensity of hypertension treatment using only health system administrative pharmacy fill data. Design, Setting, and Participants Observational, cross-sectional study of 319 randomly selected older veterans in the national Veterans Health Administration health care system who were taking multiple BP-lowering medications and had a total of 3625 ambulatory care visits from July 1, 2011, to June 30, 2013. Measure development and medical record review occurred January 1, 2017, through November 30, 2018, and data analysis was conducted from December 1, 2019, to August 31, 2020. Main Outcomes and Measures For each BP-lowering medication, a moderate hypertension daily dose (HDD) was defined as half the maximum dose above which no further clinical benefit has been demonstrated by that medication in hypertension trials. Patients’ total HDD was calculated using pharmacy data (pharmacy HDDs), accounting for substantial delays in refills (>30 days) when a patient’s pill supply was stretched (eg, cutting existing pills in half). As an external comparison, the pharmacy HDDs were correlated with doses manually extracted from clinicians’ visit notes (clinically noted HDDs). How well the pharmacy HDDs correlated with clinically noted HDDs was calculated (using C statistics). To facilitate interpretation, HDDs were described in association with the number of medications. Results A total of 316 patients (99.1%) were male; the mean (SD) age was 75.6 (7.2) years. Pharmacy HDDs were highly correlated (r = 0.92) with clinically noted HDDs, with a mean (SD) of 2.7 (1.8) for pharmacy HDDs and 2.8 (1.8) for clinically noted HDDs. Pharmacy HDDs correlated with high-intensity, clinically noted HDDs ranging from a C statistic of 92.8% (95% CI, 92.0%-93.7%) for 2 or more clinically noted HDDs to 88.1% (95% CI, 85.5%-90.6%) for 6 or more clinically noted HDDs. Conclusions and Relevance This study suggests that health system pharmacy data may be used to accurately quantify hypertension regimen dose intensity. Together with clinic-measured BP, this tool can be used in future health system–based research or quality improvement efforts to fine-tune, manage, and optimize hypertension treatment in older adults., This cross-sectional study develops and validates a method to more precisely quantify dose intensity of hypertension treatment using only health system administrative pharmacy fill data.

Aims Catheter ablation is an effective treatment for post-infarction ventricular tachycardia (VT). However, some patients may experience a worsened arrhythmia phenotype after ablation. We aimed to determine the prevalence and prognostic impact of arrhythmia exacerbation (AE) after post-infarction VT ablation. Methods and results A total of 1187 consecutive patients (93% men, median age 68 years, median ejection fraction 30%) who underwent post-infarction VT ablation at six centres were included. Arrhythmia exacerbation was defined as post-ablation VT storm or incessant VT in patients without prior similar events. During follow-up (median 717 days), 426 (36%) patients experienced VT recurrence. Events qualifying as AE occurred in 67 patients (6%). Median times to VT recurrence with and without AE were 238 [interquartile range (IQR) 35–640] days and 135 (IQR 22–521) days, respectively (P = 0.25). Almost half of the patients (46%) who experienced AE experienced it within 6 months of the index procedure. Patients with AE had had longer ablation times during the ablation procedures compared to the rest of the patients (median 42 vs. 34 min, P = 0.02). Among patients with VT recurrence, the risk of death or heart transplantation was significantly higher in patients with than without AE (hazard ratio 1.99, 95% CI 1.28–3.10; P = 0.002) after adjusting for age, gender, ejection fraction, cardiac resynchronization therapy, post-ablation non-inducibility, and post-ablation amiodarone use. Conclusion Arrhythmia exacerbation after ablation of infarct-related VT is infrequent but is independently associated with an adverse long-term outcome among patients who experience a VT recurrence. The mechanisms and mitigation strategies of AE after catheter ablation require further investigation.

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

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.

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.

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.

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.

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.

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.

Background Abdominal flap reconstruction is the most popular form of autologous breast reconstruction. The current study compared complications and patient-reported outcomes after pedicled transverse rectus abdominis myocutaneous (TRAM), free TRAM, deep inferior epigastric perforator (DIEP), and superficial inferior epigastric artery (SIEA) flaps. Methods Patients undergoing abdominally based breast reconstruction at 11 centers were prospectively evaluated for abdominal donor-site and breast complications. Patient-reported outcomes were measured by the BREAST-Q and Patient-Reported Outcomes Measurement Information System surveys. Mixed-effects regression models were used to assess the effects of procedure type on outcomes. Results Seven hundred twenty patients had 1-year follow-up and 587 had 2-year follow-up. Two years after reconstruction, SIEA compared with DIEP flaps were associated with a higher rate of donor-site complications (OR, 2.7; p = 0.001); however, SIEA flaps were associated with higher BREAST-Q abdominal physical well-being scores compared with DIEP flaps at 1 year (mean difference, 4.72, on a scale from 0 to 100; p = 0.053). This difference was not significant at 2 years. Abdominal physical well-being scores at 2 years postoperatively were lower in the pedicled TRAM flap group by 7.2 points (p = 0.006) compared with DIEP flaps and by 7.8 points (p = 0.03) compared with SIEA flaps, and in the free TRAM flap group, scores were lower by 4.9 points (p = 0.04) compared with DIEP flaps. Bilateral reconstruction had significantly lower abdominal physical well-being scores compared with unilateral reconstruction. Conclusions Although all abdominally based flaps are viable breast reconstruction options, DIEP and SIEA flaps are associated with higher abdominal physical well-being than pedicled and free TRAM flaps. Although SIEA flaps offer the advantage of not violating the fascia, higher rates of donor-site complications may diminish patient satisfaction. Clinical question/level of evidence Therapeutic, II.

Background Patients considering postmastectomy radiation and reconstruction require information regarding expected outcomes to make preference-concordant decisions. Methods A prospective multicenter cohort study of women diagnosed with breast cancer at 11 centers between 2012 and 2015 compared complications and patient-reported outcomes of 622 irradiated and 1625 unirradiated patients who received reconstruction. Patient characteristics and outcomes between irradiated and unirradiated patients were analyzed using ttests for continuous variables and chi-square tests for categorical variables. Multivariable mixed-effects regression modelsassessed the impact of reconstruction type and radiotherapy on outcomes after adjusting for relevant covariates. All statistical tests were two-sided. Results Autologous reconstruction was more commonly received by irradiated patients (37.9% vs 25.0%, P < .001). Immediate reconstruction was less common in irradiated patients (83.0% vs 95.7%, P < .001). At least one breast complication had occurred by two years in 38.9% of irradiated patients with implant reconstruction, 25.6% of irradiated patients with autologous reconstruction, 21.8% of unirradiated patients with implant reconstruction, and 28.3% of unirradiated patients with autologous reconstruction. Multivariable analysis showed bilateral treatment and higher body mass index to be predictive of developing a complication, with a statistically significant interaction between radiotherapy receipt and reconstruction type. Among irradiated patients, autologous reconstruction was associated with a lower risk of complications than implant-based reconstruction at two years (odds ratio [OR] = 0.47, 95% confidence interval [CI] = 0.27 to 0.82, P = .007); no between-procedure difference was found in unirradiated patients. The interaction was also statistically significant for satisfaction with breasts at two years (P = .002), with larger adjusted difference in satisfaction between autologous vs implant approaches (63.5, 95% CI = 55.9 to 71.1, vs 47.7, 95% CI = 40.2 to 55.2, respectively) in irradiated patients than between autologous vs implant approaches (67.6, 95% CI = 60.3 to 74.9, vs 60.5, 95% CI = 53.6 to 67.4) in unirradiated patients. Conclusions Autologous reconstruction appears to yield superior patient-reported satisfaction and lower risk of complications than implant-based approaches among patients receiving postmastectomy radiotherapy.

Importance Fat grafting has proven to be a useful adjunct to breast reconstruction for the treatment of contour irregularities and volume deficits, but the proposed US Food and Drug Administration regulations may severely limit the ability of plastic surgeons to continue its use in this clinical context. Objective To determine whether fat grafting is associated with patient-reported outcomes (PROs) in patients undergoing breast reconstruction. Design, Setting, and Participants A longitudinal, multicenter, prospective cohort study was conducted between February 1, 2012, and July 31, 2016, at the 11 sites associated with the Mastectomy Reconstruction Outcomes Consortium Study. Eligible patients included women 18 years or older presenting for breast reconstruction after mastectomy with 2 years or more of follow-up. All primary procedure types (implant based and flap based) were eligible. Patients were excluded if they had not completed breast mound reconstruction by 1 year after starting reconstruction. Interventions Fat grafting as an adjunct to breast mound reconstruction. Main Outcomes and Measures Primary end points were patient-reported outcome measures as assessed by the validated BREAST-Q survey, with higher scores on a 0- to 100-point scale indicating better health-related quality of life. Survey subscales included breast satisfaction, as well as psychosocial, physical, and sexual well-being. Patient-reported outcomes were compared between those who received and did not receive fat grafting. Results A total of 2048 women were included (mean [SD] age, 49.4 [10] years), with 165 (8.1%) undergoing fat grafting between years 1 and 2. One year postoperatively, patients who later underwent fat grafting reported significantly lower breast satisfaction (adjusted mean difference [AMD], −4.74; 95% CI, −8.21 to −1.28; P = .008), psychosocial well-being (AMD, −3.87; 95% CI, −7.33 to −0.40; P = .03), and sexual well-being (AMD, −5.59; 95% CI, −9.70 to −1.47; P = .008), compared with those who did not receive subsequent fat grafting. Following the procedure, the fat-grafted cohort reported similar breast satisfaction (AMD, −0.68; 95% CI, −4.42 to 3.06; P = .72), psychosocial well-being (AMD, −0.59; 95% CI, −3.92 to 2.74; P = .73), and sexual well-being (AMD, −2.94; 95% CI, −7.01 to 1.12; P = .15) 2 years postoperatively. Conclusions and Relevance Fat grafting may improve breast satisfaction, psychosocial well-being, and sexual well-being in patients undergoing breast reconstruction.

Background:Social support has been shown to be an important factor in improving depression symptom outcomes, yet less is known regarding its impact on antidepressant medication adherence. This study sought to evaluate the role of perceived social support on adherence to new antidepressant medication prescriptions in later-life depression.Methods:Data from two prospective observational studies of participants ≥60 years old, diagnosed with depression, and recently prescribed a new antidepressant (N = 452). Perceived social support was measured using a subscale of the Duke Social Support Index and medication adherence was assessed using a validated self-report measure.Results:At four-month follow up, 68% of patients reported that they were adherent to antidepressant medication. Examining the overall sample, logistic regression analysis demonstrated no significant relationship between perceived social support and medication adherence. However, when stratifying the sample by social support, race, and gender, adherence significantly differed by race and gender in those with inadequate social support: Among those with low social support, African-American females were significantly less likely to adhere to depression treatment than white females (OR = 4.82, 95% CI = 1.14–20.28, p = 0.032) and white males (OR = 3.50, 95% CI = 1.03–11.92, p = 0.045).Conclusions:There is a significant difference in antidepressant medication adherence by race and gender in those with inadequate social support. Tailored treatment interventions for low social support should be sensitive to racial and gender differences.

Purpose The goals of immediate postmastectomy breast reconstruction are to minimize deformity and optimize quality of life as perceived by patients. We prospectively evaluated patient-reported outcomes (PROs) in women undergoing immediate implant-based or autologous reconstruction. Methods Women undergoing immediate postmastectomy reconstruction for invasive cancer and/or carcinoma in situ were enrolled at 11 sites. Women underwent implant-based or autologous tissue reconstruction. Patients completed the BREAST-Q, a condition-specific PRO measure for breast surgery patients, and Patient-Reported Outcomes Measurement Information System–29, a generic PRO measure, before and 1 year after surgery. Mean changes in PRO scores were summarized. Mixed-effects regression models were used to compare PRO scores across procedure types. Results In total, 1,632 patients (n = 1,139 implant, n = 493 autologous) were included; 1,183 (72.5%) responded to 1-year questionnaires. After analysis was controlled for baseline values, patients who underwent autologous reconstruction had greater satisfaction with their breasts than those who underwent implant-based reconstruction (difference, 6.3; P < .001), greater sexual well-being (difference, 4.5; P = .003), and greater psychosocial well-being (difference, 3.7; P = .02) at 1 year. Patients in the autologous reconstruction group had improved satisfaction with breasts (difference, 8.0; P = .002) and psychosocial well-being (difference, 4.6; P = .047) compared with preoperative baseline. Physical well-being of the chest was not fully restored in either the implant group (difference, −3.8; P = .001) or autologous group (−2.2; P = .04), nor was physical well-being of the abdomen in patients who underwent autologous reconstruction (−13.4; P < .001). Anxiety and depression were mitigated at 1 year in both groups. Compared with their baseline reports, patients who underwent implant reconstruction had decreased fatigue (difference, −1.4; P = .035), whereas patients who underwent autologous reconstruction had increased pain interference (difference, 2.0; P = .006). Conclusion At 1 year after mastectomy, patients who underwent autologous reconstruction were more satisfied with their breasts and had greater psychosocial and sexual well-being than those who underwent implant reconstruction. Although satisfaction with breasts was equal to or greater than baseline levels, physical well-being was not fully restored. This information can help patients better understand expected outcomes and may guide innovations to improve outcomes.

Small Changes (SC) is a weight management approach that demonstrated superior 12-month outcomes compared to the existing MOVE!® Weight Management Program at two Veterans Affairs (VA) sites. However, approaches are needed to help graduates of treatment continue to lose or maintain their weight over the longer term. The purpose of the present study was to examine the effectiveness of a second year of low-intensity SC support compared to support offered by the usual care MOVE! programs. Following participation in the year-long Aspiring to Lifelong Health in VA (ASPIRE-VA) randomized controlled trial, participants were invited to extend their participation in their assigned program for another year. Three programs were extended to include six SC sessions delivered via telephone (ASPIRE-Phone) or an in-person group (ASPIRE-Group), or 12 sessions offered by the MOVE! programs. Three hundred thirty-two overweight/obese veterans who consented to extend their participation in the ASPIRE-VA trial by an additional year. Twenty-four-month weight change (kg). Twenty-four months after baseline, participants in all three groups had modest weight loss (−1.40 kg [−2.61 to −0.18] in the ASPIRE-Group, −2.13 kg [−3.43 to −0.83] in ASPIRE-Phone, and −1.78 kg [−3.07 to −0.49] in MOVE!), with no significant differences among the three groups. Exploratory post hoc analyses revealed that participants diagnosed with diabetes initially benefited from the ASPIRE-Group program (−2.6 kg [−4.37 to 0.83]), but experienced significant weight regain during the second year (+2.8 kg [0.92–4.69]) compared to those without diabetes. Participants in all three programs lost weight and maintained a statistically significant, though clinically modest, amount of weight loss over a 24-month period. Although participants in the ASPIRE-Group initially had greater weight loss, treatment was not sufficient to sustain weight loss through the second year, particularly in veterans with diabetes. Consistent, continuous-care treatment is needed to address obesity in the VA.