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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.

Background Although prostate cancer is the most common cancer among veterans receiving care in the Veterans Health Administration (VA), more needs to be done to understand and improve survivorship care for this large population. This study, funded by VA Health Services Research & Development (HSR&D), seeks to address the need to improve patient-centered survivorship care for veterans with prostate cancer. Methods/Design This is a two-armed randomized controlled trial (RCT) with a target enrollment of up to 325 prostate cancer survivors per study arm (total anticipated n = 600). Patients will be recruited from four VA sites. Patient eligibility criteria include age range of 40–80 years, one to ten years post-treatment, and currently experiencing prostate cancer symptom burden. We will compare the “Building Your New Normal” program, a personally-tailored automated telephone symptom management intervention for improving symptom self-management to usual care enhanced with a non-tailored newsletter about symptom management. Primary outcomes include changes in symptom burden, bother, and health services utilization at five and 12 months after enrollment. Secondary outcomes include long-term psychosocial outcomes (e.g. subjective health, perceived cancer control). We will use multivariable regression analysis to evaluate the impact of the intervention on primary and secondary outcomes. We will conduct a process evaluation to understand the effective intervention components and explore possibilities for broader implementation and dissemination. Discussion Our central hypothesis is that intervention group participants will have improved and more confident symptom self-management and prostate cancer quality of life following the intervention and that these outcomes will translate to more efficient use of health services. The study results will provide much needed information about how to optimize the quality of care, and life, of veteran prostate cancer survivors. Trial registration ClinicalTrials.gov ID NCT01900561; Registered on 22 July 2013. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1925-4) contains supplementary material, which is available to authorized users.

OBJECTIVES: Linaclotide and plecanatide are guanylate cyclase-C (GCC) agonists for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Our objective is to evaluate the efficacy and tolerability of GCC agonists based on data from multiple randomized controlled trials (RCTs). METHODS: We searched PubMED, EMBASE, Cochrane databases, clinicaltrials.gov, major conference abstracts, Food and Drug Administration (FDA) websites, and United States Securities and Exchange Commission filings of drug sponsors to identify RCTs of CIC or IBS-C patients. We assessed efficacy based on FDA-approved composite responder endpoints, diarrhea as an adverse event, and study withdrawal owing to diarrhea for each therapy. Trial results were pooled using DerSimonian and Laird random effects model of meta-analysis and exact logistic regression when appropriate with 95% confidence intervals. Meta-regression was performed to compare outcomes between therapies adjusting for placebo event rate. RESULTS: Eight linaclotide trials (five CIC; three IBS-C) and seven plecanatide trials (four CIC; three IBS-C) evaluating 10,369 patients met inclusion criteria. FDA publications documented that different definitions for diarrhea were used in linaclotide vs. plecanatide trials. Both drugs were efficacious in treating CIC (linaclotide 72 μg (Odds ratio (OR)=3.11, 95% CI 1.81–5.34); linaclotide 145 μg (OR=3.25, 2.15–4.91); plecanatide 3 mg (OR=1.99, 1.57–2.51)) and IBS-C (linaclotide 290 μg (OR=2.43, 1.48–3.98); plecanatide 3 mg (OR=1.87, 1.47–2.38); plecanatide 6 mg (OR=1.92, 1.48–2.48)). Diarrhea occurred in excess of placebo in treating CIC (linaclotide 72 μg (OR=3.07, 1.97–4.77); linaclotide 145 μg (OR=3.70, 2.69–5.10); plecanatide 3 mg (OR=3.86, 1.83–8.12)) and IBS-C (linaclotide 290 μg (OR=8.02, 5.20–12.37); plecanatide 3 mg (OR=5.55, 1.62–19.00); plecanatide 6 mg (OR=4.13, 1.57–10.83)). Based on meta-regression, there were no statistically significant differences between therapies in odds ratios for efficacy, diarrhea, or diarrhea-related study withdrawals. CONCLUSIONS: Both linaclotide and plecanatide demonstrate similar efficacy and tolerability in treating IBS-C and CIC. No differences in odds of diarrhea were seen between linaclotide and plecanatide.

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.

Bereavement is a potent and highly prevalent stressor among service members and veterans. However, the psychological consequences of bereavement, including complicated grief (CG), have been minimally examined. Loss was assessed in 204 post-9/11, when service members and veterans with combat-related posttraumatic stress disorder (PTSD) took part in a multicenter treatment study. Those who reported the loss of an important person completed the inventory of complicated grief (ICG; n = 160). Over three quarters (79.41%) of the sample reported an important lifetime loss, with close to half (47.06%) reporting the loss of a fellow service member (FSM). The prevalence of CG was 24.75% overall, and nearly one third (31.25%) among the bereaved. CG was more prevalent among veterans who lost a fellow service member (FSM) (41.05%, n = 39) compared to those bereaved who did not (16.92%, n = 11; OR = 3.41, 95% CI: 1.59, 7.36). CG was associated with significantly greater PTSD severity, functional impairment, trauma-related guilt, and lifetime suicide attempts. Complicated grief was prevalent and associated with adverse psychosocial outcomes in veterans and service members with combat-related PTSD. Clinicians working with this population should inquire about bereavement, including loss of a FSM, and screen for CG. Additional research examining CG in this population is needed.

Background Existing studies evaluating racial and ethnic disparities focus on describing differences in procedure type and the proportion of women who undergo reconstruction following mastectomy. This study seeks to examine racial and ethnic variations in clinical and patient-reported outcomes (PROs) following breast reconstruction. Methods The Mastectomy Reconstruction Outcomes Consortium is an 11 center, prospective cohort study collecting clinical and PROs following autologous and implant-based breast reconstruction. Mixed-effects regression models, weighted to adjust for non-response, were performed to evaluate outcomes at one-year postoperatively. Results The cohort included 2703 women who underwent breast reconstruction. In multivariable models, Hispanic or Latina patients were less likely to experience any complications and major complications. Black or African-American women reported greater improvements in psychosocial and sexual well-being. Conclusions Despite differences in pertinent clinical and socioeconomic variables, racial and ethnic minorities experienced equivalent or better outcomes. These findings provide reassurance in the context of numerous racial and ethnic health disparities and build upon our understanding of the delivery of surgical care to women with or at risk for developing breast cancer.

Background: The ideal timing of postmastectomy radiation therapy (PMRT) in the setting of two-stage implant-based breast reconstruction remains unclear. In this cohort study, the authors sought to determine whether complication rates differed between patients who received PMRT following tissue expander placement (TE-XRT) and those who received PMRT after exchange for permanent implants (Implant-XRT) utilizing using prospective, multicenter data. Methods: Eligible patients in the Mastectomy Reconstruction Outcomes Consortium study from 11 institutions across North America were included in the analysis. All patients had at least 6-month follow-up after their last intervention (i.e., implant exchange for TE-XRT patients, and radiation for Implant-XRT patients). Complications including seroma, hematoma, infection, wound dehiscence, capsular contracture, and implant loss were recorded. Results: The authors identified a total of 150 patients who underwent immediate, two-stage implant-based breast reconstruction and received PMRT. Of these, there were TE-XRT 104 patients (69.3 percent) and 46 (30.7 percent) Implant-XRT patients. There were no differences in the incidence of any complications or complications leading to reconstructive failure between the two cohorts. After adjusting for patient characteristics and site effect, the timing of PMRT (i.e., TE-XRT versus Implant-XRT) was not a significant predictor in the development of any complication, a major complication, or reconstructive failure. Conclusion: In the setting of PMRT and two-stage implant-based reconstruction, patients who received PMRT after expander placement (TE-XRT) did not have a higher incidence or increased odds of developing complications than those who received PMRT after exchange for a permanent implant (Implant-XRT). CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Nonlinear optical molecular imaging and quantitative analytic methods were developed to non-invasively assess the viability of tissue-engineered constructs manufactured from primary human cells. Label-free optical measures of local tissue structure and biochemistry characterized morphologic and functional differences between controls and stressed constructs. Rigorous statistical analysis accounted for variability between human patients. Fluorescence intensity-based spatial assessment and metabolic sensing differentiated controls from thermally-stressed and from metabolically-stressed constructs. Fluorescence lifetime-based sensing differentiated controls from thermally-stressed constructs. Unlike traditional histological (found to be generally reliable, but destructive) and biochemical (non-invasive, but found to be unreliable) tissue analyses, label-free optical assessments had the advantages of being both non-invasive and reliable. Thus, such optical measures could serve as reliable manufacturing release criteria for cell-based tissue-engineered constructs prior to human implantation, thereby addressing a critical regulatory need in regenerative medicine.

Background context A large percentage of back pain can be attributed to degeneration of the intervertebral disc (IVD). Bone morphogenetic protein 2 (BMP-2) is known to play an important role in chondrogenesis of the IVD. Simvastatin is known to upregulate expression of BMP-2. Thus, we hypothesized that intradiscal injection of simvastatin in a rat model of degenerative disc disease (DDD) would result in retardation of DDD. Purpose The purpose of the present study was to develop a novel conservative treatment for DDD and related discogenic back pain. Study design/setting The setting of this study is the laboratory investigation. Methods Disc injury was induced in 272 rats via 21-ga needle puncture. After 6 weeks, injured discs were treated with simvastatin in a saline or hydrogel carrier. Rats were sacrificed at predetermined time points. Outcome measures assessed were radiologic, histologic, and genetic. Radiologically, the magnetic resonance imaging (MRI) index (number of pixels multiplied by the corresponding image densities) was determined. Histologically, disc spaces were read by three blinded scorers using a previously described histologic grading scale. Genetically, nuclei pulposi were harvested, and polymerase chain reaction was run to determine relative levels of aggrecan, collagen type II, and BMP-2 gene expression. Results Radiologically, discs treated with 5 mg/mL of simvastatin in hydrogel or saline demonstrated MRI indices that were normal through 8 weeks after treatment, although this was more sustained when delivered in hydrogel. Histologically, discs treated with 5 mg/mL of simvastatin in hydrogel demonstrated improved grades compared with discs treated at higher doses. Genetically, discs treated with 5 mg/mL of simvastatin in hydrogel demonstrated higher gene expression of aggrecan and collagen type II than control. Conclusions Degenerate discs treated with 5 mg/mL of simvastatin in a hydrogel carrier demonstrated radiographic and histologic features resembling normal noninjured IVDs. In addition, the gene expression of aggrecan and collagen type II (important constituents of the IVD extracellular matrix) was upregulated in treated discs. Injection of simvastatin into degenerate IVDs may result in retardation of disc degeneration and represents a promising investigational therapy for conservative treatment of DDD.

ObjectiveThe authors compared fidelity to bipolar disorder treatment at community practices that received a standard or enhanced version of a novel implementation intervention called Replicating Effective Programs (REP).MethodsFive community practices in Michigan and Colorado were assigned at random to receive enhanced (N=3) or standard (N=2) REP to help implement Life Goals Collaborative Care (LGCC), a psychosocial intervention consisting of four self-management support group sessions, ongoing care management contacts by phone, and dissemination of guidelines to providers. Standard REP includes an intervention package consisting of an outline, a treatment manual and implementation guide, a standard training program, and as-needed technical assistance. Enhanced REP added customization of the treatment manual and ongoing, proactive technical assistance from internal and external facilitators. Multiple and logistic regression analyses determined the impact of enhanced versus standard REP on patient-level fi...

Background— Recurrence of ventricular tachycardia (VT) after ablation in patients with previous myocardial infarction is associated with adverse prognosis. However, the impact of the timing of VT recurrence on outcomes is unclear. Methods and Results— We analyzed data from a multicenter collaborative database of patients who underwent catheter ablation for infarct-related VT. Multivariable Cox regression analyses investigated the effect of the timing of VT recurrence on the composite outcome of death or heart transplantation using VT recurrence as a time-varying covariate. A total of 1412 patients were included (92% men; age: 66.7±10.7 years), and 605 patients (42.8%) had a recurrence after median 116 days (188 [31.1%] within 1 month, 239 [39.5%] between 1 and 12 months, and 178 [29.4%] after 12 months). At median follow-up of 670 days, 375 patients (26.6%) experienced death or heart transplantation. The median time from recurrence to death or heart transplantation was 65 and 198.5 days in patients with recurrence ≤30 days and >30 days post ablation, respectively. The adjusted hazard ratio (95% confidence interval) for the effect of VT recurrence occurring immediately post ablation on death or heart transplantation was 3.45 (2.33–5.11) in reference to no recurrence. However, the magnitude of this effect decreased statistically significantly ( P Conclusions— VT recurrence post ablation is associated with a mortality risk that is highest soon after the ablation and decreases gradually thereafter.

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

We evaluated whether treatment-resistant depression (TRD) as measured by the Massachusetts General Hospital (MGH) staging method was associated with suicide in a large U.S. health system. Data from the Veterans Health Administration and the National Death Index were used to conduct a case-control study of patients newly diagnosed with depression who received antidepressant treatment between 2003 and 2006. Suicide cases (N = 499) were matched with nonsuicide controls (N = 1994). Conditional logistic regression was used to assess whether MGH stage at time of suicide (or matched date) was associated with case status, adjusting for patient demographic characteristics, comorbidity, and service use. Results indicated 11.6% of suicide cases had MGH stage 3 or greater (indicating at least two antidepressant trials) compared to 6.4% of controls (p < .001). In adjusted analyses, suicide was not significantly more likely among patients with stage 3 or greater (OR 1.52; 95% CI: 0.98, 2.37) or stages 1.5-2.5 (OR 1.19; 95% CI: 0.91, 1.55) compared to patients with stage 1 or less (

To examine the quality of suicide risk assessment provided to veterans with a history of depression who died by suicide between 1999 and 2004.We conducted a case-control study of suicide risk assessment information recorded in 488 medical charts of veterans previously diagnosed with major depression, depression not otherwise specified, dysthymia, or other, less common ICD-9-CM depression codes. Patients dying by suicide from April 1999 through September 2004 or comparison patients (n = 244 pairs) were matched for age, sex, entry year, and region.Seventy-four percent of patients with a history of depression received a documented assessment of suicidal ideation within the past year, and 59% received more than 1 assessment. However, 70% of those who died of suicide did not have a documented assessment for suicidal ideation at their final Veterans Health Administration (VHA) visit, even if that visit occurred within 0 through 7 days prior to suicide death. Most patients dying by suicide denied suicidal ideation when assessed (85%; 95% CI, 75%-92%), even just 0 through 7 days prior to suicide death (73%; 95% CI, 39%-94%). Suicidal ideation was assessed more frequently during outpatient final visits with mental health providers (60%) than during outpatient final visits with primary care (13%) or other non-mental health providers (10%, P.0001).Most VHA patients with a history of depression received some suicide risk assessment within the past year, but suicide risk assessments were infrequently administered at the final visit of patients who eventually died by suicide. Among patients who had assessments, denial of suicidal ideation appeared to be of limited value. Practice changes are needed to improve suicide risk assessment among patients with histories of depression, including the development of assessment and prevention strategies that are less dependent on the presence or disclosure of suicidal ideation at scheduled medical visits.

Background Individuals with mental health (MH) disorders have an increased risk of being overweight/obese; however research on behavioral weight loss interventions has been limited. A priori hypothesis was that Veterans with serious mental illness (SMI) and/or affective disorders (AD) would lose significantly less weight and have a different pattern of weight loss than Veterans without these diagnoses. Methods Secondary data analysis of ASPIRE-VA study, three-arm randomized, effectiveness weight loss trial among Veterans (n=409) categorized by MH diagnoses: 1) SMI, 2) AD without SMI, or 3) No SMI/No AD. Linear mixed-effects model analyzed weight changes from baseline thru 24 months. Results SMI and AD were diagnosed in 10% (n=41) and 31% (n=125). Participants attended approximately 15 sessions from baseline to 24 months. On average, participants lost a modest amount of weight over 24 months regardless of MH diagnosis. Longitudinally, no statistically significant differences were found in weight loss patterns by MH diagnosis. Unadjusted average weight loss (kg) was 1.6±4.0 at 3 months (n=373), 1.9±6.5 at 12 months (n=361), 1.5±7.8 at 18 months (n=289), and 1.4±8.0 at 24 months (n=279). Limitations ASPIRE-VA study was not designed or powered to detect weight loss differences among MH diagnostic groups. Conclusions Veterans achieved and maintained modest weight loss, through 24 months, with the three behavioral weight loss interventions. Contrary to our hypotheses, the amount and pattern of weight loss did not differ by MH diagnosis. Greater inclusion of individuals with MH diagnoses may be warranted in behavioral weight loss interventions not specifically tailored for them.

Immunologically inert allogeneic acellular dermal scaffolds provide a matrix with molecular architecture close to native tissues, which synthetic scaffolds cannot. Not all nature-derived scaffolds possess the same biological and physical properties. The different properties of scaffolds supporting cellular growth used for manufacturing tissue engineered grafts could lead to different implantation results. The scaffold properties should be carefully considered in order to meet the expected outcomes of tissue engineered grafts. In this report, we evaluated the cellular growth on AlloDerm® and Allopatch, 2 acellular scaffolds derived from human cadaver skin, using a fabricated 3D organotypic culture with primary human oral keratinocytes to produce an ex vivo produced oral mucosa equivalent (EVPOME). A well stratified epithelium could be constructed on both scaffolds. AlloDerm® and Allopatch EVPOMEs were also implanted into severe combined immunodeficiency mice to compare the ingrowth of blood vessels into the dermal component of the two EVPOMEs. Blood vessel counts were 3.3 times higher (p = .01) within Allopatch EVPOMEs than within AlloDerm® EVPOMEs. An oral and skin keratinocyte co-culture, separated by a physical barrier to create a cell-free zone, was used to evaluate cell migration on AlloDerm® and Allopatch. Slower cell migration was observed on Allopatch than on AlloDerm®.

Introduction Postmastectomy breast reconstruction has become an increasingly important component of breast cancer treatment. Unfortunately, some patients experience severe postoperative pain, placing them at risk for increased clinical morbidity and the development of disabling chronic pain. To identify patients at risk, we prospectively evaluated patient characteristics and medical/surgical variables associated with more severe acute post-reconstruction pain. Methods Women (N = 2207; 1-week 82.8% response rate) undergoing breast reconstruction were assessed for pain experience, anxiety, depression, and sociodemographic characteristics before surgery. Pain assessments were made preoperatively and postoperatively at 1 week using validated survey instruments including the McGill Pain Questionnaire-Short Form (MPQ-SF), Numerical Pain Rating Scale (NPRS), and BREAST-Q Chest and Upper Body scale. Depressive symptoms and anxiety severity were assessed by the Patient Health Questionnaire and Generalized Anxiety Disorders Scale, respectively. Mixed-effects regression modeling was used to examine the relationships between patient characteristics and medical/surgical variables and 1-week postoperative pain. Results Younger age; bilateral reconstruction; and severity of preoperative pain, anxiety, and depression were associated with more severe acute postoperative pain on all the pain measures and BREAST-Q. Surgical procedure type indicated less severe postoperative pain for PTRAM, DIEP, and SIEA reconstructive surgery when compared with tissue expander/implant reconstruction. Conclusions This study identifies patients at risk for severe acute postoperative pain following breast reconstruction. These findings will allow plastic surgeons to better tailor postoperative care to improve patient comfort, reduce clinical morbidity, and enhance patient satisfaction with their surgical outcome.

Although bilateral prophylactic mastectomy (BPM) can reduce the risk of breast cancer, the decision to proceed surgically can have significant consequences and requires careful deliberation. To facilitate decision making for women at high risk for breast carcinoma, the risks and benefits of BPM should be well-elucidated. We sought to determine the effects of BPM and immediate reconstruction on health-related quality-of-life outcomes among a multisite cohort of women at high risk for breast carcinoma. Patient-reported outcome data were prospectively collected as part of the Mastectomy Reconstruction Outcomes Consortium Study, and data on a subgroup of 204 high-risk women who elected to have BPM and immediate reconstruction were evaluated. Baseline scores were compared with scores at 1 or 2 years after reconstruction. Satisfaction with breasts and psychosocial well-being were significantly higher at both 1 and 2 years (p

Although40% of new breast cancer diagnoses in the US are in older women, few studies have assessed the outcomes of post-mastectomy reconstruction in this population. Our objective was to evaluate age effects on postoperative complications and patient-reported outcomes in women undergoing breast reconstruction, and to investigate whether age effects differ between reconstructive procedure types.Eligible patients in the Mastectomy Reconstruction Outcomes Consortium study from 11 institutions (57 providers) in North America were analyzed. Two-year complications and patient-reported outcomes via BREAST-Q domains were compared across younger (younger than 45 years), middle-aged (45 to 60 years), and older (older than 60 years) women. Mixed-effects regression models were used, controlling for a range of demographic and clinical covariates.A total of 1,531 patients were studied: 494 younger, 803 middle-aged, and 234 older. Age was not a significant predictor of complications. For sexual well-being 2 years post-reconstruction, older women reported 4.25 (p = 0.04) higher mean scores with implant procedures, and 10.39 (p0.01) higher mean scores with autologous procedures compared with younger women. No age effect was seen with implant procedures with regard to physical and psychosocial well-being; however, older women who underwent autologous procedures reported 6.07 (p0.01) higher physical, and 8.21 (p0.01) higher psychosocial well-being scores than younger women.Age did not significantly affect complication rates. Older women demonstrated higher sexual well-being for both procedures, and better satisfaction and physical and psychosocial well-being than younger women with autologous procedures. Post-mastectomy reconstruction is a viable option for older patients, with risks and benefits comparable with those in younger women.

The study assessed correlates of emergency department use among participants in a collaborative care program for bipolar disorder.Community-based clinics from two states implemented Life Goals-Collaborative Care (LG-CC), an evidence-based model that includes self-management sessions and care management contacts. Logistic regression determined participant factors associated with emergency department use between six and 12 months after LG-CC implementation.Of 219 participants with baseline and 12-month data, 24% reported at least one emergency department visit. Participants with a recent homelessness history (odds ratio [OR]=3.76, p=.01) or five or more care management contacts (OR=2.62, p=.05) had a higher probability of visiting an emergency department, after the analyses were adjusted for demographic and clinical factors, including physical health score and hospitalization history.Participants in a collaborative care program who had a history of homelessness were more likely to use the emergency department, suggesting a greater need for more intensive care coordination.

As many as 60% of patients with Parkinson disease (PD) experience psychosis, 80% develop dementia, and the use of antipsychotics (APs) in the population with PD is common. The use of APs by patients with dementia in the general population is associated with increased mortality, but whether this risk extends to patients with PD remains unknown.To determine whether AP use in patients with PD is associated with increased mortality.This retrospective matched-cohort study used data from a Veterans Health Administration database from fiscal years 1999 to 2010 to examine the risk associated with AP use in a cohort of patients with idiopathic PD and recent stable physical health. The rates of 180-day mortality were compared in 7877 patients initiating AP therapy and 7877 patients who did not initiate AP therapy (matched for age ±2.5 years, sex, race, index year, presence and duration of dementia, PD duration, delirium, hospitalization, Charlson Comorbidity Index, and new nonpsychiatric medications). Data were analyzed from October 19, 2012, to September 21, 2015.Mortality rates at 180 days in those patients who initiated AP therapy compared with matched patients who did not use APs. Cox proportional hazards regression models were used with intent-to-treat (ITT) and exposure-only analyses.The study population included 7877 matched pairs of patients with PD (65 women [0.8%] and 7812 men [99.2%] in each cohort; mean [SD] age, 76.3 [7.7] years for those who initiated AP therapy and 76.4 [7.6] years for those who did not). Antipsychotic use was associated with more than twice the hazard ratio (HR) of death compared with nonuse (ITT HR, 2.35; 95% CI, 2.08-2.66; P .001). The HR was significantly higher for patients who used typical vs atypical APs (ITT HR, 1.54; 95% CI, 1.24-1.91; P .001). Among the atypical APs used, HRs relative to nonuse of APs in descending order were 2.79 (95% CI, 1.97-3.96) for olanzapine, 2.46 (95% CI, 1.94-3.12) for risperidone, and 2.16 (95% CI, 1.88-2.48) for quetiapine fumarate.Use of APs is associated with a significantly increased mortality risk in patients with PD, after adjusting for measurable confounders. This finding highlights the need for cautious use of APs in patients with PD. Future studies should examine the role of nonpharmacologic strategies in managing psychosis in PD. In addition, new pharmacologic treatments that do not increase mortality in patients with neurodegenerative diseases need to be developed.

National Guard (NG) soldiers returning from deployments in Iraq and Afghanistan were surveyed at 6 and 12 months following their return (N = 970). The overall prevalence of suicide risk at 6 and 12 months following their return was assessed, as were changes in suicide risk among soldiers initially at high or low risk. Factors associated with changes in risk were assessed. The percentage of NG soldiers with high suicide risk increased from 6.8% at 6 months to 9.2% at 12 months (odds ratio = 1.7, p = .02). In the 882 soldiers initially at low risk, 5.9% (52/882) became high risk at 12 months; in the 64 soldiers initially at high risk, 46.9% (30/64) became low risk at 12 months. Initial levels of depressive symptoms were predictive of changing to high risk; this association appeared to be partially explained by soldier reports of increased search in the meaning in life and higher levels of perceived stress. Because suicide risk increases over the first 12 months, continued risk assessments during this time period should be considered. Supporting soldiers to find meaning in their life after deployment and enhancing their capacity to cope with perceived stress may help prevent increases in suicide risk over time.

Researchers and policymakers do not agree about the most appropriate way to get consent for the use of donations to a biobank. The most commonly used method is blanket—or broad—consent where donors allow their donation to be used for any future research approved by the biobank. This approach does not account for the fact that some donors may have moral concerns about the uses of their biospecimens. This problem can be avoided using “real-time”—or study-by-study—consent, but this policy places a significant burden on biobanks. In order to better understand the public’s preferences regarding biobank consent policy, we surveyed a sample that was representative of the population of the United States. Respondents were presented with 5 biobank consent policies and were asked to indicate which policies were acceptable/unacceptable and to identify the best/worst policies. They were also given 7 research scenarios that could create moral concern (e.g. research intending to make abortions safer and more effective) and asked how likely they would be to provide broad consent knowing that their donation might be used in that research. Substantial minorities found both broad and study-by-study consent to be unacceptable and identified those two options as the worst policies. Furthermore, while the type of moral concern (e.g., regarding abortion, the commercial use of donations, or stem cell research) had no effect on policy preferences, an increase in the number of research scenarios generating moral concerns was related to an increased likelihood of finding broad consent to be the worst policy. The rejection of these ethically problematic and costly extremes is good news for biobanks. The challenge now is to design a policy that combines consent with access to information in a way that assures potential donors that their interests and moral concerns are being respected.

OBJECTIVE: To identify factors recorded in electronic medical chart progress notes associated with suicide among patients who had received treatment for depression. METHOD: The retrospective study sample consisted of 324 randomly selected US Veterans Health Administration (VHA) patients treated for depression who died by suicide from April 1, 1999, to September 30, 2004, stratified by geographic region, gender, and year of depression cohort entry and 312 control patients with depression who were alive on the date of suicide death (index date) and were from the same stratum as the matched suicide patient. In addition to constructing variables from administrative data, variables were abstracted from electronic medical chart notes in the year prior to the index date in 5 categories: clinical symptoms and diagnoses, substance use, life stressors, behavioral/ideation measures (eg, suicide attempts), and treatments received. Logistic regression was used to assess the associations. RESULTS: Even after we adjusted for administratively available data, suicidal behaviors and substance-related variables were the strongest independent predictors of suicide. Prescription drug misuse had an odds ratio (OR) of 6.8 (95% CI, 2.5-18.5); history of suicide attempts, 6.6 (95% CI, 1.7-26.4); and alcohol abuse/dependence, 3.3 (95% CI, 1.9-5.7). Difficulty with access to health care was a predictor of suicide (OR = 2.9; 95% CI, 1.3-6.3). Receipt of VHA substance abuse treatment was protective (OR = 0.4; 95% CI, 0.1-0.9). CONCLUSIONS: Prescription drug and alcohol misuse assessments should be prioritized in suicide assessments among depressed patients. Additionally, behavioral measures noted in electronic chart records may be useful in health system monitoring and surveillance and can potentially be accessed using word search or natural language processing approaches. Language: en

Patients with frequent premature ventricular complexes (PVCs) are at risk of developing reversible PVC-induced cardiomyopathy (rPVC-CMP). Not all determinants of rPVC-CMP are known.To assess the impact of the QRS duration of PVCs on the development of rPVC-CMP.In a consecutive series of 294 patients with frequent idiopathic PVCs referred for PVC ablation, the width of the PVC-QRS complex was assessed. The QRS width was correlated with the presence of rPVC-CMP.The PVC-QRS width was significantly greater in patients with rPVC-CMP than in patients without rPVC-CMP (164 ± 20 ms vs 149 ± 17 ms; P.0001). The site of origin of the PVC had an impact on the PVC-QRS width, with epicardial PVCs having the broadest QRS complexes. Patients with PVCs originating from the right ventricular outflow tract or the fascicles had the narrowest QRS complexes. After adjusting for PVC burden, symptom duration, and PVC site of origin, PVC-QRS width and an epicardial PVC origin were independently associated with rPVC-CMP. Based on receiver operator characteristics analysis, a QRS duration of150 ms best differentiated patients with and without rPVC-CMP (area under the curve 0.66; sensitivity 80%; specificity 52%). The PVC burden for developing rPVC-CMP is significantly lower in patients with a PVC-QRS width of ≥150 ms than in patients with a narrower PVC-QRS complex (22% ± 13% vs 28% ± 12%; P.0001).Broader PVCs and an epicardial PVC origin are associated with the development of rPVC-CMP independent of the PVC burden.

BACKGROUND: Studies report mixed findings regarding antidepressant agents and suicide risks, and few examine suicide deaths. Studies using observational data can accrue the large sample sizes needed to examine suicide death, but selection biases must be addressed. We assessed associations between suicide death and treatment with the 7 most commonly used antidepressants in a national sample of Department of Veterans Affairs patients in depression treatment. Multiple analytic strategies were used to address potential selection biases. METHODS: We identified Department of Veterans Affairs patients with depression diagnoses and new antidepressant starts between April 1, 1999, and September 30, 2004 (N = 502,179). Conventional Cox regression models, Cox models with inverse probability of treatment weighting, propensity-stratified Cox models, marginal structural models (MSM), and instrumental variable analyses were used to examine relationships between suicide and exposure to bupropion, citalopram, fluoxetine, mirtazapine, paroxetine, sertraline, and venlafaxine. RESULTS: Crude suicide rates varied from 88 to 247 per 100,000 person-years across antidepressant agents. In multiple Cox models and MSMs, sertraline and fluoxetine had lower risks for suicide death than paroxetine. Bupropion had lower risks than several antidepressants in Cox models but not MSMs. Instrumental variable analyses did not find significant differences across antidepressants. DISCUSSION: Most antidepressants did not differ in their risk for suicide death. However, across several analytic approaches, although not instrumental variable analyses, fluoxetine and sertraline had lower risks of suicide death than paroxetine. These findings are congruent with the Food and Drug Administration meta-analysis of randomized controlled trials reporting lower risks for "suicidality" for sertraline and a trend toward lower risks with fluoxetine than for other antidepressants. Nevertheless, divergence in findings by analytic approach suggests caution when interpreting results. Language: en

The use of antipsychotics to treat the behavioral symptoms of dementia is associated with greater mortality. The authors examined the mortality risk of individual agents to augment the limited information on individual antipsychotic risk.The authors conducted a retrospective cohort study using national data from the U.S. Department of Veterans Affairs (fiscal years 1999-2008) for dementia patients age 65 and older who began outpatient treatment with an antipsychotic (risperidone, olanzapine, quetiapine, or haloperidol) or valproic acid and its derivatives (as a nonantipsychotic comparison). The total sample included 33,604 patients, and individual drug groups were compared for 180-day mortality rates. The authors analyzed the data using multivariate models and propensity adjustments.In covariate-adjusted intent-to-treat analyses, haloperidol was associated with the highest mortality rates (relative risk=1.54, 95% confidence interval [CI]=1.38-1.73) followed by risperidone (reference), olanzapine (relative risk=0.99, 95% CI=0.89-1.10), valproic acid and its derivatives (relative risk=0.91, 95% CI=0.78-1.06), and quetiapine (relative risk=0.73, 95% CI=0.67-0.80). Propensity-stratified and propensity-weighted models as well as analyses controlling for site of care and medication dosage revealed similar patterns. The mortality risk with haloperidol was highest in the first 30 days but decreased significantly and sharply thereafter. Among the other agents, mortality risk differences were most significant in the first 120 days and declined in the subsequent 60 days during follow-up.There may be differences in mortality risks among individual antipsychotic agents used for treating patients with dementia. The use of valproic acid and its derivatives as alternative agents to address the neuropsychiatric symptoms of dementia may carry associated risks as well.

Objective: To assess the informed, deliberative views of the older general public toward a policy of allowing surrogate consent for Alzheimer disease (AD) research. Methods: A total of 503 persons aged 50+ recruited by random digit dialing were randomly assigned to 1 of 3 groups: deliberation, education, or control. The deliberation group attended an all-day education/peer deliberation session; the education group received written information only. Participants were surveyed at baseline, after deliberation session (or equivalent time), and 1 month after the session, regarding their attitudes toward a policy of allowing surrogate consent for research studies of varying risks and potential benefits (a lumbar puncture study, a drug randomized controlled trial, a vaccine randomized controlled trial, and an early phase gene transfer trial). Results: At baseline, a policy of surrogate consent for AD research was supported by 55%–91%, depending on the scenario. The education group had a transient increase in support for one research scenario after receiving the information materials. In the deliberation group, support for surrogate consent was higher after deliberation for all scenarios (67% to 97%), with much of the increase sustained 1 month after the deliberation session. No changes occurred in the control group. The study9s limitations include self-selection of participants due to the demanding nature of attendance at the deliberation sessions. Conclusions: This sample of the older general public generally supported a policy of surrogate consent for AD research at baseline. Their support increased with democratic deliberation involving informed, in-depth exploration of the relevant scientific and ethical issues.

This study aimed to evaluate factors associated with the selection of pharmacological treatments often given as first-line treatments to elderly patients with neuropsychiatric symptoms associated with dementia. It also evaluated patterns of medication usage over time in the year preceding and three years after the U.S. Food and Drug Administration issued a black box warning for antipsychotic usage.A retrospective cohort consisted of 19,517 Veterans Affairs patients with diagnosed dementia and a new outpatient start with an antipsychotic agent (haloperidol, olanzapine, quetiapine, or risperidone) or valproic acid and its derivatives between May 1, 2004, and September 30, 2008. Patient and facility characteristics were examined for their association with the new starts of these medications.Trends in the rate of fills for psychotropic medications varied, with yearly increases in the use of quetiapine, haloperidol, and valproic acid and decreasing use of olanzapine and risperidone. Predictors of haloperidol use included a new start in nonpsychiatric settings, prior benzodiazepine use, and any prior-year hospitalization. Anxiety disorder and major depression were predictive of not receiving haloperidol. Parkinson's disease was predictive of quetiapine use, whereas bipolar disorder was predictive of valproic acid use. Older age was predictive of use of antipsychotics rather than valproic acid. Urban facilities were less likely to use olanzapine, and significant regional variations were seen.Important patient and facility characteristics were associated with initiating different psychotropic agents among elderly dementia patients. In addition, the rate of use and the factors predictive of use varied across the study years.

Frequent premature ventricular complexes (PVCs) can cause cardiomyopathy. The mechanism is not known and may be multifactorial.This study assessed the role of PVC interpolation in PVC-induced cardiomyopathy.In 51 consecutive patients (14 women, age 49 ± 15 years, ejection fraction (EF) 0.49 ± 0.14) with frequent PVCs, 24-hour Holter recordings were performed. The amount of interpolation was determined and correlated with the presence of PVC-induced cardiomyopathy. In addition, parameters measured during an electrophysiology study were correlated with the Holter findings.Fourteen of the 21 patients (67%) with cardiomyopathy had interpolated PVCs, compared with only 6 of 30 patients (20%) without PVC-induced cardiomyopathy (P.001). Patients with interpolated PVCs had a higher PVC burden than patients without interpolation (28% ± 12% vs. 15% ± 15%; P = .002). The burden of interpolated PVCs correlated with the presence of PVC cardiomyopathy (21% ± 30% vs. 4% ± 13%; P = .008). Both PVC burden and interpolation independently predicted PVC-induced cardiomyopathy (odds ratio 1.07, 95% confidence interval 1.01 to 1.13, P = .02; and odds ratio 4.43, 95% confidence interval 1.06 to 18.48, P = .04, respectively). The presence of ventriculoatrial block at a ventricular pacing cycle length of 600 ms correlated with the presence of interpolation (P = .004). Patients with interpolation had a longer mean ventriculoatrial block cycle length than patients without interpolated PVCs (520 ± 110 ms vs. 394 ± 92 ms; P = .01).The presence of interpolated PVCs was predictive of the presence of PVC cardiomyopathy. Interpolation may play an important role in the generation of PVC-induced cardiomyopathy.

IMPORTANCE: In breast reconstruction, it is critical for patients and surgeons to have comprehensive information on the relative risks of the available options. However, previous studies that evaluated complications were limited by single-center designs, inadequate follow-up, and confounding. OBJECTIVE: To assess 2-year complication rates across common techniques for postmastectomy reconstruction in a multicenter patient population. DESIGN, SETTING, AND PARTICIPANTS: This longitudinal, multicenter, prospective cohort study conducted from February 1, 2012, through July 31, 2015, took place at the 11 study sites associated with the Mastectomy Reconstruction Outcomes Consortium study. Eligible patients included women 18 years and older presenting for first-time breast reconstruction with at least 2 years of follow-up. Procedures evaluated included direct-to-implant (DTI) technique, expander-implant (EI) technique, latissimus dorsi (LD) flap, pedicled transverse rectus abdominis myocutaneous (pTRAM) flap, free transverse rectus abdominis myocutaneous (fTRAM) flap, deep inferior epigastric perforator (DIEP) flap, and superficial inferior epigastric artery (SIEA) flap. INTERVENTIONS: Postmastectomy breast reconstruction. MAIN OUTCOMES AND MEASURES: Development of complications, reoperative complications, and wound infections during 2-year follow-up. Mixed-effects logistic regression analysis controlled for variability among centers and for demographic and clinical variables. RESULTS: A total of 2343 patients (mean [SD] age, 49.5 [10.1] years; mean [SD] body mass index, 26.6 [5.7]) met the inclusion criteria. A total of 1525 patients (65.1%) underwent EI reconstruction, with 112 (4.8%) receiving DTI reconstruction, 85 (3.6%) pTRAM flaps, 95 (4.1%) fTRAM flaps, 390 (16.6%) DIEP flaps, 71 (3.0%) LD flaps, and 65 (2.8%) SIEA flaps. Overall, complications were noted in 771 (32.9%), with reoperative complications in 453 (19.3%) and wound infections in 230 (9.8%). Two years postoperatively, patients undergoing any autologous reconstruction type had significantly higher odds of developing any complication compared with those undergoing EI reconstruction (pTRAM flap: odds ratio [OR], 1.91; 95% CI, 1.10-3.31; P = .02; fTRAM flap: OR, 2.05; 95% CI, 1.24-3.40; P = .005; DIEP flap: OR, 1.97; 95% CI, 1.41-2.76; P

Importance Previous outcome studies comparing implant and autologous breast reconstruction techniques have been limited by short-term follow-up, single-center design, and a lack of rigorous patient-reported outcome data. An understanding of the expected satisfaction and breast-related quality of life associated with each type of procedure is central to the decision-making process. Objective To determine outcomes reported by patients undergoing postmastectomy breast reconstruction using implant or autologous techniques 2 years after surgery. Design, Setting, and Participants Patients were recruited from 11 centers (57 plastic surgeons) across North America for the Mastectomy Reconstruction Outcomes Consortium study, a prospective, multicenter trial, from February 1, 2012, to July 31, 2015. Women undergoing immediate breast reconstruction using implant or autologous tissue reconstruction after mastectomy for cancer treatment or prophylaxis were eligible. Overall, 2013 women (1490 implant and 523 autologous tissue reconstruction) met the inclusion criteria. All patients included in this analysis had 2 years of follow-up. Exposures Procedure type (ie, implant vs autologous tissue reconstruction). Main Outcomes and Measures The primary outcomes of interest were scores on the BREAST-Q, a validated, condition-specific, patient-reported outcome instrument, which were collected prior to and at 2 years after surgery. The following 4 domains of the BREAST-Q reconstruction module were evaluated: satisfaction with breasts, psychosocial well-being, physical well-being, and sexual well-being. Responses from each scale were summed and transformed on a 0 to 100 scale, with higher numbers representing greater satisfaction or quality of life. Results Of the 2013 women in the study (mean [SD] age, 48.1 [10.5] years for the group that underwent implant-based reconstruction and 51.6 [8.7] years for the group that underwent autologous reconstruction), 1217 (60.5%) completed questionnaires at 2 years after reconstruction. After controlling for baseline patient characteristics, patients who underwent autologous reconstruction had greater satisfaction with their breasts (difference, 7.94; 95% CI, 5.68-10.20;P Conclusions and Relevance At 2 years, patients who underwent autologous reconstruction were more satisfied with their breasts and had greater psychosocial well-being and sexual well-being than did those who underwent implant reconstruction. These findings can inform patients and their clinicians about expected satisfaction and quality of life outcomes of autologous vs implant-based procedures and further support the adoption of shared decision making in clinical practice.

Objective. To assess the relationship between closer monitoring of depressed patients during high-risk treatment periods and death from suicide, using two analytic approaches. Data Source. VA patients receiving depression treatment between 1999 and 2004. Study Design. First, a case–control design was used, adjusting for age, gender, and high-risk days (1,032 cases and 2,058 controls). Second, an instrumental variable (IV) approach (N 5 714,106) was used, with IVs of (1) average monitoring rates in the VA facility of most use and (2) monitoring rates of VA facilities weighted inversely by distance from patients’ residences. Principal Findings. The case–control approach indicated a modest increase in suicide risk with each additional visit (odds ratio 5 1.02; 95 percent confidence interval 5 1.002, 1.04). The ‘‘facility used’’ IV estimate indicated near zero change in risk (0.0008 percent increase;p 5 .97) with each additional visit, while the distance-weighted IV estimate indicated a 0.032 percent decrease in risk (p 5 .29). An alternative analysis assuming a threshold effect of � 4 visits during high-risk periods also showed a decrease (0.15 percent; p 5 .08) using the distance IV. Conclusions. The IV approach appeared to address the selection bias more appropriately than the case–control analysis. Neither analysis clearly indicated that closer monitoring during high-risk periods was significantly associated with reduced suicide risks, but the distance-weighted IV estimate suggested a potentially protective effect.

Ambulatory surgery centers deliver surgical care more efficiently than hospitals but may increase overall procedure use and adversely affect competing hospitals. Motivated by these concerns we evaluated how opening of an ambulatory surgery center impacts stone surgery use in a health care market and assessed the effect of its opening on the patient mix at nearby hospitals.In a 100% sample of outpatient surgery from Florida we measured annual stone surgery use between 1998 and 2006. We used multiple regression to determine if the rate of change in use differed between markets, defined by the hospital service area, without and with a recently opened ambulatory surgery center.Stone surgery use increased an average of 11 procedures per 100,000 individuals per year (95% CI 1-20, p0.001) after an ambulatory surgery center opened in a hospital service area. Four years after opening the relative increase in the stone surgery rate was approximately 64% higher (95% CI 27 to 102) in hospital service areas where a center opened vs hospital service areas without a center. These market level increases in surgery were not associated with decreased surgical volume at competing hospitals and the absolute change in patient disease severity treated at nearby hospitals was small.While opening of an ambulatory surgery center did not appear to have an overly detrimental effect on competing hospitals, it led to a significant increase in the population based rate of stone surgery in the hospital service area. Possible explanations are the role of physician financial incentives and unmet surgical demand.

SUMMARY OBJECTIVES Naturalistic studies comparing differences in risks across antidepressant agents must take into account factors which influence selection of specific agents and may be associated with outcomes. We examined predictors of antidepressant choice among VA patients treated for depression. METHODS Retrospective cohort study of VA patients with depression diagnoses and a new start of one of the seven most commonly prescribed antidepressant agents between 1 April 1999 and 30 September 2004 (n ¼ 502 179). We examined the relationship between patient and facility characteristics and new starts of bupropion, citalopram, fluoxetine, mirtazapine, paroxetine, sertraline, and venlafaxine. We also examined factors associated with new starts only among patients starting selective serotonin reuptake inhibitors (SSRIs). RESULTS Thirty-three percent of patients starting mirtazapine had at least three outpatient mental health visits in the prior year, compared to � 24% of patients prescribed other antidepressants. Patients starting mirtazapine were also most likely to have received at least two other psychotropic medications in the prior year. Of the four SSRIs, 40% of the patients receiving sertraline and only 31% of those receiving fluoxetine were 65 years or older. A comorbid anxiety disorder (other than post-traumatic stress disorder) was diagnosed in 21% of paroxetine patients compared with � 15% of other SSRI patients. CONCLUSION Choice of antidepressant medication for depressed VA patients was associated with important differences in demographic and clinical variables, including psychiatric illness severity, older age, and likelihood of a comorbid anxiety disorder. These findings emphasize the importance of controlling for selection bias when using observational data to compare risks from or effect of mental health treatments. Copyright # 2010 John Wiley & Sons, Ltd.

5011Background: The purpose of this randomized trial was to compare a personally-tailored symptom management intervention consisting of 4 automated telephone assessments and tailored education for ...