An independent comparison of the Novolytix salivary melatonin radioimmunoassay with the new Novolytix salivary melatonin enzyme-linked immunosorbent assay.

The dim light melatonin onset (DLMO) is the current gold standard biomarker of the timing of the central circadian clock in humans and is often assessed from saliva samples. To date, only one commercially available salivary melatonin assay is considered accurate at the low daytime levels required to accurately detect the DLMO (Novolytix RIA RK-DSM2). The aim of this study was to conduct the first independent evaluation of a newly improved enzyme-linked immunosorbent assay (ELISA; Novolytix MLTN-96) and compare it with the recommended radioimmunoassay (RIA)-both in terms of melatonin concentrations and derived DLMOs. Twenty participants (15 females, 18-59 years old) provided saliva samples every 30 min in dim light starting 6 h before their habitual bedtime, yielding a total of 260 saliva samples. Both the RIA and ELISA yielded daytime melatonin concentrations <2 pg/mL, indicating adequate accuracy to detect the DLMO. The melatonin concentrations from the two assays were highly correlated (r = .94, p < .001), although the RIA yielded lower levels of melatonin concentration than the ELISA, on average by 0.70 pg/mL (p = .006). Seventeen DLMOs were calculated from the melatonin profiles and the DLMOs from both assays were not statistically different (p = .36) and were highly correlated (r = .97, p < .001). Two DLMOs derived from the RIA occurred more than 30 min earlier than the DLMO derived from the ELISA. These results indicate that the new Novolytix ELISA is an appropriate assay to use if the Novolytix RIA is not feasible or available.

Comparing Nipple-sparing Mastectomy to Secondary Nipple Reconstruction: A Multi-institutional Study.

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.

Arrhythmia exacerbation after post-infarction ventricular tachycardia ablation: prevalence and prognostic significance.

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.

Hospital Variations in Clinical Complications and Patient-reported Outcomes at 2 Years After Immediate Breast Reconstruction.

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.

Microbial metabolites, short-chain fatty acids, restrain tissue bacterial load, chronic inflammation, and associated cancer in the colon of mice.

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

Complications in Postmastectomy Breast Reconstruction: One-year Outcomes of the Mastectomy Reconstruction Outcomes Consortium (MROC) Study.

OBJECTIVE: 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. SUMMARY OF BACKGROUND DATA: 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. METHODS: 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. RESULTS: 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, P < 0.001) 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. CONCLUSION: 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.

The loss of a fellow service member: Complicated grief in post-9/11 service members and veterans with combat-related posttraumatic stress disorder.

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.

Nonresponse bias in survey research: lessons from a prospective study of breast reconstruction.

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.

With a little help from my friends?: racial and gender differences in the role of social support in later-life depression medication adherence.

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.

Understanding and Optimizing the Patient Experience in Breast Reconstruction.

BACKGROUND: Optimizing the patient experience is a central pillar in healthcare quality. Although this may be recognized as important in breast reconstruction, surgeons are often unaware of how well they and members of their team achieve this goal. The objective of our study was to evaluate patient satisfaction with the experience of care in a multicenter, prospective cohort of patients undergoing breast reconstruction. Specifically, we sought to determine which aspects of the care experience might be most amenable to quality improvement. METHODS: As part of the Mastectomy Reconstruction Outcomes Consortium Study, 2093 patients were recruited from 11 centers in North America. Of these, 1534 (73.3%) completed the BREAST-Q Satisfaction with Care scales (satisfaction with information, surgeon, medical team, and office staff) at 3 months after reconstruction and were included in the analysis. RESULTS: Patients scored lowest on 'Satisfaction with Information' (mean = 72.8) compared to all other Satisfaction with Care scales (mean, 89.5-95.5). Patients with immediate reconstruction were less satisfied with their plastic surgeon compared to those with delayed reconstruction. The racial category, "Other" (Asians, Pacific Islanders, Hawaiians, American Indians), was the least satisfied group across all Satisfaction with Care scales. CONCLUSIONS: Patients undergoing breast reconstruction perceive significant gaps in their knowledge and understanding of expected outcomes. Immediate reconstruction patients and minority racial groups may require additional resources and attention. As a means to improve quality of care, these findings highlight an important unmet need and suggest that improving patient education may be central to providing patient-centered care.

The Association Between Benzodiazepine Use and Depression Outcomes in Older Veterans.

Benzodiazepines (BZDs) are commonly prescribed to older adults with depression, but it is unknown whether they improve antidepressant (AD) adherence or depressive symptoms. We followed 297 older veterans diagnosed with depression and provided a new AD medication prospectively for 4 months. Data include validated self-report measures and VA pharmacy records. At initial assessment, 20.5% of participants were prescribed a BZD. Those with a BZD prescription at baseline were significantly more likely than those without to have a personality disorder, schizophrenia spectrum disorder, or other anxiety disorder, and higher depressive symptom and anxiety symptom scale scores on average. In adjusted regressions, BZD use was not significantly associated with AD adherence, any improvement in depressive symptoms, or a 50% reduction in depressive symptoms. Our results suggest BZD use concurrent with AD treatment does not significantly improve depressive outcomes in older veterans.

Long-Term Clinical Outcomes from a Randomized Controlled Trial of Two Implementation Strategies to Promote Collaborative Care Attendance in Community Practices.

This randomized controlled implementation study compared the effectiveness of a standard versus enhanced version of the replicating effective programs (REP) implementation strategy to improve the uptake of the life goals-collaborative care model (LG-CC) for bipolar disorder. Seven community-based practices (384 patient participants) were randomized to standard (manual/training) or enhanced REP (customized manual/training/facilitation) to promote LG-CC implementation. Participants from enhanced REP sites had no significant changes in primary outcomes (improved quality of life, reduced functioning or mood symptoms) by 24 months. Further research is needed to determine whether implementation strategies can lead to sustained, improved participant outcomes in addition to program uptake.

Trends and predictors of quality of care in VA nursing homes related to serious mental illness.

OBJECTIVE: Within Veterans Affairs (VA) nursing homes (NHs), quality issues have a tremendous impact on the population with serious mental illness (SMI), who are more likely than their non-SMI Veteran counterparts to use NH services. We examined recent trends in quality indicators (QIs) measuring poor performance of VA NHs and whether the facility-level QIs vary with SMI concentration within the facility. METHODS: From VA administrative records including Minimum Data Set assessments, we identified all residents in the 135 VA NHs between fiscal years 2005 (FY05) through FY07. We used a zero-inflated Poisson regression to assess trends in and facility-level predictors of 3 process-related QIs: depression without antidepressant therapy; bladder/bowel incontinence without a toileting plan; and physical restraint use. Facility-level predictors included collocated special care units, rurality, staffing, physical plant characteristics, SMI prevalence, and SMI admission volume. RESULTS: During FY05-FY07, restraint use declined from 1.2% to 1.1% and incontinence without a toileting plan from 25.8% to 22.1%, but untreated depression increased from 5.1% to 5.5%. Despite overall gains in quality, higher SMI prevalence was associated with higher odds of physical restraint use and lack of toileting plan. Higher SMI prevalence was also associated with higher frequency of untreated depression. Other characteristics such as complex building structure were predictive of variation in quality, but the relationships were not consistent across QI types. CONCLUSION: VA NHs had significant improvements in these examined QIs during the study period. Nonetheless, overall poorer quality was observed at sites with higher SMI concentrations.

DNA Methylation Is a Potential Biomarker for Cardiometabolic Health in Mexican Children and Adolescents.

DNA methylation (DNAm) is a plausible mechanism underlying cardiometabolic abnormalities, but evidence is limited among youth. This analysis included 410 offspring of the Early Life Exposure in Mexico to Environmental Toxicants (ELEMENT) birth cohort followed up to two time points in late childhood/adolescence. At Time 1, DNAm was quantified in blood leukocytes at long interspersed nuclear elements (LINE-1), H19, and 11ß-hydroxysteroid dehydrogenase type 2 (11ß-HSD-2), and at Time 2 in peroxisome proliferator-activated receptor alpha (PPAR-α). At each time point, cardiometabolic risk factors were assessed including lipid profiles, glucose, blood pressure, and anthropometry. Linear mixed effects models were used for LINE-1, H19, and 11ß-HSD-2 to account for the repeated-measure outcomes. Linear regression models were conducted for the cross-sectional association between PPAR-α with the outcomes. DNAm at LINE-1 was associated with log glucose at site 1 [ß = -0.029, p = 0.0006] and with log high-density lipoprotein cholesterol at site 3 [ß = 0.063, p = 0.0072]. 11ß-HSD-2 DNAm at site 4 was associated with log glucose (ß = -0.018, p = 0.0018). DNAm at LINE-1 and 11ß-HSD-2 was associated with few cardiometabolic risk factors among youth in a locus-specific manner. These findings underscore the potential for epigenetic biomarkers to increase our understanding of cardiometabolic risk earlier in life.

A nationally representative sample of veteran and matched non-veteran college students: Mental health symptoms, suicidal ideation, and mental health treatment.

Objective To assess mental health symptoms, suicidal ideation/behaviors, and treatment among a nationally representative probability sample of student veterans. Participants: Student veterans enrolled in post-secondary educational institutions and matched comparison students. Methods: Sampled participants completed an online survey (n = 1,838). Analyses accounted for the complex sample design and non-response. Results: Substantial percentages of student veterans screened positive for: depression (36.9%, 95% CI: 31.1-42.7), PTSD (35.7%, 95% CI 29.9-41.5), anxiety (29.5%, 95% CI 26.8-32.2), and suicidal ideation (14.6%, 95% CI 12.1-17.1), with student veterans having odds ratios between 1.7 to 2.4 for positive screens compared to non-veteran students. Only 41.5% (95% CI 33.0-50.0) of student veterans with positive screens received treatment, although they had 50% higher odds of receiving treatment than non-veteran students. Conclusions: Student veterans have high rates of mental health symptoms and low rates of treatment. However, they are more likely to receive treatment than comparison students.

Association of Clinical Complications of Chemotherapy and Patient-Reported Outcomes After Immediate Breast Reconstruction.

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 < .001), and patients with chemotherapy were more likely to have received radiotherapy (108 of 200 [54.0%] for neoadjuvant chemotherapy and 321 of 668 [48.1%] for adjuvant chemotherapy; P < .001). Among the cohort undergoing implant-based reconstruction, the rates of any complication were significantly different, with higher rates seen for adjuvant (153 of 490 [31.2%]) and neoadjuvant (44 of 153 [28.8%]) chemotherapy compared with no chemotherapy (176 of 730 [24.1%]; P = .02). On multivariable analysis, these differences were not statistically significant. For autologous reconstruction, no significant differences in complications were observed. Controlling for clinical covariates, no significant differences were seen across chemotherapy groups for the BREAST-Q subscales except for sexual well-being in the implant cohort, in which adjuvant chemotherapy had significantly lower scores (ß, -4.97 [95% CI, -8.68 to -1.27]; P = .009). Conclusions and Relevance: In this cohort study, neither neoadjuvant nor adjuvant chemotherapy was associated with the likelihood of complications in patients undergoing implant-based or autologous reconstruction, and chemotherapy was not associated with patient satisfaction with reconstruction or psychosocial well-being. This information can help patients and clinicians make informed decisions about breast reconstruction in the setting of chemotherapy.

Development of an evidence-based approach to the use of acellular dermal matrix in immediate expander-implant-based breast reconstruction.

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.

Perceived versus Patient-Reported Significance of Surgeon Gender in Breast Reconstruction.

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.

Patient-Reported Outcomes after Irradiation of Tissue Expander versus Permanent Implant in Breast Reconstruction: A Multicenter Prospective Study.

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.