A Prospective Evaluation of the Quality of Life and Mental Health Implications of Mastectomy Alone on Women in sub-Saharan Africa.

OBJECTIVE: Assess quality of life and mental health implications of mastectomy for breast cancer on sub-Saharan African women. BACKGROUND: Mortality rates amongst women diagnosed with breast cancer in sub-Saharan Africa (SSA) are high, with disparities in survival relative to women in high income countries partly attributed to advanced disease at presentation. Fears of the sequelae of mastectomy are a prominent reason for presentation delays. There is a critical need to better understand the effects of mastectomy on women in SSA to inform preoperative counseling and education for women with breast cancer. METHODS: Women with breast cancer in Ghana and Ethiopia undergoing mastectomy were followed prospectively. Breast related quality-of-life and mental health measures were evaluated preoperatively, 3 and 6 months postoperatively, using BREAST-Q, PHQ-9, and GAD-7. Bivariate and logistic regression analyses evaluated changes in these measures for the total cohort and between sites. RESULTS: A total of 133 women from Ghana and Ethiopia were recruited. The majority of women presented with unilateral disease (99%) and underwent unilateral mastectomy (98%) with axillary lymph node dissection. Radiation was more common in Ghana ( P <0.001). Across most BREAST-Q subscales, women from both countries reported significantly decreased scores at 3 months postoperative. At 6 months, the combined cohort reported decreased scores for breast satisfaction (mean difference, -3.4). Women in both countries reported similar improvements in anxiety and depression scores postoperatively. CONCLUSIONS: Women from Ghana and Ethiopia who underwent mastectomy experienced a decline in breast-related body image while also experiencing decreased levels of depression and anxiety.

Gender Affirming Mastectomy Improves Quality of Life in Transmasculine Patients: A Single-center Prospective Study.

OBJECTIVE: To determine the impact of gender-affirming mastectomy on depression, anxiety, and body image. BACKGROUND: There are many cross-sectional and ad-hoc studies demonstrating the benefits of gender-affirming surgery. There are few prospective investigations of patient-reported outcomes in gender-affirming surgery using validated instruments. METHODS: In this prospective study, patients presenting to the University of Michigan for gender-affirming Mastectomy were surveyed preoperatively and 6-months postoperatively. Primary outcomes were patient-reported measurements of anxiety measured by General Anxiety Disorder-7, depression measured by Patient Health Questionnaire-9, body image measured by BODY-Q and Body Image Quality of Life Index, psychosocial and sexual functioning measured by BREAST-Q, and satisfaction with decision measured by BREAST-Q. Linear regression analysis was used to control for presence of complication and existing history of mental health conditions. RESULTS: A total of 70 patients completed the study. The average age of participants was 26.7. The mean Patient Health Questionnaire-9 score pre-operatively was 7.8 and postoperatively was 5.4 ( P =0.001). The mean preoperative and postoperative General Anxiety Disorder-7 scores were 7.6 and 4.6, respectively ( P <0.001). There were significant improvements in both psychosocial (35 to 79.2, P <0.001) and sexual (33.9 to 67.2, P< 0.001) functioning related to chest appearance as measured by the BREAST-Q and global psychosocial functioning (-15.6 to +32, P <0.001) as measured by the Body Image Quality of Life Index. Satisfaction with chest contour (14.3 to 93.8, P <0.001) and nipple appearance (29.3 to 85.9, P <0.001) measured by the BODY-Q significantly improved. Patients had a mean satisfaction with outcome score of 93.1. CONCLUSIONS: Patients undergoing gender-affirming mastectomy in this single-center prospective study reported significant improvements in anxiety, depression, body image, psychosocial, and sexual functioning after this procedure. Patients were extremely satisfied with the decision to undergo this operation.

BMI is Not Associated with Chest-Specific Body Image, Complications or Revisions in Gender-Affirming Mastectomy: A Single-Center Cross-Sectional Study.

OBJECTIVE: To analyze the impact of Body Mass Index (BMI) on clinical and patient-reported outcomes following gender-affirming mastectomy (GM). BACKGROUND: BMI is a barrier for obese patients seeking GM despite increasing evidence that it is safe in this population. Currently little is known about the impact of BMI on chest-specific body image and satisfaction following GM. METHODS: This single-center, cross-sectional study included individuals 18 years and older who underwent GM between 1990-2020 and were at least 2 years post-operative. Patient-reported chest-specific body image was measured using the BODY-Q and Gender Congruence and Life Satisfaction (GCLS) chest subscales. Satisfaction was measured using the Holmes-Rovner Satisfaction with Decision (SWD) scale. Clinical and demographic variables were identified from chart review. Bivariate analysis was performed to determine if BMI was associated with chest-specific body image, satisfaction, complications within 30 days or revisions in GM. RESULTS: Two hundred twenty-seven individuals meeting eligibility criteria were contacted to participate and one hundred thirty-seven responded (60.4% response rate). The mean age was 29.1 (SD=9.0) and mean BMI was 30.9 (SD=8.0), with 26.4% (N=60) of the cohort having a BMI>35. Chest-specific body image, and satisfaction with decision did not vary by BMI or breast resection weight. Complications and revisions were not associated with BMI. CONCLUSION: Individuals undergoing GM reported high rates of satisfaction following GM regardless of BMI. Complication and revision rates did not vary significantly by BMI or breast resection weight. Surgeons should re-evaluate the role BMI plays in patient selection and counseling for GM.

Ultrasound appearance of regenerative peripheral nerve interface with clinical correlation.

OBJECTIVE: To describe the ultrasound (US) appearance of regenerative peripheral nerve interfaces (RPNIs) in humans, and correlate clinically and with histologic findings from rat RPNI. MATERIALS AND METHODS: Patients (≥ 18 years) who had undergone RPNI surgery within our institution between the dates of 3/2018 and 9/2019 were reviewed. A total of 21 patients (15 male, 6 female, age 21-82 years) with technically adequate US studies of RPNIs were reviewed. Clinical notes were reviewed for the presence of persistent pain after RPNI surgery. Histologic specimens of RPNIs in a rat model from prior studies were compared with the US findings noted in this study. RESULTS: There was a variable appearance to the RPNIs including focal changes involving the distal nerve, nerve-muscle graft junction, and area of the distal sutures. The muscle grafts varied in thickness with accompanying variable echogenic changes. No interval change was noted on follow-up US studies. Diffuse hypoechoic swelling with loss of the fascicular structure of the nerve within the RPNI and focal hypoechoic changes at the nerve-muscle graft junction were associated with clinical outcomes. US findings corresponded to histologic findings in the rat RPNI. CONCLUSION: Ultrasound imaging can demonstrate various morphologic changes involving the nerve, muscle, and interface between these two biological components of RPNIs. These changes correspond to expected degenerative and regenerative processes following nerve resection and muscle reinnervation and should not be misconstrued as pathologic in all cases. N5 and N1 morphologic type changes of the RPNI were found to be associated with symptoms.

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.

The Global Macroeconomic Burden of Breast Cancer: Implications for Oncologic Surgery.

OBJECTIVE: In this study, we quantified the global macroeconomic burden of breast cancer to underscore the critical importance of improving access to oncologic surgical care internationally. SUMMARY BACKGROUND DATA: Breast cancer mortality in many low and middle-income countries (LMICs) is dramatically higher than in high-income countries. Prior to identifying solutions, however, it is important to first define the burden of disease. METHODS: Data from the Institute of Health Metrics and Evaluation (2005-2015) were used to assess epidemiologic trends for 194, middle, and low-income countries. Economic burden defined by Welfare Loss (WL) was calculated by measuring disability-adjusted-life-years lost to breast cancer alongside the dollar equivalent of a value of statistical life year and as a function of each country's gross domestic product (GDP). RESULTS: Annual mortality rates among breast cancer patients were significantly greater in LMICs in South Asia (3.06 per 100 women) and Sub-Saharan Africa (2.76 per 100 women), compared with high-income countries like the United States (1.69 per 100 women). From 2005-2015, mortality in South Asia increased by 8.20% and decreased by 6.45% in Sub-Saharan Africa; mortality rates in 2015 were observed as 27.9 per 100,000 in South Asia and 18.61 per 100,000 in Sub-Saharan Africa. Countries in South Asia demonstrated the greatest rise in WL due to breast cancer, from 0.05% to 0.08% of GDP. CONCLUSIONS: The burden of disease and economic impact of breast cancer is intensifying in LMICs. Global efforts to improve access to surgical care for women with breast cancer could reduce mortality and mitigate the social and financial impact of this disease in LMICs.

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.

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.

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.

Tradeoffs Associated With Contralateral Prophylactic Mastectomy in Women Choosing Breast Reconstruction: Results of a Prospective Multicenter Cohort.

OBJECTIVE: Assess postoperative morbidity and patient-reported outcomes after unilateral and bilateral breast reconstruction in patients with unilateral breast cancer. BACKGROUND: Relatively little is known about the morbidity associated with and changes in quality of life experienced by patients who undergo contralateral prophylactic mastectomy (CPM) and breast reconstruction. This information would be valuable for decision making in patients with unilateral breast cancer. METHODS: Women undergoing mastectomy and breast reconstruction for unilateral breast cancer were recruited for this prospective observational study. Postoperative complications after implant and autologous breast reconstruction in patients undergoing unilateral or bilateral mastectomy were recorded. Preoperative and 1 year patient-reported outcomes were measured. Univariate tests and logistic regression analyses were performed, studying the effects of reconstructive method, laterality, and risk factors on surgical complication rates, patient satisfaction, and anxiety. RESULTS: We identified 1144 women who underwent either unilateral (47.2%) or bilateral (52.8%) mastectomies with reconstruction. Bilateral autologous (odds ratio 1.73, 95% confidence interval 1.07-2.81) and implant reconstructions (odds ratio 1.73, 95% confidence interval 1.22-2.47) were associated with a higher risk of complications compared with unilateral reconstructions. Baseline anxiety was greater in women who chose bilateral compared with unilateral implant reconstructions (P = 0.001). There was no difference in anxiety levels between groups postoperatively. Postoperatively, women who chose CPM with implant reconstructions were more satisfied with their breasts than women with unilateral reconstructions (P = 0.034). CONCLUSIONS: Although higher postoperative complications were observed after CPM and reconstruction, these procedures were associated with decreased anxiety levels and improved satisfaction with breasts for women who underwent implant reconstructions.

Impact of Bilateral Prophylactic Mastectomy and Immediate Reconstruction on Health-Related Quality of Life in Women at High Risk for Breast Carcinoma: Results of the Mastectomy Reconstruction Outcomes Consortium Study.

BACKGROUND: 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. METHODS: 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. RESULTS: Satisfaction with breasts and psychosocial well-being were significantly higher at both 1 and 2 years (p < 0.01); however, anxiety was significantly lower at 1 or 2 years (p < 0.01) and physical well-being of the chest and upper body was significantly worse at 1 year (p < 0.01). CONCLUSION: Our results highlight the impact of BPM and immediate reconstruction on health-related quality-of-life outcomes in this setting. BPM and reconstruction can result in significant, positive, lasting changes in a woman's satisfaction with her breasts, as well as her psychosocial well-being. Furthermore, presurgery anxiety was significantly reduced by 1 year post-reconstruction and remained reduced at 2 years. With this knowledge, women at high risk for breast carcinoma, and their providers, will be better equipped to make the best individualized treatment decisions.

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.

Physical well-being recovery trajectories by reconstruction modality in women undergoing mastectomy and breast reconstruction: Significant predictors and health-related quality of life outcomes.

OBJECTIVES: We sought to identify trajectories of patient-reported outcomes, specifically physical well-being of the chest (PWBC), in patients who underwent postmastectomy breast reconstruction, and further assessed its significant predictors, and its relationship with health-related quality of life (HRQOL). METHODS: We used data collected as part of the Mastectomy Reconstruction Outcomes Consortium study within a 2-year follow-up in 2012-2017, with 1422, 1218,1199, and 1417 repeated measures at assessment timepoints of 0,3,12, and 24 months, respectively. We performed latent class growth analysis (LCGA) in the implant group (IMPG) and autologous group (AUTOG) to identify longitudinal change trajectories, and then assessed its significant predictors, and its relationship with HRQOL by conducting multinomial logistic regression. RESULTS: Of the included 1424 patients, 843 were in IMPG, and 581 were in AUTOG. Both groups experienced reduced PWBC at follow-up. LCGA identified four distinct PWBC trajectories (χ2 = 1019.91, p<0.001): low vs medium high vs medium low vs high baseline PWBC that was restored vs. not-restored after 2 years. In 76.63%(n = 646) of patients in IMPG and 62.99% (n = 366) in AUTOG, PWBC was restored after two years. Patients in IMPG exhibited worse PWBC at 3 months post-surgery than that in AUTOG. Patients with low baseline PWBC that did not improve at 2-year follow up (n = 28, 4.82% for AUTOG) were characterized by radiation following reconstruction and non-white ethnicity. In IMPG, patients with medium low-restored trajectory were more likely to experience improved breast satisfaction, while patients developing high-restored trajectories were less likely to have worsened psychosocial well-being. CONCLUSION: Although more women in IMPG experienced restored PWBC after 2 years, those in AUTOG exhibited a more favorable postoperative trajectory of change in PWBC. This finding can inform clinical treatment decisions, help manage patient expectations for recovery, and develop rehabilitation interventions contributing to enhancing the postoperative quality of life for breast cancer patients.

Outcomes of breast reconstruction in patients with stage IV breast cancer.

BACKGROUND: Patients with Stage IV breast cancer are living longer but breast reconstruction in this setting remains controversial. There is limited research evaluating the benefits of breast reconstruction in this patient cohort. STUDY DESIGN: Drawing from the Mastectomy Reconstruction Outcomes Consortium (MROC) dataset, a prospective cohort study that involved 11 leading medical centers in the US and Canada, we compared patient-reported outcomes (PROs) assessed utilizing the BREAST-Q, a condition-specific, validated patient-reported outcome measure (PROM) for mastectomy reconstruction, as well as complications between a cohort of patients with Stage IV disease undergoing reconstruction and a control group of women with Stage I-III disease also receiving reconstruction. RESULTS: Among the MROC population, 26 patients with Stage IV and 2613 women with Stage I-III breast cancer underwent breast reconstruction. Preoperatively, the Stage IV cohort reported significantly lower baseline scores for satisfaction with breast (p = 0.004), psychosocial well-being (p = 0.043) and sexual well-being (p = 0.001), compared with Stage I-III women. Following breast reconstruction, Stage IV patients' mean PRO scores improved over baseline and were not significantly different from those of Stage I-III reconstruction patients. There were also no significant differences in overall/any (p = 0.782), major (p = 0.751) or minor complication (p = 0.787) rates between the two groups at two years following reconstruction. CONCLUSIONS: The findings in this study suggest that breast reconstruction offers significant quality-of-life benefits for women with advanced breast cancer with no increase in postoperative complications and thus may be a reasonable option in this clinical setting.

Long-Term Regret and Satisfaction With Decision Following Gender-Affirming Mastectomy.

Importance: There has been increasing legislative interest in regulating gender-affirming surgery, in part due to the concern about decisional regret. The regret rate following gender-affirming surgery is thought to be approximately 1%; however, previous studies relied heavily on ad hoc instruments. Objective: To evaluate long-term decisional regret and satisfaction with decision using validated instruments following gender-affirming mastectomy. Design, Setting, and Participants: For this cross-sectional study, a survey of patient-reported outcomes was sent between February 1 and July 31, 2022, to patients who had undergone gender-affirming mastectomy at a US tertiary referral center between January 1, 1990, and February 29, 2020. Exposure: Decisional regret and satisfaction with decision to undergo gender-affirming mastectomy. Main Outcomes and Measures: Long-term patient-reported outcomes, including the Holmes-Rovner Satisfaction With Decision scale, the Decision Regret Scale, and demographic characteristics, were collected. Additional information was collected via medical record review. Descriptive statistics and univariable analysis using Fisher exact and Wilcoxon rank sum tests were performed to compare responders and nonresponders. Results: A total of 235 patients were deemed eligible for the study, and 139 responded (59.1% response rate). Median age at the time of surgery was 27.1 (IQR, 23.0-33.4) years for responders and 26.4 (IQR, 23.1-32.7) years for nonresponders. Nonresponders (n = 96) had a longer postoperative follow-up period than responders (median follow-up, 4.6 [IQR, 3.1-8.6] vs 3.6 [IQR, 2.7-5.3] years, respectively; P = .002). Nonresponders vs responders also had lower rates of depression (42 [44%] vs 94 [68%]; P < .001) and anxiety (42 [44%] vs 97 [70%]; P < .001). No responders or nonresponders requested or underwent a reversal procedure. The median Satisfaction With Decision Scale score was 5.0 (IQR, 5.0-5.0) on a 5-point scale, with higher scores noting higher satisfaction. The median Decision Regret Scale score was 0.0 (IQR, 0.0-0.0) on a 100-point scale, with lower scores noting lower levels of regret. A univariable regression analysis could not be performed to identify characteristics associated with low satisfaction with decision or high decisional regret due to the lack of variation in these responses. Conclusions and Relevance: In this cross-sectional survey study, the results of validated survey instruments indicated low rates of decisional regret and high levels of satisfaction with decision following gender-affirming mastectomy. The lack of dissatisfaction and regret impeded the ability to perform a more complex statistical analysis, highlighting the need for condition-specific instruments to assess decisional regret and satisfaction with decision following gender-affirming surgery.

Agreement between Patient-reported Pain Medication Use and Electronic Medical Record Data in Surgical Amputation Patients.

Background: Opioid misuse after surgery remains a public health crisis in the United States. Recent efforts have focused on tracking pain medication use in surgical populations. However, accurate interpretations of medication use remain quite challenging given inconsistent usage of different datasets. The purpose of this study was to investigate the agreement between electronic medical records (EMR) versus patient self-reported use of pain medications in a surgical amputation population. Methods: Patients undergoing major lower extremity amputation or amputation-related procedures were included in this study. Both self-reported and EMR data for pain medication intake were obtained for each patient at three time points (preoperatively, 4 months postoperatively, and 12 months postoperatively). Percentage agreement and the kappa statistic were calculated for both usage (yes/no) and dose categories. Results: Forty-five patients were included in this study, resulting in 108 pairs of self-reported and EMR datasets. Substantial levels of agreement (>70% agreement, kappa >0.61) for opioid use was seen at preoperative and 12 months postoperative. However, agreement dropped at 4 months postoperatively. Anticonvulsant medication showed high levels, whereas acetaminophen showed lower levels of agreements at all time points. Conclusions: Either self-reported or EMR data may be used in research and clinical settings for preoperative or 12-month postoperative patients with little concern for discrepancies. However, at time points immediately following the expected end of acute surgical pain, self-reported data may be needed for more accurate medication reporting. With these findings in mind, usage of datasets should be driven by study objectives and the dataset's strength (eg, accuracy, ease, lack of bias).

Effective Treatment of Chronic Mastectomy Pain with Intercostal Sensory Neurectomy.

SUMMARY: Chronic postmastectomy pain affects up to 40 percent of patients and leads to diminished quality of life and increased risk of opioid dependence. The cause of this pain is incompletely understood; however, one hypothesis is that direct injury to cutaneous intercostal nerves at the time of mastectomy and/or reconstruction leads to chronic pain. As a result, proximal neurectomy of the involved sensory nerve(s) has been suggested to be effective for these patients. The purpose of this study was to determine whether chronic pain in postmastectomy patients can be diagnosed reliably in an office setting and pain reduced by intercostal sensory neurectomy. The authors performed a retrospective review of seven patients with a history of breast surgery and chronic pain who underwent intercostal neurectomy combined with muscle or dermal wrapping of the proximal end of the resected nerve. All patients were diagnosed by history and physical examination, and suspected nerves were further identified with local anesthetic nerve blocks. An average of 3.14 neurectomies were performed per patient (range, one to six). There was a significant reduction in visual analogue scale pain scores following surgery, from 9 preoperatively to 1 postoperatively (p = 0.02). Eighty-six percent of patients were pain-free or "considerably improved" at their latest follow-up appointment (average, 6.14 months). It is concluded that intercostal sensory nerve injury at the time of mastectomy and/or reconstruction can lead to chronic mastectomy pain, which can be easily diagnosed and effectively treated with intercostal neurectomy. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

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.