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Although it is intuitive that nipple-sparing mastectomy in selected patients would result in excellent cosmetic outcomes and high patient satisfaction, studies of clinical outcomes and health-related quality of life are limited and show mixed results. This study aimed to use a propensity score-matching analysis to compare satisfaction and health-related quality-of-life outcomes in patients who underwent implant-based reconstruction following bilateral nipple-sparing mastectomy or skin-sparing mastectomy.A propensity score-matching analysis (1:1 matching, no replacement) was performed comparing patients undergoing nipple-sparing or skin-sparing mastectomy with immediate bilateral implant-based breast reconstruction. Patients with a history of any radiation therapy were excluded. Matched covariates included age, body mass index, race, smoking history, neoadjuvant chemotherapy, bra size, and history of psychiatric diagnosis. Outcomes of interest included BREAST-Q scores and complications.The authors examined 1371 patients for matching and included 460 patients (nipple-sparing mastectomy, n = 230; skin-sparing mastectomy, n = 230) in the final analyses. The authors found no significant differences in baseline, cancer, and surgical characteristics between matched nipple-sparing and skin-sparing mastectomy patients, who also had similar profiles for surgical complications. Interestingly, the authors found that postoperative Satisfaction with Breasts scores and all other health-related quality-of-life domains were stable over a 3-year period and did not differ significantly between the two groups.Compared with skin-sparing mastectomy, bilateral nipple-sparing mastectomy did not improve patient-reported or clinical outcomes when combined with immediate implant-based reconstruction. The impact that nipple-sparing mastectomy may have on breast aesthetics and the ability of the BREAST-Q to gauge an aesthetic result following nipple-sparing mastectomy warrant further investigation.Therapeutic, III.

Sensory recovery of the breast is a compelling frontier in comprehensive postmastectomy breast reconstruction. This study uses the BREAST-Q Sensation Module to evaluate the differences in women who underwent an alloplastic versus autologous breast reconstruction.Women with a history of breast cancer and postmastectomy breast reconstruction were recruited through the Love Research Army, United States. Participants completed the BREAST-Q Sensation Module, which consists of three scales: Breast Symptoms, Breast Sensation, and Quality of Life Impact. Descriptive statistics and multiple linear regression analyses were used to compare outcomes between women undergoing alloplastic or autologous breast reconstruction.Of 1204 respondents, 933 were included for analysis: 620 (66.5 percent) underwent alloplastic reconstruction and 313 (33.5 percent) underwent autologous reconstruction. The average age and body mass index were 59.2 ± 10.1 years and 26 ± 5 kg/m 2 , respectively. Autologous reconstruction patients scored an average of 6.1 points (95 percent CI, 3.9 to 8.4; p0.001) and 5.3 points (95 percent CI, 2.5 to 8.1; p = 0.001) higher on the Breast Symptoms and Quality of Life Impact scales, respectively. No difference (0.0 points, 95 percent CI, -2.9 to 3.0; p = 0.75) was observed for the Breast Sensation scale. Increased time since reconstruction had a positive impact on Breast Symptoms scale scores. Radiotherapy negatively affected scores on both Breast Symptoms and Quality of Life Impact scales.Autologous breast reconstruction may be associated with fewer abnormal breast sensations and better sensation-related quality of life in comparison to alloplastic reconstruction. This information can be incorporated during preoperative patient counseling when discussing reconstructive options.

Assessing expertise using psychometric models usually yields a measure of ability that is difficult to generalize to the complexity of diagnoses in clinical practice. However, using an item response modeling framework, it is possible to create a decision-aligned response model that captures a clinician's decision-making behavior on a continuous scale that fully represents competing diagnostic possibilities. In this proof-of-concept study, the authors demonstrate the necessary statistical conceptualization of this model using a specific electrocardiogram (ECG) example.The authors collected a range of ECGs with elevated ST segments due to either ST-elevation myocardial infarction (STEMI) or pericarditis. Based on pilot data, 20 ECGs were chosen to represent a continuum from "definitely STEMI" to "definitely pericarditis," including intermediate cases in which the diagnosis was intentionally unclear. Emergency medicine and cardiology physicians rated these ECGs on a 5-point scale ("definitely STEMI" to "definitely pericarditis"). The authors analyzed these ratings using a graded response model showing the degree to which each participant could separate the ECGs along the diagnostic continuum. The authors compared these metrics with the discharge diagnoses noted on chart review.Thirty-seven participants rated the ECGs. As desired, the ECGs represented a range of phenotypes, including cases where participants were uncertain in their diagnosis. The response model showed that participants varied both in their propensity to diagnose one condition over another and in where they placed the thresholds between the 5 diagnostic categories. The most capable participants were able to meaningfully use all categories, with precise thresholds between categories.The authors present a decision-aligned response model that demonstrates the confusability of a particular ECG and the skill with which a clinician can distinguish 2 diagnoses along a continuum of confusability. These results have broad implications for testing and for learning to manage uncertainty in diagnosis.

Data heterogeneity and methodologic errors hinder the ability to draw clinically meaningful conclusions from studies using the BREAST-Q Reconstruction Module patient-reported outcome measure. In this systematic review, the authors evaluate the quality of BREAST-Q Reconstruction Module administration in relation to the BREAST-Q version 2.0 user's guide and the reporting of key methodology characteristics. The authors also describe a framework for improving the quality of BREAST-Q data analysis and reporting.The authors conducted a systematic search of PubMed, Embase, Cochrane CENTRAL, and Ovid HAPI databases to identify articles on the BREAST-Q Reconstruction Module to assess postmastectomy breast reconstruction outcomes. The authors registered the protocol before study implementation on Open Science Framework ( https://osf.io/c5236 ) and adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Data on mode of BREAST-Q administration, time horizon justification, and sample size calculation were collected.The authors included 185 studies in the analysis. Errors in BREAST-Q administration were identified in 36 studies (19.5 percent). Appropriate administration of the BREAST-Q could not be determined in 63 studies (34.1 percent) because of insufficient reporting. Time horizon for the primary outcome was reported in 71 studies (38.4 percent), with only 17 (9.2 percent) reporting a sample size calculation.The authors identified important yet actionable shortcomings in the BREAST-Q literature. Researchers are encouraged to review the BREAST-Q user's guide in the study design phase to mitigate errors in patient-reported outcome measure administration and reporting for future trials using the BREAST-Q Reconstruction Module. Adhering to these guidelines will allow for greater clinical utility and generalizability of BREAST-Q research.

From smartphones or wearables to portable physiologic sensors and apps, healthcare is witnessing an exponential growth in mHealth-digital health tools used to support medical and surgical care, as well as public health. In surgery, there is interest in harnessing the capabilities of mHealth to improve the quality of patient-centered care delivery. Digitally delivered surveys have enhanced patient-reported outcome measurement and patient engagement throughout care. Wearable devices and sensors have allowed for the assessment of physical fitness before surgery and during recovery. Smartphone-based digital phenotyping has introduced novel methods of integrating multiple data streams (accelerometer, global positioning system, call and text logs) to create multidimensional digital health footprints for patients following surgery. Yet, with all the technological sophistication and 'big data' mHealth provides, widespread implementation has been elusive. Do clinicians and patients find these data valuable or clinically actionable? How can mHealth become integrated into the day-to-day workflows of surgical systems? Do these data represent opportunities to address disparities of care or worsen them? In this review, we discuss experiences and future opportunities to use mHealth to enhance patient-centered surgical care.

Radiation therapy is increasingly used after breast cancer surgery, which may impact patients' postoperative quality of life. This study assessed differences in long-term patient satisfaction and health-related quality of life after radiation therapy administered at different stages of implant-based breast reconstruction or with no radiation after surgery.In this observational study, long-term outcomes were evaluated for four cohorts of women who completed breast reconstruction and received (1) no radiation, (2) radiation before tissue expander placement, (3) radiation after tissue expander placement, or (4) radiation after permanent implant between 2010 and 2017 at Memorial Sloan Kettering. Satisfaction and health-related quality of life were assessed using the prospectively collected Satisfaction with Breasts and Physical Well-Being of Chest BREAST-Q subscales. Score distributions were examined by radiation exposure status for 3 years after surgery using nonparametric analyses and regression models.Of 2932 patients who met the inclusion criteria, 25.8 percent received radiation during breast cancer treatment, including before tissue expander placement ( n = 239; 8.2 percent), after tissue expander placement ( n = 290; 9.9 percent), and after implant placement ( n = 228; 7.8 percent). Radiotherapy patients had average scores 7 to 9 points lower at all postoperative time points for Satisfaction with Breasts and Physical Well-Being of Chest subscales ( p0.001). Although patient-reported outcomes did not differ by radiation timing, there were higher rates of severe capsular contracture with postimplant radiotherapy ( p0.001).Radiation therapy significantly affected patient satisfaction and health-related quality of life following implant breast reconstruction through 3 years postoperatively. Patient perception of outcome was unaffected by radiotherapy timing; however, capsular contracture was higher after postimplant radiotherapy, suggesting there may be an advantage to performing radiotherapy before placement of the final reconstruction.Therapeutic, III.

PURPOSE: Cancer impacts caregivers as well as patients. Ambulatory oncology surgeries requiring a short hospital stay place additional responsibility on informal caregivers as they help patients navigate their post-operative recovery at home, and determine if symptoms are expected or emergent. Our objective was to explore the experience of informal caregivers during patients’ ambulatory cancer surgery and then recovery at home with remote monitoring of symptoms via web-based patient-reported outcomes questionnaire (“Recovery Tracker”). METHODS: Semi-structured interviews were conducted with caregivers from a larger sample participating in a randomized trial of the Recovery Tracker. Thematic analysis was applied to derive key themes and codes via NVivo qualitative analysis software (QSR International Inc.). Recruitment was conducted iteratively to ensure a heterogenous sample and thematic saturation. RESULTS: Twenty-three semi-structured interviews were conducted. Four main themes emerged: 1) Predictability reduced stress among caregivers; 2) Unexpected events caused stress for caregivers; 3) The importance of a caregiver being present during the recovery process; 4) Caregiver involvement in remote monitoring of symptoms was minimal. CONCLUSION: Caregivers report not being overly burdened by the ambulatory surgery process, but they are very sensitive to any deviations from what they expected to happen. Further research and clinical practice on caregivers in the ambulatory setting should focus on how to set expectations and avoid unexpected events.

Natural killer (NK) cells are a promising alternative to T cells for cancer immunotherapy. Adoptive therapies with allogeneic, cytokine-activated NK cells are being investigated in clinical trials. However, the optimal cytokine support after adoptive transfer to promote NK cell expansion, and persistence remains unclear. Correlative studies from 2 independent clinical trial cohorts treated with major histocompatibility complex-haploidentical NK cell therapy for relapsed/refractory acute myeloid leukemia revealed that cytokine support by systemic interleukin-15 (IL-15; N-803) resulted in reduced clinical activity, compared with IL-2. We hypothesized that the mechanism responsible was IL-15/N-803 promoting recipient CD8 T-cell activation that in turn accelerated donor NK cell rejection. This idea was supported by increased proliferating CD8+ T-cell numbers in patients treated with IL-15/N-803, compared with IL-2. Moreover, mixed lymphocyte reactions showed that IL-15/N-803 enhanced responder CD8 T-cell activation and proliferation, compared with IL-2 alone. Additionally, IL-15/N-803 accelerated the ability of responding T cells to kill stimulator-derived memory-like NK cells, demonstrating that additional IL-15 can hasten donor NK cell elimination. Thus, systemic IL-15 used to support allogeneic cell therapy may paradoxically limit their therapeutic window of opportunity and clinical activity. This study indicates that stimulating patient CD8 T-cell allo-rejection responses may critically limit allogeneic cellular therapy supported with IL-15. This trial was registered at www.clinicaltrials.gov as #NCT03050216 and #NCT01898793.

Background: Systematic reviews have identified the need for a patient-reported outcome measure for facial nerve paralysis (FNP). The aim of this study was to determine the psychometric properties of FACE-Q Craniofacial module scales when used in a combined sample of children and older adults with FNP. Methods: Data were collected between December 2016 and December 2019. We conducted qualitative interviews with children and adults with FNP. FACE-Q data were collected from patients aged 8 years and older with FNP. Rasch measurement theory analysis was used to examine the reliability and validity of the relevant scales in the FNP sample. Results: Twenty-five patients provided 2052 qualitative codes related to appearance, physical, psychological, and social function. Many patient concerns were common across age. The field-test sample included 235 patients aged 8-81 years. Of the 13 scales examined, all 122 items had ordered thresholds and good item fit to the Rasch model. For 12 scales, person separation index values were ≥0.79 and Cronbach's alpha values were ≥0.82. The 13th scale's reliability values were ≥0.71. Conclusion: The FACE-Q Craniofacial module scales described in this study can be used to collect and compare evidence-based outcome data from children and adults with FNP.

Funder: Amgen, Funder: Roche, Funder: Universitätsspital Basel, Funder: Merck, Funder: AstraZeneca, Funder: Pfizer, AIM: Demand for nipple- and skin- sparing mastectomy (NSM/SSM) with immediate breast reconstruction (BR) has increased at the same time as indications for post-mastectomy radiation therapy (PMRT) have broadened. The aim of the Oncoplastic Breast Consortium initiative was to address relevant questions arising with this clinically challenging scenario. METHODS: A large global panel of oncologic, oncoplastic and reconstructive breast surgeons, patient advocates and radiation oncologists developed recommendations for clinical practice in an iterative process based on the principles of Delphi methodology. RESULTS: The panel agreed that surgical technique for NSM/SSM should not be formally modified when PMRT is planned with preference for autologous over implant-based BR due to lower risk of long-term complications and support for immediate and delayed-immediate reconstructive approaches. Nevertheless, it was strongly believed that PMRT is not an absolute contraindication for implant-based or other types of BR, but no specific recommendations regarding implant positioning, use of mesh or timing were made due to absence of high-quality evidence. The panel endorsed use of patient-reported outcomes in clinical practice. It was acknowledged that the shape and size of reconstructed breasts can hinder radiotherapy planning and attention to details of PMRT techniques is important in determining aesthetic outcomes after immediate BR. CONCLUSIONS: The panel endorsed the need for prospective, ideally randomised phase III studies and for surgical and radiation oncology teams to work together for determination of optimal sequencing and techniques for PMRT for each patient in the context of BR.

The discipline of Cardio-Oncology has seen tremendous growth over the past decade. It is devoted to the cardiovascular (CV) care of the cancer patient, especially to the mitigation and management of CV complications or toxicities of cancer therapies, which can have profound implications on prognosis. To that effect, many studies have assessed CV toxicities in patients undergoing various types of cancer therapies; however, direct comparisons have proven difficult due to lack of uniformity in CV toxicity endpoints. Similarly, in clinical practice, there can be substantial differences in the understanding of what constitutes CV toxicity, which can lead to significant variation in patient management and outcomes. This document addresses these issues and provides consensus definitions for the most commonly reported CV toxicities, including cardiomyopathy/heart failure and myocarditis, vascular toxicity, and hypertension, as well as arrhythmias and QTc prolongation. The current document reflects a harmonizing review of the current landscape in CV toxicities and the definitions used to define these. This consensus effort aims to provide a structure for definitions of CV toxicity in the clinic and for future research. It will be important to link the definitions outlined herein to outcomes in clinical practice and CV endpoints in clinical trials. It should facilitate communication across various disciplines to improve clinical outcomes for cancer patients with CV diseases.

Background Women undergoing cancer-related mastectomy and reconstruction are facing multiple treatment choices where post-surgical satisfaction with breasts is a key outcome. We developed and validated machine learning algorithms to predict patient-reported satisfaction with breasts at 2-year follow-up to better inform the decision-making process for women with breast cancer. Methods We trained, tested, and validated three machine learning algorithms (logistic regression (LR) with elastic net penalty, Extreme Gradient Boosting (XGBoost) tree, and neural network) to predict clinically important differences in satisfaction with breasts at 2-year follow-up using the validated BREAST-Q. We used data from 1553 women undergoing cancer-related mastectomy and reconstruction who were followed-up for two years at eleven study sites in North America from 2011 to 2016. 10-fold cross-validation was used to train and test the algorithms on data from 10 of the 11 sites which were further validated using the additional site's data. Area-under-the-receiver-operating-characteristics-curve (AUC) was the primary outcome measure. Results Of 1553 women, 702 (45.2%) experienced an improved satisfaction with breasts and 422 (27.2%) a decreased satisfaction. In the validation set (n = 221), the algorithms showed equally high performance to predict improved or decreased satisfaction with breasts (all P > 0.05): For improved satisfaction AUCs were 0.86–0.87 and for decreased satisfaction AUCs were 0.84–0.85. Conclusion Long-term, individual patient-reported outcomes for women undergoing mastectomy and breast reconstruction can be accurately predicted using machine learning algorithms. Our algorithms may be used to better inform clinical treatment decisions for these patients by providing accurate estimates of expected quality of life., Highlights • Optimal treatment for women undergoing mastectomy and reconstruction is unclear. • Can machine learning algorithms predict long-term patient-reported outcomes? • An international cohort of 1553 women was used for the algorithm development. • External validation showed good performance with AUCs of 0.84–0.87 • accurate estimates of expected quality of life may help inform treatment decisions.

BACKGROUND Gender equity remains to be realized in academic plastic and reconstructive surgery. The purpose of this study was to measure the proportion of women in leadership roles in academic plastic and reconstructive surgery to verify where gender gaps may persist. METHODS Six markers of leadership were analyzed: academic faculty rank, manuscript authorship, program directorship, journal editor-in-chief positions, society board of directors membership, and professional society membership. Descriptive statistics were performed, and chi-square tests were used to compare categorical variables. RESULTS About 16 percent to 19 percent of practicing plastic surgeons are female, as measured by the percentage of female faculty and American Society of Plastic Surgeons members. Female plastic surgeons comprised 18.9 percent (n = 178) of the faculty from 88 academic plastic surgery institutions, and represented 9.9 percent of full professors and 10.8 percent of chiefs. Nineteen institutions had no female faculty. Women were first authors in 23.4 percent of publications and senior author in 14.7 percent of publications. No journal studied had a female editor-in-chief. Of the examined plastic and reconstructive societies, the proportion of women on the board of directors ranged from 16.7 percent to 23.5 percent. CONCLUSIONS The proportion of female program directors, first manuscript authors, and board members of certain societies is commensurate with the number of women in the field, suggesting an evolving landscape within the specialty. However, women remain underrepresented in many other leadership roles, heralding the work that remains to ensure gender parity exists for those pursuing leadership roles in the field of plastic and reconstructive surgery.

Key Points Variation in initial systemic therapy for chronic graft-versus-host disease includes varied prednisone dose and use of nonsteroid agents.Prospective trials are needed to verify efficacy of reduced-dose prednisone or prednisone-free initial therapy approaches., Visual Abstract, Prior clinical trials largely considered prednisone 1 mg/kg per day with or without calcineurin inhibitor as standard initial therapy for chronic graft-versus-host disease (cGVHD), but uncertainty remains regarding the extent of practice variation and whether this affects subsequent outcomes. We assembled a cohort of 745 patients with cGVHD treated with initial systemic immune suppressive (IS) therapy from 3 prior cGVHD Consortium observational studies. Initial therapy was defined as first IS therapy started for cGVHD or prednisone increased to ≥0.4 mg/kg per day from lower doses within 30 days before cGVHD diagnosis to any time afterward. Initial therapies were nonprednisone IS therapies (n = 137, 18%), prednisone alone (n = 411, 55%), or prednisone plus other IS therapy (n = 197, 26%). In multivariate analysis, initial therapy group was not associated with failure-free survival (FFS; a composite of death, relapse, and new IS therapy), overall survival (OS), or nonrelapse mortality (NRM). Among the prednisone-based approaches, steroid dose was 1.25 mg/kg per day (13%). Prednisone dose within the patients treated with steroids was not significantly associated with FFS, OS, or NRM. No significant interactions were detected between overall cGVHD severity and either initial therapy group or prednisone dose for the outcomes of FFS, OS, or NRM. These observational data document heterogeneity in more contemporary cGVHD initial treatment practices, including prednisone dose and use of nonsteroid approaches. This variation was not associated with FFS, OS, or NRM. Prospective trials are needed to verify efficacy of reduced-dose prednisone or prednisone-free initial therapy approaches.

BACKGROUND: BREAST-Q, a patient-reported outcome measure for cosmetic and reconstructive breast surgery, is widely used in both clinical research and practice. The aim of this study was to acquire normative data of BREAST-Q's Breast-Conserving Therapy Module from a Dutch population sample and to compare it with existing normative BREAST-Q values. METHODS: Flyers with QR codes, WhatsApp, and one academic center's Facebook and LinkedIn platforms were used to direct participants to self-complete an online version of four domains of the preoperative BREAST-Q Breast-Conserving Therapy Module. BREAST-Q domain scores were log transformed to normalize the distribution. Univariable regression analyses were used to assess (nonlinear) associations between age and BREAST-Q domain scores. RESULTS: Overall, 9059 questionnaire responses were analyzed. Median (±SD) BREAST-Q domain scores were 64.0 ± 18.0 (satisfaction with breasts), 69.0 ± 21.0 (psychosocial well-being), 92.0 ± 20 (physical well-being), and 59.0 ± 15.0 (sexual well-being). Age as a linear term was associated with log-transformed satisfaction with breasts, psychosocial well-being, and physical well-being; sexual well-being was a quadratic function of age. Previous breast surgery unrelated to breast cancer was a significant predictor for higher log-transformed satisfaction with breasts (β = 0.04, p < 0.001) and higher sexual well-being score (β = -0.05, p < 0.001). Compared with previously published normative data, small differences were found in mean BREAST-Q domain scores (mean differences ranging between 2.45 and 6.24). CONCLUSIONS: Normative Dutch BREAST-Q scores follow similar patterns across domains in comparison with previously published normative data. Normative Dutch BREAST-Q data enable future comparisons in breast-related satisfaction and quality of life issues of Dutch patients with breast cancer compared with their age-matched peers.

The American Medical Association formed the Accelerating Change in Medical Education Consortium through grants to effect change in medical education. The dissemination of educational innovations through scholarship was a priority. The objective of this study was to explore the patterns of collaboration of educational innovation through the consortium’s publications. Publications were identified from grantee schools’ semi-annual reports. Each publication was coded for the number of citations, Altmetric score, domain of scholarship, and collaboration with other institutions. Social network analysis explored relationships at the midpoint and end of the grant. Over five years, the 32 Consortium institutions produced 168 publications, ranging from 38 papers from one institution to no manuscripts from another. The two most common domains focused on health system science (92 papers) and competency-based medical education (30 papers). Articles were published in 54 different journals. Forty percent of publications involved more than one institution. Social network analysis demonstrated rich publishing relationships within the Consortium members as well as beyond the Consortium schools. In addition, there was growth of the network connections and density over time. The Consortium fostered a scholarship network disseminating a broad range of educational innovations through publications of individual school projects and collaborations.

PURPOSE Standard cytotoxic induction chemotherapy for acute myeloid leukemia (AML) results in prolonged neutropenia and risk of infection. Romyelocel-L is a universal, allogeneic myeloid progenitor cell product being studied to reduce infection during induction chemotherapy. PATIENTS AND METHODS One hundred sixty-three patients with de novo AML (age ≥ 55 years) receiving induction chemotherapy were randomly assigned on day 0 (d0), of whom 120 were evaluable. Subjects received either romyelocel-L infusion on d9 with granulocyte colony-stimulating factor (G-CSF) starting daily d14 (treatment group) or G-CSF daily alone on d14 (control) until absolute neutrophil count recovery to 500/µL. End points included days in febrile episode, microbiologically defined infections, clinically diagnosed infection, and days in hospital. RESULTS Mean days in febrile episode was shorter in the treatment arm from d15 through d28 (2.36 v 3.90; P = .02). Similarly, a trend toward decreased microbiologically defined infections and clinically diagnosed infection in the treatment arm was observed from d9 to d28 (35.6% v 47.5%; P = .09), reaching a statistically significant difference from d15 to d28 (6.8% v 27.9%; P = .002). Because of this, antibacterial or antifungal use for treatment of an infection was significantly less in the treatment group (d9-d28: 44.1% v 63.9%; P = .01). Significantly fewer patients in the treatment arm received empiric antifungals from d9 tod28 (42.4% v 63.9%; P = .02) and d15-d28 (42.4% v 62.3%; P = .02). Patients in the treatment arm also had 3.2 fewer hospital days compared with control (25.5 v 28.7; P = .001). Remission rates and days to absolute neutrophil count recovery were similar in the two groups. No patients in the romyelocel-L plus G-CSF group died because of infection compared with two patients in the control arm. No graft-versus-host disease was observed. CONCLUSION Subjects receiving romyelocel-L showed a decreased incidence of infections, antimicrobial use, and hospitalization, suggesting that romyelocel-L may provide a new option to reduce infections in patients with AML undergoing induction therapy.

Background The association between textured surface breast implants and breast implant-associated anaplastic large cell lymphoma has led to an increase in surgical procedures to exchange textured devices to smooth surface implants. Because patient satisfaction is an integral part of breast reconstruction, the purpose of this study was to compare patient-reported outcomes between smooth and textured implant recipients. Methods Patients aged 18 years or older who underwent implant-based postmastectomy breast reconstruction with either smooth or textured devices from 2009 to 2017 and completed the BREAST-Q patient-reported outcome measure following reconstruction were included in this analysis. The primary outcomes of interest were mean and median BREAST-Q scores and postoperative complications. Results Overall, 1077 patients were included-785 who underwent breast reconstruction with smooth implants and 292 who underwent breast reconstruction with textured implants. No statistical differences were observed between the textured and smooth implant groups for any of the BREAST-Q domain scores at any of the early (3-month) to late (2-year) postoperative time points. Smooth implant recipients reported significantly more rippling (p = 0.003) than textured implant recipients. In contrast, textured implant recipients had a higher rate of cellulitis than smooth implant recipients (p = 0.016). Conclusions These data suggest that postoperative satisfaction with breasts or health-related quality of life following immediate postmastectomy implant-based breast reconstruction is likely independent of implant surface type. However, smooth breast implants may result in more rippling. The authors' findings represent an important aid in counseling patients who have questions about the risks and benefits of replacing their textured implants with smooth surface devices. Clinical question/level of evidence Therapeutic, III.

Summary Background The CLEFT-Q includes 12 independently functioning scales that measure appearance (face, nose, nostrils, teeth, lips, jaws), health-related quality of life (psychological, social, school, speech distress), and speech function, and an eating/drinking checklist. Previous qualitative research revealed that the CLEFT-Q has content validity in noncleft craniofacial conditions. This study aimed to examine the psychometric performance of the CLEFT-Q in an international sample of patients with a broad range of facial conditions. Methods Data were collected between October 2016 and December 2019 from 2132 patients aged 8 to 29 years with noncleft facial conditions. Rasch measurement theory (RMT) analysis was used to examine Differential Item Function (DIF) by comparing the original CLEFT-Q sample and the new FACE-Q craniofacial sample. Reliability and validity of the scales in a combined cleft and craniofacial sample (n=4743) were examined. Results DIF was found for 23 CLEFT-Q items when the datasets for the two samples were compared. When items with DIF were split by sample, correlations between the original and split person locations showed that DIF had negligible impact on scale scoring (correlations ≥0.995). In the combined sample, RMT analysis led to the retention of original content for ten CLEFT-Q scales, modification of the Teeth scale, and the addition of an Eating/Drinking scale. Data obtained fit with the Rasch model for 11 scales (exception School, p=0.04). Person Separation Index and Cronbach alpha values met the criteria. Conclusion The scales described in this study can be used to measure outcomes in children and young adults with cleft and noncleft craniofacial conditions.

Summary Background There is currently a lack of patient-reported outcome measures for ear reconstruction. We developed the EAR-Q to measure ear appearance and post-operative adverse effects from the patient perspective. Methods Field-test data were collected from children and young adults in eight countries between 13 May 2016 and 12 December 2019. Rasch measurement theory (RMT) analysis was used to refine the scales and to examine their psychometric properties. Results Participants had microtia (n = 607), prominent ears (n = 145) or another ear condition (n = 111), and provided 960 assessments for the Appearance scale (e.g., size, shape, photos), and 137 assessments for the Adverse Effects scale (e.g., itchy, painful, numb). RMT analysis led to the reduction of each scale to 10-items. Data fit the Rasch model for the Appearance (X2(80) = 90.9, p = 0.19) and Adverse Effects (X2(20) = 24.5, p = 0.22) scales. All items in each scale had ordered thresholds and good item fit. There was no evidence of differential item function for the Appearance scale by age, gender, language, or type of ear condition. Reliability was high for the Appearance scale, with person separation index (PSI) and Cronbach alpha values with and without extremes ≥0.92. Reliability for the Adverse Effects scale was adequate (i.e., PSI and Cronbach alpha values ≥0.71). Higher scores (liked appearance more) correlated with higher scores (better) on Psychological, Social and School scales. Interpretation The EAR-Q can be used in those 8–29 years of age to understand the patient perspective in clinical practice and research, and in addition, can be used to benchmark outcomes for ear reconstruction internationally.

Patient‐reported outcome measures (PROMs) for chronic wounds mainly focus on specific types of wounds. Our team developed the WOUND‐Q for use with all types of wounds in any anatomic location. We conducted 60 concept elicitation interviews with patients in Canada, Denmark, the Netherlands, and the United States. Analysis identified concepts of interest to patients and scales were formed and refined through cognitive interviews with 20 patients and input from 26 wound care experts. Scales were translated into Danish and Dutch. An international field‐test study collected data from 881 patients (1020 assessments) with chronic wounds. Rasch measurement theory (RMT) analysis was used to refine the scales and examine psychometric properties. RMT analysis supported the reliability and validity of 13 WOUND‐Q scales that measure wound characteristics (assessment, discharge, and smell), health‐related quality of life (life impact, psychological, sleep impact, and social), experience of care (information, home care nurses, medical team, and office staff), and wound treatment (dressing and suction device). The WOUND‐Q can be used to measure outcomes in research and clinical practice from the perspective of patients with any type of wound.

Background A multiphased mixed-methods study was performed to develop and validate a comprehensive patient-reported outcome measure (PROM) for arm lymphedema in women with breast cancer (i.e., the LYMPH-Q Upper Extremity Module). Methods Qualitative interviews (January 2017 and June 2018) were performed with 15 women to elicit concepts specific to arm lymphedema after breast cancer treatment. Data were audio-recorded, transcribed, and coded. Scales were refined through cognitive interviews (October and Decemeber 2018) with 16 patients and input from 12 clinical experts. The scales were field-tested (October 2019 and January 2020) with an international sample of 3222 women in the United States and Denmark. Rasch measurement theory (RMT) analysis was used to examine reliability and validity. Results The qualitative phase resulted in six independently functioning scales that measure arm symptoms, function, appearance, psychological function, and satisfaction with information and with arm sleeves. In the RMT analysis, all items in each scale had ordered thresholds and nonsignificant chi-square p values. For all the scales, the reliability statistics with and without extremes for the Person Separation Index were 0.80 or higher, Cronbach’s alpha was 0.89 or higher, and the Intraclass Correlation Coefficients were 0.92 or higher. Lower (worse) scores on the LYMPH-Q Upper Extremity scales were associated with reporting of more severe arm swelling, an arm problem caused by cancer and/or its treatment, and wearing of an arm sleeve in the past 12 months. Conclusions The LYMPH-Q Upper Extremity Module can be used to measure outcomes that matter to women with upper extremity lymphedema. This new PROM was designed using a modern psychometric approach and, as such, can be used in research and in clinical care.

Background Scar revisions have been increasing in number. Patient-reported outcome measures are one tool to aid scar modulation decision-making. The aims of this study were to determine patient, scar, and clinical risk factors for (1) low SCAR-Q Appearance, Symptom, and Psychosocial Impact scores and how this differs for children; and (2) the potential need for future scar revision surgery to better identify such patients in a clinical setting. Methods A multicenter international cross-sectional cohort study based on survey data of participants with traumatic, surgical, and burn scars attending plastic, hand, and burn clinics in four countries was conducted following the Strengthening the Reporting of Observational Studies in Epidemiology checklist. Univariate analysis to identify risk factors and multivariable logistic analysis to select risk factors were completed. Collinearity for nonindependent factors and C statistic for model discrimination were also calculated. Results Seven hundred thirty-one participants completed the study booklet, and 546 participants (74.7 percent) had full data. Independent risk factors were determined to be a bothersome scar and perception of scarring badly for all three scales. Risk factors for self-reporting the need for future surgery included a health condition, scarring badly, scar diagnosis, prior scar revision, and low Psychosocial Impact scores. We did not identify evidence of multicollinearity. C statistics were high (0.81 to 0.84). Conclusions This study is the first multicenter international study to examine independent risk factors for low patient-reported outcome measure scores and the potential need for future scar revision surgery. Patients that perceive themselves as scarring badly and having a bothersome scar were at a higher risk of scar appearance concern, an increased symptom burden, and poorer psychosocial impact scores. Clinical question/level of evidence Risk, III.

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To determine diagnoses and image features that are associated with difficult prepubescent female genital image interpretations.This was a mixed-methods study conducted at a tertiary care pediatric center using images from a previously developed education platform.Participants comprised 107 medical students, residents, fellows, and attendings who interpreted 158 cases to derive case difficulty estimates.This was a planned secondary analysis of participant performance data obtained from a prospective multi-center cross-sectional study. An expert panel also performed a descriptive review of images with the highest frequency of diagnostic error.We derived the proportion of participants who interpreted an image correctly, and features that were common in images with the most frequent diagnostic errors.We obtained 16,906 image interpretations. The mean proportion correct scores for each diagnosis were as follows: normal/normal variants 0.84 (95% confidence interval [CI] 0.82, 0.87); infectious/dermatology pathology 0.59 (95% CI 0.45, 0.73); anatomic pathology 0.61 (95% CI 0.41, 0.81); and, traumatic pathology 0.64 (95% CI 0.49, 0.79). The mean proportion correct scores varied by diagnosis (P .001). The descriptive review demonstrated that poor image quality, infant genitalia, normal variant anatomy, external material (eg, diaper cream) in the genital area, and nonspecific erythema were common features in images with lower accuracy scores.A quantitative and qualitative examination of prepubescent female genital examination image interpretations provided insight into diagnostic challenges for this complex examination. These data can be used to inform the design of teaching interventions to improve skill in this area.

Visual diagnosis of radiographs, histology and electrocardiograms lends itself to deliberate practice, facilitated by large online banks of cases. Which cases to supply to which learners in which order is still to be worked out, with there being considerable potential for adapting the learning. Advances in statistical modeling, based on an accumulating learning curve, offer methods for more effectively pairing learners with cases of known calibrations. Using demonstration radiograph and electrocardiogram datasets, the advantages of moving from traditional regression to multilevel methods for modeling growth in ability or performance are demonstrated, with a final step of integrating case-level item-response information based on diagnostic grouping. This produces more precise individual-level estimates that can eventually support learner adaptive case selection. The progressive increase in model sophistication is not simply statistical but rather brings the models into alignment with core learning principles including the importance of taking into account individual differences in baseline skill and learning rate as well as the differential interaction with cases of varying diagnosis and difficulty. The developed approach can thus give researchers and educators a better basis on which to anticipate learners' pathways and individually adapt their future learning.

Introduction Electrocardiogram interpretation is an essential skill for emergency and critical care nurses and physicians. There remains a gap in standardized curricula and evaluation strategies used to achieve and assess competence in electrocardiogram interpretation. The purpose of this study was to develop an importance ranking of the 120 American Heart Association electrocardiogram diagnostic labels with interdisciplinary perspectives to inform curriculum development. Methods Data for this mixed methods study were collected through focus groups and individual semi-structured interviews. A card sort was used to assign relative importance scores to all 120 American Heart Association electrocardiogram diagnostic labels. Thematic analysis was used for qualitative data on participants' rationale for the rankings. Results The 18 participants included 6 emergency and critical care registered nurses, 5 cardiologists, and 7 emergency medicine physicians. The 5 diagnoses chosen as the most important by all disciplines were ventricular tachycardia, ventricular fibrillation, atrial fibrillation, complete heart block, and normal electrocardiogram. The “top 20” diagnoses by each discipline were also reported. Qualitative thematic content analysis revealed that participants from all 3 disciplines identified skill in electrocardiogram interpretation as clinically imperative and acknowledged the importance of recognizing normal, life threatening, and time-sensitive electrocardiogram rhythms. Additional qualitative themes, identified by individual disciplines, were reported. Discussion This mixed-methods approach provided valuable interdisciplinary perspectives concerning electrocardiogram curriculum case selection and prioritization. Study findings can provide a foundation for emergency and critical care educators to create local ECG educational programs. Further work is recommended to validate the list amongst a larger population of emergency and critical care frontline nurses and physicians.

Background The Australian Breast Device Registry (ABDR) is a clinical quality registry which utilizes both surgical data and patient-reported outcome measures (PROMs) to understand device performance. The ABDR is the first national breast device registry utilizing the BREAST-Q Implant Surveillance module to conduct PROMs via text messaging as the primary method of contact for most patients. ABDR PROMs are structured upon a successful acceptability and feasibility study and a pilot study. Objectives This aim of this paper was to examine the challenges we faced and consider how lessons learned in implementing PROMs might inform future registry studies and interventions. Methods We tracked the number of completed follow-ups and documented feedback between October 2017 and December 2018 from various stakeholders, including sites, surgeons, and patients. Results In total, 10,617 patients were contacted: 59% of breast augmentation and 77% breast reconstruction patients responded to our PROMs survey. We encountered challenges and developed solutions to overcome several key issues, including database setup; follow-up contact methods; ethics; education of surgeons and patients; associated costs; and ongoing evaluation and modification. The strategies we devised to address these challenges included drawing on experiences from previous studies, greater communication with sites and surgeons, and having the flexibility to improve and modify our PROMs. Conclusions The ABDR PROMs experience and lessons learned can inform a growing number of registries seeking to conduct PROMs. We describe our approach, obstacles encountered, and strategies to increase patient participation. As more breast device registries worldwide adopt PROMs, data harmonization is crucial to better understand patient outcomes and device performance.

OBJECTIVE. To address the lack of validated patient-reported outcome (PRO) instruments that define and quantify patient expectations in thyroid cancer surgery, we developed and initially validated ThyroidEx, a novel disease-specific PRO instrument. STUDY DESIGN. Survey study. SETTING. Single-institution tertiary care cancer center. METHODS. An expert panel drafted an initial set of thyroid cancer–specific concepts, which was used in semistructured concept elicitation interviews with patients with thyroid cancer 4 weeks before and 8 weeks after surgery. Candidate items were generated per patient responses and refined via cognitive interviewing and additional review by the expert panel. The draft ThyroidEx was then preoperatively administered to a separate cohort undergoing thyroid cancer surgery to establish a final item set and initial psychometric evidence. RESULTS. Prospective concept elicitation interviews generated 358 patient-elicited concepts (n = 15 patients). These were then placed into 70 unique subcategories from which 41 items were generated for cognitive interviews with 20 patients preoperatively and 28 postoperatively. After expert panel review, ThyroidEx included 18 items across 2 scales (Expectations and Concerns), with an additional item about beliefs. In the preoperative cohort in phase 2 (n = 67), internal consistency Cronbach’s α values ranged from 0.81 to 0.89. Descriptive analysis showed significant differences between patients’ concerns and expectations and clinicians’ perceptions. CONCLUSION. Defining expectations represents an important modifier in the measurement of PROs. Preliminary validation of ThyroidEx revealed incongruent expectations between expert opinion and patients. Future development and implementation of ThyroidEx may affect preoperative consultation and the consent process.

Background Patient-reported outcome measures (PROMs) are increasingly employed in healthcare to assess outcomes. The BREAST-Q Implant Surveillance module (BREAST-Q IS) is a 5-question PROM utilized by the Australian Breast Device Registry to monitor the performance of breast devices. Validation of this tool is needed to assess its utility in this setting. Objectives The objective of this study was to assess the test-retest reliability of the BREAST-Q IS among breast implant recipients within a registry setting. Methods A test-retest reliability study was undertaken. Patients who underwent breast augmentation or breast reconstruction and registered with the Australian Breast Device Registry were eligible to participate. A total of 250 surveys were distributed. The BREAST-Q IS was administered to the same group of participants on 2 separate occasions with a 2-week test interval. Participants were divided into 2 groups: breast augmentation and breast reconstruction. A weighted kappa coefficient was calculated to assess the degree of test-retest reliability of the BREAST-Q IS. Results A total of 207 participants completed both tests. The response rate was 82% (n = 113) for the breast augmentation group and 94% (n = 94) for the breast reconstruction group. All 5 questions on the BREAST-Q IS obtained weighted kappa scores above 0.74 among both groups. Conclusions The BREAST-Q IS has good to excellent test-retest reliability for utilization among breast implant recipients in a registry setting. Further validation of the BREAST-Q IS will be required to establish the BREAST-Q IS as a valid and reliable PROM tool for breast implant recipients following breast device surgery.

Natural killer (NK) cells are an emerging cancer cellular therapy and potent mediators of antitumor immunity. Cytokine-induced memory-like (ML) NK cellular therapy is safe and induces remissions in patients with acute myeloid leukemia (AML). However, the dynamic changes in phenotype that occur after NK-cell transfer that affect patient outcomes remain unclear. Here, we report comprehensive multidimensional correlates from ML NK cell–treated patients with AML using mass cytometry. These data identify a unique in vivo differentiated ML NK–cell phenotype distinct from conventional NK cells. Moreover, the inhibitory receptor NKG2A is a dominant, transcriptionally induced checkpoint important for ML, but not conventional NK-cell responses to cancer. The frequency of CD8α+ donor NK cells is negatively associated with AML patient outcomes after ML NK therapy. Thus, elucidating the multidimensional dynamics of donor ML NK cells in vivo revealed critical factors important for clinical response, and new avenues to enhance NK-cell therapeutics. Significance: Mass cytometry reveals an in vivo memory-like NK-cell phenotype, where NKG2A is a dominant checkpoint, and CD8α is associated with treatment failure after ML NK–cell therapy. These findings identify multiple avenues for optimizing ML NK–cell immunotherapy for cancer and define mechanisms important for ML NK–cell function. This article is highlighted in the In This Issue feature, p. 1775

Increased understanding of the constellation of symptoms referred to as breast implant illness is necessary to better address patient concerns, provide evidence-based care, and inform prospective patients about potential risks. The aim of this study was to reach consensus on the symptoms most frequently associated with breast implant illness, which will subsequently inform the development of a symptom severity scale.A literature search of peer-reviewed and gray literature was performed to identify a comprehensive list of symptoms associated with breast implant illness. This was followed by an online, three-round, modified Delphi survey where the list of symptoms was reviewed by an international panel to determine the top 20, 10, and five symptoms associated with breast implant illness. A virtual meeting of panelists was held to reach consensus on the symptoms to be included in a symptom severity scale.A total of 44 symptoms were identified through the literature search. The modified Delphi survey panel consisted of patient research partners [n = 9 (34.6 percent)], plastic surgeons [n = 10 (38.5 percent)], researchers [n = 6 (23.1 percent)], and a member of the U.S. Food and Drug Administration [n = 1 (3.8 percent)]. The response rates of round 1, 2, and 3 were 85, 96, and 100 percent, respectively. Consensus was reached on the top 19 and top six symptoms to be included in long and short forms of a symptom severity scale.There was a high level of agreement on the symptoms to be included in a symptom severity scale. The next steps include conducting in-depth qualitative interviews with women with these symptoms and breast implants to understand the experience and impact of these symptoms and develop the preliminary scale.

Obesity is a global health issue known to have a major influence on health-related quality of life (HR-QOL). HR-QOL is a concept evaluating physical and psychological health. Work life can impact HR-QOL in people with obesity. The aim of this study was to measure the association between body mass index (BMI) and satisfaction with work life. This study included participants from an international multicenter field-test study of BODY-Q scales. Recruitment took place at hospitals in Denmark, The Netherlands and USA between June 2019 and January 2020. The BODY-Q Work Life scale was used to measure work life satisfaction. The difference between BMI groups and work life satisfaction was examined using one-way analysis of variance. Multivariable linear regression analysis was used to examine the association between BMI and work life satisfaction, adjusted for significant confounders. Of 4123 participants, 2515 completed the BODY-Q Work Life scale. BMI groups showed significant difference in work life satisfaction (p .0001). The Work Life scale mean score was 77.6 for the normal BMI group, 78.5 for the overweight group and 75.0, 68.9 and 63.8 for Class 1, 2 and 3 obesity, respectively. Furthermore, BMI was significantly associated with satisfaction with work life (adjusted regression coefficient -.962, p .0001). Higher BMI was associated with lower work life satisfaction. This finding suggests that a reduction in BMI may have a positive influence on work life satisfaction in people with obesity.

Using an education and assessment tool, we examined the number of cases necessary to achieve a performance benchmark in image interpretation of pediatric soft tissue, cardiac, lung, and focused assessment with sonography for trauma (FAST) point-of-care ultrasound (POCUS) applications. We also determined interpretation difficulty scores to derive which cases provided the greatest diagnostic challenges.Pediatric emergency physicians participated in web-based pediatric POCUS courses sponsored by their institution as a credentialing priority. Participants deliberately practiced cases until they achieved diagnostic interpretation scores of combined 90% accuracy, sensitivity, and specificity.Of the 463 who enrolled, 379 (81.9%) completed cases. The median (interquartile range) number of cases required to achieve the performance benchmark for soft tissue was 94 (68-128); cardiac, 128 (86-201); lung, 87 (25-118); and FAST, 93 (68-133) (P0001). Specifically, cases completed to achieve benchmark were higher for cardiac relative to other applications (P0.0001 for all comparisons). In soft tissue cases, a foreign body was more difficult to diagnose than cobblestoning and hypoechoic collections (P = 0.036). Poor cardiac function and abnormal ventricles were more difficult to interpret with accuracy than normal (P0.0001) or pericardial effusion cases (P = 0.01). The absence of lung sliding was significantly more difficult to interpret than normal lung cases (P = 0.028). The interpretation difficulty of various FAST imaging findings was not significantly different.There was a significant variation in number of cases required to reach a performance benchmark. We also identified the specific applications and imaging findings that demonstrated the greatest diagnostic challenges. These data may inform future credentialing guidelines and POCUS learning interventions.

Chronic myeloid leukemia (CML) is defined by the presence of Philadelphia chromosome (Ph) which results from a reciprocal translocation between chromosomes 9 and 22 [t(9;22] that gives rise to aBCR-ABL1fusion gene. CML occurs in 3 different phases (chronic, accelerated, and blast phase) and is usually diagnosed in the chronic phase. Tyrosine kinase inhibitor therapy is a highly effective first-line treatment option for all patients with newly diagnosed chronic phase CML. This manuscript discusses the recommendations outlined in the NCCN Guidelines for the diagnosis and management of patients with chronic phase CML.

New therapeutic approaches are needed to improve outcomes of patients with advanced chronic graft vs. host disease (GVHD). Pre-clinical and clinical data suggest proteasome inhibition may modulate GVHD. In a phase II, single-arm, multi-center trial conducted by the Chronic GVHD Consortium, we examined the efficacy of ixazomib in advanced chronic GVHD treatment. Ixazomib was given as a 4 mg oral dose weekly on days 1, 8, and 15 of a 28-day cycle for up to 6 total cycles. An amendment permitted additional cycles beyond 6 for those with responsive chronic GVHD. The primary endpoint was 6 month treatment failure, a composite endpoint including death, relapse, and requirement for an additional line of systemic immune suppressive (IS) therapy, compared with a historical 6 month treatment failure rate of 44% based on 312 patients treated with secondary therapy. Key eligibility criteria included age ≥ 18, NIH Consensus defined chronic GVHD, failure of at least one prior line of systemic IS therapy, and adequate hematologic parameters, hepatic, and renal function. A total of 50 subjects were enrolled at 6 institutions. Median age was 58 years. Median time from transplant to enrollment was 3.6 years (IQR 2.6-5.5), and from chronic GVHD onset to enrollment 2.8 years (IQR 1.5-4.3). Chronic GVHD was NIH moderate (16%) or severe (84%), predominantly classic (80% vs. overlap 20%), with 52% having 4 or more involved organs. Patients were heavily pretreated with 39 (78%) having 3 or more prior lines of systemic therapy for chronic GVHD. Of the 50 treated subjects, 26 completed all 6 months of planned therapy. Dose reductions most commonly occurred for thrombocytopenia, fatigue, diarrhea, and infection. SAEs occurred in 38% of subjects, and 5 deaths occurred in study participants (2 deemed possibly related to ixazomib). The 6 month treatment failure rate was significantly improved vs. the historical benchmark (28% vs. 44%, p=0.01), Figure 1. No patient, transplant, or chronic GVHD variables were significantly associated with 6 month treatment failure. NIH response rates at 3, 6, and 12 months are presented in Figure 2; the ORR was 34% (17/50) at 6 months. Overall survival at 6 and 12 months was 92% and 90%. No subjects completely discontinued IS by 12 months. Ixazomib met the primary endpoint of low treatment failure at 6 months in the setting of advanced chronic GVHD. At 6 months the ORR rate was 34% and 50% remained on ixazomib suggesting the low treatment failure rate was in part due to prevention of progressive disease that would have required additional treatment. Randomized studies are warranted.

Background Limb-threatening lower extremity traumatic injuries can be devastating events with a multifaceted impact on patients. Therefore, evaluating patient-reported outcomes (PROs) in addition to traditional surgical outcomes is important. However, currently available instruments are limited as they were not developed specific to lower extremity trauma patients and lack content validity. The LIMB-Q is being developed as a novel PRO instrument to meet this need, with the goal to measure all relevant concepts and issues impacting amputation and limb-salvage patients after limb-threatening lower extremity trauma. Methods This is a qualitative interview-based study evaluating content validity for the LIMB-Q. Patients aged 18 years and older who underwent amputation, reconstruction, or amputation after failed reconstruction were recruited using purposeful sampling to maximize variability of participant experiences. Expert opinion was solicited from a variety of clinical providers and qualitative researchers internationally. Preliminary items and scales were modified, added, or removed based on participant and expert feedback after each round of participant interviews and expert opinion. Results Twelve patients and 43 experts provided feedback in a total of three rounds, with changes to the preliminary instrument made between each round. One scale was dropped after round one, one scale was added after round two, and only minor changes were needed after round three. Modifications, additions and removal of items, instructions, and response options were made after each round using feedback gathered. Conclusion The LIMB-Q was refined and modified to reflect feedback from patients and experts in the field. Content validity for the LIMB-Q was established. Following a large-scale field test, the LIMB-Q will be ready for use in research and clinical care.

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

Background With the implementation of competency-based assessment systems, education programs are collecting increasing amounts of data about medical learners. However, learning analytics are rarely employed to use this data to improve medical education. Objective We identified outstanding issues that are limiting the effective adoption of learning analytics in medical education. Methods Participants at an international summit on learning analytics in medical education generated key questions that need to be addressed to move the field forward. Small groups formulated questions related to data stewardship, learner perspectives, and program perspectives. Three investigators conducted an inductive qualitative content analysis on the participant questions, coding the data by consensus and organizing it into themes. One investigator used the themes to formulate representative questions that were refined by the other investigators. Results Sixty-seven participants from 6 countries submitted 195 questions. From them, we identified 3 major themes: implementation challenges (related to changing current practices to collect data and utilize learning analytics); data (related to data collection, security, governance, access, and analysis); and outcomes (related to the use of learning analytics for assessing learners and faculty as well as evaluating programs and systems). We present the representative questions and their implications. Conclusions Our analysis highlights themes regarding implementation, data management, and outcomes related to the use of learning analytics in medical education. These results can be used as a framework to guide stakeholder education, research, and policy development that delineates the benefits and challenges of using learning analytics in medical education.

Objectives: Although comorbidities play an essential role in risk adjustment and outcomes measurement, there is little consensus regarding the best source of this data. The aim of this study was to identify general patient-reported morbidity instruments and their measurement properties. Methods: A systematic review was conducted using multiple electronic databases (Embase, Medline, Cochrane Central, and Web of Science) from inception to March 2018. Articles focusing primarily on the development or subsequent validation of a patient-reported morbidity instrument were included. After including relevant articles, the measurement properties of each morbidity instrument were extracted by 2 investigators for narrative synthesis. Results: A total of 1005 articles were screened, of which 34 eligible articles were ultimately included. The most widely assessed instruments were the Self-Reported Charlson Comorbidity Index (n = 7), the Self-Administered Comorbidity Questionnaire (n = 3), and the Disease Burden Morbidity Assessment (n = 3). The most commonly included conditions were diabetes, hypertension, and myocardial infarction. Studies demonstrated substantial variability in item-level reliability versus the gold standard medical record review (κ range 0.66-0.86), meaning that the accuracy of the self-reported comorbidity data is dependent on the selected morbidity. Conclusions: The Self-Reported Charlson Comorbidity Index and the Self-Administered Comorbidity Questionnaire were the most frequently cited instruments. Significant variability was observed in reliability per comorbid condition of patient-reported morbidity questionnaires. Further research is needed to determine whether patient-reported morbidity data should be used to bolster medical records data or serve as a stand-alone entity when risk adjusting observational outcomes data.

Nipple-sparing mastectomy (NSM) is being performed increasingly for risk reduction in high-risk groups. There are limited data regarding complications and oncological outcomes in women undergoing bilateral prophylactic NSM. This study reviewed institutional experience with prophylactic NSM, and examined the indications, rates of postoperative complications, incidence of occult malignant disease and subsequent breast cancer diagnosis.Women who had bilateral prophylactic NSM between 2000 and 2016 were identified from a prospectively maintained database. Rates of postoperative complications, incidental breast cancer, recurrence and overall survival were evaluated.A total of 192 women underwent 384 prophylactic NSMs. Indications included BRCA1 or BRCA2 mutations in 117 patients (60·9 per cent), family history of breast cancer in 35 (18·2 per cent), lobular carcinoma in situ in 29 (15·1 per cent) and other reasons in 11 (5·7 per cent). Immediate breast reconstruction was performed in 191 patients. Of 384 NSMs, 116 breasts (30·2 per cent) had some evidence of skin necrosis at follow-up, which resolved spontaneously in most; only 24 breasts (6·3 per cent) required debridement. Overall, there was at least one complication in 129 breasts (33·6 per cent); 3·6 and 1·6 per cent had incidental findings of ductal carcinoma in situ and invasive breast cancer respectively. The nipple-areola complex was preserved entirely in 378 mastectomies. After a median follow-up of 36·8 months, there had been no deaths and no new breast cancer diagnoses.These findings support the use of prophylactic NSM in high-risk patients. The nipples could be preserved in the majority of patients, postoperative complication rates were low, and, with limited follow-up, there were no new breast cancers.La mastectomía con preservación del pezón (nipple-sparing mastectomy, NSM) se realiza cada vez más para reducir riesgos en los grupos de pacientes de alto riesgo. Se dispone de pocos datos sobre complicaciones y resultados oncológicos en mujeres sometidas a NSM bilateral profiláctica. Este estudio revisó la experiencia institucional de la NSM profiláctica, y analizó las indicaciones, tasas de complicaciones postoperatorias, incidencia de enfermedad maligna oculta y diagnóstico de subsiguiente cáncer de mama. MÉTODOS: Se identificaron mujeres sometidas a NSM bilateral profiláctica durante el periodo 2000-2016 a partir de una base de datos prospectiva. Se evaluaron tasas de complicaciones postoperatorias, cáncer de mama incidental, recidiva y supervivencia global.Un total de 192 mujeres fueron sometidas a 384 NSMs profilácticas. Las indicaciones incluyeron mutaciones BRCA1 o BRCA2 en 117 (61%) pacientes, historia familiar de cáncer de mama en 35 (18%), carcinoma lobulillar in situ en 29 (15%) y otros motivos en 11 (5,7%). La reconstrucción mamaria inmediata se realizó en 191 pacientes. De las 384 NSMs, 116 (30%) presentaron alguna evidencia de necrosis de la piel durante el seguimiento y la mayoría se resolvieron de forma espontánea, con solo 24 (6,2%) mamas que requirieron desbridamiento. Globalmente hubo al menos una complicación en 129 (34%) mamas; 3,6% y 1,6% tuvieron hallazgos incidentales de carcinoma ductal in situ o cáncer de mama invasivo, respectivamente. El complejo areola-pezón se preservó completamente en 378 mastectomías. Tras una mediana de seguimiento de 36,8 meses, no hubo fallecimientos ni ningún diagnóstico nuevo de cáncer de mama. CONCLUSIÓN: Estos hallazgos apoyan la utilización de la NSM profiláctica en pacientes de alto riesgo. En la mayoría pacientes fue posible la preservación del pezón, las tasas de complicaciones postoperatorias fueron bajas y, con un seguimiento limitado, no hubo nuevos casos de cáncer de mama.

BACKGROUND The gender disparity between the number of female and male chairs and program directors has been previously established. The aim of this study was to determine whether any differences in objective credentials existed between male and female plastic surgery department chairs/division chiefs and program directors. METHODS Information about each plastic surgery program director and chair/chief was extracted from the websites of all institutions affiliated with a plastic surgery residency program. For each individual, information about the length of their career, number of fellowships completed, and number of publications was recorded. The two-tailed t test was used to compare differences between male and female chairs and program directors. RESULTS A total of 99 chairs were recorded, of which nine (9.1 percent) were female. Of the 99 program directors, 13 (13.1 percent) were female. There was no difference in the number of years in practice or number of fellowships between men and women for either position. On average, male chairs had significantly fewer publications than female chairs (71.9 versus 128; p < 0.05). There was no significant difference in the number of publications between male and female program directors. Compared to program directors, chairs had significantly more years in practice and numbers of publications, which held true for both men and women. CONCLUSIONS Women are not only underrepresented in the department chair and program director positions, but also possess higher qualifications that may reflect differences in standards for promotion and appointment. Additional research is needed to elucidate the reasons behind the observed differences in qualifications.

Background Cellulite is a localized metabolic disorder of the subcutaneous tissue. To measure the impact of cellulite and its treatment(s) on patients’ health-related quality of life, a psychometrically sound patient-reported outcome measure is needed. Objectives The authors sought to develop and field test a new BODY-Q cellulite scale to measure the appearance of cellulite. Methods Appearance-related codes from the original BODY-Q qualitative interviews were reexamined, and a set of cellulite-specific items was developed and refined through cognitive patient interviews (n = 10) and expert input (n = 17). This scale was field-tested in adults with cellulite through 2 crowdworking platforms. Rasch Measurement Theory analysis was employed to refine the scale and examine its psychometric properties. Results The field-test sample included 2129 participants. The 15-item scale was reduced in length to 11 items. Data from the sample fit the Rasch model (X2 [99] = 21.32, P = 0.06). All items had ordered thresholds and mapped out a targeted clinical hierarchy. The reliability statistics for the person separation index was 0.94 and for Cronbach’s alpha was 0.97. In terms of validity, worse scores on the cellulite scale were associated with being more bothered by how the cellulite looked overall, having more severe cellulite on the Patient-Reported Photo-numeric Cellulite Severity Scale, and having more self-reported cellulite and more areas of the body with cellulite. Conclusions The BODY-Q cellulite scale can be utilized to measure appearance of cellulite and provides a solid basis for future studies evaluating the impact of cellulite and its treatment.