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PurposeStandard 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 methodsOne 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.ResultsMean 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.ConclusionSubjects 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.

ABSTRACTGraduate medical education (GME) and Clinical Competency Committees (CCC) have been evolving to monitor trainee progression using competency-based medical education principles and outcomes, though evidence suggests CCCs fall short of this goal. Challenges include that evaluation data are often incomplete, insufficient, poorly aligned with performance, conflicting or of unknown quality, and CCCs struggle to organize, analyze, visualize, and integrate data elements across sources, collection methods, contexts, and time-periods, which makes advancement decisions difficult. Learning analytics have significant potential to improve competence committee decision making, yet their use is not yet commonplace. Learning analytics (LA) is the interpretation of multiple data sources gathered on trainees to assess academic progress, predict future performance, and identify potential issues to be addressed with feedback and individualized learning plans. What distinguishes LA from other educational approaches is systematic data collection and advanced digital interpretation and visualization to inform educational systems. These data are necessary to: 1) fully understand educational contexts and guide improvements; 2) advance proficiency among stakeholders to make ethical and accurate summative decisions; and 3) clearly communicate methods, findings, and actionable recommendations for a range of educational stakeholders. The ACGME released the third edition CCC Guidebook for Programs in 2020 and the 2021 Milestones 2.0 supplement of the Journal of Graduate Medical Education (JGME Supplement) presented important papers that describe evaluation and implementation features of effective CCCs. Principles of LA underpin national GME outcomes data and training across specialties; however, little guidance currently exists on how GME programs can use LA to improve the CCC process. Here we outline recommendations for implementing learning analytics for supporting decision making on trainee progress in two areas: 1) Data Quality and Decision Making, and 2) Educator Development.

Learning curves can be used to design, implement, and evaluate educational interventions. Attention to key aspects of the method can improve the fidelity of this representation of learning as well as its suitability for education and research purposes. This paper addresses when to use a learning curve, which graphical properties to consider, how to use learning curves quantitatively, and how to use observed thresholds to communicate meaning. We also address the associated ethics and policy considerations. We conclude with a best practices checklist for both educators and researchers seeking to use learning curves in their work.

Background:. BODY-Q is a rigorously developed patient-reported outcome measure designed to measure outcomes of weight loss and body contouring patients. To allow interpretation and comparison of BODY-Q scores across studies, normative BODY-Q values were generated from the general population. The aim of this study was to examine the psychometric properties of BODY-Q in the normative population. Methods:. Data were collected using two crowdsourcing platforms (Prolific and Amazon Mechanical Turk) in 12 European and North American countries. Rasch measurement theory (RMT) was used to examine reliability and validity of BODY-Q scales. Results:. RMT analysis supported the psychometric properties of BODY-Q in the normative sample with ordered thresholds in all items and nonsignificant chi-square values for 167 of 176 items. Reliability was high with person separation index of greater than or equal to 0.70 in 20 of 22 scales and Cronbach alpha values of greater than or equal to 0.90 in 17 of 22 scales. Mean scale scores measuring appearance, health-related quality of life, and eating-related concerns scales varied as predicted across subgroups with higher scores reported by participants who were more satisfied with their weight. Analysis to explore differential item functioning by sample (normative versus field-test) flagged some potential issues, but subsequent comparison of adjusted and unadjusted person estimates provided evidence that the scoring algorithm worked equivalently for the normative sample as in the field-test samples. Conclusions:. The BODY-Q scales showed acceptable reliability and validity in the normative sample. The normative values can be used as reference in research and clinical practice in combination with local estimates for parallel analysis and comparison.

Abstract Purpose The BREAST-Q is the most used patient-reported outcome measure (PROM) in breast cancer surgery. The purposes of this study were to re-examine the content validity of BREAST-Q cancer modules (mastectomy, lumpectomy and reconstruction) and to determine the need for new scales. Methods Interviews were conducted with women with breast cancer (Stage 0–4, any treatment), and were audio-recorded and transcribed verbatim. Deductive (based on original BREAST-Q conceptual framework) and inductive (new codes from the data) content analysis approaches were used to analyze the data. The number of codes that mapped to BREAST-Q were recorded. Results Dataset included 3948 codes from 58 participants. Most of the breast (n = 659, 96%) and all psychosocial (n = 127, 100%), sexual (n = 179, 100%) and radiation-related (n = 79, 100%) codes mapped to BREAST-Q Satisfaction with Breast, Psychosocial Wellbeing, Sexual Wellbeing and Adverse Effects of Radiation scales, respectively. For the physical wellbeing codes (n = 939) for breast/chest and arm, 34% (n = 321) mapped to the Physical Wellbeing-Chest scale. Most of the abdomen codes (n = 311) mapped to Satisfaction with Abdomen (n = 90, 76%) and Physical Wellbeing-Abdomen (n = 171, 89%) scales. Codes that did not map (n = 697, 30%) covered breast sensation and lymphedema. Concerns related to fatigue, cancer worry, and work impact were most reported and did not map to BREAST-Q. Conclusion The BREAST-Q, which was developed using extensive patient input more than a decade ago, is still relevant. To ensure the BREAST-Q remains comprehensive, new scales for upper extremity lymphedema, breast sensation, fatigue, cancer worry, and work impact were developed.

Background:. The need to address inequities in global surgical care has garnered increased attention since 2015, after the Lancet Commission on Global Surgery underscored the importance of ensuring safe, accessible, affordable, and timely surgical and anesthetic care. The vast unmet global plastic surgery needs make plastic surgery care essential in reducing the global burden of disease. In the past, many nonprofit organizations undertook humanitarian activities within low- and middle-income countries that were primarily service-provision oriented. The Lancet Commission on Global Surgery report prompted a shift in focus from direct patient care models to sustainable global surgical models. The realization that 33% of deaths worldwide were due to unmet surgical needs led to a global shift of strategy toward the development of local systems, surgical capacity, and a focus on patient safety and quality of care within international global surgery partnerships. Methods:. In this report, the authors explore some of the primary components of sustainable international global surgical partnerships discussed in a recent panel at the American Society of Plastic Surgeons Plastic Surgery The Meeting 2022, titled “Safety and Sustainability Overseas: Optimizing Outcomes and Changing Paradigms in Global Health Endeavors.” A literature review elaborating the topics discussed was performed. Results:. This report focuses on cultural competence and humility, international collaboration, and the use of technology and innovation, all of which are needed to promote sustainability and patient safety, within global surgery efforts. Conclusions:. The adoption of these components into international surgical collaborations will lead to greatly enhancing the development and sustainability of mutually beneficial relationships.

Summary:. In sub-Saharan Africa, options for reconstruction of traumatic injuries are limited due to lack of access to microsurgery-trained surgeons. Recently, the Plastic Surgery Foundation-sponsored Surgeons in Humanitarian Alliance for Reconstruction, Research and Education group hosted a virtual microsurgery skills course for junior plastic surgeons in this region. In this report, we describe a case of complete brachial artery transection requiring microsurgical techniques and use of vein graft for repair at our provincial hospital in Mozambique. By highlighting this case, we aimed to describe a direct clinical application of the Surgeons in Humanitarian Alliance for Reconstruction, Research and Education virtual microsurgery skills course and to demonstrate the profound impact such courses can have on patient outcomes in low-and middle-income countries with limited or no access to microsurgery-trained surgeons. Further, through newly gained familiarity with standard microsurgery instruments used in reconstructive procedures, we were able to improvise and develop modified instruments to overcome lack of resources at our institution.

Abstract Purpose The impact of the COVID-19 pandemic on psychological well-being will likely be long-lasting. Efforts directed towards monitoring the onset and progression of distress and mental health disorders are needed to identify and prioritize at-risk populations. This study assesses the psychological well-being of the United States (US) general population during the early phase of the COVID-19 COVID-19 pandemic using validated patient-reported outcome measures (PROMs). Methods A cross-sectional study design was used. Adults (18 years or older) who could read and write in English were recruited through Prolific in May 2020. Participants completed a REDCap survey including demographic and health-related questions and three PROMs measuring global health (PROMIS-10 Global Health), anxiety [Generalized Anxiety Disorder Scale-7 (GAD-7)], and depression [Patient Health Questionnaire-9 (PHQ-9)]. A multivariable linear regression was used to identify key factors associated with worse psychological well-being. Results Mean age of the 2023 participants was 31.92 ± 11.57 years (range, 18–82). Participants were mainly White (64.7%, n = 1309), female (52.2%, n = 1057), working full-time before the pandemic (43.5%, n = 879), and completed a college, trade, or university degree (40.7%, n = 823). Most participants reported mild to severe anxiety (57.3%, n = 1158) and depression (60%, n = 1276) on the GAD-7 and PHQ-9, respectively. Patient characteristics associated with worse psychological well-being included: age ≤ 39 years, non-White, female or gender diverse, BMI ≥ 30, uninsured, annual income ≤ $49,999 (USD), lower educational attainment, and belief that COVID-19 is deadlier than flu. Conclusion PROMs can be used to assess and monitor psychological well-being during the COVID-19 pandemic and to inform the planning and delivery of targeted public health interventions to support at-risk populations.

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.

Chronic graft-versus-host disease (GvHD) treatment response is assessed using National Institutes of Health (NIH) Consensus Criteria in clinical trials, and by clinician assessment in routine practice. Patient-reported treatment response is central to the experience of chronic GvHD manifestations as well as treatment benefit and toxicity, but how they correlate with clinician- or NIH-responses has not been well-studied. We aimed to characterize 6-month patientreported response, determine associated chronic GvHD baseline organ features and changes, and evaluate which patientreported quality of life and chronic GvHD symptom burden measures correlated with patient-reported response. From two nationally representative Chronic GVHD Consortium prospective observational studies, 382 subjects were included in this analysis. Patient and clinician responses were categorized as improved (completely gone, very much better, moderately better, a little better) versus not improved (about the same, a little worse, moderately worse, very much worse). At six months, 270 (71%) patients perceived chronic GvHD improvement, while 112 (29%) perceived no improvement. Patient-reported response had limited correlation with either clinician-reported (kappa 0.37) or NIH chronic GvHD response criteria (kappa 0.18). Notably, patient-reported response at six months was significantly associated with subsequent failure-free survival. In multivariate analysis, NIH responses in eye, mouth, and lung had significant association with 6-month patient-reported response, as well as a change in Short Form 36 general health and role physical domains and Lee Symptom Score skin and eye changes. Based on these findings, patient-reported responses should be considered as an important complementary endpoint in chronic GvHD clinical trials and drug development.