Indirect treatment comparison of brexucabtagene autoleucel (ZUMA-2) versus standard of care (SCHOLAR-2) in relapsed/refractory mantle cell lymphoma.

The SCHOLAR-2 retrospective study highlighted poor overall survival (OS) with standard of care (SOC) regimens among patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) who failed a covalent Bruton tyrosine kinase inhibitor (BTKi). In the ZUMA-2 single-arm trial, brexucabtagene autoleucel (brexu-cel; autologous anti-CD19 CAR T-cell therapy) demonstrated high rates of durable responses in patients with R/R MCL who had previous BTKi exposure. Here, we compared OS in ZUMA-2 and SCHOLAR-2 using three different methods which adjusted for imbalances in prognostic factors between populations: inverse probability weighting (IPW), regression adjustment (RA), and doubly robust (DR). Brexu-cel was associated with improved OS compared to SOC across all unadjusted and adjusted comparisons. Hazard ratios (95% confidence intervals) were 0.38 (0.23, 0.61) for IPW, 0.45 (0.28, 0.74) for RA, and 0.37 (0.23, 0.59) for DR. These results suggest a substantial survival benefit with brexu-cel versus SOC in patients with R/R MCL after BTKi exposure.

Unanchored Population-Adjusted Indirect Comparison Methods for Time-to-Event Outcomes Using Inverse Odds Weighting, Regression Adjustment, and Doubly Robust Methods With Either Individual Patient or Aggregate Data.

OBJECTIVES: Several methods for unanchored population-adjusted indirect comparisons (PAICs) are available. Exploring alternative adjustment methods, depending on the available individual patient data (IPD) and the aggregate data (AD) in the external study, may help minimize bias in unanchored indirect comparisons. However, methods for time-to-event outcomes are not well understood. This study provides an overview and comparison of methods using a case study to increase familiarity. A recent method is applied to marginalize conditional hazard ratios, which allows for the comparisons of methods, and a doubly robust method is proposed. METHODS: The following PAIC methods were compared through a case study in third-line small cell lung cancer, comparing nivolumab with standard of care based on a single-arm phase II trial (CheckMate 032) and real-world study (Flatiron) in terms of overall survival: IPD-IPD analyses using inverse odds weighting, regression adjustment, and a doubly robust method; IPD-AD analyses using matching-adjusted indirect comparison, simulated treatment comparison, and a doubly robust method. RESULTS: Nivolumab extended survival versus standard of care with hazard ratios ranging from 0.63 (95% CI 0.44-0.90) in naive comparisons (identical estimates for IPD-IPD and IPD-AD analyses) to 0.69 (95% CI 0.44-0.98) in the IPD-IPD analyses using regression adjustment. Regression-based and doubly robust estimates yielded slightly wider confidence intervals versus the propensity score-based analyses. CONCLUSIONS: The proposed doubly robust approach for time-to-event outcomes may help to minimize bias due to model misspecification. However, all methods for unanchored PAIC rely on the strong assumption that all prognostic covariates have been included.

Matching-Adjusted Indirect Comparisons of Brexucabtagene Autoleucel with Alternative Standard Therapies for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia in Adult Patients.

INTRODUCTION: Brexucabtagene autoleucel (brexu-cel), a CD19-directed chimeric antigen receptor T-cell therapy, is approved for relapsed/refractory B-cell precursor acute lymphoblastic leukemia in adults aged 18+/26+ years in the US/European Union (EU), based on efficacy results from the single-arm ZUMA-3 trial. This study aimed to estimate the relative treatment effects of brexu-cel versus inotuzumab ozogamicin (InO), blinatumomab (blina), and chemotherapies using unanchored matching-adjusted indirect comparison (MAIC) methods. METHODS: Individual patient data from ZUMA-3 and published aggregate level data from two randomized controlled trials, INO-VATE (InO versus chemotherapy) and TOWER (blina versus chemotherapy), were used. Patient-level data from ZUMA-3 were weighted to match the mean of the following prognostic variables at baseline, which were pre-specified based on clinical input, for each comparator population: primary refractory disease, duration of first remission < 12 months, prior stem-cell transplantation, age, performance status, salvage status, bone marrow blast, complex karyotype, and Philadelphia chromosome status. The base case analysis was conducted using the modified intention-to-treat population (i.e., received brexu-cel) from ZUMA-3. Relative treatment effects for overall survival (OS) and event-free survival (EFS) were expressed as hazard ratios (HR) and differences in restricted mean survival time (RMST) with 95% confidence intervals (CI). RESULTS: The base case MAIC results suggested brexu-cel improved OS and EFS compared to blina (OS HR 0.46 [95% CI 0.28, 0.75]; EFS HR 0.37 [95% CI 0.25, 0.56]) and pooled INO-VATE/TOWER chemotherapy (OS HR 0.32 [95% CI 0.18, 0.56]; EFS HR 0.27 [0.18, 0.40]). Brexu-cel also improved OS compared to InO (HR 0.45 [95% CI 0.24, 0.85]). The point estimate for EFS favored brexu-cel over Ino but the difference was not statistically significant (HR 0.67 [95% CI 0.41, 1.10]). Findings were consistent between the HR and RMST analyses. CONCLUSION: Despite limitations, these MAIC results suggest that brexu-cel may improve OS and EFS versus currently used therapies in this population.

Neoadjuvant immunotherapy and chemotherapy regimens for the treatment of high-risk, early-stage triple-negative breast cancer: a systematic review and network meta-analysis.

BACKGROUND: Patients with triple-negative breast cancer (TNBC) are generally younger and more likely to experience disease recurrence and have the shortest survival among all breast cancer patients. Recently, neoadjuvant delivery of the programmed cell death protein-1 inhibitor pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab was approved for patients with high-risk, early-stage TNBC, but this treatment regimen has not been evaluated in head-to-head trials with other neoadjuvant treatment regimens. Therefore, the objective of this study was to estimate the relative efficacy of neoadjuvant pembrolizumab + chemotherapy followed by adjuvant pembrolizumab versus other neoadjuvant treatments for early-stage TNBC through a systematic review and network meta-analysis (NMA). METHODS: EMBASE, MEDLINE, Cochrane Central Register of Controlled Trials, conference abstracts, and clinical trial registries were searched for randomized controlled trials evaluating neoadjuvant treatments for early-stage TNBC. NMA was performed to estimate relative treatment effects among evaluated interventions. RESULTS: Five trials met the inclusion criteria and were included in the NMA. The relative efficacy of neoadjuvant pembrolizumab + chemotherapy followed by adjuvant pembrolizumab was favorable to paclitaxel followed by anthracycline + cyclophosphamide in terms of pathologic complete response (pCR), event-free survival (EFS), and overall survival; paclitaxel + carboplatin followed by anthracycline + cyclophosphamide in terms of pCR and EFS; paclitaxel + bevacizumab followed by anthracycline + cyclophosphamide + bevacizumab in terms of pCR; and paclitaxel + carboplatin + veliparib followed by anthracycline + cyclophosphamide in terms of EFS. CONCLUSIONS: Neoadjuvant pembrolizumab + chemotherapy followed by adjuvant pembrolizumab confers benefits in response and survival outcomes versus alternative neoadjuvant treatments for early-stage TNBC.

A 9-Year Review of Ethics Complaints to the American Society of Plastic Surgeons.

PURPOSE: The American Society of Plastic Surgeons (ASPS) provides an avenue for filing formal complaints regarding unethical behavior of Members. These complaints are investigated by the Ethics Committee and referred to the Judicial Council if a violation may have occurred. METHODS: A review of complaints filed with the ASPS from 2013-2021 was performed. Data surrounding both complaints and complainant type were reviewed, as well as region of complaint origin. Categories of violations resulting formal investigations and Judicial Council referrals were also reviewed. RESULTS: A total of 584 complaints were filed with the ASPS Ethics Committee from 2013-2021, which was nearly 100 fewer than from a prior review of 2004-2008. Twenty-one percent of complaints were formally investigated by the Ethics Committee, and 26% of these were referred to the Judicial Council. The most common complaint investigated was related to advertising/misleading communications, whereas the most common complaint referred to the Judicial Council was regarding expert testimony. Most complaints were filed by ASPS members. CONCLUSIONS: The total number of complaints filed decreased significantly, the reasons for which are unclear. Evolution of culture and thought likely impacted not only specific behaviors, but also the likelihood of reporting those behaviors. It remains incumbent on plastic surgeons to utilize the self-regulating mechanisms available in order to maintain the autonomy we enjoy as a profession.

Defining the Incidence of the Impostor Phenomenon in Academic Plastic Surgery: A Multi-Institutional Survey Study.

BACKGROUND: Impostor phenomenon occurs when high-achieving individuals have persistent self-doubt despite objective measures of competence and success, and has been associated with professional burnout and attenuated career advancement in medical specialties. This study aimed to define the incidence and severity of the impostor phenomenon in academic plastic surgery. METHODS: A cross-sectional survey containing the Clance Impostor Phenomenon Scale (0-100; higher scores indicating greater severity of impostor phenomenon) was distributed to residents and faculty from 12 academic plastic surgery institutions across the United States. Generalized linear regression was used to assess demographic and academic predictors of impostor scores. RESULTS: From a total of 136 resident and faculty respondents (response rate, 37.5%), the mean impostor score was 64 (SD 14), indicating frequent impostor phenomenon characteristics. On univariate analysis, mean impostor scores varied by gender (Female: 67.3 vs. Male: 62.0; p=0.03) and academic position (Residents: 66.5 vs. Attendings: 61.6; p=0.03), but did not vary by race/ethnicity, post-graduate year of training among residents, or academic rank, years in practice, or fellowship training among faculty (all p>0.05). After multivariable adjustment, female gender was the only factor associated with higher impostor scores among plastic surgery residents and faculty (Estimate 2.3; 95% Confidence Interval 0.03-4.6; p=0.049). CONCLUSION: The prevalence of the impostor phenomenon may be high among residents and faculty in academic plastic surgery. Impostor characteristics appear to be tied more to intrinsic characteristics, including gender, rather than years in residency or practice. Further research is needed to understand the influence of impostor characteristics on career advancement in plastic surgery.

Indirect treatment comparison of lurbinectedin versus other second-line treatments for small-cell lung cancer.

Aim: Compare lurbinectedin versus other second-line (2L) small-cell lung cancer (SCLC) treatments. Methods: An unanchored matching-adjusted indirect comparison connected the platinum-sensitive SCLC cohort of a single-arm lurbinectedin trial to a network of three randomized controlled trials (oral and intravenous [IV] topotecan, and platinum re-challenge) identified by systematic literature review. Network meta-analysis methods estimated relative treatment effects. Results: In platinum-sensitive patients, lurbinectedin demonstrated a survival benefit and favorable safety profile versus oral and IV topotecan and platinum re-challenge (overall survival, hazard ratio [HR]: 0.43; 95% credible interval [CrI]: 0.27, 0.67; HR: 0.43; 95% CrI: 0.26, 0.70; HR: 0.42; 95% CrI: 0.30, 0.58 respectively). Conclusion: Lurbinectedin showed a robust survival benefit and favorable safety versus other SCLC treatments in 2L platinum-sensitive SCLC.

Quantitative In Vivo Imaging of the Androgen Receptor Axis Reveals Degree of Prostate Cancer Radiotherapy Response.

Noninvasive biomarkers for androgen receptor (AR) pathway activation are urgently needed to better monitor patient response to prostate cancer therapies. AR is a critical driver and mediator of resistance of prostate cancer but currently available noninvasive prostate cancer biomarkers to monitor AR activity are discordant with downstream AR pathway activity. External beam radiotherapy (EBRT) remains a common treatment for all stages of prostate cancer, and DNA damage induced by EBRT upregulates AR pathway activity to promote therapeutic resistance. [89Zr]11B6-PET is a novel modality targeting prostate-specific protein human kallikrein 2 (hK2), which is a surrogate biomarker for AR activity. Here, we studied whether [89Zr]11B6-PET can accurately assess EBRT-induced AR activity.Genetic and human prostate cancer mouse models received EBRT (2-50 Gy) and treatment response was monitored by [89Zr]11B6-PET/CT. Radiotracer uptake and expression of AR and AR target genes was quantified in resected tissue.EBRT increased AR pathway activity and [89Zr]11B6 uptake in LNCaP-AR and 22RV1 tumors. EBRT increased prostate-specific [89Zr]11B6 uptake in prostate cancer-bearing mice (Hi-Myc x Pb_KLK2) with no significant changes in uptake in healthy (Pb_KLK2) mice, and this correlated with hK2 protein levels. IMPLICATIONS: hK2 expression in prostate cancer tissue is a proxy of EBRT-induced AR activity that can noninvasively be detected using [89Zr]11B6-PET; further clinical evaluation of hK2-PET for monitoring response and development of resistance to EBRT in real time is warranted.

Real-world experience among patients with relapsed/refractory mantle cell lymphoma after Bruton tyrosine kinase inhibitor failure in Europe: The SCHOLAR-2 retrospective chart review study.

Mantle cell lymphoma (MCL) after relapse is associated with poor prognosis. No standard of care exists and available evidence for treatments is limited, particularly in patients who fail Bruton tyrosine kinase inhibitor (BTKi) therapy. This multicentre retrospective chart review study, SCHOLAR-2, addresses this knowledge gap and reports on data collected from 240 patients with relapsed/refractory MCL in Europe who were treated with BTKi-based therapy between July 2012 and July 2018, and had experienced disease progression while on BTKi therapy or discontinued BTKi therapy due to intolerance. The median overall survival (OS) from initiation of first BTKi therapy was 14.6 months (95% confidence interval [CI] 11.6-20.0) in the overall cohort, 5.5 months (95% CI 3.9-8.2) in 91 patients without post-BTKi therapy, and 23.8 months (95% CI 18.9-30.1) in 149 patients who received post-BTKi therapy (excluding chimeric antigen receptor T-cell treatment). In the latter group, patients received a median of one (range, one to seven) line of post-BTKi therapy, with lenalidomide-containing regimens and bendamustine plus rituximab being the most frequently administered; the median OS from initiation of first post-BTKi therapy was 9.7 months (95% CI 6.3-12.7). These results provide a benchmark for survival in patients with R/R MCL receiving salvage therapy after BTKi failure.

Examining Coronary Revascularization Practice Patterns for Diabetics: Perceived Barriers, Facilitators, and Implications for Knowledge Translation.

BACKGROUND: The FREEDOM trial provided robust evidence that coronary artery bypass grafting (CABG) was superior to percutaneous coronary intervention (PCI) for coronary revascularization in patients with diabetes mellitus (DM) and multivessel coronary artery disease (MV-CAD). The present study examined practice pattern changes and perceived barriers and facilitators to implementing FREEDOM trial evidence in British Columbia (BC). METHODS: Using a population-based database of cardiac procedures in BC, PCI:CABG ratios from 2007-2014 were compared before and after publication of the FREEDOM trial in the 4 tertiary cardiac centres that provided both CABG and PCI. Surveys of barriers and facilitators to implementation of evidence in practice were completed by 57 health care providers (HCPs) attending educational outreach sessions conducted in 2016-17 at 5 tertiary cardiac centres in BC. RESULTS: The overall PCI:CABG ratio declined from 1.59 (95% confidence interval [CI] 1.48-1.70, range 1.16-1.86) before publication to 0.88 (95% CI 0.75-1.01, range 0.56-0.82) after publication (P < 0.01). This decline from before to after publication was significant in 3 centres, but not in the fourth centre (from 1.62 to 1.49; P = 0.61). Barriers were identified at the levels of evidence (applicability, credibility), HCP (awareness/knowledge, practice behaviours), patient (knowledge/misconceptions, preferences), and systems (siloing of care, financial disincentives, resource limitations, geography). Facilitators were additional studies/guidelines, education/dissemination, shared decision making, a heart team approach, changes to remuneration models, and increased resources. CONCLUSIONS: Following publication of the FREEDOM trial, the proportion of patients with DM and MV-CAD undergoing CABG increased in BC; however, practice patterns varied across cardiac centres. HCPs attributed these practice variations to multilevel barriers and facilitators. Future knowledge translation strategies should be multifaceted and tailored to identified determinants.

Ranolazine for Symptomatic Management of Microvascular Angina.

BACKGROUND: Ranolazine is approved in the United States and Europe for chronic stable angina. Microvascular angina (MVA) is defined as angina with no obstructive coronary artery disease. STUDY QUESTION: Our objective was to assess the effectiveness of ranolazine at improving angina scores and quality of life in a Canadian cohort with severe refractory angina due to MVA. STUDY DESIGN: We administered questionnaires to 31 patients at baseline and after at least 6 weeks of ranolazine treatment. MEASURES AND OUTCOMES: Validated, clinically significant changes for each Seattle Angina Questionnaire domain and the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form were obtained from the literature. Score changes between baseline and postranolazine use were analyzed using sign test. RESULTS: Patients were mostly female (27 of 31 patients) with a median age of 57 years. After initiation of ranolazine treatment, patients experienced improvements in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form scores (80.6%; P < 0.01) and in 3 of the 4 domains of the Seattle Angina Questionnaire (physical limitation: 73.3%; P = 0.02; treatment satisfaction: 80.6%; P < 0.01; and disease perception: 77.4%; P < 0.01). Patients were less likely to have interactions with the health care system after ranolazine treatment as compared with before (35.5% vs. 93.5%; P < 0.01). CONCLUSIONS: Ranolazine significantly improves symptom control and quality of life in patients with MVA and severe refractory angina and reduces their interaction with the health care system. Given the potentially debilitating effect of chronic angina in MVA, ranolazine may be an effective treatment option.

Individualizing Revascularization Strategy for Diabetic Patients With Multivessel Coronary Disease.

BACKGROUND: In patients with diabetes and multivessel coronary artery disease (CAD), the FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) trial demonstrated that, on average, coronary artery bypass grafting (CABG) was superior to percutaneous coronary intervention (PCI) for major acute cardiovascular events (MACE) and angina reduction. Nonetheless, multivessel PCI remains a common revascularization strategy in the real world. OBJECTIVES: To translate the results of FREEDOM to individual patients in clinical practice, risk models of the heterogeneity of treatment benefit were built. METHODS: Using patient-level data from 1,900 FREEDOM patients, the authors developed models to predict 5-year MACE (all-cause mortality, nonfatal myocardial infarction, and nonfatal stroke) and 1-year angina after CABG and PCI using baseline covariates and treatment interactions. Parsimonious models were created to support clinical use. The models were internally validated using bootstrap resampling, and the MACE model was externally validated in a large real-world registry. RESULTS: The 5-year MACE occurred in 346 (18.2%) patients, and 310 (16.3%) had angina at 1 year. The MACE model included 8 variables and treatment interactions with smoking status (c = 0.67). External validation in stable CAD (c = 0.65) and ACS (c = 0.68) demonstrated comparable performance. The 6-variable angina model included a treatment interaction with SYNTAX score (c = 0.67). PCI was never superior to CABG, and CABG was superior to PCI for MACE in 54.5% of patients and in 100% of patients with history of smoking. CONCLUSIONS: To help disseminate the results of FREEDOM, the authors created a personalized risk prediction tool for patients with diabetes and multivessel CAD that could be used in shared decision-making for CABG versus PCI by estimating each patient's personal outcomes with both treatments.

The Vancouver 3M (Multidisciplinary, Multimodality, But Minimalist) Clinical Pathway Facilitates Safe Next-Day Discharge Home at Low-, Medium-, and High-Volume Transfemoral Transcatheter Aortic Valve Replacement Centers: The 3M TAVR Study.

OBJECTIVES: The authors sought to prospectively determine the safety and efficacy of next-day discharge using the Vancouver 3M (Multidisciplinary, Multimodality, but Minimalist) Clinical Pathway. BACKGROUND: Transfemoral transcatheter aortic valve replacement (TAVR) is an alternative to surgery in high- and intermediate-risk patients; however, hospital stays average at least 6 days in most trials. The Vancouver 3M Clinical Pathway is focused on next-day discharge, made possible by the use of objective screening criteria as well as streamlined peri- and post-procedural management guidelines. METHODS: Patients were enrolled from 6 low-volume (<100 TAVR/year), 4 medium-volume, and 3 high-volume (>200 TAVR/year) centers in Canada and the United States. The primary outcomes were a composite of all-cause death or stroke by 30 days and the proportion of patients successfully discharged home the day following TAVR. RESULTS: Of 1,400 screened patients, 411 were enrolled at 13 centers and received a SAPIEN XT (58.2%) or SAPIEN 3 (41.8%) valve (Edwards Lifesciences, Irvine, California). In centers enrolling exclusively in the study, 55% of screened patients were enrolled. The median age was 84 years (interquartile range: 78 to 87 years) with a median STS score of 4.9% (interquartile range: 3.3% to 6.8%). Next-day discharge home was achieved in 80.1% of patients, and within 48 h in 89.5%. The composite of all-cause mortality or stroke by 30 days occurred in 2.9% (95% confidence interval: 1.7% to 5.1%), with neither component of the primary outcome affected by hospital TAVR volume (p = 0.51). Secondary outcomes at 30 days included major vascular complication 2.4% (n = 10), readmission 9.2% (n = 36), cardiac readmission 5.7% (n = 22), new permanent pacemaker 5.7% (n = 23), and >mild paravalvular regurgitation 3.8% (n = 15). CONCLUSIONS: Adherence to the Vancouver 3M Clinical Pathway at low-, medium-, and high-volume TAVR centers allows next-day discharge home with excellent safety and efficacy outcomes.

Effect of Lowering Diastolic Pressure in Patients With and Without Cardiovascular Disease: Analysis of the SPRINT (Systolic Blood Pressure Intervention Trial).

Systolic and diastolic blood pressure thresholds, below which cardiovascular events increase, are widely debated. Using data from the SPRINT (Systolic Blood Pressure Intervention Trial), we evaluated the relation between systolic and diastolic pressure and cardiovascular events among 1519 participants with or 7574 without prior cardiovascular disease. Using Cox regression, we examined the composite risk of myocardial infarction, other acute coronary syndrome, stroke, heart failure, or cardiovascular death, and follow-up systolic and diastolic pressure were analyzed as time-dependent covariates for a median of 3.1 years. Models were adjusted for age, sex, baseline systolic pressure, body mass index, 10-year Framingham risk score, and estimated glomerular filtration rate. A J-shaped relationship with diastolic pressure was observed in both treatment arms in patients with or without cardiovascular disease (P nonlinearity≤0.002). When diastolic pressure fell <55 mm Hg, the hazards were at least 25% higher relative to 70 mm Hg (P=0.29). The hazard ratios (95% CI) of diastolic pressure <55 mm Hg versus 55 to 90 mm Hg were 1.68 (1.16-2.43), P value 0.006 and 1.52 (0.99-2.34), P value 0.06 in patients without and with prior cardiovascular disease, respectively. After adjusting for follow-up diastolic pressure, follow-up systolic pressure was not associated with the outcome in those without prior cardiovascular disease (P=0.64). In those with cardiovascular disease, adjusting for diastolic pressure, follow-up systolic pressure was associated with the risk in the intensive arm (hazard ratio per 10 mm Hg decrease, 0.86; 95% CI, 0.75-0.99; P interaction=0.02). Although the observed J-shaped relationship may be because of reverse causality in the SPRINT population, we advise caution in aggressively lowering diastolic pressure.

Superficial Inferior Epigastric Artery Flap Salvage Technique Using Deep Inferior Epigastric Artery Graft.

Superficial inferior epigastric artery (SIEA) flap salvage remains challenging, particularly in cases of arterial insufficiency due to vessel spasm, pedicle kinking, or thrombosis. The already small, short SIEA pedicle, in addition to its inherent tendency toward spasm, renders the SIEA flap more difficult to manage when anastomotic revision is required. Furthermore, arterial thrombosis will cause dilation of the internal mammary artery, exacerbating vessel mismatch. In our previously published experience with 145 SIEA flaps, no flap with postoperative arterial thrombosis was salvageable. Following this experience, a new salvage technique using deep inferior epigastric artery grafts has been utilized and is described here.

SSET Project: Cost-effectiveness Analysis of Surgical Specialty Emergency Trays in the Emergency Department.

BACKGROUND: We hypothesize that reusable, on-site specialty instrument trays available to plastic surgery residents in the emergency department (ED) for bedside procedures are more cost-effective than disposable on-site and remote re-usable operating room (OR) instruments at our institution. METHODS: We completed a cost-effectiveness analysis comparing the use of disposable on-site kits and remote OR trays to a hypothetical, custom, reusable tray for ED procedures completed by PRS residents. Material costs of existing OR trays were used to estimate the purchasing and use-cost of a custom on-site tray for the same procedures. Cost of per procedure 'consult time' was estimated using procedure and resident salary. RESULTS: Sixteen bedside procedures were completed over a 4.5 month period. A mean of 2.14 disposable kits were used per-procedure. Mean consultation time was 1.66 hours. Procedures that used OR trays took 3 times as long as procedures that used on-site kits (4 vs. 1.1 hours). Necessary, additional instruments were unavailable for 75% of procedures. Mean cost of using disposable kits and OR trays was $115.03/procedure versus an estimated $26.67/procedure cost of using a custom tray, yielding $88.36/procedure cost-savings. Purchase of a single custom tray ($1,421.55) would be redeemed after 2.3 weeks at 1 procedure/day. Purchasing 4 trays has projected annual cost-savings of $26,565.20. CONCLUSION: The purchase of specialized procedure trays will yield valuable time and cost-savings while providing quality patient care. Improving time efficiency will help achieve the Accreditation Council of Graduate Medical Education (ACGME) goals of maintaining resident well-being and developing quality improvement competency.

The Impact of Reduced Cardiac Rehabilitation on Maximal Treadmill Exercise Time: A RANDOMIZED CONTROLLED TRIAL.

PURPOSE: Cardiac rehabilitation programs (CRPs) remain underutilized partly because of access barriers. We therefore evaluated a CRP with fewer center-based sessions (rCRP) compared with standard CRP (sCRP) with respect to changes in exercise capacity and cardiac risk factors. METHODS: In this randomized controlled noninferiority trial, primary and secondary prevention patients at low and moderate risk were randomized to an sCRP (n = 60) or an rCRP (n = 61). Over 4 months, sCRP and rCRP participants attended 32 and 10 on-site cardiac rehabilitation sessions, respectively. The primary outcome was the difference in the change in exercise capacity from baseline at 4 and 16 months between the groups measured in seconds from a maximal treadmill exercise test. Noninferiority of the rCRP was tested with mixed-effects model analysis with a cut point of 60 seconds for the upper value of the group estimate. RESULTS: Attendance was higher for the rCRP group (97% ± 63% vs 71% ± 22%, P = .002). Over 16 months, exercise test time increased for the sCRP (524 ± 168 to 604 ± 172 seconds, P < .01) and the rCRP (565 ± 183 to 640 ± 192 seconds, P < .01). The rCRP was not inferior to the sCRP regarding changes in treadmill time (48.47 seconds, P = .454). The rCRP was not inferior to the sCRP regarding metabolic and anthropometric risk factors. CONCLUSION: Our findings suggest that, for a selected group of low-/moderate-risk patients, the number of center-based CRP exercise sessions can be decreased while maintaining reduced cardiovascular risk factors.

Surgical Versus Percutaneous Coronary Revascularization in Patients With Diabetes and Acute Coronary Syndromes.

BACKGROUND: Randomized trial data support the superiority of coronary artery bypass grafting (CABG) surgery over percutaneous coronary intervention (PCI) in diabetic patients with multivessel coronary artery disease (MV-CAD). However, whether this benefit is seen in a real-world population among subjects with stable ischemic heart disease (SIHD) and acute coronary syndromes (ACS) is unknown. OBJECTIVES: The main objective of this study was to assess the generalizability of the FREEDOM (Future REvascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multi-vessel Disease) trial in real-world practice among patients with diabetes mellitus and MV-CAD in residents of British Columbia, Canada. Additionally, the study evaluated the impact of mode of revascularization (CABG vs. PCI with drug-eluting stents) in diabetic patients with ACS and MV-CAD. METHODS: In a large population-based database from British Columbia, this study evaluated major cardiovascular outcomes in all diabetic patients who underwent coronary revascularization between 2007 and 2014 (n = 4,661, 2,947 patients with ACS). The primary endpoint (major adverse cardiac or cerebrovascular events [MACCE]) was a composite of all-cause death, nonfatal myocardial infarction, and nonfatal stroke. The risk of MACCE with CABG or PCI was compared using multivariable adjustment and a propensity score model. RESULTS: At 30-days post-revascularization, for ACS patients the odds ratio for MACCE favored CABG 0.49 (95% confidence interval [CI]: 0.34 to 0.71), whereas among SIHD patients MACCE was not affected by revascularization strategy (odds ratio: 1.46; 95% CI: 0.71 to 3.01; pinteraction <0.01). With a median follow-up of 3.3 years, the late (31-day to 5-year) benefit of CABG over PCI no longer varied by acuity of presentation, with a hazard ratio for MACCE in ACS patients of 0.67 (95% CI: 0.55 to 0.81) and the hazard ratio for SIHD patients of 0.55 (95% CI: 0.40 to 0.74; pinteraction = 0.28). CONCLUSIONS: In diabetic patients with MV-CAD, CABG was associated with a lower rate of long-term MACCE relative to PCI for both ACS and SIHD. A well-powered randomized trial of CABG versus PCI in the ACS population is warranted because these patients have been largely excluded from prior trials.

Parental leave policies in graduate medical education: A systematic review.

BACKGROUND: A thorough understanding of attitudes toward and program policies for parenthood in graduate medical education (GME) is essential for establishing fair and achievable parental leave policies and fostering a culture of support for trainees during GME. METHODS: A systematic review of the literature was completed. Non-cohort studies, studies completed or published outside of the United States, and studies not published in English were excluded. Studies that addressed the existence of parental leave policies in GME were identified and were the focus of this study. RESULTS: Twenty-eight studies addressed the topic of the existence of formal parental leave policies in GME, which was found to vary across time and ranged between 22 and 90%. Support for such policies persisted across time. CONCLUSIONS: Attention to formal leave policies in GME has traditionally been lacking, but may be increasing. Negative attitudes towards parenthood in GME persist. Active awareness of the challenges faced by parent-trainees combined with formal parental leave policy implementation is important in supporting parenthood in GME.