"The Equipoise Ruler:" A National Survey on Surgeon Judgment about the Value of Surgery.

OBJECTIVE: The objective of this study was to understand professional norms regarding the value of surgery. SUMMARY BACKGROUND DATA: Agreed-upon professional norms may improve surgical decision making by contextualizing the nature of surgical treatment for patients. However, the extent to which these norms exist among surgeons practicing in the US is not known. METHODS: We administered a survey with 30 exemplar cases asking surgeons to use their best judgement to place each case on a scale ranging from "Definitely would do this surgery" to "Definitely would not do this surgery." We then asked surgeons to repeat their assessments after providing responses from the first survey. We interviewed respondents to characterize their rationale. RESULTS: We received 580 responses, a response rate of 28.5%. For 19 of 30 cases there was consensus (≥60% agreement) about the value of surgery (range 63% - 99%). There was little within-case variation when the mode was for surgery and more variation when the mode was against surgery or equipoise. Exposure to peer response increased the number of cases with consensus. Women were more likely to endorse a non-operative approach when treatment had high mortality. Specialists were less likely to operate for salvage procedures. Surgeons noted their clinical practice was to withhold judgment and let patients decide despite their assessment. CONCLUSIONS: Professional judgment about the value of surgery exists along a continuum. While there is less variation in judgment for cases that are highly beneficial, consensus can be improved by exposure to the assessments of peers.

U.S. weight trends: a longitudinal analysis of an NIH-partnered dataset.

BACKGROUND: Obesity is a major public health challenge in the U.S. Existing datasets utilized for calculating obesity prevalence, such as the National Health and Nutrition Examination Survey (NHANES) and Behavioral Risk Factor Surveillance System (BRFSS), have limitations. Our objective was to analyze weight trends in the U.S. using a nationally representative dataset that incorporates longitudinal electronic health record data. METHODS: Using the National Institutes of Health All of Us Research Program (AoU) dataset, we identified patients aged 18-70 years old who had at least two height and weight measurements within a 5-year period from 2008 to 2021. Baseline and most recent BMI values were used to calculate total body weight (%TBW) changes. %TBW change predictors were determined using multivariable linear regression. RESULTS: We included 30,862 patients (mean age 48.9 [ ± 12.6] years; 60.5% female). At the 5-year follow-up, the prevalences of obesity and severe obesity were 37.4% and 20.7%, respectively. The frequency of patients with normal weight or overweight BMI who gained ≥5% TBW at follow-up was 37.8% and 33.1%, respectively. Nearly 24% of the cohort lost ≥ 5% TBW, and 6.5% with severe obesity lost weight to achieve a BMI < 30 kg/m2. In adjusted analyses, male sex (-1.10%, 95% CI [-1.36, -0.85]), non-Hispanic Asian race/ethnicity (-1.69% [-2.44, -0.94]), and type 2 diabetes (-1.58% [-1.95, -1.22]) were associated with weight loss, while obstructive sleep apnea (1.80% [1.40, 2.19]) was associated with weight gain. CONCLUSIONS: This evaluation of an NIH-partnered dataset suggests that patients are continuing to gain weight in the U.S. AoU represents a unique tool for obesity prediction, prevention, and treatment given its longitudinal nature and unique behavioral and genetic data.

A Four-Arm Randomized Clinical Trial of Topical Pain Control for Sentinel Node Radiotracer Injections in Patients with Breast Cancer.

BACKGROUND: Radioactive tracer injections for breast cancer sentinel lymph node mapping can be painful. In this randomized trial, we compared four approaches to topical pain control for radiotracer injections. METHODS: Breast cancer patients were randomized (9 April 2021-8 May 2022) to receive the institutional standard of ice prior to injection (n = 44), or one of three treatments: ice plus a vibrating distraction device (Buzzy®; n = 39), 4% lidocaine patch (n = 44), or 4% lidocaine patch plus ice plus Buzzy® (n = 40). Patients completed the Wong-Baker FACES® pain score (primary outcome) and a satisfaction with pain control received scale (secondary). Nuclear medicine technologists (n = 8) rated perceived pain control and ease of administration for each patient. At study conclusion, technologists rank-ordered treatments. Data were analyzed as intention-to-treat. Wilcoxon rank-sum tests were used to compare pain scores of control versus pooled treatment arms (primary) and then control to each treatment arm individually (secondary). RESULTS: There were no differences in pain scores between the control and treatment groups, both pooled and individually. Eighty-five percent of patients were 'satisfied/very satisfied' with treatment received, with no differences between groups. No differences in providers' perceptions of pain were observed, although providers perceived treatments involving Buzzy© more difficult to administer (p < 0.001). Providers rated lidocaine patch as the easiest, with ice being second. CONCLUSION: In this randomized trial, no differences in patient-reported pain or satisfaction with treatment was observed between ice and other topical treatments. Providers found treatments using Buzzy® more difficult to administer. Given patient satisfaction and ease of administration, ice is a reasonable standard.

Validation of the AJCC 8th Edition Breast Cancer Prognostic Staging System in Legacy Alliance Trials (AFT-01).

BACKGROUND: The 8th edition American Joint Committee on Cancer staging system combined anatomic stage (AS) with receptor status and grade to create prognostic stage (PS). PS has been validated in single-institution and cancer registry studies; however, missing human epidermal growth factor receptor 2 (HER2) status and variable treatment and follow-up create limitations. OBJECTIVE: Our objective was to compare the relative prognostic ability of PS versus AS to predict survival using breast cancer clinical trial data. METHODS: Women with non-metastatic breast cancer enrolled in six Alliance for Clinical Trials in Oncology trials were included (enrollment years 1997-2010). AS and PS were constructed using pathological tumor size, nodal status, estrogen receptor (ER), progesterone receptor (PR), HER2 status, and grade. Unadjusted Cox proportional hazard models were estimated to predict overall survival within 5 years, with AS and PS as predictor variables. The relative predictive power of staging models was assessed by comparing Harrell concordance indices (C-indices). Kaplan-Meier-based mortality estimates were compared by stage. RESULTS: Overall, 6924 women were included (median age 53 years); 45.2% were diagnosed with ER+/PR+/HER2- tumors, 26.2% with HER2+ tumors, and 17.1% with ER-/PR-/HER2- tumors. Median follow-up time was 5 years (interquartile range 2.95-5.00). PS significantly improved predictive performance (C-index 0.721) for overall survival compared with AS (0.700) (p = 0.020). Kaplan-Meier hazard estimates suggested PS did not distinguish mortality risk between patients with IIB and IIIA or IB and IIA disease. CONCLUSIONS: PS has significantly improved predictive performance for OS compared with AS. As systemic therapies evolve, it will be important to re-evaluate the prognostic staging system, particularly for patients with intermediate-stage cancers. CLINICALTRIALS: gov Identifier: NCT02171078.

Sex and outcomes after stenting and endarterectomy in asymptomatic severe carotid stenosis patients.

OBJECTIVES: To determine if sex was an effect modifier in a pooled analysis of asymptomatic patients from CREST and ACT I. MATERIALS AND METHODS: We analyzed data from 2544 patients aged <80 with ≥70 % asymptomatic carotid stenosis randomized to CAS or CEA (nCREST = 1091; nACT-1 = 1453). The pre-specified primary endpoint in both trials was any stroke, myocardial infarction or death during the peri-procedural period, or ipsilateral stroke within 4 years of randomization. The secondary endpoint was any stroke or death during the peri-procedural period, or ipsilateral stroke within 4 years of randomization. RESULTS: There was no significant difference in the frequency of events for men or women between CAS and CEA for the primary or secondary endpoints. When assessing for an interaction of sex and risks between procedures, the treatment-by-sex interaction was not significant for either primary or secondary endpoints in the four-year period or the peri-procedural period. However, women had significantly fewer post-procedural events (ipsilateral stroke) with CAS than CEA (HR = 0.33, 95 % CI: 0.09-1.18) compared to men (HR = 2.09, 95 % CI: 0.78-5.61), p = 0.02 for interaction. CONCLUSIONS: In this large, pooled analysis of asymptomatic patients comparing CAS to CEA, sex did not act as an effect modifier of treatment differences in the four-year primary stroke-MI-or-death endpoint or the secondary stroke-or-death endpoint. However, during the post-procedural period men treated with CAS were at higher risk than their female counterparts.

Rheumatology High Blood Pressure Protocol Reduces Disparities, But Delays Remain for External Primary Care.

BACKGROUND/OBJECTIVE: To address high blood pressure (BP) in rheumatology patients, we previously implemented BP Connect, a brief staff-driven protocol to address high BP. Although timely follow-up and hypertension rates improved for patients with in-system primary care (PC), many receive PC and rheumatology care in separate health systems. In this cohort study, we compared rates of timely PC follow-up for high BP across-system health maintenance organizations (HMOs) before and after BP Connect implementation. METHODS: All adult patients with high rheumatology clinic BP and PC in that HMO were eligible. BP Connect's protocol engaged the staff in remeasuring high BP (≥140/90 mm Hg), advising cardiovascular disease risk, and connecting timely PC follow-up, which for patients with PC across system includes written follow-up instructions. After an eligible rheumatology visit, the next HMO PC visit with BP was used to determine rates and odds of timely follow-up before and after using multivariable logistic regression. RESULTS: Across 1327 rheumatology visits with high BP and across-system PC (2013-2019), 951 occurred after 2015 BP Connect implementation; 400 had confirmed high BP. Primary care follow-up rose from 20.5% to 23.5%. The odds of timely PC BP follow-up insignificantly changed (odds ratio, 1.19; confidence interval, 0.85-1.68). For visits with Black patients, the odds of timely follow-up did significantly increase (1.95; confidence interval, 1.02-3.79). CONCLUSIONS: Timely follow-up for Black patients did improve, highlighting protocol interventions for more equitable health care. In contrast to our prior in-system study, BP Connect did not significantly improve follow-up with an across-system PC, indicating a need for direct scheduling. Future directions include piloting direct across-system scheduling.

The influence of anatomic stage and receptor status on first recurrence for breast cancer within 5 years (AFT-01).

BACKGROUND: Risk-stratified follow-up guidelines that account for the absolute risk and timing of recurrence may improve the quality and efficiency of breast cancer follow-up. The objective of this study was to assess the relationship of anatomic stage and receptor status with timing of the first recurrence for patients with local-regional breast cancer and generate risk-stratified follow-up recommendations. METHODS: The authors conducted a secondary analysis of 8007 patients with stage I-III breast cancer who enrolled in nine Alliance legacy clinical trials from 1997 to 2013 (ClinicalTrials.gov identifier NCT02171078). Patients who received standard-of-care therapy were included. Patients who were missing stage or receptor status were excluded. The primary outcome was days from the earliest treatment start date to the date of first recurrence. The primary explanatory variable was anatomic stage. The analysis was stratified by receptor type. Cox proportional-hazards regression models produced cumulative probabilities of recurrence. A dynamic programming algorithm approach was used to optimize the timing of follow-up intervals based on the timing of recurrence events. RESULTS: The time to first recurrence varied significantly between receptor types (p < .0001). Within each receptor type, stage influenced the time to recurrence (p < .0001). The risk of recurrence was highest and occurred earliest for estrogen receptor (ER)-negative/progesterone receptor (PR)-negative/Her2neu-negative tumors (stage III; 5-year probability of recurrence, 45.5%). The risk of recurrence was lower for ER-positive/PR-positive/Her2neu-positive tumors (stage III; 5-year probability of recurrence, 15.3%), with recurrences distributed over time. Model-generated follow-up recommendations by stage and receptor type were created. CONCLUSIONS: This study supports considering both anatomic stage and receptor status in follow-up recommendations. The implementation of risk-stratified guidelines based on these data has the potential to improve the quality and efficiency of follow-up.

Local/Regional Recurrence Rates After Breast-Conserving Therapy in Patients Enrolled in Legacy Trials of the Alliance for Clinical Trials in Oncology (AFT-01).

OBJECTIVE: We sought to evaluate local/regional recurrence rates after breast-conserving surgery in a cohort of patients enrolled in legacy trials of the Alliance for Clinical Trials in Oncology and to evaluate variation in recurrence rates by receptor subtype. BACKGROUND: Multiple randomized controlled trials have demonstrated equivalent survival between breast conservation and mastectomy, albeit with higher local/regional recurrence rates after breast conservation. However, absolute rates of local/regional recurrence have been declining with multi-modality treatment. METHODS: Data from 5 Alliance for Clinical Trials in Oncology legacy trials that enrolled women diagnosed with breast cancer between 1997 and 2010 were included. Women who underwent breast-conserving surgery and standard systemic therapies (n=4,404) were included. Five-year rates of local/regional recurrence were estimated from Kaplan-Meier curves. Patients were censored at the time of distant recurrence (if recorded as the first recurrence), death, or last follow-up. Multivariable Cox proportional hazards models were used to identify factors associated with time to local/regional recurrence, including patient age, tumor size, lymph node status, and receptor subtype. RESULTS: Overall 5-year recurrence was 4.6% (95% CI=4.0-5.4%). Five-year recurrence rates were lowest in those with ER+ or PR+ tumors (Her2+ 3.4% [95% CI 2.0-5.7%], Her2- 4.0% [95% CI 3.2-4.9%]) and highest in the triple-negative subtype (7.1% [95% CI 5.4-9.3%]). On multivariable analysis, increasing nodal involvement and triple-negative subtype were positively associated with recurrence ( P <0.0001). CONCLUSIONS: Rates of local/regional recurrence after breast conservation in women with breast cancer enrolled in legacy trials of the Alliance for Clinical Trials in Oncology are significantly lower than historic estimates. This data can better inform patient discussions and surgical decision-making.

Identifying Young Adults at High Risk for Weight Gain Using Machine Learning.

INTRODUCTION: Weight gain among young adults continues to increase. Identifying adults at high risk for weight gain and intervening before they gain weight could have a major public health impact. Our objective was to develop and test electronic health record-based machine learning models to predict weight gain in young adults with overweight/class 1 obesity. METHODS: Seven machine learning models were assessed, including three regression models, random forest, single-layer neural network, gradient-boosted decision trees, and support vector machine (SVM) models. Four categories of predictors were included: 1) demographics; 2) obesity-related health conditions; 3) laboratory data and vital signs; and 4) neighborhood-level variables. The cohort was split 60:40 for model training and validation. Area under the receiver operating characteristic curves (AUC) were calculated to determine model accuracy at predicting high-risk individuals, defined by ≥ 10% total body weight gain within 2 y. Variable importance was measured via generalized analysis of variance procedures. RESULTS: Of the 24,183 patients (mean [SD] age, 32.0 [6.3] y; 55.1% females) in the study, 14.2% gained ≥10% total body weight. Area under the receiver operating characteristic curves varied from 0.557 (SVM) to 0.675 (gradient-boosted decision trees). Age, sex, and baseline body mass index were the most important predictors among the models except SVM and neural network. CONCLUSIONS: Our machine learning models performed similarly and had modest accuracy for identifying young adults at risk of weight gain. Future models may need to incorporate behavioral and/or genetic information to enhance model accuracy.

Incidence of radiation-associated sarcoma after breast-conserving surgery plus radiation.

BACKGROUND: Radiation-associated sarcoma (RAS) is a rare sequela of radiotherapy. Radiotherapy modalities for breast conservation and radiation treatment (BCT) have changed over time. We sought to determine if the incidence of RAS after BCT has changed over time. METHODS: We identified breast cancer survivors (diagnosed 1988-2012) treated with BCT within the SEER database. We excluded patients with prior cancer, <1-year follow-up/survival, and nonexternal beam radiation (n = 276 301). We identified patients with a subsequent chest sarcoma diagnosis. The primary predictor variable was a 5-year period of breast cancer diagnosis year (1988-1992, 1993-1997, etc.). The incidence of sarcoma was estimated by the Kaplan-Meier method, censoring at sarcoma diagnosis, death, or last follow-up (available through December 2017). Given the known latency of RAS, we used Joinpoint analysis to identify the time point at which RAS incidence significantly increased (start of the analytic window). A log-rank test assessed differences in RAS incidence by diagnosis year. RESULTS: The incidence of RAS was 0.03% at 5 years (95% confidence interval [CI]: 0.03-0.04) and 0.16% at 10 years (95% CI: 0.14-0.18). No statistical difference in RAS incidence by diagnosis year was observed (p = 0.2). CONCLUSIONS: RAS remains a rare but persistent sequela after BCT. As new radiation modalities become more common, ongoing surveillance is necessary to track these rare events.

A Statewide Approach to Reducing Re-excision Rates for Women With Breast-conserving Surgery.

OBJECTIVE: Test the effectiveness of benchmarked performance reports based on existing discharge data paired with a statewide intervention to implement evidence-based strategies on breast re-excision rates. BACKGROUND: Breast-conserving surgery (BCS) is a common breast cancer surgery performed in a range of hospital settings. Studies have demonstrated variations in post-BCS re-excision rates, identifying it as a high-value improvement target. METHODS: Wisconsin Hospital Association discharge data (2017-2019) were used to compare 60-day re-excision rates following BCS for breast cancer. The analysis estimated the difference in the average change preintervention to postintervention between Surgical Collaborative of Wisconsin (SCW) and nonparticipating hospitals using a logistic mixed-effects model with repeated measures, adjusting for age, payer, and hospital volume, including hospitals as random effects. The intervention included 5 collaborative meetings in 2018 to 2019 where surgeon champions shared guideline updates, best practices/challenges, and facilitated action planning. Confidential benchmarked performance reports were provided. RESULTS: In 2017, there were 3692 breast procedures in SCW and 1279 in nonparticipating hospitals; hospital-level re-excision rates ranged from 5% to >50%. There was no statistically significant baseline difference in re-excision rates between SCW and nonparticipating hospitals (16.1% vs. 17.1%, P =0.47). Re-excision significantly decreased for SCW but not for nonparticipating hospitals (odds ratio=0.69, 95% confidence interval=0.52-0.91). CONCLUSIONS: Benchmarked performance reports and collaborative quality improvement can decrease post-BCS re-excisions, increase quality, and decrease costs. Our study demonstrates the effective use of administrative data as a platform for statewide quality collaboratives. Using existing data requires fewer resources and offers a new paradigm that promotes participation across practice settings.

Barriers to breast reconstruction for socioeconomically disadvantaged women.

PURPOSE: Socioeconomic disparities in post-mastectomy breast reconstruction exist. Key informants have suggested that finding providers who accept Medicaid insurance and longer travel time to a plastic surgeon are important barriers. Our objective was to assess the relationship between these factors and reconstruction for socioeconomically disadvantaged women in Wisconsin. METHODS: We identified women < 75 years of age with stage 0-III breast cancer who underwent mastectomy using the Wisconsin Cancer Reporting System. Women in the most disadvantaged state-based tertile of the Area Deprivation Index were included (n = 1809). Geocoding determined turn-by-turn drive time from women's address to the nearest accredited Commission on Cancer or National Accreditation Program for Breast Centers. Multivariable logistic regression determined the relationship between reconstruction, Medicaid, and travel time, controlling for patient factors known to impact reconstruction. Average adjusted predicted probabilities of receiving reconstruction were calculated. RESULTS: Most patients had early-stage breast cancer (51% stage 0/I) and 15.2% had Medicaid. 37% of women underwent reconstruction. Socioeconomically disadvantaged women with Medicaid (OR = 0.62, 95% CI 0.46-0.84) and longer travel times (OR = 0.99, 95% CI 0.99-1.0) were less likely to receive reconstruction. Patients with the lowest predicted probability of reconstruction were those with Medicaid who lived furthest from a plastic surgeon. CONCLUSION: Among socioeconomically disadvantaged women, Medicaid and travel remained associated with lower rates of reconstruction. Further work will explore opportunities to improve access to reconstruction for women with Medicaid. This is particularly challenging as it may require socioeconomically disadvantaged women to travel further to receive care.

Obesity and "obesity-related" cancers: are there body mass index cut-points?

BACKGROUND: Despite compelling links between excess body weight and cancer, body mass index (BMI) cut-points, or thresholds above which cancer incidence increased, have not been identified. The objective of this study was to determine if BMI cut-points exist for 14 obesity-related cancers. SUBJECTS/METHODS: In this retrospective cohort study, patients 18-75 years old were included if they had ≥2 clinical encounters with BMI measurements in the electronic health record (EHR) at a single academic medical center from 2008 to 2018. Patients who were pregnant, had a history of cancer, or had undergone bariatric surgery were excluded. Adjusted logistic regression was performed to identify cancers that were associated with increasing BMI. For those cancers, BMI cut-points were calculated using adjusted quantile regression for cancer incidence at 80% sensitivity. Logistic and quantile regression models were adjusted for age, sex, race/ethnicity, and smoking status. RESULTS: A total of 7079 cancer patients (mean age 58.5 years, mean BMI 30.5 kg/m2) and 270,441 non-cancer patients (mean age 43.8 years, mean BMI 28.8 kg/m2) were included in the study. In adjusted logistic regression analyses, statistically significant associations were identified between increasing BMI and the incidence of kidney, thyroid, and uterine cancer. BMI cut-points were identified for kidney (26.3 kg/m2) and uterine (26.9 kg/m2) cancer. CONCLUSIONS: BMI cut-points that accurately predicted development kidney and uterine cancer occurred in the overweight category. Analysis of multi-institutional EHR data may help determine if these relationships are generalizable to other health care settings. If they are, incorporation of BMI into the screening algorithms for these cancers may be warranted.

Treatment of carotid stenosis in asymptomatic, nonoctogenarian, standard risk patients with stenting versus endarterectomy trials.

OBJECTIVE: Asymptomatic carotid stenosis is the most frequent indication for carotid endarterectomy (CEA) in the United States. Published trials and guidelines support CEA indications in selected patients with longer projected survival and when periprocedural complications are low. Transfemoral carotid artery stenting with embolic protection (CAS) is a newer treatment option. The objective of this study was to compare outcomes in asymptomatic, nonoctogenarian patients treated with CAS vs CEA. METHODS: Patient-level data was analyzed from 2544 subjects with ≥70% asymptomatic carotid stenosis who were randomized to CAS or CEA in addition to standard medical therapy. One trial enrolled 1091 (548 CAS, 543 CEA) and another enrolled 1453 (1089 CAS, 364 CEA) asymptomatic patients less than 80 years old (upper age eligibility). Independent neurologic assessment and routine cardiac enzyme screening were performed. The prespecified, primary composite endpoint was any stroke, myocardial infarction, or death during the periprocedural period or ipsilateral stroke within 4 years after randomization. RESULTS: There was no significant difference in the primary endpoint between CAS and CEA (5.3% vs 5.1%; hazard ratio, 1.02; 95% confidence interval, 0.7-1.5; P = .91). Periprocedural rates for the components are (CAS vs CEA): any stroke (2.7% vs 1.5%; P = .07), myocardial infarction (0.6% vs 1.7%; P = .01), death (0.1% vs 0.2%; P = .62), and any stroke or death (2.7% vs 1.6%; P = .07). After this period, the rates of ipsilateral stroke were similar (2.3% vs 2.2%; P = .97). CONCLUSIONS: In a pooled analysis of two large randomized trials of CAS and CEA in asymptomatic, nonoctogenarian patients, CAS achieves comparable short- and long-term results to CEA.

Analysis of the Impact of the COVID-19 Pandemic on the Multidisciplinary Management of Breast Cancer: Review from the American Society of Breast Surgeons COVID-19 and Mastery Registries.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has resulted in rapid and regionally different approaches to breast cancer care. METHODS: In order to evaluate these changes, a COVID-19-specific registry was developed within the American Society of Breast Surgeons (ASBrS) Mastery that tracked whether decisions were usual or modified for COVID-19. Data on patient care entered into the COVID-19-specific registry and the ASBrS Mastery registry from 1 March 2020 to 15 March 2021 were reviewed. RESULTS: Overall, 177 surgeons entered demographic and treatment data on 2791 patients. Mean patient age was 62.7 years and 9.0% (252) were of African American race. Initial consultation occurred via telehealth in 6.2% (173) of patients and 1.4% (40) developed COVID-19. Mean invasive tumor size was 2.1 cm and 17.8% (411) were node-positive. In estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) disease, neoadjuvant endocrine therapy (NET) was used as the usual approach in 6.9% (119) of patients and due to COVID-19 in an additional 31% (542) of patients. Patients were more likely to receive NET due to COVID-19 with increasing age and if they lived in the Northeast or Southeast (odds ratio [OR] 1.1, 2.3, and 1.7, respectively; p < 0.05). Genomic testing was performed on 51.5% (781) of estrogen-positive patients, of whom 20.7% (162) had testing on the core due to COVID-19. Patients were less likely to have core biopsy genomic testing due to COVID-19 if they were older (OR 0.89; p = 0.01) and more likely if they were node-positive (OR 4.0; p < 0.05). A change in surgical approach due to COVID-19 was reported for 5.4% (151) of patients. CONCLUSION: The ASBrS COVID-19 registry provided a platform for monitoring treatment changes due to the pandemic, highlighting the increased use of NET.

Pre-transplant bariatric surgery is associated with increased fungal infection after liver transplant.

AIM: The impact of pre-transplant (pre-TXP) bariatric surgery (BS) on outcomes after liver transplant (LTX) has not been completely elucidated. Roux-en Y gastric bypass (RYGB) is one of the most common BS procedures. The primary objective of this study was to identify the risk of infection in LTX recipients with pre-TXP RYGB. METHODS: Adult patients with LTX between 1/1/2001 and 9/30/2018 at our center were screened for pre-TXP RYGB; patients with gastrectomy via sleeve or banding were excluded. Patients with no history of BS pre- or post-transplant were placed in a comparator group, matched 2:1 via incidence density sampling on age epoch. RESULTS: There were 16 LTX recipients with pre-TXP RYGB matched to 32 controls. Median time from RYGB to transplant was 11.7 years. Mean weight loss was 66 ± 19 kg. There were significantly more women with pre-TXP RYGB than in the matched control (RYGB:68.8% vs control:25%, P = .009). Demographics were otherwise similar between groups. Pre-TXP RYGB did not significantly increase hospital or ICU length of stay (P = .5, P = .3) but was associated with a significantly increased rate of fungal infection at 1 year (RYGB:33.4% vs control:9.7%, P = .01), and a numerical trend to increased bacterial infection (RYGB:56.2% vs control:32.2%, P = .09). CONCLUSION: Despite the substantial weight loss attributed to BS, patients with pre-TXP RYGB demonstrated increased rates of fungal infection after transplant and trended toward increased bacterial infection. While the anatomical complexity associated with LTX surgery after RYGB did not appear to significantly affect ICU or hospital length of stay, it may have contributed to overall infectious risk, and possibly to impaired survival. Additionally, bypass of the host natural barrier defenses of the stomach could also have contributed to infectious risk. Our findings highlight the complexity of this patient population. Future prospective studies are needed to investigate risk of infection after LTX in the setting of pre-Txp BS. Potential modification in fungal prophylaxis protocols to include pre-TXP RYGB may be warranted.

Regularized Ordinal Regression and the ordinalNet R Package.

Regularization techniques such as the lasso (Tibshirani 1996) and elastic net (Zou and Hastie 2005) can be used to improve regression model coefficient estimation and prediction accuracy, as well as to perform variable selection. Ordinal regression models are widely used in applications where the use of regularization could be beneficial; however, these models are not included in many popular software packages for regularized regression. We propose a coordinate descent algorithm to fit a broad class of ordinal regression models with an elastic net penalty. Furthermore, we demonstrate that each model in this class generalizes to a more flexible form, that can be used to model either ordered or unordered categorical response data. We call this the elementwise link multinomial-ordinal (ELMO) class, and it includes widely used models such as multinomial logistic regression (which also has an ordinal form) and ordinal logistic regression (which also has an unordered multinomial form). We introduce an elastic net penalty class that applies to either model form, and additionally, this penalty can be used to shrink a non-ordinal model toward its ordinal counterpart. Finally, we introduce the R package ordinalNet, which implements the algorithm for this model class.

Breast Cancer Outcomes of Neoadjuvant Versus Adjuvant Chemotherapy by Receptor Subtype: A Scoping Review.

BACKGROUND: Trials demonstrate equivalent survival for breast cancers treated with neoadjuvant chemotherapy (NAC) or adjuvant chemotherapy (AC). However, these were conducted before the recognition of the importance of receptor subtype for survival and chemotherapy response. Therefore, chemotherapy timing may impact survival for certain receptor subtypes. A scoping review of studies assessing outcomes by chemotherapy timing based on receptor subtype was conducted to evaluate gaps in the existing literature. METHODS: Three databases were searched in February 2019 with terms related to breast cancer, NAC/AC, and survival. Inclusion criteria were original peer-reviewed studies published in English after 1989 comparing breast cancer outcomes for females based on chemotherapy timing. Studies/sections of studies lacking outcomes by receptor subtype or including patients missing appropriate targeted therapy were excluded. RESULTS: Of 7354 articles, 262 abstracts and 60 full texts were reviewed. Three studies met criteria. All were single-institution retrospective studies analyzing outcomes for triple negative (TN) patients with one study also examining luminal A patients. Significant differences in clinical characteristics existed between patients selected for NAC versus AC. Two studies demonstrated no survival difference by chemotherapy timing for TN patients, with the third showing improved likelihood of survival after AC for TN patients. No difference was seen for patients with luminal A cancer. CONCLUSIONS: Our scoping review reveals a significant gap in the existing literature regarding optimal timing of chemotherapy for modern-era patients receiving targeted therapy based on receptor subtype. Review of the identified studies identified methodological challenges to answering this question through observational study designs.

Time to initiation of neo-adjuvant chemotherapy for breast cancer treatment does not influence patient survival: A study of US breast cancer patients.

Delays in the initiation of adjuvant chemotherapy or radiation therapy are associated with worse outcomes in patients undergoing treatment for breast cancer. However, the impact of the time to initiation of neo-adjuvant chemotherapy (NAC) on patient outcomes has not previously been studied. The purpose of this study was to determine whether delays in NAC initiation impact patient survival. The National Cancer Database was queried for women ≥ 18 years old who underwent NAC within 6 months of being diagnosed with stage I-III invasive breast cancer in 2010-2011. ER+ or PR+, Her2- cancers were excluded from analysis. Multivariable Cox proportional hazard modeling was used to evaluate the relationship between time to NAC, sociodemographic, diagnosis, and treatment factors with patient survival. The median age of the 12 806 women included in this study was 52 (range 21-90) with 62% presenting with cT2 disease and 62% with nodal involvement. Half of the women (50%) had triple negative, 30% ER/PR+Her2+ and 20% ER-PR-Her2+ cancers. The median time to starting NAC was 4 weeks (range 0-26) for all subtypes. Time to NAC initiation was not associated with a difference in survival for triple negative or Her2+ cancers. Delays from diagnosis to starting NAC are not associated with worse survival for patients with Her2+ or triple negative breast cancer. This study demonstrates that the majority of women in the modern era start NAC in a timely fashion and delays in starting NAC within 6 months of diagnosis do not impact long-term patient outcomes.

Natural history and cost analysis of surgical bypass versus endoscopic stenting for the palliative management of malignant gastric outlet obstruction.

BACKGROUND: Malignant gastric outlet obstruction (GOO) is managed with palliative surgical bypass or endoscopic stenting. Limited data exist on differences in cost and outcomes. METHODS: Patients with malignant GOO undergoing palliative gastrojejunostomy (GJ) or endoscopic stent (ES) were identified between 2012 and 2015 using the MarketScan® Database. Median costs (payments) for the index procedure and 90-day readmissions and re-intervention were calculated. Frequency of treatment failure-defined as repeat surgery, stenting, or gastrostomy tube-was measured. RESULTS: A total of 327 patients were included: 193 underwent GJ and 134 underwent ES. Compared to GJ, stenting resulted in lower total median payments for the index hospitalization and procedure-related 90-day readmissions ($18,500 ES vs. $37,200 GJ, p = 0.032). For patients treated with ES, 25 (19%) required a re-intervention for treatment-failure, compared to 18 (9%) patients who underwent GJ (p = 0.010). On multivariable analysis, stenting remained significantly associated with need for secondary re-intervention compared to GJ (HR for ES 2.0 [1.1-3.8], p 0.028). CONCLUSION: In patients with malignant GOO, endoscopic stenting results in significant 90-day cost saving, however was associated with twice the rate of secondary intervention. The decision for surgical bypass versus endoscopic stenting should consider patient prognosis, anticipated cost, and likelihood of needing re-intervention.