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.

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.

Characterizing the Use of Time-Limited Trials in Patients With Acute Respiratory Failure: A Prospective, Single-Center Observational Study.

IMPORTANCE: A time-limited trial (TLT) is a collaborative plan among clinicians, patients, and families to use life-sustaining therapy for a defined duration, after which the patient's response informs whether to continue care directed toward recovery or shift the focus toward comfort. TLTs are a promising approach to help navigate uncertainty in critical illness, yet little is known about their current use. OBJECTIVES: To characterize TLT use in patients with acute respiratory failure (ARF). DESIGN, SETTING, AND PARTICIPANTS: Prospective 12-month observational cohort study at an U.S. academic medical center of adult ICU patients with ARF receiving invasive mechanical ventilation for greater than or equal to 48 hours. MAIN OUTCOMES AND MEASURES: Primary exposure was TLT participation, identified by patients' ICU physician. Patient characteristics, care delivery elements, and hospital outcomes were extracted from the electronic medical record. RESULTS: Among 176 eligible patients, 36 (20.5%) participated in a TLT. Among 18 ICU attending physicians, nine (50%) participated in greater than or equal to 1 TLT (frequency 0-39% of patients cared for). Median TLT duration was 3.0 days (interquartile range [IQR], 3.0-4.5 d). TLT patients had a higher mean age (67.4 yr [sd, 12.0 yr] vs. 60.0 yr [sd, 16.0 yr]; p < 0.01), higher Charlson Comorbidity Index (5.1 [sd, 2.2] vs. 3.8 [sd, 2.6]; p < 0.01), and similar Sequential Organ Failure Assessment score (9.6 [sd, 3.3] vs. 9.5 [sd, 3.7]; p = 0.93), compared with non-TLT patients. TLT patients were more likely to die or be discharged to hospice (80.6% vs. 42.1%; p < 0.05) and had shorter ICU length of stay (median, 5.7 d [IQR, 4.0-9.0 d] vs. 10.3 d [IQR, 5.5-14.5 d]; p < 0.01). CONCLUSIONS AND RELEVANCE: In this study, approximately one in five patients with ARF participated in a TLT. Our findings suggest TLTs are used primarily in patients near end of life but with substantial physician variation, highlighting a need for evidence to guide optimal use.

Best Case/Worst Case-ICU: protocol for a multisite, stepped-wedge, randomised clinical trial of scenario planning to improve communication in the ICU in US trauma centres for older adults with serious injury.

INTRODUCTION: Poor communication about serious injury in older adults can lead to treatment that is inconsistent with patient preferences, create conflict and strain healthcare resources. We developed a communication intervention called Best Case/Worst Case-intensive care unit (ICU) that uses daily scenario planning, that is, a narrative description of plausible futures, to support prognostication and facilitate dialogue among patients, their families and the trauma ICU team. This article describes a protocol for a multisite, randomised, stepped-wedge study to test the effectiveness of the intervention on the quality of communication (QOC) in the ICU. METHODS AND ANALYSIS: We will follow all patients aged 50 and older admitted to the trauma ICU for 3 or more days after a serious injury at eight high-volume level 1 trauma centres. We aim to survey one family or 'like family' member per eligible patient 5-7 days following their loved ones' admission and clinicians providing care in the trauma ICU. Using a stepped-wedge design, we will use permuted block randomisation to assign the timing for each site to begin implementation of the intervention and routine use of the Best Case/Worst Case-ICU tool. We will use a linear mixed-effects model to test the effect of the tool on family-reported QOC (using the QOC scale) as compared with usual care. Secondary outcomes include the effect of the tool on reducing clinician moral distress (using the Measure of Moral Distress for Healthcare Professionals scale) and patients' length of stay in the ICU. ETHICS AND DISSEMINATION: Institutional review board (IRB) approval was granted at the University of Wisconsin, and all study sites ceded review to the primary IRB. We plan to report results in peer-reviewed publications and national meetings. TRIAL REGISTRATION NUMBER: NCT05780918.

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.

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.

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.

Embedding an Education Intervention about Shared Decision Making into an RCT: Ensuring competency and fidelity.

Objective: To describe the outcomes of training nephrology clinicians and clinical research participants, to use the Best Case/Worst Case Communication intervention, for discussions about dialysis initiation for patients with life-limiting illness, during a randomized clinical trial to ensure competency, fidelity to the intervention, and adherence to study protocols and the intervention throughout the trial. Methods: We enrolled 68 nephrologists at ten study sites and randomized them to receive training or wait-list control. We collected copies of completed graphic aids (component of the intervention), used with study-enrolled patients, to measure fidelity and adherence. Results: We trained 34 of 36 nephrologists to competence and 27 completed the entire program. We received 60 graphic aids for study-enrolled patients for a 73% return rate in the intervention arm. The intervention fidelity score for the graphic aid reflected completion of all elements throughout the study. Conclusion: We successfully taught the Best Case/Worst Case Communication intervention to clinicians as research participants within a randomized clinical trial. Innovation: Decisions about dialysis are an opportunity to discuss prognosis and uncertainty in relation to consideration of prolonged life supporting therapy. Our study reveals a strategy to evaluate adherence to a communication intervention in real time during a clinical study.

"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.

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.

Catastrophic health expenditure in nonneurological injury due to motor vehicle crash.

BACKGROUND: Motor vehicle crashes (MVCs) are a leading cause of nonfatal injury in the United States and impose a high financial cost to the patient and the economy. For many patients, this cost may be financially devastating and contribute to worsening health outcomes after injury. We aimed to describe the population level risk of catastrophic health expenditure (CHE) and determine factors associated with risk of CHE. METHODS: We performed a retrospective review using the 2014-2017 Nationwide Inpatient Sample. The study population consisted of uninsured and privately insured adults aged 26 to 64 years who were hospitalized for nonneurologic traumatic injury due to MVCs. Our measure of financial hardship was CHE, which was defined as hospital charges ≥40% of postsubsistence income. Income estimates were derived from zip-code level data using Γ distribution modeling. RESULTS: Our sample included 189,000 patients, of which 149,705 had private insurance and 39,375 were uninsured. The median estimated income for the study cohort was $66,118 (interquartile range, $65,353-$66,884). The median cost of hospitalization was $53,467 (interquartile range, $29,854-$99,914). In addition, 91.5% of uninsured patients suffering from MVC are at risk for CHE, and 10.1% of privately insured patients are at risk for CHE. Among the insured, Black, Hispanic, and low income were associated with CHE. CONCLUSION: Nine of 10 uninsured patients are at risk for CHE after hospitalization for MVC. Despite having insurance, 10% of patients are still at risk of CHE. Black, Hispanic, and low-income communities are at highest risk of having private insurance and still experiencing CHE. This is the first population level analysis after the implementation of the Affordable Care Act that assesses the financial burden of no insurance and underinsurance. These data are important to understand the effectiveness of insurance coverage and guide hospital and policy level interventions to prevent CHE. LEVEL OF EVIDENCE: Prognostic and Epidemiological; Level III.

Identifying Patterns in Preoperative Communication about High-Risk Surgical Intervention: A Secondary Analysis of a Randomized Clinical Trial.

INTRODUCTION: Surgeons are entrusted with providing patients with information necessary for deliberation about surgical intervention. Ideally, surgical consultations generate a shared understanding of the treatment experience and determine whether surgery aligns with a patient's overall health goals. In-depth assessment of communication patterns might reveal opportunities to better achieve these objectives. METHODS: We performed a secondary analysis of audio-recorded consultations between surgeons and patients considering high-risk surgery. For 43 surgeons, we randomly selected 4 transcripts each of consultations with patients aged ≥60 y with at least 1 comorbidity. We developed a coding taxonomy, based on principles of informed consent and shared decision making, to categorize surgeon speech. We grouped transcripts by treatment plan and recorded the treatment goal. We used box plots, Sankey diagrams, and flow diagrams to characterize communication patterns. RESULTS: We included 169 transcripts, of which 136 discussed an oncologic problem and 33 considered a vascular (including cardiac and neurovascular) problem. At the median, surgeons devoted an estimated 8 min (interquartile range 5-13 min) to content specifically about intervention including surgery. In 85.5% of conversations, more than 40% of surgeon speech was consumed by technical descriptions of the disease or treatment. "Fix-it" language was used in 91.7% of conversations. In 79.9% of conversations, no overall goal of treatment was established or only a desire to cure or control cancer was expressed. Most conversations (68.6%) began with an explanation of the disease, followed by explanation of the treatment in 53.3%, and then options in 16.6%. CONCLUSIONS: Explanation of disease and treatment dominate surgical consultations, with limited time spent on patient goals. Changing the focus of these conversations may better support patients' deliberation about the value of surgery.Trial registration: ClinicalTrials.gov Identifier: NCT02623335. HIGHLIGHTS: In decision-making conversations about high-risk surgical intervention, surgeons emphasize description of the patient's disease and potential treatment, and the use of "fix-it" language is common.Surgeons dedicated limited time to eliciting patient preferences and goals, and 79.9% of conversations resulted in no explicit goal of treatment.Current communication practices may be inadequate to support deliberation about the value of surgery for individual patients and their families.

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.

Reexamining Time From Breast Cancer Diagnosis to Primary Breast Surgery.

Importance: Although longer times from breast cancer diagnosis to primary surgery have been associated with worse survival outcomes, the specific time point after which it is disadvantageous to have surgery is unknown. Identifying an acceptable time to surgery would help inform patients, clinicians, and the health care system. Objective: To examine the association between time from breast cancer diagnosis to surgery (in weeks) and overall survival and to describe factors associated with surgical delay. The hypothesis that there is an association between time to surgery and overall survival was tested. Design, Setting, and Participants: This was a case series study that used National Cancer Database (NCDB) data from female individuals diagnosed with breast cancer from 2010 to 2014 (with 5-year follow-up to 2019). The NCDB uses hospital registry data from greater than 1500 Commission on Cancer-accredited facilities, accounting for 70% of all cancers diagnosed in the US. Included participants were females 18 years or older with stage I to III ductal or lobular breast cancer who underwent surgery as the first course of treatment. Patients with prior breast cancer, missing receptor information, neoadjuvant or experimental therapy, or who were diagnosed with breast cancer on the date of their primary surgery were excluded. Multivariable Cox regression was used to evaluate factors associated with overall survival. Patients were censored at death or last follow-up. Covariates included age and tumor characteristics. Multinomial regression was performed to identify factors associated with longer time to surgery, using surgery 30 days or less from diagnosis as the reference group. Data were analyzed from March 15 to July 7, 2022. Exposures: Time to receipt of primary breast surgery. Measures: The primary outcome measure was overall survival. Results: The final cohort included 373 334 patients (median [IQR] age, 61 [51-70] years). On multivariable Cox regression analysis, time to surgery 9 weeks (57-63 days) or later after diagnosis was associated with worse overall survival (hazard ratio, 1.15; 95% CI, 1.08-1.23; P < .001) compared with surgery between 0 to 4 weeks (1-28 days). By multinomial regression, factors associated with longer times to surgery (using surgery 1-30 days from diagnosis as a reference) included the following: (1) younger age, eg, the adjusted odds ratio (OR) for patients 45 years or younger undergoing surgery 31 to 60 days from diagnosis was 1.32 (95% CI, 1.28-1.38); 61 to 74 days, 1.64 (95% CI, 1.52-1.78); and greater than 74 days, 1.58 (95% CI, 1.46-1.71); (2) uninsured or Medicaid status, eg, the adjusted OR for patients with Medicaid undergoing surgery 31 to 60 days from diagnosis was 1.35 (95% CI, 1.30-1.39); 61 to 74 days, 2.13 (95% CI, 2.01-2.26); and greater than 74 days, 3.42 (95% CI, 3.25-3.61); and (3) lower neighborhood household income, eg, the adjusted OR for patients with household income less than $38,000 undergoing surgery 31 to 60 days from diagnosis was 1.35 (95% CI, 1.02-1.07); 61 to 74 days, 1.21 (95% CI, 1.15-1.27); and greater than 74 days, 1.53 (95% CI, 1.46-1.61). Conclusions and Relevance: Findings of this case series study suggest the use of 8 weeks or less as a quality metric for time to surgery. Time to surgery of greater than 8 weeks may partly be associated with disadvantageous social determinants of health.

Greater patient sharing between hospitals is associated with better outcomes for transferred emergency general surgery patients.

BACKGROUND: Access to emergency surgical care has declined as the rural workforce has decreased. Interhospital transfers of patients are increasingly necessary, and care coordination across settings is critical to quality care. We characterize the role of repeated hospital patient sharing in outcomes of transfers for emergency general surgery (EGS) patients. METHODS: A multicenter study of Wisconsin inpatient acute care hospital stays that involved transfer of EGS patients using data from the Wisconsin Hospital Association, a statewide hospital discharge census for 2016 to 2018. We hypothesized that higher proportion of patients transferred between hospitals would result in better outcomes. We examined the association between the proportion of EGS patients transferred between hospitals and patient outcomes, including in-hospital morbidity, mortality, and length of stay. Additional variables included hospital organizational characteristics and patient sociodemographic and clinical characteristics. RESULTS: One hundred eighteen hospitals transferred 3,197 emergency general surgery patients over the 2-year study period; 1,131 experienced in-hospital morbidity, mortality, or extended length of stay (>75th percentile). Patients were 62 years old on average, 50% were female, and 5% were non-White. In the mixed-effects model, hospitals' proportion of patients shared was associated with lower odds of an in-hospital complication; specifically, when the proportion of patients shared between two hospitals doubled, the relative odds of any outcome changed by 0.85. CONCLUSION: Our results suggest the importance of emergent relationships between hospital dyads that share patients in quality outcomes. Transfer protocols should account for established efficiencies, familiarity, and coordination between hospitals. LEVEL OF EVIDENCE: Prognostic and Epidemiological; Level III.

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.

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.

Increasing socioeconomically disadvantaged patients' engagement in breast cancer surgery decision-making through a shared decision-making intervention (A231701CD): protocol for a cluster randomised clinical trial.

INTRODUCTION: Socioeconomic disparities for breast cancer surgical care exist. Although the aetiology of the observed socioeconomic disparities is likely multifactorial, patient engagement during the surgical consult is critical. Shared decision-making may reduce health disparities by addressing barriers to patient engagement in decision-making that disproportionately impact socioeconomically disadvantaged patients. In this trial, we test the impact of a decision aid on increasing socioeconomically disadvantaged patients' engagement in breast cancer surgery decision-making. METHODS AND ANALYSIS: This multisite randomised trial is conducted through 10 surgical clinics within the National Cancer Institute Community Oncology Research Program (NCORP). We plan a stepped-wedge design with clinics randomised to the time of transition from usual care to the decision aid arm. Study participants are female patients, aged ≥18 years, with newly diagnosed stage 0-III breast cancer who are planning breast surgery. Data collection includes a baseline surgeon survey, baseline patient survey, audio-recording of the surgeon-patient consultation, a follow-up patient survey and medical record data review. Interviews and focus groups are conducted with a subset of patients, surgeons and clinic stakeholders. The effectiveness of the decision aid at increasing patient engagement (primary outcome) is evaluated using generalised linear mixed-effects models. The extent to which the effect of the decision aid intervention on patient engagement is mediated through the mitigation of barriers is tested in joint linear structural equation models. Qualitative interviews explore how barriers impact engagement, especially for socioeconomically disadvantaged women. ETHICS AND DISSEMINATION: This protocol has been approved by the National Cancer Institute Central Institutional Review Board, and Certificate of Confidentiality has been obtained. We plan to disseminate the findings through journal publications and national meetings, including the NCORP network. Our findings will advance the science of medical decision-making with the potential to reduce socioeconomic health disparities. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03766009).

Best Case/Worst Case: protocol for a multisite randomised clinical trial of a scenario planning intervention for patients with kidney failure.

INTRODUCTION: Given the burdens of treatment and poor prognosis, older adults with kidney failure would benefit from improved decision making and palliative care to clarify goals, address symptoms, and reduce unwanted procedures. Best Case/Worst Case (BC/WC) is a communication tool that uses scenario planning to support patients' decision making. This article describes the protocol for a multisite, cluster randomised trial to test the effect of training nephrologists to use the BC/WC communication tool on patient receipt of palliative care, and quality of life and communication. METHODS AND ANALYSIS: We are enrolling attending nephrologists, at 10 study sites in the USA, who see outpatients with advanced chronic kidney disease considering dialysis. We aim to enrol 320 patients with an estimated glomerular filtration rate of ≤24 mL/min/1.73 m2 who are age 60 and older and have a predicted survival of 18 months or less. Nephrologists will be randomised in a 1:1 ratio to receive training to use the communication tool (intervention) at study initiation or after study completion (wait-list control). Patients in the intervention group will receive care from a nephrologist trained to use the BC/WC communication tool. Patients in the control group will receive usual care. Using chart review and surveys of patients and caregivers, we will test the efficacy of the BC/WC intervention with receipt of palliative care as the primary outcome. Secondary outcomes include intensity of treatment at the end of life, the effect of the intervention on quality of communication (QOC) between nephrologists and patients (using the QOC scale), the change in quality of life (using the Functional Assessment of Chronic Illness Therapy-Palliative Care scale) and receipt of dialysis. ETHICS AND DISSEMINATION: Approvals have been granted by the Institutional Review Board at the University of Wisconsin (ID: 2022-0193), with each study site ceding review to the primary IRB. All nephrologists will be consented and given a copy of the consent form. No patients or caregivers will be recruited or consented until their nephrology provider has chosen to participate in the study. Results will be disseminated via submission for publication in a peer-reviewed journal and at national meetings. TRIAL REGISTRATION NUMBER: NCT04466865.