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Patient and Caregiver Support for Serious Illness (PACSSI), a per-member per-month (PMPM) alternative reimbursement structure for palliative care (PC) services, has been described as overly generous by HHS. We developed a modified version, PACSSI-Flexible (PACSSI-F), by modeling reimbursement for PC based on the changes in patient functional status. We estimated reimbursement for the first year that an organization might implement the PACSSI-F for PC services.Secondary analysis using data from the Statin Discontinuation in Advanced Illness Trial.We evaluated the PACSSI vs the PACSSI-F in 3 phases. In the first phase, we calculated variable-appropriate frequencies/relative frequencies or means/SDs for the study population's available demographics and comorbidities, focusing on age, Charlson Comorbidity Index score, race and ethnicity, gender, and continued statin use. Exploratory analyses specific to reimbursement were conducted in a second phase. For each payment structure, we calculated the (1) mean (SD) total reimbursement and (2) number of weeks that a health care system would receive reimbursement, with both weekly and PMPM (4-week) averages. The third phase was designed to quantify any within-person (paired) differences in reimbursement between the original PACSSI and the PACSSI-F.PACSSI-F provides reimbursement for sustainable PC services and was cost-advantageous over PACSSI by $69.92 PMPM for 28.6% of the seriously ill population.Modeling of the PACSSI-F using secondary data provides a novel example of economic forecasting for alternative reimbursement structures in PC. Alternative reimbursement payment policies are necessary to expand PC for the seriously ill population.

Use of sleeve gastrectomy (SG) for weight loss has grown exponentially; however, clear indications for SG versus Roux-en-Y gastric bypass (RNYGB) are lacking. Certain populations may be more likely to undergo SG due to its simpler technique and without clear clinical indications. We aim to examine underlying predictors of patients undergoing SG vs RNY across a single state.We queried the Colorado All Payers Claim Database for patients undergoing laparoscopic SG or RNY. Patient-level variables included patient demographics, comorbidities, distance traveled for surgery, and distressed communities index (DCI), a zip code-based measure of socioeconomic status. Hospital-level variables included annual bariatric surgery volume, academic status, and whether hospitals were a bariatric Center of Excellence. We performed mixed-effects logistic regression adjusting for demographics, insurance coverage, and comorbidities to compare odds of undergoing SG vs RNY, with a random effect for hospital.5,017 patients were included with 3,042 (60.6%) undergoing SG and 1,975 (39.4%) undergoing RNY. On multivariable analysis, patients with a high DCI were not more likely to undergo a SG (OR 1.18, CI 0.89-1.55, p = 0.25). However, patients who underwent surgery at hospitals serving the greatest proportion of those from highly distressed communities were significantly more likely to undergo SG (OR 4.22, CI 1.38-12.96, p = 0.01). Patients managed at Bariatric Centers of Excellence were less likely to undergo SG (OR 0.22, CI 0.07-0.62, p = 0.005). Patients with higher BMI, diabetes, or GERD were all more likely to undergo RNY.While patients with high DCI were more likely to undergo SG on univariate analysis, these associations disappeared after addition of a hospital-level random effect, suggesting that disparities may be due access to surgeons or systems with preference for one procedure. However, hospitals serving a higher proportion of high-DCI patients are more likely to utilize SG.

This Viewpoint discusses the opportunities and risks of using 3 main areas of artificial intelligence in surgery: computer vision, digital transformation at the point of care, and electronic health records data.

ImportanceInvolvement of palliative care specialists in the care of medical oncology patients has been repeatedly observed to improve patient-reported outcomes, but there is no analogous research in surgical oncology populations.ObjectiveTo determine whether surgeon–palliative care team comanagement, compared with surgeon team alone management, improves patient-reported perioperative outcomes among patients pursuing curative-intent surgery for high morbidity and mortality upper gastrointestinal (GI) cancers.Design, Setting, and ParticipantsFrom October 20, 2018, to March 31, 2022, a patient-randomized clinical trial was conducted with patients and clinicians nonblinded but the analysis team blinded to allocation. The trial was conducted in 5 geographically diverse academic medical centers in the US. Individuals pursuing curative-intent surgery for an upper GI cancer who had received no previous specialist palliative care were eligible. Surgeons were encouraged to offer participation to all eligible patients.InterventionSurgeon–palliative care comanagement patients met with palliative care either in person or via telephone before surgery, 1 week after surgery, and 1, 2, and 3 months after surgery. For patients in the surgeon-alone group, surgeons were encouraged to follow National Comprehensive Cancer Network–recommended triggers for palliative care consultation.Main Outcomes and MeasuresThe primary outcome of the trial was patient-reported health-related quality of life at 3 months following the operation. Secondary outcomes were patient-reported mental and physical distress. Intention-to-treat analysis was performed.ResultsIn total, 359 patients (175 [48.7%] men; mean [SD] age, 64.6 [10.7] years) were randomized to surgeon-alone (n = 177) or surgeon–palliative care comanagement (n = 182), with most patients (206 [57.4%]) undergoing pancreatic cancer surgery. No adverse events were associated with the intervention, and 11% of patients in the surgeon-alone and 90% in the surgeon–palliative care comanagement groups received palliative care consultation. There was no significant difference between study arms in outcomes at 3 months following the operation in patient-reported health-related quality of life (mean [SD], 138.54 [28.28] vs 136.90 [28.96]; P = .62), mental health (mean [SD], −0.07 [0.87] vs −0.07 [0.84]; P = .98), or overall number of deaths (6 [3.7%] vs 7 [4.1%]; P > .99).Conclusions and RelevanceTo date, this is the first multisite randomized clinical trial to evaluate perioperative palliative care and the earliest integration of palliative care into cancer care. Unlike in medical oncology practice, the data from this trial do not suggest palliative care–associated improvements in patient-reported outcomes among patients pursuing curative-intent surgeries for upper GI cancers.Trial RegistrationClinicalTrials.gov Identifier: NCT03611309

ImportanceStandardized processes for identifying when allergic-type reactions occur and linking reactions to drug exposures are limited.ObjectiveTo develop an informatics tool to improve detection of antibiotic allergic-type events.Design, Setting, and ParticipantsThis retrospective cohort study was conducted from October 1, 2015, to September 30, 2019, with data analyzed between July 1, 2021, and January 31, 2022. The study was conducted across Veteran Affairs hospitals among patients who underwent cardiovascular implantable electronic device (CIED) procedures and received periprocedural antibiotic prophylaxis. The cohort was split into training and test cohorts, and cases were manually reviewed to determine presence of allergic-type reaction and its severity. Variables potentially indicative of allergic-type reactions were selected a priori and included allergies entered in the Veteran Affair’s Allergy Reaction Tracking (ART) system (either historical [reported] or observed), allergy diagnosis codes, medications administered to treat allergic reactions, and text searches of clinical notes for keywords and phrases indicative of a potential allergic-type reaction. A model to detect allergic-type reaction events was iteratively developed on the training cohort and then applied to the test cohort. Algorithm test characteristics were assessed.ExposurePreprocedural and postprocedural prophylactic antibiotic administration.Main Outcomes and MeasuresAntibiotic allergic-type reactions.ResultsThe cohort of 36 344 patients included 34 703 CIED procedures with antibiotic exposures (mean [SD] age, 72 [10] years; 34 008 [98%] male patients); median duration of postprocedural prophylaxis was 4 days (IQR, 2-7 days; maximum, 45 days). The final algorithm included 7 variables: entries in the Veteran Affair’s hospitals ART, either historic (odds ratio [OR], 42.37; 95% CI, 11.33-158.43) or observed (OR, 175.10; 95% CI, 44.84-683.76); PheCodes for “symptoms affecting skin” (OR, 8.49; 95% CI, 1.90-37.82), “urticaria” (OR, 7.01; 95% CI, 1.76-27.89), and “allergy or adverse event to an antibiotic” (OR, 11.84, 95% CI, 2.88-48.69); keyword detection in clinical notes (OR, 3.21; 95% CI, 1.27-8.08); and antihistamine administration alone or in combination (OR, 6.51; 95% CI, 1.90-22.30). In the final model, antibiotic allergic-type reactions were identified with an estimated probability of 30% or more; positive predictive value was 61% (95% CI, 45%-76%); and sensitivity was 87% (95% CI, 70%-96%).Conclusions and RelevanceIn this retrospective cohort study of patients receiving periprocedural antibiotic prophylaxis, an algorithm with a high sensitivity to detect incident antibiotic allergic-type reactions that can be used to provide clinician feedback about antibiotic harms from unnecessarily prolonged antibiotic exposures was developed.

Background Declines in malaria burden in Uganda have slowed. Modelling predicts that indoor residual spraying (IRS) and mass drug administration (MDA), when co-timed, have synergistic impact. This study investigated additional protective impact of population-based MDA on malaria prevalence, if any, when added to IRS, as compared with IRS alone and with standard of care (SOC). Methods The 32-month quasi-experimental controlled before-and-after trial enrolled an open cohort of residents (46,765 individuals, 1st enumeration and 52,133, 4th enumeration) of Katakwi District in northeastern Uganda. Consented participants were assigned to three arms based on residential subcounty at study start: MDA+IRS, IRS, SOC. IRS with pirimiphos methyl and MDA with dihydroartemisinin- piperaquine were delivered in 4 co-timed campaign-style rounds 8 months apart. The primary endpoint was population prevalence of malaria, estimated by 6 cross-sectional surveys, starting at baseline and preceding each subsequent round. Results Comparing malaria prevalence in MDA+IRS and IRS only arms over all 6 surveys (intention-to-treat analysis), roughly every 6 months post-interventions, a geostatistical model found a significant additional 15.5% (95% confidence interval (CI): [13.7%, 17.5%], Z = 9.6, p = 5e−20) decrease in the adjusted odds ratio (aOR) due to MDA for all ages, a 13.3% reduction in under 5’s (95% CI: [10.5%, 16.8%], Z = 4.02, p = 5e−5), and a 10.1% reduction in children 5–15 (95% CI: [8.5%, 11.8%], Z = 4.7, p = 2e−5). All ages residents of the MDA + IRS arm enjoyed an overall 80.1% reduction (95% CI: [80.0%, 83.0%], p = 0.0001) in odds of qPCR confirmed malaria compared with SOC residents. Secondary difference-in-difference analyses comparing surveys at different timepoints to baseline showed aOR (MDA + IRS vs IRS) of qPCR positivity between 0.28 and 0.66 (p < 0.001). Of three serious adverse events, one (nonfatal) was considered related to study medications. Limitations include the initial non-random assignment of study arms, the single large cluster per arm, and the lack of an MDA-only arm, considered to violate equipoise. Conclusions Despite being assessed at long time points 5–7 months post-round, MDA plus IRS provided significant additional protection from malaria infection over IRS alone. Randomized trials of MDA in large areas undergoing IRS recommended as well as cohort studies of impact on incidence. Trial registration: This trial was retrospectively registered 11/07/2018 with the Pan African Clinical Trials Registry (PACTR201807166695568).

Background:Declines in malaria burden in Uganda have slowed. Modelling predicts that indoor residual spraying (IRS) and mass drug administration (MDA), when co-timed, have synergistic impact. This study investigated additional protective impact of population-based MDA on malaria prevalence, if any, when added to IRS, as compared with IRS alone and with standard of care (SOC).Methods:The 32-month prospective controlled community trial enrolled an open cohort of residents (46,765 individuals, 1st enumeration and 52,133, 4th enumeration) in Katakwi District in northeastern Uganda. Consented participants were assigned to three arms based on residential subcounty: MDA+IRS, IRS, and SOC (insecticide treated bednets and case management). IRS with pirimiphos methyl and MDA with dihydroartemisinin- piperaquine were delivered in 4 co-timed campaign-style rounds 8 months apart. The primary endpoint was population prevalence of malaria, estimated by 6 cross-sectional surveys, starting at baseline and preceding each subsequent round.Results:Comparing malaria prevalence in MDA+IRS and IRS only arms over all 6 surveys (intention-to-treat analysis), roughly every 6 months, post-interventions, a geostatistical model found a significant additional 15.5% (95% confidence interval (CI): [13.7%, 17.5%], Z=9.6, p= 5e-20) decrease in the adjusted odds ratio (aOR) due to MDA for all ages, a 13.3% reduction in under 5's (95% CI: [10.5%, 16.8%], Z=4.02, p= 5e-5), and a 10.1% reduction in children 5-15 (95% CI: [8.5%, 11.8%], Z=4.7, p= 2e-5). All ages residents of the MDA + IRS arm enjoyed an overall 80.1% reduction (95% CI: [80.0%,83.0%, pConclusions:Despite being assessed at long timepoints 5-7 months post-round, MDA plus IRS provided significant additional protection from malaria infection over IRS alone. Future cohort studies of impact on incidence recommended. Trial registration: This trial was retrospectively registered July 7th, 2018 with the Pan African Clinical Trials Registry (PACTR 201807166695568).

Patients suspected of syncope frequently undergo laboratory and imaging studies to determine the etiology of the syncope. Variability exists in these workups across institutions. The purpose of this study was to evaluate the utilization and diagnostic yield of these workups and the patient characteristics associated with syncopal falls.A multi-institutional retrospective review was performed on adult patients admitted after a fall between 1/2017-12/2018. Syncopal falls were compared to non-syncopal falls.4478 patients were included. There were 795 (18%) patients with a syncopal fall. Electrocardiogram, troponin, echocardiogram, CT angiography (CTA), and carotid ultrasound were more frequently tested in syncope patients compared to non-syncope patients. Syncope patients had higher rates of positive telemetry/Holter monitoring, CTAs, and electroencephalograms.Patients who sustain syncopal falls frequently undergo diagnostic testing without a higher yield to determine the etiology of syncope.

Background: Same-day discharge after mastectomy has been demonstrated to be safe in appropriately selected candidates. However, the association between same-day discharge after mastectomy and quality of life (QOL) is unclear. Patient-reported outcome (PRO) measures represent important indicators of QOL among patients undergoing treatment for breast cancer. In this study, we aimed to evaluate the effect of same-day discharge after mastectomy on PROs. Methods: We performed a retrospective review of a prospectively collected, longitudinal PRO registry of female breast cancer patients treated at an academic breast center between June 2019 and June 2022. Patients were invited to complete the BREAST-Q module, a validated PRO questionnaire measuring QOL domains such as psychosocial wellbeing, physical wellbeing, satisfaction with their surgeon, and satisfaction with their medical team. Preoperative and 2-week postoperative questionnaire responses were analyzed in this study. Patients who had a mastectomy with or without reconstruction were included in this analysis. Those who underwent immediate reconstruction with autologous tissue were excluded as these operations are not conducive to same-day discharge. Patients were divided into two groups: the first was discharged on the date of surgery while the second was admitted to the hospital for a minimum of one night. Clinical and demographic factors were collected from a review of the electronic medical record. The primary endpoints were mean satisfaction scores as well as differences between postoperative and preoperative scores for the psychosocial and physical wellbeing domains. T-tests were used to evaluate differences between groups. A multiple regression model was fit to adjust for the effects of relevant clinical and demographic factors. Results: A total of 104 patients within the registry underwent mastectomy during the study period and were offered questionnaires. Of these, 58 completed both the preoperative and 2-week postoperative questionnaire (56% response rate); 20 (34%) in the same-day discharge group and 38 (66%) in the inpatient admission group. The groups were similar in age, stage, American Society of Anesthesiologists’ classification group, body mass index, frequency of unplanned readmission or reoperation, and receipt of bilateral mastectomy, axillary lymph node dissection, post-mastectomy reconstruction, and neoadjuvant chemotherapy. Mean patient satisfaction scores and mean changes in psychosocial and physical wellbeing scores were similar between the groups 2 weeks after surgery (Table 1). After controlling for age, type of reconstructive operation, receipt of unplanned reoperation, and preoperative score, same-day discharge did not have a significant effect on satisfaction with the surgeon (Beta=-4.3, p=0.37), satisfaction with the medical team (Beta=0.2, p=0.97), physical wellbeing score (Beta=-0.1, p=0.99), or psychosocial wellbeing score (Beta=8.0, p=0.15). Conclusions: Patients who are discharged from the hospital on the same day of a mastectomy display similar levels of satisfaction with their care team and similar short-term trends in physical and psychosocial wellbeing compared to those who are admitted to the hospital. While further data are being accrued, these early results suggest patients tolerate same-day discharge after mastectomy well. Table 1 Patient-reported outcomes at 2 weeks after mastectomy for patients discharged on the date of surgery compared to those admitted inpatient Citation Format: Sudheer Vemuru, Kathryn Colborn, Laura Leonard, Victoria Huynh, Christodoulos Kaoutzanis, Justin Cohen, David Mathes, Nicole Christian, Gretchen M. Ahrendt, Christine M. Fisher, Simon Kim, Sarah Tevis. Comparing Patient-Reported Outcomes for Same-day Discharge and Inpatient Admission After Mastectomy [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-05-58.

ImportanceThe total number of patients with pancreatic ductal adenocarcinoma (PDAC) who receive neoadjuvant chemotherapy (NAC) is increasing. However, the added role of adjuvant chemotherapy (AC) in these patients remains unknown.ObjectiveTo evaluate the association of AC with overall survival (OS) in patients with PDAC who received multiagent NAC followed by curative-intent surgery.Design, Setting, and ParticipantsThis retrospective, matched-cohort study used data from the National Cancer Database and included patients with PDAC diagnosed between 2010 and 2018. The study included patients at least 18 years of age who received multiagent NAC followed by surgical resection and had available records of the pathological findings. Patients were excluded if they had clinical or pathological stage IV disease or died within 90 days of their operation.ExposuresAll included patients received NAC and underwent resection for primary PDAC. Some patients received adjuvant chemotherapy.Main Outcomes and MeasuresThe main outcome was the OS of patients who received AC (AC group) vs those who did not (non-AC group). Interactions between pathological findings and AC were investigated in separate multivariable Cox regression models.ResultsIn total, 1132 patients (mean [SD] age, 63.5 [9.4] years; 577 [50.1%] male; 970 [85.7%] White) were included, 640 patients in the non-AC group and 492 patients in the AC group. After being matched by propensity score according to demographic and pathological characteristics, 444 patients remained in each group. The multivariable Cox regression model adjusted for all covariates revealed an association between AC and improved survival (hazard ratio, 0.71; 95% CI, 0.59-0.85; P P = .002), but the benefit varied by age, pathological T category, and tumor differentiation. Of note, AC was associated with better survival in patients with any pathological N category and positive margin status.Conclusions and RelevanceIn this cohort study, AC following multiagent NAC and resection in patients with PDAC was associated with significant survival benefit compared with that in patients who did not receive AC. These findings suggest that patients with aggressive tumors may benefit from AC to achieve prolonged survival, even after multiagent NAC and curative-intent resection.

645 Background: The role of surgery for small (≤2 cm), nonfunctional pancreatic neuroendocrine tumors (NF-PNETs) remains controversial due to the wide range of tumor aggressiveness. Consensus guidelines of the US, Europe, and Japan offer different recommendations for treatment of small NF-PNETs. The objective of this study is to evaluate the survival benefit of surgical resection for small NF-PNETs. Methods: Patients with NF-PNETs were identified in the National Cancer Database from 2004 to 2018. Small NF-PNETs were divided into two groups: group 1a (tumor ≤1 cm) and group 1b (tumor 1.1 – 2.0 cm). Cox regression models were used to compare the overall survival between resected and unresected small NF-PNETs patients. Interactions between preoperative factors and surgery were estimated using subgroup analyses. Results: We identified 1,278 patients in group 1a and 3,363 patients in group 1b. After adjusting for preoperative factors, surgery was associated with longer survival for patients in group 1b (HR, 0.58; 95% CI, 0.42–0.80; P

Background: Despite a strong evidence base and clinical guidelines specifically recommending against prolonged post-procedural antimicrobial use, studies indicate that the practice is common following cardiac device procedures. Formative evaluations conducted by the study team suggest that inappropriate antimicrobial use may be driven by information silos that drive provider belief that antimicrobials are not harmful, in part due to lack of complete feedback about all types of clinical outcomes. De-implementation is recognized as an important area of research that can lead to reductions in unnecessary, wasteful, or harmful practices, such as excess antimicrobial use following cardiac device procedures; however, investigations into strategies that lead to successful de-implementation are limited. The overarching hypothesis to be tested in this trial is that a bundle of implementation strategies that includes audit and feedback about direct patient harms caused by inappropriate prescribing can lead to successful de-implementation of guideline-discordant care.Methods: We propose a Hybrid Type III effectiveness-implementation stepped-wedge intervention trial at three high-volume, high-complexity VA medical centers. The main study intervention (an informatics-based, real-time audit-and-feedback tool) was developed based on learning/unlearning theory and formative evaluations and guided by the integrated-Promoting Action on Research Implementation in Health Services (i-PARIHS) Framework. Elements of the bundled and multifaceted implementation strategy to promote appropriate prescribing will include audit-and-feedback reports that include information about antibiotic harms, stakeholder engagement, patient and provider education, identification of local champions, and blended facilitation. The primary study outcome is adoption of evidence-based practice (de-implementation of inappropriate antimicrobial use). Clinical outcomes (cardiac device infections, acute kidney injuries and Clostridioides difficile infections) are secondary. Qualitative interviews will assess relevant implementation outcomes (acceptability, adoption, fidelity, feasibility).Discussion: De-implementation theory suggests that factors that may have a particularly strong influence on de-implementation include strength of the underlying evidence, the complexity of the intervention, and patient and provider anxiety and fear about changing an established practice. This study will assess whether a multifaceted intervention mapped to identified de-implementation barriers leads to measurable improvements in provision of guideline-concordant antimicrobial use. Findings will improve understanding about factors that impact successful or unsuccessful de-implementation of harmful or wasteful healthcare practices.Trial Registration: Clinicaltrials.gov (NCT05020418)

Objective: Inaccuracies in Current Procedural Terminology (CPT) coding entries for surgical procedures have a profound impact on hospital systems and surgeon compensation for services. We sought to characterize the variations of surgical CPT entry at a multi-site academic medical center and estimate the financial burden implicated by improper code entry.Methods: A mixed methods study was conducted to evaluate variations in CPT entry across an academic center. Semi-structured interviews with 8 surgical schedulers were conducted and analyzed to understand the current scheduling process. Coding data for surgical procedures performed within a 31-day period during September and October 2020 within the large healthcare system were assessed for appropriate CPT code entry. Reimbursement for the 2020 fiscal year was then analyzed to determine the impact of pre-operative CPT code accuracy on reimbursements and denials.Results: Interviews revealed a lack of standardization in the surgical scheduling process across the hospital system. Lack of standardized onboarding and variations in workflow contributed to difficult cross coverage for schedulers and errors in CPT entry. On quantitative analysis, the accuracy of pre-operative CPT code entry was poor with only 59.3% of pre-operative CPT code entries being correct. In the 2020 fiscal year, $5.4 million was lost due to problems related to CPT code entry.Conclusions: Variations and lack of standardization in CPT code entry can greatly contribute to financial losses and disrupt surgical scheduling. Standardization of workflow and CPT entry schemes can help minimize scheduling complications and enhance the quality of care provided to patients.

We sought to determine the influence of venovenous extracorporeal membrane oxygenation (ECMO) on outcomes of mechanically ventilated patients with COVID-19 during the first 120 days after hospital discharge.Five academic centers conducted a retrospective analysis of mechanically ventilated patients with COVID-19 admitted during March through May 2020. Survivors had access to a multidisciplinary postintensive care recovery clinic. Physical, psychological, and cognitive deficits were measured using validated instruments and compared based on ECMO status.Two hundred sixty two mechanically ventilated patients were compared with 46 patients cannulated for venovenous ECMO. Patients receiving ECMO were younger and traveled farther but there was no significant difference in gender, race, or body mass index. ECMO patients were mechanically ventilated for longer durations (median, 26 days [interquartile range, 19.5-41 days] vs 13 days [interquartile range, 7-20 days]) and were more likely to receive inhaled pulmonary vasodilators, neuromuscular blockade, investigational COVID-19 therapies, blood transfusions, and inotropes. Patients receiving ECMO experienced greater bleeding and clotting events (P .01). However, survival at discharge was similar (69.6% vs 70.6%). Of the 217 survivors, 65.0% had documented follow-up within 120 days. Overall, 95.5% were residing at home, 25.7% had returned to work or usual activity, and 23.1% were still using supplemental oxygen; these rates did not differ significantly based on ECMO status. Rates of physical, psychological, and cognitive deficits were similar.Our data suggest that COVID-19 survivors experience significant physical, psychological, and cognitive deficits following intensive care unit admission. Despite a more complex critical illness course, longer average duration of mechanical ventilation, and longer average length of stay, patients treated with venovenous ECMO had similar survival at discharge and outcomes within 120 days of discharge.

This study was designed to: (1) characterize longitudinal patient-reported outcomes (PROs) between breast cancer patients undergoing lumpectomy and mastectomy and (2) compare return to baseline scores at 3 months and 6 months postoperatively.Newly diagnosed breast cancer patients seen at an academic breast center between June 2019 and February 2021 were invited to participate in longitudinal PRO surveys at their initial clinic visit. If willing to participate, patients were emailed the validated BREAST-Q™ questionnaire at the initial clinic visit (baseline), 2 weeks after surgery, and then every 3 months for the first year. We used linear mixed models to estimate the differences in slopes over time between lumpectomy and mastectomy for each PRO measure. Pearson's Chi-square tests with Yates' continuity correction were used to compare proportions of patients who return to baseline PRO scores. P0.05 was considered significant.Of 164 patients invited to participate, 100 (61%) completed a baseline survey and were included in analyses. Mastectomy patients had significantly greater decreases in breast satisfaction (P = 0.002), psychosocial well-being (P0.0001), and sexual well-being (P0.0001) over time compared with lumpectomy patients. Both surgical groups reported a decrease in physical well-being, although the decline was more significant in lumpectomy patients (P = 0.005). At 3 months and 6 months after surgery, significantly larger proportions of lumpectomy patients returned to their baseline breast satisfaction, psychosocial well-being, and physical well-being compared with mastectomy patients.Understanding how outcomes important to patients change over the care continuum can provide opportunities for early intervention and may prevent debilitating long-term morbidities of treatment.

Background The impact of early post-natal Zika virus (ZIKV) infection on neurodevelopment (ND) is unknown. A prospective study of post-natal ZIKV infection in rural Guatemala (ZIKV study) enrolled a cohort of children ages 1–5 years, including children previously enrolled in a dengue virus (DENV) study during the 2015–2016 ZIKV epidemic. We evaluated ND outcomes by age and ZIKV infection status. Methods Subjects enrolled in the ZIKV study June 2017–April 2018 underwent ND testing using the Mullen Scales of Early Learning (MSEL) at baseline and 12 months later. ZIKV/DENV-1/2 FRNT50 was performed on enrollment and on banked serum samples from the 2015 to 2016 subset. ZIKV serostatus and MSEL scores were correlated using multiple linear mixed models, adjusted for age and gender when appropriate, to evaluate their association. Geolocation was used to explore clustering of ZIKV serostatus and MSEL score. Results We enrolled 183 children (43% female, mean age 3.2 years). Of these, 38 (21%) were classified as ZIKV-positive (+), 111 (61%) ZIKV-negative (-), 31 (17%) ZIKV-possible, and 3 (2%) ZIKV-indeterminate. ZIKV(+) cases and higher composite MSEL scores clustered in more densely populated areas (Figure 1). ZIKV(+) serostatus was associated with higher MSEL composite (increase in log score 0.09, P = 0.003) and subdomain scores: fine motor (0.13, P = 0.011), visual reception (0.15, P = 0.002), receptive language (0.09, P = 0.041), gross motor (0.14, P = 0.09), and expressive language (0.09, P = 0.058) (Figure 2). Of the 78 children (43%) with 2015–2016 samples, 46 (59%) remained ZIKV(−), 16 (21%) seroconverted from ZIKV(−) or possible/indeterminate to ZIKV(+), and 16 (21%) were indeterminate when enrolled in the ZIKV study. ZIKV seroconversion was associated with higher composite (0.13, P = 0.02) MSEL scores compared with ZIKV(−). Conclusion In this exploratory analysis, post-natal ZIKV infection was not associated with adverse ND outcomes in children age 1–5 years. Overall, ZIKV(+) status was associated with higher average ND scores than ZIKV(−), and scores decreased with age for most children, independent of ZIKV status. The correlation of ZIKV(+) status and higher MSEL scores may be confounded by geographic-related factors or other confounders. NIAID Contract HHSN272201300015I Task Order HHSN27200013 (Co-PIs: FMM & EJA). Disclosures Flor M. Munoz, M.D, Biocryst: Grant/Research Support; CDC: Research Grant; Moderna: Other Financial or Material Support, Safety Monitoring Board Member/Chair; NIH: Research Grant; Novavax: Research Grant; UP to Date: Author and Editor - Royalties, Other Financial or Material Support.