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.

Modeling Thyroid Cancer Epidemiology in the United States Using Papillary Thyroid Carcinoma Microsimulation Model.

OBJECTIVES: Thyroid cancer incidence increased over 200% from 1992 to 2018, whereas mortality rates had not increased proportionately. The increased incidence has been attributed primarily to the detection of subclinical disease, raising important questions related to thyroid cancer control. We developed the Papillary Thyroid Carcinoma Microsimulation model (PATCAM) to answer them, including the impact of overdiagnosis on thyroid cancer incidence. METHODS: PATCAM simulates individuals from age 15 until death in birth cohorts starting from 1975 using 4 inter-related components, including natural history, detection, post-diagnosis, and other-cause mortality. PATCAM was built using high-quality data and calibrated against observed age-, sex-, and stage-specific incidence in the United States as reported by the Surveillance, Epidemiology, and End Results database. PATCAM was validated against US thyroid cancer mortality and 3 active surveillance studies, including the largest and longest running thyroid cancer active surveillance cohort in the world (from Japan) and 2 from the United States. RESULTS: PATCAM successfully replicated age- and stage-specific papillary thyroid cancers (PTC) incidence and mean tumor size at diagnosis and PTC mortality in the United States between 1975 and 2015. PATCAM accurately predicted the proportion of tumors that grew more than 3 mm and 5 mm in 5 years and 10 years, aligning with the 95% confidence intervals of the reported rates from active surveillance studies in most cases. CONCLUSIONS: PATCAM successfully reproduced observed US thyroid cancer incidence and mortality over time and was externally validated. PATCAM can be used to identify factors that influence the detection of subclinical PTCs.

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.

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.

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.

General surgeon involvement in the care of patients designated with an American Association for the Surgery of Trauma-endorsed ICD-10-CM emergency general surgery diagnosis code in Wisconsin.

BACKGROUND: The current national burden of emergency general surgery (EGS) illnesses and the extent of surgeon involvement in the care of these patients remain largely unknown. To inform needs assessments, research, and education, we sought to: (1) translate previously developed International Classification of Diseases (ICD), 9th Revision, Clinical Modification (ICD-9-CM) diagnosis codes representing EGS conditions to ICD 10th Revision, CM (ICD-10-CM) codes and (2) determine the national burden of and assess surgeon involvement across EGS conditions. METHODS: We converted ICD-9-CM codes to candidate ICD-10-CM codes using General Equivalence Mappings then iteratively refined the code list. We used National Inpatient Sample 2016 to 2017 data to develop a national estimate of the burden of EGS disease. To evaluate surgeon involvement, using Wisconsin Hospital Association discharge data (January 1, 2016 to June 30, 2018), we selected adult urgent/emergent encounters with an EGS condition as the principal diagnosis. Surgeon involvement was defined as a surgeon being either the attending provider or procedural physician. RESULTS: Four hundred and eighty-five ICD-9-CM codes mapped to 1,696 ICD-10-CM codes. The final list contained 985 ICD-10-CM codes. Nationally, there were 2,977,843 adult patient encounters with an ICD-10-CM EGS diagnosis. Of 94,903 EGS patients in the Wisconsin Hospital Association data set, most encounters were inpatient as compared with observation (75,878 [80.0%] vs. 19,025 [20.0%]). There were 57,780 patients (60.9%) that underwent any procedure. Among all Wisconsin EGS patients, most had no surgeon involvement (64.9% [n = 61,616]). Of the seven most common EGS diagnoses, surgeon involvement was highest for appendicitis (96.0%) and biliary tract disease (77.1%). For the other five most common conditions (skin/soft tissue infections, gastrointestinal hemorrhage, intestinal obstruction/ileus, pancreatitis, diverticular disease), surgeons were involved in roughly 20% of patient care episodes. CONCLUSION: Surgeon involvement for EGS conditions ranges from highly likely (appendicitis) to relatively unlikely (skin/soft tissue infections). The wide range in surgeon involvement underscores the importance of multidisciplinary collaboration in the care of EGS patients. LEVEL OF EVIDENCE: Prognostic/epidemiological, Level III.

Opioid prescribing to preteen children undergoing ambulatory surgery in the United States.

BACKGROUND: Overuse and misuse of opioids is a continuing crisis. The most common reason for children to receive opioids is postoperative pain, and they are often prescribed more than needed. The amount of opioids prescribed varies widely, even for minor ambulatory procedures. This study uses a large national sample to describe filled opioid prescriptions to preteen patients after all ambulatory surgical procedures and common standard procedures. METHODS: We analyzed Truven Health MarketScan data for July 2012 through December 2016 to perform descriptive analyses of opioid fills by age and geographic area, change over time, second opioid fills in opioid-naïve patients, and variation in the types and amount of medication prescribed for 18 common and standard procedures in otolaryngology, urology, general surgery, ophthalmology, and orthopedics. RESULTS: Over 10% of preteen children filled perioperative opioid prescriptions for ambulatory surgery in the period 2012 to 2016. The amount prescribed varied widely (median 5 days' supply, IQR 3-8, range 1-90), even for the most minor procedures, for example, frenotomy (median 4 days' supply, IQR 2-5, range 1-60). Codeine fills were common despite safety concerns. Second opioid prescriptions were filled by opioid-naïve patients after almost all procedures studied. The rate of prescribing declined significantly over time and varied substantially by age and across census regions. CONCLUSIONS: We identified opioid prescribing outside of the norms of standard practice in all of the specialties studied. Standardizing perioperative opioid prescribing and developing guidelines on appropriate prescribing for children may reduce the opioids available for misuse and diversion.

Impact and outcomes of primary cytomegalovirus disease in seronegative abdominal solid organ transplant recipients of cytomegalovirus unexposed donors (D-/R-).

BACKGROUND: Primary cytomegalovirus (CMV) disease in high-risk (D+/R-) abdominal solid organ transplant recipients (aSOTRs) is well described, however, little is known of primary CMV disease in low-risk (D-/R-) patients. METHODS: Observational study of adult aSOTRs between 1/1/2009 and 9/1/2019 screened based on serostatus at transplant; D-/R- and D+/R- patients were included. PRIMARY OBJECTIVE: Describe epidemiology of primary CMV in D-/R- aSOTRs. SECONDARY OBJECTIVE: Compare infectious and transplant-related outcomes of primary CMV disease in the first 90 days (early CMV) between D-/R- and D+/R-. RESULTS: Of 782 D-/R- aSOTRs in the study period, 13 developed CMV at any time after transplant to last follow-up. Of 671 D+/R- patients, 186 developed CMV. Early CMV disease was significantly more common in the D-/R- group (54% vs 15.6%, P = .0005) despite populations being similar demographically, including allograft subtype. D-/R- patients with early CMV disease had median viral load >100 000 IU/mL and 42.9% had end-organ manifestations; 71.4% required hospital admission. Immunosuppressive therapy was adjusted in 100% of patients, there was an approximately 14.3% rate of antiviral resistance and 28.6% had concomitant opportunistic infection. These findings were similar to D+/R- patients. There was no difference in risk of rejection or all-cause mortality associated with early CMV disease, however, graft loss was significantly higher in D-/R-. CONCLUSION: D-/R- aSOTRs infrequently develop CMV, however, when it occurs, they present with disease manifestations similar to and graft outcomes inferior to D+/R- with CMV. Additionally, the majority of CMV disease in D-/R- occurs in the first 90 days after transplant, suggesting possible donor subclinical infection or transfusion source. The complicated course in D-/R- is likely caused by low clinical suspicion. Awareness of disease severity and aggressive upfront management may promote positive outcomes.

Factors associated with Interhospital transfers of emergency general surgery patients from emergency departments.

BACKGROUND: Emergency general surgery (EGS) conditions account for over 3 million or 7.1% of hospitalizations per year in the US. Patients are increasingly transferred from community emergency departments (EDs) to larger centers for care, and a growing demand for treating EGS conditions mandates a better understanding of how ED clinicians transfer patients. We identify patient, clinical, and organizational characteristics associated with interhospital transfers of EGS patients originating from EDs in the United States. METHOD: We analyze data from the Agency for Healthcare Research and Quality Nationwide Emergency Department Sample (NEDS) for the years 2010-2014. Patient-level sociodemographic characteristics, clinical factors, and hospital-level factors were examined as predictors of transfer from the ED to another acute care hospital. Multivariable logistic regression analysis includes patient and hospital characteristics as predictors of transfer from an ED to another acute care hospital. RESULTS: Of 47,442,892 ED encounters (weighted) between 2008 and 2014, 1.9% resulted in a transfer. Multivariable analysis indicates that men (Odds ratio (OR) 1.18 95% Confidence Interval (95% CI) 1.16-1.21) and older patients (OR 1.02 (95% CI 1.02-1.02)) were more likely to be transferred. Relative to patients with private health insurance, patients covered by Medicare (OR 1.09 (95% CI 1.03-1.15) or other insurance (OR 1.34 (95% CI 1.07-1.66)) had a higher odds of transfer. Odds of transfer increased with a greater number of comorbid conditions compared to patients with an EGS diagnosis alone. EGS diagnoses predicting transfer included resuscitation (OR 36.72 (95% CI 30.48-44.22)), cardiothoracic conditions (OR 8.47 (95% CI 7.44-9.63)), intestinal obstruction (OR 4.49 (95% CI 4.00-5.04)), and conditions of the upper gastrointestinal tract (OR 2.82 (95% CI 2.53-3.15)). Relative to Level I or II trauma centers, hospitals with a trauma designation III or IV had a 1.81 greater odds of transfer. Transfers were most likely to originate at rural hospitals (OR 1.69 (95% CI 1.43-2.00)) relative to urban non-teaching hospitals. CONCLUSION: Medically complex and older patients who present at small, rural hospitals are more likely to be transferred. Future research on the unique needs of rural hospitals and timely transfer of EGS patients who require specialty surgical care have the potential to significantly improve outcomes and reduce costs.

Age-Dependent Costs and Complications in Pediatric Umbilical Hernia Repair.

OBJECTIVES: To characterize regional variation in the age of patients undergoing umbilical hernia repair to determine costs and subsequent care. STUDY DESIGN: We performed a cross-sectional descriptive study using a large convenience sample of US employer-based insurance claims from July 2012 to December 2015. We identified children younger than 18 years of age undergoing uncomplicated (not strangulated, incarcerated, or gangrenous) umbilical hernia repair as an isolated procedure (International Classification of Diseases, Ninth Revision procedure codes 53.41, 53.42, 53.43, or 53.49, International Classification of Diseases, Tenth Revision procedure code 0WQF0ZZ, or Current Procedural Terminology procedure codes 49580 or 49585). RESULTS: In all, 5212 children met criteria for inclusion. Children younger than age 2 years accounted for 9.7% of repairs, with significant variation by census region (6% to 14%, P < .001). Total payments for surgery varied by age; children younger than 2 years averaged $8219 and payments for older children were $6137. Postoperative admissions occurred at a rate of 73.1 per 1000 for children younger than age 2 years and 7.43 for older children; emergency department visits were 41.5 per 1000 for children younger than age 2 years vs 15.9 for older children (P < .001). CONCLUSIONS: Umbilical hernias continue to be repaired at early ages with large regional variation. Umbilical hernia repair younger than age 2 years is associated with greater costs and greater frequency of postoperative hospitalization and emergency department visits.

Effect of Transfer Status on Outcomes of Emergency General Surgery Patients.

INTRODUCTION: Transferred emergency general surgery (EGS) patients are a vulnerable, high acuity population. The outcomes of and health care utilization among transferred (TRAN) as compared to directly admitted (DA) patients have been studied primarily using single institution or hospital system data which limits generalizability. We evaluated these outcomes among EGS patients using a national database. METHODS: We identified encounters of patients aged ≥18 years with a diagnosis of EGS as defined by the American Association for the Surgery of Trauma in the 2008-2011 Nationwide Inpatient Sample (NIS). Multivariable regression analyses determined if transfer status independently predicted in-hospital mortality (logistic regression) and morbidity (presence of any complication among those who survived to discharge; logistic regression), cost (log-linear regression), and duration of stay (among those who survived to discharge; log-linear regression) accounting for the NIS sampling design. RESULTS: We identified 274,145 TRAN (57,885 unweighted) and 10,456,100 DA (2,187,132 unweighted) encounters. On univariate analysis, TRAN patients were more likely to have greater comorbidity scores, have Medicare insurance, and reside in an area with a lesser median household income compared to DA patients (p<0.0001). Mortality was greater in the TRAN vs DA groups (4.4% vs 1.6%; p<0.0001). Morbidity (presence of any complication) was also greater among TRAN patients (38.8% vs 26.1%; p<0.0001). Morbidity among TRAN patients was primarily due to urinary- (13.7%), gastrointestinal- (12.9%), and pulmonary-related (13.3%) complications. Median duration of hospital stay was 4.3 days for TRAN vs 3.0 days for DA (p<0.0001) patients. Median cost was greater for TRAN patients ($8,935 vs $7,167; p<0.0001). Regression analyses determined that after adjustment, TRAN patients had statistically significantly greater mortality, morbidity, and cost as well as longer durations of stay. CONCLUSIONS: EGS patients who are transferred experience increased in-hospital morbidity and mortality as well as increased durations of stay and cost. As the population and age of patients diagnosed with EGS conditions increase while the EGS workforce decreases, the need for inter-hospital transfers will increase. Identifying risk factors associated with worse outcomes among transferred patients can inform the design of initiatives in performance improvement and direct the finite resources available to this vulnerable patient population.

Breast Cancer Found Incidentally After Reduction Mammaplasty in Young Insured Women.

BACKGROUND: Reduction mammaplasty is a common operation performed for healthy women. The estimated incidence of breast cancer diagnosed at the time of reduction mammaplasty varies from 0.06 to 4.5%, and information on the care of these patients is limited. This study aimed to determine the incidence of breast cancer identified incidentally during reduction mammaplasty and to characterize preoperative imaging. METHODS: Women 18 years of age or older who underwent reduction mammaplasty from 2013 to 2015 were identified from the Truven Health MarketScan® Research Databases. Patients with prior breast cancer were excluded. Descriptive statistics were calculated for patient characteristics, incidental breast cancer, preoperative breast imaging, and postoperative treatment. RESULTS: Reduction mammaplasty was performed for 18,969 women with a mean age of 42.5 years. Of these patients, 186 (0.98%) were incidentally found to have breast cancer, with 134 (0.71%) having invasive breast cancer and 52 (0.27%) having carcinoma in situ. The patients with incidentally found cancer were older than the patients without cancer (50.8 vs. 42.5 years; p < 0.001). Overall, 58.2% of the patients had undergone mammography before reduction mammoplasty. The rates were higher (> 80%) for the patients older than 40 years. Preoperative mammography was performed for 76.3% of those with a diagnosis of breast cancer at time of reduction mammoplasty. CONCLUSIONS: Breast cancer diagnosed incidentally at the time of reduction mammaplasty is uncommon and often radiographically occult. The majority of women older than 50 years appropriately received preoperative mammography. These data can be used to manage patient expectations about the potential for the incidental diagnosis of breast cancer at reduction mammaplasty, even with a negative preoperative mammography.

Evaluation of infectious risk and outcomes in the hmong renal transplant population.

BACKGROUND: Hmong ethnicity has been associated with infection, particularly fungal. The risk of infection after transplant in the Hmong population is unknown. METHODS: Observational study of adult renal transplant (RTX) recipients between 1/1/1994 and 12/31/2015. Primary objective was to identify infectious risk in the Hmong RTX population as compared to non-Hispanic whites (NHW). Secondary objective was to evaluate transplant outcomes. RESULTS: There was a total of 2599 patients in the study window; 95 Hmong, 2504 NHW. The Hmong population had significantly fewer bacterial and fungal infections at 1 and 3 years (Bacterial: Hmong 21.7%, 32.4% vs NHW 36.9%, 46.7%, P = .004; Fungal: Hmong 3.3%, 5.7% vs NHW 12.7%, 16.6%, P = .0005) and improved graft and patient survival at 1, 5, and 10 years (Graft: Hmong 92.6%, 78.4%, 61.9% vs NHW 90.7%, 72.2%, 48.5%, P = .006; Patient: Hmong 97.8%, 94.5%, 83.3% vs NHW 95.3%, 82.1%, 62.1% P < .001). Spectrum of bacterial infection was similar, but with significantly more Staphylococcal infection in the NHW population. Blastomycoses were the major fungal pathogen in Hmong (2/3, 67%) vs Candida in NWH (77%). When minimally adjusted for PRA and age, rates of bacterial infection (HR 0.69, 95% CI 0.48-0.99, P = .047), fungal infection (HR 0.39, 95% CI 0.17-0.87, P = .02), and mortality (HR 0.5, 95% CI 0.28-0.88, P = .02) were more favorable in the Hmong population. When analyzed in a stepwise Cox proportional hazards model; Hmong ethnicity was not a significant risk factor for graft failure, rejection, CMV, BK, or fungal infection after RTX and was associated with reduced risk of bacterial infection (HR 0.61, 95% CI 0.4-0.9, P = .02) and mortality (HR 0.51, 95% CI 0.27-0.96, P = .04). CONCLUSIONS: Despite concern regarding infective risk in the Hmong population, infection after RTX is no higher than NHW comparator. In all analyses, the Hmong population has equal or better outcomes. It does not appear variance in standard infection prophylaxis is necessary for the Hmong population after RTX.

Epidemiology, Risk Factors, and Outcomes After Early Posttransplant Clostridiodes difficile Infection in Renal Transplant Recipients.

BACKGROUND: Modifiable risk-factors associated with Clostridioides difficile infection (CDI) in renal-transplant (RTX) have not been clearly established and peri-transplant risk has not been described. OBJECTIVE: Evaluate epidemiology, risk-factors and outcomes after CDI occurring in the first 90 days after RTX (CDI-90).Methods: Observational cohort study/survival analysis of adult RTX recipients from 1/1/2012-12/31/2015. Primary outcome was CDI-90 incidence/risk-factors. Secondary outcome was evaluation of post-90 day transplant outcomes. RESULTS: 982 patients met inclusion criteria; 46 with CDI-90 and 936 without (comparator). CDI incidence in the total population was 4.7% at 90 days, 6.3% at 1 year, and 6.4% at 3 years. Incidence of CDI-90 was 5%; time to diagnosis was 19.4±25 days (median 7). Risk-factors for CDI-90 were alemtuzumab induction (Hazard ratio [HR] 1.5, 95% CI(1.1-2.0), p = 0.005) and age at transplant (HR 1.007/year, 95% CI (1.002-1.012), p= 0.007). However, risk-factors for CDI at any time were different; donation-after-circulatory-death (DCD) donor (HR 2.5 95% CI (1.3-4.9), p = 0.008) and female gender (HR 1.6 95% CI (1.0-2.7), p = 0.049). On Kaplan-Meier, CDI-90 appeared to have an impact on patient/graft survival, however when analyzed in a multivariable stepwise Cox proportional hazards model, only age was significantly associated with survival (p = 0.002). CONCLUSION AND RELEVANCE: Incidence of CDI-90 is low, mostly occurring in the first post-operative month. Risk-factors vary temporally based on time from transplant. In the early post-op period induction agent and age at transplant are significant, but not after. Associations between CDI and negative graft outcomes appear to be largely driven by age. Future studies validating these risk-factors as well as targeted prophylaxis strategies and their effect on long term graft outcomes and the host microbiome are needed.

National variation in opioid prescribing after pediatric umbilical hernia repair.

BACKGROUND: Pediatric umbilical hernia repair is a common procedure that requires minimal tissue disruption. We examined variation in opioid prescription fills after repair of uncomplicated umbilical hernias to characterize the types and doses of medication used and persistent postsurgical use. METHODS: Using the Truven Health Analytics MarketScan© Research Database for June 2012-September 2015, we identified pediatric patients undergoing umbilical hernia repair. We excluded patients with obstruction, gangrene, an earlier repair or a concurrent surgical procedure, and those without available pharmacy claim data. Analyses describe filled outpatient prescriptions by age, geographic region, drug type, quantity, and second prescriptions/refills. RESULTS: Of 4,407 procedures performed, 2,292 patients (52%) filled a prescription for postoperative opioids (age 0-1 years: 21.6%, age 2-3 years: 51.5%, age 4-5 years: 54.3%, 6 years or older: 57.9% [P < .0001]). In the northeast United States, 42% of patients filled narcotic prescriptions, compared with 59% of patients in the south (P < .0001). Hydrocodone/acetaminophen was most commonly prescribed (51%), followed by codeine/acetaminophen (30%). Durations were ≤3 days (50%), 4-10 days (46%), and >10 days (4%). A total of 6% of patients filled a second opioid prescription within 30 days. CONCLUSION: Although many patients do not require opioids for umbilical hernia repair, most pediatric patients fill opioid prescriptions, including for prolonged courses and refills. Guidelines for appropriate prescribing of opioids after common, simple procedures, such as umbilical hernia repair, could improve the quality of care for children and impact the US epidemic of opioid abuse.

A Randomized Controlled Trial Evaluating the Impact of Web-Based Information on Breast Cancer Patients' Knowledge of Surgical Treatment Options.

BACKGROUND: Previous research suggests that providing information to women newly diagnosed with breast cancer, during the gap between cancer diagnosis and their first surgeon consultation, may support decision making. Our objective was to compare patients' knowledge after the pre-consultation delivery of standard websites vs a web-based decision aid (DA). STUDY DESIGN: We randomized women with stage 0 to III breast cancer, within an academic and community breast clinic, to be emailed a link to selected standard websites (National Cancer Institute, American Cancer Society, Breastcancer.org,) vs the Health Dialog DA (Clinicaltrials.govNCT03116035). Patients seeking second opinions, diagnosed by excisional biopsy, or without an email address, were ineligible. Pre-consultation knowledge was assessed using the Breast Cancer Surgery Decision Quality Instrument. We compared differences in knowledge using t-test. RESULTS: Median patient age was 59 years, 99% were white, and 65% had a college degree or higher, with no differences in demographics between study arms. Knowledge was higher in patients who received the DA (median 80% vs 66% correct, p = 0.01). Decision-aid patients were more likely to know that waiting a few weeks to make a treatment decision would not affect survival (72% vs 54%, p < 0.01). Patients in both arms found the information helpful (median score 8 of 10). CONCLUSIONS: Although patients found receipt of any pre-consultation information helpful, the DA resulted in improved knowledge over standard websites and effectively conveyed that there is time to make a breast cancer surgery decision. Decreasing the urgency patients feel may improve the quality of patient-surgeon interactions and lead to more informed decision-making.