Racial inequities in second-line treatment and overall survival among patients with metastatic breast cancer.

BACKGROUND: Black women in the USA have a higher incidence and mortality of metastatic breast cancer (mBC) than White women, while Hispanic women have lower rates. Previous studies have focused on first-line (1L) treatment, but little is known about racial differences in treatment beyond 1L and their impact on outcomes. METHODS: This analysis utilized data from an electronic health record derived de-identified database and included patients with HR+HER2- mBC initiating 2L treatment (including CDK4/6-inhibitor [CDKi]-based, endocrine monotherapy, everolimus combination therapy, and chemotherapy and other systemic therapies) between 2/3/2015 and 7/31/2021. Real-world overall survival (rwOS) was defined as time from 2L initiation to death. Multinomial logistic regression assessed the likelihood of 2L treatment between race/ethnicity groups. Median rwOS was estimated using the Kaplan-Meier method and adjusted hazard ratios were estimated using multivariable Cox proportional hazards models. RESULTS: Among all patients who received 2L, non-Hispanic Black (NHB) and Hispanic/Latino patients were less likely to receive 2L CDKi compared to non-Hispanic White (NHW) patients (36%, 39% vs 42%, respectively). Median rwOS was 20.4, 37.6, and 25.3 months, in NHB, Hispanic/Latino and NHW patients, respectively. The rwOS remained poorer among NHB patients after adjustment (HR = 1.16; p = 0.009). In stratified analysis, adjusted rwOS was similar between NHB and NHW patients among those who received 1L CDKi. CONCLUSIONS: These findings suggest that among patients with HR+HER2- mBC, NHB patients had worse survival beyond front-line setting, mainly among the subset of women who did not receive CDKi at 1L. This inequities in rwOS between race/ethnicity groups was not observed among patients who received 1L CDKi.

An informatics infrastructure to catalyze cancer control research and practice.

PURPOSE: A disconnect often exists between those with the expertise to manage and analyze complex, multi-source data sets, and the clinical, social services, advocacy, and public health professionals who can pose the most relevant questions and best apply the answers. We describe development and implementation of a cancer informatics infrastructure aimed at broadening the usability of community cancer data to inform cancer control research and practice; and we share lessons learned. METHODS: We built a multi-level database known as The Ohio Cancer Assessment and Surveillance Engine (OH-CASE) to link data from Ohio's cancer registry with community data from the U.S. Census and other sources. Space-and place-based characteristics were assigned to individuals according to residential address. Stakeholder input informed development of an interface for generating queries based on geographic, demographic, and disease inputs and for outputting results aggregated at the state, county, municipality, or zip code levels. RESULTS: OH-CASE contains data on 791,786 cancer cases diagnosed from 1/1/2006 to 12/31/2018 across 88 Ohio counties containing 1215 municipalities and 1197 zip codes. Stakeholder feedback from cancer center community outreach teams, advocacy organizations, public health, and researchers suggests a broad range of uses of such multi-level data resources accessible via a user interface. CONCLUSION: OH-CASE represents a prototype of a transportable model for curating and synthesizing data to understand cancer burden across communities. Beyond supporting collaborative research, this infrastructure can serve the clinical, social services, public health, and advocacy communities by enabling targeting of outreach, funding, and interventions to narrow cancer disparities.

New Baseline Renal Function after Radical or Partial Nephrectomy: A Simple and Accurate Predictive Model.

PURPOSE: Preoperative estimation of new baseline glomerular filtration rate after partial nephrectomy or radical nephrectomy for renal cell carcinoma has important clinical implications. However, current predictive models are either complex or lack external validity. We aimed to develop and validate a simple equation to estimate postoperative new baseline glomerular filtration rate. MATERIALS AND METHODS: For development and internal validation of the equation, a cohort of 7,860 patients with renal cell carcinoma undergoing partial nephrectomy/radical nephrectomy (2005-2015) at the Veterans Affairs National Health System was analyzed. Based on preliminary analysis of 94,327 first-year postoperative glomerular filtration rate measurements, new baseline glomerular filtration rate was defined as the final glomerular filtration rate within 3 to 12 months after surgery. Multivariable linear regression analyses were applied to develop the equation using two-thirds of the renal cell carcinoma Veterans Administration cohort. The simplest model with the highest coefficient of determination (R2) was selected and tested. This model was then internally validated in the remaining third of the renal cell carcinoma Veterans Administration cohort. Correlation/bias/accuracy/precision of equation were examined. For external validation, a similar cohort of 3,012 patients with renal cell carcinoma from an outside tertiary care center (renal cell carcinoma-Cleveland Clinic) was independently analyzed. RESULTS: New baseline glomerular filtration rate (in ml/minute/1.73 m2) can be estimated with the following simplified equation: new baseline glomerular filtration rate = 35 + preoperative glomerular filtration rate (× 0.65) - 18 (if radical nephrectomy) - age (× 0.25) + 3 (if tumor size >7 cm) - 2 (if diabetes). Correlation/bias/accuracy/precision were 0.82/0.00/83/-7.5-8.4 and 0.82/-0.52/82/-8.6-8.0 in the internal/external validation cohorts, respectively. Additionally, the area under the curve (95% confidence interval) to discriminate postoperative new baseline glomerular filtration rate ≥45 ml/minute/1.73 m2 from receiver operating characteristic analyses were 0.90 (0.88, 0.91) and 0.90 (0.89, 0.91) in the internal/external validation cohorts, respectively. CONCLUSIONS: Our study provides a validated equation to accurately predict postoperative new baseline glomerular filtration rate in patients being considered for radical nephrectomy or partial nephrectomy that can be easily implemented in daily clinical practice.

Association between neighborhood disadvantage and fulfillment of desired postpartum sterilization.

BACKGROUND: Adequacy of prenatal care is associated with fulfillment of postpartum sterilization requests, though it is unclear whether this relationship is indicative of broader social and structural determinants of health or reflects the mandatory Medicaid waiting period required before sterilization can occur. We evaluated the relationship between neighborhood disadvantage (operationalized by the Area Deprivation Index; ADI) and the likelihood of undergoing postpartum sterilization. METHODS: Secondary analysis of a single-center retrospective cohort study examining 8654 postpartum patients from 2012 to 2014, of whom 1332 (15.4%) desired postpartum sterilization (as abstracted from the medical record at time of delivery hospitalization discharge) and for whom ADI could be calculated via geocoding their home address. We determined the association between ADI and sterilization completion, postpartum visit attendance, and subsequent pregnancy within 365 days of delivery via logistic regression and time to sterilization via Cox proportional hazards regression. RESULTS: Of the 1332 patients included in the analysis, patients living in more disadvantaged neighborhoods were more likely to be younger, more parous, delivered vaginally, Black, unmarried, not college educated, and insured via Medicaid. Compared to patients living in less disadvantaged areas, patients living in more disadvantaged areas were less likely to obtain sterilization (44.8% vs. 53.5%, OR 0.84, 95% CI 0.75-0.93), experienced greater delays in the time to sterilization (HR 1.23, 95% CI 1.06-1.44), were less likely to attend postpartum care (58.9% vs 68.9%, OR 0.86, CI 0.79-0.93), and were more likely to have a subsequent pregnancy within a year of delivery (15.1% vs 10.4%, OR 1.56, 95% CI 1.10-1.94). In insurance-stratified analysis, for patients with Medicaid, but not private insurance, as neighborhood disadvantage increased, the rate of postpartum sterilization decreased. The rate of subsequent pregnancy was positively associated with neighborhood disadvantage for both Medicaid as well as privately insured patients. CONCLUSION: Living in an area with increased neighborhood disadvantage is associated with worse outcomes in terms of desired postpartum sterilization, especially for patients with Medicaid insurance. While revising the Medicaid sterilization policy is important, addressing social determinants of health may also play a powerful role in reducing inequities in fulfillment of postpartum sterilization.

Revisiting the "July Effect" in Plastic Surgery: New Data to Support Resident Autonomy.

BACKGROUND: The "July Effect" represents a topic of considerable interest across residency programs. This study investigated the frequency of postoperative complications following procedures with plastic surgery resident participation (all postgraduate year [PGY] levels) during the first (quarter 3, July-September) and last academic quarters. METHODS: The American College of Surgeons National Surgical Quality Improvement Program database was used to calculate complication rates from 2006 to 2010. Resident involvement was analyzed as a categorical variable consisting of "juniors" (PGY1-PGY3), and "seniors" (PGY4-PGY6). Outcomes from procedures during Q3 were compared with all quarters. Propensity score matching and adjustment enabled logistic regression identifying the effect of resident involvement and admission. RESULTS: Among all cosmetic and reconstructive procedures (n = 6625), mean operative time was not significantly greater in Q3 compared with all other quarters (P = 0.069); no significant differences in complication rates were observed between Q3 and all other quarters, though superficial surgical site infection (SSI) approached significance (3.3% of procedures in Q3 vs 2.5% in all other quarters, P = 0.063). Among reconstructive procedures only (n = 5677), mean operative time was not significantly greater in Q3 compared with all other quarters (P = 0.119); the same held true for cosmetic procedures only (P = 0.275). Surgical site infection, however, was significantly more likely to occur with reconstructive procedures only, in Q3 compared with all other quarters (3.5% of cases vs 2.3%, P = 0.024). When adjusting for PGY status and matching populations, superficial SSI and return to the operating room were not significantly more common in Q3. When adjusting for quarter of admission, however, superficial SSI was significantly more common among the overall and noncosmetic cases with participation by junior residents (P = 0.013 and 0.020, respectively). CONCLUSIONS: This may represent the first fully reproducible, transparent National Surgical Quality Improvement Program study in plastic surgery that demonstrates the absence of a clinically significant "July Effect," and suggests that an appropriate degree of resident autonomy may pose minimal risk during both cosmetic and reconstructive procedures in residency training. Additionally, the findings encourage the development a plastic surgery-specific database to remedy inherent difficulties with larger, more comprehensive surgical databases.

Applied Deep Learning in Plastic Surgery: Classifying Rhinoplasty With a Mobile App.

BACKGROUND: Advances in deep learning (DL) have been transformative in computer vision and natural language processing, as well as in healthcare. The authors present a novel application of DL to plastic surgery. Here, the authors describe and demonstrate the mobile deployment of a deep neural network that predicts rhinoplasty status, assess model accuracy compared to surgeons, and describe future directions for such applications in plastic surgery. METHODS: A deep convolutional neural network ("RhinoNet") was developed to classify rhinoplasty images using only pixels and rhinoplasty status labels ("before"/"after") as inputs. RhinoNet was trained using a dataset of 22,686 before and after photos which were collected from publicly available sites. Network classification was compared to that of plastic surgery attendings and residents on 2269 previously-unseen test-set images. RESULTS: RhinoNet correctly predicted rhinoplasty status in 85% of the test-set images. Sensitivity and specificity of model predictions were 0.840 (0.79-0.89) and 0.826 (0.77-0.88), respectively; the corresponding values for expert consensus predictions were 0.814 (0.76-0.87) and 0.867 (0.82-0.91). RhinoNet and humans performed with effectively equivalent accuracy in this classification task. CONCLUSION: The authors describe the development of DL applications to identify the presence of superficial surgical procedures solely from images and labels. DL is especially well suited for unstructured, high-fidelity visual and auditory data that does not lend itself to classical statistical analysis, and may be deployed as mobile applications for potentially unbridled use, so the authors expect DL to play a key role in many areas of plastic surgery.

A review of the utility of tacrolimus in the management of adults with autoimmune hepatitis.

BACKGROUND: There is paucity of data on alternative drug therapies for patients with autoimmune hepatitis (AIH). Tacrolimus (TAC) is a promising salvage agent. We present a review of TAC therapy in AIH patients. METHODS: A search for studies with keywords 'autoimmune hepatitis' and 'tacrolimus' was performed. Reviews, studies of AIH post-transplant and AIH in children were excluded. Diagnosis of AIH was based on criteria established by the International Autoimmune Hepatitis Group. Complete biochemical response was defined as normalisation of aspartate aminotransferase (AST <45) and alanine aminotransferase (ALT <50). No biochemical response was defined as failure to return to normalisation at the end of follow-up. Demographic information and details of pre- and post-treatment liver biopsy were collected. RESULTS: Seven articles achieved the inclusion criteria and reported data for a total of 162 adult patients. The majority of studies reported average ages approximately 35 years old. Treatment duration ranged from 1 to 136 months. Indications for therapy were mostly AIH refractory to steroid treatment or inability to tolerate standard steroid treatment. Eighty-three patients (51.2%) were reported to have pre-therapy liver biopsy. Of 49 patients for whom stage was reported, 6 patients were stage 1, 16 were stage 2, 14 were stage 3 and 13 were stage 4. Of 40 patients for whom grade was reported, 1 patient was grade 0, 3 were grade 1, 9 were grade 2, 14 were grade 3 and 13 were grade 4. Dosing regimens were between 1 and 8 mg/day. Target trough TAC serum concentrations ranged from 0.5 to 10.7 ng/mL TAC was discontinued in 28 (17.3%) patients for various reasons. Renal function remained stable in most patients. One hundred and twenty-one patients (74.7%) demonstrated complete biochemical response to treatment. Post-therapy liver biopsy was obtained for 30 (18.5%) patients, and 25 (15.4%) of these patients were noted to have histological remission according to the grade of inflammation or stage of fibrosis. CONCLUSION: TAC is relatively effective in the treatment of AIH refractory to traditional therapy. It appears that liver function can be enhanced at a minimal cost to renal function. Key Points There is a cohort of patients with autoimmune hepatitis (AIH) who do not respond to standard therapy. Alternative treatment options for these patients have been explored, but outcomes have not been comprehensively examined. We report the use and efficacy of tacrolimus (TAC) in patients with AIH. We found that TAC can be safely and effectively used in patients with AIH with minimal side effects. TAC can be a potential treatment option for patients with AIH refractory to standard therapy.

Sex-specific enlarged vestibular aqueduct morphology and audiometry.

OBJECTIVE: Enlargement of the vestibular aqueduct (EVA) is one of the most common congenital malformations in pediatric patients presenting with sensorineural or mixed hearing loss. The relationship between vestibular aqueduct (VA) morphology and hearing loss across sex is not well characterized. This study assesses VA morphology and frequency-specific hearing thresholds with sex as the primary predictor of interest. MATERIALS AND METHODS: A retrospective, longitudinal, and repeated-measures study was used. 47 patients at an academic tertiary care center with hearing loss and a record of CT scan of the internal auditory canal were candidates, and included upon meeting EVA criteria after confirmatory measurements of vestibular aqueduct midpoint and operculum widths. Audiometric measures included pure-tone average and frequency-specific thresholds. RESULTS: Of the 47 patients (23 female and 24 male), 79 total ears were affected by EVA; the median age at diagnosis was 6.60 years. After comparing morphological measurements between sexes, ears from female patients were observed to have a greater average operculum width (3.25 vs. 2.70 mm for males, p = 0.006) and a greater average VA midpoint width (2.80 vs. 1.90 mm for males, p = 0.004). After adjusting for morphology, male patients' ears had pure-tone average thresholds 17.6 dB greater than female patients' ears (95% CI, 3.8 to 31.3 dB). CONCLUSIONS: Though females seem to have greater enlargement of the vestibular aqueduct, this difference does not extend to hearing loss. Therefore, our results indicate that criteria for EVA diagnoses may benefit from re-evaluation. Further exploration into morphological and audiometric discrepancies across sex may help inform both clinician and patient expectations.

Morphology and cochlear implantation in enlarged vestibular aqueduct.

PURPOSE: The purpose of this work is to explore audiometry following cochlear implantation (CI) in patients with enlarged vestibular aqueduct (EVA) and to investigate the effects of inner ear morphological variation on post CI audiometry. METHODS: This was a retrospective review of both natural and cochlear-implant-aided audiometry results, using all available measurements in a mixed-effects model accounting for longitudinal change and the grouping structure of ears. Patients who visited our tertiary academic medical center between 2000 and 2016 were identified as having EVA according to Cincinnati criteria on radiological examination; patients eligible for CI were then selected for analysis. RESULTS: Multivariable modeling showed a statistically significant hearing improvement in ears with EVA undergoing CI with regards to pure tone average (-64.0 dB, p < 0.0001), speech reception threshold (-57.90 dB, p < 0.0001), and word score (34.8%, p > 0.0001). Vestibular aqueduct midpoint size and the presence of incomplete partition type II (IP II) did not have significant independent associations with audiometric findings. However, multivariable modeling revealed a statistically significant interaction between IP II and CI such that IP II ears demonstrated a decrease in WS improvement of 30.2% (p = 0.0059) compared to non-IP II ears receiving CI. CONCLUSION: There is a statistically significant audiometric benefit to ears with EVA receiving CI. Morphology, specifically the presence of IP II, may hinder CI benefit in terms of word score however this finding needs clinical validation. This data improves personalization of surgical counseling and planning for patients with EVA considering CI.