Persistent Disparities in Access to Elective Colorectal Cancer Surgery After Medicaid Expansion Under the Affordable Care Act: A Multistate Evaluation.

BACKGROUND: Despite their higher incidence of colorectal cancer, ethnoracial minority and low-income patients have reduced access to elective colorectal cancer surgery. Although the Affordable Care Act's Medicaid expansion increased screening of colonoscopies, its effect on disparities in elective colorectal cancer surgery remains unknown. OBJECTIVE: This study assessed the effects of Medicaid expansion on elective colorectal cancer surgery rates overall and by race-ethnicity and income. DESIGN: Using the 2012 to 2015 State Inpatient Databases, a retrospective cohort study was conducted. SETTINGS: State Inpatient Databases from 3 expansion states (Maryland, New Jersey, and Kentucky) and 2 nonexpansion states (Florida and North Carolina) were used. PATIENTS: This study examined 22,304 adult patients aged 18 to 64 years who underwent colorectal cancer surgery. MAIN OUTCOME MEASURES: Using interrupted time series analysis, the effect of Medicaid expansion on the odds of elective colorectal cancer surgery was assessed. RESULTS: Elective vs nonelective surgery rates remained unchanged overall (70.2% vs 70.7%, p = 0.63) and in ethnoracial minorities in expansion states (whites from 72.8% to 73.8% pre to post, p = 0.40 and non-white from 64.0% to 63.1% pre to post, p = 0.67). There was an instantaneous increase in odds of elective surgery in expansion vs nonexpansion states at policy implementation (adjusted OR 1.37; 95% CI, 1.05-1.79; p = 0.02), but it subsequently decreased (combined adjusted OR 0.95; 95% CI, 0.92-0.99; p = 0.03). Elective surgery rates were also unchanged among ethnoracial minorities (instantaneous changes in expansion states, combined effect 1.06; pre-trend 1.01 vs post-trend 0.98) and low-income persons in expansion states (pre-trend 1.03 vs post-trend 0.97) (for all, p > 0.1). LIMITATIONS: The study was limited to 5 states. Although patients may have increased access to cancer screening services and surgery after expansion, the State Inpatient Databases only provide information on patients who underwent surgery. CONCLUSIONS: Despite gains in screening, Medicaid expansion was not associated with reductions in known ethnoracial or income-based disparities in elective colorectal cancer surgery rates. Expanding access to colorectal cancer surgery for underserved populations likely requires attention to provider and health system factors contributing to persistent disparities. See Video Abstract at http://links.lww.com/DCR/C217 . DISPARIDADES PERSISTENTES EN EL ACCESO A LA CIRUGA ELECTIVA DEL CNCER COLORRECTAL DESPUS DE LA EXPANSIN DE MEDICAID EN VIRTUD DE LA LEY DEL CUIDADO DE SALUD A BAJO PRECIO UNA EVALUACIN MULTIESTATAL: ANTECEDENTES: A pesar de su mayor incidencia de cáncer colorrectal, los pacientes de minorías etnoraciales y de bajos ingresos tienen un acceso reducido a la cirugía electiva de cáncer colorrectal. Aunque la expansión de Medicaid de la Ley del Cuidado de Salud a Bajo Precio aumentó las colonoscopias de detección, aún se desconoce su efecto sobre las disparidades en la cirugía electiva de cáncer colorrectal.OBJETIVO: Este estudio evaluó los efectos de la expansión de Medicaid en las tasas de cirugía electiva de cáncer colorrectal en general y por raza, etnia e ingresos.DISEÑO: Utilizando las bases de datos estatales de pacientes hospitalizados de 2012-2015, se realizó un estudio de cohorte retrospectivo.CONFIGURACIÓN: Se utilizaron bases de datos estatales de pacientes hospitalizados de tres estados en expansión (Maryland, Nueva Jersey, Kentucky) y dos estados sin expansión (Florida, Carolina del Norte).PACIENTES: Este estudio examinó a 22,304 pacientes adultos de 18 a 64 años que se sometieron a cirugía de cáncer colorrectal.RESULTADO PRINCIPAL: Mediante el análisis de series de tiempo interrumpido, se evaluó el efecto de la expansión de Medicaid en las probabilidades de cirugía electiva de cáncer colorrectal.RESULTADOS: Las tasas de cirugía electiva frente a no electiva permanecieron sin cambios en general (70,2% frente a 70,7%, p = 0,63) y en las minorías etnoraciales en los estados de expansión (blancos del 72,8% al 73,8 % antes y después, p = 0,40 y no blancos del 64,0% al 63,1% pre a post, p = 0,67). Hubo un aumento instantáneo en las probabilidades de cirugía electiva en los estados de expansión frente a los de no expansión en la implementación de la política (OR ajustado 1,37, IC del 95%, 1,05-1,79, p = 0,02), pero disminuyó posteriormente (OR ajustado combinado 0,95, 95% IC, 0,92-0,99, p = 0,03). Las tasas de cirugía electiva también se mantuvieron sin cambios entre las minorías etnoraciales (cambios instantáneos en los estados de expansión, efecto combinado 1,06; antes de la tendencia 1,01 frente a la postendencia 0,98) y las personas de bajos ingresos en los estados de expansión (antes de la tendencia 1,03 frente a la postendencia 0,97; para todos, p > 0,1).LIMITACIONES: El estudio se limitó a cinco estados. Si bien los pacientes pueden tener un mayor acceso a los servicios de detección de cáncer y la expansión posterior a la cirugía, la base de datos de pacientes hospitalizados del estado solo brinda información sobre los pacientes que se sometieron a cirugía.CONCLUSIONES: A pesar de los avances en la detección, la expansión de Medicaid no se asoció con reducciones en las disparidades etnoraciales o basadas en los ingresos conocidas en las tasas de cirugía electiva de cáncer colorrectal. Ampliar el acceso a la cirugía del cáncer colorrectal para las poblaciones desatendidas probablemente requiera atención a los factores del proveedor y del sistema de salud que contribuyen a las disparidades persistentes. Consulte el Video Resumen en http://links.lww.com/DCR/C217 . (Traducción-Dr. Yesenia.Rojas-Khalil ).

National evaluation of patterns and predictors of underuse of multimodal therapy for high-risk extremity soft tissue sarcoma.

BACKGROUND: Treatment of high-risk extremity soft tissue sarcomas remains widely varied. Despite growing support for a multimodal approach for treatment of these rare and aggressive neoplasms, its dissemination remains underused. This national study aimed to evaluate variations in treatment patterns and uncover factors predictive of underuse of multimodal therapy in high-risk extremity soft tissue sarcomas. METHODS: The 2010 to 2015 National Cancer Database was used to evaluate trends in 3 common treatment patterns: surgery alone, surgery + adjuvant therapy, and neoadjuvant therapy + surgery. Demographic-, sarcoma-, hospital-, and treatment-level factors of 6,725 surgically treated patients with stage II or III intermediate- to high-grade extremity soft tissue sarcomas were evaluated by types of treatment modality. Stepwise multivariable logistic regression was performed to identify factors predictive of each treatment modality. RESULTS: When compared to surgery alone (34.6%) and adjuvant therapy (41.2%), use of neoadjuvant therapy + surgery for high-risk extremity soft tissue sarcomas remained low (25.3%). However, time trend analysis demonstrated that neoadjuvant therapy + surgery has significantly increased by 7% per year, whereas surgery alone decreased by 4% every year (P < .05 for both). Factors predictive of surgery alone were older age, nonprivate insurance, increasing travel distance, and multimorbidity (P < .05). Conversely, factors associated with neoadjuvant therapy + surgery were private insurance, higher education, and care at academic or high-volume institutions (for all, P < .05). Tumor-related factors predictive for neoadjuvant therapy + surgery included size <5 cm and higher-grade tumors (P < .05). CONCLUSION: Adoption of multimodality therapy for high-risk extremity soft tissue sarcomas remains low and gradual in the United States. Dissemination of multimodality therapy will require attention to access and hospital factors to maximize these therapies for high-risk extremity soft tissue sarcomas.

Increased Access to Cardiac Surgery Did Not Improve Outcomes: Early Look Into Medicaid Expansion.

BACKGROUND: Cardiac surgery utilization has increased after passage of the Affordable Care Act. This multistate study examined whether changes in access after Medicaid expansion (ME) have led to improved outcomes, overall and particularly among ethnoracial minorities. METHODS: State Inpatient Databases were used to identify nonelderly adults (ages 18-64 years) who underwent coronary artery bypass grafting, aortic valve replacement, mitral valve replacement, or mitral valve repair in 3 expansion (Kentucky, New Jersey, Maryland) vs 2 nonexpansion states (North Carolina, Florida) from 2012 to 2015. Linear and logistic interrupted time series were used with 2-way interactions and adjusted for patient-level, hospital-level, and county-level factors to compare trends and instantaneous changes at the point of ME implementation (quarter 1 of 2014) for mortality, length of stay, and elective status. Interrupted time series models estimated expansion effect, overall and by race-ethnicity. RESULTS: Analysis included 22 038 cardiac surgery patients from expansion states and 33 190 from nonexpansion states. In expansion states, no significant trend changes were observed for mortality (odds ratio, 1.01; P = .83) or length of stay (ß = -0.05, P = .20), or for elective surgery (odds ratio, 1.00; P = .91). There were similar changes seen in nonexpansion states. Among ethnoracial minorities, ME did not impact outcomes or elective status. CONCLUSIONS: Despite an increase in cardiac surgery utilization after ME, outcomes remained unchanged in the early period after implementation, overall and among ethnoracial minorities. Future research is needed to confirm long-term trends and examine reasons behind this lack of improved outcomes.

Defining a minimum hospital volume threshold for minimally invasive colon cancer resections.

BACKGROUND: Laparoscopic colectomy is considered the standard of care in colon cancer treatment when appropriate expertise is available. However, guidelines do not delineate what experience is required to implement this approach safely and effectively. This study aimed to establish a data-derived, hospital-level annual volume threshold for laparoscopic colectomy at which patient outcomes are optimized. METHODS: This evaluation included 44,157 stage I to III adenocarcinoma patients aged ≥40 years who underwent laparoscopic colon resection between 2010 and 2015 within the National Cancer Database. The primary outcome was overall survival, with 30- and 90-day mortality, duration of stay, days to receipt of chemotherapy, and number of lymph nodes examined as secondary. Segmented logistic and Cox regression models were used to identify volume thresholds which optimized these outcomes. RESULTS: In hospitals performing ≥30 laparoscopic colectomies per year there were incremental improvements in overall survival for each additional resection beyond 30. Hospitals performing ≥30 procedures/year demonstrated improved 30-day mortality (1.3% vs 1.7%, P < .001), 90-day mortality (2.3% vs 2.9%, P < .001), and overall survival (84.3% vs 82.3%, P < .001). Those hospitals performing <30 procedures/year had no significant benefit in overall survival. Thresholds were not identified for any other outcomes. Results were comparable in colon cancer patients with stage IV or multiple cancers. CONCLUSION: A high-volume hospital threshold of ≥30 cases/year for laparoscopic colectomies is associated with improved patient survival and outcomes. A minimum volume standard may help providers determine which approach is most suitable for their hospital's practice as open procedures may yield better oncologic results in low volume settings.

Surgical Outcomes in Urogynecology-Assessment of Perioperative and Postoperative Complications Relative to Preoperative Hemoglobin A1c-A Fellows Pelvic Research Network Study.

OBJECTIVES: Poor control of diabetes mellitus is a known predictor of perioperative and postoperative complications. No literature to date has established a hemoglobin A1c (HbA1c) cutoff for risk stratification in the urogynecology population. We sought to identify an HbA1c threshold predictive of increased risk for perioperative and postoperative complications after pelvic reconstructive surgery. METHODS: This multicenter retrospective cohort study involving 10 geographically diverse U.S. female pelvic medicine and reconstructive surgery programs identified women with diabetes who underwent prolapse and/or stress urinary incontinence surgery from September 1, 2013, to August 31, 2018. We collected information on demographics, preoperative HbA1c levels, surgery type, complications, and outcomes. Sensitivity analyses identified thresholds of complications stratified by HbA1c. Multivariate logistic regression further evaluated the association between HbA1c and complications after adjustments. RESULTS: Eight hundred seven charts were identified. In this diabetic cohort, the rate of overall complications was 44.1%, and severe complications were 14.9%. Patients with an am HbA1c value of 8% or greater (reference HbA1c, <8%) had an increased rate of both severe (27.1% vs 12.8%, P < 0.001) and overall complications (57.6% vs 41.8%, P = 0.002) that persisted after multivariate logistic regression (odds ratio, 2.618; 95% confidence interval, 1.560-4.393 and odds ratio, 1.931; 95% confidence interval, 1.264-2.949, respectively). Mesh complications occurred in 4.6% of sacrocolpopexies and 1.7% of slings. The average HbA1c in those with mesh exposures was 7.5%. CONCLUSIONS: Preoperative HbA1c of 8% or higher was associated with a 2- to 3-fold increased risk of overall and severe complications in diabetic patients undergoing pelvic reconstructive surgery that persisted after adjustments.

ACA Medicaid expansion reduced disparities in use of high-volume hospitals for pancreatic surgery.

BACKGROUND: Early evaluation of the Affordable Care Act's Medicaid expansion demonstrated persistent disparities among Medicaid beneficiaries in use of high-volume hospitals for pancreatic surgery. Longer-term effects of expansion remain unknown. This study evaluated the impact of expansion on the use of high-volume hospitals for pancreatic surgery among Medicaid and uninsured patients. METHODS: State inpatient databases (2012-2017), the American Hospital Association Annual Survey Database, and the Area Resource File from the Health Resources and Services Administration, were used to examine 8,264 non-elderly adults who underwent pancreatic surgery in nine expansion and two non-expansion states. High-volume hospitals were defined as performing 20 or more resections/year. Linear probability triple differences models measured pre- and post-Affordable Care Act utilization rates of pancreatic surgery at high-volume hospitals among Medicaid and uninsured patients versus privately insured patients in expansion versus non-expansion states. RESULTS: The Affordable Care Act's expansion was associated with increased rates of utilization of high-volume hospitals for pancreatic surgery by Medicaid and uninsured patients (48% vs 55.4%, P = .047) relative to privately insured patients in expansion states (triple difference estimate +11.7%, P = .022). A pre-Affordable Care Act gap in use of high-volume hospitals among Medicaid and uninsured patients in expansion states versus non-expansion states (48% vs 77%, P < .0001) was reduced by 15.1% (P = .001) post Affordable Care Act. A pre Affordable Care Act gap between expansion versus non-expansion states was larger for Medicaid and uninsured patients relative to privately insured patients by 24.9% (P < .0001) and was reduced by 11.7% (P = .022) post Affordable Care Act. Rates among privately insured patients remained unchanged. CONCLUSION: Medicaid expansion was associated with greater utilization of high-volume hospitals for pancreatic surgery among Medicaid and uninsured patients. These findings are informative to non-expansion states considering expansion. Future studies should target understanding referral mechanism post-expansion.

Clobetasol Compared With Fractionated Carbon Dioxide Laser for Lichen Sclerosus: A Randomized Controlled Trial.

OBJECTIVE: To compare 6-month safety and efficacy outcomes of fractionated CO2 laser (laser) with topical clobetasol propionate (steroid) for treatment of symptomatic vulvar lichen sclerosus. METHODS: We conducted a single-center randomized controlled trial that compared fractionated CO2 laser with steroid treatment for patients with biopsy-proven lichen sclerosus. Randomization was stratified by prior clobetasol propionate use. The primary outcome was mean change in Skindex-29 score at 6 months. A total sample size of 52 participants were recruited to detect a mean difference of 16 points on the Skindex-29 (SD±22) with 80% power, based on a one-sided two-sample t test with α=0.05, accounting for 10% attrition. Secondary outcomes included validated subjective and objective measures. Intention-to-treat, per protocol, and regression analysis based on prior steroid exposure were performed. RESULTS: From October 2015 to July 2018, 202 women were screened, 52 were randomized, and 51 completed a 6-month follow-up. No significant difference was found in baseline demographics, symptoms, and physician assessment scores. There was greater improvement in the Skindex-29 score in the laser arm at 6-months (10.9 point effect size, 95% CI 3.42-18.41; P=.007). Overall, 89% (23/27) of patients in the laser group rated symptoms as being "better or much better" compared with 62% (13/24) of patients in the steroid group, P=.07. More patients (81%, 21/27) were "satisfied or very satisfied" with laser treatment compared with steroid treatment (41%, 9/24); P=.01. After stratification for previous steroid use, the significant change of Skindex-29 score was only seen in the previously exposed group. There was one adverse event in each group: minor burning and blistering at the laser site and reactivation of genital herpes 1 week after starting steroid. CONCLUSION: Fractionated CO2 laser treatment showed significant improvement in subjective symptoms and objective measures compared with clobetasol propionate, without serious safety or adverse events at 6 months. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02573883.

Analysis of lesional color to differentiate infantile hemangiomas from port-wine birthmarks in infants less than 3 months old: A pilot study.

BACKGROUND: In their early phase, infantile hemangiomas (IH) can sometimes be difficult to differentiate from port-wine birthmarks (PWB). Until recently, inexpensive diagnostic tools have not been readily available. OBJECTIVE: To determine the diagnostic utility of widely available colorimetric technology when differentiating PWB from IH in photographs of infants less than 3 months old. METHODS: Multi-center, retrospective analysis of RGB (red, green, and blue) and HSL (hue, saturation, lightness) values collected using electronic colorimeters from images of clinically confirmed untreated IH or PWB. Subgroup analysis of flat vascular birthmarks was subsequently performed. RESULTS: Images of 119 IH (specifically, 45 flat IH) and 59 PWB were identified. PWB had significantly (P < .001) higher RGB values of all primary colors, most notably for blue and green (mean difference: >50), irrespective of thickness. RGB or RGB with HSL values had an excellent accuracy (90%), sensitivity (92%), specificity (98%), and positive predictive value (98%) when discriminating PWB from flat IH. IH could be distinctly clustered from PWB when combining their RGB with HSL values. CONCLUSION: Electronic colorimeters with emphasis on blue and green values, are able to differentiate PWB from IH, irrespective of thickness, with a high degree of accuracy. A larger scale evaluation is now required.

Identification of Risk Factors for Testing of Hepatitis C in Non-Birth Cohort Patients: Is Universal Screening Necessary?

OBJECTIVES: CDC reported that 45% of Hepatitis C (HCV) infected people denied known risk factors. Electronic health record RF-based, non-Birth Cohort (born outside of years 1945-1965) screening is challenging as risk factors are often input as nonsearchable data. Testing non-Birth Cohort patients solely based on risk factors has the potential to miss a substantial number of HCV infected patients. The aim was to determine the HCV antibody positive prevalence who would have been missed had providers only followed risk factor based screening recommendations. METHODS: A 1:3 case-control retrospective nested chart review was conducted. HCV risk factors and opioid prescriptions were manually abstracted from the Electronic Health Record; other variables were collected using Explorys. In July 2015 HCV screening data was collected on non-Birth Cohort patients who were HCV tested across MedStar Health, as a presumptive marker for high risk. Univariate and multivariate logistic regression models were utilized to determine HCV antibody positive predictors. RESULTS: Eighteen (23%) HCV antibody positive and 123 (49%) HCV antibody negative had no identified risk factors; 6 (33%) HCV antibody positive reported risk factors only after a positive test result. There was a significant interaction between age over 40 and opioid prescription use; these groups were 11× more likely to be HCV antibody positive (CI95 1.6-74.8). CONCLUSIONS: HCV testing solely based on presence of risk factors in non-Birth Cohort patients has the potential to miss a significant number of HCV antibody positive patients. Given patient- and provider-level barriers in elucidating risk factors, universal HCV antibody screening may be warranted.

Sex and Racial Disparities in the Treatment and Outcomes of Muscle-invasive Bladder Cancer.

OBJECTIVE: To identify racial and sex disparities in the treatment and outcomes of muscle-invasive bladder cancer (MIBC) using a nationwide oncology outcomes database. METHODS: Using the National Cancer Database, we identified patients with muscle invasive bladder cancer from 2004 to 2014. Treatments analyzed included no treatment, cystectomy, neoadjuvant chemotherapy plus cystectomy ("optimal treatment"), cystectomy plus adjuvant chemotherapy, and chemoradiation. Propensity matching compared mortality outcomes between sexes. Logistic models evaluated predictors of receiving optimal treatment, as well as mortality. RESULTS: Forty seven thousand two hundred and twenty nine patients were identified. Most patients were male (73.4%) and underwent cystectomy alone (69.0%). Propensity score matching demonstrated increased 90-day mortality in women vs men (13.0% vs 11.6%, P = .009), despite adjusting for differences in treatments between sexes. Logistic regression models showed no difference in receipt of optimal treatment between sexes (odds ratio [OR] 1.01, 95% confidence interval [CI] 0.83-1.22) although black patients were less likely to receive optimal treatment (OR 0.15, 95% CI 0.05-0.48). Logistic regression models confirmed increased 90-day mortality in female (OR 1.17, CI 1.08-1.27, P < .001) and black (OR 1.29, CI 1.11-1.50, P = .001) patients. Females had a lower overall survival on Cox regression analysis (Hazard Ratio 0.92, 95% CI 0.87-0.97). CONCLUSION: While there do not appear to be significant treatment disparities between sexes, women experience higher 90-day mortality and lower overall survival. Black patients are less likely to receive optimal treatment and have a higher risk of 90-day mortality. Additional research is needed to determine the variables leading to worse outcomes in females and identify impediments to black patients receiving optimal treatment.

Cardiac Surgery Utilization Across Vulnerable Persons After Medicaid Expansion.

BACKGROUND: Medicaid expansion (ME) under the Affordable Care Act has reduced the number of uninsured patients, although its preferential effects on vulnerable populations have been mixed. This study examined whether ME preferentially improved cardiac surgery use by insurance strata, race, and income level. METHODS: Non-elderly adults (aged 18-64 years) who underwent coronary artery bypass grafting, aortic valve replacement, mitral valve replacement, or mitral valve repair were identified in the State Inpatient Databases for 3 expansion states (Kentucky, New Jersey, and Maryland) and 2 non-expansion states (North Carolina and Florida) from 2012 to the third quarter of 2015. We used adjusted Poisson interrupted time series to determine the impact of ME on cardiac surgery use for Medicaid or uninsured (MCD/UIS) patients, racial and ethnic minorities, and individuals from low-income areas. RESULTS: In expansion states, use among non-White MCD/UIS patients had a positive trend after ME (2.3%/quarter; P = .156), whereas use for White MCD/UIS patients fell (-1.7%/quarter; P = .117). In contrast, use among non-White MCD/UIS in non-expansion states decreased by 4.4% (P < .001) which was a greater decline than among White MCD/UIS patients (-1.8%/quarter; P = .057). There was no substantial effect of ME on cardiac surgery use for MCD/UIS patients from low- versus high-income areas. CONCLUSIONS: These findings demonstrate that the use of cardiac surgical procedures was generally unchanged after ME; however, nonsignificant trend differences suggest a narrowing gap between vulnerable and non-vulnerable groups in ME states. These preliminary findings help describe the association of insurance coverage as a driver of cardiac surgery use among vulnerable patients.

Unintended Consequences of Health Care Reform: Impact of Changes in Payor Mix on Patient Safety Indicators.

OBJECTIVE: To evaluate the impact of the Affordable Care Act's Medicaid expansion on patient safety metrics at the hospital level by expansion status, across varying levels of safety-net burden, and over time. SUMMARY BACKGROUND DATA: Medicaid expansion has raised concerns over the influx of additional medically and socially complex populations on hospital systems. Whether increases in Medicaid and uninsured payor mix impact hospital performance metrics remains largely unknown. We sought to evaluate the effects of expansion on Centers for Medicare and Medicaid Services-endorsed Patient Safety Indicators (PSI-90). METHODS: Three hundred fifty-eight hospitals were identified using State Inpatient Databases (2012-2015) from 3 expansions (KY, MD, NJ) and 2 nonexpansion (FL, NC) states. PSI-90 scores were calculated using Agency for Healthcare Research and Quality modules. Hospital Medicaid and uninsured patients were categorized into safety-net burden (SNB) quartiles. Hospital-level, multivariate linear regression was performed to measure the effects of expansion and change in SNB on PSI-90. RESULTS: PSI-90 decreased (safety improved) over time across all hospitals (-5.2%), with comparable reductions in expansion versus nonexpansion states (-5.9% vs -4.7%, respectively; P = 0.441) and across high SNB hospitals within expansion versus nonexpansion states (-3.9% vs -5.2%, P = 0.639). Pre-ACA SNB quartile did not predict changes in PSI-90 post-ACA. However, when hospitals increased their SNB by 5%, they incurred significantly more safety events in expansion relative to nonexpansion states (+1.87% vs -14.0%, P = 0.013). CONCLUSIONS: Despite overall improvement in patient safety, increased SNB was associated with increased safety events in expansion states. Accordingly, Centers for Medicare and Medicaid Services measures may unintentionally penalize hospitals with increased SNB following Medicaid expansion.

Effect of Outpatient Rehabilitation on Functional Mobility After Single Total Knee Arthroplasty: A Randomized Clinical Trial.

Importance: Even without evidence, rehabilitation practitioners continue to introduce new interventions to enhance the mobility outcomes for the increasing population with a recent total knee arthroplasty (TKA). Objective: To compare post-TKA functional mobility outcomes among 3 newly developed physical therapy protocols with a standard-of-care post-TKA rehabilitation protocol. Design, Setting, and Participants: This randomized clinical trial included 4 study arms implemented in 15 outpatient clinics within a single health system in the Baltimore, Maryland, and Washington, District of Columbia, region from October 2013 to April 2017. Participants included patients who underwent elective unilateral TKA, were aged 40 years and older, and began outpatient physical therapy within 24 days after TKA. A total of 505 patients were screened and 386 participants were enrolled. Patients provided informed consent and were randomly assigned to 1 of 4 groups. Blinding patients and treating therapists was not feasible owing to the nature of the intervention. Analysis was conducted under the modified intent-to-treat principle from October 2017 to May 2019. Interventions: The control group used a standard recumbent bike for 15 to 20 minutes each session. Interventions used 1 of 3 modalities for 15 to 20 minutes each session: (1) a body weight-adjustable treadmill, (2) a patterned electrical neuromuscular stimulation device, or (3) a combination of the treadmill and electrical neuromuscular stimulation. Main Outcomes and Measures: Outcomes included the Activity Measure for Post-acute Care basic mobility score, a patient-reported outcome measure, and the 6-minute walk test. Outcomes were measured at baseline, monthly, and on discharge from outpatient therapy. Results: Data from 363 patients (mean [SD] age, 63.4 [7.9] years; 222 [61.2%] women) were included in the final analysis, including 92 participants randomized to the control group, 91 participants randomized to the treadmill group, 90 participants randomized to the neuromuscular stimulation device group, and 90 participants randomized to the combination intervention group. Activity Measure for Post-acute Care scores at discharge were similar across groups, ranging from 61.1 to 61.3 (P = .99) with at least 9.0 points improvement (P = .80) since baseline. The distances as measured by the 6-minute walking test were not statistically different across groups (range, 382.9-404.5 m; P = .60). Conclusions and Relevance: This randomized clinical trial found no statistically or clinically significant differences in outcomes across the 4 arms. Because outcomes were similar among arms, clinicians should instead consider relative cost in tailoring TKA rehabilitation. Trial Registration: ClinicalTrials.gov Identifier: NCT02426190.

Radical excision for retroperitoneal soft tissue sarcoma: A national propensity-matched outcomes analysis.

BACKGROUND: Given the rarity of retroperitoneal soft tissue sarcoma, few studies have assessed if radical excision of retroperitoneal soft tissue sarcoma with adjacent organs improves survival outcomes. This propensity score-matched study aimed to evaluate the impact of radical excision versus resection of tumor alone. METHODS: The National Cancer Database 2004 to 2015 was used to assess short- and long-term outcomes of resection of tumor alone versus radical excision (tumor plus ≥1 adjacent organs) via 1:1 propensity-matched analyses. Subgroup analyses included low-grade, high-grade, liposarcoma, leiomyosarcoma, adjacent organ involvement alone, localized tumors alone, and high-volume hospitals (≥10 resections/y). Multivariable logistic regression models identified factors associated with radical excision. RESULTS: Comparison of propensity-matched groups (N = 1,139/group) revealed no significant differences in 30-day mortality, 90-day mortality, or overall survival (for all, P > .580). For all subgroup analyses comparing resection of tumor alone with radical excision, including localized tumors without organ invasion (N = 208/group), there were no identified differences in short- or long-term survival. Although it yielded lower R2 resection rates (P = .007), radical excision was associated with greater mean length of stay (P < .001). CONCLUSION: Radical excision was not associated with improved retroperitoneal soft tissue sarcoma survival irrespective of grade, histology, hospital volume, or adjacent organ involvement. Resection of ostensibly involved adjacent viscera may increase morbidity without survival benefit. These results inform ongoing discussion regarding histology-tailored, situation-specific extent of retroperitoneal soft tissue sarcoma resections.

Determinants of neoadjuvant chemotherapy use in muscle-invasive bladder cancer.

Purpose: Cisplatin-based neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC) is standard of care for muscle-invasive bladder cancer (MIBC). However, NAC is used in less than 20% of patients with MIBC. Our goal is to investigate factors that contribute to underutilization NAC to facilitate more routine incorporation into clinical practice. Materials and Methods: We identified 5,915 patients diagnosed with cT2-T3N0M0 MIBC who underwent RC between 2004 and 2014 from the National Cancer Database. Univariate and multivariable models were created to identify variables associated with NAC utilization. Results: Only 18.8% of patients received NAC during the study period. On univariate analyses, NAC utilization was more likely at academic hospitals, US South and Midwest (p<0.05). Higher Charlson score was associated with decrease use of NAC (p<0.05). On multivariate analysis, treatment in academic hospitals (odds ratio [OR], 1.367; 95% confidence interval [CI], 1.186-1.576), in the Midwest (OR, 1.538; 95% CI, 1.268-1.977) and South (OR, 1.424; 95% CI, 1.139-1.781) were independently associated with NAC utilization. Older age (75 to 84 years old; OR, 0.532; 95% CI, 0.427-0.664) and higher Charlson score (OR, 0.607; 95% CI, 0.439-0.839) were associated with decreased NAC utilization. Sixty-eight percent of patients did not receive NAC because it was not planned and only 2.5% of patients had contraindications for NAC treatment. Conclusions: Our study demonstrates that NAC is underutilized. Decreased utilization of NAC was associated with older patients and higher Charlson score. This underutilization may be related to practice patterns as very few patients have true contraindications.

A multicenter retrospective cohort study comparing urethral diverticulectomy with and without pubovaginal sling.

BACKGROUND: Urethral diverticulum is a rare entity and requires a high suspicion for diagnosis based on symptoms and physical exam with confirmation by imaging. A common presenting symptom is stress urinary incontinence (SUI). The recommended treatment is surgical excision with urethral diverticulectomy. Postoperatively, approximately 37% of patients may have persistent and 16% may have de novo SUI. An autologous fascial pubovaginal sling (PVS) placed at the time of urethral diverticulectomy (UD) has the potential to prevent and treat postoperative SUI. However, little has been published about the safety and efficacy of a concomitant pubovaginal sling. OBJECTIVE: The objective of this study was to compare the clinical presentation, outcomes, complications, and diverticulum recurrence rates in women who underwent a urethral diverticulectomy with vs without a concurrent pubovaginal sling. STUDY DESIGN: This multicenter, retrospective cohort study included women who underwent a urethral diverticulectomy between January 1, 2000, and December 31, 2016. Study participants were identified by Current Procedure Terminology codes, and their records were reviewed for demographics, medical or surgical history, symptoms, preoperative testing, concomitant surgeries, and postoperative outcomes. Symptoms, recurrence rates, and complications were compared between women with and without a concomitant pubovaginal sling. The primary outcome was the presence of postoperative stress urinary incontinence symptoms. Based on a stress urinary incontinence rate of 50% with no pubovaginal sling and 10% with a pubovaginal sling, we needed a sample size of 141 participants who underwent diverticulectomy without a pubovaginal sling and 8 participants with a pubovaginal sling to achieve 83% power with P<.05. RESULTS: We identified 485 diverticulectomy cases from 11 institutions who met the inclusion criteria; of these, 96 (19.7%) cases had a concomitant pubovaginal sling. Women with a pubovaginal sling were older than those without a pubovaginal sling (53 years vs 46 years; P<.001), and a greater number of women with pubovaginal sling had undergone diverticulectomy previously (31% vs 8%; P<.001). Postoperative follow-up period (14.6±26.9 months) was similar between the groups. The pubovaginal sling group had greater preoperative stress urinary incontinence (71% vs 33%; P<.0001), dysuria (47% vs 30%; P=.002), and recurrent urinary tract infection (49% vs 33%; P=.004). The addition of a pubovaginal sling at the time of diverticulectomy significantly improved the odds of stress urinary incontinence resolution after adjusting for prior diverticulectomy, prior incontinence surgery, age, race, and parity (adjusted odds ratio, 2.27; 95% confidence interval, 1.02-5.03; P=.043). It was not significantly protective against de novo stress urinary incontinence (adjusted odds ratio, 0.86; 95% confidence interval, 0.25-2.92; P=.807). Concomitant pubovaginal sling increased the odds of postoperative short-term (<6 weeks) urinary retention (adjusted odds ratio, 2.5; 95% confidence interval, 1.04-6.22; P=.039) and long-term urinary retention (>6 weeks) (adjusted odds ratio, 6.98; 95% confidence interval, 2.20-22.11; P=.001), as well as recurrent urinary tract infections (adjusted odds ratio, 3.27; 95% confidence interval, 1.26-7.76; P=.013). There was no significant risk to develop a de novo overactive bladder (adjusted odds ratio, 1.48; 95% confidence interval, 0.56-3.91; P=.423) or urgency urinary incontinence (adjusted odds ratio, 1.47; 95% confidence interval, 0.71-3.06; P=.30). A concomitant pubovaginal sling was not protective against a recurrent diverticulum (adjusted odds ratio, 1.38; 95% confidence interval, 0.67-2.82; P=.374). Overall, the diverticulum recurrence rate was 10.1% and did not differ between the groups. CONCLUSION: This large retrospective cohort study demonstrated a greater resolution of stress urinary incontinence with the addition of a pubovaginal sling at the time of a urethral diverticulectomy. There was a considerable risk of postoperative urinary retention and recurrent urinary tract infections in the pubovaginal sling group.

Innovative Devices Did Not Provide Superior Total Knee Arthroplasty Outcomes in Post-Operative Rehabilitation: Results From a Four-Arm Randomized Clinical Trial.

BACKGROUND: Orthopedic surgeons face an increasing array of post-TKA (total knee arthroplasty) rehabilitation interventions that entail innovative equipment and devices, but their relative effectiveness remains unknown. The study compared patient outcomes among primary unilateral TKA patients participating in one of 4 post-TKA rehabilitation interventions-a standard-of-care intervention and 3 more recently developed physical therapy interventions. METHODS: The Knee Arthroplasty Rehabilitation Outcomes Study is a 4-arm randomized clinical trial conducted across 15 outpatient rehabilitation clinics. The trial evaluated 4 alternative interventions: (1) a stationary recumbent bike (control intervention); (2) a body weight-adjustable treadmill; (3) a recumbent bike and use of a patterned electrical neuromuscular stimulation device; and (4) a body weight-adjustable treadmill and a patterned electrical neuromuscular stimulation device. The study's outcome measures were patient walking speed and the Knee injury and Osteoarthritis Outcome Score (KOOS) measured at therapy discharge and at follow-up. RESULTS: The study enrolled 363 TKA patients with 90-92 patients in each of the 4 study arms. Participants were similar across the 4 groups: They were about 63 years old, 61% female, 67% white, living at home, overweight (mean body mass index = 31.6), with mostly private insurance (61%) or Medicare (32%). Walking speed was similar at admission and discharge; KOOS scores were similar at admission, discharge, and follow-up across the 4 intervention groups. CONCLUSION: The study found no statistical or clinically meaningful differences across the 4 study arms in walking speed or KOOS outcomes. Clinicians, payers, and policy makers will want to encourage providers and patients to use the least expensive intervention since each provide similar outcomes. TRIAL REGISTRATION: NCT02426190; https://clinicaltrials.gov/ct2/show/NCT02426190?term=NCT02426190&cntry=US&rank=1.

Variations in Retroperitoneal Soft Tissue Sarcoma Outcomes by Hospital Type: A National Cancer Database Analysis.

PURPOSE: Surgical resection remains the cornerstone of retroperitoneal soft tissue sarcoma (RPS) treatment. Patient- and sarcoma-related factors are well known to influence survival outcomes. The effect of hospital-related factors on long-term survival, however, are not well understood. We sought to assess the relative contribution of hospital-level factors to mortality after surgical treatment of RPS. METHODS AND MATERIALS: The 2004-2015 National Cancer Database was used to identify 10,113 patients who underwent surgical treatment of RPS. Patient-, sarcoma-, hospital-, and treatment-level factors were compared by increasing survival times. Stepwise multivariable Cox regression was performed that controlled for covariates to measure the relative contributions of these factors on overall survival (OS). Effect modification analyses ascertained how hospital type modulates the volume relationship with respect to RPS mortality. RESULTS: Factors predictive of worsening OS were older age, nonprivate insurance, low income, presence of comorbidities, tumor histology, high grade or stage, and R2 resection (for all, P < .05). Increasing hospital surgical volume predicted decreasing risk of death across all survival times. However, analysis by hospital type demonstrated that compared with academic centers, the risk of death at community centers increased significantly as surgical volume increased (hazard ratio, 1.26; 95% CI, 1.03 to 1.53). CONCLUSION: Hospital factors affect mortality after surgical treatment of RPS. Specifically, hospital type alters the surgical volume-outcome relationship for RPS mortality such that community centers perform worse with increasing volumes. Recommendations that higher surgical volume improves outcomes cannot be applied universally and must be re-examined in other complex surgical cancers.

Overweight and obese children with optimal control in the T1D Exchange Registry: How are they different from lean children with optimal control?

AIMS: Increased adiposity is a risk factor for suboptimal diabetes control and cardiovascular disease (CVD) complications. Our goal was to identify modifiable behavioral characteristics of overweight and obese pediatric patients with type 1 diabetes mellitus (T1DM) who achieve optimal glycemic control and to evaluate their CVD risk compared to lean patients. Our hypothesis was that optimally controlled obese and overweight participants require more total daily insulin and are at higher CVD risk compared to optimally controlled lean participants. METHODS: We analyzed a cohort of 9263 participants with T1DM aged <21 years in the T1D Exchange Registry. Optimal diabetes control was defined as HbA1c ≤ 7.5% (58 mmol/mol). We compared factors that influence glycemic control in lean, overweight and obese participants with optimal vs. suboptimal control, using logistic regression. RESULTS: Age, race, overweight status, continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) use were important variables influencing glycemic control. In the optimally controlled cohort, 27% of participants were overweight or obese versus 30% in the suboptimally controlled cohort (P < 0.001). Overweight and obese participants with optimal control were not significantly different from lean participants in terms of CSII use, total daily insulin dosage per kg of bodyweight, glucose checks per day, boluses with bedtime snack, use of CGM, but had higher LDL cholesterol and triglycerides, and lower HDL cholesterol (P < 0.05). CONCLUSIONS: There were no differences in modifiable behavioral characteristics between the obese, overweight and lean optimally controlled participants. However, predictors of cardiovascular disease were higher in the overweight and obese group.