Age-related differences in risks and outcomes of 30-day readmission in adults with sickle cell disease.

BACKGROUND: Literature on 30-day readmission in adults with sickle cell disease (SCD) is limited. This study examined the overall and age-stratified rates, risk factors, and healthcare resource utilization associated with 30-day readmission in this population. METHODS: Using the Nationwide Readmissions Database, a retrospective cohort study was conducted to identify adult patients (aged ≥ 18) with SCD in 2016. Patients were stratified by age and followed for 30 days to assess readmission following an index discharge. The primary outcome was 30-day unplanned all-cause readmission. Secondary outcomes included index hospitalization costs and readmission outcomes (e.g., time to readmission, readmission costs, and readmission lengths of stay). Separate generalized linear mixed models estimated the adjusted odds ratios (aORs) for associations of readmission with patient and hospital characteristics, overall and by age. RESULTS: Of 15,167 adults with SCD, 2,863 (18.9%) experienced readmission. Both the rates and odds of readmission decreased with increasing age. The SCD complications vaso-occlusive crisis and end-stage renal disease (ESRD) were significantly associated with increased likelihood of readmission (p < 0.05). Age-stratified analyses demonstrated that diagnosis of depression significantly increased risk of readmission among patients aged 18-to-29 years (aOR = 1.537, 95%CI: 1.215-1.945) but not among patients of other ages. All secondary outcomes significantly differed by age (p < 0.05). CONCLUSION: This study demonstrates that patients with SCD are at very high risk of 30-day readmission and that younger adults and those with vaso-occlusive crisis and ESRD are among those at highest risk. Multifaceted, age-specific interventions targeting individuals with SCD on disease management are needed to prevent readmissions.

Cost-Effectiveness of Medication Therapy Management Program Across Racial and Ethnic Groups Among Medicare Beneficiaries.

OBJECTIVES: Equity and effectiveness of the medication therapy management (MTM) program in Medicare has been a policy focus since its inception. The objective of this study was to evaluate the cost-effectiveness of the Medicare MTM program in improving medication utilization quality across racial and ethnic groups. METHODS: This study analyzed 2017 Medicare data linked to the Area Health Recourses File. A propensity score was used to match MTM enrollees and nonenrollees, and an incremental cost-effectiveness ratio between the 2 groups was calculated. Effectiveness was measured as the proportion of appropriate medication utilization based on medication utilization measures developed by Pharmacy Quality Alliance. Net monetary benefits were compared across racial and ethnic groups at various societal willingness-to-pay (WTP) thresholds. The 95% confidence intervals were obtained by nonparametric bootstrapping. RESULTS: MTM dominated non-MTM among the total sample (N = 699 992), as MTM enrollees had lower healthcare costs ($31 135.89 vs $32 696.69) and higher proportions of appropriate medication utilization (87.47% vs 85.31%) than nonenrollees. MTM enrollees had both lower medication costs ($10 681.21 vs $11 003.08) and medical costs ($20 454.68 vs $21 693.61) compared with nonenrollees. The cost-effectiveness of MTM was higher among Black patients than White patients across the WTP thresholds. For instance, at a WTP of $3006 per percentage point increase in effectiveness, the net monetary benefit for Black patients was greater than White patients by $2334.57 (95% confidence interval $1606.53-$3028.85). CONCLUSIONS: MTM is cost-effective in improving medication utilization quality among Medicare beneficiaries and can potentially reduce disparities between Black and White patients. Expansion of the current MTM program could maximize these benefits.

Survival Benefit Associated With the Use of Extracorporeal Life Support for Neonates With Congenital Diaphragmatic Hernia.

OBJECTIVE: To measure the survival among comparable neonates with CDH supported with and without ECLS. SUMMARY OF BACKGROUND DATA: Despite widespread use in the management of newborns with CDH, ECLS has not been consistently associated with improved survival. METHODS: A retrospective cohort study was performed using ECLS-eligible CDH Study Group registry patients born between 2007 and 2019. The primary outcome was in-hospital mortality. Neonates who did and did not receive ECLS were matched based on variables affecting risk for the primary outcome. Iterative propensity score-matched, survival (Cox regression and Kaplan-Meier), and center effects analyses were performed to examine the association of ECLS use and mortality. RESULTS: Of 5855 ECLS-eligible CDH patients, 1701 (29.1%) received ECLS. "High-risk" patients were best defined as those with a lowest achievable first-day arterial partial pressure of CO2 of ≥60 mm Hg. After propensity score matching, mortality was higher with ECLS (47.8% vs 21.8%, odds ratio 3.3, 95% confidence interval 2.7-4.0, hazard ratio 2.3, P < 0.0001). For the subgroup of high-risk patients, there was lower mortality observed with ECLS (64.2% vs 84.4%, odds ratio 0.33, 95% confidence interval 0.17-0.65, hazard ratio 0.33, P = 0.001). This survival advantage was persistent using multiple matching approaches. However, this ECLS survival advantage was found to occur primarily at high CDH volume centers that offer frequent ECLS for the high-risk subgroup. CONCLUSIONS: Use of ECLS is associated with excess mortality for low- and intermediate-risk neonates with CDH. It is associated with a significant survival advantage among high-risk infants, and this advantage is strongly influenced by center CDH volume and ECLS experience.

Effects of Medicare comprehensive medication review on racial/ethnic disparities in nonadherence to statin medications among patients with Alzheimer's Disease: an observational analysis.

BACKGROUND: Alzheimer's Disease (AD) is the mostcommon cause of dementia, a neurological disorder characterized by memory loss and judgment impairment. Hyperlipidemia, a commonly co-occurring condition, should be treated to prevent associated complications. Medication adherence may be difficult for individuals with AD due to the complexity of AD management. Comprehensive Medication Reviews (CMRs), a required component of Medicare Part D Medication Therapy Management (MTM), have been shown to improve medication adherence. However, many MTM programs do not target AD. Additionally, racial/ethnic disparities in MTM eligibility have been revealed. Thus, this study examined the effects of CMR receipt on reducing racial/ethnic disparities in the likelihood of nonadherence to hyperlipidemia medications (statins) among the AD population. METHODS: This retrospective study used 2015-2017 Medicare data linked to the Area Health Resources Files. The likelihood of nonadherence to statin medications across racial/ethnic groups was compared between propensity-score-matched CMR recipients and non-recipients in a ratio of 1 to 3. A difference-in-differences method was utilized to determine racial/ethnic disparity patterns using a logistic regression by including interaction terms between dummy variables for CMR receipt and each racial/ethnic minority group (non-Hispanic Whites, or Whites, as reference). RESULTS: The study included 623,400 Medicare beneficiaries. Blacks and Hispanics had higher statin nonadherence than Whites: Compared to Whites, Blacks' nonadherence rate was 4.53% higher among CMR recipients and 7.35% higher among non-recipients; Hispanics' nonadherence rate was 2.69% higher among CMR recipients and 7.38% higher among non-recipients. Differences in racial/ethnic disparities between CMR recipients and non-recipients were significant for each minority group (p < 0.05) except Others. The difference between Whites and Hispanics in the odds of statin nonadherence was 11% lower among CMR recipients compared to non-recipients (OR = 0.89; 95% Confidence Interval = 0.85-0.94 for the interaction term between dummy variables for CMR and Hispanics). Interaction terms between dummy variables for CMR and other racial/ethnic minorities were not significant. CONCLUSIONS: Receiving a CMR was associated with a disparity reduction in nonadherence to statin medications between Hispanics and Whites among patients with AD. Strategies need to be explored to increase the number of MTM programs that target AD and promote CMR completion.

Racial and ethnic disparities associated with the measure for drug-drug interactions among Medicare beneficiaries.

BACKGROUND: Drug-drug interactions (DDIs) cause many preventable hospitalizations and admissions. Efforts have been made to raise DDI awareness and reduce DDI occurrence; for example, Medicare Part D Star Ratings, a health plan quality assessment program, included a DDI measure. Previous research reported racial and ethnic disparities in health services utilization and that racial and ethnic minorities, compared with non-Hispanic whites (whites), may be less likely to be targeted for a similar measure, a Star Ratings adherence measure for diabetes medications. OBJECTIVE: This study aimed to investigate whether any racial and ethnic disparities are associated with the DDI measure in Part D Star Ratings among Medicare populations with diabetes, hypertension, and hyperlipidemia. METHODS: This cross-sectional study analyzed a 2017 Medicare Part D data sample, including 3,960,813 beneficiaries. Because the inclusion in the denominator of the Star Ratings DDI measure was determined by the use of a list of target medications, the likelihood of using a listed target medication was compared between racial and ethnic minorities and whites. Individuals with diabetes, hypertension, and hyperlipidemia were included in the analysis owing to the high prevalence of these conditions. Patient- and community-level characteristics were adjusted by logistic regression. RESULTS: Of the entire study sample, 26.2% used a target medication. Compared with whites, most racial and ethnic minorities were less likely to use a target medication. For example, among individuals with diabetes, blacks, Hispanics, Asians/Pacific Islanders, and others had, respectively, 14% (odds ratio 0.86 [95% CI 0.84-0.88]), 5% (0.95 [0.93-0.98]), 12% (0.88 [0.84-0.92]), and 10% (0.90 [0.87-0.93]) lower odds compared with whites. Findings were similar among hypertension and hyperlipidemia cohorts, except that Hispanics had similar odds of use as whites. CONCLUSION: Most racial and ethnic minorities may have lower likelihood of being targeted for the DDI measure compared with whites. Future studies should examine whether these disparities affect health outcomes and devise new DDI measures for racial and ethnic minorities.

Reliability Testing of the Mayo Elbow Performance Score in Post-operative Patients.

This study aimed to determine intra-observer and inter-observer reliability of the Mayo Elbow Performance Score (MEPS). Patients undergoing elbow surgery completed a MEPS questionnaire initially and another 2-3 weeks later. During the second interview, patients completed the Oxford Elbow Score (OES) for comparison. Intraclass correlation coefficients (ICC) and Pearson correlation coefficients (PCC) > 0.80 indicated substantial agreement. In 42 patients who had elbow surgery, the average MEPS score initially was 78 (range, 5-100, SD 22.4) and 77 (range, 5-100, SD 21.5) at second interview. The average normalized OES score was 79 (range, 17-100, SD 23.6). The ICC for MEPS scores at the two time points was 0.90, and the PCC between the MEPS and OES scores was 0.87, indicating substantial agreement. The MEPS has strong intra-observer reliability at different time points and strong inter-observer reliability when compared with the OES, validating the MEPS as an outcome measure of elbow surgery. (Journal of Surgical Orthopaedic Advances 31(4):229-232, 2022).

Elevated Serum α-Fetoprotein is Associated with Abbreviated Survival for Patients with Fibrolamellar Hepatocellular Carcinoma Who Undergo a Curative Resection.

BACKGROUND: Fibrolamellar hepatocellular carcinoma (FLC) is a rare variant of hepatocellular carcinoma (HCC), with most clinical data stemming from single-institution series. The variability in the literature lends support for analysis using a large national dataset. In doing so, we sought to (1) define the characteristics and outcomes of patients with FLC; (2) determine factors associated with survival in patients undergoing resection; and (3) compare the overall survival (OS) of patients with FLC with a matched group of patients with HCC. METHODS: The National Cancer Database was queried for patients with FLC, and their clinicopathologic features were recorded. Univariate and multivariate analyses were performed to delineate factors associated with survival. RESULTS: Between 2004 and 2015, 496 patients were diagnosed with FLC, 229 of whom underwent a curative resection. The median OS for patients with FLC undergoing curative resection was 78.5 months. Factors associated with abbreviated OS in this surgical cohort include multiple tumors [hazard ratio (HR) 3.15, p = 0.025], positive regional lymph nodes (HR 2.83, p = 0.023), and elevated serum α-fetoprotein (AFP; HR 2.81, p = 0.034). When the OS of patients with FLC was compared with a matched group of patients with HCC, no difference was detected (p = 0.748); however, patients with FLC and elevated AFP had abbreviated OS compared with patients with HCC and elevated AFP (43 vs. 82 months, p ≤ 0.001). CONCLUSIONS: Elevations in serum AFP occur more frequently than previously documented for patients with FLC and are associated with abbreviated OS. AFP levels may help guide the decision for operative intervention in patients with FLC.

The effect of current and former tobacco use on outcomes after primary reverse total shoulder arthroplasty.

BACKGROUND: The purpose of this study was to determine the influence of current and former tobacco use on minimum 2-year clinical and radiographic outcomes after reverse total shoulder arthroplasty (RTSA). METHODS: Review of primary RTSA patient data identified 186 patients with at least 2 years of follow-up. Patients were classified as nonsmokers (76 patients), former smokers (89 patients), or current smokers (21 patients). Assessment included preoperative and postoperative visual analog scale pain scores, American Shoulder and Elbow Surgeons scores, strength, range of motion, complications, revisions, and narcotic use. Radiographs were analyzed for signs of loosening or mechanical failure. RESULTS: Overall mean age of the patients was 70 (48-87) years, and mean follow-up was 2.6 (2.0-5.7) years. Smokers (62.1 years) were significantly younger than nonsmokers (70.7 years) and former smokers (70.8 years; P = .00002). All patients had significant improvements in pain, American Shoulder and Elbow Surgeons score, strength, and forward flexion range of motion; however, smokers had higher visual analog scale pain scores (mean, 2.5) than nonsmokers (mean, 1.8) or former smokers (mean, 1.0; P = .014). Otherwise, no differences were found regarding any of the postoperative parameters (P > .05). CONCLUSIONS: Aside from increased patient-reported pain, current tobacco use does not appear to negatively affect outcomes after primary RTSA. The RTSA design obviates the need for a functioning rotator cuff, possibly mitigating tobacco's negative effects previously demonstrated in rotator cuff repair and anatomic total shoulder arthroplasty. Former users obtained outcomes similar to those of nonusers, suggesting that tobacco use is a modifiable risk factor to achieve optimal pain relief after RTSA.

Resection and chemotherapy is the optimal treatment approach for patients with clinically node positive intrahepatic cholangiocarcinoma.

BACKGROUND: Clinically lymph node positive (cLNP) intrahepatic cholangiocarcinoma (ICC) carries a poor prognosis, without clear management guidelines for the practicing clinician. We sought to evaluate current practice patterns for cLNP ICC, including associations with survival. METHODS: The National Cancer Database was queried for patients with cLNP ICC, without extrahepatic metastases. RESULTS: We identified 1023 patients with cLNP ICC, 77%% (n = 784) of whom received chemotherapy alone. Resection was undertaken in 23% (n = 239) of patients and was most commonly utilized in combination with chemotherapy (n = 150). Median survival for all patients was 13.6 months. Patients undergoing resection in combination with chemotherapy were associated with an improved survival (22.5 months) as compared to those patients receiving chemotherapy alone (11.9 months) or resection alone (12.4 months) (p < 0.01). Finally, we compared the survival of patients with cLNP ICC with that of patients with pathologically proved lymph node positive (pLNP) ICC, all of whom were treated with resection with chemotherapy, and found no difference in survival (22.5 months-19.3 months, p = 0.99, respectively). CONCLUSIONS: While the decision to pursue resection for ICC is multifactorial and patient specific, the presence of clinically positive LNs should not represent a contraindication.

Laparoscopic Approach to Intrahepatic Cholangiocarcinoma is Associated with an Exacerbation of Inadequate Nodal Staging.

INTRODUCTION: Laparoscopic approach to liver resection is feasible and safe, though its utilization with intrahepatic cholangiocarcinoma (ICC) remains poorly documented. We sought to evaluate the use laparoscopy for ICC, and to examine adherence to oncologic standards. METHODS: The National Cancer Database was queried for patients who underwent resection for ICC. Patients were stratified by laparoscopic (LLR) versus open liver resection (OLR). Clinicopathologic parameters and hospital volumes were recorded. RESULTS: In total, 2309 patients with ICC underwent hepatic resection (1997 OLR, 312 LLR) between 2010 and 2015. LLR increased from 12 to 16% during the study period and was utilized more commonly than OLR for wedge and segmental resections (56% vs. 33%, p < 0.001). Nodal evaluation was performed in 58% of all patients with ICC and was significantly more common in patients undergoing OLR (61%, n = 1210) versus LLR (39%, n = 120), p < 0.001. Of the 120 patients undergoing LLR with any nodal evaluation, 31% (n = 37) had a single node evaluated. Patients who underwent LLR were less likely to have ≥ 6 lymph nodes evaluated compared with those who underwent OLR (9% vs. 15%, respectively, p < 0.001). CONCLUSIONS: The use of laparoscopy for ICC is associated with an exacerbation of inadequate nodal evaluation compared with open resections.

Effect of Intensive Interdisciplinary Transitional Care for High-Need, High-Cost Patients on Quality, Outcomes, and Costs: a Quasi-Experimental Study.

BACKGROUND: Many health systems have implemented team-based programs to improve transitions from hospital to home for high-need, high-cost patients. While preliminary outcomes are promising, there is limited evidence regarding the most effective strategies. OBJECTIVE: To determine the effect of an intensive interdisciplinary transitional care program emphasizing medication adherence and rapid primary care follow-up for high-need, high-cost Medicaid and Medicare patients on quality, outcomes, and costs. DESIGN: Quasi-experimental study. PATIENTS: Among 2235 high-need, high-cost Medicare and Medicaid patients identified during an index inpatient hospitalization in a non-profit health care system in a medically underserved area with complete administrative claims data, 285 participants were enrolled in the SafeMed care transition intervention, and 1950 served as concurrent controls. INTERVENTIONS: The SafeMed team conducted hospital-based real-time screening, patient engagement, enrollment, enhanced discharge care coordination, and intensive home visits and telephone follow-up for at least 45 days. MAIN MEASURES: Primary difference-in-differences analyses examined changes in quality (primary care visits, and medication adherence), outcomes (preventable emergency visits and hospitalizations, overall emergency visits, hospitalizations, 30-day readmissions, and hospital days), and medical expenditures. KEY RESULTS: Adjusted difference-in-differences analyses demonstrated that SafeMed participation was associated with 7% fewer hospitalizations (- 0.40; 95% confidence interval (CI), - 0.73 to - 0.06), 31% fewer 30-day readmissions (- 0.34; 95% CI, - 0.61 to - 0.07), and reduced medical expenditures ($- 8690; 95% CI, $- 14,441 to $- 2939) over 6 months. Improvements were limited to Medicaid patients, who experienced large, statistically significant decreases of 39% in emergency department visits, 25% in hospitalizations, and 79% in 30-day readmissions. Medication adherence was unchanged (+ 2.6%; 95% CI, - 39.1% to 72.9%). CONCLUSIONS: Care transition models emphasizing strong interdisciplinary patient engagement and rapid primary care follow-up can enable health systems to improve quality and outcomes while reducing costs among high-need, high-cost Medicaid patients.

The impact of unplanned conversion to an open procedure during minimally invasive pancreatectomy.

BACKGROUND: Minimally invasive pancreatic resection (MIPR) is being increasingly utilized. Outcomes for patients experiencing unplanned conversion to an open procedure during MIPR have been incompletely assessed. We sought to determine the short-term outcomes and factors associated with unplanned conversion during MIPR. METHODS: A retrospective cohort study using the American College of Surgeons National Surgical Quality Improvement Program pancreatectomy-targeted data set was conducted. Successful MIPR was compared with unplanned conversion. Propensity matching was used to separately compare unplanned conversion during MIPR with planned open pancreatectomy. RESULTS: Unplanned conversion occurred in 24.6% of 350 attempted minimally invasive pancreatoduodenectomy (MIPD) and 19.6% of 1174 attempted minimally invasive distal pancreatectomy (MIDP). Conversion was associated with greater overall morbidity and 30-day mortality compared with successful MIPR for both MIPD and MIDP. After matching, unplanned conversion resulted in outcomes equivalent or inferior to open pancreatectomy. Factors significantly associated with unplanned conversion during MIPD included intermediate gland texture, vascular resection, hypertension, disseminated cancer, and chronic steroid use. For MIDP, male sex, hard gland texture, vascular resection, smoking, and recent weight loss were independently associated with conversion. A robotic approach was inversely associated with conversion for MIPD and MIDP. CONCLUSIONS: Unplanned conversion during MIPR is associated with greater morbidity and 30-day mortality. Conversion resulted in outcomes that, at best, mimicked those of open pancreatectomy. Several risk factors including the need for vascular resection are associated with unplanned conversion and should be acknowledged when planning an operative approach.

Ampullary adenocarcinoma: Defining predictors of survival and the impact of adjuvant therapy following surgical resection for stage I disease.

BACKGROUND AND OBJECTIVES: Outcomes and recommendations regarding adjuvant therapy (AT) for stage I ampullary adenocarcinoma (AAC) are inadequately described. We sought to determine factors associated with survival and better define the impact of AT. METHODS: The NCDB was queried for stage I AAC patients undergoing resection. We evaluated variables influencing the administration of AT and affecting survival, including the receipt of AT. RESULTS: Five hundred thirty-seven patients were identified. 1, 3, and 5-year OS were 91.3%, 78.8%, and 67.4%, respectively. 103 received AT: 101 chemotherapy, 31 radiation, and 29 a combination of both. AT was more commonly utilized in patients with poorly differentiated and T2 tumors. Comorbid disease was inversely associated with use of AT. Age ≥65 was associated with decreased survival for stage IA and IB, while positive resection margins and sampling of <12 LNs were associated with decreased OS for stage IA and IB, respectively. After propensity matching key covariates, no significant difference in OS was observed between those receiving and not receiving AT (P = 0.449). CONCLUSION: This analysis revealed a modest 5-year OS for stage I AAC. Age, positive resection margins, and evaluation of <12 LNs negatively influenced OS and AT did not convey a survival benefit.

Higher Predictive Value Positive for MMA Than ACA MTM Eligibility Criteria Among Racial and Ethnic Minorities: An Observational Study.

The objective of this study was to examine positive predictive value (PPV) of medication therapy management (MTM) eligibility criteria under Medicare Modernization Act (MMA) and Affordable Care Act (ACA) in identifying patients with medication utilization issues across racial and ethnic groups. The study analyzed Medicare data (2012-2013) for 2 213 594 beneficiaries. Medication utilization issues were determined based on medication utilization measures mostly developed by Pharmacy Quality Alliance. MMA was associated with higher PPV than ACA in identifying individuals with medication utilization issues among non-Hispanic blacks (blacks) and Hispanics than non-Hispanic whites (whites). For example, odds ratio for having medication utilization issues to whites when examining MMA in 2013 and ACA were 1.09 (95% confidence interval [CI] = 1.04-1.15) among blacks, and 1.17 (95% CI = 1.10-1.24) among Hispanics, in the main analysis. Therefore, MMA was associated with 9% and 17% higher PPV than ACA in identifying patients with medication utilization issues among blacks and Hispanics, respectively, than whites.

A Randomized Trial Comparing Metered Dose Inhalers and Breath Actuated Nebulizers.

BACKGROUND: Despite little evidence for its effectiveness, the breath-actuated nebulizer (BAN) is the default albuterol delivery method in our pediatric emergency department. OBJECTIVE: We compared the clinical efficacy of BAN and the metered-dose inhaler (MDI) in treating subjects patients 2 to 17 years of age who presented with mild to moderate asthma exacerbations. METHODS: This is a randomized, nonblinded, noninferiority study conducted at a single pediatric tertiary care emergency department. Subjects presenting with a Pediatric Asthma Score ranging from 5 to 11 received albuterol by BAN or MDI via standard weight-based and symptom severity dosing protocols. Aerosolized ipratropium (via BAN) and intravenous magnesium sulfate were given when clinically indicated. The primary outcome was patient disposition. The noninferiority margin for the primary outcome was an admission rate difference ≤10%. Analyses were adjusted for confounders that were significant at p ≤ 0.10. RESULTS: We enrolled 890 subjects between October 2014 and April 2015. BAN and MDI groups were comparable for age, gender, and race but not for pretreatment symptom severity; 51% in the MDI group had a Pediatric Asthma Score of moderate severity (8-11) vs. 63% in the BAN group (p < 0.003). Unadjusted admission rates were 11.9% for MDI and 12.8% for BAN, for an unadjusted risk difference of -0.9% (95% confidence interval -5% to 3%). After adjusting for baseline confounder severity, the risk difference was 2% (95% confidence interval -4% to 7%), which met the criteria for noninferiority. CONCLUSIONS: Albuterol therapy by MDI is noninferior to BAN for the treatment of mild to moderate asthma exacerbations in children 2 to 17 years of age.

Clinical significance of MUC13 in pancreatic ductal adenocarcinoma.

BACKGROUND: Poor prognosis of pancreatic cancer (PanCa) is associated with lack of an effective early diagnostic biomarker. This study elucidates significance of MUC13, as a diagnostic/prognostic marker of PanCa. METHODS: MUC13 was assessed in tissues using our in-house generated anti-MUC13 mouse monoclonal antibody and analyzed for clinical correlation by immunohistochemistry, immunoblotting, RT-PCR, computational and submicron scale mass-density fluctuation analyses, ROC and Kaplan Meir curve analyses. RESULTS: MUC13 expression was detected in 100% pancreatic intraepithelial neoplasia (PanIN) lesions (Mean composite score: MCS = 5.8; AUC >0.8, P < 0.0001), 94.6% of pancreatic ductal adenocarcinoma (PDAC) samples (MCS = 9.7, P < 0.0001) as compared to low expression in tumor adjacent tissues (MCS = 4, P < 0.001) along with faint or no expression in normal pancreatic tissues (MCS = 0.8; AUC >0.8; P < 0.0001). Nuclear MUC13 expression positively correlated with nodal metastasis (P < 0.05), invasion of cancer to peripheral tissues (P < 0.5) and poor patient survival (P < 0.05; prognostic AUC = 0.9). Submicron scale mass density and artificial intelligence based algorithm analyses also elucidated association of MUC13 with greater morphological disorder (P < 0.001) and nuclear MUC13 as strong predictor for cancer aggressiveness and poor patient survival. CONCLUSION: This study provides significant information regarding MUC13 expression/subcellular localization in PanCa samples and supporting the use anti-MUC13 MAb for the development of PanCa diagnostic/prognostic test.

Recruitment methods in a clinical trial of provoked vulvodynia: Predictors of enrollment.

BACKGROUND: Successful recruitment in clinical trials for chronic pain conditions is challenging, especially in women with provoked vulvodynia due to reluctance in discussing pain associated with sexual intercourse. The most successful recruitment methods and the characteristics of women reached with these methods are unknown. OBJECTIVE: To compare the effectiveness and efficiency of four recruitment methods and to determine socioeconomic predictors for successful enrollment in a National Institutes of Health-sponsored multicenter clinical trial evaluating a gabapentin intervention in women with provoked vulvodynia. METHODS: Recruitment methods utilized mass mailing, media, clinician referrals and community outreach. Effectiveness (number of participants enrolled) and efficiency (proportion screened who enrolled) were determined. Socioeconomic variables including race, educational level, annual household income, relationship status, age, menopausal status and employment status were also evaluated regarding which recruitment strategies were best at targeting specific cohorts. RESULTS: Of 868 potential study participants, 219 were enrolled. The most effective recruitment method in enrolling participants was mass mailing ( p < 0.001). There were no statistically significant differences in efficiency between recruitment methods ( p = 0.11). Relative to clinician referral, black women were 13 times as likely to be enrolled through mass mailing (adjusted odds ratio 12.5, 95% confidence interval, 3.6-43.1) as white women. There were no differences in enrollment according to educational level, annual income, relationship status, age, menopausal status, or employment status and recruitment method. CONCLUSION: In this clinical trial, mass mailing was the most effective recruitment method. Race of participants enrolled in a provoked vulvodynia trial was related to the recruitment method.

Predictors and implications of unplanned conversion during minimally invasive hepatectomy: an analysis of the ACS-NSQIP database.

BACKGROUND: Minimally-invasive hepatectomy (MIH) is increasingly utilized; however, predictors and outcomes for patients requiring conversion to an open procedure have not been adequately studied. METHODS: The 2014-15 ACS-NSQIP database was analyzed. Unplanned conversion was compared to successful MIH and elective open hepatectomy. RESULTS: Among 6918 hepatectomies, 1062 (15.4%) underwent attempted MIH: 989 laparoscopic, 73 robotic. Conversion occurred in 203 (19.1%). Compared to successful MIH, patients requiring unplanned conversion experienced higher rates of complications (34.5% vs 14.6%, p<0.001), including bile leaks (7.4% vs 2.8%, p=0.002), organ space infection (6.4% vs 2.9%, p=0.016), UTI (4.9% vs 1.2%, p=0.002), perioperative bleeding (21.2% vs 6.1%, p<0.001), DVT (3.0% vs 0.8%, p=0.024), and sepsis (5.9% vs 1.9%, p=0.001). Conversion led to greater LOS (5 days vs 3 days, p<0.001) and 30-day mortality (3.0% vs 0.5%, p=0.005). Compared to elective open hepatectomy, conversion was associated with greater perioperative bleeding (21.2% vs 15.3%, p = 0.037). On multivariate analysis, major hepatectomy (OR 2.21, p<0.001), concurrent ablation (OR 1.79, p=0.020), and laparoscopic approach (vs. robotic) (OR 3.22, p=0.014) were associated with conversion. CONCLUSION: Analysis of this national database revealed unplanned conversion during MIH is associated with greater morbidity and mortality. MIH should be approached cautiously in patients requiring major hepatectomy.

Hypomagnesemia Is Prevalent in Patients Undergoing Gynecologic Surgery by a Gynecologic Oncologist.

OBJECTIVE: The aim of this study was to assess the incidence of and risk factors for hypomagnesemia in patients undergoing gynecologic surgery by a gynecologic oncologist. METHODS: A retrospective chart review was performed on all patients undergoing surgery for gynecologic pathology from July 2011 to July 2015 by a single surgeon. Demographic data, surgical indication, surgery performed, preoperative laboratory values, postoperative laboratory values, and medical history were examined. Hypomagnesemia was defined as less than 1.8 mg/dL. Hypermagnesemia was defined as greater than 2.5 mg/dL. RESULTS: Six hundred sixty-nine patients were identified for analysis. One hundred ninety-seven patients had hypomagnesemia (29.4%). Four hundred sixty-six patients had normal magnesium levels (69.5%), and 6 patients had hypermagnesemia (1%). Among patients with benign disease, 24.9% had preoperative hypomagnesemia compared with 32.7% of patients with a gynecologic malignancy. African American race (P = 0.041), diabetes mellitus (P < 0.001), and malignancy (P = 0.029) were all associated with preoperative hypomagnesemia. Diabetes and major surgery were associated with postoperative hypomagnesemia (P = 0.012 and P = 0.048, respectively). Hypomagnesemia was associated with increased preoperative and postoperative pain (P = 0.049 and P < 0.001, respectively) as well as postoperative hypokalemia (P = 0.001). Age, body mass index, hypertension, cancer type, hematocrit, surgical indication, and length of hospital stay were not associated with hypomagnesemia. CONCLUSIONS: Perioperative hypomagnesemia is prevalent in patients undergoing gynecologic surgery by a gynecologic oncology, especially in patients who have a gynecologic malignancy. We recommend routine preoperative and postoperative evaluation of serum magnesium in all patients undergoing gynecologic surgery by a gynecologic oncologist.

Impact of renal surgery for cortical neoplasms on lipid metabolism.

OBJECTIVE: To examine the incidence of and risk factors for development of hyperlipidaemia in patients undergoing radical nephrectomy (RN) or partial nephrectomy (PN) for renal cortical neoplasms, as hyperlipidaemia is a major source of morbidity in chronic kidney disease (CKD). PATIENTS AND METHODS: We conducted a two-centre retrospective analysis of 905 patients (mean age 57.5 years, mean follow-up 78 months), who underwent RN (n = 610) or PN (n = 295) between July 1987 and June 2007. Demographics, preoperative and postoperative hyperlipidaemia were recorded. De novo hyperlipidaemia was defined as that ocurring ≥6 months after surgery in cases where laboratory values met National Cholesterol Education Program Adult Treatment Panel III definitions. The Kaplan-Meier method was used to assess freedom from de novo hyperlipidaemia. Multivariable analysis was conducted to determine the risk factors for de novo hyperlipidaemia. RESULTS: There were no significant differences with respect to demographics, preoperative glomerular filtration rate (GFR) <60 mL/min/1.73 m(2) (P = 0.123) and hyperlipidaemia (P = 0.144). Tumour size (cm) was significantly larger in the RN group vs the PN group (7.0 vs 3.7; P < 0.001). Significantly greater postoperative GFR <60 mL/min/1.73 m(2) was noted in the RN group (45.7 vs 18%, P < 0.001). Significantly, more de novo hyperlipidaemia developed in the RN group than in the PN group (23 vs 6.4%; P < 0.001). The mean time to development of hyperlipidaemia was longer for PN than for RN (54 vs 44 months; P = 0.03). Five-year freedom from de novo hyperlipidaemia probability was 76% for RN vs 96% for PN (P < 0.001). Multivariable analysis showed that RN (odds ratio [OR] 2.93; P = 0.0107), preoperative GFR <60 mL/min/1.73 m(2) (OR 1.98; P = 0.037) and postoperative GFR <60 mL/min/1.73 m(2) (OR 7.89; P < 0.001) were factors associated with hyperlipidaemia development. CONCLUSION: Patients who underwent RN had a significantly higher incidence of and shorter time to development of de novo hyperlipidaemia. RN and pre- and postoperative eGFR <60 mL/min/1.73 m(2) were associated with development of hyperlipidaemia. Further follow-up and prospective investigation are necessary to confirm these findings.