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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.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.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).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.

Previous analysis of policy scenarios reported potential disparities in eligibility in the Medicare Medication Therapy Management (MTM) program. With recently released MTM data, this study aimed to determine if racial/ethnic disparities exist in MTM enrollment among Medicare beneficiaries with Alzheimer's disease and related dementias (ADRD).Medicare claims/records (from 2013-2014 and 2016-2017) linked to the Area Health Resources File were examined. Included individuals were patients with ADRD and diabetes, hypertension or hyperlipidemia. The proportions of MTM enrollment were compared between non-Hispanic White (White) patients and racial/ethnic minority groups in descriptive analysis. Racial/ethnic disparities were then examined using a logistic regression adjusting for patient and community characteristics. Disparities across study periods were compared by estimating a logistic regression model with interaction terms between dummy variables for each racial/ethnic minority group and 2016-2017.In unadjusted analyses, minorities had higher enrollment proportions than Whites. In 2016-2017, for example, enrollment percentages for Whites, Blacks, Hispanics, Asian/Pacific Islanders (Asians) and Others were respectively 14.44%, 16.71%, 19.83%, 16.66%, and 17.78%. In adjusted analyses, Blacks had lower enrollment odds than Whites within all cohorts. In the entire study sample in 2016-2017, for example, Blacks with ADRD had 9% lower odds of MTM enrollment (odds ratio 0.91, 95% confidence interval [CI] = 0.86-0.97) than Whites. These disparities decreased over time among the ADRD sample and all sub-groups. The interaction term between Blacks and 2016-2017, for instance, indicated that disparities were lowered by 11% (odds ratio 1.11, 95% CI = 1.05-1.16) across study periods among those with ADRD.Blacks with ADRD, and diabetes, hypertension or hyperlipidemia have lower likelihood of MTM enrollment than Whites. Racial disparities were reduced over time but not eliminated.

Objectives Racial/ethnic disparities have been found in prior literature examining enrolment in Medicare medication therapy management programs. However, those studies were based on various eligibility scenarios because enrolment data were unavailable. This study tested for potential disparities in enrolment using actual MTM enrolment data. Methods Medicare Parts A&B claims, Medication Therapy Management Data Files, and the Area Health Resources File from 2013 to 2014 and 2016 to 2017 were analysed in this retrospective analysis. An adjusted logistic regression compared odds of enrolment between racial/ethnic minorities and non-Hispanic Whites (Whites) in the total sample and subpopulations with diabetes, hypertension, or hyperlipidaemia. Trends in disparities were analysed by including interaction terms in regressions between dummy variables for race/ethnic minority groups and period 2016-2017. Key Findings Disparities in MTM enrolment were detected between Blacks and Whites with diabetes in 2013-2014 (Odds Ratio = 0.78, 95% Confidence Interval = 0.75-0.81). This disparity improved from 2013-2014 to 2016-2017 for Blacks (Odds Ratio=1.08, 95% Confidence Interval = 1.04-1.11) but persisted in 2016-2017 (Odds Ratio = 0.84, 95% Confidence Interval = 0.81-0.87). A disparity was identified between Blacks and Whites with hypertension in 2013-2014 (Odds Ratio = 0.92, 95% Confidence Interval = 0.89-0.95) but not in 2016-2017. Enrolment for all groups, however, declined between periods. For example, in the total sample, the odds of enrolment declined from 2013-2014 to 2016-2017 by 22% (Odds Ratio=0.78, 95% Confidence Interval=0.75-0.81). Conclusions Racial disparities in MTM enrolment were found between Blacks and Whites among Medicare beneficiaries with diabetes in both periods and among individuals with hypertension in 2013-2014. As overall enrolment fell between periods, concerns about program enrolment remain.

Background Subscapularis management during total shoulder arthroplasty (TSA) remains an area of debate. Although subscapularis-sparing techniques exist, most TSAs are performed through a deltopectoral interval with the subscapularis released and repaired. A paucity of literature exists comparing transosseous repair (TOR) with direct primary tendon repair (PTR) of a subscapularis tenotomy. Our study compared outcomes after TOR and PTR in patients undergoing anatomic TSA. Methods This retrospective study included patients who underwent primary anatomic TSA through a deltopectoral approach with subscapularis tenotomy using either PTR or TOR for repair. Outcome measures included subscapularis failure rates, visual analog scale (VAS) scores, American Shoulder and Elbow Surgeons (ASES) survey scores, internal rotation range of motion and strength, complications, and reoperation rates at 3 months, 1 year, and 2 years. Results Institutional database query identified 306 patients who had primary anatomic TSA, 114 of whom had PTR and 192 TOR. Postoperative ASES and VAS scores were significantly improved at all time points in both groups compared with the preoperative scores (P Conclusion Both transosseous and primary soft-tissue repair techniques after subscapularis tenotomy result in good outcomes after primary anatomic TSA. No differences were found between groups regarding clinical subscapularis failure rate, internal rotation range of motion or strength, VAS, or ASES scores at 2-year follow-up. Level of evidence Level III; Retrospective Study

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).

Background Recent literature supports that outpatient total shoulder arthroplasty (TSA) is a safe alternative to the traditional inpatient setting in appropriately selected patients; however, one concern with outpatient TSA is the inability to administer 24 hours of intravenous (IV) prophylactic antibiotics. The purpose of this study was to determine the infection and revision rates after outpatient TSA using single-dose preoperative IV antibiotics in an ambulatory setting and compare those to TSA performed inpatient with 24 hours of IV antibiotics. Methods An institutional database query was used to identify patients undergoing either primary anatomic TSA or reverse TSA. Patients were grouped into inpatient receiving 24 hours of IV antibiotics or outpatient receiving a single dose of IV antibiotics. Outcomes measured included overall infection (superficial and deep) and revision rates (infectious or noninfectious indications). Timing of infection was categorized as early (diagnosis 3 months postoperatively). Patient demographics and comorbidities were analyzed. Results Of the total 1022 patients identified, 896 were inpatient and received 24 hours of IV antibiotics, and 126 patients were outpatient and received a single dose of IV antibiotics prior to TSA at an ambulatory surgery center. Average follow-up was 23 ± 21 and 18 ± 16 months for the 24-hour antibiotic cohort and single-dose cohort, respectively. The 896 patients receiving 24-hour antibiotics were on average 10.3 years older than the 129 patients who received a single dose ( Conclusion Postoperative infection rates were low in both groups. There were no statistically significant differences in postoperative infection or revision rates. Patients in the single-dose cohort were significantly younger and had fewer comorbidities than patients in the 24-hour cohort; however, the single-dose cohort was more likely to have had previous nonarthroplasty shoulder surgery, which was most likely related to stricter patient selection criteria. The results of this study suggest that a single dose of IV antibiotic prophylaxis can be safely used in patients having outpatient TSA in an ambulatory center. Level of Evidence. Level III; Retrospective Cohort

Many studies have evaluated factors that influence the course of the COVID-19 pandemic in different countries. This multicountry study assessed the influence of democracy and other factors on the case fatality rate of COVID-19 during the early stage of the pandemic. We accessed the World Health Organization, World Bank, and the Democracy Index 2019 databases for data from the 148 countries. Multiple analyses were conducted to examine the association between the Democracy Index and case fatality rate of COVID-19. Within 148 countries, the percentage of the population aged 65 years and above (p = 0.0193), and health expenditure as a percentage of GDP (p = 0.0237) were positively associated with countries’ case fatality rates. By contrast, hospital beds per capita helped to reduce the case fatality rates. In particular, the Democracy Index was positively associated with case fatality rates in a subgroup of 47 high-income countries. This study suggests that enhancing the health system with increased hospital beds and healthcare workforce per capita should reduce case fatality rate. The findings suggest that a higher Democracy Index is associated with more deaths from COVID-19 at the early stage of the pandemic, possibly due to the decreased ability of the government.

Background Evidence is sparse on the effects of Medicare medication therapy management on racial/ethnic disparities in medication adherence among patients with Alzheimer’s disease and related dementias. The objective of this study was to examine the Medicare medication therapy management program’s effects on racial/ethnic disparities in the adherence to antidementia medications among patients with Alzheimer’s disease and related dementias. Methods This is a retrospective analysis of 2016 and 2017 Medicare Parts A, B, and D data linked to Area Health Resources Files. The study outcome was nonadherence to antidementia medications, and intervention was defined as new medication therapy management enrollment in 2017. Propensity score matching was conducted to create intervention and comparison groups with comparable characteristics. A difference-in-differences model was employed with a logistic regression, including interaction terms of dummy variables for the intervention group and racial/ethnic minorities. Results Unadjusted comparisons revealed that Black, Hispanic, and Asian/Pacific Islander (Asian) patients were more likely to be nonadherent than non-Hispanic White (White) patients in 2016. Differences in odds of nonadherence between Black and White patients were lower in 2017 than in 2016 by 27% (odds ratios [OR]: 0.73, 95% confidence interval [CI]: 0.65–0.82). The same difference was also lower between Hispanic and White patients by 26% (OR: 0.74, 95% CI: 0.63–0.87). The MTM enrollment was associated with reduced disparities for Black-White patients of 33% (OR: 0.67, 95% CI: 0.57–0.78) and Hispanic-White patients of 19% (OR: 0.81, 95% CI: 0.67–0.99). Conclusions Medicare medication therapy management program was associated with lower disparities between Black and Hispanic patients with Alzheimer’s disease and related dementias than their White counterparts. Expanding the medication therapy management program may particularly benefit racial/ethnic minorities in Alzheimer’s disease and related dementias care.

Objective: Sphingolipids (SPL) have been associated with type 2 diabetes (T2D) risk. Here, we examined plasma SPL profiles in relation to prediabetes risk in Black and White adults. Methods: Assessments included OGTT, insulin sensitivity (Si-clamp) and insulin secretion (AIRg) . Baseline plasma levels of 54 SPL species (ceramides {CER}, monohexosyl ceramides, sphingomyelins {SM}, and sphingosine {SO}) were assayed using LC/mass spectrometry. The initially normoglycemic adult with parental T2D were followed for 5y for the occurrence of prediabetes. Results: The subjects' mean age was 48.1 + 8.69 y, BMI 30.1 + 5.78 kg/m2, fasting plasma glucose (FPG) 92.7 + 5.84 mg/dl and 2-hrPG 121 + 23.3 mg/dl. We analyzed SPL data from 70 progressors to prediabetes (P) and 70 nonprogressors (NP) . After full adjustments, the levels of SO and saturated (Sat) SPLs (C26:0 CER, C26:0 SM) were higher, and unsaturated (Unsat) SPLs (C18:1 CER; C18:1 SM) and SM% of SPL were lower in P vs.NP (Table 1) . CER and SM levels correlated with Si-clamp and AIRg. The Sat/Unsat SPL ratios were higher in P vs. NP. The C18:0/C18:1 CER (OR 1.22, 95%CI [1.07 - 1.39], P=0.0028) and C26:0/C26:1 SM (OR 2.65, 95%CI [1.39 - 5.06], P=0.0032) ratios predicted prediabetes risk after adjusting for age, race, sex, BMI, FPG and 2hPG. Conclusion: The Sat/Unsat ratios of CER and SM C18 and C26 predicted incident prediabetes in a diverse cohort, and may be potential biomarkers of prediabetes risk. Disclosure N. Mandal: None. J. Y. Wan: None. F. B. Stentz: None. S. Dagogo-jack: Consultant; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Janssen Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Sanofi. Funding National Institutes of Health (5R01DK128129)

Objective: Ceramides (CER) and sphingolipids (SPL) have been linked to type 2 Diabetes (T2D) . Here we compared plasma SPL profiles in Black and White adults without a family history of T2D (FH−) vs. those with parental T2D (FH+) . Methods: We studied 240 healthy subjects: 140 FH+ (70 B, 70 W) and 100 FH− (50 B, 50 W) . Assessments included OGTT, insulin sensitivity (Si-clamp) and insulin secretion (AIRg) . Liquid chromatography/mass spectrometry was used to assay fasting plasma levels of 54 SPL species (18 each from 3 major classes: CER, monohexosyl ceramide {MHC}, and sphingomyelins {SM}) . We compared mole percent composition of SPL species within each class in FH+ and FH− groups. Results: The subjects’ mean (SD) age was 43.1 + 12.0 y, BMI 29.4 + 6.21, fasting glucose 91.4 + 6.90 mg/dl and 2-hr plasma glucose (2hPG) 123 + 26.3 mg/dl. Total levels of SPL, CER, MHC and SM did not differ by race or sex, and correlated with 2hPG and AIRg but not age, BMI, FPG or Si-clamp. FH+ and FH− adults were concordant for 37 of 54 SPL and discordant for 17 species. Compared with FH−, the FH+ subjects had higher molar abundance of 8 CER, 4 MHC and 2 SM, but lower values for C24:0 Cer, C24:0 MHC, and C26:0 MHC (Table 1) . Conclusion: Plasma SPL species correlate with glucose tolerance, are altered by parental T2D history, and may reflect heritable elements linking SPL and glucose metabolism. Disclosure N. Mandal: None. J. Y. Wan: None. F. B. Stentz: None. E. Nyenwe: None. A. A. Patel: None. S. Dagogo-jack: Consultant; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Janssen Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Sanofi. Funding National Institutes of Health (5R01DK128129)

The ability to predict prediabetes, which affects ∼90 million adults in the US and ∼400 million adults worldwide, would be valuable to public health. Acylcarnitines, fatty acid metabolites, have been associated with type 2 diabetes risk in cross-sectional studies of mostly Caucasian subjects, but prospective studies on their link to prediabetes in diverse populations are lacking. Here, we determined the association of plasma acylcarnitines with incident prediabetes in African Americans and European Americans enrolled in a prospective study. We analyzed 45 acylcarnitines in baseline plasma samples from 70 adults (35 African-American, 35 European-American) with incident prediabetes (progressors) and 70 matched controls (non-progressors) during 5.5-year (mean 2.6 years) follow-up in the Pathobiology of Prediabetes in a Biracial Cohort (POP-ABC) study. Incident prediabetes (impaired fasting glucose/impaired glucose tolerance) was confirmed with OGTT. We measured acylcarnitines using tandem mass spectrometry, insulin sensitivity by hyperinsulinemic euglycemic clamp, and insulin secretion using intravenous glucose tolerance test. The results showed that progressors and non-progressors during POP-ABC study follow-up were concordant for 36 acylcarnitines and discordant for nine others. In logistic regression models, beta-hydroxy butyryl carnitine (C4-OH), 3-hydroxy-isovaleryl carnitine/malonyl carnitine (C5-OH/C3-DC), and octenoyl carnitine (C8:1) were the only significant predictors of incident prediabetes. The combined cut-off plasma levels of 0.25 micromol/L for C8:1 acylcarnitines predicted incident prediabetes with 81.9% sensitivity and 65.2% specificity. Thus, circulating levels of one medium-chain and two short-chain acylcarnitines may be sensitive biomarkers for the risk of incident prediabetes among initially normoglycemic individuals with parental history of type 2 diabetes.

Background Repair of the subscapularis tendon following rTSA has been shown to decrease postoperative dislocations in some studies, but the effect of repair on other outcomes has not been defined. We proposed to assess differences in postoperative pain, function, range of motion, strength, complications, and reoperations after three types of management of the subscapularis tendon—primary repair (tendon-to-tendon), transosseous repair, and no repair—at a minimum of two years of follow-up after rTSA. Methods Review of an institutional database identified patients with primary rTSA treated by a single surgeon using the same operative technique and implant (medial glenoid with lateral humeral implant) except for subscapularis repair (tendon-to-tendon repair, transosseous repair, no repair). Patients with revision rTSA, anatomic TSA, hemiarthroplasty, or surgery for proximal humeral fracture, nonunion, or malunion were excluded. Results Of 210 patients meeting inclusion criteria, 82 (39%) had primary tendon repair of the subscapularis (PTR), 88 (41.9%) had transosseous repair (TOR), and 40 (19%) did not have the subscapularis repaired (NR). Of all demographics and comorbidities measured, the only significant differences among treatments groups were in gender (54.9% female in PTR, 43.2% in TOR, and 72.5% in NR, p = 0.008) and subscapularis status before surgery (89% intact in PTR, 80.7% in TOR, and 38.5% in NR, p Conclusion Subscapularis management technique in rTSA did not affect complication or reoperation rates, and the procedure led to improvements in pain, function, range of motion, and strength in all three treatment groups. Repair of the subscapularis, regardless of technique, led to greater improvements in pain compared to no repair, although this may be partially attributable to better preoperative subscapularis status in the repair groups. Both repair techniques led to equal improvements in all measured outcomes, with the exception of primary tendon repair producing more improvement in ER strength compared to transosseous repair. Level of evidence Level III; Case Control Study

Background Cross-sectional surveys report a higher prevalence of diagnosed type 2 diabetes mellitus (T2DM) in African Americans (AA) than European Americans (EA). We studied 5-year glycemic excursions among AA and EA in the Pathobiology of Prediabetes in A Biracial Cohort study, to assess ethnic disparities. Materials and Methods Pathobiology of Prediabetes in A Biracial Cohort followed normoglycemic offspring of parents with T2DM for 5 years, with serial assessments of oral glucose tolerance test , anthropometry, body fat, insulin sensitivity and beta-cell function. The primary outcome was progression to prediabetes (impaired fasting glucose and/or impaired glucose tolerance). We further analyzed 5-year changes in fasting (FPG) and 2-hour plasma glucose (2hrPG). Results One hundred and one (52 AA, 49 EA) out of 343 subjects developed prediabetes during follow-up. The change in FPG ranged from −24 mg/dl to +38 mg/dl. The FPG remained stable (± 5 mg/dl from baseline) in 50% of EA and 46.8% of AA and the 2hrPG remained stable (± 25 mg/dl from baseline) in 73.7% of EA and 71.0 % of AA during follow-up. The proportions with change in FPG of 5mg/dl to >25 mg/dl and 2hrPG of 25 mg/dl to >50 mg/dl were similar in EA and AA offspring, as were the 10th - 90th percentiles of the distribution of 5-year changes in FPG and 2hrPG. Conclusions During 5 years of follow-up, black and white offspring of parents with T2DM exhibited remarkable phenotypic concordance of glycemic trajectories. Thus, parental history of T2DM may be a stronger factor than race/ethnicity in the prediction of longitudinal glycemic trends.

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.

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.

Aim: To define the optimal cutoff point for determining methylation status of O6-methylguanine-DNA methyltransferase (MGMT) by pyrosequencing in glioblastoma. Patients & methods: A retrospective study of 109 glioblastoma patients was performed to determine the optimal cutoff point for MGMT methylation status. Results: Receiver operating characteristic (ROC) analysis revealed 21% as the optimal cutoff (sensitivity: 68%; specificity: 59%) for MGMT methylation corresponding with the highest likelihood ratio of 1.66 and accuracy of 0.65. Methylation status (hazard ratio: 0.453; 95% CI: 0.279–0.735; p = 0.001) was associated with better overall survival. The crude model indicated linearity between methylation percent and survival rate; an increase of 10% of methylation resulted in a reduction of risk of death by 20% (p = 0.004). Conclusion: ROC analysis determined 21% as the optimal cutoff point for MGMT methylation status by pyrosequencing., Lay abstract Glioblastoma is a highly aggressive cancer with less than 6% of patients surviving at 2 years from diagnosis. Patients with hypermethylation of the MGMT gene promoter have improved survival compared with those with unmethylated MGMT. There is considerable debate regarding the ideal cutoff value for calling MGMT promoter hypermethylated or not. The authors performed a retrospective study of 109 patients diagnosed with glioblastoma from 2000 to 2018 to determine the optimal cutoff point. Using receiver operating characteristic (ROC) analysis, the researchers determined that 21% is the optimal cutoff for MGMT methylation. Methylation status and total surgical resection were associated with better survival. Further, the crude model indicates linearity between methylation percent and survival rate; an increase of 10% methylation resulted in a reduction of risk of death by 20% (p = 0.004).

Background: There has been a lack of evidence on whether there are racial and ethnic disparities in medication nonadherence among individuals receiving comprehensive medication review (CMR), a required component of the Medicare Part D medication therapy management (MTM) services. Objectives: To explore racial/ethnic disparities in medication nonadherence among older MTM enrollees who received a CMR and to determine how much the identified disparities can be explained by observed characteristics. Methods: The retrospective study used 100% of the 2017 Medicare claims, including MTM data. Linked Area Health Resources Files provided community characteristics. Nonadherence was defined as proportion of days covered

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.

OBJECTIVE: Older patients with Alzheimer’s disease (AD) are challenged with adhering to complex medication regimens. We examined effects of Comprehensive Medication Review (CMR), a required Medicare Part D Medication Therapy Management (MTM) program component, on medication adherence among AD patients. METHODS: This retrospective study analyzed 100% of 2016–2017 Medicare claims covering the entire United States, linked to Area Health Resources Files. Medicare beneficiaries aged ≥65 years were included. Propensity score matching identified comparable intervention and comparison groups with the intervention defined as receiving a CMR in 2017. A difference-in-differences analysis included in multivariate logistic regressions an interaction term between CMR receipt and year 2017. The outcome measured was the nonadherence to diabetes, hypertension, and hyperlipidemia medications, with nonadherence defined as proportion of days covered

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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s11606-019-05082-8) contains supplementary material, which is available to authorized users.

Abuse of alcohol and tobacco could exacerbate HIV pathogenesis by transferring materials through exosomes (small nanovesicles). Exosomes present a stable and accessible source of information concerning the health and/or disease status of patients, which can provide diagnostic and prognostic biomarkers for myriad conditions. Therefore, we aimed to study the specific exosomal proteins that are altered in both HIV-infected subjects and alcohol/tobacco users. Exosomes were isolated from plasma of the following subjects: a) HIV-negative subjects (healthy), b) HIV-positive subjects (HIV), c) HIV-negative alcohol drinkers (drinkers), d) HIV-negative tobacco smokers (smokers), e) HIV-positive drinkers (HIV + drinkers), and f) HIV-positive smokers (HIV + smokers). Quantitative proteomic profiling was then performed from these exosomes. Sixteen proteins were significantly altered in the HIV group, ten in drinkers, four in HIV + drinkers, and fifteen in smokers compared to healthy subjects. Only one protein, fibulin-1 (FBLN1), was significantly altered in HIV + smokers. Interestingly, hemopexin was not significantly altered in drinkers or HIV patients but was significantly altered in HIV + drinkers. Further, our study is the first to show properdin expression in plasma exosomes, which was decreased in HIV + smokers and HIV + drinkers compared to HIV patients. The present findings suggest that hemopexin and properdin show potential as markers for physiological effects that may arise in HIV-infected individuals who abuse alcohol and tobacco. Graphical abstract This study presents a proteomic analysis of plasma-derived exosomes from HIV-infected alcohol drinkers and smokers. Among the proteins altered due to drug-abuse, hemopexin and properdin were of highest significance. These proteins can be potential biomarkers for co-morbid conditions associated with drug abuse in HIV-patients.

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

BACKGROUND: Substantial research has documented inequalities between US minorities and whites in meeting the eligibility criteria for the Medicare Part D medication therapy management (MTM) program. Even though the Centers for Medicare & Medicaid Services attempted to relax the eligibility criteria, a critical barrier to effective MTM reform is a lack of stronger evidence about the effects of MTM on minorities' health outcomes. OBJECTIVE: To examine the effects of comprehensive medication review (CMR), an MTM core component, on racial and ethnic disparities in adherence to diabetes, hypertension, and hyperlipidemia medications among Medicare beneficiaries aged ≥65 years. METHODS: This study used full-year 2017 Medicare Parts A, B, and D claims data, including MTM data, linked to the Area Health Resources Files. Racial and ethnic disparities in nonadherence to diabetes, hypertension, and hyperlipidemia medications were compared between CMR recipients and nonrecipients matched by their propensity scores. To determine the changes in racial and ethnic disparities after receiving CMR, a difference-in-differences framework was applied, by including in logistic regression analyses interaction terms between dummy variables for CMR receipt and each racial or ethnic minority group. RESULTS: Compared with CMR nonrecipients, CMR recipients had significantly lower racial and ethnic disparities across the 3 outcome measures, with the exception of the difference between whites and blacks in nonadherence to diabetes medications. For example, compared with CMR nonrecipients, among CMR recipients the differences in the odds of nonadherence to hypertension medications were reduced, respectively, by 8% (95% confidence interval [CI], 0.88–0.96) between whites and blacks; by 18% (95% CI, 0.78–0.86) between whites and Hispanics; by 16% (95% CI, 0.77–0.91) between whites and Asians; and by 9% (95% CI, 0.85–0.98) between whites and other racial and ethnic groups. CONCLUSION: Receiving a CMR reduced the racial and ethnic disparities in adherence to diabetes, hypertension, and hyperlipidemia medications among Medicare beneficiaries aged ≥65 years. These findings provide critical empirical evidence that may inform the future design of the Medicare Part D MTM program, which is valuable for improving pharmacotherapy outcomes and could further realize its potential when additional people from racial and ethnic minorities are enrolled.

Background Previous literature reported racial/ethnic disparities in the measure assessment of diabetes medication adherence in the Medicare Part D Star Ratings program. Objective This study examined the likelihood of inclusion in measure calculation across racial/ethnic groups for adherence metrics in Part D Star Ratings among individuals with diabetes, hypertension, and/or hyperlipidemia. Methods This was a retrospective cross sectional analysis of a 10% random sample of 2017 Medicare claims linked to Area Health Resources Files. Inclusion in measure calculation was determined based on inclusion/exclusion criteria in adherence metrics for adherence medications for diabetes, hypertension, and hyperlipidemia in Part D Star Ratings developed by the Pharmacy Quality Alliance. Logistic regression and multinomial logistic regression were used to adjust for patient/community characteristics. Results The study sample size was 2 707 216. Compared to Non-Hispanic White (White) beneficiaries, minorities were more likely to be excluded from measure calculation among individuals with 1 condition. For example, among individuals with hypertension, compared to White individuals, the adjusted odds ratios for exclusion for Black, Hispanic, Asian/Pacific Islander and other individuals were 1.46 (95% confidence interval, or CI = 1.42–1.50), 1.38 (95% CI = 1.33–1.43), 1.28 (95% CI = 1.21–1.35), and 1.08 (95% CI = 1.02–1.15), respectively. Among individuals with more than 1 chronic condition, minorities were more likely to be included in fewer calculations for medication adherence measures. For example, among individuals with all 3 conditions, the adjusted relative risk ratios for Black, compared to White, beneficiaries for being included in 0, 1, and 2 measures, versus all 3 measures, were 2.14 (95% CI = 1.99–2.30), 1.49 (95% CI = 1.41–1.56), 1.20 (95% CI = 1.18–1.23), respectively. Conclusions Compared to White beneficiaries, racial/ethnic minorities are more likely to be excluded from the calculation for adherence measures among individuals with diabetes, hypertension, and/or hyperlipidemia. Future studies should examine whether such disparities exacerbate existing racial/ethnic disparities in health outcomes and devise solutions for these disparities.

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.

Background Prediabetes, an often unrecognized precursor of type 2 diabetes (T2DM), is associated with cardiometabolic complications. Here, we investigated the utility of dexamethasone challenge in predicting incident prediabetes among normoglycemic subjects with parental T2DM enrolled in the prospective Pathobiology of Prediabetes in a Biracial Cohort study. Design and Methods After documenting normoglycemic status with an oral glucose tolerance test (OGTT), participants ingested dexamethasone (2 mg) at 10:00 pm, and fasting plasma glucose (FPG-Dex) and cortisol were measured at 8:00 am the next day. Subjects were followed quarterly for 5 years, the primary outcome being incident prediabetes. Serial assessments included body composition, blood chemistry, OGTT, insulin sensitivity, and secretion. Results We analyzed data from 190 participants (107 Black, 83 white; mean age 44.7 ± 10.0 years; body mass index [BMI] 29.8 ± 6.8 kg/m2; fasting plasma glucose [FPG] 90.9 ± 5.7 mg/dL). Following dexamethasone ingestion, plasma cortisol was < 5 µg/dL; FPG-Dex levels displayed marked variability (81-145 mg/dL) as did delta FPG (–7 to +48 mg/dL). During 5 years of follow-up, 58 of 190 subjects (30.5%) progressed to prediabetes. FPG-Dex (116.8 ± 10.9 vs 106.9 ± 10.8 mg/dL, P < 0.0001) and delta FPG (23.4 ± 10.1 vs 17.0 ± 10.2 mg/dL, P < 0.0001) were higher in progressors than nonprogressors. FPG-Dex (P = 0.007) was an independent predictor of incident prediabetes in a multivariate model that included age, race, gender, BMI, waist circumference, FPG, insulin sensitivity, and secretion. In further analyses, an FPG-Dex level ≥ 107 mg/dL predicted incident prediabetes with 88% sensitivity and 49% specificity. Conclusions The glycemic response to dexamethasone significantly predicted incident prediabetes among offspring of parents with T2DM, and may be a tool for uncovering latent risk of dysglycemia.

IntroductionIntensive lifestyle intervention (ILI) prevents progression from prediabetes to type 2 diabetes (T2D) but reversal of prediabetes is less well studied.Research design and methodsThe overall objectives of the Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) Study (ClinicalTrials.gov ID: NCT02027571) are to determine the natural history and reversibility of prediabetes. The study tests specific hypotheses on the patterns of progression to prediabetes among normoglycemic African-American (AA) and European-American (EA) offspring of parents with T2D; emergence of microvascular and macrovascular complications during transition from normal to impaired glucose regulation; significance of the ‘metabolically healthy’ obese phenotype; and effect of duration of the prediabetic state on its reversibility with lifestyle intervention. Participants who developed incident prediabetes were offered ILI and evaluated quarterly for 5 years. The primary outcome was restoration of normal glucose regulation (fasting plasma glucose ResultsOf the 223 subjects enrolled in the PROP-ABC Study, 158 participants with incident prediabetes started ILI. The mean age was 53.3±9.28 years; body mass index 30.6±6.70 kg/m2; 70% were female, 52.4% AA and 47.6% EA. The ILI program used goal setting, weight-based calorie restriction, physical activity (180 min/week), self-monitoring, and meal replacement. Monthly face-to-face (F2F) counseling sessions during the initial 6 months, and quarterly visits thereafter, were supplemented with electronic and postal contacts. Attendance at F2F sessions was highly correlated with weight loss (r=0.98, pConclusionThe PROP-ABC Study has demonstrated the feasibility of executing an ILI program designed to test reversibility of incident prediabetes in a biracial cohort.

Objectives To examine whether mental health conditions, opioid use, and medication nonadherence are associated with inpatient and emergency department (ED) use among Medicare super-utilizers from medically underserved areas. Study design Retrospective panel study. Methods The study included Medicare super-utilizers (≥3 hospitalizations or ≥2 hospitalizations with ≥2 ED visits in 6 months) served by a health system in a medically underserved area in the South from February 2013 to December 2014 with at least 1 filled prescription for hypertension, type 2 diabetes, cardiovascular, and/or chronic obstructive pulmonary disease/asthma medications. We used random effects negative binomial models to assess whether mental health diagnosis, opioid use, and medication nonadherence were associated with preventable and overall hospitalizations and ED visits stratified by age (18-64 vs ≥65 years). Results Overall chronic disease medication nonadherence was associated with more frequent hospitalizations and ED visits for both younger (hospitalizations: incidence rate ratio [IRR], 1.31; 95% CI, 1.16-1.47; ED visits: IRR, 1.33; 95% CI, 1.14-1.55) and older (hospitalizations: IRR, 1.34; 95% CI, 1.20-1.49; ED visits: IRR, 1.18; 95% CI, 1.02-1.38) beneficiaries. Mental health diagnosis was significantly associated with higher hospitalizations and ED visits among both age groups. Although associations between opioid medication use and inpatient and ED use were inconsistent and not significant in most cases, we found that 7 or more days' supply of opioids was associated with lower preventable hospitalizations in Medicare beneficiaries 65 years or older. Conclusions The study findings highlight the importance of improving medication adherence and addressing behavioral health needs in Medicare super-utilizers.

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

BACKGROUND: Previous research found racial and ethnic disparities in meeting medication therapy management (MTM) eligibility criteria implemented by the Centers for Medicare & Medicaid Services (CMS) in accordance with the Medicare Modernization Act (MMA). OBJECTIVE: To examine whether alternative MTM eligibility criteria based on the CMS Part D star ratings quality evaluation system can reduce racial and ethnic disparities. METHODS: This study analyzed the Beneficiary Summary File and claims files for Medicare beneficiaries linked to the Area Health Resource File. Three million Medicare beneficiaries with continuous Parts A, B, and D enrollment in 2012-2013 were included. Proposed star ratings criteria included 9 existing medication safety and adherence measures developed mostly by the Pharmacy Quality Alliance. Logistic regression and the Blinder-Oaxaca approach were used to test disparities in meeting MMA and star ratings eligibility criteria across racial and ethnic groups. Multinomial logistic regres...

Data from the early stage of a novel infectious disease outbreak provide vital information in risk assessment, prediction, and precise disease management. Since the first reported case of COVID-19, the pattern of the novel coronavirus transmission in Wuhan has become the interest of researchers in epidemiology and public health. To thoroughly map the mechanism of viral spreading, we used the patterns of data at the early onset of COVID-19 from seven countries to estimate the time lag between peak days of cases and deaths. This study compared these data with those of Wuhan and estimated the natural history of disease across the infected population and the time lag. The findings suggest that comparative analyses of data from different regions and countries reveal the differences between peaks of cases and deaths caused by COVID-19 and the incomplete and underestimated cases in Wuhan. Different countries may show different patterns of cases peak days, deaths peak days, and peak periods. Error in the early COVID-19 statistics in Brazil was identified. This study provides sound evidence for policymakers to understand the local circumstances in diagnosing the health of a population and propose precise and timely public health interventions to control and prevent infectious diseases.

Minimally-invasive hepatectomy (MIH) is increasingly utilized; however, predictors and outcomes for patients requiring conversion to an open procedure have not been adequately studied.The 2014-15 ACS-NSQIP database was analyzed. Unplanned conversion was compared to successful MIH and elective open hepatectomy.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%, p0.001), 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%, p0.001), 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, p0.001) 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, p0.001), concurrent ablation (OR 1.79, p=0.020), and laparoscopic approach (vs. robotic) (OR 3.22, p=0.014) were associated with conversion.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.

Objectives/Hypothesis Graduate medical education has traditionally required long work hours, allowing trainees little time for adequate rest. Based on concerns over performance deterioration with sleep deprivation and its effect on patient outcomes, duty hour restrictions have been mandated. We sought to characterize complications from otolaryngology key indicator procedures performed before and after duty hour reform. Study Design Retrospective cross-sectional analysis of National Inpatient Sample (NIS). Methods The NIS was queried for procedure codes associated with head and neck key indicator groupings for the years 2000–2002 (45,363 procedures) and 2006–2008 (51,144 procedures). Hospitals were divided into three groups: nonteaching hospitals (NTH), teaching hospitals without otolaryngology programs (TH), and teaching hospitals with otolaryngology programs (TH-OTO). Surgical complication rates, length of stay, and mortality rates were analyzed using logistic and linear regression. Results The number of procedures increased (12.7%), with TH-OTO contributing more in postrestriction years (21% to 30%). Overall complication rates between the two periods revealed no difference, regardless of hospital setting. Subset analysis showed some variation within each complication within each grouping. Length of stay increased at TH-OTO (2.75 to 2.78 days) and decreased at NTH (2.28 to 2.24 days) and TH (2.39 to 2.36 days). Mortality did not increase among the three hospital types (NTH, P

Objective To evaluate whether extended-release gabapentin is more effective than placebo among women with vulvodynia. Methods In a multicenter double-blind, placebo-controlled randomized crossover trial, gabapentin (1,200-3,000 mg/d) was compared with a placebo. The primary outcome was mean pain intensity (0, no pain at all to 10, worst pain ever) on the tampon test (a standardized tampon insertion and removal test used as a surrogate marker for dyspareunia) during the last 7 days of the maintenance phase. Secondary outcomes included sexual intercourse pain and daily pain. A sample size of 53 provided 90% power to detect a 1-point reduction on the tampon test (.05 level, two-sided) between the two treatment phases. Results From August 2012 to January 2016, 230 women were screened at three academic institutions and 89 (mean age 37 years; 65% black) were randomized: 45 to gabapentin first and then placebo and 44 to placebo first and then gabapentin. Tampon test pain with gabapentin was not different compared with the placebo (adjusted mean 4.0, 95% CI 3.0-4.9 vs 4.3, 95% CI 3.4-5.2, difference -0.3, 95% CI -0.7 to 0.0; P=.07). Gabapentin also did not improve pain over placebo for sexual intercourse pain (adjusted mean 3.9, 95% CI 2.4-5.3 vs 4.0, 95% CI 2.5-5.4, difference -0.1, 95% CI -0.9 to 0.6; P=.76) and daily pain (adjusted mean 2.7, 95% CI 1.8-3.6 vs 2.9, 95% CI 2.0-3.8, difference -0.2, 95% CI -0.5 to -0.2; P=.36). Subset analyses found that longer pain duration and oral contraceptive nonuse were associated with minimal improvement in tampon test pain with gabapentin. Conclusion In this cohort, extended-release gabapentin, as compared with a placebo, did not reduce tampon test pain. These data do not support the recommendation of gabapentin alone as treatment for vulvodynia. Clinical trial registration ClinicalTrials.gov, NCT01301001.

Background: Dexamethasone (dex) challenge was used historically to diagnose chemical diabetes. Here we determined its utility in predicting prediabetes in a biracial cohort. Methods: We studied 190 euglycemic subjects with parental type 2 diabetes. After a baseline 75-gram OGTT, subjects ingested 2 mg dex at 10 PM and returned at 8AM for measurement of plasma cortisol and glucose. Subjects were followed quarterly for incident prediabetes for 5 years. Serial assessments included OGTT, insulin secretion (IVGTT), and insulin sensitivity (euglycemic clamp). Results: Table 1 shows baseline characteristics and response to dex. Progressors to prediabetes had a higher glycemic response to dex than nonprogressors ( Conclusion: Glycemic response to 2mg dex predicts incident prediabetes and could be useful for stratification and selection of high-risk subjects for lifestyle intervention. Table 1: Baseline demographic and glucoregulatory characteristics of subjects who developed prediabetes compared to those who remained normoglycemic. Disclosure E. Nyenwe: None. N.A. Umekwe: None. D.J. James: None. F. Ariganjoye: None. J.Y. Wan: None. S. Dagogo-Jack: Board Member; Self; Jana Care Inc. Consultant; Self; Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Sanofi-Aventis. Research Support; Self; AstraZeneca, Novo Nordisk Inc. Stock/Shareholder; Self; Dance Biopharm Holdings Inc. Funding American Diabetes Association (7-07-MN-13 to S.D-J.); National Institutes of Health

OBJECTIVE: Circulating branched-chain amino acids (BCAAs, isoleucine, leucine, valine) and aromatic amino acids (AAAs, tyrosine and phenylalanine) predicted type 2 diabetes mellitus (T2DM) risk in a Caucasian population. Here, we assessed amino acid levels in relation to incident prediabetes among initially normoglycemic African Americans (AA) and European Americans (EA). RESEARCH DESIGN AND METHODS: Using a nested case-control design, we studied 70 adults (35 AA, 35 EA) who developed prediabetes (progressors) and 70 matched participants who maintained normoglycemia (nonprogressors) during 5.5 years of follow-up in the Pathobiology of Prediabetes in a Biracial Cohort study. Assessments included plasma amino acid levels, insulin sensitivity, and beta-cell function. RESULTS: The total level of all 18 amino acid assayed was significantly associated with lean mass (r=0.36, P

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.