Search

Complex studying of functional condition of small intestine at bile stone disease and analyzing connection of small intestine functional disorders with formation of lithogenic bile. 123 patients with Bile stone disease were examined at pre-stone stage. Examinations done include ultrasonic exam of gallbladder, biochemical examination of bile, studying of bile acids in the bile by method of mass-spectrometry, morphological examination of duodenal mucous membrane, functional examination of small intestine with loading test., Results: As the survey showed, a biliary sludge was found at 86,2% of the patients at ultrasonic examination of gallbladder In the patients' bile there were noticed changes of both general pool of bile acids and of ratio of their separate fractions. 82% of patients with bile stone disease at pre-stone stage had disorders of digestive and absorbing functions of small intestine, connected with reducing of general pool of bile acids in bile.

Background: Type I endoleak (TIE) during endovascular aneurysm repair (EVAR) is usually identified and treated intraoperatively. We evaluated the outcomes of patients who, despite possible treatment, had TIE at completion of EVAR., Methods: We examined consecutive EVAR for nonruptured abdominal aortic aneurysm (AAA) within the Vascular Study Group of New England database (2003-2012) and compared the outcomes of patients who had TIE at completion with those who did not. Outcomes included perioperative death, cardiac complication, reoperation, and 1-year mortality. Multivariable logistic regression was used to determine factors associated with perioperative mortality, as well as factors associated with TIE. Anatomic factors associated with TIE were not evaluated because of the limitations of the Vascular Study Group of New England database., Results: Among the 2402 EVARs for nonruptured AAA in the Vascular Study Group of New England sample, 93% (n = 2235) were performed electively and 7% had (n = 167) symptomatic AAA. Eighty patients (3.3%) had TIE at completion of surgery. Patients with TIE were older (77.9 vs 73.9 years; P < .001), had higher female preponderance (34% vs 20%; P = .004), larger endograft main body diameter (28.8 vs 27.2 mm; P < .001), and more unplanned graft extension (32% vs 10%; P < .001) than those without TIE. At 1-year follow-up, 90% of patients who had TIE at the completion of their EVAR had resolution of TIE without further need for endovascular intervention or open conversion type I endoleak at the completion of surgery was associated with increased in-hospital mortality (5% vs 0.6%; P = .002) and cardiac dysrhythmia (8.8% vs 3.2%; P = .02). In multivariable analysis, TIE was independently associated with increased odds of in-hospital mortality (odds ratio [OR], 4.4; 95% confidence interval [CI], 1.2-16.4; P = .03). Multivariable analysis revealed the following factors to be independently predictive of TIE: female gender (OR, 2.2, 95% CI, 1.3-3.7; P = .002), patients older than 70 years of age (OR, 2.0; 95% CI, 1.1-3.8; P = .02), those with main body graft diameter >30 mm (OR, 2.6; 95% CI, 1.6-4.3; P < .001), and those undergoing unplanned graft extension (OR, 4.6; 95% CI, 2.7-7.7; P < .001)., Conclusions: TIE occurred in 3% of patients at completion of EVAR with more than 90% resolved spontaneously at 1-year follow-up. It is associated with increased risk of in-hospital mortality and cardiac complication. Additional investigation is needed to further define anatomic factors associated with TIE and to improve perioperative outcomes of these at-risk patients., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

This study aimed to compare expectations and experiences of fellows to those of faculty in vascular surgery fellowship programs with regard to endovascular training. Anonymous surveys were sent to fellows (n = 235) and program directors (n = 147), with 79 fellows and 65 faculty members responding. Fellows noted higher expectations of their endovascular skills prior to starting fellowship than the faculty group reported expecting. Faculty assessed fellows' pre-training endovascular skills at a significantly lower level than the fellows' self-assessment. Fellows were significantly less satisfied with the structured aspects of endovascular training than the faculty believed them to be. Only 3% of fellows vs. 32% of faculty felt that the presence of an endovascular simulator affected how residents ranked fellowship programs during the match. In conclusion, incoming fellows in vascular surgery fellowship programs have high expectations of themselves, but may overestimate their actual pre-training endovascular skills. Fellows desire more structured endovascular training, which is not recognized by faculty. Endovascular simulators are valued, but may not be a significant draw in the match process., (© The Author(s) 2015.)

Background: Neuromuscular electrical stimulation (NMES) is a highly sought after but poorly studied treatment for dysphagia among patients with head and neck cancer with dysphagia. This study investigated the efficacy of NMES in this patient population., Methods: In this double-blinded, randomized controlled trial, 170 patients with head and neck cancer experiencing posttreatment dysphagia were randomized into active NMES + swallow exercise versus sham NMES + swallow exercise groups. Outcomes after a 12-week program included changes in fluoroscopy measures, diet, and quality of life., Results: After the 12-week program, the active NMES group had significantly worse Penetration Aspiration Scale scores than the sham group. Both groups reported significantly better diet and quality of life. No other measures were significant., Conclusion: NMES did not add benefit to traditional swallow exercises. Unfortunately, swallow exercises were not effective by themselves either. For patients with head and neck cancer with moderate to severe dysphagia caused by radiation therapy, current behavioral therapies are of limited help in reversing long-term dysphagia. © 2015 Wiley Periodicals, Head Neck 38: E1221-E1231, 2016., (© 2015 Wiley Periodicals, Inc.)

Objective: Patients undergoing major lower extremity amputations are at risk for a wide variety of perioperative complications. Elderly patients with any functional impairment have been shown to be at high risk for these adverse events. Our goal was to determine the association between the type of anesthesia-general anesthesia (GA) and regional/spinal anesthesia (RA)-on perioperative outcomes after lower extremity amputation in these elderly and functionally impaired patients., Methods: The American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) data set (2005-2012) was queried to identify all patients aged ≥75 years with partial or total functional impairment who underwent major lower extremity amputations. Propensity matching and multivariate analysis were performed to isolate the effect of anesthesia type., Results: We identified 3260 patients (50% male), 2558 GA patients and 702 RA patients, who were a mean age of 82 years. Anatomic distribution was 59% above-the-knee and 41% below-the-knee amputations. Patients undergoing GA were more likely to have impaired sensorium (9% vs 6%; P = .035), be on anticoagulation or have a bleeding disorder (33% vs 17%; P < .001), have had a previous operation ≤30 days (16% vs 10%; P < .001), and be operated on by a nonvascular surgeon (16% vs 12%; P = .033). GA was associated with shorter anesthesia time to surgery (36 ± 48 vs 42 ± 49 minutes; P < .001) but a similar operative time (66 ± 33 vs 64 ± 33 minutes; P = .292) compared with RA. After propensity matching, rates of 30-day mortality (14% vs 12%; P = .135), postoperative myocardial infarction/cardiac arrest (2.9% vs 3.1%; P = .756), pulmonary complications (7.3% vs 6.7%; P = .632), stroke (0.7% vs 0.9%; P = .694), urinary tract infections (6.7% vs 6.5%; P = .887), and wound complications (7.6% vs 7.6%; P = .999) were similar in patients undergoing GA and RA, respectively. Median length of stay was similar in both groups (5 vs 5.5 days; P = .309). Multivariable analyses confirmed that anesthesia type did not significantly affect morbidity and mortality., Conclusions: The mode of anesthesia, GA vs RA, did not have significant effect on perioperative outcomes after major lower extremity amputation in the functionally impaired geriatric population. These findings provide an evidence base that will allow surgeons, anesthesiologists, and patients to make an informed decision about anesthesia type for their procedure., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: "Never events" refers to harmful hospital-acquired conditions that the Centers for Medicare and Medicaid Services identified in 2008 as largely preventable and that would no longer be reimbursed. Our goal was to identify the incidence, predictive factors, temporal trend, and associated consequences of never events after major open vascular surgery procedures., Methods: The Nationwide Inpatient Sample (NIS) (2003-2011) was queried to identify never events applicable to vascular surgery patients, including air embolism, catheter-based urinary tract infections (UTIs), stage 3 and 4 pressure ulcers, falls/trauma, blood incompatibility, vascular catheter infections, complications of poor glucose control, retained foreign objects, and wrong-site surgery. We specifically evaluated open abdominal aortic aneurysm repair, carotid endarterectomy, and lower extremity bypass/femoral endarterectomy. Multivariable logistic regression was used to predict never events based on preoperative variables. Multivariable logistic and gamma regression models were used to study mortality, hospital length of stay (LOS), and charges., Results: Never events were identified in 774 of 267,734 patients. The distribution of never events were falls/trauma (59%), pressure ulcers (19%), catheter-based UTI (9%), vascular catheter infection (6%), complications of poor glucose control (5%), and retained objects (4%). Rates of falls and catheter-based UTIs have increased since 2008. Multivariable predictors of any never event included lower extremity bypass, abdominal aortic aneurysm, weight loss, nonelective admission, paralysis, repair, congestive heart failure, altered mental status, renal failure, weekend admission, diabetes, female gender, and age. Race, insurance, hospital type, income level, geography, July to September admission, and other comorbidities were not predictive. After risk factor adjustment, never events were associated with increased perioperative mortality (odds ratio, 2.7; 95% confidence interval [CI], 1.5-34.8; P < .001), LOS (means ratio, 1.9; 95% CI, 1.7-2.0; P < .001), and total charges (means ratio, 1.7; 95% CI, 1.6-1.8; P < .001)., Conclusions: Never events after major vascular surgery are associated with a number of perioperative factors and are predictive of increased charges, LOS, and mortality. Falls and catheter-based UTIs have increased in frequency since the Centers for Medicare and Medicaid Services announced that it would no longer reimburse for these complications. This study establishes baseline never event rates in the vascular surgery patient population and identifies high-risk patients to target for quality improvement., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: The goal of this study was to construct and externally validate a risk prediction model for patients who undergo carotid endarterectomy (CEA)., Methods: The Vascular Study Group of New England (VSGNE) and Vascular Quality Initiative (VQI) databases were queried for patients who underwent CEA. Data on perioperative variables, comorbidities, and medications were entered into a logistic regression model as predictors of the composite adverse outcomes in the VSGNE sample. Adverse outcomes were defined if the patient experienced any of the following events: postoperative stroke, myocardial infarction, mortality, or discharge to rehabilitation facility. Backward elimination (α level of .2) was then used to select a more parsimonious model. Calibration was performed to measure how closely predicted outcomes agreed with observed outcomes. To assess calibration we used Hosmer-Lemeshow test, the predictive value of the model was assessed via the C-statistic. The external validation was then performed using the VQI sample after excluding those in the VSGNE sample (VQI-VSGNE) following a similar method., Results: The constructed model showed a substantial predictive capability of adverse outcomes (C = 0.711) with goodness of fit (Hosmer-Lemeshow lack of fit test, P = .494). A significantly higher rate of adverse outcomes was noted for the VQI sample (5.2%; n = 12,075) compared with the VSGNE sample (4.49%; n = 8661; P = .017). The discriminating ability of the VSGNE model remained substantial in the external data (C = 0.702)., Conclusions: The internally validated VSGNE CEA risk model, which robustly predicted adverse outcome after CEA, was externally validated by testing it against the remainder of VQI patients who underwent CEA by a diverse array of physicians. This tool provides a simple and reliable method to risk-stratify CEA patients using only their preoperative conditions. A risk score based on this model can reliably stratify patients according to their risk of adverse outcomes after CEA., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Introduction: In this study, we evaluated if increase in utilization of endovascular surgery has affected in-hospital mortality rates among patients with acute mesenteric ischemia., Methods: The National Inpatient Sample (2003-2011) was queried for acute mesenteric ischemia using ICD-9 code for acute mesenteric ischemia (557.1). This cohort was divided into patients treated with open vascular surgery (open vascular group) and by endovascular therapies (endovascular group) based on the ICD-9CM procedure codes. Multivariable logistic regression was used to determine temporal trend for mortality while adjusting for confounding variables., Results: There was 1.45-fold increase in utilization of endovascular techniques in this study. In-hospital mortality rate, total median charges and length of stay were significantly lower among the endovascular group than the open vascular group despite having significantly higher Elixhauser comorbidities index (3 ± 0.1 vs. 2.7 ± 0.1, p = .003). Over the course of the study period, there was no change in the overall mortality rate despite higher endovascular utilization. Factors associated with increased mortality included age, open surgical repair (Odds ratio: 1.45, 95% Confidence Interval: 1.10-1.91, p = .016) and bowel resection Odds ratio: 2.88, 95% Confidence Interval: 2.01-4.12)., Conclusion: The mortality rate for acute mesenteric ischemia remains unchanged throughout this contemporary study. Open surgical intervention, bowel resection and age were associated with increased mortality. Endovascular group patients had better survival despite higher morbidity indices., (© The Author(s) 2015.)

Objective: Although the effect of trainee involvement has been evaluated across different specialties, their effects on perioperative outcomes after abdominal aortic aneurysm (AAA) repair have not been examined. Our goal was to examine the association between resident and fellow intraoperative participation with perioperative outcomes of endovascular AAA repair (EVAR), open infrarenal AAA repair (OIAR), and open juxtarenal AAA repair (OJAR)., Methods: The American College of Surgeons National Surgical Quality Improvement Program data set (2005-2012) was queried to identify all patients who underwent EVAR, OIAR, or OJAR. Multivariate analysis was performed to assess the association of trainee involvement with perioperative morbidity and mortality., Results: We identified 16,977 patients: 12,003 with EVAR, 3655 with OIAR, and 1319 with OJAR. Propensity matching and multivariate analyses revealed that there was no significant difference in perioperative death, cardiac arrest/myocardial infarction, pulmonary, renal, venous thromboembolic, or wound complications, or return to the operating room. However, trainee involvement in AAA repair led to a significant increase in operative time for EVAR (163 ± 77 vs 140 ± 67 minutes; P < .001), OIAR (217 ± 91 vs 185 ± 76 minutes; P < .001), and OJAR (267 ± 115 vs 214 ± 106 minutes; P < .001) and an extended length of stay for EVAR (3.1 ± 5.3 vs 2.8 ± 4.5 days; P < .001) and OIAR (10.6 ± 11.8 vs 9.1 ± 8.9 days; P < .001)., Conclusions: Trainee participation in aneurysm repair was not associated with major adverse perioperative outcomes. However, it was associated with an increased operative time and length of stay and therefore may lead to increased resource utilization and cost., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: We evaluated the outcomes of patients undergoing major lower-extremity amputation who received packed red blood cell transfusion., Methods: Using the dataset of the National Surgical Quality Improvement Program (2005-2011), we examined 5,739 above-knee and 6,725 below-knee amputations. Patients were stratified by perioperative (preoperative, intraoperative, or postoperative) blood transfusion. Outcomes included perioperative mortality, myocardial infarction (MI), thromboembolism, and duration of stay (DOS) at the hospital. Adjusted comparisons of outcomes between transfused and not-transfused patients were performed by matching the 2 groups for age, smoking, diabetes, renal failure, coronary artery disease, classification of the American Society of Anesthesiologists, functional status, and procedure type. Multivariable logistic and gamma regression were used to examine associations between transfusion and outcomes., Results: Of the 12,464 amputations in the study cohort 2,133 (17%) required transfusion. The majority of the cases were performed for critical limb ischemia (8,205 amputations; 66%) and the overall 30-days mortality was 9%. In both crude and matched cohorts, although perioperative mortality and cardiac complication rates were similar, transfusion was associated with a greater incidence of pneumonia (crude: 6.1% vs 3%, P < .001; matched: 5.9% vs 3.7%, P < .001), thromboembolism (2.5% vs 1.6%, P = .003; 2.5% vs 1.4%, P = .002) and longer DOS (18 ± 19 vs 13.6 ± 14.3 days, P < .001; 17.8 ± 18.4 vs 14.2 ± 14.5 days, P < .001). Multivariable adjustment for confounding variables in the crude cohort demonstrated that transfusion was independently associated with a greater odds of perioperative pneumonia (odds ratio [OR]:1.6; 95% confidence interval [CI]:1.3-2; P < .001), thromboembolism (OR 1.3, 95% CI 1.0-1.9, P = .09) and longer DOS (mean ratio: 1.1; 95% CI 1.1-1.6; P = .006)., Conclusion: Among patients who had major lower-extremity amputation, perioperative transfusion independently predicted greater risks for perioperative pneumonia, thromboembolism, and prolonged hospital DOS., (Copyright © 2015 Elsevier Inc. All rights reserved.)

We performed fine mapping of 39 established type 2 diabetes (T2D) loci in 27,206 cases and 57,574 controls of European ancestry. We identified 49 distinct association signals at these loci, including five mapping in or near KCNQ1. 'Credible sets' of the variants most likely to drive each distinct signal mapped predominantly to noncoding sequence, implying that association with T2D is mediated through gene regulation. Credible set variants were enriched for overlap with FOXA2 chromatin immunoprecipitation binding sites in human islet and liver cells, including at MTNR1B, where fine mapping implicated rs10830963 as driving T2D association. We confirmed that the T2D risk allele for this SNP increases FOXA2-bound enhancer activity in islet- and liver-derived cells. We observed allele-specific differences in NEUROD1 binding in islet-derived cells, consistent with evidence that the T2D risk allele increases islet MTNR1B expression. Our study demonstrates how integration of genetic and genomic information can define molecular mechanisms through which variants underlying association signals exert their effects on disease.

Background: Iliac conduit or direct iliac access (ICDA) can be used when anatomy is unfavorable for femoral access during abdominal endovascular aortic aneurysm repair (EVAR). The impact of this approach has not been adequately addressed. The objective of this study was to analyze perioperative outcomes of patients requiring use of ICDAs for EVAR., Methods: Patients undergoing EVAR with and without ICDA were identified in the 2005-2012 National Surgical Quality Improvement Program data sets. Perioperative morbidity and mortality were assessed by crude comparison of matched groups and multivariate analyses., Results: Of 15,082 patients undergoing infrarenal EVAR 147 (1%) required ICDA. The ICDA group had a higher proportion of females (25.9% vs. 17.8%, P = 0.017), peripheral vascular disease (12.9% vs. 5.5%, P = 0.001), and patients with a history of dyspnea (31.3% vs. 23.1%, P = 0.024). There was no difference in age (74.5 ± 8.4 conduit vs. 73.5 ± 8.5). On multivariate analysis, the ICDA cohort had a higher rate of mortality (odds ratio [OR], 2.7; 95% confidence interval [CI], 1.4-5.4; P = 0.004) and an increase in other major complications including cardiac arrest and/or myocardial infarction (OR, 2.9; 95% CI, 1.3-6.3; P = 0.007), pulmonary complications (OR, 2.1; 95% CI, 1.2-3.9; P = 0.013), and postoperative length of stay (means ratio, 1.3; 95% CI, 1.1-1.4; P = 0.001). There was a trend toward increased bleeding complications with ICDA. Matched analyses of comorbidities revealed that patients requiring ICDA had higher perioperative mortality (6.8% vs. 2.3%, P = 0.008), cardiac (4.8% vs. 1%, P = 0.004), pulmonary (8.8% vs. 3.4%, P = 0.006), and bleeding complications (10.2% vs. 4.6%, P = 0.016)., Conclusions: Our results demonstrate that the use of ICDA during EVAR is associated with increased morbidity and mortality. In situations where anatomy mandates the use of iliac conduits or access for EVAR, surgeons should consider this increased risk. Open repair or the use of lower profile devices, if possible, should be considered as options for these patients., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: A certain number of deaths may result from elective abdominal aortic aneurysm (AAA) repair due to inherent risks of operation; however, no agreement exists about which predictive model for in-hospital mortality is most accurate in predicting these events. This study developed a risk prediction model using Vascular Study Group of New England (VSGNE) data and compared it with established models., Methods: VSGNE data (2003-2013) were queried for patients undergoing elective AAA repair by open or endovascular techniques. Clinical variables and known predictors of mortality were included in a full prediction model. Backward elimination with α = .2 was used to construct a parsimonious model. This VSGNE model was compared with established models-Medicare, Glasgow Aneurysm Score (GAS), and Vascular Governance North West (VGNW)-based on the scope of VSGNE data collection. Model fit was compared with the Vuong test. Model discrimination was compared in equally sized risk-group VSGNE terciles., Results: The overall mortality rate for 4431 elective AAA patients was 1.4%. The discriminating ability of the VSGNE model was high (C statistic = 0.822) and corrected slightly to 0.779 after internal validation. Vuong tests yielded significant overall fit difference favoring the VSGNE model over the Medicare (C statistic = 0.769), VGNW (C statistic = 0.767), and GAS (C statistic = 0.685) models. The VGNW and Medicare models performed better than GAS in predicting mortality among risk-group terciles., Conclusions: The VSGNE risk prediction model is best at forecasting mortality among this patient population. The Medicare and VGNW models showed good discrimination., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: We sought to evaluate the impact of race on treatment approaches and mortality following arterial trauma., Methods: The National Trauma Data Bank (version 7.2, American College of Surgeons) was queried from 2002 to 2012 to identify patients aged 18 to 65 years with arterial trauma. The association between race (white, black, and Hispanic) and mortality following arterial injury was assessed, stratified by penetrating or blunt injury. Temporal trends in the use of open and endovascular procedures were evaluated across the racial groups. Multivariable regression models adjusting for patient demographics, injury severity, hospital characteristics, insurance status, and type of intervention performed were used to evaluate potential contributors to the association of race with mortality., Results: The study cohort consisted of 58 626 patients (52% white, 31% black, and 17% Hispanic). A majority (57%) of patients had penetrating injuries, with black and Hispanic patients being more likely to sustain penetrating injuries (80% and 65%, respectively) compared to white patients (41%, P < .001). Overall, black patients had higher mortality for penetrating injuries (16.8% vs 13.0% vs 7.8%, P < .001) when compared to Hispanic and white patients, correspondingly. Over the study period, there was increasing use of endovascular and decreasing open surgical procedures for treatment of arterial trauma. This finding was similar across all groups studied. In multivariable analysis, black race was found to be associated with higher mortality compared to white for both penetrating (odds ratio [OR] 1.52, 95% confidence interval [CI] 1.33-1.75, P < .001) and blunt (OR 1.27 95%CI 1.09-1.47, P = .002) arterial trauma., Conclusion: Even after adjusting for potential confounders, minority patients had increased odds of mortality following arterial trauma compared to their white counterparts. Further studies are needed to understand and to eliminate these observed disparities in outcome., (© The Author(s) 2015.)

The Sequential Parallel Comparison Design (SPCD) is one of the novel approaches addressing placebo response. The analysis of SPCD data typically classifies subjects as 'placebo responders' or 'placebo non-responders'. Most current methods employed for analysis of SPCD data utilize only a part of the data collected during the trial. A repeated measures model was proposed for analysis of continuous outcomes that permitted the inclusion of information from all subjects into the treatment effect estimation. We describe here a new approach using a weighted repeated measures model that further improves the utilization of data collected during the trial, allowing the incorporation of information that is relevant to the placebo response, and dealing with the problem of possible misclassification of subjects. Our simulations show that when compared to the unweighted repeated measures model method, our approach performs as well or, under certain conditions, better, in preserving the type I error, achieving adequate power and minimizing the mean squared error., (Copyright © 2015 John Wiley & Sons, Ltd.)

Background: Use of fluoroscopy and bone landmarks to guide percutaneous common femoral artery (CFA) access has decreased access site complications compared with palpation alone. However, only limited case series have examined the benefits of ultrasound to guide CFA access during peripheral vascular intervention (PVI). We evaluated the effect of routine vs selective use of ultrasound guidance (UG) on groin hematoma rates after PVI., Methods: The Vascular Study Group of New England database (2010-2014) was queried to identify the complication of postprocedural groin hematoma after 7359 PVIs performed through CFA access. Hematoma (including pseudoaneurysms) was defined as minor (requiring compression or observation), moderate (requiring transfusion or thrombin injection), and major (requiring operation). Both procedure-level and interventionalist-level analyses were performed. Multivariable Poisson regression models were used to compare hematoma rates of interventionalists based on routine (≥80% of PVIs) and selective (<80%) utilization of UG in the adjusted overall sample and in multiple subgroups., Results: The overall postprocedural groin hematoma rate after PVI was 4.5%, and the rate of combined moderate and major hematoma was 0.8%. Among 114 interventionalists with ≥10 PVI procedures, routine and selective UG was used by 31 (27%) and 83 (73%) interventionalists, respectively. Routine UG was protective against hematoma (rate ratio [RR], 0.62; 95% confidence interval [CI], 0.46-0.84; P < .01). Subgroup analysis revealed that routine UG was also protective against hematoma under the following circumstances: age >80 years (RR, 0.47; 95% CI, 0.27-0.85; P = .01), body mass index ≥30 (RR, 0.51; 95% CI, 0.29-0.90; P = .02), and sheath size >6F (RR, 0.43; 95% CI, 0.23-0.79; P < .01)., Conclusions: Routine UG may potentially protect against the complication of hematoma for both modifiable and nonmodifiable patient and procedural characteristics. Encouraging routine UG is a feasible quality improvement opportunity to decrease patient morbidity after PVI., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Introduction: The optimal method for placement of peritoneal dialysis catheters (PDC) is unclear. The objective of this study was to compare the outcomes of laparoscopic and open surgical placement of PDC., Materials and Methods: Patients who underwent laparoscopic (LPD) and open (OPD) surgical placement of PDC between 2007 and 2011 were identified from the American College of Surgeons National Surgical Quality Initiative Project (NSQIP) dataset using current procedural terminology (CPT) and international classification of diseases 9th revision (ICD-9) codes. Perioperative outcomes were compared using Fisher's exact test for categorical variables, Student's t-test and Gamma regression were used for continuous variables. Catheter function was not reported in the dataset., Results: There were 1,560 PDC procedures in our study and most were performed laparoscopically (89%). 83% of these procedures were performed by general surgeons, mostly, with the patients under general anesthesia (95%). OPD was associated with a higher rate of perioperative deep organ infection (3.5% vs. 1.1%, p = 0.02) and need for reoperation (10.4% vs. 5.0%, p = 0.007). Operative time was, however, significantly longer with LPD (53.3 vs. 45.5 minutes, p < 0.001). In multivariate analysis, OPD was independently associated with increased risk of perioperative deep organ infection (odds ratio (OR) 3.7,95%, Confidence Interval (CI) 1.3 - 10.2, p = 0.01) and reoperation (OR 2.3, 95% CI 1.3 - 4.1, p = 0.005)., Conclusions: Laparoscopic PDC placement is more commonly performed and is associated with a lower risk of perioperative deep organ infection and reoperation than the open surgical approach. When possible, laparoscopic PDC placement might be preferable over open surgical placement.

Objectives: The objectives of the paper are to describe characteristics of participants who chose moderation and abstinence drinking goals, and to examine post-treatment drinking outcomes based on patterns of goal choice during a Web-based alcohol intervention for returning U.S. Veterans., Method: We conducted a descriptive secondary analysis of a subsample of 305 of 600 Veterans who participated in a clinical trial of VetChange, an 8-module, cognitive-behavioural intervention. Participants self-selected abstinence or moderation drinking goals, initially at Module 3, and weekly during subsequent modules. Alcohol use and alcohol-related problems were measured using the Alcohol Use Disorders Identification Test (AUDIT), Quick Drink Screen (QDS), and Short Inventory of Problems (SIP-2R)., Results: Initial goal choices were 86.9% moderation and 13.1% abstinence. Approximately 20% of participants from each initial choice changed goals during the intervention; last goal choices were 68.6% moderation and 31.4% abstinence. Participants who initially chose moderation reported higher percent heavy drinking days at baseline; participants who initially chose abstinence were more likely to report recent substance abuse treatment and were older. Post-intervention levels of alcohol use and alcohol-related problems were significantly reduced in all goal-choice patterns (i.e., Moderation Only, Abstinence Only, Moderation to Abstinence, and Abstinence to Moderation; all measures p < 0.05 or less). Baseline drinking severity did not differentially relate to outcomes across goal-choice patterns., Conclusions: Participants in a Web-based alcohol intervention for returning U.S. Veterans demonstrated improvements in drinking regardless of whether they chose an abstinence or moderation drinking goal, and whether the goal was maintained or changed over the course of the intervention.

Objective: Open (OPAR) and endovascular (EPAR) repair are both used to treat popliteal artery aneurysm (PAA). We assessed outcomes of both modalities in the treatment of asymptomatic PAAs., Methods: Vascular Quality Initiative (VQI) databases (2010 to 2013) were queried for patients undergoing asymptomatic PAA repair using OPAR and EPAR. The groups were compared with respect to demographics, medical history, and procedural characteristics. Outcomes of interest were length of stay (LOS), major adverse limb events (MALE), MALE or perioperative death (MALE-POD), and loss of primary patency compared using Kaplan-Meier estimates. Proportional hazard Cox regression was used to compare the outcomes across the treatment groups. Multivariable regression with backward elimination procedure (α = .5) was used to construct parsimonious models to predict MALE and MALE-POD. Gamma regression was used to compare LOS., Results: From 2010 to 2013, 390 patients with asymptomatic PAAs were identified (221 OPAR, 169 EPAR) and included in this study. Preoperative comorbidities were similar between the two groups, except for a higher rate of congestive heart failure (19.5% vs 11.8%, P = .042) and chronic obstructive pulmonary disease (19.5% vs 11.8%, P = .042) in the EPAR group. No in-hospital mortality was observed. LOS was significantly longer in the OPAR group (3.8 ± 2.5 vs 1.4 ± 1.9 days; P < .001). OPAR patients had a significantly higher MALE-free survival (95% vs 80%; P < .001) as was MALE-POD-free survival (93% vs 80%; P < .001) rates at 1 year after the procedure. OPAR was associated with lower hazard of MALE (hazard ratio [HR], 0.35; 95% confidence interval [CI], 0.15-0.86; P < .05), MALE-POD (HR, 0.28; 95% CI, 0.13-0.63; P < .05), and primary patency loss (HR, 0.25; 95% CI, 0.10-0.58; P < .05)., Conclusions: This retrospective analysis suggests that OPAR is associated with better outcomes than EPAR. Ultimately, the ongoing, adequately powered Open versus Endovascular Popliteal Artery Aneurysm Repair (OVERPAR) trial will definitively compare these procedures., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Asthma is the most common chronic condition of childhood and disproportionately affects inner-city minority children. Low rates of asthma preventer medication adherence is a major contributor to poor asthma control in these patients. Web-based methods have potential to improve patient knowledge and medication adherence by providing interactive patient education, monitoring of symptoms and medication use, and by facilitation of communication and teamwork among patients and health care providers. Few studies have evaluated web-based asthma support environments using all of these potentially beneficial interventions. The multidimensional website created for this study, BostonBreathes, was designed to intervene on multiple levels, and was evaluated in a pilot trial., Methods: An interactive, engaging website for children with asthma was developed to promote adherence to asthma medications, provide a platform for teamwork between caregivers and patients, and to provide primary care providers with up-to-date symptom information and data on medication use. Fifty-eight (58) children primarily from inner city Boston with persistent-level asthma were randomised to either usual care or use of BostonBreathes. Subjects completed asthma education activities, and reported their symptoms and medication use. Primary care providers used a separate interface to monitor their patients' website use, their reported symptoms and medication use, and were able to communicate online via a discussion board with their patients and with an asthma specialist., Results: After 6-months, reported wheezing improved significantly in both intervention and control groups, and there were significant improvements in the intervention group only in night-time awakening and parental loss of sleep, but there were no significant differences between intervention and control groups in these measures. Emergency room or acute visits to a physician for asthma did not significantly change in either group. Among the subgroup of subjects with low controller medication adherence at baseline, adherence improved significantly only in the intervention group. Knowledge of the purpose of controller medicine increased significantly in the intervention group, a statistically significant improvement over the control group., Conclusions: This pilot study suggests that a multidimensional web-based educational, monitoring, and communication platform may have positive influences on pediatric patients' asthma-related knowledge and use of asthma preventer medications.

Missing data pose a serious challenge to the integrity of randomized clinical trials, especially of treatments for prolonged illnesses such as schizophrenia, in which long-term impact assessment is of great importance, but the follow-up rates are often no more than 50%. Sensitivity analysis using Bayesian modeling for missing data offers a systematic approach to assessing the sensitivity of the inferences made on the basis of observed data. This paper uses data from an 18-month study of veterans with schizophrenia to demonstrate this approach. Data were obtained from a randomized clinical trial involving 369 patients diagnosed with schizophrenia that compared long-acting injectable risperidone with a psychiatrist's choice of oral treatment. Bayesian analysis utilizing a pattern-mixture modeling approach was used to validate the reported results by detecting bias due to non-random patterns of missing data. The analysis was applied to several outcomes including standard measures of schizophrenia symptoms, quality of life, alcohol use, and global mental status. The original study results for several measures were confirmed against a wide range of patterns of non-random missingness. Robustness of the conclusions was assessed using sensitivity parameters. The missing data in the trial did not likely threaten the validity of previously reported results., (Copyright © 2014 John Wiley & Sons, Ltd.)

Objective: This study compared in-hospital mortality and resource utilization among vascular surgical patients at safety net public hospitals (SNPHs) with those at nonsafety net public hospitals (nSNPHs)., Methods: The National Inpatient Sample (2003-2011) was queried to identify surgical patients with peripheral arterial disease (PAD), carotid stenosis, or nonruptured abdominal aorta aneurysm based on International Classification of Diseases, Ninth Revision, Clinical Modification diagnostic and procedure codes. The cohort was then divided into SNPH and nSNPH groups according to the definition of SNPH used by the National Association of Public Hospitals. Clinical characteristics, length of stay, in-hospital mortality, and hospital charges were compared between groups. Advanced PAD was defined as that associated with rest pain or tissue loss. Statistical methods included bivariate χ(2) tests for categoric variables, t-tests for continuous variables, and multivariable linear and logistic regression to adjust for confounding variables (in-hospital mortality)., Results: We identified 306,438 patients operated on for PAD, carotid stenosis, and abdominal aortic aneurysm. Patients at SNPHs were younger, the percentage of female and minority patients was higher, and patients had a higher Elixhauser comorbidity index (P < .001). Nonelective admissions were more common among SNPH patients who presented with more advanced PAD (P > .05) and symptomatic carotid stenosis (P < .05). Patients at SNPHs had a significantly longer length of stay, higher hospital charges, and higher in-hospital mortality (P < .05 for all variables). Crude odds of mortality at SNPHs were 1.28 higher than at nSNPHs (95% confidence interval, 1.13-1.46; P < .001), but adjusted analyses revealed no statistically significant difference between the odds of in-hospital mortality at both hospital groups., Conclusions: Patients undergoing vascular surgery at SNPHs, despite being younger, had higher comorbidities, presented more urgently with more advanced disease, and incurred higher costs than the SNPH cohort despite similar adjusted odds of in-hospital mortality. Delayed presentation and higher comorbidities are most likely related to poor access to routine and preventive health care for the SNPH patients., (Copyright © 2014 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: To evaluate patient characteristics, practice patterns, and outcomes for patients treated for chronic venous insufficiency (CVI)., Background: Chronic venous insufficiency is a common problem treated using open or endovascular methods by physicians from a number of surgical and nonsurgical specialties., Methods: Patients treated for CVI in the American College of Surgeons National Surgical Quality Improvement Program data set (2005-2011) were identified. Analyses were based on open surgical treatment (open surgery of varicose vein [OSVV]) versus endovenous ablation (EVA), specialty of treating surgeon, and by the presence of venous ulceration (VU). Preoperative patient characteristics and intraoperative measures were examined, and multivariate logistic regression analyses were performed for the postoperative outcomes of superficial surgical site infection (sSSI) and deep venous thrombosis (DVT)., Results: A total of 4366 patients were identified. Patients undergoing EVA were older (53.3 vs 51.8 years; P < .001), had higher body mass index (BMI; 29.9 vs 29.0; P < .001), and more commonly presented with VU (20.9% vs 13.3%; P < .001). Vascular surgeons were more likely than general surgeons to treat patients with VU (17.0% vs 13.4%; P = .017). Patients with VU had higher BMI (32.2 vs 28.8; P < .001), were older (57.9 vs 51.4 years; P < .001), and more likely to be diabetic (9.0% vs 4.7%; P < .001). Factors associated with sSSI were OSVV (adjusted odds ratio [AOR] 2.56; 95% confidence interval [CI] 1.19-5.50; P = .016), obesity (AOR 2.16; 95% CI 1.10-4.24; P = .025), and VU (AOR 2.56; 95% CI 1.19-5.50; P = .016). Patients undergoing OSVV had significantly lower odds of DVT when compared to EVA (AOR 0.52; 95% CI 0.28-0.97; P = .040)., Conclusions: The OSVV, obesity, and VU increase the odds of sSSI after procedures treating CVI. Patients in these categories should be monitored closely for signs of infection in the perioperative period. Patients undergoing EVA have higher odds of postoperative DVT, suggesting that routine screening after EVA for DVT may be justified., (© The Author(s) 2014.)

Background: Significant variability exists in completion imaging (CIM) after infrainguinal lower extremity bypass (LEB). We evaluated the use of CIM and compared graft patency in patients treated by surgeons who performed routine CIM vs those who performed selective CIM., Methods: We reviewed the Vascular Study Group of New England database (2003-2010) and assessed the use of CIM (angiography or duplex ultrasound) among patients undergoing LEB. The surgeon-specific CIM strategy was categorized as routine (≥80% of LEBs) vs selective (<80% of LEBs). Exclusion criteria included acute limb ischemia, bilateral procedures, and surgeon volume <10 cases per study period. Primary graft patency at discharge and at 1 year was analyzed on the basis of CIM use and surgeon-specific CIM strategy. Multivariable analyses were performed using Poisson regression., Results: Among 2032 LEB procedures performed by 48 surgeons, CIM was used in 1368 cases (67.3%). CIM was performed in 72% of autogenous LEBs and 52% of prosthetic grafts. Dialysis (odds ratio [OR], 1.7; 95% confidence interval [CI], 1.1-2.6; P = .01), elective LEB (OR, 2.6; 95% CI, 1.4-4.8; P = .002), great saphenous vein conduit (OR, 2.0; 95% CI, 1.6-2.5; P < .001), and tibial or pedal target artery (OR, 1.8; 95% CI, 1.4-2.3; P < .001) were associated with CIM use. In multivariate models, CIM was not associated with improved primary graft patency at discharge (OR, 1.1; 95% CI, 0.7-1.7; P = .64) or at 1 year (OR, 0.9; 95% CI, 0.7-1.2; P = .47). Sixteen surgeons (33%) were routine users and 32 (67%) were selective users of CIM. Among patients of routine vs selective CIM users, primary graft patency at discharge and at 1 year was 96% vs 94% (P = .21) and 68% vs 72% (P = .09), respectively. In multivariate analysis, routine or selective CIM strategy was not associated with improved discharge (rate ratio, 0.8; 95% CI, 0.6-1.1; P = .31) or 1-year (rate ratio, 1.1; 95% CI, 0.9-1.2; P = .56) graft patency., Conclusions: In our observational cohort, CIM does not improve short-term and 1-year bypass graft patency in infrainguinal LEB. The surgeon-specific strategy of selective CIM after LEB has outcomes comparable to those of routine CIM., (Copyright © 2014 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

This study investigated the impact of English health literacy and spoken proficiency and acculturation on preventive dental care use among Somali refugees in Massachusetts. 439 adult Somalis in the US ≤10 years were interviewed. English functional health literacy, dental word recognition, and spoken proficiency were measured using STOFHLA, REALD, and BEST Plus. Logistic regression tested associations of language measures with preventive dental care use. Without controlling for acculturation, participants with higher health literacy were 2.0 times more likely to have had preventive care (P = 0.02). Subjects with higher word recognition were 1.8 times as likely to have had preventive care (P = 0.04). Controlling for acculturation, these were no longer significant, and spoken proficiency was not associated with increased preventive care use. English health literacy and spoken proficiency were not associated with preventive dental care. Other factors, like acculturation, were more predictive of care use than language skills.

Background: The ideal treatment for blunt brachial artery (BBA) injury in pediatric patients is controversial. We compared outcomes of surgical and nonsurgical management of BBA injury using the National Trauma Data Bank., Methods: All patients younger than 18 years who had suffered BBA injury were identified in the pediatric National Trauma Data Bank (2002-2010) by Current Procedural Terminology code. Patients with a penetrating mechanism of injury were excluded. By the International Classification of Diseases, Ninth Revision procedure codes, patients were stratified on the basis of treatment modality: observation vs arterial surgery. Outcomes including upper extremity amputation, mortality, and intensive care unit length of stay were compared between the two groups by two-sample t-test or χ(2) test as appropriate., Results: Among 119 patients with BBA injury, 49 patients (41.2%) underwent arterial surgery and 70 patients (58.8%) were observed. Patients treated with observation were significantly younger, whereas other characteristics including gender and Injury Severity Score were similar. There was no difference in the type of hospital (academic vs nonacademic) or trauma center category between the groups. Two amputations were identified in the database, and both were in the 13- to 17-year age group of the observation cohort (vs arterial surgery; P = .22). There were eight fasciotomies identified; five were in the arterial surgery group (10.2% vs observation, 4.3%; P = .20). No amputation or fasciotomy was required in the 0- to 6-year age group. Length of stay was similar between groups., Conclusions: Despite slightly lower adverse outcomes, arterial surgery does not appear to confer a significant advantage over nonoperative treatment in pediatric patients with BBA injury. In patients younger than 6 years, both modalities appear to be equality effective., (Copyright © 2014 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Patients with established type 2 diabetes display both β-cell dysfunction and insulin resistance. To define fundamental processes leading to the diabetic state, we examined the relationship between type 2 diabetes risk variants at 37 established susceptibility loci, and indices of proinsulin processing, insulin secretion, and insulin sensitivity. We included data from up to 58,614 nondiabetic subjects with basal measures and 17,327 with dynamic measures. We used additive genetic models with adjustment for sex, age, and BMI, followed by fixed-effects, inverse-variance meta-analyses. Cluster analyses grouped risk loci into five major categories based on their relationship to these continuous glycemic phenotypes. The first cluster (PPARG, KLF14, IRS1, GCKR) was characterized by primary effects on insulin sensitivity. The second cluster (MTNR1B, GCK) featured risk alleles associated with reduced insulin secretion and fasting hyperglycemia. ARAP1 constituted a third cluster characterized by defects in insulin processing. A fourth cluster (TCF7L2, SLC30A8, HHEX/IDE, CDKAL1, CDKN2A/2B) was defined by loci influencing insulin processing and secretion without a detectable change in fasting glucose levels. The final group contained 20 risk loci with no clear-cut associations to continuous glycemic traits. By assembling extensive data on continuous glycemic traits, we have exposed the diverse mechanisms whereby type 2 diabetes risk variants impact disease predisposition., (© 2014 by the American Diabetes Association.)

To further understanding of the genetic basis of type 2 diabetes (T2D) susceptibility, we aggregated published meta-analyses of genome-wide association studies (GWAS), including 26,488 cases and 83,964 controls of European, east Asian, south Asian and Mexican and Mexican American ancestry. We observed a significant excess in the directional consistency of T2D risk alleles across ancestry groups, even at SNPs demonstrating only weak evidence of association. By following up the strongest signals of association from the trans-ethnic meta-analysis in an additional 21,491 cases and 55,647 controls of European ancestry, we identified seven new T2D susceptibility loci. Furthermore, we observed considerable improvements in the fine-mapping resolution of common variant association signals at several T2D susceptibility loci. These observations highlight the benefits of trans-ethnic GWAS for the discovery and characterization of complex trait loci and emphasize an exciting opportunity to extend insight into the genetic architecture and pathogenesis of human diseases across populations of diverse ancestry.

Importance: A strong association between infant bed sharing and sudden infant death syndrome or unintentional sleep-related death in infants has been established. Occurrences of unintentional sleep-related deaths among infants appear to be increasing., Objectives: To determine the trends and factors associated with infant bed sharing from 1993 through 2010, including the association of physician advice on bed sharing., Design: National Infant Sleep Position study conducted with annual telephone surveys., Setting: The 48 contiguous states., Participants: Nighttime caregivers of infants born within 7 months of each survey administration. Approximately 1000 interviews were completed annually., Main Outcomes and Measures: Infant bed sharing as a usual practice., Results: Of 18 986 participants, 11.2% reported an infant sharing a bed as a usual practice. Bed sharing increased from 1993 (6.5%) to 2010 (13.5%). Although bed sharing increased significantly among white respondents from 1993 to 2000 (P < .001), the increase from 2001 to 2010 was not significant (P = .48). Black and Hispanic respondents reported an increase in bed sharing throughout the study period, with no difference between the earlier and later periods (P = .63 and P = .77, respectively). After accounting for the study year, factors associated with increase in infant bed sharing as a usual practice included maternal educational level of less than high school compared with college or greater (adjusted odds ratio, 1.42 [95% CI, 1.12-1.79]); black (3.47 [2.97-4.05]), Hispanic (1.33 [1.10-1.61]), and other (2.46 [2.03-2.97]) maternal race or ethnicity compared with white race; household income of less than $20,000 (1.69 [1.44-1.99]) and $20,000 to $50,000 (1.29 [1.14-1.45]) compared with greater than $50,000; living in the West (1.61 [1.38-1.88]) or the South (1.47 [1.30-1.66]) compared with the Midwest; infants younger than 8 weeks (1.45 [1.21-1.73]) or ages 8 to 15 weeks (1.31 [1.17-1.45]) compared with 16 weeks or older; and being born prematurely compared with full-term (1.41 [1.22-1.62]). Almost 46% of the participants reported talking to a physician about bed sharing. Compared with those who did not receive advice from a physician, those who reported their physicians had a negative attitude were less likely to have the infant share a bed (adjusted odds ratio, 0.66 [95% CI, 0.53-0.82]), whereas a neutral attitude was associated with increased bed sharing (1.38 [1.05-1.80])., Conclusions and Relevance: Our finding of a continual increase in bed sharing throughout the study period among black and Hispanic infants suggests that the current American Academy of Pediatrics recommendation about bed sharing is not universally followed. The factors associated with infant bed sharing may be useful in evaluating the impact of a broad intervention to change behavior.

Objective: Veterans who served in Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) commonly experience alcohol misuse and symptoms of posttraumatic stress disorder (PTSD) following their return from deployment to a war zone. We conducted a randomized clinical trial to evaluate the efficacy of a newly developed, 8-module, self-management web intervention (VetChange) based on motivational and cognitive-behavioral principles to reduce alcohol consumption, alcohol-related problems, and PTSD symptoms in returning combat veterans., Method: Six hundred participants, recruited through targeted Facebook ads, were randomized to either an Initial Intervention Group (IIG; n = 404) or a Delayed Intervention Group (DIG; n = 196) that waited 8 weeks for access to VetChange. Primary outcome measures were Drinks per Drinking Day, Average Weekly Drinks, Percent Heavy Drinking Days, and PTSD symptoms. Intent-to-treat analyses compared changes in outcome measures over time between IIG and DIG as well as within-group changes., Results: IIG participants demonstrated greater reductions in drinking (p < .001 for each measure) and PTSD symptoms (p = .009) between baseline and end-of-intervention than did DIG participants between baseline and the end of the waiting period. DIG participants showed similar improvements to those in IIG following participation in VetChange. Alcohol problems were also reduced within each group between baseline and 3-month follow-up., Conclusions: Results indicate that VetChange is effective in reducing drinking and PTSD symptoms in OIF/OEF veterans. Further studies of VetChange are needed to assess web-based recruitment and retention methods and to determine VetChange's effectiveness in demographic and clinical sub-populations of returning veterans., ((c) 2013 APA, all rights reserved.)

Objectives: We assessed the impact of health literacy and acculturation on oral health status of Somali refugees in Massachusetts., Methods: Between December 2009 and June 2011, we surveyed 439 adult Somalis who had lived in the United States 10 years or less. Assessments included oral examinations with decayed, missing, and filled teeth (DMFT) counts and measurement of spoken English and health literacy. We tested associations with generalized linear regression models., Results: Participants had means of 1.4 decayed, 2.8 missing, and 1.3 filled teeth. Among participants who had been in the United States 0 to 4 years, lower health literacy scores correlated with lower DMFT (rate ratio [RR] = 0.78; P = .016). Among participants who had been in the country 5 to 10 years, lower literacy scores correlated with higher DMFT (RR = 1.37; P = .012). Literacy was not significantly associated with decayed teeth. Lower literacy scores correlated marginally with lower risk of periodontal disease (odds ratio = 0.22; P = .047)., Conclusions: Worsening oral health of Somali refugees over time may be linked to less access to preventive care and less utilization of beneficial oral hygiene practices.

Previous authors have proposed the sequential parallel comparison design (SPCD) to address the issue of high placebo response rate in clinical trials. The original use of SPCD focused on binary outcomes, but recent use has since been extended to continuous outcomes that arise more naturally in many fields, including psychiatry. Analytic methods proposed to date for analysis of SPCD trial continuous data included methods based on seemingly unrelated regression and ordinary least squares. Here, we propose a repeated measures linear model that uses all outcome data collected in the trial and accounts for data that are missing at random. An appropriate contrast formulated after the model has been fit can be used to test the primary hypothesis of no difference in treatment effects between study arms. Our extensive simulations show that when compared with the other methods, our approach preserves the type I error even for small sample sizes and offers adequate power and the smallest mean squared error under a wide variety of assumptions. We recommend consideration of our approach for analysis of data coming from SPCD trials., (Copyright © 2013 John Wiley & Sons, Ltd.)

Introduction: Iliac vessel trauma (IVT) is traditionally associated with high mortality. We evaluated a modern series of patients with IVT to assess current outcomes and endovascular therapy use., Methods: We performed a retrospective review of the National Trauma Data Bank. Patients with IVT were stratified by blunt and penetrating mechanism and arterial and venous injury., Results: In blunt IVT, there was no significant difference in mortality between those with and without pelvic fractures (odds ratio [OR] 0.61, 95% confidence interval [CI] 0.36-1.06). In penetrating IVT, combined arterial and venous IVT was associated with higher mortality (OR 1.70, 95% CI 1.06-2.70) compared to isolated arterial IVT. Isolated venous IVT was associated with lower mortality (OR 0.55, 95% CI 0.35-0.85) compared to isolated arterial IVT. Endovascular stenting was utilized in 11.3% of blunt IVT with pelvic fractures, 6.3% of blunt IVT without pelvic fractures, and 1.8% of penetrating IVT., Conclusion: Iliac Vessel Trauma has significant mortality. Endovascular intervention for IVT is applied sparingly.

Background: Packed RBC transfusion has been postulated to increase morbidity and mortality after cardiac/general surgical operations, but its effects after lower extremity bypass (LEB) have not been studied extensively., Study Design: Using the Vascular Study Group of New England's database (2003-2010), we examined 1,880 consecutive infrainguinal LEB performed for critical limb ischemia. Perioperative transfusion was categorized as 0 U, 1 to 2 U, and ≥3 U. Cohort frequency group matching was used to compare groups of patients receiving 1 to 2 U and 0 U with patients receiving ≥3 U using age, coronary artery disease, diabetes, urgency, and indication of revascularization. Primary end points were perioperative mortality, wound infection, and loss of primary graft patency at discharge, as well as 1-year mortality and loss of primary graft patency., Results: In the study cohort, 1,532 LEBs (81.5%) received 0 U, 248 LEBs (13.2%) received 1 to 2 U, and 100 LEBs (5.3%) received ≥3 U transfusion. In the study cohort and group frequency matched cohort, transfusion was associated with significantly higher perioperative wound infection (0 U:4.8% vs 1 to 2 U: 6.5% vs ≥3 U: 14.0%; p = 0.0004) and graft thrombosis at discharge (4.5% vs 7.7% vs 15.3%; p < 0.0001). At 1 year, there were no differences in infection or graft patency. In multivariate analysis, transfusion was independently associated with increased perioperative wound infection in the study cohort and group frequency matched cohort (1 to 2 U vs 0 U: adjusted odds ratio [OR] = 1.4; 95% CI, 0.8-2.5; p = 0.263; ≥3 U vs 0 U: OR = 3.5; 95% CI, 1.8-6.7; p = 0.0002; overall p = 0.002) and increased graft thrombosis at discharge (1 to 2 U vs 0 U: OR = 2.1; 95% CI, 1.2-3.6; p = 0.01; ≥3 U vs 0 U: OR = 4.8; 95% CI, 2.5-9.2; p < 0.0001, overall p < 0.0001)., Conclusions: Perioperative transfusion in patients undergoing LEB is associated with increased perioperative wound infection and graft thrombosis. From this observational study, it appears transfusion does not have major consequences during mid-term follow-up, but the presumed benefits of blood replacement should be weighed carefully because of the increased risk of perioperative complications with transfusion., (Copyright © 2013 American College of Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: Although dextran has been theorized to diminish the risk of stroke associated with carotid endarterectomy (CEA), variation exists in its use. We evaluated outcomes of dextran use in patients undergoing CEA to clarify its utility., Methods: We studied all primary CEAs performed by 89 surgeons within the Vascular Study Group of New England database (2003-2010). Patients were stratified by intraoperative dextran use. Outcomes included perioperative death, stroke, myocardial infarction (MI), and congestive heart failure (CHF). Group and propensity score matching was performed for risk-adjusted comparisons, and multivariable logistic and gamma regressions were used to examine associations between dextran use and outcomes., Results: There were 6641 CEAs performed, with dextran used in 334 procedures (5%). Dextran-treated and untreated patients were similar in age (70 years) and symptomatic status (25%). Clinical differences between the cohorts were eliminated by statistical adjustment. In crude, group-matched, and propensity-matched analyses, the stroke/death rate was similar for the two cohorts (1.2%). Dextran-treated patients were more likely to suffer postoperative MI (crude: 2.4% vs 1.0%; P = .03; group-matched: 2.4% vs 0.6%; P = .01; propensity-matched: 2.4% vs 0.5%; P = .003) and CHF (2.1% vs 0.6%; P = .01; 2.1% vs 0.5%; P = .01; 2.1% vs 0.2%; P < .001). In multivariable analysis of the crude sample, dextran was associated with a higher risk of postoperative MI (odds ratio, 3.52; 95% confidence interval, 1.62-7.64) and CHF (odds ratio, 5.71; 95% confidence interval, 2.35-13.89)., Conclusions: Dextran use was not associated with lower perioperative stroke but was associated with higher rates of MI and CHF. Taken together, our findings suggest limited clinical utility for routine use of intraoperative dextran during CEA., (Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Axillosubclavian vessel injury (ASVI) is associated with high morbidity and mortality. Most studies are single-center experiences of small numbers of patients with penetrating injury. We assessed 21st-century presentation and management of ASVI and focused on outcomes of combined arterial/venous injury. We reviewed the National Trauma Data Bank for patients with isolated arterial ASVI (group 1) and combined arterial/venous ASVI (group 2). Demographics, injury severity parameters, interventions, complications, and outcomes were compared. We identified 581 patients with ASVI (mean age 35.1; 88.1% male), with 466 isolated arterial injuries and 115 combined arterial/venous injuries. Group 2 had lower presenting systolic blood pressure and Glasgow Coma Scale, and had higher rates of operative repair (55.7 vs. 43.1%, p = 0.016) and higher mortality (33.9 vs. 13.9%, p < 0.001). There were no differences in amputation (5.2 vs. 2.4%, p = 0.121), compartment syndrome (2.6 vs. 1.9%, p = 0.713), and deep vein thrombosis (0.9 vs. 0.2%, p = 0.357). When separated by mechanism of injury, combined injuries from blunt trauma did increase amputation rates (27.8 vs. 4.2%, p = 0.002). Multivariate analysis revealed that combined arterial/venous injury significantly increased risk of death (odds ratio [OR], 2.99; confidence interval [CI], 1.73 to 5.17; p = 0.0001). Penetrating injury had higher odds of death than blunt injury (OR, 1.96; CI, 1.03 to 3.73; p = 0.041). ASVI is rare but extremely lethal. Concomitant venous and arterial injury is not associated with worse limb-related outcomes, except in blunt injuries and resultant amputations, but is associated with a threefold increase in mortality rates compared with isolated arterial injury.

Objective: No evidence-based methods exist to identify prescription drug use disorder (PDUD) in primary care (PC) patients prescribed controlled substances. Aberrant drug-related behaviors (ADRBs) are suggested as a proxy. Our objective was to determine whether ADRBs documented in electronic medical records (EMRs) of patients prescribed opioids and benzodiazepines could serve as a proxy for identifying PDUD., Design: A cross-sectional study of PC patients at an urban, academic medical center., Subjects: Two hundred sixty-four English-speaking patients (ages 18-60) with chronic pain (≥3 months), receiving ≥1 opioid analgesic or benzodiazepine prescription in the past year, were recruited during outpatient PC visits., Outcome Measures: Composite International Diagnostic Interview defined Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnoses of past year PDUD and no disorder. EMRs were reviewed for 15 prespecified ADRBs (e.g., early refill, stolen medications) in the year before and after study entry. Fisher's exact test compared frequencies of each ADRB between participants with and without PDUD., Results:  Sixty-one participants (23%) met DSM-IV PDUD criteria and 203 (77%) had no disorder; 85% had one or more ADRB documented. Few differences in frequencies of individual behaviors were noted between groups, with only "appearing intoxicated or high" documented more frequently among participants with PDUD (N = 10, 16%) vs no disorder (N = 8, 4%), P = 0.002. The only common ADRB, "emergency visit for pain," did not discriminate between those with and without the disorder (82% PDUD vs 78% no disorder, P = 0.6)., Conclusions: EMR documentation of ADRBs is common among PC patients prescribed opioids or benzodiazepines, but unsystematic clinician documentation does not identify PDUDs. Evidence-based approaches are needed., (Wiley Periodicals, Inc.)

Background: Duration of femoral-popliteal bypass is based on multiple patient-specific, system-specific, and surgeon-specific factors, and is subject to considerable variability. We hypothesized that shorter operative duration is associated with improved outcomes and might represent a potential quality-improvement measure., Study Design: Patients who underwent primary femoral-popliteal bypass with autogenous vein between 2005 and 2009 were identified from the American College of Surgeons NSQIP dataset using ICD-9 codes. Operative duration quartiles (Q) were determined (Q1: ≤149 minutes, Q2: 150 to 192 minutes, Q3: 193 to 248 minutes; and Q4: ≥249 minutes). Perioperative outcomes included mortality, surgical site infection, cardiopulmonary complications, and length of hospital stay. Relevant patient-specific and system-specific confounders, including age, body mass index, smoking, diabetes, end-stage renal disease, indication, American Society of Anesthesiologists' class, type of anesthesia, intraoperative transfusion, nonoperative time in the operating room, and participation of a trainee during the procedure, were adjusted for using multivariable regression., Results: There were 2,644 femoral-popliteal bypass procedures in our study. Mean age was 65.9 years and 62% of patients were male. Longer duration of surgery was associated with increased perioperative surgical site infection (Q1: 6.3%; Q2: 9.0%; Q3: 10.1%; and Q4: 13.9%; p < 0.001) and longer length of stay (5.4 ± 6.8 days; 6.1 ± 6.7 days; 7.0 ± 11.3 days; 8.1 ± 8.0 days, respectively; p < 0.001). In multivariable analysis, longer operative duration was independently associated with higher surgical site infection and longer hospital length of stay. Operative duration of ≥260 minutes increased the risk of surgical site infection by 50% compared with operative time of 150 minutes., Conclusions: Longer duration of femoral-popliteal bypass with autogenous vein was associated with a significantly higher risk of perioperative surgical site infection and longer hospital length of stay. Surgeon-specific parameters that lead to faster operative time might lead to improved clinical outcomes and more efficient hospital resource use., (Copyright © 2012 American College of Surgeons. Published by Elsevier Inc. All rights reserved.)

Through genome-wide association meta-analyses of up to 133,010 individuals of European ancestry without diabetes, including individuals newly genotyped using the Metabochip, we have increased the number of confirmed loci influencing glycemic traits to 53, of which 33 also increase type 2 diabetes risk (q < 0.05). Loci influencing fasting insulin concentration showed association with lipid levels and fat distribution, suggesting impact on insulin resistance. Gene-based analyses identified further biologically plausible loci, suggesting that additional loci beyond those reaching genome-wide significance are likely to represent real associations. This conclusion is supported by an excess of directionally consistent and nominally significant signals between discovery and follow-up studies. Functional analysis of these newly discovered loci will further improve our understanding of glycemic control.

To extend understanding of the genetic architecture and molecular basis of type 2 diabetes (T2D), we conducted a meta-analysis of genetic variants on the Metabochip, including 34,840 cases and 114,981 controls, overwhelmingly of European descent. We identified ten previously unreported T2D susceptibility loci, including two showing sex-differentiated association. Genome-wide analyses of these data are consistent with a long tail of additional common variant loci explaining much of the variation in susceptibility to T2D. Exploration of the enlarged set of susceptibility loci implicates several processes, including CREBBP-related transcription, adipocytokine signaling and cell cycle regulation, in diabetes pathogenesis.

Introduction and Objectives: Lower extremity (LE) arterial trauma and its treatment may lead to extremity compartment syndrome (ECS). In that setting, the decision to perform fasciotomies is multifactoral and is not well delineated. We evaluated the outcomes of patients with surgically treated LE arterial injury who underwent early or delayed fasciotomies., Methods: The National Trauma Data Bank (NTDB) was retrospectively reviewed for patients who had LE arterial trauma and underwent both open vascular repair and fasciotomies. Exclusion criteria were additional non-LE vascular trauma, head or spinal cord injuries, crush injuries, burn injuries, and declaration of death on arrival. Patients were divided into those who had fasciotomies performed within 8h (early group) or >8h after open vascular repair (late group). Comparative analyses of demographics, injury characteristics, complications, and outcomes were performed., Results: Of the 1469 patient admissions with lower extremity arterial trauma that met inclusion criteria there were 612 patients (41.7%) who underwent fasciotomies. There were 543 and 69 patients in the early and late fasciotomy groups, respectively. There was no significant difference in age, injury severity, mechanism of injury, associated injuries, and type of vascular repair between the groups. A higher rate of iliac artery injury was observed in the late fasciotomy group (23.2% vs. 5.9%, P<.001). Patients in the early fasciotomy group had lower amputation rate (8.5% vs. 24.6%, P<.001), lower infection rate (6.6% vs. 14.5%, P = .028) and shorter total hospital stay (18.5 ± 20.7 days vs. 24.2 ± 14.7 days, P = .007) than those in the late fasciotomy group. On multivariable analysis, early fasciotomy was associated with a 4-fold lower risk of amputation (Odds Ratio 0.26, 95% CI 0.14-0.50, P<.0001) and 23% shorter hospital LOS (Means Ratio 0.77, 95% CI 0.64-0.94, P = .01)., Conclusion: Early fasciotomy is associated with improved outcomes in patients with lower extremity vascular trauma treated with surgical intervention. Our findings suggest that appropriate implementation of early fasciotomy may reduce amputation rates in extremity arterial injury., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Gene-lifestyle interactions have been suggested to contribute to the development of type 2 diabetes. Glucose levels 2 h after a standard 75-g glucose challenge are used to diagnose diabetes and are associated with both genetic and lifestyle factors. However, whether these factors interact to determine 2-h glucose levels is unknown. We meta-analyzed single nucleotide polymorphism (SNP) × BMI and SNP × physical activity (PA) interaction regression models for five SNPs previously associated with 2-h glucose levels from up to 22 studies comprising 54,884 individuals without diabetes. PA levels were dichotomized, with individuals below the first quintile classified as inactive (20%) and the remainder as active (80%). BMI was considered a continuous trait. Inactive individuals had higher 2-h glucose levels than active individuals (β = 0.22 mmol/L [95% CI 0.13-0.31], P = 1.63 × 10(-6)). All SNPs were associated with 2-h glucose (β = 0.06-0.12 mmol/allele, P ≤ 1.53 × 10(-7)), but no significant interactions were found with PA (P > 0.18) or BMI (P ≥ 0.04). In this large study of gene-lifestyle interaction, we observed no interactions between genetic and lifestyle factors, both of which were associated with 2-h glucose. It is perhaps unlikely that top loci from genome-wide association studies will exhibit strong subgroup-specific effects, and may not, therefore, make the best candidates for the study of interactions.

Common diseases such as type 2 diabetes are phenotypically heterogeneous. Obesity is a major risk factor for type 2 diabetes, but patients vary appreciably in body mass index. We hypothesized that the genetic predisposition to the disease may be different in lean (BMI<25 Kg/m²) compared to obese cases (BMI≥30 Kg/m²). We performed two case-control genome-wide studies using two accepted cut-offs for defining individuals as overweight or obese. We used 2,112 lean type 2 diabetes cases (BMI<25 kg/m²) or 4,123 obese cases (BMI≥30 kg/m²), and 54,412 un-stratified controls. Replication was performed in 2,881 lean cases or 8,702 obese cases, and 18,957 un-stratified controls. To assess the effects of known signals, we tested the individual and combined effects of SNPs representing 36 type 2 diabetes loci. After combining data from discovery and replication datasets, we identified two signals not previously reported in Europeans. A variant (rs8090011) in the LAMA1 gene was associated with type 2 diabetes in lean cases (P = 8.4×10⁻⁹, OR = 1.13 [95% CI 1.09-1.18]), and this association was stronger than that in obese cases (P = 0.04, OR = 1.03 [95% CI 1.00-1.06]). A variant in HMG20A--previously identified in South Asians but not Europeans--was associated with type 2 diabetes in obese cases (P = 1.3×10⁻⁸, OR = 1.11 [95% CI 1.07-1.15]), although this association was not significantly stronger than that in lean cases (P = 0.02, OR = 1.09 [95% CI 1.02-1.17]). For 36 known type 2 diabetes loci, 29 had a larger odds ratio in the lean compared to obese (binomial P = 0.0002). In the lean analysis, we observed a weighted per-risk allele OR = 1.13 [95% CI 1.10-1.17], P = 3.2×10⁻¹⁴. This was larger than the same model fitted in the obese analysis where the OR = 1.06 [95% CI 1.05-1.08], P = 2.2×10⁻¹⁶. This study provides evidence that stratification of type 2 diabetes cases by BMI may help identify additional risk variants and that lean cases may have a stronger genetic predisposition to type 2 diabetes., Competing Interests: The authors have declared that no competing interests exist.

African Americans are disproportionately affected by type 2 diabetes (T2DM) yet few studies have examined T2DM using genome-wide association approaches in this ethnicity. The aim of this study was to identify genes associated with T2DM in the African American population. We performed a Genome Wide Association Study (GWAS) using the Affymetrix 6.0 array in 965 African-American cases with T2DM and end-stage renal disease (T2DM-ESRD) and 1029 population-based controls. The most significant SNPs (n = 550 independent loci) were genotyped in a replication cohort and 122 SNPs (n = 98 independent loci) were further tested through genotyping three additional validation cohorts followed by meta-analysis in all five cohorts totaling 3,132 cases and 3,317 controls. Twelve SNPs had evidence of association in the GWAS (P<0.0071), were directionally consistent in the Replication cohort and were associated with T2DM in subjects without nephropathy (P<0.05). Meta-analysis in all cases and controls revealed a single SNP reaching genome-wide significance (P<2.5×10(-8)). SNP rs7560163 (P = 7.0×10(-9), OR (95% CI) = 0.75 (0.67-0.84)) is located intergenically between RND3 and RBM43. Four additional loci (rs7542900, rs4659485, rs2722769 and rs7107217) were associated with T2DM (P<0.05) and reached more nominal levels of significance (P<2.5×10(-5)) in the overall analysis and may represent novel loci that contribute to T2DM. We have identified novel T2DM-susceptibility variants in the African-American population. Notably, T2DM risk was associated with the major allele and implies an interesting genetic architecture in this population. These results suggest that multiple loci underlie T2DM susceptibility in the African-American population and that these loci are distinct from those identified in other ethnic populations.

Circulating levels of adiponectin, a hormone produced predominantly by adipocytes, are highly heritable and are inversely associated with type 2 diabetes mellitus (T2D) and other metabolic traits. We conducted a meta-analysis of genome-wide association studies in 39,883 individuals of European ancestry to identify genes associated with metabolic disease. We identified 8 novel loci associated with adiponectin levels and confirmed 2 previously reported loci (P = 4.5×10(-8)-1.2×10(-43)). Using a novel method to combine data across ethnicities (N = 4,232 African Americans, N = 1,776 Asians, and N = 29,347 Europeans), we identified two additional novel loci. Expression analyses of 436 human adipocyte samples revealed that mRNA levels of 18 genes at candidate regions were associated with adiponectin concentrations after accounting for multiple testing (p<3×10(-4)). We next developed a multi-SNP genotypic risk score to test the association of adiponectin decreasing risk alleles on metabolic traits and diseases using consortia-level meta-analytic data. This risk score was associated with increased risk of T2D (p = 4.3×10(-3), n = 22,044), increased triglycerides (p = 2.6×10(-14), n = 93,440), increased waist-to-hip ratio (p = 1.8×10(-5), n = 77,167), increased glucose two hours post oral glucose tolerance testing (p = 4.4×10(-3), n = 15,234), increased fasting insulin (p = 0.015, n = 48,238), but with lower in HDL-cholesterol concentrations (p = 4.5×10(-13), n = 96,748) and decreased BMI (p = 1.4×10(-4), n = 121,335). These findings identify novel genetic determinants of adiponectin levels, which, taken together, influence risk of T2D and markers of insulin resistance., Competing Interests: DM Waterworth, X Yuan, and VE Mooser are full-time employees of GlaxoSmithKline. P Vollenweider received grant money from GlaxoSmithKline to fund the CoLaus study. The other authors declare no competing financial interests.

Objective: To examine the outcomes of lower extremity (LE) and upper extremity (UE) arterial trauma., Methods: Retrospective review of 2008 version of National Trauma Databank. Adult patient with LE and UE arterial trauma was identified and outcomes were compared., Results: There were 8311 cases of extremity arterial trauma and 37% involved the LE. The LE cohort had higher blunt injury (56.2% vs 37.4%; P < .0001). The LE cohort was more likely to require fasciotomy (23.6% vs 6.7%; P < .0001) and amputation (7.8% vs 1.3%; P < .0001). Complication (18.8% vs 5.1%; P < .0001) and mortality rate (7.7% vs 2.2%, P < .0001) were higher in the LE cohort. Regardless of extremity, blunt trauma was associated with higher mortality (4.8% vs 3.8%; P = .03) and amputation (6.7% vs 1.3%; P < .0001). In multivariable analysis, LE arterial trauma was associated with increased mortality (odds ratio [OR] 2.2, 95% confidence interval [CI] 1.7-2.9; P < .0001) and amputation (OR 4.3, 95% CI 3.2-5.8; P < .0001)., Conclusions: Lower and upper extremity arterial injuries have different modes of presentation and outcomes. Lower extremity arterial trauma is more commonly caused by blunt injury and associated with worse outcomes despite more intensive intervention.

Objective: To report longitudinal home recordings of hemoglobin O(2) saturation by pulse oximetry (Spo(2)) during unperturbed sleep in preterm and term infants., Study Design: We recorded continuous pulse oximetry during the first 3 minutes of each hour of monitor use (nonevent epochs) for 103 preterm infants born at <1750 g and ≤ 34 weeks postmenstrual age (PMA), and 99 healthy term infants., Results: Median baseline Spo(2) was approximately 98% for both the preterm and term groups. Episodes of intermittent hypoxemia occurred in 74% of preterm and 62% of term infants. Among infants with intermittent hypoxemia, the number of seconds/hour of monitoring <90% Spo(2) was initially significantly greater in the preterm than the term group and declined with age at a similar rate in both groups. The 75(th) to 95(th) percentiles for seconds/hour of Spo(2) <90% in preterm infants were highest at 36 weeks PMA and progressively decreased until 44 weeks PMA, after which time they did not differ from term infants., Conclusions: Clinically inapparent intermittent hypoxemia occurs in epochs unperturbed by and temporally unrelated to apnea or bradycardia events, especially in preterm infants at 36 to 44 weeks PMA., (Copyright © 2011 Mosby, Inc. All rights reserved.)

Objective: To determine the association of weight-based insulin dose with hypoglycemia in noncritically ill inpatients with diabetes., Research Design and Methods: We performed a retrospective, case-control study of 1,990 diabetic patients admitted to hospital wards. Patients with glucose levels <70 mg/dL (case subjects) were matched one to one with nonhypoglycemic control subjects on the basis of the hospital day of hypoglycemia, age, sex, and BMI., Results: Relative to 24-h insulin doses <0.2 units/kg, the unadjusted odds of hypoglycemia increased with increasing insulin dose. Adjusted for insulin type, sliding-scale insulin use, and albumin, creatinine, and hematocrit levels, the higher odds of hypoglycemia with increasing insulin doses remained (0.6-0.8 units/kg: odds ratio 2.10 [95% CI 1.08-4.09], P = 0.028; >0.8 units/kg: 2.95 [1.54-5.65], P = 0.001). The adjusted odds of hypoglycemia were not greater in patients who received 0.2-0.4 units/kg (1.08 [0.64-1.81], P = 0.78) or 0.4-0.6 units/kg (1.60 [0.90-2.86], P = 0.11). Although the relationship between insulin dose and hypoglycemia did not vary by insulin type, patients who received NPH trended toward greater odds of hypoglycemia compared with those given other insulins., Conclusions: Higher weight-based insulin doses are associated with greater odds of hypoglycemia independent of insulin type. However, 0.6 units/kg seems to be a threshold below which the odds of hypoglycemia are relatively low. These findings may help clinicians use insulin more safely.

Adherence to antiretroviral therapy (ART) represents one of the strongest predictors of progression to AIDS, yet it is difficult for most patients to sustain high levels of adherence. This study compares the efficacy of a personalized cell phone reminder system (ARemind) in enhancing adherence to ART versus a beeper. Twenty-three HIV-infected subjects on ART with self-reported adherence less than 85% were randomized to a cellular phone (CP) or beeper (BP). CP subjects received personalized text messages daily; in contrast, BP subjects received a reminder beep at the time of dosing. Interviews were scheduled at weeks 3 and 6. Adherence to ART was measured by self-report (SR, 7-day recall), pill count (PC, past 30 days at baseline, then past 3 weeks), Medication Event Monitoring System (MEMS; cumulatively at 3 and 6 weeks), and via a composite adherence score constructed by combining MEMS, pill count, and self report. A mixed effects model adjusting for baseline adherence was used to compare adherence rates between the intervention groups at 3 and 6 weeks. Nineteen subjects completed all visits, 10 men and 9 females. The mean age was 42.7 ± 6.5 years, 37% of subjects were Caucasian and 89% acquired HIV heterosexually. The average adherence to ART was 79% by SR and 65% by PC at baseline in both arms; over 6 weeks adherence increased and remained significantly higher in the ARemind group using multiple measures of adherence. A larger and longer prospective study is needed to confirm these findings and to better understand optimal reminder messages and user fatigue.