Diaspirin-crosslinked hemoglobin reduces blood transfusion in noncardiac surgery: a multicenter, randomized, controlled, double-blinded trial.

UNLABELLED: In this randomized, prospective, double-blinded clinical trial, we sought to investigate whether diaspirin-crosslinked hemoglobin (DCLHb) can reduce the perioperative use of allogeneic blood transfusion. One-hundred-eighty-one elective surgical patients were enrolled at 19 clinical sites from 1996 to 1998. Selection criteria included anticipated transfusion of 2-4 blood units, aortic repair, and major joint or abdomino-pelvic surgery. Once a decision to transfuse had been made, patients received initially up to 3 250-mL infusions of 10% DCLHb (n = 92) or 3 U of packed red blood cells (PRBCs) (n = 89). DCLHb was infused during a 36-h perioperative window. On the day of surgery, 58 of 92 (64%; confidence interval [CI], 54%-74%) DCLHb-treated patients received no allogeneic PRBC transfusions. On Day 1, this number was 44 of 92 (48%; CI, 37%-58%) and decreased further until Day 7, when it was 21 of 92 (23%; CI, 15%-33%). During the 7-day period, 2 (1-4) units of PRBC per patient were used in the DCLHb group compared with 3 (2-4) units in the control patients (P = 0.002; medians and 25th and 75th percentiles). Mortality (4% and 3%, respectively) and incidence of suffering at least one serious adverse event (21% and 15%, respectively) were similar in DCLHb and PRBC groups. The incidence of jaundice, urinary side effects, and pancreatitis were more frequent in DCLHb patients. The study was terminated early because of safety concerns. Whereas the side-effect profile of modified hemoglobin solutions needs to be improved, our data show that hemoglobin solutions can be effective at reducing exposure to allogeneic blood for elective surgery. IMPLICATIONS: In a randomized, double-blinded red blood cell controlled, multicenter trial, diaspirin-crosslinked hemoglobin spared allogeneic transfusion in 23% of patients undergoing elective noncardiac surgery. The observed side-effect profile indicates a need for improvement in hemoglobin development

Reoperation for recurrent carotid stenosis: Early results and late outcome in 199 patients

AbstractPurpose: This study was undertaken to determine the safety and efficacy of reoperations for recurrent carotid stenosis (REDOCEA) at the Cleveland Clinic. Materials and Methods: From 1989 to 1999, 206 consecutive REDOCEAs were performed in 199 patients (131 men, 68 women) with a mean age of 68 years (median, 69 years; range, 47-86 years). A total of 119 procedures (57%) were performed for severe asymptomatic stenosis, 55 (27%) for hemispheric transient ischemic attacks or amaurosis fugax, 26 (13%) for prior stroke, and 6 (3%) for vertebrobasilar symptoms. Eleven REDOCEAs (5%) were combined with myocardial revascularization, and another 19 (9%) represented multiple carotid reoperations (17 second reoperations and 2 third reoperations). Three REDOCEAs (1%) were closed primarily, and nine (4%) required interposition grafts, whereas the remaining 194 (95%) were repaired with either vein patch angioplasty (139 [68%]) or synthetic patches (55 [27%]). Three patients (2%) were lost to follow-up, but late information was available for 196 patients (203 operations) at a mean interval of 4.3 years (median, 3.9 years; maximum, 10.2 years). Results: Considering all 206 procedures, there were 7 early (< 30 days) postoperative neurologic events (3.4%), including 6 perioperative strokes (2.9%) and 1 occipital hemorrhage (0.5%) on the 12th postoperative day. Seventeen additional neurologic events occurred during the late follow-up period, consisting of eight strokes (3.9%) and nine transient ischemic attacks (4.4 %). With the Kaplan-Meier method, the estimated 5-year freedom from stroke was 92% (95% CI, 88%-96%). There were two early postoperative deaths (1%), both from cardiac complications after REDOCEAs combined with myocardial revascularization procedures. With the Kaplan-Meier method, the estimated 5-year survival was 81% (range, 75%-88%). A univariate Cox regression model yielded the presence of coronary artery disease as the only variable that was significantly associated with survival (P =.024). The presence of pulmonary disease (P =.036), diabetes (P =.01), and advancing age (P =.006) was found to be significantly associated with stroke after REDOCEA. Causes of 53 late deaths were cardiovascular problems in 25 patients (47%), unknown in 14 (26%), renal failure in 4 (8%), stroke in 3 (6%), and miscellaneous in 7 (13%). Conclusions: We conclude that REDOCEA may be safely performed in selected patients with recurrent carotid stenosis and that most of these patients enjoy long-term freedom from stroke. (J Vasc Surg 2001;34:5-12.

Bioelectrical Impedance Phase Angle Changes During Hydration and Prognosis in Advanced Cancer

Introduction. We wished to determine bioelectrical impedance (BIA) correlates before hydration or changes during hydration and determine if these changes were prognostically important

Gender Differences in Physicians' Financial Ties to Industry: A Study of National Disclosure Data.

Academic literature extensively documents gender disparities in the medical profession with regard to salary, promotion, and government funded research. However, gender differences in the value of financial ties to industry have not been adequately studied despite industry's increasing contribution to income and research funding to physicians in the U.S.We analyzed publicly reported financial relationships among 747,603 physicians and 432 pharmaceutical, device and biomaterials companies. Demographic and payment information were analyzed using hierarchical regression models to determine if statistically significant gender differences exist in physician-industry interactions regarding financial ties, controlling for key covariates. In 2011, 432 biomedical companies made an excess of $17,991,000 in payments to 220,908 physicians. Of these physicians, 75.1$3,598.63, p<0.001) per person than men. Additionally, female physicians received significantly lower amounts for meals (-$41.80, p<0.001), education (-$1,893.14, p<0.001), speaker fees (-$2,898.44, p<0.001), and sponsored research (-$15,049.62, p=0.05). For total dollars, an interaction between gender and institutional reputation was statistically significant, implying that the differences between women and men differed based on industry's preference for an institution, with larger differences at higher reputation institutions.Female physicians receive significantly lower compensation for similarly described activities than their male counterparts after controlling for key covariates. As regulations lead to increased transparency regarding these relationships, efforts to standardize compensation should be considered to promote equitable opportunities for all physicians

A new survey to evaluate conflict of interest policies at academic medical centers

<div><p>Background</p><p>A majority of academic medical centers (AMCs) have now adopted conflict of interest policies (COI) to address relationships with pharmaceutical and device industries that can increase the risk of bias in patient care, education and research. However, AMCs may have little information on the impact of their policies. This paper provides a new method, which is a free, publicly-available survey, to fill this information gap and improve COI programs at AMCs.</p><p>Methods & findings</p><p>The survey, piloted in three AMCs and designed in collaboration with national conflicts of interest policy experts, covers a range of universal compliance-related concerns, which allows institutions to tailor questions to align with their own policies and culture. The survey was low-burden, and provided important data for these AMCs to evaluate their policies. A descriptive analysis of the pooled pilot site data (n = 1578) was performed, which found that a majority of respondents did not have financial ties with industry and a majority was satisfied with specific COI policies at their institutions. The analysis also showed that the survey is sensitive to differences that AMCs will find meaningful. For instance, individuals with industry ties were significantly more likely than individuals without ties to think that COI policies unnecessarily hindered interactions with industry (p = .004), were ineffective at reducing harm to patients (p < .001), and were ineffective in reducing bias in medical education (p>.001).</p><p>Conclusion</p><p>The survey is now free and publicly available for use by any institution. AMCs can use the results to update and refine policies, and to provide ongoing education regarding existing policies.</p></div

Value of financial relationships by type, physician and institutional factors.

<p>^A20,510 out of the 33,338 reported $500.50 in the Other Category.</p><p>Value of financial relationships by type, physician and institutional factors.</p

Categorization of Relationship Types.

<p>Categorization of Relationship Types.</p

Demographic information on physicians with and without financial relationships with industry.

<p>^A: Large hospitals were considered any hospital with > 500 beds as per the AHA survey data.</p><p>^B: City Rank is determined by the AHA, and considers only the top 100 US cities based on population.</p><p>Shaded area: Granular data on these variables are only available for physicians receiving at least $1 from industry.</p><p>Demographic information on physicians with and without financial relationships with industry.</p

Gender differences for reported financial affiliations after adjustment^A.

<p>^A: Adjusted for Physician factors (Specialty: Medical vs. Surgical vs. Other and Age), as well as institutional factors (Hospital > 500 beds, has a medical school affiliation, has any NIH awards, Located in an AHA Top 100 ranked city) P value for Gender main effect from linear mixed effects model with these adjustments. Indicated by * for P<0.05, ** for P<0.01, and *** for P<0.001</p><p>^B: From the same model as A, but using Log(Total Dollars) as the predicted outcome. Results are the back-transformed to reflect the dollar amount received by females per dollar received by males.</p><p>Gender differences for reported financial affiliations after adjustment<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0129197#t004fn001" target="_blank">^A</a>.</p