Carson J.L.,UMDNJ Robert Wood Johnson Medical School |
Grossman B.J.,Washington University |
Kleinman S.,University of British Columbia |
Tinmouth A.T.,Ottawa Hospital Research Institute |
And 13 more authors.
Annals of Internal Medicine | Year: 2012
Description: Although approximately 85 million units of red blood cells (RBCs) are transfused annually worldwide, transfusion practices vary widely. The AABB (formerly, the American Association of Blood Banks) developed this guideline to provide clinical recommendations about hemoglobin concentration thresholds and other clinical variables that trigger RBC transfusions in hemodynamically stable adults and children. Methods: These guidelines are based on a systematic review of randomized clinical trials evaluating transfusion thresholds. We performed a literature search from 1950 to February 2011 with no language restrictions. We examined the proportion of patients who received any RBC transfusion and the number of RBC units transfused to describe the effect of restrictive transfusion strategies on RBC use. To determine the clinical consequences of restrictive transfusion strategies, we examined overall mortality, nonfatal myocardial infarction, cardiac events, pulmonary edema, stroke, thromboembolism, renal failure, infection, hemorrhage, mental confusion, functional recovery, and length of hospital stay. Recommendation 1: The AABB recommends adhering to a restrictive transfusion strategy (7 to 8 g/dL) in hospitalized, stable patients (Grade: strong recommendation; high-quality evidence). Recommendation 2: The AABB suggests adhering to a restrictive strategy in hospitalized patients with preexisting cardiovascular disease and considering transfusion for patients with symptoms or a hemoglobin level of 8 g/dL or less (Grade: weak recommendation; moderate-quality evidence). Recommendation 3: The AABB cannot recommend for or against a liberal or restrictive transfusion threshold for hospitalized, hemodynamically stable patients with the acute coronary syndrome (Grade: uncertain recommendation; very low-quality evidence). Recommendation 4: The AABB suggests that transfusion decisions be influenced by symptoms as well as hemoglobin concentration (Grade: weak recommendation; low-quality evidence). © 2012 American College of Physicians.
A randomized phase III study evaluating the efficacy and safety of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy
Aapro M.,Institute Multidisciplinaire dOncologie |
Rugo H.,University of California at San Francisco |
Rossi G.,Data Management |
Rizzi G.,Data Management |
And 9 more authors.
Annals of Oncology | Year: 2014
Background: Antiemetic guidelines recommend co-administration of agents that target multiple molecular pathways involved in emesis to maximize prevention and control of chemotherapy-induced nausea and vomiting (CINV). NEPA is a new oral fixed-dose combination of 300 mg netupitant, a highly selective NK1 receptor antagonist (RA) and 0.50 mg palonosetron (PALO), a pharmacologically and clinically distinct 5-HT3 RA, which targets dual antiemetic pathways. Patients and methods: This multinational, randomized, double-blind, parallel group phase III study (NCT01339260) in 1455 chemotherapy-naïve patients receiving moderately emetogenic (anthracycline-cyclophosphamide) chemotherapy evaluated the efficacy and safety of a single oral dose of NEPA versus a single oral dose (0.50 mg) of PALO. All patients also received oral dexamethasone (DEX) on day 1 only (12 mg in the NEPA arm and 20 mg in the PALO arm). The primary efficacy end point was complete response (CR: no emesis, no rescue medication) during the delayed (25-120 h) phase in cycle 1. Results: The percentage of patients with CR during the delayed phasewas significantly higher in the NEPA group compared with the PALO group (76.9% versus 69.5%; P = 0.001), as were the percentages in the overall (0-120 h) (74.3% versus 66.6%; P = 0.001) and acute (0-24 h) (88.4% versus 85.0%; P = 0.047) phases. NEPAwas also superior to PALO during the delayed and overall phases for all secondary efficacy end points of no emesis, no significant nausea and complete protection (CR plus no significant nausea). NEPAwas well tolerated with a similar safety profile as PALO. Conclusions: NEPA plus a single dose of DEX was superior to PALO plus DEX in preventing CINV following moderately emetogenic chemotherapy in acute, delayed and overall phases of observation. As a fixed-dose antiemetic drug combination, NEPA along with a single dose of DEX on day 1 offers guideline-based prophylaxis with a convenient, single-day treatment. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
Wallaert J.B.,Dartmouth Hitchcock Medical Center |
Cronenwett J.L.,Dartmouth Hitchcock Medical Center |
Bertges D.J.,Fletcher Allen Health Care |
Schanzer A.,UMass Memorial Health Care |
And 4 more authors.
Journal of Vascular Surgery | Year: 2013
Objective: Although carotid endarterectomy (CEA) is performed to prevent stroke, long-term survival is essential to ensure benefit, especially in asymptomatic patients. We examined factors associated with 5-year survival following CEA in patients with asymptomatic internal carotid artery (ICA) stenosis. Methods: Prospectively collected data from 4114 isolated CEAs performed for asymptomatic stenosis across 24 centers in the Vascular Study Group of New England between 2003 and 2011 were used for this analysis. Late survival was determined with the Social Security Death Index. Cox proportional hazard models were used to identify risk factors for mortality within the first 5 years after CEA and to calculate a risk score for predicting 5-year survival. Results: Overall 3- and 5-year survival after CEA in asymptomatic patients were 90% (95% CI 89%-91%) and 82% (95% CI 81%-84%), respectively. By multivariate analysis, increasing age, diabetes, smoking history, congestive heart failure, chronic obstructive pulmonary disease, poor renal function (estimated glomerular filtration rate <60 or dialysis dependence), absence of statin use, and worse contralateral ICA stenosis were all associated with worse survival. Patients classified as low (27%), medium (68%), and high risk (5%) based on number of risk factors had 5-year survival rates of 96%, 80%, and 51%, respectively (P <.001). Conclusions: More than four out of five asymptomatic patients selected for CEA in the Vascular Study Group of New England achieved 5-year survival, demonstrating that, overall, surgeons in our region selected appropriate patients for carotid revascularization. However, there were patients selected for surgery with high risk profiles, and our models suggest that the highest risk patients (such as those with multiple major risk factors including age ≥80, insulin-dependent diabetes, dialysis dependence, and severe contralateral ICA stenosis) are unlikely to survive long enough to realize a benefit of prophylactic CEA for asymptomatic stenosis. Predicting survival is important for decision making in these patients. © 2013 by the Society for Vascular Surgery.
Kuruvilla K.,University of Vermont |
Osler T.,Fletcher Allen Health Care |
Hyman N.H.,Fletcher Allen Health Care
Diseases of the Colon and Rectum | Year: 2012
Total proctocolectomy with IPAA is frequently considered the procedure of choice for surgical patients with ulcerative colitis, presumably owing to an expectation of improved quality of life in comparison with an ileostomy. OBJECTIVE: The goal of our study was to determine whether long-term quality of life among patients with a pelvic pouch is better than those who chose a permanent stoma. DESIGN: This investigation is a cross-sectional observational study using a prospective database. SETTING: This study was conducted at an academic medical center. PATIENTS: Consecutive patients who had undergone IPAA or a permanent ileostomy for ulcerative colitis by a single surgeon, presenting for their annual follow-up visit from July through September 2011, were offered participation in the study. A randomly chosen group of subjects who did not have scheduled appointments during the study period were sent a letter inviting them to participate in the study. MAIN OUTCOME MEASURES: The primary outcome measures used were EQ-5D-3L, the Short Quality of Life in Inflammatory Bowel Disease questionnaire, the Cleveland Global Quality of Life instrument, the Fecal Incontinence Quality of Life scale, and the Stoma Quality of Life scale. RESULTS: Thirty-five patients with a pelvic pouch and 24 ostomates were accrued and comprehensively studied. Global quality-of-life scores were virtually identical for the 2 groups. Patients with a pelvic pouch had better subscores in current quality of health and energy level, Fazio score, sexuality/body image, and work/social function. LIMITATIONS: This study was limited by its small sample size, and some of our patients were enrolled through mailed surveys and, hence, nonresponse bias may be present. The follow-up time since surgery was longer in the pelvic pouch group than in the ileostomy group. CONCLUSION: Informed patients with ulcerative colitis choosing an ileostomy have a health-related global quality of life very similar to patients with a pelvic pouch. Better outcomes in patients with an ileal pouch were most evident in the areas of sexuality/body image and work/social function. © The ASCRS 2012.
Huber L.,University of Vermont |
Gennari F.J.,University of Vermont |
Gennari F.J.,Fletcher Allen Health Care
American Journal of Kidney Diseases | Year: 2011
We present a patient with end-stage kidney disease receiving hemodialysis therapy who developed severe metabolic alkalosis secondary to vomiting. This case illustrates the important differences in pathogenesis, diagnosis, and management of this common acid-base disorder in patients without kidney function. The diagnostic approach and management strategy for metabolic alkalosis are discussed, highlighting the special issues to be considered in dialysis patients. © 2011 National Kidney Foundation, Inc.
Weaver D.L.,University of Vermont |
Weaver D.L.,Vermont Cancer Center |
Weaver D.L.,Fletcher Allen Health Care
Modern Pathology | Year: 2010
Sentinel lymph nodes (SLN) are more likely to contain metastatic breast carcinoma than non-SLNs. The limited number of SLNs compared with an axillary dissection has prompted more comprehensive lymph node analysis increasing detection of micrometastases. National data show that many women previously classified node negative are now classified minimally node positive. As a result, our nodal classification and cancer staging have evolved to recognize the continuum of nodal tumor burden rather than a simplistic dichotomous stratification. It is quite clear that the more sections we evaluate from SLNs the more metastases we identify; however, it is impractical to expect the practicing pathologist to mount, stain, and microscopically examine every section through the SLN paraffin blocks. Despite recommendations from the College of American Pathologists and the American Society of Clinical Oncology, heterogeneity in the approach to SLN evaluation exists. What is needed is adherence to a standardized evaluation protocol. The most important aspect of the sentinel node examination is careful attention to slicing the SLN no thicker than 2.0 mm and correct embedding of the slices to assure we identify all macrometastases larger than 2.0 mm. A single section from blocks prepared in this manner will identify all macrometastases present but smaller metastases will be missed. The prognostic significance of these missed micrometastases is still being evaluated as we await SLN outcome studies. In the context of the new molecular classification of breast cancer, subgroups may be identified where detection of micrometastases has clinical significance. It is critical that both clinicians and pathologists understand there is a random component to micrometastasis distribution within the three-dimensional paraffin tissue blocks. If we ultimately adopt more comprehensive microscopic evaluation of SLNs, the candidate sampling strategies need to be carefully considered in the context of statistically valid sampling strategies. © 2010 USCAP, Inc. All rights reserved.
Persing S.,University of Vermont |
James T.A.,University of Vermont |
Mace J.,University of Vermont |
Goodwin A.,Fletcher Allen Health Care |
Geller B.,University of Vermont
Annals of Surgical Oncology | Year: 2011
Background: Accurately determining margin status is important for breast cancer treatment. The College of American Pathologists (CAP) developed guidelines to standardize reporting of margin status. The aim of this study is to determine statewide concordance with CAP breast cancer reporting guidelines for margin status. Methods: The Vermont Breast Cancer Surveillance System (VBCSS) tracks mammography-related services provided to all women treated for breast cancer at hospitals in Vermont. These data include accompanying pathology reports, which were analyzed for descriptions of margin status. The CAP protocols have both requirements and recommendations for margin status reporting. Reports were "minimally compliant" if they adhered to the requirements stated in the CAP protocols or "maximally compliant" if they included the recommended protocols in addition to those required. Results: There were 2,016 reports that met the inclusion criteria. A total of 71.1% were minimally compliant and 37.3% were maximally compliant with the CAP guideline standards. There was a statistically significant rise in compliant reports, with minimally compliant reports increasing from 55.7% in 1998 to 79.3% in 2006, and maximally compliant reports rising from 4.7% in 1998 to 53.7% in 2006 (χ 2 trend test, P <0.001) for both cohorts. Conclusions: Reporting of margin status in breast-conserving surgery varies widely. There is a significant rise in guideline compliance with margin status reporting from 1998 to 2006; however, overall compliance remains suboptimal. This study provides evidence to support the need for quality improvement measures in the implementation of CAP guidelines for reporting margin status following breast-conserving surgery. © Society of Surgical Oncology 2011.
Solomon R.,University of Vermont |
Solomon R.,Fletcher Allen Health Care
Journal of Cardiology | Year: 2014
Kidney injury following the administration of iodinated contrast media occurs particularly in patients with reduced kidney and cardiac function and when large doses of contrast are used. There is little compelling evidence that vasodilators and anti-oxidants prevent this injury. Most prevention trials have employed intravenous volume loading as a central strategy. However, the success of this approach depends upon maintaining euvolemia while producing a vigorous diuresis. A novel strategy for maintaining euvolemia and inducing a vigorous diuresis has been developed using the RenalGuard system. In this review; the mechanism of protective action is reviewed. The trials of the RenalGuard device are reviewed and future uses of the device are discussed. © 2013.
Ricci M.A.,University of Vermont |
Brumsted J.R.,Fletcher Allen Health Care
Aviation Space and Environmental Medicine | Year: 2012
Introduction: Since the publication of the Institute of Medicine report estimating nearly 100,000 deaths per year from medical errors, hospitals and physicians have a renewed focus upon error reduction. We implemented a surgical crew resource management (CRM) program for all operating room (OR) personnel. Methods: In our academic medical center, 19,000 procedures per year are performed in 27 operating rooms. Mandatory CRM training was implemented for all peri-operative personnel. Aviation techniques introduced included a pre-operative checklist and brief, post-operative debrief, read and initial files, and various other aviationbased techniques. Compliance with conduct of the brief/debrief was monitored as well as wrong-site surgeries and retained foreign body events. The malpractice insurance database for claims was also queried for the period prior to and after training. Results: Initial training was accomplished for 517 people, including all anesthesiologists, surgeons, nurses, technicians, and OR assistants. Pre-operative briefing increased from 6.7 to 99% within 4 mo. Wrong site surgeries and retained foreign bodies decreased from a high of seven in 2007 to none in 2008, but, after 14 mo without additional training, these rose to five in 2009. Malpractice expenses (payouts and legal fees) totaled $793,000 (2003-2007), but have been zero since 2008. Discussion: CRM training and implementation had an impact on reducing the incidence of wrong site surgery and retained foreign bodies in our operating rooms. However, constant reinforcement and refresher training is necessary for sustained results. Though no one technique can prevent all errors, CRM can effect culture change, producing a safer environment. © by the Aerospace Medical Association, Alexandria, VA.
Johnson J.M.,Fletcher Allen Health Care |
Moonis G.,Harvard University |
Green G.E.,University of Michigan |
Carmody R.,University of Arizona |
Burbank H.N.,Fletcher Allen Health Care
American Journal of Neuroradiology | Year: 2011
A variety of congenital syndromes affecting the face occur due to defects involving the first and second BAs. Radiographic evaluation of craniofacial deformities is necessary to define aberrant anatomy, plan surgical procedures, and evaluate the effects of craniofacial growth and surgical reconstructions. High-resolution CT has proved vital in determining the nature and extent of these syndromes. The radiologic evaluation of syndromes of the first and second BAs should begin first by studying a series of isolated defects: CL with or without CP, micrognathia, and EAC atresia, which compose the major features of these syndromes and allow more specific diagnosis. After discussion of these defects and the associated embryology, we proceed to discuss the VCFS, PRS, ACS, TCS, Stickler syndrome, and HFM. Copyright © 2011 by the American Society of Neuroradiology.