bluuebunny/crossref_metadata_2025_split huggingface dataset:
Funding and Publishing Trends of Original Research by Emergency Medicine Investigators over the Past Decade
Authors: Birkhahn Robert H. , Van Deusen Shawn K. , Okpara Okemefuna I. , Datillo Paris A. , Briggs William M. , Gaeta Theodore J. 
Published: December 2005

Abstract Objectives: To update the profile of author‐reported funding of reports of original research published since 1994 in the four U.S. peer‐reviewed general emergency medicine (EM) journals. Methods: For the primary analysis, articles published in Academic Emergency Medicine, American Journal of Emergency Medicine, Annals of Emergency Medicine, and Journal of Emergency Medicine between 1994 and 2003 were reviewed by two emergency physicians trained in abstracting from the literature. Original research was identified; case reports, case series, abstracts, and meta‐analysis were excluded. Articles were classified by author report of extramural funding as government (public), private nonprofit (foundation), for profit (industry), or multiple. Data are reported as percent per year per journal. A secondary analysis of MEDLINE was performed to identify publishing trends by EM investigators outside of these four journals over the same period. Results: The primary analysis identified 5,728 articles; 3,278 (57%) were considered original research, with 32% of these reporting extramural funding. In 1994, there were 292 articles with 28% funded (28% public, 43% foundation, 17% industry, and 12% multiple). By 2003, there were 358 articles with 36% funded (42% public, 30% foundation, 18% industry, and 10% multiple). There was a trend toward increased extramural funding in all four journals (p = 0.007), with an estimated growth of 3.6% (95% confidence interval = 1.0% to 6.3%) per year over the past decade. The primary review identified 48% of all articles published by EM investigators. Conclusions: Author‐reported extramural funding rates for original research have increased in the EM literature over the past decade. Foundations have funded the largest number of studies, with public (government) sources increasing in 2003.
Early Goal‐directed Therapy, Corticosteroid, and Recombinant Human Activated Protein C for the Treatment of Severe Sepsis and Septic Shock in the Emergency Department
Authors: Nguyen H. Bryant , Corbett Stephen W. , Menes Kevin , Cho Thomas , Daugharthy Jennifer , Klein Walter , Wittlake William A. 
Published: December 2005

Abstract Objectives: To describe our experience with early goal‐directed therapy (EGDT), corticosteroid administration, and recombinant human activated protein C (rhAPC) administration in patients with severe sepsis or septic shock and an Acute Physiology and Chronic Health Evaluation (APACHE) II score ≥25 in the emergency department (ED). Methods: This was a retrospective case series of a prospectively maintained ED sepsis registry. Data are presented as median (25th, 75th percentile). The setting was an academic tertiary ED with approximately 60,000 annual patient visits. Patients with severe sepsis or septic shock and an APACHE II score ≥25 entered in an ED sepsis registry over a four‐month period were included. Patients who received rhAPC in the intensive care unit were excluded. Central venous catheterization for central venous pressure and central venous oxygen saturation monitoring, antibiotics, fluid resuscitation, mechanical ventilation, vasopressors, inotropes, corticosteroids, and rhAPC were initiated by the emergency physicians and continued in the intensive care unit by intensivists. Results: Twenty‐four patients were enrolled. Patient characteristics were as follows: age, 79.5 (68.0, 83.5) years; APACHE II score, 31.5 (29.8, 36.0); ED length of stay, 6.5 (4.0, 10.5) hours; predicted mortality, 76.7% (71.9, 86.4); and in‐hospital mortality, 45.8%. All patients received broad‐spectrum antibiotics, 54.2% completed EGDT, 33.3% received corticosteroids, and 33.3% received rhAPC. Time of antibiotic administration was 1.5 (1.0, 2.0) hours, time of central venous pressure/central venous oxygen saturation monitoring was 1.0 (0.5, 2.5) hour, and time of rhAPC administration was 9.5 (6.8, 10.5) hours after patients met criteria for severe sepsis or septic shock. In‐hospital mortality of patients who received rhAPC in addition to other therapies was 25.0%. Conclusions: EGDT, corticosteroid administration, and rhAPC administration are feasible in the ED setting. While these evidence‐based therapies individually have been shown to improve outcomes for patients with severe sepsis or septic shock, further studies are needed to examine their combined effectiveness during the early stages of this disease.
Propofol for Emergency Department Procedural Sedation and Analgesia: A Tale of Three Centers
Authors: Burton John H. , Miner James R. , Shipley Eric R. , Strout Tania D. , Becker Chris , Thode Henry C. 
Published: December 2005

AbstractObjectives:To characterize propofol procedural sedation and analgesia (PSA) encounters for a large patient population at multiple emergency department (ED) sites. The authors sought to assess the frequency of respiratory and cardiovascular events during propofol PSA within these settings.Methods:This study was a prospective, descriptive series of a consecutive sample of ED patients receiving propofol for PSA at three study sites. Patients were monitored for PSA‐related events, including predefined clinically relevant cardiovascular and respiratory events. Data collection was performed during PSA with a standardized data collection sheet unique to each site.Results:Propofol was administered during PSA to 792 patients during the respective reporting period at each center. Indications for sedation included dislocation reduction (38%), cardioversion (10%), fracture reduction (35%), abscess incision and drainage (8%), computed tomography imaging (2%), and tube thoracostomy (1%). The cumulative rate of oxygen desaturation events for all study sites was 7.7% with a brief period of assisted ventilation with bag‐valve mask in 3.9%. The cumulative rate of PSA‐related hypotensive events was 3.5%. Increasing patient age and specific clinical procedure were clinical variables most associated with any propofol‐related respiratory event. All PSA‐related events resolved with supportive interventions during the PSA encounter. No patients required endotracheal intubation, prolonged observation, or admission for PSA‐related complications.Conclusions:Propofol typically confers a deep sedation experience for ED PSA. The most common PSA events associated with propofol are respiratory related and appear consistent across these three practice settings. All propofol‐related PSA events resolved with brief supportive interventions in the ED with no adverse sequelae.
Dealing With a Deluge of Data: An Assessment of Adverse Event Data on North Central Cancer Treatment Group Trials
Authors: Mahoney Michelle R. , Sargent Daniel J. , O'Connell Michael J. , Goldberg Richard M. , Schaefer Paul , Buckner Jan C. 
Published: December 2005

Purpose Adverse events (AEs) are monitored in clinical trials for patient safety, to satisfy reporting requirements, and develop safety profiles. Recently, much attention has been placed on the reporting of serious AEs (SAEs) that are either life threatening or lethal in clinical trials. However, SAEs comprise a small subset of all AE data collected for trials; the majority of AE data collected are routine AEs (RAEs) regarding non–life-threatening events. We assessed the utility of the RAE data collected, relative to the volume. Patients and Methods We surveyed the RAE data from 26 North Central Cancer Treatment Group coordinated trials. Results A total of 8,318 (11%) of 75,598 of RAEs required queries. Of these, 86% were protocol-required RAEs, 83% of RAEs required per protocol were within normal limits (eg, platelets) or not present, and 61% of extra AEs were mild. One fifth of RAEs were considered unlikely to be related or unrelated to treatment. Overall, 3% of events were severe, life threatening, or caused death. Only 1% of RAE data reported required expedited reporting (eg, via Adverse Event Expedited Reporting System). Results indicate that 72% of RAEs would be eliminated if only the maximum severity per patient and type were required. These results were validated in a large phase III trial. Conclusion The majority of RAEs identified, transcribed, and entered are not clinically important. Our data suggest that reducing the number of AEs monitored will affect substantially neither overall patient safety nor compromise evaluation of regimens undergoing testing. We present several considerations for such a reduction in data collection, as well as a policy that we have used to address the deluge of RAE data.
Phase I Clinical and Pharmacokinetic Study of Flavopiridol in Children With Refractory Solid Tumors: A Children's Oncology Group Study
Authors: Whitlock James A. , Krailo Mark , Reid Joel M. , Ruben Stacie L. , Ames Matthew M. , Owen William , Reaman Gregory 
Published: December 2005

Purpose To determine the dose-limiting toxicities, maximum-tolerated dose, and pharmacokinetics of the cyclin-dependent kinase inhibitor flavopiridol (NSC 649890) when administered as a 1-hour infusion over 3 consecutive days to children with recurrent or refractory solid tumors. Patients and Methods Flavopiridol was administered as a 1-hour intravenous infusion daily for 3 consecutive days every 21 days, or when hematologic toxicity or any grade 2 or greater nonhematologic toxicity resolved. The starting dose was 37.5 mg/m2/d. Dose escalation was in cohorts of three patients in a standard fashion until dose-limiting toxicity and the maximum-tolerated dose were determined. Flavopiridol levels were measured on days 1, 2, and 3. Results Twenty-five children received flavopiridol at doses of 37.5 to 80 mg/m2/day over 3 consecutive days. The maximum-tolerated dose was 62.5 mg/m2/d. The primary dose-limiting toxicities were neutropenia and diarrhea. No antitumor effect was observed in this population. Mean peak plasma concentrations of 3.71 and 9.11 μmol/L were achieved at the end of the 1-hour infusion, following dose escalation from 37.5 mg/m2 to 80 mg/m2, respectively. The median flavopiridol plasma clearance was 8.0 L/h/m2 (range, 2.6 to 17.1 L/h/m2). Conclusion The maximum-tolerated dose of flavopiridol in children, and the recommended phase II dose for pediatric studies, was 62.5 mg/m2/day when administered as a 1-hour infusion for 3 consecutive days. Dose-limiting toxicities of neutropenia and diarrhea were similar to those in adult studies.
Phase III Trial of Paclitaxel Plus Carboplatin With or Without Tirapazamine in Advanced Non–Small-Cell Lung Cancer: Southwest Oncology Group Trial S0003
Authors: Williamson Stephen K. , Crowley John J. , Lara Primo N. , McCoy Jason , Lau Derick H.M. , Tucker Robert W. , Mills Glenn M. , Gandara David R. 
Published: December 2005

Purpose Tumor hypoxia confers chemotherapy resistance. Tirapazamine is a cytotoxin that selectively targets hypoxic cells. We conducted a phase III clinical trial to determine whether the addition of tirapazamine to paclitaxel and carboplatin offered a survival advantage when used in the treatment of patients with advanced non–small-cell lung cancer (NSCLC). Patients and Methods Of 396 patients registered, 367 eligible patients were randomly assigned to either arm 1 (n = 181), which consisted of treatment every 21 days with paclitaxel 225 mg/m2/3 h, carboplatin (area under the curve = 6), and tirapazamine 260 mg/m2 in cycle 1 (which was escalated, if tolerable, to 330 mg/m2 in cycle 2), or arm 2 (n = 186), which consisted of paclitaxel and carboplatin as in arm 1 with no tirapazamine. Results Patient characteristics were similar between the two arms. There were no statistically significant differences in response rates, progression-free survival, or overall survival. Patients on arm 1 had significantly (P < .05) more abdominal cramps, fatigue, transient hearing loss, febrile neutropenia, hypotension, myalgias, and skin rash and were removed from treatment more often as a result of toxicity than patients in arm 2 (26% v 13%, respectively; P = .003). More than 40% of patients did not have the tirapazamine dose escalated, primarily because of toxicity. The trial was closed early after an interim analysis demonstrated that the projected 37.5% improvement in survival (8 v 11 months median survival) in arm 1 was unachievable (P = .003). Conclusion The addition of tirapazamine to paclitaxel and carboplatin does not result in improved survival in advanced NSCLC compared with paclitaxel and carboplatin alone but substantially increases toxicity.
Health Insurance Coverage in Survivors of Childhood Cancer: The Childhood Cancer Survivor Study
Authors: Park Elyse R. , Li Frederick P. , Liu Yan , Emmons Karen M. , Ablin Arthur , Robison Leslie L. , Mertens Ann C. 
Published: December 2005

Purpose To examine the prevalence and predictors of health insurance coverage and the difficulties obtaining coverage in a large cohort of childhood cancer survivors. Patients and Methods This study included 12,358 5-year survivors of childhood cancer and 3,553 sibling controls participating in the Childhood Cancer Survivor Study. Data were collected by surveys distributed in 1994 (baseline) and 2000 (follow-up). Results At baseline, 83.9% of adult survivors, compared with 88.3% of siblings, had health insurance coverage (P < .01); 6 years later, small but significant survivor-sibling differences remained (88% v 91%; P < .01). Twenty-nine percent of survivors reported having had difficulties obtaining coverage, compared with only 3% of siblings (P < .01). In multivariate analysis of survivors 18 years of age or older, factors associated with being uninsured included younger age at diagnosis (diagnosis age of 0 to 4 years; odds ratio [OR] = 1.7; 95% CI, 1.3 to 2.2), male sex (OR = 1.3; 95% CI, 1.2 to 1.5), age at baseline survey (age 22 to 24 years; OR = 1.6; 95% CI, 1.2 to 2.1), lower level of attained education (less than high school, OR = 2.6, 95% CI, 2.1 to 3.3; high school graduate, OR = 2.1, 95% CI, 1.8 to 2.5), income less than $20,000 (OR = 5.6, 95% CI, 4.5 to 7.1), marital status (widowed/divorced/separated; OR = 1.3; 95% CI, 1.1 to 1.6), smoking status (current smoker, OR = 2.0, 95% CI, 1.7 to 2.3; former smoker, OR = 1.4, 95% CI, 1.2 to 1.8), and treatment that included cranial radiation (OR = 1.3, 95% CI, 1.0 to 1.6). Conclusion Compared with siblings, adult survivors of childhood cancer had significantly lower rates of health insurance coverage and more difficulties obtaining coverage. Since lack of coverage likely has serious health and financial implications for this at-risk population, any disparity in availability and quality of coverage is of great concern.
Efficacy and Safety Analysis of Epoetin Alfa in Patients With Small-Cell Lung Cancer: A Randomized, Double-Blind, Placebo-Controlled Trial
Authors: Grote Thomas , Yeilding Allen L. , Castillo Rene , Butler Dean , Fishkin Ellioth , Henry David H. , DeLeo Michael , Fink Kenneth , Sullivan Daniel J. 
Published: December 2005

Purpose This randomized, double-blind, placebo-controlled trial (N93-004) evaluated the effects of epoetin alfa on tumor response to chemotherapy and survival in patients with small-cell lung cancer (SCLC). Patients and Methods Adult patients with hemoglobin ≤ 14.5 g/dL starting chemotherapy received epoetin alfa 150 U/kg or placebo subcutaneously 3 times weekly until 3 weeks after completion of chemotherapy. Survival was assessed for 3 years. The primary end point was the proportion of patients with complete or partial response after three chemotherapy cycles. Results The trial was terminated prematurely after 224 of a projected 400 patients were accrued. Baseline characteristics were similar between groups. Epoetin alfa and placebo patients (n = 109 and n = 115, respectively) had mean baseline hemoglobin of 12.8 g/dL and 13.0 g/dL, respectively. Overall tumor response was similar between the epoetin alfa and placebo groups after three chemotherapy cycles (72% and 67%, respectively; 95% CI of difference, −6% to 18%) and after completion of chemotherapy (60% and 56%, respectively; 95% CI of difference, −9% to 17%). Epoetin alfa and placebo groups had similar median overall survival (10.5 and 10.4 months, respectively) and overall mortality (91.7% and 87.8%, respectively; hazard ratio, 1.172; 95% CI, 0.887 to 1.549; P = .264). Hemoglobin was maintained in the prechemotherapy range in epoetin alfa patients, but decreased substantially in placebo patients. Fewer epoetin alfa patients than placebo patients required transfusion. Conclusion These results suggest that in newly diagnosed patients with SCLC epoetin alfa does not affect tumor response to chemotherapy or survival. However, the early trial closure makes these conclusions preliminary.
Dietary Patterns and Survival After Breast Cancer Diagnosis
Authors: Kroenke Candyce H. , Fung Teresa T. , Hu Frank B. , Holmes Michelle D. 
Published: December 2005

Purpose There is little prior study of major dietary patterns and breast cancer survival. Methods Patients included 2,619 Nurses' Health Study participants who were diagnosed with invasive breast cancer between 1982 and 1998 and completed a dietary questionnaire more than 1 year after diagnosis. Participants were followed through 2002 (median = 9 years). During follow-up, 414 patients died of any cause, 242 patients died of breast cancer, and 172 patients died from causes other than breast cancer. Women with in situ or metastatic disease at diagnosis were excluded. We used Cox proportional hazards models to evaluate prospective associations of prudent and Western dietary patterns assessed both before and after diagnosis with time to event after diagnosis. Results In multivariate-adjusted analyses assessed after diagnosis, the Western and prudent dietary patterns were unrelated to all-cause or breast cancer mortality. However, compared with women with the lowest intake of the prudent dietary pattern, the relative risks (and 95% CIs) of death from causes other than breast cancer were 0.85 (95% CI, 0.53 to 1.35), 0.74 (95% CI, 0.45 to 1.21), 0.70 (95% CI, 0.42 to 1.17), and 0.54 (95% CI, 0.31 to 0.95; P = .03, from lowest to highest quintile of intake). In contrast, the Western dietary pattern was positively associated with this outcome (P = .04). Results for the assessment of dietary patterns before diagnosis were similar, except the prudent dietary pattern was unrelated to mortality. Conclusion A higher intake of the prudent pattern and a lower intake of the Western pattern may protect against mortality from causes unrelated to breast cancer.
Role of Imaging in Pretreatment Evaluation of Early Invasive Cervical Cancer: Results of the Intergroup Study American College of Radiology Imaging Network 6651–Gynecologic Oncology Group 183
Authors: Hricak Hedvig , Gatsonis Constantine , Chi Dennis S. , Amendola Marco A. , Brandt Kathy , Schwartz Lawrence H. , Koelliker Susan , Siegelman Evan S. , Brown Jeffrey J. , McGhee Robert B. , Iyer Revathy , Vitellas Kenneth M. , Snyder Bradley , Long Harry J. , Fiorica James V. , Mitchell Donald G. 
Published: December 2005

Purpose To compare magnetic resonance imaging (MRI) and computed tomography (CT) with each other and to International Federation of Gynecology and Obstetrics (FIGO) clinical staging in the pretreatment evaluation of early invasive cervical cancer, using surgicopathologic findings as the reference standard. Patients and Methods This prospective multicenter clinical study was conducted by the American College of Radiology Imaging Network and the Gynecologic Oncology Group from March 2000 to November 2002; 25 United States health centers enrolled 208 consecutive patients with biopsy-confirmed cervical cancer of FIGO stage ≥ IB who were scheduled for surgery based on clinical assessment. Patients underwent FIGO clinical staging, helical CT, and MRI. Surgicopathologic findings constituted the reference standard for statistical analysis. Results Complete data were available for 172 patients; surgicopathologic findings were consistent with FIGO stages IA to IIA in 76% and stage ≥ IIB in 21%. For the detection of advanced stage (≥ IIB), sensitivity was poor for FIGO clinical staging (29%), CT (42%), and MRI (53%); specificity was 99% for FIGO clinical staging, 82% for CT, and 74% for MRI; and negative predictive value was 84% for FIGO clinical staging, 84% for CT, and 85% for MRI. MRI (area under the receiver operating characteristic curve [AUC], 0.88) was significantly better than CT (AUC, 0.73) for detecting cervical tumors (P = .014). For 85% of patients, FIGO clinical staging forms were submitted after MRI and/or CT was performed. Conclusion CT and MRI performed similarly; both had lower staging accuracy than in prior single-institution studies. Accuracy of FIGO clinical staging was higher than previously reported. The temporal data suggest that FIGO clinical staging was influenced by CT and MRI findings.
Docetaxel Plus Gemcitabine or Docetaxel Plus Cisplatin in Advanced Pancreatic Carcinoma: Randomized Phase II Study 40984 of the European Organisation for Research and Treatment of Cancer Gastrointestinal Group
Authors: Lutz Manfred P. , Cutsem Eric Van , Wagener Theo , Van Laethem Jean-Luc , Vanhoefer Udo , Wils Jacques A. , Gamelin Eric , Koehne Claus H. , Arnaud Jean P. , Mitry Emmanuel , Husseini Faress , Reichardt Peter , El-Serafi Mustafa , Etienne Pierre-Luc , Lingenfelser Thomas , Praet Michel , Genicot Bruno , Debois Muriel , Nordlinger Bernard , Ducreux Michel P. 
Published: December 2005

Purpose To define the efficacy and toxicity of docetaxel plus gemcitabine or docetaxel plus cisplatin for advanced pancreatic carcinoma. Patients and Methods Chemotherapy-naive patients with measurable disease and WHO performance status less than 2 were randomly assigned to receive 21-day cycles of gemcitabine 800 mg/m2 on days 1 and 8 plus docetaxel 85 mg/m2 on day 8 (arm A) or docetaxel 75 mg/m2 on day 1 plus cisplatin 75 mg/m2 on day 1 (arm B). Primary end points were tumor response and rate of febrile neutropenia grade. Results Of 96 randomly assigned patients (49 patients in arm A and 47 patients in arm B), 70 patients were analyzed for response (36 in arm A and 34 in arm B) and 89 patients were analyzed for safety (45 in arm A and 44 in arm B). Confirmed responses were observed in 19.4% (95% CI, 8.2% to 36.0%) of patients in arm A and 23.5% (95% CI, 10.7% to 41.2%) in arm B. In arm A, the median progression-free survival (PFS) was 3.9 months (95% CI, 3.0 to 4.7 months), median survival was 7.4 months (95% CI, 5.6 to 11.0 months), and 1-year survival was 30%. In arm B, the median PFS was 2.8 months (95% CI, 2.6 to 4.6 months), median survival was 7.1 months (95% CI, 4.8 to 8.7 months), and 1-year survival was 16%. Febrile neutropenia occurred in 9% and 16% of patients in arms A and B, respectively. Conclusion Both regimens are well tolerated and show activity in advanced pancreatic carcinoma. The safety profile and survival analyses favor docetaxel plus gemcitabine for further evaluation.