The Red Cross Red Crescent Health Information System (RCHIS): an electronic medical records and health information management system for the red cross red crescent emergency response units.

Background: The Red Cross and Red Crescent Movement (RCRC) utilizes specialized Emergency Response Units (ERUs) for international disaster response. However, data collection and reporting within ERUs have been time-consuming and paper-based. The Red Cross Red Crescent Health Information System (RCHIS) was developed to improve clinical documentation and reporting, ensuring accuracy and ease of use while increasing compliance with reporting standards.

Guilt, shame and negative emotion in undergraduate medical education: is there a role for Balint groups?

Balint groups are a structured discussion which explores non-clinical aspects of the doctor-patient relationship. In this commentary piece we describe our experience of a Balint group for final-year medical students in a large regional hospital. We discuss that our participants reported a significant burden of negative emotion, primarily guilt and shame, in attempting to navigate the hospital environment as learners.

International Emergency Medical Teams Training Workshop Special Report.

The World Health Organization's (WHO; Geneva, Switzerland) Emergency Medical Team (EMT) Initiative created guidelines which define the basic procedures to be followed by personnel and teams, as well as the critical points to discuss before deploying a field hospital. However, to date, there is no formal standardized training program established for EMTs before deployment. Recognizing that the World Association of Disaster and Emergency Medicine (WADEM; Madison, Wisconsin USA) Congress brings together a diverse group of key stakeholders, a pre-Congress workshop was organized to seek out collective expertise and to identify key EMT training competencies for the future development of training programs and protocols.

Optimal management of malignant pleural effusions (results of CALGB 30102).

The optimal strategy to achieve palliation of malignant pleural effusions (MPEs) is unknown. This multi-institutional, prospective, randomized trial compares 2 established methods for controlling symptomatic unilateral MPEs. Patients with unilateral MPEs were randomized to either daily tunneled catheter drainage (TCD) or bedside talc pleurodesis (TP).

Impact of age, comorbidity and symptoms on physical function in long-term breast cancer survivors (CALGB 70803).

PURPOSE: The purpose of this study was to assess the impact of aging, comorbidities and symptoms on physical function in patients surviving 20 years since adjuvant treatment for breast cancer. PATIENTS #ENTITYSTARTX00026; METHODS: Patients were originally treated on CALGB 7581 (from 1975-1980), a randomized trial of three adjuvant therapies and reassessed (153 of 193 eligible survivors) 20 years from the onset of therapy for physical function and symptoms by the EORTC QLQ-C30 and comorbidities by the OARS questionnaire. RESULTS: The average age at reassessment was 64.

Combination external beam radiation and brachytherapy boost with androgen deprivation for treatment of intermediate-risk prostate cancer: long-term results of CALGB 99809.

Background: Combined transperineal prostate brachytherapy and external beam radiation therapy (EBRT) is widely used for treatment of prostate cancer. Long-term efficacy and toxicity results of a multicenter phase 2 trial assessing combination of EBRT and transperineal prostate brachytherapy boost with androgen deprivation therapy (ADT) for intermediate-risk prostate cancer are presented.

Methods: Intermediate-risk patients per Memorial Sloan-Kettering Cancer Center/National Comprehensive Cancer Network criteria received 6 months of ADT, and 45 grays (Gy) EBRT to the prostate and seminal vesicles, followed by transperineal prostate brachytherapy with I125 (100 Gy) or Pd103 (90 Gy).

Patient advocates' role in clinical trials: perspectives from Cancer and Leukemia Group B investigators and advocates.

Background: Patient advocates are increasingly involved in cooperative group trials, single-institution cancer programs, and peer-review of research applications. The purpose of this study was to evaluate the role and value of patient advocates from the perspective of Cancer and Leukemia Group B (CALGB) advocates and investigators.

Methods: An online survey was sent to current and past (within 5 years) patient advocates and investigators.

Does health-related quality of life improve for advanced pancreatic cancer patients who respond to gemcitabine? Analysis of a randomized phase III trial of the cancer and leukemia group B (CALGB 80303).

Context: Gemcitabine for advanced pancreatic cancer (APC) is palliative and the prognosis is poor, making health-related quality of life (HRQOL) particularly important.

Objectives: We evaluated HRQOL with the EuroQol (EQ-5D™) in patients with APC participating in Cancer and Leukemia Group B 80303, a multicenter, double-blind, randomized trial comparing overall survival (OS) between two treatment arms: gemcitabine with bevacizumab or gemcitabine with placebo.

Methods: A consecutive subsample of patients was invited to complete the EQ-5D surveys.

Quality of life of older patients with early-stage breast cancer receiving adjuvant chemotherapy: a companion study to cancer and leukemia group B 49907.

Purpose: A phase III trial (Cancer and Leukemia Group B CALGB-49907) was conducted to test whether older patients with early-stage breast cancer would have equivalent relapse-free and overall survival with capecitabine compared with standard chemotherapy. The quality of life (QoL) substudy tested whether capecitabine treatment would be associated with a better QoL than standard chemotherapy.

Patients And Methods: QoL was assessed in 350 patients randomly assigned to either standard chemotherapy (cyclophosphamide, methotrexate, and fluorouracil [CMF] or doxorubicin and cyclophosphamide [AC]; n = 182) or capecitabine (n = 168).

Factor V Leiden mutation and thromboembolism risk in women receiving adjuvant tamoxifen for breast cancer.

Background: Tamoxifen use has been associated with increased risk of thromboembolic events (TEs) in women with breast cancer and women at high risk for the disease. Factor V Leiden (FVL) is the most common inherited clotting factor mutation and also confers increased thrombosis risk. We investigated whether FVL was associated with TE risk in women with early-stage breast cancer who took adjuvant tamoxifen.

Adherence and persistence with oral adjuvant chemotherapy in older women with early-stage breast cancer in CALGB 49907: adherence companion study 60104.

Purpose: Patient adherence is critical in evaluating the effectiveness of an oral therapy. We sought to measure adherence among women randomly assigned to capecitabine in a preplanned substudy of a multicenter clinical trial.

Patients And Methods: Cancer and Leukemia Group B study CALGB 49907 was a randomly assigned trial comparing standard chemotherapy versus oral chemotherapy with capecitabine in patients age 65 years or older with early-stage breast cancer.

Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: final results of CALGB 90206.

Purpose: Bevacizumab is an antibody that binds vascular endothelial growth factor and has activity in metastatic renal cell carcinoma (RCC). Interferon alfa (IFN-alpha) is the historic standard initial treatment for RCC. A prospective, randomized, phase III trial of bevacizumab plus IFN-alpha versus IFN-alpha monotherapy was conducted.

Perioperative outcomes among patients with end-stage renal disease following coronary artery bypass surgery in the USA.

Background: Patients with end-stage renal disease (ESRD) requiring chronic haemodialysis who undergo coronary artery bypass graft surgery (CABG) are at significant risk for perioperative mortality. However, the impact of changes in ESRD patient volume and characteristics over time on operative outcomes is unclear.

Methods: Using the Nationwide Inpatient Sample database (1988-03), we evaluated rates of CABG surgery with and without concurrent valve surgery among ESRD patients and outcomes including in-hospital mortality, and length of hospital stay.

Increasing healthcare resource utilization after coronary artery bypass graft surgery in the United States.

Background: Despite declining lengths of stay, postdischarge healthcare resource utilization may be increasing because of shifts to nonacute care settings. Although changes in hospital stay after coronary artery bypass graft (CABG) surgery have been described, patterns of discharge remain unclear. Our objective was to determine patterns of discharge disposition after CABG surgery in the United States.

Differences in clinical trial patient attributes and outcomes according to enrollment setting.

Purpose: During the last 25 years, National Cancer Institute (NCI) cooperative trial groups have extended trial networks from academic centers to include certain community and Veterans Health Administration (VHA) centers. We compared trial patients' attributes and outcomes by these enrollment settings.

Patients And Methods: Studying 2,708 patients on one of 10 cooperative group, randomized lung trials at 272 institutions, we compared patient attributes by enrollment setting (ie, academic, community, and VHA affiliates).

Single-dose pharmacokinetics and pharmacodynamics of anacetrapib, a potent cholesteryl ester transfer protein (CETP) inhibitor, in healthy subjects.

Aims: Anacetrapib is an orally active and potent inhibitor of CETP in development for the treatment of dyslipidaemia. These studies endeavoured to establish the safety, tolerability, pharmacokinetics and pharmacodynamics of rising single doses of anacetrapib, administered in fasted or fed conditions, and to preliminarily assess the effect of food, age, gender and obesity on the single-dose pharmacokinetics and pharmacodynamics of anacetrapib.

Methods: Safety, tolerability, anacetrapib concentrations and CETP activity were evaluated.

Trends in cardiac surgery-associated acute renal failure in the United States: a disproportionate increase after heart transplantation.

Acute renal failure (ARF) is common after cardiac surgery and more frequent after complex cardiac surgery. While the incidence of ARF is increasing after coronary artery bypass graft (CABG) surgery, trends in other forms of cardiac surgery remain unclear. We investigated the trend of ARF in various cardiac procedures and compared patterns using CABG surgery as a reference group.

Reproducibility of random periareolar fine needle aspiration in a multi-institutional Cancer and Leukemia Group B (CALGB) cross-sectional study.

Background: Random periareolar fine needle aspiration (RPFNA) is a research technique developed to assess short-term breast cancer risk in women at increased risk of breast cancer. Although there is increasing acceptance of RPFNA, neither the reproducibility nor the inter-institutional compatibility of RPFNA has been established. To address these key limitations, the Cancer and Leukemia Group B (CALGB) Prevention Group tested the reproducibility of RPFNA in a multi-institutional cross-sectional study.

Progression-free survival as a predictor of overall survival in men with castrate-resistant prostate cancer.

Purpose: To explore whether progression-free survival (PFS) or biochemical PFS can be used as a predictor of overall survival (OS) and to investigate the dependence between PFS and OS in men with castrate-resistant prostate cancer.

Patients And Methods: Data from nine Cancer and Leukemia Group B trials that enrolled 1,296 men from 1991 to 2004 were pooled. Men were eligible if they had prostate cancer that had progressed during androgen deprivation therapy and did not receive prior treatment with chemotherapy, immunotherapy, or other nonhormonal therapy.

Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma: CALGB 90206.

Purpose: Bevacizumab is an antibody that binds to vascular endothelial growth factor (VEGF) and has activity in metastatic renal cell carcinoma (RCC). Interferon alfa (IFN) is a historic standard first-line treatment for RCC. A prospective, randomized phase III trial of bevacizumab plus IFN versus IFN monotherapy was conducted.

p53 protein expression status and recurrence in men treated with radiation and androgen suppression therapy for higher-risk prostate cancer: a prospective phase II Cancer and Leukemia Group B Study (CALGB 9682).

Objectives: It has been hypothesized that abnormal p53 protein expression is associated with a worse prognosis after radiation (RT) and androgen suppression therapy (AST). This hypothesis was prospectively tested.

Methods: Between May 1997 and April 2001, 180 men with clinical stage T1c-T3cN0M0 adenocarcinoma of the prostate were registered on a study evaluating whether the endorectal magnetic resonance imaging (eMRI)-defined change in tumor volume (TV) during neoadjuvant (n) AST was associated with prostate-specific antigen (PSA) outcome.

Trends in acute renal failure associated with coronary artery bypass graft surgery in the United States.

Objective: Acute renal failure remains a major complication of coronary artery bypass graft surgery that is strongly associated with in-hospital mortality. Based on similar observations in other clinical settings, we tested the hypothesis that the diagnosis of acute renal failure associated with coronary artery bypass graft surgery is increasing in the United States.

Design: Observational cohort study.