The competency index for clinical research professionals: a potential tool for competency-based clinical research academic program evaluation.

Background: Accreditation of graduate academic programs in clinical research requires demonstration of program achievement of Joint Task Force for Clinical Trial Competence-based standards. Evaluation of graduate programs include enrollment, student grades, skills-based outcomes, and completion rates, in addition to other measures. Standardized measures of competence would be useful.

The Competency of Clinical Research Coordinators: The Importance of Education and Experience.

Background: The organization and operation of clinical trials have become increasingly complex requiring the coordination of a well-trained workforce to ensure that complicated protocols yield valid results that will advance human health. We hypothesized that formal education in clinical research is equivalent to a number of years of work experience as a clinical research professional in terms of self-perceived clinical research competence.

Methods: Using REDCap, we conducted a survey of students and recent graduates from academic programs in clinical research in the USA using the CICRP index that consists of 20 clinical research core competencies.

Indices of Clinical Research Coordinators' Competence.

Introduction: There is a clear need to educate and train the clinical research workforce to conduct scientifically sound clinical research. Meeting this need requires the creation of tools to assess both an individual's preparedness to function efficiently in the clinical research enterprise as well as tools to evaluate the quality and effectiveness of programs that are designed to educate and train clinical research professionals. Here we report the development and validation of a competency self-assessment entitled the Competency Index for Clinical Research Professionals, version II (CICRP-II).

Androgens, Bilateral Oophorectomy, and Cardiovascular Disease Mortality in Postmenopausal Women With and Without Diabetes: The Study of Osteoporotic Fractures.

Objective: Diabetes elevates cardiovascular disease (CVD) risk more markedly in women than in men. Because the high risk of CVD among women with type 2 diabetes (DM2) may be partly due to increased ovarian androgen production, we investigated whether a history of bilateral salpingo oophorectomy (BSO) is inversely associated with CVD mortality among women with DM2.

Research Design And Methods: Data were obtained from 7,977 women (a random subset of 564 had measurements of sex-steroid hormones) enrolled in the Study of Osteoporotic Fractures (SOF), a community-based, multicenter study that monitored women aged ≥65 years for a mean of 15.

Charting a future for epidemiologic training.

Purpose: To identify macro-level trends that are changing the needs of epidemiologic research and practice and to develop and disseminate a set of competencies and recommendations for epidemiologic training that will be responsive to these changing needs.

Methods: There were three stages to the project: (1) assembling of a working group of senior epidemiologists from multiple sectors, (2) identifying relevant literature, and (3) conducting key informant interviews with 15 experienced epidemiologists.

Results: Twelve macro trends were identified along with associated actions for the field and educational competencies.

Cardiovascular disease among women with and without diabetes mellitus and bilateral oophorectomy.

Aims: Women with type-2 diabetes (DM2) are at high risk of cardiovascular disease (CVD) which may be partly due to increased ovarian androgen production. Since the association of bilateral oophorectomy (BSO) with CVD remains controversial, we evaluated whether BSO is inversely associated with CVD among DM2.

Methods: Data were obtained from a national sample of 9599 postmenopausal women.

Empirically derived subtypes of serious emotional disturbance in a large adolescent sample.

Purpose: The heterogeneity of serious emotional disturbance has been thoroughly documented among adolescents with nationally representative data derived from structured interviews, although use of these interviews may not be feasible within the context of brief and self-administered school surveys. This study seeks to identify distinct subtypes of serious emotional disturbance in a large school-based sample.

Methods: A total of 108,736 students fully completed the K6 scale that was included on the 2012 Kentucky Incentives for Prevention Survey.

Risk of heart failure among postmenopausal women: a secondary analysis of the randomized trial of vitamin D plus calcium of the women's health initiative.

Background: Vitamin D supplementation may be an inexpensive intervention to reduce heart failure (HF) incidence. However, there are insufficient data to support this hypothesis. This study evaluates whether vitamin D plus calcium (CaD) supplementation is associated with lower rates of HF in postmenopausal women and whether the effects differ between those at high versus low risk for HF.

Challenges in implementing a pediatric cardiovascular home telehealth project.

Objective: Infants with "single ventricle" congenital heart disease are at high risk for sudden death following palliative surgical management. We developed a pilot telemedicine project to evaluate the feasibility of using Web-based daily reporting of clinical data with the goal of reducing unexpected admissions and sudden death.

Subjects And Methods: We enrolled 9 subjects (enrolled subjects [ES]) following surgical palliation over 12 months.

Bilateral oophorectomy and the risk of incident diabetes in postmenopausal women.

Objective: Ovarian hormones regulate glucose uptake and insulin sensitivity. Despite the high frequency of surgical menopause, its relationship with diabetes has not been extensively investigated. We assessed the association between hysterectomy with or without bilateral oophorectomy (BSO) status, menopausal age, and reproductive life span with incident diabetes.

A systematic review of prognosis and therapy of anal malignant melanoma: a plea for more precise reporting of location and thickness.

Anal malignant melanoma (AMM) is a rare tumor with poor prognosis. We performed a systematic review of reports on wide local excision (WLE) and abdominoperineal resection (APR) for treatment of AMM in an attempt to define a precise set of reporting measures for outcomes of treatment of AMM. A systematic review of the literature was performed.

Perioperative supplemental oxygen therapy and surgical site infection: a meta-analysis of randomized controlled trials.

Objective: To conduct a meta-analysis of randomized controlled trials in which high inspired oxygen concentrations were compared with standard concentrations to assess the effect on the development of surgical site infections (SSIs).

Data Sources: A systematic literature search was conducted using the MEDLINE, EMBASE, and Cochrane databases and included a manual search of references of original articles, poster presentations, and abstracts from major meetings ("gray" literature).

Study Selection: Twenty-one of 2167 articles met the inclusion criteria.

Another duel in the sun: weighing the balances between sun protection, tanning beds, and malignant melanoma.

Objective: The purpose of this report is to put the dueling factors of risk and prevention for melanoma in perspective for the thoughtful pediatric specialist to facilitate preteen preventive health counseling.

Study Design: We examined the rate of malignant melanoma among Kentucky residents and compared this rate with indicators of tanning bed prevalence in a large metropolitan area and sunscreen sales from a major distributor. We obtained malignant melanoma annual incidence data from the Kentucky Cancer Registry, which recorded Kentucky population incidence rates over the years 1995 to 2004.

Meta-analysis of cholecystectomy in symptomatic patients with positive hepatobiliary iminodiacetic acid scan results without gallstones.

Objective: To study the clinical results of surgical management in patients with right upper quadrant pain, a positive hepatobiliary iminodiacetic acid (HIDA) scan result, and no gallstones.

Data Sources: Health care databases and gray literature.

Study Selection: Each article was scrutinized to determine whether it met inclusion criteria.

Antibiotic prophylaxis is not protective in severe acute pancreatitis: a systematic review and meta-analysis.

Background: The use of prophylactic systemic antibiotics to prevent infection and reduce mortality in severe acute pancreatitis (SAP) remains a contentious issue. We assessed the clinical outcome of patients with SAP treated with prophylactic antibiotics compared with that of patients not treated with antibiotics.

Methods: We performed a systematic search of MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials, using PubMed, Google Scholar, and Ovid as search engines without language restriction until the end of May 2008.

Granulocyte colony-stimulating factor therapy for cardiac repair after acute myocardial infarction: a systematic review and meta-analysis of randomized controlled trials.

Background: Small clinical studies of granulocyte colony-stimulating factor (G-CSF) therapy for cardiac repair after acute myocardial infarction (MI) have yielded divergent results. The effect of G-CSF therapy on left ventricular (LV) function and structure in these patients remains unclear.

Methods: We searched MEDLINE, EMBASE, Science Citation Index, CINAHL, and the Cochrane CENTRAL database of controlled clinical trials (July 2007) for randomized controlled trials of G-CSF therapy in patients with acute MI.

Caveat emptor: the need for evidence, regulation, and certification of home telehealth systems for the management of chronic conditions.

The home telehealth market is rapidly expanding. The technology and capabilities currently available have the potential to significantly affect the clinical management of an aging population, particularly, the large number with multiple coexisting disease processes. Potential benefits of home-monitoring systems for patients with heart failure range from decreased rates of mortality and improved quality of life to providing third party payers, including the federal government (ie, Centers for Medicare and Medicaid Services), with significant long-term cost savings.

Meta-analysis: sequential therapy appears superior to standard therapy for Helicobacter pylori infection in patients naive to treatment.

Background: Standard proton-pump inhibitor-based therapy for Helicobacter pylori infection fails in up to one quarter of patients. Sequential therapy may be more efficacious.

Purpose: To compare sequential therapy with standard triple therapy for H.

Adult bone marrow-derived cells for cardiac repair: a systematic review and meta-analysis.

Background: The results from small clinical studies suggest that therapy with adult bone marrow (BM)-derived cells (BMCs) reduces infarct size and improves left ventricular function and perfusion. However, the effects of BMC transplantation in patients with ischemic heart disease remains unclear.

Methods: We searched MEDLINE, EMBASE, Science Citation Index, CINAHL (Cumulative Index to Nursing and Allied Health), and the Cochrane Central Register of Controlled Trials (CENTRAL) (through July 2006) for randomized controlled trials and cohort studies of BMC transplantation to treat ischemic heart disease.

Smoking and inflammatory bowel disease: a meta-analysis.

Objective: To assess whether there is a true effect of smoking on the 2 most prevalent forms of inflammatory bowel disease (IBD): Crohn disease (CD) and ulcerative colitis (UC).

Methods: For this meta-analysis, we searched multiple health care databases, including MEDLINE and EMBASE (January 1980 to January 2006), to examine the relationship between smoking and IBD. Keywords searched included smoking, Inflammatory bowel disease, Crohn's disease, and ulcerative colitis.

Delayed preconditioning-mimetic actions of nitroglycerin in patients undergoing exercise tolerance tests.

Background: Nitroglycerin (NTG) induces delayed preconditioning (PC)-mimetic effects in animal models and in humans during coronary angioplasty. We tested the hypothesis that NTG mitigates ischemia and enhances functional capacity during an exercise tolerance test (ETT) in patients with coronary artery disease.

Methods And Results: Twenty-eight patients with stable angina and ischemia documented by a stress test were randomized in a double-masked, crossover design to receive a titrated intravenous infusion of NTG or normal saline over 4 hours.

Methamphetamine laboratory explosions: a new and emerging burn injury.

The proliferation of clandestine methamphetamine laboratories (meth labs) as a result of the growing popularity of the drug has resulted in an increasing incidence of burn injuries associated with laboratory accidents. We undertook this study to characterize these injuries. Fifteen consecutive patients were identified and case-matched by age and TBSA to 45 control subjects.

Does this patient have influenza?

Context: Influenza vaccination lowers, but does not eliminate, the risk of influenza. Making a reliable, rapid clinical diagnosis is essential to appropriate patient management that may be especially important during shortages of antiviral agents caused by high demand.

Objectives: To systematically review the precision and accuracy of symptoms and signs of influenza.

CYP2D6, GST-M1 and GST-T1 enzymes: expression in parathyroid gland and association with the parathyroid hormone concentration during early renal replacement therapy.

Aims: The purpose of this research was to characterize CYP2D6, GST-M1 and GST-T1 enzyme expression in human parathyroid tissue, and to determine whether or not there is any association between deficiencies in these enzymes and serum parathyroid hormone concentrations in patients with end-stage renal disease.

Methods: Surgical human parathyroid tissue was obtained and evaluated by immunohistochemistry for cellular localization of CYP2D6, GST-M1 and GST-T1 and colocalization of CYP2D6 with parathyroid hormone. Blood samples were collected from 328 Caucasian patients with end-stage renal disease for genetic testing of CYP2D6*3, *4, *5, *6, *7 and GST-M1*0 and GST-T1*0 alleles.

Frequency and severity of systemic disease in patients with subacute cutaneous lupus erythematosus.

Objective: To compare the frequency and severity of systemic disease in patients with subacute cutaneous lupus erythematosus (SCLE) followed up in a dermatology practice vs patients with systemic lupus erythematosus (SLE) followed up in a rheumatology practice.

Design: Case-control comparison of patients matched for age, sex, and ethnicity.

Setting: University-affiliated dermatology and rheumatology practices.