Education and training of clinical and translational study investigators and research coordinators: A competency-based approach.

INTRODUCTION: Training for the clinical research workforce does not sufficiently prepare workers for today's scientific complexity; deficiencies may be ameliorated with training. The Enhancing Clinical Research Professionals' Training and Qualifications developed competency standards for principal investigators and clinical research coordinators. METHODS: Clinical and Translational Science Awards representatives refined competency statements. Working groups developed assessments, identified training, and highlighted gaps. RESULTS: Forty-eight competency statements in 8 domains were developed. CONCLUSIONS: Training is primarily investigator focused with few programs for clinical research coordinators. Lack of training is felt in new technologies and data management. There are no standardized assessments of competence.

Enhancing Clinical Research Professionals' Training and Qualifications (ECRPTQ): Recommendations for Good Clinical Practice (GCP) training for investigators and study coordinators.

INTRODUCTION: The translation of discoveries to drugs, devices, and behavioral interventions requires well-prepared study teams. Execution of clinical trials remains suboptimal due to varied quality in design, execution, analysis, and reporting. A critical impediment is inconsistent, or even absent, competency-based training for clinical trial personnel. METHODS: In 2014, the National Center for Advancing Translational Science (NCATS) funded the project, Enhancing Clinical Research Professionals' Training and Qualifications (ECRPTQ), aimed at addressing this deficit. The goal was to ensure all personnel are competent to execute clinical trials. A phased structure was utilized. RESULTS: This paper focuses on training recommendations in Good Clinical Practice (GCP). Leveraging input from all Clinical and Translational Science Award hubs, the following was recommended to NCATS: all investigators and study coordinators executing a clinical trial should understand GCP principles and undergo training every 3 years, with the training method meeting the minimum criteria identified by the International Conference on Harmonisation GCP. CONCLUSIONS: We anticipate that industry sponsors will acknowledge such training, eliminating redundant training requests. We proposed metrics to be tracked that required further study. A separate task force was composed to define recommendations for metrics to be reported to NCATS.

Effects of fluid load on human urine characteristics related to workplace drug testing.

During workplace drug testing, urine is tested for dilution, substitution and adulteration. Donors argue that these findings are due to medical, health or working conditions or diet and genetic differences. There is a paucity of data correlating changes in urine characteristics after a fluid load to various body parameters. Therefore, five urine specimens (one in the morning, one prior to drinking 800 mL of a beverage, and three time intervals thereafter) from 12 males and 12 females were tested for four different beverages on separate occasions. Of the 480 samples, 376 were in sufficient amounts. Of these 376, 36 (10%) had creatinine <20 mg/dL but ≥2 mg/dL; 27 (75%) of 36 had specific gravity <1.0030 but >1.0010. Thus, these 27 samples can be considered to be dilute; 20 (74%) of 27 were from females. For males with at least one dilute sample, body fat was 11% less and resting metabolic rate (RMR) was 29% more than males with no dilute samples (p > 0.05); for females with at least one dilute sample, height was 8% less and weight 20% less than females with no dilute samples (p > 0.05). Individuals with a higher RMR appear to have a greater potential for producing dilute urine specimens than those with a lower RMR. Thus, a dilute sample does not necessarily indicate that it was intentionally diluted. Such samples must be carefully evaluated in consideration with recent consumption of liquid by donors to avoid false accusations.

A review of cancer in U.S. Hispanic populations.

There are compelling reasons to conduct studies of cancer in Hispanics, the fastest growing major demographic group in the United States (from 15% to 30% of the U.S. population by 2050). The genetically admixed Hispanic population coupled with secular trends in environmental exposures and lifestyle/behavioral practices that are associated with immigration and acculturation offer opportunities for elucidating the effects of genetics, environment, and lifestyle on cancer risk and identifying novel risk factors. For example, traditional breast cancer risk factors explain less of the breast cancer risk in Hispanics than in non-Hispanic whites (NHW), and there is a substantially greater proportion of never-smokers with lung cancer in Hispanics than in NHW. Hispanics have higher incidence rates for cancers of the cervix, stomach, liver, and gall bladder than NHW. With respect to these cancers, there are intriguing patterns that warrant study (e.g., depending on country of origin, the five-fold difference in gastric cancer rates for Hispanic men but not Hispanic women). Also, despite a substantially higher incidence rate and increasing secular trend for liver cancer in Hispanics, there have been no studies of Hispanics reported to date. We review the literature and discuss study design options and features that should be considered in future studies.

Pressure ulcers and endothelial dysfunction: is there a link?

Pressure ulcers were first described in the medical literature in the mid-16th century. Today, in the 21st century, pressure ulcers continue to cause pain and suffering to patients and increase the cost of medical care. Researchers and clinicians have used significant time and money to develop prevention and treatment strategies for pressure ulcers. Accepted risk factors for pressure ulcer development include pressure, shear force, friction, moisture and malnutrition. Yet despite procedures to help minimize these risk factors, pressure ulcers are still problematic. Endothelial dysfunction, which is a well-documented cardiovascular risk factor, has been proposed as another risk factor for pressure ulcers. Yet little is known about how pressure ulcers and endothelial dysfunction are linked. In this article we explore the literature to build an argument that research into the role of endothelial function is a plausible line of translational investigation that would contribute greatly to the knowledge base that guides present-day practices in the prevention and treatment of pressure ulcers.

Health promotion in older adults: the role of lifestyle in the metabolic syndrome.

The metabolic syndrome, also known as dysmetabolic syndrome, Syndrome X, or insulin resistance syndrome, is an amalgam of obesity-related health risks that significantly increases the chance of developing diabetes, coronary artery disease, and stroke. Progress in understanding the metabolic syndrome has confirmed the importance of metabolic imbalances in the development of serious and chronic cardiovascular, neurologic, immunologic, renal, and endocrine diseases. Crucial to planning treatment is the understanding that the metabolic syndrome is largely a disorder caused by behavior, thus its most important therapeutic intervention entails lifestyle change: Significant behavioral change can dramatically modify and even reverse all factors of the metabolic syndrome and its consequences. We examine the pathophysiology of the metabolic syndrome and provide strategies to encourage weight loss and dietary modifications and to promote increased physical activity.

Sleep disorders in the elderly.

Problems with sleep, including acute and chronic conditions, increase with age. Expertise in dealing with sleep problems using pragmatic management strategies is an essential component of comprehensive geriatric patient care. This article provides a succinct review of the physiology, diagnosis, and treatment of sleep disorders in the elderly.

Obesity in the elderly: survival of the fit or fat.

Obesity is an important health problem for the growing elderly segment of the population. Age-related changes in body composition should be taken into account when considering morbidity. Today, sarcopenic obesity, which is defined as excess fat with loss of lean body mass, is a highly prevalent problem. Obesity in the elderly is related to morbidity; e.g., sleep apnea, cancer, osteoarthritis, diabetes and hypertension. The advantages and disadvantages of using BMI, waist circumference, waist: hip ratio, and body weight to measure age-related changes in obesity are discussed. In addition, the merits of treatment options for obesity; e.g., behavioral modifications, diet, and exercise--are described. One important conclusion derived from a review of these treatments is that age itself is not a contraindication for pharmacotherapy or even surgery for morbid obesity.