EMS providers and exception from informed consent research: benefits, ethics, and community consultation.

BACKGROUND: As attention to, and motivation for, emergency medical services (EMS)-related research continues to grow, particularly exception from informed consent (EFIC) research, it is important to understand the thoughts, beliefs, and experiences of EMS providers who are actively engaged in the research. OBJECTIVE: We explored the attitudes, beliefs, and experiences of EMS providers regarding their involvement in prehospital emergency research, particularly EFIC research. METHODS: Using a qualitative design, 24 participants were interviewed including nationally registered paramedics and Virginia-certified emergency medical technicians employed at Richmond Ambulance Authority, the participating EMS agency. At the time of our interviews, the EMS agency was involved in an EFIC trial. Transcribed interview data were coded and analyzed for themes. Findings were presented back to the EMS agency for validation. RESULTS: Overall, there appeared to be support for prehospital emergency research. Participants viewed research as necessary for the advancement of the field of EMS. Improvement in patient care was identified as one of the most important benefits. A number of ethical considerations were identified: individual risk versus public good and consent. The EMS providers in our study were open to working with EMS researchers throughout the community consultation and public disclosure process. CONCLUSION: The EMS providers in our study valued research and were willing to participate in studies. Support for research was balanced with concerns and challenges regarding the role of providers in the research process.

Complementary effects of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in slowing the progression of chronic kidney disease.

Chronic kidney disease (CKD) and end-stage renal disease continue to pose major healthcare challenges. Early initiation of therapy aimed at slowing the progression of CKD is essential. Increased renin-angiotensin-aldosterone-system activity and, in particular, elevated levels of angiotensin II (AII) play important roles in the development and progression of CKD. Therefore, pharmacologic therapies that block the effects of AII and reduce its pathogenic effects are cornerstones of clinical management. Angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) have been shown to have renoprotective effects in addition to their ability to control blood pressure. There is accumulating clinical evidence that the combination of an ACEI and an ARB provides greater renal protection, particularly in decreasing proteinuria, than does either agent alone.

Pharmacoeconomic considerations in the health system management of anaemia in patients with chronic kidney disease and end stage renal disease.

Anaemia is prevalent in patients with chronic kidney disease and end stage renal disease. If left untreated, it greatly affects patient survival, quality of life and functional status. Epoetin and darbepoetin are two biotechnology drugs that effectively stimulate the production of red blood cells. These drugs have been shown to significantly increase haemoglobin concentrations and improve quality of life. So far, there have been no head-to-head pharmacoeconomic studies that have compared epoetin to darbepoetin. Health system decision makers need to evaluate important considerations when comparing these agents. These considerations include drug acquisition costs, the patient population being treated, the location of drug administration (in-patient versus ambulatory) and federal government reimbursement. This review details these important pharmacoeconomic considerations.

Reorganizing the General Clinical Research Center to improve the clinical and translational research enterprise.

In 2010, Virginia Commonwealth University (VCU) was granted a Clinical and Translational Science Award which prompted reorganization and expansion of their clinical research infrastructure. A case study approach is used to describe the implementation of a business and cost recovery model for clinical and translational research and the transformation of VCU's General Clinical Research Center and Clinical Trials Office to a combined Clinical Research Services entity. We outline the use of a Plan, Do, Study, Act cycle that facilitated a thoughtful transition process, which included the identification of required changes and cost recovery processes for implementation. Through this process, the VCU Center for Clinical and Translational Research improved efficiency, increased revenue recovered, reduced costs, and brought a high level of fiscal responsibility through financial reporting.

Guiding the next generation of NIH investigators in responsible conduct of research: the role of the mentor.

National Institutes of Health (NIH) K award recipients and their mentors were surveyed to investigate the role of the mentor. We found that a majority of mentors provided guidance in responsible research conduct (RCR), and that most of these relationships were deemed helpful. Mentors also responded that they played a greater importance in RCR training of their mentees than the mentees reported. Our results suggest both mentors and mentees report that mentors ideally should play a more important role in RCR training than was actually the case. For conflicting interests, subjects' protection, and misconduct, approximately 50% of K recipients found the mentor to be not at all important or only somewhat important for these areas of RCR training. We conclude the mentor's role is important but not optimal based on the results of our study cohort.

Training NIH K award recipients: the role of the mentor.

UNLABELLED: Mentors play important roles in training new investigators. This study was designed to determine characteristics of NIH mentored K award recipients and their mentors, their interpersonal interactions, and the factors, which influence satisfaction within this relationship. METHOD: A survey of 3027 NIH mentored K recipients and 1384 mentors was conducted in 2009. Nine hundred twenty-nine (30.7%) of the K recipients and 448 (32.4%) mentors completed the survey. RESULTS: The gender of K respondents was evenly divided while the mentors were 72.1% male. The overall rating of their mentors was positive. Ideally, both thought the mentor should be important in research training; however, in actual practice, both rated the importance as lower. A total of 88.2% of recipients were satisfied with their relationship. Although the number of black K recipients was low, this group was more likely to be dissatisfied with the mentor relationship (6/29 or 20.7%) than their white counterparts. The frequency of meeting or communicating was correlated with K recipient satisfaction. CONCLUSIONS: Overall K recipients are satisfied with their mentor relationships. Although the number of black K recipient respondents was small, the higher level of mentor dissatisfaction should be further evaluated. Qualities of mentors, including the frequency of interactions and accessibility, can influence satisfaction.

Community consultation and public disclosure: preliminary results from a new model.

Emergency medicine research conducted under the exception from informed consent (EFIC) regulation enables critical scientific advancements. When EFIC is proposed, there is a requirement for broad community consultation and public disclosure (CC/PD) regarding the risks and benefits of the study. At the present time, no clear guidelines or standards exist for conducting and evaluating the CC/PD. This preliminary study tested the feasibility and acceptability of a new approach to CC/PD for a large-scale EFIC trial by engaging community members in designing and conducting the strategies. The authors enrolled key community members (called community advocates for research, or CARs) to use community-based participatory methods to design and implement CC/PD. By partnering with community members who represent target populations for the research study, this new approach has demonstrated a feasible CC/PD plan with greater community participation and less cost than previous studies. In a community survey, the percentage of community members reporting having heard about the EFIC trial more than doubled after employing the new approach. This article discusses initial implementation and results.

Fifteen years of losartan: what have we learned about losartan that can benefit chronic kidney disease patients?

Losartan, the first AT1 receptor blocker (ARB), was FDA approved 15 years ago. During those years, researchers and clinicians have developed a growing base of knowledge on the benefits of losartan, particularly for hypertension and renal disease. These benefits include decreasing proteinuria, slowing the progression of diabetic nephropathy, controlling hypertension, and decreasing stroke risk in patients with left ventricular hypertrophy. Although many of the benefits of losartan represent a class effect for ARBs, losartan has pharmacokinetic and pharmacodynamic characteristics and effects that are unique and are not a class effect. For example, a shorter duration of action is seen with this first ARB compared with other more recently approved ARBs. Losartan also has a uricosuric effect not seen in other ARBs and attenuates platelet aggregation, which is not seen or is seen to a lesser extent with the other ARBs. This review presents the physiological effects of losartan on the kidney and discusses relevant clinical outcomes.

Why do we pay? A national survey of investigators and IRB chairpersons.

The principle that payment to participants should not be undue or coercive is the consensus of international and national guidelines and ethical debates; however, what this means in practice is unclear. This study determined the attitudes and practices of IRB chairpersons and investigators regarding participant payment. One thousand six hundred investigators and 1900 IRB chairpersons received an invitation to participate in a web-based survey. Four hundred and fifty-five investigators (28.3%) and 395 IRB chairpersons (18.6%) responded. The survey was designed to gather considerations that govern payment determination and practical application of these considerations in hypothetical case studies. The survey asked best answer, multiple choice, and open text questions. Short hypothetical case scenarios where presented, and participants were asked to rate factors in the study that might impact payment and then determine their recommended payment. A predictive model was developed for each case to determine factors which affected payment. Although compensation was the primary reason given to justify payment by both investigators and IRB chairpersons, the cases suggested that, in practice, payment is often guided by incentive, as shown by the impact of anticipated difficulty recruiting, inconvenience, and risk in determining payment. Payment models varied by type of study. Ranges for recommended payments by both groups for different types of procedures and studies are presented.

Who's doing the math? Are we really compensating research participants?

Although compensation for expenses to participants in research projects is considered important and the primary reason for paying, there is no evidence to support that investigators and IRB members actually calculate participant cost. Payment recommendations for six hypothetical studies were obtained from a national survey of IRB chairpersons (N = 353) and investigators (N = 495). Survey respondents also recommended payment for specific study procedures. We calculated participant cost for the six hypothetical cases both by procedures and by time involvement. A large percentage recommended only token payments for survey, registry, and medical record review studies. Most chose payment for pharmaceutical studies but the recommended payment did not compensate for calculated costs. Results suggest that compensation and reimbursement as the primary reasons for paying research participants may not match actual practice.

Where does the nephrologist stand with a non-compliant, abusive dialysis patient?

Physicians have sworn to treat for the good of their patients. However, there are often conflicting needs and pressures which are ethical, medical, and legal which impact the ability of the physician to provide that care. Although most dialysis patients work with the physician and dialysis facility to obtain quality care, there are a few which are noncompliant and even abusive. This small minority requires an inordinate amount of work and presents the physician with a variety of ethical and legal issues. Unlike many other specialties, dialysis care presents additional problems due to the frequent interactions, limited treatment options, and morbid consequences of lack of care. This article outlines these issues and summarizes the difficult position that the nephrologist encounters when dealing with a noncompliant or abusive patient.

A Review of Paying Research Participants: It's Time to Move Beyond the ethical Debate.

CURRENT REGULATORY GUIDELINES REQUIRE the ethical review committee to consider one question when evaluating payment: Is the payment to the participant undue or coercive? Although this is a seemingly simple question, determining appropriate payment involves a series of complex issues. There is limited empirical knowledge to assist with this determination and little consensus on which elements of a study should be considered in making these decisions. For example, should the culture of the study population or the potential risks and benefits of the research be considered in the selection of appropriate payment? Following a review of national and international guidelines, the concerns and benefits of paying research participants are presented, and prior ethical debate is outlined. The current research literature on the practice of paying participants and the impact of payment on participants and study integrity are reviewed. Finally, given continued debate with limited data to help determine best practices, a research agenda is proposed to assist in the development of an empirical basis to aid investigators and ethical review committees in making appropriate decisions about payment to research participants.

Paying Clinical Research Participants: One Institution's Research Ethics Committees' Perspective.

REGULATORY GUIDELINES LEAVE determination of coercion and undue influence of research participants open to interpretation. A web-based survey was conducted of the research ethics committees members at Virginia Commonwealth University (VCU) to evaluate their perspectives on paying participants in clinical research via general questions, as well as 8 short cases involving hypertension placebo-controlled trials, a pilot exercise study, a survey of substance abusers, a healthy-volunteer pharmacokinetic study, a twin study involving DNA samples, and an asthma medication study in children. Research ethics committee members were asked to state what payment they would consider appropriate for a given type of protocol. The results suggest that risk, time required, reimbursement for expenses, and inconvenience were important in determining appropriate payment, while income and funding source were not. The case studies revealed wide variation in recommended payments both within type of study and between studies.

Darbepoetin alfa therapeutic interchange protocol for anemia in dialysis.

BACKGROUND: Erythropoiesis-stimulating proteins, such as erythropoietin alfa and darbepoetin alfa, have positively impacted anemia management. These medications improve patient outcomes and quality of life. Their costs, however, remain a major barrier for health systems. OBJECTIVE: To evaluate the development, implementation, and cost-effectiveness of an inpatient therapeutic interchange protocol for erythropoiesis-stimulating proteins at a large, tertiary care, university-affiliated health system. METHODS: Virginia Commonwealth University Health System (VCUHS) developed and implemented a therapeutic interchange program to convert therapy for all inpatients undergoing dialysis from erythropoietin alfa to darbepoetin alfa for treatment of chronic kidney disease-related anemia. An evaluation of the economic impact of this program on drug expenditures over a fiscal quarter (2003) was conducted using historical comparator data (2002). RESULTS: Preliminary evaluation of the program demonstrated cost-savings and reduced drug utilization of erythropoiesis-stimulating proteins in hospitalized dialysis patients. For the first quarter of 2003 compared with the first quarter of 2002, VCUHS realized a cost-savings of nearly 10,000 US dollars, which was related to the program's aggressive screening procedure. When these data were normalized for equal numbers of patients in each group receiving one of the drugs, the actual cost-savings was over 2000 US dollars. These cost-savings are largely due to reduced utilization of these expensive biotechnology products with implementation of a dosing protocol. CONCLUSIONS: VCUHS has successfully developed and implemented a darbepoetin alfa therapeutic interchange protocol for hospitalized dialysis patients. This has translated into reduced use of erythropoiesis-stimulating proteins, resulting in cost-savings for the health system.