ABSTRACT
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.
ABSTRACT
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.
ABSTRACT
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.
ABSTRACT
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.
