n. a state of genuine and substantial uncertainty as to which of two or more courses of action will be best for a patient. Equipoise is an important ethical principle in research, specifically in the design of clinical trials. It is generally held that the random allocation of patients to one or other arm of a trial is ethically acceptable only where there is a genuine uncertainty (equipoise) as to which treatment will most benefit trial participants. Knowingly to assign an individual to inferior or ineffective treatment (such as a placebo) would offend against the principle that his or her *best interests are paramount. A distinction is sometimes made between clinical equipoise, which refers to uncertainty across the medical profession as a whole, and theoretical equipoise, which refers to the uncertainty of an individual doctor. In addition, patients may not share the state of equipoise; for example, if a patient has his or her own preferences and there are significant side-effects influencing the choice of treatment, it would be *paternalistic and counter to *beneficence not to respect that patient’s wishes.
(in medical ethics) the situation in which a health professional is subject to potential or actual pressures that may conflict with his or her obligation to promote the *best interests of the patient over and above all else. A conflict of interest arises from a particular context or situation and may threaten a doctor’s integrity and undermine trust between professional and patient. For example, a drug company may encourage a doctor to prescribe a particular medicine, which may not be the treatment of choice for a patient, or contractual financial disincentives may discourage a doctor from providing a more expensive treatment of choice for a patient. In medical research, there is always a potential conflict between protecting the individual and benefiting society. Particular problems of this kind occur in randomized controlled trials (see equipoise; intervention study). Doctors will always experience competing pressures and it is important for them to be able to recognize and then, where possible, disclose, resolve, or mitigate morally problematic conflicts.... conflict of interest
a comparison of the outcome between two or more groups of patients that are deliberately subjected to different regimes to test a hypothesis, usually of treatment (in a clinical trial). Wherever possible those entering the trial should be allocated to their respective groups by means of random numbers, and one such group (the control group) should have no active treatment (randomized controlled trial). Ideally neither the patient nor the person assessing the outcome should be aware of which group each patient is allocated to. In a blind trial, the patients are not aware of their group; in a double-blind trial, neither the patients nor the doctor or observer are aware of the therapy group. The groups may exchange treatment after a prearranged period (cross-over trial). Randomized controlled trials are increasingly used to assess new treatments against current standards; for example, to compare new chemotherapeutic agents to established treatment (the control group). To be ethically sound, there must not be evidence at the time of the study to show conclusively which arm of the trial is the best (see equipoise).... intervention study
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