Controlled clinical trials
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Control Clin Trials · Jun 2001
Randomized Controlled Trial Clinical TrialThe prehospital treatment of status epilepticus (PHTSE) study: design and methodology.
Status epilepticus is a neurological emergency that is typically first encountered and managed in the prehospital environment. Although aggressive pharmacological treatment of status epilepticus is well established in the emergency department and hospital settings, the relative risks and benefits of active therapy for status epilepticus in the prehospital setting are not known. ⋯ The initial phase of the PHTSE study began in January 1994 and was completed in February 1999 after the successful enrollment of 205 patients into the three treatment arms. In this paper, we describe the rationale for the conceptualization of the study and details of the study design and methodology, and emphasize some aspects of study implementation that are unique to research involving the emergency medical system.
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The ethical tension in research design is often characterized as that between individual and collective ethics. While adaptive clinical trials (ACTs) are generally considered to be more sensitive to individual ethics, the concomitant loss of statistical power associated with them is often used to justify randomized clinical trials (RCTs). This paper challenges this characterization of the central ethical problem in research design. ⋯ However, in desperate medical situations the process of informed consent is often undermined. It is argued that in such situations ACTs are ethically required. We introduce "the principle of interchangeability" and argue that it must be satisfied if research in desperate medical situations is to be justified.