Prospective preference assessment: a method to enhance the ethics and efficiency of randomized controlled trials.
The concomitant problems of underenrollment and selective enrollment limit the efficiency of many randomized controlled trials (RCTs). In addition, the traditional informed consent process is often inadequate to respect research participants' autonomy. Past efforts to overcome these problems are not universally applicable. A new method, called prospective preference assessment (PPA), is suggested as a way to simultaneously enhance participant accrual, identify groups of patients to whom a trial's results may apply, and promote participants' interests. PPA is a method by which investigators would evaluate potential trial participants' motivations for and concerns about enrolling in a planned trial prior to formal recruitment. The information provided by PPA would then be used to (1) modify the final trial design and conduct to make enrollment more attractive, and (2) identify ways in which the patients who do enroll may differ from those who do not, thereby elucidating the trial's generalizability. The methodologic and ethical advantages of this method are described, and potential barriers to the method's implementation are addressed. The added costs of prospectively assessing the views of potential research participants prior to initiating RCTs are considered in relation to the method's ability to enhance the value of the information to be obtained. It is concluded that PPA is a feasible approach to a more democratic and efficient research process and that its adoption would be consistent with current trends in health care.
Halpern
Scott D
SD
Center for Clinical Epidemiology and Biostatistics, Center for Bioethics, University of Pennsylvania School of Medicine, Philadelphia, PA 19104-6021, USA. shalpern@mail.med.upenn.edu
D006805:Human Experimentation; D006801:Humans; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D018401:Sample Size