Effective Strategies for Maintaining Research Participation in Clinical Trials
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Allen Zweben, DSW Professor and Associate Dean, Columbia University, School of Social Work. New York, New York
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Effective Strategies for Maintaining Research Participation in Clinical Trials
Lisa M. Frrito, PhD Postdoctoral Fellow, Yale University School of Medicine. Department of Psychiatry, New Haven, Connecticut
Stephanie 5. O'Molley, PhD Professor of Psychiatry. Yale University School of Medicine, Department of Psychiatry, New Haven, Connecticut
Key Words Research retention; Clinical trial; Alcohol and substance dependence Correspondenre Address Allen Zweben. DSW. Columbia University, School ofsocial Work, Mail Code 4600, 1255 Amsterdam Avenue, Room 619, New York, N Y 10027 (email: az 173 @columbia.edu).
INTRODUCTION The randomized controlled trial (RCT) design is the most scientifically rigorous methodology for evaluating treatment efficacy (1). The success of RCTs is contingent upon adequate retention of research participants (2-4) and there is evidence that rates could be improved (5-7). Poor retention may increase study duration and costs and, in the worst cases, result in premature termination of research (3,6,8).The treatment literature has devoted more attention to examining recruitment barriers and less to retention, particularly among special populations such as those with substance use problems, a group known to have poor adherence rates (9-12). In addition, the current literature on retention has been limited by not always making a clear distinction between research retention and treatment retention in RCT (l3,14). Failure to retain a sufficient number of participants in the protocol may threaten the internal and external validity of RCTs (11,15,16). High rates of attrition from follow-up may produce bias; results may not be due to treatment effects but rather to a disproportional loss of participants who were more or less symptomatic or unresponsive to the study medication than other participants (3,17). Furthermore, high attrition rates may result in significant differences between participants who remain in research and
those who drop out, thereby limiting the generality of findings to the population of interest (3,17).Also, high attrition limits statistical validity by reducing the power to detect true differences between treatments (3). Previous research has revealed that high study demands (eg, frequent appointments, long study duration, and extra, inconvenient, or uncomfortable procedures) and greater travel and travel costs may deter participants from remaining in research (17-21). Participants' concerns about taking medication, experiencing adverse events, or being assigned to a placebo condition may also increase attrition (18-20). Other participant factors including greater problem severity and distress, lower socioeconomic status and education, lack of social support, and minority status may also play a role, though research is equivocal (19-22). Conducting RCTs with alcohol- and substance-dependentparticipants poses additional challenges since it is well documented that r
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