title: Who enrolls in prevention trials? Discordance in perception of risk by professionals and participants.
abstract: Internal and external validity problems permeate all intervention studies but are accentuated in primary preventive intervention research, particularly when studies target or recruit individuals based on their risk for psychopathology. Since many people who are at risk do not yet experience distress, they may not perceive the need for intervention. Recruitment tactics based on explaining extent of risk are unlikely to be persuasive and may have negative consequences. If respondents are not motivated to participate, a small or biased subset of the target population will participate in the intervention. Bias is of special concern when those enrolled represent only part of the continuum of risk. Selective enrollment may compromise both internal validity (the interpretation of the research results) and external validity (the generalizability of the findings) of intervention trials in primary prevention. This article discusses the effects of partial enrollment and the resultant bias. It suggests several strategies for increasing the enrollment of the target population and examines some of their ethical ramifications. It also stresses the importance of collecting systematic data documenting how the participants in the intervention differ from the target group as a whole.
authors.affiliation: Department of Pediatrics, Albert Einstein College of Medicine, Bronx, New York 10461.
authors.forename: R E
authors.initials: RE
authors.lastname: Stein
authors.forename: L J
authors.initials: LJ
authors.lastname: Bauman
authors.forename: H T
authors.initials: HT
authors.lastname: Ireys
mesh_terms: D015982:Bias; D002986:Clinical Trials as Topic; D003625:Data Collection / Q000379:methods; D005260:Female; D006801:Humans; D001523:Mental Disorders / Q000517:prevention & control*; D010358:Patient Participation; D018579:Patient Selection; D012107:Research Design; D012307:Risk Factors