title: Randomized trial of risk information formats in direct-to-consumer prescription drug advertisements.
abstract: Federal regulations specify that print advertisements for prescription drugs and biological products must provide a true statement of information "in brief summary" about each advertised product's "side effects, contraindications, and effectiveness." Some of the current approaches to fulfilling the brief summary requirement, although adequate from a regulatory perspective, result in ads that may be difficult to read and understand when used in consumer-directed promotion.
  
  
  
  . To explore ways in which the brief summary might be improved.
  
  
  
  . The authors conducted an experimental study that examined 300 consumers' (mall visitors ever told that they were overweight) understanding of and preference for 4 different brief summary formats: traditional (a plain-language version of the risk sections from professional labeling), question and answer (Q&A; with headings framed in the form of questions), highlights (a summary section from revised professional labeling), and prescription drug facts box (similar to the current over-the-counter drug facts label).
  
  
  
  . The format had several effects. For instance, participants who viewed the drug facts format were better able to recall risks (P < .01) and reported greater confidence to perform the tasks (P < .01) than those who saw the traditional format. Differences in preference were noted; for example, the drug facts format was ranked highest, followed by the Q&A format, the traditional format, and finally the highlights format, P < 0.001.
  
  
  
  . Taken together, these data suggest that the traditional method of conveying information in the brief summary is neither the most comprehensible nor the most preferred by consumers. These data provide policy makers and researchers with important information regarding the role of format in consumers' understanding of the brief summary.
authors.affiliation: Division of Drug Marketing, Advertising and Communications, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration (FDA) Silver Spring, Maryland (KJA, ACO, HWS)
authors.forename: Kathryn J
authors.initials: KJ
authors.lastname: Aikin
authors.affiliation: Division of Drug Marketing, Advertising and Communications, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration (FDA) Silver Spring, Maryland (KJA, ACO, HWS)
authors.forename: Amie C
authors.initials: AC
authors.lastname: O'Donoghue
authors.affiliation: Kogod School of Business, American University, Washington, DC (JLS)
authors.forename: John L
authors.initials: JL
authors.lastname: Swasy
authors.affiliation: Division of Drug Marketing, Advertising and Communications, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration (FDA) Silver Spring, Maryland (KJA, ACO, HWS)
authors.forename: Helen W
authors.initials: HW
authors.lastname: Sullivan
mesh_terms: D000328:Adult; D000329:Advertising; D004345:Drug Industry / Q000458:organization & administration*; D011307:Drug Prescriptions; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018570:Risk Assessment; D014481:United States