Abstract
Objective
To explore the impact of the inclusion of a benefit message in a patient package insert on knowledge about medicines and on subjective benefit/risk perception.
Setting
Female members of community social organizations, female relatives of psychology students, and caregivers to psychotic patients.
Nature of the study
Randomized, controlled healthy human volunteer study with three parallel experiments, involving the inserts of cisapride, itraconazol, and risperidon.
Design
Subjects were recruited in a convenience sample and randomized to one control and two intervention groups (one with a normal insert and one with an insert with a benefit message). Material and methods: Subjects were asked to read the inserts (using mock text in the control group) in 5 to 15 minutes. Knowledge of the medication was tested with 20 simple questions (to be answered Yes/No/Don’t know) and benefit/risk perception with a five-point bipolar Likert scale. Results: In the three experiments respectively 89, 102, and 83 subjects were recruited. The provision of inserts increased the knowledge about medication in all the intervention groups. Thirty-one percent, 41%, and 54% of the subjects who read a normal insert agreed that the benefit of the medicine was greater than its risks, compared to 62%, 64%, and 70% of subjects who read an insert with a benefit message included (P < 0.05 in all 3 experiments). Discussion: A hypothesis for further research is formulated: adding a section on benefit information within a patient package insert helps to integrate increased knowledge about medication into a more balanced benefit/risk perception.
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Vander Stichele, R.H., Vandierendonck, A., De Vooght, G. et al. Impact of Benefit Messages in Patient Package Inserts on Subjective Drug Perception. Ther Innov Regul Sci 36, 201–208 (2002). https://doi.org/10.1177/009286150203600126
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DOI: https://doi.org/10.1177/009286150203600126