Perception of risk associated with asthma research procedures among adolescents, parents, and pediatricians

Background

Little empirical data exist about how adolescents with asthma, their parents, and pediatricians view the risks and benefits associated with asthma clinical research.

Objective

Two studies examined similarities and differences in the perception of risks and benefits associated with asthma research.

Methods

In study I questionnaires were completed by adolescents with asthma and parents at the end of an audio and written presentation of a hypothetical research vignette. In study II adolescents with asthma, their parents, and pediatricians rated the risks and benefits associated with discreet asthma research procedures.

Results

In study I adolescents and parents made distinctions in riskiness among the asthma research procedures (P < .001 and P < .001, respectively). With the exception of venipuncture, rank orders of risk ratings among procedures were similar for both groups. In study II significant differences in risk and benefit ratings for individual procedures were found among respondent groups, including experimental medication, placebo, and venipuncture. Overall, asthma research procedures were viewed as more beneficial than risky (P < .001).

Conclusion

Participants generally viewed asthma research procedures as more beneficial than risky. Overall, the relative risk rankings among all respondents were similar. However, there were between-group difference in ratings of risk associated with venipuncture and experimental medication. Parents and adolescents rated the benefit of placebo significantly higher than did pediatricians.

Key words: Bioethics, risk-benefit evaluation

Abbreviations used: FDA, US Food and Drug Administration, IRB, Institutional review boards, MANOVA, Multivariate analysis of variance