An Experimental Study to Improve Risk/Benefit Appraisal

The specific aims of this research are to develop, implement, and assess the effectiveness of a decision balance risk-benefit component as part of the informed consent process for women deciding to accept or reject free hemophilia A Carrier testing. To accomplish this, this project will randomly assign 414 women, by family membership, to receive either a standard or experimental informed consent statement. One month after their decision, all women, both those who chose testing and those who did not, will complete a self administered questionnaire and six and twelve months later they will complete telephone interviews. Major outcome variables include
-satisfaction with the testing decision;
-level of post decision regret;
-post decision assessments of the adequacy of pre decision risk/benefit considerations;
-stability and change in assessed risks and benefits from before to 6 and 12 months post decision; and
-similarities and differences between black/white, as well as in carrier/non carrier risk and benefit assessments at each data collections point as well as over the period of the study.
The study will employ both quantitative methods (SUUDAN cluster analyses) and qualitative methods (in depth interviews, theme and cases analyses.) If demonstrated to be effective, the decision balance risk/benefit procedure could be widely used in research involving human subjects. (Informed Consent RFA)