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. The decision balance risk-benefit procedure is derived from Decision Conflict Theory, and in particular the decision balance-sheet methodology for assisting decision making. This method increases pre-decisional scanning of utilitarian and nonutilitarian consequences of decision alternatives to compensate for common pre-decisional deficiencies in such assessments. If effective, women whose informed consent statement includes a decision balance risk-benefit component, in contrast to women whose informed consent statement includes the usual listing of potential risks and benefits should (a) be aware of more potential harms and benefits associated with their decision; (b) have a clearer assessment of the importance of these for themselves; (c) report they considered more potential harms and benefits prior to their decision; and (d) experience less post-decision regret. To accomplish the specific aims the investigators 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 (a) satisfaction with the testing decision; (b) level of post-decision regret; (c) post-decision assessments of the adequacy of pre decision risk/benefit considerations; (d) stability and change in assessed risks and benefits from before to 6 and 12 months post-decision; and (e) similarities and differences between black/white, as well as in carrier/noncarrier risk and benefit assessments at each data collection point as well as over the period of the study. The investigators 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.
| Sorenson, J R; Lakon, C; Spinney, T et al. (2004) Assessment of a decision aid to assist genetic testing research participants in the informed consent process. Genet Test 8:336-46 |
| Sorenson, James R; Jennings-Grant, Tracey; Newman, Jamie (2003) Communication about carrier testing within hemophilia A families. Am J Med Genet C Semin Med Genet 119C:3-10 |
