Randomized controlled trial of decision aids for women considering prenatal testing: The effect of the Ottawa Personal Decision Guide on decisional conflict

Abstract

AbstractAim: The aim of this research study was to clarify the effect that counseling using the Ottawa Personal Decision Guide had on pregnant women in helping them to decide whether or not to undergo prenatal testing. It compared the “decisional conflict” of a group of women interviewed by a nurse using the guide with that of a second group who were only given standard genetic counseling.Methods: A group of pregnant women attending the hospital for genetic counseling was randomly divided into an intervention group and a control group. The women in the intervention group were given standard genetic counseling, followed by an interview based on the decision aid guide. The women in the control group were given only standard genetic counseling. Both groups were followed up. The primary outcome of the study was to determine the level of decisional conflict, as measured by the Japanese version of the Decisional Conflict Scale. The secondary outcome was self‐esteem, based on the Rosenburg Self‐Esteem Scale. The outcome indicators were obtained from responses given in patient questionnaires conducted after standard genetic counseling (pre‐intervention) and after the conclusion of the decision‐making process (postintervention).Results: The pre‐intervention and postintervention changes in decisional conflict scores (primary outcome) indicated no significant difference between the two groups. However, with regard to postintervention decisional conflict, the rate of the response “mild to high decisional conflict” was lower for the intervention group than the control group. No significant difference between the two groups was detected for the secondary outcome of self‐esteem.Conclusions: The reasons for the lack of a clear effect on the level of decisional conflict are that the pre‐intervention responses for both groups were obtained after completion of the standard genetic counseling program and because follow‐up conducted by the nurses took the form of care given in response to patients’ needs. The use of decision aids to assist in the decision‐making process had no effect on the level of self‐esteem in the two groups. As a result, there was a similar level of intervention for both groups. However, as there was no clear indication that the use of the Ottawa Personal Decision Guide was harmful, it will be a useful tool in the medical care setting.