Educational intervention for women undergoing image-guided breast biopsy: results of a randomized clinical trial

The process of informed consent has been examined for patients undergoing various procedures but not breast biopsy. Our study was a randomized trial that examined the effect of an educational flip chart as part of the informed consent.

A total of 122 patients referred for stereotactic or ultrasound-guided core breast biopsy were randomly assigned to receive an informed consent discussion with or without an illustrated flip chart. The chart included information about breast anatomy, pathology, and diagnostic procedures. Outcome measures included objective knowledge, subjective knowledge, anxiety, and satisfaction.

Analysis showed few significant main effects of the intervention. However, results showed interactions between experimental condition and race/ethnicity, indicating that the intervention was effective in enhancing objective and subjective knowledge for African American but not Caucasian patients. Anxiety after consultation was higher among patients assigned to the flip chart condition, possibly because they were better informed about the risks of the procedure. Patients who underwent biopsy sooner after learning they needed one were more satisfied with their care.

The usual care consent process is effective for many but not all patients. Informed consent that employs visual aids may help overcome characteristics of the consent process that are ineffective for some patients.