Can a Checklist Improve the Informed Consent Process?

Informed consent often fails to provide patients and families with a full understanding of the proposed procedure. We developed an informed consent checklist for identifying specific aspects of the surgical consent that were not fully understood by families. The purpose of this study was to measure the effect of using this checklist on families’ knowledge, satisfaction, experience, and decisional conflict during the consent process. The families of pediatric patients scheduled for an orthopaedic preoperative visit were prospectively randomized into one of two groups: checklist or traditional appointment. Families in the checklist group completed the informed consent checklist which was then used by the surgeon to further discuss aspects of the surgery that needed clarification. Those in the traditional group had similar discussions about surgery without the aid of a checklist. Sixty-one families participated in the study; 27 in the checklist group and 34 in the traditional group without a checklist. The checklist group reported no difference in mean scores for all satisfaction (P = 0.37), decisional conflict (P = 0.51), and knowledge items (P = 0.31). For patient experience, the traditional group reported the visits were significantly more relaxed (mean 4.9, 95% confidence interval (CI) 4.8-5.0) than the checklist group (mean 4.5, 95% CI 4.3-4.7). Our results suggest that having a family member complete the informed consent checklist prior to meeting with the surgeon did not improve, and may worsen, the consent experience for some families. Other methods need to be evaluated to determine the optimal consent process from the family’s perspective.