Research methodologies in informed consent studies involving surgical and invasive procedures: time to re-examine?

We conducted a review of informed consent studies involving surgical and invasive procedures and report the degree to which current research targets a broader scope of patient outcomes beyond comprehension.

Using PubMed, Cumulative Index to Nursing and Allied Health Literature, and Excerpta Medical Database, we identified 97 articles for review. Six members coded articles and generated scores of study design quality.

The mean quality score (10.7 out of a total score of 20) was low. Most studies were single institution-based, relying on one-time data collections. Randomly assigning subjects to study conditions, using power analysis to determine subject numbers, and reporting psychometric evidence, such as reliability and validity, were not widely reported. Most frequently targeted patient outcomes were knowledge, understanding and satisfaction. Core informed consent outcomes (e.g. capacity, voluntariness, decision making) and emotional factors (e.g. anxiety) were not extensively addressed.

Informed consent research may benefit from applying qualitative methods to more directly tap into patients' beliefs and decisions by eliciting in patients' own words their emotions and reasoning around processing informed consent content.

Research that addresses patient perspectives toward surgical interventions should tap into underexplored ethical and emotional factors that shape decision making.