title: Research methodologies in informed consent studies involving surgical and invasive procedures: time to re-examine?
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  Research that addresses patient perspectives toward surgical interventions should tap into underexplored ethical and emotional factors that shape decision making.
authors.affiliation: ISIS (Institute of Simulation and Interprofessional Studies), Department of Surgery, School of Medicine, University of Washington, Seattle, USA. Electronic address: sarakim@uw.edu.
authors.forename: Sara
authors.initials: S
authors.lastname: Kim
authors.forename: Sinan
authors.initials: S
authors.lastname: Jabori
authors.forename: Jessica
authors.initials: J
authors.lastname: O'Connell
authors.forename: Shanna
authors.initials: S
authors.lastname: Freeman
authors.forename: Cha Chi
authors.initials: CC
authors.lastname: Fung
authors.forename: Sahrish
authors.initials: S
authors.lastname: Ekram
authors.forename: Amruta
authors.initials: A
authors.lastname: Unawame
authors.forename: Gail
authors.initials: G
authors.lastname: Van Norman
mesh_terms: D000328:Adult; D032882:Comprehension; D003657:Decision Making; D003661:Decision Support Techniques; D004992:Ethics, Medical; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D012107:Research Design; D013514:Surgical Procedures, Operative
keywords: Ethics; Informed consent; Patient perspectives; Research design