Predictors of comprehension during surgical informed consent.
BACKGROUND
Patient comprehension during surgical informed consent remains problematic. Using data from our randomized trial of methods to improve informed consent comprehension, we performed an additional analysis to define independent factors associated with improved patient understanding.


METHODS
Patients scheduled for 1 of 4 elective operations (total hip arthroplasty [n = 137], carotid endarterectomy [n = 178], laparoscopic cholecystectomy [n = 179], or radical prostatectomy [n = 81]) at 7 Department of Veterans Affairs (VA) medical centers were enrolled. All informed consent discussions were performed using iMedConsent (Dialog Medical), the VA's computerized informed consent platform. Using a unique module within iMedConsent, we randomized patients to repeat back (RB), requiring correct reiteration of procedure-specific facts, or standard (STD) iMedConsent. Patient comprehension was tested after the informed consent discussion using procedure-specific questionnaires. Time spent completing the informed consent process was measured using time stamps within iMedConsent. Multiple linear regression identified factors independently associated with improved comprehension.


RESULTS
We enrolled 575 patients (276 RB, 299 standard); 93% were male, 74% were Caucasian, and 89% had at least a high school education. Independent factors associated with improved comprehension included race (p < 0.01), ethnicity (p < 0.05), age (p < 0.02), operation type (p < 0.01), group assignment (+/- RB; p < 0.05), and total consent time (p < 0.0001). Patient comprehension was maximized when informed consent took between 15 and 30 minutes. RB's positive impact on patient comprehension was weaker in the analysis including consent time.


CONCLUSIONS
Comprehension during informed consent discussions may be limited in individuals with potential language difficulty due to ethnicity or education. Total consent time was the strongest predictor of patient comprehension. Affording adequate time for informed consent discussions and using informed consent adjuncts such as RB may enhance comprehension in such individuals.
Fink
Aaron S
AS
Atlanta Veterans Affairs Medical Center, 1670 Clairmont Road, Decatur, GA 30033, USA. aaron.fink@va.gov
Prochazka
Allan V
AV
Henderson
William G
WG
Bartenfeld
Debra
D
Nyirenda
Carsie
C
Webb
Alexandra
A
Berger
David H
DH
Itani
Kamal
K
Whitehill
Thomas
T
Edwards
James
J
Wilson
Mark
M
Karsonovich
Cynthia
C
Parmelee
Patricia
P
D000367:Age Factors; D000368:Aged; D000704:Analysis of Variance; D019644:Arthroplasty, Replacement, Hip; D017081:Cholecystectomy, Laparoscopic; D032882:Comprehension; D004522:Educational Status; D016894:Endarterectomy, Carotid; D005260:Female; D006787:Hospitals, Veterans; D006801:Humans; D007258:Informed Consent; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011468:Prostatectomy; D013997:Time Factors; D014481:United States