Modifying a standard industry clinical trial consent form improves patient information retention as part of the informed consent process.
OBJECTIVE
Informed consent is a required part of clinical research. Industry consent forms may be complex and difficult to understand. A comparison was performed between a standard, industry consent form (IF) and a modified, shortened version of the same form (MF) to determine which allows the patient to retain more information in the immediate postconsent period.


METHODS
This was a prospective, randomized study performed in an urban, county teaching emergency department (ED). A convenience sample (based on the availability of one of two research assistants being present in the ED) of 100 patients with a history of asthma seen in the ED were enrolled. After reading the consent form, 50 MF and 50 IF patients were given a postconsent test to determine how much information was retained. Mean differences in test scores between the IF and MF were determined.


RESULTS
The population had a mean age (+/-SD) of 39.4 +/- 12.1 years (range 18-80); 52% were female. The overall score for the study population was 9.6 (+/-2.0), range 2-12 (maximum 12). The MF score was 10.6 (+/-1.4) vs the IF score of 8.6 (+/-2.1); mean difference = 2.0 (95% CI = 1.3 to 2.7, p < 0.0001). The MF group had significantly more correct answers than the IF group with the following questions (MF%, IF%; mean difference in proportions with 95% CIs): purpose (96, 70; 26, 95% CI = 12 to 40); randomization (78, 44; 34, 95% CI = 16 to 52); study duration (94, 70; 24, 95% CI = 10 to 38); risks (92, 74; 18, 95% CI = 4 to 32); benefits (94, 78; 16, 95% CI = 3 to 29); alternative treatments (88, 70; 18, 95% CI = 2 to 34); confidentiality (98, 88; 10, 95% CI = 0.2 to 20); and voluntary participation (74, 54; 20, 95% CI = 2 to 38). Adverse event compensation had the poorest correct rate (54, 38; 13, 95% CI = -6 to 32). Subsequently, after taking the postconsent test, 98% wrote that they read the entire MF, while only 68% wrote that they read the entire IF (mean difference in proportions 30%, 95% CI = 17% to 43%).


CONCLUSIONS
Compared with an industry consent form, a shortened version, focusing on Food and Drug Administration and Department of Health and Human Services informed consent guidelines, allowed patients to retain more information in the immediate postconsent period.
Department of Emergency Medicine, Alameda County Medical Center, Highland Campus, Oakland, CA, USA.
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Dresden
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Levitt
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003219:Confidentiality; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D010358:Patient Participation / Q000706:statistics & numerical data; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*