TY - JOUR
T1 - Effect of Consent and Educational Adjuncts to Consent on Patient Perceptions about Colonoscopy
AU - Fudman, David I.
AU - Papamichael, Konstantinos
AU - Roemi, Lilach
AU - Rao, Varun
AU - Falchuk, Kenneth R.
AU - Leffler, Daniel A.
AU - Feuerstein, Joseph D.
N1 - Funding Information:
Supported by an unrestricted internal Shapiro Institute Educational Research Grant. Data analysis planning was conducted with support from Harvard Catalyst| The Harvard Clinical and Translational Science Center (National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health Award UL1 TR001102) and financial contributions from Harvard University and its affiliated academic health care centers.
Publisher Copyright:
© 2018 Wolters Kluwer Health, Inc. All rights reserved.
PY - 2019/9/1
Y1 - 2019/9/1
N2 - Background and Aims:Informed consent is a vital preprocedural step for endoscopy but there are substantial variations in its delivery. We therefore sought to assess a multifaceted intervention to improve the consent process.Methods:Gastroenterologists at a tertiary center were educated on the recommended components of informed consent. Following this, 3 cohorts of patients undergoing colonoscopy were surveyed before and after consent. In one cohort, the effect of optimized verbal consent alone was assessed. In the second and third groups, the effects of the addition of either a handout or a video describing colonoscopy and its risks were evaluated. The primary outcomes were the changes between preconsent and postconsent survey responses regarding confidence in understanding the procedure's purpose, likelihood of adverse events, and levels of anxiety.Results:In total, 240 patients were included with 79 to 81 patients per group. There were no significant differences among the groups' survey responses. Compared with patients receiving verbal consent alone, fewer patients in the handout and video groups increased their perceived risk of adverse events following consent, but this difference did not reach significance (P=0.08). Examining all groups together, anxiety levels changed significantly after consent (P=0.003), with 31% of patients reducing their anxiety level, 8% increasing it, and 62% having no change.Conclusions:The consent process appears to decrease patient anxiety about colonoscopy. When used in conjunction with a high-quality verbal consent, written or video educational adjuncts provided on the day of colonoscopy likely have no effect on patient perceptions.
AB - Background and Aims:Informed consent is a vital preprocedural step for endoscopy but there are substantial variations in its delivery. We therefore sought to assess a multifaceted intervention to improve the consent process.Methods:Gastroenterologists at a tertiary center were educated on the recommended components of informed consent. Following this, 3 cohorts of patients undergoing colonoscopy were surveyed before and after consent. In one cohort, the effect of optimized verbal consent alone was assessed. In the second and third groups, the effects of the addition of either a handout or a video describing colonoscopy and its risks were evaluated. The primary outcomes were the changes between preconsent and postconsent survey responses regarding confidence in understanding the procedure's purpose, likelihood of adverse events, and levels of anxiety.Results:In total, 240 patients were included with 79 to 81 patients per group. There were no significant differences among the groups' survey responses. Compared with patients receiving verbal consent alone, fewer patients in the handout and video groups increased their perceived risk of adverse events following consent, but this difference did not reach significance (P=0.08). Examining all groups together, anxiety levels changed significantly after consent (P=0.003), with 31% of patients reducing their anxiety level, 8% increasing it, and 62% having no change.Conclusions:The consent process appears to decrease patient anxiety about colonoscopy. When used in conjunction with a high-quality verbal consent, written or video educational adjuncts provided on the day of colonoscopy likely have no effect on patient perceptions.
KW - anxiety
KW - colonoscopy
KW - consent
KW - endoscopy
KW - patient education
KW - quality
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U2 - 10.1097/MCG.0000000000001093
DO - 10.1097/MCG.0000000000001093
M3 - Article
C2 - 30001290
AN - SCOPUS:85049886385
SN - 0192-0790
VL - 53
SP - e316-e321
JO - Journal of Clinical Gastroenterology
JF - Journal of Clinical Gastroenterology
IS - 8
ER -