BACKGROUND: Informed consent is a phrase often used in the law to indicate that the consent a person gives meets certain minimum standards. It relies on patients' ability to understand risk information. Evidence suggests that people may extract the gist of any risk information to make medical decisions. Existing evidence also suggests that there is an inverse relationship between the perception of risk and the perception of benefit. Informed consent is the method by which fully informed, rational persons may be involved in choices about their health care. AIM: The aims of this study were to study how much patients remember of the risks discussed with them about their otolaryngologic surgery and to evaluate whether a simple intervention, the addition of an information handout, improves their recall. METHODS: This was a prospective study carried out between January and December 2009 in the Department of Otorhinolaryngology, University of Ilorin teaching hospital. Fifty patients undergoing a variety of otorhinolaryngologic procedures, including mastoidectomy, tympanoplasty, nasal polypectomy, rhinotomy, maxillectomy, and laryngoscopy, were verbally consented by the operating surgeon with a standard checklist of potential surgical complications and adverse effects. Three surgeons participated in the study. Patients were stratified into 2 groups: a higher education group and a lower education group. Within each group, patients were randomized to either a control group, consisting of a verbal explanation only, or an intervention group, which added a written handout to the verbal explanation. A follow-up telephone interview was conducted at an average of 20.6 days (range, 14-53 days) to survey for recall of the complications discussed. The main outcome measure is risk recall. This was analyzed by education level and written sheet intervention. Other parameters examined were patient demographics and time elapsed from when the consent was obtained. RESULTS: Of the 50 patients involved in the study, 30 were men and 20 were women, with male/female ratio of 1.5:1.0. The average age was 43 years (range, 16-76 years). With respect to educational status, 26 patients had the equivalent of high school or less (group 1), and 24 had some degree of postsecondary training (group 2). Overall recall of potential complications was 56%. Those who received the handout recalled 67% of the complications overall, whereas those who did not receive the handout remembered 51% of the complications. The difference was significant recall of the specific risks varied considerably. For those with potential risk of facial nerve paralysis, 88% of them recalled, which was the highest in the study. This was followed by hearing loss (85%) and nasal adhesion (23%). The least were anesthetic reactions (4%) and hoarseness (2%). Those who received the handout recalled 62% of the complications overall, whereas those who did not receive the handout remembered 51% the complications. CONCLUSION: The addition of a handout significantly alters recall of potential complications of otorhinolaryngologic surgery with the recall of specific risk highest for facial nerve paralysis.
RCT Entities:
BACKGROUND: Informed consent is a phrase often used in the law to indicate that the consent a person gives meets certain minimum standards. It relies on patients' ability to understand risk information. Evidence suggests that people may extract the gist of any risk information to make medical decisions. Existing evidence also suggests that there is an inverse relationship between the perception of risk and the perception of benefit. Informed consent is the method by which fully informed, rational persons may be involved in choices about their health care. AIM: The aims of this study were to study how much patients remember of the risks discussed with them about their otolaryngologic surgery and to evaluate whether a simple intervention, the addition of an information handout, improves their recall. METHODS: This was a prospective study carried out between January and December 2009 in the Department of Otorhinolaryngology, University of Ilorin teaching hospital. Fifty patients undergoing a variety of otorhinolaryngologic procedures, including mastoidectomy, tympanoplasty, nasal polypectomy, rhinotomy, maxillectomy, and laryngoscopy, were verbally consented by the operating surgeon with a standard checklist of potential surgical complications and adverse effects. Three surgeons participated in the study. Patients were stratified into 2 groups: a higher education group and a lower education group. Within each group, patients were randomized to either a control group, consisting of a verbal explanation only, or an intervention group, which added a written handout to the verbal explanation. A follow-up telephone interview was conducted at an average of 20.6 days (range, 14-53 days) to survey for recall of the complications discussed. The main outcome measure is risk recall. This was analyzed by education level and written sheet intervention. Other parameters examined were patient demographics and time elapsed from when the consent was obtained. RESULTS: Of the 50 patients involved in the study, 30 were men and 20 were women, with male/female ratio of 1.5:1.0. The average age was 43 years (range, 16-76 years). With respect to educational status, 26 patients had the equivalent of high school or less (group 1), and 24 had some degree of postsecondary training (group 2). Overall recall of potential complications was 56%. Those who received the handout recalled 67% of the complications overall, whereas those who did not receive the handout remembered 51% of the complications. The difference was significant recall of the specific risks varied considerably. For those with potential risk of facial nerve paralysis, 88% of them recalled, which was the highest in the study. This was followed by hearing loss (85%) and nasal adhesion (23%). The least were anesthetic reactions (4%) and hoarseness (2%). Those who received the handout recalled 62% of the complications overall, whereas those who did not receive the handout remembered 51% the complications. CONCLUSION: The addition of a handout significantly alters recall of potential complications of otorhinolaryngologic surgery with the recall of specific risk highest for facial nerve paralysis.
Authors: Johanna Glaser; Sarah Nouri; Alicia Fernandez; Rebecca L Sudore; Dean Schillinger; Michele Klein-Fedyshin; Yael Schenker Journal: Med Decis Making Date: 2020-01-16 Impact factor: 2.583