OBJECTIVE: Informed consent is a critical component of all surgical procedures, but patients' understanding and recall of the potential risks/benefits is poor. We hypothesized that utilization of multiple standardized education modalities in the informed consent process would allow for better retention and a more informed patient. METHODS: A total of 151 patients undergoing primary total knee arthroplasty (TKA) were randomized to 3 groups: group 1 received standardized informed consent and a paper handout detailing the risks/benefits of TKA; group 2 received standardized informed consent, a paper handout, and a video discussing the risks/benefits of TKA; and group 3 followed the same process as group 2 plus formal nurse education. All patients completed a 15-item questionnaire (risks, indications, and expectations) immediately following this consent process on the morning of surgery and 6 weeks postoperatively. We used t-test and analysis of variance for data analyses. RESULTS: There was no difference (P = 0.79) in satisfaction with the consent process between the 3 groups; 92-97% of the patients rated the consent process as good to excellent at all time points. The number of correct answers did not differ significantly between the groups at any time period (P = 0.31-0.81). Scores dropped significantly (P = 0.004) from preoperatively to the 6-week postoperative visit in all groups combined. A higher level of satisfaction with the process was reflected in higher scores preoperatively in all groups (P = 0.028). CONCLUSION: Preoperatively, patients satisfied with the consent process may have better recall of risks/benefits and expectations of surgery. Neither retention nor satisfaction was influenced by reinforcement methods, such as video or nurse education; they may therefore be unnecessary.
RCT Entities:
OBJECTIVE: Informed consent is a critical component of all surgical procedures, but patients' understanding and recall of the potential risks/benefits is poor. We hypothesized that utilization of multiple standardized education modalities in the informed consent process would allow for better retention and a more informed patient. METHODS: A total of 151 patients undergoing primary total knee arthroplasty (TKA) were randomized to 3 groups: group 1 received standardized informed consent and a paper handout detailing the risks/benefits of TKA; group 2 received standardized informed consent, a paper handout, and a video discussing the risks/benefits of TKA; and group 3 followed the same process as group 2 plus formal nurse education. All patients completed a 15-item questionnaire (risks, indications, and expectations) immediately following this consent process on the morning of surgery and 6 weeks postoperatively. We used t-test and analysis of variance for data analyses. RESULTS: There was no difference (P = 0.79) in satisfaction with the consent process between the 3 groups; 92-97% of the patients rated the consent process as good to excellent at all time points. The number of correct answers did not differ significantly between the groups at any time period (P = 0.31-0.81). Scores dropped significantly (P = 0.004) from preoperatively to the 6-week postoperative visit in all groups combined. A higher level of satisfaction with the process was reflected in higher scores preoperatively in all groups (P = 0.028). CONCLUSION: Preoperatively, patients satisfied with the consent process may have better recall of risks/benefits and expectations of surgery. Neither retention nor satisfaction was influenced by reinforcement methods, such as video or nurse education; they may therefore be unnecessary.
Authors: Sonia Ranganath Adams; Michele R Hacker; Anna Merport Modest; Peter L Rosenblatt; Eman A Elkadry Journal: Female Pelvic Med Reconstr Surg Date: 2012 Nov-Dec Impact factor: 2.091
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
Authors: Louis Courtot; Fabrice Ferre; Nicolas Reina; Vincent Marot; Philippe Chiron; Emilie Berard; Etienne Cavaignac Journal: Orthop J Sports Med Date: 2019-04-29