Original Contributions A Risk-Specific Anesthesia Consent Form May Hinder the Informed Consent Process Scott K. Clark, MD,* Barbara L. Leighton, Joseph L. Seltzer, MD$ Department versity,
*Assistant Professor of Anesthesiology, Department of Anesthesiology, Pennsylvania State University TAssistant Professor of Anesthesiology, Department of Anesthesiology, Jefferson Medical College SProfessor and Chairman, Department of Anesthesiology, Jefferson Medical College Address reprint requests to Dr. Clark at the Department of Anesthesiology, Pennsylvania State University, Milton S. Hershey Medical Center, P.O. Box 850, Hershey, PA 17033. USA. Presented in part at the Annual Meeting of the International Anesthesia Research Society, San Diego, March 1988. Received for publication December 28,1989; revised manuscript accepted for publication April 3, 1990. 0 1991 Butterworth-Heinemann
of Anesthesiology,
Philadelphia,
Jefferson
Medical College,
Thomas
MD,? Jefferson
Uni-
PA.
Study Objective: To evaluate the effect of a preprinted, risk-specific consent form on the amount of anesthetic risk information patients retain from the preoperative interoiew. Design: Postoperative survey of consecutive inpatients to determine risk information retained before and after implementation of a preprinted anesthesia consent form, using standard preoperative risk discussions. Setting: Inpatient units of a university medical center. Patients: Two groups of patients, both of whom received a standard oral discussion of anesthetic risk information, were compared. Patients in the control group (125 consecutive inpatients) received this information only orally and were interviewed two weeks prior to implementation of a preprinted anesthesia consent form. Patients in the study group (92 consecutive inpatients) received this information orally and via a preprinted consent form and were interviewed between the fourth and sixth weeks after implementation of a preprinted anesthesia consent form. Interventions: Anesthesia residents discussed five standard anesthetic risks with elective, adult inpatients (n = 233) during a two-week period immediately before and between the fourth and sixth weeks after instituting the mandatory use of a risk-specific anesthesia consent form. These patients were interviewed postoperatively by one of the authors to determine the amount of anesthesia risk information they retained. Measurements and Main Results: Results of the postoperative survey showed that patients in the control group retained more information concerning anesthetic risks than did those in the study group (33% vs 19%, p < 0.01). Conclusions: To improve the informed consent process, either a better method of presenting the pejninted, risk-specific consent form or another method of simultaneously conveying and documenting risk information is needed. Keywords: Anesthesia, risk management; anesthesia, consent; education, patient; informed consent; truth disclosure; documentation.
J. Clin. Anesth.,
vol. 3, January/February
1991
11
Original Contributions
Introduction The use of a risk-specific anesthesia consent form is becoming an increasingly recommended practice.’ Ideally, the use of such a form should increase patient knowledge of anesthesia while allaying anxiety. In a healthy outpatient population, however, presentation of a risk-specific anesthesia consent form during the preoperative interview increased anxiety and decreased retention of information from the risk discussion.* Giving the patient the consent form two or more hours before the preoperative interview ameliorated these effects,2 but the time required to implement this consent procedure may deter its use in many busy inpatient clinical practices. The authors performed this study to assess the effect of their consent form on anxiety and information retention in an inpatient population.
Materials and Methods In this study, approved by the Thomas Jefferson University Institutional Review Board, anesthesia residents interviewed all consenting, elective adult inpatients (n = 233) during a 2-week period immediately before and between the fourth and sixth weeks after instituting the mandatory use of a risk-specific anesthesia consent form. Two patients refused to participate in this study, one from each time period. The 125 patients interviewed before consent form implementation, who did not receive an anesthesia consent form, constituted the control group. Of the 106 patients who received a consent form, 92 patients saw the consent form for the first time during the interview; these patients constituted the study group. The remaining 14 patients were excluded because they received the consent form prior to the interview. Residents, while doing their routine preoperative anesthetic evaluations, conducted all preoperative discussions of risk and administered all preoperative surTable 1.
One of the authors interviewed each patient on the first postoperative day. During this interview, the author recited a list of the same five true risks specifically discussed with each patient preoperatively, as well as four false risks not discussed. The four false risks used for this study were arthritis flare-up, blindness, diabetes, and hair loss. Patients were asked to choose from this list the complications they remembered discussing during the preoperative interview. Patients also were asked if they had received enough information about the risks of anesthesia, if they felt a riskspecific consent form separate from the surgical consent was or would have been helpful to them, how they felt about learning the risks of anesthesia, and the highest level of education they had completed. An ordered chi-square test with Yate’s correction was used to analyze the difference between the groups. P < 0.05 was considered significant.
Results Age, ASA physical status, education level, type of surgery, and number of patients with cancer-related surgery did not significantly differ between the groups. Patients in the study group remembered 19% of the true anesthetic risks, while those in the control group remembered 33% of the true anesthetic risks overall (Table 1). The difference between these groups was statistically significant (p < 0.01). Analyzing the risks
Memory of True Risks
Risk
Control Group (%)
Study Group (%I
38 23 41 33
12* 17.t 13* 18 35 19”
Tooth damage Kidney damage Backache Paralysis Death Total
*p < 0.01 compared to control group. to control group.
tp < 0.05 compared
12
veys the night before surgery. All of these residents had at least 8 months of anesthesia training. During the preoperative interview, the resident specifically discussed with every patient five risks of anesthesia: damaged teeth, backache, kidney damage, paralysis, and death. They also recorded demographic data. Before concluding the interview, they asked the patients to rate their anxiety level on a four-point scale (calm, a little nervous, nervous, and very nervous). In the study group, the residents reviewed the consent form with the patients and discussed the same five risks as above.
J. Clin. Anesth., vol. 3, January/February
1991
Total (%) 24 25 27 21 38
Consent form may hinder informed consent process: Clark et al. Table 2.
Memory of False Risks
Risk
Arthritis flare-up Blindness Diabetes Hair loss Total
Control Group (%)
Study Group (%)
10 11 14 4 10
7 5 2* 6 6
Total (%)
9 9 9 5
*p < 0.01 compared to control group. separately, the recall rates for backache (p < O.Ol), tooth damage (p < O.Ol), and kidney damage (p < 0.05) differed significantly between the two groups. The recall rates for paralysis and death individually did not differ significantly between the groups. Overall “recall” of false risks did not differ between the groups (Table 2). However, analysis of the individual risks demonstrated that the control group “remembered” diabetes significantly more than the study group (p < 0.01). The authors found no difference in anxiety level between the groups during the preoperative or postoperative interview. Ninety percent of the patients felt that they had received enough information about the risks of anesthesia. Fifty-three percent of the patients thought that a separate anesthesia consent form either was useful or would be useful to them in the future. These percentages did not differ significantly between the groups. Two percent of the patients considered canceling their surgery after learning the risks of anesthesia, but no patient did so.
Discussion This study and a previous study the authors conducted among outpatients* are the only studies they are aware of that assess the effect of a preprinted, risk-specific consent form on patients’ memory and perception of a preoperative interview. In this study, the authors found that patients remembered less of the information conveyed during the preoperative interview if they were given a preprinted consent form at the beginning of the interview. The authors theorize that patients who see an anesthesia consent form for the first time during the preoperative interview may try to read and listen simultaneously and with their attention divided, may remember less of the preoperative discussion. The authors previously found that surgical outpatients were both more anxious and remembered
less of the information presented if they received a preprinted, risk-specific consent form at the beginning of the preoperative interview, as compared with patients who did not receive such a form.* The lack of effect on patient anxiety in the present study may be related to the use of a four-point anxiety scale rather than a visual analog scale3 or to differences in patient susceptibility to anxiety in the two groups. The present study confirms the detrimental effect of preprinted, risk-specific consent forms on patient memory. The use of risk-specific anesthesia consent forms is recommended to decrease allegations of a lack of informed consent in malpractice lawsuits.’ These forms may speed and standardize documentation of informed consent, but such a form may decrease the patient’s memory of the information discussed during the preoperative interview, as demonstrated by the present data. The risk-specific anesthesia consent form, therefore, may not serve the patient’s best interest. In summary, the authors found that patients remembered less of the information concerning anesthetic risks discussed during the preoperative interview if they received a preprinted, risk-specific anesthesia consent form at the beginning of the interview. In the present study, this form did not increase patient anxiety. Patients may benefit if physicians use an alternative method of presenting a preprinted, risk-specific consent form to them or another means of documenting informed consent.
References Bowyer EA, Paulson L: Informed consent allegations affect all specialties. Risk Management Foundation Forum 1986;7:3-6.
Leighton BL, Bauman J, Seltzer JL, Menduke H: The effect of a detailed anesthesia consent form on patient recall and anxiety [Abstract]. Anesthesiology 1987;67:A567. Joyce CRB, Zutshi DW, Hrubes V, Mason RM: Comparison of fixed interval and visual analog scales for rating chronic pain. Eur J Clin Ph~~rmacol 1975;8:41520.
J. Clin. Anesth.,
vol. 3, January/February
1991
13
*Assistant Professor of Anesthesiology, Department of Anesthesiology, Pennsylvania State University TAssistant Professor of Anesthesiology, Department of Anesthesiology, Jefferson Medical College SProfessor and Chairman, Department of Anesthesiology, Jefferson Medical College Address reprint requests to Dr. Clark at the Department of Anesthesiology, Pennsylvania State University, Milton S. Hershey Medical Center, P.O. Box 850, Hershey, PA 17033. USA. Presented in part at the Annual Meeting of the International Anesthesia Research Society, San Diego, March 1988. Received for publication December 28,1989; revised manuscript accepted for publication April 3, 1990. 0 1991 Butterworth-Heinemann
of Anesthesiology,
Philadelphia,
Jefferson
Medical College,
Thomas
MD,? Jefferson
Uni-
PA.
Study Objective: To evaluate the effect of a preprinted, risk-specific consent form on the amount of anesthetic risk information patients retain from the preoperative interoiew. Design: Postoperative survey of consecutive inpatients to determine risk information retained before and after implementation of a preprinted anesthesia consent form, using standard preoperative risk discussions. Setting: Inpatient units of a university medical center. Patients: Two groups of patients, both of whom received a standard oral discussion of anesthetic risk information, were compared. Patients in the control group (125 consecutive inpatients) received this information only orally and were interviewed two weeks prior to implementation of a preprinted anesthesia consent form. Patients in the study group (92 consecutive inpatients) received this information orally and via a preprinted consent form and were interviewed between the fourth and sixth weeks after implementation of a preprinted anesthesia consent form. Interventions: Anesthesia residents discussed five standard anesthetic risks with elective, adult inpatients (n = 233) during a two-week period immediately before and between the fourth and sixth weeks after instituting the mandatory use of a risk-specific anesthesia consent form. These patients were interviewed postoperatively by one of the authors to determine the amount of anesthesia risk information they retained. Measurements and Main Results: Results of the postoperative survey showed that patients in the control group retained more information concerning anesthetic risks than did those in the study group (33% vs 19%, p < 0.01). Conclusions: To improve the informed consent process, either a better method of presenting the pejninted, risk-specific consent form or another method of simultaneously conveying and documenting risk information is needed. Keywords: Anesthesia, risk management; anesthesia, consent; education, patient; informed consent; truth disclosure; documentation.
J. Clin. Anesth.,
vol. 3, January/February
1991
11
Original Contributions
Introduction The use of a risk-specific anesthesia consent form is becoming an increasingly recommended practice.’ Ideally, the use of such a form should increase patient knowledge of anesthesia while allaying anxiety. In a healthy outpatient population, however, presentation of a risk-specific anesthesia consent form during the preoperative interview increased anxiety and decreased retention of information from the risk discussion.* Giving the patient the consent form two or more hours before the preoperative interview ameliorated these effects,2 but the time required to implement this consent procedure may deter its use in many busy inpatient clinical practices. The authors performed this study to assess the effect of their consent form on anxiety and information retention in an inpatient population.
Materials and Methods In this study, approved by the Thomas Jefferson University Institutional Review Board, anesthesia residents interviewed all consenting, elective adult inpatients (n = 233) during a 2-week period immediately before and between the fourth and sixth weeks after instituting the mandatory use of a risk-specific anesthesia consent form. Two patients refused to participate in this study, one from each time period. The 125 patients interviewed before consent form implementation, who did not receive an anesthesia consent form, constituted the control group. Of the 106 patients who received a consent form, 92 patients saw the consent form for the first time during the interview; these patients constituted the study group. The remaining 14 patients were excluded because they received the consent form prior to the interview. Residents, while doing their routine preoperative anesthetic evaluations, conducted all preoperative discussions of risk and administered all preoperative surTable 1.
One of the authors interviewed each patient on the first postoperative day. During this interview, the author recited a list of the same five true risks specifically discussed with each patient preoperatively, as well as four false risks not discussed. The four false risks used for this study were arthritis flare-up, blindness, diabetes, and hair loss. Patients were asked to choose from this list the complications they remembered discussing during the preoperative interview. Patients also were asked if they had received enough information about the risks of anesthesia, if they felt a riskspecific consent form separate from the surgical consent was or would have been helpful to them, how they felt about learning the risks of anesthesia, and the highest level of education they had completed. An ordered chi-square test with Yate’s correction was used to analyze the difference between the groups. P < 0.05 was considered significant.
Results Age, ASA physical status, education level, type of surgery, and number of patients with cancer-related surgery did not significantly differ between the groups. Patients in the study group remembered 19% of the true anesthetic risks, while those in the control group remembered 33% of the true anesthetic risks overall (Table 1). The difference between these groups was statistically significant (p < 0.01). Analyzing the risks
Memory of True Risks
Risk
Control Group (%)
Study Group (%I
38 23 41 33
12* 17.t 13* 18 35 19”
Tooth damage Kidney damage Backache Paralysis Death Total
*p < 0.01 compared to control group. to control group.
tp < 0.05 compared
12
veys the night before surgery. All of these residents had at least 8 months of anesthesia training. During the preoperative interview, the resident specifically discussed with every patient five risks of anesthesia: damaged teeth, backache, kidney damage, paralysis, and death. They also recorded demographic data. Before concluding the interview, they asked the patients to rate their anxiety level on a four-point scale (calm, a little nervous, nervous, and very nervous). In the study group, the residents reviewed the consent form with the patients and discussed the same five risks as above.
J. Clin. Anesth., vol. 3, January/February
1991
Total (%) 24 25 27 21 38
Consent form may hinder informed consent process: Clark et al. Table 2.
Memory of False Risks
Risk
Arthritis flare-up Blindness Diabetes Hair loss Total
Control Group (%)
Study Group (%)
10 11 14 4 10
7 5 2* 6 6
Total (%)
9 9 9 5
*p < 0.01 compared to control group. separately, the recall rates for backache (p < O.Ol), tooth damage (p < O.Ol), and kidney damage (p < 0.05) differed significantly between the two groups. The recall rates for paralysis and death individually did not differ significantly between the groups. Overall “recall” of false risks did not differ between the groups (Table 2). However, analysis of the individual risks demonstrated that the control group “remembered” diabetes significantly more than the study group (p < 0.01). The authors found no difference in anxiety level between the groups during the preoperative or postoperative interview. Ninety percent of the patients felt that they had received enough information about the risks of anesthesia. Fifty-three percent of the patients thought that a separate anesthesia consent form either was useful or would be useful to them in the future. These percentages did not differ significantly between the groups. Two percent of the patients considered canceling their surgery after learning the risks of anesthesia, but no patient did so.
Discussion This study and a previous study the authors conducted among outpatients* are the only studies they are aware of that assess the effect of a preprinted, risk-specific consent form on patients’ memory and perception of a preoperative interview. In this study, the authors found that patients remembered less of the information conveyed during the preoperative interview if they were given a preprinted consent form at the beginning of the interview. The authors theorize that patients who see an anesthesia consent form for the first time during the preoperative interview may try to read and listen simultaneously and with their attention divided, may remember less of the preoperative discussion. The authors previously found that surgical outpatients were both more anxious and remembered
less of the information presented if they received a preprinted, risk-specific consent form at the beginning of the preoperative interview, as compared with patients who did not receive such a form.* The lack of effect on patient anxiety in the present study may be related to the use of a four-point anxiety scale rather than a visual analog scale3 or to differences in patient susceptibility to anxiety in the two groups. The present study confirms the detrimental effect of preprinted, risk-specific consent forms on patient memory. The use of risk-specific anesthesia consent forms is recommended to decrease allegations of a lack of informed consent in malpractice lawsuits.’ These forms may speed and standardize documentation of informed consent, but such a form may decrease the patient’s memory of the information discussed during the preoperative interview, as demonstrated by the present data. The risk-specific anesthesia consent form, therefore, may not serve the patient’s best interest. In summary, the authors found that patients remembered less of the information concerning anesthetic risks discussed during the preoperative interview if they received a preprinted, risk-specific anesthesia consent form at the beginning of the interview. In the present study, this form did not increase patient anxiety. Patients may benefit if physicians use an alternative method of presenting a preprinted, risk-specific consent form to them or another means of documenting informed consent.
References Bowyer EA, Paulson L: Informed consent allegations affect all specialties. Risk Management Foundation Forum 1986;7:3-6.
Leighton BL, Bauman J, Seltzer JL, Menduke H: The effect of a detailed anesthesia consent form on patient recall and anxiety [Abstract]. Anesthesiology 1987;67:A567. Joyce CRB, Zutshi DW, Hrubes V, Mason RM: Comparison of fixed interval and visual analog scales for rating chronic pain. Eur J Clin Ph~~rmacol 1975;8:41520.
J. Clin. Anesth.,
vol. 3, January/February
1991
13
![[Patient information through informed consent form].](/assets/img/hold.png)
