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Pilot study using an Internet-based program in informed consent
Journal of Pediatric Surgery (2010) 45, 1137–1141
www.elsevier.com/locate/jpedsurg
Pilot study using an Internet-based program in informed consent Beth Rymeski a,b,⁎, Michael Marchildon b , Douglas A. Katz b , Charles D. Vinocur b , Stephen P. Dunn b , Kirk W. Reichard b , Jennifer Cassity b , Dorothy Gould b , Stephen G. Murphy b,⁎ a
Department of Surgery, Christiana Care Health System, Newark, DE 19713, USA Department of Pediatric General Surgery, A.I. duPont Hospital for Children, Wilmington, DE 19803, USA
b
Received 10 February 2010; accepted 22 February 2010
Key words: Informed consent; Recall; Surgical complications; Internet; Emmi program
Abstract Purpose: To examine the effect of an internet-based aid to informed consent on parent recall of potential surgical complications. Methods: Parents of children scheduled for elective inguinal hernia repair were assigned to a control group or were enrolled in an internet-based program designed to aid in the consent process. Nine potential surgical complications were presented to the parent(s) in the consent discussion and in the Internet program. Parent recall of potential surgical complications was assessed immediately after the consent discussion and on the day of surgery. Results: Overall recall of complications was poor in both groups, both immediately and on the day of surgery. Parents in the control group (n = 13) recalled a mean of 2.9 complications immediately and 1.5 on the day of surgery, approaching statistical significance (P = .056). The parents in the internet program group (n = 17) recalled a mean of 2.6 complications immediately and 2.9 on the day of surgery (P = NS). There was no significant difference in immediate recall between the two groups, but there was a trend towards statistically significant improvement in recall in the study group the day of surgery vs. controls (P = .06). Conclusion: Although overall recall of potential surgical complications was poor in both groups, there was a trend towards a significant improvement in recall in the study group after viewing the Internetbased program. © 2010 Elsevier Inc. All rights reserved.
The problem of informed consent is neither new nor unique to surgery, yet it is something that we face on a daily basis as surgeons. Many studies have documented how ⁎ Corresponding author. Beth Rymeski c/o Stephen Murphy Department of General Surgery A.I. duPont Hospital for Children, Wilmington, DE 19803, USA. E-mail address: [email protected] (B. Rymeski). 0022-3468/$ – see front matter © 2010 Elsevier Inc. All rights reserved. doi:10.1016/j.jpedsurg.2010.02.071
poorly “informed” patients seemingly are about the surgery that has been performed, including a study by Byrne at al [1]. In this study, 100 post-surgical patients were asked between postoperative days 2 and 5 some basic information on the surgery that had been performed. An alarming 27% did not know which organ had been operated on and 47% lacked basic understanding of the procedure that had been performed (ie, gallbladder was removed in a cholecystectomy).
1138
B. Rymeski et al.
In response to the apparent lack of understanding despite signing “informed consent” for procedures, many groups have tried different techniques to improve patient understanding and recall including written sheets, preoperative counseling, tests prior to signing consent, and videos [2-6]. Results from these studies have been largely mixed and overall unsatisfying. Other studies have examined patient characteristics that affect ability to recall and/or understand medical and surgical risks, demonstrating some mixed results as well. Some studies have shown that advancing age, lower IQ, and lack of education negatively affect ability to recall risks and information about surgery [7,8]. Our pilot study looked at a new internet-based program now available to aid with informed consent at our institution. An initial study performed when the program was first introduced at our institution demonstrated that parents felt that the program both affected their understanding of their child's procedure and covered risks of the procedure that were previously unknown [9] (Table 1). These results made us wonder whether the parents were actually learning new information or just forgetting information that had been presented. The goal of our pilot study was to see if use of the internet program affected recall of potential surgical complications by comparing parents who had completed the program to those who had the conventional consent discussion without the additional use of the Internet program.
1. Materials and methods 1.1. Study design The study was a prospective, randomized trial approved by the institutional review board at the A.I. duPont Hospital for Children. All children seen in the outpatient general surgery clinic for inguinal hernia or hydrocele repair were considered for the trial. Exclusion criteria were language other than English as primary spoken language and lack of access to a computer and/or the internet. Patients were screened for study inclusion primarily by a nurse in the office trained for this task and also by the participating surgeons. All parents who did not meet the exclusion criteria were invited to participate in the Table 1
trial and randomized into the control or experimental group using an odd/even system based on the last digit of the child's medical record number. Informed consent was obtained from the parent or parents of the minor child. Parent completion of the Emmi program was tracked through a designated Emmi manager (first author) to determine whether the program had been started or completed. Parents who were assigned to the Emmi group and either started or completed the program were analyzed as part of the Emmi group. Parents who were assigned to the Emmi group but who never logged into the program were analyzed with the control group.
1.2. Emmi program The Internet program utilized for this study was the Emmi (Expectation Management and Medical Information) program which was jointly developed by Emmi Solutions and KidsHealth with input from physician experts on each topic. Each Emmi program reviews the pertinent anatomy and physiology, details of the surgical procedure, what to expect before and after surgery, and the risks and benefits of the surgery. Emmi utilizes a combination of audio, visual, and animation to review the above topics. Emmi can be stopped and restarted multiple times and can be viewed an unlimited number of times. The program can be accessed by parents only after being issued a unique code by the surgical office. Each parent with a code can be tracked through the system by designated Emmi managers to determine if the program was started or completed. Separate Emmi programs are available for male and female hernia anatomy.
1.3. Consent discussion At the presurgical meeting, a discussion of the surgery and its risks and benefits took place between the surgeon and the parent(s) according to the individual surgeon's typical consent discussion. Each surgeon was, however, required to discuss each of the risks of surgery described on the Internet program and document this in the study paperwork. For male patients, 9 potential risks or complications were discussed: hernia recurrence, surgical site infection, injury to the vas
Parent Impression of the Emmi program
Survey question
2007 survey (% positive responses)
Current study (% positive responses)
Affected understanding of anticipated procedure/surgery Provided new information Increased comfort level Answered questions and/or saved phone call to physician Covered risks previously unknown Better understanding of what to expect BEFORE Better understanding of what to expect AFTER
90 74 72 53 66 90 92
94 94 88 50 50 75 81
First column shows data collected from our initial study when the Emmi program was launched in 2007 (n = 107). Second column shows data collected during current study of parents who completed the Emmi program (n = 16). Scored on a ranking system 1 to 5; score of 4 or 5 taken as a positive response.
Internet-based program in informed consent deferens, injury to intraabdominal organs, injury to the spermatic cord, bleeding, migration of the testes out of the scrotum, injury to nerves, and complications from anesthesia. For female patients, only 6 potential complications were discussed as the risks of injury to the vas deferens, injury to the spermatic cord, and migration of the testes out of the scrotum were omitted.
1.4. Study surveys The first survey was completed at the time of the initial pre-surgical evaluation after the informed consent discussion had taken place between the surgeon and the parent(s). The same parent was required to complete both surveys for consistency of data. Information obtained on the first survey included: parent age, highest level of education completed, occupation, home ZIP code, history of previous hernia surgery in any family member, and whether any reading or research had been done in reference to hernias. The parent was also asked to answer questions about his or her satisfaction with the consent discussion that had taken place with the surgeon prior to completing the survey using a 1-5 scale. Answers of 1 or 2 were taken as negative responses, 3 as neutral, and 4 or 5 as positive responses. The main purpose of the survey was to obtain the number of potential risks or complications of the surgery that the parent could recall and they were asked to list all that they could remember in a blank space on the form. The second survey was completed on the day of surgery in the preoperative waiting area by the same parent who had completed the first survey. The second survey also asked the parent to recall as many of the potential risks or complications of the surgery as he or she was able to in a blank space on the form. Parents who had completed the Emmi program were asked to answer the same questions about the Emmi program as had been asked in the initial study (see Table 1).
2. Results 2.1. Study demographics In the initial pilot study, 13 control group patients and 17 Emmi group patients were analyzed. The mean age of the parent completing the surveys was 33.3 years in the control group and 34.9 years in the Emmi group (P = NS). There was no significant difference in the educational background of the parent completing the survey in the control compared to the Emmi group. Three parents in the control group worked or had worked in the healthcare field (1 registered nurse, 1 medical coder, and 1 physician office manager). Five parents in the Emmi group worked or had worked in the healthcare field (1 registered nurse, 1 speech pathologist, 1 physician business manager, and 2 unknown positions). The mean time between the first and second surveys (ie, the mean time
1139 between the consent discussion and surgery) was 31.2 days in the control versus 33.4 days in the Emmi group (P = NS). Socioeconomic status was derived by using the mean adjusted gross income (AGI) for the zip code provided on the survey and comparing that to the AGI for the state that the parent lived in. Using this method, there was no significant difference in the AGI of the control versus the Emmi groups (control mean 96% of state AGI vs. Emmi mean 102% of state AGI). There was no difference in the number of parents in either group that reported a history of hernia surgery in the family or that admitted to reading or researching hernia surgery prior to the office visit.
2.2. Initial evaluation of surgeon consent discussion All study participants were asked to evaluate the initial discussion about the risks and benefits of the surgery using a 1-5 scale; 100% of the study participants (control and Emmi groups) answered questions regarding their comfort level with the consent discussion favorably (ie, rated a 4 or 5 with positively phrased questions or a 1 or 2 with negatively phrased questions). Questions in this portion of the survey included: “I feel that my surgeon took time to explain the procedure to me and make sure I was comfortable with the surgery,” “My surgeon used language that I could understand when explaining the procedure,” and “I am happy with the process of obtaining consent for surgery” among others. Six percent of the study participants responded with a 4 or 5 in response to the statement, “I feel that I need more information about the surgery.”
2.3. Recall of potential surgical complications Parents in the control group recalled a mean of 2.9 potential risks or complications immediately following the consent discussion with the surgeon (range, 0-8). Parents in the Emmi group recalled a mean of 2.6 potential risks or complications immediately (range, 0-6). At the time of the second survey, the control group recalled a mean of 1.5 complications (range, 0-4) compared to the Emmi group who recalled a mean of 2.9 complications (range, 0-8). Comparing number of complications remembered in the control group between surveys 1 and 2, there was a trend towards a significant decrease in the number of complications recalled (P = .056). There was no difference between the number of complications recalled in the Emmi group between surveys 1 and 2. There was also a trend towards significance when comparing the number of complications recalled at survey 2 between the control and Emmi groups (P = .06). Summary of the results is displayed in Figs. 1A and 1B.
2.4. Parent impression of Emmi program Parents who completed the Emmi program were asked to evaluate the program on survey 2. The same questions that
1140
Fig. 1 A and B, Recall of potential surgical complications. A, Comparison of control group and study group at two survey time points demonstrating a trend towards a significant decrease in the mean number of complications recalled in the control group. B, Comparison of control group and study group at two survey time points demonstrating a trend towards significant improvement of mean number of complications recalled on the day of surgery by the study group.
were asked in the initial study shown in Table 1 were asked of the parents in this study. One of the parents who completed the Emmi program did not answer the questions about the program on survey 2. All of the parents who completed the survey reported that they found the Emmi program easy to use. Of the 16 parents, 15 (94%) reported learning new information about the surgery from the Emmi program and that the Emmi program had affected their understanding of the surgery. Of the 16 parents, 8 (50%) reported that the Emmi program covered risks of the surgery previously unknown to them.
3. Discussion Patient recall of potential surgical complications has been shown in multiple studies to be poor, despite the use of multiple methods to attempt to improve patient understanding. Our study represents an attempt to use a new technology to assist with the consent discussion in order to improve parent comfort with their child's surgery and to
B. Rymeski et al. improve understanding of the potential surgical complications. Our results proved similar to previous studies, in that overall recall of complications was poor. Even at the initial survey completed within 30 minutes of the consent discussion with the surgeon, the mean recall was less than 3 of 9 complications. At the second survey, recall worsened in the control group and maintained at approximately the same level in the Emmi group. This would lead one to believe that completion of the Emmi program resulted in maintenance of knowledge of complications, perhaps owing to the repetition of information previously conveyed by the surgeon. What is perhaps more interesting about our results is the parent's perception of both the Emmi program and the information that was presented in the program. All of the parents who completed the Emmi program rated it favorably and none found it difficult to use. Like our first study, the parents felt that they learned new information about the surgery from the program and stated that they felt more comfortable with the surgery after viewing the program. Perhaps it is the combination of audio, visual, animation, and voice information that allows the parent to absorb more information about the surgery. It is not unreasonable to assume that viewing the information outside of the hectic and perhaps stressful setting of a surgeon's office aids in parent ability to really “hear” the information. Half of the parents in the Emmi group reported that they learned new complications of the surgery, despite the fact that all of the potential complications were actually told to them by the surgeon in the pre-operative meeting. This tells us that despite the words being said, the parents either did not hear them or did not understand them; we suspect that it is likely a combination of both. It seems that the addition of the Emmi program was able to describe the surgical risks in a way that the surgeon alone was not able. While we cannot definitively say that recall of potential surgical complications was improved by completion of the Emmi program, there does seem to be some maintenance of recall that was not seen in the control group. What may be more important, however, is the parental impression that use of the program positively affected understanding of the surgical procedure and its inherent risks. This benefit alone may be enough to support the use of the Emmi program as an aid in the consent discussion.
References [1] Byrne DJ, Napier A, Cuschieri A. How informed is signed consent? BMJ 1988;296:839-40. [2] Langdon IJ, Hardin R, Learmonth ID. Informed consent for total hip arthroplasty: does a written information sheet improve recall by patients? Ann R Coll Surg Engl 2002;84:404-8. [3] Madan AK, et al. Postoperative laparoscopic bariatric surgery patients do not remember potential complications. Obesity Surgery 2007;17: 885-8.
Internet-based program in informed consent [4] Hutson MM, Blaha JD. Patients' recall of preoperative instruction for informed consent for an operation. J Bone Joint Surg 1991;73:160-2. [5] Eggers C, Obliers R, Koerfer A, et al. A multimedia tool for the informed consent of patients prior to gastric banding. Obesity 2007;15: 2866-73. [6] Steffenino G, Viada E, Marengo B, et al. Effectiveness of video-based patient information before percutaneous cardiac interventions. J Cardiovasc Med 2007;8:348-53. [7] Lavelle-Jones C, Bryne DJ, Rice P, et al. Factors affecting quality of informed consent. BMJ 1993;306:885-90. [8] Lemaire R. Informed consent—contemporary myth? J Bone Joint Surg 2006;88-B:2-7. [9] Rymeski BA, Wolfson P, Murphy SG. The use of an Internet-based module to improve the informed consent process in pediatric procedures: initial data from the Emmi program. Presented at the 39th annual meeting of the Canadian Association of Pediatric Surgeons, St John's, New Foundland, Canada, August 23-26; 2007.
Discussion Mary Brandt, MD (Houston, Tex): Did I understand you say this is commercially available? Would you tell us just a little bit about this such as the cost? Beth Rymeski, MD (response): This is a program that was developed with a company and with the doctors at our hospital. It's commercially available, but I do not know the specific cost. Robert Sollingberger (Moody, Tex): The U.S. government has been pushing e-based programs for permits for a long time. Did you have a feel for how much time you spent getting the permit by using the internet-based permit as opposed to the verbal one? It's been my experience that the longer you spend talking with a patient, the better understanding they have, and I know that time is money. Beth Rymeski, MD (response): This was not meant to replace the consent discussion with the surgeon. In all of these cases, regardless of whether or not they completed the internet program, they had a consent discussion with the surgeon in the office, which was per that surgeon’s typical routine. The only caveat was that they had to mention and document those nine potential complications. The consent discussion would be variable in exactly how the information was presented and exactly what was said depending surgeon to surgeon. The internet program was in addition to that, so probably if you or I went
1141 through this program, it would take us about 20-30 minutes; if a parent were going through it who is unfamiliar with this, it may take up to an hour to go through. It also has the option of you can go back and repeat slides, you could watch this an unlimited number of times, so the amount of time that the parents use it is very variable but it was not meant to replace a consent discussion with the surgeon. Stephen Shochat, MD (Memphis, Tenn): If you're having this problem with hernia repairs, how difficult it is in patients with a malignancy that are being enrolled on a controlled clinical trial. It's not only information issues but it's also trying to take out the bias of the principal investigator. So we are developing similar techniques and developing videos and so forth to show to the parents prior to the discussion of the protocol. When do you show this to the parents? Do the parents get this before they see the surgeon, and then the surgeon can interpret some parts of the program? Or does the surgeon see the parents first, then you show the web, because I think that is an important issue. Beth Rymeski, MD (response): The typical scenario would be that the patient was referred to us by their pediatrician for evaluation of an inguinal hernia, they were determined to have an inguinal hernia and given the option to schedule for surgery, so they would be given the log-on code at that time. So they wouldn't access the program until after they have already talked to their surgeon. There is a feature on the program where you can, if you want to ask questions to your surgeon, you can email them to the surgeon, it goes to our secretaries, and then they can pass those along to the doctor who is going to be the operating surgeon. Steven Stylianos, MD (Miami, Fla): We have used the Emmi product for about two years at Miami Children's in a multilingual population and it is an outstanding product. They have a beautiful segment on anesthesia in children and that's the one that's viewed more than the actual procedure, we found in our two-year experience. So the parents take the code home and rather than logging onto the hernia, they'll log onto the anesthesia section. It's been remarkable in how much customer satisfaction we have had with the program.
www.elsevier.com/locate/jpedsurg
Pilot study using an Internet-based program in informed consent Beth Rymeski a,b,⁎, Michael Marchildon b , Douglas A. Katz b , Charles D. Vinocur b , Stephen P. Dunn b , Kirk W. Reichard b , Jennifer Cassity b , Dorothy Gould b , Stephen G. Murphy b,⁎ a
Department of Surgery, Christiana Care Health System, Newark, DE 19713, USA Department of Pediatric General Surgery, A.I. duPont Hospital for Children, Wilmington, DE 19803, USA
b
Received 10 February 2010; accepted 22 February 2010
Key words: Informed consent; Recall; Surgical complications; Internet; Emmi program
Abstract Purpose: To examine the effect of an internet-based aid to informed consent on parent recall of potential surgical complications. Methods: Parents of children scheduled for elective inguinal hernia repair were assigned to a control group or were enrolled in an internet-based program designed to aid in the consent process. Nine potential surgical complications were presented to the parent(s) in the consent discussion and in the Internet program. Parent recall of potential surgical complications was assessed immediately after the consent discussion and on the day of surgery. Results: Overall recall of complications was poor in both groups, both immediately and on the day of surgery. Parents in the control group (n = 13) recalled a mean of 2.9 complications immediately and 1.5 on the day of surgery, approaching statistical significance (P = .056). The parents in the internet program group (n = 17) recalled a mean of 2.6 complications immediately and 2.9 on the day of surgery (P = NS). There was no significant difference in immediate recall between the two groups, but there was a trend towards statistically significant improvement in recall in the study group the day of surgery vs. controls (P = .06). Conclusion: Although overall recall of potential surgical complications was poor in both groups, there was a trend towards a significant improvement in recall in the study group after viewing the Internetbased program. © 2010 Elsevier Inc. All rights reserved.
The problem of informed consent is neither new nor unique to surgery, yet it is something that we face on a daily basis as surgeons. Many studies have documented how ⁎ Corresponding author. Beth Rymeski c/o Stephen Murphy Department of General Surgery A.I. duPont Hospital for Children, Wilmington, DE 19803, USA. E-mail address: [email protected] (B. Rymeski). 0022-3468/$ – see front matter © 2010 Elsevier Inc. All rights reserved. doi:10.1016/j.jpedsurg.2010.02.071
poorly “informed” patients seemingly are about the surgery that has been performed, including a study by Byrne at al [1]. In this study, 100 post-surgical patients were asked between postoperative days 2 and 5 some basic information on the surgery that had been performed. An alarming 27% did not know which organ had been operated on and 47% lacked basic understanding of the procedure that had been performed (ie, gallbladder was removed in a cholecystectomy).
1138
B. Rymeski et al.
In response to the apparent lack of understanding despite signing “informed consent” for procedures, many groups have tried different techniques to improve patient understanding and recall including written sheets, preoperative counseling, tests prior to signing consent, and videos [2-6]. Results from these studies have been largely mixed and overall unsatisfying. Other studies have examined patient characteristics that affect ability to recall and/or understand medical and surgical risks, demonstrating some mixed results as well. Some studies have shown that advancing age, lower IQ, and lack of education negatively affect ability to recall risks and information about surgery [7,8]. Our pilot study looked at a new internet-based program now available to aid with informed consent at our institution. An initial study performed when the program was first introduced at our institution demonstrated that parents felt that the program both affected their understanding of their child's procedure and covered risks of the procedure that were previously unknown [9] (Table 1). These results made us wonder whether the parents were actually learning new information or just forgetting information that had been presented. The goal of our pilot study was to see if use of the internet program affected recall of potential surgical complications by comparing parents who had completed the program to those who had the conventional consent discussion without the additional use of the Internet program.
1. Materials and methods 1.1. Study design The study was a prospective, randomized trial approved by the institutional review board at the A.I. duPont Hospital for Children. All children seen in the outpatient general surgery clinic for inguinal hernia or hydrocele repair were considered for the trial. Exclusion criteria were language other than English as primary spoken language and lack of access to a computer and/or the internet. Patients were screened for study inclusion primarily by a nurse in the office trained for this task and also by the participating surgeons. All parents who did not meet the exclusion criteria were invited to participate in the Table 1
trial and randomized into the control or experimental group using an odd/even system based on the last digit of the child's medical record number. Informed consent was obtained from the parent or parents of the minor child. Parent completion of the Emmi program was tracked through a designated Emmi manager (first author) to determine whether the program had been started or completed. Parents who were assigned to the Emmi group and either started or completed the program were analyzed as part of the Emmi group. Parents who were assigned to the Emmi group but who never logged into the program were analyzed with the control group.
1.2. Emmi program The Internet program utilized for this study was the Emmi (Expectation Management and Medical Information) program which was jointly developed by Emmi Solutions and KidsHealth with input from physician experts on each topic. Each Emmi program reviews the pertinent anatomy and physiology, details of the surgical procedure, what to expect before and after surgery, and the risks and benefits of the surgery. Emmi utilizes a combination of audio, visual, and animation to review the above topics. Emmi can be stopped and restarted multiple times and can be viewed an unlimited number of times. The program can be accessed by parents only after being issued a unique code by the surgical office. Each parent with a code can be tracked through the system by designated Emmi managers to determine if the program was started or completed. Separate Emmi programs are available for male and female hernia anatomy.
1.3. Consent discussion At the presurgical meeting, a discussion of the surgery and its risks and benefits took place between the surgeon and the parent(s) according to the individual surgeon's typical consent discussion. Each surgeon was, however, required to discuss each of the risks of surgery described on the Internet program and document this in the study paperwork. For male patients, 9 potential risks or complications were discussed: hernia recurrence, surgical site infection, injury to the vas
Parent Impression of the Emmi program
Survey question
2007 survey (% positive responses)
Current study (% positive responses)
Affected understanding of anticipated procedure/surgery Provided new information Increased comfort level Answered questions and/or saved phone call to physician Covered risks previously unknown Better understanding of what to expect BEFORE Better understanding of what to expect AFTER
90 74 72 53 66 90 92
94 94 88 50 50 75 81
First column shows data collected from our initial study when the Emmi program was launched in 2007 (n = 107). Second column shows data collected during current study of parents who completed the Emmi program (n = 16). Scored on a ranking system 1 to 5; score of 4 or 5 taken as a positive response.
Internet-based program in informed consent deferens, injury to intraabdominal organs, injury to the spermatic cord, bleeding, migration of the testes out of the scrotum, injury to nerves, and complications from anesthesia. For female patients, only 6 potential complications were discussed as the risks of injury to the vas deferens, injury to the spermatic cord, and migration of the testes out of the scrotum were omitted.
1.4. Study surveys The first survey was completed at the time of the initial pre-surgical evaluation after the informed consent discussion had taken place between the surgeon and the parent(s). The same parent was required to complete both surveys for consistency of data. Information obtained on the first survey included: parent age, highest level of education completed, occupation, home ZIP code, history of previous hernia surgery in any family member, and whether any reading or research had been done in reference to hernias. The parent was also asked to answer questions about his or her satisfaction with the consent discussion that had taken place with the surgeon prior to completing the survey using a 1-5 scale. Answers of 1 or 2 were taken as negative responses, 3 as neutral, and 4 or 5 as positive responses. The main purpose of the survey was to obtain the number of potential risks or complications of the surgery that the parent could recall and they were asked to list all that they could remember in a blank space on the form. The second survey was completed on the day of surgery in the preoperative waiting area by the same parent who had completed the first survey. The second survey also asked the parent to recall as many of the potential risks or complications of the surgery as he or she was able to in a blank space on the form. Parents who had completed the Emmi program were asked to answer the same questions about the Emmi program as had been asked in the initial study (see Table 1).
2. Results 2.1. Study demographics In the initial pilot study, 13 control group patients and 17 Emmi group patients were analyzed. The mean age of the parent completing the surveys was 33.3 years in the control group and 34.9 years in the Emmi group (P = NS). There was no significant difference in the educational background of the parent completing the survey in the control compared to the Emmi group. Three parents in the control group worked or had worked in the healthcare field (1 registered nurse, 1 medical coder, and 1 physician office manager). Five parents in the Emmi group worked or had worked in the healthcare field (1 registered nurse, 1 speech pathologist, 1 physician business manager, and 2 unknown positions). The mean time between the first and second surveys (ie, the mean time
1139 between the consent discussion and surgery) was 31.2 days in the control versus 33.4 days in the Emmi group (P = NS). Socioeconomic status was derived by using the mean adjusted gross income (AGI) for the zip code provided on the survey and comparing that to the AGI for the state that the parent lived in. Using this method, there was no significant difference in the AGI of the control versus the Emmi groups (control mean 96% of state AGI vs. Emmi mean 102% of state AGI). There was no difference in the number of parents in either group that reported a history of hernia surgery in the family or that admitted to reading or researching hernia surgery prior to the office visit.
2.2. Initial evaluation of surgeon consent discussion All study participants were asked to evaluate the initial discussion about the risks and benefits of the surgery using a 1-5 scale; 100% of the study participants (control and Emmi groups) answered questions regarding their comfort level with the consent discussion favorably (ie, rated a 4 or 5 with positively phrased questions or a 1 or 2 with negatively phrased questions). Questions in this portion of the survey included: “I feel that my surgeon took time to explain the procedure to me and make sure I was comfortable with the surgery,” “My surgeon used language that I could understand when explaining the procedure,” and “I am happy with the process of obtaining consent for surgery” among others. Six percent of the study participants responded with a 4 or 5 in response to the statement, “I feel that I need more information about the surgery.”
2.3. Recall of potential surgical complications Parents in the control group recalled a mean of 2.9 potential risks or complications immediately following the consent discussion with the surgeon (range, 0-8). Parents in the Emmi group recalled a mean of 2.6 potential risks or complications immediately (range, 0-6). At the time of the second survey, the control group recalled a mean of 1.5 complications (range, 0-4) compared to the Emmi group who recalled a mean of 2.9 complications (range, 0-8). Comparing number of complications remembered in the control group between surveys 1 and 2, there was a trend towards a significant decrease in the number of complications recalled (P = .056). There was no difference between the number of complications recalled in the Emmi group between surveys 1 and 2. There was also a trend towards significance when comparing the number of complications recalled at survey 2 between the control and Emmi groups (P = .06). Summary of the results is displayed in Figs. 1A and 1B.
2.4. Parent impression of Emmi program Parents who completed the Emmi program were asked to evaluate the program on survey 2. The same questions that
1140
Fig. 1 A and B, Recall of potential surgical complications. A, Comparison of control group and study group at two survey time points demonstrating a trend towards a significant decrease in the mean number of complications recalled in the control group. B, Comparison of control group and study group at two survey time points demonstrating a trend towards significant improvement of mean number of complications recalled on the day of surgery by the study group.
were asked in the initial study shown in Table 1 were asked of the parents in this study. One of the parents who completed the Emmi program did not answer the questions about the program on survey 2. All of the parents who completed the survey reported that they found the Emmi program easy to use. Of the 16 parents, 15 (94%) reported learning new information about the surgery from the Emmi program and that the Emmi program had affected their understanding of the surgery. Of the 16 parents, 8 (50%) reported that the Emmi program covered risks of the surgery previously unknown to them.
3. Discussion Patient recall of potential surgical complications has been shown in multiple studies to be poor, despite the use of multiple methods to attempt to improve patient understanding. Our study represents an attempt to use a new technology to assist with the consent discussion in order to improve parent comfort with their child's surgery and to
B. Rymeski et al. improve understanding of the potential surgical complications. Our results proved similar to previous studies, in that overall recall of complications was poor. Even at the initial survey completed within 30 minutes of the consent discussion with the surgeon, the mean recall was less than 3 of 9 complications. At the second survey, recall worsened in the control group and maintained at approximately the same level in the Emmi group. This would lead one to believe that completion of the Emmi program resulted in maintenance of knowledge of complications, perhaps owing to the repetition of information previously conveyed by the surgeon. What is perhaps more interesting about our results is the parent's perception of both the Emmi program and the information that was presented in the program. All of the parents who completed the Emmi program rated it favorably and none found it difficult to use. Like our first study, the parents felt that they learned new information about the surgery from the program and stated that they felt more comfortable with the surgery after viewing the program. Perhaps it is the combination of audio, visual, animation, and voice information that allows the parent to absorb more information about the surgery. It is not unreasonable to assume that viewing the information outside of the hectic and perhaps stressful setting of a surgeon's office aids in parent ability to really “hear” the information. Half of the parents in the Emmi group reported that they learned new complications of the surgery, despite the fact that all of the potential complications were actually told to them by the surgeon in the pre-operative meeting. This tells us that despite the words being said, the parents either did not hear them or did not understand them; we suspect that it is likely a combination of both. It seems that the addition of the Emmi program was able to describe the surgical risks in a way that the surgeon alone was not able. While we cannot definitively say that recall of potential surgical complications was improved by completion of the Emmi program, there does seem to be some maintenance of recall that was not seen in the control group. What may be more important, however, is the parental impression that use of the program positively affected understanding of the surgical procedure and its inherent risks. This benefit alone may be enough to support the use of the Emmi program as an aid in the consent discussion.
References [1] Byrne DJ, Napier A, Cuschieri A. How informed is signed consent? BMJ 1988;296:839-40. [2] Langdon IJ, Hardin R, Learmonth ID. Informed consent for total hip arthroplasty: does a written information sheet improve recall by patients? Ann R Coll Surg Engl 2002;84:404-8. [3] Madan AK, et al. Postoperative laparoscopic bariatric surgery patients do not remember potential complications. Obesity Surgery 2007;17: 885-8.
Internet-based program in informed consent [4] Hutson MM, Blaha JD. Patients' recall of preoperative instruction for informed consent for an operation. J Bone Joint Surg 1991;73:160-2. [5] Eggers C, Obliers R, Koerfer A, et al. A multimedia tool for the informed consent of patients prior to gastric banding. Obesity 2007;15: 2866-73. [6] Steffenino G, Viada E, Marengo B, et al. Effectiveness of video-based patient information before percutaneous cardiac interventions. J Cardiovasc Med 2007;8:348-53. [7] Lavelle-Jones C, Bryne DJ, Rice P, et al. Factors affecting quality of informed consent. BMJ 1993;306:885-90. [8] Lemaire R. Informed consent—contemporary myth? J Bone Joint Surg 2006;88-B:2-7. [9] Rymeski BA, Wolfson P, Murphy SG. The use of an Internet-based module to improve the informed consent process in pediatric procedures: initial data from the Emmi program. Presented at the 39th annual meeting of the Canadian Association of Pediatric Surgeons, St John's, New Foundland, Canada, August 23-26; 2007.
Discussion Mary Brandt, MD (Houston, Tex): Did I understand you say this is commercially available? Would you tell us just a little bit about this such as the cost? Beth Rymeski, MD (response): This is a program that was developed with a company and with the doctors at our hospital. It's commercially available, but I do not know the specific cost. Robert Sollingberger (Moody, Tex): The U.S. government has been pushing e-based programs for permits for a long time. Did you have a feel for how much time you spent getting the permit by using the internet-based permit as opposed to the verbal one? It's been my experience that the longer you spend talking with a patient, the better understanding they have, and I know that time is money. Beth Rymeski, MD (response): This was not meant to replace the consent discussion with the surgeon. In all of these cases, regardless of whether or not they completed the internet program, they had a consent discussion with the surgeon in the office, which was per that surgeon’s typical routine. The only caveat was that they had to mention and document those nine potential complications. The consent discussion would be variable in exactly how the information was presented and exactly what was said depending surgeon to surgeon. The internet program was in addition to that, so probably if you or I went
1141 through this program, it would take us about 20-30 minutes; if a parent were going through it who is unfamiliar with this, it may take up to an hour to go through. It also has the option of you can go back and repeat slides, you could watch this an unlimited number of times, so the amount of time that the parents use it is very variable but it was not meant to replace a consent discussion with the surgeon. Stephen Shochat, MD (Memphis, Tenn): If you're having this problem with hernia repairs, how difficult it is in patients with a malignancy that are being enrolled on a controlled clinical trial. It's not only information issues but it's also trying to take out the bias of the principal investigator. So we are developing similar techniques and developing videos and so forth to show to the parents prior to the discussion of the protocol. When do you show this to the parents? Do the parents get this before they see the surgeon, and then the surgeon can interpret some parts of the program? Or does the surgeon see the parents first, then you show the web, because I think that is an important issue. Beth Rymeski, MD (response): The typical scenario would be that the patient was referred to us by their pediatrician for evaluation of an inguinal hernia, they were determined to have an inguinal hernia and given the option to schedule for surgery, so they would be given the log-on code at that time. So they wouldn't access the program until after they have already talked to their surgeon. There is a feature on the program where you can, if you want to ask questions to your surgeon, you can email them to the surgeon, it goes to our secretaries, and then they can pass those along to the doctor who is going to be the operating surgeon. Steven Stylianos, MD (Miami, Fla): We have used the Emmi product for about two years at Miami Children's in a multilingual population and it is an outstanding product. They have a beautiful segment on anesthesia in children and that's the one that's viewed more than the actual procedure, we found in our two-year experience. So the parents take the code home and rather than logging onto the hernia, they'll log onto the anesthesia section. It's been remarkable in how much customer satisfaction we have had with the program.