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Innovations: Technology & Techniques in Cardiothoracic & Vascular Surgery:
doi: 10.1097/IMI.0b013e3181c45e4f
Original Article

How Informed is “Informed Consent” for Robotic Cardiothoracic Surgery?

Ryan, Sean BS; Chirumamilla, Vasu MD; Bello, Ricardo A. MD, PhD; D’Alessandro, David A. MD; Michler, Robert E. MD; Rabin, Jonathan MD; Ashton, Robert C. Jr MD; DeRose, Joseph J. Jr MD

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Author Information

From the Montefiore-Einstein Heart Center, Montefiore Medical Center, Bronx, NY USA.

Accepted for publication August 12, 2009.

Presented at the Annual Scientific Meeting of the International Society for Minimally Invasive Cardiothoracic Surgery, Boston, MA USA, June 11–14, 2008.

Address correspondence and reprint requests to Sean Ryan, BS, Montefiore-Einstein Medical Center, 3400 Bainbridge Avenue, Bronx, NY 10467 USA. E-mail: sryan@aecom.yu.edu.

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Abstract

Objective: The education of patients in the informed consent process remains a challenge for many surgeons. In cardiothoracic surgery, emerging minimally invasive techniques including robotics add another level of complexity to the patient education process. We sought to evaluate our patients’ perceptions and informed knowledge after robotic-assisted cardiothoracic surgery.

Methods: A survey containing questions designed to elicit patients’ perceptions about robotic cardiothoracic surgery was given postoperatively by telephone 1 month to 12 months after surgery. The survey included questions about the type of procedure, function of the organ operated on, purpose of the operation, primary “surgeon” (robot vs. human), patients’ opinion about robotic-assisted surgery, educational level, and socioeconomic background. Continuous variables are reported as mean ± SD. Continuous and categorical variables were compared using the Student t test and Pearson χ2 test, respectively. Ordinal variables were compared using the Mann-Whitney U test. P values of <0.05 were considered significant.

Results: Between 2002 and 2007, 198 patients underwent robotic cardiothoracic surgery. One hundred fifty patients (76%) were contacted and 89 (45%) fully completed the survey. Of the respondents, there were 31 coronary artery bypasses, 33 pacemaker lead implantations, esophageal resections, 8 thymectomies, and 9 others. The mean age of the patients was 61.1 ± 15 years (range, 23–87) and there were 52 men (58.4%). A total of 96.6% of patients were satisfied with the information provided by the surgeon and 92.1% felt that they understood the information. The diagnosis, target organ, and procedure were correctly identified by 81 (91.0%), 83 (93.3%), and 76 (85.4%) of the patients, respectively. A total of 80 (89.9%) knew a robot was involved and 73.8% understood the role of the robot in the surgery. These results were independent of age, income, and education level achieved.

Conclusions: Overall, patients demonstrated an understanding of the role of the robot in their cardiothoracic surgery. Despite the increasing complexity of robotics, preoperative patient education can result in patients who are both satisfied and well educated about their cardiothoracic surgery procedures.

The education of patients in the informed consent process remains a challenge for many surgeons. Numerous reports indicate that patients show poor understanding and recall of information presented to them before providing written consent. Details that patients struggle to recall include the diagnosis, purpose of the surgery, and target organ.1–6 Furthermore, because not all patients desire the same level of disclosure about the risks of surgery,7 surgeons have the added challenge of tailoring informed consent discussions to individual patient preferences. Improvement in the dialogue between doctors and patients is essential to ensure the integrity of the informed consent process.

Suboptimal recollection and understanding of informed consent information may be the result of the high level of complexity of the information and written materials provided to the patient. Several investigators have shown that written consent forms may be written for a reading level higher than the educational level achieved by patient signing the form.8,9 Campbell et al10 have demonstrated improved recall and understanding of informed consent information among low-income patients, by simplifying the presentation of informed consent material.

The difficulty of educating patients in the informed consent process is magnified in complex fields such as cardiothoracic surgery.7,11 To convey the risks of surgery, physicians must often invoke medical concepts unfamiliar to many patients. The recent introduction of robotics to cardiothoracic surgery has added yet another layer of complexity to patient evaluations. In this study, we sought to evaluate our patients’ perception and knowledge of information provided in the informed consent process before robotically assisted cardiothoracic surgery.

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MATERIALS AND METHODS

All patients undergoing robotic-assisted cardiothoracic surgery between February 2002 and June 2007 by two surgeons were selected for enrollment in the study. Informed consent and preoperative education were provided by the attending surgeon (J.J.D. and R.C.A.) and included in-depth discussions of the pathology, planned procedure, and alternative treatments. Minimally invasive surgical approaches to the particular disease process were also discussed and frequently included photographs, diagrams, and videos of the robot (DaVinci; Intuitive Surgical Incorporated, Sunnyvale, CA).

Interviews were conducted between 1 month and 12 months after surgery (mean 84.6 ± 31 days). Exclusion criteria included psychiatric impairments and limited command of the English or Spanish language. Patients who died in the follow-up period were also not included (three patients who underwent epicardial pacemaker lead placement). The survey (Table 3) included questions about the type of procedure, function of the organ operated on, purpose of the operation, primary “surgeon” (robot vs. human), patients’ opinion about robotics, educational level, and socioeconomic background.

Table 3
Table 3
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A deidentified database was established for data collection and analysis. Data analysis was performed using SPSS 15 (SPSS, Chicago, IL). Continuous variables are reported as mean ± SD. Continuous and categorical variables were compared using the Student t test and Pearson χ2 test, respectively. Ordinal variables were compared using the Mann-Whitney U test. P values of <0.05 were considered significant.

The questionnaire and study protocol were both approved by the local institutional review board.

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RESULTS

From February 2002 to June 2007, 198 patients underwent robotic-assisted cardiothoracic surgery at two institutions. This included 60 robotic coronary artery bypasses (CABG), 85 robotic left ventricular lead placements, 13 thymectomies, 11 esophageal resections, 11 atrial septal defect repairs, 9 Heller myotomies, 3 mitral valve repairs, 3 lung biopsies with radiation seed implantation, and 3 MAZE procedures. Of these patients, 150 were reachable by telephone. Eighty-nine patients agreed to participate and completed the survey for a respondent rate of 45%.

Table 1 shows the distribution of procedures that were performed in the 89 respondents. CABG and epicardial lead placement were the two most commonly performed operations and accounted for 72% of the procedures. The demographics of the study population are shown in Table 2.

Table 1
Table 1
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Table 2
Table 2
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The results of the survey are listed in Table 3. In summary, a majority of the patients (96.6%) were satisfied with the information provided by their surgeon, and most patients (92.1%) felt that they understood the information as it was described to them. Diagnosis, organ operated on, and procedure were correctly identified by 81 (91.0%), 83 (93.3%), and 76 (85.4%) of the patients, respectively. Eighty patients (89.9%) knew a robot was involved, but only 59 of those patients (73.8%) understood the role of the robot in the surgery. A majority of patients felt that either the surgeon or both the surgeon and the robot performed the procedure. However, 6 (7.5%) respondents felt that the robot performed the procedure alone and 11 (13.8%) patients thought that neither the robot nor the surgeon performed the procedure. For each question in the survey, responses of participants who completed the survey in 0 to 3 months were compared with participants who completed the survey in 3 to 6 months after surgery. There were no significant differences between groups (data not shown).

Most patients (80.9%) felt that they knew the risks of the procedure. However, only 65.3% (47 of 72) could identify possible risks when asked to list them. A total of 88.8% of patients (71 of 80) thought that they benefited from having robotic surgery over a traditional open procedure and 88.8% (71 of 80) would choose robotic surgery again. A large proportion of patients (93.8%) also affirmed that they would recommend robotic surgery to family and friends.

A correct answer for question 7 was given by patients with more advanced education level (P = 0.003) and higher income (P = 0.001). Questions 1 and 9 were answered correctly more frequently by patients with higher income (P = 0.025 and 0.006, respectively). All other results were independent of age, sex, income, and education level achieved.

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DISCUSSION

The technologic developments that have taken place in cardiothoracic surgery during the past 10 years have added complexity to the process of obtaining informed consent. Robotic surgery has been plagued by sensationalism and misinformation in both lay and scientific outlets since its introduction to the field in 2001. This study aimed to evaluate our patients’ understanding of robotics, in the context of consenting to complicated cardiac and thoracic surgical procedures.

Most of our patients were very satisfied with the surgery as well as their outcome and would recommend such surgery to family members. Most patients also felt that they received adequate information and were well informed about robotics. Almost all patients knew what operation they had, the target organ, and the purpose of the surgery. Most patients knew that the robot was used but the role of the robot still remained unclear with only 79% of patients responding that either the surgeon or the surgeon and robot together performed the surgery.

It is not surprising that the role of the robot in cardiothoracic operations remains a challenging concept to describe to patients. It is at times a confusing concept for trained cardiothoracic surgeons who do not use robotics in their practice. Most minimally invasive cardiothoracic surgeons view robotics as an instrument that can be used in some minimally invasive operations to improve the accuracy of the procedure. Although the role of the robot in each procedure can be hotly debated, it is clear that “the robot” is not the operation. The different roles that the robot can serve in robotic CABG alone (robotic-assisted minimally invasive direct coronary artery bypass, totally endoscopic beating heart robotic CABG, totally endoscopic arrested heart robotic CABG, etc) have encouraged confusion among cardiac surgeons and patients alike. Nonetheless, this study does show that most patients can understand the basic role of minimally invasive approaches and robotics in their treatment. Diagrams, patient education resources available on the internet, and videos have facilitated patient comprehension of these complex procedures.

As many previous authors have shown, our study reveals that patients continue to have a poor understanding of the potential risks of surgery.1–6 Patients tend to focus on their diagnosis and the surgical procedure while devoting less attention to the possible risks and complications of their procedure.4 Studies in cardiothoracic and other surgical subspecialties have shown that despite increased attention to patient education by surgeons, <50% of patients typically recall of the risks of surgery.3,11 In our study, 47 (65.3%) patients were able to identify the risks of their surgery. These risks are essentially the same whether the operations are performed conventionally or with the assistance of the robot. These findings suggest that patients’ understanding of their procedure is not compromised by the complexity that robotics adds to the informed consent discussion.

A significant challenge in this study is interpreting patient understanding in a survey conducted anywhere from 1 month to 12 months after surgery. Assessment of patient comprehension is best performed at the time of the informed consent discussion. Although the patient may have had the knowledge necessary to make a decision during the informed consent discussion, recall of the facts required for the decision may be difficult after a certain amount of time has passed.

Our study showed differences in correct response rates among different economic or educational strata on only 3 of the 14 questions. Age and sex were not predictive of correct response rate. This is in contrast to previous reports of informed consent in other surgical fields.2,10 Our patient distribution did include 93% of patients who had a high school education or higher. The complexity of minimally invasive cardiothoracic surgery may serve to level the playing field because all patients come to the discussion with little previous knowledge. Nonetheless, it seems that with proper preoperative patient education, all patients, regardless of socioeconomic position, are able to achieve a basic level of understanding about robotic cardiothoracic operations.

In summary, informed consent during complex surgical procedures remains an ongoing challenge for all cardiothoracic surgeons. The implementation of minimally invasive techniques, including robotics, has required improvement in the patient education processes to insure thorough informed consent. An ongoing dialogue with both patients and colleagues in cardiothoracic surgery will serve to clarify the role of minimally invasive techniques and preserve the integrity of the informed consent process.

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REFERENCES

1. Byrne DJ, Napier A, Cuschieri A. How informed is signed consent? Br Med J (Clin Res Ed). 1988;296:839–840.

2. Lavelle-Jones C, Byrne DJ, Rice P, Cuschieri A. Factors affecting informed consent. BMJ. 1993;306:885–890.

3. Herz DA, Looman JE, Lewis SK. Informed consent: is it a myth? Neurosurgery. 1992;30:453–458.

4. Robinson G. Informed consent: recall by patients tested postoperatively. Ann Thorac Surg. 1976;22:209–212.

5. Leeb D. Observations on the myth of “informed consent”. Plast Reconstr Surg. 1976;58:280–282.

6. Priluck IA. What patients recall of the preoperative discussion after retinal detachment surgery. Am J Ophthalmol. 1979;87:620–623.

7. Beresford N, Seymour L, Vincent C, Moat N. Risks of elective cardiac surgery: what do patients want to know? Heart. 2001;86:626–631.

8. Christopher PP, Foti ME, Roy-Bujnowski K, Appelbaum PS. Consent form readability and educational levels of potential participants in mental health research. Psychiatr Serv. 2007;58:227–232.

9. Davis TC, Crouch MA, Wills G, et al. The gap between patient reading comprehension and the readability of patient education materials. J Fam Pract. 1990;31:533–538.

10. Campbell FA, Goldman BD, Boccia ML, Skinner M. The effect of format modifications and reading comprehension on recall of informed consent information by low-income parents: a comparison of print, video, and computer-based presentations. Patient Educ Couns. 2004;53:205–216.

11. Larobina ME, Merry CJ, Negri JC, Pick AW. Is informed consent in cardiac surgery and percutaneous coronary intervention achievable? ANZ J Surg. 2007;77:530–534.

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CLINICAL PERSPECTIVE

This unique article evaluates patients’ perceptions of informed consent before robotic-assisted cardiothoracic surgery. A survey about robotic cardiothoracic surgery was given postoperatively by telephone 1 month to 12 months after surgery. Eighty-nine patients fully completed the survey. Ninety percent of patients knew a robot was involved in their surgery and 74% understood the role of the robot in the surgery. The patients’ understanding was not affected by their age, income, or education level, although the study was too small to truly evaluate these questions. Although the article does show that most patients understand this new technology, it is also clear that as surgeons we often do not do an adequate job of informed consent. One quarter of patients in this study did not understand the role of the robot in the surgery, and 10% did not even know a robot was involved. Although patients felt that they knew the risk of the procedure, less than two thirds could identify the possible risks when asked to list them. Studies like this one provide an important barometer of the effectiveness of the informed consent process. Although the integrity of informed consent is critical in the doctor-patient relationship, our effectiveness as surgeons in providing this has for too long received very little attention both in our educational programs and in our literature. The authors are to be congratulated for shedding some sorely needed light in this area.

Keywords:

Robotic; Informed; Consent; Cardiothoracic surgery

© 2009 Lippincott Williams & Wilkins, Inc.

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