Live Case Demonstrations: Attitudes and Ethical Implications for Practice

Live Case Demonstrations: Attitudes and Ethical Implications for Practice

Clinical Research Live Case Demonstrations: Attitudes and Ethical Implications for Practice Jeremy Sugarman,1,2,3 Holly Taylor,1,3 Michael R. Jaff,4,5...

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Clinical Research Live Case Demonstrations: Attitudes and Ethical Implications for Practice Jeremy Sugarman,1,2,3 Holly Taylor,1,3 Michael R. Jaff,4,5 and Timothy M. Sullivan,6 Baltimore, Maryland; Boston, Massachusetts; and Minneapolis, Minnesota

Background: Live case demonstrations (LCDs) are now prevalent in medical education courses despite ethical concerns including that they may expose patients to undue risk. However, there are limited data regarding many aspects of LCDs to help inform policies and guidelines regarding them. Methods: We conducted an Internet-based survey of clinicians who have served as faculty or attended the 2009 and 2010 professional meetings sponsored by VIVA (Vascular Interventional Advances). Results: There were 106 VIVA 2009 respondents and 165 VIVA 2010 respondents. Observing an LCD was more valuable than watching a prerecorded video for most (70% in 2009; 82% in 2010) respondents. About one-third of respondents thought that LCD patients are exposed to more risk than non-LCD patients. Respondents who had been operators were more likely to agree that LCD patients are exposed to more risk ( p ¼ 0.001 in 2009; p ¼ 0.022 in 2010). Approximately one-third of respondents in 2009 and one-half in 2010 thought that patients experience direct medical benefit in an LCD. The majority (71% in 2009; 76% in 2010) indicated that they would support the decision of a family member or friend to be an LCD patient, few (44% in 2009; 58% in 2010) indicated that they personally would agree to be an LCD patient. Conclusions: This survey provides new insights into the value and risk of LCDs. Obtaining the perspective of patients would be extremely valuable in helping to ensure that the ethical aspects of LCDs are addressed properly and thoroughly.

The VIVA Board (Gary Ansel, MD; Michael Dake, MD; Tony Das, MD; Michael R. Jaff, DO; James Joye, DO; John Kaufman, MD; John Laird, MD; Manish Mehta, MD; Krishna Rocha-Singh, MD; Kenneth Rosenfield, MD; Peter Schneider, MD; and Timothy M. Sullivan, MD) authorized the project. Under the leadership of Rebecca Hall, VIVA staff graciously facilitated scheduling in-depth interviews with clinicians (Theresa Chavez) and sent e-mail messages to attendees at VIVA meetings (Keith Rochkind). The authors appreciate the time taken by the respondents to participate in this project. J.S. and H.T. served as paid consultants to VIVA Physicians, a notfor-profit 501 (c) (3) organization, for work on this project. M.R.J. and T.M.S. are on the Board of VIVA. VIVA had no role in the analysis or interpretation of the data or in preparation of the manuscript or its approval. VIVA Physicians, a not-for-profit 501 (c) (3) organization, provided funding for this project. 1 Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD.

2 Department of Medicine, Johns Hopkins School of Medicine, Baltimore, MD. 3

Department of Health Policy and Management, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD. 4 Department of Medicine, Massachusetts General Hospital Vascular Center, Boston, MA. 5

Department of Medicine, Harvard Medical School, Boston, MA.

6

Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, MN. Correspondence to: Jeremy Sugarman, MD, MPH, MA, Johns Hopkins Berman Institute of Bioethics, Johns Hopkins University, 1809 Ashland Ave., Room 203, Baltimore, MD 21205, USA, E-mail: [email protected] Ann Vasc Surg 2011; 25: 867-872 DOI: 10.1016/j.avsg.2011.03.014 Ó Annals of Vascular Surgery Inc. Published online: June 15, 2011

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INTRODUCTION

METHODS

Live case demonstrations (LCDs) are now commonly incorporated into postgraduate training courses and programs, especially for cardiac and peripheral vascular interventions. LCDs are somewhat analogous to other forms of bedside clinical teaching methods and training programs, where procedures being performed are described to trainees. However, LCDs differ from traditional teaching methods in that procedures are broadcast, often through satellite, to large audiences within specific timeframes to meet the constraints of professional meetings. Further, moderators and expert panelists, from a variety of disciplines, who attend these meetings, provide critiques and comments on the procedures in real time. LCDs are believed to be vital to medical education and training in that they are perceived as being uniquely effective in demonstrating clinical approaches and subtle techniques that cannot be conveyed by prerecorded cases or by didactic training.1,2 However, there are concerns that LCDs may expose patients to undue risk, and may simply be a means of promoting attendance at medical meetings. Further, although LCD operators use many medical products and devices, commonly for reasons not included in United States Food and Drug Administration labeling, their use in LCDs can raise the specter of conflict of interest.2-4 In the surgical setting, the Society of Thoracic Surgeons has prohibited the broadcasting of surgical procedures at its meetings.2,5 Three Japanese professional societies have outlined guidelines for live broadcasts of surgical procedures.6 More recently, six professional societies in fields that typically use LCDs convened and published a consensus document regarding LCDs.1 The consensus document includes a ‘‘Code of Conduct for Live Case Demonstrations,’’ which, if implemented and adhered to, promises to help mitigate major ethical concerns. Nevertheless, with a few exceptions,7,8 a limiting factor in the construction of these guidelines is the lack of systematic data regarding many aspects of LCDs, such as the actual risk to patients,9 how operators and procedures are selected, and the attitudes and perceptions of those conducting, observing, and participating in LCDs. We report data reflecting the perspectives of those individuals observing LCDs from two large peripheral vascular continuing medical education meetings regarding the educational value of LCDs, as well as the observers’ perception of risk and benefit to patients as a first step in providing data to inform the development of appropriate policies.

We designed and conducted an Internet-based survey of clinicians who have served as faculty or attended professional meetings at which LCDs were presented. Our goal was to identify attitudes, opinions, and beliefs of attendees about the use of live cases and the ethical issues associated with them. The survey was developed based on the findings of semistructured interviews with clinicians familiar with LCDs, having served as faculty members for meetings in which LCDs were conducted, or as operators from LCD sites. The project was approved by the Johns Hopkins Medicine Institutional Review Board. For the semistructured interviews, leaders and staff of VIVA (Vascular Interventional Advances, www. vivapvd.com) contacted clinicians who had served as faculty and/or conducted LCDs at professional meetings and facilitated scheduling interviews for those who were willing to participate. VIVA Physicians is a not-for-profit 501 (c) (3) organization dedicated to education and research in the field of vascular medicine. After obtaining oral informed consent, semistructured interviews were conducted. The interview guide was developed based on a review of the published literature as well as conversations with VIVA leaders (T.M.S., M.R.J.). The interviews took less than an hour to complete. They were digitally recorded and notes were taken during the interviews. All interviews were conducted by the principal investigator (J.S.). Interviews were conducted with six clinicians at which point informational redundancy was achieved. The interview notes and audio recordings were reviewed (J.S., H.T.). The reviewers then met to identify key themes. These themes included a belief that LCDs provide value over other didactic approaches, including video recordings; LCDs are akin to usual clinical teachings received by medical students and trainees; there are characteristics of what constitutes a ‘‘good’’ or a ‘‘bad’’ LCD, determined by an array of clinical, operator, and panelist factors; and there are potential risks to patients treated during LCDs which are related to conflicts of interest, conflicts of obligation, inexperience, and distraction. Based on the issues raised in the published literature and the findings of the in-depth interviews, a survey was developed. It was then pilot-tested with VIVA leaders as well as individuals with experience in conducting surveys in bioethics. The final survey was loaded into SurveyMonkey (SurveyMonkey.com LLC, Palo Alto, CA).10 The sample of eligible participants was developed with assistance from the VIVA staff. VIVA maintains

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e-mail lists of previous conference attendees. We separately conducted two surveys for individuals who attended VIVA 2009 (October 19-23, 2009) and VIVA 2010 (October 19-22, 2010). The VIVA 2009 survey was initiated on September 8, 2010; the VIVA 2010 survey was initiated on November 18, 2010. In both cases, eligible subjects were recruited through an e-mail request from the VIVA Board President (T.S.) and the principal investigator (J.S.). A reminder message was sent during the month-long period during which each survey was open. VIVA attendees willing to participate clicked on an embedded link in the e-mail message to connect to the Web-based survey. At the beginning of the survey, a statement indicated that completion of the survey implied consent to participate. No unique personal identifiers were collected from respondents to encourage respondents to be candid in their responses. The survey was designed so that it took <15 minutes to complete. Survey data were downloaded from SurveyMonkey and descriptive and bivariate analyses were conducted with STATA 10 (StataCorp. LP, College Station, TX).11

RESULTS Requests for participation were sent by e-mail to clinician attendees and faculty members from two VIVA meetings, VIVA 2009 and VIVA 2010. There were 106 VIVA 2009 and 165 VIVA 2010 respondents. The VIVA 2009 sample consisted of 782 clinicians and 56 faculty members, although 39 messages were undeliverable (response rate ¼ 13.1%). The VIVA 2010 sample consisted of 1,037 clinicians and 65 faculty members (response rate ¼ 14.9%). The demographic characteristics of the respondents are presented in Table I. Most respondents were male physicians, and most specialized in either interventional cardiology or vascular surgery. As shown in Table II, respondents believed that both videos and LCDs contribute to their professional development, can improve problem-solving skills, and are suspenseful. However, respondents were more likely to agree that observing LCDs is more suspenseful than watching videos ( p ¼ 0.005 in 2009; p ¼ 0.002 in 2010). In addition, most respondents (70% in 2009; 82% in 2010) reported that observing an LCD was more valuable than watching a prerecorded video of an expert conducting the same medical procedure. Several survey items addressed beliefs about how cases were selected for LCDs. Respondents agreed that operators selected cases that would be

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Table I. Demographic characteristics Characterisitic

2009

2010

Profession (% physicians) Specialty (%) Interventional cardiology Vascular surgery Interventional radiology Years in practice (% >10 years) Gender (% male)

86

74

36 36 18 72 84

38 30 14 53 89

educational for the audience (90% in 2009; 94% in 2010) and approximately half agreed that they select cases with highly predictable outcomes (54% in 2009; 48% in 2010). A significant minority of respondents thought that the choice of LCDs is influenced by vendors who want to see their device being used (49% in 2009; 44% in 2010). Respondents generally agreed (60% in 2009; 54% in 2010) that patients have a good sense of what will happen during the case. Many agreed (44% in 2009; 50% in 2010) that patients seldom refuse when approached by physician to participate, and one-quarter agreed that LCD patients are more likely than patients not participating in LCDs to have their personal information made public (26% in 2009; 24% in 2010). The survey also asked about risks and benefits to patients related to participating in an LCD. About one-third of respondents (30% in 2009; 28% in 2010) thought that patients who participate in LCDs are exposed to more risk than the average patient in need of the same procedure. As compared with almost one-half (46%) of the 2010 respondents, about one-third (29%) of the 2009 respondents thought that patients who participate in LCDs experience more direct medical benefit than the average patient in need of the same procedure. As shown in Table III, those respondents who had experience as an operator were more likely to agree that patients who participate in LCDs are exposed to more risk than those who had not had that experience ( p ¼ 0.001 in 2009; p ¼ 0.022 in 2010). There were no statistically different assessments of benefits to LCD patients among those with experience as an operator compared with those who did not. Respondents who strongly agreed, sort of agreed, or sort of disagreed that LCD patients may experience more risk (n ¼ 54 in 2009; n ¼ 89 in 2010) were asked whether they agreed with statements about what may lead to risk, which included the following: LCD takes more time than a routine case (62% in 2009; 68% in 2010); logistics of scheduling during a conference may result in delay (79%

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Table II. Value of watching prerecorded videos and observing LCDs at VIVA Level of agreement (sort of or strongly agreed) 2009

2010

Statement

Watching a video

Observing an LCD

Watching a video

Observing an LCD

Valuable to professional development Improved problem-solving skills Was suspenseful Total

84 78 34 89

91 89 75 98

124 118 72 130

151 146 134 157

(94%) (88%) (38%) (100%)

(94%) (91%) (77%) (100%)

(95%) (91%) (55%) (100%)

(97%) (93%) (86%) (100%)

LCD, live case demonstration; VIVA, Vascular Interventional Advances.

Table III. Increased risk from LCD

0.8

LCD patients are exposed to more risk

0.7

2009*

2010**

Experience as an operator

Number who agree (%)

Total

Number who agree (%)

Total

Yes No Total

14 (56) 11 (19) 25 (30)

25 59 84

16 (44) 26 (24) 42 (29)

36 107 143

0.6

*p ¼ 0.001. **p ¼ 0.022.

in 2009; 79% in 2010); operators may be distracted (83% in 2009; 83% in 2010); and interruption by expert panel (92% in 2009; 83% in 2010). Similarly, those who strongly agreed, sort of agreed, or sort of disagreed that LCD patients experience more direct medical benefit (n ¼ 65 in 2009; n ¼ 107 in 2010) were asked why they thought so. Their responses included the following: expert panel consultation (82% in 2009; 94% in 2010); expert panel observing (85% in 2009; 94% in 2010); and because operators are experts (89% in 2009; 96% in 2010). Finally, although the majority (71% in 2009; 76% in 2010) indicated that they would support the decision of a family member or friend to be a patient in an LCD, fewer (44% in 2009; 58% in 2010) indicated that they personally would agree to be an LCD patient if asked to do so (Fig. 1).

DISCUSSION Data from clinicians who have direct experience observing LCDs provide an important perspective on the ethical issues related to LCDs. The primary moral argument justifying any form of clinical teaching seems to rest in the obligation to help future patients. However, this obligation is not absolute. Rather, it is limited by other moral obligations to the safety, well-being, and rights of current patients.

Yes No Don’t Know

0.5 0.4 0.3 0.2 0.1 0 Agree for Agree for Self 2009 Self 2010

Support Decision 2009

Support Decision 2010

Fig. 1. Willingness to be a patient in a live case demonstration and to support the decision of others (proportions).

In addition, the method of teaching arguably should itself be not only relatively safe, but also effective. Our data reveal that operators and observers value LCDs over recorded cases. However, the only substantial difference reported was that LCDs were more suspenseful than recorded cases. Although suspense is fine, and may perhaps add salience to an educational experience, LCDs cannot be justified if there are increased risks to patients. Of note, although observers did not feel that LCDs posed increased risk to patients, those with experience as operators did. This finding is important because the operator would seem to be in a much better position to make an accurate assessment of risk than those observing an LCD. If we assume that there may be some incremental risks inherent to LCDs, there is a need to ensure that factors that contribute to this risk (such as the increased time of an LCD, the need to schedule

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procedures to synchronize with meetings, distraction of the operator, and interruption by the panelists) be aggressively managed. Simple approaches to minimize such concerns should be developed and implemented. These could include using a second operator to minimize distraction and having strict guidelines for panelists in terms of how and when commentary should be provided during an LCD. Moreover, such risks should be disclosed to patients during the informed consent process for an LCD. Nevertheless, it is important to note that about half of the respondents thought that patients benefit from being in an LCD, due perhaps to the presence or advice of the expert panel and the fact that many LCD operators are themselves experts in the field. Although firm data about risks and benefits of LCDs are lacking, this finding highlights the need to balance both potential risks and benefits from LCDs. Although most respondents indicated that they would support the decision of a family member or friend to be a patient in an LCD, they themselves were less likely to agree to be a patient in an LCD. This is similar to the anecdotal report by Takamoto regarding willingness to participate in a live surgical broadcast.12 Uncovering why these responses differ may suggest ways of further improving the manner in which LCDs are planned and conducted. In this study, we were able to obtain information from a large number of respondents; however, these data must be interpreted with some limitations in mind. First, our sample was derived from those who attended meetings from only one professional organization that convenes meetings using LCDs. Although the manner in which these LCDs are performed is similar in other settings, every organization has unique ways of arranging and conducting LCDs. As a result, these data would be expected to be generalizable to only meetings that use the same or similar approaches to the VIVA meeting. In addition, although the absolute number of responses is quite high, the response rates to the two surveys are low, raising the possibility of a response bias, in which those who completed the survey may have different perspectives and attitudes toward LCDs than those who did not complete the surveys. Of course, data from those who observe LCDs are necessary, but insufficient in helping to understanding the ethical appropriateness of LCDs. Further empirical work is needed to gather data from and about other stakeholders, especially patients. This includes the need for not only the data regarding patient safety, but also their attitudes and perceptions of the process. To be meaningful, such data will need to be collected proximate to the time of the LCD.

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CONCLUSIONS LCDs have become an established component of cardiovascular medical meetings. Although many participants who attend these meetings now expect LCDs, the rationale, educational value, and risk to patients remain unclear. This survey of conference attendees and LCD operators provides new insights into the value and risk of LCD procedures. Although attendees find LCDs thrilling, they are also unlikely to volunteer, if asked, to serve as a patient during an LCD, and these respondents believe that patients are at higher risk of complications than those who are not treated during a live broadcast. Interestingly, respondents also feel that patients benefit from being included in an LCD. Obtaining the perspective of patients, particularly of those who have undergone standard procedures and have participated as patients in LCDs, would be extremely valuable in developing a rationale for the continuing, safe, and educational performance of LCDs. Guidelines for the ethical performance of LCDs are essential. Such guidelines should be based on a commitment to patient safety and privacy, and include a clear disclosure of conflicts of interest among operators and expert panelists.

REFERENCES 1. Dehmer GJ, Douglas JS Jr, Abizaid A, et al. SCAI/ACCF/ HRS/ESC/SOLACI/APSIC statement on the use of live case demonstrations at cardiology meetings: assessments of the past and standards for the future. J Am Coll Cardiol 2010;56:1267-1282. 2. Sade RM. American Association for Thoracic Surgery Ethics Committee; Society of Thoracic Surgeons Standards and Ethics Committee. Broadcast of surgical procedures as a teaching instrument in cardiothoracic surgery. Ann Thorac Surg 2008;86:357-361. 3. Cameron DE. Surgery as spectacle. CTSNet. July 21, 2008. Available at: http://www.ctsnet.org/sections/newsandviews/ inmyopinion/articles/article-55.html. Accessed January 1, 2011. 4. Mackay CR. Ethical considerations of live case transmissions. JACC Cardiovasc Interv 2009;2:892-893. 5. Society of Thoracic Surgeons. Guidelines for ethical relations with communications media. January 27, 2008. Available at: http://www.sts.org/sections/aboutthesociety/policies/Ethical %20Relations/index.html. Accessed January 1, 2011. 6. Japanese Society for Cardiovascular Surgery, Japanese Association for Thoracic Surgery, Japanese Society for Vascular Surgery. Guidelines for live presentations and cardiovascular surgery. August 10, 2007. Available at: http://square.umin. ac.jp/jscvs/eng/live.html. Accessed January 1, 2011. 7. Chatelain P, Meier B, de la Serna F, et al. Success with coronary angioplasty as seen at demonstrations of procedure. Lancet 1992;340:1202-1205. 8. Franke J, Reimers B, Scarpa M, et al. Complications of carotid stenting during live transmissions. JACC Cardiovasc Interv 2009;2:887-891.

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9. Farb A, Brown SA, Wolf DA, Zuckerman B. Interventional cardiology live case presentations: regulatory considerations. J Am Coll Cardiol 2010;56:1283-1285. 10. Available at: SurveyMonkey.com. LLC 1999-2011, Portland, OR.

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11. StataCorp. Stata statistical software: release 10. College Station, TX: StataCorp LP, 2007. 12. Takamoto S. Guidelines for live surgery. CTSNEt. October 19, 2007. Available at: http://www.ctsnet.org/sections/newsandviews/ inmyopinion/articles/article-63.html. Accessed January 1, 2011.