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SURGEONS’ DISCLOSURE OF CLINICAL ADVERSE EVENTS
February 13, 2018
A panel discussion was held at the May 2017 Annual meeting of the AVAS regarding “Never Events.” during which Dr. A. Rani Elwy discussed her group’s experience with surgeon disclosures of adverse events to patients and families. My interest in her group’s work began in July 2016 when CBS News released a web-report titled “would a surgeon tell you if something went wrong during your operation?” Fortunately, this was a positive report regarding a VA study which revealed that most Veterans Health Administration (VHA) surgeons do follow guidelines for disclosure when a procedure has an associated adverse event. I subsequently contacted one of the authors of that study, Dr. Elwy, to discuss the paper further.
The institution of policy within VHA regarding the disclosure of adverse events has been relatively slow. This began with a local policy on disclosure of adverse events published at the Lexington VAMC in 1987. It was not until 1995 that VHA published a National VHA policy requiring disclosure to patients. The process was relatively unknown to most until the National VHA Ethics Committee published a Disclosure of Adverse Events report in 2003. This report recommended the disclosure of adverse events to the patients and/or their families when the following criteria existed:
The adverse event has a perceptible effect on the patient that was not discussed in advance as a known risk.
The adverse event necessitates a change in the patient’s care.
The adverse event potentially poses a significant risk to the patient’s future health, even if the likelihood of that risk is extremely small.
The adverse event involves providing a treatment or procedure without the patient’s consent.
In this report, the definition of adverse events was “untoward incidents, therapeutic misadventures, iatrogenic injuries, or other adverse occurrences directly associated with care or services provided within the jurisdiction of a medical center, outpatient clinic, or other VHA facility. Adverse events may result from acts of commission or omission (e.g., administration of the wrong medication, failure to make a timely diagnosis or institute the appropriate therapeutic intervention, adverse reactions or negative outcomes of treatment). Some examples of more common adverse events include: patient falls, adverse drug events, procedural errors and/or complications, completed suicides, parasuicidal behaviors (attempts, gestures, and/or threats), and missing patient events.”
Even in 2003, disclosure policies were viewed as extreme and followed less than whole-heartedly. Physicians were skeptical about disclosure policies that compelled them to disclose incomplete or inaccurate information. This reluctance was centered on legitimate and unfounded concerns about legal and financial repercussions. Physicians were also concerned about the negative consequences of emotional stress upon the family or patient by revealing that information (‘too much information can be harmful on the spirit’).
Following the 2003 report, several VHA Handbooks on disclosure of adverse events to patients were published- the most recent of which is VHA HANDBOOK 1004.08 October 2012. In this document, adverse events were defined as “untoward incidents, diagnostic or therapeutic misadventures, iatrogenic injuries, or other occurrences of harm or potential harm directly associated with care or services provided within the jurisdiction of the Veterans Healthcare System.”
VHA HANDBOOK 1004.08 stipulates that institutional disclosure must be initiated “as soon as reasonably possible and generally within 72 hours. This time frame does not apply to adverse events that are only recognized after the associated episode of care (e.g., through investigation of a sentinel event, a routine quality review, or a look-back). Under such circumstances, if the adverse event has resulted in or is reasonably expected to result in death or serious injury, institutional disclosure is required, but disclosure may be delayed to allow for a thorough investigation of the facts provided.” According to the 2012 Handbook, Institutional disclosure of adverse events must document the following SEVEN steps in the medical record:
(1) An expression of concern and an apology, including an explanation of the facts to the extent that they are known. (2) An outline of treatment options, if appropriate. (3) Arrangements for a second opinion, additional monitoring, expediting clinical consultations, bereavement support, or whatever might be appropriate depending on the circumstances and within the constraints of VA’s statutory and regulatory authority. (4) Contact information regarding designated staff who are to respond to questions (5) Notification that the patient or personal representative has the option of obtaining outside medical or legal advice for further guidance. (6) Offering information about potential compensation under 38 U.S.C. § 1151 and the Federal Tort Claims Act where the patient is a Veteran or under the Federal Tort Claims Act where the patient is a non-Veteran. (7) Ongoing communication whereby the Risk Manager or organizational leaders engages the patient or personal representative to keep them apprised, as appropriate, of information that emerges from investigation of the facts related to the adverse event.
In July 2016, at the same time that the JAMA Surgery study was published online, social media stemming from the medical community regarding physicians’ experience relating to disclosure of adverse events to patients, spanned the spectrum from positive (provision of an outlet for the emotional toll) to negative (concerns of repercussions, shame guilt) emotions. Until the VA study, few studies had assessed the emotional experience of physicians after exposure to disclosure of an adverse event by survey. By gaining this knowledge, educating physicians on disclosing adverse events could potentially become more effective thereby improving the outcome of the disclosure process with patients and physicians. Elwy et. al. set out to assess the following:
A. The compliance with each of the eight elements of disclosure, compiled from recommendations by the National Quality Forum and the VHA Handbook 1004.08, and from interviews with 9 surgeon-patient pairs where clinical disclosures had previously occurred (see inset RATE OF COMPLETION OF EIGHT RECOMMENDED DISCLOSURE STEPS ACCORDING TO INTERVIEWED PHYSICIANS below) as well as the relative likelihood of disclosure based on the risk of harm due to the adverse event (literature supports that surgeons are more likely to disclose if the event has a risk for high harm than with low harm).
B. the emotional experience of physicians who provided such disclosure to determine if those physicians that followed the disclosure policy were more or less likely to experience negative effects as suspected above.
C. The relationship of physician attitude regarding disclosure with the effect on that physician following disclosure.
When discussing disclosure, one should consider the various reasons why we are so averse to disclosing adverse events. That is- why is there so much anxiety? The obvious reason for anxiety in this process is the fear of repercussion. The not so obvious reason is our response and recognition of failure. Amy Edmondson reminds us in her book that success in business comes with a risk of failure and that it is important to accept failure as an outcome. However, this may be much more difficult in practice than in principle. Humans have a natural aversion to failure itself, causing public discussion of their failure extremely difficult. It is our fundamental nature to preserve our self-esteem. Compounding that is our innate heuristic trait of confirmation bias which prevents our dismissing any early conception of an event, and instead leads to distortion of the facts to support our conclusion that this was "not my fault." We find it easier to diminish our responsibility and blame others to preserve our dignity in front of our peers. This then strengthens the emotion surrounding any discussion of failure. For us to analyze and discuss failure we must be open, patient and able to tolerate ambiguity. For this to occur we must be taught humility in our training. To be fair, when we fail, we theoretically risk punishment in medicine either by our peers at the medical executive board, hospital leadership, state licensing boards or ultimately in the courts. Furthermore, the public is quick to equate failure with liability. Frankly, it is difficult to blame the public for that preconceived notion given the volume of commercialism focused on class action litigation and the like in the media.
Dr. Elwy agreed to discuss their paper with us. My first question for her was what prompted them to look at disclosures?
• Dr. Elwy- I have always had an interest in the disclosure process. In my Ph.D dissertation I began with a discussion about how physicians disclose “bad news” to parents who have either just given birth to a baby with Down syndrome, or to parents who have had Down syndrome diagnosed in utero. I also had an emotional experience personally regarding my son who underwent a tracheostomy, in which the surgeon presented to me an eloquent discussion about an adverse event that had occurred in the week following surgery. I became interested in how patients feel and what surgeons feel during this process, and I wanted to begin a study assessing this further. I approached Dr. Itani in 2007 and he was very engaging. He suggested we start with a pilot study because everyone doubted surgeons would be willing to participate. There was skepticism that the IRB would approve a study where we discussed this with surgeons. Everyone was concerned about surgeons as a vulnerable population and about confidentiality, and coercion - enrollment issues. We were relieved that the pilot confirmed these concerns were unfounded. What we found was that Surgeons in this small group were not aware of VHA guidelines but were willing to discuss what they disclosed to patients. Patients, also, were willing to talk to us about this most personal of discussions with their surgeons.
What were some of your conclusions from this study?
Dr. Elwy- 1. Surgeons who were more likely to be negatively affected by the event were less likely to discuss prevention, as they felt that that the event was serious and found it very difficult to discuss the event.
2. Surgeons noted that they frequently told the family more than was required. Many noted they did apologize but it was clear that perhaps the definition of what is an apology is not well-defined. We learned that patients want to hear an expression of concern. They want the surgeons to be honest and transparent. They want to know the surgeon is concerned about what happened to them. It turns out that simply saying ‘I am sorry you have to go thru this’ is sufficient in most cases. They do not want a very formal apology. They don’t even expect that the surgeon take the responsibility for the incident, just that the surgeon is empathetic. It is not clear that the surgeons understood what an apology really was because the patients frequently said they were given an apology and several surgeons stated they did not offer a formal apology. All the patients conveyed that they were satisfied when the surgeon was concerned about them and their condition and that the surgeon was as concerned about the patient as the patient was. Surgeons often equated an apology to a formal acceptance of responsibility for the patient’s condition and that actually was not what the patients were looking for.
3. Many noted that the negative connotation of this process arises from the fact that Risk Management typically institutes or manages this process instead of Quality Management. One of the best suggestions resulting from this work was that this disclosure process would be best managed by quality and probably not risk management. If the connotation is risk management, this can create a significant barrier in these frank conversations. We need to move away from the perception that these conversations are a bad thing. “It matters more what the patient hears and it is apparent they want to hear that the surgeon is concerned and wants the patient to be better.”
What do we need to do to break down the barrier to surgeons feeling comfortable in this process especially given the inherent nature of these events and surgeon personalities in general (as noted above)?
Dr. Elwy: There is a lot of anxiety about disclosure. There is a lot of fear. There are many misperceptions. We need to teach that this can be a positive event. We need to teach that the surgeon needs to be open and honest. Even among the surgeons who agreed to participate in the study, some had negative attitudes toward disclosure, so we can infer that those who did not volunteer possibly had a more significant negative attitude. Those that had a negative attitude, had more anxiety about future disclosures and events.
Were you able to assess surgeon exposure personally to negative responses they may have experienced during this process following a negative patient outcome such as bad publicity, bad exposure in the hospital peer review process, legal action, to see if that may explain the reaction? Dr. Elwy: Because the survey was short and we wanted to encourage participation, this was not specifically asked but there was a write-in, text box option in the survey for surgeons to provide more details on the case if they wished. The interviews were about a very specific case and the study design prevented more expansive discussion about disclosure. The surgeons were asked to account how they managed specific cases. Patients and/or their family members (if patients were unable to participate) were then contacted and interviewed by the research team. We also had to limit the surgeon interviews to less than 20-25 minutes to respect their time.
Any final message you wish to convey?
Dr. Elwy: Unfortunately there is no avenue for surgeons to discuss how they are personally affected by disclosures. M&M is not the place. This sets the surgeons up for burnout. We need this disclosure process to build up resilience. I think we should consider what others have written about this topic. Marjorie Siegler, MD, wrote a piece about this in JAMA, where she notes that after a catastrophic event, in any arena, all other professionals have period of time to regroup prior to going back on duty. Further studies need to be done to assess what support is needed after a traumatic event in healthcare. Physicians do not want to discuss this event with a mental health provider. Physicians want to talk to a peer who has had that same experience. Dr. Jo Shapiro’s work at the Brigham and Women’s Hospital has led to the Center for Professionalism and Peer Support, designed specifically for this purpose. My wish is that we can develop a similar network of trained peers in the VA, in every medical center, to provide this support that is so needed following clinical disclosures of adverse events.
• http://www.cbsnews.com/news/would-a-surgeon-tell-you-if-something-went-wrong-during-an-operation/ • A. Rani Elwy, Kamal M. F. Itani, Barbara G. Bokhour, Nora M. Mueller, Mark E. Glickman, Shibei Zhao, Amy K. Rosen, Dana Lynge, Melissa Perkal, Erica A. Brotschi, Vivian M. Sanchez, Thomas H. Gallagher. Surgeons’ Disclosures of Clinical Adverse Events. JAMA Surgery, 2016; DOI: 10.1001/jamasurg.2016.1787 • Disclosing Adverse Events to Patients A Report by the National Ethics Committee of the Veterans Health Administration March 2003 http://www.ethics.va.gov/docs/necrpts/NEC_Report_20030301_Disclosing_Adverse_Events.pdf • Edmondson AC. Teaming: How Organizations Learn, Innovate, and Compete in the Knowledge Economy. John Wiley & Sons 2012.