SURGEONS’
DISCLOSURE OF CLINICAL ADVERSE EVENTS
On July 21st 2016 a tweet went out with the subject line:
“Disclosure of harm is a must-Would a surgeon tell you if something went
wrong?” followed by the commentary “new survey of surgeons reveals the truth
about disclosure and medical errors”. My immediate assumption was that this must
be a bad news release revealing that surgeons do not inform their patients when
mistakes or complications happen (and assume d that the public likely had the
same perception). To my relief the CBS
website - July 20th news feed “would
a surgeon tell you if something went wrong during your operation?” reported
that the study revealed that most Veterans
Health Administration (VHA) surgeons do follow guidelines for disclosure when a procedure has an
associated adverse event. On that note I
retrieved the VHA study, contacted the authors (Elwy, Itani and Perkal) to
discuss this further and reviewed the VHA policies on disclosure of adverse
events. I learned that the process for
making recommendations and the institution of policy within VHA and elsewhere
on the disclosure of adverse events has been relatively slow, but while there
is clearly a ways to go in this endeavor, progress is being made.
While a local policy on
disclosure of adverse events was 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 very skeptical about disclosure policies
leading many compelled to disclose incomplete or inaccurate information. This
reluctance was centered on legitimate and unfounded concerns about legal and
financial ramifications. In addition, physicians were concerned about the
negative consequences of the emotional stress on the family or patient by
revealing that information (‘too much information can be harmful on the
spirit’).
Subsequent
to that 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 timeframe 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 director:
(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 engage 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.
Literature discussion, regarding the physician
experience relating to disclosure of adverse events to patients, spans the
spectrum from positive (provision of an outlet for the emotional toll) to
negative (concerns of repercussions, shame guilt) emotions. Few studies have
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 may become more effective thereby improving the
outcome of the disclosure process with patients and physicians. Elwy et al set out to assess
A. The compliance with each of the eight elements
recommended by the National Quality Forum and The VA (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.
Before
discussing this with the lead author, Dr. Elwy, I researched the question: What makes it so difficult to disclose
adverse events to patients? The obvious reason for anxiety in this
process is the fear of repercussions. The not so obvious reason is our response
and recognition of failure. Amy Edmondson reminds us in her book (p. 155) that
success in business comes with a risk of failure and that it is important to
accept failure as an outcome. This may be much more difficult in practice than
in principle however. 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
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 them for
that preconceived notion given the volume of commercialism focused on class
action litigation and the like in the media.
On
that note, Dr. Elwy was very gracious to talk with me about this paper and her
processes of implementing this study:
Dr.
Elwy, I agree we need to rethink how we disclose adverse events in medicine but
it is a very emotional process that appears to instill anxiety in most of us
for one reason or another as I alluded to in my discussion of this paper. What prompted this study? What prompted
your group to look at this?
·
Dr.
Elwy- let me start with a disclaimer that
I am not a surgeon, I am a psychologist.
I have always had an interest in the disclosure process. In my PhD
dissertation I began with a discussion about how physicians disclose bad
information to parents who have deliveries of babies with challenging medical
conditions. I had an emotional experience personally regarding a child in which
a surgeon presented to me an eloquent discussion about an adverse event. I
became interested in how patients feel and what surgeons feel during this
process. When I moved here 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 did disclose what they
said to patients.
What were some of your take home messages
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 I take the responsibility for the incident, just that I am
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 biggest suggestions was that
this process was best managed by quality and probably not risk management. If
the connotation is risk management, this creates 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 the surgeon is concerned and want 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 is positive. We need to teach that the surgeon just needs to be
open and honest. Even in the Surgeons who agreed to do the study, had some
negative attitudes 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 disclosure.
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? I discussed risk aversion and risk taking previously with Dr. Moulton
after they wrote about why we are risk averse or bold when we take on surgical
cases (http://crisislead.blogspot.com/2016/08/comfort-zones-and-risk-taking-in.html)
Dr.
Elwy: Because the survey was short and we
wanted to encourage participation this was not specifically asked but there was
a block to discuss this. The interviews were about a very specific case and the
study designed prevented more expansive disclosure. The surgeons were asked to
account how they managed specific cases. Family members were then contacted and
interviewed- thru patient safety. Plus we had to keep the surgeon interviews to
less than 20-25 minutes to respect their time.
Any
final message about this you wanted to convey?
Dr.
Elwy: Unfortunately there is no avenue
for surgeons to discuss this. M&M is not the place. This sets the surgeons
up for burnout. We need this process to build up resilience. Would recommend we
think about what others have said on this topic.
Marjorie Siegler wrote a piece about
this in JAMA, where she notes that after a catastrophic event 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. Physicians do not want to discuss this with a mental health provider.
Physicians want to talk to a peer who has had that same experience. Jo Shapiro’s,
Brigham Women’s, Center for Professionalism and Peer Support designed for that
purpose. http://www.brighamandwomens.org/medical_professionals/career/cpps/default.aspx
Kenneth A. Lipshy, MD, FACS
www.crisisleadershipmanagement.com
www.crisisleadershipmanagement.com
·
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
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