World J Surg DOI 10.1007/s00268-014-2564-5

Disclosure of Adverse Events and Errors in Surgical Care: Challenges and Strategies for Improvement Lauren E. Lipira • Thomas H. Gallagher

Ó Socie´te´ Internationale de Chirurgie 2014

Abstract The disclosure of adverse events to patients, including those caused by medical errors, is a critical part of patient-centered healthcare and a fundamental component of patient safety and quality improvement. Disclosure benefits patients, providers, and healthcare institutions. However, the act of disclosure can be difficult for physicians. Surgeons struggle with disclosure in unique ways compared with other specialties, and disclosure in the surgical setting has specific challenges. The frequency of surgical adverse events along with a dysfunctional tort system, the team structure of surgical staff, and obstacles created inadvertently by existing surgical patient safety initiatives may contribute to an environment not conducive to disclosure. Fortunately, there are multiple strategies to address these barriers. Participation in communication and resolution programs, integration of Just Culture principles, surgical team disclosure planning, refinement of informed consent and morbidity and mortality processes, surgeryspecific professional standards, and understanding the complexities of disclosing other clinicians’ errors all have the potential to help surgeons provide patients with complete, satisfactory disclosures. Improvement in the regularity and quality of disclosures after surgical adverse events and errors will be key as the field of patient safety continues to advance.

L. E. Lipira (&)  T. H. Gallagher Department of Medicine, University of Washington, Seattle, WA, USA e-mail: [email protected] T. H. Gallagher e-mail: [email protected]

Introduction You are performing a laparoscopic cholecystectomy. A surgical device representative has asked you to try a new coagulation-dissection device. He mentions in passing that the tip of the device can get hot. You are dissecting with the new device, and the procedure is going smoothly. A surgical resident asks you a question. With the dissection device off, you look in the resident’s direction to answer the question. When you turn back to the operative field, you realize that the tip of the dissection device is now resting against the common bile duct, which has been burned. You did not realize that this new device could cause such tissue damage even when turned off. You convert the procedure to an open cholecystectomy and repair the injured common bile duct. The remainder of the procedure is unremarkable, and you expect the patient to make a full recovery. In the informed consent before surgery, you explicitly told the patient that an open procedure might be required. You wonder how you should talk about this sequence of events with the patient. A major transformation is underway across healthcare regarding communication with patients following adverse events and errors in their medical treatment [1]. Disclosure of these events is a fundamental component of delivering truly patient-centered healthcare and is critical for improving quality and safety. Surgeons rightly can be proud of a culture that has long embraced the importance of transparency and has recognized the critical role that open discussion can have on learning and improvement [2]. However, the very same surgical culture contains elements within it that may inhibit open conversation with patients. In this paper, we review what is currently known about the disclosure of surgical adverse events and errors to patients, outline barriers specific to surgery, and highlight opportunities for improvement.

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Background ‘‘Unanticipated outcome’’ refers to an outcome of care that was different from what was expected by the provider, institution, or patient. More frequently used, but not interchangeable, terminology includes ‘‘adverse event’’ and ‘‘medical error.’’ An adverse event is any harm that was caused by the process of medical care rather than by the patients underlying disease. A ‘‘medical error’’ is defined by the Institute of Medicine as the failure of a planned action to be completed as intended, or the use of a wrong plan to achieve an aim [3]. Most adverse events are not associated with a medical error and therefore are not preventable. Similarly, most medical errors are not associated with harm.

Disclosure: what it is, the rationale, and potential benefits For patients, complete disclosure after an adverse event or error, even a minor one, includes acknowledgment that an event has happened and an explanation of how the event impacts the patient’s health and how that impact will be mitigated [4, 5]. Moreover, the disclosure should explicitly state if an error was involved and, if so, why the error happened and how recurrences will be prevented. Patients desire not only information; they also want emotional support, including an empathic apology. Disclosure supports patient autonomy [6]. Patients have the right to understand what has transpired in their medical care, both positive and negative. Beyond simply demonstrating respect for persons, disclosure can be an important component of informed decision-making. Knowing exactly what happened allows patients to make educated decisions about subsequent care and understand when compensation is appropriate [7]. Disclosing adverse events and errors to patients is also a critical element of enhancing the quality and safety of healthcare overall [8]. The need to talk with patients about what happened and how it will be prevented helps to drive thorough investigations and initiatives to improve quality. It also provides the opportunity for patients to share their insights, a perspective that is often missing from traditional hospital root-cause analyses. During the past decade, expectations for disclosure have been codified into regulatory requirements, guidelines released by professional societies, and other resources meant to support the disclosure process. The entity responsible for accreditation of hospitals and healthcare organizations in United States, The Joint Commission, requires that patients be informed about all outcomes of care, including unanticipated outcomes [9]. Similarly, the United States National

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Quality Forum and Institute for Healthcare Improvement have both issued thoughtful and detailed recommendations for how healthcare providers in institutions should approach the disclosure process [10–12].

Disclosure barriers Despite rationale favoring disclosure, multiple barriers can preclude complete and effective disclosures. Research suggests that physicians are less likely to disclose errors that they perceive as less severe, difficult to correct, or for which they feel less personally responsible [13, 14]. Shame, embarrassment, concern about loss of professional reputation or patient trust, and fear of triggering litigation also complicate physicians’ efforts to talk with patients about adverse events and errors [4, 14]. Furthermore, few physicians have had formal training in conducting error disclosure conversations with patients, and clinicians frequently cite uncertainty about what to say to the patient as an additional impediment to disclosure [4, 15]. Physicians also struggle with effectively incorporating compassion and support for the patient. For example, many physicians would like to apologize to patients following adverse events and errors, but worry that an apology might be misconstrued by the patient as an admission of fault [4]. It is also a challenge to balance empathy with professionalism. Sincerely acknowledging and validating patients’ distress could inadvertently communicate that the event was more serious than it actually was. Conversely, when physicians adopt an overly detached and professional demeanor, it can appear to be cold and uncaring [16]. Notably, physicians may experience significant emotional distress after adverse events and errors [17]. These responses range from anxiety about future events and loss of confidence in one’s clinical skills to sleeplessness, depression, and in rare cases, suicidality [18]. The degree of emotional distress experienced by clinicians does not appear to be closely correlated with the severity of the event, but can be particularly pronounced for trainees [19]. The absence of effective support for clinicians following adverse events and errors not only affects the well-being of these individuals, it also appears to affect their willingness to disclose [13, 17].

Disclosure gap The impact of these barriers on disclosure is apparent. Despite a decade’s attention to the importance of improving disclosure practices, compelling evidence suggests that a major gap exists between expectations for disclosure and current practice. The first major publication exploring this

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issue was a 1991 study of house officers, in which only 24 % reported disclosing a serious error that they had made to the patient or family [17]. In a 2005 study, 26 % of patients who believed they had experienced a medical error in their care received a disclosure and apology for what happened [20]. More current data confirm that serious problems persist with disclosure processes. A 2012 interview study of 100 patients and family members who experienced disclosure of an adverse event highlighted how relatively few of the disclosures met patient and family member expectations for basic information and apology [21]. Survey studies of surgeons elucidate a disclosure gap specific to surgery. In a survey of thousands of physicians in the United States and Canada, participants were asked to respond to hypothetical error scenarios [14]. Half of the surgeons were randomized to a surgical error that would be apparent to the patient (retained surgical sponge), whereas the other half received an error that would be less apparent to the patient in the absence of disclosure (the bile duct injury presented at the onset of this article). Only 66 % of surgeons said they would definitely disclose that there was an error involved in the bile duct injury to the patient compared with 97 % who reported that they would definitely disclose the error associated with the retained sponge. Overall, compared with medical specialists, surgeons were more likely to report that they would disclose but choose to disclose less information [14]. More specifically, surgeons were less likely to include the word ‘‘error,’’ use an explicit apology, and provide details about preventing reoccurrences. In a 2005 study, 30 academic surgeons were asked to disclose error scenarios with standardized patients. Surgeons performed well in explaining the medical effects of the error, but did less satisfactorily in explicitly calling out the error and confirming patient understanding of the event. Surgeons also particularly struggled with more ‘‘systemrelated’’ errors [16]. Interviews with surgical team members in a 2006 study indicated that they are more likely to provide partial rather than full disclosure as a means of diffusing culpability [22]. Data about actual communication after adverse events in surgery is limited, but telling. Krizek’s [23] 2000 retrospective study of adverse events on three surgical units found that almost 80 % of adverse events and errors were not even officially recognized, severely hampering efforts to inform the patient or family about what happened.

Challenges associated with disclosure in surgery So, why does the disclosure gap look different for surgeons? Distinct aspects of surgical adverse events and the profession

of surgery itself may engender unique obstacles to providing complete and satisfactory disclosures with patients in the surgical setting. Challenges associated with the frequency of adverse events and fear of litigation First, the high frequency of surgical adverse events, combined with the current tort environment, contributes to disclosure challenges. Retrospective reviews indicate that more than 40 % of adverse events occurring in hospitals result from treatments provided in the operating room [24, 25] with certain surgical subspecialties having even higher rates of adverse events [26]. A 2000 prospective assessment of three surgical units stated that 45 % of surgery patients experienced at least one adverse event and close to 18 % experienced a serious event [23]. Significantly, while surgeons may have a high rate of adverse events, surgical adverse events are not more likely to be due to error than nonsurgical adverse events [23, 25– 27]. However, in the current tort system, the relationship between errors and medical malpractice claims is ‘‘lopsided and mismatched’’ [28], leaving surgeons vulnerable despite the high quality of care that they deliver. Some studies have indicated that disclosure of errors to patients reduces the chances of them filing a malpractice lawsuit; however, there is no guarantee that full disclosure would definitely preclude a claim [29]. Given the inequitable malpractice environment, the lack of complete protection provided by disclosure, plus the frequency at which surgical adverse events occur, fear of litigation may be an especially strong deterrent to surgeons disclosing problems in care to patients. Challenges associated with the team structure of surgical care Additionally, operating room staff members, perhaps more regularly than any other medical providers, work in teams. This standard practice presents several challenges in terms of disclosure. First, the more people that are in attendance when an adverse event occurs, the more diffuse and unclear the responsibility to communicate can become [30]. For example, one study showed that while surgeons and anesthesiologists did not believe that reporting was their responsibility, operating room nurses stated that they were not willing to report outside of their profession [22]. In other words, nobody was taking accountability for reporting on behalf of the operating room physicians. That mentality could easily transfer to the responsibility to disclose, resulting in no individual taking the initiative to communicate with the patient.

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Secondly, multiple people present during a procedure increases the chance that multiple people will have their own interpretation of an event [7]. This can create discrepancies between team members in terms of what exactly happened and who was responsible. In these cases, it is difficult to create a consistent narrative to share with the patient, which can lead to confusion in the disclosure process. Not surprisingly, the majority of surgical errors cannot be attributed exclusively to an individual clinician [31, 32]. However, the collaborative nature of surgical procedures and adverse events exists in direct contrast to the prevalent ‘‘blame and shame’’ culture around accountability [13, 33]. The fact that individual clinicians are often identified as solely responsible and punished for team and system errors is another understandable disincentive to open communication around surgical adverse events. Of all of the operating room team members, the disconnect between collective culpability and individual blame is particularly relevant to the attending surgeon, the traditional ‘‘captain of the ship’’ [2]. Naunheim emphasizes the tension between surgeons’ expectations of complete power and the need to acknowledge factors and outcomes outside of one’s control [34]. This difficult balance may explain why surgeons struggle particularly with system-related error disclosure [16]. Challenges associated with traditional surgical patient safety initiatives Notably, surgical culture is beset with a rich history of patient safety initiatives. Informed consent, morbidity and mortality (M&M) conference, and checklists have all prospered in the surgical context, contributing vastly to the safety of patients and continued improvement of the profession. However, these very same patient safety initiatives could inadvertently be creating barriers to communicating with patients after adverse events and errors. First, the process and culture around informed consent could be hindering effective disclosure. The range of unanticipated outcomes in medical care is unquestionable; an adverse event is not necessarily due to negligence or error. However, the surgical vernacular lends itself to an especially gray spectrum. Due to the nature of informed consent, from the surgeon’s perspective, very few events should be considered truly unanticipated. More so, many adverse events, aside from those caused by egregious mistakes, could be discussed easily within the context of possible outcomes reviewed before the operation without explicitly explaining what happened and why. In the case of the burned bile duct, for example, the patient could be told that as was mentioned as a possibility during informed consent, there were complications during

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surgery that required an open procedure. This communication is not inaccurate, but it certainly does not convey that the surgeon’s misunderstanding of how to use the instrument caused the event. Indeed, Pierluissi et al. [31] found that surgeons, especially surgical leaders, were hesitant to call out their errors as such. Reluctance to recognize errors when appropriate, and any adverse event as unanticipated from the patient perspective, prohibits complete, satisfactory disclosure. Likewise, M&M conferences are considered a critical part of surgical quality improvement. Nonetheless, this customary practice of candidly discussing adverse events and errors amongst peers may give surgeons a false sense of transparency, obviating the urge to communicate openly with patients and patient’s families. Even if M&Ms are not dissuading surgeons in this way, they may not be preparing them for the most effective interactions with patients. First, many adverse events will not be identified for M&M conference [17, 35, 36]. Furthermore, involved clinicians often are not present for the presentation of their case [35, 37]. These disparities deprive the surgeon of the chance to process the case with colleagues in preparation of explaining to a patient what happened, why it happened, and how reoccurrences will be avoided. Moreover, when the relevant surgeon is present, blame can be shifted unfoundedly towards an attendee [2] or resident [23], depending on the traditions of a given institution. This obscurity in roles can follow to the disclosure conversation, making it difficult for a practitioner to explain clearly to the patient his or her part in the event. It is agreed that M&M is an essential component of surgical patient safety. However, in their traditional form, M&Ms may not support more frequent or improved disclosure of adverse events and errors to patients. Lastly, there is a lack of professional guidelines around disclosure in surgery. This deficiency is evident both in the absence of disclosure and in the variation in which surgeons’ have expressed their disclosure practices [16]. Without clear, reasonable, profession-specific standards, surgeons will inevitably continue to struggle with consistent, effective disclosures.

Strategies to improve disclosure in surgery Disclosure after adverse events and errors is challenging for many clinicians. Fortunately, multiple strategies have been identified to assist providers with these difficult conversations. Just-in-time disclosure coaching, role modeling by senior physicians, skills training, simulation, and offering clinical coverage and provider support after adverse events and errors are just a few ways that physicians and institutions

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can improve disclosure culture and implementation [5, 7, 33]. All physicians should be aware of the disclosure support resources that their institution or malpractice insurer offers and ensure that they take full advantage of these supports before and after disclosure conversations with patients. In addition to these general tactics, surgeons should consider further means for encouraging, guiding, and supporting disclosure in the surgical context. Strategies to address challenges associated with fear of litigation Improving disclosure conversations after surgical adverse events and errors will require many surgeons to address their fears regarding litigation. Fortunately, there is evidence that these fears may not be aligned with reality. The vast majority of harmful errors do not result in lawsuits, and physicians substantially overestimate the risk that they will be sued [24, 38]. Additionally, the majority of states now provide some degree of protection against disclosures and apologies being used as evidence of fault in the event a malpractice suit is filed [39]. Furthermore, although it is by no means fail proof, multiple studies suggest that effective disclosure decreases, rather than increases, the chances of a patient filing a lawsuit, and facilitates the faster resolution of those lawsuits that are filed and for lower dollar figures [40–42]. Improving their understanding of the relationship between disclosure and litigation may help physicians to feel more comfortable being open with patients when care has not gone well. In cases of error, coupling disclosure with proactive offers of compensation has also been shown to be effective [43]. Based on pioneering work done at the University of Michigan, COPIC Insurance, University of Illinois at Chicago, the Lexington Kentucky VA, and Stanford University, ‘‘communication and resolution programs’’ are proliferating nationally [10, 44–46]. Following adverse events, these programs conduct a rapid investigation of what happened, provide a full explanation about the event and apology to the patient, proactively make an offer of compensation to the patient if the care was found to be unreasonable, and ensure that lessons learned are integrated back into care delivery to prevent recurrences. Data from the University of Michigan communication and resolution program showed a significant decrease in the number of claims and lawsuits, legal expenses, and time to resolution of claims [47]. Work is ongoing at several institutions to understand whether these results can be replicated outside the walls of a closed, self-insured, academic health center. The decision about whether to provide an offer of compensation to a patient following an adverse event is complex and should be the purview of risk managers,

claims staff, or administrators rather than individual physicians. Even well-meaning comments by physicians regarding the possibility of compensation for patient can be misconstrued by the patient as a guarantee, heightening the patient’s anger if the expected amount is not forthcoming. Therefore, it is critical that physicians defer all questions about compensation to appropriate risk, claims, or administrative staff at their institution. Nonetheless, surgeons should be aware of the growth of communication resolution programs, and explore opportunities at their institution or malpractice insurer. Strategies to address challenges associated with the team structure of surgical care Individual surgeons and healthcare institutions can utilize collaborative disclosure planning strategies to overcome obstacles associated with the team structure of surgical care. A recent review of disclosure in anesthesia advocates for a ‘‘disclosure timeout’’ [7]. If an adverse event or error occurs during surgery, after the case has ended and the entire operating room team is still present, the involved healthcare workers collaboratively plan for the communication with the patient. At this time, an individual can be identified to speak with the patient and any discrepancies about the event can be reconciled. This process could be a standalone activity or a component of a larger postoperative team debrief. If possible, it is recommended that the initial timeout be followed with consultation with risk management or a disclosure coach before speaking with the patient or patient family [11, 12]. As surgeons move towards more of a ‘‘team-based’’ model of disclosure planning and implementation, it will be important to make individual, institutional, and professional progress towards an environment supportive of Just Culture. Just Culture is a concept that attempts to strike the appropriate balance between individual and system accountability for problems in healthcare [48]. Almost perpetually working in teams, surgeons are ideally suited to guide the medical profession towards the Just Culture paradigm, modeling collective accountability rather than individual blame. Collective accountability involves not just taking responsibility for the disclosure conversation; it implies an equally strong obligation to participate in institutional initiatives to understand why the adverse event happened and how recurrences can be prevented [30]. Strategies that address challenges associated with traditional surgical patient safety initiatives Another strategy for communication after adverse events in surgery is one that addresses the ambiguity in surgical

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dialect, especially in the context of informed consent. As discussed before, the use of informed consent can create divergence around what is and is not unanticipated, making surgeons feel that it is unnecessary for them to explicitly note whether the adverse event was due to an error. In this setting, it is especially important to be explicit when communicating with patients [16]. Disclosure rapport begins in the informed consent process and disclosure is arguably a continuation of the consent conversation [7]. Revisiting the consent form after the operation could provide a standard structure for disclosure conversations. In reviewing the procedure, the surgeon should strive to remember that a patient’s perception of ‘‘unanticipated’’ may be very different than his or her own. A satisfying, and subsequently effective, disclosure will address the patient’s standpoint. Lastly, of paramount importance, is the use of clear and unequivocal language, especially in terms of error. If an adverse event is the result of an error, whether of judgment, technique, communication, or other, it should be recognized as such to the patient. Next, Mavroudis et al. [34] argues that ethical choices become ‘‘second nature’’ only after teaching and experience. In order to implement disclosure skills confidently and successfully, surgeons need the opportunity to practice. Historically, M&Ms may have been part of the problem, but innovations are helping to make them an environment conducive to disclosure training. The OBGYN department at Duke University recently piloted a program that utilized M&M to impart disclosure instruction and skill building [49]. After real M&M cases were presented, there was a didactic presentation about communication with patient and families, and then the cases were discussed in terms of communication strategies. In other sessions, physicians were given the opportunity to role-play skills and practice with simulated patients. More than 80 % of participants rated the conferences as excellent or very good and said that their abilities were improved by the activity. Standardized patient exercises have already been shown to be effective for disclosure training [16], but the Duke study showed that basing the practice activities on actual cases engendered ‘‘buy-in’’ from participants who were learning the skills [49]. Pierluissi et al. [31] also argue that modeling error disclosure in M&M can help to prepare clinicians for successful disclosure conversations. Practice also may help to lessen apprehension about disclosure provoking litigation [50]. Finally, the most effective standards can only be generated from within the surgical profession. Surgeons seeking advice in disclosure will benefit most from guidelines designed and provided by entities such as the American College of Surgery and potentially, individual subspecialties. After all, nobody understands the context for communication after surgical events more than surgeons themselves.

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Disclosure of other providers’ errors Physicians frequently confront the challenge of whether and how to discuss another clinicians’ error with the patient [13, 23]. Several studies have suggested that physicians often are aware that their colleagues have made an error in a patient’s care, yet hesitate to report their concerns to the institution or to share what happened with the patient [13, 51]. For many physicians, confronting the colleague about a potential error or lapse in professionalism is even more difficult than discussing what happened with the patient [52, 53]. Multiple challenges, such as uncertainty about what happened, professional loyalty, issues of hierarchy, and fear of retaliation, make it very difficult for physicians to know how to respond to these cases [2, 13, 26, 33, 54–56]. Historically, little guidance was available for physicians about responding to errors involving colleagues. However, this issue was recently elucidated in a consensus report by a diverse panel of patient safety experts [52]. While recognizing the unique challenges that arise in situations involving communication with patients about other clinicians’ errors, the group articulated three basic principles for moving forward: (1) Patients and families come first. Concerns about disrupting collegial relationships do not lessen the obligation to inform patients about adverse events and errors in their care; (2) Explore, do not ignore. Rather than looking the other way when we think a colleague may have made an error, clinicians need to become more skilled at having supportive, nonaccusatory conversations with each other about potential errors; (3) Institutions should lead. For many cases involving an error made by a colleague, institutional leadership and support will be key. While preliminary, these principles provide some initial guidance for surgeons as they confront this vexing dilemma.

Conclusions The disclosure of adverse events and errors to patients is ethical, patient-centered, and contributes to overall quality improvement. However, the act of disclosure can be difficult, and currently, physicians are not disclosing at a frequency or level of quality satisfactory to patients. Disclosure in the surgical context has unique challenges stemming from the frequency of surgical adverse events in conjunction with an imbalanced tort system, the team structure of surgical staff, and barriers created inadvertently by existing surgical patient safety initiatives. Fortunately, as discussed here, there are multiple strategies that can be implemented at the individual, institutional, and professional levels to help surgeons provide patients with complete, satisfactory disclosures. As the culture around

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patient safety continues to advance, improvement in the regularity and quality of disclosures after surgical adverse events and errors is a key way that surgeons can continue to be clinical leaders in quality improvement and communication. Acknowledgments The authors would like to acknowledge Angelo Lipira, MD, for his review of the manuscript and insights into the surgical profession. Conflict of interest report.

The authors have no conflicts of interest to

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Disclosure of adverse events and errors in surgical care: challenges and strategies for improvement.

The disclosure of adverse events to patients, including those caused by medical errors, is a critical part of patient-centered healthcare and a fundam...
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