It is now well established that patients commonly suffer injuries on account of medical treatment (‘incidents’ or ‘adverse events’). Studies done in Canada,1 Spain,2 Australia,3 the UK,4 and the US5 reveal very similar rates of adverse events: about 10% of hospitalized patients experience an adverse event, 1 in 200 die in part due to these incidents, and 40% of all such incidents are considered preventable. The rate of serious adverse events in community or ambulatory settings – such as the dentist’s office – is not known but likely to be lower, given the less intensive care provided there.
What to tell patients or their families about adverse events is an important issue. While in years past, clinicians might have been loath to reveal the true nature of medically-related harm, there has more recently been a sea-change in attitudes towards disclosure.6
For example, the ‘new professionalism’ initiative launched in 2002 by the American Board of Internal Medicine (ABIM), American College of Physicians-American Society of Internal Medicine (ACP-ASIM), and the European Federation of Internal Medicine (EFIM) promulgated the ‘Medical Professionalism in the New Millennium: A Physician Charter’.7 According to this charter, physician obligations include the commitment to:
• professional competence,
• honesty with patients,
• improving quality of care,
• maintaining trust in health care.
Consistent with these commitments, current opinion for all healthcare professionals calls for open and timely disclosure of harmful medical incidents to patients (and / or, where appropriate, to the patient’s family or substitute decision-maker).8 The question, then, is not whether but how and when to disclose information regarding such events. Despite this, evidence from the literature suggests such disclosure does not always take place and, when it does transpire, may not go well.9 This may be for a variety of reasons including uncertainty as to who should do the disclosing, what should be disclosed, and to whom should the disclosure be made.
The failure of healthcare professionals to meet expectations regarding the disclosure of adverse events has led to new Canadian regulations and laws compelling such disclosure. For example, several provinces have enacted laws requiring disclosure of harmful incidents occurring in hospitals – albeit to health authorities and not to patients.10 Professional and regulatory medical authorities, however, mandate openness with patients concerning adverse events.11 Even professional insurers, typically considered resistant to openness for fear of self-incrimination, now recognize that honesty about adverse events is the best medico-legal course.12 Canadian accreditation standards will this year require that all hospitals have a system in place to ensure disclosure of ‘critical incidents’ to patients.13 Recent national guidelines also encourage hospitals to devise open disclosure policies.14
While these regulations and policies may focus on hospital settings, they are no less pertinent to community clinicians in terms of public expectations. The threshold for disclosure of incidents is any harm or significant threats to patient welfare. Where a harmful incident has occurred or has a significant likelihood of causing harm, this ought to be disclosed.15 If the harms to patients are serious and seemingly avoidable, the professional’s reaction can be one of shame, guilt and embarrassment.16 Nonetheless, the task for any healthcare professional, faced with an untoward event, is to be prepared and to assume that his or her patient would, in general, prefer more information than less regarding the incident.
Ensuring rapport with patients is a critical part of the interaction with patients. Patients need to have realistic expectations of medical interventions. When events do not proceed as planned, patients and their families need to be apprised of this as expeditiously as possible. For example, disclosure of a harmful outcome should take place as soon as possible after an incident has been identified and when the patient is stable and able to understand and appreciate the information. At the outset, empathic expressions, such as “I am sorry to see how things have turned out”, can set an appropriate tone of acknowledgement of the harm. The focus of the disclosure should be a narrative account of what transpired – a truthful account of what is known to have happened – rather than obfuscations or hasty conclusions as to ‘who did it’. Uncertainty concerning the incident should not delay initial meetings but rather call for future meetings. Any questions the patient or family may have should be solicited and answers sought in an expeditious manner. It is frequently important for patients or families also to be told what is being done to prevent the event’s recurrence.
No matter how innocuous or how serious the adverse event might be, the offer of genuine apologies by those caring for the patient is critical, whether or not they were ‘responsible’ for the incident. Expressions of regret and acceptance of responsibility are morally proper, interpersonally appropriate, and should not be legally contentious. Studies do not bear out the worry that admitting to harm or error is likely to increase one’s medico-legal liability, although, admittedly, the evidence is limited.17 Most notably, in 2009, Ontario, like many other provinces, passed the ‘Apology Act, 2009‘ that prevents statements by clinicians who make apologies, whether they are expressions of empathy or acceptance of responsibility for adverse medical events, from being used against them in a court of law.18 The hope is this law will, in encouraging honesty about medical error, lead to improvements in patient safety. It is too early to say whether this law will make a difference, but it will not eliminate malpractice claims.
The new laws and regulations accord with what we know concerning patient attitudes. A need for explanation and accountability and a concern for the standards of care underlie many medico-legal actions.19 One study revealed that over 90% of patients want to be informed about even minor errors.20 Another study in 2004 suggested ‘full disclosure’ of an adverse event reduces a clinician’s malpractice relative risk by about one-third (absolute risk reduction, 8%).21 While disclosure does not and cannot confer immunity against lawsuits and complaints, such honesty has been shown to reduce the punitive ‘sting’ that sometimes accompanies proceedings against clinicians and hospitals.22 In a recent US study, for adverse events with a severe outcome, an honest, empathic, and accountable approach decreased by 59% the probability of participants’ support for strong sanctions against the physician involved.23
All healthcare professionals have an interest in preventing errors and harm to patients. New rules and expectations should encourage clinicians to meet new professional standards of openness and ensure they are forthcoming with their clients or patients when things do not turn out as expected. If uncertain how to proceed, independent healthcare professionals would be well advised to seek guidance and advice from peer groups and their regulatory bodies. OH
Dr Hébert is a Professor of Family Medicine at the University of Toronto. He has a long-standing interest in medical ethics and the law. In 2008 he received the Canadian William Marsden Medal for ethics teaching. The 2nd edition of his book, “Doing Right: A Practical Guide to Ethics for Medical Trainees and Physicians” was published by Oxford University Press in 2009. He can be reached at philip.hebert@sunnybrook.ca
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12. The Canadian Medical Protective Association. Communicating with your patient about harm: Disclosure of Adverse Events. (Ottawa, October 2008)
13. Hospital management. R.R.O. 1990, Regulation 965 of the Public Hospitals Act (Ontario, 2008).
14. 2008 Canadian Disclosure Guidelines (Ottawa, April 2008) CPSI. Accessed at: http://www.patientsafetyinstitute.ca/uploadedFiles/Resources/cpsl_english._april28.pdf
15. Regulation 423/07. Disclosure of critical incidents to patients: Frequently asked questions. OHA. (Toronto, August 2007)
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