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The disclosure dilemma--large-scale adverse events. [N Engl J Med. 2010] - PubMed result

N Engl J Med. 2010 Sep 2;363(10):978-86.

The disclosure dilemma--large-scale adverse events.
Dudzinski DM, Hébert PC, Foglia MB, Gallagher TH.

Department of Bioethics and Humanities, University of Washington School of Medicine, Box 357120, Seattle, WA 98195-7120, USA
. dudzin@uw.edu
Erratum in:

N Engl J Med. 2010 Oct 21;363(17):1682.

Comment in:

N Engl J Med. 2010 Dec 16;363(25):2471.

PMID: 20818911 [PubMed - indexed for MEDLINE]
Free Article
The disclosure dilemma--large-scale adverse events. [N Engl J Med. 2010] - PubMed result



The Disclosure Dilemma — Large-Scale Adverse Events
Denise M. Dudzinski, Ph.D., Philip C. Hébert, M.D., Ph.D., Mary Beth Foglia, R.N., Ph.D., and Thomas H. Gallagher, M.D.

N Engl J Med 2010; 363:978-986September 2, 2010



In 2003, the infection-control staff of a Toronto teaching hospital realized that the sterility of prostate-biopsy equipment had been inadvertently compromised by incomplete cleaning.1 Although the risk of infectious transmission was considered very low, hospital officials could not be certain that hundreds of men had not been exposed to harmful pathogens. The hospital faced a dilemma: should they disclose this adverse event that may have harmed many patients (a large-scale adverse event)? Or should they not disclose the event if the risk of harm was remote and if the disclosure would primarily cause anxiety to patients who would ultimately not be physically harmed by the event?

The hospital decided it had a duty to inform more than 900 men and offer them pathogen testing. Infection linked to the biopsy was not detected in any of the notified patients. Nevertheless, a $100 million (Canadian) class-action suit with punitive damages of $50 million (Canadian) was filed on behalf of the notified patients.2,3 This suit claimed that the disclosure and subsequent period of waiting for test results had caused psychological harm. The hospital settled the suit without admitting liability and offered a total of $1.2 million (Canadian) to 748 class-action members.4

Such large-scale adverse events are not uncommon.5-45 (Table 1Table 1

Large-Scale Adverse Events.). Yet, whether and how to disclose such events to patients pose substantial challenges,47,48 especially when the majority are more likely to be harmed by the disclosure itself than by the event. In this article, we define large-scale adverse events, describe several representative cases, and recommend key elements of a policy concerning these events.

Large-Scale Adverse Events Defined

Large-scale adverse events are individual events or a series of related events that injured or increased the risk that many patients would be injured because of health care management. The increased risk was not anticipated by health care professionals, and often was not recognized at the time of the incident. Without further testing, the subgroup of patients who have been injured generally cannot be distinguished from the group of patients who have not been harmed. Look-back investigations are the root-cause analyses, tests, and audits that ensue after such an event has been identified.

Reluctance to Disclose

There are ethical reasons why institutions may hesitate to disclose large-scale adverse events to patients. As in the Toronto case, in many such events there is good reason to believe at the outset that the majority of patients have escaped physical harm and had a “near miss.”49 Although the ethical justification for disclosing harmful errors to patients is strong,50 there is no consensus about the need to disclose near-miss incidents.51-53 Because patients involved in a near-miss incident are not physically injured, they may not benefit from the disclosure and may in fact be psychologically harmed. However, without disclosing the event and conducting look-back investigations, institutions cannot be sure whether any patient was physically harmed by the event.

Practical, legal, and financial considerations, such as the difficulty in predicting the likelihood of harm and identifying the injured patients, may also lead well-meaning institutions to consider not disclosing large-scale adverse events. In addition, for many such events, the disclosure leads to media coverage, with potential legal risk and injury to the institution's reputation. Finally, conducting the disclosure and providing follow-up counseling, testing, and treatment require considerable resources. Especially with look-back investigations involving thousands of persons, testing will inevitably identify patients with hepatitis or human immunodeficiency virus infection for whom a link between the infection and the large-scale adverse event is extremely unlikely but cannot be disproved.34

These barriers have led to instances in which these events were not disclosed. Published reports of 21 cases of endoscope contamination in England showed that although corrective actions were undertaken, in most cases patients were not notified.8 A subsequent task force concluded that the risk of infection associated with such incidents was “too low” to warrant notification of involved patients.8,13

full-text:
The Disclosure Dilemma — Large-Scale Adverse Events — NEJM

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