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Diagnostic errors cause substantial harm to patients but remain largely unappreciated within the patient safety movement in health care.1 The National Academy of Medicine defines a diagnostic error as “failure to (a) establish an accurate and timely explanation of the patient’s health problem(s) or (b) communicate that explanation to the patient,” but this universal definition can be difficult to apply in a fast-paced critical care environment, such as the intensive care unit.1 An operational definition adopted by some researchers is that a diagnostic error is present if there is unequivocal evidence of a missed opportunity during the diagnostic process to establish a timely and accurate diagnosis.2 This is especially applicable in settings such as the neonatal intensive care unit, where the length of stay is often prolonged and most diagnoses will be discovered before discharge. The key to determining if a diagnostic error occurred is to establish whether there was an opportunity to make the diagnosis sooner. However, when performing retrospective evaluations for the presence of diagnostic errors, researchers operate without a direct association with either the treating clinician or patient. This leads to the following quandary: do researchers have an ethical obligation to inform patients or clinicians when they discover previously unrecognized diagnostic errors? In this Viewpoint, we review the current literature on the ethics of disclosing adverse events, such as diagnostic errors, and then formulate a framework to guide the researcher in this scenario.
The current ethical discourse suggests that failure by the clinician to disclose medical errors to patients represents a breach of professional ethics. The American Medical Association’s Council on Ethical and Judicial Affairs recommends full disclosure to the patient when an error causes harm, which is corroborated by the American Academy of Pediatrics Committee on Medical Liability and Risk Management, which recommends that clinicians and institutions identify and disclose adverse events to patients and families.3,4 However, none of these groups address the obligations of the researcher, who is outside the patient-clinician dyad. For example, patient safety researchers may observe practices or events that already have or will harm the patient. These investigators have no direct association with the patient and thus may be uncertain if they are obligated to disclose these errors. Although slightly different, a corollary is the current discussion associated with pathologists amending pathology reports—acknowledging a diagnostic error. The pathologist is involved in the patient’s diagnostic process but generally does not have direct patient contact and thus may be uncertain who bears the obligation of disclosing pathology-related diagnostic errors to the patient. Traditionally, this responsibility has fallen to the treating clinician, but there is a growing belief that given their active role in diagnosis, the disclosure of pathology-related errors should be done by the pathologist.5
To delineate the researcher’s obligations, we will examine the responsibilities to patients and treating clinicians. The ethical principles of respect for autonomy and nonmaleficence can frame the obligations to patients and their surrogate decision-makers (ie, parents). Respecting parental autonomy requires health care clinicians to support parents’ rights to make informed decisions about their child’s care. Diagnostic errors prevent parents from having an accurate understanding of their child’s health problems and treatments. However, in the setting of a retrospective medical record review, parents are no longer in the decision-making phase, and thus informed decision-making would not be supported by disclosing the diagnostic error. It is conceivable that in a rare situation, a diagnostic error could remain undetected and continue to affect the patient’s health at the time of medical record review. For example, a missed positive result of an HIV test during admission would continue to affect the patient after discharge. In this case, given that this error would almost certainly cause future harm, nonmaleficence obligates the researcher to intervene on the patient’s behalf. This approach is corroborated by the World Health Organization guidelines; the criteria guiding when a researcher performing a medical record review should intervene are strict, requiring evidence that disclosure will reverse some of the negative effects from the error and the absence of evidence that an intervention has already occurred.6 This is often difficult to ascertain from medical record review, and most errors discovered during previous medical record review studies did not meet the threshold for intervention.7 Additionally, even if the researcher were to intervene, direct contact with the patient may not be appropriate. The patient safety researcher has not entered into a formal physician-patient relationship and thus is not well situated to become an active participant by disclosing the diagnostic error to the patient. This course of action also prioritizes the role of the researcher over the treating clinician, which is a dangerous precedent to set and not supported by organizational guidelines.
The other question to consider is whether the researcher has an obligation to disclose the diagnostic error to the treating clinician. Professionalism can be used to construct a guiding framework. The goal of patient safety research is to improve patient outcomes and researchers have a professional responsibility to ensure that their colleagues are providing the best care possible. A diagnostic error represents suboptimal care, and disclosure to the clinician who committed the error raises awareness of the deficit, which may improve care in the future. Even if it does not markedly alter future care, discussion with the clinician who made the diagnostic error is unlikely to worsen outcomes in the future. Thus, given the potential for improvement in care, professionalism would dictate that informing the clinician who made the error is the best course of action when a diagnostic error is confirmed.
However, given the sensitive nature of this subject, great care should be exercised when proceeding with disclosure. We recommend that communication to the treating clinician take place in a structured setting to ensure that the details of the error are conveyed in a clear and impartial manner. There should also be a system in place for the clinician to provide additional information or feedback not available in the patient’s medical record, which may frame the event in a different light. In some settings, it may be appropriate to have a separate entity be the one to disclose to the treating clinician if there is concern that the exchange could affect the professional relationship between the researcher and clinician. Once disclosure to the clinician has occurred and a diagnostic error is confirmed, the treating clinician then assumes the responsibility of communicating the error to the patient. These recommendations are by no means complete, and as this is a delicate situation with many potential pitfalls, we recommend that researchers consult with the appropriate individuals at their institutions to ensure a suitable system exists to guide the disclosure process.
A researcher performing retrospective medical record reviews is not ethically obligated to disclose a diagnostic error directly to a patient with whom they have no formal patient-physician relationship. However, there is potentially a responsibility to discuss with the treating clinician, who then assumes the responsibility of contacting the patient. This ethical framework provides guidance on how researchers should proceed when in the course of their research they discover previously unknown patient safety events, such as diagnostic errors.
Corresponding Author: Grant J. Shafer, MD, Division of Neonatal-Perinatal Medicine, Texas Children’s Hospital, 6621 Fannin St, Ste W6014, Houston, TX 77020 (firstname.lastname@example.org).
Published Online: March 16, 2020. doi:10.1001/jamapediatrics.2020.0031
Conflict of Interest Disclosures: None reported.
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Shafer GJ, Placencia FX. The Ethics of Disclosing Diagnostic Errors: What Is the Researcher’s Duty? JAMA Pediatr. Published online March 16, 2020. doi:10.1001/jamapediatrics.2020.0031
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