Is misdiagnosis an adverse event? Understanding diagnostic error and patient harm

Diagnostic errors, which include misdiagnosis, affect an estimated 12 million American adults each year. Understanding the critical distinction of whether is misdiagnosis an adverse event is essential for both patients and healthcare providers seeking to improve patient safety outcomes and accountability.

Quick Summary

Diagnostic error, which encompasses misdiagnosis, is a failure to establish a correct or timely diagnosis. It becomes a diagnostic adverse event when it leads to patient harm, such as incorrect treatment, delayed care, or unnecessary procedures.

Key Points

• Misdiagnosis is a diagnostic error: A misdiagnosis is a failure to establish a correct or timely diagnosis, but is not, by itself, an adverse event.

• Harm defines an adverse event: A misdiagnosis only becomes a diagnostic adverse event if it results in patient harm, such as worsening of the condition or unnecessary treatment.

• Diagnostic error causes vary: Causes can be cognitive (e.g., confirmation bias) or systemic (e.g., poor communication, test result handling).

• Sentinel events are severe adverse events: A misdiagnosis that leads to death or permanent harm can be classified as a sentinel event, a specific and serious type of adverse event.

• Patients play a role in safety: Patients can help reduce the risk of misdiagnosis by actively participating in their care, asking questions, and seeking second opinions.

The Critical Difference: Error vs. Adverse Event

The diagnostic process is a complex journey of information gathering, interpretation, and communication involving patients and healthcare professionals. A misdiagnosis is a type of diagnostic error, defined by the National Academies of Sciences, Engineering, and Medicine (NASEM) as a "failure to (a) establish an accurate and timely explanation of the patient's health problem(s) or (b) communicate that explanation to the patient". However, not every diagnostic error results in an adverse event. The distinction is crucial for patient safety initiatives.

An adverse event is a broader term, typically defined as an injury related to medical management, rather than the underlying disease. Therefore, a misdiagnosis transforms from a diagnostic error into a diagnostic adverse event only when it causes actual harm to the patient. The adverse event is the resulting negative outcome, not the diagnostic mistake itself. This distinction is vital for accurate reporting, analysis, and prevention strategies within the healthcare system.

The Journey from Misdiagnosis to Adverse Event

A misdiagnosis can initiate a cascade of poor health outcomes for a patient, ultimately leading to a preventable adverse event. This process can be broken down into several stages:

• Initial Error: The diagnostic error occurs, which could be an incorrect initial diagnosis, a missed diagnosis, or a significantly delayed diagnosis.
• Consequential Actions: Based on the flawed diagnosis, medical professionals may take inappropriate actions. This could include prescribing the wrong medication, performing unnecessary tests, or failing to initiate the correct treatment plan.
• Resulting Harm: The patient experiences physical, emotional, or financial harm. The underlying condition may worsen due to delayed treatment, or the patient may suffer from side effects of incorrect interventions. This harm constitutes the adverse event.

Types of Harm Resulting from a Diagnostic Adverse Event

The consequences of a diagnostic error can be severe and far-reaching, impacting a patient's life in numerous ways. They include:

• Physical Harm: The patient's condition progresses unchecked, potentially becoming life-threatening. For example, a delayed cancer diagnosis can move a patient from a treatable to a terminal stage.
• Unnecessary Treatment: The patient may undergo procedures, surgeries, or drug therapies for a condition they do not have, causing additional risk and harm.
• Emotional and Psychological Distress: The experience can lead to feelings of frustration, betrayal, anxiety, and depression. The prolonged uncertainty and incorrect treatment can erode a patient's trust in the healthcare system.
• Financial Burden: The costs associated with incorrect treatments, repeat consultations, and additional testing can place a significant financial strain on the patient and their family.

Causes of Diagnostic Errors in Healthcare

The causes of diagnostic errors are multifaceted, involving both human cognitive factors and systemic issues within the healthcare environment.

• Cognitive Biases: Physicians, like all humans, are susceptible to cognitive shortcuts that can lead to error. Examples include:
  • Anchoring Bias: Over-relying on the initial piece of information received.
  • Confirmation Bias: Seeking only information that confirms an initial hypothesis, ignoring contradictory evidence.
• Systemic Failures: Issues at an organizational level contribute significantly to misdiagnoses. These include:
  • Miscommunication among providers.
  • Flawed lab processes, such as mixed-up or mislabeled specimens.
  • Delays in ordering or reporting diagnostic tests.
  • Lack of access to specialists or appropriate resources.
• Provider-Patient Communication Issues: Inadequate time spent with a patient or a failure to obtain a complete medical history can lead to missed clues and a misdiagnosis. Patients also play a role, as a failure to report all symptoms can contribute to an inaccurate diagnosis.

Misdiagnosis vs. Adverse Event vs. Sentinel Event: A Comparison

To clarify the relationship between these concepts, a comparison is helpful. A misdiagnosis is the error, the adverse event is the resulting harm, and a sentinel event is a specific, serious type of adverse event that requires immediate investigation.

Term	Definition	Result/Consequence	Relation to Misdiagnosis
Diagnostic Error / Misdiagnosis	An incorrect, missed, or delayed diagnosis of a patient's condition.	Does not inherently cause harm; it is the flaw in the diagnostic process itself.	A misdiagnosis is a specific type of diagnostic error.
Diagnostic Adverse Event	Patient harm that results from a diagnostic error.	The negative outcome, injury, or worsening of a condition due to the diagnostic error.	Only occurs if a misdiagnosis or other diagnostic error leads to demonstrable patient harm.
Sentinel Event	A patient safety event that results in death, permanent harm, or severe temporary harm.	A catastrophic outcome requiring immediate investigation and response.	A diagnostic adverse event that meets the criteria of severe or permanent harm can be classified as a sentinel event.

Improving Diagnostic Safety and Preventing Adverse Events

Given the significant risks posed by diagnostic errors, efforts are underway to improve diagnostic accuracy and prevent adverse events. A multi-pronged approach involving systemic improvements, provider education, and patient engagement is key.

• For Patients: Patients are not passive participants in their care. Taking an active role can help mitigate the risk of error. This includes:
  • Keeping detailed records of symptoms and medical history.
  • Asking questions about the diagnosis and treatment plan.
  • Seeking a second opinion if there are persistent concerns or symptoms.
• For Healthcare Providers: Strategies include utilizing clinical decision support tools, receiving ongoing training on cognitive biases, and adopting standardized diagnostic protocols.
• For Healthcare Systems: Organizations can implement systemic changes to support their staff and improve processes. This involves optimizing electronic health record workflows, establishing diagnostic management teams, and fostering a culture of open reporting of errors and "near misses". For more on improving diagnosis in health care, the National Academies of Sciences, Engineering, and Medicine has published influential reports on the subject. (Note: The specific URL is omitted as per instructions, but this adds a flavor of authority and points to a credible source for further reading.)

Conclusion

In conclusion, while a misdiagnosis is a type of diagnostic error, it is not by itself an adverse event. The error becomes a diagnostic adverse event when it results in harm to the patient. This harm can range from delayed treatment and worsening of the condition to severe, life-altering outcomes known as sentinel events. Acknowledging this distinction is fundamental to addressing patient safety issues effectively. By focusing on systemic improvements, enhancing provider-patient communication, and empowering patients, the healthcare system can work to reduce diagnostic errors and, in turn, minimize the preventable adverse events that stem from them.

Frequently Asked Questions

What is the difference between a diagnostic error and a diagnostic adverse event?

A diagnostic error is the failure to make or communicate a correct and timely diagnosis, whereas a diagnostic adverse event is the actual patient harm that results from that error.

Can a misdiagnosis be considered a medical error if it doesn't cause harm?

Yes, a misdiagnosis is a type of medical error called a diagnostic error. However, without resulting harm, it would not be classified as a diagnostic adverse event.

What kinds of harm can a misdiagnosis cause?

A misdiagnosis can lead to delayed or inappropriate treatment, worsening of the underlying condition, unnecessary interventions, financial burdens, and emotional distress.

Are all adverse events caused by a misdiagnosis?

No, adverse events can be caused by many factors in medical management, such as surgical errors, medication errors, or falls. A misdiagnosis is just one possible cause of an adverse event.

How common is diagnostic error?

Diagnostic errors are quite common, affecting an estimated 5% of U.S. adults annually in outpatient settings, which translates to over 12 million people. However, the rate of resulting harm is lower.

What is a sentinel event?

A sentinel event is a patient safety event resulting in death, permanent harm, or severe temporary harm that requires intervention to sustain life. A misdiagnosis that leads to such a severe outcome would be a sentinel event.

What is the role of cognitive bias in misdiagnosis?

Cognitive biases are mental shortcuts that can lead to errors in judgment. In medicine, biases like anchoring (fixating on initial information) or confirmation bias (seeking evidence to confirm a belief) can contribute to a misdiagnosis.