In the context of psychological research on stress and immune function, if a participant reports a migraine headache and misses work for a day, is this considered an adverse event (AE)?

• A. No, adverse events (AE) only include physical injuries, not headaches.
• B. Yes, but only if the participant is hospitalized.
• C. No, only life-threatening conditions are classified as adverse events (AE).
• D. Yes, a migraine headache resulting in missed work is considered an adverse event (AE).

Answer: (D)

Verified step by step guidance

1. Understand the definition of an adverse event (AE) in psychological and medical research: An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a treatment or participation in a study, regardless of whether it is considered related to the treatment.
2. Recognize that adverse events are not limited to physical injuries but include any negative health-related occurrences, such as headaches, migraines, or other symptoms that impact the participant's well-being.
3. Consider the impact of the event on the participant's daily functioning; if a migraine headache causes the participant to miss work, it indicates a significant negative effect on their health and functioning.
4. Note that hospitalization is not a requirement for an event to be classified as an AE; even less severe but impactful symptoms like migraines can qualify as adverse events.
5. Conclude that a migraine headache resulting in missed work fits the criteria of an adverse event because it is an unfavorable health occurrence affecting the participant's normal activities.