Skip to main content

Advertisement

Table 1 Definitions of terminology for study protocol [20]

From: Active versus passive adverse event reporting after pediatric chiropractic manual therapy: study protocol for a cluster randomized controlled trial

Adverse event (AE) Any unfavorable sign, symptom or disease temporally associated with the treatment, whether or not caused by the treatment. Specifically, any new symptom of moderate severity or a pre-existing symptom that is worse after treatment
Seriousness Mild: asymptomatic or mild symptoms, self-care only (e.g., ice/heat, over-the-counter analgesic)
Moderate: limiting age-appropriate activities of daily living (e.g., work, school); or sought care from a physician
Severe: medically significant but not immediately life-threatening; temporarily limits self-care (e.g., bathing, dressing, eating) (for 5 years of age and older); or urgent or emergency room assessment sought
Serious: results in death or a life-threatening adverse event or an adverse event resulting in inpatient hospitalization or prolongation of existing hospitalization for more than 24 h: a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect
Causality (i.e., relatedness) Certain: a clinical event occurring in a plausible time relationship to treatment, and which cannot be explained by concurrent disease or other drugs or therapies
Probable/likely: a clinical event with a reasonable time sequence to treatment, unlikely to be attributed to concurrent disease or other drugs or therapies
Possible: a clinical event with a reasonable time sequence to treatment, but which could also be explained by concurrent disease or other drugs or therapies
Unlikely: a clinical event with a temporal relationship to treatment which makes a causal relationship improbable, and in which drugs, other therapies or underlying disease provide plausible explanations
Preventability 1: Virtually no evidence of preventability
2: Slight to modest evidence of preventability
3: Preventability not quite likely (less than 50/50, but “close call”)
4: Preventability more than likely (more than 50/50, but “close call”)
5: Strong evidence of preventability
6: Virtually certain evidence of preventability
Patient disposition 1: Resolved, no sequelae
2: AE still present – no treatment
3: AE still present – being treated
4: Residual effects present – no treatment
5: Residual effects present – treated
6: Death
7: Unknown