Table 2.

Problems and Vignettes Regarding Defining and Classifying SAEs/AEs in Clinical Trials Involving Seriously Ill Older Adults

Problem 1: Implausible relationships SAE/AE unlikely to be causally related to the study interventions

a. Reporting falls in nursing home residents as an AE in a study that introduces education modules to improve vaccination information and uptake among nursing home staff.  b. Expedited reporting of hospitalizations and deaths as SAEs in a study of an evidence-based team huddle to coordinate care among clinical and non-clinical providers in an outpatient oncology clinic.  c. Reporting delirium as an AE in a psychosocial-behavioral study to support patients’ emotional coping strategies transitioning to nursing home care.  d. Expedited reporting of death as an SAE of end-of-life patients in a video behavioral intervention study to improve coping skills in caregivers of patients with a terminal illness.  e. Expedited reporting of acute lung injury as an SAE even though it is secondary to initial resuscitation and hospital-acquired pneumonia during prolonged mechanical ventilation in a trial of intensive insulin therapy in patients with trauma.

Problem 2: Misaligned values SAE/AE that could plausibly be causally related to the study intervention, but events are concordant with a study participant’s goals of care

a. Expedited reporting of death as an SAE after a patient elects to terminate life-sustaining therapy in a study of a video intervention to help patients with serious illness and poor prognosis make an advanced care planning decision.  b. Expedited reporting of a breathlessness crisis as an SAE in palliative sedation when consistent with established goals of care.

Problem 3: Well-known relationships SAEs/AEs that are already known to be associated or caused by the study’s invention mechanisms

a. Reporting common and normal feelings of distress and grief as AEs in a video behavioral intervention to improve coping skills in caregivers of patients with a terminal illness prognosis.  b. Expedited reporting of treatable infection as an AE in a hip replacement intervention.  c. Expedited reporting of severe neutropenia as an SAE in a study involving chemotherapy in a population with advanced cancer.