Safety
death
ADVERSE EVENTS
We defined serious adverse events as unexpected admission to hospital, death related to the study intervention, or both. Suspected serious adverse events were both reported prospectively by general practitioners and identified retrospectively by the trial manager through proactive monthly contact with care homes. The resident’s general practitioner assessed serious adverse events for causality and association with the PIP intervention. In addition, a dedicated email address was provided to all care home staff to report concerns. Finally, a study geriatrician assessed a 20% random sample of pharmaceutical care plans (weighted towards earlier trial stages) for clinical appropriateness and safety.