Harm and adverse events
deaths, death
ADVERSE EVENTS, ADVERSE EVENT, EVENTS
Adverse events were classified as serious (death, life threatening events, hospital admission, substantial incapacity) or potentially related to the intervention or to PrAISED exercises undertaken independently. Adverse events were ascertained by participants or their carer reporting them to the study or intervention delivery teams or through the monthly calendars. The intervention group had more exposure to study therapists, and consequently more opportunity to report adverse events, resulting in an ascertainment (information) bias. To compare the safety of the intervention we considered deaths, hospital admissions, and falls to be core adverse events. To investigate the possibility of an early falls hazard associated with increased activity, we analysed falls in the first three months separately.