Strengths and limitations of study
deaths, fractures
RECRUITMENT
In terms of validity, this was a large trial, involving 72 care homes, 49 PIPs and general practices, and 876 residents. We recruited to target, so we had sufficient power to test our hypothesis of a 21% decrease in falls. As this was a cluster trial, we removed the potential for contamination affecting performance of different care homes managed by the same general practice. Follow-up of residents was thorough and complete, with primary outcome data available for 96% of residents at six months when deaths were excluded.This trial was the culmination of a five year programme grant during which the team, assiduously following Medical Research Council guidance,In hindsight, benefits from drug related interventions, particularly deprescribing, take time to be realised, so a six month intervention and follow-up period may have been insufficient. The intervention development phase also highlighted a need for PIPs to be part of the general practice team; however, during recruitment, insufficient general practice based pharmacists were available to allow us to recruit solely from that pool. That three (12%) PIPs failed to deliver the full intervention was also unfortunate, but, as this was a pragmatic study, this is consistent with what would happen in everyday practice. Blinding care homes to their group status was also not possible, and researchers may have been aware of that status when collecting follow-up data.We developed a core outcome set to support selection of the most valid outcome measures for this group,In our process evaluation,Anticholinergic/sedative burden is associated with increased mortality, falls, hip fractures, frailty, and reduced quality of life.