Core Outcome Set for Trials Aimed at Improving the Appropriateness of Polypharmacy in Older People in Primary Care

OBJECTIVESTo develop a core outcome set (COS) for use in effectiveness trials of interventions aiming to improve the appropriateness of polypharmacy in older people in primary care. DESIGNStandard COS development methodology was followed, comprising identification of outcomes of studies from an update of a Cochrane systematic review and previously collected qualitative data and an online Delphi consensus exercise involving three rounds. PARTICIPANTSAn international panel of 160 stakeholders comprising 120 healthcare experts and a public participant panel of 40 older people. MEASUREMENTS: Outcomes identified from studies included in the Cochrane review and secondary analysis of previously collected qualitative data were scored on a 9-point Likert scale using the GRADE scoring system anchored at 1 (not important) and 9 (critical). Consensus criteria for the COS were defined as 70% or more of participants scoring the outcome as critical and 15% or fewer scoring the outcome as not important. RESULTSTwenty-nine outcomes identified from the Cochrane review and existing qualitative data were included in the Delphi exercise. The final COS comprised 16 outcomes. The 7 highest-ranked outcomes were serious adverse drug reactions, medication appropriateness, falls, medication regimen complexity, quality of life, mortality, and medication side effects. CONCLUSIONA COS for interventions aiming to improve the appropriateness of polypharmacy for older people in primary care has been developed. Future work will focus on identifying appropriate tools to measure these outcomes and testing the implementation of the COS.