Development of a core outcome set for effectiveness trials aimed at optimising prescribing in older adults in care homes

Abstract

BackgroundPrescribing medicines for older adults in care homes is known to be sub-optimal. Whilst trials testing interventions to optimise prescribing in this setting have been published, heterogeneity in outcome reporting has hindered comparison of interventions, thus limiting evidence synthesis. The aim of this study was to develop a core outcome set (COS), a list of outcomes which should be measured and reported, as a minimum, for all effectiveness trials involving optimising prescribing in care homes. The COS was developed as part of the Care Homes Independent Pharmacist Prescribing Study (CHIPPS).MethodsA long-list of outcomes was identified through a review of published literature and stakeholder input. Outcomes were reviewed and refined prior to entering a two-round online Delphi exercise and then distributed via a web link to the CHIPPS Management Team, a multidisciplinary team including pharmacists, doctors and Patient Public Involvement representatives (amongst others), who comprised the Delphi panel. The Delphi panellists (n = 19) rated the importance of outcomes on a 9-point Likert scale from 1 (not important) to 9 (critically important). Consensus for an outcome being included in the COS was defined as ≥70% participants scoring 7–9 and <15% scoring 1–3. Exclusion was defined as ≥70% scoring 1–3 and <15% 7–9. Individual and group scores were fed back to participants alongside the second questionnaire round, which included outcomes for which no consensus had been achieved.ResultsA long-list of 63 potential outcomes was identified. Refinement of this long-list of outcomes resulted in 29 outcomes, which were included in the Delphi questionnaire (round 1). Following both rounds of the Delphi exercise, 13 outcomes (organised into seven overarching domains: medication appropriateness, adverse drug events, prescribing errors, falls, quality of life, all-cause mortality and admissions to hospital (and associated costs)) met the criteria for inclusion in the final COS.ConclusionsWe have developed a COS for effectiveness trials aimed at optimising prescribing in older adults in care homes using robust methodology. Widespread adoption of this COS will facilitate evidence synthesis between trials. Future work should focus on evaluating appropriate tools for these key outcomes to further reduce heterogeneity in outcome measurement in this context.

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

“…The value of public participants’ involvement was evidenced within the final round of the consensus exercise, because the outcome patient knowledge would not have been included in the final COS if only experts had been included. Finally, a high response rate across the 3 Delphi rounds (93.3%, 92.1%, and 90.7%, respectively) was achieved and is similar to that reported in other COSs …”

“…Polypharmacy management in older adults is an active area of research, with numerous calls for trials to consider the relevance of outcomes selected to assess interventions targeting the appropriateness of polypharmacy in older people . Alongside the development of the current COS for use in polypharmacy interventions, a number of other COSs are being developed in the area of pharmaceutical care (e.g., optimization of prescribing for older adults in nursing homes, medication reviews in older people in any healthcare setting). Each COS has a unique scope, but collectively, their implementation will add rigor to effectiveness studies of pharmaceutical care.…”

“…Some limitations must be noted. First, participants in the Delphi panel were confined to English speakers, and public participants were sampled only from Northern Ireland, although it is unclear whether including panel members outside of this location would have resulted in different outcomes being selected for inclusion in the COS. Second, for financial reasons, we were unable to supplement the Delphi rounds with a face‐to‐face consensus meeting, with other COS studies not conducting meetings for similar reasons . Finally, the number of outcomes included in the COS could be considered large, but this may be related to the scope of the COS, because a wide range of multifaceted approaches to interventions (provided to improve the appropriateness of polypharmacy), may affect resource use, medications, and the patient.…”

Standard of practice in geriatric medicine for pharmacy services

“…It is advisable to establish an interdisciplinary research team, including consumer representation, to ensure the research is relevant to key stakeholders. Where applicable, core outcome sets for trials aimed at improving medicines use in older people should be used . Research Ethics Committee approval should be sought for all intervention studies and for audits or quality improvement projects that will be presented or published.…”

“…Where applicable, core outcome sets for trials aimed at improving medicines use in older people should be used. [71][72][73][74] Research Ethics Committee approval should be sought for all intervention studies and for audits or quality improvement projects that will be presented or published.…”