Background
Prescribing 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).
Methods
A 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.
Results
A 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.
Conclusions
We 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.
Anna N. Millar1*, Amrit Daffu-O’Reilly2, Carmel M. Hughes1, David P. Alldred2, Garry Barton3, Christine M. Bond4, James A. Desborough5, Phyo K. Myint4, Richard Holland3, Fiona M. Poland6, David Wright5 and On behalf of the CHIPPS Team, University of East Anglia
Disease Category: Health care of older people
Disease Name: N/A
Age Range: 65 - 100
Sex: Either
Nature of Intervention: Drug
- Clinical experts
- Consumers (caregivers)
- Economists
- Families
- Service providers
- COS for clinical trials or clinical research
- Delphi process
- Focus group(s)
- Literature review
- Semi structured discussion
- Systematic review
Outcomes have been identified through reviewing the published literature and stakeholder focus groups and meetings.
Outcomes have been identified from the published literature in two ways: (1) from a recently updated Cochrane systematic review, and (2) from a literature review focused in quality of life (QOL) in care home residents. All outcomes that were measured in the studies included in the updated Cochrane review (‘Interventions to optimise prescribing for older people in care homes’, Alldred et al., 2015) have been identified for consideration. The studies identified by this Cochrane review represent all randomised controlled trials (RCTs) focusing on optimising prescribing in care homes, published before 2015. When the Cochrane review was published initially in 2013, it was noted that quality of life (QOL) was a potentially overlooked outcome measure in RCTs in this area. Therefore, a series of further literature reviews was conducted to identify RCTs, conducted in care homes, which measured QOL as either a primary or secondary outcome. The authors of all the included studies were contacted to obtain their views on the outcomes which they had used in their studies, and those outcomes which they may have considered and then rejected.
Following an initial screening of a long list of identified outcomes by four members of the CHIPPS team, a Delphi exercise will be conducted using an electronic survey which will be distributed via a web-link to the wider CHIPPS team (excluding those who participated in initial screening), who will constitute the Delphi panel. Within the survey, panellists will be shown the outcomes, with a brief explanation of each, and asked to score each outcome. We will use the scale proposed by the GRADE group (www.gradeworkinggroup.org) in which 1 to 3 signifies an ‘outcome of limited importance’, 4 to 6 ‘important but not critical’ and 7 to 9 ‘critical’. Consensus regarding whether an outcome should be in the COS will be defined as 70% or more of the respondents scoring it 7 to 9, and fewer than 15% scoring it as 1 to 3. Removal of an outcome will be based on 70% or more scoring it as a 1 to 3, and fewer than 15% scoring it as 7 to 9. All other score distributions will be taken to indicate lack of agreement for inclusion of a given outcome in the COS. Two rounds will be conducted, with the second round consisting only of those outcomes where between 15-70% of respondents gave scores between 4-9.
Following the Delphi exercise, where applicable, possible outcome measurement tools for outcomes included in the COS will be identified from the review of the literature detailed previously. Identified outcome measurement tools will then be judged by four member of the CHIPPS team with regards to their validity, sensitivity and reliability.