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

OBJECTIVES: To 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.

DESIGN: Standard COS development methodology was followed, comprising identi?cation 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.

PARTICIPANTS: An 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.

RESULTS: Twenty-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.

CONCLUSION: A 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.


Project Steering Group
Professor Carmel Hughes, Queen’s University Belfast (QUB; Principal Investigator)
Dr. Audrey Rankin, QUB
Dr. Janine Cooper, QUB
Dr. Cristín Ryan, Royal College of Surgeons in Ireland (RCSI)
Dr. Cathal Cadogan, RCSI
Professor Susan Smith, RCSI
Dr. Barbara Clyne, RCSI


Journal: J Am Geriatr Soc.
Pages: -
Year: 2018
DOI: 10.1111/jgs.15245

Further Study Information

Current Stage: Not Applicable
Date: September 2016 - May 2017
Funding source(s): Health Research Board (HRB)

Health Area

Disease Category: Health care of older people

Disease Name: Polypharmacy

Target Population

Age Range: 65 - 100

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Journal editors
- Patient/ support group representatives
- Policy makers
- Service providers
- Service users

Study Type

- COS for clinical trials or clinical research


- Delphi process
- Focus group(s)
- Interview
- Systematic review

The initial stages of this work have involved the extraction of key outcomes from an updated Cochrane review and previously collected qualitative data.

Cochrane Systematic Review:
As part of an earlier project, a Cochrane review of interventions to improve appropriate polypharmacy in older people was updated (Patterson et al., 2014). The initial phase of developing this COS included updating this review again with further publications from the period of December 2013 until May 2016. Studies were included if they aimed to improve appropriate polypharmacy in older people in any healthcare setting and included a validated measure of appropriate prescribing (e.g. Beers’ criteria or Medication Appropriateness Index).

The authors of all of the studies included in the review were contacted to obtain their views on the outcomes selected in their studies, and asked if any additional outcomes had been considered in the planning stage of the intervention, and subsequently not selected.

Compilation of outcomes from previously collected data:
The preceding study involving semi-structured interviews [GPs (n=15) and community pharmacists (n=15)] and focus groups (patients n=50) undertaken in 2013 by Cadogan et al. (2016) aimed to identify barriers and facilitators to prescribing and dispensing appropriate polypharmacy. Extraction and compilation of outcomes from these transcripts will be undertaken to enable the identification of potential outcomes as defined by the three stakeholder groups.

Outcome Inventory:
Key outcomes extracted from the systematic review and the qualitative data have been collated into the COS long-list (i.e. all potential outcomes that will be considered for inclusion in the consensus exercise) and organised into key domains (i.e. a broad class of outcomes).

Consensus Exercise:
Following an initial screening of a long list of identified outcomes by the Project Steering Group, a Delphi exercise will be conducted using a web-based survey, which will be distributed via e-mail to the Delphi panel members (stakeholders named below).

Within the on-line questionnaire, participants will be prompted to rate each outcome on a 9-point Likert scale anchored between 1 (‘limited importance’) and 9 (‘critical importance’). The scoring of the Delphi rounds will adopt the GRADE scoring system (Guyatt et al., 2011) which is often used in COS development, whereby a score of 1-3 represents an outcome of limited importance, 4-6 the outcome is important but not critical and 7-9 the outcome is critical.

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