Core Outcome Measures in Effectiveness Trials

FOCUS: The Frailty Outcomes Consensus Project

General Information

The Canadian Frailty Network (CFN) will be leading an international initiative to identify Common Outcome Measures (COMs) and Common Data Elements (CDEs), in an effort to standardize research studies and ensure that these COMs and CDEs are captured in all frailty studies. The planned protocol includes literature review and broad consultation with relevant stakeholders to identify all possible COMs and CDEs. Under the guidance of a steering committee, a Delphi process will be undertaken with approximately 300 Delphi panel members, including stakeholders from research, clinical, industry, and policy environments. Additionally, persons living with frailty and their family/friend caregivers will be included in the Delphi panel. By developing a standard set of Frailty COMs and CDEs, future findings from research and knowledge translation studies can be collectively analyzed to better inform patient care.

John Muscedere (Queen's University), Darryl Rolfson (University of Alberta), Matteo Cesari (Universita di Milano), Bev Shea (University of Ottawa), Leocadio Rodriguez Manas (Hospital Universitario de Getafe), Paula Williamson (University of Liverpool)

Dr. John Muscedere is the principal investigator.

Further Study Information

Current Stage:
May 2019 - May 2020
Funding source(s):
Funded by the Government of Canada through the Networks of Centres of Excellence (NCE) Program

Health Area

Disease Category
Health care of older people

Disease Name

Target Population

Age Range
65 - 110


Nature / type of Intervention


Delphi process
Systematic review

COMs and CDEs to be voted on will be identified through a systematic review as well as broad consultation with researchers and clinicians. Additionally, a mixed methods survey will be administered to persons living with frailty and paid/unpaid caregivers to identify COMs and CDEs which they feel are important to include in the Delphi Process. A steering committee has been convened to guide the Delphi process (listed as collaborators on this project). An international Delphi Panel of approximately 300 individuals will be identified. Panelists will be invited to take part in Delphi Process, which will be facilitated using DelphiManager. The criteria for consensus will be set a priori by the steering committee. Once consensus is reached, the final set of COMs/CDEs will be confirmed by a review committee, which will consist of the steering committee and a representative group of Delphi panelists.

Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Governmental agencies
Patient/ support group representatives
Pharmaceutical industry representatives
Policy makers
Regulatory agency representatives
Service providers
Service users

Study Type

COS for clinical trials or clinical research
Minimum dataset

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