Background
Despite increased recognition of frailty and its importance, high quality evidence to guide decision-making is lacking. There has been variation in reported data elements and outcomes which makes it challenging to interpret results across studies as well as to generalize research findings. The creation of a frailty core set, consisting of a minimum set of data elements and outcomes to be measured in all frailty studies, would allow for findings from research and translational studies to be collectively analyzed to better inform care and decision-making. To achieve this, the Frailty Outcomes Consensus Project was developed to reach consensus from the international frailty community on a set of common data elements and core outcomes for frailty.
Methods
An international steering committee developed the methodology and the consensus process to be followed. The committee formulated the initial list of data elements and outcomes. Participants from across the world were invited to take part in the Delphi consensus process. The Delphi consisted of three rounds. Following review of data after three rounds, a final ranking round of data elements and outcomes was conducted. A required retention rate of 80% between rounds was set a priori.
Results
One hundred and eighty-four panelists from 25 different countries participated in the first round of the Delphi consensus process. This included researchers, clinicians, administrators, older adults, and caregivers. The retention rate between rounds was achieved. Data elements and outcomes forming primary and secondary core sets were identified, within the domains of participant characteristics, physical performance, physical function, physical health, cognition and mental health, socioenvironmental circumstances, frailty measures, and other.
Conclusion
It is anticipated that implementation and uptake of the frailty core set will enable studies to be collectively analyzed to better inform care for persons living with frailty and ultimately improve their outcomes. Future work will focus on identification of measurement tools to be used in the application of the frailty core set.
Jeanette C. Prorok, Paula R. Williamson, Beverley Shea, Darryl Rolfson, Leocadio Rodriguez Mañas, Matteo Cesari, Perry Kim & John Muscedere
Disease Category: Health care of older people
Disease Name: Frailty
Age Range: 65 - 110
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Families
- Governmental agencies
- Methodologists
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Policy makers
- Regulatory agency representatives
- Researchers
- Service providers
- Service users
- COS for clinical trials or clinical research
- Minimum dataset
- Delphi process
- Survey
- 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.