Optimising the selection of outcomes for healthy ageing trials: a mixed methods study

Advancing age is associated with chronic diseases which are the largest cause of death and disability in developed countries. With increasing life expectancy and an ageing population, there is a need to conduct trials to extend healthy ageing, including targeting biological ageing processes, and prevent ageing-related diseases. The main objectives of the study are as follows: (i) to review outcome measures utilised in healthy ageing trials focusing on pharmacological therapies, nutritional supplements and medical devices; (ii) to summarise the views of key stakeholders on outcome selection for healthy ageing trials. An analysis of records from the Clinicaltrials.gov database pertaining to healthy ageing trials from inception to May 2022 was conducted. In addition, the findings of a workshop attended by key stakeholders at the 2022 annual UKSPINE conference were qualitatively analysed. Substantial heterogeneity was found in the interventions evaluated and the outcomes utilised by the included studies. Recruitment of participants with diverse backgrounds and the confounding effects of multi-morbidity in older adults were identified as the main challenges of measuring outcomes in healthy ageing trials by the workshop participants. The development of a core outcome set for healthy ageing trials can aid comparability across interventions and within different settings. The workshop provided an important platform to garner a range of perspectives on the challenges with measuring outcomes in this setting. It is critical to initiate such discussions to progress this field and provide practical answers to how healthy ageing trials are designed and structured in the future.

Aim

The main objectives of the study are as follows: (i) to review outcome measures utilised in healthy ageing trials focusing on pharmacological therapies, nutritional supplements and medical devices; (ii) to summarise the views of key stakeholders on outcome selection for healthy ageing trials.

Contributors

Muslim Abbas Syed, Olalekan Lee Aiyegbusi, Eliot Marston, Janet M. Lord, Harriet Teare, Melanie Calvert

Publication

Journal: GeroScience
Volume: 44
Issue: 6
Pages: 2585 - 2609
Year: 2022
DOI: 10.1007/s11357-022-00690-5

Further Study Information

Current Stage: Completed
Date:
Funding source(s): The study is part of the UK SPINE project and was funded by the respective organisation.


Health Area

Disease Category: Other

Disease Name: healthy ageing

Target Population

Age Range: Unknown

Sex: Either

Nature of Intervention: Device, Diet and nutrition, Drug

Stakeholders Involved

- Academic research representatives
- Clinical experts
- Consumers (patients)
- Funders
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Policy makers

Study Type

- Systematic review of outcomes measured in trials

Method(s)

- Semi structured discussion
- Systematic review

The ClinicalTrials.gov database was searched for records of relevant studies. The database is designed to provide easy access to summary information on publicly and privately funded clinical trials and observational studies . The terms ‘healthy ageing’, ‘ageing well’, ‘ageing’, ‘anti-aging’ and ‘aging process’ were searched from inception to May 2022. A stakeholder workshop was then used to identify opinions from key stakeholders

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