Abstract
Introduction: Impaired capacity towards the end of life is common, but involvement in clinical research is rare. Existing reporting practices often fail to include information about mechanism of consent to research, or use of consultees/proxy decision makers.
Aim: We aimed to determine the extent to which studies on the National Institute for Health and Care Research Clinical Research Network (NIHR CRN) Portfolio were inclusive of people with impaired mental capacity in studies relevant to palliative and end of life care.
Methods: A scoping review of NIHR CRN Portfolio trials register. The study collated data on:
1. Inclusion and exclusion criteria of NIHR CRN portfolio studies in the specialties of Ageing, Palliative care, Hospice, Dementia or Care homes studies. Studies must have recruited participants between April 2018 –November 2023.
2. Relevance of identified studies to target population (palliative and end of life care)
3. Study recruitment rates, between studies that included people with impaired capacity to consent to participation and those that did not include this population.
Results: 1,752 unique studies were identified; 150 of which were relevant to palliative and end of life care. 73% (n =109/150) studies excluded people lacking capacity, 31 21% (n = 31/150) explicitly allowed for the inclusion of people lacking capacity and in 6% (n = 10/150) cases it was not clear. Only 5% (n = 5/95) of palliative care studies allowed for recruitment of people with impaired capacity. There was no correlation between studies including those who lacked capacity and failure to achieve minimum recruitment targets.
Conclusions: Exclusion of people with impaired capacity from research relevant to palliative care is commonplace, despite impaired capacity being highly prevalent in this population.
Impact: This work is part of a wider NHS England funded project which aims to understand and mitigate structural barriers to research participation.
Aim: We aimed to determine the extent to which studies on the National Institute for Health and Care Research Clinical Research Network (NIHR CRN) Portfolio were inclusive of people with impaired mental capacity in studies relevant to palliative and end of life care.
Methods: A scoping review of NIHR CRN Portfolio trials register. The study collated data on:
1. Inclusion and exclusion criteria of NIHR CRN portfolio studies in the specialties of Ageing, Palliative care, Hospice, Dementia or Care homes studies. Studies must have recruited participants between April 2018 –November 2023.
2. Relevance of identified studies to target population (palliative and end of life care)
3. Study recruitment rates, between studies that included people with impaired capacity to consent to participation and those that did not include this population.
Results: 1,752 unique studies were identified; 150 of which were relevant to palliative and end of life care. 73% (n =109/150) studies excluded people lacking capacity, 31 21% (n = 31/150) explicitly allowed for the inclusion of people lacking capacity and in 6% (n = 10/150) cases it was not clear. Only 5% (n = 5/95) of palliative care studies allowed for recruitment of people with impaired capacity. There was no correlation between studies including those who lacked capacity and failure to achieve minimum recruitment targets.
Conclusions: Exclusion of people with impaired capacity from research relevant to palliative care is commonplace, despite impaired capacity being highly prevalent in this population.
Impact: This work is part of a wider NHS England funded project which aims to understand and mitigate structural barriers to research participation.
| Original language | English |
|---|---|
| Article number | A2 |
| Journal | BMJ Supportive & Palliative Care |
| Volume | 15 |
| Issue number | Suppl1 |
| DOIs | |
| Publication status | Published - 9 Feb 2025 |