Improving the inclusion of an under-served group in trials: development and implementation of the INCLUDE Impaired Capacity to Consent Framework.
Adults lacking capacity to consent
Cognitive impairment
Inclusivity
Trial methodology
Under-served groups
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
25 Jan 2024
25 Jan 2024
Historique:
received:
17
03
2023
accepted:
18
01
2024
medline:
26
1
2024
pubmed:
26
1
2024
entrez:
25
1
2024
Statut:
epublish
Résumé
For the potential benefits of trials to reach all that they should, trials must be designed to ensure that those taking part reflect the population who will receive the intervention. However, adults with impaired capacity to consent are frequently excluded from trials - partly because researchers are unfamiliar with the legal and ethical frameworks and lack the necessary methodological expertise. Researchers identified a need for guidance on designing more inclusive trials. Building on the NIHR INCLUDE initiative, we developed the INCLUDE Impaired Capacity to Consent Framework to help researchers design inclusive trials. The framework was developed over five phases: (1) establishing the scope and content of the framework and adapting the INCLUDE Ethnicity Framework for this population; (2) scoping the relevance of the framework to different populations and piloting in a range of trials; (3) consulting people living with impairing conditions and carers to explore their views about the framework and identify missing content areas; (4) refining the framework; and (5) the development of an implementation toolkit of resources to support researchers using the framework. The framework has two parts: a set of four key questions to help researchers identify who should be included in their trial, and a series of worksheets covering intervention design, recruitment and consent processes, data collection and analysis, and public involvement and dissemination. It is supported by a summary of the ethical and legal frameworks and a website of resources on capacity and consent. Implementation resources include infographics and animations, a library of completed frameworks, and facilitated workshops for researchers. The framework and toolkit were launched at a webinar (November 2022), with polling demonstrating an increase in attendees' awareness about research involving adults lacking capacity. A post-webinar survey found that stakeholders viewed the framework and toolkit as valuable tools to facilitate greater inclusion of this under-served population in trials. The framework is available online: https://www.capacityconsentresearch.com/include-impaired-capacity-to-consent-framework.html . The INCLUDE Impaired Capacity to Consent Framework and implementation toolkit can support researchers to design more inclusive trials and other types of research studies. Further engagement, including with funders who are key to ensuring uptake, and evaluation is needed.
Sections du résumé
BACKGROUND
BACKGROUND
For the potential benefits of trials to reach all that they should, trials must be designed to ensure that those taking part reflect the population who will receive the intervention. However, adults with impaired capacity to consent are frequently excluded from trials - partly because researchers are unfamiliar with the legal and ethical frameworks and lack the necessary methodological expertise. Researchers identified a need for guidance on designing more inclusive trials. Building on the NIHR INCLUDE initiative, we developed the INCLUDE Impaired Capacity to Consent Framework to help researchers design inclusive trials.
METHODS
METHODS
The framework was developed over five phases: (1) establishing the scope and content of the framework and adapting the INCLUDE Ethnicity Framework for this population; (2) scoping the relevance of the framework to different populations and piloting in a range of trials; (3) consulting people living with impairing conditions and carers to explore their views about the framework and identify missing content areas; (4) refining the framework; and (5) the development of an implementation toolkit of resources to support researchers using the framework.
RESULTS
RESULTS
The framework has two parts: a set of four key questions to help researchers identify who should be included in their trial, and a series of worksheets covering intervention design, recruitment and consent processes, data collection and analysis, and public involvement and dissemination. It is supported by a summary of the ethical and legal frameworks and a website of resources on capacity and consent. Implementation resources include infographics and animations, a library of completed frameworks, and facilitated workshops for researchers. The framework and toolkit were launched at a webinar (November 2022), with polling demonstrating an increase in attendees' awareness about research involving adults lacking capacity. A post-webinar survey found that stakeholders viewed the framework and toolkit as valuable tools to facilitate greater inclusion of this under-served population in trials. The framework is available online: https://www.capacityconsentresearch.com/include-impaired-capacity-to-consent-framework.html .
CONCLUSIONS
CONCLUSIONS
The INCLUDE Impaired Capacity to Consent Framework and implementation toolkit can support researchers to design more inclusive trials and other types of research studies. Further engagement, including with funders who are key to ensuring uptake, and evaluation is needed.
Identifiants
pubmed: 38273417
doi: 10.1186/s13063-024-07944-x
pii: 10.1186/s13063-024-07944-x
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
83Subventions
Organisme : Cardiff University
ID : IfA
Informations de copyright
© 2024. The Author(s).
Références
Curley LE, Lin JC. Randomised Controlled Trials and Pharmacy Practice Research. In: Babar Z-U-D, editor. Pharmacy Practice Research Methods. Singapore: Springer; 2020. p. 203–18.
doi: 10.1007/978-981-15-2993-1_10
Witham MD, Anderson E, Carroll C, Dark PM, Down K, Hall AS, et al. Developing a roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process. Trials. 2020;21:694.
doi: 10.1186/s13063-020-04613-7
pubmed: 32738919
pmcid: 7395975
Clark LT, Watkins L, Piña IL, Elmer M, Akinboboye O, Gorham M, et al. Increasing Diversity in Clinical Trials: Overcoming Critical Barriers. Curr Probl Cardiol. 2019;44:148–72.
doi: 10.1016/j.cpcardiol.2018.11.002
pubmed: 30545650
Shepherd V, Wood F, Griffith R, Sheehan M, Hood K. Protection by Exclusion? The (lack of) inclusion of adults who lack capacity to consent to research in clinical trials in the UK. Trials. 2019; https://doi.org/10.1186/s13063-019-3603-1 .
Shepherd V. An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent. Trials. 2020;21:445.
doi: 10.1186/s13063-020-04406-y
pubmed: 32471488
pmcid: 7257506
Evans CJ, Yorganci E, Lewis P, Koffman J, Stone K, Tunnard I, et al. Processes of consent in research for adults with impaired mental capacity nearing the end of life: systematic review and transparent expert consultation (MORECare_Capacity statement). BMC Med. 2020;18:221.
doi: 10.1186/s12916-020-01654-2
pubmed: 32693800
pmcid: 7374835
Hotter B, Ulm L, Hoffmann S, Katan M, Montaner J, Bustamante A, et al. Selection bias in clinical stroke trials depending on ability to consent. BMC Neurol. 2017;17:206.
doi: 10.1186/s12883-017-0989-9
pubmed: 29202730
pmcid: 5716230
Brady MC, Fredrick A, Williams B. People with Aphasia: Capacity to Consent, Research Participation and Intervention Inequalities. Int J Stroke. 2013;8:193–6.
doi: 10.1111/j.1747-4949.2012.00900.x
pubmed: 23130972
Taylor JS, DeMers SM, Vig EK, Borson S. The Disappearing Subject: Exclusion of People with Cognitive Impairment and Dementia from Geriatrics Research. J Am Geriatr Soc. 2012;60:413–9.
doi: 10.1111/j.1532-5415.2011.03847.x
pubmed: 22288835
Feldman MA, Bosett J, Collet C, Burnham-Riosa P. Where are persons with intellectual disabilities in medical research? A survey of published clinical trials. J Intellect Disabil Res. 2014;58:800–9.
doi: 10.1111/jir.12091
pubmed: 24001184
Seitz DP, Adunuri N, Gill SS, Rochon PA. Prevalence of Dementia and Cognitive Impairment Among Older Adults With Hip Fractures. J Am Med Dir Assoc. 2011;12:556–64.
doi: 10.1016/j.jamda.2010.12.001
pubmed: 21450227
Ioannidis I, Mohammad Ismail A, Forssten MP, Ahl R, Cao Y, Borg T, et al. The mortality burden in patients with hip fractures and dementia. Eur J Trauma Emerg Surg. 2022;48:2919–25.
doi: 10.1007/s00068-021-01612-4
pubmed: 33638650
Mundi S, Chaudhry H, Bhandari M. Systematic review on the inclusion of patients with cognitive impairment in hip fracture trials: a missed opportunity? Can J Surg. 2014;57:E141–5.
doi: 10.1503/cjs.023413
pubmed: 25078940
pmcid: 4119128
Sheehan KJ, Fitzgerald L, Hatherley S, Potter C, Ayis S, Martin FC, et al. Inequity in rehabilitation interventions after hip fracture: a systematic review. Age Ageing. 2019;48:489–97.
doi: 10.1093/ageing/afz031
pubmed: 31220202
Clevenger CK, Chu TA, Yang Z, Hepburn KW. Clinical care of persons with dementia in the emergency department: a review of the literature and agenda for research. J Am Geriatr Soc. 2012;60:1742–8.
doi: 10.1111/j.1532-5415.2012.04108.x
pubmed: 22985144
Southerland LT, Benson KK, Schoeffler AJ, Lashutka MA, Borson S, Bischof JJ. Inclusion of older adults and reporting of consent processes in randomized controlled trials in the emergency department: A scoping review. Journal of the American College of Emergency Physicians Open. 2022;3:e12774.
doi: 10.1002/emp2.12774
pubmed: 35919513
pmcid: 9337842
Shepherd V, Hood K, Wood F. Unpacking the ‘Black Box of Horrendousness’: A Qualitative Exploration of the Barriers and Facilitators to Conducting Trials Involving Adults Lacking Capacity to Consent. Trials. 2022;23
Griffiths S, Manger L, Chapman R, Weston L, Sherriff I, Quinn C, et al. Letter on “Protection by exclusion? The (lack of) inclusion of adults who lack capacity to consent to research in clinical trials in the UK” | Trials | Full Text. Trials. 2020;21
Bodicoat DH, Routen AC, Willis A, Ekezie W, Gillies C, Lawson C, et al. Promoting inclusion in clinical trials—a rapid review of the literature and recommendations for action. Trials. 2021;22:880.
doi: 10.1186/s13063-021-05849-7
pubmed: 34863265
pmcid: 8643184
National Institute for Health Research. Best Research for Best Health: The Next Chapter. 2021.
NIH Minority Health and Health Disparities Strategic Plan 2021-2025. National Institutes of Health.
Treweek S, Banister K, Bower P, Cotton S, Devane D, Gardner HR, et al. Developing the INCLUDE Ethnicity Framework—a tool to help trialists design trials that better reflect the communities they serve. Trials. 2021;22:337.
doi: 10.1186/s13063-021-05276-8
pubmed: 33971916
pmcid: 8108025
Implementation of the ‘INCLUDE Impaired Capacity to Consent Framework’ for researchers. Cardiff University. https://www.cardiff.ac.uk/centre-for-trials-research/research/studies-and-trials/view/implementation-of-the-include-impaired-capacity-to-consent-framework-for-researchers . Accessed 9 Aug 2022.
Morris L, Dumville J, Treweek S, Miah N, Curtis F, Bower P. Evaluating a tool to improve engagement and recruitment of under-served groups in trials. Trials. 2022;23:867.
doi: 10.1186/s13063-022-06747-2
pubmed: 36210444
pmcid: 9549666
CONSULT. Cardiff University. https://www.cardiff.ac.uk/centre-for-trials-research/research/studies-and-trials/view/consult . Accessed 12 Oct 2021.
Kendig CE. What is Proof of Concept Research and how does it Generate Epistemic and Ethical Categories for Future Scientific Practice? Sci Eng Ethics. 2016;22:735–53.
doi: 10.1007/s11948-015-9654-0
pubmed: 26009258
Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021;n2061
Clinical trials: an easy read guide. National Institue for Health and Care Research.
Thinklusive | Accessible information design for health and social care. Thinklusive. https://thinklusive.org/ . Accessed 22 Jan 2023.
Hawe P, Shiell A, Riley T. Theorising Interventions as Events in Systems. Am J Community Psychol. 2009;43:267–76.
doi: 10.1007/s10464-009-9229-9
pubmed: 19390961
Bauer MS, Kirchner J. Implementation science: What is it and why should I care? Psychiatry Res. 2020;283:112376.
doi: 10.1016/j.psychres.2019.04.025
pubmed: 31036287
Murray E, Treweek S, Pope C, MacFarlane A, Ballini L, Dowrick C, et al. Normalisation process theory: a framework for developing, evaluating and implementing complex interventions. BMC Med. 2010;8:63.
doi: 10.1186/1741-7015-8-63
pubmed: 20961442
pmcid: 2978112
Reed MS, Graves A, Dandy N, Posthumus H, Hubacek K, Morris J, et al. Who’s in and why? A typology of stakeholder analysis methods for natural resource management. J Environ Manag. 2009;90:1933–49.
doi: 10.1016/j.jenvman.2009.01.001
Reed MS. The Research Impact Handbook. 2nd ed. Fast Track Impact; 2018.
Funnell Sue C, Rogers Patricia J. Purposeful Program Theory: Effective Use of Theories of Change and Logic Models; 2011.
May CR, Mair F, Finch T, MacFarlane A, Dowrick C, Treweek S, et al. Development of a theory of implementation and integration: Normalization Process Theory. Implement Sci. 2009;4:29.
doi: 10.1186/1748-5908-4-29
pubmed: 19460163
pmcid: 2693517
Shepherd V, Griffith R, Sheehan M, Wood F, Hood K. Healthcare professionals’ understanding of the legislation governing research involving adults lacking mental capacity in England and Wales: a national survey. J Med Ethics. 2018; https://doi.org/10.1136/medethics-2017-104722 .
Capacity and consent to research. CONSULT. https://www.capacityconsentresearch.com/ . Accessed 27 Sep 2021.
Shepherd V. Research involving adults lacking capacity to consent: the impact of research regulation on “evidence biased” medicine. BMC Medical Ethics. 2016;17:8.
doi: 10.1186/s12910-016-0138-9
Jayes M, Palmer R. Initial evaluation of the Consent Support Tool: A structured procedure to facilitate the inclusion and engagement of people with aphasia in the informed consent process. International Journal of Speech-Language Pathology. 2014;16:159–68.
doi: 10.3109/17549507.2013.795999
pubmed: 23826849
Mielke J, Brunkert T, Zúñiga F, Simon M, Zullig LL, De Geest S. Methodological approaches to study context in intervention implementation studies: an evidence gap map. BMC Med Res Methodol. 2022;22:320.
doi: 10.1186/s12874-022-01772-w
pubmed: 36517765
pmcid: 9749183