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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)

Research output: Contribution to journalArticle

Standard

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). / MORECare_Capacity.

In: BMC Medicine, Vol. 18, No. 1, 221, 22.07.2020, p. 221.

Research output: Contribution to journalArticle

Harvard

MORECare_Capacity 2020, '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 Medicine, vol. 18, no. 1, 221, pp. 221. https://doi.org/10.1186/s12916-020-01654-2

APA

MORECare_Capacity (2020). 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 Medicine, 18(1), 221. [221]. https://doi.org/10.1186/s12916-020-01654-2

Vancouver

MORECare_Capacity. 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 Medicine. 2020 Jul 22;18(1):221. 221. https://doi.org/10.1186/s12916-020-01654-2

Author

MORECare_Capacity. / 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). In: BMC Medicine. 2020 ; Vol. 18, No. 1. pp. 221.

Bibtex Download

@article{902caecbb6cd4917a065a2d3cf4793e7,
title = "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)",
abstract = "BACKGROUND: Involving adults lacking capacity (ALC) in research on end of life care (EoLC) or serious illness is important, but often omitted. We aimed to develop evidence-based guidance on how best to include individuals with impaired capacity nearing the end of life in research, by identifying the challenges and solutions for processes of consent across the capacity spectrum.METHODS: Methods Of Researching End of Life Care_Capacity (MORECare_C) furthers the MORECare statement on research evaluating EoLC. We used simultaneous methods of systematic review and transparent expert consultation (TEC). The systematic review involved four electronic databases searches. The eligibility criteria identified studies involving adults with serious illness and impaired capacity, and methods for recruitment in research, implementing the research methods, and exploring public attitudes. The TEC involved stakeholder consultation to discuss and generate recommendations, and a Delphi survey and an expert 'think-tank' to explore consensus. We narratively synthesised the literature mapping processes of consent with recruitment outcomes, solutions, and challenges. We explored recommendation consensus using descriptive statistics. Synthesis of all the findings informed the guidance statement.RESULTS: Of the 5539 articles identified, 91 met eligibility. The studies encompassed people with dementia (27%) and in palliative care (18%). Seventy-five percent used observational designs. Studies on research methods (37 studies) focused on processes of proxy decision-making, advance consent, and deferred consent. Studies implementing research methods (30 studies) demonstrated the role of family members as both proxy decision-makers and supporting decision-making for the person with impaired capacity. The TEC involved 43 participants who generated 29 recommendations, with consensus that indicated. Key areas were the timeliness of the consent process and maximising an individual's decisional capacity. The think-tank (n = 19) refined equivocal recommendations including supporting proxy decision-makers, training practitioners, and incorporating legislative frameworks.CONCLUSIONS: The MORECare_C statement details 20 solutions to recruit ALC nearing the EoL in research. The statement provides much needed guidance to enrol individuals with serious illness in research. Key is involving family members early and designing study procedures to accommodate variable and changeable levels of capacity. The statement demonstrates the ethical imperative and processes of recruiting adults across the capacity spectrum in varying populations and settings.",
keywords = "Consensus, Consent, Decision-making, Ethics, Methods, Palliative care, Systematic review, Terminal care",
author = "MORECare_Capacity and Evans, {C J} and E Yorganci and P Lewis and J Koffman and K Stone and I Tunnard and B Wee and W Bernal and M Hotopf and Higginson, {I J}",
year = "2020",
month = jul,
day = "22",
doi = "10.1186/s12916-020-01654-2",
language = "English",
volume = "18",
pages = "221",
journal = "BMC Medicine",
issn = "1741-7015",
publisher = "BIOMED CENTRAL LTD",
number = "1",

}

RIS (suitable for import to EndNote) Download

TY - JOUR

T1 - Processes of consent in research for adults with impaired mental capacity nearing the end of life

T2 - systematic review and transparent expert consultation (MORECare_Capacity statement)

AU - MORECare_Capacity

AU - Evans, C J

AU - Yorganci, E

AU - Lewis, P

AU - Koffman, J

AU - Stone, K

AU - Tunnard, I

AU - Wee, B

AU - Bernal, W

AU - Hotopf, M

AU - Higginson, I J

PY - 2020/7/22

Y1 - 2020/7/22

N2 - BACKGROUND: Involving adults lacking capacity (ALC) in research on end of life care (EoLC) or serious illness is important, but often omitted. We aimed to develop evidence-based guidance on how best to include individuals with impaired capacity nearing the end of life in research, by identifying the challenges and solutions for processes of consent across the capacity spectrum.METHODS: Methods Of Researching End of Life Care_Capacity (MORECare_C) furthers the MORECare statement on research evaluating EoLC. We used simultaneous methods of systematic review and transparent expert consultation (TEC). The systematic review involved four electronic databases searches. The eligibility criteria identified studies involving adults with serious illness and impaired capacity, and methods for recruitment in research, implementing the research methods, and exploring public attitudes. The TEC involved stakeholder consultation to discuss and generate recommendations, and a Delphi survey and an expert 'think-tank' to explore consensus. We narratively synthesised the literature mapping processes of consent with recruitment outcomes, solutions, and challenges. We explored recommendation consensus using descriptive statistics. Synthesis of all the findings informed the guidance statement.RESULTS: Of the 5539 articles identified, 91 met eligibility. The studies encompassed people with dementia (27%) and in palliative care (18%). Seventy-five percent used observational designs. Studies on research methods (37 studies) focused on processes of proxy decision-making, advance consent, and deferred consent. Studies implementing research methods (30 studies) demonstrated the role of family members as both proxy decision-makers and supporting decision-making for the person with impaired capacity. The TEC involved 43 participants who generated 29 recommendations, with consensus that indicated. Key areas were the timeliness of the consent process and maximising an individual's decisional capacity. The think-tank (n = 19) refined equivocal recommendations including supporting proxy decision-makers, training practitioners, and incorporating legislative frameworks.CONCLUSIONS: The MORECare_C statement details 20 solutions to recruit ALC nearing the EoL in research. The statement provides much needed guidance to enrol individuals with serious illness in research. Key is involving family members early and designing study procedures to accommodate variable and changeable levels of capacity. The statement demonstrates the ethical imperative and processes of recruiting adults across the capacity spectrum in varying populations and settings.

AB - BACKGROUND: Involving adults lacking capacity (ALC) in research on end of life care (EoLC) or serious illness is important, but often omitted. We aimed to develop evidence-based guidance on how best to include individuals with impaired capacity nearing the end of life in research, by identifying the challenges and solutions for processes of consent across the capacity spectrum.METHODS: Methods Of Researching End of Life Care_Capacity (MORECare_C) furthers the MORECare statement on research evaluating EoLC. We used simultaneous methods of systematic review and transparent expert consultation (TEC). The systematic review involved four electronic databases searches. The eligibility criteria identified studies involving adults with serious illness and impaired capacity, and methods for recruitment in research, implementing the research methods, and exploring public attitudes. The TEC involved stakeholder consultation to discuss and generate recommendations, and a Delphi survey and an expert 'think-tank' to explore consensus. We narratively synthesised the literature mapping processes of consent with recruitment outcomes, solutions, and challenges. We explored recommendation consensus using descriptive statistics. Synthesis of all the findings informed the guidance statement.RESULTS: Of the 5539 articles identified, 91 met eligibility. The studies encompassed people with dementia (27%) and in palliative care (18%). Seventy-five percent used observational designs. Studies on research methods (37 studies) focused on processes of proxy decision-making, advance consent, and deferred consent. Studies implementing research methods (30 studies) demonstrated the role of family members as both proxy decision-makers and supporting decision-making for the person with impaired capacity. The TEC involved 43 participants who generated 29 recommendations, with consensus that indicated. Key areas were the timeliness of the consent process and maximising an individual's decisional capacity. The think-tank (n = 19) refined equivocal recommendations including supporting proxy decision-makers, training practitioners, and incorporating legislative frameworks.CONCLUSIONS: The MORECare_C statement details 20 solutions to recruit ALC nearing the EoL in research. The statement provides much needed guidance to enrol individuals with serious illness in research. Key is involving family members early and designing study procedures to accommodate variable and changeable levels of capacity. The statement demonstrates the ethical imperative and processes of recruiting adults across the capacity spectrum in varying populations and settings.

KW - Consensus

KW - Consent

KW - Decision-making

KW - Ethics

KW - Methods

KW - Palliative care

KW - Systematic review

KW - Terminal care

UR - http://www.scopus.com/inward/record.url?scp=85088529044&partnerID=8YFLogxK

U2 - 10.1186/s12916-020-01654-2

DO - 10.1186/s12916-020-01654-2

M3 - Article

C2 - 32693800

VL - 18

SP - 221

JO - BMC Medicine

JF - BMC Medicine

SN - 1741-7015

IS - 1

M1 - 221

ER -

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