Methods for Researching End of Life Care - Processes of consent
Aims
Despite being a core business of medicine, end of life care (EoLC) is neglected. It is hampered by research that is difficult to conduct with no common standards. The Methods for Researching End of Life Care Capacity project (MORECare) aimed to identify, appraise and synthesise ‘best practice’ methods to determine how best to include individuals near to death with limited, fluctuating, diminishing or lack of capacity in research on end-of-life care (EoLC). Funded by Marie Curie (September 2011-March 2013) Dr Catherine Evans, Principal Investigator
This progressed the project MORECare that developed evidence-based guidance on the best methods for the design and conduct of research on EoLC to further knowledge in the field, focusing on managing missing data and attrition, outcome measurement, ethical issues, mixed methods and health economics. Funder by the Medical Research Council (November 2009-January 2021), Professor Irene Higginson. Principal Investigator
Methods
MORECare built on the Medical Research Council guidance on the development and evaluation of complex interventions. We conducted systematic literature reviews, transparent expert consultations (TEC) involving consensus methods of nominal group and online voting, and stakeholder workshops to identify challenges and best practice in EoLC research, including: participation recruitment, ethics, attrition, integration of mixed methods, complex outcomes and economic evaluation.
MORECare Capacity 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.
Summary of Findings
MORECare Capacity statement
Details 20 solutions to recruit adults lacking capacity nearing the end of life 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. Please read the full paper here.
MORECare statement
36 best practice solutions to develop and evaluate complex interventions in palliative and EoLC. Please read the full paper here.
Methods Review
MRC guidance on developing and evaluating complex interventions (NIHR School for Social Care Research Methods Review): Application to research on palliative and end of life care.
Systematic reviews
- Participation in EoLC research
- ‘Best practice’ to develop and evaluate palliative and EoLC services
- What is the evidence that palliative care teams improve outcomes for cancer patients and their families?
Further guidance on specific topics
- Recommendations for managing missing data, attrition and response shift
- Outcome measurement selection and use
- Ethical issues
- Mixed methods
- Health economics (EAPC abstract)
MORECare Elearning
We have developed a short e-learning course based on MORECare research findings. The course registration is now open. Read more
For more information or questions, please contact Hamid Benalia.
We would like to thank the workshop participants for their time and contributions to developing the guidance statement.
Publications
Evans CJ, Yorganci E, Lewis P, Koffman J, Stone K, Tunnard I, Wee B, Bernal W, Hotopf M, and Higginson IJ 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 18(1): 221. https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-020-01654-2
Conferences
MORECare Capacity conferences
Oral presentations
- Evans CJ, invited speaker on behalf of MORECare Capacity ‘I can’t tell you I want to participate” ; mental capacity and the processes of consent in research on end of life care’, Marie Curie Cancer Care and the Palliative Care Section of the Royal Society of Medicine meeting, 22nd March 2013 Curie
- Gysels M, Evans CJ, Lewis P, Speck P, Benali H, Preston N, Grande G, Short V, Owen-Jones E, Todd C, Higginson IJ. on behalf of MORECare (2013). “Obtaining and maintaining consent for research participation from patients with impaired capacity: Best practice recommendations from the MORECare consultation workshop on ethical issues in palliative care research”, Alzheimer Europe Conference, Malta, 11th October 2013
Poster presentations
- Stone K, Evans CJ on behalf of MORECare Capacity, Mental capacity and processes of consent for research on end-of-life care (EoLC); part of the MORECare project. EAPC 2013 1
- Stone K, Evans CJ on behalf of MORECare Capacity, Mental capacity and processes of consent for research on end-of-life care (EoLC); part of the MORECare project. Marie Curie Conference 22nd March 2013
- Evans CJ, Stone K, on behalf of MORECare Capacity, Mental capacity and processes of consent for research on end-of-life care (EoLC); part of the MORECare project, International Collaboration for Community Health Nursing Research, 13th March 2013, University of Edinburgh, Edinburgh
Media coverage
From Mr Luis Juste, Director of Santander Universities UK sent to Professor Sir Rick Trainor, Principle and President of King’s College London, date 25th October 2011, stating:
"Reading the latest issue of the Times Higher Education magazine I came across really good news for King’s College London and I would like to congratulate you as one of your investigators has received an award from the Marie Curie Cancer Care Research Programme:
- Catherine Evans for her study on mental capacity and processes of informed consent for research on end-of-life care.
This is an important achievement for your institution and shows why King’s College London is renowned worldwide for excellence in education and research."
Publications
Evans CJ, Yorganci E, Lewis P, Koffman J, Stone K, Tunnard I, Wee B, Bernal W, Hotopf M, and Higginson IJ 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 18(1): 221. https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-020-01654-2
Conferences
MORECare Capacity conferences
Oral presentations
- Evans CJ, invited speaker on behalf of MORECare Capacity ‘I can’t tell you I want to participate” ; mental capacity and the processes of consent in research on end of life care’, Marie Curie Cancer Care and the Palliative Care Section of the Royal Society of Medicine meeting, 22nd March 2013 Curie
- Gysels M, Evans CJ, Lewis P, Speck P, Benali H, Preston N, Grande G, Short V, Owen-Jones E, Todd C, Higginson IJ. on behalf of MORECare (2013). “Obtaining and maintaining consent for research participation from patients with impaired capacity: Best practice recommendations from the MORECare consultation workshop on ethical issues in palliative care research”, Alzheimer Europe Conference, Malta, 11th October 2013
Poster presentations
- Stone K, Evans CJ on behalf of MORECare Capacity, Mental capacity and processes of consent for research on end-of-life care (EoLC); part of the MORECare project. EAPC 2013 1
- Stone K, Evans CJ on behalf of MORECare Capacity, Mental capacity and processes of consent for research on end-of-life care (EoLC); part of the MORECare project. Marie Curie Conference 22nd March 2013
- Evans CJ, Stone K, on behalf of MORECare Capacity, Mental capacity and processes of consent for research on end-of-life care (EoLC); part of the MORECare project, International Collaboration for Community Health Nursing Research, 13th March 2013, University of Edinburgh, Edinburgh
Media coverage
From Mr Luis Juste, Director of Santander Universities UK sent to Professor Sir Rick Trainor, Principle and President of King’s College London, date 25th October 2011, stating:
"Reading the latest issue of the Times Higher Education magazine I came across really good news for King’s College London and I would like to congratulate you as one of your investigators has received an award from the Marie Curie Cancer Care Research Programme:
- Catherine Evans for her study on mental capacity and processes of informed consent for research on end-of-life care.
This is an important achievement for your institution and shows why King’s College London is renowned worldwide for excellence in education and research."
Principal Investigators
Catherine Evans
Professor of Palliative Care
Irene Higginson
Executive Dean, Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care
Investigators
Jonathan Koffman
Reader of Palliative Care
Penney Lewis
Professor of Law
Affiliations
Funding
Funding Body: Marie Curie
Amount: -
Period: September 2011 - March 2013