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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. 

Reference: Evans C, Stone K, Manthorpe J, Higginson I (2014) MRC Guidance on Developing and Evaluating Complex Interventions: Application to Research on Palliative and End of Life Care, SSCR Methods Review 15, NIHR School for Social Care Research, London.

Systematic reviews

Further guidance on specific topics

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

Evans CJ, Stone KA, Manthorpe J and Higginson IJ. (2013) NIHR School of Social Care Research Methods Review MRC Guidance Developing and Evaluating Complex Interventions: Application to research on palliative and end of life care. Method review 15. London: NIHR School of Social Care Research, London School of Economics and Political Sciences

Evans CJ, Harding R, Higginson IJ; MORECare. 'Best practice' in developing and evaluating palliative and end-of-life care services: a meta-synthesis of research methods for the MORECare project. Palliat Med. 2013 Dec;27(10):885-98. doi: 10.1177/0269216312467489. Epub 2013 Jan 15. PMID: 23322647.

Preston NJ, Fayers P, Walters SJ, Pilling M, Grande GE, Short V, Owen-Jones E, Evans CJ, Benalia H, Higginson IJ, Todd CJ; MORECare. Recommendations for managing missing data, attrition and response shift in palliative and end-of-life care research: part of the MORECare research method guidance on statistical issues. Palliat Med. 2013 Dec;27(10):899-907. doi: 10.1177/0269216313486952. Epub 2013 May 7. PMID: 23652842.

Evans CJ, Benalia H, Preston NJ, Grande G, Gysels M, Short V, Daveson BA, Bausewein C, Todd C, Higginson IJ; MORECare. The selection and use of outcome measures in palliative and end-of-life care research: the MORECare International Consensus Workshop. J Pain Symptom Manage. 2013 Dec;46(6):925-37. doi: 10.1016/j.jpainsymman.2013.01.010. Epub 2013 Apr 28. PMID: 23628515; PMCID: PMC3858887.

Gysels M, Evans CJ, Lewis P, Speck P, Benalia H, Preston NJ, Grande GE, Short V, Owen-Jones E, Todd CJ, Higginson IJ. MORECare research methods guidance development: recommendations for ethical issues in palliative and end-of-life care research. Palliat Med. 2013 Dec;27(10):908-17. doi: 10.1177/0269216313488018. Epub 2013 May 21. PMID: 23695828.

Farquhar M, Preston N, Evans CJ, Grande G, Short V, Benalia H, Higginson IJ, Todd C; MOREcare. Mixed methods research in the development and evaluation of complex interventions in palliative and end-of-life care: report on the MORECare consensus exercise. J Palliat Med. 2013 Dec;16(12):1550-60. doi: 10.1089/jpm.2012.0572. Epub 2013 Nov 6. PMID: 24195755; PMCID: PMC3868265.

Gysels, M.H., Evans, C. & Higginson, I.J. Patient, caregiver, health professional and researcher views and experiences of participating in research at the end of life: a critical interpretive synthesis of the literature. BMC Med Res Methodol 12, 123 (2012). https://doi.org/10.1186/1471-2288-12-123

Higginson IJ, Evans CJ. What is the evidence that palliative care teams improve outcomes for cancer patients and their families? Cancer J. 2010 Sep-Oct;16(5):423-35. doi: 10.1097/PPO.0b013e3181f684e5. PMID: 20890138.

 

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

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

Evans CJ, Stone KA, Manthorpe J and Higginson IJ. (2013) NIHR School of Social Care Research Methods Review MRC Guidance Developing and Evaluating Complex Interventions: Application to research on palliative and end of life care. Method review 15. London: NIHR School of Social Care Research, London School of Economics and Political Sciences

Evans CJ, Harding R, Higginson IJ; MORECare. 'Best practice' in developing and evaluating palliative and end-of-life care services: a meta-synthesis of research methods for the MORECare project. Palliat Med. 2013 Dec;27(10):885-98. doi: 10.1177/0269216312467489. Epub 2013 Jan 15. PMID: 23322647.

Preston NJ, Fayers P, Walters SJ, Pilling M, Grande GE, Short V, Owen-Jones E, Evans CJ, Benalia H, Higginson IJ, Todd CJ; MORECare. Recommendations for managing missing data, attrition and response shift in palliative and end-of-life care research: part of the MORECare research method guidance on statistical issues. Palliat Med. 2013 Dec;27(10):899-907. doi: 10.1177/0269216313486952. Epub 2013 May 7. PMID: 23652842.

Evans CJ, Benalia H, Preston NJ, Grande G, Gysels M, Short V, Daveson BA, Bausewein C, Todd C, Higginson IJ; MORECare. The selection and use of outcome measures in palliative and end-of-life care research: the MORECare International Consensus Workshop. J Pain Symptom Manage. 2013 Dec;46(6):925-37. doi: 10.1016/j.jpainsymman.2013.01.010. Epub 2013 Apr 28. PMID: 23628515; PMCID: PMC3858887.

Gysels M, Evans CJ, Lewis P, Speck P, Benalia H, Preston NJ, Grande GE, Short V, Owen-Jones E, Todd CJ, Higginson IJ. MORECare research methods guidance development: recommendations for ethical issues in palliative and end-of-life care research. Palliat Med. 2013 Dec;27(10):908-17. doi: 10.1177/0269216313488018. Epub 2013 May 21. PMID: 23695828.

Farquhar M, Preston N, Evans CJ, Grande G, Short V, Benalia H, Higginson IJ, Todd C; MOREcare. Mixed methods research in the development and evaluation of complex interventions in palliative and end-of-life care: report on the MORECare consensus exercise. J Palliat Med. 2013 Dec;16(12):1550-60. doi: 10.1089/jpm.2012.0572. Epub 2013 Nov 6. PMID: 24195755; PMCID: PMC3868265.

Gysels, M.H., Evans, C. & Higginson, I.J. Patient, caregiver, health professional and researcher views and experiences of participating in research at the end of life: a critical interpretive synthesis of the literature. BMC Med Res Methodol 12, 123 (2012). https://doi.org/10.1186/1471-2288-12-123

Higginson IJ, Evans CJ. What is the evidence that palliative care teams improve outcomes for cancer patients and their families? Cancer J. 2010 Sep-Oct;16(5):423-35. doi: 10.1097/PPO.0b013e3181f684e5. PMID: 20890138.

 

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

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."

Project status: Completed

Principal Investigators

Investigators

Funding

Funding Body: Marie Curie

Amount: -

Period: September 2011 - March 2013

Keywords

PALLIATIVE CARETERMINAL CARERESEARCH DESIGNMETHODSEVALUATIONETHICSDECISION-MAKING