Ethical considerations in research on palliative and end of life care
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1 WHO Collaborating Centre for Palliative Care, Policy and Rehabilitation Ethical considerations in research on palliative and end of life care Dr. Catherine Evans NIHR Clinical Lecturer in Palliative Care Head of Research and Development, and Clinical Nurse Specialist Sussex Community NHS Trust Cicely Saunders Institute Department of Palliative Care, Policy & Rehabilitation King s College London
2 Overview of session What are the key ethical challenges and solutions in research on palliative and end of life care? Recommendations for best research practice Implementation into research practice.
3 What are the key challenges to undertaking research on palliative care services and treatments? Complex needs (physical, psychosocial, spiritual, pts, families) Complex interventions with numerous interacting layers Difficult to conduct trials: recruitment, changing clinical situation, declining capacity, limited survival, attrition, gatekeeping, defining effect and outcomes Rinck GC et al. J Clinical Oncol 1997
4 MORECare- Methods of Research for Evaluating EoLC
5 MORECare research methods Initial literature scoping, formation of expert group, initial identification of issues Literature appraisals of methodological, ethical, legal and other issues and identify solutions and best practice Stakeholder consultation on needs and views, web-based followed by nominal group techniques Preliminary synthesis of issues, best practice and potential solutions Transparent expert consultations (adapted Delphi): outcome measures, health economic, ethics, mixed methods and statistics Final synthesis MOREcare Statement on best practice
6 Evaluating complex service and treatments Question : How many hats does it take to evaluate complex interventions in EoL&PC? Answer: Many... here are the ones we looked at in more detail for the MORECare project Attrition Health economic assessment Ethics Mixed methods research Outcome measurement I MRC Guidance MORECare trying to make it more manageable
7
8 Palliative care patients wish to participate in research Ask questions important to patients and families Design and methods enable participation Most a positive experience - benefit legacy, some distressed Non-participation physical and cognitive impairment Altruism praised by society, allowing participation enables contribute to society (Herring Medical Law and Ethics)
9 MORECare Capacity Aim: To examine how to include individuals near to death in research on EoLC by identifying solutions to processes of consent for people with cognitive incapacity. Guidance on process of consent as an addendum to MORECare Statement
10 Main messages and areas uncertainty process of consent impaired capacity Consultees the most significant other 1. Personal consultee assent most commonest approach 2. Professional (nominated) consultee no personal consultee seek member clinical team (Jones et al 2012; Scott et al 2011 UCL team); Whelan et al 2013 care home staff, few agreed n=40/304, concerns re responsibility 3. Advanced consent less common, but used studies on dying phase (Gibbins et al 2013; Rees and Hardy 2003) and 85+ study (Davies et al 2010) 4. Or combination Gibbins et al 2013
11 ALC- Resource and expertise Low recruitment eligible patients Average 44%, range 3.6% (Mason et al 2006) to 72% advanced consent (Davies 2010) Lower dying phase: Nearness to death 70/327 (21%) Gibbins et al 2013 Death rattle 54% (58/107), only 15 randomised (Rees and Hardy 2003) Identify and engage consultees resource intense Low recruitment sample bias, involve wrong population Capacity assessment Most 'Clinical judgement by HCP and/or researcher e.g. MCA 2005 criteria. Formal assessment uncommon e.g. MMSE (Abernathy et al 2006).
12 How can we best support and involve consultees? Recognised national body, HCP act as advocates, carers indicate available Recommendation 6: Researchers to make available to patients and/or carers a patient advocate/public representative to support them to decide if they wish to participate in a research study and in the consent process Consultation - Public representative or research link seen as helpful, but not framed as an advocate
13 Challenges and solutions 1. Anticipate and plan for cognitive impairment all studies on palliative and EoLC 2. Consent procedures that accommodate adults with capacity, may loose capacity and lack capacity 3. Researcher expertise to assess capacity, enable informed decision making, undertake consent/assent 4. Resources to identify and engage personal consultees 5. Professional consultees not a simple solution 6. Independent risk/benefit expert panels e.g. Independent Mental Capacity Advocates (MCA 2005) (Whelan 2013)
14 Evidence of innovation Novel consent process for research in dying patients unable to give consent Rees & Hardy BMJ 2003, 327:198.
15 Implementation in practice OPTCare Elderly feasibility trial Adapted: MCA ALC Toolkit University of Leicester & University of Bristol
16 Reference list 1. Allmark, P. and S. Mason, Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent process. J Med Ethics, (8): p Davies, K., et al., Engaging the oldest old in research: lessons from the Newcastle 85+ study. BMC Geriatr, : p Dewing, J., Participatory research: A method for process consent with persons who have dementia. Dementia, (1): p Gibbins, J., et al., Change the culture around death and dying in acute hospitals. BMJ, : p. f Gibbins, J., et al., Overcoming barriers to recruitment in care of the dying research in hospitals. J Pain Symptom Manage, (5): p Gysels, M.H., C. Evans, and I.J. Higginson, 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, (1): p Higginson, I.J., et al., Evaluating complex interventions in End of Life Care: the MORECare Statement on good practice generated by a synthesis of transparent expert consultations and systematic reviews. BMC Medicine, : Jones, L., et al., CoMPASs: IOn programme (Care Of Memory Problems in Advanced Stages of dementia: Improving Our Knowledge): protocol for a mixed methods study. BMJ Open, (6). 9. Okai, D., et al., Mental capacity in psychiatric patients: Systematic review. British Journal of Psychiatry, : p Rees, E. and J. Hardy, Novel consent process for research in dying patients unable to give consent. BMJ, (7408): p Rinck, G.C., et al., Methodologic issues in effectiveness research on palliative cancer care: a systematic review. Journal of Clinical Oncology, (4): p Scott, S., et al., Study protocol: the behaviour and pain in dementia study (BePAID). BMC Geriatr, : p University of Leicester and University of Bristol, Adults lacking capacity on-line toolkit. 2010, NRES. 14. Whelan P.J., Walwyn R., Gaughran F., MacDonald A., Impact of the demand for proxy assent on recruitment to a randomised controlled trial of vaccination testing in care homes. J Med Ethics, 2013; 39:36-40
17 Acknowledgements Prof Todd Dr Preston MORECare is funded by the NIHR and managed by the MRC as part of the Methodology Research Programme (MRP) (project number: G /1). MORECare aims to identify, appraise and synthesise best practice methods to develop and evaluate palliative and end-of-life care, particularly focussing on complex service-delivery interventions and reconfigurations. Principal investigator: Irene J Higginson. Co-principal investigator: Chris Todd. The members of MORECare are: Co-investigators - Peter Fayers, Gunn Grande, Richard Harding, Matthew Hotopf, Penney Lewis, Paul McCrone, Scott Murray, Myfanwy Morgan; Project advisory group - Massimo Costantini, Steve Dewar, John Ellershaw, Claire Henry, William Hollingworth, Philip Hurst, Tessa Inge, Jane Maher, Irene McGill, Elizabeth Murray, Ann Netten, Sheila Payne, Roland Petchey, Wendy Prentice, Deborah Tanner and Celia A Taylor; Researchers - Hamid Benalia, Catherine J Evans, Marjolein Gysels, Nancy J Preston and Vicky Short.
18 Acknowledgements MORECare Capacity Funder: Marie Curie CRUK(no. C38812/A12533) Principal investigators: Catherine Evans and Irene J Higginson; Co-investigators Bee Wee, Penney Lewis, Jonathan Koffman, William Bernal, and Matthew Hotopf Project Advisory Group: Deborah Tanner, Claire Henry, Gunn Grande, Steve Dewar, Gareth Owen, Rachel Burman, Dimitrios Adamis, Michael Dunn, Scott Kim and Simon Woods Researchers: Katie Stone and Rowena Vohora.
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