Improving research in palliative and end of life care: what, why, how, where, when, who? Prof Irene J Higginson Cicely Saunders Institute Department of Palliative Care, Policy & Rehabilitation King’s College London @ij_higginson @csi_kcl @cicelysaunders1 www.csi.kcl.ac.uk www.csi.kcl.ac.uk
Outline • Why do research in pallia4ve care? • Whose business is it? • Landscape of research ac4vity in France… • Research designs and solu4ons for tomorrow – Fast track randomised trial – MORECare statement for complex interven4ons – The right outcomes • Discussion and next steps? Download presenta.on: www..nyurl.com/parisCSI TwiGer @CSI_KCL www.csi.kcl.ac.uk
Why do research in pallia3ve care? • Evidence based prac4ce to improve care quality • Training opportunity, doing the trials of tomorrow • Cri4cal enquiry – finding out what works • Recogni4on of the uncertainty of effec4veness underpinning many treatments • To provide beGer care for pa4ents and those close to them in the future .. AND NOW www.csi.kcl.ac.uk
The landscape of research in pallia3ve care in France? • Survey of 420 pallia4ve care departments in 2014, 382 responses • Only 92 (24.1%) involved in a research project during the last 5 years. • Challenges as to why not: – Lack of 4me (80%), … But do you have time NOT to research? – Pa4ent issues (47%) … ? – Lack of methodological support (33%) – Lack of financial resources (30%) Rhondali et al BMJ Supportive & Palliative Care 2014;4:182-189. www.csi.kcl.ac.uk
No 3me for research? What is the basis for clinical decisions? Evidence based medicine or one of the alterna4ves? Isaacs D, Fitzgerald D. BMJ. 1999 Dec 18-25;319(7225):1618 www.csi.kcl.ac.uk
Whose business is it? Do research ac3ve healthcare services deliver beNer healthcare? …. YES Finnish Leukaemia Group 1979 – 1985 introducing clinical trials into 17 out of 21 hospital districts in Finland for the treatment of mul4ple myeloma matched to comprehensive Finnish registry data “A natural experiment”. District Outcomes Trial districts 24 � 38% R. Survival Others 28 � 28% R. Survival PaGern of care and impact of par4cipa4on in Karjalainen S, Palva I. BMJ 1989 Oct clinical studies on the outcome in ovarian 28;299(6707):1069-72. cancer, Du Bois et al, Int J Gynecol Cancer 2005, 15, 183. (Germany) Cross-sec4onal rela4onship: research ac4ve hospitals appeared to have lower mortality. PLOS One, 2015 (England) www.csi.kcl.ac.uk
Pa3ent issues? Do our pa3ents and families want to take part in research? www.csi.kcl.ac.uk
Pa3ent & Public Involvement at the heart of PC research: examples from Cicely Saunders Ins3tute (CSI) Engagement in the planning and design of the Ins4tute, in all studies, plans.. hGps://www.youtube.com/watch?v=_St3Mbcekrs Research carried out Videos from several user representa4ves with or by members Go to our You Tube channel to see of the public/ pa4ents Soap Box Cynthia Benz: rather than to, about hGps://www.youtube.com/watch?v=WvPEGfozVtI or for them hGps://www.youtube.com/watch?v=SebZ-83WG3I hGps://www.youtube.com/watch?v=wYxvzWyAyyQ (INVOLVE 2012) www.csi.kcl.ac.uk
Study design: choice Aim determines the design, essentially four (plus one) main categories of design 1. To explore, describe – Descriptive studies / surveys / quantitative or qualitativ e 2. To explore whether something is related to something else ( analytical ) – Quasi-experimental, analytical – e.g. cohort (longitudinal study with two groups different at the start), time-series, geographical, (case control) studies, natural experiment, mixed-methods 3. To make sense of a situation , develop new theory, model, relationships – Qualitative, grounded theory, ethnographic, mixed methods 4. To test whether something causes something else, or if a new service or treatment is effective – Experimental or intervention studies, can be mixed methods • Systematic literature reviews – can combine the literature to describe or be analytical or can combine experiments www.csi.kcl.ac.uk
Experimental studies, traditional options in randomisation Parallel design Crossover trial Cluster randomisation Patient preference trial • Individual patients • Patients randomly • Randomisation unit is • Individual as they are allocated to different group of individuals patients are referred/ identified treatment sequences instead of individual randomised but patients those with a • Optimal and most • Simplest: AB/BA – half strong common approach of patients receive • i.e. all patients in a preference are treatment A, followed • Challenges include health district or on a not randomised by control/B, half – if ‘control’ group ward or GP practice but allocated receive control/ drop out more than • Good especially if preferred treatment B followed intervention group, there is ‘education’ in treatment by A or people try to the intervention • BUT need large ‘substitute for • Only suitable for those numbers, as intervention group’ interventions with • BUT need very large analysis is really short-term effect and numbers between the can be difficult to work • May struggle to recruit groups without out wash out period in control preferences www.csi.kcl.ac.uk
How did we come to think of a fast- track randomised trial ? Recommenda4ons to extend pallia4ve • care to non-cancer condi4ons but liGle evalua4on People severely affected by mul4ple • sclerosis (MS) have unmet needs – symptoms, disability, effect on family Developing a new (short term) pallia4ve • care service for people severely affected by MS www.csi.kcl.ac.uk
Fast-track Randomised Controlled Trial (RCT) • Names – delayed-intervenKon, wait-list, delayed- start trial • All pa4ents will eventually receive interven4on, but some receive it later than others • Pa4ents are randomly allocated to interven4on • Pros – uses randomised design, but gets over problem of feeling some pa4ents never receive service/treatment • Cons – can’t use in short survival, some people may not want to wait www.csi.kcl.ac.uk
History of wait-list / delayed interven3on RCT • Originated from idea of recrui4ng people from a ‘real’ wai4ng list into a trial. E.g. A randomised controlled trial of methadone maintenance treatment versus wait-list control in an Australian prison system . Dolan KA, et al Drug Alcohol Depend. 2003 Oct 24;72(1):59-65. • Others follow all people in trial – E.g. The value of service dogs for people with severe ambulatory disabilities. A randomized controlled trial. Allen K, Blascovich J. JAMA. 1996 Apr 3;275(13):1001-6. www.csi.kcl.ac.uk
First successful ‘fast-track trial’ in palliative care among people with Multiple Sclerosis Higginson et al BMC Palliat Care 2008;7:7 We designed the study – aim to recruit 50 patients in one year www.csi.kcl.ac.uk
Second fast-track trial, early pallia3ve care, triggered by Breathlessness Higginson et al. Lancet Respir Med 2014;2(12):978-87 • Early pallia4ve care integrated with respiratory services • 16 % improvement in QoL • No difference in costs to health care www.csi.kcl.ac.uk
Complex Interven3ons and Pallia3ve and End of Life Care Pallia3ve care – which are the “ac3ve ingredients”? • Highly trained staff? • Suitably designed premises & facili4es? • Ethos? • Assessment process? • Absence of compe4ng demands and priori4es in terms of pa4ent mix? Outcomes are complex, mul4ple and ouen interact or are ac4ng in a changing situa4on (e.g. dying) TwiGer @CSI_KCL www.csi.kcl.ac.uk
Why does it maNer? addi3onal problems for evaluators, over and above usual prac3cal and methodological difficul3es, E.g. • difficulty standardising the design and delivery of the interven4ons (e.g. treatment, service, pathway) • and of the control group • sensi4vity to features of the local context, may not be replicated • organisa4onal and logis4cal difficulty of applying experimental methods to service or policy change • length and complexity of the causal chains that link interven4on with outcome www.csi.kcl.ac.uk
Why does it maNer? Consequences of failing to recognise you are dealing with complex interven3ons: • Failed studies – when the interven4on has an effect • Posi4ve studies – but no one knows what the ac4ve ingredients are – ‘evalua4ng a ‘black box’ and so it can’t be reliably replicated elsewhere • Results which don’t apply to anywhere else • Results which can’t be implemented • Dangerous implementa4on, failing to recognise key components that are needed, and missing them • Cuwng costs by policy makers to implement without key ingredients, because not shown they are important TwiGer @CSI_KCL www.csi.kcl.ac.uk
Which of the following are ‘complex interven3ons’ in the context of pallia3ve care? • A new community pallia4ve care service? • A new outpa4ent clinic? • A new rehabilita4on interven4on – e.g. physiotherapy plus educa4on? • A new care pathway for a care home? • A new set of advance direc4ves? • A new analgesic for pain? • A new an4depressant for depression? www.csi.kcl.ac.uk
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