RESEARCH IN PALLIATIVE CARE: GOALS AND LIMITATIONS

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1 CAMPUS GROSSHADERN CAMPUS INNENSTADT RESEARCH IN PALLIATIVE CARE: GOALS AND LIMITATIONS Prof. Dr. Claudia Bausewein PhD MSc

2 Research and hospice/palliative care Not new! Emphasis of Cicely Saunders from the early beginning ~1960: regular opioids cause addiction; > 4 patients treated with regular morphine: no addiction ~1970 Diamorphine better analgesic than morphine > first blinded RCT comparing diamorphine with morphine (Twycross RG. Br J Pharmacol 1972) ~1985: Gastrointestinal obstruction: 40 autopsies (Baines et al, Lancet 1985)

3 Research in palliative care Better understanding of the patient s perspective and situation in all its dimensions (physical, psychological, social and spiritual) at one point in time and over time Evaluation of the effectiveness of specific interventions though randomised controlled trials (drugs or more complex interventions, e.g. breathlessness service or a clinical pharmacy programme for palliative care patients) >> health services research Multiprofessional: doctors, nurses, pharmacists, sociologists etc. Not large scale studies as in oncology or cardiology

4 Rationale for undertaking research in palliative care Enable evidence-based decisions by health care professionals Cost effectiveness and best use of resources Therapeutic approaches to a range of challenging symptoms Need for research on the implementation of an intervention if it is to be translated effectively into routine practice or other models of care Understanding mechanisms of symptoms and translate these into pharmacological and non-pharmacological interventions Bennett et al Pall Med 2010

5 Challenges in palliative care research Terminology: definition of end of life care (Bennett Pall Med 2010) Timing: when does hospice or palliative care start (Bennett Pall Med 2010) Patients complexity: high symptom burden, cognitive impairment, short life expectancy Primary end points: symptoms, subjektive experience subjektives Empfinden, not tumour response, survival Slow recruitment, high attrition

6 Mixed methods research Johnson, Onwuegbuzie. Mixed methods research 2004

7 Grimes & Schultz Lancet 2002

8

9 MRC Framework for complex interventions

10 Qualitative Research Is concerned with the meanings people attach to their experiences of the social world an how they make sense of that world (Pope & Mays 2008) Methods Semi-structured or indepth interviews Focus groups Participant oberservation Analysis of texts, documents, audio or visual material Focus more on talking and action rather than numbers

11 Grimes & Schultz Lancet 2002

12 Early Integration of Palliative Care newly diagnosed metastatic non smallcell lung cancer stage III b ECOG 0-2 standard oncologic care alone early palliative care integrated with standard oncological care palliative care when needed 3 weeks after diagnoses, at least monthly Temel J. et al N Engl J Med. 2010

13 Results Improved quality of life (98.0 vs. 91.5; p=0.03) Less depression (16% vs. 38%, p = 0.01). Fewer patients received aggressive end-of-life care (33% vs. 54%, p=0.05) Survival: 11,6 vs. 8,9 months (p=0.02) Temel J. et al N Engl J Med. 2010

14 Slow release morphine for refractory dypsnoea Double blind RCT 48 patients with refractory dyspnoea 88% with COPD 20 mg slow release morphine over 4 days Significant improvement of dyspnoea Only study adequately powered: confirms benefit of opioids Abernethy et al BMJ 2003

15 Grimes & Schultz Lancet 2002

16 Impact of dignity therapy Dignity Therapy prospective (pre/post) evaluation design brief, psychosocial intervention Facilitated interview, patients have opportunity to review their life and convey important messages and reflections for friends or relatives Interview transcribed, edited, and a generativity document provided to the patient for their use and dissemination Evaluation questionnaires completed when patients received the generativity document (T1) and 2 weeks later (T2) Houman et al Pall Med 2009

17 Houman et al Pall Med 2009

18 Grimes & Schultz Lancet 2002

19 Symptom burden in breathless patients Cancer patients with significantly shorter survival Bausewein et al J Pall Med 2010

20 Grimes & Schultz Lancet 2002

21 Trajectories of Illness in Stage 5 Chronic Kidney Disease Murtagh et al Clin J Am Soc Nephr 2011

22 Trajectories of Illness in Stage 5 Chronic Kidney Disease Murtagh et al Clin J Am Soc Nephr 2011

23 The Invisibility of Breathlessness Qualitative study with 18 patients with moderate/severe COPD Nature of breathlessness Especially in the early stages, felt by the sufferer alone Not mentioned when seeking professional advice Stigma Shameful, socially unacceptable, embarrassment when breathless in the company of friends Response from services Great difficulties with access to health care services Helplessness, lack of knowledge for the relief of breathlessness and the inadequacy of referral Gysels M, Higginson IJ JPSM 2008

24 Evidence in palliative care literature Between 1970 and fold increase of studies in palliative care (0.1% versus 0.4%) Clincial trials in palliative care/ total palliative care literature %, increase 7% Clincial trials in palliative care/ total clinical trials %, % 38 journals für hospice, palliative care, end-of-life care Most studies are not interventional (RCT) but case series and non-randomised trials Research articles in palliative care : 388 original papers, 8% RCTs and 2% controlled trials Tienan et al JCO 2008

25 Limitations to palliative care research Patients Often too ill and frail to take part in research Willingness to take part in palliative care research high Skills Lack of standardized research methodologies and research infrastructure Institutional level Staff often protecting patients from research as research in this patient group is too burdensome Many services small and lack of research support leading to small scale studies with loss to follow up and data heterogeneity.

26 Gate keeping Reluctance on the part of healthcare professionals to refer patients for research studies (Aoun Pall Med 2005) Arguments for gatekeeping: Research in dying patients inappropriate Patients physically unwell, fatigued, emotionally & psychologically vulnerable Healthcare professionals want to protect patients from overly demanding research projects Reluctance to challenge evidence behind treatments Lack of time, resources BUT: Lack of respect for patients autonomy

27 Patients views on research High motivation to participate in research (Terry In J Med 2006, White EJC 2008) 92% would participate in studies involving simple interventions, whereas only 26% would consider studies of complex interventions Challenging: randomisation, placebo control and blinding Capable of deciding whether to participate in interviews (Gysels JPSM 2008) Motivations to participate in research (Terry In J Med 2006, Gysels JPSM 2008) Altruism Gratitude and concerns about care Need to have somebody to talk to, need for information/ access to services Sense of personal value, assertion of persisting autonomy

28 Conclusion Research in palliative care possible and desperately needed Multitude of methods Increasing number of studies Challenges because of patient population, staff attitudes, lack of research infrastructure Research networks and special funding needed Association for Palliative Medicine

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