Presentation given to KU Palliative Medicine Fellowship April 15th, 2010 Revised March 17, 2011

1. Research Methods and Dilemmasin Palliative Care Christian Sinclair, MD, FAAHPM Kansas City Hospice & Palliative Care March 17, 2011

2. DISCLAIMER DISCLAIMER DIS D This document: does not constitute professional medical advice does not constitute a doctor-patient relationship Any medical decisions regarding your health should be discussed with your health care providers. Use common sense when researching health issues online. The goal of sharing is to advance medical education. References are included wherever possible.

3. Please Click lots of links included in this slidedeck

4. Objectives 1. Identify specific barriers to research in palliative care populations 2. Highlight strategies for increased availability for publication and research in academic and non-academic palliative care venues. 3. Discuss basic models of structuring research for symptom control

5. Dogmatic Battle “Don’t do research on the dying” vs. “All medicine needs to be evidence based”

9. Current Approach to Research Experiential and anecdotal ‘The serendipity model’ Publish expert guidelines Identifies knowledge gaps Few centers capable of consistent research

10. Barriers to Palliative Care Research Funding Infrastructure Training/Mentor availability Whole person approach Rapidly changing patient population Ethics Research design

11. Barrier: Lack of Funding <5 % of palliative investigators rec’d NIH grant >50% from private sector philanthropy Robert Woods Johnson Foundation Open Society Institute Fetzer Institute Mayday Fund A significant minority with no funding at all <1% of all NIH grants on palliative care issues Gelfman LP, Morrison RS. Research funding for palliative medicine. J Palliat Med. 2008

12. Solution: Lack of Funding Find money trees Change development requests/distribution Use private foundation to support infrastructure over single studies Write your congressional representatives Find areas pharma would be interested in

13. Barriers: Lack of Infrastructure Closely related to funding Foundation dollars driven to clinical services Community hospices Provide bulk of palliative care Yet little experience/culture of research Academic centers Palliative care low priority compared to others

14. Solution: Lack of Infrastructure Collaborate with related fields in an institution Collaborate with research centers NPCRC Grants for infrastructure/collaboration Increase workforce to decrease clinical time Co-opt QI/QA staff Develop research networks PoPCRN – Jean Kutner PCRC – Amy Abernethy and Jean Kutner KCPCRN? – KU, KCCC, KCHPC, TMC

15. Barriers: Lack of Training/Mentors Palliative medicine fellowships Most are 1-year, few do 2-year with research Just starting 2nd wave of key researchers Morrison, Goldstein, Prigerson, Abernethy, Kutner

16. Solution: Lack of Training/Mentors Research retreats NPCRC – Annual research retreat AAHPM – Leadership Education and Academic Development project (LEAD) AAHPM – Mentors project Find mentors in other fields within institution

17. Barriers to Palliative Care Research Funding Infrastructure Training/Mentor availability Whole person approach Rapidly changing patient population Ethics Research design

18. Barriers: Whole Person Approach Primacy of the individual as whole person Ethical dilemma pitting four major bioethical principles Emphasis away from bio-medical model Reinforced by an interdisciplinary approach Clinical duties of the day win over research

19. Solutions: Whole Person Approach Research is more than a nice add-on Ethical imperative to correctly treat the individual Reinforce good aspects of bio-medical model Having research staff separate from clinical

20. Barriers: Rapidly Changing Patients The prognostic dilemma – research attrition Short temporal access to patients US Hospice median LOS – Three weeks Altered mental status and informed consent Patients don’t want to participate (?) Heterogeneous patient population Multi-system disease Polypharmacy NHPCO Facts & Figures Oct 2009.

21. Solutions: Rapidly Changing Patients Research prognostication – objectively! Automatic research enrollment at admission Carefully screen for ability to consent Develop consent procedures for proxies Heterogeneous, polypharmacy can be helpful It is who you are talking care of anyway PPS studies are great examples Harrold et al. Is PPS a useful predictor of mortality in a heterogeneous hospice population? J Palliat Med. 2005

22. Do Patients Want to Participate? Positive themes emerge (60-90%) Altruism Benefit self Maintaining hope Few negative themes (10-30%) White C. 2009

23. Do Patients Want to Participate? Pautex S et al. Is Research Really Problematic in Palliative Care? A Pilot Study. JPSM 2005 Anorexia Delirium

24. Barriers: Research Ethics IRB approval Harm of asking dying people about dying (?) Informed consent Appropriate methodology Obligation to do research to please staff Pediatric populations

25. Solutions: Research Ethics Work closely with IRB, explain study well Patients interested in research Careful informed consent Understand research methodology Separate research and clinical staff

26. Research Methods Data types: Qualitative Quantitative Study designs: Observational v. Interventional Size of study Singe vs. multi-center design Quality initiative Domain of study

27. Qualitative Research Methods Theories: Ethnographic Grounded theory Data: Interviews Observation

28. Research Methods Observational Case study/series Severity Prevalence Descriptive Narrative Retrospective Case-control v cohort

29. Wikipedia

30. Research Methods Interventional Tool validation Randomized Blinded Quasi-experimental Research Methods Knowledge Base

31. Areas of Study Grant et al. Current Status of Pall. Care—Clinical Implementation, Education, & Research. 2009

32. National Palliative Care Research Center Established 2005 Headed by Sean Morrison, MD Current AAHPM president Based out of Mt. Sinai SOM Funded by

33. Dartmouth Atlas

34. Future American Cancer Society $1.5M towards palliative care research 136 applicants with majority in the funding range Only 7 applicants were given grants Lack of funds Palliative Care Research Collaborative $7.5M from NINR Headed by Kutner and Abernethy

35. Summary Many barriers exist to good palliative care research With applied effort they may be overcome Patients are not afraid of research Don’t be afraid to ask Funding and mentorship opportunities exist

36. References BrueraE. Ethical issues in palliative care research. J Palliat Care. 1994 Autumn;10(3):7-9. PubMed PMID: 7531237. GelfmanLP, Morrison RS. Research funding for palliative medicine. J Palliat Med. 2008 Jan-Feb;11(1):36-43. Review. PubMed PMID: 18370891. Grant M, Elk R, Ferrell B, Morrison RS, von Gunten CF. Current status of palliative care--clinical implementation, education, and research. CA Cancer J Clin. 2009 Sep-Oct;59(5):327-35. PubMed PMID: 19729681. JochamHR, Dassen T, Widdershoven G, Halfens R. Quality of life in palliative care cancer patients: a literature review. J ClinNurs. 2006 Sep;15(9):1188-95. Review. PubMed PMID: 16911060. KaasaS, Caraceni A. Palliative cancer care research. Palliat Med. 2010 Apr;24(3):259-60. PubMed PMID: 20371636. KaasaS, Radbruch L. Palliative care research--priorities and the way forward. EurJ Cancer. 2008 May;44(8):1175-9. Epub 2008 Apr 18. PubMed PMID: 18374560.

37. References Kaasa S, Hjermstad MJ, Loge JH. Methodological and structural challenges in palliative care research: how have we fared in the last decades? Palliat Med. 2006 Dec;20(8):727-34. Review. PubMed PMID: 17148527. Kaasa S, De Conno F. Palliative care research. Eur J Cancer. 2001 Oct;37 Suppl 8:S153-9. Review. PubMed PMID: 11602381. Kramer BJ, Christ GH, Bern-Klug M, Francoeur RB. A national agenda for social work research in palliative and end-of-life care. J Palliat Med. 2005 Apr;8(2):418-31. Review. PubMed PMID: 15890053. Rinck GC, van den Bos GA, Kleijnen J, de Haes HJ, Schadé E, Veenhof CH. Methodologic issues in effectiveness research on palliative cancer care: a systematic review. J ClinOncol. 1997 Apr;15(4):1697-707. Review. PubMed PMID: 9193371. Saunders C. Hospice Care. Am J Medicine. 1978. 65, 76-8. PMID: 81612 White C, Hardy J. What do palliative care patients and their relatives think about research in palliative care?-a systematic review. Support Care Cancer. 2009 Aug 25. [Epub ahead of print] PubMed PMID: 19705165.

38. References Todd AMH et al. A Systematic Review Examining the Literature on Attitudes of Patients with Advanced Cancer Toward Research. JPSM 2009 37(6), p. 1078-1085, DOI: 10.1016/j.jpainsymman.2008.07.009 Pautex S et al. Is Research Really Problematic in Palliative Care? A Pilot Study. JPSM 2005 Vol. 30, Issue 2, Pages 109-111, DOI: 10.1016/j.jpainsymman.2005.05.010 Lipman AG, Jackson KC, Tyler LS. Evidence Based Symptom Control in Palliative Care, 2000informa Healthcare.

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