Research Methods and Dilemmasin Palliative Care

Christian Sinclair, MD, FAAHPMKansas City Hospice & Palliative Care

March 17, 2011

D ISCL A IMER DI SCL A IMER

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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

Dogmatic Battle

“Don’t do research on the dying”

vs.

“All medicine needs to be evidence based”

http://www.flickr.com/photos/pomphorhynchus/2258282195/

Current Approach to Research

• Experiential and anecdotal– ‘The serendipity model’

• Publish expert guidelines– Identifies knowledge gaps

• Few centers capable of consistent research

Barriers to Palliative Care Research

• Funding• Infrastructure• Training/Mentor availability• Whole person approach• Rapidly changing patient population• Ethics• Research design

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

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

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

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

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

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

Barriers to Palliative Care Research

• Funding• Infrastructure• Training/Mentor availability• Whole person approach• Rapidly changing patient population• Ethics• Research design

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

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

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.

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

Do Patients Want to Participate?

• Positive themes emerge (60-90%)– Altruism– Benefit self– Maintaining hope

• Few negative themes (10-30%)

White C. 2009

Do Patients Want to Participate?

Pautex S et al. Is Research Really Problematic in Palliative Care? A Pilot Study. JPSM 2005

Anorexia Delirium

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

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

Research Methods

• Data types:– Qualitative– Quantitative

• Study designs:– Observational v. Interventional– Size of study– Singe vs. multi-center design– Quality initiative– Domain of study

Qualitative Research Methods

• Theories:– Ethnographic– Grounded theory

• Data:– Interviews– Observation

Research Methods

• Observational– Case study/series– Severity– Prevalence– Descriptive– Narrative– Retrospective– Case-control v cohort

Wikipedia

Research Methods

• Interventional– Tool validation– Randomized– Blinded– Quasi-experimental

Research Methods Knowledge Base

Areas of Study

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

National Palliative Care Research Center

• Established 2005• Headed by Sean Morrison, MD– Current AAHPM president

• Based out of Mt. Sinai SOM• Funded by

Dartmouth Atlas

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

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

References Bruera E. Ethical issues in palliative care research. J Palliat Care. 1994 Autumn;10(3):7-9. PubMed PMID: 7531237

. Gelfman LP, 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. Jocham HR, Dassen T, Widdershoven G, Halfens R. Quality of life in palliative care cancer patients: a literature

review. J Clin Nurs. 2006 Sep;15(9):1188-95. Review. PubMed PMID: 16911060. Kaasa S, Caraceni A. Palliative cancer care research. Palliat Med. 2010 Apr;24(3):259-60. PubMed PMID:

20371636. Kaasa S, Radbruch L. Palliative care research--priorities and the way forward. Eur J Cancer. 2008 May;44(8):1175-

9. Epub 2008 Apr 18. PubMed PMID: 18374560.

ReferencesKaasa 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 Clin Oncol. 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.

ReferencesTodd 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.

Christian Sinclair, MD, FAAHPM

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