title: Developing the evidence base for palliative care: formation of the Palliative Care Research Cooperative and its first trial.
abstract: The field of palliative care and hospice has gained accreditation, with a growing cadre of specialists being trained, but there is a dearth of robust research evidence to guide clinical practice. After 2 years of planning, a group of senior investigators convened in January 2010 to explore the possibility of forming a research cooperative group dedicated to advancing the evidence base in palliative care and hospice. The meeting launched the Palliative Care Research Cooperative (PCRC) with an initial national/international membership, and a plan for developing policies and procedures. Proof of the concept for the PCRC is being established through the design, conduct, and dissemination of a multi-site clinical trial targeting a consensually selected, clinically relevant research question: Should patients who are taking statins for primary or secondary prevention, and who have a prognosis of < 6 months, discontinue these medications? A core group of PCRC members have developed the flagship study for the PCRC, evaluating the discontinuation of statin medications in the palliative care setting. Using the proposed trial as a case study, we underscore several approaches to overcoming common research challenges in end-of-life settings, including: 1) study design, to ensure feasibility and timeliness; 2) strategies to overcome barriers to research in this population; 3) data collection and management, to reduce the burden on patients, caregivers, research personnel, and sites while maximizing quality and efficiency; and 4) agenda setting. This article describes the rationale for convening the PCRC and highlights core principles for developing the evidence base in palliative medicine.
authors.affiliation: Division of Medical Oncology, Department of Medicine, Duke University Medical Center, Durham, NC 27710, USA.
authors.forename: Thomas W
authors.initials: TW
authors.lastname: LeBlanc
authors.forename: Jean S
authors.initials: JS
authors.lastname: Kutner
authors.forename: Danielle
authors.initials: D
authors.lastname: Ko
authors.forename: Jane L
authors.initials: JL
authors.lastname: Wheeler
authors.forename: Janet
authors.initials: J
authors.lastname: Bull
authors.forename: Amy P
authors.initials: AP
authors.lastname: Abernethy
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D003625:Data Collection / Q000379:methods; D017051:Hospice Care / Q000458:organization & administration*; D006801:Humans; D015337:Multicenter Studies as Topic / Q000379:methods; D010166:Palliative Care / Q000458:organization & administration*; D012107:Research Design