Implementing the PAIN RelieveIt Randomized Controlled Trial in Hospice Care: Mechanisms for Success and Meeting PCORI Methodology Standards.
This purpose of this article is to describe how we adhere to the Patient-Centered Outcomes Research Institute's (PCORI) methodology standards relevant to the design and implementation of our PCORI-funded study, the PAIN RelieveIt Trial. We present details of the PAIN RelieveIt Trial organized by the PCORI methodology standards and components that are relevant to our study. The PAIN RelieveIt Trial adheres to four PCORI standards and 21 subsumed components. The four standards include standards for formulating research questions, standards associated with patient centeredness, standards for data integrity and rigorous analyses, and standards for preventing and handling missing data. In the past 24 months, we screened 2,837 cancer patients and their caregivers; 874 dyads were eligible; 223.5 dyads consented and provided baseline data. Only 55 patients were lost to follow-up-a 25% attrition rate. The design and implementation of the PAIN RelieveIt Trial adhered to PCORI's methodology standards for research rigor.
2 University of Florida, Gainesville, FL, USA.
Miriam O
MO
Ezenwa
1 University of Illinois at Chicago, IL, USA.
Marie L
ML
Suarez
1 University of Illinois at Chicago, IL, USA.
Jesus D
JD
Carrasco
3 JourneyCare, Glenview, IL, USA.
Theresa
T
Hipp
4 Rainbow Hospice and Palliative Care, Mount Prospect, IL, USA.
Anayza
A
Gill
3 JourneyCare, Glenview, IL, USA.
Jacob
J
Miller
4 Rainbow Hospice and Palliative Care, Mount Prospect, IL, USA.
Robert
R
Shea
1 University of Illinois at Chicago, IL, USA.
David
D
Shuey
1 University of Illinois at Chicago, IL, USA.
Zhongsheng
Z
Zhao
1 University of Illinois at Chicago, IL, USA.
Veronica
V
Angulo
4 Rainbow Hospice and Palliative Care, Mount Prospect, IL, USA.
Timothy
T
McCurry
3 JourneyCare, Glenview, IL, USA.
Joanna
J
Martin
2 University of Florida, Gainesville, FL, USA.
Yingwei
Y
Yao
1 University of Illinois at Chicago, IL, USA.
Robert E
RE
Molokie
1 University of Illinois at Chicago, IL, USA.
Zaijie Jim
ZJ
Wang
2 University of Florida, Gainesville, FL, USA.
Diana J
DJ
Wilkie
D000368:Aged; D017028:Caregivers / Q000523:psychology; D005006:Ethnicity; D005260:Female; D017051:Hospice Care / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000628:therapy; D015404:Nursing Methodology Research; D010146:Pain / Q000188:drug therapy* / Q000523:psychology; D010147:Pain Measurement; D063868:Patient Outcome Assessment; D012107:Research Design
PAINRelieveIt; PCORI; cancer; hospice; pain