Patient-reported outcomes assessment in cancer trials: taking stock, moving forward.
To evaluate and improve the use of cancer trial end points that reflect the patient's own perspective, the National Cancer Institute organized an international conference, Patient-Reported Outcomes Assessment in Cancer Trials (PROACT), in 2006. The 13 preceding articles in this special issue of the Journal were commissioned in preparation for or in response to the PROACT conference, which was cosponsored by the American Cancer Society. Drawing from these articles and also commentary from the conference itself, this concluding report takes stock of what has been learned to date about the successes and challenges in patient-reported outcome (PRO) assessment in phase III, phase II, and symptom management trials in cancer and identifies ways to improve the scientific soundness, feasibility, and policy relevance of PROs in trials. Building on this synthesis of lessons learned, this article discusses specific administrative policies and management procedures to improve PRO data collection, analysis, and dissemination of findings; opportunities afforded by recent methodologic and technologic advances in PRO data collection and analysis to enhance the scientific soundness and cost efficiency of PRO use in trials; and the importance of better understanding the usefulness of PRO data to the full spectrum of cancer decision makers, including patients and families, health providers, public and private payers, regulatory agencies, and standards-setting organizations.
Lipscomb
Joseph
J
Emory University, Atlanta, GA 30322, USA. jlipsco@sph.emory.edu
Reeve
Bryce B
BB
Clauser
Steven B
SB
Abrams
Jeffrey S
JS
Bruner
Deborah Watkins
DW
Burke
Laurie B
LB
Denicoff
Andrea M
AM
Ganz
Patricia A
PA
Gondek
Kathleen
K
Minasian
Lori M
LM
O'Mara
Ann M
AM
Revicki
Dennis A
DA
Rock
Edwin P
EP
Rowland
Julia H
JH
Sgambati
Maria
M
Trimble
Edward L
EL
D002986:Clinical Trials as Topic / Q000639:trends; D003657:Decision Making; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D017060:Patient Satisfaction; D019984:Quality Indicators, Health Care; D011788:Quality of Life; D018434:Sickness Impact Profile; D016896:Treatment Outcome