Using a population-based observational cohort study to address difficult comparative effectiveness research questions: the CEASAR study.
BACKGROUND
While randomized controlled trials represent the highest level of evidence we can generate in comparative effectiveness research, there are clinical scenarios where this type of study design is not feasible. The Comparative Effectiveness Analyses of Surgery and Radiation in localized prostate cancer (CEASAR) study is an observational study designed to compare the effectiveness and harms of different treatments for localized prostate cancer, a clinical scenario in which randomized controlled trials have been difficult to execute and, when completed, have been difficult to generalize to the population at large.


METHODS
CEASAR employs a population-based, prospective cohort study design, using tumor registries as cohort inception tools. The primary outcome is quality of life after treatment, measured by validated instruments. Risk adjustment is facilitated by capture of traditional and nontraditional confounders before treatment and by propensity score analysis.


RESULTS
We have accrued a diverse, representative cohort of 3691 men in the USA with clinically localized prostate cancer. Half of the men invited to participate enrolled, and 86% of patients who enrolled have completed the 6-month survey.


CONCLUSIONS
Challenging comparative effectiveness research questions can be addressed using well-designed observational studies. The CEASAR study provides an opportunity to determine what treatments work best, for which patients, and in whose hands.
Vanderbilt University, Nashville, TN, USA.
Daniel A
DA
Barocas
Vivien
V
Chen
Matthew
M
Cooperberg
Michael
M
Goodman
John J
JJ
Graff
Sheldon
S
Greenfield
Ann
A
Hamilton
Karen
K
Hoffman
Sherrie
S
Kaplan
Tatsuki
T
Koyama
Alicia
A
Morgans
Lisa E
LE
Paddock
Sharon
S
Phillips
Matthew J
MJ
Resnick
Antoinette
A
Stroup
Xiao-Cheng
XC
Wu
David F
DF
Penson
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D057186:Comparative Effectiveness Research; D003625:Data Collection / Q000379:methods; D006801:Humans; D008297:Male; D008499:Medical Records; D008875:Middle Aged; D010358:Patient Participation; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000628:therapy*; D011788:Quality of Life; D011795:Surveys and Questionnaires; D057832:Watchful Waiting