INTRODUCTION Comparative effectiveness research (CER) is an
emerging field that compares the relative effectiveness of
alternative strategies to prevent, diagnose, or treat patients that
are typical of day-to-day clinical practice.
In 2009 the Institute of Medicine (IOM) published a priority
list for CER for all of medicine.To assist the field of IBD in CER
it is necessary to develop priorities specific to Crohns and
colitis.
AIM To develop a priority list of CER studies for IBD.
METHODS Following the IOM's approach for developing CER
priorities, we surveyed practicing GIs to determine their most
important CER topics in IBD.
The survey was electronically distributed to an international
sample of GIs from the membership of:American College of
GastroenterologyCanadian Association of GastroenterologyAustralian
IBD AssociationBritish Society of Gastroenterology
In addition, an international panel of 13 IBD experts (BRIDGe
group) independently proposed CER studies.
Two patient focus groups were convened to determine their
opinions of the most important IBD research topics.
All candidate CER studies were compiled into 21 topic
categories.
CER studies were presented to the expert panel using the
validated RAND/UCLA method. Rated using a standard 1-9 point scale
(1=lowest priority; 9=highest; >7=high priority).
Following the initial ratings the panel met in person to re-rate
priorities after group discussion.
Disagreement was assessed using a validated index.Setting
Priorities For Comparative Effectiveness Research In IBD: Results
Of An International Provider Survey, Expert RAND Panel, And Patient
Focus Groups A. Cheifetz1, G. Melmed2, B. Spiegel3, J. Talley4, S.
Devlin5, L. Harrell6, P. Irving7,*, J. Jones8, G. Kaplan5, P.
Kozuch9, M. Sparrow10, F. Velayos11, L. Baidoo12,B. Bressler13, C.
Siegel14
1Beth Israel Deaconess Medical Center, Boston,MA 2Cedars-Sinai
Medical Center,3VA Greater Los Angeles Healthcare System,4CURE
Digestive Disease Research Center , Los Angeles, CA,5University of
Calgary, Calgary, Canada,6University of Chicago, Chicago, IL,7Guy's
and St. Thomas' Hospitals, London, United Kingdom,8University of
Saskatchewan, Saskatoon, Canada,9Jefferson University,
Philadelphia, PA,10The Alfred Hospital, Melbourne,
Australia,11University of California San Francisco, San
Francisco,CA 12University of Pittsburgh, Pittsburgh,
PA,13University of British Columbia, Vancouver,
Canada,14Dartmouth-Hitchcock Medical Center, Lebanon, NHCONCLUSIONS
We systematically developed a list of high priority CERs for IBD
based on a survey of GIs, expert review, and patient input.
This list can guide IBD researchers and funding agencies towards
the most important CERs. RESULTS 234 unique CER questions.
Based on the initial round of ranking and clinical relevance,
the RAND panel selected 87 CER questions to re-rate in person. 40
were rated as high priority. Disagreement was observed in only 5 of
87 CER questions.
The panel then distributed points to the highest rated CER
questions to develop the top 10 CER priorities for IBD. Top 10
Comparative Effectiveness Research PrioritiesCompare the
effectiveness ofwww.BRIDGeIBD.comThe panel meeting was supported by
an unrestricted grant from Warner Chilcott, Abbott, and Shire.
Unrestricted funding for the BRIDGe group is provided by Abbott,
UCB, Salix and Warner Chilcott.
Withdrawal of biologic therapy vs. withdrawal of immunomodulator
therapy vs. continued combination therapy in Crohns disease
patients who achieved remission on combination therapyEfficacy and
safety of infliximab vs. cyclosporine vs. surgery in hospitalized
steroid-refractory ulcerative colitisUsing biomarkers (genetics,
immunology) vs. standard of care in predicting response and
toxicity to therapy of IBDDifferent TNF inhibitors for the
induction and maintenance of remission and mucosal healing in
Crohn's disease
6MP versus anti-TNF agents in preventing clinical and endoscopic
post-op recurrence of Crohn's disease after resectionAnti-TNF alone
versus anti-TNF+6MP in patients with moderate to severe Crohn's
disease failing 6MPScheduled post-operative colonoscopy vs.
clinical follow-up guiding post-operative managementTailoring
therapy to mucosal healing vs. standard clinical factors on
long-term outcomes in IBDStandard anti-TNF dosing vs. trough-level
anti-TNF dosing in IBDThe efficacy and safety of long-term
immunomodulation (6MP/AZA) versus biologic (anti-TNF) therapy in
Crohn's disease and UC
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