Discrepancy between Results and Abstract Conclusions
in Industry- vs Nonindustry-funded Studies Comparing
Topical Prostaglandins
TARIQ ALASBALI, MICHAEL SMITH, NOA GEFFEN, GRAHAM E. TROPE, JOHN G. FLANAGAN,
YAPING JIN, AND YVONNE M. BUYS
●
PURPOSE: To investigate the relationship between
industry- vs nonindustry-funded publications compar-
ing the efficacy of topical prostaglandin analogs by
evaluating the correspondence between the statistical
significance of the publication’s main outcome measure
and its abstract conclusions.
●
DESIGN: Retrospective, observational cohort study.
●
METHODS: English publications comparing the ocular
hypotensive efficacy between any or all of latanoprost,
travoprost, and bimatoprost were searched from the
MEDLINE database. Each article was reviewed by three
independent observers and was evaluated for source of
funding, study quality, statistically significant main out-
come measure, correspondence between results of main
outcome measure and abstract conclusion, number of
intraocular pressure outcomes compared, and journal
impact factor. Funding was determined by published
disclosure or, in cases of no documented disclosure, the
corresponding author was contacted directly to confirm
industry funding. Discrepancies were resolved by con-
sensus. The main outcome measure was correspondence
between abstract conclusion and reported statistical sig-
nificance of the publications’ main outcome measure.
●
RESULTS: Thirty-nine publications were included, of
which 29 were industry funded and 10 were nonindustry
funded. The published abstract conclusion was not con-
sistent with the results of the main outcome measure in
18 (62%) of 29 of the industry-funded studies compared
with zero (0%) of 10 of the nonindustry-funded studies
(P .0006). Twenty-six (90%) of the industry-funded
studies had proindustry abstract conclusions.
●
CONCLUSIONS: Twenty-four percent of the industry-
funded publications had a statistically significant main
outcome measure; however, 90% of the industry-funded
studies had proindustry abstract conclusions. Both read-
ers and reviewers should scrutinize publications carefully
to ensure that data support the authors’ conclusions.
(Am J Ophthalmol 2009;147:33–38. © 2009 by
Elsevier Inc. All rights reserved.)
F
INANCIAL RELATIONSHIPS BETWEEN PHARMACEUTI-
cal companies and researchers and funding of med-
ical research by drug companies has increased
dramatically during the last two decades.
1–4
This can result
in industry bias where the source of funding of clinical
trials either affects the results in a systematic way or leads
to selective presentation of the results. Industry funding
often has been associated with proindustry results
2,5–20
and
publication bias,
21–23
which can affect the interpretation
and presentation of outcomes resulting in conclusions that
overstate results without statistical support. The purpose
of this study was to investigate the relationship between
industry- vs nonindustry-funded publications comparing
ocular hypotensive efficacy of the topical prostaglandin
analogs (PGA) latanoprost 0.005%, travoprost 0.004%,
and bimatoprost 0.03% by evaluating the correspondence
between the statistical significance of the publication’s main
outcome measure and its published abstract conclusions.
METHODS
A MEDLINE SEARCH FROM 1966 TO THE SECOND WEEK OF
November 2007 using any combination of the keywords
latanoprost, travoprost, and bimatoprost was conducted. The
title and abstracts from the initial search were reviewed
and those included were English language publications
comparing the intraocular pressure (IOP)-lowering efficacy
of any combination of latanoprost; travoprost; or bimato-
prost. The complete articles were obtained and the refer-
ences also were searched to identify relevant publications
missed during the initial search.
Each publication was reviewed by three independent
observers using a standardized data collection sheet eval-
uating: source of funding, industry author, study quality,
main outcome measure, statistical significance (P .05) of
main outcome measure, abstract conclusion, correspon-
dence between statistical significance (P .05) of main
See accompanying Editorial on page 1.
Accepted for publication Jul 1, 2008.
From the Department of Ophthalmology and Vision Sciences, Uni-
versity of Toronto, Toronto Western Hospital, Toronto, Ontario, Canada
(T.A., M.S., N.G., G.E.T., J.G.F., Y.M.B.); the Department of Ophthal-
mology, King Faisal University, King Fahad Hospital of the University,
Riyad, Saudi Arabia (T.A.); the School of Optometry, University of
Waterloo, Waterloo, Ontario, Canada (J.G.F.); and the Department
of Public Health Sciences, University of Toronto, Toronto, Ontario,
Canada (Y.J.).
Inquiries to Yvonne M. Buys, Toronto Western Hospital, 399 Bathurst
Street, EW6-405, Toronto, Ontario, Canada M5T 2S8; e-mail: y.buys@
utoronto.ca
© 2009 BY ELSEVIER INC.ALL RIGHTS RESERVED. 0002-9394/09/$36.00 33
doi:10.1016/j.ajo.2008.07.005