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Journal ArticleDOI

Declaring Conflict of Interest - Current State of Affairs in the Ophthalmic Literature.

26 Jul 2017-Accountability in Research (TAYLOR & FRANCIS LTD)-Vol. 24, Iss: 7, pp 375-383

TL;DR: Consistency and completeness of declaration of COI in the ophthalmic literature is analyzed and journals and editors may need to take a more active role in ensuring accurate and consistent COI reporting.
Abstract: The importance of transparency with financial ties in biomedical research is widely recognized, and most peer-reviewed journals require declarations of Conflicts of Interest (COI). Nonetheless, variability in the consistency of declarations of COI has been sparsely assessed. To assess consistency and rates of COI declarations in the ophthalmic literature and the effectiveness of journal COI policies. We analyzed consistency and completeness of declaration of COI in the ophthalmic literature and compared the levels of completeness to specific journal requirements. Six-hundred forty-two peer reviewed articles satisfied the inclusion criteria. In 64%, COIs were unreported, in 25% declaration of COI was incomplete, and 11% of the articles reviewed had complete declaration of COI. Of the 33 journals in which the most frequently published authors' articles appeared, 10 required the authors to complete the International Committee of Medical Journal Editors (ICMJE) form or an equivalent form, but this did not affect the rates of COI declaration. In a random sampling of the most frequently published authors in the field of ophthalmology, declaration of COI was low and highly inconsistent. Requiring a standardized COI form has no significant effect on the rate of accurate COI reporting. Our findings lend support to the growing body of literature that shows that journals and editors may need to take a more active role in ensuring accurate and consistent COI reporting.
Topics: Declaration (53%)

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Declaring Conflict of Interest - Current State of Affairs in the Ophthalmic Literature
Peer-reviewed author version
Schaefer, Jamie Lea; AUBERT BONN, Noemie & Craenen, Geert (2017) Declaring
Conflict of Interest - Current State of Affairs in the Ophthalmic Literature. In:
ACCOUNTABILITY IN RESEARCH-POLICIES AND QUALITY ASSURANCE, 24(7),
p. 375-383.
DOI: 10.1080/08989621.2017.1357474
Handle: http://hdl.handle.net/1942/27528

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Accountability in Research
Policies and Quality Assurance
ISSN: 0898-9621 (Print) 1545-5815 (Online) Journal homepage: http://www.tandfonline.com/loi/gacr20
Declaring conflict of interest – current state of
affairs in the ophthalmic literature
Jamie Lea Schaefer , Noemie Aubert Bonn & Geert Craenen
To cite this article: Jamie Lea Schaefer , Noemie Aubert Bonn & Geert Craenen (2017): Declaring
conflict of interest – current state of affairs in the ophthalmic literature, Accountability in Research,
DOI: 10.1080/08989621.2017.1357474
To link to this article: http://dx.doi.org/10.1080/08989621.2017.1357474
Accepted author version posted online: 26
Jul 2017.
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Accepted Manuscript
Declaring Conflict of Interest – Current State of Affairs in the
Ophthalmic Literature.
Jamie Lea Schaefer MD
1
, Noemie Aubert Bonn MSc
2
, Geert Craenen MD MBE
1,3,4
University at Buffalo Ross Eye Institute
1
; Hasselt University, Faculty of Medicine and Life
Sciences
2
; University at Buffalo Center for Clinical Ethics, Western New York VAMC
4
.
CONTACT
Geert Craenen MD MBE
Dept. of Ophthalmology; Room 627 D
WNYVAMC
3495 Bailey Avenue
Buffalo NY 14215
Email: Geert.Craenen@VA.Gov
Abstract:
Context: The importance of transparency with financial ties in biomedical research is widely
recognized, and most peer-reviewed journals require declarations of Conflicts of Interest (COI).
Nonetheless, variability in the consistency of declarations of COI has been sparsely assessed.
Objectives: To assess consistency and rates of COI declarations in the ophthalmic literature and
the effectiveness of journal COI policies.
Methods: We analyzed consistency and completeness of declaration of COI in the ophthalmic
literature and compared the levels of completeness to specific journal requirements.
Results: 642 peer reviewed articles satisfied the inclusion criteria. In 64%, COIs were
unreported, in 25% declaration of COI was incomplete, and 11% of the articles reviewed had
complete declaration of COI. Of the 33 journals in which the most frequently published authors’
Downloaded by [Australian Catholic University] at 04:49 05 August 2017

Accepted Manuscript
articles appeared, 10 required the authors to complete the International Committee of Medical
Journal Editors (ICMJE) form or an equivalent form but this did not affect the rates of COI
declaration.
Conclusions: In a random sampling of the most frequently published authors in the field of
ophthalmology, declaration of COI was low and highly inconsistent. Requiring a standardized
COI form has no significant effect on the rate of accurate COI reporting. Our findings lend
support to the growing body of literature that shows that journals and editors may need to take a
more active role in ensuring accurate and consistent COI reporting.
Introduction:
The November and December 2014 issues of Ophthalmology and the American Journal of
Ophthalmology feature a joint editorial addressing ongoing issues with declaration of authors’
conflicts of interest and recent changes in the recommendations of the International Committee
of Medical Journal Editors (ICMJE) on financial disclosure
1,2
. In the editorial Liesegang and
Bartley, the respective editors, commit to maintaining physician and public trust through
enhanced transparency. Amongst other things, both editors argue that disclosure of interests
should include all ties to industry encompassing the 36 months preceding submission, even if not
specific to the submitted work. The two editors also submit that terms such as “potential conflict
of interest” and “relevant financial information” lead to confusion and form an impediment to
transparency.
Liesegang and Bartley advocate for universal adoption of the ICMJE form to effect this
transparency. To the ICMJE, improved transparency takes the form of requiring all authors to
Downloaded by [Australian Catholic University] at 04:49 05 August 2017

Accepted Manuscript
disclose all financial ties and interests, and letting the readers decide on their significance for
themselves. “Confusion and subjectivity in reporting financial conflict” the editors argue, now
including continuing medical education presentations in their scope of comments, “would be
lessened simply by disclosing everything and having the same disclosures at each presentation
and each manuscript submission.”
1
We applaud these editors of two of the leading journals in ophthalmology for taking this
strong public stance on an issue vital to the future of scientific reporting, and this leads us to
wonder: How well does the literature in our own field of ophthalmology live up to these high
standards?
The same December issue of Ophthalmology, for example, contains back-to-back articles in
which the same author, writing on the same subspecialty topic, using the same methods and
materials, reports very different financial interests. Illustrative of the findings reported in our
paper, such discrepancies demonstrate the need for a better understanding of the declaration of
conflict of interests (DOI) in practice.
DOI presumes an understanding of which interests may be considered conflicting, biased, or
requiring special mention. Agreement on what should be declared, even amongst the publishing
arm of the research enterprise, is far from universal, and DOI requirements differ dramatically
from journal to journal.
3,4
In the past few years, increasing efforts have been made to arrive at a
consistent, common DOI format. The International committee for Medical Journal Editors
(ICMJE), for example, probably provides the most highly endorsed DOI form – the ICMJE Form
for Disclosure of Potential Conflicts of Interests – intended to be completed by all authors at the
time of submission and to be confirmed before publication. This form ensures that each author
declares any payment or services received for any aspect of the work submitted, but also any
Downloaded by [Australian Catholic University] at 04:49 05 August 2017

Citations
More filters

Journal ArticleDOI
TL;DR: Sponsorship and COI information seem to be underreported in dental journals and efforts should be made by authors, journals, and publishers to provide more comprehensive information to allow the reader to understand the potential impact of sponsorship andCOI on study results.
Abstract: Objective Detailed information on potential conflict of interest (COI) and sponsorship is pivotal for the adequate understanding and appropriate interpretation of the reported study results. The reporting of COI and sponsorship and any potential associations with study characteristics in publications of all dental journals with impact factor was examined. Methods The Web of Science database was searched, in March 2019, for articles published from February 28, 2018 to March 1, 2019. A random a sample of 1000 articles in English was selected. Two independent authors extracted the following article characteristics: type of article, dental field, number of authors, country/continent affiliation of the first author, dental journal, journal impact factor, number of citations, Altmetric score, type of COI and sponsorship. Disagreements during data extraction were resolved by discussion and consensus. Descriptive statistics were calculated for the selected variables and multinomial logistic regression was implemented to assess the association between COI, sponsorship, and the other variables. Results 3% of dental publications declared a COI, whereas in 32.5% of publications the presence of COI was unclear. The most prevalent type of COI was financial (n = 26). Non-profit organizations funded 37.2% of the articles, while the sponsorship for 40.4% articles was unclear. Regression analysis showed that publications reporting COI had greater odds of receiving sponsorship from for-profit sources. Conclusions Sponsorship and COI information seem to be underreported in dental journals. Efforts should be made by authors, journals, and publishers to provide more comprehensive information to allow the reader to understand the potential impact of sponsorship and COI on study results. Clinical significance The underreporting of COI and sponsorship in dental articles hinders the interpretation of findings by readers. The results of the present study bring attention to this important topic as well as guide further improvements on the reporting of COI and sponsorship in dental articles.

3 citations


References
More filters

Journal ArticleDOI
Lee S. Friedman, Elihu D. Richter1Institutions (1)
TL;DR: COI is widespread among the authors of published manuscripts and these authors are more likely to present positive findings, and a strong association between positive results and COI (ICMJE definition) is observed.
Abstract: CONTEXT: To date, research regarding the influence of conflicts of interest on the presentation of findings by researchers has been limited.

200 citations


Journal ArticleDOI
25 Nov 2009-JAMA
TL;DR: In 2008, most medical journals with relatively high impact factors had author COI policies available for public review, and among journals, there was substantial variation in policies for solicitation of author COIs and in definitions of COI.
Abstract: Context Conflicts of interest (COIs) may influence medical literature. However, it is unclear whether medical journals have consistent policies for defining and soliciting COI disclosures. Objective To determine the prevalence of author COI policies, requirements for signed disclosure statements, and variability in COI definitions among medical journals. Design A cross-sectional survey of Instructions for Authors and manuscript submission documents, including authorship responsibility forms, for high-impact medical journals across 35 subject categories available from March through October 2008. Main Outcome Measure Presence of language referring to COI disclosure in the Instructions for Authors or manuscript submission documents. Results Of 256 journals, 89% had author COI policies. Fifty-four percent required authors to sign a disclosure statement, and 77% provided definitions of COI. Most definitions were limited to direct financial relationships; a minority of journals requested disclosure of other potential conflicts such as personal relationships (42%), paid expert testimony (42%), relationships with other organizations (26%), or travel grants (12%). The prevalence of policies varied by subject category: all internal medicine, respiratory medicine, and toxicology journals studied had comprehensive COI definitions, with 19 of these 24 journals requiring signed disclosure attestations. In contrast, 6 of 19 geriatrics, radiology, and rehabilitation journals requested author COI disclosure. Most journals that officially endorsed International Committee of Medical Journal Editors guidelines had COI policies (68/69), compared with 84% of journals not endorsing the guidelines (158/187). Conclusions In 2008, most medical journals with relatively high impact factors had author COI policies available for public review. Among journals, there was substantial variation in policies for solicitation of author COIs and in definitions of COI.

113 citations


"Declaring Conflict of Interest - Cu..." refers background in this paper

  • ...Agreement on what should be declared, even amongst the publishing arm of the research enterprise, is far from universal, and DOI requirements differ dramatically from journal to journal (Ancker and Flanagin 2007; Blum 2009)....

    [...]


Journal ArticleDOI
Jessica S. Ancker1, Annette FlanaginInstitutions (1)
TL;DR: The prevalence of published Conflict of interest policies was higher than that reported in a 1997 study, an increase that might be attributable to heightened awareness of conflict of interest issues.
Abstract: Scientific journals can promote ethical publication practices through policies on conflicts of interest. However, the prevalence of conflict of interest policies and the definition of conflict of interest appear to vary across scientific disciplines. This survey of high-impact, peer-reviewed journals in 12 different scientific disciplines was conducted to assess these variations. The survey identified published conflict of interest policies in 28 of 84 journals (33%). However, when representatives of 49 of the 84 journals (58%) completed a Web-based survey about journal conflict of interest policies, 39 (80%) reported having such a policy. Frequency of policies (including those not published) varied by discipline, from 100% among general medical journals to none among physics journals. Financial interests were most frequently addressed with relation to authors; policies for reviewers most often addressed non-financial conflicts. Twenty-two of the 39 journals with policies (56%) had policies about editors’ conflicts. The highest impact journals in each category were most likely to have a published policy, and the frequency of policies fell linearly with rank; for example, policies were published by 58% of journals ranked 1 in their category, 42% of journals ranked third, and 8% of journals ranked seventh (test for trend, p = 0.003). Having a conflict of interest policy was also associated with a self-reported history of problems with conflict of interest. The prevalence of published conflict of interest policies was higher than that reported in a 1997 study, an increase that might be attributable to heightened awareness of conflict of interest issues. However, many of the journals with policies do not make them readily available and many of those policies that were available lacked clear definitions of conflict of interest or details about how disclosures would be managed during peer review and publication.

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Journal ArticleDOI
Sheldon Krimsky1Institutions (1)
Abstract: In the mid-1980s, social scientists compared outcome measures of related drug studies, some funded by private companies and others by nonprofit organizations or government agencies. The concept of a “funding effect” was coined when it was discovered that study outcomes could be statistically correlated with funding sources, largely in drug safety and efficacy studies. Also identified in tobacco research and chemical toxicity studies, the “funding effect” is often attributed, implicitly or explicitly, to research bias. This article discusses the meaning of scientific bias in research, examines the strongest evidence for the “funding effect,” and explores the question of whether the “funding effect” is an indicator of biased research that is driven by the financial interests of the for-profit sponsor. This article argues that the “funding effect” is merely a symptom of the factors that could be responsible for outcome disparities in product assessment. Social scientists should not suspend their skepticism a...

61 citations


"Declaring Conflict of Interest - Cu..." refers background in this paper

  • ...Therefore, in order to preserve the authenticity of the knowledge captured by researchers, transparency, rather than independence, is put forward as the summum bonum (Cosgrove et al. 2016; Krimsky 2013)....

    [...]


Journal ArticleDOI
Matthew S. McCoy1, Ezekiel J. Emanuel1Institutions (1)
02 May 2017-JAMA
TL;DR: Labeling certain COI as merely “potential” or “perceived” diminishes their seriousness and obscures the ethical rationale for trying to limit COI in medical practice and research.
Abstract: During the Institute of Medicine’s 2013 workshop on conflict of interest (COI) and medical innovation, a presentation from PhRMA, the pharmaceutical industry association, delineated 5 types of potential conflict in medical research and the likelihood of each resulting in a true conflict.1 Even though these sorts of distinctions between potential or perceived COI on one hand and true or actual COI on the other have become commonplace,2,3 they are misguided. Not only is the notion of a potential COI conceptually confused, labeling certain COI as merely “potential” or “perceived” diminishes their seriousness and obscures the ethical rationale for trying to limit COI in medical practice and research.

38 citations


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