This document discusses various issues related to ensuring integrity in scientific publishing, including biases, conflicts of interest, and the responsibilities of journal editors. It notes that selectively publishing positive results over negative ones, failing to publish entire studies, and other biases can mislead readers and compromise the integrity of the scientific record. Maintaining quality and preventing business interests from influencing standards is challenging for editors. Strict ethical guidelines and transparency around financial interests are important to uphold scientific integrity.

1. Mischief, Malfeasance
and Incompetence:
The editor’s enemies
John Hoey
COPE Seminar 2009
London
johnhoeymd@gmail.com
slideshare

2. COPE
Code of Conduct
General duties and responsibilities of Editors
Be responsible for everything published in their
journals.
• Strive to meet the needs of readers and
authors
• constantly improve the journal
• Ensure the quality of the material they
publish
• champion freedom of expression
• Maintain the integrity of the academic
record
• Preclude business needs from
compromising intellectual standards
•
always
be
willing
to
publish
corrections,
clarifications,
retractions
and
apologies
when
needed.

3. COPE
Code of Conduct
General duties and responsibilities of Editors
Be responsible for everything published in their
journals.
• Strive to meet the needs of readers and
authors
• constantly improve the journal
• Ensure the quality of the material they
publish
• champion freedom of expression
• Maintain the integrity of the academic
record
• Preclude business needs from
compromising intellectual standards
•
always
be
willing
to
publish
corrections,
clarifications,
retractions
and
apologies
when
needed.

4. Maintaining the Integrity of the
Scientific Record.......why?
• Ethics - Nuremburg Trials - Helsinki Decl.
• Harm to patients and the public
• Physical harm
• Financial harm

5. Ethical Basis
Nuremberg -
Helsinki
• research
funding
orgs
• ICMJE
• WAME
• COPE

6. Ethical Basis
“Both authors and publishers have ethical
obligations.
Nuremberg -
Helsinki
In publication of the results of research, the
investigators are obliged to preserve the
• research
accuracy of the results.
funding
orgs
Negative as well as positive results should be
published or otherwise publicly available.
• ICMJE
Sources of funding, institutional afiliations
• WAME and any possible conflicts of interest should
be declared in the publication.
• COPE
Reports of experimentation not in
accordance with the principles laid
down in this Declaration should not be
accepted for publication.”

7. Small Journals
Ensure Quality/Integrity?
• Relationships with journal owners
• Threats to quality/integrity from authors

8. Authors
Research
Sponsors/ Journal Owners
advertisers
Readers

9. Authors
Research
Sponsors/ Journal Owners
advertisers
Ideological
political
self-interest
....
Readers

10. Authors
$£
Research
Sponsors/ Journal Owners
advertisers
Readers

11. Authors
Research
Sponsors/ Journal Owners
advertisers
Readers

12. Authors
Research
Sponsors/ Journal Owners
advertisers
Readers

13. Authors
Research
Sponsors/ Journal Owners
advertisers
Readers

14. Authors
Research
Sponsors/ Journal Owners
advertisers
Readers

15. Authors
Research
Sponsors/ Journal Owners
advertisers
Readers

16. Authors
Research
Sponsors/ Journal Owners
advertisers
Readers

17. $ Journal Owners
Revenue - Expenses = Break Even or Profit Targets

18. $ Journal Owners
Revenue - Expenses = Break Even or Profit Targets
Revenue
-subscriptions
-advertising (requires readers)
-author charges
-reprints
-supplements
-special issues
etc.

19. $ Journal Owners
Revenue - Expenses = Break Even or Profit Targets
Expenses
Revenue
-editorial salary costs
-subscriptions
-technical editing
-advertising (requires readers)
-distribution
-author charges
-reprints
-supplements
-special issues
etc.

20. Publisher/Editor
Business needs compromise editorial standards
• Explicit contract
• Helsinki Declaration
• WAME/ICMJE
• Publisher goals
• Disclosure of contract
• Disclosure of editorial
publisher Conflicts of
interest

21. Collaborative
Open Source Software (Open Journal Systems - OJS)
No author charges
No pharmaceutical advertsing

22. COPE
Code of Conduct
General duties and responsibilities of Editors
Be responsible for everything published in their
journals.
• Strive to meet the needs of readers and
authors
• constantly improve the journal
• Ensure the quality of the material they
publish
• champion freedom of expression
• Maintain the integrity of the academic
record
• Preclude business needs from
compromising intellectual standards
•
always
be
willing
to
publish
corrections,
clarifications,
retractions
and
apologies
when
needed.

23. Quality threats
$$
Conflict
of
Interest
Incompetence/
Carelessness

24. What does an Editor do?
Soliciting papers
Peer review
Editorial decisions
Editing
Substantive
Technical
On-line and print layout
Etc. Etc. Etc...
Photo by CAM MAN www.flickr.com/people/pcasey/

25. Letters and obituaries editor
Research papers editors Deputy managing editor
Sharon Davies
Kristina Fister Lucy Banham
email Douglas Kamerow
BMJ Editorial Staff email email
T:+44 (0)20 7383 6716 email
T:+44 (0)20 7383 6365
Trish Groves Observations and reviews editor
Editor in chief PA to editor in chief Career Focus
email Technical editors
Trevor Jackson
Fiona Godlee Julia Burrell Edward Davies
Jackie Annis
email email
email email
Elizabeth Loder email
T:+44 (0)20 7383 6677 T:+44 (0)20 7383 6102
T: + 44(0)20 7383 6102 T: + 44 (0) 20 7383 6562
email T:+44 (0)20 7383 6658
Departmental administrator
Deputy editors Christopher Martyn Maggie Butler studentBMJ
Roger Robinson editorial registrar Chelsey White
Jane Smith email email Jessie Colquhoun
Helen Macdonald email
T:+44 (0)20 7383 6074
email email studenteditor@bmj.com
T:+44 (0)20 7383 6109
Alison Tonks
T:+44 (0)20 7383 6009 T: + 44 (0)20 7 874 7022 T: +44 (0)20 7874 7016
email Sally Carter
email
Senior researcher
Tony Delamothe Visiting editors
T:+44 (0)20 7383 6659
Primary care editor Sara Schroter
email Jennifer Leaning (USA)
Benchpress database manager
Domhnall MacAuley email
T: +44 (0) 20 7383 6006 Ray Moynihan (USA)
Gary Bryan
email Margaret Cooter
T: +44 (0)20 7383 6744
email Joanne Roberts (USA)
email
Trish Groves T:+44 (0)20 7383 6304 Charlie Wilson (USA)
T:+44 (0)20 7383 6657
Patient editor
News editors
email Peter Lapsley
Annabel Ferriman
T:+44 (0)20 7383 6018 Benchpress administrator Editorial advisers
email
email Greg Cotton
Sue Minns Steven Reid
T: 44 (0)20 7383 6035 email
email
Magazine editor Ian Maconochie
T:+44 (0)20 7383 6685
Web team
T:+44 (0)20 7383 6309
Trevor Jackson Editor bmj.com Peter Leman
Zosia Kmietowicz
email David Payne
email Clare Griffith Nick Dunn
Chief production editor
T:+44 (0)20 7383 6677 email email Frank Sullivan
John Mayor
T: +44 (0)20 7383 6051
Features editors Pippa Oakeshott
email
Assistant editor, bmj.com
Deborah Cohen
bmj.com editor Aziz Sheikh
T:+44 (0)20 7383 6355
Birte Twisselmann Richard Hurley
email
David Payne Lucy Chappell
email email
T: +44 (0)20 7383 6183
email Christopher Whitty
Assistant production editor
T: +44 (0)20 7383 6720 T: + 44 (0)20 7383 6051
T:+44 (0)20 7383 6532 Scott Murray
Edwyn Mayhew
Rebecca Coombes
email Julia Hippisley-Cox
Print journal team Elizabeth Payne
email
Editorials editor T:+44 (0)20 7383 6145 Josip Car
Magazine editor email
T: +44 (0)20 7383 6243
Giselle Jones Robin Fox
Trevor Jackson T: + 44 (0)20 7383 6449
Production editor Sue Morgan
email
Clinical reviews editor
Jett Aislabie
Karl Sharrock
Kirsten Patrick
email
Designer Statistical advisers
email
email
T:+44 (0)20 7874 7014
Jane Walker T:+44 (0)20 7383 6658 Doug Altman
email Tim Cole
Practice editor
Malcolm Brown (maternity cover)
Barbara Squire
Mabel Chew Hazel Inskip
T:+44 (0)20 7874 7014
Senior art worker email
email Julie Morris
Adam di Chiara T:+44 (0)20 7383 6658 Deborah Ashby
Illustrator
email
Analysis editor Jon Deek
Anthea Wilkie
Julia Thompson
Tessa Richards
email
Picture editor email
email
T:+44 (0)1737 215143
Vanessa Fletcher T:+44 (0)20 7383 6691
T: +44 (0) 20 7383 61
email
Copyright administrator
email

26. EDITOR-in-CHIEF
M.H Bagheri, MD
DEPUTY EDITOR
B Astaneh, MD
EDITORIAL BOARD
Editor
B Aarabi, MD
M Razeghinejad, MD
David Bevan MB
M.A Aboulghar, MD
Toronto
G.H Shahcheragi, MD
A Alborzi, MD
T Tulandi, MD
M Askarian, MD
F Zand, MD
A Anand, PhD
A Banani, MD
EDITORIAL ASSISTANTS
Z Mostafavi Pour, PhD
Z Barzin, Msc
A.R Nikseresht, MD
F Jalalat
M.R Panjehshahin, PhD
M Keshmiri, Bsc
M.E Parsanezhad, MD
Z Safa, Bsc
F Peyvandi, MD PhD
M Rabiee

28. Reporting Bias
Kay Dickersin,
Reporting and other biases in studies of Neurontin
for migraine, psychiatric/bipolar disorders,
nociceptive pain, and neuropathic pain.
August, 2008
http://dida.library.ucsf.edu/pdf/oxx18r10

29. Some definitions
• Positive= Study shows results favourable to
the intersts of the author/sponsor. Usually
statistically significant.
• Negative = Study shows results unfavourable
to the interest of the the author/sponsor -
may or may not be statisticaly significant.

30. Reporting Biases
Malfeasance or Incompetence?
• Non-publication of negative or neutral
results
• Selective publication of results - outcome
bias
• Multiple publication bias
• Language bias - and publishing in the grey
literature
• Time lag bias
• Undeclared conflicts of interest
• Dickersin
Ghost writing

31. Selective publication - Outcome bias
publishing the more interesting (usually positive) result
Was there an hypothesis?
A plan for analysis and reporting of data?
In an RCT, this is the primary outcome

32. Selective publication - Outcome bias
(publishing the more interesting result)
48 trials
1402 outcomes
31% - 59% incompletely reported
(40% not reported at all)
Chan, A.-W. et al. CMAJ 2004;171:735-740

33. Selective publication - Outcome bias
(publishing the more interesting result)

34. Selective publication - Outcome bias
(publishing the more interesting result)

35. Selective publication - Outcome bias
(publishing the more interesting result)
Interpretation: Intensive
multitherapy for patients with
poorly controlled type 2
diabetes is successful in
helping patients meet most of
the goals set by a national diabetes
association. However, 6 months after intensive therapy stopped and patients
returned to usual care the benefits had vanished,

36. Selective publication - Outcome bias
(publishing the more interesting result)
Interpretation: Intensive
multitherapy for patients with
poorly controlled type 2
diabetes is successful in
helping patients meet most of
the goals set by a national diabetes
association. However, 6 months after intensive therapy stopped and patients
returned to usual care the benefits had vanished,
However, 6 months after intensive
therapy stopped and patients returned
to usual care the benefits had
vanished.

37. Neurontin
(gabapentin)
images from Wikipedia

38. P Wessely, C Baumgartner, D Klinger, J Kreczi, N … -
Cephalalgia, 1987
Bias Example
Publication Final negative primary results not published, only
positive preliminary results
Selective outcome Outcome reported was not primary or secondary
reporting outcome
Selective statistical 2 nonrandomized patients assigned to neurotin
analyses were include with those randomized
Spin Emphasis on “positive” outcomes

39. 16 Citations
P Wessely, C Baumgartner, D Klinger, J Kreczi, N … - Cephalalgia, 1987
Does it matter?
General Principles of
Migraine Management: The
Changing Role of Prevention
Practice parameter: Evidence-based
E Loder, D Biondi - Headache:
The Journal of Head and Face
guidelines for migraine headache (an
Pain, 2005 - Blackwell Synergy
Preventive treatment of
evidence-based review)
migraine -
SD Silberstein - Trends in
Pharmacological Sciences, 2006 -
Stephen D. Silberstein, MD, FACP, for the US
Elsevier
Headache Consortium*
Migraine prevention
Neurology 2000;55:754-762
DW Dodick, SD Silberstein -
British Medical Journal, 2007 -
pn.bmj.com
Neuromodulators for
Migraine Prevention
R Kaniecki - Headache: The
Journal of Head and Face Pain,
2008 - Blackwell Synergy

42. So what?
“Using data on the estimated level of spending on
allegedly fraudulent promotion, I am able to quantify this
impact in terms of prescriptions for specific off-label uses
and high-dose prescriptions.
43 million
In total, I find that there were
off-label prescriptions
of Neurontin as a result of the ... promotional activities
related to the off-label uses ... that would not have
occurred absent the challenged conduct.”
Meredith Rosenthal
http://dida.library.ucsf.edu/pdf/oxx18r10

43. Editorial strategies?
Soliciting papers
Peer review
Editorial decisions
Editing
Substantive
Technical
On-line and print layout
Etc. Etc. Etc...

44. Science is complex

45. • Author checklists
• Financial conflicts of interest
• Study design and reporting requirements

46. Conflict of Interests -
Is disclosure enough?
Who was responsible for?
• Study
• design
• data collection
• analysis
• write up
• decision to publish
• etc

47. 1109 Canadian clinicaltrials.gov
732 investigators
11 ideal practices to mitigate fCOI
- control over design
- data collection
- analysis
- interpretation
-write up
-authorship
-decision to publish
-etc.
6% of investigators met all ideal practices
Rochon P, et al. - submitted

48. Financial Conflict of Interest Checklist
Rochon P., et al - submitted recently

49. Financial Conflict of Interest Checklist
Rochon P., et al - submitted recently

50. Reporting Guidelines
Consort - RCTs
Quorum - Systematic reviews
Moose - Meta-analyses
Stard - Diagnositic tests
Grade - Clinical guidelines
Strobe - Observational studies
etc. (~160)
www.equator-network.org

51. Publisher/Editor Author/Editor
• Explicit contract
• Aim for quality
• Helsinki Declaration
• Publish less
• WAME/ICMJE
• Author guidelines/instructions
• Publisher goals
• Use reporting guidelines
• Disclosure of contract
• Require authors use them
• Disclosure of editorial
• Use checklists with
publisher Conflicts of
submissions
interest

52. American College of Physicians
(Annals Intern Med
American Medical Association
JAMA
Mass. Medical Society
New Engl J Medicine
Croatian Medical Schools
Croatian Medical Journal
Thank you