c o p e washington 9 nov09
DESCRIPTION
committee on publication ethics talkresearch misconductrole of editorsresearch reporting guidelinesconflict of interest checklists for editorsTRANSCRIPT
Published ResearchFlawed, misleading,
deceitful ?John Hoey
COPE U.S Seminar 2009Washington, DC
oey
Role’s, Responsibilities of Editors
Research manuscripts
Bailar’s pyramid of faults
Examples
What can an editor do?
Reporting guidelines
Conflict of Interest checklists
Outline
COPECode 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 whenneeded.
Maintaining the Integrity of the Scientific Record.......why?
•Ethics - Nuremburg Trials - Helsinki Declaration.
•Harm to patients and the public
•Physical harm
•Financial harm
Editorial Ethical Responsibilites
• Helsinki Declarations
“Both authors and publishers have ethical obligations.
In publication of the results of research, the investigators are obliged to preserve the accuracy of the results.
Negative as well as positive results should be published or otherwise publicly available.
Sources of funding, institutional affiliations and any possible conflicts of interest should be declared in the publication.
Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication.”
$$ Conflict
of Interest
Carelessness
Incompetence
John Bailar’s Pyramid of Manuscript Problems
a few examplesof problems editors face
Kay Dickinson, 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
Reporting Bias
Some definitions
• Positive= Study shows results favourable to the interests 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 statistically significant.
Reporting Biases
•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
•Ghost writingDickinson
Hypothesis testing or Hypothesis generating?
Hypothesis testing Hypothesis generating
Prior specification before study begins
eg. RCT, observational studies, etc.
Finding an interesting result among man possible results
eg. Survey, cohort study etc..
Selective publication - Outcome biaspublishing 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
RCT
RRx A
Placebo
Outcome
Study design - RCT
RRx A
Placebo
Outcome
Primary Outcome -Specified in Protocol?or fishing expedition?
QuickTime™ and aPhoto - JPEG decompressor
are needed to see this picture.
Consort Statement•Poor quality of reporting RCTs.
•Could not be trusted for use in clinical practice
•Could not be combined in systematic reviews
•Identified 22 essential items needed to conduct a RCT.
Ann Intern Med. 2001;134:663-694. www.annals.org David Moher
Selective publication - Outcome bias(publishing the more interesting result)
1402 outcomes31% - 59% incompletely reported(40% not reported at all)
Chan, A.-W. et al. CMAJ 2004;171:735-740
48 RCTs funded by national granting
agency
Selective publication - Outcome bias(publishing the more interesting result)
Primary Outcome
Diabetic control 6 months after the end of intensive multithearpy
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.
does any of this matter?
images from Wikipedia which also has a nice summary of court proceedings and results
Neurontin(gabapenti
n)
For minor seizuresFDA approved 1994By 2003 one of Pfizer’s best selling drugsOff-label uses account for 90% of sales
Multiple small RCTs Benefit for other disorderse.g. migraine
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 reporting
Outcome reported was not primary or secondary outcome
Selective statistical analyses
2 nonrandomized patients assigned to neurotin were include with those randomized
Spin Emphasis on “positive” outcomes
A seriously flawed RCT - Accepted for publication by someone
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 PreventionE Loder, D Biondi - Headache: The Journal of Head and Face Pain, 2005 - Blackwell Synergy
Preventive treatment of migraine - SD Silberstein - Trends in Pharmacological Sciences, 2006 - Elsevier
Migraine preventionDW Dodick, SD Silberstein - British Medical Journal, 2007 - pn.bmj.com
Neuromodulators for Migraine PreventionR Kaniecki - Headache: The Journal of Head and Face Pain, 2008 - Blackwell Synergy
Practice parameter: Evidence-based guidelines for migraine headache (an evidence-based review)
Stephen D. Silberstein, MD, FACP, for the US Headache Consortium
Neurology 2000;55:754-762
a typical editor
and their support staff...
the editor’s desk
BMJ Editorial Staff
Editor in chiefFiona GodleeemailT: + 44(0)20 7383 6102Deputy editorsJane SmithemailT:+44 (0)20 7383 6009Tony DelamotheemailT: +44 (0) 20 7383 6006Trish GrovesemailT:+44 (0)20 7383 6018Magazine editorTrevor Jackson emailT:+44 (0)20 7383 6677bmj.com editorDavid Payne emailT:+44 (0)20 7383 6532Editorials editorGiselle Jones
Research papers editorsKristina Fister email
Trish Groves email
Elizabeth Loder email
Christopher Martyn email
Alison Tonks email
Primary care editorDomhnall MacAuley email
News editorsAnnabel Ferriman emailT: 44 (0)20 7383 6035
Zosia Kmietowicz email
Features editorsDeborah Cohen emailT: +44 (0)20 7383 6183
Rebecca Coombes emailT: +44 (0)20 7383 6243
Clinical reviews editorKirsten Patrick email
Practice editorMabel Chew email
Analysis editorTessa Richards emailT: +44 (0) 20 7383 61
Letters and obituaries editorSharon Davies emailT:+44 (0)20 7383 6716
Observations and reviews editorTrevor JacksonemailT:+44 (0)20 7383 6677
Roger Robinson editorial registrarHelen MacdonaldemailT: + 44 (0)20 7 874 7022
Senior researcherSara Schroter emailT: +44 (0)20 7383 6744Patient editorPeter Lapsley email
Web teamEditor bmj.comDavid PayneemailAssistant editor, bmj.comBirte Twisselmann emailT: +44 (0)20 7383 6720
Print journal teamMagazine editorTrevor Jacksonemail
DesignerJane Walkeremail
Senior art workerAdam di Chiaraemail
Picture editorVanessa Fletcheremail
Deputy managing editorLucy Banham emailT:+44 (0)20 7383 6365
Technical editorsJackie AnnisemailT:+44 (0)20 7383 6658
Maggie Butler emailT:+44 (0)20 7383 6074
Sally Carter emailT:+44 (0)20 7383 6659
Margaret Cooter emailT:+44 (0)20 7383 6657
Greg Cotton emailT:+44 (0)20 7383 6685
Clare Griffith emailT: +44 (0)20 7383 6051
Richard Hurley emailT: + 44 (0)20 7383 6051
Elizabeth Payne emailT: + 44 (0)20 7383 6449
Karl Sharrock emailT:+44 (0)20 7383 6658
Barbara Squire emailT:+44 (0)20 7383 6658
Julia Thompson emailT:+44 (0)20 7383 6691
Douglas Kamerow email
PA to editor in chiefJulia Burrell emailT:+44 (0)20 7383 6102
Departmental administratorChelsey White emailT:+44 (0)20 7383 6109
Benchpress database managerGary BryanemailT:+44 (0)20 7383 6304
Benchpress administratorSue MinnsemailT:+44 (0)20 7383 6309
Chief production editorJohn MayoremailT:+44 (0)20 7383 6355
Assistant production editorEdwyn MayhewemailT:+44 (0)20 7383 6145
Production editorJett AislabieemailT:+44 (0)20 7874 7014
Malcolm Brown (maternity cover)T:+44 (0)20 7874 7014
IllustratorAnthea WilkieemailT:+44 (0)1737 215143
Copyright administratoremail
Career FocusEdward Davies emailT: + 44 (0) 20 7383 6562
studentBMJJessie [email protected]: +44 (0)20 7874 7016
Visiting editorsJennifer Leaning (USA)Ray Moynihan (USA)Joanne Roberts (USA)Charlie Wilson (USA)
Editorial advisersSteven ReidIan MaconochiePeter LemanNick DunnFrank SullivanPippa OakeshottAziz SheikhLucy ChappellChristopher WhittyScott MurrayJulia Hippisley-CoxJosip CarRobin FoxSue Morgan
Statistical advisersDoug AltmanTim ColeHazel InskipJulie MorrisDeborah AshbyJon Deek
The Lancet Editorial office
“The Apartment” Billy Wilder, Jack Lemnon, 1959
EditorDavid Bevan MBToronto
Photo by Waldo www.flickr.com/photos/waldo4/2178788631/
Manuscripts are messy & confusing
Editorial checklists for authors
RCTs Consort guideline
Checklists for KEY elements of a study that need to be reported in published papers.
Minimal required content
www.equator-network.org
? CONSORT
Enrolment
Allocation
Follow-up
Analysis
Editorial checklists for authors
Guidelines for research reportingConsortPrismaOthers ~ 60 known guidelines
www.equator-network.org
Editorial checklists for authors
www.equator-network.org
Notions Key elements of research that ought to be reported For use by
authors in writing manuscriptsresearchers writing grantsgrant review committeesEDITORS
What can editor’s do to improve quality of what they publish?
• Explicit contract
• Helsinki Declaration
• WAME/ICMJE
• Publisher goals
• Disclosure of contract
• Disclosure of editorial & publisher Conflicts of interest
Publisher/Editor Author/Editor
• Aim for quality
• Publish less
• Author guidelines/instructions
•Use reporting guidelines
•Require authors use them
•Use checklists with submissions
Conflict of Interest -
Conflict of Interest -
Conflict of Interests - Who was responsible for?
•Study
•design
•data collection
•analysis
•write up
•decision to publish
•etc
1109 Canadian clinicaltrials.gov732 investigators11 ideal practices to mitigate fCOI
- control over design- data collection- analysis- interpretation-write up-authorship-decision to publish-etc.
Only 6% of investigators met all ideal practices
Rochon P, et al. - manuscript in review
