Mischief, Malfeasance and Incompetence:

The editor’s enemies

John HoeyCOPE Seminar 2009

Londonjohnhoeymd@gmail.com

slideshare

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 when needed.

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 when needed.

Maintaining the Integrity of the Scientific Record.......why?

• Ethics - Nuremburg Trials - Helsinki Decl.

• Harm to patients and the public

• Physical harm

• Financial harm

Ethical Basis• Nuremberg -

Helsinki

• research funding orgs

• ICMJE

• WAME

• COPE

Ethical Basis• Nuremberg -

Helsinki

• research funding orgs

• ICMJE

• WAME

• COPE

“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.”

Small JournalsEnsure Quality/Integrity?

• Relationships with journal owners

• Threats to quality/integrity from authors

Research Sponsors/advertisers

Journal Owners

Authors

Readers

Research Sponsors/advertisers

Journal Owners

Authors

Readers

Ideologicalpoliticalself-interest....

Research Sponsors/advertisers

Journal Owners

Authors

Readers

$£

Research Sponsors/advertisers

Journal Owners

Authors

Readers

Research Sponsors/advertisers

Journal Owners

Authors

Readers

Research Sponsors/advertisers

Journal Owners

Authors

Readers

Research Sponsors/advertisers

Journal Owners

Authors

Readers

Research Sponsors/advertisers

Journal Owners

Authors

Readers

Research Sponsors/advertisers

Journal Owners

Authors

Readers

$ Journal Owners

Revenue - Expenses = Break Even or Profit Targets

$ Journal Owners

Revenue -subscriptions -advertising (requires readers) -author charges -reprints -supplements -special issuesetc.

Revenue - Expenses = Break Even or Profit Targets

$ Journal Owners

Revenue -subscriptions -advertising (requires readers) -author charges -reprints -supplements -special issuesetc.

Expenses -editorial salary costs -technical editing -distribution

Revenue - Expenses = Break Even or Profit Targets

• Explicit contract

• Helsinki Declaration

• WAME/ICMJE

• Publisher goals

• Disclosure of contract

• Disclosure of editorial & publisher Conflicts of interest

Publisher/EditorBusiness needs compromise editorial standards

Collaborative Open Source Software (Open Journal Systems - OJS)No author chargesNo pharmaceutical advertsing

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 when needed.

$$ Conflict

of Interest

Incompetence/Carelessness

Quality threats

Soliciting papersPeer reviewEditorial decisionsEditing

SubstantiveTechnical

On-line and print layoutEtc. Etc. Etc...

What does an Editor do?

Photo by CAM MAN www.flickr.com/people/pcasey/

BMJ Editorial Staff

Editor in chiefFiona GodleeemailT: + 44(0)20 7383 6102

Deputy editorsJane SmithemailT:+44 (0)20 7383 6009

Tony DelamotheemailT: +44 (0) 20 7383 6006

Trish GrovesemailT:+44 (0)20 7383 6018

Magazine editorTrevor Jackson emailT:+44 (0)20 7383 6677

bmj.com editorDavid Payne emailT:+44 (0)20 7383 6532

Editorials 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 6744

Patient editorPeter Lapsley email

Web teamEditor bmj.comDavid Payneemail

Assistant 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 Colquhounstudenteditor@bmj.comT: +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

EDITOR-in-CHIEFM.H Bagheri, MDDEPUTY EDITORB Astaneh, MD

EDITORIAL BOARD B Aarabi, MD M Razeghinejad, MD  M.A Aboulghar, MD 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

EditorDavid Bevan MBToronto

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

Reporting Bias

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.

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

• Ghost writing Dickersin

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

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

48 trials1402 outcomes

31% - 59% incompletely reported(40% not reported at all)

Chan, A.-W. et al. CMAJ 2004;171:735-740

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

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

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,

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.

images from Wikipedia

Neurontin(gabapentin)

P Wessely, C Baumgartner, D Klinger, J Kreczi, N … - Cephalalgia, 1987

Bias ExamplePublication 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

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

So what?

http://dida.library.ucsf.edu/pdf/oxx18r10

“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.

In total, I find that there were 43 million 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

Editorial strategies?

Soliciting papersPeer reviewEditorial decisionsEditing

SubstantiveTechnical

On-line and print layoutEtc. Etc. Etc...

Science is complex

• Author checklists

• Financial conflicts of interest

• Study design and reporting requirements

Conflict of Interests - Is disclosure enough?

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.

6% of investigators met all ideal practices

Rochon P, et al. - submitted

Rochon P., et al - submitted recently

Financial Conflict of Interest Checklist

Rochon P., et al - submitted recently

Financial Conflict of Interest Checklist

Reporting GuidelinesConsort - RCTsQuorum - Systematic reviewsMoose - Meta-analysesStard - Diagnositic testsGrade - Clinical guidelinesStrobe - Observational studies

etc. (~160)www.equator-network.org

• 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

Mass. Medical SocietyNew Engl J Medicine

Croatian Medical SchoolsCroatian Medical Journal

American Medical AssociationJAMA

American College of Physicians(Annals Intern Med

Thank you