How does the process work?

Submissions in 2007 (n=13,043) Perspectives

Editor in Chief & Executive Editor Deputy Editors Associate Editors

Editor-in-chief Associate/ Deputy Editor Peer Review Editorial Meeting Statistical Review Initial Decision Initial Submission

Editor-in-chief Associate/ Deputy Editor Peer Review Editorial Meeting Statistical Review Initial Decision Initial Submission

Editor-in-chief Associate/ Deputy Editor Peer Review Editorial Meeting Statistical Review Initial Decision Initial Submission

Editors ask Peer Reviewers if the work is…. High Quality Novel Ethical

High Quality Clinical Trials Journals want the published research to be right. Findings from well designed and executed studies are more likely to be valid Strongest evidence for cause and effect = Double Blind Randomized Controlled Trial

High Quality Clinical Trials Randomization Appropriate control group Research subjects and investigators blinded to treatment assignment

High Quality All patients screened and randomized are accounted for Few patients lost to follow-up

High Quality - Analyses Primary and secondary outcomes pre- specified and clearly defined Data analyzed according to pre-specified plan Intention To Treat – data analyzed according to patients’ original treatment assignment Secondary and post-hoc analyses distinguished from primary analyses

High Quality Sample size large enough to provide sufficient power to answer research question

Negative Trials We ARE interested in negative trials! Negative trials are of interest when: –Negative findings have important implications for practice or direction of future research –Large enough to provide definitive answer to question framed

Uninformative Negative Study RCT of 20 patients Primary Outcome P value Treatment A30%0.10 Treatment B50% Too small: clinically important benefit not ruled out

N Engl J Med Volume 354;21: May 25, 2006 Informative Negative Study

Study Overview In this randomized, controlled trial, there was no significant difference in 60-day mortality whether monitoring was performed with a pulmonary-artery catheter or a central venous catheter

High Quality Complete and accurate reporting of adverse events Statements such as the drug was “generally well tolerated” are not informative (and often not accurate) Acknowledge when larger and longer studies are required to fully assess safety

Novelty Study breaks new ground, defines new treatments or resolves major controversies

Ethical Clinical Trials Adequate informed consent obtained Protocol approved by an IRB Risks to research subjects minimized and reasonable

Editors use the Reviews Once reviews are in the editor reads the paper and the reviews The editor, not the reviewer, makes the decision about the paper We value the reviewers’ comments, but they are only consultants to our thinking process

Associate Editor makes a decision Full consideration? –Manuscript is presented to all the editors Minimal consideration? –Manuscript is on the agenda but discussion is minimal

Editor-in-chief Associate/ Deputy Editor Peer Review Editorial Meeting Statistical Review Initial Decision Initial Submission

The Editors Meet

Editor-in-chief Associate/ Deputy Editor Peer Review Editorial Meeting Statistical Review Initial Decision Initial Submission About 20% of papers fail at this step

Possible Decisions Initial Reject 52% Reject After Peer Review 42% We’re very interested 0.5% Needs additional Experiments-0.5% We’re interested 5%

Three Major Reasons for Rejection Quality – the science is flawed Novelty – the science is good, but has previously been published or does not advance the field Specialty – it’s good, but not of general interest and belongs in a specialty journal

Editor-in-chief Associate/ Deputy Editor Peer Review Editorial Meeting Statistical Review Initial Decision Initial Submission Associate Editor Peer Review Editorial Meeting Final Decision Revision Submitted

Revision Process The Journal (In House Editors) The Author

Articles Published 2007 Original Research n= % Letters n= % Review Articles n= % Images n=97 3.3% Other Articles n= % Editorials n=130 92% Perspectives n= %

Data from the Science Citation Index Impact Factor Impact Factor: The number of citations of a journal’s articles from the previous two years divided by the number of articles published during those same two years. Impact Factor Source: Institute for Scientific Information, Journal Citation Reports, 2008.

Data from the Science Citation Index Immediacy Index Immediacy Index: The number of citations of a journal’s articles from the current year divided by number of articles published during that same year. Immediacy Index Source: Institute for Scientific Information, Journal Citation Reports, 2008.

Trial Registration