Journal editor perspectives Digital Health Learning & Clinical Effectiveness Research Collaboratives Journal editor perspectives Elizabeth Loder, MD, MPH Head of Research, The BMJ Associate Editor, Headache Professor of Neurology, Harvard Medical School Chief, Division of Headache, Department of Neurology Brigham and Women’s Hospital

ICMJE definition of a clinical trial "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.“ Includes process-of-care interventions Err on the side of registration if you wish to seek publication in an ICMJE journal. What about trials that assign providers not patients to intervention and comparison/control groups? http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/

Ideal vs Reality Results from learning health system clinical trials should be: Published rapidly Freely accessible In a single location Presented with additional content Highly visible, publicized, read, and used

Reality High profile journals are selective Value novelty, clinical impact, generalizability and methodological rigor Unlikely to publish all trial outputs Not all are open access Lower profile journals are less selective Less attention to copy-editing, additional content Less visibility and attention

Review and editorial processes for manuscripts describing results from health system based analyses… The same as for other papers! Competing with those other papers (at selective journals)

Considerations Trial registration Prespecified vs post-hoc analyses Reasons for registration apply to all trials Trials are done to test hypotheses not to generate them Prespecified vs post-hoc analyses Is publication in a peer reviewed journal always the goal? If so, piecemeal publication and delays are inevitable Choice of journal must be realistic Alternatives Preprints? Registered reports? Or establish your own journal or agree that a relevant journal will publish trial output as a package