1. 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

2. 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?

3. 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

4. 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

5. 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)

6. 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