ISSUES RELATED TO PUBLICATION OF health system-based investigations sSD Fihn MD MPH Stephan D Fihn MD MPH Professor of Medicine and Health Services University of Washington Deputy Editor, JAMA Network Open

What Journal Editors (Really) Want “Hot” or innovative topics relevant to readership For general journals this includes effectiveness studies High likelihood of citation Strong methodology Clear and concise writing Adherence to reporting guidelines, e.g, CONSORT, STROBE, PRISMA, SQUIRE, etc. (http://www.equator-network.org/) Measured interpretation of results

Increasing attention to lay press & social media

Methodologic Issues Registration Statistical testing Premier journals will not consider unregistered trials Predefined analyses Concerns about “data-dredging” Statistical testing “p values” as “significant” increasingly controversial. Also need to consider: Sample size Clinical significance Effect size

Other Issues Other Statistical issues Evolving study designs Multiple comparisons Unit of analysis: Pts. vs. sites Hierarchical clustering Evolving study designs Adaptive/pragmatic designs Adaptive randomization Generalizability Single vs. multiple site Reproducibility Avoiding unsupported causal inference Open Access