1. Journal Editor Perspectives
Digital Health Learning & Clinical Effectiveness Research Collaboratives
Journal Editor Perspectives
May 22, 2019
Joseph S. Ross, MD, MHS
Section of General Internal Medicine, School of Medicine
Center for Outcomes Research and Evaluation, Yale-New Haven Hospital
Associate Editor, JAMA Internal Medicine
Former Deputy Editor, Journal of General Internal Medicine

2. Source: Grady, Redberg and O’Malley JAMA Internal Medicine 2018;178:187.

3. Observational Research Studies
Studies using data from clinical registries, administrative claims, electronic health records
Increasingly, medical product evaluations …
… but also quality improvement studies, health system innovations, policy evaluations, and more.
Source: Corrigan-Curay et. al., JAMA 2018;320: Califf et. al., NEJM 2016;375:

4. Special Considerations
Generalizability: Single system vs. multiple systems
What can be learned from single system evaluations?
Intervention and Control Groups: How defined?
Accounting for non-random treatment allocation
Effectiveness and Safety Endpoints: How ascertained?
Codes accurate and clinically meaningful?
Over what period of follow-up?
Negative “control” endpoint?
Study protocol / registration?
Public pre-specification of data source; inclusion/exclusion criteria; primary, secondary and safety endpoints; and statistical analysis plan.