Laboring Under the Stone : Answers to the January 2015 Annals of Emergency Medicine Journal Club - 24/05/15

Doi : 10.1016/j.annemergmed.2015.02.005

Ryan P. Radecki, MD ^a, Rory Spiegel, MD ^b
^a University of Texas Health Science Center–Houston, Houston, TX
^b Newark Beth Israel Medical Center, Newark, NJ

Section editors: Tyler W. Barrett, MD, MSCI; David L. Schriger, MD, MPH

Plan

Discussion Points

Answer 1

Proposal for Handling Changes in Endpoints in Clinical Trials

Questions to Ask

Documenting the Endpoint Changes

Reporting the Trial Results

Answer 2

Answer 3

Answer 4

Editor’s Note: You are reading the 43rd installment of Annals of Emergency Medicine Journal Club. This Journal Club refers to the article by Smith-Bindman et al published in the September 18, 2014, edition of the New England Medical Journal. Information about journal club can be found at journalclub. Readers should recognize that these are suggested answers. We hope they are accurate; we know that they are not comprehensive. There are many other points that could be made about these questions or about the article in general. Questions are rated “novice,” (

) “intermediate,” (

) and “advanced (

) so that individuals planning a journal club can assign the right question to the right student. The “novice” rating does not imply that a novice should be able to spontaneously answer the question. “Novice” means we expect that someone with little background should be able to do a bit of reading, formulate an answer, and teach the material to others. Intermediate and advanced questions also will likely require some reading and research, and that reading will be sufficiently difficult that some background in clinical epidemiology will be helpful in understanding the reading and concepts. We are interested in receiving feedback about this feature. Please e-mail journalclub@acep.org with your comments.