Talk to the Veterans Crisis Line now
U.S. flag
An official website of the United States government

VA Health Systems Research

Go to the VA ORD website
Go to the QUERI website

HSR Citation Abstract

Search | Search by Center | Search by Source | Keywords in Title

Choosing outcomes for clinical trials: a pragmatic perspective.

Iwashyna TJ, McPeake J. Choosing outcomes for clinical trials: a pragmatic perspective. Current opinion in critical care. 2018 Oct 1; 24(5):428-433.

Dimensions for VA is a web-based tool available to VA staff that enables detailed searches of published research and research projects.

If you have VA-Intranet access, click here for more information

VA staff not currently on the VA network can access Dimensions by registering for an account using their VA email address.
   Search Dimensions for VA for this citation
* Don't have VA-internal network access or a VA email address? Try searching the free-to-the-public version of Dimensions


PURPOSE OF REVIEW: The turn to evidence-based medicine in critical care has lead to a dramatic increase in the number of randomized clinical trials. Yet many of these trials are not showing differences on an appropriately prespecified primary outcome. In light of this, there have been some heated arguments as to what sorts of clinical trials should be conducted. We synthesize pragmatic recommendations from two governing bases: rigorous statistical practice and a commitment to insuring trials provide information that should help guide patient-centered decision-making. RECENT FINDINGS: We suggest six principles for the selection of an randomized clinical trial primary outcome: (1) your intervention should plausibly change your primary outcome. (2) The primary outcome should be cared about by your audience. (3) The primary outcome should be relevant to patients. (4) The primary outcome should be measured efficiently. (5) The primary outcome should be measured reliably. (6) When possible, use a well understood continuous scale. In addition, principles for selecting secondary outcomes are described. SUMMARY: It may be of value, when proposing a trial, to present preliminary evidence documenting the extent to which a proposed primary outcome actually accords each of these principles.

Questions about the HSR website? Email the Web Team

Any health information on this website is strictly for informational purposes and is not intended as medical advice. It should not be used to diagnose or treat any condition.