We have located links that may give you full text access.
Choosing outcomes for clinical trials: a pragmatic perspective.
Current Opinion in Critical Care 2018 October
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.
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.
Full text links
Related Resources
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app
All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.
By using this service, you agree to our terms of use and privacy policy.
Your Privacy Choices
You can now claim free CME credits for this literature searchClaim now
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app