Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Apr;44(4):464-466.
doi: 10.1007/s00134-017-4859-0. Epub 2017 Jun 12.

Should we rely on trials with disease- rather than patient-oriented endpoints?

Harm-Jan de Grooth  1   2 , Jean-Jacques Parienti  3   4 , Heleen M Oudemans-van Straaten  5
Affiliations

Should we rely on trials with disease- rather than patient-oriented endpoints?

Harm-Jan de Grooth et al. Intensive Care Med. 2018 Apr.
No abstract available

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no conflicts of interest.

Figures

Fig. 1
Fig. 1
Primary endpoints of ICU-related randomized controlled trials (RCTs) in five intensive care journals and three high-impact journals. a Among trials with a sample size greater than 200, there is no trend in patient-oriented endpoints, but the prevalence of disease-oriented endpoints is progressively increasing. b Among trials published in high-impact general medical journals, there is no trend in patient-oriented endpoints, but the prevalence of disease-oriented endpoints is progressively increasing. c The boxplot (IQR, range) of reported p values by endpoint category shows that trials with a disease-oriented endpoint report significantly lower median p values and more often report “positive” (p < 0.05) results
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Bucher HC, Guyatt GH, Cook DJ, Evidence-Based Medicine Working Group et al. Users’ guides to the medical literature: XIX. Applying clinical trial results A. How to use an article measuring the effect of an intervention on surrogate end points. JAMA. 1999;282:771–778. doi: 10.1001/jama.282.8.771. - DOI - PubMed
    1. Tibby SM. Does PELOD measure organ dysfunction…and is organ function a valid surrogate for death? Intensive Care Med. 2010;36:4–7. doi: 10.1007/s00134-009-1712-0. - DOI - PMC - PubMed
    1. Kellum JA, Zarbock A, Nadim MK. What endpoints should be used for clinical studies in acute kidney injury? Intensive Care Med. 2017 - PubMed
    1. Fleming TR, DeMets DL. Surrogate end points in clinical trials: are we being misled? Ann Intern Med. 1996;125:605–613. doi: 10.7326/0003-4819-125-7-199610010-00011. - DOI - PubMed
    1. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (1998) ICH harmonized tripartite guideline: statistical principles for clinical trials E9

LinkOut - more resources