Why we should be wary of single-center trials

Bellomo, Rinaldo, Warrillow, Stephen J. and Reade, Michael C. (2009) Why we should be wary of single-center trials. Critical Care Medicine, 37 12: 3114-3119. doi:10.1097/CCM.0b013e3181bc7bd5

Author Bellomo, Rinaldo
Warrillow, Stephen J.
Reade, Michael C.
Title Why we should be wary of single-center trials
Journal name Critical Care Medicine   Check publisher's open access policy
ISSN 0090-3493
Publication date 2009-12-01
Sub-type Critical review of research, literature review, critical commentary
DOI 10.1097/CCM.0b013e3181bc7bd5
Open Access Status Not yet assessed
Volume 37
Issue 12
Start page 3114
End page 3119
Total pages 6
Place of publication Philadelphia, PA, United States
Publisher Lippincott Williams & Wilkins
Language eng
Formatted abstract
Objective: To highlight the limitations of single-center trials in critical care, using prominent examples from the recent literature; to explore possible reasons for discrepancies between these studies and subsequent multicenter effectiveness trials; and to suggest how the evidence from single-center trials might be used more appropriately in clinical practice.

Study Selection: Topical and illustrative examples of the concepts discussed including trials of patient positioning, the use of steroids for acute respiratory distress syndrome, the dose of hemofiltration, the control of glycemia, and the targets of resuscitation in sepsis.

Data Synopsis: Many positive single-center trials have been contradicted when tested in other settings and, in one case, the subsequent definitive multicentered trial has found a previously recommended intervention associated with active harm. Problems inherent in the nature of single-center studies make recommendations based on their results ill advised. Single-center studies frequently either lack the scientific rigor or external validity required to support widespread changes in practice, and their premature incorporation into guidelines may make the conduct of definitive studies more difficult.

Conclusions: We recommend that practice guidelines should rarely, if ever, be based on evidence from single-center trials. Physicians should apply the findings of single-center trials only after careful evaluation of their methodology, and in particular after comparing the context of the trial with their own situation.
Keyword Clinical trial
Clinical trials
Hawthorne effect
Intensive care
Phase II
Population characteristics
Practice guideline
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Critical review of research, literature review, critical commentary
Collection: School of Medicine Publications
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Citation counts: TR Web of Science Citation Count  Cited 86 times in Thomson Reuters Web of Science Article | Citations
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