Impact of Centre Differences on Treatment Effects in Traumatic Brain Injury Trials
Author Information
Author(s): Hester F Lingsma, Bob Roozenbeek, Pablo Perel, Ian Roberts, Andrew I Maas, Ewout W Steyerberg
Primary Institution: Erasmus MC
Hypothesis
Do between-centre differences in outcome influence the estimated treatment effect in randomized controlled trials for traumatic brain injury?
Conclusion
Large between-centre differences in outcome do not necessarily affect the estimated treatment effect in randomized controlled trials.
Supporting Evidence
- The study included 9978 patients from 237 centres.
- Mortality was higher in the treatment group with an odds ratio of 1.22.
- The estimated treatment effect did not substantially change when accounting for between-centre differences.
Takeaway
This study looked at how differences between hospitals affect treatment results for brain injuries. It found that these differences don't change the overall effectiveness of the treatment.
Methodology
Data from the MRC CRASH trial was analyzed using fixed and random effects logistic regression to assess treatment effects and between-centre differences.
Potential Biases
Potential bias due to unaccounted differences in care and patient characteristics across centres.
Limitations
Differences in data quality between centres were not considered, which might affect the estimated treatment effect.
Participant Demographics
Patients from 237 centres in 48 countries, median age 33, with a majority being male (81.3%).
Statistical Information
P-Value
0.00003
Confidence Interval
1.17-1.26
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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