Understanding the importance of the primary trial hypothesis: The randomized trial on the timing of ruptured aneurysm surgery

L. Olijnyk, T. E. Darsaut, J. Öhman, J. Raymond

Forskningsoutput: TidskriftsbidragArtikelVetenskapligPeer review

Sammanfattning

Background and purpose: The primary hypothesis of a trial must be explicitly formulated. The primary hypothesis is essential for the proper interpretation of trial results. Methods: We review the seminal Finnish randomized trial on the timing of aneurysm surgery, and re-examine how trial results could have been interpreted at the time had a precise primary hypothesis been pre-specified. Finally, we compare the power of this single center randomized trial with the multicenter International Cooperative (observational) Study that examined the same clinical problem. Results: Had the Finnish authors worked under a pragmatic hypothesis in favor of early surgery (within 3 days) versus delayed surgery, the trial results could have been interpreted as conclusive. The randomized trial was more appropriate, more ethical, and more efficient than the inconclusive International Cooperative study. Conclusion: The randomized trial on the timing of aneurysm surgery was a landmark in neurovascular research. A precise pragmatic primary hypothesis is a crucial step in trial design and interpretation.

Originalspråkengelska
TidskriftNeurochirurgie
Volym68
Nummer5
Sidor (från-till)474-477
Antal sidor4
ISSN0028-3770
DOI
StatusPublicerad - okt. 2022
MoE-publikationstypA1 Tidskriftsartikel-refererad

Bibliografisk information

Publisher Copyright:
© 2022 Elsevier Masson SAS

Vetenskapsgrenar

  • 3112 Neurovetenskaper
  • 3124 Neurologi och psykiatri
  • 3126 Kirurgi, anestesiologi, intensivvård, radiologi

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