Correction: PAIS: paracetamol (acetaminophen) in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN74418480].
BACKGROUND
The Paracetamol (Acetaminophen) In Stroke (PAIS) study is a phase III multicenter, double blind, randomized, placebo-controlled clinical trial of high-dose acetaminophen in patients with acute stroke. The trial compares treatment with a daily dose of 6 g acetaminophen, started within 12 hours after the onset of symptoms, with matched placebo. The purpose of this study is to assess whether treatment with acetaminophen for 3 days will result in improved functional outcome through a modest reduction in body temperature and prevention of fever.The previously planned statistical analysis based on a dichotomization of the scores on the modified Rankin Scale (mRS) may not make the most efficient use of the available baseline information. Therefore, the planned primary analysis of the PAIS study has been changed from fixed dichotomization of the mRS to a sliding dichotomy analysis.


METHODS
Instead of taking a single definition of good outcome for all patients, the definition is tailored to each individual patient's baseline prognosis on entry into the trial.


CONCLUSIONS
The protocol change was initiated because of both advances in statistical approaches and to increase the efficiency of the trial by improving statistical power.


BACKGROUND
Current Controlled Trials [ISCRTN74418480].
den Hertog
Heleen M
HM
Department of Neurology, Erasmus MC University Medical Center, Rotterdam, The Netherlands. m.denhertog@erasmusmc.nl
van der Worp
H Bart
HB
van Gemert
H Maarten A
HM
Algra
Ale
A
Kappelle
L Jaap
LJ
van Gijn
Jan
J
Koudstaal
Peter J
PJ
Dippel
Diederik W J
DW