Correction: PAIS: paracetamol (acetaminophen) in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN74418480]
<p>Abstract</p> <p>Background</p> <p>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 wit...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2008-11-01
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| Series: | BMC Cardiovascular Disorders |
| Online Access: | http://www.biomedcentral.com/1471-2261/8/29 |
| _version_ | 1818146336812302336 |
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| author | Kappelle L Jaap Algra Ale van Gemert H Maarten A Worp H Bart den Hertog Heleen M van Gijn Jan Koudstaal Peter J Dippel Diederik WJ |
| author_facet | Kappelle L Jaap Algra Ale van Gemert H Maarten A Worp H Bart den Hertog Heleen M van Gijn Jan Koudstaal Peter J Dippel Diederik WJ |
| author_sort | Kappelle L Jaap |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>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.</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Conclusion</p> <p>The protocol change was initiated because of both advances in statistical approaches and to increase the efficiency of the trial by improving statistical power.</p> <p>Trial Registration</p> <p>Current Controlled Trials [ISCRTN74418480]</p> |
| first_indexed | 2024-12-11T12:17:44Z |
| format | Article |
| id | doaj.art-12a58e4aee1c4a85a5d93f20e57eec2f |
| institution | Directory Open Access Journal |
| issn | 1471-2261 |
| language | English |
| last_indexed | 2024-12-11T12:17:44Z |
| publishDate | 2008-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cardiovascular Disorders |
| spelling | doaj.art-12a58e4aee1c4a85a5d93f20e57eec2f2022-12-22T01:07:37ZengBMCBMC Cardiovascular Disorders1471-22612008-11-01812910.1186/1471-2261-8-29Correction: PAIS: paracetamol (acetaminophen) in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN74418480]Kappelle L JaapAlgra Alevan Gemert H Maarten AWorp H Bartden Hertog Heleen Mvan Gijn JanKoudstaal Peter JDippel Diederik WJ<p>Abstract</p> <p>Background</p> <p>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.</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Conclusion</p> <p>The protocol change was initiated because of both advances in statistical approaches and to increase the efficiency of the trial by improving statistical power.</p> <p>Trial Registration</p> <p>Current Controlled Trials [ISCRTN74418480]</p>http://www.biomedcentral.com/1471-2261/8/29 |
| spellingShingle | Kappelle L Jaap Algra Ale van Gemert H Maarten A Worp H Bart den Hertog Heleen M van Gijn Jan Koudstaal Peter J Dippel Diederik WJ Correction: PAIS: paracetamol (acetaminophen) in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN74418480] BMC Cardiovascular Disorders |
| title | Correction: PAIS: paracetamol (acetaminophen) in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN74418480] |
| title_full | Correction: PAIS: paracetamol (acetaminophen) in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN74418480] |
| title_fullStr | Correction: PAIS: paracetamol (acetaminophen) in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN74418480] |
| title_full_unstemmed | Correction: PAIS: paracetamol (acetaminophen) in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN74418480] |
| title_short | Correction: PAIS: paracetamol (acetaminophen) in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN74418480] |
| title_sort | correction pais paracetamol acetaminophen in stroke protocol for a randomized double blind clinical trial iscrtn74418480 |
| url | http://www.biomedcentral.com/1471-2261/8/29 |
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