Meta-analysis of the placebo-treated groups in clinical trials of progressive MS
The behavior of the control groups can substantially affect the power and outcome of a clinical trial.We report a meta-analysis of the control groups of four large, double-blind, placebo-controlled clinical trials of immunosuppressive treatment of progressive MS to address the sensitivity of five hy...
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| Veröffentlicht in: | Neurology 1996-06, Vol.46 (6), p.1613-1619 |
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| container_title | Neurology |
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| creator | Weinshenker, Brian G Issa, Maher Baskerville, Jon |
| description | The behavior of the control groups can substantially affect the power and outcome of a clinical trial.We report a meta-analysis of the control groups of four large, double-blind, placebo-controlled clinical trials of immunosuppressive treatment of progressive MS to address the sensitivity of five hypothetical definitions of treatment failure (TF). The rate of TF in the aggregate control groups (n = 427) was 31% when a confirmed increase of 1.0 expanded disability status scale (EDSS) point was required at the end of the trial; it was 51% when confirmation was not required and TF was allowed at the first point where the criteria for TF were met. The rate of confirmed TF was 45% when the TF criteria were indexed to baseline EDSS, accounting for the observed differences in staying times at different EDSS levels. We developed models predicting TF in progressive MS. In addition to baseline EDSS, the pyramidal functional score and, for one definition, brainstem functional score were associated with probability of TF.
NEUROLOGY 1996;461613-1619 |
| doi_str_mv | 10.1212/WNL.46.6.1613 |
| format | Article |
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NEUROLOGY 1996;461613-1619</description><subject>Autoimmune Diseases - drug therapy</subject><subject>Autoimmune Diseases - epidemiology</subject><subject>Autoimmune Diseases - therapy</subject><subject>Azathioprine - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Brain Stem - physiopathology</subject><subject>Clinical Trials, Phase III as Topic</subject><subject>Cyclosporine - therapeutic use</subject><subject>Disease Progression</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Humans</subject><subject>Immunosuppressive Agents - therapeutic use</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Methylprednisolone - therapeutic use</subject><subject>Multiple Sclerosis - drug therapy</subject><subject>Multiple Sclerosis - epidemiology</subject><subject>Multiple Sclerosis - therapy</subject><subject>Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis</subject><subject>Neurology</subject><subject>Placebos</subject><subject>Plasma Exchange</subject><subject>Pyramidal Tracts - physiopathology</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Severity of Illness Index</subject><subject>Treatment Failure</subject><issn>0028-3878</issn><issn>1526-632X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1996</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo9kE1r3DAQhkVoSTcfxxwDPpTctNWXZfkYQtMGNm0gKe1NjOVRVo3W3kp2Q_59le4SgRDD-2iGeQg542zJBReffn5bLZVe6iXXXB6QBa-FplqKX-_IgjFhqDSN-UCOcv7NWAmb9pAcGq3aum4X5O4WJ6AwQHzJIVejr6Y1VtsIDruRTglhwr56TOO8zVUYKhfDEBzEakoB4v8P2zQ-Jsw5_MXq9v6EvPclwNP9e0x-XH9-uPpKV9-_3FxdrqiTWkhqwPfMM8VBQ--9FBJqidBD30nXN7pXqmlRcjSd60D5jqNwTncNOgO6bHpMLnZ9y_g_M-bJbkJ2GCMMOM7ZNoYZrhtWQLoDXRpzTujtNoUNpBfLmX01aItBq7TV9tVg4c_3jedug_0bvVdW8o_7HHIR4RMMLuQ3THJec6YKpnbY8xgnTPkpzs-Y7BohTmvLytGcK8rbVjNdKlqukPIfvMeJng</recordid><startdate>199606</startdate><enddate>199606</enddate><creator>Weinshenker, Brian G</creator><creator>Issa, Maher</creator><creator>Baskerville, Jon</creator><general>American Academy of Neurology</general><general>Lippincott Williams & Wilkins</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>199606</creationdate><title>Meta-analysis of the placebo-treated groups in clinical trials of progressive MS</title><author>Weinshenker, Brian G ; Issa, Maher ; Baskerville, Jon</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3623-8afd0f041a6adff323a53eadadb3cd76d4479e31e8bcba4fb1e2cc6b7ec8a6613</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1996</creationdate><topic>Autoimmune Diseases - drug therapy</topic><topic>Autoimmune Diseases - epidemiology</topic><topic>Autoimmune Diseases - therapy</topic><topic>Azathioprine - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Brain Stem - physiopathology</topic><topic>Clinical Trials, Phase III as Topic</topic><topic>Cyclosporine - therapeutic use</topic><topic>Disease Progression</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Humans</topic><topic>Immunosuppressive Agents - therapeutic use</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Methylprednisolone - therapeutic use</topic><topic>Multiple Sclerosis - drug therapy</topic><topic>Multiple Sclerosis - epidemiology</topic><topic>Multiple Sclerosis - therapy</topic><topic>Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis</topic><topic>Neurology</topic><topic>Placebos</topic><topic>Plasma Exchange</topic><topic>Pyramidal Tracts - physiopathology</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Severity of Illness Index</topic><topic>Treatment Failure</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Weinshenker, Brian G</creatorcontrib><creatorcontrib>Issa, Maher</creatorcontrib><creatorcontrib>Baskerville, Jon</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Neurology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Weinshenker, Brian G</au><au>Issa, Maher</au><au>Baskerville, Jon</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Meta-analysis of the placebo-treated groups in clinical trials of progressive MS</atitle><jtitle>Neurology</jtitle><addtitle>Neurology</addtitle><date>1996-06</date><risdate>1996</risdate><volume>46</volume><issue>6</issue><spage>1613</spage><epage>1619</epage><pages>1613-1619</pages><issn>0028-3878</issn><eissn>1526-632X</eissn><coden>NEURAI</coden><abstract>The behavior of the control groups can substantially affect the power and outcome of a clinical trial.We report a meta-analysis of the control groups of four large, double-blind, placebo-controlled clinical trials of immunosuppressive treatment of progressive MS to address the sensitivity of five hypothetical definitions of treatment failure (TF). The rate of TF in the aggregate control groups (n = 427) was 31% when a confirmed increase of 1.0 expanded disability status scale (EDSS) point was required at the end of the trial; it was 51% when confirmation was not required and TF was allowed at the first point where the criteria for TF were met. The rate of confirmed TF was 45% when the TF criteria were indexed to baseline EDSS, accounting for the observed differences in staying times at different EDSS levels. We developed models predicting TF in progressive MS. In addition to baseline EDSS, the pyramidal functional score and, for one definition, brainstem functional score were associated with probability of TF.
NEUROLOGY 1996;461613-1619</abstract><cop>Hagerstown, MD</cop><pub>American Academy of Neurology</pub><pmid>8649559</pmid><doi>10.1212/WNL.46.6.1613</doi><tpages>7</tpages></addata></record> |
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| ispartof | Neurology, 1996-06, Vol.46 (6), p.1613-1619 |
| issn | 0028-3878 1526-632X |
| language | eng |
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| source | MEDLINE; Journals@Ovid Complete |
| subjects | Autoimmune Diseases - drug therapy Autoimmune Diseases - epidemiology Autoimmune Diseases - therapy Azathioprine - therapeutic use Biological and medical sciences Brain Stem - physiopathology Clinical Trials, Phase III as Topic Cyclosporine - therapeutic use Disease Progression Double-Blind Method Female Humans Immunosuppressive Agents - therapeutic use Male Medical sciences Methylprednisolone - therapeutic use Multiple Sclerosis - drug therapy Multiple Sclerosis - epidemiology Multiple Sclerosis - therapy Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis Neurology Placebos Plasma Exchange Pyramidal Tracts - physiopathology Randomized Controlled Trials as Topic Severity of Illness Index Treatment Failure |
| title | Meta-analysis of the placebo-treated groups in clinical trials of progressive MS |
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