A tutorial on sensitivity analyses in clinical trials: the what, why, when and how
Identifieur interne : 001504 ( Ncbi/Curation ); précédent : 001503; suivant : 001505A tutorial on sensitivity analyses in clinical trials: the what, why, when and how
Auteurs : Lehana Thabane [Canada] ; Lawrence Mbuagbaw [Canada] ; Shiyuan Zhang [Canada] ; Zainab Samaan [Canada] ; Maura Marcucci [Canada] ; Chenglin Ye [Canada] ; Marroon Thabane [Canada] ; Lora Giangregorio [Canada] ; Brittany Dennis [Canada] ; Daisy Kosa [Canada] ; Victoria Borg Debono [Canada] ; Rejane Dillenburg [Canada] ; Vincent Fruci [Canada] ; Monica Bawor [Canada] ; Juneyoung Lee [Corée du Sud] ; George Wells [Canada] ; Charles H. Goldsmith [Canada]Source :
- BMC Medical Research Methodology [ 1471-2288 ] ; 2013.
Abstract
Sensitivity analyses play a crucial role in assessing the robustness of the findings or conclusions based on primary analyses of data in clinical trials. They are a critical way to assess the impact, effect or influence of key assumptions or variations—such as different methods of analysis, definitions of outcomes, protocol deviations, missing data, and outliers—on the overall conclusions of a study.
The current paper is the second in a series of tutorial-type manuscripts intended to discuss and clarify aspects related to key methodological issues in the design and analysis of clinical trials.
In this paper we will provide a detailed exploration of the key aspects of sensitivity analyses including: 1) what sensitivity analyses are, why they are needed, and how often they are used in practice; 2) the different types of sensitivity analyses that one can do, with examples from the literature; 3) some frequently asked questions about sensitivity analyses; and 4) some suggestions on how to report the results of sensitivity analyses in clinical trials.
When reporting on a clinical trial, we recommend including planned or
Url:
DOI: 10.1186/1471-2288-13-92
PubMed: 23855337
PubMed Central: 3720188
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<author><name sortKey="Samaan, Zainab" sort="Samaan, Zainab" uniqKey="Samaan Z" first="Zainab" last="Samaan">Zainab Samaan</name>
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<country xml:lang="fr">Canada</country>
<wicri:regionArea>Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON</wicri:regionArea>
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<affiliation wicri:level="4"><nlm:aff id="I6">Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, ON, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, ON</wicri:regionArea>
<orgName type="university">Université McMaster</orgName>
<placeName><settlement type="city">Hamilton (Ontario)</settlement>
<region type="state">Ontario</region>
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<affiliation wicri:level="4"><nlm:aff id="I7">Population Genomics Program, McMaster University, Hamilton, ON, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Population Genomics Program, McMaster University, Hamilton, ON</wicri:regionArea>
<orgName type="university">Université McMaster</orgName>
<placeName><settlement type="city">Hamilton (Ontario)</settlement>
<region type="state">Ontario</region>
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<author><name sortKey="Marcucci, Maura" sort="Marcucci, Maura" uniqKey="Marcucci M" first="Maura" last="Marcucci">Maura Marcucci</name>
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<country xml:lang="fr">Canada</country>
<wicri:regionArea>Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON</wicri:regionArea>
<orgName type="university">Université McMaster</orgName>
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<region type="state">Ontario</region>
</placeName>
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<author><name sortKey="Ye, Chenglin" sort="Ye, Chenglin" uniqKey="Ye C" first="Chenglin" last="Ye">Chenglin Ye</name>
<affiliation wicri:level="4"><nlm:aff id="I1">Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON</wicri:regionArea>
<orgName type="university">Université McMaster</orgName>
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<region type="state">Ontario</region>
</placeName>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="I4">Biostatistics Unit, Father Sean O’Sullivan Research Center, St Joseph’s Healthcare Hamilton, Hamilton, ON, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
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<wicri:noRegion>ON</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Thabane, Marroon" sort="Thabane, Marroon" uniqKey="Thabane M" first="Marroon" last="Thabane">Marroon Thabane</name>
<affiliation wicri:level="4"><nlm:aff id="I1">Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON</wicri:regionArea>
<orgName type="university">Université McMaster</orgName>
<placeName><settlement type="city">Hamilton (Ontario)</settlement>
<region type="state">Ontario</region>
</placeName>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="I8">GSK, Mississauga, ON, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>GSK, Mississauga, ON</wicri:regionArea>
<wicri:noRegion>ON</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Giangregorio, Lora" sort="Giangregorio, Lora" uniqKey="Giangregorio L" first="Lora" last="Giangregorio">Lora Giangregorio</name>
<affiliation wicri:level="1"><nlm:aff id="I9">Department of Kinesiology, University of Waterloo, Waterloo, ON, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Department of Kinesiology, University of Waterloo, Waterloo, ON</wicri:regionArea>
<wicri:noRegion>ON</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Dennis, Brittany" sort="Dennis, Brittany" uniqKey="Dennis B" first="Brittany" last="Dennis">Brittany Dennis</name>
<affiliation wicri:level="4"><nlm:aff id="I1">Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON</wicri:regionArea>
<orgName type="university">Université McMaster</orgName>
<placeName><settlement type="city">Hamilton (Ontario)</settlement>
<region type="state">Ontario</region>
</placeName>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="I4">Biostatistics Unit, Father Sean O’Sullivan Research Center, St Joseph’s Healthcare Hamilton, Hamilton, ON, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Biostatistics Unit, Father Sean O’Sullivan Research Center, St Joseph’s Healthcare Hamilton, Hamilton, ON</wicri:regionArea>
<wicri:noRegion>ON</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Kosa, Daisy" sort="Kosa, Daisy" uniqKey="Kosa D" first="Daisy" last="Kosa">Daisy Kosa</name>
<affiliation wicri:level="4"><nlm:aff id="I1">Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON</wicri:regionArea>
<orgName type="university">Université McMaster</orgName>
<placeName><settlement type="city">Hamilton (Ontario)</settlement>
<region type="state">Ontario</region>
</placeName>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="I4">Biostatistics Unit, Father Sean O’Sullivan Research Center, St Joseph’s Healthcare Hamilton, Hamilton, ON, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Biostatistics Unit, Father Sean O’Sullivan Research Center, St Joseph’s Healthcare Hamilton, Hamilton, ON</wicri:regionArea>
<wicri:noRegion>ON</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="I10">Department of Nephrology, Toronto General Hospital, Toronto, ON, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Department of Nephrology, Toronto General Hospital, Toronto, ON</wicri:regionArea>
<wicri:noRegion>ON</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Debono, Victoria Borg" sort="Debono, Victoria Borg" uniqKey="Debono V" first="Victoria Borg" last="Debono">Victoria Borg Debono</name>
<affiliation wicri:level="4"><nlm:aff id="I1">Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON</wicri:regionArea>
<orgName type="university">Université McMaster</orgName>
<placeName><settlement type="city">Hamilton (Ontario)</settlement>
<region type="state">Ontario</region>
</placeName>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="I4">Biostatistics Unit, Father Sean O’Sullivan Research Center, St Joseph’s Healthcare Hamilton, Hamilton, ON, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Biostatistics Unit, Father Sean O’Sullivan Research Center, St Joseph’s Healthcare Hamilton, Hamilton, ON</wicri:regionArea>
<wicri:noRegion>ON</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Dillenburg, Rejane" sort="Dillenburg, Rejane" uniqKey="Dillenburg R" first="Rejane" last="Dillenburg">Rejane Dillenburg</name>
<affiliation wicri:level="4"><nlm:aff id="I11">Department of Pediatrics, McMaster University, Hamilton, ON, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Department of Pediatrics, McMaster University, Hamilton, ON</wicri:regionArea>
<orgName type="university">Université McMaster</orgName>
<placeName><settlement type="city">Hamilton (Ontario)</settlement>
<region type="state">Ontario</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Fruci, Vincent" sort="Fruci, Vincent" uniqKey="Fruci V" first="Vincent" last="Fruci">Vincent Fruci</name>
<affiliation wicri:level="4"><nlm:aff id="I12">Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON</wicri:regionArea>
<orgName type="university">Université McMaster</orgName>
<placeName><settlement type="city">Hamilton (Ontario)</settlement>
<region type="state">Ontario</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Bawor, Monica" sort="Bawor, Monica" uniqKey="Bawor M" first="Monica" last="Bawor">Monica Bawor</name>
<affiliation wicri:level="4"><nlm:aff id="I13">McMaster Integrative Neuroscience Discovery & Study (MiNDS) Program, McMaster University, Hamilton, ON, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>McMaster Integrative Neuroscience Discovery & Study (MiNDS) Program, McMaster University, Hamilton, ON</wicri:regionArea>
<orgName type="university">Université McMaster</orgName>
<placeName><settlement type="city">Hamilton (Ontario)</settlement>
<region type="state">Ontario</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Lee, Juneyoung" sort="Lee, Juneyoung" uniqKey="Lee J" first="Juneyoung" last="Lee">Juneyoung Lee</name>
<affiliation wicri:level="3"><nlm:aff id="I14">Department of Biostatistics, Korea University, Seoul, Korea</nlm:aff>
<country xml:lang="fr">Corée du Sud</country>
<wicri:regionArea>Department of Biostatistics, Korea University, Seoul</wicri:regionArea>
<placeName><settlement type="city">Séoul</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Wells, George" sort="Wells, George" uniqKey="Wells G" first="George" last="Wells">George Wells</name>
<affiliation wicri:level="1"><nlm:aff id="I15">Department of Clinical Epidemiology, University of Ottawa, Ottawa, ON, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Department of Clinical Epidemiology, University of Ottawa, Ottawa, ON</wicri:regionArea>
<wicri:noRegion>ON</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Goldsmith, Charles H" sort="Goldsmith, Charles H" uniqKey="Goldsmith C" first="Charles H" last="Goldsmith">Charles H. Goldsmith</name>
<affiliation wicri:level="4"><nlm:aff id="I1">Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON</wicri:regionArea>
<orgName type="university">Université McMaster</orgName>
<placeName><settlement type="city">Hamilton (Ontario)</settlement>
<region type="state">Ontario</region>
</placeName>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="I4">Biostatistics Unit, Father Sean O’Sullivan Research Center, St Joseph’s Healthcare Hamilton, Hamilton, ON, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Biostatistics Unit, Father Sean O’Sullivan Research Center, St Joseph’s Healthcare Hamilton, Hamilton, ON</wicri:regionArea>
<wicri:noRegion>ON</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="I16">Faculty of Health Sciences, Simon Fraser University, Burnaby, BC, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Faculty of Health Sciences, Simon Fraser University, Burnaby, BC</wicri:regionArea>
<wicri:noRegion>BC</wicri:noRegion>
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</analytic>
<series><title level="j">BMC Medical Research Methodology</title>
<idno type="eISSN">1471-2288</idno>
<imprint><date when="2013">2013</date>
</imprint>
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<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p>Sensitivity analyses play a crucial role in assessing the robustness of the findings or conclusions based on primary analyses of data in clinical trials. They are a critical way to assess the impact, effect or influence of key assumptions or variations—such as different methods of analysis, definitions of outcomes, protocol deviations, missing data, and outliers—on the overall conclusions of a study.</p>
<p>The current paper is the second in a series of tutorial-type manuscripts intended to discuss and clarify aspects related to key methodological issues in the design and analysis of clinical trials.</p>
</sec>
<sec><title>Discussion</title>
<p>In this paper we will provide a detailed exploration of the key aspects of sensitivity analyses including: 1) what sensitivity analyses are, why they are needed, and how often they are used in practice; 2) the different types of sensitivity analyses that one can do, with examples from the literature; 3) some frequently asked questions about sensitivity analyses; and 4) some suggestions on how to report the results of sensitivity analyses in clinical trials.</p>
</sec>
<sec><title>Summary</title>
<p>When reporting on a clinical trial, we recommend including planned or <italic>posthoc</italic>
sensitivity analyses, the corresponding rationale and results along with the discussion of the consequences of these analyses on the overall findings of the study.</p>
</sec>
</div>
</front>
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