A tutorial on sensitivity analyses in clinical trials: the what, why, when and how
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, definit...
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| Veröffentlicht in: | BMC medical research methodology 2013-07, Vol.13 (1), p.92-92, Article 92 |
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| creator | Thabane, Lehana Mbuagbaw, Lawrence Zhang, Shiyuan Samaan, Zainab Marcucci, Maura Ye, Chenglin Thabane, Marroon Giangregorio, Lora Dennis, Brittany Kosa, Daisy Borg Debono, Victoria Dillenburg, Rejane Fruci, Vincent Bawor, Monica Lee, Juneyoung Wells, George Goldsmith, Charles H |
| description | 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 posthoc sensitivity analyses, the corresponding rationale and results along with the discussion of the consequences of these analyses on the overall findings of the study. |
| doi_str_mv | 10.1186/1471-2288-13-92 |
| format | Article |
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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 posthoc sensitivity analyses, the corresponding rationale and results along with the discussion of the consequences of these analyses on the overall findings of the study.</description><identifier>ISSN: 1471-2288</identifier><identifier>EISSN: 1471-2288</identifier><identifier>DOI: 10.1186/1471-2288-13-92</identifier><identifier>PMID: 23855337</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Clinical trials ; Clinical Trials as Topic - standards ; Humans ; Methods ; Outcome and Process Assessment, Health Care ; Research Design ; Sensitivity analysis ; Sensitivity and Specificity</subject><ispartof>BMC medical research methodology, 2013-07, Vol.13 (1), p.92-92, Article 92</ispartof><rights>COPYRIGHT 2013 BioMed Central Ltd.</rights><rights>2013 Thabane et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</rights><rights>Copyright © 2013 Thabane et al.; licensee BioMed Central Ltd. 2013 Thabane et al.; licensee BioMed Central Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c488t-8b8f13eec7486601db5c95888d425f9d4c7383404116af0c3520abba37bb56d23</citedby><cites>FETCH-LOGICAL-c488t-8b8f13eec7486601db5c95888d425f9d4c7383404116af0c3520abba37bb56d23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3720188/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3720188/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23855337$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Thabane, Lehana</creatorcontrib><creatorcontrib>Mbuagbaw, Lawrence</creatorcontrib><creatorcontrib>Zhang, Shiyuan</creatorcontrib><creatorcontrib>Samaan, Zainab</creatorcontrib><creatorcontrib>Marcucci, Maura</creatorcontrib><creatorcontrib>Ye, Chenglin</creatorcontrib><creatorcontrib>Thabane, Marroon</creatorcontrib><creatorcontrib>Giangregorio, Lora</creatorcontrib><creatorcontrib>Dennis, Brittany</creatorcontrib><creatorcontrib>Kosa, Daisy</creatorcontrib><creatorcontrib>Borg Debono, Victoria</creatorcontrib><creatorcontrib>Dillenburg, Rejane</creatorcontrib><creatorcontrib>Fruci, Vincent</creatorcontrib><creatorcontrib>Bawor, Monica</creatorcontrib><creatorcontrib>Lee, Juneyoung</creatorcontrib><creatorcontrib>Wells, George</creatorcontrib><creatorcontrib>Goldsmith, Charles H</creatorcontrib><title>A tutorial on sensitivity analyses in clinical trials: the what, why, when and how</title><title>BMC medical research methodology</title><addtitle>BMC Med Res Methodol</addtitle><description>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 posthoc sensitivity analyses, the corresponding rationale and results along with the discussion of the consequences of these analyses on the overall findings of the study.</description><subject>Clinical trials</subject><subject>Clinical Trials as Topic - standards</subject><subject>Humans</subject><subject>Methods</subject><subject>Outcome and Process Assessment, Health Care</subject><subject>Research Design</subject><subject>Sensitivity analysis</subject><subject>Sensitivity and Specificity</subject><issn>1471-2288</issn><issn>1471-2288</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNptksFrFTEQxoMotlbP3iTgxYPbZjLJJs-D8ChWhYIgeg7ZbLYvZV9SN9mW99-bbeuzFQlMhsnv-0JmQshrYMcAuj0BoaDhXOsGsFnxJ-RwX3n6ID8gL3K-ZAyUxvY5OeCopURUh-T7mpa5pCnYkaZIs485lHAdyo7aaMdd9pmGSN0YYnCVKQuZP9Cy8fRmY8v7GndL8LEKerpJNy_Js6Ey_tX9fkR-nn36cfqlOf_2-evp-rxxQuvS6E4PgN47JXTbMug76VZSa90LLodVL5xCjYIJgNYOzKHkzHadRdV1su05HpGPd75Xc7f1vfOxTHY0V1PY2mlnkg3m8UkMG3ORrg0qzkDravDu3mBKv2afi9mG7Pw42ujTnA0I4FKqSlb07T_oZZqn2qBbChkqUPwvdWFHb0IcUr3XLaZmLVFI3bJ2oY7_Q9XV-21wKfoh1PojwcmdwE0p58kP-zcCM8s3MMugzTJoA2hWi-LNw9bs-T9zx9-7GKr-</recordid><startdate>20130716</startdate><enddate>20130716</enddate><creator>Thabane, Lehana</creator><creator>Mbuagbaw, Lawrence</creator><creator>Zhang, Shiyuan</creator><creator>Samaan, Zainab</creator><creator>Marcucci, Maura</creator><creator>Ye, Chenglin</creator><creator>Thabane, Marroon</creator><creator>Giangregorio, Lora</creator><creator>Dennis, Brittany</creator><creator>Kosa, Daisy</creator><creator>Borg Debono, Victoria</creator><creator>Dillenburg, Rejane</creator><creator>Fruci, Vincent</creator><creator>Bawor, Monica</creator><creator>Lee, Juneyoung</creator><creator>Wells, George</creator><creator>Goldsmith, Charles H</creator><general>BioMed Central Ltd</general><general>BioMed Central</general><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>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PHGZM</scope><scope>PHGZT</scope><scope>PIMPY</scope><scope>PJZUB</scope><scope>PKEHL</scope><scope>PPXIY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20130716</creationdate><title>A tutorial on sensitivity analyses in clinical trials: the what, why, when and how</title><author>Thabane, Lehana ; 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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 posthoc sensitivity analyses, the corresponding rationale and results along with the discussion of the consequences of these analyses on the overall findings of the study.</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>23855337</pmid><doi>10.1186/1471-2288-13-92</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Clinical trials Clinical Trials as Topic - standards Humans Methods Outcome and Process Assessment, Health Care Research Design Sensitivity analysis Sensitivity and Specificity |
| title | A tutorial on sensitivity analyses in clinical trials: the what, why, when and how |
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