The importance of clinical importance when determining the target difference in sample size calculations
Abstract Recently, it was argued that clinically important differences should play no role in sample size calculations. Instead, it was proposed that sample size calculations should focus on setting realistic estimates of treatment benefit. We disagree, and argue in this article that considering the...
| Main Authors: | , |
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| Format: | Article |
| Language: | English |
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BMC
2023-08-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-023-07532-5 |
| _version_ | 1797451581135781888 |
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| author | Richard A. Parker Jonathan A. Cook |
| author_facet | Richard A. Parker Jonathan A. Cook |
| author_sort | Richard A. Parker |
| collection | DOAJ |
| description | Abstract Recently, it was argued that clinically important differences should play no role in sample size calculations. Instead, it was proposed that sample size calculations should focus on setting realistic estimates of treatment benefit. We disagree, and argue in this article that considering the importance of a target difference is necessary in the context of randomised controlled trials of effectiveness, particularly definitive phase III trials. Ignoring clinical importance could have serious ethical and practical consequences. |
| first_indexed | 2024-03-09T14:56:43Z |
| format | Article |
| id | doaj.art-00b69d54cf9b46c2a86e548131088870 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-09T14:56:43Z |
| publishDate | 2023-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-00b69d54cf9b46c2a86e5481310888702023-11-26T14:08:59ZengBMCTrials1745-62152023-08-012411510.1186/s13063-023-07532-5The importance of clinical importance when determining the target difference in sample size calculationsRichard A. Parker0Jonathan A. Cook1Edinburgh Clinical Trials Unit, Usher Institute, University of EdinburghCentre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordAbstract Recently, it was argued that clinically important differences should play no role in sample size calculations. Instead, it was proposed that sample size calculations should focus on setting realistic estimates of treatment benefit. We disagree, and argue in this article that considering the importance of a target difference is necessary in the context of randomised controlled trials of effectiveness, particularly definitive phase III trials. Ignoring clinical importance could have serious ethical and practical consequences.https://doi.org/10.1186/s13063-023-07532-5Clinical trialRCTPowerEffect sizeAssumed benefitClinically relevant difference |
| spellingShingle | Richard A. Parker Jonathan A. Cook The importance of clinical importance when determining the target difference in sample size calculations Trials Clinical trial RCT Power Effect size Assumed benefit Clinically relevant difference |
| title | The importance of clinical importance when determining the target difference in sample size calculations |
| title_full | The importance of clinical importance when determining the target difference in sample size calculations |
| title_fullStr | The importance of clinical importance when determining the target difference in sample size calculations |
| title_full_unstemmed | The importance of clinical importance when determining the target difference in sample size calculations |
| title_short | The importance of clinical importance when determining the target difference in sample size calculations |
| title_sort | importance of clinical importance when determining the target difference in sample size calculations |
| topic | Clinical trial RCT Power Effect size Assumed benefit Clinically relevant difference |
| url | https://doi.org/10.1186/s13063-023-07532-5 |
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