FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4386169219> ?p ?o ?g. }

• W4386169219 abstract "In a non-inferiority trial, the choice of margin depends on the expected control event risk. If the true risk differs from expected, power and interpretability of results can be affected. A non-inferiority frontier pre-specifies an appropriate non-inferiority margin for each value of control event risk. D3 is a non-inferiority trial comparing two treatment regimens in children living with HIV, designed assuming a control event risk of 12%, a non-inferiority margin of 10%, 80% power and a significance level (α) of 0.025. We consider approaches to choosing and implementing a frontier for this already funded trial, where changing the sample size substantially would be difficult.In D3, we fix the non-inferiority margin at 10%, 8% and 5% for control event risks of ≥9%, 5% and 1%, respectively. We propose four frontiers which fit these fixed points, including a Smooth Away From Expected (SAFE) frontier. Analysis approaches considered are as follows: using the pre-specified significance level (α=0.025); always using a reduced significance level (to achieve α≤0.025 across control event risks); reducing significance levels only when the control event risk differs significantly from expected (control event risk <9%); and using a likelihood ratio test. We compare power and type 1 error for SAFE with other frontiers.Changing the significance level only when the control event risk is <9% achieves approximately nominal (<3%) type I error rate and maintains reasonable power for control event risks between 1 and 15%. The likelihood ratio test method performs similarly, but the results are more complex to present. Other analysis methods lead to either inflated type 1 error or badly reduced power. The SAFE frontier gives more interpretable results with low control event risks than other frontiers (i.e. it uses more reasonable non-inferiority margins). Other frontiers do not achieve power close (i.e. within 1%) to SAFE across the range of likely control event risks while controlling type I error.The SAFE non-inferiority frontier will be used in D3, and the non-inferiority margin and significance level will be modified if the control event risk is lower than expected. This ensures results will remain interpretable if design assumptions are incorrect, while achieving similar power. A similar approach could be considered for other non-inferiority trials where the control event risk is uncertain." @default.
• W4386169219 created "2023-08-26" @default.
• W4386169219 creator A5015015632 @default.
• W4386169219 creator A5015306937 @default.
• W4386169219 creator A5056796025 @default.
• W4386169219 creator A5058039205 @default.
• W4386169219 creator A5090095722 @default.
• W4386169219 date "2023-08-25" @default.
• W4386169219 modified "2023-10-18" @default.
• W4386169219 title "The Smooth Away From Expected (SAFE) non-inferiority frontier: theory and implementation with an application to the D3 trial" @default.
• W4386169219 cites W1978764499 @default.
• W4386169219 cites W2011777324 @default.
• W4386169219 cites W2096913021 @default.
• W4386169219 cites W2170331545 @default.
• W4386169219 cites W2513676493 @default.
• W4386169219 cites W2529652362 @default.
• W4386169219 cites W2598366255 @default.
• W4386169219 cites W2729724518 @default.
• W4386169219 cites W2761854305 @default.
• W4386169219 cites W2799409858 @default.
• W4386169219 cites W3005074268 @default.
• W4386169219 cites W3098865414 @default.
• W4386169219 cites W3189355562 @default.
• W4386169219 cites W3203679619 @default.
• W4386169219 doi "https://doi.org/10.1186/s13063-023-07586-5" @default.
• W4386169219 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/37626423" @default.
• W4386169219 hasPublicationYear "2023" @default.
• W4386169219 type Work @default.
• W4386169219 citedByCount "0" @default.
• W4386169219 crossrefType "journal-article" @default.
• W4386169219 hasAuthorship W4386169219A5015015632 @default.
• W4386169219 hasAuthorship W4386169219A5015306937 @default.
• W4386169219 hasAuthorship W4386169219A5056796025 @default.
• W4386169219 hasAuthorship W4386169219A5058039205 @default.
• W4386169219 hasAuthorship W4386169219A5090095722 @default.
• W4386169219 hasBestOaLocation W43861692191 @default.
• W4386169219 hasConcept C105795698 @default.
• W4386169219 hasConcept C119857082 @default.
• W4386169219 hasConcept C121332964 @default.
• W4386169219 hasConcept C129848803 @default.
• W4386169219 hasConcept C149782125 @default.
• W4386169219 hasConcept C154945302 @default.
• W4386169219 hasConcept C2775924081 @default.
• W4386169219 hasConcept C2779662365 @default.
• W4386169219 hasConcept C2781067378 @default.
• W4386169219 hasConcept C33923547 @default.
• W4386169219 hasConcept C40696583 @default.
• W4386169219 hasConcept C41008148 @default.
• W4386169219 hasConcept C62520636 @default.
• W4386169219 hasConcept C65409693 @default.
• W4386169219 hasConcept C71924100 @default.
• W4386169219 hasConcept C774472 @default.
• W4386169219 hasConcept C87007009 @default.
• W4386169219 hasConceptScore W4386169219C105795698 @default.
• W4386169219 hasConceptScore W4386169219C119857082 @default.
• W4386169219 hasConceptScore W4386169219C121332964 @default.
• W4386169219 hasConceptScore W4386169219C129848803 @default.
• W4386169219 hasConceptScore W4386169219C149782125 @default.
• W4386169219 hasConceptScore W4386169219C154945302 @default.
• W4386169219 hasConceptScore W4386169219C2775924081 @default.
• W4386169219 hasConceptScore W4386169219C2779662365 @default.
• W4386169219 hasConceptScore W4386169219C2781067378 @default.
• W4386169219 hasConceptScore W4386169219C33923547 @default.
• W4386169219 hasConceptScore W4386169219C40696583 @default.
• W4386169219 hasConceptScore W4386169219C41008148 @default.
• W4386169219 hasConceptScore W4386169219C62520636 @default.
• W4386169219 hasConceptScore W4386169219C65409693 @default.
• W4386169219 hasConceptScore W4386169219C71924100 @default.
• W4386169219 hasConceptScore W4386169219C774472 @default.
• W4386169219 hasConceptScore W4386169219C87007009 @default.
• W4386169219 hasFunder F4320312382 @default.
• W4386169219 hasFunder F4320334626 @default.
• W4386169219 hasIssue "1" @default.
• W4386169219 hasLocation W43861692191 @default.
• W4386169219 hasLocation W43861692192 @default.
• W4386169219 hasOpenAccess W4386169219 @default.
• W4386169219 hasPrimaryLocation W43861692191 @default.
• W4386169219 hasRelatedWork W1991018803 @default.
• W4386169219 hasRelatedWork W2036600297 @default.
• W4386169219 hasRelatedWork W2753031227 @default.
• W4386169219 hasRelatedWork W2897830442 @default.
• W4386169219 hasRelatedWork W3003558595 @default.
• W4386169219 hasRelatedWork W3090624304 @default.
• W4386169219 hasRelatedWork W3113118296 @default.
• W4386169219 hasRelatedWork W3137029931 @default.
• W4386169219 hasRelatedWork W4295441906 @default.
• W4386169219 hasRelatedWork W4295905522 @default.
• W4386169219 hasVolume "24" @default.
• W4386169219 isParatext "false" @default.
• W4386169219 isRetracted "false" @default.
• W4386169219 workType "article" @default.