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dc.contributor.authorGibbons, KS
dc.contributor.authorSchlapbach, LJ
dc.contributor.authorHorton, SB
dc.contributor.authorLong, DA
dc.contributor.authorBeca, J
dc.contributor.authorErickson, S
dc.contributor.authorFesta, M
dc.contributor.authorD’udekem, Y
dc.contributor.authorAlphonso, N
dc.contributor.authorWinlaw, D
dc.contributor.authorJohnson, K
dc.contributor.authorDelzoppo, C
dc.contributor.authorvan Loon, K
dc.contributor.authorGannon, B
dc.contributor.authorFooken, J
dc.contributor.authoret al.
dc.date.accessioned2021-12-15T23:01:49Z
dc.date.available2021-12-15T23:01:49Z
dc.date.issued2021
dc.identifier.issn1441-2772
dc.identifier.doi10.51893/2021.1.oa4
dc.identifier.urihttp://hdl.handle.net/10072/410844
dc.description.abstractBackground: The NITric oxide during cardiopulmonary bypass (CPB) to improve Recovery in Infants with Congenital heart defects (NITRIC) trial, a 1320-patient, multicentre, randomised controlled trial, is aiming to improve survival free of ventilation after CPB by using nitric oxide delivered into the oxygenator of the CPB. Objective: To provide a statistical analysis plan before completion of patient recruitment and data monitoring. Final analyses for this study will adhere to this statistical analysis plan, which details all key pre-planned analyses. Stata scripts for analyses have been prepared alongside this statistical analysis plan. Methods: The statistical analysis plan was designed collaboratively by the chief investigators and trial statistician and builds on the previously published study protocol. All authors remain blinded to treatment allocation. Detail is provided on statistical analyses including cohort description, analysis of primary and secondary outcomes and adverse events. Statistical methods to compare outcomes are planned in detail to ensure methods are verifiable and reproducible. Results: The statistical analysis plan developed provides the trial outline, list of mock tables, and analysis scripts. The plan describes statistical analyses on cohort and baseline description, primary and secondary outcome analyses, process of care measures, physiological descriptors, and safety and adverse event reporting. We define the pre-specified subgroup analyses and the respective statistical tests used to compare subgroups. Conclusion: The statistical analysis plan for the NITRIC trial establishes detailed pre-planned analyses alongside Stata scripts to analyse the largest trial in the field of neonatal and paediatric heart surgery. The plan ensures standards for trial analysis validity aiming to minimise bias of analyses. Trial registration: ACTRN12617000821392.
dc.description.peerreviewedYes
dc.publisherCollege Of Intensive Care Medicine Of Australia And New Zealand
dc.relation.ispartofpagefrom47
dc.relation.ispartofpageto58
dc.relation.ispartofissue1
dc.relation.ispartofjournalCritical Care and Resuscitation
dc.relation.ispartofvolume23
dc.subject.fieldofresearchCardiology (incl. cardiovascular diseases)
dc.subject.fieldofresearchPaediatrics
dc.subject.fieldofresearchcode320101
dc.subject.fieldofresearchcode3213
dc.titleStatistical analysis plan for the NITric oxide during cardiopulmonary bypass to improve recovery in infants with congenital heart defects (NITRIC) trial
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationGibbons, KS; Schlapbach, LJ; Horton, SB; Long, DA; Beca, J; Erickson, S; Festa, M; D’udekem, Y; Alphonso, N; Winlaw, D; Johnson, K; Delzoppo, C; van Loon, K; Gannon, B; Fooken, J; Blumenthal, A; Young, PJ; Butt, W; Schibler, A, Statistical analysis plan for the NITric oxide during cardiopulmonary bypass to improve recovery in infants with congenital heart defects (NITRIC) trial, Critical Care and Resuscitation, 2021, 23 (1), pp. 47-58
dc.date.updated2021-12-08T23:33:11Z
gro.hasfulltextNo Full Text
gro.griffith.authorLong, Debbie A.


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