Detailed statistical analysis plan for a randomised controlled trial of the effects of a modified muscle sparing posterior technique (SPAIRE) in hip hemiarthroplasty for displaced intracapsular fractures on post-operative function compared to a standard lateral approach: HemiSPAIRE
Abstract Background The HemiSPAIRE trial is being conducted to determine whether a modified muscle sparing technique (SPAIRE-“Save Piriformis and Internus, Repairing Externus”) in hip hemiarthroplasty brings clinical benefits compared to the standard lateral technique in adults aged 60 years or olde...
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| Format: | Article |
| Language: | English |
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BMC
2022-11-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06790-z |
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| author | Susan Ball Amy McAndrew Alex Aylward Emma Cockcroft Elizabeth Gordon Alison Kerridge Sarah Morgan-Trimmer Roy Powell Anna Price Shelley Rhodes Andrew J. Timperley Jayden van Horik Robert Wickins John Charity |
| author_facet | Susan Ball Amy McAndrew Alex Aylward Emma Cockcroft Elizabeth Gordon Alison Kerridge Sarah Morgan-Trimmer Roy Powell Anna Price Shelley Rhodes Andrew J. Timperley Jayden van Horik Robert Wickins John Charity |
| author_sort | Susan Ball |
| collection | DOAJ |
| description | Abstract Background The HemiSPAIRE trial is being conducted to determine whether a modified muscle sparing technique (SPAIRE-“Save Piriformis and Internus, Repairing Externus”) in hip hemiarthroplasty brings clinical benefits compared to the standard lateral technique in adults aged 60 years or older, with a displaced intracapsular hip fracture. This article describes the detailed statistical analysis plan for the trial. Methods and design HemiSPAIRE is a definitive, pragmatic, superiority, multicentre, randomised controlled trial (with internal pilot) with two parallel groups. Participants, ward staff and all research staff involved in post-operative assessments are blinded to allocation. This article describes in detail (1) the primary and secondary outcomes; (2) the statistical analysis principles, including a survivor average causal effect (SACE) method chosen specifically to address the issue of potential bias from differential survival between trial arms, which was seen from data review by the Trial Steering Committee, the participants that will be included in each analysis, the covariates that will be included in each analysis, and how the results will be presented; (3) planned main analysis of the primary outcome; (4) planned analyses of the secondary outcomes; and (5) planned additional analyses of the primary and secondary outcomes. Trial registration ClinicalTrials.gov NCT04095611. Registered on 19 September 2019. |
| first_indexed | 2024-04-12T08:30:44Z |
| format | Article |
| id | doaj.art-4ff2101434334ad383361a6cd3167990 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-12T08:30:44Z |
| publishDate | 2022-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-4ff2101434334ad383361a6cd31679902022-12-22T03:40:13ZengBMCTrials1745-62152022-11-012311910.1186/s13063-022-06790-zDetailed statistical analysis plan for a randomised controlled trial of the effects of a modified muscle sparing posterior technique (SPAIRE) in hip hemiarthroplasty for displaced intracapsular fractures on post-operative function compared to a standard lateral approach: HemiSPAIRESusan Ball0Amy McAndrew1Alex Aylward2Emma Cockcroft3Elizabeth Gordon4Alison Kerridge5Sarah Morgan-Trimmer6Roy Powell7Anna Price8Shelley Rhodes9Andrew J. Timperley10Jayden van Horik11Robert Wickins12John Charity13Applied Research Collaboration South West Peninsula (PenARC), National Institute for Health and Care Research (NIHR), University of ExeterExeter Clinical Trials Unit, University of Exeter Medical SchoolApplied Research Collaboration South West Peninsula (PenARC) Patient Engagement Group, National Institute for Health and Care Research (NIHR), University of ExeterPrimary Care Research Group, University of Exeter Medical SchoolResearch and Development Department, Royal Devon University Healthcare NHS Foundation TrustResearch and Development Department, Royal Devon University Healthcare NHS Foundation TrustDepartment of Health and Community Sciences, University of Exeter Medical SchoolResearch Design Service – South West, Royal Devon University Healthcare NHS Foundation TrustPrimary Care Research Group, University of Exeter Medical SchoolExeter Clinical Trials Unit, University of Exeter Medical SchoolExeter Hip Unit, Royal Devon University Healthcare NHS Foundation TrustExeter Clinical Trials Unit, University of Exeter Medical SchoolPhysiotherapy, Royal Devon University Healthcare NHS Foundation TrustExeter Hip Unit, Royal Devon University Healthcare NHS Foundation TrustAbstract Background The HemiSPAIRE trial is being conducted to determine whether a modified muscle sparing technique (SPAIRE-“Save Piriformis and Internus, Repairing Externus”) in hip hemiarthroplasty brings clinical benefits compared to the standard lateral technique in adults aged 60 years or older, with a displaced intracapsular hip fracture. This article describes the detailed statistical analysis plan for the trial. Methods and design HemiSPAIRE is a definitive, pragmatic, superiority, multicentre, randomised controlled trial (with internal pilot) with two parallel groups. Participants, ward staff and all research staff involved in post-operative assessments are blinded to allocation. This article describes in detail (1) the primary and secondary outcomes; (2) the statistical analysis principles, including a survivor average causal effect (SACE) method chosen specifically to address the issue of potential bias from differential survival between trial arms, which was seen from data review by the Trial Steering Committee, the participants that will be included in each analysis, the covariates that will be included in each analysis, and how the results will be presented; (3) planned main analysis of the primary outcome; (4) planned analyses of the secondary outcomes; and (5) planned additional analyses of the primary and secondary outcomes. Trial registration ClinicalTrials.gov NCT04095611. Registered on 19 September 2019.https://doi.org/10.1186/s13063-022-06790-zStatistical analysis planHip hemiarthroplastySPAIRERandomised controlled trialSurvivor average causal effect |
| spellingShingle | Susan Ball Amy McAndrew Alex Aylward Emma Cockcroft Elizabeth Gordon Alison Kerridge Sarah Morgan-Trimmer Roy Powell Anna Price Shelley Rhodes Andrew J. Timperley Jayden van Horik Robert Wickins John Charity Detailed statistical analysis plan for a randomised controlled trial of the effects of a modified muscle sparing posterior technique (SPAIRE) in hip hemiarthroplasty for displaced intracapsular fractures on post-operative function compared to a standard lateral approach: HemiSPAIRE Trials Statistical analysis plan Hip hemiarthroplasty SPAIRE Randomised controlled trial Survivor average causal effect |
| title | Detailed statistical analysis plan for a randomised controlled trial of the effects of a modified muscle sparing posterior technique (SPAIRE) in hip hemiarthroplasty for displaced intracapsular fractures on post-operative function compared to a standard lateral approach: HemiSPAIRE |
| title_full | Detailed statistical analysis plan for a randomised controlled trial of the effects of a modified muscle sparing posterior technique (SPAIRE) in hip hemiarthroplasty for displaced intracapsular fractures on post-operative function compared to a standard lateral approach: HemiSPAIRE |
| title_fullStr | Detailed statistical analysis plan for a randomised controlled trial of the effects of a modified muscle sparing posterior technique (SPAIRE) in hip hemiarthroplasty for displaced intracapsular fractures on post-operative function compared to a standard lateral approach: HemiSPAIRE |
| title_full_unstemmed | Detailed statistical analysis plan for a randomised controlled trial of the effects of a modified muscle sparing posterior technique (SPAIRE) in hip hemiarthroplasty for displaced intracapsular fractures on post-operative function compared to a standard lateral approach: HemiSPAIRE |
| title_short | Detailed statistical analysis plan for a randomised controlled trial of the effects of a modified muscle sparing posterior technique (SPAIRE) in hip hemiarthroplasty for displaced intracapsular fractures on post-operative function compared to a standard lateral approach: HemiSPAIRE |
| title_sort | detailed statistical analysis plan for a randomised controlled trial of the effects of a modified muscle sparing posterior technique spaire in hip hemiarthroplasty for displaced intracapsular fractures on post operative function compared to a standard lateral approach hemispaire |
| topic | Statistical analysis plan Hip hemiarthroplasty SPAIRE Randomised controlled trial Survivor average causal effect |
| url | https://doi.org/10.1186/s13063-022-06790-z |
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