ACL Surgery Necessity in Non-Acute Patients (ACL SNNAP): a statistical analysis plan for a randomised controlled trial
Abstract Background Rupture of the anterior cruciate ligament (ACL) is a common injury, primarily affecting young, active individuals. Despite surgical intervention being the more common treatment for patients suffering ACL ruptures, current management is based on limited and generally low-quality e...
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| Format: | Article |
| Language: | English |
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BMC
2022-05-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06309-6 |
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| author | Jamie R. Stokes David J. Beard Loretta Davies Beverly A. Shirkey Andrew Price Jonathan A. Cook The ACL SNNAP Study Group |
| author_facet | Jamie R. Stokes David J. Beard Loretta Davies Beverly A. Shirkey Andrew Price Jonathan A. Cook The ACL SNNAP Study Group |
| author_sort | Jamie R. Stokes |
| collection | DOAJ |
| description | Abstract Background Rupture of the anterior cruciate ligament (ACL) is a common injury, primarily affecting young, active individuals. Despite surgical intervention being the more common treatment for patients suffering ACL ruptures, current management is based on limited and generally low-quality evidence. We describe a statistical analysis plan (SAP) for the ACL SNNAP randomised controlled trial, which aims to investigate the necessity of surgical management in patients with ACL injuries. Methods/design ACL SNNAP is a pragmatic, multi-centre, superiority, parallel-group randomised controlled trial in participants with a symptomatic non-acute ACL deficient knee. Participants are allocated in a 1:1 ratio to either non-surgical management (rehabilitation) or surgical management (reconstruction) with the aim of assessing the efficacy and cost-effectiveness. The primary outcome of the study is the Knee Injury and Osteoarthritis Outcome Score (KOOS4) at 18 months post-randomisation. The KOOS4 score at 18 months will be evaluated using a linear regression model adjusting for recruitment centre and baseline KOOS4 scores, allowing for intra-centre correlation. A secondary analysis of the primary outcome will be carried out using an area under the curve (AUC) approach using treatment estimates obtained from a mixed model using baseline, 6 months, 12 months, and 18 months post-randomisation outcome data. Secondary outcomes will be measured at 18 months and will include return to activity/level of sport participation, intervention-related complications, the EQ-5D-5L questionnaire, all 5 individual subscales of the KOOS questionnaire, the ACL-QOL score, expectations of return to activity and cost-effectiveness of the interventions. Missing primary outcome data will be investigated through a sensitivity analysis. Full details of the planned methods for the statistical analysis of clinical outcomes are presented in this paper. The study protocol for the ACL SNNAP trial has been published previously. Discussion The methods of analysis for the ACL SNNAP trial have been described here to minimise the risk of data-driven results and reporting bias. Any deviations from the analysis methods described in this paper will be described in full and justified in the publications of the trial results. Trial registration ISRCTN ISRCTN10110685 . Registered on 16 November 2016 |
| first_indexed | 2024-04-14T00:32:27Z |
| format | Article |
| id | doaj.art-a8e245dd41b443a49b2c778e000b2972 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-14T00:32:27Z |
| publishDate | 2022-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-a8e245dd41b443a49b2c778e000b29722022-12-22T02:22:31ZengBMCTrials1745-62152022-05-012311910.1186/s13063-022-06309-6ACL Surgery Necessity in Non-Acute Patients (ACL SNNAP): a statistical analysis plan for a randomised controlled trialJamie R. Stokes0David J. Beard1Loretta Davies2Beverly A. Shirkey3Andrew Price4Jonathan A. Cook5The ACL SNNAP Study GroupOxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of OxfordSurgical Interventional Trials Unit, Nuffield Department Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordSurgical Interventional Trials Unit, Nuffield Department Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordSchool of Social and Community Medicine, University of BristolNuffield Orthopaedic Centre, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of OxfordOxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of OxfordAbstract Background Rupture of the anterior cruciate ligament (ACL) is a common injury, primarily affecting young, active individuals. Despite surgical intervention being the more common treatment for patients suffering ACL ruptures, current management is based on limited and generally low-quality evidence. We describe a statistical analysis plan (SAP) for the ACL SNNAP randomised controlled trial, which aims to investigate the necessity of surgical management in patients with ACL injuries. Methods/design ACL SNNAP is a pragmatic, multi-centre, superiority, parallel-group randomised controlled trial in participants with a symptomatic non-acute ACL deficient knee. Participants are allocated in a 1:1 ratio to either non-surgical management (rehabilitation) or surgical management (reconstruction) with the aim of assessing the efficacy and cost-effectiveness. The primary outcome of the study is the Knee Injury and Osteoarthritis Outcome Score (KOOS4) at 18 months post-randomisation. The KOOS4 score at 18 months will be evaluated using a linear regression model adjusting for recruitment centre and baseline KOOS4 scores, allowing for intra-centre correlation. A secondary analysis of the primary outcome will be carried out using an area under the curve (AUC) approach using treatment estimates obtained from a mixed model using baseline, 6 months, 12 months, and 18 months post-randomisation outcome data. Secondary outcomes will be measured at 18 months and will include return to activity/level of sport participation, intervention-related complications, the EQ-5D-5L questionnaire, all 5 individual subscales of the KOOS questionnaire, the ACL-QOL score, expectations of return to activity and cost-effectiveness of the interventions. Missing primary outcome data will be investigated through a sensitivity analysis. Full details of the planned methods for the statistical analysis of clinical outcomes are presented in this paper. The study protocol for the ACL SNNAP trial has been published previously. Discussion The methods of analysis for the ACL SNNAP trial have been described here to minimise the risk of data-driven results and reporting bias. Any deviations from the analysis methods described in this paper will be described in full and justified in the publications of the trial results. Trial registration ISRCTN ISRCTN10110685 . Registered on 16 November 2016https://doi.org/10.1186/s13063-022-06309-6Anterior cruciate ligamentACLRandomised controlled trialStatisticAnalysis planReconstruction |
| spellingShingle | Jamie R. Stokes David J. Beard Loretta Davies Beverly A. Shirkey Andrew Price Jonathan A. Cook The ACL SNNAP Study Group ACL Surgery Necessity in Non-Acute Patients (ACL SNNAP): a statistical analysis plan for a randomised controlled trial Trials Anterior cruciate ligament ACL Randomised controlled trial Statistic Analysis plan Reconstruction |
| title | ACL Surgery Necessity in Non-Acute Patients (ACL SNNAP): a statistical analysis plan for a randomised controlled trial |
| title_full | ACL Surgery Necessity in Non-Acute Patients (ACL SNNAP): a statistical analysis plan for a randomised controlled trial |
| title_fullStr | ACL Surgery Necessity in Non-Acute Patients (ACL SNNAP): a statistical analysis plan for a randomised controlled trial |
| title_full_unstemmed | ACL Surgery Necessity in Non-Acute Patients (ACL SNNAP): a statistical analysis plan for a randomised controlled trial |
| title_short | ACL Surgery Necessity in Non-Acute Patients (ACL SNNAP): a statistical analysis plan for a randomised controlled trial |
| title_sort | acl surgery necessity in non acute patients acl snnap a statistical analysis plan for a randomised controlled trial |
| topic | Anterior cruciate ligament ACL Randomised controlled trial Statistic Analysis plan Reconstruction |
| url | https://doi.org/10.1186/s13063-022-06309-6 |
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