STeroids Against Radiculopathy (STAR) trial: a statistical analysis plan
Abstract Background Transforaminal epidural injections with steroids (TESI) are used increasingly for patients with sciatica. However, their safety, effectiveness, and cost-effectiveness are still a matter of debate. This a priori statistical analysis plan describes the methodology of the analysis f...
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| Format: | Article |
| Language: | English |
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BMC
2021-01-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-020-05018-2 |
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| author | Bastiaan C. ter Meulen Johanna M. van Dongen Marinus van der Vegt Henry C. Weinstein Raymond W. J. G. Ostelo |
| author_facet | Bastiaan C. ter Meulen Johanna M. van Dongen Marinus van der Vegt Henry C. Weinstein Raymond W. J. G. Ostelo |
| author_sort | Bastiaan C. ter Meulen |
| collection | DOAJ |
| description | Abstract Background Transforaminal epidural injections with steroids (TESI) are used increasingly for patients with sciatica. However, their safety, effectiveness, and cost-effectiveness are still a matter of debate. This a priori statistical analysis plan describes the methodology of the analysis for the STAR trial that assesses the (cost-)effectiveness of TESI during the acute stage of sciatica (< 8 weeks). Methods The STAR trial is a multicentre, randomized controlled, prospective trial (RCT) investigating the (cost-)effectiveness of TESI by making a three-group comparison among patients with acute sciatica due to a herniated lumbar disc (< 8 weeks): (1) TESI combined with levobupivacaine added to oral pain medication (intervention group 1) versus oral pain medication alone (control group), (2) intervention group 1 versus transforaminal epidural injection with levobupivacaine and saline solution added to oral pain medication (intervention group 2), and (3) intervention group 2 versus control group. Co-primary outcomes were physical functioning (Roland Morris Disability Questionnaire), pain intensity (10-point numerical rating scale), and global perceived recovery (7-point Likert scale, dichotomized into ‘recovered’ and ‘not recovered’). For all three comparisons, we defined the following minimal clinically relevant between-group differences: two points for pain intensity (range 0–10), four points for physical functioning (range 0–24) and a 20% difference in recovery rate. Secondary outcomes are health-related quality of life (EQ-5D-5L) and patient satisfaction (7-point Likert scale) and surgery rate. We also collected resource use data to perform an economic evaluation. Analyses will be conducted by intention-to-treat with p < 0.05 (two-tailed) for all three comparisons. Effects will be estimated using mixed models by maximum likelihood. For each comparison, mean differences, or difference in proportions, between groups will be tested per time point and an overall mean difference, or difference in proportions, between groups during the complete duration of follow-up (6 months) will be estimated. In the economic evaluation, Multivariate Imputation by Chained Equations will be used to handle missing data. Cost and effect differences will be estimated using seemingly unrelated regression, and uncertainty will be estimated using bootstrapping techniques. Discussion This statistical analysis plan provides detailed information on the intended analysis of the STAR trial, which aims to deliver evidence about the (cost-)effectiveness of TESI during the acute phase of sciatica (< 8 weeks). Trial registration Dutch National trial register NTR4457 (6 March 2014) |
| first_indexed | 2024-12-20T14:41:40Z |
| format | Article |
| id | doaj.art-bfbe0d2b7ed84f61b927ef5615f27a81 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-20T14:41:40Z |
| publishDate | 2021-01-01 |
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| spelling | doaj.art-bfbe0d2b7ed84f61b927ef5615f27a812022-12-21T19:37:16ZengBMCTrials1745-62152021-01-0122111110.1186/s13063-020-05018-2STeroids Against Radiculopathy (STAR) trial: a statistical analysis planBastiaan C. ter Meulen0Johanna M. van Dongen1Marinus van der Vegt2Henry C. Weinstein3Raymond W. J. G. Ostelo4Department of Neurology, OLVG AmsterdamDepartment of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Movement SciencesDepartment of Anesthesiology Zaans Medisch CentrumDepartment of Neurology, OLVG AmsterdamDepartment of Epidemiology and Biostatistics Amsterdam Movement Sciences Research Institute, Amsterdam UMC, Vrije Universiteit AmsterdamAbstract Background Transforaminal epidural injections with steroids (TESI) are used increasingly for patients with sciatica. However, their safety, effectiveness, and cost-effectiveness are still a matter of debate. This a priori statistical analysis plan describes the methodology of the analysis for the STAR trial that assesses the (cost-)effectiveness of TESI during the acute stage of sciatica (< 8 weeks). Methods The STAR trial is a multicentre, randomized controlled, prospective trial (RCT) investigating the (cost-)effectiveness of TESI by making a three-group comparison among patients with acute sciatica due to a herniated lumbar disc (< 8 weeks): (1) TESI combined with levobupivacaine added to oral pain medication (intervention group 1) versus oral pain medication alone (control group), (2) intervention group 1 versus transforaminal epidural injection with levobupivacaine and saline solution added to oral pain medication (intervention group 2), and (3) intervention group 2 versus control group. Co-primary outcomes were physical functioning (Roland Morris Disability Questionnaire), pain intensity (10-point numerical rating scale), and global perceived recovery (7-point Likert scale, dichotomized into ‘recovered’ and ‘not recovered’). For all three comparisons, we defined the following minimal clinically relevant between-group differences: two points for pain intensity (range 0–10), four points for physical functioning (range 0–24) and a 20% difference in recovery rate. Secondary outcomes are health-related quality of life (EQ-5D-5L) and patient satisfaction (7-point Likert scale) and surgery rate. We also collected resource use data to perform an economic evaluation. Analyses will be conducted by intention-to-treat with p < 0.05 (two-tailed) for all three comparisons. Effects will be estimated using mixed models by maximum likelihood. For each comparison, mean differences, or difference in proportions, between groups will be tested per time point and an overall mean difference, or difference in proportions, between groups during the complete duration of follow-up (6 months) will be estimated. In the economic evaluation, Multivariate Imputation by Chained Equations will be used to handle missing data. Cost and effect differences will be estimated using seemingly unrelated regression, and uncertainty will be estimated using bootstrapping techniques. Discussion This statistical analysis plan provides detailed information on the intended analysis of the STAR trial, which aims to deliver evidence about the (cost-)effectiveness of TESI during the acute phase of sciatica (< 8 weeks). Trial registration Dutch National trial register NTR4457 (6 March 2014)https://doi.org/10.1186/s13063-020-05018-2SciaticaLumbar disc herniationTransforaminal epidural steroidsEconomic evaluationRandomized controlled trial |
| spellingShingle | Bastiaan C. ter Meulen Johanna M. van Dongen Marinus van der Vegt Henry C. Weinstein Raymond W. J. G. Ostelo STeroids Against Radiculopathy (STAR) trial: a statistical analysis plan Trials Sciatica Lumbar disc herniation Transforaminal epidural steroids Economic evaluation Randomized controlled trial |
| title | STeroids Against Radiculopathy (STAR) trial: a statistical analysis plan |
| title_full | STeroids Against Radiculopathy (STAR) trial: a statistical analysis plan |
| title_fullStr | STeroids Against Radiculopathy (STAR) trial: a statistical analysis plan |
| title_full_unstemmed | STeroids Against Radiculopathy (STAR) trial: a statistical analysis plan |
| title_short | STeroids Against Radiculopathy (STAR) trial: a statistical analysis plan |
| title_sort | steroids against radiculopathy star trial a statistical analysis plan |
| topic | Sciatica Lumbar disc herniation Transforaminal epidural steroids Economic evaluation Randomized controlled trial |
| url | https://doi.org/10.1186/s13063-020-05018-2 |
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