Pain treatment after total hip arthroplasty: Detailed statistical analysis plan for the RECIPE randomised clinical trial

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Standard

Pain treatment after total hip arthroplasty : Detailed statistical analysis plan for the RECIPE randomised clinical trial. / Steiness, Joakim; Hägi-Pedersen, Daniel; Lunn, Troels H.; Nørskov, Anders K.; Lindberg-Larsen, Martin; Graungaard, Ben K.; Lundstrøm, Lars H.; Lindholm, Peter; Brorson, Stig; Bieder, Manuel J.; Beck, Torben; Skettrup, Michael; von Cappeln, Adam G.; Thybo, Kasper H.; Varnum, Claus; Pleckaitiene, Lina; Pedersen, Niels Anker; Overgaard, Søren; Mathiesen, Ole; Jakobsen, Janus C.

I: Acta Anaesthesiologica Scandinavica, Bind 67, Nr. 3, 2023, s. 372-380.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt

Harvard

Steiness, J, Hägi-Pedersen, D, Lunn, TH, Nørskov, AK, Lindberg-Larsen, M, Graungaard, BK, Lundstrøm, LH, Lindholm, P, Brorson, S, Bieder, MJ, Beck, T, Skettrup, M, von Cappeln, AG, Thybo, KH, Varnum, C, Pleckaitiene, L, Pedersen, NA, Overgaard, S, Mathiesen, O & Jakobsen, JC 2023, 'Pain treatment after total hip arthroplasty: Detailed statistical analysis plan for the RECIPE randomised clinical trial', Acta Anaesthesiologica Scandinavica, bind 67, nr. 3, s. 372-380. https://doi.org/10.1111/aas.14179

APA

Steiness, J., Hägi-Pedersen, D., Lunn, T. H., Nørskov, A. K., Lindberg-Larsen, M., Graungaard, B. K., Lundstrøm, L. H., Lindholm, P., Brorson, S., Bieder, M. J., Beck, T., Skettrup, M., von Cappeln, A. G., Thybo, K. H., Varnum, C., Pleckaitiene, L., Pedersen, N. A., Overgaard, S., Mathiesen, O., & Jakobsen, J. C. (2023). Pain treatment after total hip arthroplasty: Detailed statistical analysis plan for the RECIPE randomised clinical trial. Acta Anaesthesiologica Scandinavica, 67(3), 372-380. https://doi.org/10.1111/aas.14179

Vancouver

Steiness J, Hägi-Pedersen D, Lunn TH, Nørskov AK, Lindberg-Larsen M, Graungaard BK o.a. Pain treatment after total hip arthroplasty: Detailed statistical analysis plan for the RECIPE randomised clinical trial. Acta Anaesthesiologica Scandinavica. 2023;67(3):372-380. https://doi.org/10.1111/aas.14179

Author

Steiness, Joakim ; Hägi-Pedersen, Daniel ; Lunn, Troels H. ; Nørskov, Anders K. ; Lindberg-Larsen, Martin ; Graungaard, Ben K. ; Lundstrøm, Lars H. ; Lindholm, Peter ; Brorson, Stig ; Bieder, Manuel J. ; Beck, Torben ; Skettrup, Michael ; von Cappeln, Adam G. ; Thybo, Kasper H. ; Varnum, Claus ; Pleckaitiene, Lina ; Pedersen, Niels Anker ; Overgaard, Søren ; Mathiesen, Ole ; Jakobsen, Janus C. / Pain treatment after total hip arthroplasty : Detailed statistical analysis plan for the RECIPE randomised clinical trial. I: Acta Anaesthesiologica Scandinavica. 2023 ; Bind 67, Nr. 3. s. 372-380.

Bibtex

@article{0d6846eb75f8480cb0c2368182f6ba0e,
title = "Pain treatment after total hip arthroplasty: Detailed statistical analysis plan for the RECIPE randomised clinical trial",
abstract = "BACKGROUND: The RECIPE trial systematically investigates effects of different combinations of paracetamol, ibuprofen and dexamethasone for pain treatment after total hip arthroplasty. To preserve transparency, minimize risk of bias, and to prevent data-driven analysis, we present this detailed statistical analysis plan.METHODS: The RECIPE trial is a randomized, blinded, parallel four-group multicenter clinical trial for patients undergoing planned primary total hip arthroplasty. Interventions are initiated preoperatively and continued for 24 hours postoperatively. Primary outcome is total opioid consumption 0-24 hours after end of surgery. Primary analysis will be performed in the modified intention to treat population of all patients undergoing total hip arthroplasty, and all analyses will be stratified for site. We will perform pairwise comparisons between each of the four groups. The primary outcome will be analysed using the van Elteren test and we will present Hodges-Lehmann median differences and confidence intervals. Binary outcomes will be analysed using logistic regression. To preserve a family-wise error rate of <0.05, we will use a Bonferroni-adjusted alfa of 0.05/6 = 0.0083 for all six pairwise comparisons between groups when analysing the primary outcome. We will systematically assess the underlying statistical assumptions for each analysis. Data will be analysed by two blinded independent statisticians, and we will write abstracts covering all possible combinations of conclusions, before breaking the blind.DISCUSSION: The RECIPE trial will provide important information on benefit and harm of combinations of the most frequently used non-opioid analgesics for pain after primary hip arthroplasty.",
author = "Joakim Steiness and Daniel H{\"a}gi-Pedersen and Lunn, {Troels H.} and N{\o}rskov, {Anders K.} and Martin Lindberg-Larsen and Graungaard, {Ben K.} and Lundstr{\o}m, {Lars H.} and Peter Lindholm and Stig Brorson and Bieder, {Manuel J.} and Torben Beck and Michael Skettrup and {von Cappeln}, {Adam G.} and Thybo, {Kasper H.} and Claus Varnum and Lina Pleckaitiene and Pedersen, {Niels Anker} and S{\o}ren Overgaard and Ole Mathiesen and Jakobsen, {Janus C.}",
note = "This article is protected by copyright. All rights reserved.",
year = "2023",
doi = "10.1111/aas.14179",
language = "English",
volume = "67",
pages = "372--380",
journal = "Acta Anaesthesiologica Scandinavica",
issn = "0001-5172",
publisher = "Wiley-Blackwell",
number = "3",

}

RIS

TY - JOUR

T1 - Pain treatment after total hip arthroplasty

T2 - Detailed statistical analysis plan for the RECIPE randomised clinical trial

AU - Steiness, Joakim

AU - Hägi-Pedersen, Daniel

AU - Lunn, Troels H.

AU - Nørskov, Anders K.

AU - Lindberg-Larsen, Martin

AU - Graungaard, Ben K.

AU - Lundstrøm, Lars H.

AU - Lindholm, Peter

AU - Brorson, Stig

AU - Bieder, Manuel J.

AU - Beck, Torben

AU - Skettrup, Michael

AU - von Cappeln, Adam G.

AU - Thybo, Kasper H.

AU - Varnum, Claus

AU - Pleckaitiene, Lina

AU - Pedersen, Niels Anker

AU - Overgaard, Søren

AU - Mathiesen, Ole

AU - Jakobsen, Janus C.

N1 - This article is protected by copyright. All rights reserved.

PY - 2023

Y1 - 2023

N2 - BACKGROUND: The RECIPE trial systematically investigates effects of different combinations of paracetamol, ibuprofen and dexamethasone for pain treatment after total hip arthroplasty. To preserve transparency, minimize risk of bias, and to prevent data-driven analysis, we present this detailed statistical analysis plan.METHODS: The RECIPE trial is a randomized, blinded, parallel four-group multicenter clinical trial for patients undergoing planned primary total hip arthroplasty. Interventions are initiated preoperatively and continued for 24 hours postoperatively. Primary outcome is total opioid consumption 0-24 hours after end of surgery. Primary analysis will be performed in the modified intention to treat population of all patients undergoing total hip arthroplasty, and all analyses will be stratified for site. We will perform pairwise comparisons between each of the four groups. The primary outcome will be analysed using the van Elteren test and we will present Hodges-Lehmann median differences and confidence intervals. Binary outcomes will be analysed using logistic regression. To preserve a family-wise error rate of <0.05, we will use a Bonferroni-adjusted alfa of 0.05/6 = 0.0083 for all six pairwise comparisons between groups when analysing the primary outcome. We will systematically assess the underlying statistical assumptions for each analysis. Data will be analysed by two blinded independent statisticians, and we will write abstracts covering all possible combinations of conclusions, before breaking the blind.DISCUSSION: The RECIPE trial will provide important information on benefit and harm of combinations of the most frequently used non-opioid analgesics for pain after primary hip arthroplasty.

AB - BACKGROUND: The RECIPE trial systematically investigates effects of different combinations of paracetamol, ibuprofen and dexamethasone for pain treatment after total hip arthroplasty. To preserve transparency, minimize risk of bias, and to prevent data-driven analysis, we present this detailed statistical analysis plan.METHODS: The RECIPE trial is a randomized, blinded, parallel four-group multicenter clinical trial for patients undergoing planned primary total hip arthroplasty. Interventions are initiated preoperatively and continued for 24 hours postoperatively. Primary outcome is total opioid consumption 0-24 hours after end of surgery. Primary analysis will be performed in the modified intention to treat population of all patients undergoing total hip arthroplasty, and all analyses will be stratified for site. We will perform pairwise comparisons between each of the four groups. The primary outcome will be analysed using the van Elteren test and we will present Hodges-Lehmann median differences and confidence intervals. Binary outcomes will be analysed using logistic regression. To preserve a family-wise error rate of <0.05, we will use a Bonferroni-adjusted alfa of 0.05/6 = 0.0083 for all six pairwise comparisons between groups when analysing the primary outcome. We will systematically assess the underlying statistical assumptions for each analysis. Data will be analysed by two blinded independent statisticians, and we will write abstracts covering all possible combinations of conclusions, before breaking the blind.DISCUSSION: The RECIPE trial will provide important information on benefit and harm of combinations of the most frequently used non-opioid analgesics for pain after primary hip arthroplasty.

U2 - 10.1111/aas.14179

DO - 10.1111/aas.14179

M3 - Journal article

C2 - 36539915

VL - 67

SP - 372

EP - 380

JO - Acta Anaesthesiologica Scandinavica

JF - Acta Anaesthesiologica Scandinavica

SN - 0001-5172

IS - 3

ER -

ID: 330895400