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Cost–utility analysis of antibiotic treatment in patients with chronic low back pain and Modic changes: results from a randomised, placebo-controlled trial in Norway (the AIM study)

OBJECTIVE: To evaluate the cost–utility of 100 days of antibiotics in patients with chronic low back pain (LBP) and type I or II Modic changes included in the Antibiotic treatment In patients with chronic low back pain and Modic changes (AIM) study. DESIGN: A cost–utility analysis from a societal an...

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Autores principales: Grotle, Margreth, Bråten, Lars Christian, Brox, Jens Ivar, Espeland, Ansgar, Zolic-Karlsson, Zinajda, Munk Killingmo, Rikke, Tingulstad, Alexander, Grøvle, Lars, Froholdt, Anne, Kristoffersen, Per Martin, Wigemyr, Monica, van Tulder, Maurits W, Storheim, Kjersti, Zwart, John-Anker
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7299049/
https://www.ncbi.nlm.nih.gov/pubmed/32546490
http://dx.doi.org/10.1136/bmjopen-2019-035461
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author Grotle, Margreth
Bråten, Lars Christian
Brox, Jens Ivar
Espeland, Ansgar
Zolic-Karlsson, Zinajda
Munk Killingmo, Rikke
Tingulstad, Alexander
Grøvle, Lars
Froholdt, Anne
Kristoffersen, Per Martin
Wigemyr, Monica
van Tulder, Maurits W
Storheim, Kjersti
Zwart, John-Anker
author_facet Grotle, Margreth
Bråten, Lars Christian
Brox, Jens Ivar
Espeland, Ansgar
Zolic-Karlsson, Zinajda
Munk Killingmo, Rikke
Tingulstad, Alexander
Grøvle, Lars
Froholdt, Anne
Kristoffersen, Per Martin
Wigemyr, Monica
van Tulder, Maurits W
Storheim, Kjersti
Zwart, John-Anker
author_sort Grotle, Margreth
collection PubMed
description OBJECTIVE: To evaluate the cost–utility of 100 days of antibiotics in patients with chronic low back pain (LBP) and type I or II Modic changes included in the Antibiotic treatment In patients with chronic low back pain and Modic changes (AIM) study. DESIGN: A cost–utility analysis from a societal and healthcare perspective alongside a double-blinded, parallel group, placebo, multicentre trial. SETTING: Hospital outpatient clinics at six hospitals in Norway. The main results from the AIM study showed a small effect in back-related disability in favour of the antibiotics group, and slightly larger in those with type I Modic changes, but this effect was below the pre-defined threshold for clinically relevant effect. PARTICIPANTS: 180 patients with chronic LBP, previous disc herniation and Modic changes type I (n=118) or type II (n=62) were randomised to antibiotic treatment (n=89) or placebo-control (n=91). INTERVENTIONS: Oral treatment with either 750 mg amoxicillin or placebo three times daily for 100 days. MAIN OUTCOME MEASURES: Quality-adjusted life years (QALYs) by EuroQoL-5D over 12 months and costs for healthcare and productivity loss measured in Euro (€1=NOK 10), in the intention-to-treat population. Cost–utility was expressed in incremental cost-effectiveness ratio (ICER). RESULTS: Mean (SD) total cost was €21 046 (20 105) in the amoxicillin group and €19 076 (19 356) in the placebo group, mean difference €1970 (95% CI; −3835 to 7774). Cost per QALY gained was €24 625. In those with type I Modic changes, the amoxicillin group had higher healthcare consumption than the placebo group, resulting in €39 425 per QALY gained. Given these ICERs and a willingness-to-pay threshold of €27 500 (NOK 275 000), the probability of amoxicillin being cost-effective was 51%. Even when the willingness-to-pay threshold increased to €55 000, the probability of amoxicillin being cost-effective was never higher than 53%. CONCLUSIONS: Amoxicillin treatment showed no evidence of being cost-effective for people with chronic LBP and Modic changes during 1-year follow-up. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT02323412.
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spelling pubmed-72990492020-06-22 Cost–utility analysis of antibiotic treatment in patients with chronic low back pain and Modic changes: results from a randomised, placebo-controlled trial in Norway (the AIM study) Grotle, Margreth Bråten, Lars Christian Brox, Jens Ivar Espeland, Ansgar Zolic-Karlsson, Zinajda Munk Killingmo, Rikke Tingulstad, Alexander Grøvle, Lars Froholdt, Anne Kristoffersen, Per Martin Wigemyr, Monica van Tulder, Maurits W Storheim, Kjersti Zwart, John-Anker BMJ Open Health Economics OBJECTIVE: To evaluate the cost–utility of 100 days of antibiotics in patients with chronic low back pain (LBP) and type I or II Modic changes included in the Antibiotic treatment In patients with chronic low back pain and Modic changes (AIM) study. DESIGN: A cost–utility analysis from a societal and healthcare perspective alongside a double-blinded, parallel group, placebo, multicentre trial. SETTING: Hospital outpatient clinics at six hospitals in Norway. The main results from the AIM study showed a small effect in back-related disability in favour of the antibiotics group, and slightly larger in those with type I Modic changes, but this effect was below the pre-defined threshold for clinically relevant effect. PARTICIPANTS: 180 patients with chronic LBP, previous disc herniation and Modic changes type I (n=118) or type II (n=62) were randomised to antibiotic treatment (n=89) or placebo-control (n=91). INTERVENTIONS: Oral treatment with either 750 mg amoxicillin or placebo three times daily for 100 days. MAIN OUTCOME MEASURES: Quality-adjusted life years (QALYs) by EuroQoL-5D over 12 months and costs for healthcare and productivity loss measured in Euro (€1=NOK 10), in the intention-to-treat population. Cost–utility was expressed in incremental cost-effectiveness ratio (ICER). RESULTS: Mean (SD) total cost was €21 046 (20 105) in the amoxicillin group and €19 076 (19 356) in the placebo group, mean difference €1970 (95% CI; −3835 to 7774). Cost per QALY gained was €24 625. In those with type I Modic changes, the amoxicillin group had higher healthcare consumption than the placebo group, resulting in €39 425 per QALY gained. Given these ICERs and a willingness-to-pay threshold of €27 500 (NOK 275 000), the probability of amoxicillin being cost-effective was 51%. Even when the willingness-to-pay threshold increased to €55 000, the probability of amoxicillin being cost-effective was never higher than 53%. CONCLUSIONS: Amoxicillin treatment showed no evidence of being cost-effective for people with chronic LBP and Modic changes during 1-year follow-up. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT02323412. BMJ Publishing Group 2020-06-15 /pmc/articles/PMC7299049/ /pubmed/32546490 http://dx.doi.org/10.1136/bmjopen-2019-035461 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Health Economics
Grotle, Margreth
Bråten, Lars Christian
Brox, Jens Ivar
Espeland, Ansgar
Zolic-Karlsson, Zinajda
Munk Killingmo, Rikke
Tingulstad, Alexander
Grøvle, Lars
Froholdt, Anne
Kristoffersen, Per Martin
Wigemyr, Monica
van Tulder, Maurits W
Storheim, Kjersti
Zwart, John-Anker
Cost–utility analysis of antibiotic treatment in patients with chronic low back pain and Modic changes: results from a randomised, placebo-controlled trial in Norway (the AIM study)
title Cost–utility analysis of antibiotic treatment in patients with chronic low back pain and Modic changes: results from a randomised, placebo-controlled trial in Norway (the AIM study)
title_full Cost–utility analysis of antibiotic treatment in patients with chronic low back pain and Modic changes: results from a randomised, placebo-controlled trial in Norway (the AIM study)
title_fullStr Cost–utility analysis of antibiotic treatment in patients with chronic low back pain and Modic changes: results from a randomised, placebo-controlled trial in Norway (the AIM study)
title_full_unstemmed Cost–utility analysis of antibiotic treatment in patients with chronic low back pain and Modic changes: results from a randomised, placebo-controlled trial in Norway (the AIM study)
title_short Cost–utility analysis of antibiotic treatment in patients with chronic low back pain and Modic changes: results from a randomised, placebo-controlled trial in Norway (the AIM study)
title_sort cost–utility analysis of antibiotic treatment in patients with chronic low back pain and modic changes: results from a randomised, placebo-controlled trial in norway (the aim study)
topic Health Economics
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7299049/
https://www.ncbi.nlm.nih.gov/pubmed/32546490
http://dx.doi.org/10.1136/bmjopen-2019-035461
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