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)
dc.contributor.author | Grotle, Margreth | |
dc.contributor.author | Bråten, Lars Christian Haugli | |
dc.contributor.author | Brox, Jens Ivar | |
dc.contributor.author | Espeland, Ansgar | |
dc.contributor.author | Zolic-Karlsson, Zinajda | |
dc.contributor.author | Killingmo, Rikke Munk | |
dc.contributor.author | Tingulstad, Alexander | |
dc.contributor.author | Grøvle, Lars | |
dc.contributor.author | Johanessen, Anne Froholdt | |
dc.contributor.author | Kristoffersen, Per Martin | |
dc.contributor.author | Wigemyr, Monica | |
dc.contributor.author | van Tulder, Maurits W. | |
dc.contributor.author | Storheim, Kjersti | |
dc.contributor.author | Zwart, John-Anker | |
dc.date.accessioned | 2020-06-24T13:18:38Z | |
dc.date.accessioned | 2020-08-05T08:23:56Z | |
dc.date.available | 2020-06-24T13:18:38Z | |
dc.date.available | 2020-08-05T08:23:56Z | |
dc.date.issued | 2020-06-15 | |
dc.identifier.citation | Grotle M, Bråten LCH, Brox JI, Espeland A, Zolic-Karlsson, Killingmo RM, Tingulstad A, Grøvle L, Johanessen AF, Kristoffersen, Wigemyr M, van Tulder MW, Storheim K, Zwart J. 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) . BMJ Open. 2020 | en |
dc.identifier.issn | 2044-6055 | |
dc.identifier.issn | 2044-6055 | |
dc.identifier.uri | https://hdl.handle.net/10642/8794 | |
dc.description.abstract | 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. | en |
dc.description.sponsorship | This work was supported by the South- Eastern Norway Regional Health Authority (Helse Sør-Øst, grant no: 2015090) and Western Norway Regional Health Authority (Helse Vest, grant no: 911 938 and 911891). | en |
dc.language.iso | en | en |
dc.publisher | BMJ Publishing Group | en |
dc.relation.ispartofseries | BMJ Open;Volume 10, Issue 6 | |
dc.rights | © 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. 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/. | en |
dc.rights.uri | https://creativecommons.org/licenses/by-nc/4.0/ | |
dc.subject | Cost–utility analyses | en |
dc.subject | Antibiotic treatments | en |
dc.subject | Low back pains | en |
dc.subject | Placebo trials | en |
dc.subject | Modic changes | en |
dc.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) | en |
dc.type | Journal article | en |
dc.type | Peer reviewed | en |
dc.date.updated | 2020-06-24T13:18:38Z | |
dc.description.version | publishedVersion | en |
dc.identifier.cristin | 1816711 | |
dc.source.journal | BMJ Open |
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Except where otherwise noted, this item's license is described as © 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. 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/.