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)
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. A cost-utility analysis from a societal and healthcare perspe...
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| creator | 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 |
| description | 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.
A cost-utility analysis from a societal and healthcare perspective alongside a double-blinded, parallel group, placebo, multicentre trial.
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.
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).
Oral treatment with either 750 mg amoxicillin or placebo three times daily for 100 days.
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).
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%.
Amoxicillin treatment showed no evidence of being cost-effective for people with chronic LBP and Modic changes during 1-year follow-up.
ClinicalTrials.gov NCT02323412. |
| doi_str_mv | 10.1136/bmjopen-2019-035461 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7299049</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2664048081</sourcerecordid><originalsourceid>FETCH-LOGICAL-c457t-77a58d90ffb053e226791e14edff72ba6554dcfd909104cee9cfc9fb9525f8503</originalsourceid><addsrcrecordid>eNpdkt9uFCEUxidGY5vaJzBREm9q4igwMDN4YdJs_NOk1Ru9JgwDXVYGVmDczIP5fp7NbpsqN5xwfud8HPiq6jnBbwlp2nfDtIlbE2qKiahxw1lLHlWnFDNWt5jzxw_ik-o85w2GxbjgnD6tThoKBUzg0-rPKuZSz8V5VxakgvJLdhlFC3Fxg4vFaVSSUWUyoSAX0FYVB2FGO1fWSK9TDID4uEOD0j8hDYwKI7qJI5zrtQq3Jr9HyeTZQ5VNcUIKJUDi5LIZ36CtV9oMsdYxlBS9NyMoOuX3al9j2qkFXZS1QZdXNyiXeVxeP6ueWOWzOT_uZ9WPTx-_r77U198-X60ur2vNeFfqrlO8HwW2dsC8MZS2nSCGMDNa29FBtZyzUVsgBMFMGyO01cIOglNue46bs-rDoe92HiYzapg7KS-3yU0qLTIqJ__NBLeWt_G37KgQmAlo8PLQQCeXiwsyxKQkwT2nsuuJ6IG4OEqk-Gs2uUh4FW28V8HEOUvKCGOkgS8G9NV_6CbOCb4MqLZlmPW4J0A1d5Ix52Ts_XUJlnvvyKN35N478uAdqHrxcNL7mjunNH8Bo5_EOg</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2664048081</pqid></control><display><type>article</type><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><source>BMJ Open Access Journals</source><source>MEDLINE</source><source>NORA - Norwegian Open Research Archives</source><source>DOAJ Directory of Open Access Journals</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>PubMed Central</source><source>PubMed Central Open Access</source><creator>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</creator><creatorcontrib>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 ; AIM-study group</creatorcontrib><description>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.
A cost-utility analysis from a societal and healthcare perspective alongside a double-blinded, parallel group, placebo, multicentre trial.
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.
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).
Oral treatment with either 750 mg amoxicillin or placebo three times daily for 100 days.
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).
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%.
Amoxicillin treatment showed no evidence of being cost-effective for people with chronic LBP and Modic changes during 1-year follow-up.
ClinicalTrials.gov NCT02323412.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2019-035461</identifier><identifier>PMID: 32546490</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Amoxicillin - therapeutic use ; Anti-Bacterial Agents - therapeutic use ; Antibiotics ; Back pain ; Bone Marrow Diseases - drug therapy ; Chronic Disease ; Consumption ; Cost analysis ; Cost-Benefit Analysis ; Disability pensions ; Double-Blind Method ; Edema - drug therapy ; Employment ; Health care ; Health Economics ; Health services utilization ; Humans ; Intention to Treat Analysis ; Low back pain ; Low Back Pain - drug therapy ; Low Back Pain - economics ; Middle Aged ; Norway ; Pain Measurement ; Patients ; Penicillin ; Productivity ; Quality-Adjusted Life Years ; Sick leave ; Tariffs ; Therapy ; Valuation</subject><ispartof>BMJ open, 2020-06, Vol.10 (6), p.e035461-e035461</ispartof><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.</rights><rights>2020 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/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>info:eu-repo/semantics/openAccess</rights><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. 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c457t-77a58d90ffb053e226791e14edff72ba6554dcfd909104cee9cfc9fb9525f8503</citedby><cites>FETCH-LOGICAL-c457t-77a58d90ffb053e226791e14edff72ba6554dcfd909104cee9cfc9fb9525f8503</cites><orcidid>0000-0002-7589-8471 ; 0000-0002-2507-1812 ; 0000-0001-8243-1143 ; 0000-0002-2560-2556</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7299049/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7299049/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,26546,27903,27904,53769,53771</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32546490$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Grotle, Margreth</creatorcontrib><creatorcontrib>Bråten, Lars Christian</creatorcontrib><creatorcontrib>Brox, Jens Ivar</creatorcontrib><creatorcontrib>Espeland, Ansgar</creatorcontrib><creatorcontrib>Zolic-Karlsson, Zinajda</creatorcontrib><creatorcontrib>Munk Killingmo, Rikke</creatorcontrib><creatorcontrib>Tingulstad, Alexander</creatorcontrib><creatorcontrib>Grøvle, Lars</creatorcontrib><creatorcontrib>Froholdt, Anne</creatorcontrib><creatorcontrib>Kristoffersen, Per Martin</creatorcontrib><creatorcontrib>Wigemyr, Monica</creatorcontrib><creatorcontrib>van Tulder, Maurits W</creatorcontrib><creatorcontrib>Storheim, Kjersti</creatorcontrib><creatorcontrib>Zwart, John-Anker</creatorcontrib><creatorcontrib>AIM-study group</creatorcontrib><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><title>BMJ open</title><addtitle>BMJ Open</addtitle><description>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.
A cost-utility analysis from a societal and healthcare perspective alongside a double-blinded, parallel group, placebo, multicentre trial.
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.
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).
Oral treatment with either 750 mg amoxicillin or placebo three times daily for 100 days.
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).
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%.
Amoxicillin treatment showed no evidence of being cost-effective for people with chronic LBP and Modic changes during 1-year follow-up.
ClinicalTrials.gov NCT02323412.</description><subject>Amoxicillin - therapeutic use</subject><subject>Anti-Bacterial Agents - therapeutic use</subject><subject>Antibiotics</subject><subject>Back pain</subject><subject>Bone Marrow Diseases - drug therapy</subject><subject>Chronic Disease</subject><subject>Consumption</subject><subject>Cost analysis</subject><subject>Cost-Benefit Analysis</subject><subject>Disability pensions</subject><subject>Double-Blind Method</subject><subject>Edema - drug therapy</subject><subject>Employment</subject><subject>Health care</subject><subject>Health Economics</subject><subject>Health services utilization</subject><subject>Humans</subject><subject>Intention to Treat Analysis</subject><subject>Low back pain</subject><subject>Low Back Pain - drug therapy</subject><subject>Low Back Pain - economics</subject><subject>Middle Aged</subject><subject>Norway</subject><subject>Pain Measurement</subject><subject>Patients</subject><subject>Penicillin</subject><subject>Productivity</subject><subject>Quality-Adjusted Life Years</subject><subject>Sick leave</subject><subject>Tariffs</subject><subject>Therapy</subject><subject>Valuation</subject><issn>2044-6055</issn><issn>2044-6055</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><sourceid>3HK</sourceid><recordid>eNpdkt9uFCEUxidGY5vaJzBREm9q4igwMDN4YdJs_NOk1Ru9JgwDXVYGVmDczIP5fp7NbpsqN5xwfud8HPiq6jnBbwlp2nfDtIlbE2qKiahxw1lLHlWnFDNWt5jzxw_ik-o85w2GxbjgnD6tThoKBUzg0-rPKuZSz8V5VxakgvJLdhlFC3Fxg4vFaVSSUWUyoSAX0FYVB2FGO1fWSK9TDID4uEOD0j8hDYwKI7qJI5zrtQq3Jr9HyeTZQ5VNcUIKJUDi5LIZ36CtV9oMsdYxlBS9NyMoOuX3al9j2qkFXZS1QZdXNyiXeVxeP6ueWOWzOT_uZ9WPTx-_r77U198-X60ur2vNeFfqrlO8HwW2dsC8MZS2nSCGMDNa29FBtZyzUVsgBMFMGyO01cIOglNue46bs-rDoe92HiYzapg7KS-3yU0qLTIqJ__NBLeWt_G37KgQmAlo8PLQQCeXiwsyxKQkwT2nsuuJ6IG4OEqk-Gs2uUh4FW28V8HEOUvKCGOkgS8G9NV_6CbOCb4MqLZlmPW4J0A1d5Ix52Ts_XUJlnvvyKN35N478uAdqHrxcNL7mjunNH8Bo5_EOg</recordid><startdate>20200615</startdate><enddate>20200615</enddate><creator>Grotle, Margreth</creator><creator>Bråten, Lars Christian</creator><creator>Brox, Jens Ivar</creator><creator>Espeland, Ansgar</creator><creator>Zolic-Karlsson, Zinajda</creator><creator>Munk Killingmo, Rikke</creator><creator>Tingulstad, Alexander</creator><creator>Grøvle, Lars</creator><creator>Froholdt, Anne</creator><creator>Kristoffersen, Per Martin</creator><creator>Wigemyr, Monica</creator><creator>van Tulder, Maurits W</creator><creator>Storheim, Kjersti</creator><creator>Zwart, John-Anker</creator><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>COVID</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>3HK</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-7589-8471</orcidid><orcidid>https://orcid.org/0000-0002-2507-1812</orcidid><orcidid>https://orcid.org/0000-0001-8243-1143</orcidid><orcidid>https://orcid.org/0000-0002-2560-2556</orcidid></search><sort><creationdate>20200615</creationdate><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><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></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c457t-77a58d90ffb053e226791e14edff72ba6554dcfd909104cee9cfc9fb9525f8503</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Amoxicillin - therapeutic use</topic><topic>Anti-Bacterial Agents - therapeutic use</topic><topic>Antibiotics</topic><topic>Back pain</topic><topic>Bone Marrow Diseases - drug therapy</topic><topic>Chronic Disease</topic><topic>Consumption</topic><topic>Cost analysis</topic><topic>Cost-Benefit Analysis</topic><topic>Disability pensions</topic><topic>Double-Blind Method</topic><topic>Edema - drug therapy</topic><topic>Employment</topic><topic>Health care</topic><topic>Health Economics</topic><topic>Health services utilization</topic><topic>Humans</topic><topic>Intention to Treat Analysis</topic><topic>Low back pain</topic><topic>Low Back Pain - drug therapy</topic><topic>Low Back Pain - economics</topic><topic>Middle Aged</topic><topic>Norway</topic><topic>Pain Measurement</topic><topic>Patients</topic><topic>Penicillin</topic><topic>Productivity</topic><topic>Quality-Adjusted Life Years</topic><topic>Sick leave</topic><topic>Tariffs</topic><topic>Therapy</topic><topic>Valuation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Grotle, Margreth</creatorcontrib><creatorcontrib>Bråten, Lars Christian</creatorcontrib><creatorcontrib>Brox, Jens Ivar</creatorcontrib><creatorcontrib>Espeland, Ansgar</creatorcontrib><creatorcontrib>Zolic-Karlsson, Zinajda</creatorcontrib><creatorcontrib>Munk Killingmo, Rikke</creatorcontrib><creatorcontrib>Tingulstad, Alexander</creatorcontrib><creatorcontrib>Grøvle, Lars</creatorcontrib><creatorcontrib>Froholdt, Anne</creatorcontrib><creatorcontrib>Kristoffersen, Per Martin</creatorcontrib><creatorcontrib>Wigemyr, Monica</creatorcontrib><creatorcontrib>van Tulder, Maurits W</creatorcontrib><creatorcontrib>Storheim, Kjersti</creatorcontrib><creatorcontrib>Zwart, John-Anker</creatorcontrib><creatorcontrib>AIM-study group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>Coronavirus Research Database</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Psychology Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>NORA - Norwegian Open Research Archives</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMJ open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Grotle, Margreth</au><au>Bråten, Lars Christian</au><au>Brox, Jens Ivar</au><au>Espeland, Ansgar</au><au>Zolic-Karlsson, Zinajda</au><au>Munk Killingmo, Rikke</au><au>Tingulstad, Alexander</au><au>Grøvle, Lars</au><au>Froholdt, Anne</au><au>Kristoffersen, Per Martin</au><au>Wigemyr, Monica</au><au>van Tulder, Maurits W</au><au>Storheim, Kjersti</au><au>Zwart, John-Anker</au><aucorp>AIM-study group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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)</atitle><jtitle>BMJ open</jtitle><addtitle>BMJ Open</addtitle><date>2020-06-15</date><risdate>2020</risdate><volume>10</volume><issue>6</issue><spage>e035461</spage><epage>e035461</epage><pages>e035461-e035461</pages><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>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.
A cost-utility analysis from a societal and healthcare perspective alongside a double-blinded, parallel group, placebo, multicentre trial.
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.
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).
Oral treatment with either 750 mg amoxicillin or placebo three times daily for 100 days.
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).
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%.
Amoxicillin treatment showed no evidence of being cost-effective for people with chronic LBP and Modic changes during 1-year follow-up.
ClinicalTrials.gov NCT02323412.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>32546490</pmid><doi>10.1136/bmjopen-2019-035461</doi><orcidid>https://orcid.org/0000-0002-7589-8471</orcidid><orcidid>https://orcid.org/0000-0002-2507-1812</orcidid><orcidid>https://orcid.org/0000-0001-8243-1143</orcidid><orcidid>https://orcid.org/0000-0002-2560-2556</orcidid><oa>free_for_read</oa></addata></record> |
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| issn | 2044-6055 2044-6055 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7299049 |
| source | BMJ Open Access Journals; MEDLINE; NORA - Norwegian Open Research Archives; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; PubMed Central Open Access |
| subjects | Amoxicillin - therapeutic use Anti-Bacterial Agents - therapeutic use Antibiotics Back pain Bone Marrow Diseases - drug therapy Chronic Disease Consumption Cost analysis Cost-Benefit Analysis Disability pensions Double-Blind Method Edema - drug therapy Employment Health care Health Economics Health services utilization Humans Intention to Treat Analysis Low back pain Low Back Pain - drug therapy Low Back Pain - economics Middle Aged Norway Pain Measurement Patients Penicillin Productivity Quality-Adjusted Life Years Sick leave Tariffs Therapy Valuation |
| 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) |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-27T17%3A12%3A14IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Cost-utility%20analysis%20of%20antibiotic%20treatment%20in%20patients%20with%20chronic%20low%20back%20pain%20and%20Modic%20changes:%20results%20from%20a%20randomised,%20placebo-controlled%20trial%20in%20Norway%20(the%20AIM%20study)&rft.jtitle=BMJ%20open&rft.au=Grotle,%20Margreth&rft.aucorp=AIM-study%20group&rft.date=2020-06-15&rft.volume=10&rft.issue=6&rft.spage=e035461&rft.epage=e035461&rft.pages=e035461-e035461&rft.issn=2044-6055&rft.eissn=2044-6055&rft_id=info:doi/10.1136/bmjopen-2019-035461&rft_dat=%3Cproquest_pubme%3E2664048081%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2664048081&rft_id=info:pmid/32546490&rfr_iscdi=true |