Assessing the effect of interventions for axial spondyloarthritis according to the endorsed ASAS/OMERACT core outcome set: a meta-research study of trials included in Cochrane reviews
Abstract The Assessment of SpondyloArthritis international Society (ASAS) has defined core sets for (i) symptom-modifying anti-rheumatic drugs (SM-ARD), (ii) clinical record keeping, and (iii) disease-controlling anti-rheumatic therapy (DC-ART). These include the following domains for all three core...
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| Language: | English |
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BMC
2020-07-01
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| Series: | Arthritis Research & Therapy |
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| Online Access: | http://link.springer.com/article/10.1186/s13075-020-02262-4 |
| _version_ | 1818486378060578816 |
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| author | Rikke A. Andreasen Lars E. Kristensen Xenofon Baraliakos Vibeke Strand Philip J. Mease Maarten de Wit Torkell Ellingsen Inger Marie J. Hansen Jamie Kirkham George A. Wells Peter Tugwell Lara Maxwell Maarten Boers Kenneth Egstrup Robin Christensen |
| author_facet | Rikke A. Andreasen Lars E. Kristensen Xenofon Baraliakos Vibeke Strand Philip J. Mease Maarten de Wit Torkell Ellingsen Inger Marie J. Hansen Jamie Kirkham George A. Wells Peter Tugwell Lara Maxwell Maarten Boers Kenneth Egstrup Robin Christensen |
| author_sort | Rikke A. Andreasen |
| collection | DOAJ |
| description | Abstract The Assessment of SpondyloArthritis international Society (ASAS) has defined core sets for (i) symptom-modifying anti-rheumatic drugs (SM-ARD), (ii) clinical record keeping, and (iii) disease-controlling anti-rheumatic therapy (DC-ART). These include the following domains for all three core sets: “physical function,” “pain,” “spinal mobility,” “spinal stiffness,” and “patient’s global assessment” (PGA). The core set for clinical record keeping further includes the domains “peripheral joints/entheses” and “acute phase reactants,” and the core set for DC-ART further includes the domains “fatigue” and “spine radiographs/hip radiographs.” The Outcome Measures in Rheumatology (OMERACT) endorsed the core sets in 1998. Using empirical evidence from axSpA trials, we investigated the efficacy (i.e., net benefit) according to the ASAS/OMERACT core outcome set for axSpA across all interventions tested in trials included in subsequent Cochrane reviews. For all continuous scales, we combined data using the standardized mean difference (SMD) to meta-analyze outcomes involving the same domains. Also, through meta-regression analysis, we examined the effect of the separate SMD measures (independent variables) on the primary endpoint (log [OR], dependent variable) across all trials. Based on 11 eligible Cochrane reviews, from these, 85 articles were screened; we included 43 trials with 63 randomized comparisons. Mean (SD) number of ASAS/OMERACT core outcome domains measured for SM-ARD/physical therapy trials was 4.2 (1.7). Six trials assessed all proposed domains. Mean (SD) for number of core outcome domains for DC-ART trials was 5.8 (1.7). No trials assessed all nine domains. Eight trials (16%) were judged to have inadequate (i.e., high risk of) selective outcome reporting bias. The most responsible core domains for achieving success in meeting the primary objective per trial were pain, OR (95% CI) 5.19 (2.28, 11.77), and PGA, OR (95% CI) 1.87 (1.14, 3.07). In conclusion, selective outcome reporting (and “missing data”) should be reduced by encouraging the use of the endorsed ASAS/OMERACT outcome domains in clinical trials. Overall outcome reporting was good for SM-ARD/physical therapy trials and poor for DC-ART trials. Our findings suggest that both PGA and pain provide a valuable holistic construct for the assessment of improvement beyond more objective measures of spinal inflammation. |
| first_indexed | 2024-12-10T16:22:09Z |
| format | Article |
| id | doaj.art-eefffea5dd794fc9ba05927fabe30a52 |
| institution | Directory Open Access Journal |
| issn | 1478-6362 |
| language | English |
| last_indexed | 2024-12-10T16:22:09Z |
| publishDate | 2020-07-01 |
| publisher | BMC |
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| series | Arthritis Research & Therapy |
| spelling | doaj.art-eefffea5dd794fc9ba05927fabe30a522022-12-22T01:41:47ZengBMCArthritis Research & Therapy1478-63622020-07-0122111610.1186/s13075-020-02262-4Assessing the effect of interventions for axial spondyloarthritis according to the endorsed ASAS/OMERACT core outcome set: a meta-research study of trials included in Cochrane reviewsRikke A. Andreasen0Lars E. Kristensen1Xenofon Baraliakos2Vibeke Strand3Philip J. Mease4Maarten de WitTorkell Ellingsen5Inger Marie J. Hansen6Jamie Kirkham7George A. Wells8Peter Tugwell9Lara Maxwell10Maarten Boers11Kenneth Egstrup12Robin Christensen13Department of Medicine, Section of Rheumatology, Odense University Hospital, Svendborg and University of Southern DenmarkMusculoskeletal Statistics Unit, the Parker Institute, Bispebjerg and Frederiksberg Hospital, University HospitalRheumazentrum Ruhrgebiet Herne, Ruhr-University BochumDivision Immunology/Rheumatology, Stanford UniversitySwedish Medical Centre/Providence St. Joseph Health and University of WashingtonResearch Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University HospitalDepartment of Medicine, Section of Rheumatology, Odense University Hospital, Svendborg and University of Southern DenmarkCentre for Biostatistics, Manchester Academic Health ScienceDepartment of Medicine, University of OttawaFaculty of Medicine, University of OttawaFaculty of Medicine, University of OttawaDepartment of Epidemiology & Biostatistics, Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Vrije UniversiteitCardiovascular Research Unit, Odense University HospitalMusculoskeletal Statistics Unit, the Parker Institute, Bispebjerg and Frederiksberg Hospital, University HospitalAbstract The Assessment of SpondyloArthritis international Society (ASAS) has defined core sets for (i) symptom-modifying anti-rheumatic drugs (SM-ARD), (ii) clinical record keeping, and (iii) disease-controlling anti-rheumatic therapy (DC-ART). These include the following domains for all three core sets: “physical function,” “pain,” “spinal mobility,” “spinal stiffness,” and “patient’s global assessment” (PGA). The core set for clinical record keeping further includes the domains “peripheral joints/entheses” and “acute phase reactants,” and the core set for DC-ART further includes the domains “fatigue” and “spine radiographs/hip radiographs.” The Outcome Measures in Rheumatology (OMERACT) endorsed the core sets in 1998. Using empirical evidence from axSpA trials, we investigated the efficacy (i.e., net benefit) according to the ASAS/OMERACT core outcome set for axSpA across all interventions tested in trials included in subsequent Cochrane reviews. For all continuous scales, we combined data using the standardized mean difference (SMD) to meta-analyze outcomes involving the same domains. Also, through meta-regression analysis, we examined the effect of the separate SMD measures (independent variables) on the primary endpoint (log [OR], dependent variable) across all trials. Based on 11 eligible Cochrane reviews, from these, 85 articles were screened; we included 43 trials with 63 randomized comparisons. Mean (SD) number of ASAS/OMERACT core outcome domains measured for SM-ARD/physical therapy trials was 4.2 (1.7). Six trials assessed all proposed domains. Mean (SD) for number of core outcome domains for DC-ART trials was 5.8 (1.7). No trials assessed all nine domains. Eight trials (16%) were judged to have inadequate (i.e., high risk of) selective outcome reporting bias. The most responsible core domains for achieving success in meeting the primary objective per trial were pain, OR (95% CI) 5.19 (2.28, 11.77), and PGA, OR (95% CI) 1.87 (1.14, 3.07). In conclusion, selective outcome reporting (and “missing data”) should be reduced by encouraging the use of the endorsed ASAS/OMERACT outcome domains in clinical trials. Overall outcome reporting was good for SM-ARD/physical therapy trials and poor for DC-ART trials. Our findings suggest that both PGA and pain provide a valuable holistic construct for the assessment of improvement beyond more objective measures of spinal inflammation.http://link.springer.com/article/10.1186/s13075-020-02262-4Axial spondyloarthritisAnkylosing spondylitisCore outcome setMeta-analysis |
| spellingShingle | Rikke A. Andreasen Lars E. Kristensen Xenofon Baraliakos Vibeke Strand Philip J. Mease Maarten de Wit Torkell Ellingsen Inger Marie J. Hansen Jamie Kirkham George A. Wells Peter Tugwell Lara Maxwell Maarten Boers Kenneth Egstrup Robin Christensen Assessing the effect of interventions for axial spondyloarthritis according to the endorsed ASAS/OMERACT core outcome set: a meta-research study of trials included in Cochrane reviews Arthritis Research & Therapy Axial spondyloarthritis Ankylosing spondylitis Core outcome set Meta-analysis |
| title | Assessing the effect of interventions for axial spondyloarthritis according to the endorsed ASAS/OMERACT core outcome set: a meta-research study of trials included in Cochrane reviews |
| title_full | Assessing the effect of interventions for axial spondyloarthritis according to the endorsed ASAS/OMERACT core outcome set: a meta-research study of trials included in Cochrane reviews |
| title_fullStr | Assessing the effect of interventions for axial spondyloarthritis according to the endorsed ASAS/OMERACT core outcome set: a meta-research study of trials included in Cochrane reviews |
| title_full_unstemmed | Assessing the effect of interventions for axial spondyloarthritis according to the endorsed ASAS/OMERACT core outcome set: a meta-research study of trials included in Cochrane reviews |
| title_short | Assessing the effect of interventions for axial spondyloarthritis according to the endorsed ASAS/OMERACT core outcome set: a meta-research study of trials included in Cochrane reviews |
| title_sort | assessing the effect of interventions for axial spondyloarthritis according to the endorsed asas omeract core outcome set a meta research study of trials included in cochrane reviews |
| topic | Axial spondyloarthritis Ankylosing spondylitis Core outcome set Meta-analysis |
| url | http://link.springer.com/article/10.1186/s13075-020-02262-4 |
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