C. Hansen, B. A. Esbensen, A. De Thurah, R. Christensen, M. De Wit, P. F. Cromhout
2022 Annals of the Rheumatic Diseases  
BackgroundSelf-management refers to the patient's ability to manage a large range of consequences such as symptoms, medication, emotions, and preferable life-style changes coherent with living with a chronic disease. Evaluating the effect of interventions targeting to improve people with inflammatory arthritis (IA) self-management is a challenge because self-management interventions are complex and consensus on important outcomes is lacking. Solutions to these issues could be to consensus on a
more » ... ore Outcome Set (COS) describing what outcomes are relevant and should be applied in future studies hereby lessening the heterogeneity between future studies. The purpose of this study was therefore to take the first actions in identifying possible candidate outcomes for such a COS.ObjectivesThe aim was to identify, and map applied outcome domains and outcome measurement instruments from previous trials measuring the effect of self-management interventions targeting people with IA.MethodsWe performed an informative systematic literature review following guidance from the Handbooks described by 'Outcome Measures in Rheumatology' (OMERACT) and 'Core Outcome Measures in Effectiveness Trials' (COMET) initiatives. Randomized and non-randomized trials describing their experimental intervention as "self-management" and included a population of adults (≥18 years) with at least 50% diagnoses with IA (Rheumatoid arthritis, Psoriatic arthritis, Spondylarthritis) was included. Both screening of possible trials and data extraction was performed independently by two reviewers. Extracted data included: study characteristics, outcome domains and the corresponding measurement instruments. During analysis two reviewers simultaneously grouped and categorized domains and subdomains, and two senior researchers approved the categorization.ResultsSearches was performed 2021.02.08 on online databases, trial registers, conference abstracts and references of included trials. From a total of 2,502 records, we included 38 trials published between 1988 and 2021. The interventions were heterogenic and patients primarily female, diagnosed with Rheumatoid Arthritis, and a calculated mean age of 54 years. We identified 12 different outcome domains, covering 39 subdomains, collected with 119 different measurement instruments. The most frequently applied outcome domains were self-efficacy, pain, physical functioning/disability, anxiety and depression, quality of life, fatigue, global assessment/disease activity and coping. Please see Figure 1 for all outcome domains identified. The applied measurement instruments varied within each outcome domain with up to 10 different instruments applied to measure the same domain. Instruments were predominantly patient-reported outcomes.ConclusionThe outcome domains and measurement instruments used in self-management trials were widely diverse and differ from the current general OMERACT Core Outcome Sets (COS) for IA conditions. Further steps towards the establishment of a COS to be reported in all self-management intervention trials will enhance the relevance and the subsequent impact on the body of evidence from these trials.ReferencesThe protocol was registered in PROSPERO (ID CRD42021238749).[1]OMERACT Handbook 2019. Available at: https://www.dropbox.com/s/fd3673fsma45qe0/OMERACT Handbook Chapter 4 Apr 16 2019.pdf?dl=0.[2]Williamson PR, Altman DG, Bagley H, Barnes KL, Blazeby JM, Brookes ST, m.fl. The COMET Handbook: Version 1.0, 2017. Available at: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-1978-4Disclosure of InterestsNone declared
doi:10.1136/annrheumdis-2022-eular.1608 fatcat:fr3cgl3uorccbapiyejwbavdfi