Open access
Figure 1 Flow diagram showing the selection of trials. Boxes are shaded dark grey (study identification), light grey (screening) and white (inclusion of final reports for the systematic review and meta-analysis) to illustrate the three stages outlined in the PRISMA 2020 flow diagram. Studies available only as abstracts will be considered for inclusion; however, they will be included in the meta-analysis only if sufficient data are available for analysis. AIRD, autoimmune and inflammatory rheumatic disease. ICTRP, WHO International Clinical Trial Registry Platform portal; PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses.
concurrent anti-inflammatory medication (including dosage, frequency and timing relative to the exper- imental intervention) and country of trial conduct. Financial support sources will also be recorded. 2. Intervention and outcome data: details of the exper- imental and control interventions, including gener- ic and trade names, route of administration, dosage, frequency, duration of treatment, single versus mixed donor (for FMT) and control type. Outcome data will include the definition of the primary endpoint as reported in the trial, secondary outcomes and all reported outcome domains. Where necessary, sum- mary statistics will be approximated from figures. For cross-over trials, only first-period data will be extract- ed to avoid carry-over effects. Response rates will be calculated based on the total number of randomised
participants (intention-to-treat population), and we will prioritise intention-to-treat results whenever available. Risk of bias assessment in the individual trials Eligible trials will be assessed independently pairwise by four reviewers for methodological issues using the Cochrane Risk of Bias tool V.2. 55 This risk of bias tool covers six domains of bias: selection bias, performance bias, detection bias, attrition bias, reporting bias and other bias. For each item in the tool, the assessment of risk of bias is in two parts (risk judgement and trial description that supports this judgement). The support for judge- ment provides a concise free text description or summary of the relevant trial characteristic on which judgments of risk of bias are based and aims to ensure transparency in
6
Kragsnaes MS, et al . BMJ Open 2025; 15 :e101593. doi:10.1136/bmjopen-2025-101593
Powered by FlippingBook