An abnormal composition of gut bacteria along with alterations in microbial metabolites and reduced gut barrier integrity has been associated with the pathogenesis of chronic autoimmune and inflammatory rheumatic diseases (AIRDs). The aim of the systematic review, for which this protocol is presented, is to evaluate the clinical benefits and potential harms of therapies targeting the intestinal microbiota and/or gut barrier function in AIRDs to inform clinical practice and future research.
This protocol used the reporting guidelines from the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocol. We will search Embase (Ovid), Medline (Ovid) and the Cochrane Library (Central) for reports of randomised controlled trials of patients diagnosed with an AIRD. Eligible interventions are therapies targeting the intestinal microbiota and/or gut barrier function including probiotics, synbiotics, faecal microbiota transplantation, live biotherapeutic products and antibiotics with the intent to modify disease activity in AIRDs. The primary outcome of the evidence synthesis will be based on the primary endpoint of each trial. Secondary efficacy outcomes will be evaluated and selected from the existing core domain sets of the individual diseases and include the following domains: disease control, patient global assessment, physician global assessment, health-related quality of life, fatigue, pain and inflammation. Harms will include the total number of withdrawals, withdrawals due to adverse events, number of patients with serious adverse events, disease flares and deaths. A meta-analysis will be performed for each outcome domain separately. Depending on the type of outcome, the quantitative synthesis will encompass both ORs and standardised mean differences with corresponding 95% CIs.
No ethics approval will be needed for this systematic review. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to disseminate the study results through a peer-reviewed publication.
CRD42025644244.
Fatigue, depression, anxiety and cognitive difficulties are reported by 1/3 of patients following transient ischemic attack (TIA).
To explore the timeline and how the diagnosis impacts individuals experiencing lasting challenges after TIA. Furthermore, to identify what they believed facilitated return to everyday life.
Qualitative exploratory study with a phenomenological-hermeneutic approach.
Individual semi-structured interviews and thematic analysis.
Fifteen patients were included. Four themes were identified; (1) ‘They say it is transient – no, not for me’ where all participants described lasting challenges emphasizing invalidating fatigue and impaired social participation, (2) ‘I am a changed person; how does this impact my future?’ which reflects altered identity and elevated alertness to symptoms, (3) ‘Time has been my ally and new perspectives have evolved’ where most participants described improvement over time and a few considered the diagnosis a wake-up call to change lifestyle. Lastly (4) ‘What would have helped me recover?’ which unfolds that close, trustful relations influence positively. In addition, the system often failed to support. Participants described pressure to return to work and lack of trust and negative experiences when involving their general practitioner.
During the 4 months since diagnosis, participants experienced limitations impacting physical, psychological and social domains. They felt uninformed that lasting challenges could affect them. Different coping strategies were activated, and participants with close, supportive relations managed better. A pressure to return to work and a lack of trust in the general practitioner affected their recovery negatively. Overall, return to everyday life after TIA was considered stressful and appropriate support lacking.
To be able to support patients with challenges following TIA, we as healthcare professionals need to understand the identified impact and life changing circumstances. Currently the system seemingly is not able to provide timely, sufficient and competent support.
We know from the literature that up to 1/3 of patients following transient ischemic attack experience lasting challenges measured on a variety of questionnaires. This is paradoxical to a diagnosis defined by focal neurological symptoms that resolve within 24 h. It is unknown how patients with lasting challenges experience the timeline from diagnosis and until 4 months after, how the diagnosis impacts the lives of these individuals, and what they believe as beneficial in returning to their everyday life.
These participants with self-reported lasting challenges experienced substantial impacts on physical, psychological and social domains. Further, they felt alone with their struggles and when in need of support from the healthcare system, it failed to provide this. A pressure to return to work and a lack of trust in the general practitioner affected return to everyday life negatively, whereas close and supportive relations facilitated positively.
This study will have an impact on the healthcare professionals that provide support and the (limited) follow-up services to patients after TIA. These healthcare professionals are often specialized nurses who need to know what these patients experience and need in order to act upon their struggles and provide timely support.
The Standards of Reporting Qualitative Research (SRQR).
Patients with TIA was involved in planning this study. They participated in a panel to plan a prospective observational cohort study and emphasized the importance of exploring the subjective perspectives of impact and prognosis for those patients struggling in a longer term (through qualitative interviews).