Post-COVID-19 syndrome (PCS) is characterised by persistent symptoms, such as fatigue, dyspnoea, depression and sleep problems, following SARS-CoV-2 infection. The long-term course and impact on quality of life remain unclear. This review aims to synthesise evidence on longitudinal changes in symptom prevalence, severity and health-related quality of life (HRQoL) in adults with PCS.

This systematic review will include longitudinal studies (randomised controlled trials, non-randomised trials, prospective and retrospective cohort studies) of adults (≥18 years) with PCS, defined by symptoms persisting beyond 4 weeks after acute infection. Eligible studies must report changes in prevalence or severity of fatigue, dyspnoea, depression, sleep problems or HRQoL from baseline to at least one follow-up visit.

We will systematically search MEDLINE, Embase, PsycINFO, Web of Science, Scopus, CINAHL and Epistemonikos, with no restrictions on language, date or publication status. Two reviewers will independently screen studies, extract data and assess risk of bias using validated tools appropriate to study design. Disagreements will be resolved by consensus or a third reviewer.

A narrative synthesis will summarise study characteristics and symptom trajectories. Where sufficient data are available, random-effects meta-analyses will be conducted to estimate pooled changes in symptom prevalence (ORs), severity ((standardised) mean differences) and HRQoL ((standardised) mean differences). Meta-regression and subgroup analyses will explore potential effect modifiers. Certainty of evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

No ethical approval is required. Findings will be disseminated via peer-reviewed publication, conference presentations and plain language summaries.

CRD420251011612.

To identify predictors of treatment changes and to evaluate the effectiveness and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) initiating tofacitinib in a real-world setting.

The non-interventional study ESCALATE-RA included 1518 patients with RA from Germany. RA treatment, including all changes in therapy, was documented for 24 months starting from the initial intake of tofacitinib.

All patients started with tofacitinib therapy, either as monotherapy or in combination with methotrexate (MTX).

The impact of several factors of interest on the number and timing of treatment changes was assessed as primary outcome using Cox proportional hazards models. Further outcomes were tofacitinib drug survival and the use of follow-up disease-modifying antirheumatic drugs after first treatment change. We also assessed the effectiveness, concomitant glucocorticoid (GC) use, PROs (such as functional ability, patient satisfaction, pain and quality of life) and safety. Analyses were based on observed data.

‘Lack of efficacy’ (HR 3.30) and ‘intolerance’ (HR 4.43) leading to termination of tofacitinib were key factors favouring therapy changes. Higher patient satisfaction was significantly associated with a reduced likelihood of treatment changes (HR 0.82). Increasing GC doses were associated with a higher probability of step-up/switch changes (HR 1.21). The estimated tofacitinib drug survival was 48% at the end of study. Proportions of patients achieving low disease activity (both Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) 62%) and remission (SDAI 25%, CDAI 28%) increased from baseline under tofacitinib and were comparable between monotherapy and combination therapy with MTX. Mean concomitant GC dose decreased (2 mg/day). PROs indicated reduced pain and fatigue, while functional ability and quality of life improved. 63.9% of the patients experienced a treatment-emergent adverse event (AE), 8.8% a treatment-emergent AE of special interest and deaths occurred in 0.5%.

Key factors for therapy changes in patients with RA treated with tofacitinib were lack of efficacy and intolerance. Higher patient satisfaction was associated with a reduced probability of treatment changes, while increased GC doses led to a higher likelihood of step-ups/switches. Patients demonstrated a marked reduction in disease activity for up to 24 months, along with improvements in functional ability, pain and quality of life. Observed AEs were consistent with the known safety profile of tofacitinib.

NCT03387423.

Traditional epidemiological approaches usually assume a constant relationship between cumulative exposure and disease, which implies that exposure duration and intensity contribute equally to the studied outcome. But individuals with the same cumulative exposure but different temporal exposure patterns may show different risks. Trajectory classification is a good way to assess exposure–risk associations and leads to a better understanding of lifetime variability in exposure levels. Therefore, this study aimed to estimate lung cancer risk according to the exposure trajectory classes on welding fumes and cigarette smoking.

Two population-based German case–control studies.

3498 male lung cancer cases and 3539 male control subjects.

Separate latent class mixed models (LCMM) were determined to identify profiles of exposure trajectories of cigarette smoking and occupational exposure to welding fumes. To investigate the risk of lung cancer by class membership, ORs with 95% CI were estimated via multiple logistic regression analyses.

LCMM each identified four latent classes of smoking and welding-fume exposure. Classes of smokers showed much higher risk of lung cancer compared with never smokers or subjects exposed to welding fumes. Smokers in one class characterised with the highest exposure over the past 10 years had the highest adjusted lung cancer risk (OR=39; 95% CI 29 to 53). For welding, the highest lung cancer risks were found for the class in which exposure to welding fumes in the past 10 years prior to the diagnosis of lung cancer was highest and the duration of welding was also quite high (OR=1.71; 95% CI 0.92 to 3.15).

In summary, LCMM opens a new perspective on dose–effect relationships and could be employed to complement established epidemiological methods.

The Research Domain Criteria (RDoC) approach initiated by the National Institute of Mental Health provides a comprehensive framework for guiding research on mental illness and health. Since retrospective studies have indicated associations between RDoC characteristics and clinically relevant as well as care-relevant outcomes, there is a need for prospective, theory-driven investigations that systematically link a priori defined assessments of RDoC constructs to clinically and care-relevant outcomes in a transdiagnostic psychiatric sample.

This prospective observational study assesses six domains—Positive Valence Systems, Negative Valence Systems, Cognitive Systems, Social Processes, Arousal and Regulatory Systems and Sensorimotor Systems—employing a comprehensive set of self-report and additional paradigms to assess cognitive functioning developed a priori in alignment with the RDoC framework while also assessing clinically and care-relevant variables (eg, length of hospital stay). A total of 300 adult participants will be recruited among in- and outpatients of two psychiatric hospitals in Germany (patient group) as well as from the general population (healthy control group). Including healthy individuals will allow for the investigation of continuous variations in psychological functioning rather than categorical distinctions between health and disease. Data collection includes self-reports, clinician ratings, file review and behavioural assessments. Electroencephalography is recorded in a subgroup of participants. A confirmatory factor analysis will be conducted to reproduce the factor structure and regression models will be used to investigate associations between RDoC domains and clinically relevant as well as care-related variables.

Ethics approval was obtained from the local ethics committee of the Brandenburg Medical School—Theodor Fontane (E-01-20220822). Results will be disseminated through peer-reviewed journals and academic conferences.

Forcibly displaced children and adolescents in the WHO European Region have high mental health needs, yet few manage to access mental health services and even fewer receive high-quality care. Addressing this gap is crucial, as inadequate mental health support has profound and lasting negative effects on individuals, families and communities. This scoping review aims to identify and synthesise the available evidence on the barriers and facilitators to quality mental healthcare for forcibly displaced children and adolescents in the WHO European Region.

Quantitative, qualitative and mixed-method studies that examine barriers and facilitators of quality mental healthcare for forcibly displaced children and adolescents in the WHO European Region will be included. Eligible participants include forcibly displaced children and adolescents, mental healthcare providers, policymakers and humanitarian actors in the mental health and psychosocial support field. We will adhere to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews) guidelines. A comprehensive search of databases, including Embase, Medline, PsycINFO, Scopus and Web of Science, will be conducted. We will systematically search for relevant studies published between January 2004 and December 2024. At least two reviewers will independently screen titles, abstracts and full texts. Data extraction will involve systematically charting relevant information from included studies. We will use the WHO Quality Standards for Child and Adolescent Mental Health Services as an analytical lens to map the evidence. Our study will provide a comprehensive overview of the barriers and facilitators to quality mental healthcare for forcibly displaced children and adolescents, and identify knowledge gaps and areas for potential quality improvement.

Ethical approval will not be required since this study will retrieve data from already published research and no new data will be collected. The results of this study will be published in a peer-reviewed journal and presented at international conferences in order to disseminate to academic and non-academic stakeholders such as non-governmental organisations, government bodies and community organisations involved in mental healthcare for forcibly displaced persons.

https://doi.org/10.17605/OSF.IO/AK74F.