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Abstract Background In patients with axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA), concomitant depression might have a negative impact on the course of disease and treatment outcomes. The aims of this analysis are to determine the prevalence of depressive symptoms in axSpA and PsA patients in a real-world cohort study and to identify sociodemographic and clinical associated factors for moderate or severe depressive symptoms in both diseases. Methods Patients from the RABBIT-SpA cohort with an axSpA or PsA diagnosis and a valid WHO-5 Well-Being Index score at baseline were included. A descriptive analysis of baseline and outcome parameters by category of depressive symptoms was performed and factors associated with the presence of depressive symptoms (moderate or severe) were examined in a logistic regression. Results Two thousand four hundred seventy patients (1,245 axSpA; 1,225 PsA) were included in the analysis. In both diagnoses, the proportion of patients with moderate depressive symptoms was 8% and 21% with severe symptoms. Patients with moderate or severe depressive symptoms were less likely to engage in sports than those with no or mild depressive symptoms, had more comorbidities and higher scores for disease activity, functional limitations, fatigue, and pain and took more analgesics. In axSpA, patients with a higher disease activity, a greater functional impairment and more severe fatigue were more likely to experience depressive symptoms, while patients with more years in education and engaging in sports for at least 1 h/week were less likely to experience depressive symptoms. PsA patients with a greater functional impairment and more severe fatigue were more likely to experience depressive symptoms while those engaging in sports for at least 1 h/week were less likely to experience depressive symptoms. Conclusion We confirmed a high prevalence of depressive symptoms in both PsA and axSpA. Factors negatively associated with the presence of depressive symptoms were fatigue, not engaging in sports, and greater functional limitations. Depressive symptoms may affect the perception of disease activity / severity by patients. Thus, depressive symptoms are an important condition in axSpA and PsA that should be considered when evaluating disease activity and treatment outcomes.

Abstract Background Clinical data collection requires correct and complete data sets in order to perform correct statistical analysis and draw valid conclusions. While in randomized clinical trials much effort concentrates on data monitoring, this is rarely the case in observational studies- due to high numbers of cases and often-restricted resources. We have developed a valid and cost-effective monitoring tool, which can substantially contribute to an increased data quality in observational research. Methods An automated digital monitoring system for cohort studies developed by the German Rheumatism Research Centre (DRFZ) was tested within the disease register RABBIT-SpA, a longitudinal observational study including patients with axial spondyloarthritis and psoriatic arthritis. Physicians and patients complete electronic case report forms (eCRF) twice a year for up to 10 years. Automatic plausibility checks were implemented to verify all data after entry into the eCRF. To identify conflicts that cannot be found by this approach, all possible conflicts were compiled into a catalog. This “conflict catalog” was used to create queries, which are displayed as part of the eCRF. The proportion of queried eCRFs and responses were analyzed by descriptive methods. For the analysis of responses, the type of conflict was assigned to either a single conflict only (affecting individual items) or a conflict that required the entire eCRF to be queried. Results Data from 1883 patients was analyzed. A total of n = 3145 eCRFs submitted between baseline (T0) and T3 (12 months) had conflicts (40–64%). Fifty-six to 100% of the queries regarding eCRFs that were completely missing were answered. A mean of 1.4 to 2.4 single conflicts occurred per eCRF, of which 59–69% were answered. The most common missing values were CRP, ESR, Schober’s test, data on systemic glucocorticoid therapy, and presence of enthesitis. Conclusion Providing high data quality in large observational cohort studies is a major challenge, which requires careful monitoring. An automated monitoring process was successfully implemented and well accepted by the study centers. Two thirds of the queries were answered with new data. While conventional manual monitoring is resource-intensive and may itself create new sources of errors, automated processes are a convenient way to augment data quality.

Abstract Background Physical activity referral schemes (PARS) are composed of various components, such as a written prescription or a person-centered approach. The role of these components in their effectiveness is yet to be understood. Therefore, we aimed to explore the relationships between PARS components and physical activity, scheme uptake, and adherence rate; and to estimate the effect of PARS. Methods We searched Scopus, PubMed, Web of Science, CINAHL, ScienceDirect, SpringerLink, HTA, Wiley Online Library, SAGE Journals, Taylor & Francis, Google Scholar, OpenGrey, and CORE. Eligible studies were published between 1990 and November 2023 in English or German, investigated PARS with participants aged ≥ 16 years, and reported physical activity, scheme uptake, or scheme adherence. Separate random-effects meta-analysis by comparison group were conducted for physical activity. Scheme uptake and adherence rates were pooled using proportional meta-analysis. The components were analyzed via univariate meta-regression. We rated the risk of bias using RoB2 and ROBINS-I, and the certainty of evidence using GRADE. Results Fifty-two studies were included. PARS were more effective in increasing physical activity than usual care (k = 11, n = 5046, Hedges’ g = 0.18, 95%CI 0.12 to 0.25; high certainty of evidence). When PARS were compared with physical activity advice or enhanced scheme versions, the pooled Hedges’ g values for physical activity were -0.06 (k = 5, n = 1082, 95%CI -0.21 to 0.10; low certainty of evidence), and 0.07 (k = 9, n = 2647, 95%CI -0.03 to 0.18; low certainty of evidence) respectively. Scheme uptake was 87% (95%CI 77% to 94%, k = 14, n = 5000) across experimental studies and 68% (95%CI 51% to 83%, k = 14, n = 25,048) across non-experimental studies. Pooled scheme adherence was 68% (95%CI 55% to 80%, k = 16, n = 3939) and 53% (95%CI 42% to 63%, k = 18, n = 14,605). The meta-regression did not detect any significant relationships between components and physical activity or scheme uptake. A person-centered approach, screening, and brief advice were positively associated with scheme adherence, while physical activity sessions were negatively associated. Conclusion PARS are more effective in increasing physical activity than usual care only. We did not identify any components as significant predictors of physical activity and scheme uptake. Four components predicted scheme adherence, indicating that the component-effectiveness relationship warrants further research.

Abstract Background Physical activity referral schemes (PARS) are complex multicomponent interventions that represent a promising healthcare-based concept for physical activity (PA) promotion. This systematic review and narrative synthesis aimed to identify the constitutive components of PARS and provide an overview of their effectiveness. Methods Following a published protocol, we conducted a systematic search of PubMed, Scopus, Web of Science, CINAHL, ScienceDirect, SpringerLink, HTA, Wiley Online Library, SAGE Journals, Taylor & Francis, Google Scholar, OpenGrey, and CORE from 1990 to January 2023. We included experimental, quasi-experimental, and observational studies that targeted adults participating in PARS and reported PA outcomes, scheme uptake, or adherence rates. We performed an intervention components analysis using the PARS taxonomy to identify scheme components and extracted data related to uptake, adherence, and PA behavior change. We combined these to provide a narrative summary of PARS effectiveness. Results We included 57 studies reporting on 36 PARS models from twelve countries. We identified 19 PARS components: a patient-centered approach, individualized content, behavior change theory and techniques, screening, brief advice, written materials, a written prescription, referral, baseline and exit consultation, counselling support session(s), PA sessions, education session(s), action for non-attendance, structured follow-up, a PA network, feedback for the referrer, and exit strategies/routes. The PARS models contained a mean of 7 ± 2.9 components (range = 2–13). Forty-five studies reported PA outcome data, 28 reported uptake, and 34 reported adherence rates. Of these, approximately two-thirds of studies reported a positive effect on participant PA levels, with a wide range of uptake (5.7–100.0%) and adherence rates (8.5–95.0%). Conclusions Physical activity referral scheme components are an important source of complexity. Despite the heterogeneous nature of scheme designs, our synthesis was able to identify 19 components. Further research is required to determine the influence of these components on PARS uptake, adherence, and PA behavior change. To facilitate this, researchers and scheme providers must report PARS designs in more detail. Process evaluations are also needed to examine implementation and increase our understanding of what components lead to which outcomes. This will facilitate future comparisons between PARS and enable the development of models to maximize impact.

Abstract Background While effective physical activity referral schemes (PARSs) and related structures for promoting physical activity (PA) already exist in several countries, in Germany, PARSs have not yet been implemented systematically and nationwide. Through a co-production approach with relevant actors in the German healthcare system, a PARS was developed, and an implementation plan was created (e.g. financing). This study protocol aims to evaluate the developed PARS for people with non-communicable diseases (NCDs) in Germany regarding its potential effectiveness and implementation success. Methods To evaluate the effectiveness and implementation success of the PARS, we will apply a pragmatic cluster-randomised controlled trial (cRCT) in Hybrid II design by comparing two intervention groups (PARS vs PA advice [PAA]). The trial will take place in the Nürnberg metropolitan region, with 24 physician practices recruiting 567 people with NCDs. Both groups will receive brief PA advice from a physician to initially increase the participants’ motivation to change their activity level. Subsequently, the PARS group will be given individualised support from an exercise professional to increase their PA levels and be transferred to local exercise opportunities. In contrast, participants in the PAA group will receive only the brief PA advice as well as information and an overview of regional PA offerings to become more active at their own initiative. After 12 and 24 weeks, changes in moderate to vigorous PA and in physical activity-related health competence (movement competence, control competence, self-regulation competence) will be measured as primary outcomes. Secondary outcomes will include changes in quality of life. To measure implementation success, we refer to the RE-AIM framework and draw on patient documentation, interviews, focus groups and surveys of the participating actors (physicians, exercise professionals). Discussion Through a between-group comparison, we will investigate whether additional individual support by an exercise professional compared to brief PA advice alone leads to higher PA levels in people with NCDs. The acceptance and feasibility of both interventions in routine care in the German healthcare system will also be evaluated. Trial registration ClinicalTrials.gov, NCT04947787 . Registered 01 June 2021.