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Background. To evaluate safety of filgotinib in terms of frequency, severity, and type of adverse events (AEs) and to identify predictors of AEs in a multicentre cohort of patients with rheumatoid arthritis (RA).   Materials and Methods. This is a prospective multicentre study that included patients with RA (ACR/EULAR 2010 criteria) treated with filgotinib in six different Italian centres. At follow-up visits, conducted every 3-6 months, AEs were recorded and classified as attributable to drug use with almost certain/high/low/no probability according to clinical judgement. AEs were described as severe in accordance with the EMA definition. Possible risk factors for AEs were examined using the t-test, chi-square test or Fisher's exact test as appropriate. The analysis was performed using SPSS version 29.   Results. A total of 190 patients with RA were enrolled, with a mean age of 59±11 years and a mean disease duration of 17±10 years. The mean baseline Charlson Comorbidity Index (CCI) was 2±1 (Table 1). Out of 463 follow-up visits, 128 AEs and one death were recorded, the latter considered unlikely to be associated with filgotinib use (Table 2). The most frequent AEs were infections (53 events), only 5 of which were classified as severe (9.5%). We recorded 18 AEs attributable to cardiovascular risk, all of which were considered mild except for one serious cardiovascular event, which was judged unlikely to be drug-related (Table 2). Overall, in 8% of cases, AE was considered almost certainly associated with the use of the drug, while in 27% of cases, the association was denied (Table 2). AEs caused discontinuation of therapy in 14 cases (7.3% of patients). The only factor associated with AEs that emerged at multiple time points was male gender (6 months p=0.04, 12 months p=0.02, 24 months p=0.04). Besides, a lower baseline CCI was associated with a significant reduction in AEs at 24 months (p<0.001).   Conclusions. In a large cohort of patients with RA, non-severe infections were the most frequent AE. No clinical or therapeutic risk factors (e.g., concomitant use of csDMARDs, steroid dose) associated with AEs emerged. As expected, the presence of comorbidities, assessed using the CCI, was associated with an increased risk of AEs in the long term. 

Background Survivors of intensive care are known to be at increased risk of developing longer-term psychopathology issues. We present a large UK multicentre study assessing the anxiety, depression and post-traumatic stress disorder (PTSD) caseness in the first year following discharge from an intensive care unit (ICU). Methods Design: prospective multicentre follow-up study of survivors of ICU in the UK. Setting: patients from 26 ICUs in the UK. Inclusion criteria: patients who had received at least 24 h of level 3 ICU care and were 16 years of age or older. Interventions: postal follow up: Hospital Anxiety and Depression Score (HADS) and the Post-Traumatic Stress Disorder (PTSD) Check List-Civilian (PCL-C) at 3 and 12 months following discharge from ICU. Main outcome measure: caseness of anxiety, depression and PTSD, 2-year survival. Results In total, 21,633 patients admitted to ICU were included in the study. Postal questionnaires were sent to 13,155 survivors; of these 38% (4943/13155) responded and 55% (2731/4943) of respondents passed thresholds for one or more condition at 3 or 12 months following discharge. Caseness prevalence was 46%, 40% and 22% for anxiety, depression and PTSD respectively; 18% (870/4943 patients) met the caseness threshold for all three psychological conditions. Patients with symptoms of depression were 47% more likely to die during the first 2 years after discharge from ICU than those without (HR 1.47, CI 1.19–1.80). Conclusions Over half of those who respond to postal questionnaire following treatment on ICU in the UK reported significant symptoms of anxiety, depression or PTSD. When symptoms of one psychological disorder are present, there is a 65% chance they will co-occur with symptoms of one of the other two disorders. Depression following critical illness is associated with an increased mortality risk in the first 2 years following discharge from ICU. Trial registration ISRCTN Registry, ISRCTN69112866 . Registered on 2 May 2006.

Background Major Depressive Disorder (MDD) is prevalent, often chronic, and requires ongoing monitoring of symptoms to track response to treatment and identify early indicators of relapse. Remote Measurement Technologies (RMT) provide an opportunity to transform the measurement and management of MDD, via data collected from inbuilt smartphone sensors and wearable devices alongside app-based questionnaires and tasks. A key question for the field is the extent to which participants can adhere to research protocols and the completeness of data collected. We aimed to describe drop out and data completeness in a naturalistic multimodal longitudinal RMT study, in people with a history of recurrent MDD. We further aimed to determine whether those experiencing a depressive relapse at baseline contributed less complete data. Methods Remote Assessment of Disease and Relapse – Major Depressive Disorder (RADAR-MDD) is a multi-centre, prospective observational cohort study conducted as part of the Remote Assessment of Disease and Relapse – Central Nervous System (RADAR-CNS) program. People with a history of MDD were provided with a wrist-worn wearable device, and smartphone apps designed to: a) collect data from smartphone sensors; and b) deliver questionnaires, speech tasks, and cognitive assessments. Participants were followed-up for a minimum of 11 months and maximum of 24 months. Results Individuals with a history of MDD ( n  = 623) were enrolled in the study,. We report 80% completion rates for primary outcome assessments across all follow-up timepoints. 79.8% of people participated for the maximum amount of time available and 20.2% withdrew prematurely. We found no evidence of an association between the severity of depression symptoms at baseline and the availability of data. In total, 110 participants had > 50% data available across all data types. Conclusions RADAR-MDD is the largest multimodal RMT study in the field of mental health. Here, we have shown that collecting RMT data from a clinical population is feasible. We found comparable levels of data availability in active and passive forms of data collection, demonstrating that both are feasible in this patient group.

Dry skin and pressure injuries in older persons have become global health care problems. This was a multicentre, prospective cross‐sectional study in 44 hospitals and 8 long term care institutions from 20 provinces, autonomous regions and municipalities in China and aimed to explore the relationship between the two skin problems in older patients. We mainly found 11 602 cases with dry skin and 1076 cases with pressure injuries in a total of 33 769 valid participants. The overall prevalence of dry skin and pressure injuries was 34.4% (95% confidence interval [CI] 33.9–34.9) and 3.1% (95% CI 2.9–3.3). Stage 2+ pressure injuries were the most (32.9%), followed by stage 1 (32.4%). The patients with dry skin had more pressure injuries than ones without dry skin (50.0% vs 33.9%). The patients with very severe and severe dry skin had more pressure injury risk (OR 2.22 and 1.90) and more stage 2+ pressure injury risk (OR 2.83 and 1.63). Other nine predictors associated with overall pressure injuries and stage 2+ pressure injuries. The area under receiver operating characteristic (ROC) curve of the predictive models of overall pressure injuries and stage 2+ pressure injuries were 0.89 (95% CI 0.88–0.90) and 0.91 (95% CI 0.90–0.92), respectively.

•Compulsory vaccination is generally welcome in Italy.•Mandatory vaccinations are not affected by social determinants.•Confidence in the health system determines the trustworthiness of mandatory vaccination. Vaccine hesitancy is a considerable issue in European countries and leads to low coverage rates. After a long debate, Italy has made vaccination mandatory for admission to its schools. In the NAVIDAD study (a cross-sectional multicentre study), a 63-item questionnaire was administered to 1820 pregnant women from 15 Italian cities. The questionnaire assessed the interviewee's opinion on mandatory vaccines, as well as their socioeconomic status, sources of information about vaccines, confidence in the Italian National Healthcare Service (NHS), and intention to vaccinate their newborn. Information sources play a key role in determining the opinion on restoration of mandatory vaccines; in particular, women who obtained information from anti-vaccination movements are less likely to accept the vaccines (OR: 0.35, 95% CI: 0.21–0.58, p < 0.001). Women who had confidence in healthcare professional information agreed more on mandatory vaccination than did the other women (OR: 2.66, 95% CI: 1.62–4.36, p < 0.001); those who perceived that healthcare professionals have economic interest in child immunization and who declared that healthcare providers inform only on vaccinations benefits not on risks were less likely to agree on compulsory vaccination (OR: 0.66, CI 95%: 0.46–0.96, p = 0.03; OR: 0.66, CI 95%: 0.46–0.95, p = 0.03, respectively). Information sources and confidence towards health professionals are the main determinants of acceptance of mandatory vaccine restoration. To increase the acceptability of the restoration and reduce vaccine hesitancy, these aspects need to be strengthened.

Type-2 diabetes mellitus (DM) is associated with an increased risk of atrial fibrillation (AF). It is unclear whether DM is a risk factor for arrhythmia recurrence following catheter ablation of AF. We performed a nonrandomised, observational study in 7 high-volume European centres. A total of 2,504 patients who underwent catheter ablation of AF were included, and procedural outcomes were compared among patients with or without DM. Patients with DM (234) accounted for 9.3% of the sample, and were significantly older, had a higher BMI and suffered more frequently from persistent AF. Arrhythmia relapses at 12 months after AF ablation occurred more frequently in the DM group (32.0% vs 25.3%, p = 0.031). After adjusting for type of AF (i.e., paroxysmal vs persistent), during a median follow-up of 17 ± 16 months, atrial arrhythmia free-survival was lower in the diabetics with persistent AF (log-rank p = 0.003), and comparable for paroxysmal AF (log-rank p = 0.554). These results were confirmed in a propensity-matched analysis, and DM was also an independent predictor of AF recurrence on the multivariate analysis (hazard ratio 1.39; 95% confidence interval 95%1.07 to 1.88; p = 0.016). There was no significant difference in the rate of periprocedural complications among DM and non-DM patients (3.8% vs 6.3%, p = 0.128). Efficacy and safety of cryoballoon ablation were comparable to radiofrequency ablation in both DM and no-DM groups. In conclusion, catheter ablation of AF appears to be safe in patients with DM. However, DM is associated with higher rate of atrial arrhythmia relapse, particularly for patients with persistent AF.

Background Visceral obesity is associated with high cardiovascular events risk in type 2 diabetes mellitus (T2DM). Whether normal-weight visceral obesity will pose a higher atherosclerotic cardiovascular disease (ASCVD) risk than body mass index (BMI)-defined overweight or obese counterparts with or without visceral obesity remains unclear. We aimed to explore the relationship between general obesity and visceral obesity and 10-year ASCVD risk in patients with T2DM. Methods Patients with T2DM (6997) who satisfied the requirements for inclusion were enrolled. Patients were considered to have normal weight when 18.5 kg/m 2  ≤ BMI < 24 kg/m 2 ; overweight when 24 kg/m 2  ≤ BMI < 28 kg/m 2 ; and obesity when BMI ≥ 28 kg/m 2 . Visceral obesity was defined as a visceral fat area (VFA) ≥ 100 cm 2 . Patients were separated into six groups based on BMI and VFA. The odd ratios (OR) for a high 10-year ASCVD risk for different combinations of BMI and VFA were analysed using stepwise logistic regression. Receiver operating characteristic (ROC) curves for diagnosing the high 10-year ASCVD risk were constructed, and areas under the ROC curves were estimated. Potential non-linear relationships between VFA levels and high 10-year ASCVD risk were examined using restricted cubic splines (knot = 4). Multilinear regression was used to identify factors affecting VFA in patients with T2DM. Results In patients with T2DM, subjects with normal-weight visceral obesity had the highest 10-year ASCVD risk among the six groups, which had more than a 2-fold or 3-fold higher OR than those who were overweight or obese according to BMI but did not have visceral obesity (all P < 0.05). The VFA threshold for high 10-year ASCVD risk was 90 cm 2 . Multilinear regression showed significant differences in the effect of age, hypertension, drinking, fasting serum insulin, fasting plasma glucose, 2 h postprandial C-peptide, triglyceride, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol on VFA in patients with T2DM (all P < 0.05). Conclusions T2DM patients with normal-weight visceral obesity had a higher 10-year ASCVD risk than BMI-defined overweight or obese counterparts with or without visceral obesity, which should initiate standardised management for ASCVD primary prevention.

PurposeDosimetry is rarely performed for the treatment of differentiated thyroid cancer patients with Na[131I]I (radioiodine), and information regarding absorbed doses delivered is limited. Collection of dosimetry data in a multi-centre setting requires standardised quantitative imaging and dosimetry. A multi-national, multi-centre clinical study was performed to assess absorbed doses delivered to normal organs for differentiated thyroid cancer patients treated with Na[131I]I.MethodsPatients were enrolled in four centres and administered fixed activities of 1.1 or 3.7 GBq of Na[131I]I using rhTSH stimulation or under thyroid hormone withdrawal according to local protocols. Patients were imaged using SPECT(/CT) at variable imaging time-points following standardised acquisition and reconstruction protocols. Whole-body retention data were collected. Dosimetry for normal organs was performed at two dosimetry centres and results collated.ResultsOne hundred and five patients were recruited. Median absorbed doses per unit administered activity of 0.44, 0.14, 0.05 and 0.16 mGy/MBq were determined for the salivary glands of patients treated at centre 1, 2, 3 and 4, respectively. Median whole-body absorbed doses for 1.1 and 3.7 GBq were 0.05 Gy and 0.16 Gy, respectively. Median whole-body absorbed doses per unit administered activity of 0.04, 0.05, 0.04 and 0.04 mGy/MBq were calculated for centre 1, 2, 3 and 4, respectively.ConclusionsA wide range of normal organ doses were observed for differentiated thyroid cancer patients treated with Na[131I]I, highlighting the necessity for individualised dosimetry. The results show that data may be collated from multiple centres if minimum standards for the acquisition and dosimetry protocols can be achieved.

Markerless motion capture addresses key barriers limiting the clinical uptake of biomechanical assessments by enabling efficient data collection and standardized modeling, making it well-suited for multicentre research. This study assessed whether gait deviations associated with knee osteoarthritis (OA) could be consistently detected using markerless motion capture across three clinical centres in Canada. Gait data from 486 participants (351 with knee OA; 135 controls) were analyzed, with body segment kinematics estimated from video using Theia3D. Principal component analysis and linear models were used to evaluate joint kinematics and temporal-distance parameters across groups and sites. After pooling data across centres, individuals with knee OA exhibited characteristic gait deviations, including slower walking speed, reduced hip, knee, and ankle range of motion, and increased knee adduction, compared to controls. These deviations were observed consistently across all three centres. Inter-site differences in joint kinematics were minor (RMS < 3°), remained within reported inter-site error thresholds from marker-based systems, and did not obscure group-level effects. These findings demonstrate that clinically meaningful gait deviations can be reliably detected using markerless motion capture in varied clinical environments without extensive standardization. This work supports its use in multicentre studies and highlights its potential to enable large-scale biomechanical research, an essential step toward broader clinical integration of movement analysis.