Oral abstracts 3: RA Treatment and outcomesO13. Validation of jadas in all subtypes of juvenile idiopathic arthritis in a clinical setting

Background: Juvenile Arthritis Disease Activity Score (JADAS) is a 4 variable composite disease activity (DA) score for JIA (including active 10, 27 or 71 joint count (AJC), physician global (PGA), parent/child global (PGE) and ESR). The validity of JADAS for all ILAR subtypes in the routine clinical setting is unknown. We investigated the construct validity of JADAS in the clinical setting in all subtypes of JIA through application to a prospective inception cohort of UK children presenting with new onset inflammatory arthritis. Methods: JADAS 10, 27 and 71 were determined for all children in the Childhood Arthritis Prospective Study (CAPS) with complete data available at baseline. Correlation of JADAS 10, 27 and 71 with single DA markers was determined for all subtypes. All correlations were calculated using Spearman's rank statistic. Results: 262/1238 visits had sufficient data for calculation of JADAS (1028 (83%) AJC, 744 (60%) PGA, 843 (68%) PGE and 459 (37%) ESR). Median age at disease onset was 6.0 years (IQR 2.6-10.4) and 64% were female. Correlation between JADAS 10, 27 and 71 approached 1 for all subtypes. Median JADAS 71 was 5.3 (IQR 2.2-10.1) with a significant difference between median JADAS scores between subtypes (p < 0.01). Correlation of JADAS 71 with each single marker of DA was moderate to high in the total cohort (see Table 1). Overall, correlation with AJC, PGA and PGE was moderate to high and correlation with ESR, limited JC, parental pain and CHAQ was low to moderate in the individual subtypes. Correlation coefficients in the extended oligoarticular, rheumatoid factor negative and enthesitis related subtypes were interpreted with caution in view of low numbers. Conclusions: This study adds to the body of evidence supporting the construct validity of JADAS. JADAS correlates with other measures of DA in all ILAR subtypes in the routine clinical setting. Given the high frequency of missing ESR data, it would be useful to assess the validity of JADAS without inclusion of the ESR. Disclosure statement: All authors have declared no conflicts of interest. Table 1Spearman's correlation between JADAS 71 and single markers DA by ILAR subtype ILAR Subtype Systemic onset JIA Persistent oligo JIA Extended oligo JIA Rheumatoid factor neg JIA Rheumatoid factor pos JIA Enthesitis related JIA Psoriatic JIA Undifferentiated JIA Unknown subtype Total cohort Number of children 23 111 12 57 7 9 19 7 17 262 AJC 0.54 0.67 0.53 0.75 0.53 0.34 0.59 0.81 0.37 0.59 PGA 0.63 0.69 0.25 0.73 0.14 0.05 0.50 0.83 0.56 0.64 PGE 0.51 0.68 0.83 0.61 0.41 0.69 0.71 0.9 0.48 0.61 ESR 0.28 0.31 0.35 0.4 0.6 0.85 0.43 0.7 0.5 0.53 Limited 71 JC 0.29 0.51 0.23 0.37 0.14 -0.12 0.4 0.81 0.45 0.41 Parental pain 0.23 0.62 0.03 0.57 0.41 0.69 0.7 0.79 0.42 0.53 Childhood health assessment questionnaire 0.25 0.57 -0.07 0.36 -0.47 0.84 0.37 0.8 0.66 0.4

Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study

Background: The impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on postoperative recovery needs to be understood to inform clinical decision making during and after the COVID-19 pandemic. This study reports 30-day mortality and pulmonary complication rates in patients with perioperative SARS-CoV-2 infection. Methods: This international, multicentre, cohort study at 235 hospitals in 24 countries included all patients undergoing surgery who had SARS-CoV-2 infection confirmed within 7 days before or 30 days after surgery. The primary outcome measure was 30-day postoperative mortality and was assessed in all enrolled patients. The main secondary outcome measure was pulmonary complications, defined as pneumonia, acute respiratory distress syndrome, or unexpected postoperative ventilation. Findings: This analysis includes 1128 patients who had surgery between Jan 1 and March 31, 2020, of whom 835 (74·0%) had emergency surgery and 280 (24·8%) had elective surgery. SARS-CoV-2 infection was confirmed preoperatively in 294 (26·1%) patients. 30-day mortality was 23·8% (268 of 1128). Pulmonary complications occurred in 577 (51·2%) of 1128 patients; 30-day mortality in these patients was 38·0% (219 of 577), accounting for 81·7% (219 of 268) of all deaths. In adjusted analyses, 30-day mortality was associated with male sex (odds ratio 1·75 [95% CI 1·28–2·40], p\textless0·0001), age 70 years or older versus younger than 70 years (2·30 [1·65–3·22], p\textless0·0001), American Society of Anesthesiologists grades 3–5 versus grades 1–2 (2·35 [1·57–3·53], p\textless0·0001), malignant versus benign or obstetric diagnosis (1·55 [1·01–2·39], p=0·046), emergency versus elective surgery (1·67 [1·06–2·63], p=0·026), and major versus minor surgery (1·52 [1·01–2·31], p=0·047). Interpretation: Postoperative pulmonary complications occur in half of patients with perioperative SARS-CoV-2 infection and are associated with high mortality. Thresholds for surgery during the COVID-19 pandemic should be higher than during normal practice, particularly in men aged 70 years and older. Consideration should be given for postponing non-urgent procedures and promoting non-operative treatment to delay or avoid the need for surgery. Funding: National Institute for Health Research (NIHR), Association of Coloproctology of Great Britain and Ireland, Bowel and Cancer Research, Bowel Disease Research Foundation, Association of Upper Gastrointestinal Surgeons, British Association of Surgical Oncology, British Gynaecological Cancer Society, European Society of Coloproctology, NIHR Academy, Sarcoma UK, Vascular Society for Great Britain and Ireland, and Yorkshire Cancer Research

Analysis of predictors of effect in a study of guided Internet-based Cognitive-Behavioral Therapy of Insomnia (ICBT-I)

Introduction: Understanding which factors predict iCBT-I's effectiveness can help referrers to select the target group of patients that benefit most or directly refer patients that are unlikely to benefit from this intervention to a more resource-intensive treatment setting. Methods: This is a post-hoc analysis of a three-arm randomized controlled trial (RCT) comparing the effectiveness of guided internet-based multi-component treatment (MCT), an internet-based guided sleep restriction treatment (ST), and care as usual (CAU) for 104 chronic insomnia patients (Krieger et al., 2019). Demographics (including social and work status, level of education), medical history (use of medication) and baseline scores of sleep quality, dysfunctional beliefs and attitudes about sleep, depressive symptoms, quality of life, personal significance of the sleep problems, and expectations about treatment success were obtained before the intervention. Primary outcome - the insomnia severity index (ISI) was assessed before and after the 8 weeks intervention. Since treatment groups in the RCT proved to be equally effective in reducing ISI, the MCT and ST groups were merged and compared to CAU. The ISI improvement from baseline to posttreatment was the dependent variable to assess the impact of predictors on the negative change in symptom severity over time (prognostic analysis) and response to treatment (predictive analysis). Predictors were analyzed with multiple linear regression models including ISI at baseline and condition (treatment or CAU). Results: Higher education (Std β = 0.88 score points, p = 0.033) and female gender (Std β = 1.65 for females vs. males, p = 0.051) had prognostic value for a better outcome in both arms. Individuals who consumed medications (Std β = −3.81, p = 0.059) and those expecting high therapy success showed better effect in treatment group (Std β = 1.33, p = 0.024). The worst ISI dynamic was in the CAU group participants with the high personal significance of sleep problem (Std β = 0.21, p = 0.071) and those who were divorced (Std β = 7.36, p = 0.0036). Conclusions: Findings indicate that insomnia patients receiving pharmacotherapy for insomnia, and those with a higher success expectancy regarding the intervention profit most of iCBT-I. Results suggest that patients requiring closer medical and/or psychological attention are those that are divorced and those who attribute a high personal relevance to sleep problems

Burden of illness of people with persistent symptoms of schizophrenia: A multinational cross-sectional study.

BACKGROUND Few studies have examined the impact of persistent symptoms of schizophrenia, especially with respect to patient-reported outcomes (PROs), carer burden and health economic impact. AIMS Analyse data relating to burden and severity of illness, functional impairment and quality of life for patients with persistent symptoms of schizophrenia. METHODS A cohort of stable outpatients with persistent symptoms of schizophrenia across seven countries were assessed in a multicentre, non-interventional, cross-sectional survey and retrospective medical record review using PRO questionnaires, clinical rating scales and carer questionnaires. RESULTS Overall, 1,421 patients and 687 carers were enrolled. Approximately two-thirds of patients had moderate/mild schizophrenia with more severe negative symptoms predominating. Patients showed impaired personal/social functioning and unsuitability for work correlated with various patient factors, most notably symptom-related assessments. Quality-of-life assessments showed 25% to ⩾30% of patients had problems with mobility, washing or dressing. Carer burden was also considerable, with carers having to devote an average of 20.5 hours per week and notable negative impact on quality-of-life measures. Healthcare resource utilisation for in-hospital, outpatient and other care provider visits was significant. CONCLUSION These results demonstrate the significant burden of schizophrenia for patients, carers and society and highlight the need for improved treatment approaches

Quantitative electroencephalography supports diagnosis of natalizumab-associated progressive multifocal leukoencephalopathy

Long-term treatment of multiple sclerosis with natalizumab (NTZ) carries the risk of a devastating complication in the form of an encephalopathy caused by a reactivation of a latent John Cunningham virus infection (progressive multifocal leucoencephalopathy, PML). Early diagnosis is associated with considerably better prognosis. Quantitative EEG as an objective, rater-independent technique provides high sensitivity (88) and specificity (82) for the diagnosis of NTZ-PML. Combination of diagnostic modalities addressing static morphological (brain MRI) as well as functional (EEG) pathologic changes may improve risk management programmes

Patterns of tocilizumab use, effectiveness and safety in patients with rheumatoid arthritis: core data results from a set of multinational observational studies.

OBJECTIVES To observe patients with rheumatoid arthritis (RA) treated with the interleukin-6 receptor-alpha inhibitor tocilizumab (TCZ) in routine clinical practice. METHODS Data on concomitant medications, effectiveness and safety were pooled from independent, multinational studies in patients with RA initiating intravenous TCZ according to local label recommendations observed in routine practice for 6 months. Patients were grouped by TCZ monotherapy or combination therapy with conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs). The primary endpoint was the proportion of patients receiving TCZ after 6 months. RESULTS Of 1336 patients enrolled, 506 (37.9%) received TCZ monotherapy and 830 (62.1%) received combination therapy. Kaplan-Meier analysis estimated that 80% (95% CI, 76%-83%) of monotherapy and 87% (95% CI, 84%-89%) of combination therapy patients continued to receive TCZ at 6 months (log-rank p<0.001). During the observation period, TCZ was discontinued by 113 (22.3%) monotherapy patients and 116 (14.0%) patients on combination therapy. The mean prednisone-equivalent oral corticosteroid dose was 8.4 mg/day for monotherapy and combination therapy patients at baseline and 7.7 and 7.6 mg/day, respectively, at month 6. Adverse events or laboratory abnormalities requiring TCZ dose modification were reported for 66 (13.0%) monotherapy and 130 (15.7%) combination therapy patients. Effectiveness at 6 months was similar between groups; mean (SD) change from baseline in Clinical Disease Activity Index (CDAI) was -20.3 (14.18) for monotherapy and -22.3 (16.09) for combination therapy (p=0.7347). CONCLUSIONS In routine clinical practice, 38% of patients received TCZ as monotherapy. Persistence on monotherapy or in combination therapy with csDMARDs was high, with a slight trend towards a higher rate with combination therapy, and effectiveness was similar between groups

Virtual car accidents of epilepsy patients, interictal epileptic activity, and medication.

OBJECTIVE To investigate effects of interictal epileptic activity (IEA) and antiepileptic drugs (AEDs) on reactivity and aspects of the fitness to drive for epilepsy patients. METHODS Forty-six adult patients with demonstration of focal or generalized bursts of IEA in electroencephalography (EEG) readings within 1 year prior to inclusion irrespective of medication performed a car driving computer test or a single light flash test (39 patients performed both). Reaction times (RTs), virtual crashes, or lapses (RT ≥ 1 s in the car or flash test) were measured in an IEA burst-triggered fashion during IEA and compared with RT-measurements during unremarkable EEG findings in the same session. RESULTS IEA prolonged RTs both in the flash and car test (p 26% in sessions with generalized IEA with s/w. The frequency of IEA-associated RT >1 s exceeded predictions (p < 0.001) based on simple RT shift, suggesting functional impairment beyond progressive RT prolongation by IEA. The number of AEDs correlated with prolonged RTs during normal EEG (p < 0.021) but not with IEA-associated RT prolongation or crashes/lapses. SIGNIFICANCE IEA prolonged RTs to varying extents, dependent on IEA type. IEA-associated RTs >1 s were more frequent than predicted, suggesting beginning cerebral decompensation of visual stimulus processing. AEDs somewhat reduced psychomotor speed, but it was mainly the IEA that contributed to an excess of virtual accidents