Janus kinase inhibitors and tumour necrosis factor inhibitors show a favourable safety profile and similar persistence in rheumatoid arthritis, psoriatic arthritis and spondyloarthritis: real-world data from the BIOBADASER registry.

OBJECTIVES: To compare the safety of Janus kinase inhibitors (JAKi) with that of tumour necrosis factor inhibitors (TNFi) and determine drug persistence among patients with rheumatoid arthritis (RA) and spondyloarthritis (SpA). METHODS: We analysed data from patients included in BIOBADASER 3.0 and treated with JAKi or TNFi from 2015 to 2023 and estimated the incidence rate ratio (IRR) of adverse events and persistence. RESULTS: A total of 6826 patients were included. Of these, 52% had RA, 25% psoriatic arthritis and 23% axial SpA. Treatment was with TNFi in 86%. The mean duration of treatment was 2.2±2.0 years with TNFi versus 1.8±1.5 with JAKi. JAKis were prescribed in older patients with longer term disease, greater comorbidity and later treatment lines and more frequently as monotherapy. The IRR of all infections and gastrointestinal events was higher among patients with RA treated with JAKi. Drug persistence at 1, 2 and 3 years was 69%, 55% and 45% for TNFi and 68%, 54% and 45% for JAKi. Multivariate regression models showed a lower probability of discontinuation for JAKi (HR=0.85; 95% CI 0.78-0.92) and concomitant conventional synthetic disease-modifying antirheumatic drugs (HR=0.90; 95% CI 0.84-0.96). The risk of discontinuation increased with glucocorticoids, comorbidities, greater disease activity and later treatment lines. CONCLUSIONS: Infections, herpes zoster and gastrointestinal adverse events in patients with RA tended to be more frequent with JAKi. However, prognosis was poor in patients receiving JAKi. Persistence was similar for TNFi and JAKi, although factors associated with discontinuation differed by diagnostic group.

Sex differences in patient-reported outcomes and the association with clinical factors in axial spondyloarthritis patients treated with tumour necrosis factor inhibitors.

OBJECTIVES: To investigate sex differences in patient-reported outcome measures (PROMs) among axSpA patients initiating their first TNFi and identify factors contributing to these disparities over the follow-up. METHODS: Data were included from 15 EuroSpA registries and consisted of axSpA patients initiating their first TNFi, with ≥2 measurements for each analysed PROM (BASDAI and BASFI, scale 0-100) taken at any time point. Linear mixed models were employed to analyse sex differences in PROMs over 24 months and to evaluate how baseline characteristics were related to the observed sex differences. RESULTS: We analysed 13 102 (38% women) in the BASDAI analyses and 10 623 (38% women) in the BASFI analyses. At follow-up, mean sex differences in BASDAI increased from 4.3 units at baseline (95% CI, 3.5-5.1)-8.0 (7.2-8.8) at 6 months, and in BASFI from 2.2 (1.4-3.1)-4.6 (3.6-5.5), with consistently worse scores in women. Baseline characteristics could not substantially account for the observed sex differences over time; however, the magnitude of the sex differences was reduced by HLA-B27 positivity, longer disease duration, and increased CRP levels, but increased by TNFi initiation in later years and peripheral arthritis. CONCLUSION: In axSpA patients initiating their first TNFi, baseline sex differences in BASDAI and BASFI increased two-fold after 6 months of treatment and persisted thereafter, with worse scores in women. Several baseline characteristics moderated the sex differences, though none could fully account for them. These findings improve our understanding of sex differences and underscore their importance in axSpA.

Development of Data Quality Indicators for Improving Hospital International Classification of Diseases-Coded Health Data Quality Globally.

BACKGROUND: Hospital inpatient data, coded using the International Classification of Diseases (ICD), is widely used to monitor diseases, allocate resources and funding, and evaluate patient outcomes. As such, hospital data quality should be measured before use; however, currently, there is no standard and international approach to assess ICD-coded data quality. OBJECTIVE: To develop a standardized method for assessing hospital ICD-coded data quality that could be applied across countries: Data quality indicators (DQIs). RESEARCH DESIGN: To identify a set of candidate DQIs, we performed an environmental scan, reviewing gray and academic literature on data quality frameworks and existing methods to assess data quality. Indicators from the literature were then appraised and selected through a 3-round Delphi process. The first round involved face-to-face group and individual meetings for idea generation, while the second and third rounds were conducted remotely to collect online ratings. Final DQIs were selected based on the panelists' quantitative and qualitative feedback. SUBJECTS: Participants included international experts with expertise in administrative health data, data quality, and ICD coding. RESULTS: The resulting 24 DQIs encompass 5 dimensions of data quality: relevance, accuracy and reliability; comparability and coherence; timeliness; and Accessibility and clarity. These will help stakeholders (eg, World Health Organization) to assess hospital data quality using the same standard across countries and highlight areas in need of improvement. CONCLUSIONS: This novel area of research will facilitate international comparisons of ICD-coded data quality and be valuable to future studies and initiatives aimed at improving hospital administrative data quality.

Long-Term Survival of Subcutaneous Biosimilar Tumor Necrosis Factor Inhibitors Compared to Originators: Results From a Multicenter Prospective Registry.

OBJECTIVE: To analyze the long-term survival of subcutaneous biosimilar tumor necrosis factor inhibitors compared to the originator molecules in patients with rheumatic diseases, as well as the factors associated with drug discontinuation. METHODS: Retrospective analysis of BIOBADASER, the Spanish multicenter prospective registry of patients with rheumatic disease receiving biologic and targeted disease-modifying antirheumatic drugs. Patients who started etanercept (ETN) or adalimumab (ADA) from January 2016 to October 2023 were included. The survival probabilities of biosimilars and originators were compared using Kaplan-Meier estimating curves. To identify factors associated with differences in the retention rates, hazard ratios (HR) were estimated using Cox regression models for all and specific causes (inefficacy or adverse events [AEs]) of discontinuation. RESULTS: A total of 4162 patients received 4723 treatment courses (2991 courses of ADA and 1732 courses of ETN), of which 722 (15.29%) were with originator molecules and 4001 (84.71%) were with biosimilars. The originators were more frequently discontinued than biosimilars (53.32% vs 33.37%, respectively). The main reason for discontinuation was inefficacy (60.35% of the treatments). The risk of overall discontinuation was lower for biosimilars (adjusted HR 0.84, 95% CI 0.75-0.95). Female sex, obesity, and second or later treatment lines increased the risk of discontinuation, whereas disease duration and the use of concomitant methotrexate were associated with a greater survival. When assessing cause-specific reasons of discontinuation, excluding nonmedical switching, the results from the crude and adjusted analyses showed no significant differences in the retention rate between biosimilars and originators. CONCLUSION: No significant differences were found between treatments in long-term survival due to inefficacy or AEs.

Exploring the differences in ICD and hospital morbidity data collection features across countries: an international survey.

BACKGROUND: The International Classification of Diseases (ICD) is the reference standard for reporting diseases and health conditions globally. Variations in ICD use and data collection across countries can hinder meaningful comparisons of morbidity data. Thus, we aimed to characterize ICD and hospital morbidity data collection features worldwide. METHODS: An online questionnaire was created to poll the World Health Organization (WHO) member countries that were using ICD. The survey included questions focused on ICD meta-features and hospital data collection systems, and was distributed via SurveyMonkey using purposive and snowball sampling. Accordingly, senior representatives from organizations specialized in the topic, such as WHO Collaborating Centers, and other experts in ICD coding were invited to fill out the survey and forward the questionnaire to their peers. Answers were collated by country, analyzed, and presented in a narrative form with descriptive analysis. RESULTS: Responses from 47 participants were collected, representing 26 different countries using ICD. Results indicated worldwide disparities in the ICD meta-features regarding the maximum allowable coding fields for diagnosis, the definition of main condition, and the mandatory type of data fields in the hospital morbidity database. Accordingly, the most frequently reported answers were "reason for admission" as main condition definition (n = 14), having 31 or more diagnostic fields available (n = 12), and "Diagnoses" (n = 26) and "Patient demographics" (n = 25) for mandatory data fields. Discrepancies in data collection systems occurred between but also within countries, thereby revealing a lack of standardization both at the international and national level. Additionally, some countries reported specific data collection features, including the use or misuse of ICD coding, the national standards for coding or lack thereof, and the electronic abstracting systems utilized in hospitals. CONCLUSIONS: Harmonizing ICD coding standards/guidelines should be a common goal to enhance international comparisons of health data. The current international status of ICD data collection highlights the need for the promotion of ICD and the adoption of the newest version, ICD-11. Furthermore, it will encourage further research on how to improve and standardize ICD coding.

Extended reality training for mass casualty incidents: a systematic review on effectiveness and experience of medical first responders.

INTRODUCTION: Mass casualty incidents (MCI) are unforeseeable and complex events that occur worldwide, therefore enhancing the training that medical first responders (MFRs) receive is fundamental to strengthening disaster preparedness and response. In recent years, extended reality (XR) technology has been introduced as a new approach and promising teaching technique for disaster medicine education. OBJECTIVE: To assess the effectiveness of XR simulation as a tool to train MFRs in MCIs, and to explore the perception and experience of participants to these new forms of training. DESIGN: Systematic review. METHODS: This systematic review was conducted in accordance with the "Preferred reporting items for systematic reviews and meta-analyses" (PRISMA) statement. Four databases were searched (MEDLINE, EMBASE, CINAHL and LILACs) using a comprehensive search strategy to identify relevant articles, and MetaQAT was used as a study quality assessment tool. Data from included studies was not pooled for meta-analysis due to heterogeneity. Extracted data was synthesised in a narrative, semi-quantitative manner. RESULTS: A total of 18 studies were included from 8 different countries. Studies encompassed a variety of participants (e.g., nurses, paramedics, physicians), interventions (virtual, mixed and augmented reality), comparators (comparison between two groups and single groups with pre-post evaluation), and outcomes (effectiveness and MFR perception). The synthesis of data indicated that XR was an effective tool for prehospital MCI training by means of improved triage accuracy, triage time, treatment accuracy, performance correctness and/or knowledge acquired. These XR systems were well perceived by MFRs, who expressed their interest and satisfaction towards this learning experience and emphasized its usefulness and relevance. CONCLUSION: This research supports the usefulness and significance of XR technology that allows users to enhance their skills and confidence when facing forthcoming disasters. The findings summarize recommendations and suggestions for the implementation, upgrade and/or assessment of this novel and valuable teaching method.

Impact of multimorbidity on the first ts/bDMARD effectiveness and retention rate after two years of follow-up in patients with rheumatoid arthritis from the BIOBADASER registry.

BACKGROUND: Patients with Rheumatoid Arthritis (RA) have a higher prevalence of comorbidities compared to the general population. However, the implications of multimorbidity on therapeutic response and treatment retention remain unexplored. OBJECTIVES: (a) To evaluate the impact of multimorbidity on the effectiveness of the first targeted synthetic or biologic disease-modifying antirheumatic drug (ts/bDMARD), in patients with RA after 2-year follow-up; (b) to investigate the influence of multimorbidity on treatment retention rate. METHODS: Patients with RA from the BIOBADASER registry exposed to a first ts/bDMARDs were included. Patients were categorized based on multimorbidity status at baseline, defined as a Charlson Comorbidity index (CCI) score ≥ 3. A linear regression model, adjusted for sex and age, was employed to compare the absolute DAS28 score over time after ts/bDMARD initiation between the two groups. The Log-Rank test and Kaplan-Meier curve were used to compare the retention rates of the first ts/bDMARD between the groups. RESULTS: A total of 1128 patients initiating ts/bDMARD were included, with 107 (9.3%) exhibiting multimorbidity. The linear regression model showed significantly higher DAS28 (beta coefficient 0.33, 95%CI:0.07-0.58) over a two-year period in patients with multimorbidity, even after adjusting for age and sex. Finally, no differences in the ts/bDMARD retention rate were found between groups (median 6.94-6.96 years in CCI < 3 vs. 5.68-5.62 in CCI ≥ 3; p = 0.610). CONCLUSIONS: Multimorbidity in patients with RA was associated with greater DAS28 scores within the first two years after ts/bDMARD initiation, in comparison with patients without multimorbidity. A slightly shorter retention rate was found in patients with multimorbidity, although the difference was non-significant.

Effectiveness of secukinumab in radiographic and non-radiographic axial spondyloarthritis: a European routine-care observational study.

OBJECTIVES: To compare the treatment effectiveness of secukinumab in radiographic (r) versus non-radiographic (nr) axial spondyloarthritis (axSpA) patients treated in routine care across Europe. METHODS: Prospectively collected data on secukinumab-treated axSpA patients with known radiographic status were pooled from nine countries.Remission rates based on patient-reported outcomes (PROs; Numeric Rating Scale (0-10), for example, pain ≤2/Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≤2 and Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease (ID) <1.3 after 6/12/24 months of secukinumab treatment were calculated.Remission and drug retention rates in r-axSpA versus nr-axSpA patients were compared by logistic and Cox regression models (unadjusted/adjusted for age+sex/adjusted for multiple confounders). RESULTS: Overall, 1161 secukinumab-treated patients were included (r-axSpA/nr-axSpA: 922/239). At baseline, r-axSpA patients had longer disease duration and higher C reactive protein, were more often male and HLA-B27 positive and had received fewer prior biological or targeted synthetic disease-modifying antirheumatic drugs compared with nr-axSpA patients, whereas PROs were largely similar.During follow-up, crude PRO remission rates were significantly higher in r-axSpA compared with nr-axSpA patients (6 months: pain≤2: 40%/28%, OR=1.7; BASDAI≤2: 37%/25%, OR=1.8), as were drug retention rates (24 months: 66%/58%, HR 0.73 (ref: r-axSpA)). Proportions of patients achieving ASDAS ID were low for both groups, particularly nr-axSpA (6 months: 11%/8%).However, when adjusting for age+sex, these differences diminished, and after adjusting for multiple confounders, no significant between-group differences remained for either remission or drug retention rates. CONCLUSION: Crude remission/drug retention rates in European secukinumab-treated patients were higher in r-axSpA compared with nr-axSpA patients. In adjusted analyses, secukinumab effectiveness was similar in both groups, suggesting that observed differences were related to factors other than radiographic status.

Patient-reported outcomes in axial spondyloarthritis and psoriatic arthritis patients treated with secukinumab for 24 months in daily clinical practice.

OBJECTIVES: In patients with axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA) initiating secukinumab, we aimed to assess and compare the proportion of patients achieving 6-, 12- and 24-month patient-reported outcomes (PRO) remission and the 24-month retention rates. PATIENTS AND METHODS: Patients with axSpA or PsA from 16 European registries, who initiated secukinumab in routine care were included. PRO remission rates were defined as pain, fatigue, Patient Global Assessment (PGA) ≤2 (Numeric Rating Scale (NRS) 0-10) and Health Assessment Questionnaire (HAQ) ≤0.5, for both axSpA and PsA, and were calculated as crude values and adjusted for drug adherence (LUNDEX). Comparisons of axSpA and PsA remission rates were performed using logistic regression analyses (unadjusted and adjusted for multiple confounders). Kaplan-Meier plots with log-rank test and Cox regression analyses were conducted to assess and compare secukinumab retention rates. RESULTS: We included 3087 axSpA and 3246 PsA patients initiating secukinumab. Crude pain, fatigue, PGA and HAQ remission rates were higher in axSpA than in PsA patients, whereas LUNDEX-adjusted remission rates were similar. No differences were found between the patient groups after adjustment for confounders. The 24-month retention rates were similar in axSpA vs. PsA in fully adjusted analyses (HR [95 %CI] = 0.92 [0.84-1.02]). CONCLUSION: In this large European real-world study of axSpA and PsA patients treated with secukinumab, we demonstrate for the first time a comparable effectiveness in PRO remission and treatment retention rates between these two conditions when adjusted for confounders.

Extended reality as a training method for medical first responders in mass casualty incidents: A protocol for a systematic review.

INTRODUCTION/BACKGROUND: Mass-casualty incidents (MCIs) and disasters require an organised and effective response from medical first responders (MFRs). As such, novel training methods have emerged to prepare and adequately train MFRs for these challenging situations. Particular focus should be placed on extended reality (XR), which encompasses virtual, augmented and mixed reality (VR, AR, and MR, respectively), and allows participants to develop high-quality skills in realistic and immersive environments. Given the rapid evolution of high-fidelity simulation technology and its advantages, XR simulation has become a promising tool for emergency medicine. Accordingly, this systematic review aims to: 1) evaluate the effectiveness of XR training methods and 2) explore the experience of MFRs undergoing such training. METHODS: A comprehensive search strategy will encompass four distinct themes: MFRs, disasters/MCIs, education and simulation, and XR. Four databases (MEDLINE, EMBASE, CINAHL and LILACs) will be searched along with an in-depth examination of the grey literature and reference lists of relevant articles. MetaQAT will be used as a study quality assessment tool and integrated into Covidence as part of the data extraction form. Given the predicted high heterogeneity between studies, it may not be possible to standardise data for quantitative comparison and meta-analysis. Thus, data will be synthesised in a narrative, semi-quantitative manner. DISCUSSION: This review will examine the existing literature on the effectiveness of XR simulation as a tool to train MFRs for MCIs, which could ultimately improve preparedness and response to disasters. TRIAL REGISTRATION: Protocol registration: PROSPERO CRD42021275692.

International Classification of Diseases clinical coding training: An international survey.

BACKGROUND: The International Classification of Diseases (ICD) is widely used by clinical coders worldwide for clinical coding morbidity data into administrative health databases. Accordingly, hospital data quality largely depends on the coders' skills acquired during ICD training, which varies greatly across countries. OBJECTIVE: To characterise the current landscape of international ICD clinical coding training. METHOD: An online questionnaire was created to survey the 194 World Health Organization (WHO) member countries. Questions focused on the training provided to clinical coding professionals. The survey was distributed to potential participants who met specific criteria, and to organisations specialised in the topic, such as WHO Collaborating Centres, to be forwarded to their representatives. Responses were analysed using descriptive statistics. RESULTS: Data from 47 respondents from 26 countries revealed disparities in all inquired topics. However, most participants reported clinical coders as the primary person assigning ICD codes. Although training was available in all countries, some did not mandate training qualifications, and those that did differed in type and duration of training, with college or university degree being most common. Clinical coding certificates most frequently entailed passing a certification exam. Most countries offered continuing training opportunities, and provided a range of support resources for clinical coders. CONCLUSION: Variability in clinical coder training could affect data collection worldwide, thus potentially hindering international comparability of health data. IMPLICATIONS: These findings could encourage countries to improve their resources and training programs available for clinical coders and will ultimately be valuable to the WHO for the standardisation of ICD training.

Evaluation of interventions to improve electronic health record documentation within the inpatient setting: a protocol for a systematic review.

BACKGROUND: Electronic health records (EHRs) are increasing in popularity across national and international healthcare systems. Despite their augmented availability and use, the quality of electronic health records is problematic. There are various reasons for poor documentation quality within the EHR, and efforts have been made to address these areas. Previous systematic reviews have assessed intervention effectiveness within the outpatient setting or within paper documentation. This systematic review aims to assess the effectiveness of different interventions seeking to improve EHR documentation within an inpatient setting. METHODS: We will employ a comprehensive search strategy that encompasses four distinct themes: EHR, documentation, interventions, and study design. Four databases (MEDLINE, EMBASE, CENTRAL, and CINAHL) will be searched along with an in-depth examination of the grey literature and reference lists of relevant articles. A customized hybrid study quality assessment tool has been designed, integrating components of the Downs and Black and Newcastle-Ottawa Scales, into a REDCap data capture form to facilitate data extraction and analysis. Given the predicted high heterogeneity between studies, it may not be possible to standardize data for a quantitative comparison and meta-analysis. Thus, data will be synthesized in a narrative, semi-quantitative manner. DISCUSSION: This review will summarize the current level of evidence on the effectiveness of interventions implemented to improve inpatient EHR documentation, which could ultimately enhance data quality in administrative health databases. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017083494.

Evaluation of interventions to improve inpatient hospital documentation within electronic health records: a systematic review.

OBJECTIVE: Despite the widespread and increasing use of electronic health records (EHRs), the quality of EHRs is problematic. Efforts have been made to address reasons for poor EHR documentation quality. Previous systematic reviews have assessed intervention effectiveness within the outpatient setting or paper documentation. The purpose of this systematic review was to assess the effectiveness of interventions seeking to improve EHR documentation within an inpatient setting. MATERIALS AND METHODS: A search strategy was developed based on elaborated inclusion/exclusion criteria. Four databases, gray literature, and reference lists were searched. A REDCap data capture form was used for data extraction, and study quality was assessed using a customized tool. Data were analyzed and synthesized in a narrative, semiquantitative manner. RESULTS: Twenty-four studies were included in this systematic review. Owing to high heterogeneity, quantitative comparison was not possible. However, statistically significant results in interventions and affected outcomes were analyzed and discussed. Education and implementation of a new EHR reporting system were the most successful interventions, as evidenced by significantly improved EHR documentation. DISCUSSION: Heterogeneity of interventions, outcomes, document type, EHR user, and other variables led to difficulty in measuring EHR documentation quality and effectiveness of interventions. However, the use of education as a primary intervention aligned closely with existing literature in similar fields. CONCLUSIONS: Interventions implemented to enhance EHR documentation are highly variable and require standardization. Emphasis should be placed on this novel area of research to improve communication between healthcare providers and facilitate data sharing between centers and countries.PROSPERO Registration Number: CRD42017083494.