INTRODUCTION:Few studies have assessed the distribution and temporal trends of healthcare expenditures related to inflammatory bowel disease (IBD). The aims of the study were to analyze the expenditure trends for IBD patients in Catalonia from 2011 to 2024, to identify key cost drivers, and to forecast future costs through 2036. METHODS:All patients with a diagnosis of IBD included in the Catalan Health Surveillance System (CHSS) were eligible. CHSS compiles prospective data from public healthcare coverage of 8 million people in 2024. Healthcare utilization was analyzed, and expenditures were calculated using standard costs defined by the Catalan Department of Health. All expenditures were adjusted to 2024 euros using the Consumer Price Index to enable comparisons across years. Costs were estimated for IBD overall, Crohn's disease (CD) and ulcerative colitis (UC). An autoregressive integrated moving average model was used to forecast total costs up to 2036. RESULTS:IBD-related healthcare expenditure tripled from €67.4 M in 2011 to €201.6 M in 2024, while per-patient costs rose from €3,981 to €4,753. Biologic therapies were the main cost driver, especially in CD. Mean per-patient biologic costs decreased by 16.6% in CD but increased by 44.5% in UC. CD patients consistently incurred higher per capita costs. Forecasts indicate continued growth in total expenditure, reaching €319.0 M by 2036. CONCLUSION:Overall, IBD-related healthcare expenditures in Catalonia markedly increased from 2011 to 2024, driven mainly by the increase in IBD prevalence. Per-patient cost moderately increased. Per-patient cost containment was observed in pharmaceutical costs, probably due to a strict policy favoring the use of biosimilars. These findings may be of help for designing future healthcare policies.

Abstract Background Colon capsule endoscopy (CCE) has been proposed as a non-invasive alternative to colonoscopy for colorectal cancer (CRC) screening, offering greater patient comfort and potentially reducing healthcare burden. However, its cost-effectiveness in population-based screening remains uncertain. Methods This study used a state-transition (Markov) model to simulate lifetime outcomes of CRC screening in Denmark, Scotland, and Spain, comparing the standard pathway based on fecal immunochemical testing (FIT) followed by colonoscopy with an alternative pathway replacing colonoscopy with CCE after a positive FIT result. The model incorporated costs (2024 euros), quality-adjusted life-years (QALYs), and CRC cases avoided, applying a yearly discount rate of 3%. Deterministic sensitivity analyses explored uncertainty in capsule cost, adherence, and reinvestigation rates for non-advanced polyps. Results Across all settings, CCE resulted in higher costs but slightly increased effectiveness and utility (mean QALYs 28.7 vs. 28.8; CRC detected 0.032–0.034 vs. 0.035–0.037 per person). Incremental cost-effectiveness ratios (ICER) ranged from €43,538 in Spain to €136,930 in Denmark per additional CRC detected. Capsule cost was the main driver of ICER variation, whereas adherence rates had minimal effect on cost-effectiveness. Changes in the prevalence of non-advanced polyps had a modest impact, except when capsule prices were high. Conclusions Overall, replacing colonoscopy with CCE slightly increases detection and health gains at the expense of higher costs. Cost-effectiveness largely depends on capsule price and adherence. Artificial intelligence-assisted CCE interpretation may further improve diagnostic and economic performance, potentially supporting adoption in large-scale CRC screening programs.

Multimorbidity, a major driver of healthcare demand and clinical complexity, is often addressed in a disease-centric manner and remains insufficiently understood in its population-level dynamics. Using data from a 10-year population-based cohort of 5.5 million adults in Catalonia, Spain, we quantified multimorbidity-associated clinical complexity using the Adjusted Morbidity Groups (AMG) index to predict progression from low/moderate ( < P80) to high/very high ( ≥ P80) complexity. Machine learning models identified predictive factors, while network analyses explored co-occurrence patterns among chronic conditions. During follow-up, 39.2% of the individuals who remained alive throughout the analysis period transitioned to high/very high complexity. Baseline AMG score was the strongest predictor of progression, surpassing models relying solely on individual diagnoses. The most prevalent conditions were nutritional and endocrine disorders, anxiety, and hypertension, with notable sequential links between mental and physical disorders. Findings emphasize the need for integrated, patient-centred care strategies and population-based prevention approaches to mitigate multimorbidity progression.

OBJECTIVES:The epidemiologic status of pediatric inflammatory bowel disease (PIBD) has not been widely studied in Western Europe. The prevalence and incidence trends of the disease are largely unknown. The aim of this study was to determine the prevalence, incidence and mortality of PIBD in Catalonia in the period 2011-2023. METHODS:A longitudinal study from 2011 to 2023 was performed using population-based data from the Catalan Health Surveillance System (CHSS). Data on prevalence, incidence and mortality of inflammatory bowel disease (IBD) in patients under the age of 18 years were obtained. Trends in age- and sex-adjusted rates were estimated. Crohn's disease (CD) and ulcerative colitis (UC) were also analysed separately. RESULTS:The number of prevalent PIBD cases rose from 307 in 2011 to 725 in 2023, with increases of 173% in UC and 113% in CD. The age- and sex adjusted prevalence of PIBD rose from 23 (95%CI 20.5-25.7) to 48.1 (95%CI 44.7-51.7) per 100,000 children. Annual incidence doubled, from 81 to 168. Age- and sex- adjusted incidence rates increased from 6 to 11.2 per 100,000 children/year with data suggesting a flattening of the incidence curve in recent years. All-cause mortality was low: seven patients died during the study period with a mean estimated mortality of 0.5 per 100 patients/year. CONCLUSIONS:The prevalence of PIBD is increasing rapidly in Catalonia. We observed also a trend towards a flattening trend in incidence that may suggest that prevalence might stabilize in the coming years.

The treatment of multiple myeloma (MM) has changed substantially in the last two decades due to many therapeutic innovations. This study aims to analyse the authorization trends of drug regimens for the treatment of MM in Spain and evaluate their availability within the Spanish National Health System (NHS). Drug regimens authorized in the European Union (EU) and/or in Spain for MM treatment between April 2004 and November 2024 were identified through regulatory agencies' websites. Authorization trends were analysed by number of components, line of treatment and approval frequency. Reimbursement information was extracted from the Spanish Ministry of Health website. A total of 48 drug regimens were authorized for MM treatment in the EU and/or in Spain. Of these, 25

Background The European Medicines Agency (EMA) implemented ‘fast-track' programmes, like conditional marketing authorisations (CMA), where the benefits of immediate drugs’ availability outweigh the risks associated with incomplete evidence. However, payers in the European Union (EU) decide on medicines’ coverage based on clinical benefits assessment, cost-effectiveness and/or budget impact. We investigated differences in the time-to-access of drugs approved via CMA vis-à-vis standard marketing authorisation (SMA) in Italy, Germany, and Spain.Methods CMA-licenced drugs from 2006 to 2022 were retrieved and matched with comparable SMA drugs. Collected data were as follows: marketing authorisation details, drug characteristics, pivotal trials’ characteristics and national reimbursement decision dates. Data sources included European Public Assessment Reports, and country-specific databases (Farmadati®, Lauer-Taxe®, BIFIMED).Results CMA drugs take longer, in days, to reach reimbursement compared to SMA drugs both in Italy (CMA: median 523, mean 635, standard deviation (SD 364; SMA: median 455, mean 497, SD 242) and Spain (CMA: median 691, mean 779, SD 456; SMA: median 534, mean 568, SD 273). Cox regressions and Kaplan-Meier survival analyses corroborate these findings.Conclusions The EMA’s intent to accelerate access to promising medicines may be offset by longer timelines to secure national reimbursement in major EU nations.

INTRODUCTION:Data on temporal trends in treatment use in pediatric inflammatory bowel disease (PIBD) are limited. This study aimed to evaluate treatment trends in PIBD in Catalonia and to explore their association with outcomes, including surgery and hospitalization. MATERIAL AND METHODS:We conducted a population-based cohort study including all pediatric patients (<18 years) with IBD included in the Catalan Health Surveillance System, covering a population of more than 7.5 million individuals, between 2011 and 2023 were identified. Exposure to IBD treatments was obtained from electronic dispensation records. Temporal trends in treatment use, surgical procedures, and hospitalization rates were analyzed. Correlation analyses between treatments and outcomes were performed at the population level. RESULTS:The use of salicylates and corticosteroids increased from 18.6% to 24.8% and from 5.2% to 12.3%, respectively. Immunosuppressive treatment increased during the early study period and subsequently declined, with similar rates at baseline and study end (28.3% vs 29.5%). Advanced therapies increased markedly from 27.0% to 41.8%, with infliximab remaining the most frequently prescribed advanced therapy. Surgical rates (ostomies and resections per 1,000 patient-years) fluctuated over time without a consistent trend (p=0.21). Rates of PIBD-related hospitalization decreased from 205.2 to 150.3 per 1,000 patient-years. CONCLUSIONS:Advanced therapies use in PIBD increased substantially over the study period in Catalonia. This trend coincided with a reduction in PIBD-related hospitalization rates, whereas surgical outcomes remained unchanged. This increase occurred concurrently with a reduction in hospitalization rates, whereas no statistically significant linear trend was observed for surgical outcomes.

Effective implementation of evidence-based programmes in real-world settings requires the capacity to adapt programmes and tailor implementation strategies to local contexts. Many primary cancer prevention (PCP) programmes that are effective in controlled settings struggle in routine practice. Although several frameworks outline principles of adaptation and tailoring, practical guidance on how to operationalise these processes remains limited. The PIECES project aims to help address this gap by developing, implementing, and evaluating structured support for tailored implementation of PCP programmes. Within the PIECES project, a toolkit was co-developed with practitioners and researchers to provide theory- and evidence-informed guidance for adapting, tailoring, implementing, and evaluating PCP programmes. The toolkit aims to strengthen implementation competencies through structured planning, collaborative learning, and evidence-informed decision-making. This paper presents the protocol for the PIECES study which evaluates the toolkit’s usability, feasibility, and mechanisms of impact of PCP programmes across diverse healthcare and community settings. The PIECES study uses a multi-site pre-post comparative case study design with a mixed-methods implementation evaluation across 11 sites in Europe and Australia, reflecting variation in organisational structures, resources, and cultural contexts. The primary outcome is change in implementation competencies among toolkit users. Guided by the UK MRC Process Evaluation Framework and Proctor’s implementation outcomes, the process evaluation examines toolkit usability, feasibility, user satisfaction, and perceived impact on implementation processes and outcomes. Quantitative and qualitative data, toolkit log data, and structured field notes will be collected at six-month intervals (2025–2027). In parallel, a realist evaluation will explore how, why, and under what conditions the toolkit supports tailored implementation. Together, these approaches provide complementary descriptive and explanatory insights into the mechanisms and contextual factors shaping tailored implementation of PCP programmes. This study is expected to contribute to implementation science by evaluating a structured, evidence-informed tool designed to strengthen capacity for tailored implementation of PCP programmes. Its multi-country design offers a natural field-laboratory to explore how implementation support tools function across varying contexts. By integrating process and realist evaluation approaches, the study is designed to generate practical and theoretical evidence to inform scalable, context-sensitive strategies and enhance the sustainability and impact of evidence-based prevention efforts. ClinicalTrials.gov ID NCT06718322.

Background:Suicidal behavior is a major public health problem worldwide. The exact etiology remains unclear, representing a complex problem involving multiple factors. Evidence indicates that around 50% to 80% of people who die by suicide have had contact with the health care system in the year prior to their death. Objective:We present the IDICIUS project, whose objective is to develop a clinical decision support system that functions as an early warning system and applies AI to prevent suicide risk using anonymized electronic health record data. Methods:This study shows the first 2 stages of the IDICIUS project, where real-world data from 4 public sources were integrated, curated, standardized, and anonymized in phase 1, and analysis and modeling of suicide risk were performed in phase 2. This retrospective population-based study included 41,557 adult patients receiving mental health care at a large hospital. We evaluated the performance of machine learning classifiers with increasing complexity: logistic regression, elastic net, decision trees and random forests, bagging and boosting ensemble methods (GradientBoosting, XGBoost [extreme gradient boosting], CatBoost, RandomForest, and AdaBoost [adaptive boosting]), support vector machines, and deep neural networks. To address class imbalance, we tested several balancing techniques, with random undersampling providing the best results. Results:Phase 1 yielded a useful database of 32,661 patients receiving mental health care and 112 features. Of those, 2764 patients exhibited suicidal behavior (target), while 29,897 did not (control). The undersampling reduced the class distribution to 4422 vs 2211 (control vs target). The most prevalent features in the target class (N=2764) were psychiatric conditions, anxiety episodes (n=2269, 82.1%) and depressive episodes (n=1682, 60.9%), along with demographic and behavioral factors: female sex (n=1672, 60.5%), alcohol consumption (n=770, 27.9%), and conduct disorder (n=709, 25.7%). The largest patient subgroups were females with combined depression and anxiety (n=300, 10.9%), females with anxiety disorders only (n=182, 6.6%), males with anxiety disorders only (n=120, 4.3%), and males with combined depression and anxiety (n=106, 3.8%). In phase 2, ensemble methods, especially GradientBoosting and XGBoost, achieved the best performance, with receiver operating characteristic-area under the curve scores around 0.95. While these models showed moderate precision in identifying true positives (0.51-0.58), they demonstrated high sensitivity in detecting at-risk patients, with recall scores of 0.85 and 0.84, respectively. Both models achieved a good balance between precision and recall (F1-scores: 0.68 and 0.67). The strongest predictors were corticosteroid use, psychiatric medications (olanzapine and lorazepam), female sex, and depression. Conclusions:We integrated multiple electronic health record data sources and applied AI to develop, model, and optimize ensemble algorithms for suicide prevention, maximizing effectiveness, efficiency, and generalizability. These AI-generated algorithms, based on readily available and well-structured data, may advance the identification of at-risk patients and function as early warning systems, thereby increasing opportunities for timely preventive interventions.

PurposeBayesian approaches may improve the efficiency of trials and accelerate decision-making, but reluctance to depart from traditional frequentist statistics may limit their use. Because oncology trials generally involve severe conditions with no or limited therapeutic options, they are well-suited to applying Bayesian methodologies and are perceived as using these methods often in early phases.ObjectivesIn this study, we aim to describe the use of Bayesian methods and designs in oncology clinical trials in the last 20 years.MethodA cross-sectional observational study was conducted to identify oncology clinical trials using Bayesian approaches registered in clinicaltrials.gov between 2004 and 2024. Trials were searched in clinicaltrials.gov, PubMed, and through manual search of cross-references.ResultsBayesian trials were retrieved, and their main characteristics were extracted using R and verified manually. Between 2004 and 2024, 384,298 trials were registered in clinicaltrials.gov; we identified 84,850 oncology clinical trials (22%), of which 640 (0.75%) used Bayesian approaches. The adoption of Bayesian trials increased significantly after 2011, but while half of all Bayesian studies started in the last 5 years, this paralleled the overall increase in oncology research rather than an increase in the proportion of Bayesian trials. The majority of Bayesian trials were phase 1 and phase 2 studies, and two-thirds of Bayesian trials with efficacy objectives had single-arm designs, often utilizing binary endpoints, such as overall response, as the primary measure.ConclusionThe uptake of Bayesian methods in oncology clinical trials has flattened and is still scarce, and is mostly applied to the analysis of treatment efficacy in single-arm trials with binary endpoints. There is room for further uptake and use of their potential advantages in settings with small populations and severe conditions with unmet needs.

AIMS:Low-Intervention Clinical Trials (LICTs) are generally pragmatic trials that investigate medicinal products already authorized for use. In 2014, simplified regulatory frameworks were introduced for LICTs with the aim of reducing regulatory burden and operational complexity, to foster non-commercial clinical trials (NCCTs); the mandatory implementation of CTIS in 2023 may have impacted LICTs feasibility. Our aim was to describe the main characteristics of LICTs approved in Spain over a ten-year period. METHODS:Cross-sectional descriptive analysis of LICTs registered between 2014 and 2023, in the Spanish Clinical Studies Registry (REec) database, mandatory to all authorized trials. RESULTS:Between January 2014 and December 2023, 8497 clinical trials were registered in REec, of which only 3.8% (N = 322) were classified as LICTs. No drop in the overall proportion of LICTs was seen in 2023. Most LICTs were sponsored by non-commercial entities and funded primarily through sponsors' own resources. LICTs were frequently monocentric phase IV studies evaluating commercialized medicinal products. The principal objectives of the trials included efficacy and/or safety, while pharmacoeconomics, pharmacogenetics, pharmacogenomics and bioequivalence were comparatively infrequent as main objectives. Most trial designs were randomized, but blinded trials were less frequent, and only a minority were placebo-controlled. CONCLUSIONS:Despite their critical role in establishing effectiveness and safety of authorized medicinal products in pragmatic clinical settings, LICTs still constitute a relatively small proportion of all clinical trials approved in Spain, and their designs have area for improvement in terms of robustness. There was no apparent effect of CTIS implementation on LICTs activity.

Background: The prevalence of inflammatory bowel disease (IBD) is increasing worldwide, while the incidence is tending to stabilize. Moreover, the use of biological treatments is increasing; some studies suggest that surgeries and hospitalizations are decreasing instead. Methods: A population-based, retrospective cohort study was conducted using data from the Catalan Health Surveillance System (CHSS). All patients diagnosed with IBD were included between 2017 and 2023. Crude incidence and prevalence rates were calculated for the Catalan population. Data on pharmacological therapy, surgical procedures, hospitalizations, and mortality were analyzed. Trends in age-sex-adjusted rates were also estimated, and logistic regression was used to calculate the adjusted mortality odds ratio (OR). Data for Crohn’s disease (CD) and ulcerative colitis (UC) were analyzed separately. Results: The number of prevalent IBD cases rose from 28,752 in 2017 to 41,423 in 2023. Despite incidence rates remaining stable (30.8 in 2017 and 29.9 per 100,000 inhabitants in 2023), prevalence rates increased (386.9 and 510.9 per 100,000 inhabitants, respectively). The use of biologics significantly increased (from 13.5% in 2017 to 21.0% in 2023), particularly ustekinumab and vedolizumab. In parallel, a decline in the use of immunosuppressants was observed. IBD-related surgeries and hospitalizations decreased during the study period, particularly among CD patients. Mortality remained low but was higher among IBD patients compared to the general population. Conclusions: The incidence of IBD in Catalonia has stabilized, while its prevalence continues rising, suggesting a transition to Stage 3 (compounding prevalence). The use of biological treatments is increasing steadily, whereas rates of surgeries and hospitalizations are consistently decreasing.

Multimorbidity, a major driver of healthcare demand and clinical complexity, is often addressed in a disease-centric manner and remains insufficiently understood in its population-level dynamics. Using data from a 10-year population-based cohort of 5.5 million adults in Catalonia, Spain, we quantified multimorbidity burden using the Adjusted Morbidity Groups (AMG) index to predict progression from low/moderate (< percentile 80) to high/very high (≥ P80) burden. Machine learning and statistical models (including random forest, neural networks, and gradient boosting) were used to assess predictive factors, while network analyses explored co-occurrence patterns among chronic conditions. During follow-up, 39.2% of individuals transitioned to high/very high burden. Baseline AMG score was the strongest predictor of progression, surpassing models relying solely on individual diagnoses. The most prevalent conditions were nutritional and endocrine disorders, anxiety, and hypertension, with notable sequential links between mental and physical disorders. Findings emphasize the need for integrated, patient-centred care strategies and population-based prevention approaches to mitigate multimorbidity progression. Clinical trial number : Not applicable.

Abstract Background: Introduction The epidemiologic status of pediatric inflammatory bowel disease (PIBD) has not been widely studied in Western Europe. The prevalence and incidence trends of the disease are largely unknown. The aim of this study is to determine the prevalence and incidence of PIBD and its mortality rate in Catalonia in the period 2011-2023. Methods: Material and methods A longitudinal study was performed using population-based data from the Catalan Health Surveillance System (CHSS). Data on prevalence, incidence and mortality of IBD in patients under the age of 18 years were obtained. Trends in age- and sex-adjusted rates were estimated. Crohn's disease (CD) and ulcerative colitis (UC) were also analysed separately. Results The number of PIBD patients rose from 307 in 2011 to 725 in 2023, with increases of 173% in UC and 113% in CD. The age- and sex-adjusted prevalence of PIBD rose from 23 (95%CI 20.5-25.7) to 48.1 (95%CI 44.7-51.7) per 1,000,000 inhabitants, while the annual incidence doubled, from 81 to 168. Although the peak incidence was recorded in 2022, the data suggest a flattening of the incidence curve in recent years. Seven patients died during follow-up, although the mortality rates were too low for further analysis. Conclusion Conclusion: The prevalence of PIBD is increasing rapidly in Catalonia. We observed also a trend towards a plateauing in the incidence that may suggest that prevalence might stabilize in the coming years. References N/A