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Global Healthcare Study on Psoriasis (GHSP): cohort profile and first findings

Por: Maul · J.-T. · Fröhlich · F. · Nielsen · M.-L. · Maul · L. V. · Torres · T. · Thyssen · J. P. · Armstrong · A. · Oon · H. H. · Ji · M. · Kang · X. · Valenzuela · F. · Romiti · R. · Carvalho · A. V. E. d. · Novoa · F. · Sousa · M. · Luz · M. · Guevara · B. E. K. · doss · N. · Gisondi · P.
Purpose

Despite the intention of international psoriasis treatment guidelines to cover all patients globally, disparities persist in the availability and accessibility of adequate therapy in many countries. The Global Healthcare Study on Psoriasis (GHSP) aims to study patient characteristics, disease impact, treatment accessibility and healthcare systems worldwide. This study provides a description and data analysis of 22 countries.

Participants

The GHSP cohort was initiated in 2020, and the number of recruiting centres has gradually grown. Participants are recruited by dermatologists at reference centres worldwide. Data are collected using a standardised assessment questionnaire comprising 88 items, administered by trained experts.

Findings to date

By 26 October 2024, cross-sectional data had been collected from 3950 psoriasis patients at 130 reference centres in 22 countries on six continents. The majority (55.7%) of patients were male, and the median (IQR) body mass index was 26.5 (23.7–30.1) kg/m2. The median (IQR) Psoriasis Area and Severity Index was 5.0 (2.0–11.4), and median (IQR) Dermatology Life Quality Index was 7.0 (2.0–14.0). Psoriatic arthritis was present in 20.2% of the patients and nail psoriasis in 36.7%. Additionally, 16.5% of patients were current smokers, and 26.4% reported regular alcohol consumption.

Future plans

By identifying inequalities, special patient populations and country-specific differences, the GHSP will guide the development of strategies to enhance psoriasis care on a global level. Future directions include expanding the study to additional countries and sites worldwide, while transitioning into a long-term global registry of skin diseases, including atopic dermatitis and hidradenitis suppurativa, termed ‘Global Healthcare Registry on Skin Diseases’.

Brief narrative interventions for adults with chronic illness or psychosocial distress: a scoping review protocol

Por: Polenz · B. · Rigby · T. · Logue · C. · Krein · S. L. · Powell · V. D.
Introduction

Narrative interventions elicit personal stories from participants to impact outcome(s). The process of organising a troublesome experience into a cohesive story may benefit individuals dealing with a variety of complex medical conditions and psychosocial stressors. A better understanding of prior work is a critical step to guide further development, refinement and expansion of this under-recognised therapeutic modality for new populations.

Methods and analysis

This scoping review will follow recommendations of the Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews to map and summarise the content and context of brief narrative interventions intended for individuals with chronic illness and/or psychosocial distress. Inclusion criteria are records describing brief (≤4 discrete session) interventions eliciting personal stories with the intent of impacting patient-centred outcomes (eg, depression, quality of life) delivered in any context. Participants will be adults (≥18 years old) living with chronic medical or psychiatric conditions (eg, metastatic cancer, chronic pain) or psychosocial distress (eg, grief, loneliness). Studies whose focus is not direct participant benefit or studies conducted in populations without evident illness or psychosocial stressors will be excluded. An initial search of PubMed (MEDLINE) identified sentinel articles; a comprehensive strategy was developed with the assistance of a librarian for systematically searching PubMed (MEDLINE), PsycInfo (EBSCOhost), CINAHL (EBSCOhost) and Embase (Ovid). Bibliographies of relevant articles will also be examined. Two independent reviewers will screen articles; disagreements will be discussed at regular meetings. U-M GPT, an artificial intelligence-powered institutional large language model, will perform initial data abstraction with a human reviewer verifying accuracy. Findings will be qualitatively summarised according to the three research questions, presented in tabular format, and described narratively.

Ethics and dissemination

As data will be obtained only from secondary sources, no ethics approval will be sought. Findings will be disseminated via the scoping review Open Science Framework (OSF) project site and submitted for peer review. Results will elucidate promising areas for future research, including narrative intervention development and refinement; these findings will guide expansion into new populations.

Trial registration number

https://osf.io/85hjd/

Test to assess claims about treatment effects for Spanish primary school children: the development process and cross-sectional validation study of the test

Por: Samso Jofra · L. · Dahlgren · A. · Alonso-Coello · P. · Canovas Martinez · E. · Perez-Gaxiola · G. · Roque i Figuls · M. · Rosenbaum · S. · Sanz-Herranz · H. · Valenzuela Rubio · N. G. · Martinez Garcia · L.
Objectives

The aims of this study were (1) to develop and validate the interactive CLAIM Test (iCLAIM Test) to measure children’s ability to assess claims about treatment effects and make informed health choices and (2) to measure this ability in Spanish primary school children using the developed test.

Design

We followed a multistep process including (1) definition of the test scope, (2) selection of the questions, (3) translation process, (4) design and development of the online test, (5) external review with experts, (6) user-test with children and (7) cross-sectional validation study with Rasch analysis.

Setting

Spanish primary schools.

Participants

Twelve experts (75% women) participated in the review, 11 children (45% girls) participated in the user-test and 480 Spanish primary school children (46.5% girls) from fourth to sixth grades (9–12 years old) participated in the cross-sectional validation study.

Results

The iCLAIM Test is an online, interactive and user-friendly test in Spanish that measures children’s ability to understand and apply key concepts of the informed health choices (IHC) Project when assessing claims about treatment effects and making IHCs. The test includes 30 questions: six demographic questions and 24 questions from the Claim Evaluation Tools item bank. Less than 40% of the students who participated in the cross-sectional validation study showed basic knowledge of the IHC Key Concepts and how to apply them, and less than 4% showed a clear knowledge. The test showed a good fit to the Rasch model and was acceptable to the target audience.

Conclusions

The iCLAIM Test is the first instrument validated for measuring children’s ability to assess treatment claims in Spain. In the future, we can tailor IHC education interventions and improve critical thinking skills about the health of Spanish children.

Faster but less accurate: An explorative study on the effects of three weeks of ketogenic diet on cognitive functions in undergraduate students

by Gianluigi Serio, Consiglia Pacelli, Claudia Piccoli, Nazzareno Capitanio, Giuseppe Cibelli, Anna Antonia Valenzano, Francesca Landini, Leonardo Carlucci, Paola Palladino

The ketogenic diet (KD) is a low-carbohydrate diet that induces and sustains a ketosis state and minimizes somatic glucose levels. Several psychological studies have described the positive effects of ketosis on cognitive functions for a wide range of neuropsychiatric conditions (e.g., Alzheimer’s disease; epilepsy), leading to greater interest in the KD today. However, the psychological and cognitive effects of inducing ketosis via diet remain unclear, especially in healthy people. From an initial pool of thirty participants, eight undergraduate students performed a cognitive assessment before (baseline) and after three weeks (follow-up) of an isocaloric ketogenic diet. Several neuropsychological measures and psychometric tests have been administered to investigate psychological chronotype, sleep quality, eating habits, anxiety and cognitive components of attention, inhibition, and memory. Non-parametric Bayesian analysis showed that the ketogenic diet affected cognitive functions. Participants performed cognitive tests faster at follow-up than at baseline, showing improvements in visual-motor cognitive and processing speed components. However, they were less accurate on working memory tasks, suggesting a decreasing performance of higher cognitive functions. Finally, no differences in anxiety levels were found between baseline and follow-up. The results could have significant implications for identifying specific cognitive models of students based on specific lifestyle habits and nutritional patterns, allowing the implementation of targeted interventions to improve university learning conditions.

Identifying risk patterns for sudden cardiac death in athletes: A clustering and principal component analysis approach

by Giacinto Angelo Sgarro, Paride Vasco, Domenico Santoro, Luca Grilli, Marco Giglio, Natale Daniele Brunetti, Luigi Traetta, Giuseppe Cibelli, Anna Antonia Valenzano

Sudden Cardiac Death (SCD) is a critical and unexpected condition that occurs due to cardiac causes within one hour of the onset of acute cardiovascular symptoms or twenty-four hours in unwitnessed cases. Despite advancements in cardiovascular medicine, practical methods for predicting SCD are still lacking, and there are no standardized systems to identify individuals at risk, especially in seemingly healthy populations such as athletes. In this study, we employed hierarchical clustering and principal component analysis (PCA) on data from 711 competitive athletes, revealing distinct patterns and cluster distributions in PCA space. Specifically, Clustering revealed characteristic feature combinations associated with increased SCD risk in athletes. Notably, certain clusters shared traits, including participation in Class C sports, sinus tachycardia, ventricular pre-excitation, personal or family history of heart disease, T-wave inversions, and prolonged QTc intervals. PCA helped visualize these patterns in distinct spatial regions, highlighting underlying structures and aiding intuitive risk interpretation. These results enable scientists to derive cluster metrics that serve as reference points for classifying new individuals and visually representing risk patterns in a clear graphical format. These findings establish a foundation for predictive tools that, with additional clinical validation, could aid in the prevention of SCD. The dataset used in this study, along with the clustering and PCA results, is available to the scientific community in an open format, together with the necessary tools and scripts to enable independent experimentation and further analysis.

Gender- and sex-sensitive psychopharmacotherapy of alcohol use disorder: a systematic review and meta-analysis protocol

Por: Hiss · I. C. · Hoffmann · S. · Reinhard · I. · Siegmann · E.-M. · Bach · P. · Kiefer · F. · Fischer · R. · Jäger · K. · Lenz · B.
Introduction

Alcohol use disorder (AUD) is a prevalent, chronic condition generating considerable global morbidity, mortality and socioeconomic burden. Despite the availability of established pharmacotherapies, overall treatment uptake remains low and effect sizes are moderate at best. Emerging evidence highlights substantial differences in treatment response between sexes and genders, yet these factors are rarely systematically considered in clinical trials or routine care. Existing reviews have limited scope and often exclude gender-diverse populations. This project aims to (1) Synthesise evidence on gender- and sex-specific efficacy, safety and adherence in AUD pharmacotherapies, (2) Evaluate the consideration of sex and gender beyond binary classifications in existing research and (3) Develop recommendations for gender- and sex-sensitive treatment strategies.

Methods and analysis

A systematic review and meta-analysis will be conducted using (PubMed, Web of Science, Scopus, Google Scholar, German Clinical Trials Register and ClinicalTrials.gov). We will include randomised controlled trials of pharmacotherapies for AUD with a minimum treatment duration of 4 weeks, reporting gender-specific and/or sex-specific results. The literature search will cover studies published up to October 2025, with inclusion restricted to articles published in English or German, regardless of setting. Two reviewers will independently screen records and assess risk of bias (Cochrane RoB), with evidence certainty evaluated using Grading of Recommendations Assessment, Development and Evaluation and aligned to Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 and Sex and Gender Equity in Research guidelines.

Ethics and dissemination

Ethics approval is not required as only data from already completed studies and supplementary information directly provided by study authors are used. Findings and recommendations will be disseminated in peer-reviewed journals and presented at conferences and workshops.

PROSPERO registration number

CRD420251079160.

Investigation of the combined effects of cannabidiol plus naltrexone on alcohol craving in alcohol dependence: study protocol of a phase II randomised, double-blind, placebo-controlled, parallel-group trial - ICONICplus Trial

Por: Vetter · S. · Weinberg · J. · Thomas · B. C. · Kirchner · M. · Thalmann · P. · Klose · C. · Pfisterer · M. · Kölsch · T. · Oesterle · S. · Vollstaedt-Klein · S. · Koopmann · A. · Lenz · B. · Kiefer · F. · Link · T. · Bach · P.
Introduction

Alcohol dependence (AD) is highly prevalent and has severe consequences on health and quality of life. However, the efficacy of approved pharmacotherapies such as naltrexone (NTX) remains limited, highlighting the need for novel pharmacotherapeutic approaches. Cannabidiol (CBD) is a promising candidate, which has shown potential to reduce craving and alcohol use by modulating brain circuits involved in craving and addiction. Preclinical studies suggest that CBD may enhance NTX’s therapeutic effects.

Methods and analysis

This is a three-armed, randomised, double-blind, placebo-controlled parallel group, multicentre phase II clinical trial. A total of 150 patients with AD will be randomised (1:1:1) to receive either 800 mg or 1200 mg CBD plus 50 mg oral NTX or placebo plus 50 mg oral NTX for 14 days. Alcohol craving will be assessed using the Obsessive Compulsive Drinking Scale (OCDS-G) where the primary endpoint is the change from baseline to the end of treatment. Secondary outcomes include craving during the entire study, quality of life, depressive symptoms, anxiety, patient-reported outcomes, neural brain activation, CBD plasma levels, time to relapse, alcohol use and treatment safety. For the comparison of each experimental group to the control group, a strata-adjusted (centre and baseline OCDS-G) van Elteren test is applied with adjustment for multiple testing by Bonferroni-Holm.

Ethics and dissemination

The trial has been approved by the Ethics Committee and the competent authority (ID: B_03510). All participants will provide written informed consent. An independent Data and Safety Monitoring Board will monitor safety. This trial complies with national and international regulations.

Trial registration number

NCT06845124; EU Trial Number: 2024-518164-12-00.

Association between multimorbidity and capacity impairment in the adult population of Chile: findings of the National Health Survey 2016-2017

Por: Seron · P. · Valenzuela-Suazo · R. · Oliveros · M. J. · Morales · C. · Ulloa · C. · Sanhueza · A. · Neculhueque · X.
Objective

This study aims to assess the association of multimorbidity with capacity impairment in the Chilean population.

Design

Cross-sectional study.

Setting

We analysed data from the National Health Survey performed in Chile in 2016 and 2017.

Participants

Persons aged 15 years and over were selected using a random, stratified and multistage sampling by clusters in all 15 geographical regions of the country.

Primary and secondary outcomes

We consider the WHO’s definition of multimorbidity as the coexistence of two or more chronic conditions in the same person. For capacity impairment, the survey included 24 items in eight dimensions that represent functioning as a reflection of the overall health experience perceived by an individual with a health condition and interacting with the environment.

Results

The 2016–2017 ENS (Encuesta Nacional de Salud) included 6233 participants (mean age 48.9±19.3, and 62% women). There is an association between impairment of capacity and being a woman (OR=1.62; 95% CI 1.37 to 1.92) and between being under 45 years old and conserved capacity (OR=0.8, 95% CI 0.64 to 0.99). The predictive model determined that women classified with five or more chronic conditions of 80 years and over and with less than 8 years of formal education reach the highest probability of having any impairment of capacity.

Conclusion

Multimorbidity is associated with impaired capacity in the adult population in Chile, and these public health problems are present at early ages and have a greater impact on women.

Efectividad de una intervención enfermera de información, sobre el nivel de ansiedad del familiar del paciente quirúrgico programado

Objetivo principal: Analizar si una intervención de enfermería de información sobre la cirugía y el circuito quirúrgico, tendría como efecto la disminución del nivel de ansiedad en el familiar del paciente quirúrgico programado. Metodología: Ensayo clínico controlado no aleatorizado. Se efectúa la comparación del nivel de ansiedad entre los familiares pertenecientes al grupo control (con intervención estándar preexistente) respecto a los del grupo intervención (sometidos a la nueva intervención de enfermería). Se utiliza un instrumento validado como el inventario de ansiedad estado-rasgo (STAI) para medir el nivel de ansiedad. Resultados principales: Participaron en el estudio 76 familiares, 37 en el grupo control y 39 en el grupo intervención. Ambos grupos eran comparables respecto a sus características basales. Se observa una disminución estadísticamente significativa en la ansiedad situacional durante el postoperatorio en el grupo intervención respecto al grupo control. Conclusión principal: Una intervención de enfermería de información sobre la cirugía y el circuito quirúrgico reduce la ansiedad situacional del familiar del paciente quirúrgico programado.

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