Scientia, Dipòsit d’Informació Digital del Departament de Salut
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Índex de qualitat de la prescripció farmacèutica per professional (IQF)
Get PDFÍndex de Qualitat de la Prescripció Farmacèutica; IQF; ProfessionalsÍndice de Calidad de la Prescripción Farmacéutica; IQF; ProfesionalesPharmaceutical Prescription Quality Index; IQF; ProfessionalsL'any 2025, s’ha elaborat per primera vegada un IQF per professional de medicina familiar i comunitària. La seva composició, el repartiment de punts entre indicadors i la puntuació de cada indicador. L’IQF professional 2025 està format per una bateria de 20 indicadors, amb objectius específics de millora per a cadascun d’ells i ponderats d’acord amb la seva contribució a la millora global de la qualitat de la prescripció farmacèutica
Systematic review of pharmacological treatment options for orthostatic tremor in prospective patient cohorts and randomized controlled trials
Get PDFOrthostatic tremor; Pharmacological treatment; Prospective trialsTemblor ortostático; Tratamiento farmacológico; Ensayos prospectivosTremolor ortostàtic; Tractament farmacològic; Assajos prospectiusIntroduction
Orthostatic tremor is an infrequent movement disorder characterized by a high-frequency tremor manifesting primarily in the standing position. This condition can lead to relevant restrictions of mobility in everyday life and adversely affect the quality of life. The etiology has not been conclusively clarified. To date, there are few therapy studies of sufficient quality.
Aim
The aim of the present literature analysis is to systematically evaluate the existing evidence of pharmacological therapies for orthostatic tremor.
Materials and methods
This study searched for publications via PubMed and Google Scholar using the terms “orthostatic tremor” AND “therapy” and “shaky legs syndrome” AND “therapy”. The main inclusion criteria were a subject number ≥ 5, pharmacological treatment approaches and the presence of a prospective experimental design.
Results
The evaluation of the results indicated the most positive evidence for therapy with gabapentin. Additionally, other drugs such as perampanel and levodopa also showed positive outcomes regarding specific endpoints. In contrast, there is a lack of evidence supporting the efficacy of levetiracetam and botulinum toxin in the context of primary orthostatic tremor.
Discussion and conclusion
According to current evidence, gabapentin is the drug with the most robust data. However, further studies are needed to support the evidence for different pharmacological therapeutic approaches for orthostatic tremor. Future investigations should emphasize larger sample sizes, placebo-controlled, double-blinded methodologies and a longer follow-up to be able to make more precise recommendations with greater generalizability.Open Access funding enabled and organized by Projekt DEAL
Enhanced Versus Standard Dermatologic Management With Amivantamab-Lazertinib in EGFR-Mutated Advanced NSCLC: The COCOON Global Randomized Controlled Trial
Get PDFAmivantamab; Dermatologic adverse events; Dermatologic managementAmivantamab; Eventos adversos dermatológicos; Manejo dermatológicoAmivantamab; Esdeveniments adversos dermatològics; Maneig dermatològicIntroduction: Amivantamab plus lazertinib significantly improved progression-free and overall survival versus osimertinib in patients with previously untreated, EGFR-mutant advanced NSCLC. EGFR-targeted therapies are associated with dermatologic adverse events (AEs), which can affect quality of life (QoL). COCOON was conducted to assess prophylactic management and improve treatment experience.
Methods: In the phase 2 COCOON study (NCT06120140), participants with previously untreated, EGFR-mutant, locally advanced or metastatic NSCLC received intravenous amivantamab plus oral lazertinib and were randomized 1:1 to enhanced dermatologic management (COCOON DM) or standard of care (SoC DM) per local guidelines. COCOON DM included oral doxycycline or minocycline (100 mg twice daily; weeks 1-12), clindamycin 1% (on scalp daily; weeks 13-52), chlorhexidine 4% (on fingernails and toenails daily), and ceramide-based moisturizer (on body and face at least daily). Primary end point was incidence of grade 2 or higher dermatologic AEs of interest (DAEIs) by week 12.
Results: In total, 201 participants were randomized (99 to COCOON DM and 102 to SoC DM). At a median follow-up of 7.1 months, COCOON DM demonstrated significant reduction in the primary end point versus SoC DM (42% versus 75%; OR, 0.24; 95% confidence interval, 0.13-0.45; p < 0.0001). By week 12, the largest benefit with COCOON DM was observed in DAEIs involving the face and body (excludes paronychia; 26% versus 60%; p < 0.0001) and DAEIs involving the scalp (10% versus 26%; p = 0.0049). This benefit was maintained at 6 months, with significant reductions of DAEIs involving face, body, and scalp (excluding paronychia). Patient-reported outcomes favored COCOON DM, indicating reduced impact of dermatologic symptoms on QoL.
Conclusion: An uncomplicated, widely available, prophylactic regimen (COCOON DM) reduced the incidence of DAEIs with amivantamab-lazertinib and the impact of symptoms on QoL.This study was funded by Janssen Research & Development, LLC, a Johnson & Johnson company
Catàleg de prestacions ortoprotètiques a càrrec del Servei Català de la Salut
Get PDFPrestacions ortoprotètiques; Catàleg; Servei Català de la SalutPrestaciones ortoprotéticas; Catálogo; Servicio Catalán de la SaludOrthoprosthetic benefits; Catalogue; Catalan Health ServiceEl catálogo de prestaciones ortoprotésicas incluye la relación de artículos ortoprotésicos (prótesis, sillas de ruedas, órtesis, ...) especificando el precio y la aportación máxima del CatSalut.The catalogue of orthoprosthetic benefits includes the list of orthoprosthetic items (prostheses, wheelchairs, orthoses, ...) specifying the price and the maximum contribution covered by CatSalut.El catàleg de prestacions ortoprotètiques inclou la relació d'articles ortoprotètics (pròtesis, cadires de rodes, ortesis...) especificant el preu i l'aportació màxima del CatSalut. Actualització de novembre del 2025
Deep Sequencing Reveals Dual Evolution of SARS-CoV-2: Insights Into Defective Genomes From Wuhan-Hu-1 Variants to Omicron Subvariants
Get PDFOmicron; Deep‐sequencing; Dual evolutionÒmicron; Seqüenciació profunda; Evolució dualÓmicron; Secuenciación profunda; Evolución dualSARS-CoV-2 has evolved from early variants dominating the first (B.1.5, B.1.1) and second (B.1.177) pandemic waves, which exhibited a higher frequency of minority mutants with deletions leading to Defective Viral Genomes (DVGs) in the spike region near the S1/S2 cleavage site than the Alpha, Beta, and Delta variants. The emergence of Omicron has significantly altered the dominant variant profile, with Omicron subvariants now representing 100% of circulating viruses. To monitor the evolution and adaptation of Omicron in the human population, a deep-sequencing study was performed in RNA samples of BA.1, BA.1.1, BA.2, BA.5, BQ.1.1, XBB.1.5 and BA.2.86 Omicron subvariants. The findings reveal two occurrences of similar evolutionary patterns within SARS-CoV-2 characterized by a shift from a significant to a very low production of DVGs. This event suggests that DVGs might play a role in the virus's spread and adaptation for persistence in infected humans.This study was supported by the Centro para el Desarrollo Tecnológico Industrial (CDTI) of the Spanish Ministry of Economy and Business, grant number IDI-20200297; Grant PID2021-126447OB-I00 funded by MCIN/AEI/10.13039/501100011033 and by the ERDF A way of making Europe; Fondo de Investigación Sanitaria, Spanish Ministry of Economy and Competitiveness (grants FIS PI19/00301, PI19/00533, PI22/00258, PI22/00023, and PI23/01065); CIBER—Consorcio Centro de Investigación Biomédica en Red—(CIBERINFEC, ISCIII—CIBER of Infectious Diseases & CIBEREHD, ISCIII—CIBER of Hepatic and Digestive Diseases), Instituto de Salud Carlos III, Ministry of Science and Innovation and the European Union—NextGenerationEU. Research contributions of Wageningen Bioveterinary Research are funded from the ERRAZE (Early Response and Rapid Action Zoonotic Emergencies Program). C.C. received a predoctoral fellowship from the Vall d'Hebron Institute of Research (VHIR). M.I.-L. was supported by a fellowship from the “La Caixa” Foundation (ID 100010434), with code “LCF/BQ/DR23/12000020”. S.C-C. received support from the Spanish Ministry of Education grant FPU21/04150
Clinical Validity of FoundationOne Liquid CDx for Detection of BRAFV600E in Colorectal Cancer
Get PDFBRAF inhibitor; Colorectal cancerInhibidor de BRAF; Cáncer colorrectalInhibidor de BRAF; Càncer colorectalPurpose: The BRAF inhibitor encorafenib (Enco) plus the anti-EGFR antibody cetuximab (Cetux) improved overall survival, objective response rate, and progression-free survival in previously treated BRAFV600E-mutant metastatic colorectal cancer in BEACON, a phase III randomized trial, leading to regulatory approval for this indication. To support rapid, plasma-based testing for BRAFV600E identification, clinical validity of a ctDNA-based assay, FoundationOneLiquid CDx (F1LCDx), was assessed against the reference tumor-based clinical trial assay (CTA) in liquid biopsy-evaluable samples from BEACON and commercially obtained tissue-matched plasma samples.
Patients and methods: Pretreatment tissue samples were collected in BEACON to confirm BRAF mutational status using the central single gene PCR assay. Concordance between the CTA and liquid biopsy tests was assessed, and clinical validity of liquid biopsy testing was examined using clinical outcomes from BEACON.
Results: Of the 523 evaluable patients, 433 with matched tissue and plasma samples had CTA and F1LCDx results available (BEACON, n = 328; commercial, n = 105). A strong concordance in detecting BRAFV600E was found between F1LCDx and CTA, with a positive percent agreement of 87.2% and negative percent agreement of 97.1%. Among 42 F1LCDx-/CTA+ samples, 41 (97.6%) had ctDNA tumor fraction 1%, the positive percent agreement was 99.4% and negative percent agreement was 86.7%. Clinical outcomes with Enco plus Cetux were similar between those identified as F1LCDx+/CTA+ and CTA+ overall.
Conclusions: This study supports using liquid biopsies as a clinically valid assay for identifying BRAFV600E alterations in patients with metastatic colorectal cancer, particularly when ctDNA tumor fraction was >1%.
Significance: In the phase III BEACON trial, which established Enco plus Cetux as a standard of care for previously treated BRAFV600E-mutant metastatic colorectal cancer, mutational status was confirmed through testing of tumor tissue. To support rapid, less invasive testing for BRAFV600E in plasma, this retrospective study assessed a ctDNA-based assay and found strong concordance between the liquid biopsy test and the tumor-based assay in detecting BRAFV600E
AI-driven reclassification of multiple sclerosis progression
Get PDFMachine learning; Multiple sclerosis; ProgressionAprendizaje automático; Esclerosis múltiple; ProgresiónAprenentatge automàtic; Esclerosis múltiple; ProgresióMultiple sclerosis (MS) affects 2.9 million people. Traditional classification of MS into distinct subtypes poorly reflects its pathobiology and has limited value for prognosticating disease evolution and treatment response, thereby hampering drug discovery. Here we report a data-driven classification of MS disease evolution by analyzing a large clinical trial database (approximately 8,000 patients, 118,000 patient visits and more than 35,000 magnetic resonance imaging scans) using probabilistic machine learning. Four dimensions define MS disease states: physical disability, brain damage, relapse and subclinical disease activity. Early/mild/evolving (EME) MS and advanced MS represent two poles of a disease severity spectrum. Patients with EME MS show limited clinical impairment and minor brain damage. Transitions to advanced MS occur via brain damage accumulation through inflammatory states, with or without accompanying symptoms. Advanced MS is characterized by moderate to high disability levels, radiological disease burden and risk of disease progression independent of relapses, with little probability of returning to earlier MS states. We validated these results in an independent clinical trial database and a real-world cohort, totaling more than 4,000 patients with MS. Our findings support viewing MS as a disease continuum. We propose a streamlined disease classification to offer a unifying understanding of the disease, improve patient management and enhance drug discovery efficiency and precision.Open access funding provided by Albert-Ludwigs-Universität Freiburg im Breisgau
Combined dendritic cell and anti-TIGIT immunotherapy potentiates adaptive NK cells against HIV-1
Get PDFDendritic cell; HIV; Natural killerCèl·lula dendrítica; VIH; Assassí naturalCélula dendrítica; VIH; Asesino naturalNatural Killer (NK) cells are promising candidates for targeting persistently infected CD4 + T cells in people with HIV-1 (PWH). However, chronicity of HIV-1 infection impairs NK cell functionality, requiring additional strategies to potentiate their cytotoxic activity. This study demonstrates that dendritic cells primed with nanoparticles containing Poly I:C (Nano-PIC-MDDC) enhance the natural cytotoxic function of NK cells from effective responder PWH. These NK cells exhibit increased proportions of NKG2C+ cell subsets capable of eliminating HIV-1 infected CD4 + T cells through the TRAIL receptor. In contrast, in non-responder PWH, elevated expression of the inhibitory receptor TIGIT is associated with reduced frequencies of NKG2C + NK cells and diminished TRAIL expression. TIGIT blockade restores cytotoxicity of NK cells from non-responder PWH against HIV-1-infected cells by upregulating TRAIL. Furthermore, combining Nano-PIC-MDDC-primed NK cells with anti-TIGIT immunotherapy in humanized NSG mice reduces the expansion of HIV-1 infected cells, preserves NKG2C + NK cell precursors and increases TRAIL expression in tissue. Collectively, these findings support the combined use of Nano-PIC-MDDC and TIGIT blockade as a promising immunotherapeutic strategy toward an HIV-1 cure.EMG was supported by Ramón y Cajal Program (RYC2018-024374-I), the Spanish Agencia Estatal de Investigación RETOS, Generación de conocimiento and consolidation programs (RTI2018-097485-A-I00; PID2021-127899OB-I00; CNS2023-144841), La Caixa Banking Foundation ETI-CureHIV (HR20-00218), GLD24/00117 grant from Gilead Biosciences and infectious diseases CIBER (CIBERINFEC) from ISCIII (CB21/13/00107). MAL was supported by the Formación de Personal Investigador (FPI) grant PRE2022-104516. IT was supported by FPI UAM fellowship. CDA was supported by Comunidad de Madrid Talento Program (2017-T1/BMD-5396). MCM was supported by La Caixa Foundation ETI-CureHIV (HR20-00218). P2022/BMD7209-INTEGRAMUNE from Comunidad Autónoma de Madrid and La Caixa Health Research Grant LCF/PR/HR23/52430018 to and PID2023-149541OB-I00 FSM also supported the study. ISC was supported by infectious diseases CIBER from ISCIII (CB21/13/00107). JGP was supported by La Caixa Health program ETI-CureHIV project (HR20-00218), the CIBERINFECC from the National Health Institute Carlos III, and the project PI22/01120. MLT was supported by the Spanish Agencia Estatal de Investigación, Ministerio de Ciencia, Innovación y Universidades (PID2022-138880OB-I00 and PDC2021-121238-I00). NMC contributed to ROC Curve analysis
Uncovering a bias in estimated treatment effects on PIRA in multiple sclerosis clinical trials
Get PDFMultiple sclerosis; Treatment effect bias; Progression independent of relapse activity (PIRA)Esclerosi múltiple; Biaix de l'efecte del tractament; Progressió independent de l'activitat de recaigudaEsclerosis múltiple; Sesgo del efecto del tratamiento; Progresión independiente de la actividad de recaídaBackground: Interest in progression independent of relapse activity (PIRA) as an endpoint in multiple sclerosis (MS) clinical trials is surging. However, established definitions of PIRA may produce biased treatment effect estimates in the presence of a treatment-induced relapse reduction.
Methods: We applied different definitions of PIRA to pooled data from the OPERA I/II clinical trials (clinicaltrials.gov identifiers: NCT01247324, NCT01412333). Treatment effects on PIRA according to different methods were quantified by hazard ratios (HRs) and risk ratios (RRs). Next, we evaluated the bias in each definition using synthetic Expanded Disability Status Scale (EDSS) data simulating a control and an experimental arm with varying treatment effects on relapses and on PIRA. We quantified the bias by comparing the estimated effect on PIRA with the known true effect.
Findings: The pooled OPERA I/II population included 1656 participants. Estimated treatment effects on PIRA varied from a non-significant HR of 0.83 (CI = 0.66-1.04) to an HR of 0.73 (CI = 0.59-0.90) depending on the definition used. Follow-up analyses on simulated data (n = 800 per arm) revealed an underestimation of the true treatment effect on PIRA when using established definitions, with increasing bias as treatment effect on relapses increased. Defining PIRA as complementary to relapse-associated worsening (RAW) provided a less biased and operationally simple alternative.
Interpretation: For clinical trials with PIRA as an endpoint, we suggest a "complementary" definition of PIRA, relying on accurate exclusion of RAW promoted by appropriate visit timing.Italian Ministry of University and Research
Cirurgia personalitzada 3D aplicada a cirurgies protèsiques d’espatlla, maluc i genoll. Mapeig sistemàtic de la literatura i revisió sistemàtica de seguretat i eficàcia/efectivitat
Get PDFArtroplàstia; Espatlla; Maluc; Genoll; Impressió tridimensionalArtroplastia; Hombro; cadera; Rodilla; Impresión tridimensionalArthroplasty; Shoulder; Hip; Knee; Three-dimensional printingSíntesi dels principals resultats de l'informe elaborat per avaluar l'evidència disponible sobre la cirurgia 3D personalitzada, utilitzant instrumental quirúrgic i/o pròtesi a mida del pacient, en cirurgies protètiques.Síntesis de los principales resultados del informe elaborado para evaluar la evidencia disponible sobre la cirugía 3D personalizada utilizando instrumental quirúrgico y/o prótesis a medida del paciente, en cirugías protéticas.Summary of the main results of the report prepared to evaluate the available evidence on personalized 3D surgery, using surgical instruments and/or patient-tailored prosthesis, in prosthetic surgeries