Scientia, Dipòsit d’Informació Digital del Departament de Salut
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Total knee arthroplasty revision risks depending on the bone cement used-Data from 50,545 knee replacements of the Catalan Arthroplasty Registry
Full text linkTotal knee arthroplasty; Bone cement; Catalan Arthroplasty Register (RACat)Artroplàstia total de genoll; Ciment ossi; Cirurgia de revisióArtroplastia total de rodilla; Cemento óseo; Cirugía de revisiónClinical data on individual bone cement brands and viscosities in cemented total knee arthroplasty (TKA) is scarce. The Catalan arthroplasty registry (RACat) documents usage of cement brands including viscosities and the inclusion of antibiotics. The objective was to compare the clinical performance of the widely used bone cement brand PALACOS® to other blinded bone cement brands in TKA using data from the RACat.
Patient data on 50,545 primary TKA between 2007 and 2017 in the RACat were analysed retrospectively. Implant survival of PALACOS bone cement was compared to other blinded bone cement brand groups using the all-cause revision risk as primary study endpoint.
Comparing implant survival, it was found that (1) PALACOS® (with or without gentamicin) was associated with a significantly lower revision risk compared to other cement brands (with or without antibiotics) (
Type of cement brand, viscosity and the addition of antibiotics have an impact on revision risk of TKA. Medium viscosity cement with gentamicin (PALACOS MV+G), for which no clinical data were previously available, was associated with the lowest revision risk in TKA.
Level III, retrospective comparative study
Pla d'enquestes de percepció, experiència i satisfacció d'usuaris del Servei Català de la Salut (PLAENSA): atenció hospitalària urgent
No full textAtenció urgent hospitalària; Enquestes de satisfaccióAtención urgente hospitalaria; Encuestas de satisfacciónUrgent hospital care; Satisfaction surveysLa novena edició de l’estudi de percepció, experiència i satisfacció amb el servei d’atenció hospitalària urgent, dut a terme per la Unitat d’Avaluació i Experiència del Pacient en el marc del Pla d’enquestes de percepció, experiència i satisfacció dels usuaris del Servei Català de la Salut, ha mostrat que les persones que han utilitzat aquest servei durant l’any 2024 valoren la satisfacció amb l’atenció rebuda amb un 7,18 sobre 10 de mitjana. A més a més, de les persones que s’han entrevistat, un 72,7 % ha respost que “Sí” a la pregunta: “Si poguéssiu triar, continuaríeu venint a aquest centre?”.
Les preguntes amb una major freqüència de respostes positives es troben dins dels àmbits de tracte i informació del servei: la “P16. Tracte personal dels zeladors i zeladores”, amb un 94,2 % de respostes positives; la “P14. Tracte personal infermers/infermeres”, amb un 90,6 %, i finalment la “P24. Explicació del perquè de l’ingrés”, amb un 89,9 %.
Aquest estudi compta amb 4.239 casos, procedents del registre d’activitat dels centres proveïdors. Durant aquesta edició de l’any 2024, s’ha utilitzat un qüestionari validat durant l’any 2023, que s’ha tornat a validar després de l’edició d’enguany. El treball de camp s’ha dut a terme entre el 21 i el 23 de maig de l’any 2024, utilitzant un qüestionari web amb invitació per SMS
Chimeric antigen receptor T-cell therapy outcomes in T cell/histiocyte-rich large B-cell lymphoma and subsequent treatment strategies after disease progression: A GELTAMO/GETH study
Full text linkT-cell therapy; Large B-cell lymphoma; Disease progressionTerapia de células T; Linfoma de células B grandes; Progresión de la enfermedadTeràpia de cèl·lules T; Limfoma de cèl·lules B grans; Progressió de la malalti
Help deliver safer paediatric care
Full text linkSeguretat; Atenció; Etapa pediàtricaSeguridad; Atención; Etapa pediátricaSafety; Care; Pediatric stageAquest document recull deu recomanacions clau per garantir la seguretat en l’atenció durant l’etapa pediàtrica.Este documento recoge diez recomendaciones clave para garantizar la seguridad en la atención durante la etapa pediátrica.This document outlines ten key recommendations to ensure safety in care during the pediatric stage
Humoral and cellular immune responses after 6 months of a heterologous SARS-CoV-2 booster with the protein-based PHH-1V vaccine in a phase IIb trial
Full text linkCovid-19; Heterologous booster; Protein-based vaccineCovid-19; Refuerzo heteróloga; Vacuna basada en proteínasCovid-19; Reforç heteròleg; Vacuna basada en proteïnesThe HIPRA-HH-2 was a multicentre, randomized, active-controlled, double-blind, non-inferiority phase IIb clinical trial comparing the immunogenicity and safety of the PHH-1V adjuvanted recombinant vaccine as a heterologous booster against homologous booster with BNT162b2. Interim results demonstrated strong humoral and cellular immune response against the SARS-CoV-2 Wuhan-Hu-1 strain and the Beta, Delta, and Omicron BA.1 variants up to day 98 post-dosing. Here we report that these responses with PHH-1V are sustained up to 6 months, including in participants over 65 years, despite their smaller sample size. The PHH-1V booster was non-inferior in eliciting neutralizing antibodies for SARS-CoV-2 Omicron XBB.1.5 variant compared to BNT162b2 after 6 months. No severe COVID-19 cases occurred in any group, and mild cases were similar (50.4 % for PHH-1V vs. 47.8 % for BNT162b2). While both groups may have reached comparable immunity levels, these findings suggest that the PHH-1V vaccine provides long-lasting immunity against various of SARS-CoV-2 variants. ClinicalTrials.gov Identifier: NCT05142553.This study was sponsored by HIPRA SCIENTIFIC, S.L.U. (HIPRA) and partially funded by the Centre for the Development of Industrial Technology (CDTI, IDI-20211192), a public organisation answering to the Spanish Ministry of Science and Innovation. HIPRA was involved in the study design; in the collection, analysis, and interpretation of data; in writing of the report; and in the decision to submit the paper for publication
Factors in Time to Full Approval or Withdrawal for Anticancer Medicines Granted Accelerated Approval by the FDA
Full text linkApproval anticancer medicines; Accelerated approvalAprobación de medicamentos anticancerígenos; Aprobación aceleradaAprovació de medicaments anticancerígens; Aprovació acceleradaImportance The accelerated approval pathway was developed to expedite US Food and Drug Administration (FDA) drug approval for life-threatening conditions based on changes to unvalidated surrogate measures, with conversion to regular approval then based on a required confirmatory trial. However, confirmatory trials may not be completed in a timely fashion.
Objective To analyze factors associated with time to conversion to regular approval.
Design, setting, and participants This cohort study of cancer drugs FDA-approved from 1992 to 2022 extracted pivotal and confirmatory trial characteristics, outcomes, safety data, and confirmatory study status at approval from drug labels and published reports. Clinical benefit was assessed using the European Society of Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) for pivotal and confirmatory studies. High benefit was defined as grade A or B (for trials of curative intent) and 4 or 5 (palliative intent) and low benefit as grade C and 2 or below. Data were analyzed between August 2023 and August 2024.
Main Outcome and Measure Time to full approval or withdrawal.
Results This cohort study analyzed 102 cancer drug indications granted accelerated approval by the FDA between 1992 and 2022 and converted to regular approval by August 31, 2024. The median (IQR) time to conversion was 3.1 (1.9-4.8) years. Of these, 83 (81%) received priority review, and 27 (26%) carried boxed warnings. On the ESMO-MCBS scale, 12 of 101 pivotal trials that were scorable showed high benefit (12%), 27 intermediate benefit (27%), and 62 low benefit (61%). Twenty-one confirmatory trials (21%) were initiated after accelerated approval. Factors at the time of accelerated approval that were associated with shorter times to full approval included priority review designation, absence of boxed warnings, initiation of confirmatory studies before approval, and pivotal trials showing intermediate or high benefit on the ESMO-MCBS framework. Among the 102 confirmatory trials, 34 (33%) demonstrated significant improvements in overall survival, and 14 of 35 trials (40%) reporting on quality of life showed significant benefits. The ESMO-MCBS scale was applicable to 98 trials, with 46 (47%) scoring high clinical benefit, 29 (30%) intermediate, and 23 (23%) low. Indications with benefits in overall survival (median [IQR], 2.15 [1.40-3.38] vs 3.70 [2.33-5.78] years), quality of life (median [IQR], 2.29 [1.85-3.53] vs 4.22 [2.52-5.72] years), and high clinical benefit in confirmatory trials (median [IQR], 2.34 [1.52-3.39] vs 3.91 [2.59-6.42] years) were associated with faster conversion to full approval.
Conclusions and Relevance In this cohort study, drugs with low clinical benefit or safety concerns at accelerated approval were linked to delayed confirmatory studies, while high clinical benefit in confirmatory trials correlated with faster conversion. These associations can help guide patient decision-making around accelerated approval drugs.Funded by the Kaiser Permanente Institute for Health Policy. Authors were supported by grants from Arnold Ventures and Commonwealth Fund (Kesselheim) and Alfonso Martín Escudero Foundation (Tibau)
New Oral Selective Estrogen Receptor Degraders Redefine Management of Estrogen Receptor–Positive Breast Cancer
Full text linkBreast cancer; Camizestrant; Estrogen receptorCáncer de mama; Camizestrant; Receptor de estrógenoCàncer de mama; Camizestrant; Receptor d'estrògensOral selective estrogen receptor degraders (SERDs) are pure estrogen receptor antagonists that have the potential to overcome common resistance mechanisms to endocrine therapy in estrogen receptor–positive breast cancer. There are currently five oral SERDs in published and ongoing clinical trials—elacestrant, camizestrant, giredestrant, imlunestrant, and amcenestrant—with more in development. They offer a reasonably well-tolerated oral therapy option with low discontinuation rates in studies. This review summarizes the currently available literature on this new class of drugs
Considerations and recommendations from the ISMRM diffusion study group for preclinical diffusion MRI: Part 2—Ex vivo imaging: Added value and acquisition
Full text linkDiffusion MRI; Diffusion tensor; Ex vivoResonancia magnética de difusión; Tensor de difusión; Ex vivoRessonància magnètica de difusió; Tensor de difusió; Ex vivoThe value of preclinical diffusion MRI (dMRI) is substantial. While dMRI enables in vivo non-invasive characterization of tissue, ex vivo dMRI is increasingly being used to probe tissue microstructure and brain connectivity. Ex vivo dMRI has several experimental advantages including higher SNR and spatial resolution compared to in vivo studies, and enabling more advanced diffusion contrasts for improved microstructure and connectivity characterization. Another major advantage of ex vivo dMRI is the direct comparison with histological data, as a crucial methodological validation. However, there are a number of considerations that must be made when performing ex vivo experiments. The steps from tissue preparation, image acquisition and processing, and interpretation of results are complex, with many decisions that not only differ dramatically from in vivo imaging of small animals, but ultimately affect what questions can be answered using the data. This work represents “Part 2” of a three-part series of recommendations and considerations for preclinical dMRI. We describe best practices for dMRI of ex vivo tissue, with a focus on the value that ex vivo imaging adds to the field of dMRI and considerations in ex vivo image acquisition. We first give general considerations and foundational knowledge that must be considered when designing experiments. We briefly describe differences in specimens and models and discuss why some may be more or less appropriate for different studies. We then give guidelines for ex vivo protocols, including tissue fixation, sample preparation, and MR scanning. In each section, we attempt to provide guidelines and recommendations, but also highlight areas for which no guidelines exist (and why), and where future work should lie. An overarching goal herein is to enhance the rigor and reproducibility of ex vivo dMRI acquisitions and analyses, and thereby advance biomedical knowledge.The authors acknowledge financial support from: the National Institutes of Health (K01EB032898, R01AG057991, R01NS125020, R01EB017230, R01EB 019980, R01EB031954, R01CA160620, R01NS109090), the National Institute of Biomedical Imaging and Bioengineering (R01EB031765, R56EB031765), the National Institute on Drug Abuse (P30DA048742), the Secretary of Universities and Research (Government of Catalonia) Beatriu de Pinós postdoctoral fellowship (2020 BP 00117), “la Caixa” Foundation Junior Leader fellowship (LCF/BQ/PR22/11920010), the Research Foundation Flanders (FWO: 12M3119N), the Belgian Science Policy Prodex (Grant ISLRA 2009–1062), the μNEURO Research Center of Excellence of the University of Antwerp, the Institutional research chair in Neuroinformatics (Sherbrooke, Canada), the NSERC Discovery Grant, the European Research Council Consolidator grant (101044180), the Canada Research Chair in Quantitative Magnetic Resonance Imaging [950-230815], the Canadian Institute of Health Research [CIHR FDN-143263], the Canada Foundation for Innovation [32 454, 34 824], the Fonds de Recherche du Québec—Santé [322736], the Natural Sciences and Engineering Research Council of Canada [RGPIN-2019-07244], the Canada First Research Excellence Fund (IVADO and TransMedTech), the Courtois NeuroMod project, the Quebec BioImaging Network [5886, 35 450], the Mila—Tech Transfer Funding Program and the Swiss National Science Foundation (Eccellenza Fellowship PCEFP2_194260), the Wellcome Trust (202788/Z/16/A, 203139/Z/16/Z and 203139/A/16/Z)
SMART DIABETES HOSPITAL: CLINICAL IMPACT IN COMPLEX SURGICAL UNITS OF A TERTIARY HOSPITAL
Full text linkDiabetes; Smart diabetes Hospital; Specialized diabetes teamDiabetis; Hospital intel·ligent de diabetis; Equip especialitzat en diabetisDiabetes; Hospital inteligente de diabetes; Equipo especializado en diabetesAim: To evaluate the impact of a proactive action of a specialized diabetes team (SDT) on different health outcomes in patients hospitalized in high complexity surgery units, including solid organ transplant surgical units, of a tertiary hospital.
Methods: Nested case control study matched (1:1) by age and gender. The control group consisted of patients (n = 120) who were under the standard of care diabetes management admitted three months' prior the cases. The cases were admitted in the same surgical units (n = 120) and were treated in the setting of the so called "Smart Diabetes Hospital" (SDH) consisting in a SDT that prioritized their actions through a digital map showing blood glucose levels obtained during the previous 24 h.
Results: SDH implementation resulted in a significant reduction in both blood glucose levels (mean 162.1 ± SD 44.4 vs. mean 145.5 ± SD 48.0; p = 0.008) and hypoglycaemic episodes (19.7% vs. 8.4%: p = 0.002). Furthermore, a reduction of 3 days in the length of stay (LOS) was observed (15.6 ± 10.3 vs. 12.4 ± 6.0), which represents a significant cost-saving. Moreover, more new cases of diabetes were detected during the SDT period (2.5% vs. 6.7%, p = 0.04).
Conclusion: SDH is effective in diabetes management and reduce LOS in complex surgical units
Evaluation of magnetic resonance spectroscopy total sodium concentration measures, and associations with microstructure and physical impairment in cervical myelopathy
Full text linkCervical myelopathy; Macromolecular tissue volume; Spinal cordMielopatia cervical; Volum del teixit macromolecular; Medul·la espinalMielopatía cervical; Volumen del tejido macromolecular; Médula espinalSpinal cord injury causes a cascade of physiological responses, which may trigger a subsequent neurotoxic increase in intracellular sodium. This can lead to neurodegeneration, both at and beyond the site of injury, causing clinical symptoms and loss of function. However, in vivo measurements of tissue sodium remain challenging. Here we utilise sodium magnetic resonance spectroscopy (23Na-MRS) at 3T to measure tissue sodium concentration (TSC) and its association with microstructural measures and macromolecular MRI metrics in the cervical spinal cord, distal to the site of injury. Twenty people with cervical myelopathy and twenty healthy controls, were studied. Associations with motor and sensory impairments were explored using ASIA and jOAMEQ scores. No significant difference in TSC in the cervical myelopathy group (39 ± 10 mM) relative to healthy controls (35 ± 13 mM) was found. However, patients had a significantly lower cord-cross-sectional area than controls (70 ± 9 mm2 vs. 82 ± 9 mm2, p < 0.001). Lower-extremity function positively correlated with intracellular volume fraction (p = 0.031). In conclusion, using 23Na-MRS, TSC in cervical myelopathy patients was successfully measured. Differences in TSC relative to healthy controls did not reach significance, despite a significant reduction in cord-cross-sectional area. However, lower intracellular volume fraction, indicating reduced neurite density distal to the site of injury, was associated with physical impairment.This study was supported by Wings for Life (#169111) to CGWK and BS. CGWK receives funding from MRC (#MR/S026088/1), Ataxia UK, Rosetrees Trust (#PGL22/100041 and #PGL21/10079). JNP is supported in part by funding from the United Kingdom’s Department of Health NIHR University College London Hospitals Biomedical Research Centres funding scheme. BS is also supported by the Multiple Sclerosis Society (175). CT is currently being funded by a Miguel Servet contract, awarded by the Instituto de Salud Carlos III (ISCIII), Ministerio de Ciencia e Innovación de España (CP23/00117). FG receives the support of a fellowship from “la Caixa” Foundation (ID 100010434). The fellowship code is "LCF/BQ/PR22/11920010"