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Manual de notifiació: registre del conjunt mínim bàsic de dades d'hospitals generals d'aguts
No full textMBDS; Minimum basic data set; Disease notificationConjunto mínimo básico de datos; Notificación de enfermedadesCMBD; Conjunt mínim bàsic de dades; Notificació de malaltiesAquest manual detalla els nous requisits específics del CMBD-HA. Aquest registre es nodreix de l’activitat d’hospitalització convencional, hospitalització a domicili i de la cirurgia majora ambulatòria de tots els centres pertanyents al sistema sanitari integral d’utilització pública de Catalunya (SISCAT) i de la majoria de centres privats de Catalunya, independentment del tipus de finançament de l’atenció en cadascun dels pacients atesos
Evaluating Families' Opinions of Routine Influenza Vaccination in Children Under 5 Years of Age in Spain
Get PDFVacunació Infantil; Antivacunes; Grip EstacionalChildhood Vaccination; Vaccine hesitancy; Seasonal InfluenzaVacunación Infantil; Antivacunas; Gripe EstacionalInfluenza vaccination is the main method for preventing influenza. The objectives of this study are to evaluate the opinions of families on influenza vaccination and to determine the acceptance of influenza vaccination as a routine vaccine in children under 5 years of age.
The method used was a descriptive cross-sectional study based on an ad-hoc survey. Between October 2023 and January 2024, an online survey was conducted among families with children between 6 months and 14 years of age attending paediatric consultations at a health centre.
A total of 388 families were surveyed. Out of these, 22.68% reported having ever vaccinated their children against influenza. The main reason for having them vaccinated was having received the recommendation from the paediatrician (68.18%). While 53.61% agreed with routine influenza vaccination, 53.09% did not intend to vaccinate their children against influenza in the 2023/24 period. The reasons for not vaccinating in 2023/24 were unawareness of the disease (29.41%), fear of unwanted effects of vaccination (27.94%) and lack of information about vaccination (19.61%). The reasons for vaccination in 2023/24 were protection of the child (81.87%), recommendation by the paediatrician (43.41%) and protection of the general population and susceptible persons (20.33%).
Routine influenza vaccination is accepted by half of the parents. A lack of risk perception of the disease, concern about vaccine safety and lack of information are the main reasons for not vaccinating. It is essential to follow the health professionals' recommendation to vaccinate.This research has received a predoctoral grant from IDIAP Jordi Gol. The financial provision was 9015 euros. Number of Register: 21256. Code: 7Z24/004
Clinical Course, Outcomes, and Risk Factors of Myocarditis and Pericarditis Following Administration of mRNA-1273 Vaccination: A Protocol for a Federated Real-World Evidence Vaccine Safety Study Using Data from Five European Data Sources
Get PDFMiocarditis postvacunal; Pericarditis associada a vacunes; Vacuna mRNA-1273Post-vaccine Myocarditis; Vaccine-associated Pericarditis; mRNA-1273 VaccineMiocarditis postvacunal; Pericarditis asociada a vacunas; Vacuna mRNA-1273Myocarditis and pericarditis are recognised risks following COVID-19 vaccination, including the mRNA-1273 vaccine. Most cases occur shortly following the second dose of this vaccine, and incidence is highest among young males. However, little is known about risk factors beyond age and sex and about the longer-term clinical course. This study aims to identify possible risk factors for myocarditis and pericarditis following mRNA-1273 vaccination, to characterise the clinical course of myocarditis and pericarditis, both associated with mRNA-1273 vaccination and not associated with vaccination, and to identify risk factors for severe outcomes (i.e., cardiac or thromboembolic complications, severe hospital outcomes, all-cause hospital readmission, and death). Methods: This study is being conducted within the Vaccine Monitoring Collaboration for Europe (VAC4EU) association using routinely collected healthcare data from five data sources from four European countries (Denmark, Norway, Spain, and the United Kingdom). The study is being performed using a common data model, and all analyses are performed separately in each data source in a federated manner following a common protocol. A case-cohort analysis set is identified within each data source for identifying potential risk factors for myocarditis and pericarditis following mRNA-1273 vaccination using logistic regression analysis. The clinical course of myocarditis and pericarditis is being assessed using a cohort study design and describes all cases (i.e., cases associated with mRNA-1273 and unexposed cases). Cox regression analysis is applied to assess the associations between risk factors and several follow-up outcomes. Conclusions: This protocol describes the study methodology of an international collaborative initiative with the aim of assessing the risk factors and clinical course of myocarditis and pericarditis following mRNA-1273 vaccination using a federated network of five European data sources.This study was performed within the VAC4EU (Vaccine Monitoring Collaboration for Europe) association and received funding from Moderna Tx
Long-Term Evaluation of Givinostat in Duchenne Muscular Dystrophy, and Natural History Comparisons
Get PDFDuchenne muscular dystrophy; Efficacy; Long termDistrofia muscular de Duchenne; Eficacia; Largo plazoDistròfia muscular de Duchenne; Eficàcia; Llarg terminiObjectives
This ongoing, open-label extension study is evaluating the long-term safety, tolerability, and efficacy of givinostat, a Class I and II histone deacetylase inhibitor, in patients with Duchenne muscular dystrophy (DMD).
Methods
The recruited patients completed one of two prior clinical studies (one Phase 2 and one Phase 3 [EPIDYS]), receiving givinostat or placebo, or were successfully screened but not randomized into EPIDYS. All receive givinostat oral suspension open-label at a flexible, weight-based dose in addition to systemic corticosteroids, and attend visits every 4 months.
Results
A total of 194 patients are included in the current analyses, with a mean duration of givinostat exposure (excluding use in prior studies) of 559.6 days (SD 373.0); when including use in the prior studies, the maximum exposure to givinostat was > 8 years. Although the majority of patients reported ≥ 1 adverse event (169/194 [87.1%]), most were mild/moderate in severity, and the safety profile of givinostat was consistent with prior studies. Post hoc comparisons with natural history datasets (ImagingDMD and CINRG) suggest, in propensity matched populations, givinostat added to systemic corticosteroids significantly delayed the loss of the ability to rise from the floor, the loss of the ability to complete the 4-stair climb test, and the loss of ambulation (by medians of 2.0–3.3 years; all nominal p < 0.05).
Interpretation
Overall, the safety and tolerability of long-term administration of givinostat in patients with DMD was consistent with previous studies. Comparisons with natural history data suggest that givinostat delays the occurrence of major disease progression milestones.
Trial Registration
EudraCT number: 2017-000397-10; ClinicalTrials.gov identifier: NCT0337396
Characteristics of Patients and Prognostic Factors Across Treatment Lines in Metastatic Colorectal Cancer: An Analysis From the Aide et Recherche en Cancérologie Digestive Database
Get PDFPrognostic factors; Metastatic colorectal cancerFactores pronósticos; Cáncer colorrectal metastásicoFactors pronòstics; Càncer colorectal metastàticPurpose: Several lines of treatment can be used sequentially in patients with metastatic colorectal cancer. We investigated the evolution of patient/tumor characteristics and their prognostic impact across treatment lines to develop an overall prognostic score (OPS).
Patients and methods: Individual patient data from 48 randomized trials were analyzed. The end point was overall survival (from random assignment to death). Missing data were imputed. The complete data set was then separated into construction (80%) and validation sets (20%). The Cox's model was used to define risk groups for survival using the OPS. The discrimination capability was assessed in each treatment-line via bootstrapping to obtain optimism-corrected calibration and discrimination C-indices. Internal validation was done in the validation set.
Results: A total of 37,560 patients (26,974 in first-line [1L], 7,693 in second-line [2L], and 2,893 in third-line [3L]) were analyzed. Some clinical, biological, and molecular characteristics of patients/tumors included in therapeutic trials evolve over the lines. Seven independent prognostic variables were retained in the final multivariate model common to all lines: Eastern Cooperative Oncology Group performance status, hemoglobin, platelet count, WBC/absolute neutrophil count ratio, lactate dehydrogenase, alkaline phosphatase, and the number of metastatic sites. The OPS was used to define four patient subgroups with significantly different prognoses in 1L, 2L, and 3L, separately, with adequate C-indices: 0.65, 0.66, and 0.69 in the construction set and 0.65, 0.66, and 0.68 in the validation set, respectively. The OPS was not predictive, with 3L drugs (v placebo) or subsequent line (2L/1L or 3L/2L) extending survival in all prognostic groups.
Conclusion: The same prognostic model using practical variables can be used before all treatment lines. The OPS could better stratify patients in future clinical trials and help to therapeutic decision in routine practice
Amivantamab Plus Lazertinib in Patients With EGFR-Mutant NSCLC After Progression on Osimertinib and Platinum-Based Chemotherapy: Results From CHRYSALIS-2 Cohort A
Get PDFAmivantamab; Biomarker analyses; LazertinibAmivantamab; Anàlisi de biomarcadors; LazertinibAmivantamab; Análisis de biomarcadores; LazertinibIntroduction
Treatment options for patients with EGFR-mutated NSCLC with disease progression on or after osimertinib and platinum-based chemotherapy are limited.
Methods
CHRYSALIS-2 cohort A evaluated amivantamab plus lazertinib in patients with EGFR exon 19 deletion- or L858R-mutated NSCLC with disease progression on or after osimertinib and platinum-based chemotherapy. Primary end point was investigator-assessed objective response rate (ORR). The patients received 1050 mg of intravenous amivantamab (1400 mg if ≥ 80 kg) plus 240 mg of oral lazertinib.
Results
In cohort A (N = 162), the investigator-assessed ORR was 28% (95% confidence interval [CI]: 22–36). The blinded independent central review–assessed ORR was 35% (95% CI: 27–42), with a median duration of response of 8.3 months (95% CI: 6.7–10.9) and a clinical benefit rate of 58% (95% CI: 50–66). At a median follow-up of 12 months, 32 of 56 responders (57%) achieved a duration of response of more than or equal to 6 months. Median progression-free survival by blinded independent central review was 4.5 months (95% CI: 4.1–5.8); median overall survival was 14.8 months (95% CI: 12.2–18.0). Preliminary evidence of central nervous system antitumor activity was reported in seven patients with baseline brain lesions and no previous brain radiation or surgery. Exploratory biomarker analyses using next-generation sequencing of circulating tumor DNA revealed responses in patients with and without EGFR- or MET-dependent resistance. The most frequent adverse events were rash (grouped term; 81%), infusion-related reaction (68%), and paronychia (52%). The most common grade greater than or equal to 3 treatment-related adverse events were rash (grouped term; 10%), infusion-related reaction (9%), and hypoalbuminemia (6%).
Conclusions
For patients with limited treatment options, amivantamab plus lazertinib demonstrated an antitumor activity with a safety profile characterized by EGFR- or MET-related adverse events, which were generally manageable.This study (NCT04077463) was funded by Janssen Research and Development, LLC, a Johnson & Johnson Company. Medical writing and editorial support were provided by David Le, PharmD, of Lumanity Communications Inc., and funded by Johnson & Johnson
An expert patient program for people living with multiple sclerosis improves knowledge and empowerment: a pre-test, post-test multicenter implementation study
Get PDFDisability status; Expert patient program; Multiple sclerosisEstado de discapacidad; Programa de pacientes expertos; Esclerosis múltipleEstat de discapacitat; Programa de pacients experts; Esclerosi múltipleBackground: Multiple sclerosis (MS) is associated with complex needs and demands, which require patient-centered care. Expert patient (EP) programs foster knowledge transfer through peer learning, facilitating patients’ empowerment to self-manage their disease. Based on a previous focus group study, we designed an EP program for MS coordinated by nursing professionals for implementation in the different MS reference units of Catalonia (Southwestern Europe). This study aimed to deploy a nurse-led Expert Patient Program of Catalonia™ (EPPC) for people with MS and evaluate its impact on disease-related knowledge, empowerment, and health indicators.
Methods: Pre-test, post-test interventional, multicenter study conducted between January 2021 and December 2023 (NCT NCT04988880). Six MS teams recruited 12 groups of people with relapsing and progressive MS. Participants attended nine virtual sessions led by an EP, trained and supported by a nurse. Questionnaires were delivered after certain sessions and at 6 and 12 months.
Results: Fifty-five participants with relapsing disease and 57 with progressive disease received the intervention. Nine of 18 knowledge questions showed significantly higher post-test vs. pre-test correct answers. Hospital Anxiety and Depression Scale remained unchanged for anxiety and transiently increased for depression, whereas the Patient Activation Measure-13 increased at 12 months, by mean (SD) 2.04 [5.88] points (p = 0.0001) in patients with relapsing MS and by 3.28 (5.24) points (p = 0.0004) in those with progressive MS. Lifestyle habits remained mostly unchanged, except for medication self-management and diet, whereas visits to nurses and other professionals in MS units significantly decreased. Physical health composite scores in the MS quality of life-54 questionnaire decreased, while the mental health composite scores remained unchanged. Fatigue Severity Scale scores remained unchanged and Expanded Disability Status Scale scores increased in participants with progressive disease. In conclusion, the nurse-led program was successfully implemented across Catalonia and resulted in increased MS knowledge and patient activation, impacting medication self-management, diet, and visits to certain professionals in MS units, despite decreased quality of life and disability in participants with progressive disease.The author(s) declare that financial support was received for the research and/or publication of this article. This study was promoted by the MS unit at Vall d’Hebron Hospital and had no external sponsor. The PhD candidate/first author was supported through the Strategic Plan for Research and Innovation in Health 2016–2020 (PERIS) (ref. BDNS 542793) funded by the Health Department of Catalonia. This study had been partially funded by the Official College of Nurses of Barcelona (www.coib.cat) as part of the Nurse Research Project Grants (PRN-475/2021). None of the funders was involved in the study design, manuscript writing or data collection, and will not be involved in data analysis or interpretation and manuscript writing in the future. The only requirement for funders is that any publications associated with this study must be open access and kept in an institutional repository
Head and Neck Cancer in Fanconi Anemia: Report of 11 Cases and a Systematic Review
Get PDFFanconi anemia; Head and neck cancer; SurvivalAnèmia de Fanconi; Càncer de cap i coll; SupervivènciaAnemia de Fanconi; Cáncer de cabeza y cuello; SupervivenciaBackground/Objectives: Head and neck cancer is one of the most common malignancies in patients with Fanconi anemia (FA), with a greater than 500-fold incidence of head and neck squamous cell carcinoma. Treatment of HNSCC in these patients is particularly challenging because of poor tolerance to radiation therapy and to some chemotherapeutic agents such as cisplatin. For these reasons, new research is needed to determine the best treatment course for these patients. With this goal in mind, we assessed the characteristics of head and neck squamous cell carcinoma (SCC) in Fanconi anemia (FA). Subjects and Methods: Data for 11 patients (mean age 31 years) with head and neck SCC and FA attended to between 2005 and 2021 were analyzed. Results: The primary tumor site was the oral cavity in eight patients, and five had advanced stages. All patients underwent primary tumor resection. Four patients received adjuvant radiotherapy (mean 57.2 Gy), but three developed toxicity. The mean follow-up was 48.4 months. Six patients experienced 19 episodes of primary tumor recurrence and five developed secondary head and neck tumors. The 3-year disease-free survival was 47%, and the 5-year cause-specific survival was 48%. These findings are similar to the data for 72 patients collected from the literature. Conclusions: The prognosis of head and neck cancer in patients with Fanconi anemia is poor, with an overall survival lower than 50% at 5 years
Effectiveness of the BNT162b2 XBB.1.5-adapted vaccine against COVID-19 hospitalization related to the JN.1 variant in Europe: a test-negative case-control study using the id.DRIVE platform
Get PDFCOVID-19 vaccination; SARS-CoV-2; Vaccine effectivenessVacunació contra la COVID-19; SARS-CoV-2; Eficàcia de la vacunaVacunación contra la COVID-19; SARS-CoV-2; Efectividad de la vacunaBackground
Prior studies have reported lower effectiveness of XBB.1.5-adapted vaccines against hospitalization related to the Omicron JN.1 variant than the XBB variant. This study evaluated the effectiveness and durability of the BNT162b2 XBB.1.5-adapted vaccine against JN.1-related hospitalization during the 2023–2024 season in Europe.
Methods
A test-negative case–control study was carried out in adults (≥18 y) hospitalized between 2 October 2023 and 2 April 2024 with severe acute respiratory infection (SARI) within the id.DRIVE partnership. This study included nine sites across Belgium, Germany, Italy, and Spain. Cases had a laboratory-confirmed JN.1 infection or a positive SARS-CoV-2 test with symptom onset during JN.1 predominance; controls had a negative SARS-CoV-2 test and symptom onset during JN.1 predominance. The primary objective was to estimate BNT162b2 XBB.1.5-adapted vaccine effectiveness (VE) against COVID-19 hospitalization. One case was matched with up to four controls, according to symptom onset date and site. Multivariable analyses were adjusted for symptom onset date, age, sex, and number of chronic conditions.
Findings
Among 308 test-positive cases and 1117 test-negative controls, BNT162b2 XBB.1.5-adapted VE against hospitalization compared to no vaccination this season was 53.8% (95% CI 38.4–65.4) after a median of 63 days following vaccination. Protection was sustained through five months; VE was 52.2% (95% CI 41.3–61.1) 2 to <4 weeks after vaccination, 48.9% (95% CI 17.9–68.2) at 4 to <8 weeks, and ranged from 54.6% to 59.5% at 4-week intervals from 8 to <22 weeks.
Interpretation
BNT162b2 XBB.1.5-adapted vaccine provided protection against JN.1-related hospitalization, regardless of prior vaccination history, with no evidence of waning through five months. These data support yearly vaccination against COVID-19 to prevent severe illness during the respiratory virus season.Pfizer
Vaccine effectiveness of JCOVDEN single-dose against COVID-19 hospitalisation in Europe: An id.DRIVE test-negative case-control study
Get PDFEffectiveness; SARS-CoV-2; Severe acute respiratory infectionEficàcia; SARS-CoV-2; Infecció respiratòria aguda greuEfectividad; SARS-CoV-2; Infección respiratoria aguda graveBackground
JCOVDEN (Ad26.COV2.S), a viral-vector vaccine, was granted conditional marketing authorisation in the European Union for the prevention of COVID-19 in early 2021. We present JCOVDEN single-dose vaccine effectiveness (VE) estimates against COVID-19 hospitalisation.
Methods
The id.DRIVE (previously COVIDRIVE) COVID-19 VE study is an ongoing European non-interventional, multi-centre study with a test-negative case-control design. Study participants were adults ≥ 18 years old, hospitalised with severe acute respiratory infection between 1 May 2021 and 28 February 2023. Estimated as a single measure over the entire study period, VE was stratified by risk group, time since vaccination intervals (14 days-12 weeks, 12-to-25 weeks, 25-to-52 weeks, >52 weeks), SARS-CoV-2 variant and calendar time categories. All estimates were adjusted for symptom-onset date, age, sex, and number of pre-defined chronic conditions.
Results
Overall, VE was 55.6 % (95 % CI 23.6; 74.2) for a median time since vaccination of 146 days. For 18- to 49-year-olds, VE was 61.6 % (95 % CI 16.2; 82.4), 57.7 % (95 % CI 3.4; 81.5) for 50- to-64-years-olds, and 40.8 % (95 % CI −6.0; 66.9) for ≥ 65-year-olds. Most precise estimates were obtained for time since vaccination 12-to- 25-week interval (59.2 % [95 % CI 25.0; 77.8]) and for the calendar time period 1 Aug 2021 −30 Nov 2021 (Delta predominant; 51.2 % [95 % CI 21.7; 69.6]).
Conclusion
The JCOVDEN single-dose protected against COVID-19 hospitalisation. It is effective for at least six months, with VE estimates comparatively lower in the older age groups. Results had low to medium levels of certainty and are to be interpreted with caution.id.DRIVE COVID-19 VE study has received funds from the pharmaceutical partners of COVIDRIVE and id.DRIVE (AstraZeneca, Bavarian Nordic, CureVac, GlaxoSmithKline, Janssen, Novavax, Moderna, Pfizer, Sanofi, and Valneva), and has leveraged public health capacity from FISABIO (Foundation for the Promotion of Health and Biomedical Research in the Valencian Community) and THL (Finnish Institute for Health and Welfare), and existing infrastructure at P95, which acts as the Sponsor of the study. This JCOVDEN study was further financed by Janssen. Authors responsible for writing this manuscript are employees of P95 and Janssen