Influenza vaccine effectiveness estimates in the Dutch population from 2003 to 2014:The test-negative design case-control study with different control groups

Information about influenza vaccine effectiveness (IVE) is important for vaccine strain selection and immunization policy decisions. The test-negative design (TND) case-control study is commonly used to obtain IVE estimates. However, the definition of the control patients may influence IVE estimates. We have conducted a TND study using the Dutch Sentinel Practices of NIVEL Primary Care Database which includes data from patients who consulted the General Practitioner (GP) for an episode of acute influenza-like illness (ILI) or acute respiratory infection (ARI) with known influenza vaccination status. Cases were patients tested positive for influenza virus. Controls were grouped into those who tested (1) negative for influenza virus (all influenza negative), (2) negative for influenza virus, but positive for respiratory syncytial virus, rhinovirus or enterovirus (non-influenza virus positive), and (3) negative for these four viruses (pan-negative). We estimated the IVE over all epidemic seasons from 2003/2004 through 2013/2014, pooled IVE for influenza vaccine partial/full matched and mismatched seasons and the individual seasons using generalized linear mixed-effect and multiple logistic regression models. The overall IVE adjusted for age, GP ILI/ARI diagnosis, chronic disease and respiratory allergy was 35% (95% CI: 15-48), 64% (95% CI: 49-75) and 21% (95% CI: -1 to 39) for all influenza negative, non-influenza virus positive and pan-negative controls, respectively. In both the main and subgroup analyses IVE estimates were the highest using non-influenza virus positive controls, likely due to limiting inclusion of controls without laboratory-confirmation of a virus causing the respiratory disease

Study protocol for a multicenter randomised controlled trial on the (cost)effectiveness of biopsy combined with same-session MR-guided LITT versus biopsy alone in patients with primary irresectable glioblastoma (EMITT trial)

Background: Glioblastoma (GBM) is the most common primary, malignant brain tumour with a 5-year survival of 5%. If possible, a glioblastoma is resected and further treated with chemoradiation therapy (CRT), but resection is not feasible in about 30% of cases. Current standard of care in these cases is a biopsy followed by CRT. Magnetic resonance (MR) imaging-guided laser interstitial thermal therapy (LITT) has been suggested as a minimally invasive alternative when surgery is not feasible. However, high-quality evidence directly comparing LITT with standard of care is lacking, precluding any conclusions on (cost-)effectiveness. We therefore propose a multicenter randomized controlled study to assess the (cost-)effectiveness of MR-guided LITT as compared to current standard of care (EMITT trial). Methods and analysis: The EMITT trial will be a multicenter pragmatic randomized controlled trial in the Netherlands. Seven Dutch hospitals will participate in this study. In total 238 patients will be randomized with 1:1 allocation to receive either biopsy combined with same-session MR-guided LITT therapy followed by CRT or the current standard of care being biopsy followed by CRT. The primary outcomes will be health-related quality of life (HR-QoL) (non-inferiority) using EORTC QLQ-C30 + BN20 scores at 5 months after randomization and overall survival (superiority). Secondary outcomes comprise cost-effectiveness (healthcare and societal perspective) and HR-QoL of life over an 18-month time horizon, progression free survival, tumour response, disease specific survival, longitudinal effects, effects on adjuvant treatment, ablation percentage and complication rates. Discussion: The EMITT trial will be the first RCT on the effectiveness of LITT in patients with glioblastoma as compared with current standard of care. Together with the Dutch Brain Tumour Patient association, we hypothesize that LITT may improve overall survival without substantially affecting patients’ quality of life. Trial registration: This trial is registered at ClinicalTrials.gov (NCT05318612)

Respiratory syncytial, parainfluenza and influenza virus infection in young children with acute lower respiratory infection in rural Gambia.

Respiratory viral infections contribute significantly to morbidity and mortality worldwide, but representative data from sub-Saharan Africa are needed to inform vaccination strategies. We conducted population-based surveillance in rural Gambia using standardized criteria to identify and investigate children with acute lower respiratory infection (ALRI). Naso- and oropharyngeal swabs were collected. Each month from February through December 2015, specimens from 50 children aged 2-23 months were randomly selected to test for respiratory syncytial (RSV), parainfluenza (PIV) and influenza viruses. The expected number of viral-associated ALRI cases in the population was estimated using statistical simulation that accounted for the sampling design. RSV G and F proteins and influenza hemagglutinin genes were sequenced. 2385 children with ALRI were enrolled, 519 were randomly selected for viral testing. One or more viruses were detected in 303/519 children (58.4%). RSV-A was detected in 237 and RSV-B in seven. The expected incidence of ALRI associated with RSV, PIV or influenza was 140 cases (95% CI, 131-149) per 1000 person-years; RSV incidence was 112 cases (95% CI, 102-122) per 1000 person-years. Multiple strains of RSV and influenza circulated during the year. RSV circulated throughout most of the year and was associated with eight times the number of ALRI cases compared to PIV or IV. Gambian RSV viruses were closely related to viruses detected in other continents. An effective RSV vaccination strategy could have a major impact on the burden of ALRI in this setting

Deferral of routine percutaneous coronary intervention in patients undergoing transcatheter aortic valve implantation:Rationale and design of the PRO-TAVI trial

Background: Concomitant coronary artery disease (CAD) is highly prevalent in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). The optimal treatment strategy for CAD is a topic of debate. An initial conservative strategy for CAD in patients undergoing TAVI may be favorable as multiple studies have failed to show an evident beneficial effect of percutaneous coronary intervention (PCI) on mortality after TAVI. However, more randomized, controlled trials are warranted. Methods: The PeRcutaneous cOronary Intervention before Transcatheter Aortic Valve Implantation (PRO-TAVI) trial is an investigator-initiated, multicenter, open-label, randomized controlled trial comparing TAVI with or without routine preprocedural PCI. A total of 466 patients undergoing TAVI will be randomized in a 1:1 ratio to PCI (reference group) or no PCI (index group). Concomitant CAD is defined as at least 1 stenosis of 70% to 99%, or at least 1 stenosis between 40% and 70% combined with positive physiological measurement in a coronary artery with a minimal diameter of 2.5 mm or bypass graft. The primary endpoint is a composite of all-cause mortality, myocardial infarction, stroke, or type 2 - 4 bleeding at 12 months after randomization, in accordance with Valve Academic Research Consortium-3 criteria. Key secondary endpoints include the individual components of the primary endpoint, revascularization, quality of life and cost-effectiveness. The primary endpoint will be analyzed to assess non-inferiority of deferral of routine PCI in patients undergoing TAVI against the prespecified margin of 11 percentage points. Conclusion: The PeRcutaneous cOronary intervention before Transcatheter Aortic Valve Implantation (PRO-TAVI) trial is designed to investigate the hypothesis that deferral of routine PCI in patients undergoing TAVI is non-inferior to TAVI with preceding PCI. Clinical trial registration: clinicaltrials.gov.</p

Deferral of routine percutaneous coronary intervention in patients undergoing transcatheter aortic valve implantation: Rationale and design of the PRO-TAVI trial

Background: Concomitant coronary artery disease (CAD) is highly prevalent in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). The optimal treatment strategy for CAD is a topic of debate. An initial conservative strategy for CAD in patients undergoing TAVI may be favorable as multiple studies have failed to show an evident beneficial effect of percutaneous coronary intervention (PCI) on mortality after TAVI. However, more randomized, controlled trials are warranted. Methods: The PeRcutaneous cOronary Intervention before Transcatheter Aortic Valve Implantation (PRO-TAVI) trial is an investigator-initiated, multicenter, open-label, randomized controlled trial comparing TAVI with or without routine preprocedural PCI. A total of 466 patients undergoing TAVI will be randomized in a 1:1 ratio to PCI (reference group) or no PCI (index group). Concomitant CAD is defined as at least 1 stenosis of 70% to 99%, or at least 1 stenosis between 40% and 70% combined with positive physiological measurement in a coronary artery with a minimal diameter of 2.5 mm or bypass graft. The primary endpoint is a composite of all-cause mortality, myocardial infarction, stroke, or type 2 - 4 bleeding at 12 months after randomization, in accordance with Valve Academic Research Consortium-3 criteria. Key secondary endpoints include the individual components of the primary endpoint, revascularization, quality of life and cost-effectiveness. The primary endpoint will be analyzed to assess non-inferiority of deferral of routine PCI in patients undergoing TAVI against the prespecified margin of 11 percentage points. Conclusion: The PeRcutaneous cOronary intervention before Transcatheter Aortic Valve Implantation (PRO-TAVI) trial is designed to investigate the hypothesis that deferral of routine PCI in patients undergoing TAVI is non-inferior to TAVI with preceding PCI. Clinical trial registration: clinicaltrials.gov

Religiewetenschappen specialisatie Geestelijke Verzorging

Mensen die worstelen met levensvragen vanuit rouw en voor wie woorden op enig moment tekortschieten, kunnen gebaat zijn bij ritueel handelen. Het gebruik van een ritueel binnen de geestelijke verzorging thuis is echter niet vanzelfsprekend. Om meer licht te werpen op de rituele dimensie van dit specifieke werkveld worden concepten uit vakliteratuur bestudeerd, zoals rouw, ritueel en ritualiseren. De gevonden concepten worden vervolgens gebruikt voor de evaluatie van twee praktijkgevallen. Op basis van de toepassing van concepten uit de literatuur op de praktijkgevallen, is een reflectievragenlijst gemaakt voor geestelijk verzorgers thuis. Tevens worden op basis van het gedane onderzoek aanbevelingen gedaan voor het ritualiseren van rouw in de praktijk van de geestelijk verzorger thuis