Implementing the EU HTA regulation: Insights from semi-structured interviews on patient expectations, Belgian and European institutional perspectives, and industry outlooks.

The goal of the Health Technology Assessment (HTA) Regulation 2021/2282 is to establish a more harmonized HTA framework, fostering member states cooperation and enabling equal patient access to innovative health technologies in Europe. This research aimed to assess the impact of the regulation on national HTAs, the strategic implications for health technology developers, and its influence on price and reimbursement negotiations. A scoping literature review encompassing peer-reviewed literature as well as grey literature was conducted.

The diagnostic accuracy of the GeneXpert ESBL- prototype assay for rapid PCR-based detection of extended-spectrum beta-lactamase genes directly from urine.

Early identification of complicated urinary tract infections caused by ESBL-producing Enterobacterales has the potential to limit the use of carbapenems to those patients without alternative antibiotic options and avoid the empirical use of carbapenems in patients without ESBL-producing bacteria. The purpose for such a test will differ by setting and ESBL prevalence rates. Countries with low ESBL rates and cephalosporins as empiric treatment (e.

Cost Effectiveness of Rectal Culture-based Antibiotic Prophylaxis in Transrectal Prostate Biopsy: The Results from a Randomized, Nonblinded, Multicenter Trial.

Background: Culture-based antibiotic prophylaxis is a plausible strategy to reduce infections after transrectal prostate biopsy (PB) related to fluoroquinolone-resistant pathogens.

Objective: To assess the cost effectiveness of rectal culture-based prophylaxis compared with empirical ciprofloxacin prophylaxis.

Design Setting And Participants: The study was performed alongside a trial in 11 Dutch hospitals investigating the effectiveness of culture-based prophylaxis in transrectal PB between April 2018 and July 2021 (trial registration number: NCT03228108).

Rectal Culture-Based Versus Empirical Antibiotic Prophylaxis to Prevent Infectious Complications in Men Undergoing Transrectal Prostate Biopsy: A Randomized, Nonblinded Multicenter Trial.

Background: An increase in infections after transrectal prostate biopsy (PB), related to an increasing number of patients with ciprofloxacin-resistant rectal flora, necessitates the exploration of alternatives for the traditionally used empirical prophylaxis of ciprofloxacin. We compared infectious complication rates after transrectal PB using empirical ciprofloxacin prophylaxis versus culture-based prophylaxis.

Methods: In this nonblinded, randomized trial, between 4 April 2018 and 30 July 2021, we enrolled 1538 patients from 11 Dutch hospitals undergoing transrectal PB.

Real-world Endoscopic and Histological Outcomes Are Correlated with Ustekinumab Exposure in Patients with Ulcerative Colitis.

Background: Histo-endoscopic outcomes are being proposed as new treatment targets in ulcerative colitis [UC]. Little is known about the pharmacokinetic-pharmacodynnamic [PK-PD] relationship of ustekinumab [UST] in UC patients or whether serum UST concentrations reflect tissue drug exposure. We aimed to study UST serum concentrations and their relation to tissue exposure and drug effectiveness in a real-world setting.

The Effect of Different Types of Prostate Biopsy Techniques on Post-Biopsy Infectious Complications.

Purpose: The aim of our study was to compare infectious complication rates between different prostate biopsy techniques with various number of biopsy cores.

Materials And Methods: In this retrospective study, all patients from 2 hospitals who underwent prostate biopsy between 2012 and 2019 were identified. Cohorts with different types of prostate biopsies were compiled within these hospitals.

Acceptability of innovative culture-based antibiotic prophylaxis strategies: a multi-method study on experiences regarding transrectal prostate biopsy.

Background: The acceptability of innovative medical strategies among healthcare providers and patients affects their uptake in daily clinical practice.

Objectives: To explore experiences of healthcare providers and patients with culture-based antibiotic prophylaxis in transrectal prostate biopsy with three swab-screening scenarios: self-sampling at home, self-sampling in the hospital and sampling by a healthcare provider.

Methods: We performed focus group interviews with urologists and medical microbiologists from 11 hospitals and six connected clinical microbiological laboratories.

Infliximab Concentrations during Induction Are Predictive for Endoscopic Remission in Pediatric Patients with Inflammatory Bowel Disease under Combination Therapy.

Objectives: To study infliximab (IFX) pharmacokinetics in children with inflammatory bowel disease (IBD) during induction therapy to predict outcome and explore if other covariates influenced outcome.

Study Design: All children with IBD starting IFX therapy (5 mg/kg at weeks 0, 2, 6, and 12) for active luminal disease from May 2017 to May 2019 were included and followed prospectively. Patients were sampled at multiple timepoints during induction (trough concentrations and peak concentration at weeks 0, 2, 6, and 12, and intermediate concentration at weeks 1-4).

Neurobiobehavioral responses to virtual social rejection in females-exploring the influence of oxytocin.

In recent years, especially adolescents and young adults interact frequently via social media and digital communication. Mimicking an online communication platform where participants could initiate short conversations with two computerized interlocutors, the Verbal Interaction Social Threat Task (VISTTA) was used to induce feelings of social rejection. Motivational and physiological reactions were investigated in 43 healthy young women undergoing functional magnetic resonance imaging (fMRI), of which 22 received 24 international units (IU) intranasal oxytocin and 21 received placebo.

Recovery of aerobic gram-negative bacteria from the Copan Eswab transport system after long-term storage.

We evaluated the Copan Eswab transport system for the quantitative recovery of Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa after 1, 2, 3, 5, and 7 days of storage at room and refrigerator temperatures, and 7 and 30 days of storage at -80 °C and -20 °C using mono- and polymicrobial samples. The study was based on Clinical and Laboratory Standards Institute (CLSI) M40-A2 standard procedures on the quality control of microbiological transport systems. Eswab met the CLSI standards at room and refrigerator temperatures for all (combinations of) bacterial strains tested.

Prostate biopsy techniques and pre-biopsy prophylactic measures: variation in current practice patterns in the Netherlands.

Background: The clinical landscape of prostate biopsy (PB) is evolving with changes in procedures and techniques. Moreover, antibiotic resistance is increasing and influences the efficacy of pre-biopsy prophylactic regimens. Therefore, increasing antibiotic resistance may impact on clinical care, which probably results in differences between hospitals.

Evaluating an easy sampling method using dried blood spots to determine vedolizumab concentrations.

An association between vedolizumab (VDZ) trough concentrations and therapeutic outcome has been observed in patients with inflammatory bowel diseases. VDZ samples are typically collected via venous sampling for therapeutic drug monitoring (TDM), but can alternatively be collected via dried blood spot (DBS) samples, which can be used for intensive sampling to investigate pharmacokinetic profiles. Therefore, we have developed a DBS method for determining VDZ concentrations and validated this method by comparing VDZ measurements in paired DBS and venous patient samples.

Anti-infliximab antibodies: How to compare old and new data?

Background: Anti-drug-antibodies (ADA) against infliximab are frequently measured in patients receiving infliximab treatment with loss of response and undetectable infliximab concentrations. Different ADA bridging assays (1st generation, 2nd generation and ready-to-use kit) have been developed successively and were applied over the last 10 years, making comparison between ADA concentrations very challenging. A cutoff of 8 μg/ml was established to discriminate low from high ADA concentrations using the 1st generation ADA bridging assay.

Influence of Drug Exposure on Vedolizumab-Induced Endoscopic Remission in Anti-Tumour Necrosis Factor [TNF] Naïve and Anti-TNF Exposed IBD Patients.

Background And Objectives: Vedolizumab has demonstrated efficacy and safety in patients with Crohn's disease [CD] and ulcerative colitis [UC]. Endoscopic outcome data are limited, especially in anti-tumour necrosis factor [TNF] naïve patients. The present study compared endoscopic outcome in anti-TNF naïve and exposed patients, and explored if this was affected by drug exposure.

The Verbal Interaction Social Threat Task: A New Paradigm Investigating the Effects of Social Rejection in Men and Women.

In recent years, digital communication and social media have taken an indispensable role in human society. Social interactions are no longer bound to real-life encounters, but more often happen from behind a screen. Mimicking an online communication platform, we developed a new, fMRI compatible, social threat paradigm to investigate sex differences in reactions to social rejection.

Evaluating Efficacy, Safety, and Pharmacokinetics After Switching From Infliximab Originator to Biosimilar CT-P13: Experience From a Large Tertiary Referral Center.

Background: The use of infliximab biosimilar CT-P13 has increased in patients with inflammatory bowel disease. Nevertheless, doubts about switching from infliximab originator to biosimilar still exist among patients and health care professionals.

Methods: Our tertiary referral center underwent a mandatory switch from infliximab originator to CT-P13 in 2017.

Impact of first-line infliximab on the pharmacokinetics of second-line vedolizumab in inflammatory bowel diseases.

Background: Very little is known about the impact of the wash-out period on the pharmacokinetics of a second-line biologic.

Objective: The objective of this article is to explore the impact of two different wash-out periods on the pharmacokinetics of vedolizumab and infliximab.

Methods: Patients switching from infliximab to vedolizumab were retrospectively identified.

Early vedolizumab trough levels predict combined endoscopic and clinical remission in inflammatory bowel disease.

Background: The relationship between vedolizumab trough levels and combined endoscopic and clinical remission is unknown.

Objective: To compare vedolizumab trough levels in patients with and without combined remission within the first year of treatment.

Methods: We prospectively collected vedolizumab trough levels in 51 consecutive patients (28 Crohn's disease (CD) and 23 ulcerative colitis (UC)) before all infusions up to week 22, and at weeks 38 and 54, with concentrations measured after study completion.

Incidence and microbiology of post-operative infections after radical cystectomy and ureteral stent removal; a retrospective cohort study.

Background: Post-operative infections are frequent after radical cystectomy with urinary diversion surgery (UDS). Reduction of post-operative infections necessitates appropriate peri-operative antimicrobial prophylaxis targeting causative bacteria. We assessed the incidence and microbiology of infections in the 30-day post-operative period after UDS and investigated effectiveness of the currently used peri-operative antibacterial prophylaxis.

Early vedolizumab trough levels at induction in inflammatory bowel disease patients with treatment failure during maintenance.

Background: Vedolizumab (VDZ) is effective as an induction and maintenance treatment for Crohn's disease and ulcerative colitis, but, as observed with antitumour necrosis factor-α (anti-TNFα) agents, some patients are nonetheless experiencing loss of response.

Objective: The aim of this study was to investigate the impact of the pharmacokinetics of VDZ during induction on long-term treatment response.

Patients And Methods: This study focused on a single cohort of 103 inflammatory bowel disease patients treated with VDZ.

Mucosal IL13RA2 expression predicts nonresponse to anti-TNF therapy in Crohn's disease.

Background: Ileocolonic expression of IL13RA2 has been identified as a predictive marker for nonresponsiveness to infliximab (IFX) in patients with Crohn's disease (CD).

Aim: To validate the IL13RA2 biomarker, study its anti-TNF specificity and get a better understanding of the underlying biology driving its expression.

Methods: IL13RA2 mucosal expression was studied in a cohort of adalimumab and vedolizumab treated patients.

Immunogenicity is not the driving force of treatment failure in vedolizumab-treated inflammatory bowel disease patients.

Background And Aim: The pivotal GEMINI trials reported low immunogenicity of vedolizumab. However, anti-vedolizumab antibodies (AVA) are frequently underestimated because most assays are not drug-tolerant and unable to detect antidrug antibodies while there is drug in the circulation. This study aimed to explore which antidrug antibody assay is best suited to detect AVA and investigated immunogenicity of vedolizumab in inflammatory bowel disease (IBD) patients discontinuing vedolizumab therapy.

Golimumab Dried Blood Spot Analysis (GOUDA): a Prospective Trial Showing Excellent Correlation with Venepuncture Samples and More Detailed Pharmacokinetic Information.

Development of a dried blood spot (DBS) method for golimumab will facilitate sample collection in a study setting and will give a more complete insight in the total drug exposure (area under the curve, AUC). We established a DBS method and assessed its robustness, user-friendliness and clinical usefulness in 10 patients with ulcerative colitis during golimumab induction and maintenance regimens. DBS was obtained through spotting of golimumab spiked in whole citrated blood to a filter paper.

Performance Validation of Selective Screening Agars for Guiding Antimicrobial Prophylaxis in Patients Undergoing Prostate Biopsy.

A rectal culture-guided antimicrobial prophylaxis strategy may prevent infections after transrectal ultrasound-guided prostate biopsy (TRUSP). The use of selective culture media could assist the choice of appropriate antibiotic prophylaxis. The objective of our study was to evaluate the performance of four selective media used for guidance of oral antibiotic prophylaxis in TRUSP.