Revising EU pharmaceutical legislation: will it foster drug repurposing?

Repurposing off-patent drugs can be a potential source of low-cost treatments for patients with unmet medical needs. Here, we review the proposed new European Union (EU) pharmaceutical legislation in which two articles address drug repurposing. We find certain barriers hindering the adoption of these new incentives by academic and not-for-profit stakeholders, including lack of knowledge on regulatory aspects, pharmacovigilance, and restrictions in data protection.

Attention deployment in natural scenes: Higher-order scene statistics rather than semantics modulate the N2pc component.

Which properties of a natural scene affect visual search? We consider the alternative hypotheses that low-level statistics, higher-level statistics, semantics, or layout affect search difficulty in natural scenes. Across three experiments (n = 20 each), we used four different backgrounds that preserve distinct scene properties: (a) natural scenes (all experiments); (b) 1/f noise (pink noise, which preserves only low-level statistics and was used in Experiments 1 and 2); (c) textures that preserve low-level and higher-level statistics but not semantics or layout (Experiments 2 and 3); and (d) inverted (upside-down) scenes that preserve statistics and semantics but not layout (Experiment 2). We included "split scenes" that contained different backgrounds left and right of the midline (Experiment 1, natural/noise; Experiment 3, natural/texture).

How health technology assessment can help to address challenges in drug repurposing: a conceptual framework.

Drug repurposing faces various challenges that can impede its success. We developed a framework outlining key challenges in drug repurposing to explore when and how health technology assessment (HTA) methods can address them. We identified 20 drug-repurposing challenges across the categories of data access, research and development, collaboration, business case, regulatory and legal challenges.

High visual salience of alert signals can lead to a counterintuitive increase of reaction times.

It is often assumed that rendering an alert signal more salient yields faster responses to this alert. Yet, there might be a trade-off between attracting attention and distracting from task execution. Here we tested this in four behavioral experiments with eye-tracking using an abstract alert-signal paradigm.

Software with artificial intelligence-derived algorithms for analysing CT brain scans in people with a suspected acute stroke: a systematic review and cost-effectiveness analysis.

Background: Artificial intelligence-derived software technologies have been developed that are intended to facilitate the review of computed tomography brain scans in patients with suspected stroke.

Objectives: To evaluate the clinical and cost-effectiveness of using artificial intelligence-derived software to support review of computed tomography brain scans in acute stroke in the National Health Service setting.

Methods: Twenty-five databases were searched to July 2021.

Conditional deviant repetition in the oddball paradigm modulates processing at the level of P3a but not MMN.

The auditory system has an amazing ability to rapidly encode auditory regularities. Evidence comes from the popular oddball paradigm, in which frequent (standard) sounds are occasionally exchanged for rare deviant sounds, which then elicit signs of prediction error based on their unexpectedness (e.g.

Using event-related brain potentials to evaluate motor-auditory latencies in virtual reality.

Actions in the real world have immediate sensory consequences. Mimicking these in digital environments is within reach, but technical constraints usually impose a certain latency (delay) between user actions and system responses. It is important to assess the impact of this latency on the users, ideally with measurement techniques that do not interfere with their digital experience.

Neural signatures of automatic repetition detection in temporally regular and jittered acoustic sequences.

Detection of repeating patterns within continuous sound streams is crucial for efficient auditory perception. Previous studies demonstrated a remarkable sensitivity of the human auditory system to periodic repetitions in unfamiliar, meaningless sounds. Automatic repetition detection was reflected in different EEG markers, including sustained activity, neural synchronisation, and event-related responses to pattern occurrences.

That sounds awful! Does sound unpleasantness modulate the mismatch negativity and its habituation?

There are sounds that most people perceive as highly unpleasant, for instance, the sound of rubbing pieces of polystyrene together. Previous research showed larger physiological and neural responses for such aversive compared to neutral sounds. Hitherto, it remains unclear whether habituation, i.

Deviants violating higher-order auditory regularities can become predictive and facilitate behaviour.

The human auditory system is believed to represent regularities inherent in auditory information in internal models. Sounds not matching the standard regularity (deviants) elicit prediction error, alerting the system to information not explainable within currently active models. Here, we examine the widely neglected characteristic of deviants bearing predictive information themselves.

The value of correctly diagnosing axial spondyloarthritis for patients and society.

Objective: To demonstrate the value of diagnosing axSpA, by comparing health and costs associated with available diagnostic algorithms and perfect diagnosis.

Methods: Using data from SPACE and other cohorts, a model was developed to estimate health (quality-adjusted life-years, QALYs) and costs (healthcare consumption and work productivity losses) of different diagnostic algorithms for axSpA amongst patients with low back pain referred to a rheumatologist, over a 60-year horizon. The model combined a decision-tree (diagnosis) with a state-transition model (treatment).

Consolidated Health Economic Evaluation Reporting Standards - Value of Information (CHEERS-VOI): Explanation and Elaboration.

Objectives: Although the ISPOR Value of Information (VOI) Task Force's reports outline VOI concepts and provide good-practice recommendations, there is no guidance for reporting VOI analyses. VOI analyses are usually performed alongside economic evaluations for which the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 Statement provides reporting guidelines. Thus, we developed the CHEERS-VOI checklist to provide reporting guidance and checklist to support the transparent, reproducible, and high-quality reporting of VOI analyses.

Oral Azacitidine for Maintenance Treatment of Acute Myeloid Leukaemia After Induction Therapy: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

The National Institute for Health and Care Excellence (NICE) invited the manufacturer (Celgene) of oral azacitidine (ONUREG), as part of the Single Technology Appraisal (STA) process, to submit evidence for the clinical effectiveness and cost-effectiveness of oral azacitidine for maintenance treatment of acute myeloid leukaemia (AML) after induction therapy compared with watch-and-wait plus best supportive care (BSC) and midostaurin. Kleijnen Systematic Reviews Ltd, in collaboration with Maastricht University Medical Centre+, was commissioned to act as the independent Evidence Review Group (ERG). This paper summarises the company submission (CS), presents the ERG's critical review on the clinical and cost-effectiveness evidence in the CS, highlights the key methodological considerations and describes the development of the NICE guidance by the Appraisal Committee.

Perceptual learning of random acoustic patterns: Impact of temporal regularity and attention.

Perceptual learning is a powerful mechanism to enhance perceptual abilities and to form robust memory representations of previously unfamiliar sounds. Memory formation through repeated exposure takes place even for random and complex acoustic patterns devoid of semantic content. The current study sought to scrutinise how perceptual learning of random acoustic patterns is shaped by two potential modulators: temporal regularity of pattern repetition and listeners' attention.

Comprehensive Review of Methods to Assess Uncertainty in Health Economic Evaluations.

Uncertainty assessment is a cornerstone in model-based health economic evaluations (HEEs) that inform reimbursement decisions. No comprehensive overview of available uncertainty assessment methods currently exists. We aimed to review methods for uncertainty assessment for use in model-based HEEs, by conducting a snowballing review.