There is currently a heightened need for transparency in pharmaceutical sectors. The inclusion of real-world (RW) evidence, in addition to clinical trial evidence, in decision-making processes, was an important step forward toward a more inclusive established value proposition. This advance has introduced new transparency challenges. Increasing transparency is a critical step toward accelerating improvement in type, quality, and access to data, regardless of whether these originate from clinical trials or from RW studies. However, so far, advances in transparency have been relatively restricted to clinical trials, and there remains a lack of similar expectations or standards of transparency concerning the generation and reporting of RW data. This perspective paper aims to highlight the need for transparency concerning RW studies, data, and evidence across health care sectors, to identify areas for improvement, and provide concrete recommendations and practices for the future. Specific issues are discussed from different stakeholder perspectives, culminating in recommended actions, from individual stakeholder perspectives, for improved RW study, data, and evidence transparency. Furthermore, a list of potential guidelines for consideration by stakeholders is proposed. While recommendations from different stakeholder perspectives are made, true transparency in the processes involved in the generation, reporting, and use of RW evidence will require a concerted effort from all stakeholders across health care sectors.
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http://dx.doi.org/10.1017/S1744133122000056 | DOI Listing |
Eur J Radiol
January 2025
Department of Diagnostic and Interventional Radiology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany; Division of Cardiovascular Imaging, Department of Radiology and Radiological Science, Medical University of South Carolina, Charleston, USA. Electronic address:
Purpose: To evaluate the feasibility of aortoiliac CT-Angiography (CTA) using dual-source photon-counting detector (PCD)-CT with minimal iodine dose.
Methods: This IRB-approved, single-center prospective study enrolled patients with indications for aortoiliac CTA from December 2022 to March 2023. All scans were performed using a first-generation dual-source PCD-CT.
Aten Primaria
January 2025
Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, España; Department of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Bellaterra, Cerdanyola del Vallès, Barcelona, España; Institut Català de la Salut, Barcelona, España.
Objective: To characterise patients with heart failure (HF) in Primary Health Care (PHC) and describe their socio-demographic and clinical characteristics and pharmacological treatment.
Design: Descriptive cohort study. SITE: Information System for the Development of Research in Primary Care (SIDIAP), which captures information from the electronic health records of PHC of the Catalan Institute of Health (approximately 80% of the Catalan population).
Pediatr Infect Dis J
January 2025
Public Health Secretariat, Department of Health, Generalitat de Catalunya, Barcelona, Spain.
Background: In Catalonia, infants <6 months old were eligible to receive nirsevimab, a novel monoclonal antibody against respiratory syncytial virus (RSV). We aimed to analyze nirsevimab's effectiveness in hospital-related outcomes of the seasonal cohort (born during the RSV epidemic from October to January 2024) and compared them with the catch-up cohort (born from April to September 2023).
Methods: Retrospective cohort study of all infants born between October 1, 2023, and January 21, 2024, according to their immunization with nirsevimab (immunized and nonimmunized).
JMIR Form Res
January 2025
Early Intervention in Psychosis Advisory Unit for South-East Norway, Division of Mental Health and Addiction, Oslo University Hospital, Oslo, Norway.
Background: Shared decision-making between clinicians and service users is crucial in mental health care. One significant barrier to achieving this goal is the lack of user-centered services. Integrating digital tools into mental health services holds promise for addressing some of these challenges.
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