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A systematic literature review of real-world evidence (RWE) on post-market assessment of medical devices.
Health Econ Policy Law
January 2025
Management and Health Laboratory, Institute of Management and EMbeDS Department, Scuola Superiore Sant'Anna, Pisa, Italy.
The increasing use of real-world evidence (RWE) and real-world data (RWD) to assess post-market medical devices (MDs) might satisfy the urgent need for data sharing and traceability. This study sought to (i) get an overview of current practice in post-market assessments of MDs reporting on RWE/RWD; (ii) draw policy recommendations for governments and health organisations and identify a research agenda for scholars.A systematic review was undertaken until February 2024 following the PRISMA guidelines.
View Article and Find Full Text PDFMolecular and phylogenetic analyses of the first complete genome sequence of Duck hepatitis A virus genotype 2 from India.
Gene
March 2025
National Institute of Animal Biotechnology, Hyderabad, Telangana 500032, India; Regional Center for Biotechnology (RCB), Faridabad, Haryana, India. Electronic address:
Duck viral hepatitis (DVH) caused by duck hepatitis A virus (DHAV) is a highly contagious and economically important disease of ducklings worldwide. In many parts of the globe, disease outbreaks are reported in spite of vaccinations, probably due to antigenic diversity among DHAV genotypes. We previously reported the first isolation of DHAV-2 (Genotype-2) from ducklings in Tamil Nadu, India.
View Article and Find Full Text PDFDevelopment and validation of the Iranian Minimum Data Set for Epidermolysis Bullosa: A mixed method approach.
PLoS One
January 2025
Assistant Professor of Health Information Management, Department of Health Information Technology, Ferdows Faculty of Medical Sciences, Birjand University of Medical Sciences, Birjand, Iran.
Minimum Data Set (MDS) enables integration in data collection, uniform data reporting, and data exchange across clinical and research information systems. The current study was conducted to determine a comprehensive national MDS for the Epidermolysis Bullosa (EB) information management system in Iran. This cross-sectional descriptive study consists of three steps: systematic review, focus group discussion, and the Delphi technique.
View Article and Find Full Text PDFClinical trial eligibility in PSP: Population representativeness and potential criteria adjustment based on PSP-NET findings.
Parkinsonism Relat Disord
February 2025
Neurology Unit and Neurobiorepository and Laboratory of Advanced Biological Markers, Department of Clinical and Experimental Sciences, University of Brescia, And Department of Continuity of Care and Frailty, ASST Spedali Civili Brescia Hospital, Brescia, Italy.
Background: Progressive Supranuclear Palsy (PSP) is a rare, heterogeneous neurodegenerative disease for which no treatment is currently available. In the context of clinical trials, the representativeness of the included patients is crucial for the generalizability of the results. Herein, we present results from a multicenter perspective study to identify the most restrictive criteria for patient selection and to assess the representativeness of eligible patients.
View Article and Find Full Text PDFBenefit of Avasopasem Manganese on Severe Oral Mucositis in Head and Neck Cancer in the ROMAN Trial: Unplanned Secondary Analysis.
Adv Radiat Oncol
January 2025
International Drug Development Institute (IDDI), Louvain-la-Neuve, Belgium.
Purpose: Oral mucositis (OM) is a debilitating side effect of cisplatin and intensity-modulated radiation therapy (IMRT) in patients with head and neck cancer. The phase 3 ROMAN trial showed avasopasem manganese (AVA) significantly decreased individual endpoints of incidence and duration of severe oral mucositis (SOM, World Health Organization [WHO] grade 3-4), with nominal decrease in severity (WHO grade 4) and significant increase in the delay in onset of SOM. We sought to determine the Net Treatment Benefit (NTB) of AVA versus placebo (PBO) using the generalized pairwise comparisons (GPC) method.
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