Publications by authors named "L Sampietro-Colom"

"Evidence" is a key term in medicine and health services research, including Health Technology Assessment (HTA). Randomized clinical trials (RCTs) have undoubtedly dominated the scene of generating evidence for a long period of time, becoming the hallmark of evidence-based medicine (EBM). However, due to a number of misunderstandings, the lay audience and some researchers have sometimes placed too much trust in RCTs compared to other methods of investigation.

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The use of treatment effects derived from nonrandomized studies (NRS) in health technology assessment (HTA) is growing. NRS carry an inherently greater risk of bias than randomized controlled trials (RCTs). Although bias can be mitigated to some extent through appropriate approaches to study design and analysis, concerns around data availability and quality and the absence of randomization mean residual biases typically render the interpretation of NRS challenging.

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Introduction: Melanoma is the deadliest of all the skin cancers and its incidence is increasing every year in Europe. Patients with melanoma often present late to the specialist and treatment is delayed for many reasons (delay in patient consultation, misdiagnosis by general practitioners, and/or limited access to dermatologists). Beyond this, there are significant inequalities in skin cancer between population groups within the same country and between countries across Europe.

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Article Synopsis
  • The new EU Regulations aim to enhance the quality of clinical evidence for medical devices and streamline market access processes across EU countries.
  • Recommendations suggest that the assessment of medical devices and health technology should be better coordinated, especially for innovative, high-risk devices, and an accelerated approval program could be beneficial.
  • The article reviews past global accelerated approval programs, highlighting issues like uncertainty in clinical evidence and calls for an Accelerated Access Pathway in the EU to improve timely access for patients and encourage collaboration among member states on coverage decisions.
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Science and technology have evolved quickly during the two decades of the 21st century, but healthcare systems are grounded in last century's structure and processes. Changes in the way health care is provided are demanded; digital transformation is a key driver making healthcare systems more accessible, agile, efficient, and citizen-centered. Nevertheless, the way healthcare systems function challenges the development (Innovation + Development and regulatory requirements), assessment (methodological guidance weaknesses), and adoption of digital applications (DAs).

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