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Large simple randomized controlled trials-from drugs to medical devices: lessons from recent experience.
Trials
January 2025
Department of Cardiology, University Hospital of Wales, Cardiff, UK.
Randomized controlled trials (RCTs) are the cornerstone of modern evidence-based medicine. They are considered essential to establish definitive evidence of efficacy and safety for new drugs, and whenever possible they should also be the preferred method for investigating new high-risk medical devices. Well-designed studies robustly inform clinical practice guidelines and decision-making, but administrative obstacles have made it increasingly difficult to conduct informative RCTs.
View Article and Find Full Text PDFNeutrophil-to-Lymphocyte Ratio and Other Complete Blood Count Parameters in the Diagnosis of Serious Bacterial Infections in Febrile Infants Under Three Months.
Cureus
December 2024
Pediatrics, First Department of Pediatrics, Medical School, National and Kapodistrian University of Athens, Athens, GRC.
Background: The incidence of serious bacterial infections (SBI) in febrile infants under three months is high. Complete blood count parameters, an easily accessible and low-cost test, may have diagnostic potential for SBI.
Objectives: This study evaluated the efficacy of absolute neutrophil count (ANC), neutrophil-to-lymphocyte ratio (NLR), lymphocyte-to-monocyte ratio (LMR), platelet-to-lymphocyte ratio (PLR), platelet-to-mean platelet volume ratio (PLT/MPV), red cell distribution width (RDW), and C-reactive protein (CRP) in distinguishing febrile infants under three months with SBI.
The prognostic value of global longitudinal strain in patients with myocardial infarction and preserved ejection fraction - a prespecified substudy of the REDUCE-AMI trial.
Eur Heart J Cardiovasc Imaging
January 2025
Department of Clinical Science and Education, Division of Cardiology, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden.
Aims: The REDUCE-AMI trial showed that beta-blockers in patients with preserved left ventricular ejection fraction (LVEF) after acute myocardial infarction (AMI) had no effect on mortality or cardiovascular outcomes. The aim of this substudy was to evaluate whether global longitudinal strain (GLS) is a better prognostic marker than LVEF, and if beta-blockers have a beneficial effect in patients with decreased GLS.
Methods And Results: REDUCE-AMI was a registry-based randomized clinical trial.
Immune Checkpoint Blockade Combined with AbnobaViscum Therapy Is Linked to Improved Survival in Advanced or Metastatic Non-Small-Cell Lung Cancer Patients: A Registry Study in Accordance with the ESMO Guidance for Reporting Real-World Evidence.
Pharmaceuticals (Basel)
December 2024
Lung Cancer Center, Hospital Havelhöhe, Kladower Damm 221, 14089 Berlin, Germany.
Recent advancements in cancer treatment have shown the potential of immune checkpoint blockade (ICB) plus L. therapy in improving survival rates for patients with advanced or metastatic non-small-cell lung cancer (NSCLC). The objective of this study was to investigate factors associated with improved survival in NSCLC patients treated with a combination of ICB and abnobaViscum.
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