Current medical research and opinion
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As lifetime horizons are considered for economic evaluations, the Kaplan-Meier (KM) estimate is used to extrapolate survival in cases of immature overall survival (OS) data. This study estimated the error induced by the choice of distribution when extrapolating different levels of OS maturity. ⋯ The extent of OS maturity increases the risk of error when projecting long-term life expectancy for economic models. Even marginal gains in OS maturity result in more accurate estimations and should be considered when developing models.
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Schizophrenia is a chronic, heterogeneous, severe psychiatric disorder characterized by a spectrum of symptomology and is associated with substantial morbidity and mortality. For the last 70 years, available treatments have shared blockade of dopamine D2 receptors as their primary mechanism of action (MOA), the efficacy of which has been limited by incomplete resolution of all symptoms as well as treatment non-response in a select subset of patients. In addition, antipsychotics are associated with class-related side effects attributed to this primary MOA, including extrapyramidal symptoms (EPS). ⋯ In a dataset of 545 clinical trials identified in ClinicalTrials.gov from January 2002 to July 2022, total enrollments in trials of non-D2-based compounds for the treatment of schizophrenia summed to approximately 34,000 patients, compared with 27,144 patients for D2-based compounds. These data indicate that there remains substantial and ongoing investment in the development of novel non-D2 options for schizophrenia, with a success rate measured by regulatory approval that is well-below recent benchmarks for the broader category of CNS drugs. Improved trial design, conduct, endpoints, and analyses/methods may influence signal detection and reliability to support development and registration of non-D2 compounds.
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Review Meta Analysis
Neutrophil-lymphocyte ratio, monocyte-lymphocyte ratio, and platelet-lymphocyte ratio in stroke-associated pneumonia: a systematic review and meta-analysis.
Predicting stroke-associated pneumonia (SAP) is crucial for intensifying preventive measures and decreasing morbidity and mortality. This meta-analysis aims to evaluate the association between baseline neutrophil-lymphocyte ratio (NLR), monocyte-lymphocyte ratio (MLR), and platelet-lymphocyte ratio (PLR) with SAP and to determine the strength of the association. ⋯ This systematic review and meta-analysis suggest that an elevated NLR, MLR, and PLR were associated with SAP, indicating that they could be promising blood-based biomarkers for predicting SAP. Large-scale prospective studies from various ethnicities are recommended to validate this association before they can be applied in clinical practice.
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To conduct a content analysis of IRB webpages of select universities (academic health centers) in the USA that describe post IRB- approval monitoring activities. ⋯ REC/IRB post-approval monitoring of clinical trials is a valuable mechanism of protection for research participants while giving educational and quality assurance support to researchers. The program enables early detection and resolution of non-compliance to approved protocols. The impact of the program in the USA requires further exploration.
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Cancer patients are at high risk of venous thromboembolism (VTE), a significant cause of cancer-related death. Historically, low molecular weight heparins (LMWH) were the gold standard therapy for cancer-associated VTE, but recent evidence supports the use of direct factor Xa inhibitors in cancer-associated VTE and this is now reflected in many guidelines. However, uptake of direct factor Xa inhibitors varies and guidance on the use of direct factor Xa inhibitors in specific cancer sub-populations and clinical situations is lacking. This review presents consensus expert opinion alongside evaluation of evidence to support healthcare professionals in the use of direct factor Xa inhibitors in cancer-associated VTE. ⋯ Anticoagulant therapy for cancer-associated VTE patients should be carefully selected with consideration given to the relative benefits of specific drugs when individualizing care. Direct factor Xa inhibitors are typically the treatment of choice for preventing VTE recurrence in non-cancer patients and should also be considered as such for cancer-associated VTE in most situations.