Clinical chemistry
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Meta Analysis
Completeness of Reporting of Systematic Reviews of Diagnostic Test Accuracy Based on the PRISMA-DTA Reporting Guideline.
We evaluated the completeness of reporting of diagnostic test accuracy (DTA) systematic reviews using the recently developed Preferred Reporting Items for Systematic Reviews and MetaAnalyses (PRISMA)-DTA guidelines. ⋯ Recently published reports of DTA systematic reviews are not fully informative when evaluated against the PRISMA-DTA guidelines. These results should guide knowledge translation strategies, including journal level (e.g., PRISMA-DTA adoption, increased abstract word count, and use of supplementary material) and author level (PRISMA-DTA citation awareness) strategies.
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Twenty-five years ago, the Food and Drug Administration (FDA) asserted in a draft document that "home brew" tests-now commonly referred to as laboratory-developed tests (LDTs)-are subject to the same regulatory oversight as other in vitro diagnostics (IVDs)4. In 2010, the FDA began work on developing a proposed framework for future LDT oversight. Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation. While the proposed guidance has not been implemented, many questions regarding LDT oversight remain unresolved. ⋯ Federal statutes regarding IVDs were passed without substantive evidence of congressional consideration toward the concept of LDTs. The FDA has clear oversight authority over IVD reagents introduced into interstate commerce. A 16-year delay in publicly asserting FDA authority over LDTs, the pursuit of a draft guidance approach toward oversight, and establishment of regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) applicable to LDTs contributed to community uncertainty toward LDT oversight. Future regulatory and/or legislative efforts may be required to resolve this uncertainty.
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The use of opioids to alleviate pain is complicated by the risk of severe adverse events and the large variability in dose requirements. Pharmacogenetics (PGx) could possibly be used to tailor pain medication based on an individual's genetic background. Many potential genetic markers have been described, and the importance of genetic predisposition in opioid efficacy and toxicity has been demonstrated in knockout mouse models and human twin studies. Such predictors are especially of value for neonates and young children, in whom the assessment of efficacy or side effects is complicated by the inability of the patient to communicate this properly. The current problem is determining which of the many potential candidates to focus on for clinical implementation. ⋯ The application of PGx in the management of pain with opioids has the potential to improve therapy. We provide a shortlist of 10 genes that are the most promising markers for clinical use in this context.
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Pulmonary embolism (PE) is associated with high all-cause and PE-related mortality and requires individualized management. After confirmation of PE, a refined risk stratification is particularly warranted among normotensive patients. Previous prognostic models favored combinations of echocardiography or computed tomography suggestive of right ventricular (RV) dysfunction together with biomarkers of RV dysfunction (natriuretic peptides) or myocardial injury (cardiac troponins) to identify candidates for thrombolysis or embolectomy. In contrast, current predictive models using clinical scores such as the Pulmonary Embolism Severity Index (PESI) or its simplified version (sPESI) rather seek to identify patients, not only those at higher risk requiring observation for early detection of hemodynamic decompensation, and the need for initiation of rescue reperfusion therapy, but also those at low risk qualifying for early discharge and outpatient treatment. Almost all prediction models advocate the additional measurement of biomarkers along with imaging of RV dysfunction as part of a comprehensive algorithm. ⋯ Ideally, biomarkers should be part of a comprehensive risk stratification algorithm used together with clinical risk scores as a basis, and/or imaging. For this purpose, cardiac troponins, including high-sensitivity troponin generations, natriuretic peptides, and h-FABP (heart-type fatty acid-binding protein) are currently recommended in guidelines. There is emerging evidence for several novel biomarkers that require further validation before being applied in clinical practice.
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Review Meta Analysis
Biomarker changes after strenuous exercise can mimic pulmonary embolism and cardiac injury--a metaanalysis of 45 studies.
Biomarkers are well established for diagnosis of myocardial infarction [cardiac troponins, high-sensitivity cardiac troponins (hs-cTn)], exclusion of acute and chronic heart failure [B-type natriuretic peptide (BNP), N-terminal proBNP (NT-proBNP)] and venous thromboembolism (d-dimers). Several studies have demonstrated acute increases in cardiac biomarkers and altered cardiac function after strenuous sports that can pretend a cardiovascular emergency and interfere with state-of-the-art clinical assessment. ⋯ Current cardiovascular biomarkers (cTnT, hs-cTnT, BNP, NT-proBNP, and d-dimer) that are used in clinical diagnosis of pulmonary embolism, acute coronary syndrome, and heart failure are prone to alterations due to strenuous exercise. Hence, it is necessary to take previous physical exercise into account when a cardiac emergency is suspected.