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The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia

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The World Health Organization (WHO) classification of tumors of the hematopoietic and lymphoid tissues was last updated in 2008. Since then, there have been numerous advances in the identification of unique biomarkers associated with some myeloid neoplasms and acute leukemias, largely derived from gene expression analysis and next-generation sequencing that can significantly improve the diagnostic criteria as well as the prognostic relevance of entities currently included in the WHO classification and that also suggest new entities that should be added. Therefore, there is a clear need for a revision to the current
classification. The revisions to the categories of myeloid neoplasms and acute leukemia will be published in a monograph in 2016 and reflect a consensus of opinion of hematopathologists, hematologists, oncologists, and geneticists.

The 2016 edition represents a revision of the prior classification rather than an entirely new classification and attempts to incorporate new clinical, prognostic, morphologic, immunophenotypic, and genetic data that have emerged since the last edition. The major changes in the classification and their rationale are presented here. (Blood. 2016; 127(20):2391-2405)

THE UPDATED WHO CLASSIFICATION OF HEMATOLOGICAL MALIGNANCIES

Authors: Daniel A. Arber,1 Attilio Orazi,2 Robert Hasserjian,3 Jürgen Thiele,4 Michael J. Borowitz,5 Michelle M. Le Beau,6 Clara D. Bloomfield,7 Mario Cazzola,8 and James W. Vardiman9

  1. Department of Pathology, Stanford University, Stanford, CA;
  2. Department of Pathology, Weill Cornell Medical College, New York, NY;
  3. Department of Pathology, Massachusetts General Hospital, Boston, MA;
  4. Institute of Pathology, University of Cologne, Cologne, Germany;
  5. Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, MD;
  6. Section of Hematology/Oncology, University of Chicago, Chicago, IL;
  7. Comprehensive Cancer Center, James Cancer Hospital and Solove Research Institute, The Ohio State University, Columbus, OH;
  8. Department of Molecular Medicine, University of Pavia, and Department of Hematology Oncology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; and
  9. Department of Pathology, University of Chicago, Chicago, IL

Listado de emisiones anteriores

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A “vaccine” that lowers cholesterol could help stave off heart disease

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The whole idea might appear a bit weird. Vaccinations are usually against pathogens (not fat), but researchers have worked out how to use the immune system to stop bad cholesterol, also known as low-density lipoprotein cholesterol (LDL). In a paper published in the European Heart Journal, researchers have shown how the vaccine taught the immune system to fight off an enzyme that stops the natural clearing of LDL from the blood.

The enzyme in question is PCSK9 (Proprotein convertase subtilisin/Kexin type 9), and the vaccine directly linked to its reduction is known as AT04A. There are already approved therapies that target PCSK9 with antibodies, but those are usually put into the patients rather than having the human body produce them.

In this experiment, mice were genetically modified and fed a western-style food to induce high cholesterol and atherosclerosis. AT04A reduced the total amount of cholesterol in these mice by 53%, atherosclerosis damage went down by 64%, and the biological markers of blood vessel inflammation were reduced by 21-28% compared to unvaccinated mice.

“The reduction in total cholesterol levels was significantly correlated with induced antibody concentration, proving that induced antibodies caused the reduction in cholesterol and also are ultimately responsible for the reduction of atherosclerosis development,” co-author Dr Günther Staffler, chief technology officer at AFFiRis (who developed the vaccine), said in a statement. “As antibody concentrations remained high at the end of the study, it can be assumed they would continue to reduce cholesterol levels for some time afterwards, resulting in a long-lasting effect, as has been shown in previous studies.”

If the vaccine is able to replicate the same beneficial effects in humans, it could lead to long-lasting effective therapies that only need annual boosters to remain at full potency.

“The way that AT04A is administered is comparable to a vaccine,” added Dr Staffler. “However, the difference between a conventional vaccine and our approach is that a vaccine induces antibodies that are specific to bacterial or viral proteins that are foreign to the body – pathogens – whereas AT04A induces antibodies against a target protein that is produced by the body – endogenous proteins. This is really an immunotherapeutic approach rather than a vaccine approach.”

Human tests are currently investigating the safety of AT04A in 72 people. This phase I trial is expected to be concluded by the end of the year.

Source: iflscience.com

Interpretation of blood microbiology results: function of the clinical microbiologist

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Effective implementation of this function requires careful consideration of specimen collection and processing, pathogen detection techniques, and prompt and precise reporting of identification and susceptibility results. The responsibility of the treating physician is proper formulation of the analytical request and to provide the laboratory with complete and precise patient information, which are inevitable prerequisites of a proper testing and interpretation. The clinical microbiologist can offer advice concerning the differential diagnosis, sampling techniques and detection methods to facilitate diagnosis. Rapid detection methods are essential, since the sooner a pathogen is detected, the better chance the patient has of getting cured. Besides the gold-standard blood culture technique, microbiologic methods that decrease the time in obtaining a relevant result are more and more utilized today. In the case of certain pathogens, the pathogen can be identified directly from the blood culture bottle after propagation with serological or automated/semi-automated systems or molecular methods or with MALDI-TOF MS (matrix-assisted laser desorption-ionization time of flight mass spectrometry). Molecular biology methods are also suitable for the rapid detection and identification of pathogens from aseptically collected blood samples. Another important duty of the microbiology laboratory is to notify the treating physician immediately about all relevant information if a positive sample is detected. The clinical microbiologist may provide important guidance regarding the clinical significance of blood isolates, since one-third to one-half of blood culture isolates are contaminants or isolates of unknown clinical significance. To fully exploit the benefits of blood culture and other (non- culture based) diagnoses, the microbiologist and the clinician should interact directly.

Author: Katalin Kristóf, Júlia Pongrácz

Click here to access full PDF.

Copyright © 2016 International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). All rights reserved.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

FDA approves new antibiotic to treat serious skin infections

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A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed

The drug, Baxdela, or delafloxacin, is designed to treat skin and skin structure infections caused by a range of bacteria, including methicillin-resistant staphylococcus aureus, or MRSA.

Baxdela belongs to a common class of broad-spectrum antibiotics known as fluoroquinolones, which are typically given by infusion. Baxdela can be given both by infusion and in oral form.

The drug was shown in clinical trials to be no less effective than a combination of vancomycin, the go-to drug for serious gram-positive infections, and aztreonam, a drug to treat gram-negative infections, both of which are available in generic form.

Melinta estimates that about 40 percent of the 3 million patients hospitalized for serious skin infections receive two drugs, typically vancomycin and a gram-negative drug, rather than waiting for a lab test to determine whether the bug is gram-positive or gram-negative.

Dr. Eugene Sun, Melinta’s chief executive, said the company plans to price the drug “competitively with other agents in the same space. We are acutely aware of the stresses on the (healthcare) system,” he said.

Source: Reuters

Cytomegalovirus infection associated with inflammatory bowel disease

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Hence the diagnosis of additional complications is of utmost importance. Colitis mediated by cytomegalovirus is one such complication. The high seroprevalence and latent nature of cytomegalovirus, with the possibility of viral replication without mediating disease, poses a real challenge for the diagnosis of cytomegalovirus-mediated colitis. The challenge in daily clinical practice is to distinguish cytomegalovirus replication from cytomegalovirus-mediated colitis in patients with inflammatory bowel disease who have refractory colitis. This Review discusses the scientific literature and provides a diagnostic and therapeutic algorithm for clinical practice.

Autho: Prof Britta Siegmund, MD

DOI: dx.doi.org/10.1016/S2468-1253(16)30159-5

Click here to see the PDF (To read this article in full you will need to make a payment)

Incorrect aseptic techniques in medicine preparation and recommendations for safer practices: a systematic review

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A systematic literature search was conducted in PubMed covering 2007–2015. Studies were included if they concerned aseptic medicine preparation and administration in hospitals by different healthcare professionals, assessed incorrect practices and made recommendations for safer aseptic preparation and administration.

Authors: Eeva Suvikas-Peltonen, Suvi Hakoinen, Ercan Celikkayalar, Raisa Laaksonen, Marja Airaksinen

Methods A systematic literature search was conducted in PubMed covering 2007–2015. Studies were included if they concerned aseptic medicine preparation and administration in hospitals by different healthcare professionals, assessed incorrect practices and made recommendations for safer aseptic preparation and administration.

Conclusions: The review discusses many appropriate and enhanced practices in aseptic drug preparation and administration. As the change for the better in contamination rates of administered medicines seems to be challenging to achieve in hospitals, better and possibly international procedures for safe parenteral practices need to be developed

To cite: Suvikas-Peltonen E, Hakoinen S, Celikkayalar E, et al. Eur J Hosp Pharm 2017; 24:175–181.

Click here to download the PDF.

Journal of Negative Results in BioMedicine

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Journal of Negative Results in BioMedicine is an open access, peer reviewed journal that  provides a platform for the publication and discussion of non-confirmatory and “negative” data, as well as unexpected, controversial and provocative results in the context of current tenets.

Click here to Explore Journals

About the Editor

Bjorn R. Olsen, Editor-in-Chief

Bjorn Olsen is Professor of Developmental Biology at Harvard School of Dental Medicine and the Dean for Research at Harvard School of Dental Medicine.

“This is an exciting time for research in the life sciences. Major discoveries providing deep insights into disease mechanisms and the basis for preventive, diagnostic and therapeutic strategies are coming at a fast and furious pace. Problems that only a few years ago were beyond technical limits, can now be successfully addressed and ‘old’ questions can be re-examined with increasingly powerful methods. Open access journals provide the ideal environment for the rapid dissemination and discussion of all aspects of the results of this research.”

Source: biomedcentral.com

#EuroMedLab2017 Daily News: Monday 12

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22nd IFCC – EFLM European Congress of Clinical Chemistry and Laboratory Medicine
25th Meeting of Balkan Clinical Laboratory Federation
15th National Congress of GSCC-CB

Click here to view this issue.

 

 

Demonstrating the Value of Laboratory Medicine

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Improving quality of health care and patient safety in times of budgetary constraints: Demonstrating the value of laboratory medicine

Healthcare providers are required to continue improving quality of health care and patient safety in a context of ever decreasing budgets. This occurs at a time when the overall cost of health care continues to rise at a rate significantly greater than the general consumer price index, placing unprecedented strains on the funders, whether they are insurance companies or governments. Hence the major question is whether the current model is sustainable over the longer term. To address this question, leaders in the healthcare field are calling for a shift in the evaluation of the delivery of healthcare from assessment based on activity to assessment based on patient outcomes.

Current business models for the healthcare delivery, which include laboratory medicine, are primarily activity-based, and designed, managed, and executed in individual, independent units or silos. The consequences of such a model are that each individual unit is managed according to its performance metrics rather than the product of the healthcare system that includes the clinical pathway for the patient and the contribution of the stakeholders. Consequently in the case of laboratory medicine, which operates on the fee-for-service (or cost-per-test), the focus is on the quality of analytical performance, volume of activity, and cost of delivery. However, the central role of the laboratory medicine service is to deliver results of procedures that enable clinicians and other stakeholders to improve their decisions and thus improve patients’ outcomes. Consequently, the value of laboratory medicine in achieving these goals must be found in other silos and be founded on outcome- and value-based agendas through a paradigm shift in its business model.

One such business model is adoption of the concept of a value proposition for individual test utilities, embedded in the overall healthcare service. This needs to be developed on the basis of evidence of impact on clinical, operational, and resource outcomes, and in the context of a patient-centred care pathway. Details of this concept have been recently published (1).

The value proposition of any product or service describes the utility of the product or service in terms of benefit to the customer. In the context of laboratory medicine the value proposition comprises (i) the unmet clinical need, (ii) the nature of the service, (iii) the potential benefits of the service, and (iv) the demonstration that the benefit claimed can be achieved. The customer values the resolution of a problem or the service provided to meet an unmet need, which can be defined in terms of clinical, operational, and economic (resource) outcomes. In health care, while the patient is the ultimate and most important stakeholder, all stakeholders can be considered as customers. Thus while laboratory medicine may provide a service that directly impacts a patient, typically it offers benefits to carers, healthcare providers, those purchasing healthcare services, and policymakers.

The value of laboratory medicine can only be considered in the context of the patient care pathway in which the test is used, as the delivery of a laboratory test result, in and of itself, will not deliver any benefit. In other words, a particular action has to be taken on receipt of the result. Therefore, the value proposition for laboratory medicine is expressed in terms of contributions to guide decision making in clinical care, the process of the care delivered, and the resource required to deliver that care.

If assessment of value in health care is to move away from activity-based metrics and move towards an outcome-based and patient value-based approach, then the value of all contributors to health care needs to be demonstrated and recognised, and importantly become the basis on which health care is resourced, organised, and delivered.

The key objective of laboratory medicine is to contribute to guiding decision making that ensures the best health outcome for the individual patient, while minimising risk and adverse outcomes, and maintaining reasonable cost. Adoption of a value proposition in health care, including that for laboratory medicine, carries with it significant implications for all stakeholders. The clinical and cost effectiveness to be gained from the appropriate utilisation of laboratory medicine can deliver clinical, operational, and/or economic benefits spread across the whole care pathway, thereby addressing the interests – and responsibilities – of all stakeholders.

Ultimately the value proposition will offer the opportunity to develop a healthcare system that will be financially sustainable over the longer term.

References

1. Price CP, John AS, Christenson R, Scharnhorst V, Oellerich M, Jones P, Morris HA. Leveraging the real value of laboratory medicine with the value proposition. Clin Chim Acta. 2016 Sep 17. pii: S0009-8981(16)30379-5. doi: 10.1016/j.cca.2016.09.006. [Epub ahead of print]

Authors

Christopher P Price1, Andrew St John2, Robert Christenson3, Volker Scharnhorst4, Michael Oellerich5, Patricia Jones6, Howard A Morris7

  1. Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, United Kingdom
  2.  ARC Consulting, Mt Lawley, W Australia 6050
  3. Laboratories of Pathology, University of Maryland Medical Center, 22 South Greene Street, Baltimore, MD 21201, USA
  4. Clinical Laboratory, Catharina Hospital and Dept. of Biomedical Technology, Technical University Eindhoven, Eindhoven, The Netherlands
  5. Department of Clinical Pharmacology, University Medicine Göttingen (UMG), Kreuzbergring 36, 37075 Göttingen, Germany
  6. Department of Pathology, University of Texas Southwestern Medical Center and Children’s Medical Center, 1935 Medical District Drive, Dallas, Texas 75235 USA
  7. School of Pharmacy and Medical Sciences, University of South Australia and Chemical Pathology Directorate, SA Pathology, Adelaide, South Australia 5000

Source: Labs Are Vital

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