Likelihood Ratios as Value Proposition for Diagnostic Laboratory Tests

2020 ◽  
Vol 5 (5) ◽  
pp. 1061-1069 ◽  
Author(s):  
Walter Fierz ◽  
Xavier Bossuyt

Abstract The clinical and health economic value of clinical laboratory diagnostics has been debated increasingly in recent years without resulting in practical recommendations for measuring the effectiveness of diagnostic tests. One way to achieve such a goal could be to enrich the mere data of laboratory test results with additional information about their likelihood ratios for diagnosis. The diagnostic significance of test results can be judged subjectively based on the experience of the treating physician or expressed objectively in the form of likelihood ratios. The provision of likelihood ratios by the laboratory would increase the impact of laboratory diagnostics in healthcare and thus have positive economic value. Consequently, likelihood ratios should be taken into account in reimbursement strategies.

Author(s):  
Elena Vitalievna Perminova

Clinical laboratory diagnostics is a medical specialty, which is based on in vitro diagnostic studies of biomaterial obtained from an individual. At the present stage, there are three main types of organization of the laboratory research process — a laboratory service as part of a medical and preventive institution, a centralized laboratory where biomaterials are delivered for research from various healthcare institutions, as well as mobile laboratories that allow conducting the research directly at the patient’s bedside. This discipline involves the use of a wide variety of diagnostic research methods and the use of a huge number of specific techniques. Their list should include carrying out hematological, microbiological, virological, immunological, serological, parasitic, and biochemical studies. Also, when organizing laboratory diagnostic activities, a number of other studies (cytological, histological, toxicological, genetic, molecular biological, etc.) are provided. A laboratory report is formulated after obtaining clinical data and comparing them with the obtained test results. The quality of laboratory tests is ensured through the systematic implementation of internal laboratory control, as well as participation in a national program for external quality assessment. The activities of the clinical diagnostic laboratory should be organized in accordance with the requirements of the standard GOST R ISO 15189–2015 «Medical laboratories. Particular requirements for quality and competence», which is based on the provisions of two more fundamental standards — ISO 9001 and ISO 17025, and adds a number of special requirements related to medical laboratories.


2006 ◽  
Vol 130 (4) ◽  
pp. 521-528 ◽  
Author(s):  
Amitava Dasgupta ◽  
David W. Bernard

AbstractContext.—Complementary and alternative medicine (herbal medicines) can affect laboratory test results by several mechanisms.Objective.—In this review, published reports on effects of herbal remedies on abnormal laboratory test results are summarized and commented on.Data Sources.—All published reports between 1980 and 2005 with the key words herbal remedies or alternative medicine and clinical laboratory test, clinical chemistry test, or drug-herb interaction were searched through Medline. The authors' own publications were also included. Important results were then synthesized.Data Synthesis.—Falsely elevated or falsely lowered digoxin levels may be encountered in a patient taking digoxin and the Chinese medicine Chan Su or Dan Shen, owing to direct interference of a component of Chinese medicine with the antibody used in an immunoassay. St John's wort, a popular herbal antidepressant, increases clearance of many drugs, and abnormally low cyclosporine, digoxin, theophylline, or protease inhibitor concentrations may be observed in a patient taking any of these drugs in combination with St John's wort. Abnormal laboratory results may also be encountered owing to altered pathophysiology. Kava-kava, chaparral, and germander cause liver toxicity, and elevated alanine aminotransferase, aspartate aminotransferase, and bilirubin concentrations may be observed in a healthy individual taking such herbal products. An herbal product may be contaminated with a Western drug, and an unexpected drug level (such as phenytoin in a patient who never took phenytoin but took a Chinese herb) may confuse the laboratory staff and the clinician.Conclusions.—Use of alternative medicines may significantly alter laboratory results, and communication among pathologists, clinical laboratory scientists, and physicians providing care to the patient is important in interpreting these results.


Author(s):  
Petr Jarolim

AbstractWe discuss the sensitivity terminology of cardiac troponin assays and its dependence on the selection of the reference population. In addition, the need for reasonable censoring of clinical laboratory test results is contrasted with potential loss of valuable clinical information.


2011 ◽  
Vol 57 (8) ◽  
pp. 1108-1117 ◽  
Author(s):  
W Greg Miller ◽  
Gary L Myers ◽  
Mary Lou Gantzer ◽  
Stephen E Kahn ◽  
E Ralf Schönbrunner ◽  
...  

Abstract Results between different clinical laboratory measurement procedures (CLMP) should be equivalent, within clinically meaningful limits, to enable optimal use of clinical guidelines for disease diagnosis and patient management. When laboratory test results are neither standardized nor harmonized, a different numeric result may be obtained for the same clinical sample. Unfortunately, some guidelines are based on test results from a specific laboratory measurement procedure without consideration of the possibility or likelihood of differences between various procedures. When this happens, aggregation of data from different clinical research investigations and development of appropriate clinical practice guidelines will be flawed. A lack of recognition that results are neither standardized nor harmonized may lead to erroneous clinical, financial, regulatory, or technical decisions. Standardization of CLMPs has been accomplished for several measurands for which primary (pure substance) reference materials exist and/or reference measurement procedures (RMPs) have been developed. However, the harmonization of clinical laboratory procedures for measurands that do not have RMPs has been problematic owing to inadequate definition of the measurand, inadequate analytical specificity for the measurand, inadequate attention to the commutability of reference materials, and lack of a systematic approach for harmonization. To address these problems, an infrastructure must be developed to enable a systematic approach for identification and prioritization of measurands to be harmonized on the basis of clinical importance and technical feasibility, and for management of the technical implementation of a harmonization process for a specific measurand.


2018 ◽  
Vol 9 (2) ◽  
pp. 209
Author(s):  
Erniati Erniati

Meatball is a favorite food of children, because it is a good taste and cheap. Meatballs is not always healthy to consume because of the addition of borax so the texture of meatballs more chewy, more bright and more durable in order not easily rotted. The purpose of this study was to analyze the level of education, knowledge, attitude of meatball sellers and the use of borax on meatballs at Lemahputro III Sidoarjo State Elementary School. Population of research as many as 10 pieces of meatballs and samples taken in total sampling. The result of the research is the level of education of meatballs sellers is still low (not graduated from primary/junior high school) by 50%, knowledge is not good about the meaning, benefi t, and the use of borax on meatballs by 30%. Less attitude when answering questions about the impact of borax use and supporting or not supporting the use of borax on meatballs by 40%. Laboratory test results on positive meatballs contain borax by 30%. Suggestion for schools are to establish cooperation between the school and health centers in the supervision of sellers who sell in the school environment and to admonish, to write a warning, and to give a sanction prohibiting to sell meatball. If the meatball sellers is still using borax then they will be not allowed to sell meatball.


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