In 1989 we reviewed the effectiveness of the Clinical Pharmacokinetics Service * at Glasgow Royal Infirmary for 574 digoxin requests and concluded that the service "probably contributed to improved clinical decision making" (1). We have now reviewed a total of 2961 requests, asking the following questions: Was adequate clinical information provided? Did the digoxin concentration confirm or refute the clinical impression? Was the service being sensibly used?
The indications for measurement of serum drug concentrations are that there are no readily quantifiable pharmacological manifestation, adequate demonstration that pharmacological effects, whether therapeutic or toxicological, are related to serum drug concentration, and agreement that knowledge of the serum drug concentration will affect therapeutic decision-making in the individual. High-performance liquid chromatography was applied to the measurement of drugs, and as liquid chromatography (LC) systems have become more widely available an increasing number of methods related to the determination of drugs for therapeutic drug monitoring (TDM) have been published. Reversed-phase LC, which is compatible with aqueous solutions, is widely used in TDM and clinical toxicology and a number of protein removal procedures have been developed. With the flexibility and cost-effectiveness inherent in the technique, it is inevitable that LC applications in therapeutic drug monitoring and poisoning will continue to grow.
Background Many of the mobile applications (apps) used for delivering health interventions involve laboratory medicine data. This survey was conducted to search the online market for health apps that manage laboratory medicine data. The aim was to review them and perform a quality evaluation. Methods Apps search criteria were "Lab results blood work", "Lab results", and "Health apps". After the stepwise exclusion process, 52 selected apps were downloaded and analyzed. For review and content analysis of the apps, a multidimensional tool for classifying and rating the quality of mobile health apps - Mobile App Rating Scale (MARS), was used. Results Selected apps were classified into five categories according to their intended use by patients or physicians, and the type of data engaged. Spearman's correlation analysis found significant correlations between MARS individual scoring items, as with the subjective quality and number of technical aspects. Kruskal-Wallis analysis showed a significant difference in the number of technical aspects employed, MARS engagement and informational quality score items, total score, and subjective quality. The lowest values for all of these items were in the category of apps designed for patients, and the post hoc test showed that the difference was statistically significant between this and the values in all other categories. Conclusions Apps designed for patients, are of the poorest quality, considering the total quality of the content and information they provide, estimated using the MARS tool. This estimation needs to be validated for laboratory medicine apps, and eventually modified after consideration of specific quality benchmarks.
Technological change is driving individualized healthcare delivery including laboratory medicine. Ensuring patients gain from their empowerment it is essential that they access data that enables them to utilize reliable information. The potential difficulties of comprehension, information retention and imperfect modes of communication can significantly impair utilization of information by patients. Support for understanding and decision-making needs to be clinically competent and integrated within the healthcare team. Specialists in laboratory medicine are well placed to undertake such a role, the issues around this are explored and proposals for better direct engagement with patients made.
Healthcare delivery and responsibility is changing. Patient-centered care is gaining international acceptance with the patient taking greater responsibility for his/her health and sharing decision making for the diagnosis and management of illness. Laboratory medicine must embrace this change and work in a tripartite collaboration with patients and with the clinicians who use clinical laboratory services. Improved communication is the key to participation, including the provision of educational information and support. Knowledge management should be targeted to each stakeholder group. As part of collaborative healthcare clinical laboratory service provision needs to be more flexible and available, with implications for managers who oversee the structure and governance of the service. Increased use of managed point of care testing will be essential. The curriculum content of laboratory medicine training programs will require trainees to undertake practice-based learning that facilitates interaction with patients, clinicians and managers. Continuing professional development for specialists in laboratory medicine should also embrace new sources of information and opportunities for collaborative healthcare.
Abstract Background: There is increasing interest in direct patient engagement including receiving their laboratory medicine results. We previously established an appetite for Specialists in Laboratory Medicine to support patients in understanding results. The aim of this study was to establish whether patients agreed with such an approach, determined through surveying views in eight European countries. Methods: A standardized five-question survey was administered across eight European countries to a total of 1084 individuals attending medical outpatient clinics, with 100 patients each in Poland, Serbia, Netherlands, Turkey and Czech Republic, 101 in Estonia, 116 in Denmark and 367 in Norway. The responses across countries were compared using the chi-square test (p<0.05). Results: Patients wanting their results ranged from 50% to 94% (mean 65%) of those responding positively, a mean of 72% wanted additional information with their results; direct receipt was preferred over referral to a website. Specialists in Laboratory Medicine providing such information were acceptable to a mean of 62% of those respondents wishing their results; in countries where payment was possible, there was little interest in making additional payment for such a service. Conclusions: A clear proportion of patients are interested in receiving their laboratory medicine results, the majority with explanatory notes; a role for Specialists in Laboratory Medicine is acceptable and raises the potential for direct engagement by such specialists with patients offering a new paradigm for the provision of laboratory medicine activities.
O'Kane和他的同事们提出若患者能够直接获得其检验结果,是否有助于患者有效地使用这些结果1.欧洲临床化学与检验医学联盟(European Federation of Clinical Chemistryand Laboratory Medicine,EFLM)成立了关注患者的检验医学工作组,在欧洲的专业人士和患者中开展相关调查.有些专业人士反对让患者直接获得检验结果.个别认为需要对此进行监管;而大多数专业人士则担心患者无法正确理解检验结果的含义.其他医务人员对此十分支持2.
The authors consider acute problems in the quality and management of medical services challenging health care systems worldwide. This actuality has motivated the representatives of the European Association of Predictive, Preventive and Personalised Medicine and European Federation of Clinical Chemistry and Laboratory Medicine to consider the efforts in promoting an integrative approach based on multidisciplinary expertise to advance health care. The position paper of EPMA and EFLM [1] provides a global overview of the problems related to medical services: pandemic scenario in the progression of common chronic diseases, delayed interventional approaches of reactive medicine, poor economy of health care systems, lack of specialised educational programmes, problematic ethical aspects of treatments as well as inadequate communication among professional groups and policy makers. The common position is focused on the patients' needs, expert recommendations for the relevant medical fields and plausible solutions which have a potential to advance health care services if the long-term strategies were to be effectively implemented as proposed in the position paper. In particular, the paper makes following statements: ➣ Since chronic pathologies are generally triggered at the molecular level with consequent symptomatic manifestation of the disease, a laboratory based detection of pathology-specific molecular patterns would create a well-founded basis for the desirable predictive medical services giving the opportunity for optimal health care. This requires the application of innovative biotechnologies to predict human pathologies, the devising of appropriate and timely preventive strategies and individualised treatment planning. ➣ Multimodal diagnostics represents a model-based examination procedure with several levels of examination resulting in extended patient profiles and medical records which obligate inclusion of an interview with the patient/a questionnaire filled in for relevant information on any known pathology, medical imaging, laboratory diagnostics and evaluation of relevant risk factors. For laboratory diagnostics, it is highly recommended to use minimally invasive validated blood tests for the detection of stage-specific molecular patterns at complementary levels of targeted regulation (DNA polymorphisms, transcripts, protein expression, posttranslational modification, stage-specific sub-cellular imaging, shifted enzymatic activity etc.). ➣ Shifting the role of laboratory from the ‘passive performing’ to the ‘active advising’ is the next paradigm change in health care. This reconsideration of the laboratory-clinician interface might significantly advance the quality of current medical services, although the implementation of this approach across countries should be adapted to local conditions. ➣ The globalisation of markets and laboratory related business requires the comparability, or the unification, of laboratory test values. The mobility of both patients and health care professionals as well as the increasing global data flow require such comparability. Hence, the unification of laboratory tests should be placed at the top of the list of corresponding adapting measures. ➣ A new generation of ‘point-of-care’ monitoring devices is required. These mobile health technologies must enable both the remote management of the analytical process and the active engagement of laboratory professionals at the clinical level. ➣ Regarding the promotion of the concepts of ‘participatory’ medicine, people need to be advised of reliable information sources that are well adapted to a corresponding level of understanding (categories of children, youth and adults) and concrete interests of subpopulations (level of education, groups of professionals, patient cohorts). In the field of education, laboratory medicine may play a leading role providing up-to-date information that is accessible to the layman on laboratory tests and their interpretation for individual health and disease conditions. A professional version will enable for a detailed knowledge about bioactive molecules, enzymatic reactions, molecular and cellular processes which underlie the pathomechanisms of individual predispositions and pathologies as well as medical treatments. ➣ A creation of innovative medical records should be considered as a priority for scientific programmes of multidisciplinary character. An integrative bioinformatics is considered as the powerful tool to fulfil this highly ambitious task. ➣ Progressing from ‘disease care’ to ‘health care’ means a mandated implementation of a new philosophy of the well-being concept tailored to the person (age, gender, socio-economic status, individual predispositions, patient-specific profile etc.) as a carefully elaborated spectrum of measures for professional care that promotes the mental and physical health of an individual concept. ➣ Considering the sensitive ethical aspects of the laboratory medicine and biobanking, robust information governance of the database and high quality of ethical standards are the prerequisites for the successful implementation of PPPM in health care systems. ➣ Currently, bio-banking is facing major viability challenges. These critical problems may be optimally solved by relevant professional groups with complementary expertise such as the International Federations of Laboratory Medicine, EPMA and ESBB followed by adequate decisions of policymakers resulting in the creation of a robust juristic platform. ➣ Standardisation of health care services in Europe is a strategic issue for policymakers after detailed consultations with health care professionals. ➣ Professional education: we need to develop a new culture among experts in order to promote the multidisciplinary character of predictive, preventive and personalised medicine and concomitantly to advance currently deficient health care services. The innovative PPPM-related educational programmes for professionals should be prioritised in the Common Strategic Framework (also called as the New European Framework Programme Horizon 2020) as well as by other global and topic-relevant national programmes.
To enable consistency of investigation and the establishment of best practice standards, consensus guidelines were formulated previously by the UK National Poisons Information Service and the Association for Clinical Biochemistry. These joint guidelines have now been updated to reflect current best practice. The types of laboratory investigation required for poisoned patients are categorized as either (a) essential common laboratory investigations or (b) specific toxicological assays, and also as either (i) common or (ii) specialist or infrequent. Tests in categories (a) and (bi) should be available 24 hours per day, with a maximum turnaround time of 2 h. For the specialist assays, i.e. category (bii), availability and turnaround times have been specified individually. The basis for selection of these times has been clinical utility. The adoption of these guidelines, along with the use of the National Poisons Information Service (0844 8920111) and its online poisons information resource TOXBASE® ( www.toxbase.org ) enable the poisoned patient to receive appropriate, ‘best practice’ investigations according to their clinical needs and will avoid unnecessary investigations.
The digital age is empowering patients and the paradigm of the patients' relationship with healthcare delivery is changing.If 70% of patient episodes involve laboratory medicine, then the patient's access to this and their understanding of its meaning for them needs to be addressed, a potentially significant task.There is a growing awareness that we should empower patients with better access to their tests and to the necessary information and that in addition to support from their physician that Specialists in Laboratory Medicine can enable this agenda.The potential limitations and problems inherent in this approach are as much to do with boundaries and communication methods as they are to do with the recipient's comprehension, which we would need to understand.
Background: The preanalytical phase represents the major source of variability in laboratory diag-nostics. Our aim was to assess to what extent un-derfi lling of primary blood tubes may impact upon routine coagulation testing. Materials and methods: Blood was drawn by syringe from 21 healthy volunteers and 6 patients on warfarin therapy, and immediately transferred into 3.6 mL vacuum tubes containing 3.2% sodium cit-rate (Terumo Europe N.V., Leuven, Belgium). All tubes were fi lled using standardized volumes of whole blood to produce scalar amounts of fi lling: 3.6 mL (i.e., 100%), 3.2 mL (89%), 2.8 mL (78%) and 2.4 mL (67%). Samples were mixed and centrifuged at 1300 x g for 10 min. The plasma was tested for prothrombin time (PT), activated partial thrombo-plastin time (APTT) and fi brinogen (FBG) on ACL TOP (Instrumentation Laboratory-IL, Milan, Italy), using IL reagents. A polynomial plot was derived for each parameter from interpolation of clotting values obtained with diff erent percentages of fi ll-ing, and these plots were compared with quality specifi cations (± 2.0 for PT, ± 2.3 for APTT and ± 4.8 for FBG) to calculate the minimal fi lling volume required to produce clinically acceptable results. + 422.1 x PF + 147.07 (r = 0.994). According to these equations, the minimum allowed thresholds of blood tubes fi lling were > 61% for PT, > 87% for APTT and > 71% for FBG. Conclusions: Our results confi rm that routine co-agulation testing performed on underfi lled tubes may generate biased and clinically misleading test results. This is particularly critical for APTT, wherein tubes fi lled at less than ~90% generate unreliable data. The FBG and the PT seem more resistant to underfi lling, clinical signifi cant biases being observed only where blood tubes were fi lled at less than ~60 and ~70%, respectively. Background: Coagulation assays performed with photo-optical coagulometers may be aff ected by interfering substances, including lipids. According to the NCCLS guideline clotting parameters in li-pemic specimens should ideally be measured by mechanical or electromechanical methods, which are not always available. Elimination of interference by ultracentrifugation of lipemic plasma samples may aff ect accuracy due to concomitant sedi-mentation of fi brinogen. We aimed to determine the accuracy of fi brinogen measurement in lipemic plasma samples cleared by high-speed centrifuga-tion using an optical measurement procedure. Materials and methods: Twenty-two lipemic plasma samples with triglyceride concentration range of 6.01 to 40.18 mmol/L …
Background: Ingestion of ethylene glycol is a relatively rare event but one with potentially lethal consequences. Early diagnosis and appropriate treatment are essential. However, diagnosis of poisoning can only be confirmed definitively by the measurement of ethylene glycol and/or its metabolites, usually performed by gas chromatographic methods. These methods are complex, requiring specialized equipment and expertise, and are often not available on an emergency basis. Methods: A quick, simple, and inexpensive enzymatic assay has been developed to detect glycolic acid, the major metabolite of ethylene glycol and the main cause of the resulting metabolic acidosis. In this assay, glycolic acid is converted to glyoxylic acid by glycolate oxidase, with the production of hydrogen peroxide, which is converted to a quinoneimine dye for spectrophotometric detection. Results: The assay has a functional sensitivity of 26 mg/L and coefficients of variation less than 13% (interassay) and less than 10% (intra-assay). No significant interference was observed for a range of compounds, and a comparison with a gas chromatography–mass spectrometry method gave clinical sensitivity of 86% and clinical specificity of 92%. Stability of enzyme solutions was increased by the use of an alternative buffer, in which greater than 90% of the original activity was retained after storage at −20°C. Conclusions: As ethylene glycol poisoning is a medical emergency, there is a need for a screening test to minimize delays in diagnosis. The assay we describe is a simple and effective way to detect ethylene glycol poisoning, enabling earlier initiation of appropriate therapy and improving patient outcomes.
In the last few years, there has been a marked increase in the number of scientific publications on biomarker research. According to the NIH RePORT database, of the >14 000 grants for biomarker research funded between 2009 and 2011, >4000 dealt with biomarker discovery and validation (1). A search with “biomarker” in PubMed identified approximately 140 000 publications from the same period. The great interest in biomarkers reflects their clinical utility. Biomarkers are routinely used in the diagnosis, staging, screening, and prediction of risk of disease, for prediction and monitoring of treatment response, and for treatment compliance. Additionally, the search for a biomarker to be used as a surrogate for a clinical end point in clinical trials is of considerable interest, because it has the potential to shorten the trial, thus reducing both cost and the time to get novel therapies to patients. The biomarker pipeline is a long and uncertain road. It involves multiple complex steps and requires the talents of a diverse group of scientists, including analytical and protein chemists, mass spectrometrists, clinical chemists, and clinical investigators. The paradigm starts with a discovery stage and progresses to qualification, verification, and, finally, validation of the candidate biomarker for an intended clinical use (2). The 4 stages differ with respect to types of samples used, the technologies employed, and the patient populations examined, with the emphasis changing from sensitivity to specificity as one proceeds downstream. Typically, various types of mass spectrometers are used in …
The authors consider acute problems in the quality and management of medical services challenging health care systems worldwide. This actuality has motivated the representatives of the European Association for Predictive, Preventive and Personalised Medicine and European Federation of Clinical Chemistry and Laboratory Medicine to consider the efforts in promoting an integrative approach based on multidisciplinary expertise to advance health care. The current paper provides a global overview of the problems related to medical services: pandemic scenario in the progression of common chronic diseases, delayed interventional approaches of reactive medicine, poor economy of health care systems, lack of specialised educational programmes, problematic ethical aspects of treatments as well as inadequate communication among professional groups and policymakers. Further, in the form of individual paragraphs, the article presents a consolidated position of the represented European organisations. This position is focused on the patients' needs, expert recommendations for the relevant medical fields and plausible solutions which have a potential to advance health care services if the long-term strategies were to be effectively implemented as proposed here.
Glucose meters have improved considerably since they were first introduced in 1960, but many questions are being asked about their accuracy and reliability in certain clinical situations. These questions have arisen because of the widespread use of these meters into clinical areas they have not been designed for such as critical care. The lack of understanding by some health professionals on factors that affect glucose results, such as sample type, glucose test strip methodologic limitations, calibration to recognized reference methods, and interferences, leads to misleading results that may affect patient care. Much debate continues on the quality specifications for glucose meters. Because there is an extensive use of these meters in different clinical scenarios, the setting of quality specifications will remain a challenge for regulatory and professional organizations. In this article, we have attempted to collect and provide relevant information addressing the limitations above. Pivotal to obtaining the best quality of results is education, particularly for diabetic patients monitoring their glucose. The International Federation of Clinical Chemistry and Laboratory Medicine through its Point-of-Care Testing Task Force and its Working Group on Glucose Point-of-Care Testing is actively working toward improving the quality of glucose results by improving education and working with the industry to improve strip performance and work toward the better standardization of strips.
Question:who invented the computer?Hint:not Bill Gates or Steve Jobs.Would you be surprised to know that the computer was conceived in Victorian times?The Universal Machine's history is as colorful as the people who created it. They include an aristocratic lady whose talents and lifestyle were quite scandalous at the time, the tragic Alan Turing, whose genius helped win WWII, and a rag-tag bunch of dropouts who not only shaped the PC, but gave birth to the counter-culture that drives Silicon Valley today. To understand the pivotal role that computers play in our lives, you must get to know these people to seehow their innovative thinking changed our lives irrevocably, and made and lost fortunes overnight.This book also tracks some of the more intriguing (if not baffling) developments, from hacking to social networking, and demonstrates how the computer has become central to everything we do.So, take the plunge. Learn how the Analytical Engine became a Universal Machine, and shrank from a monster that required a room of its own, to something that fits into your pocket and one day soon will be part of you.