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PubMed | Aotea Pathology, St Vincents Hospital, Sonic Healthcare, Royal Brisbane and Womens Hospital and 8 more.
Type: Journal Article | Journal: The Clinical biochemist. Reviews | Year: 2015

Harmonisation of reference intervals for routine general chemistry analytes has been a goal for many years. Analytical bias may prevent this harmonisation. To determine if analytical bias is present when comparing methods, the use of commutable samples, or samples that have the same properties as the clinical samples routinely analysed, should be used as reference samples to eliminate the possibility of matrix effect. The use of commutable samples has improved the identification of unacceptable analytical performance in the Netherlands and Spain. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has undertaken a pilot study using commutable samples in an attempt to determine not only country specific reference intervals but to make them comparable between countries. Australia and New Zealand, through the Australasian Association of Clinical Biochemists (AACB), have also undertaken an assessment of analytical bias using commutable samples and determined that of the 27 general chemistry analytes studied, 19 showed sufficiently small between method biases as to not prevent harmonisation of reference intervals. Application of evidence based approaches including the determination of analytical bias using commutable material is necessary when seeking to harmonise reference intervals.


Horvath A.R.,University of New South Wales | Horvath A.R.,University of Sydney | Lord S.J.,University of Sydney | Lord S.J.,The University of Notre Dame Australia | And 8 more authors.
Clinica Chimica Acta | Year: 2014

Regulators and healthcare payers are increasingly demanding evidence that biomarkers deliver patient benefits to justify their use in clinical practice. Laboratory professionals need to be familiar with these evidence requirements to better engage in biomarker research and decisions about their appropriate use.This paper by a multidisciplinary group of the European Federation of Clinical Chemistry and Laboratory Medicine describes the pathway of a laboratory assay measuring a biomarker to becoming a medically useful test. We define the key terms, principles and components of the test evaluation process. Unlike previously described linearly staged models, we illustrate how the essential components of analytical and clinical performances, clinical and cost-effectiveness and the broader impact of testing assemble in a dynamic cycle. We highlight the importance of defining clinical goals and how the intended application of the biomarker in the clinical pathway should drive each component of test evaluation. This approach emphasizes the interaction of the different components, and that clinical effectiveness data should be fed back to refine analytical and clinical performances to achieve improved outcomes.The framework aims to support the understanding of key stakeholders. The laboratory profession needs to strengthen collaboration with industry and experts in evidence-based medicine, regulatory bodies and policy makers for better decisions about the use of new and existing medical tests. © 2013 Elsevier B.V.


Price C.P.,University of Oxford | John A.S.,ARC Consulting | Christenson R.,University of Maryland, Baltimore | Scharnhorst V.,TU Eindhoven | And 3 more authors.
Clinica Chimica Acta | Year: 2016

Improving quality and patient safety, containing costs and delivering value-for-money are the key drivers of change in the delivery of healthcare and have stimulated a shift from an activity-based service to a service based on patient-outcomes. The delivery of an outcomes-based healthcare agenda requires that the real value of laboratory medicine to all stakeholders be understood, effectively defined and communicated. The value proposition of any product or service is the link between the provider and the needs of the customer describing the utility of the product or service in terms of benefit to the customer. The framework of a value proposition for laboratory medicine provides the core business case that drives key activities in the evolution and maintenance of high quality healthcare from research through to adoption and quality improvement in an established service. The framework of a value proposition for laboratory medicine is described. The content is endorsed by IFCC and WASPaLM. © 2016 Elsevier B.V.


PubMed | University of Maryland, Baltimore, TU Eindhoven, University of South Australia, ARC Consulting and 3 more.
Type: | Journal: Clinica chimica acta; international journal of clinical chemistry | Year: 2016

Improving quality and patient safety, containing costs and delivering value-for-money are the key drivers of change in the delivery of healthcare and have stimulated a shift from an activity-based service to a service based on patient-outcomes. The delivery of an outcomes-based healthcare agenda requires that the real value of laboratory medicine to all stakeholders be understood, effectively defined and communicated. The value proposition of any product or service is the link between the provider and the needs of the customer describing the utility of the product or service in terms of benefit to the customer. The framework of a value proposition for laboratory medicine provides the core business case that drives key activities in the evolution and maintenance of high quality healthcare from research through to adoption and quality improvement in an established service. The framework of a value proposition for laboratory medicine is described. The content is endorsed by IFCC and WASPaLM.


Price C.P.,University of Oxford | St John A.,ARC Consulting
Clinica Chimica Acta | Year: 2014

Value is now becoming a key driver in the ongoing development of healthcare delivery; key facets include the identification of what is valuable and how that value can be identified, leveraged, and delivered. The concept of a value proposition is widely used in business but can be used in healthcare as a statement of the benefits, costs and value that an organization can deliver to its customers. The foundation of this statement in laboratory medicine is evidence of clinical and cost effectiveness, not only for the patient, but also for other stakeholders involved in the delivery of healthcare, e.g., the carer, service provider, commissioner, purchaser, and the supplier of the test or device, as well as society as a whole. However the value of any laboratory medicine investigation is only achieved if the output (the test result(s)), is acted upon by the initiator of the investigation. Laboratory medicine is one part of a complex intervention, and so the value proposition should encompass the breadth of that intervention - from addressing the unmet need through the generation of clinical, operational and economic outcomes. A value proposition in laboratory medicine is central to successful innovation and quality improvement in healthcare. © 2014 Elsevier B.V.


Price C.P.,University of Oxford | St. John A.,ARC Consulting
Clinica Chimica Acta | Year: 2014

The delivery of healthcare is the product of a complex organization and it is not entirely surprising that innovation is not always considered to deliver on the expectations generated by invention. As policymakers and payers seek to improve the quality and value-for-money of healthcare, more attention is being directed at the barriers to innovation, and the challenges of translating inventions into outcomes. Laboratory medicine is one facet of healthcare that has generated considerable levels of invention but, while showing increasing volumes of activity over the past decades, it has not been recognized for generating the benefit in outcomes that might have been expected. One of the major reasons for this position has been the poor quality of evidence available to demonstrate the impact of laboratory investigations on health outcomes. Consequently an absence of evidence stifles the opportunity to develop the business case that demonstrates the link between test result and improved outcome. This has a major influence on the success of innovation in laboratory medicine. This review explores the process of innovation applied to laboratory medicine and offers an insight into how the impact of laboratory medicine on health outcomes can be improved.© 2013 Elsevier B.V.


Dimeski G.,Princess Alexandra Hospital | Badrick T.,Sullivan Nicolaides Pathology | John A.S.,ARC Consulting
Clinica Chimica Acta | Year: 2010

Ion Selective Electrodes (ISEs) are used to measure some of the most critical analytes on clinical laboratory and point-of-care analysers. These analytes which include Na+, K+, Cl-, Ca2+, Mg2+ and Li+ are used for rapid patient care decisions. Although the electrodes are very selective, they are not free of interferences. It is important for laboratories to have an understanding of the type and extent of interferences in order to avoid incorrect clinical decisions and treatment. © 2009 Elsevier B.V. All rights reserved.


John A.S.,ARC Consulting | Price C.P.,University of Oxford
Clinical Biochemist Reviews | Year: 2013

Health economics has been an established feature of the research, policymaking, practice and management in the delivery of healthcare. However its role is increasing as the cost of healthcare begins to drive changes in most healthcare systems. Thus the output from cost effectiveness studies is now being taken into account when making reimbursement decisions, e.g. in Australia and the United Kingdom. Against this background it is also recognised that the health economic tools employed in healthcare, and particularly the output from the use of these tools however, are not always employed in the routine delivery of services. One of the notable consequences of this situation is the poor record of innovation in healthcare with respect to the adoption of new technologies, and the realisation of their benefits. The evidence base for the effectiveness of diagnostic services is well known to be limited, and one consequence of this has been a very limited literature on cost effectiveness. One reason for this situation is undoubtedly the reimbursement strategies employed in laboratory medicine for many years, simplistically based on the complexity of the test procedure, and the delivery as a cost-per-test service. This has proved a disincentive to generate the required evidence, and little effort to generate an integrated investment and disinvestment business case, associated with care pathway changes. Point-of-care testing creates a particularly challenging scenario because, on the one hand, the unit cost-per-test is larger through the loss of the economy of scale offered by automation, whilst it offers the potential of substantial savings through enabling rapid delivery of results, and reduction of facility costs. This is important when many health systems are planning for complete system redesign. We review the literature on economic assessment of point-of-care testing in the context of these developments.


St John A.,ARC Consulting | Davis W.A.,University of Western Australia | Price C.P.,University of Oxford | Davis T.M.E.,University of Western Australia
Journal of Diabetes and its Complications | Year: 2010

Aims: To review the recent literature relating to the role of self-monitoring of blood glucose (SMBG) and glycemic control. Methods: Medline and EMBASE databases were searched between 1996 and June 2008 using terms that included diabetes mellitus, self-care, and blood glucose self monitoring. Both experimental and nonexperimental studies with HbA1c as an outcome measure were included. A meta-analysis was performed on randomized controlled trials (RCTs) in type 2 diabetes which met the inclusion criteria. Results: From 1102 relevant papers, 34 original containing 38 separate studies were identified as being published between 2000 and June 2008. There were 23 studies of type 2 diabetes and, of these, 13 were nonexperimental and 10 experimental, including six RCTs. The results of five of these RCTs in non-insulin-treated type 2 diabetic patients were combined in a meta-analysis with two earlier RCTs which yielded a significant pooled SMBG-related decrease in HbA1c of -0.22 (95% CI -0.34% to -0.11%). Conclusions: The present meta-analysis showed an SMBG-related HbA1c reduction in non-insulin-treated type 2 diabetes patients that was similar to that in previous systematic reviews but in a substantially larger patient sample. This finding is consistent with most observational studies of similarly treated patients. © 2010 Elsevier Inc.


PubMed | University of Oxford and ARC Consulting
Type: Journal Article | Journal: The Clinical biochemist. Reviews | Year: 2014

The volume of point-of-care testing (PoCT) has steadily increased over the 40 or so years since its widespread introduction. That growth is likely to continue, driven by changes in healthcare delivery which are aimed at delivering less costly care closer to the patients home. In the developing world there is the challenge of more effective care for infectious diseases and PoCT may play a much greater role here in the future. PoCT technologies can be split into two categories, but in both, testing is generally performed by technologies first devised more than two decades ago. These technologies have undoubtedly been refined and improved to deliver easier-to-use devices with incremental improvements in analytical performance. Of the two major categories the first is small handheld devices, providing qualitative or quantitative determination of an increasing range of analytes. The dominant technologies here are glucose biosensor strips and lateral flow strips using immobilised antibodies to determine a range of parameters including cardiac markers and infectious pathogens. The second category of devices are larger, often bench-top devices which are essentially laboratory instruments which have been reduced in both size and complexity. These include critical care analysers and, more recently, small haematology and immunology analysers. New emerging devices include those that are utilising molecular techniques such as PCR to provide infectious disease testing in a sufficiently small device to be used at the point of care. This area is likely to grow with many devices being developed and likely to reach the commercial market in the next few years.

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