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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. Source

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. Source

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. Source

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. Source

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. Source

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