The Value of Diagnostic Information in Personalised Healthcare: A Comprehensive Concept to Facilitate Bringing This Technology into Healthcare Systems

Wurcel, Victoria; Cicchetti, Americo; Garrison, Louis P.; Kip, Michelle M.A.; Koffijberg, Hendrik; Kolbe, Anne; Leeflang, Mariska; Merlin, Tracy; Mestre-Ferrandiz, J.; Oortwijn, Wija; Oosterwijk, Cor; Tunis, Sean; Zamora, Bernarda

doi:10.1159/000501832

Cited by 57 publications

(44 citation statements)

References 12 publications

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“…Pharmacists perceived that a multidisciplinary team of physician, pharmacist and genetic counsellor may be the best approach to tackle pharmacogenomic communication in the light of the current scene of the lack of knowledge, workload and shortage of personal [ 33 ].…”

Section: Discussionmentioning

confidence: 99%

Genomics and Pharmacogenomics Knowledge, Attitude and Practice of Pharmacists Working in United Arab Emirates: Findings from Focus Group Discussions—A Qualitative Study

Rahma

Elbarazi

Ali

et al. 2020

JPM

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(1) Background: Genomics and pharmacogenomics are relatively new fields in medicine in the United Arab Emirates (UAE). Understanding the knowledge, attitudes and current practices among pharmacists is an important pillar to establish the roadmap for implementing genomic medicine and pharmacogenomics; (2) Methods: A qualitative method was used, with focus group discussions (FGDs) being conducted among pharmacists working in public and private hospitals in Abu Dhabi Emirate. Snowball sampling was used. Thematic inductive analysis was performed by two researchers independently. NVIVO software was used to establish the themes; (3) Results: Lack of knowledge of genomics and pharmacogenomics among pharmacists was one of the most prominent findings. Therefore, the role of pharmacist in making the right decisions was highlighted to be a barrier for pharmacogenomics implementation in the UAE. Pharmacists have a positive attitude toward pharmacogenomics, but they are preoccupied with concern of confidentiality. In addition, religion and culture shadowed their attitudes toward genetic testing; (4) Conclusions: It is highly recommended to introduce new courses and training workshops for healthcare providers to improve the opportunities for genomics and pharmacogenomics application in the UAE. Pharmacists agreed that the health authorities should take the lead for improving trust and confidence in the system for a better future in the era of genomics and pharmacogenomics.

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Section: Discussionmentioning

confidence: 99%

Genomics and Pharmacogenomics Knowledge, Attitude and Practice of Pharmacists Working in United Arab Emirates: Findings from Focus Group Discussions—A Qualitative Study

Rahma

Elbarazi

Ali

et al. 2020

JPM

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“…Although the stakeholders will focus on different value propositions, they are, to use a sporting metaphor, all in the same game, and therefore each has an interest in the others' priorities-assuming decision-making is well informed and rational. To ensure they have not overlooked a health value potentially provided by their device, manufacturers may find it helpful to consult the frameworks developed by Ferrante di Ruffano and Wurcel and their colleagues [9,10].…”

Section: Articulating Value Propositionsmentioning

confidence: 99%

How to Ease the Pain of Taking a Diagnostic Point of Care Test to the Market: A Framework for Evidence Development

et al. 2020

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Bringing a diagnostic point of care test (POCT) to a healthcare market can be a painful experience as it requires the manufacturer to meet considerable technical, financial, managerial, and regulatory challenges. In this opinion article we propose a framework for developing the evidence needed to support product development, marketing, and adoption. We discuss each step in the evidence development pathway from the invention phase to the implementation of a new POCT in the healthcare system. We highlight the importance of articulating the value propositions and documenting the care pathway. We provide guidance on how to conduct care pathway analysis as little has been published on this. We summarize the clinical, economic and qualitative studies to be considered for developing evidence, and provide useful links to relevant software, on-line applications, websites, and give practical advice. We also provide advice on patient and public involvement and engagement (PPIE), and on product management. Our aim is to help device manufacturers to understand the concepts and terminology used in evaluation of in vitro diagnostics (IVDs) so that they can communicate effectively with evaluation methodologists, statisticians, and health economists. Manufacturers of medical tests and devices can use the proposed framework to plan their evidence development strategy in alignment with device development, applications for regulatory approval, and publication.

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“…The initial and immediate need is for a framework that provides a minimum level of biomarker provision across Europe -an "essential package" on the testing that needs to be offered to all EU patients for diagnosis and prevention over the next 5 years, detailing the type, the technique and the methods of implementation, and ensuring access to high-quality [3,10]. Figure 8 offers a schematic summary of what a minimum service in biomarker testing might bring -and of the steps that would be necessary to achieve it.…”

Section: Minimum Testingmentioning

confidence: 99%

Bringing Greater Accuracy to Europe’s Healthcare Systems: The Unexploited Potential of Biomarker Testing in Oncology

Horgan¹,

Ciliberto²,

Conté³

et al. 2020

Biomed Hub

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Rapid and continuing advances in biomarker testing are not being matched by take-up in health systems, and this is hampering both patient care and innovation. It also risks costing health systems the opportunity to make their services more efficient and, over time, more economical. This paper sets out the potential of biomarker testing, the unfolding precision and range of possible diagnosis and prediction, and the many obstacles to adoption. It offers case studies of biomarker testing in breast, ovarian, prostate, lung, thyroid and colon cancers, and derives specific lessons as to the potential and actual use of each of them. It also draws lessons about how to improve access and alignment, and to remedy the data deficiencies that impede development. And it suggests solutions to outstanding issues – notably including funding and the tangled web of obtaining reimbursement or equivalent coverage that Europe’s fragmented health system implies. It urges a European evolution towards an initial minimum testing scenario, which would guarantee universal access to a suite of biomarker tests for the currently most common conditions, and, further into the future, to an optimum testing scenario in which a much wider range of biomarker tests would be introduced and become part of a more sophisticated health system articulated around personalised medicine. For exploiting genomics to the full, it argues the need for a new policy framework for Europe. Biomarker testing is not an issue that can be treated in isolation, since the purpose of testing is to improve health. Its use is therefore always closely linked to specific health challenges and needs to be viewed in the broader policy context in the EU and more widely. The paper is the result of extensive engagement with experts and decision makers to develop the framework, and consequently represents a wide consensus of views on how healthcare systems should respond from push and pull factors at local, national and cross-border and EU level. It contains strong views and clear recommendations springing from the convictions of patients, clinicians, academics, medicines authorities, HTA bodies, payers, the diagnostic, pharmaceutical and ICT industries, and national policy makers.

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The Value of Diagnostic Information in Personalised Healthcare: A Comprehensive Concept to Facilitate Bringing This Technology into Healthcare Systems

Cited by 57 publications

References 12 publications

Genomics and Pharmacogenomics Knowledge, Attitude and Practice of Pharmacists Working in United Arab Emirates: Findings from Focus Group Discussions—A Qualitative Study

Genomics and Pharmacogenomics Knowledge, Attitude and Practice of Pharmacists Working in United Arab Emirates: Findings from Focus Group Discussions—A Qualitative Study

How to Ease the Pain of Taking a Diagnostic Point of Care Test to the Market: A Framework for Evidence Development

Bringing Greater Accuracy to Europe’s Healthcare Systems: The Unexploited Potential of Biomarker Testing in Oncology

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