Phillip J Monaghan1, Sarah J Lord2, Andrew St John3, Sverre Sandberg4, Christa M Cobbaert5, Lieselotte Lennartz6, Wilma D J Verhagen-Kamerbeek7, Christoph Ebert8, Patrick M M Bossuyt9, Andrea R Horvath10. 1. Department of Clinical Biochemistry, The Christie Pathology Partnership, The Christie NHS Foundation Trust, Manchester, UK. Electronic address: phillip.monaghan@nhs.net. 2. School of Medicine, University of Notre Dame, Australia; National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Australia. 3. ARC Consulting, Perth, Australia. 4. The Norwegian Quality Improvement of Primary Care Laboratories (NOKLUS), Haraldsplass Deaconess Hospital, Bergen, Norway; Department of Public Health and Primary Health Care, University of Bergen, Norway; Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway. 5. Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, The Netherlands. 6. Abbott Diagnostics, Wiesbaden, Germany. 7. Medical and Scientific Affairs, Roche Diagnostics International Ltd., Rotkreuz, Switzerland. 8. Medical and Scientific Affairs, Roche Diagnostics GmbH, Penzberg, Germany. 9. Department of Clinical Epidemiology, Biostatistics & Bioinformatics, Academic Medical Center, University of Amsterdam, The Netherlands. 10. SEALS Department of Clinical Chemistry and Endocrinology, Prince of Wales Hospital and School of Medical Sciences, University of New South Wales, Australia; Screening and Test Evaluation Program, School of Public Health, University of Sydney, Australia.
Abstract
BACKGROUND: The introduction of new biomarkers can lead to inappropriate utilization of tests if they do not fill in existing gaps in clinical care. We aimed to define a strategy and checklist for identifying unmet needs for biomarkers. METHODS: A multidisciplinary working group used a 4-step process: 1/ scoping literature review; 2/ face-to-face meetings to discuss scope, strategy and checklist items; 3/ iterative process of feedback and consensus to develop the checklist; 4/ testing and refinement of checklist items using case scenarios. RESULTS: We used clinical pathway mapping to identify clinical management decisions linking biomarker testing to health outcomes and developed a 14-item checklist organized into 4 domains: 1/ identifying and 2/ verifying the unmet need; 3/ validating the intended use; and 4/ assessing the feasibility of the new biomarker to influence clinical practice and health outcome. We present an outcome-focused approach that can be used by multiple stakeholders for any medical test, irrespective of the purpose and role of testing. CONCLUSIONS: The checklist intends to achieve more efficient biomarker development and translation into practice. We propose the checklist is field tested by stakeholders, and advocate the role of the clinical laboratory professional to foster trans-sector collaboration in this regard.
BACKGROUND: The introduction of new biomarkers can lead to inappropriate utilization of tests if they do not fill in existing gaps in clinical care. We aimed to define a strategy and checklist for identifying unmet needs for biomarkers. METHODS: A multidisciplinary working group used a 4-step process: 1/ scoping literature review; 2/ face-to-face meetings to discuss scope, strategy and checklist items; 3/ iterative process of feedback and consensus to develop the checklist; 4/ testing and refinement of checklist items using case scenarios. RESULTS: We used clinical pathway mapping to identify clinical management decisions linking biomarker testing to health outcomes and developed a 14-item checklist organized into 4 domains: 1/ identifying and 2/ verifying the unmet need; 3/ validating the intended use; and 4/ assessing the feasibility of the new biomarker to influence clinical practice and health outcome. We present an outcome-focused approach that can be used by multiple stakeholders for any medical test, irrespective of the purpose and role of testing. CONCLUSIONS: The checklist intends to achieve more efficient biomarker development and translation into practice. We propose the checklist is field tested by stakeholders, and advocate the role of the clinical laboratory professional to foster trans-sector collaboration in this regard.
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Authors: Paola Cocco; Anam Ayaz-Shah; Michael Paul Messenger; Robert Michael West; Bethany Shinkins Journal: BMC Med Date: 2020-05-11 Impact factor: 8.775
Authors: Phillip J Monaghan; Sarah Robinson; Daniel Rajdl; Patrick M M Bossuyt; Sverre Sandberg; Andrew St John; Maurice O'Kane; Lieselotte Lennartz; Ralf Röddiger; Sarah J Lord; Christa M Cobbaert; Andrea R Horvath Journal: EJIFCC Date: 2018-07-11
Authors: Christa M Cobbaert; Figen Arslan; Imma Caballé Martín; Antoni Alsius Serra; Ester Picó-Plana; Víctor Sánchez-Margalet; Antonio Carmona-Fernández; John Burden; André Ziegler; Walter Bechel Journal: Pract Lab Med Date: 2019-09-19
Authors: Mathijs C Bodde; Maaike P J Hermans; Arnoud van der Laarse; Bart Mertens; Fred P H T M Romijn; Martin J Schalij; Christa M Cobbaert; J Wouter Jukema Journal: Cardiol Ther Date: 2019-01-30