Outcome-based analytical performance specifications: current status and future challenges

doi:10.1515/cclm-2024-0125

Review

. 2024 Jun 6;62(8):1474-1482.

doi: 10.1515/cclm-2024-0125. Print 2024 Jul 26.

Outcome-based analytical performance specifications: current status and future challenges

Affiliations

¹ Department of Chemical Pathology, 441551 New South Wales Health Pathology, Prince of Wales Hospital , Sydney, Australia.
² School of Public Health, University of Sydney, Sydney, Australia.
³ Faculty of Medicine, University of New South Wales, Sydney, Australia.
⁴ Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
⁵ Clinical Laboratory, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
⁶ Department of Chemical Pathology, SydPath, St Vincent's Hospital, Darlinghurst, NSW, Australia.
⁷ Department of Laboratory Medicine, National University Hospital, Singapore, Singapore.
⁸ School of Medicine, University of Notre Dame, Darlinghurst, New South Wales, Australia.
⁹ NHMRC Clinical Trials Centre, The University of Sydney, Camperdown, New South Wales, Australia.
¹⁰ Norwegian Organization for Quality Improvement of Laboratory Examinations (NOKLUS), Haraldsplass Deaconess Hospital, Bergen, Norway.
¹¹ Norwegian Porphyria Centre, Department of Medical Biochemistry and Pharmacology, Haukeland University Hospital, Bergen, Norway.
¹² Institute of Public Health and Primary Health Care, University of Bergen, Bergen, Norway.

PMID: 38836433
DOI: 10.1515/cclm-2024-0125

Free article

Review

Outcome-based analytical performance specifications: current status and future challenges

Andrea Rita Horvath et al. Clin Chem Lab Med. 2024.

Free article

. 2024 Jun 6;62(8):1474-1482.

doi: 10.1515/cclm-2024-0125. Print 2024 Jul 26.

Affiliations

¹ Department of Chemical Pathology, 441551 New South Wales Health Pathology, Prince of Wales Hospital , Sydney, Australia.
² School of Public Health, University of Sydney, Sydney, Australia.
³ Faculty of Medicine, University of New South Wales, Sydney, Australia.
⁴ Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
⁵ Clinical Laboratory, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
⁶ Department of Chemical Pathology, SydPath, St Vincent's Hospital, Darlinghurst, NSW, Australia.
⁷ Department of Laboratory Medicine, National University Hospital, Singapore, Singapore.
⁸ School of Medicine, University of Notre Dame, Darlinghurst, New South Wales, Australia.
⁹ NHMRC Clinical Trials Centre, The University of Sydney, Camperdown, New South Wales, Australia.
¹⁰ Norwegian Organization for Quality Improvement of Laboratory Examinations (NOKLUS), Haraldsplass Deaconess Hospital, Bergen, Norway.
¹¹ Norwegian Porphyria Centre, Department of Medical Biochemistry and Pharmacology, Haukeland University Hospital, Bergen, Norway.
¹² Institute of Public Health and Primary Health Care, University of Bergen, Bergen, Norway.

PMID: 38836433
DOI: 10.1515/cclm-2024-0125

Abstract

Analytical performance specifications (APS) based on outcomes refer to how 'good' the analytical performance of a test needs to be to do more good than harm to the patient. Analytical performance of a measurand affects its clinical performance. Without first setting clinical performance requirements, it is difficult to define how good analytically the test needs to be to meet medical needs. As testing is indirectly linked to health outcomes through clinical decisions on patient management, often simulation-based studies are used to assess the impact of analytical performance on the probability of clinical outcomes which is then translated to Model 1b APS according to the Milan consensus. This paper discusses the related key definitions, concepts and considerations that should assist in finding the most appropriate methods for deriving Model 1b APS. We review the advantages and limitations of published methods and discuss the criteria for transferability of Model 1b APS to different settings. We consider that the definition of the clinically acceptable misclassification rate is central to Model 1b APS. We provide some examples and guidance on a more systematic approach for first defining the clinical performance requirements for tests and we also highlight a few ideas to tackle the future challenges associated with providing outcome-based APS for laboratory testing.

Keywords: analytical performance; clinical performance; laboratory test; outcomes.

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References

1. Sandberg, S, Fraser, CG, Horvath, AR, Jansen, R, Jones, G, Oosterhuis, W, et al.. Defining analytical performance specifications: consensus statement from the 1st strategic conference of the European federation of clinical chemistry and laboratory medicine. Clin Chem Lab Med 2015;53:833–5. https://doi.org/10.1515/cclm-2015-0067 . - DOI
1. Staub, LP, Lord, SJ, Simes, RJ, Dyer, S, Houssami, N, Chen, RYM, et al.. Using patient management as a surrogate for patient health outcomes in diagnostic test evaluation. BMC Med Res Methodol 2012;12:12. https://doi.org/10.1186/1471-2288-12-12 . - DOI
1. di Ruffano, FL, Hyde, C, McCaffery, KJ, Bossuyt, PM, Deeks, JJ. Assessing the value of diagnostic tests: a framework for designing and evaluating trials. Br Med J 2012;344:e686. https://doi.org/10.1136/bmj.e686 . - DOI
1. Horvath, AR, Bossuyt, PMM, Sandberg, S, StJohn, A, Monaghan, PJ, Verhagen-Kamerbeek, WDJ, et al.. For the test evaluation working group of the European federation of clinical chemistry and laboratory medicine setting analytical performance specifications based on outcome studies – is it possible? Clin Chem Lab Med 2015;53:841–8. https://doi.org/10.1515/cclm-2015-0214 . - DOI
1. Lord, SJ, StJohn, A, Bossuyt, PMM, Sandberg, S, Monaghan, PJ, O’Kane, M, et al.. For the test evaluation working group of the European federation of clinical chemistry and laboratory medicine. Setting clinical performance specifications to develop and evaluate biomarkers for clinical use. Ann Clin Biochem 2019;56:527–35. https://doi.org/10.1177/0004563219842265 . - DOI

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[1] Sandberg, S, Fraser, CG, Horvath, AR, Jansen, R, Jones, G, Oosterhuis, W, et al.. Defining analytical performance specifications: consensus statement from the 1st strategic conference of the European federation of clinical chemistry and laboratory medicine. Clin Chem Lab Med 2015;53:833–5. https://doi.org/10.1515/cclm-2015-0067 . - DOI

[2] Sandberg, S, Fraser, CG, Horvath, AR, Jansen, R, Jones, G, Oosterhuis, W, et al.. Defining analytical performance specifications: consensus statement from the 1st strategic conference of the European federation of clinical chemistry and laboratory medicine. Clin Chem Lab Med 2015;53:833–5. https://doi.org/10.1515/cclm-2015-0067 . - DOI

[3] Staub, LP, Lord, SJ, Simes, RJ, Dyer, S, Houssami, N, Chen, RYM, et al.. Using patient management as a surrogate for patient health outcomes in diagnostic test evaluation. BMC Med Res Methodol 2012;12:12. https://doi.org/10.1186/1471-2288-12-12 . - DOI

[4] Staub, LP, Lord, SJ, Simes, RJ, Dyer, S, Houssami, N, Chen, RYM, et al.. Using patient management as a surrogate for patient health outcomes in diagnostic test evaluation. BMC Med Res Methodol 2012;12:12. https://doi.org/10.1186/1471-2288-12-12 . - DOI

[5] di Ruffano, FL, Hyde, C, McCaffery, KJ, Bossuyt, PM, Deeks, JJ. Assessing the value of diagnostic tests: a framework for designing and evaluating trials. Br Med J 2012;344:e686. https://doi.org/10.1136/bmj.e686 . - DOI

[6] di Ruffano, FL, Hyde, C, McCaffery, KJ, Bossuyt, PM, Deeks, JJ. Assessing the value of diagnostic tests: a framework for designing and evaluating trials. Br Med J 2012;344:e686. https://doi.org/10.1136/bmj.e686 . - DOI

[7] Horvath, AR, Bossuyt, PMM, Sandberg, S, StJohn, A, Monaghan, PJ, Verhagen-Kamerbeek, WDJ, et al.. For the test evaluation working group of the European federation of clinical chemistry and laboratory medicine setting analytical performance specifications based on outcome studies – is it possible? Clin Chem Lab Med 2015;53:841–8. https://doi.org/10.1515/cclm-2015-0214 . - DOI

[8] Horvath, AR, Bossuyt, PMM, Sandberg, S, StJohn, A, Monaghan, PJ, Verhagen-Kamerbeek, WDJ, et al.. For the test evaluation working group of the European federation of clinical chemistry and laboratory medicine setting analytical performance specifications based on outcome studies – is it possible? Clin Chem Lab Med 2015;53:841–8. https://doi.org/10.1515/cclm-2015-0214 . - DOI

[9] Lord, SJ, StJohn, A, Bossuyt, PMM, Sandberg, S, Monaghan, PJ, O’Kane, M, et al.. For the test evaluation working group of the European federation of clinical chemistry and laboratory medicine. Setting clinical performance specifications to develop and evaluate biomarkers for clinical use. Ann Clin Biochem 2019;56:527–35. https://doi.org/10.1177/0004563219842265 . - DOI

[10] Lord, SJ, StJohn, A, Bossuyt, PMM, Sandberg, S, Monaghan, PJ, O’Kane, M, et al.. For the test evaluation working group of the European federation of clinical chemistry and laboratory medicine. Setting clinical performance specifications to develop and evaluate biomarkers for clinical use. Ann Clin Biochem 2019;56:527–35. https://doi.org/10.1177/0004563219842265 . - DOI

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Outcome-based analytical performance specifications: current status and future challenges

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Outcome-based analytical performance specifications: current status and future challenges

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Abstract

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