Setting analytical performance specifications based on outcome studies - Is it possible?

Clinical Chemistry and Laboratory Medicine

Volumn 53, Issue 6, 2015, Pages 841-848

  Horvath, Andrea Rita ^a,b   Bossuyt, Patrick M M ^c   Sandberg, Sverre ^d,e   John, Andrew St ^f   Monaghan, Phillip J ^g   Verhagen Kamerbeek, Wilma D J ^h   Lennartz, Lieselotte ⁱ   Cobbaert, Christa M ^j   Ebert, Christoph ^k   Lord, Sarah J ^l,m  

^a PRINCE OF WALES HOSPITAL   (Australia)

^b UNIVERSITY OF SYDNEY   (Australia)

^c UNIVERSITY OF AMSTERDAM   (Netherlands)

^d HAUKELAND UNIVERSITY HOSPITAL   (Norway)

^e UNIVERSITY OF BERGEN   (Norway)

^f Australian Government Australian Research Council   (Australia)

^g CHRISTIE HOSPITAL   (United Kingdom)

^h Roche Diagnostics Ltd   (Switzerland)

ⁱ ABBOTT GMBH AND CO KG   (Germany)

^j LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^k ROCHE DIAGNOSTICS GMBH   (Germany)

^l UNIVERSITY OF NOTRE DAME   (Australia)

^m UNIVERSITY OF SYDNEY   (Australia)

more..

Author keywords

analytical performance; clinical effectiveness; evidence based laboratory medicine; outcome

Indexed keywords

ANALYTICAL PERFORMANCE SPECIFICATION; ANALYTICAL RESEARCH; CLINICAL CLASSIFICATION; CLINICAL EFFECTIVENESS; CLINICAL PATHWAY; CONFERENCE PAPER; COST EFFECTIVENESS ANALYSIS; HEALTH CARE COST; HUMAN; LABORATORY TEST; MEDICAL SOCIETY; META ANALYSIS (TOPIC); OUTCOME ASSESSMENT; PERFORMANCE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); CLASSIFICATION; CONSENSUS; EVIDENCE BASED MEDICINE; HEALTH CARE QUALITY;

CLINICAL LABORATORY TECHNIQUES; CONSENSUS; EVIDENCE-BASED MEDICINE; QUALITY ASSURANCE, HEALTH CARE;

EID: 84929075789     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/cclm-2015-0214     Document Type: Conference Paper

References (21)

1. Fraser CG, Kallner A, Kenny D, Petersen PH. Introduction: strategies to set global quality specifications in laboratory medicine. Scand J Clin Lab Invest 1999;59:477-8.
2. Fraser CG, Hyltoft Petersen P. Analytical performance characteristics should be judged against objective quality specifications. Clin Chem 1999;45:321-3.
3. Horvath AR, Lord SJ, St John A, Sandberg S, Cobbaert CM, Lorenz S, et al. For the Test Evaluation Working Group of the European Federation of Clinical Chemistry Laboratory Medicine. From biomarkers to medical tests: the changing landscape of test evaluation. Clin Chim Acta 2014;427:49-57.
4. Bossuyt PM, McCaffery K. Additional patient outcomes and pathways in evaluations of testing. Med Decis Making 2009;29:E30-8.
5. Ferrante di Ruffano L, 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.
6. Ferrante di Ruffano L, Davenport C, Eising A, Hyde C, Deeks J. A capture-recapture analysis demonstrated that randomized controlled trials evaluating the impact of diagnostic tests on patient outcomes are rare. J Clin Epidemiol 2012;65:282-7.
7. Merlin T. The use of the 'linked evidence approach' to guide policy on the reimbursement of personalized medicines. Pers Med 2014;11:435-48.
8. Eddington H, Hudson JE, Oliver RL, Fraser WD, Hutchison AJ, Kalra PA. Variability in parathyroid hormone assays confounds clinical practice in chronic kidney disease patients. Ann Clin Biochem 2014;51:228-36.
9. Beko G, Butz H, Berta K, Tisler A, Olajos F, Vasarhelyi B, et al. Switching between parathormone (PTH) assays: the impact on the diagnosis of renal osteodystrophy. Clin Chem Lab Med 2013;51:1251-6.
10. Christensen TD. Self-management of oral anticoagulation therapy-methodological and clinical aspects. Dan Med Bull 2011;58:B4284.
11. Garcia-Alamino JM, Ward AM, Alonso-Coello P, Perera R, Bankhead C, Fitzmaurice D, et al. Self-monitoring and self-management of oral anticoagulation. Cochrane Database Syst Rev 2010:CD003839. doi:10.1002/14651858.CD003839.pub2.
12. Werner M. Linking analytic performance goals to medical outcome. Clin Chim Acta 1997;260:99-115.
13. St. John A, Price CP. Measures of outcome. In: Price CP, Christenson RH, editors. Evidence-based laboratory medicine. From principles to outcomes. Washington: AACC Press, 2003:55-74.
14. Bissell MG. Introduction: what's in a laboratory outcome? In: Bissell MG, editor. Laboratory-related measures of patient outcomes: an introduction. Washington DC; AACC, 2000:3-10.
15. Trikalinos TA, Siebert U, Lau J. Decision-analytic modeling to evaluate benefits and harms of medical tests: uses and limitations. Med Decis Making 2009;29:E22-9.
16. Botkin JR, Teutsch SM, Kaye CI, Hayes M, Haddow JE, Bradley LA, et al. Outcomes of interest in evidence-based evaluations of genetic tests. Genet Med 2010;12:228-35.
17. Lijmer J, Bossuyt P. Various randomized designs can be used to evaluate medical tests. J Clin Epidemiol 2009;62:364-73.
18. Lord SJ, Irwig L, Bossuyt PM. Using the principles of randomized controlled trial design to guide test evaluation. Med Decis Making 2009;29:E1-12.
19. Lord SJ, Irwig L, Simes RJ. When is measuring sensitivity and specificity sufficient to evaluate a diagnostic test, and when do we need randomized trials? Ann Intern Med 2006;144:850-5.
20. Klee GG. Establishment of outcome-related analytic performance goals. Clin Chem 2010;56:714-22.
21. Karon BS, Boyd JC, Klee GG. Glucose meter performance criteria for tight glycemic control estimated by simulation modeling. Clin Chem 2010;56:1091-7.