Assessing the value of cardiac biomarkers: Going beyond diagnostic accuracy?

Future Cardiology

Volumn 10, Issue 3, 2014, Pages 367-380

  Durtschi, Amy ^a   Jülicher, Paul ^b  

^a ABBOTT LABORATORIES   (United States)

^b ABBOTT GMBH AND CO KG   (Germany)

Author keywords

cardiac biomarker; cost effectiveness; economic modeling; health economics; health technology assessment; laboratory diagnostics; linked evidence approach

Indexed keywords

BIOLOGICAL MARKER; MOLECULAR MARKER;

ACUTE CORONARY SYNDROME; AUSTRALIA; CANADA; CANCER RISK; CARDIAC IMAGING; CLINICAL DECISION MAKING; CLINICAL EFFECTIVENESS; COST EFFECTIVENESS ANALYSIS; COST UTILITY ANALYSIS; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST ACCURACY STUDY; DIAGNOSTIC VALUE; ECONOMIC EVALUATION; EMERGENCY CARE; EUROPE; HEALTH CARE POLICY; HEART FAILURE; HUMAN; IN VITRO STUDY; LABORATORY TEST; LENGTH OF STAY; META ANALYSIS (TOPIC); PATIENT SATISFACTION; PREDICTIVE VALUE; PRIORITY JOURNAL; QUALITY ADJUSTED LIFE YEAR; QUALITY OF LIFE; RADIATION EXPOSURE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SENSITIVITY AND SPECIFICITY; SYSTEMATIC REVIEW (TOPIC); UNITED KINGDOM; COST BENEFIT ANALYSIS; DIFFERENTIAL DIAGNOSIS; ECONOMICS; HEART DISEASES; METABOLISM; REPRODUCIBILITY;

BIOLOGICAL MARKERS; COST-BENEFIT ANALYSIS; DIAGNOSIS, DIFFERENTIAL; HEART DISEASES; HUMANS; REPRODUCIBILITY OF RESULTS;

EID: 84903712257     PISSN: 14796678     EISSN: 17448298     Source Type: Journal    
DOI: 10.2217/fca.14.26     Document Type: Review

References (55)

1. Porter ME. What is value in healthcare? N. Engl. J. Med. 363, 2477-2481 (2010).
2. Drummond MF, Sculpher MJ, Torrance GW, O'Brian BJ, Stoddart SL. Methods for the Economic Evaluation of Health Care Programmes (3rd Edition). Oxford University Press, NY, USA (2005).
3. Lee DW, Neumann PJ, Rizzo JA. Understanding the medical and nonmedical value of diagnostic testing. Value Health 13(2), 310-314 (2010).
4. Bossuyt PMM, McCaffery K. Additional patient outcomes and pathways in evaluations of testing. Med. Decis. Making 29(5), E30-E38 (2009).
5. Asch DA, Patton JP, Hershey JC. Knowing for the sake of knowing: the value of prognostic information. Med. Decis. Making. 10(1), 47-57 (1990).
6. Haynes RB, You JJ. The Architecture of Diagnostic Research. The Evidence of Clinical Diagnosis: Theory and Methods of Diagnostic Research (2nd Edition). Knotterus A, Buntnix F (Eds). BMJ Books, London, UK (2009).
7. Bayley MD, Schwartz JS, Shofer FS et al. The financial burden of emergency department congestion and hospital crowding for chest pain patients awaiting admission. Ann. Emerg. Med. 45, 110-117 (2005).
8. Pines JM, Pollack CV, Diercks DB et al. The Association between emergency department crowding and adverse cardiovascular outcomes in patients with chest pain. Acad. Emerg. Med 16, 617-625 (2009).
9. Lazar EJ, Fleischut P, Regan BK. Quality measurement in healthcare. Annu. Rev. Med. 64, 485-496 (2013).
10. Gutacker N, Bojke C, Daidone S, Devlin N, Street A. Hospital variation in patient-reported outcomes at the level of eq-5d dimensions: evidence from England. Med. Decis. Making 33, 804-818 (2013).
11. Blendon R, Schoen C, DesRoches CM et al. Confronting competing demands to improve quality: a five-country hospital survey. Health Aff. 23(5), 119-135 (2004).
12. Coyle ME, Francis K, Chapman Y. Self-management activities in diabetes care: a systematic review. Aust. Health Rev. 37(4), 513-522 (2013).
13. Mushlin AI, Kern LM, Paris M, Lambert DR, Williams G. The value of diagnostic information to patients with chest pain suggestive of coronary artery disease. Med. Decis. Making 25, 149-157 (2005).
14. Eisenberg MJ, Afilalo J, Lawler PR, Abrahamowicz M, Richard H, Pilote L. Cancer risk related to low-dose ionizing radiation fromcardiac imaging in patients after acute myocardial infarction. CMAJ 183(4), 430-436 (2011).
15. Mushlin AI, Ruchlin HS, Callahan MA. Cost-effectiveness of diagnostic tests. Lancet 358, 1353-1355 (2001).
16. Sutton AJ, Cooper NJ, Goodacre S, Stevenson M. Integration of meta-analysis and economic decision modeling for evaluating diagnostic tests. Med. Decis. Making 28, 650-667 (2008).
17. Deeks JJ. Systematic reviews of evaluations of diagnostic and screening tests. BMJ 323, 21 (2001).
18. Van den Bruel A, Cleemput I, Aertgeerts B, Ramaekers D, Buntinx F. The evaluation of diagnostic tests: evidence on technical and diagnostic accuracy, impact on patient outcome and cost-effectiveness is needed. J. Clin. Epidemiol. 60, 1116-1122 (2007).
19. Tatsioni A, Zarin DA, Aronson N et al. Challenges in systematic reviews of diagnostic technologies. Ann. Intern. Med. 142, 1048-1055 (2005).
20. Schaafsma JD, van der Graaf Y, Rinkel GJE, Buskens E. Decision analysis to complete diagnostic research by closing the gap between test characteristics and cost-effectiveness. J. Clin. Epidem. 62, 1248-1252 (2009).
21. Staub LP, Lord SJ, Simes RJ et al. Using patient management as a surrogate for patient health outcomes in diagnostic test evaluation. BMC Med. Res. Methodol. 12 (12) (2012).
22. Knottnerus JA, Dinant GJ, van Schayck OP. The diagnostic before-after study to assess clinical impact. In: The Evidence of Clinical Diagnosis: Theory and Methods of Diagnostic Research (2nd Edition). Knotterus A, Buntnix F (Eds). BMJ Books, London, UK (2009).
23. Medical Services Advisory Committee. Guidelines for the Assessment of Diagnostic Technologies. Canberra, ACT, Commonwealth of Australia, August 2005. www.msac.gov.au
24. Merlin T, Lehman S. The "Linked Evidence Approach" to assess medical tests: a critical analysis. Int. J. Technol. Assess. Health Care 29, 343-350 (2013)
25. International Network of Agencies for Health Technology Assessment. About HTA. www.inahta.org/HTA
26. Bossuyt PMM, Lijmer JG, Mol BWJ. Randomised comparisons of medical tests: sometimes invalid, not always efficient. Lancet 356, 1844-1847 (2000).
27. Lijmer JG, Bossuyt PMM. Various randomized designs can be used to evaluate medical tests. J. Clin. Epidemiol. 62, 364-373 (2009).
28. Lord SJ, Irwig L, Bossuyt PMM. Using the principles of randomized controlled trial design to guide test evaluation. Med. Decis. Making 29, E1-E12 (2009).
29. EUnetHTA. HTA Core Model for Diagnostic Technologies. Work Package 4. European Network For Health Technology Assessment, Brussels, Belgium (2008).
30. Di Ruffano LF, Hyde CJ, McCaffery KJ, Bossuyt PMM, Deeks JJ. Assessing the value of diagnostic tests: a framework for designing and evaluating trials. BMJ 344, e686 (2012).
31. Schunemann HJ, Oxman AD, Brozek J et al. GRADE: grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ 336, 1106-1110 (2008).
32. Siebert U. When should decision-analytic modeling be used in the economic evaluation of healthcare? Eur. J. Health Econom. 4, 143-150 (2003).
33. Husereau D, Drummond M, Petrou S et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. J. Med. Econ. 16(6), 713-719 (2013).
34. Caro JJ, Briggs AH, Siebert U et al. Modeling good research practices-overview: a report of the ISPOR-SMDM modeling good research practices task force-1. Value Health 15, 796-803 (2012).
35. Trikalinos T, Siebert U, Lau J. Decision-analytic modeling to evaluate benefits and harms of medical tests: uses and limitations. Med. Decis. Making 29, E22-E29 (2009).
36. Canadian Agency for Drugs and Technologies in Health. High-Sensitivity Cardiac Troponin for the Rapid Diagnosis of Acute Coronary Syndrome in the Emergency Department: A Clinical and Cost-Effectiveness Evaluation. Canadian Agency for Drugs and Technologies in Health Optimal Use Report 2(1A). Canadian Agency for Drugs and Technologies in Health, Ontario, Canada (2009).
37. Goodacre S, Thokala P, Carroll C et al. Systematic review, meta-analysis and economic modelling of diagnostic strategies for suspected acute coronary syndrome. Health Technol. Assess. 17, 1-210 (2013).
38. Thokala P, Goodacre SW, Collinson PO et al. Cost-effectiveness of presentation versus delayed troponin testing for acute myocardial infarction. Heart 98, 1498-1503 (2012).
39. Ingles J, McGaughran J, Scuffham PA, Atherton J, Semsarian C. A cost-effectiveness model of genetic testing for the evaluation of families with hypertrophic cardiomyopathy. Heart 98, 625-630 (2012).
40. Wordsworth S, Leal J, Blair E et al. DNA testing for hypertrophic cardiomyopathy: a cost-effectiveness model. Eur. Heart J. 31(8), 926-935 (2010).
41. Shaw AD, Chalfin D, Kleintjens J. The economic impact and cost-effectiveness of urinary neutrophil gelatinase-associated lipocalin after cardiac surgery. Clin. Ther. 33, 1713-1725 (2011).
42. Lakić D, Bogavac-Stanojević N, Jelić-Ivanović Z, Kotur-Stevuljević J, Spasić S, Kos M. A multimarker approach for the prediction of coronary artery disease: cost-effectiveness analysis. Value Health 13, 770-777 (2010).
43. Fitzgerald P, Goodacre SW, Cross E, Dixon S. Cost-effectiveness of point-of-care biomarker assessment for suspected myocardial infarction: the randomized assessment of treatment using panel assay of cardiac markers (RATPAC) trial. Acad. Emerg. Med. 18, 488-495 (2011).
44. Henriksson M, Palmer S, Chen R et al. Assessing the cost-effectiveness of using prognostic biomarkers with decision models: case study in prioritising patients waiting for coronary artery surgery. BMJ 340, b5606 (2010).
45. Adlbrecht C, Huelsmann M, Berger R et al. Cost analysis and cost-effectiveness of NT-proBNP-guided heart failure specialist care in addition to home-based nurse care. Eur. J. Clin. Invest. 41(3), 315-322 (2011).
46. Moertl D, Steiner S, Coyle D, Berger R. Cost-utility analysis of NT-proBNP-guided multidisciplinary care in chronic heart failure. Int. J. Technol. Assess. Health Care 29, 3-11 (2013).
47. Sanders-van Wijk S, van Asselt AD, Rickli H et al. Cost-effectiveness of N-terminal pro-B-type natriuretic-guided therapy in elderly heart failure patients. Results from TIME-CHF (Trial of intensified versus standard medical therapy in elderly patients with congestive heart failure). JACC Heart Fail. 1(1), 64-71 (2013).
48. National Institute for Health and Clinical Excellence. Diagnostics Assessment Programme Manual. National Institute for Health and Clinical Excellence, London, UK (2011).
49. Fryback DG, Thornbury Jr. The efficacy of diagnostic imaging. Med. Decis. Making 11, 88-94 (1991).
50. Vickers AJ, Jang K, Sargent D, Lilja H, Kattan MW. Systematic review of statistical methods used in molecular marker studies in cancer. Cancer 112, 1862-1868 (2008).
51. Redekop WK. Cost-effectiveness analyses of diagnostic strategies: a literature survey using the NHS Economic Evaluation Database. Expert Rev. Pharmacoecon. Outcomes Res. 6, 41-48 (2006).
52. Fang C, Otero HJ, Greenberg D, Neumann PJ. Cost-utility analyses of diagnostic laboratory tests: a systematic review. Value Health 14, 1010-1018 (2011).
53. Scopus Website. www.scopus.com
54. Walter SD, Macaskil P, Lord SJ, Irwig L. Effect of dependent errors in the assessment of diagnostic or screening test accuracy when the reference standard is imperfect. Statist. Med. 31, 1129-1138 (2012).
55. Kassenärztliche Bundesvereinigung. Verfahrensordnung zur Beurteilung innovativer Laborleistungen(Anlage 22 BMV-Ä/EKV). Dtsch Arztebl. 106(30), A1532-A1534 (2009).