How to evaluate and implement new technologies in an era of managed care and cost containment

Clinical Chemistry

Volumn 42, Issue 5, 1996, Pages 797-802

  Koch, David D ^a  

^a UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

Author keywords

diagnostic performance; laboratory management; method evaluation; technology assessment

Indexed keywords

BIOMEDICAL TECHNOLOGY ASSESSMENT; CLINICAL LABORATORY; COST CONTROL; HEALTH INSURANCE; LABORATORY TEST; REVIEW; RISK BENEFIT ANALYSIS;

EID: 0030012083     PISSN: 00099147     EISSN: None     Source Type: Journal    
DOI: 10.1093/clinchem/42.5.797     Document Type: Review

References (34)

1. Palmer SM, Kaufman RA, Salamone SJ, Blake-Courtney J, Bette W, Wahl H-P, Furrer F. Cobas® Integra: clinical laboratory instrument with continuous and random-access capabilities. Clin Chem 1995; 41:1751-60.
2. Kricka U. Selected strategies for improving sensitivity and reliability of immunoassays. Clin Chem 1994;40:347-57.
3. Lott JA, Abbott LB, Koch DD. An evaluation of the DuPont aca IV: does it meet medical needs? Clin Chem 1985;31:281-6.
4. Walker GT, Nadeau JG, Linn CP, Devlin RF, Dandliker WB. Strand displacement amplification (SDA) and transient state fluorescence polarization detection of Mycobacterium tuberculosis DNA. Clin Chem 1996;42:9-13.
5. U.S. Dept. of Health and Human Services: regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Final rule. Fed Regist 1992;57:7172-86.
6. Lifshitz MS, DeCresce RP. Selecting instruments with an eye to CLIA. Med Lab Observ 1992;24:33-6.
7. Auxter S. As concern over FDA backlog grows, Congress considers user fees. Clin Chem News 1994;20, No. 6:1.
8. Auxter S. U.S. companies seek favorable regulatory climate abroad. Clin Chem News 1994;20, No. 6:3.
9. Robinson A. Rationale for cost-effective laboratory medicine. Clin Microbiol Rev 1994;7:185-99.
10. McDonald JM, Smith JA. Value-added laboratory medicine in an era of managed care. Clin Chem 1995;41:1256-62.
11. Elmer R. Key trends in cost containment. Med Lab Observ 1995;27, No. 6:30-3.
12. Various authors. 1992 Clinical Chemistry Forum - Accuracy and precision goals in clinical chemistry testing: can they be defined by medical relevance? Clin Chem 1993;39:1446-544.
13. Fraser CG, Hyltoft Peterson P. Desirable standards for laboratory tests if they are to fulfill medical needs. Clin Chem 1993;39: 1447-55.
14. Westgard JO, Seehafer JJ, Barry PL. Allowable imprecision for laboratory tests based on clinical and analytical test outcome criteria. Clin Chem 1994;40:1909-14.
15. Auxter S. FDA solicits industry, laboratorians advice on IVD review process. Clin Lab News 1995;21, No. 12:15.
16. Taylor JK. Quality assurance of chemical measurements. Chelsea, Ml: Lewis Publishers, 1987:328pp.
17. Fryback DG, Thornbury JR. The efficacy of diagnostic imaging. Med Decis Making 1991;11:88-94.
18. Silverstein MD, Boland BJ. Conceptual framework for evaluating laboratory tests: case-finding in ambulatory patients. Clin Chem 1994;40:1621-7.
19. Fraser CG. Data on biological variation: essential prerequisites for introducing new procedures [Editorial]? Clin Chem 1994;40: 1671-3.
20. Robertson EA, Zweig MH, Van Steirteghem AC. Evaluating the clinical efficacy of laboratory tests. Am J Clin Pathol 1983;79:78-86.
21. Koch DD, Peters T Jr. Selection and evaluation of methods. In: Burtis CA, Ashwood ER, eds. Tietz textbook of clinical chemistry, 2nd ed. Philadelphia: WB Saunders, 1994:508-25.
22. Carey RN, Garber CC. Evaluation of methods. In: Kaplan LA, Pesce AJ, eds. Clinical chemistry: theory, analysis, and correlation, 2nd ed. St. Louis: CV Mosby, 1989:290-310.
23. NCCLS. Specialty Collection SC1-L. Evaluation protocols. Wayne, PA: National Committee for Clinical Laboratory Standards, October, 1995.
24. Westgard JO, Hunt MR. Use and interpretation of common statistical tests in method-comparison studies. Clin Chem 1973;19:49-57.
25. Wians FH, Baskin LB, Keffer JH, Koch DD. Evaluation and implementation of an immunochemiluminometric assay (ICMA) for quantifying CK-MB concentration. Clin Lab Sci 1995;8:334-8.
26. NCCLS. Approved Guideline C 28-A. How to define, determine, and utilize reference intervals in the clinical laboratory. Wayne, PA: National Committee for Clinical Laboratory Standards, October, 1995.
27. Zweig MH, Campbell G. Receiver-operating characteristic (ROC) plots: a fundamental evaluation tool in clinical medicine [Review]. Clin Chem 1993;39:561-77.
28. Huguet J, Castineiras MJ, Fuentes-Arderiu X. Diagnostic accuracy evaluation using ROC curve analysis. Scand J Clin Lab Invest 1993;53:693-9.
29. Kazmierczak SC, Catrou PG, Van Lente F. Diagnostic accuracy of pancreatic enzymes evaluated by use of multivariate data analysis. Clin Chem 1993;39:1960-5.
30. NCCLS. Approved Guideline GP 10-A. Assessment of the clinical accuracy of laboratory tests using receiver operating characteristic (ROC) plots. Wayne, PA: National Committee for Clinical Laboratory Standards, October, 1993.
31. Irwig L, Tosteson ANA, Gastonis C, Lau J, Colditz G, Chalmers TC, Mosteller F. Guidelines for meta-analyses evaluating diagnostic tests. Ann Intern Med 1994;120:667-76.
32. Wu AHB, Lane PL. Metaanalysis in clinical chemistry: validation of cardiac troponin T as a marker for ischemic heart diseases. Clin Chem 1995;41:1228-33.
33. Burke MD, Bailey DN, Bennett BD, King G, McDonald JM, Matsen JM, et al. Graylyn Conference Report. Am J Clin Pathol 1995;103: 127-9.
34. Byham WC. Zappl - Empowerment in health care. New York: Fawcett Columbine, Ballantine Books, 1993: 309 pp.