Approach to maintaining comparability of biochemical data during long- term clinical trials

Clinical Chemistry

Volumn 43, Issue 10, 1997, Pages 1913-1918

  Cull, Carole A ^a   Manley, Susan E ^a   Stratton, Irene M ^a   Neil, H Andrew W ^a   Ross, Iain S ^b   Holman, Rury R ^a   Turner, Robert C ^a   Matthews, David R ^a  

^a RADCLIFFE INFIRMARY   (United Kingdom)

^b UNIVERSITY OF ABERDEEN   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

HEMOGLOBIN A1C; TRIACYLGLYCEROL;

ARTICLE; BIOCHEMISTRY; CLINICAL TRIAL; HUMAN; INFORMATION PROCESSING; INTERMETHOD COMPARISON; LABORATORY APPARATUS, EQUIPMENT AND SUPPLIES; MAJOR CLINICAL STUDY; MONITORING; QUALITY CONTROL; STATISTICAL ANALYSIS;

EID: 0030774650     PISSN: 00099147     EISSN: None     Source Type: Journal    
DOI: 10.1093/clinchem/43.10.1913     Document Type: Article

References (18)

1. Vartiainen E, Puska P, Pekkanen J, Tuomilehto J, Jousilahti P. Changes in risk factors explain changes in mortality from ischaemic heart disease in Finland. BMJ (Br Med J) 1994;309: 23-7.
2. UKPDS Group. UK Prospective Diabetes Study VIII: study design, progress and performance. Diabetologia 1991;34:877-90.
3. UKPDS Group. UK Prospective Diabetes Study XI: biochemical risk factors in type 2 diabetic patients at diagnosis compared with age-matched normal subjects. Diabetic Medicine 1994;11:534-44.
4. Moore JC, Bown E, Outlaw MC, Jelfs R, Holman RR, Turner RC. Glycosylated haemoglobin: comparison of five different methods, including measurement on capillary blood samples. Ann Clin Biochem 1985;23:85-91.
5. Westgard JO, Barry PL, Hunt MR, Groth T. A multi-rule Shewhart chart for quality control in clinical chemistry. Clin Chem 1981;27: 493-501.
6. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986;i:307-10.
7. Porter MA. Practical significance? R Stat Soc News 1995;22:5.
8. Whitby LG, Mitchell FL, Moss DW. Quality control in routine clinical chemistry. Adv Clin Chem 1967;10:65-76.
9. North WRS. The Quangle - a modification of the Cusum chart. Appl Statistics 1982;31:155-8.
10. Standing SJ, Taylor RP. Glycated haemoglobin: an assessment of high capacity liquid chromatographic and immunoassay methods. Ann Clin Biochem 1992;29:494-505.
11. Packard CJ, Bell MA, Eaton RH, Dagen MM, Cassidy M, Shepherd J. A pilot scheme for improving the accuracy of serum cholesterol measurement in Scotland and Northern Ireland. Ann Clin Biochem 1993;30:387-93.
12. Thienpont L, Franzini C, Kratochvila J, Middle J, Ricos C, Siekmann L, et al. Analytical quality specifications for reference methods and operating specifications for networks of reference laboratories. Eur J Clin Chem Clin Biochem 1995;33:949-57.
13. Holzel W, Miedema K, Finke A, Goldstein D, Goodall I, Jeppsson J, et al. Development of a reference system for the international standardisation of HbA1c/glycated haemoglobin determinations [Abstract]. Proc Int Congr Clin Chem 1996;16:374.
14. Weykamp CW, Penders TJ, Miedema K, Muskiet FA, van der Slik W. Standardisation of glycohemoglobin results and reference values in whole blood studied in 103 laboratories using 20 methods. Clin Chem 1995;41:82-6.
15. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977-86.
16. Petersen PH, Blaabjerg O. Reference intervals for plasma proteins. Upsala J Med Sci 1994;99:307-14.
17. Charlton B. Does the size count for the clinical survey? Hosp Doctor 1995;6:26.
18. Petersen PH, Groth T, de Verdier C-H. Principles for assessing analytical quality specifications ("AQSpecs") and their use in design of control systems. Upsala J Med Sci 1993;98:195-214.