Journal of Clinical Epidemiology
Volume 50, Issue 7 , Pages 793-800 , July 1997

Efficiency Optimization of the Selection Period in Therapeutic Trials

  • Carl K.G.M Moons

      Affiliations

    • Department of Epidemiology & Biostatistics, Erasmus University Medical School, Rotterdam, The Netherlands
    • Centre for Clinical Decision Sciences, Department of Public Health, Erasmus University Medical School, Rotterdam, The Netherlands
    • Consultation Centre for Clinical Research, Academic Hospital Rotterdam, Dijkzigt, The Netherlands
    • Julius Center for Patient Oriented Research, Utrecht University Medical School, Utrecht, The Netherlands
    • Corresponding Author InformationC. K. G. M. Moons, Ph.D., Julius Center for Patient Oriented Research, Utrecht University Medical School, P.O. Box 80035, 3508 TA Utrecht, The Netherlands
    • ,
  • Gerrit-Anne van Es

      Affiliations

    • Cardialysis, Rotterdam, The Netherlands
    • ,
  • Theo Stijnen

      Affiliations

    • Department of Epidemiology & Biostatistics, Erasmus University Medical School, Rotterdam, The Netherlands
    • Consultation Centre for Clinical Research, Academic Hospital Rotterdam, Dijkzigt, The Netherlands
    • ,
  • Annette A.A Bak

      Affiliations

    • Department of Epidemiology & Biostatistics, Erasmus University Medical School, Rotterdam, The Netherlands
    • Rotterdam Medical Research Foundation (ROMERES), Rotterdam, The Netherlands
    • Julius Center for Patient Oriented Research, Utrecht University Medical School, Utrecht, The Netherlands
    • ,
  • Albert Hofman

      Affiliations

    • Department of Epidemiology & Biostatistics, Erasmus University Medical School, Rotterdam, The Netherlands
    • ,
  • Jan J.C Jonker

      Affiliations

    • Rotterdam Medical Research Foundation (ROMERES), Rotterdam, The Netherlands
    • ,
  • J.Dik F Habbema

      Affiliations

    • Centre for Clinical Decision Sciences, Department of Public Health, Erasmus University Medical School, Rotterdam, The Netherlands
    • Consultation Centre for Clinical Research, Academic Hospital Rotterdam, Dijkzigt, The Netherlands
    • ,
  • Diederick E Grobbee

      Affiliations

    • Department of Epidemiology & Biostatistics, Erasmus University Medical School, Rotterdam, The Netherlands
    • Consultation Centre for Clinical Research, Academic Hospital Rotterdam, Dijkzigt, The Netherlands
    • Julius Center for Patient Oriented Research, Utrecht University Medical School, Utrecht, The Netherlands

,Accepted 8 April 1997.

References 

  1. Knipschild P, Leffers P, Feinstein AR. The qualification period. J Clin Epidemiol. 1991;44:461–464
  2. The West of Scotland Coronary Prevention Study Group . A coronary primary prevention study of Scottish men aged 45–64 years (Trial design). J Clin Epidemiol. 1992;45:849–860
  3. Neaton JD, Grimm RH, Cutler JA. Recruitment of participants for the Multiple Risk Factor Intervention Trial (MRFIT). Contr Clin Trials. 1987;8:41S–53S
  4. The Scandinavian Simvastatin Survival Study Group . Design and baseline results of the Scandinavian Simvastatin Survival study of patients with stable angina and/or previous myocardial infarction. Am J Cardiol. 1993;71:393–400
  5. Silagy CA, Campion K, McNeil JJ, et al.  Comparison of recruitment strategies for a large-scale clinical trial in the elderly. J Clin Epidemiol. 1991;44:1105–1114
  6. Hansson L, Dahlof B, Ekbom T, et al.  Key learnings from the STOP-Hypertension Study (An update in the progress of the ongoing Swedish study of antihypertensive treatment in the elderly). Cardiovasc Drugs Ther. 1991;4(Suppl. 6):1253–1255
  7. MRC European Carotid Surgery Trial (Interim results for symptomatic patients with severe (70–99%) or with mild (0–29%) carotid stenosis). Lancet. 1991;337:1235–1243
  8. Gardner MJ, Heady JA. Some effects of within person variability in epidemiological studies. J Chron Dis. 1973;26:781–799
  9. Rotterdam EP, Katan MB, Knuiman JT. Importance of time interval between repeated measurements of total or high-density lipoprotein cholesterol when estimating an individual's baseline concentrations. Clin Chem. 1987;33:1913–1915
  10. Natelson BH, Tapp WN, Munsif A, Burns W. Fluctuating serum cholesterol (Implications of coronary prevention). Lancet. 1988;2:404–405
  11. Thompson SG, Pocock SJ. The variability of serum cholesterol measurements (Implications for screening and monitoring). J Clin Epidemiol. 1990;43:783–789
  12. Rotterdam Cardiovascular Risk Intervention Study (ROCARI) Protocol. Rotterdam: Rotterdam Medical Research Foundation; 1990;
  13. Rao CR. Linear Statistical Inference and Its Applications. New York: Wiley & Sons; 1973;388–389
  14. Harrel FE. The LOGIST procedure. In:  Hastings RP editors. SUGI Supplemental Library User's Guide, Version 5 edition. Cary, NC: SAS Institute Inc; 1986;p. 269–293
  15. Hanley JA, McNeil BJ. The meaning and use of the area under a receiver operating characteristic (ROC) curve. Radiology. 1982;143:29–36
  16. Hanley JA, McNeil BJ. A method of comparing the areas under receiver operating characteristic curves derived from the same cases. Radiology. 1983;148:839–843
  17. Women's Health Initiative (WHI) Protocol. Seattle, Washington: WHI Clinical Coordinating Center, Fred Hutchinson Cancer Research Center; 1994;September
  18. Fox K, Pool J, Vos J, Lubsen J. The effects of nisoldipine on the total ischaemic burden (The results of the ROCKET study). Eur Heart J. 1991;12:1283–1287
  19. Pocock SJ, Thompson SG. Primary prevention trials in cardiovascular disease. J Epidemiol Comm Health. 1990;44:3–6

PII: S0895-4356(97)00069-3

Journal of Clinical Epidemiology
Volume 50, Issue 7 , Pages 793-800 , July 1997

Article Tools

* Image Usage & Resolution