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Study Population

  • Lawrence M. Friedman
  • Curt D. Furberg
  • David L. DeMets
Chapter

Abstract

Defining the study population is an integral part of posing the primary question. It is not enough to claim that an intervention is or is not effective without describing the type of participant on which the intervention was tested. The description requires specification of criteria for eligibility. This chapter focuses on how to define the study population. In addition, it considers two questions. First, to what extent will the results of the trial be generalizable to a broader population? Second, what impact does selection of eligibility criteria have on participant recruitment, or, more generally, study feasibility? This issue is also discussed in Chap. 10.

Keywords

Diastolic Blood Pressure Eligibility Criterion Lipid Research Clinic Participant Safety Coronary Artery Surgery Study 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

  1. 1.
  2. 2.
    Van Spall HGC, Toren A, Kiss A, Fowler RA. Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review. JAMA 2007;297:1233–1240.CrossRefGoogle Scholar
  3. 3.
    Diabetic Retinopathy Study Research Group. Preliminary report on effects of photocoagulation therapy. Am J Ophthalmol 1976;81:383–396.Google Scholar
  4. 4.
    Diabetic Retinopathy Study Research Group. Photocoagulation treatment of proliferative diabetic retinopathy: the second report of diabetic retinopathy study findings. Ophthalmology 1978;85:82–106.CrossRefGoogle Scholar
  5. 5.
    Fraser DW, Tsai TR, Orenstein W, et al. Legionnaires’ Disease: description of an epidemic of pneumonia. N Engl J Med 1977;297:1189–1197.CrossRefGoogle Scholar
  6. 6.
    Veterans Administration Cooperative Study Group on Antihypertensive Agents. Effects of treatment on morbidity in hypertension: results in patients with diastolic blood pressures averaging 115 through 129 mm Hg. JAMA 1967;202:1028–1034.CrossRefGoogle Scholar
  7. 7.
    Veterans Administration Cooperative Study Group on Antihypertensive Agents. Effects of treatment on morbidity in hypertension: II. Results in patients with diastolic blood pressure averaging 90 through 114 mm Hg. JAMA 1970;213:1143–1152.CrossRefGoogle Scholar
  8. 8.
    Hypertension Detection and Follow-up Program Cooperative Group. Five-year findings of the hypertension detection and follow-up program. 1. Reduction in mortality of persons with high blood pressure, including mild hypertension. JAMA 1979;242:2562–2571.CrossRefGoogle Scholar
  9. 9.
    Ridker PM, Danielson E, Fonseca FAH, et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008;359:2195–2207.CrossRefGoogle Scholar
  10. 10.
    Sondik EJ, Brown BW, Jr., Silvers A. High risk subjects and the cost of large field trials. J Chronic Dis 1974;27:177–187.CrossRefGoogle Scholar
  11. 11.
    Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA 2003;290:1624–1632.CrossRefGoogle Scholar
  12. 12.
    Douglas PS. Gender, cardiology, and optimal medical care. Circulation 1986;74:917–919.CrossRefGoogle Scholar
  13. 13.
    Bennett JC, for the Board on Health Sciences Policy of the Institute of Medicine. Inclusion of women in clinical trials – policies for population subgroups. N Engl J Med 1993;329:288–292.CrossRefGoogle Scholar
  14. 14.
    Freedman LS, Simon R, Foulkes MA, et al. Inclusion of women and minorities in clinical trials and the NIH Revitalization Act of 1993 – the perspective of NIH clinical trialists. Control Clin Trials 1995;16:277–285.CrossRefGoogle Scholar
  15. 15.
    NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research – Amended, October, 2001. http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm
  16. 16.
    Horwitz O, Wilbek E. Effect of tuberculosis infection on mortality risk. Am Rev Respir Dis 1971;104:643–655.Google Scholar
  17. 17.
    Wilhelmsen L, Ljungberg S, Wedel H, Werko L. A comparison between participants and non-participants in a primary preventive trial. J Chronic Dis 1976;29:331–339.CrossRefGoogle Scholar
  18. 18.
    Smith P, Arnesen H. Mortality in non-consenters in a post-myocardial infarction trial. J Intern Med 1990;228:253–256.CrossRefGoogle Scholar
  19. 19.
    Pedersen TR. The Norwegian Multicenter Study of timolol after myocardial infarction. Circulation 1983;67(suppl 1):I-49–I-53.Google Scholar
  20. 20.
    CASS Principal Investigators and Their Associates. Coronary Artery Surgery Study (CASS): a randomized trial of coronary artery bypass surgery. Comparability of entry characteristics and survival in randomized patients and nonrandomized patients meeting randomization criteria. J Am Coll Cardiol 1984;3:114–128.CrossRefGoogle Scholar
  21. 21.
    Antithrombotic Trialists’ Collaboration. Collaborative meta-analysis of randomised clinical trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ 2002;324:71–86; correction BMJ 2002;324:141.CrossRefGoogle Scholar
  22. 22.
    Steering Committee of the Physicians’ Health Study Research Group. Final report on the aspirin component of the ongoing Physicians’ Health Study. N Engl J Med 1989;321:129–135.CrossRefGoogle Scholar
  23. 23.
    Peto R, Gray R, Collins R, et al. Randomized trial of prophylactic daily aspirin in British male doctors. Br Med J 1988;296:313–316.CrossRefGoogle Scholar
  24. 24.
    Ridker PM, Cook NR, Lee I-M, et al. A randomized trial of low-dose aspirin in the primary prevention of cardiovascular disease in women. N Engl J Med 2005;352:1293–1304.CrossRefGoogle Scholar
  25. 25.
    Berger JS, Roncaglioni MC, Avanzini F, et al. Aspirin for the primary prevention of cardiovascular events in women and men: a sex-specific meta-analysis of randomized controlled trials. JAMA 2006;295:306–313; correction JAMA 2006;295:2002.CrossRefGoogle Scholar
  26. 26.
    Benedict GW. LRC Coronary Prevention Trial: Baltimore. Clin Pharmacol Ther 1979;25:685–687.Google Scholar

Copyright information

© Springer New York 2010

Authors and Affiliations

  • Lawrence M. Friedman
    • 1
  • Curt D. Furberg
    • 2
  • David L. DeMets
    • 3
  1. 1.BethesdaUSA
  2. 2.School of MedicineWake Forest UniversityWinston-SalemUSA
  3. 3.Department of Biostatistics & Medical InformaticsUniversity of WisconsinMadisonUSA

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