Journal of Clinical Epidemiology
Volume 57, Issue 12 , Pages 1237-1243 , December 2004

Blinding decreased recruitment in a prevention trial of postmenopausal hormone therapy

  • Elina Hemminki

      Affiliations

    • Health and Social Services, National Research and Development Center for Welfare and Health (STAKES), P.O. Box 220, 00531 Helsinki, Finland
    • Corresponding Author InformationCorresponding author. Tel. +358-9-3967-2307; fax: 358-9-3967-2227.
  • ,
  • Sirpa-Liisa Hovi

      Affiliations

    • Health and Social Services, National Research and Development Center for Welfare and Health (STAKES), P.O. Box 220, 00531 Helsinki, Finland
    • School of Public Health, University of Tampere, Tampere, Finland
  • ,
  • Piret Veerus

      Affiliations

    • School of Public Health, University of Tampere, Tampere, Finland
    • National Institute for Health Development (TAI), Department of Epidemiology and Biostatistics, Tallinn, Estonia
    • Estonian Center for Excellence in Behavioral and Health Sciences, Tallinn, Estonia
  • ,
  • Tiina Sevón

      Affiliations

    • Health and Social Services, National Research and Development Center for Welfare and Health (STAKES), P.O. Box 220, 00531 Helsinki, Finland
  • ,
  • Risto Tuimala

      Affiliations

    • Tampere University Hospital, Department of Obstetrics and Gynecology, Tampere, Finland
  • ,
  • Mati Rahu

      Affiliations

    • National Institute for Health Development (TAI), Department of Epidemiology and Biostatistics, Tallinn, Estonia
    • Estonian Center for Excellence in Behavioral and Health Sciences, Tallinn, Estonia
  • ,
  • Matti Hakama

      Affiliations

    • School of Public Health, University of Tampere, Tampere, Finland

,Accepted 20 April 2004.

References 

  1. Gallo C, Perrone F, De Placido S, Giusti C. Informed versus randomised consent to clinical trials. Lancet. 1995;346:1060–1064
  2. Lovato LC, Hill , Hertert S, Hunninghake DB, Probstfield JL. Recruitment for controlled clinical trials: literature summary and annotated bibliography. Control Clin Trials. 1997;18:328–352
  3. Ellis PM. Attitudes towards and participation in randomised clinical trials in oncology: a review of the literature. Ann Oncol. 2000;11:939–945
  4. Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol. 1999;52:1143–1156
  5. Prescott RJ, Counsell CE, Gillespie WJ, Grant AM, Russell IT, Kiauka S, et al. Factors that limit the quality, number and progress of randomised controlled trials. Health Technol Assess. 1999;3(20):1–143(Available from http://www.hta.nhsweb.nhs.uk or http://www.ncchta.org/execsumm/summ320.htm)
  6. Ruffin MT, Baron J. Recruiting subjects in cancer prevention and control studies. J Cell Biochem Suppl. 2000;34:80–83
  7. Vickers A. Evaluation of specific and non-specific effects in homeopathy: feasibility study for a randomised trial. Br Homeopath J. 2000;89(Suppl 1):48–49
  8. Hrobjartsson A. What are the main methodological problems in the estimation of placebo effects?. J Clin Epidemiol. 2002;55:430–435
  9. Vickers AJ, de Craen AJ. Why use placebos in clinical trials? A narrative review of the methodological literature. J Clin Epidemiol. 2000;53:157–161
  10. Hall JA, Dornan M. Meta-analysis of satisfaction with medical care: description of research domain and analysis of overall satisfaction levels. Soc Sci Med. 1988;27:637–644
  11. Hall JA, Dornan MC. Patient sociodemographic characteristics as predictors of satisfaction with medical care: A meta-analysis. [Erratum in Soc Sci Med 1990;30(12):following 1368.] Soc Sci Med. 1990;30:811–818
  12. Fitzpatrick R. Scope and measurement of patient satisfaction. In:  Fitzpatrick R,  Hopkins A editor. Measurement of patients' satisfaction with their care. London: Royal College of Physicians of London; 1993;p. 1–17
  13. Welton AJ, Vickers MR, Cooper JA, Meade TW, Marteau TM. Is recruitment more difficult with a placebo arm in randomised controlled trials? A quasirandomised, interview based study. BMJ. 1999;318:1114–1117
  14. Hovis S-L, Karttunen T, Karro H, Hemminki E. Comparison of Estonain and Finnis physician's opintions of menopause and hormone therapy. Maturitas. 2004;49:107–113
  15. Rolnick SJ, Flores SK, Fowler SE, Derman R, Davidson B. Conducting randomized, controlled trials. Experience with the dysfunctional uterine bleeding intervention trial. J Reprod Med. 2001;46:1–5
  16. Connolly M, Low T. Assessment of patient sociodemographic variables in clinical trials: can patient characteristics make a difference?. Ann Acad Med Singapore. 2000;29:570–575
  17. Britton A, McKee M, Black N, McPherson K, Sanderson C, Bain C. Threats to applicability of randomised trials: exclusions and selective participation. J Health Serv Res Policy. 1999;4:112–121
  18. Zelen M. A new design for randomized clinical trials. N Engl J Med. 1979;300:1242–1245
  19. Hemminki E, Uski A, Koponen P, Rimpelä U. Iron supplementation during pregnancy: experiences of a randomized trial relying on health service personnel. Control Clin Trials. 1989;10:290–298
  20. Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women. Principal results from the Women's Health Initiative randomized controlled trial. JAMA. 2002;288:321–333
  21. den Tonkelaar I, Oddens BJ. Determinants of long-term hormone replacement therapy and reasons for early discontinuation. Obstet Gynecol. 2000;95:507–512
  22. Li C, Samsioe G, Lidfelt J, Nerbrand C, Agardh CD. Women's Health in Lund Area (WHILA) Study. Important factors for use of hormone replacement therapy: a population-based study of Swedish women. The Women's Health in Lund Area (WHILA) Study. Menopause. 2000;7:273–281
  23. Pilon D, Castilloux A-M, Lelorier J. Estrogen replacement therapy: determinants of persistence with treatment. Obstet Gynecol. 2001;97:97–100
  24. Reynolds RF, Walker AM, Makhlouf Obermeyer C, Rahman O, Guilbert D. Discontinuation of postmenopausal hormone therapy in a Massachusetts HMO. J Clin Epidemiol. 2001;54:1056–1064

PII: S0895-4356(04)00173-8

doi: 10.1016/j.jclinepi.2004.04.009

Journal of Clinical Epidemiology
Volume 57, Issue 12 , Pages 1237-1243 , December 2004