Are the results of randomized trials influenced by preference effects? Part II. Why current studies often fail to answer this question

Optimizing Health: Improving the Value of Healthcare Delivery

Volumn , Issue , 2006, Pages 292-297

  Porzsolt, Franz ^a   Stengel, Dirk ^b  

^a UNIVERSITY HOSPITAL ULM   (Germany)

^b Clinical Epidemiology Division   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 50249130384     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1007/978-0-387-33921-4_28     Document Type: Chapter

References (18)

1. Brewin, C.R., Bradley, C. (1989). Patient preferences and randomized clinical trials. British Medical Journal, 299, 313-315.
2. Fergusson, D., Glass, K.C., Waring, D., Shapiro, S. (2004) Turning a blind eye: the success of blinding reported in a random sample of randomized, placebo controlled trials. British Medical Journal 2004, 328-432.
3. Halpern, S.D. (2003). Evaluating preference effects in partially unblinded, randomized clinical trials. Journal of Clinical Epidemiology, 56,109-115.
4. Kaptchuk, T.J. (2001). The double-blind, randomized, placebo-controlled trial: gold standard or golden calf? Journal of Clinical Epidemiology, 54, 541-549.
5. King, M., Nazareth, I., Lampe, F., Bower, P., Chandler, M., Morou, M., et al. (2005). Impact of participant and physician intervention preferences on randomized trials: a systematic review. Journal of the American Medical Association, 293, 1089-1099.
6. MacLehose, R.R., Reeves, B.C., Harvey, I.M., Sheldon, T.A., Russell, I.T., Black, A.M. (2000). A systematic review of comparisons of effect sizes derived from randomized and non-randomized studies. Health Technology Assessment, 4(34), 1-154.
7. McPherson, K., Chalmers, I. (1998). Incorporating patient preferences into clinical trials: information about patientś preference must be obtained first. British Medical Journal, 317, 78.
8. McPherson, K., Britton, A., Wennberg, J. E. (1997). Are randomized controlled trials controlled? Patient preferences and unblind trials. Journal of the Royal Society of Medicine, 90, 652-656.
9. Olschewski, M., Scheurlen, H. (1985). Comprehensive Cohort Study: an alternative to randomized consent design in a breast preservation trial. Methods of Information in Medicine, 24, 131-134.
10. Porzsolt, F., Kumpf, J., Coppin, C., Pöppel, E. (2003). Stringent application of epidemiologic criteria changes the interpretation of the effects of immunotherapy in advanced renal cell cancer. In: C. William, V. Bramwell, X. Bonfill, J. Cuzick, J.F. Forbes, R. Grant, et al. (Eds). Evidence-based oncology. Oxford: British Medical Journal Books.
11. Porzsolt, F., Schlotz-Gorton, N., Biller-Andorno, N., Thim, A., Meissner, K., Roeckl- Wiedmann, I., et al. (2004). Applying evidence to support ethical decisions: is the placebo really powerless? Science and Engineering Ethics, 10, 119-132.
12. Riethmüller, G., Schneider-Gädicke, E., Schlimok, G., Schmiegel, W., Raab, R., Höffken, K., et al. (1994). Randomized trial of monoclonal antibody for adjuvant therapy of resected Dukes' C colorectal carcinoma: German Cancer Aid 17-1A Study Group. Lancet, 343, 1177-1183.
13. Ross, S., Grant, A., Counsell, C., Gillespie, W., Russell, I., Prescott, R. (1999). Barriers to participation in randomized controlled trials: a systematic review. Journal of Clinical Epidemiology, 52, 1143-1156.
14. Rothwell, P.M. (2005). External validity of randomized controlled trials: "to whom do the results of this trial apply?" Lancet, 365, 82-93.
15. Schulz, K.F. (1995). Subverting randomization in controlled trials. Journal of the American Medical Association, 274, 1456-1458.
16. Sehouli, J., Kostromitskaia, J., Stengel, D., Bois, A. (2005). Why institutions do not participate in ovarian cancer trials: results from a survey in Germany. Onkologie, 28, 13-17.
17. Zelen, M. (1979). A new design for randomized clinical trials. New England Journal of Medicine, 300, 1242-1245.
18. Zelen, M. (1990). Randomized consent designs for clinical trials: an update. Statistics in Medicine, 9, 645-656.