Evaluating preference effects in partially unblinded, randomized clinical trials

Journal of Clinical Epidemiology

Volumn 56, Issue 2, 2003, Pages 109-115

  Halpern, Scott D ^a  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

Bias; Clinical trials; Placebo effect; Placebo controlled trials; Preferences; Randomization

Indexed keywords

ANTIHYPERTENSIVE AGENT; PLACEBO;

ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DRUG EFFICACY; HUMAN; HYPERTENSION; PRIORITY JOURNAL; PROGNOSIS; PSYCHOLOGICAL ASPECT; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT;

EID: 0037295487     PISSN: 08954356     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0895-4356(02)00598-X     Document Type: Article

References (32)

1. Jüni P., Altman D.G., Egger M. Assessing the quality of controlled clinical trials. BMJ. 323:2001;42-46.
2. Kaptchuk T.J. The double-blind, randomized, placebo-controlled trial. gold standard or golden calf? J Clin Epidemiol. 54:2001;541-549.
3. Kramer M.S., Shapiro S.H. Scientific challenges in the application of randomized trials. JAMA. 252(19):1984;2739-2745.
4. Karlowski T.R., Chalmers T.C., Frenkel L.D., Kapikian A.Z., Lewis T.L., Lynch J.M. Ascorbic acid for the common cold. a prophylactic and therapeutic trial JAMA. 231:1975;1038-1042.
5. Howard J., Whittemore A.S., Hoover J., Panos M. The Aspirin Myocardial Infarction Study Research Group. how blind was the patient blind in AMIS? Clin Pharmacol Ther. 32:1982;543-553.
6. Brownell K.D., Stunkard A.J. The double-blind in danger. untoward consequences of informed consent Am J Psychiatry. 139:1982;1487-1489.
7. Byrington R., Curb D.J., Mattson M.E. Assessment of blindness at the conclusion of the beta-blocker heart attack trial. JAMA. 253:1985;1733-1736.
8. Rabkin J.G., Markowitz J.S., Stewart J.et al. How blind is blind? Assessment of patient and doctor medication guesses in a placebo-controlled trial of imipramine and phenelzine. Psychiatry Res. 19:1986;75-86.
9. Moscussi M., Byrne L., Weintraub M., Cox C. Blinding, unblinding and the placebo effect. an analysis of patients' guesses of treatment assignment in a double-blind clinical trial Clin Pharmacol Ther. 41:1987;259-265.
10. Fisher S., Greenberg R.P. How sound is the double-blind design for evaluating psychotropic drugs? J Nerv Ment Dis. 181:1993;345-350.
11. Noseworthy J.H., Elbers G.C., Vandervoort M.K., Farquhar R.E., Yetisir E., Roberts R. The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial. Neurology. 44:1994;16-20.
12. Morin C.M., Colecchi C., Brink D., Astruc M., Mercer J., Remsberg S. How "blind" are double-blind placebo-controlled trials of benzodiazepine hypnotics? Sleep. 18:1995;240-245.
13. Basoglu M., Marks I., Livanou M., Swinson R. Double-blindness procedures, rater blindness, and ratings of outcome. observations from a controlled trial Arch Gen Psychiatry. 54(8):1997;744-748.
14. Brewin C.R., Bradley C. Patient preferences and randomized clinical trials. BMJ. 299:1989;313-315.
15. McPherson K., Britton A.R., Wennburg J.E. Are randomized controlled trials controlled? Patient preferences and unblind trials. J R Soc Med. 90:1997;652-656.
16. Silverman W.A., Altman D.G. Patients' preferences and randomised trials. Lancet. 347:1996;171-174.
17. Rücker G. A two-stage trial design for testing treatment, self-selection and treatment preference effects. Stat Med. 8:1989;477-485.
18. Bradley C. Designing medical and educational intervention studies. a review of some alternatives to conventional randomized controlled trials Diabetes Care. 16(2):1993;509-518.
19. Kleijnen J., de Craen A.J.M., Everdingen J.V., Krol L. Placebo effect in double-blind clinical trials. a review of interactions with medications Lancet. 344:1994;1347-1349.
20. Kaptchuk T.J. Powerful placebo. the dark side of the randomised controlled trial Lancet. 351:1998;1722-1725.
21. Hughes J.R., Gulliver S.B., Amori G., Mireault G.C., Fenwsick J. Effect of instructions and nicotine on smoking cessation, withdrawal symptoms and self-administration of nicotine gum. Psychopharmacology (Berlin). 99:1989;486-491.
22. Kirsch I., Rosadino J. Do double-blind studies with informed consent yield externally valid results? Psychopharmacology (Berlin). 110:1993;437-442.
23. Torgerson D.J., Klaber-Moffett J., Russell I.T. Patient preferences in randomised trials. threat or opportunity? J Health Serv Res Policy. 1(4):1996;194-197.
24. Torgerson D.J., Sibbald B. Understanding controlled trials. what is a patient preference trial? BMJ. 316:1998;360.
25. McPherson K., Chalmers I. Incorporating patient preferences into clinical trials. information about patients' preference must be obtained first BMJ. 317:1998;78.
26. Klaber-Moffett J., Torgerson D.J., Bell-Syer S.et al. Randomised controlled trial of exercise for low back pain. clinical outcomes, costs, and preferences BMJ. 319:1999;279-283.
27. Clement S., Sikorski J., Wilson J., Candy B. Merits of alternative strategies for incorporating patient preferences into clinical trials must be considered carefully. BMJ. 317:1998;78. [letter].
28. McDonald C.J., Massuca S.A., McCabe G.P. How much of the placebo "effect" is really statistical regression? Stat Med. 2:1983;417-427.
29. Hrobjartsson A., Gotzsche P.C. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. N Engl J Med. 344:2001;1594-1602.
30. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 317:1987;141-145.
31. Torgerson D.J., Sibbald B. Incorporating patient preferences into clinical trials. BMJ. 317:1998;79. [letter].
32. Freedman B. Scientific value and validity as ethical requirements for research. a proposed explication IRB Rev Hum Subjects Res. 9(6):1987;7-10.