The control group dilemma in clinical research: Applications for psychosocial and behavioral medicine trials

Psychosomatic Medicine

Volumn 59, Issue 4, 1997, Pages 362-371

  Schwartz, Carolyn E ^a,b   Chesney, Margaret A ^c   Irvine, M Jane ^d   Keefe, Francis J ^e  

^a FRONTIER SCIENCE AND TECHNOLOGY RESEARCH FOUNDATION   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d UNIVERSITY OF TORONTO   (Canada)

^e DUKE UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

Behavioral medicine; Control group; Placebo; Psychosocial; Study design

Indexed keywords

ADAPTATION; ANALYTIC METHOD; ARTICLE; BEHAVIOR; CLINICAL RESEARCH; COPING BEHAVIOR; DOSE RESPONSE; ETHICS; HUMAN; OUTCOMES RESEARCH; PRIORITY JOURNAL; SELF HELP; SKILL; SOCIAL PSYCHOLOGY; WELLBEING;

EID: 0030794444     PISSN: 00333174     EISSN: None     Source Type: Journal    
DOI: 10.1097/00006842-199707000-00005     Document Type: Article

References (54)

1. Eisenberg DM, Kessler RC, Foster C, et al.: Unconventional medicine in the United States: Prevalence, costs, and patterns of use. N Engl J Med 328:246-252, 1993
2. Schwartz CE: Teaching coping skills enhances quality of life more than nondirective behavioral intervention: Results of a randomized trial with multiple sclerosis patients. Manuscript submitted for publication, 1997
3. Schwartz CE, Rogers M: Designing a psychosocial intervention to teach coping flexibility. Rehabil Psychol 39:61-76, 1994
4. Freedman B: Equipoise and the ethics of clinical research. N Engl J Med 317:141-145, 1987
5. Spiegel D, Bloom J, Kraemer HC, et al.: The beneficial effect of psychosocial treatment on survival of metastatic breast cancer patients: A randomized prospective outcome study. Lancet October 14, 1989:888-891, 1989
6. McCracken LM. Cognitive-behavioral treatment of rheumatoid arthritis: A preliminary review of efficacy and methodology. Ann Behav Med 13:57-65, 1991
7. Antoni MH, Baggett HL, Ironson G, et al.: Cognitive behavioral stress management buffers affective distress and immunologic changes following HIV-1 seropositivity. J Consult Clin Psychol 59:906-915, 1991
8. Rains J, Penzien D, Jamison RN: A time-limited, structured behavioral pain management program. In VandeCreek, L. (ed), Innovations in Clinical Practice, 11. Sarasota, FL, Professional Resource Press, 1992
9. Cook TD, Campbell DT. Quasi-Experimentation: Design and Analysis Issues for Field Settings. Boston, Houghton Mifflin, 1979
10. Berkman LF, Syme SL: Social networks, host resistance, and mortality: A nine-year follow-up study of Alameda county residents. Am J Epidemiol 109:186-204, 1979
11. Elkin I, Pilkonis PA, Docherty JP, et al.: Conceptual and methodological issues in comparative studies of psychotherapy and pharmacotherapy. II: Nature and timing of treatment effects. Am J Psychiatry 145:1070-1076, 1988
12. Tversky A, Kahneman D: The framing of decisions and the psychology of choice. Science 211:453-458, 1981
13. McNeil BJ, Pauker SG, Sox HC, et al.: On the elicitation of preferences for alternative therapies. N Engl J Med 306:1259-62, 1982
14. Detsky AS: Using cost-effectiveness analysis to improve the efficiency of allocating funds to clinical trials. Stat Med 9: 1-2: 173-84, 1990
15. Parloff MB: Placebo controls in psychotherapy research: A sine qua non or a placebo for research problems? J Consult Clin Psychol 54:79-87, 1986
16. Elkin I, Pilkonis PA, Docherty JP, et al.: Conceptual and methodological issues in comparative studies of psychotherapy and pharmacotherapy. I: Active ingredients and mechanisms of change. Am J Psychiatry 145:909-917, 1988
17. Scheier MF, Mathews KA, Owens JF, et al.: Dispositional optimism and recovery from coronary artery bypass surgery: The beneficial effects of physical and psychological wellbeing. J Pers Soc Psychol 57:1024-1040, 1989
18. Carver CS, Pozo C, Harris SD, et al.: How coping mediates the effect of optimism on distress: A study of women with early stage breast cancer. J Pers Soc Psychol 65:375-390, 1993
19. Alexy BB: Factors associated with participation or nonparticipation in a workplace wellness center. Res Nurs Health 14:33-40, 1991
20. Amori G, Lenox RH: Do volunteer subjects bias clinical trials? J Clin Psychopharmacol 9:321-327, 1989
21. McConnaughy EA, Prochaska JO, Velicer WF: Stages of change in psychotherapy: Measurement and sample profiles. Psychother Theory Res Pract 20:368-375, 1983
22. Bergner M, Bobbitt RA, Kressel S, et al.: The Sickness Impact Profile: Conceptual formulation and development revision of a health status measure. Int J Health Serv 6:393-415, 1976
23. Gale FM, Kirk JC, Davis R: Patient education and self-management: Randomized study of effects on health status of a mail-delivered program. Arthritis Rheum 37:S197, 1994
24. Wynne A: Is it any good? The evaluation of therapy by participants in a clinical trial. Soc Sci Med 29:1289-1297, 1989
25. Lorig K, Seleznick M, Lubeck D, et al.: The beneficial outcomes of the arthritis self-management course are inadequately explained by behavior change. Arthritis Rheum 32: 91-95, 1989
26. Williams DA, Thorn BE: An empirical assessment of pain beliefs. Pain 36:351-358, 1989
27. Stone A, Shiftman S: Reflections on the intensive measurement of stress, coping, and mood, with an emphasis on daily measures. Psychol Health 7:115-129, 1992
28. Affleck G, Urrows S, Tennen H, Higgins P: Daily coping with pain from rheumatoid arthritis: patterns and correlates. Pain 51:221-229, 1992
29. Turner JA, Deyo RA, Loeser JD, et al.: The importance of placebo effects in pain treatment and research. JAMA 271: 1609-1614, 1994
30. Breetvelt IS, VanDam FSAM: Underreporting by cancer patients: The case of response-shift. Soc Sci Med 32:981-987, 1991
31. Sprangers MAG, Broersen J, Lodder L, et al.: The need to control for response shift bias in longitudinal quality of life research [Abstract]. Qual Life Res 4:488, 1995
32. Sprangers MAG, Rozemuller N, Vanden Berk MBP, et al.: Response shift bias in longitudinal quality of life research [Abstract]. Qual Life Res 3:49, 1994
33. Bach JR, Tilton MC: Life satisfaction and well-being measures in ventilator assisted individuals with traumatic tetraplegia. Arch Phys Med Rehabil 75:66-632, 1994
34. Blalock SJ, DeVellis BM, DeVellis RF, et al.: Self-evaluation processes and adjustment to rheumatoid arthritis. Arthritis Rheum 31:1245-1251, 1993
35. Kurtzke JF: Rating neurologic impairment in multiple sclerosis: An expanded disability status scale (EDSS). Neurology 33:1444-1452, 1983
36. Ferrans CE, Powers MJ: Psychometric assessment of the quality of life index. Res Nurs Health 15:29-38, 1992
37. Smith B, Sechrest L: Treatment of aptitude X treatment interactions. In: Kazdin, AE. (ed), Methodological Issues and Strategies in Clinical Research. Washington, DC, American Psychological Association, 1992, 557-585
38. Iezzoni LI (ed). Risk Adjustment for Measuring Health Care Outcomes. Ann Arbor, MI, AHSR Health Administration Press, 1994
39. Irvine MJ, Logan AG: Relaxation behavior therapy as sole treatment for mild hypertension. Psychosom Med 53:587-597, 1991
40. Borkovec TD, Nau SD: Credibility of analogue therapy rationales. J Behav Ther Exp Psychiatry 3:257060, 1972
41. Vincent C, Lewith G: Placebo controls for acupuncture studies. J R Soc Med 88:199-202, 1995
42. Schwartz CE, Fox B: Who says yes? Identifying selection biases in a psychosocial intervention study of multiple sclerosis. Soc Sci Med 40:359-370, 1995
43. Pocock SJ. Clinical Trials: A Practical Approach. New York, Wiley, 1983, 182
44. Shaw WS, Cronan TA, Christie MD: Predictors of attrition in health intervention research among older subjects with osteoarthritis. Health Psychol 13:321-431, 1994
45. Weinberger M, Tierney WM, Booker P, et al.: Can the provision of information to patients with osteroarthritis improve functional status? Arthritis Rheum 23:1577-1583, 1989
46. Cook D. The Impact of the Hawthorne Effect in Experimental Designs in Educational Research. (US Office of Education, No. 0726, June 1967). Washington DC, US Government Printing Office, 1967
47. Parker JC, Singsen BH, Hewett JE, et al.: Educating patients with rheumatoid arthritis: A prospective analysis. Arch Phys Med Rehabil 65:771-774, 1984
48. Schwartz CE, Cole BF, Gelber RD: Measuring patient-centered outcomes in neurologic disease: Extending the Q-TWiST methodology. Arch Neurol 52:754-762, 1995
49. Schwartz CE, Cole B, Vickrey B, et al.: The Q-TWiST approach for assessing health-related quality of life in epilepsy. Qual Life Res 4:135-141, 1995
50. Kraemer HC, Thiemann S: A strategy to use soft data effectively in randomized controlled clinical trials. J Consult Clin Psychol 57:148-154, 1989
51. Kazdin AE, Bass D: Power to detect differences between alternative treatments in comparative psychotherapy outcome research. J Consult Clin Psychol 57:138-147, 1989
52. Fleiss JL: The Design and Analysis of Clinical Experiments. New York, Wiley, 1986, 371
53. Thoresen CE: Long-term results of recurrent coronary prevention project at eight years. Invited paper presentation at the First International Congress of Behavioral Medicine, Upsala, Sweden, 1991.
54. Sprangers MAG: Response Shift and the Retrospective Pretest: on the Usefulness of Retrospective Pretest-Posttest Designs in Detecting Training Related Response Shifts. Amsterdam, SVO, 1988