Research to improve the quality of care for depression: Alternatives to the simple randomized clinical trial

General Hospital Psychiatry

Volumn 25, Issue 2, 2003, Pages 115-123

  TenHave, Thomas R ^a   Coyne, James ^a   Salzer, Mark ^a   Katz, Ira ^a,b  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b VETERANS AFFAIRS MEDICAL CENTER   (United States)

Author keywords

Adaptive randomized; Partial patient preference; Randomized consent; Randomized encouragement

Indexed keywords

ANALYTIC METHOD; CLINICAL PRACTICE; COMMUNITY MENTAL HEALTH; DEPRESSION; EVALUATION; EXPERIMENTAL DESIGN; HEALTH CARE QUALITY; HUMAN; INTERMETHOD COMPARISON; MEDICAL RESEARCH; MENTAL HEALTH SERVICE; PATIENT COMPLIANCE; RANDOMIZATION; REVIEW; VALIDATION PROCESS;

EID: 0037351829     PISSN: 01638343     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0163-8343(02)00275-X     Document Type: Review

References (50)

1. Ormel J., Kempen G.I., Deeg D.J., et al. Functioning, well-being, and health perception in late middle-aged, and older people comparing the effects of depressive symptoms, and chronic medical conditions . J Am Geriatr Soc. 46:(1):1998;39-48.
2. Callahan C.M., Hendrie H.C., Dittus R.S., et al. Improving treatment of late life depression in primary care a randomized clinical trial . J Am Geriatr Soc. 42:1994;839-846.
3. Schulberg H.C., Block M.R., Madonia M.J., et al. The "usual care" of major depression in primary care practice. Arch Fam Med. 6:1997;334-339.
4. Schulberg H.C., Mulsant B., Schulz R., et al. Characteristics and course of major depression in older primary care patients. Int J Psychiatry Med. 28:(4):1998;421-436.
5. Thase M.E. How should efficacy be evaluated in randomized clinical trials of treatments for depression? J Clin Psychiatry. 60:(Suppl 4):1999;23-31.
6. Cole M.G., Bellavance F., Mansour A. Prognosis of depression in elderly community and primary care populations a systematic review and meta-analysis . Am J Psychiatry. 156:(8):1999;1182-1189.
7. Thase M.E. Long-term nature of depression. J Clin Psychiatry. 60:(Suppl 14):1999;3-9. [discussion 31-5].
8. Walsh B.T., Seidman S.N., Sysko R., Gould M. Placebo response in studies of major depression. Variable, substantial, and growing. JAMA. 287:2002;1840-1847.
9. Simon G.E., Von Korff M., Rutter C.M., Peterson D.A. Treatment process and outcomes for managed care patients receiving new antidepressant prescriptions from psychiatrists and primary care physicians. Arch Gen Psych. 58:2001;395-401.
10. AHCPR, Volume 2. AHCPR Guidelines (Depression Guideline Panel. Depression in Primary Care. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service, Agency for Health Care Policy and Research. AHCPR Publication No. 93-0551, 1993.
11. Alvidrez J., Azocar F. Distressed women's clinic patients: preferences for mental health treatments and perceived obstacles. Gen Hosp Psychiatry. 21:(5):1999;340-347.
12. Bakker A., Spinhaven P., van Balkom A.J.L.M., Vleugel L., van Dyck R. Cognitive therapy by allocation versus cognitive therapy by preference in the treatment of panic disorder. Psychoth and Psychosom. 69:2000;240-243.
13. Bradley C. Psychological issues in clinical trial design. Irish J Psychol. 18:1997;67-87.
14. Morin C., Gaulier B., Barry T., Kowatch R.A. Patients' acceptance of psychological, and pharmacological therapies for insomnia. Sleep. 15:1992;302-305.
15. Walker J., Vincent N., Furer P., Cox B., Kjernisted K. Treatment preference in hypochondriasis. J Behav Ther Exp Psychiat. 30:1999;251-258.
16. Zimmerman M., Mattia J.I., Posternak M.A. Are subjects in pharmacological treatment trials of depression representative of patients in routine clinical practice? Am J Psychiatry. 159:2002;469-473.
17. Leon A.C., Portera L., Olfson M., et al. Diagnostic errors of primary care screens for depression and panic disorder. Int J Psychiat Med. 29:1999;1-11.
18. Wells K.B., Sherbourne C., Schoenbaum M., et al. Impact of disseminating quality improvement programs for depression in managed primary care a randomized controlled trial . JAMA. 283:2000;212-220.
19. Coyne JC, Thompson R, Klinkman MS, Nease DE. Emotional Disorders in primary care. Emotional disorders in primary care. J Consult Clin Psychol 2002;70:798-809.
20. Corrigan PW, Salzer MS. The conflict between random assignment and treatment preference: implications for internal validity. Evaluation and Program Planning, (in press).
21. Schulberg H.C., Block M.R., Madonia M.J., et al. Applicability of clinical pharmacotherapy guidelines for major depression in primary care settings. Arch Fam Med. 4:(2):1995;106-112.
22. Schulberg H.C., Block M.R., Madonia M.J., et al. Treating major depression in primary care practice. Eight-month clinical outcomes. Arch Gen Psychiatry. 53:(10):1996;913-919.
23. Oxman T.E., Barrett J.E., Sengupta A., et al. Status of minor depression or dysthymia in primary care following a randomized controlled treatment. Gen Hosp Psych. 23:(6):2001;301-310.
24. Katon W., Vonkorff M., Lin E., Bush T., Ormel J. Adequacy and duration of antidepressant treatment in primary care. Medical Care. 30:1992;67-76.
25. Stevens T., Katona C., Manela M., Watkin V., Livingston G. Drug treatment of older people with affective disorders in the community. Int'l J Ger Psychiatry. 6:1999;467-472.
26. Leff J., Vearnals S., Brewin C.R., et al. The London depression intervention trial randomised controlled trial of antidepressants vs couple therapy in the treatment and maintenance of people with depression living with a partner: clinical outcome and costs . Br J Psychiatry. 177:2000;95-100.
27. Collins LM, Murphy SA, Bierman KA, Design, and evaluation of adaptive preventive interventions, (unpublished manuscript).
28. Duan N, Wells KB, Braslow JT, Weisz JR. Randomized encouragement trial: a paradigm for public health intervention evaluation (unpublished manuscript).
29. Katon W., Von Korff M., Lin E., et al. Stepped collaborative care for primary care patients with persistent symptoms of depression: a randomized trial. Arch Gen Psychiat. 56:1999;1109-1115.
30. Unutzer J., Katon W., Williams J.W., et al. Improving primary care for depression in late life the design of a multicenter randomized trial . Med Care. 39:2001;785-799.
31. Wells K.B. The design of Partners in Care evaluating the cost-effectiveness of improving care for depression in primary care . Sociological Psychiatr Epidemiol. 34:1999;20-29.
32. Lavori P.W., Dawson R. A design for testing clinical strategies biased adaptive within-subject randomization . J Roy Stat Soc A Sta. 163:2000;29-38.
33. Zelen M. Play the winner rule and the controlled clinical trial. JASA. 64:1969;131-146.
34. Wei L.J., Smythe R.T., Lin D.Y., Park T.S. Statistical inference with data-dependent treatment allocation rules. JASA. 85:1990;156-162.
35. Editorial, British Journal of Obstetrics, and Gynaecology, 1997;104:1332-35.
36. Bedi N., Chilvers C., Churchill R., et al. Assessing effectiveness of treatment of depression in primary care. Partially randomised preference trial. Br J Psychiatry. 177:2000;312-318.
37. Ward E., King M., Lloyd M., et al. Randomised controlled trial of non-directive counseling, cognitive-behavior therapy, and usual general practitioner care for patients with depression. I. Clinical effectiveness. BMJ. 321:2000;1383-1388.
38. Bradley C. Patient preferences and clinical trial design and interpretation appreciation and critique of a paper by Feine, Awad & Lund . Community Dentistry and Oral Epidemiology. 27:1999;85-88.
39. Feine J.S., Awad M.A., Lund J.P. The impact of patient preference on the design and interpretation of clinical trials. Community Dentistry and Oral Epidemiology. 26:1998;70-74.
40. Cooper K.G. The impact of using a partially randomized patient preference design when evaluating alternative managements for heavy menstrual bleeding. Brit J Obstet Gyn. 104:1997;1367-1373.
41. Brewin C.R., Bradley C. Patient preferences and randomized clinical trials. BMJ. 299:1989;313-315.
42. Hunter M.S., Liao K.L.M. Evaluation of a four-session cognitive-behavioral intervention for menopausal hot flashes. Br J Hlth Psych. 1:1996;113-125.
43. Chilvers C., Dewey M., Fielding K., et al. Antidepressant drugs and generic counseling for treatment of major depression in primary care randomised trial with patient preference arms . BMJ. 322:2001;1-5.
44. Lavori P.W., Rush J.A., Wisniewski S.R., et al. Strengthening clinical effectiveness trials equipoise-stratified randomization . Arch Biol Psychiat. 50:2001;792-801.
45. Zelen M. A new design for randomized clinical trials. NEJM. 300:1979;1242-1246.
46. Zelen M. Randomized consent designs for clinical trials an update . Statistics in Medicine. 9:1990;645-656.
47. Wells K. The design of partners in care evaluating the cost-effectiveness of improving care for depression in primary care . Soc Psychiatry Epidemiol. 34:1999;20-29.
48. Rubin D.B. More powerful randomization-based p-values in double-blind trials with non-compliance. Statistics in Medicine. 17:1998;371-385.
49. Murphy SA, Van der Laan MJ, Robins JM, CPPRG. Marginal mean models for dynamic regimes. J Am Stat Assoc 2001;96:1410-1423.
50. Muthen B., Shedden K. Finite mixture modeling with mixture outcomes using the EM algorithm. Biometrics. 55:1999;463-469.