Intent-to-treat vs. Non-intent-to-treat analyses under treatment non-adherence in mental health randomized trials

Psychiatric Annals

Volumn 38, Issue 12, 2008, Pages 772-783

  Ten Have, Thomas R ^a,j   Normand, Sharon Lise T ^b,c   Marcus, Sue M ^d   Brown, C Hendricks ^e   Lavori, Philip ^f,g   Duan, Naihua ^h,i  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^d MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^e UNIVERSITY OF SOUTH FLORIDA   (United States)

^f Departments of Biostatistics

^g STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^h Och Spine at New York Presbyterian Hospitals

ⁱ NEW YORK STATE PSYCHIATRIC INSTITUTE   (United States)

^j 607 Blockley Hall ^*

more..

Author keywords

[No Author keywords available]

Indexed keywords

EID: 58149159718     PISSN: 00485713     EISSN: None     Source Type: Journal    
DOI: 10.3928/00485713-20081201-10     Document Type: Article

References (34)

1. Lavori PW. Clinical trials in psychiatry: should protocol deviation censor patient data? Neuropsychopharmacology. 1992;6(1):39-48.
2. Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomized controlled trials. BMJ. 1999;319(7211):670-674.
3. Lewis JA, Machin D. Intention-to-treat: who should use ITT? Br J Cancer. 1993;68(4):647-650.
4. Food and Drug Administration. International Conference on Harmonization: Guidelines on general considerations for clinical trials. Federal Register. 1997;62(242):66113-66119.
5. Petkova E, Teresi J. Some statistical issues in the analyses of data from longitudinal studies of elderly chronic care populations. Psychosom Med. 2002;64(3):531-547.
6. Hill AB. Principles of Medical Statistics. 7th ed. London: Lancet; 1961.
7. Horvitz-Lennon M, O'Malley AJ, Frank RG, Normand SL. Improving traditional intention-to-treat analyses: A new approach. Psychol Med. 2005;35(7):961.-970.
8. Lewis SW, Barnes TR, Davies LM, et al. Randomized controlled trial of effect of prescription of clozapine versus other second-generation antipsychotic drugs in resistant schizophrenia. Schizophr Bull. 2006;32(4):715-723.
9. Oslin DW, Lynch KG, Pettinati HM, et al. A placebo-controlled randomized clinical trial of naltrexone in the context of different levels of psychosocial intervention. Alcoholism: Clinical and Experimental Research. 2008;32(7):1299-1308.
10. Prinz RJ, Smith EP, Dumas JE, Laughlin JE, White DW, Barron R. Recruitment and retention of participants in prevention trials involving family-based interventions. Am J Prev Med. 2001;20(1 Suppl):31-37.
11. Gross D, Fogg L. A critical analysis of the intent to treat principle in prevention analysis. Journal of Primary Prevention. 2004;25:475-489.
12. Ten Have TR, Coyne JC, Salzer M, Katz IR. Research to improve the quality of care for depression: alternatives to the simple randomized clinical trial. Gen Hosp Psychiatry. 2003;25(2): 115-123.
13. Bellamy S, Lin J, Ten Have T. An introduction to causal modeling in clinical trials. Clinical Trials: Journal of the Society for Clinical Trials. 2007;4(1):58-73.
14. Ten Have TR, Elliott M, Joffe M, Zanutto E, Datto C. Causal models for randomized physician encouragement trials in treating primary care depression. Journal of the American Statistical Association. 2004;99:8-16.
15. Schulberg HC, Block MR, Madonia MJ, et al. Treating major depression in primary care practice. Eight-month clinical outcomes. Arch Gen Psychiatry. 1996;53(10):913-919.
16. Katon W, Vonkorff M, Lin E, Bush T, Ormel J. Adequacy and duration of antidepressant treatment in primary care. Med Care. 1992;30(1):67-76.
17. Stevens T, Katona C, Manela M, Watkin V, Livingston G. Drug treatment of older people with affective disorders in the community. Intl J Ger Psychiatry. 1999;14(6):467-472.
18. Corrigan PW, Salzer MS. The conflict between random assignment and treatment preference: implications for internal validity. Evaluation and Program Planning. 2003;26:109-121.
19. Fogg L, Gross D. Threats to validity in randomized clinical trials. Res Nurs Health. 2000;23(1):79-87.
20. Stein REK, Bauman LJ, Ireys HT. Who enrolls in prevention trials? Discordance in perception of risk by professional and participants. American Journal of Community Psychology. 1991;19:603-617.
21. nd ed. New York: Springer Verlag; 2002.
22. Little R, Long Q, Lin X. A comparison of methods for estimating the causal effect of a treatment in randomized clinical trials subject to noncompliance. Biometrics. May 28, 2008.
23. Heiss G, Wallace R, Anderson G, et al; for the WHI Investigators. Health risks and benefits 3 years after stopping randomized treatment with estrogen and progestin. JAMA. 2008;299(9):1036-1045.
24. Sommer A, Zeger S. On estimating efficacy from clinical trials. Statistics in Medicine. 1991;10(1):45-52.
25. Bao Y, Duan N, Fox SA. Is some provider advice on smoking cessation better than no advice? An instrumental variable analysis of the 2001 National Health Interview Survey. Health Serv Res. 2006;41(6):2114-2135.
26. O'Malley AJ, Normand SL. Likelihood methods for treatment-noncompliance and subsequent nonresponse in randomized trials. Biometrics. 2005;61(2):325-334.
27. Marcus S, Gibbons R. Estimating the efficacy of receiving treatment in randomized clinical trials with noncompliance. Journal Health Services and Outcomes Research Methodology. 2001;2:247-258.
28. Bound J, Jaeger DA, Baker RM. Problems with instrumental variables estimation when the correlation between the instrumental variable and endogenous explanatory variable is weak. Journal of the American Statistical Association. 1995;90:433-450.
29. Brookhart AM, Schneeweiss S. Preference-based instrumental variable methods for the estimation of treatment effects: assessing validity and interpreting results. The International Journal of Biostatistics. 2007;3:Article 14.
30. Dunn G, Bentall R. Modeling treatment-effect heterogeneity in randomized controlled trials of complex interventions (psychological treatments). Statistics in Medicine. 2007;26(26):4719-4745.
31. Heman MA, Robins JM. Instruments for causal inference an epidemiologist's dream? Epidemiology. 2006;17(4):360-372.
32. Kraemer HC, Wilson GT, Fairburn CG, Agras WS. Mediators and moderators of treatment effects in randomized clinical. Archives of General Psychiatry. 2002;59(10):877-883.
33. Genomics and Personalized Medicine Act of 2006. 109th Congress, 2nd session (August 3, 2006). S. 3822.
34. Overview of NIMH Priorities. http://www.nimh.nih.gov/about/strategic- planning-reports/index.shtml/priori.ties-overview. Accessed November 24, 2008.