Using causal models to show the effect of untestable assumptions on effect estimates in randomized controlled trials

Clinical Trials

Volumn 4, Issue 6, 2007, Pages 611-620

  Allard, Robert ^a,b,c   Boivin, Jean François ^b  

^a Regional Health Agency   (Canada)

^b MCGILL UNIVERSITY   (Canada)

^c Gouvernement du Quebec   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CAUSAL ATTRIBUTION; COMPARATIVE STUDY; EXPERIMENTAL MODEL; EXPOSURE; INCIDENCE; PREVENTIVE MEDICINE; PRIORITY JOURNAL; PROBABILITY; RANDOMIZED CONTROLLED TRIAL; STATISTICAL ANALYSIS; SURVIVAL; SURVIVAL RATE; TREATMENT OUTCOME; UNCERTAINTY; CANADA; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; STATISTICAL MODEL; STATISTICS;

PLACEBO; ZIDOVUDINE;

DATA INTERPRETATION, STATISTICAL; HIV INFECTIONS; HUMANS; MODELS, STATISTICAL; PLACEBOS; QUEBEC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SURVIVAL ANALYSIS; ZIDOVUDINE;

EID: 40949131890     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774507085279     Document Type: Article

References (31)

1. Editors. Looking back on the millennium in medicine. New Engl J Med 2000; 342: 42-48.
2. Collins R, MacMahon S. Reliable assessment of the effects of treatment on mortality and major morbidity, I: clinical trials. Lancet 2001; 357: 373-80.
3. Grann A, Grann VR. The case for randomized trials in cancer treatment: New is not always better. JAMA 2005; 293: 1001-003.
4. Kramer MS, Shapiro SH. Scientific challenges in the application of randomized trials. JAMA 1984; 252: 2739-45.
5. Rothman KJ, Greenland S. Modern Epidemiology (2nd edn) Lippincott-Raven, Philadelphia, PA, 1998.
6. Gray-Donald K, Kramer MS. Causality inference in observational vs. experimental studies: An empirical comparison. Am J Epidemiol 1988; 127: 885-92.
7. Greenland S, Robins JM. Identifiability, exchangeability, and epidemiological confounding. Int J Epidemiol 1986; 15: 413-19.
8. Holland PW. Statistics and causal inference. J Am Statistical Assoc 1986; 81: 945-70.
9. Rubin DB. Bayesian inference for causal effects: the role of randomization. Annals Stat 1978; 6: 34-58.
10. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. Amer Stat Assoc J 1958; 53: 457-81.
11. Cox DR. Regression models and life-tables. J R Statist Soc B 1972; 34: 187-202.
12. Kramer MS, Lane DA. Causal propositions in clinical research and practice. J Clin Epidemiol 1992; 45: 639-49.
13. Walker AM. Observation and Inference: An Introduction to the Methods of Epidemiology. Epidemiology Resources Inc., Chestnut Hill MA, 1991.
14. Greenland S. Relation of probability of causation to relative risk and doubling dose: A methodological error that has become a social problem. Am J Public Health 1999; 89: 1166-69.
15. Robins J, Greenland S. The probability of causation under a stochastic model for individual risk. Biometrics 1989; 45: 1125-38.
16. Halloran ME. Concept and estimation of attributable risks in HIV epidemiologic research. In Nicolosi E. (ed). HIV Epidemiology: Models and Methods. Raven Press, Ltd, New York, 1994, pp. 211-227.
17. MacMahon B, Trichopoulos D. Epidemiology: Principles and Methods (2nd edn), Brown and Company, Boston: Little, 1996.
18. Miettinen OS. Proportion of disease caused or prevented by a given exposure, trait or intervention. Am J Epidemiol 1974; 99: 325-32.
19. Allard R, Boivin JF. Measures of effect based on the sufficient causes model. 2. Risks and rates of disease associated with a single preventive agent. Epidemiology 1993; 4: 517-23.
20. Allard R, Boivin JF. Measures of effect based on the sufficient causes model. 1. Risks and rates of disease associated with a single causative agent. Epidemiology 1993; 4: 37-42.
21. Allard R, Boivin JF, Lepage Y. Measures of effect based on the sufficient causes model. 3. Multivariate analysis. Epidemiology 1997; 8: 93-98.
22. Fischl MA, Richman DD, Grieco MH, et al. The efficacy of azidothymidine (AZT) in the treatment of patients with AIDS and AIDS-related complex: A double-blind, placebo-controlled trial. New Engl J Med 1987; 317: 185-91.
23. Greenland S, Robins JM. Conceptual problems in the definition and interpretation of attributable fractions. Am J Epidemiol 1988; 128: 1185-97.
24. Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the women's health initiative randomized controlled trial. JAMA 2002; 288: 321-33.
25. Gillespie MJ, Fisher L. Confidence bands for the Kaplan-Meier survival curve estimate. Annals Stat 1979; 7: 920-24.
26. MacLehose RF, Kaufman S, Kaufman JS, Poole C. Bounding causal effects under uncontrolled confounding using counterfactuals. Epidemiology 2005; 16: 548-55.
27. King G. A Solution to the Ecological Inference Problem. Princeton University Press, Princeton NJ, 1997.
28. Rothman KJ. Causes. Am J Epidemiol 1976; 104: 587-92.
29. Weinberg CR. Applicability of the simple independent action model to epidemiologic studies involving two factors and a dichotomous outcome. Am J Epidemiol 1986; 123: 162-73.
30. Little RJ, Rubin DB. Causal effects in clinical and epidemiological studies via potential outcomes: concepts and analytical approaches. Annu Rev Public Health 2000; 21: 121-45.
31. Rubin DB. Comment [on Dawid AP: Causal inference without counterfactuals]. J Amer Stat Assoc 2000; 95: 435-38.