On design considerations and randomization-based inference for community intervention trials

Statistics in Medicine

Volumn 15, Issue 11, 1996, Pages 1069-1092

  Gail, Mitchell H ^a   Mark, Steven D ^a   Carroll, Raymond J ^a,b   Green, Sylvan B ^a   Pee, David ^c  

^a NATIONAL CANCER INSTITUTE   (United States)

^b TEXAS A AND M UNIVERSITY   (United States)

^c INFORMATION MANAGEMENT SERVICES INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; COHORT ANALYSIS; COMMUNITY; LONGITUDINAL STUDY; METHODOLOGY; RANDOMIZATION; SAMPLE; STATISTICAL ANALYSIS; VARIANCE;

CLINICAL TRIALS; COHORT STUDIES; CROSS-SECTIONAL STUDIES; FOLLOW-UP STUDIES; LONGITUDINAL STUDIES; RANDOM ALLOCATION; RESEARCH DESIGN; SAMPLE SIZE;

EID: 0030013294     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1097-0258(19960615)15:11<1069::AID-SIM220>3.0.CO;2-Q     Document Type: Article

References (57)

1. Cornfield, J. 'Randomization by group: a formal analysis', American Journal of Epidemiology, 108, 100-102 (1978).
2. Aitkin, M. and Longford, N. 'Statistical modelling issues in school effectiveness studies', Journal of the Royal Statistical Society, Series A, 149, 1-43 (1986).
3. Williams, P. T., Fortmann, S. P., Farquhar, J. W., Varady, A. and Mellen, S. 'A comparison of statistical methods for evaluating risk factor changes in community-based studies: an example from the Stanford three-community study', Journal of Chronic Diseases, 34, 565-571 (1981).
4. Donner, A., Birkett, N. and Buck, C. 'Randomization by cluster: sample size requirements and analysis', American Journal of Epidemiology, 114, 906-914 (1981).
5. Simon, R. 'Composite randomization designs for clinical trials', Biometrics, 37, 723-731 (1981).
6. Maritz, J. S. and Jarrett, R. G. 'The use of statistics to examine the association between fluoride in drinking water and cancer death rates', Applied Statistics, 32, 97-101 (1983).
7. Donner, A. and Donald, A. 'Analysis of data arising from a stratified design with the cluster as unit of randomization', Statistics in Medicine, 6, 43-52 (1987).
8. Murray, D. M. and Hannan, P. J. 'Planning for the appropriate analysis in school-based drug-use prevention studies', Journal of Consulting and Clinical Psychology, 58, 458-468 (1990).
9. Koepsell, T. D., Martin, D. C., Diehr, P. H., Psaty, B. M., Wagner, E. H., Perrin, E. B. and Cheadle, A. 'Data analysis and sample size issues in evaluations of community-based health promotion and disease prevention programs: a mixed model analysis of variance approach', Journal of Clinical Epidemiology, 44, 701-713 (1991).
10. Gail, M. H., Byar, D. P., Pechacek, T. F. and Corle, D. K. 'Aspects of statistical design for the community intervention trial for smoking cessation (COMMIT)', Controlled Clinical Trials, 13, 16-21 (1992).
11. Feldman, H. A. and McKinlay, S. M. 'Cohort versus cross-sectional design in large field trials: precision, sample size, and a unifying model', Statistics in Medicine, 13, 61-78 (1994).
12. Donner, A. and Klar, N. 'Methods for comparing event rates in intervention studies when the unit of allocation is a cluster', American Journal of Epidemiology, 140, 279-289 (1994).
13. Donner, A. and Hauck, W. 'Estimation of a common odds ratio in paired-cluster randomization designs', Statistics in Medicine, 8, 599-607 (1989).
14. Donner, A. and Klar, N. 'Confidence interval construction for effect measures arising from cluster randomization trials', Journal of Clinical Epidemiology, 46, 123-131 (1993).
15. Donner, A. 'A regression analysis approach to the analysis of data arising from cluster randomization', International Journal of Epidemiology, 14, 322-326 (1985).
16. Donner, A. 'Statistical methodology for paired cluster designs', American Journal of Epidemiology, 126, 972-979 (1987).
17. Moore, D. F. and Tsiatis, A. 'Robust estimation of the variance in moment methods for extra-binomial and extra-Poisson variation', Biometrics, 47, 383-401 (1991).
18. Duffy, S. W., South, M. C. and Day, N. E. 'Cluster randomization in large public health trials: the importance of antecedent data', Statistics in Medicine, 11, 307-316 (1992).
19. The COMMIT Research Group. 'Community intervention trial for smoking cessation (COMMIT). I. Cohort results from a four-year community intervention', American Journal of Public Health, 85, 183-192 (1995).
20. Byar, D. P. 'The design of cancer prevention trials', in Kay, R. and Scheurlen, H. (eds), Recent Results in Cancer Research, Springer-Verlag, Heidelberg, 1988, pp. 34-48.
21. Hsieh, F. Y. 'Sample size formulae for intervention studies with the cluster as unit of randomization', Statistics in Medicine, 8, 1195-1201 (1988).
22. Shipley, M. J., Smith, P. G. and Dramaix, M. 'Calculation of power for matched pair studies when randomization is by group', International Journal of Epidemiology, 18, 457-461 (1989).
23. Donner, A. 'Sample size requirements for stratified cluster randomization designs', Statistics in Medicine, 11, 743-750 (1992).
24. Feng, Z. and Grizzle, J. E. 'Correlated binomial variates: properties of estimator of intraclass correlation and its effect on sample size', Statistics in Medicine, 11, 1607-1614 (1992).
25. Shoukri, M. M. and Martin, S. W. 'Estimating the number of clusters for the analysis of correlated binary response variables from unbalanced data', Statistics in Medicine, 11, 751-760 (1992).
26. Freedman, L. S., Green, S. B. and Byar, D. P. 'Assessing the gain in efficiency due to matching in a community intervention study', Statistics in Medicine, 9, 943-952 (1990).
27. Martin, D. C., Diehr, P., Perrin, E. B. and Koepsell, T. D. 'The effect of matching on the power of randomized community intervention studies', Statistics in Medicine, 12, 329-338 (1993).
28. Salonen, J. T., Kottke, T. E., Jacobs, D. R. and Hannon, P. J. 'Analysis of community-based cardiovascular disease prevention studies: evaluation issues in the North Karelia project and the Minnesota Heart Health Program', International Journal of Epidemiology, 15, 176-182 (1986).
29. Prentice, R. L. 'Correlated binary regression with covariates specific to each binary observation', Biometrics, 44, 1033-1048 (1988).
30. Bock, D. R. Multilevel Analysis of Educational Data, Academic Press, San Diego, 1989.
31. Qaquish, B. F. and Liang, K. Y. 'Marginal models for correlated binary responses with multiple classes and multiple levels of nesting', Biometrics, 48, 939-950 (1992).
32. Neyman, J., Iwaskiewicz, K. and Kolodziejczyk, T. 'Statistical problems in agricultural experimentation', Journal of the Royal Statistical Society, 2, 107-180 (1935).
33. Fisher, R. A. The Design of Experiments, Oliver and Boyd, Edinburgh, 1935.
34. Edgington, E. S. Randomization Tests, Marcel Decker, New York, 1987.
35. Good, P. Permutation Tests, Springer-Verlag, New York, 1994.
36. Manly, B. F. Randomization and Monte Carlo Methods in Biology, Chapman and Hall, New York, 1991.
37. Boik, R. J. 'The Fisher-Pitman permutation test: a non-robust to the normal theory F test when variances are heterogeneous', British Journal of Mathematical and Statistical Psychology, 40, 26-42 (1987).
38. Romano, J. P. 'On the behavior of randomization tests without a group invariance assumption', Journal of the American Statistical Association, 85, 686-692 (1990).
39. Sommer, A., Djunaedi, E., Loeden, A. A., Tarwotjo, I., Jr., West, K. P. and Tilden, R. 'Impact of vitamin A supplementation on childhood mortality, a randomized clinical trial', Lancet, 1, 1169-1173 (1986).
40. The COMMIT Research Group. 'Community intervention trial for smoking cessation (COMMIT). II. Changes in adult smoking prevalence', American Journal of Public Health, 85, 193-200 (1995).
41. Duncan, G. J. and Kalton, G. 'Issues of design and analysis of surveys across time', International Statistical Review, 55, 97-117 (1987).
42. Dwyer, J. and Feinleib, M. 'Introduction to statistical models for longitudinal observation', in Dwyer, J. H., Feinleib, M., Lippert, P. and Hoffmeister, H. (eds), Statistical Models for Longitudinal Studies of Health, Oxford University Press, New York, 1992, pp. 3-47.
43. Donner, A. 'An empirical study of cluster randomization', International Journal of Epidemiology, 11, 283-286 (1982).
44. Rubin, D. B. and Little, J. A. Statistical Analysis with Missing Data, Wiley, New York, 1987.
45. Cox, D. R. 'Causality: some statistical aspects', Journal of the Royal Statistical Society, Series A, 155, 291-301 (1992).
46. Pitman, E. J. G. 'Significance tests which may be applied to samples from any population. III. The analysis of variance test', Biometrika, 29, 322-335 (1938).
47. Wald, A. and Wolfowitz, J. 'Statistical tests based on permutations of the observations', Annals of Mathematical Statistics, 15, 358-372 (1944).
48. Miller, R. G. Jr Beyond ANOVA, Basics of Applied Statistics, Wiley, New York, 1986.
49. Harwell, M. R., Rubinstein, E. N., Hayes, W. S. and Olds, C. C. 'Summarizing Monte Carlo results in methodological research: the one-and two-factor fixed effects ANOVA cases', Journal of Educational Statistics, 17, 315-339 (1992).
50. Efron, B. 'Student's t-test under symmetry conditions', Journal of the American Statistical Association, 64, 1278-1302 (1969).
51. Gail, M. H., Tan, W. Y. and Piantadosi, S. 'Tests for no treatment effect in randomized clinical trials', Biometrika, 75, 57-64 (1988).
52. Commenges, D. and Jacqmin, H. 'The intraclass correlation coefficient: distribution free definition and test', Biometrics, 50, 517-526 (1994).
53. Murray, D. M., Rooney, B. L., Hannan, P. J., Peterson, A. V., Ary, D. V., Biglan, A., Botvin, G. J., Evans, R. I., Flay, B. R., Futterman, R., Getz, J. G., Marek, P. M., Orlandi, M., Pentz, M. A., Perry, C. L. and Schinke, S. P. 'Intraclass correlation among common measures of adolescent smoking: estimates, correlates and applications in smoking prevention studies', American Journal of Epidemiology, 140, 1038-1050 (1994).
54. Mark, S. D. and Gail, M. H. 'A comparison of likelihood-based and marginal estimating equation methods for analyzing repeated ordinal categorical responses with missing data: application to an intervention trial of vitamin prophylaxis for oesophageal dysplasia', Statistics in Medicine, 13, 479-493 (1994).
55. Donner, A., Eliasziw, M. and Klar, N. 'A comparison of methods for testing homogeneity of proportions for teratologic studies', Statistics in Medicine, 13, 1253-1264 (1994).
56. Fung, K. Y., Krewski, D., Rao, J. N. K. and Scott, A. J. 'Tests for trend in developmental toxicity experiments with correlated binary data', Risk Analysis, 14, 639-648 (1994).
57. Abramowitz, M. and Stegun, I. A. Handbook of Mathematical Functions, Dover Publications, Inc., New York, 1972.