Statistical reporting of clinical trials with individual changes from allocated treatment

Statistics in Medicine

Volumn 15, Issue 3, 1996, Pages 249-262

  White, Ian R ^a   Pocock, Stuart J ^a  

^a LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BETA ADRENERGIC RECEPTOR BLOCKING AGENT; DIURETIC AGENT;

ARTICLE; CARDIOVASCULAR DISEASE; CAUSE OF DEATH; CLINICAL TRIAL; HUMAN; HYPERTENSION; RANDOMIZATION; RISK; STATISTICAL ANALYSIS; TREATMENT PLANNING;

ADRENERGIC BETA-ANTAGONISTS; AGED; DATA COLLECTION; DATA INTERPRETATION, STATISTICAL; DIURETICS; FEMALE; GREAT BRITAIN; HUMANS; HYPERTENSION; MALE; PROPORTIONAL HAZARDS MODELS; RANDOMIZED CONTROLLED TRIALS; RISK; SELECTION BIAS; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 0030069898     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1097-0258(19960215)15:3<249::AID-SIM160>3.0.CO;2-J     Document Type: Article

References (19)

1. Committee for the Assessment of Biometric Aspects of Controlled Trials of Hypoglycemic Agents. 'Report of the Committee for the Assessment of Biometric Aspects of Controlled Trials of Hypoglycemic Agents', Journal of the American Medical Association, 231, 583-608 (1975).
2. Peduzzi, P., Wittes, J. and Detre, K. 'Analysis as-randomised and the problem of non-adherence: an example from the Veterans Affairs randomized trial of coronary artery bypass surgery', Statistics in Medicine, 12, 1185-1195 (1993).
3. Schwartz, D. and Lellouch, J. 'Explanatory and pragmatic attitudes in therapeutic trials', Journal of Chronic Diseases, 20, 637-648 (1967).
4. Lee, Y.J., Ellenberg, J.H., Hirtz, D.G. and Nelson, K.B. 'Analysis of clinical trials by treatment actually received: is it really an option?', Statistics in Medicine, 10, 1595-1605 (1991).
5. Newell, D.J. 'Intention-to-treat analysis: implications for quantitative and qualitative research', International Journal of Epidemiology, 21, 837-841 (1992).
6. Lewis, J.A. and Machin, D. 'Intention to treat - who should use ITT?', British Journal of Cancer, 68, 647-650 (1993).
7. The Coronary Drug Project Research Group. 'Influence of adherence to treatment and response of cholesterol on mortality in the Coronary Drug Project', New England Journal of Medicine, 303, 1038-1041 (1980).
8. Horwitz, R.I., Viscoli, C.M., Berkman, L. et al. 'Treatment adherence and risk of death after myocardial infarction', Lancet, 336, 542-545 (1990).
9. Efron, B. and Feldman, D. 'Compliance as an explanatory variable in clinical trials', Journal of the American Statistical Association, 86, 9-17 (1991).
10. Heyting, A., Tolboom, J.T.B.M. and Essers, J.G.A. 'Statistical handling of drop-outs in longitudinal clinical trials', Statistics in Medicine, 11, 2043-2061 (1992).
11. Lagakos, S.W., Lim, L.L-Y. and Robins, J.M. 'Adjusting for early treatment termination in comparative clinical trials', Statistics in Medicine, 9, 1417-1424 (1990).
12. Newcombe, R.G. 'Explanatory and pragmatic estimates of the treatment effect when deviations from allocated treatment occur', Statistics in Medicine, 7, 1179-1186 (1988).
13. Sommer, A. and Zeger, S.L. 'On estimating efficacy from clinical trials', Statistics in Medicine, 10, 45-52 (1991).
14. Mark, S.D. and Robins, J.M. 'A method for the analysis of randomised trials with compliance information: an application to the multiple risk factor intervention trial', Controlled Clinical Trials, 14, 79-97 (1993).
15. MRC working party. 'Medical Research Council trial of treatment of hypertension in older adults: principal results', British Medical Journal, 304, 405-412 (1992).
16. Oakes, D. et al. 'Use of compliance measures in an analysis of the effect of diltiazem on mortality and reinfarction after myocardial infarction'. Journal of the American Statistical Association, 88, 44-49 (1993).
17. The Systolic Hypertension in the Elderly Program cooperative research group. 'Implications of the Systolic Hypertension in the Elderly Program', Hypertension, 21, 335-343 (1993).
18. Psaty, B.M., Koepsell, T.D., Wagner, E.H., LoGerfo, J.P. and Inui, T.S. 'The relative risk of incident coronary hear disease associated with recently stopping the use of β-blockers', Journal of the American Medical Association, 263, 1653-1657 (1990).
19. D'Agostino, R.B., Belanger, A.J., Kannel, W.B. and Cruickshank, J.M. 'Relation of low diastolic blood pressure to coronary heart disease death in presence of myocardial infarction: the Framingham study', British Medical Journal, 303, 385-389 (1991).