Design and testing for clinical trials faced with misclassified causes of death

Biostatistics

Volumn 11, Issue 3, 2010, Pages 546-558

  Van Rompaye, Bart ^a   Goetghebeur, Els ^a   Jaffar, Shabbar ^b  

^a GHENT UNIVERSITY   (Belgium)

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

Author keywords

Cause specific analysis; Clinical trials; Competing risks; Misclassification; Sample size; Survival analysis; Verbal autopsy

Indexed keywords

PNEUMOCOCCUS VACCINE;

ARTICLE; CAUSE OF DEATH; COMPUTER SIMULATION; GAMBIA; HUMAN; IMMUNOLOGY; METHODOLOGY; MORTALITY; PNEUMOCOCCAL INFECTION; PRESCHOOL CHILD; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFECTION; SAMPLE SIZE;

CAUSE OF DEATH; CHILD, PRESCHOOL; COMPUTER SIMULATION; GAMBIA; HUMANS; PNEUMOCOCCAL INFECTIONS; PNEUMOCOCCAL VACCINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; RESPIRATORY TRACT INFECTIONS; SAMPLE SIZE;

EID: 77956626573     PISSN: 14654644     EISSN: 14684357     Source Type: Journal    
DOI: 10.1093/biostatistics/kxq011     Document Type: Article

References (28)

1. ANKER, M. (1997). The effect of misclassifcation error on reported cause-specifc mortality fractions from verbal autopsy. International Journal of Epidemiology 26, 1090-1096.
2. ARCHER, L. E. AND RYAN, L. M. (1989). Accounting for misclassifcation in the cause-of-death test for carcino-genicity. Journal of the American Statistical Association 84, 787-791.
3. CHANDRAMOHAN, D., SOLEMAN, N., SHIBUYA, K. AND PORTER, J. (2005). Ethical issues in the application of verbal autopsies in mortality surveillance systems. Tropical Medicine and International Health 10, 1087-1089.
4. CUTTS, F. T., ZAMAN, S. M. A., ENWERE, G., JAFFAR, S., LEVINE, O. S., OKOKO, J. B., OLUWALANA, C., VAUGHAN, A., OBARO, S. K., LEACH, A. and others (2005). Effcacy of nine-valent pneumococcal conjugate vaccine against pneumonia and invasive pneumococcal disease in The Gambia: randomised, double-blind, placebo-controlled trial. Lancet 365, 1139-1146.
5. CUZICK, J. (2008). Primary endpoints for randomised trials of cancer therapy. Lancet 371, 2156-2158.
6. DE FRANCISCO, A., HALL, A. J., ARMSTRONG-SCHELLENBERG, J. R. M., GREENWOOD, A. M. AND GREENWOOD, B. M. (1993). The pattern of infant and childhood mortality in Upper River Division, The Gambia. Annals of Tropical Paediatrics 13, 345-352.
7. DEWANJI, A. (1992). A note on a test for competing risks with missing failure type. Biometrika 79, 855-857.
8. DEWANJI, A. AND SENGUPTA, D. (2003). Estimation of competing risks with general missing pattern in failure types. Biometrics 59, 1063-1070.
9. EBRAHIMI, N. (1996). The effects of misclassifcation of the actual cause of death in competing risks analysis. Statistics in Medicine 15, 1557-1566.
10. FINE, J. P. AND GRAY, R. J. (1999). A proportional hazards model for the subdistribution of a competing risk. Journal of the American Statistical Association 94, 496-509.
11. FLEMING, T. R. AND HARRINGTON, D. P. (1991). Counting Processes and Survival Analysis. New York: John Wiley & Sons, Inc.
12. GOETGHEBEUR, E. AND RYAN, L. (1990). A modifed log rank test for competing risks with missing failure type. Biometrika 77, 207-211.
13. GOETGHEBEUR, E. AND RYAN, L. (1995). Analysis of competing risks survival data when some failure types are missing. Biometrika 82, 821-833.
14. JAFFAR, S., LEACH, A., GREENWOOD, A. M., JEPSON, A., MULLER, O., OTA, M. O. C., BOJANG, K., OBARO, S. AND GREENWOOD, B. M. (1997). Changes in the pattern of infant and childhood mortality in upper river division, The Gambia, from 1989 to 1993. Tropical Medicine and International Health 2, 28-37.
15. JAFFAR, S., LEACH, A., SMITH, P. G., CUTTS, F. AND GREENWOOD, B. (2003). Effects of misclassifcation of causes of death on the power of a trial to assess the effcacy of a pneumococcal conjugate vaccine in The Gambia. International Journal of Epidemiology 32, 430-436.
16. LADOUCEUR, M., RAHME, E., PINEAU, C. A. AND JOSEPH, L. (2007). Robustness of prevalence estimates derived from misclassifed data from administrative databases. Biometrics 63, 272-279.
17. LATOUCHE, A. AND PORCHER, R. (2007). Sample size calculations in the presence of competing risks. Statistics in Medicine 26, 5370-5380.
18. LU, K. AND TSIATIS, A. (2005). Comparison between two partial likelihood approaches for the competing risks model with missing cause of failure. Lifetime Data Analysis 11, 29-40.
19. MAUDE, G. H AND ROSS, D. A. (1997). The effect of different sensitivity, specifcity and cause-specifc mortality fractions on the estimation of differences in cause-specifc mortality rates in children from studies using verbal autopsies. International Journal of Epidemiology 26, 1097-1106.
20. O'DEMPSEY, T. J., MCARDLE, T. F., LLOYD-EVANS, N., BALDEH, I., LAWRENCE, B. E., SECKA, O. AND GREENWOOD, B. (1996). Pneumococcal disease among children in a rural area of West Africa. The Pediatric Infectious Disease Journal 15, 431-437.
21. ROWE, A. K. (2006). Analysis of deaths with an unknown cause in epidemiologic analyses of mortality burden. Tropical Medicine and International Health 11, 540-550.
22. SCHOENFELD, D. (1981). The asymptotic properties of nonparametric tests for comparing survival distributions. Biometrika 68, 316-319.
23. SCHULGEN, G., OLSCHEWSKI, M., KRANE, V., WANNER, C., RUF, G. AND SCHUMACHER, M. (2005). Sample sizes for clinical trials with time-to-event endpoints and competing risks. Contemporary Clinical Trials 26, 386-396.
24. SNOW, R. W., ARMSTRONG, J. R. M., FORSTER, D., WINSTANLEY, M. T., MARSH, V. M., NEWTON, C. R. J. C., WARUIRU, C., MWANGI, I., WINSTANLEY, P. A. AND MARSH, K. (1992). Childhood deaths in Africa: uses and limitations of verbal autopsies. Lancet 340, 351-355.
25. SOLEMAN, N., CHANDRAMOHAN, D. AND SHIBUYA, K. (2006). Verbal autopsy: current practices and challenges. Bulletin of the World Health Organization 84, 239-245.
26. SPIRTES P., GLYMOUR C., SCHEINES R., MEEK C., FIENBERG S. AND SLATE E. (1999). Prediction and experimental design with graphical causal models. In: Glymour, C. and Cooper, G. F. (editors), Computation, Causation & Discovery. Menlo Park, CA: AAAI Press/The MIT Press, pp. 65-94.
27. WALDEMAR, G., DUBOIS, B., EMRE, M., GEORGES, J., MCKEITH, I. G., ROSSOR, M., SCHELTENS, P., TARISKA, P. AND WINBLAD, B. (2007). Recommendations for the diagnosis and management of Alzheimers disease and other disorders associated with dementia: EFNS guideline. European Journal of Neurology 14, e1-e26.
28. WORLD HEALTH ORGANIZATION (1999). Pneumococcal vaccines\WHO position paper. Weekly Epidemiological Record 74, 177-184. Available at http://www.who.int/docstore/wer/pdf/1999/wer7423.pdf.