Evaluation of a sequential global test of improved recovery following stroke as applied to the ICTUS trial of citicoline

Pharmaceutical Statistics

Volumn 8, Issue 2, 2009, Pages 136-149

  Bolland, Kim ^a   Whitehead, John ^b   Cobo, Erik ^c   Secades, Julio J ^d  

^a UNIVERSITY OF READING   (United Kingdom)

^b LANCASTER UNIVERSITY   (United Kingdom)

^c UNIVERSITAT POLITÈCNICA DE CATALUNYA   (Spain)

^d Centro de Investigaciones Farmaceuticos Grupo Ferrer   (Spain)

Author keywords

Binary data; Global test; Sample size; Sequential clinical trial; Stroke

Indexed keywords

CITICOLINE; PLACEBO;

ARTICLE; BARTHEL INDEX; CEREBROVASCULAR ACCIDENT; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FISHER EXACT TEST; FOLLOW UP; GENERAL CONDITION IMPROVEMENT; GENERALIZED ESTIMATING EQUATION; HUMAN; LOGISTIC REGRESSION ANALYSIS; MAJOR CLINICAL STUDY; METHODOLOGY; MULTICENTER STUDY; NATIONAL INSTITUTES OF HEALTH STROKE SCALE; NORMAL DISTRIBUTION; NULL HYPOTHESIS; PROBABILITY; PROGNOSIS; RANDOMIZED CONTROLLED TRIAL; RANKIN SCALE; SAMPLE SIZE; SIMULATION; STATISTICAL ANALYSIS; COMPUTER SIMULATION; META ANALYSIS; PHASE 3 CLINICAL TRIAL; STATISTICS; STROKE;

CLINICAL TRIALS, PHASE III AS TOPIC; COMPUTER SIMULATION; CYTIDINE DIPHOSPHATE CHOLINE; HUMANS; META-ANALYSIS AS TOPIC; MULTICENTER STUDIES AS TOPIC; RESEARCH DESIGN; STATISTICS AS TOPIC; STROKE;

EID: 69149092730     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.344     Document Type: Article

References (25)

1. Dávalos A. Protocol 06PRT/3005: ICTUS study: International Citicoline Trial on acUte Stroke (NCT00331890) oral citicoline in acute ischemic stroke. Lancet Protocol Reviews 2007. http:// www.thelancet.com/journals/ lancet/misc/protocol/ protocolreviews.
2. Dávalos A, Castillo J, Álvarez-Sabin J, Secades JJ, Mercadal J, López S, Cobo E, Warach S, Sherman D, Clark WM, Lozano R. Oral citicoline in acute ischemic stroke. Stroke 2002; 33:2850-2857.
3. Tilley PC, Marler J, Geller NL, Lu M, Legler J, Brott T, Lyden P, Grotta J, for the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA Stroke Trial Study Group. Use of a global test for multiple outcomes in stroke trials with application to the National Institute of Neurological Disorders and t-PA Stroke Trial. Stroke 1996; 27:2136-2142.
4. Hacke W, Bluhmki E, Steiner T, Tatlisumak T, Mahagne MH, Sacchetti ML, Meier D, for the ECASS Study Group. Dichotomized efficacy end points and global end-point analysis applied to the ECASS intention-to-treat data set. Post hoc analysis of ECASS I. Stroke 1998; 29:2073-2075. (Pubitemid 28443520)
5. Mahoney FI, Barthel DW. Functional evaluation: the Barthel Index. Maryland State Medical Journal 1965; 14:61-65.
6. Granger CV, Dewis LS, Peters MC, Sherwood CC, Barrett JE. Stroke rehabilitation: analysis of repeated Barthel index measures. Archives of Physical Medicine and Rehabilitation 1979; 60:14-17.
7. Rankin J. Cerebral vascular accidents in patients over the age of 60: II. Prognosis. Scottish Medical Journal 1957; 2:200-215.
8. Van Swieten JC, Koudstaal PJ, Visser MC, Southen HJA, Van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke 1988; 24:35-41. (Pubitemid 18126965)
9. Brott TG, Adams HP, Olinger CP, Marler JR, Barsan WG, Biller J, Spilker J, Holleran R, Eberle R, Hertzberg V, Rorick M, Moomaw CJ, Walker M. Measurements of acute cerebral infarction: a clinical examination scale. Stroke 1989; 20:864-870. (Pubitemid 19188240)
10. Goldstein LB, Bertels C, Davis JN. Interrater reliability of the NIH stroke scale. Archives of Neurology 1989; 46:660-662. (Pubitemid 19150945)
11. Whitehead J. Application of sequential methods to a phase III clinical trial in stroke. Drug Information Journal 1993; 27:733-740. (Pubitemid 23247524)
12. Bolland K, Weeks A, Whitehead J, Lees KR. How a sequential design would have affected the GAIN International Study of Gavestinel in Stroke. Cerebrovascular Diseases 2004; 17:111-117. (Pubitemid 38529185)
13. Whitehead J, Bolland K, Branson M, Todd S. Combining binary and ordinal endpoints from clinical trials: a non-GEE approach, in preparation.
14. O'Brien PC. Procedures for comparing samples with multiple endpoints. Biometrics 1984; 40: 1079-1087.
15. Pocock SJ, Geller NL, Tsiatis AA. The analysis of multiple endpoints in clinical trials. Biometrics 1987; 43:487-498. (Pubitemid 18045135)
16. Liang KY, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika 1986; 73:13-22.
17. SAS Institute. The SAS System for Windows, Release V9.1. SAS Institute: Cary, 2002.
18. Lefkopoulou M, Moore D, Ryan L. The analysis of multiple correlated binary outcomes: application to rodent teratology experiments. Journal of the American Statistical Association 1989; 84:810-815.
19. Legler JM, Lefkopoulou M, Ryan L. Efficiency and power of tests for multiple binary outcomes. Journal of the American Statistical Association 1995; 90: 680-693.
20. Whitehead J. The design and analysis of sequential clinical trials (revised 2nd edn).Wiley: Chichester, 1997.
21. Whitehead J. Use of the triangular test in sequential clinical trials. In Handbook of statistics in clinical oncology, Crowley J (ed.). Dekker: New York, 2001; pp. 211-228.
22. Lan KKG, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika 1983; 70:659-663.
23. O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979; 35:549-556.
24. Armitage P, McPherson CK, Rowe BC. Repeated significance tests on accumulating data. Journal of the Royal Statistical Society, Series A 1969; 132:235-244.
25. Whitehead J. Overrunning and underruning in sequential clinical trials. Controlled Clinical Trials 1992; 13:106-121.