Statistical analysis plan for the Erythropoietin in Traumatic Brain Injury trial: A randomised controlled trial of erythropoietin versus placebo in moderate and severe traumatic brain injury

Trials

Volumn 15, Issue 1, 2014, Pages

  Presneill, Jeffrey ^a,b   Little, Lorraine ^a   Nichol, Alistair ^a,c,d,e   French, Craig ^f,g   Cooper, D James ^a,e   Haddad, Samir ^a,h   Duranteau, Jacques ^a,i   Huet, Olivier ^j   Skrifvars, Markus ^k   Arabi, Yaseen ^a,l   Bellomo, Rinaldo ^a,g,m  

^a MONASH UNIVERSITY   (Australia)

^b MATER HOSPITAL   (Australia)

^c ST VINCENT S UNIVERSITY HOSPITAL   (Ireland)

^d UNIVERSITY COLLEGE DUBLIN   (Ireland)

^e The Alfred   (Australia)

^f WESTERN HEALTH   (Australia)

^g UNIVERSITY OF MELBOURNE   (Australia)

^h KING SAUD BIN ABDULAZIZ UNIVERSITY FOR HEALTH SCIENCES   (Saudi Arabia)

ⁱ BICÊTRE HOSPITAL   (France)

^j SERVICE DE RHUMATOLOGIE   (France)

^k HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^l KING SAUD BIN ABDULAZIZ UNIVERSITY FOR HEALTH SCIENCES   (Saudi Arabia)

^m AUSTIN HEALTH   (Australia)

more..

Author keywords

Critical care; Erythropoietin; Outcome; Randomised controlled trials; Traumatic brain injury

Indexed keywords

PLACEBO; RECOMBINANT ERYTHROPOIETIN; ERYTHROPOIETIN; NEUROPROTECTIVE AGENT;

ADOLESCENT; ADULT; AGED; ARTICLE; CEREBROVASCULAR DISEASE; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; CRITICALLY ILL PATIENT; DEEP VEIN THROMBOSIS; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; GLASGOW OUTCOME SCALE; HEART ARREST; HEART INFARCTION; HUMAN; INTENTION TO TREAT ANALYSIS; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MEDICATION COMPLIANCE; MORTALITY; MULTICENTER STUDY; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL; QUALITY ADJUSTED LIFE YEAR; RANDOMIZED CONTROLLED TRIAL; RISK BENEFIT ANALYSIS; RISK REDUCTION; TRAUMATIC BRAIN INJURY; TREATMENT OUTCOME; AUSTRALIA; BRAIN INJURIES; CLINICAL PROTOCOL; CLINICAL TRIAL; CONVALESCENCE; COST BENEFIT ANALYSIS; CRITICAL ILLNESS; DISABILITY; DRUG ADMINISTRATION; DRUG COST; ECONOMICS; EUROPE; FEMALE; INJURY SCALE; MALE; METHODOLOGY; MIDDLE AGED; NEW ZEALAND; PROSPECTIVE STUDY; QUALITY OF LIFE; SAUDI ARABIA; STATISTICAL ANALYSIS; STATISTICAL MODEL; STATISTICS AND NUMERICAL DATA; SUBCUTANEOUS DRUG ADMINISTRATION; TIME FACTOR; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AUSTRALIA; BRAIN INJURIES; CLINICAL PROTOCOLS; COST-BENEFIT ANALYSIS; CRITICAL ILLNESS; DATA INTERPRETATION, STATISTICAL; DISABILITY EVALUATION; DRUG ADMINISTRATION SCHEDULE; DRUG COSTS; ERYTHROPOIETIN; EUROPE; FEMALE; HUMANS; INJECTIONS, SUBCUTANEOUS; INJURY SEVERITY SCORE; MALE; MIDDLE AGED; MODELS, STATISTICAL; NEUROPROTECTIVE AGENTS; NEW ZEALAND; PROSPECTIVE STUDIES; QUALITY OF LIFE; RECOVERY OF FUNCTION; RESEARCH DESIGN; SAUDI ARABIA; TIME FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84928545094     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-15-501     Document Type: Article

References (28)

1. Nichol AD, Higgins AM, Gabbe BJ, Murray LJ, Cooper DJ, Cameron PA: Measuring functional and quality of life outcomes following major head injury: common scales and checklists. Injury 2011, 42:281-287. 10.1016/j.injury.2010.11.047.
2. Myburgh JA, Cooper DJ, Finfer SR, Venkatesh B, Jones D, Higgins A, Bishop N, Higlett T: Epidemiology and 12-month outcomes from traumatic brain injury in Australia and New Zealand. J Trauma 2008, 64:854-862. 10.1097/TA.0b013e3180340e77.
3. Moore EM, Bellomo R, Nichol AD: Erythropoietin as a novel brain and kidney protective agent. Anaesth Intensive Care 2011, 39:356-372.
4. Nichol AD, Cooper DJ: Can we improve neurological outcomes in severe traumatic brain injury? Something old (early prophylactic hypothermia) and something new (erythropoietin). Injury 2009, 40:471-478. 10.1016/j.injury.2009.01.002.
5. Nichol A, Little L, French C: Erythropoietin for traumatic brain injury. JAMA 2014, 312:1928-1929. 10.1001/jama.2014.12738.
6. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH Harmonised Tripartite Guideline: E6(R1) - Guideline for good clinical practice. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf
7. Erythropoietin in Traumatic Brain Injury (EPO-TBI) http://clinicaltrials.gov/show/NCT00987454
8. Schulz KF, Altman DG, Moher D: CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010, 340:c332. 10.1136/bmj.c332.
9. ICH Harmonised Tripartite Guideline: E9 - Statistical principles for clinical trials http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf
10. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH Harmonised Tripartite Guideline: E3 - Structure and content of clinical study reports. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf
11. Monash University: The Clinical Informatics and Data Management Unit (CIDMU). http://www.med.monash.edu.au/sphpm/cidmu/
12. Fergusson D, Aaron SD, Guyatt G, Hebert P: Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis. BMJ 2002, 325:652-654. 10.1136/bmj.325.7365.652.
13. Teasdale GM, Pettigrew LE, Wilson JT, Murray G, Jennett B: Analyzing outcome of treatment of severe head injury: a review and update on advancing the use of the Glasgow Outcome Scale. J Neurotrauma 1998, 15:587-597. 10.1089/neu.1998.15.587.
14. European Medicines Agency: Guideline on adjustment for baseline covariates. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/06/WC500144946.pdf
15. Marshall LF, Marshall SB, Klauber MR, Van Berkum CM, Eisenberg H, Jane JA, Luerssen TG, Marmarou A, Foulkes MA: The diagnosis of head injury requires a classification based on computed axial tomography. J Neurotrauma 1992,9(Suppl 1):S287-S292.
16. Hosmer DW, Lemeshow S, Sturdivant RX: Applied Logistic Regression. Hoboken, New Jersey: Wiley; 2013.
17. Roozenbeek B, Lingsma HF, Perel P, Edwards P, Roberts I, Murray GD, Maas AI, Steyerberg EW: The added value of ordinal analysis in clinical trials: an example in traumatic brain injury. Crit Care 2011, 15:R127. 10.1186/cc10240.
18. Steyerberg EW, Mushkudiani N, Perel P, Butcher I, Lu J, McHugh GS, Murray GD, Marmarou A, Roberts I, Habbema JD, Maas AI: Predicting outcome after traumatic brain injury: development and international validation of prognostic scores based on admission characteristics. PLoS Med 2008, 5:e165. 10.1371/journal.pmed.0050165.
19. Cummings P: Converting an adjusted odds ratio to a risk ratio will produce biased estimates. BMJ 2014, 348:f7450/rr/684808.
20. Grant RL: Converting an odds ratio to a range of plausible relative risks for better communication of research findings. BMJ 2014, 348:g2124.
21. Norton EC, Miller MM, Kleinman LC: Computing adjusted risk ratios and risk differences in Stata. Stata J 2013, 13:492-509.
22. Ware J Jr, Kosinski M, Keller SD: A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996, 34:220-233. 10.1097/00005650-199603000-00003.
23. Group EQ: EuroQol - a new facility for the measurement of health-related quality of life. Health Policy 1990, 16:199-208.
24. Jennison C, Turnbull BW: Group Sequential Methods with Applications to Clinical Trials. Boca Raton, Florida: Chapman & Hall/CRC; 2000.
25. The SAFE Study Investigators: Saline or albumin for fluid resuscitation in patients with traumatic brain injury. N Engl J Med 2007, 357:874-884.
26. Hardin JW, Hilbe JM: Generalized Linear Models and Extensions. College Station, Texas, USA: Stata Press; 2012.
27. Brant R: Assessing proportionality in the proportional odds model for ordinal logistic regression. Biometrics 1990, 46:1171-1178. 10.2307/2532457.
28. Grambsch PM, Therneau TM: Proportional hazards tests and diagnostics based on weighted residuals. Biometrika 1994, 81:515-526. 10.1093/biomet/81.3.515.