Minimizing errors in acute traumatic spinal cord injury trials by acknowledging the heterogeneity of spinal cord anatomy and injury severity: An observational Canadian cohort analysis

Journal of Neurotrauma

Volumn 31, Issue 18, 2014, Pages 1540-1547

  Dvorak, Marcel F ^a   Noonan, Vanessa K ^a,b   Fallah, Nader ^a,b   Fisher, Charles G ^a   Rivers, Carly S ^b   Ahn, Henry ^c   Tsai, Eve C ^d   Linassi, A G ^e   Christie, Sean D ^f   Attabib, Najmedden ^g,h   Hurlbert, R John ⁱ   Fourney, Daryl R ^u   Johnson, Michael G ^j   Fehlings, Michael G ^k   Drew, Brian ^l,m   Bailey, Christopher S ⁿ   Paquet, Jérôme ^o   Parent, Stefan ^p,q   Townson, Andrea ^a   Ho, Chester ⁱ   Craven, B C ^r   Gagnon, Dany ^q   Tsui, Deborah ^s   Fox, Richard ^t   Mac Thiong, Jean Marc ^p   Kwon, Brian K ^a   more..

^a UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^b RICK HANSEN INSTITUTE   (Canada)

^c ST MICHAEL'S HOSPITAL   (Canada)

^d UNIVERSITY OF OTTAWA   (Canada)

^e UNIVERSITY OF SASKATCHEWAN   (Canada)

^f DALHOUSIE UNIVERSITY   (Canada)

^g HORIZON HEALTH NETWORK   (Canada)

^h SAINT JOHN REGIONAL HOSPITAL   (Canada)

ⁱ UNIVERSITY OF CALGARY   (Canada)

^j UNIVERSITY OF MANITOBA   (Canada)

^k UNIVERSITY OF TORONTO   (Canada)

^l Hamilton General Division   (Canada)

^m MCMASTER UNIVERSITY   (Canada)

ⁿ UNIVERSITY OF WESTERN ONTARIO   (Canada)

^o LAVAL UNIVERSITY   (Canada)

^p UNIVERSITY OF MONTREAL   (Canada)

^q UNIVERSITÉ DE MONTRÉAL   (Canada)

^r TORONTO REHABILITATION INSTITUTE   (Canada)

^s HAMILTON HEALTH SCIENCES   (Canada)

^t ROYAL ALEXANDRA HOSPITAL   (Canada)

^u UNIVERSITY OF SASKATCHEWAN   (Canada)

more..

Author keywords

bias; motor score; neurological recovery; spinal cord injury; statistical error

Indexed keywords

ADOLESCENT; ADULT; AGED; AMERICAN SPINAL INJURY ASSOCIATION IMPAIRMENT SCALE; ARTICLE; CAUDA EQUINA; COHORT ANALYSIS; DISEASE REGISTRY; FEMALE; FOLLOW UP; GLASGOW COMA SCALE; HUMAN; INJURY SEVERITY; KRUSKAL WALLIS TEST; MAJOR CLINICAL STUDY; MALE; NEUROLOGIC EXAMINATION; OBSERVATIONAL STUDY; SAMPLE SIZE; SPINAL CORD INJURY; THORAX INJURY; CANADA; CLINICAL TRIAL; CONVALESCENCE; INJURY SCALE; MIDDLE AGED; MULTICENTER STUDY; PATHOLOGY; PHYSIOLOGY; RANDOMIZED CONTROLLED TRIAL (TOPIC); SPINAL CORD INJURIES; STANDARDS; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; CANADA; COHORT STUDIES; FEMALE; HUMANS; MALE; MIDDLE AGED; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECOVERY OF FUNCTION; SPINAL CORD INJURIES; TRAUMA SEVERITY INDICES; YOUNG ADULT;

EID: 84907057757     PISSN: 08977151     EISSN: 15579042     Source Type: Journal    
DOI: 10.1089/neu.2013.3278     Document Type: Article

References (35)

1. Tator, C.H., Hashimoto, R., Raich, A., Norvell, D., Fehlings, M.G., Harrop, J.S., Guest, J., Aarabi, B., and Grossman, R.G. (2012). Translational potential of preclinical trials of neuroprotection through pharmacotherapy for spinal cord injury. J. Neurosurg. Spine 17(1 Suppl), 157-229.
2. Blight, A., Curt, A., Ditunno, J.F., Dobkin, B., Ellaway, P., Fawcett, J., Fehlings, M., Grossman, R.G., Lammertse, D.P., Privat, A., Steeves, J., Tuszynski, M., Kalichman, M., and Guest, J.D. (2009). Position statement on the sale of unproven cellular therapies for spinal cord injury The International Campaign for Cures of Spinal Cord Injury Paralysis. Spinal Cord 7, 713-714.
3. Bailey, C.S., Fisher, C.G., and Dvorak, M.F. (2004). Type II error in the spine surgical literature. Spine 29, 1146-1149.
4. Button, K.S., Ioannidis, J.P.A., Mokrysz, C., Nosek, B.A., Flint, J., Robinson, E.S.J., and Munafò, M.R. (2013). Power failure: why small sample size undermines the reliability of neuroscience. Nat. Rev. Neurosci. 14, 65-76.
5. Steeves, J.D., Lammertse, D., Curt, A., Fawcett, J.W., Tuszynski, M.H., Ditunno, J.F., Dobkin, B.H., Havton, L.A., Ellaway, P.H., Fehlings, M.G., Privat, A., Grossman, R., Guest, J.D., Kleitman, N., Nakamura, M., Gaviria, M., and Short, D. (2006). Guidelines for the conduct of clinical trials for spinal cord injury (SCI) as developed by the ICCP panel: clinical trial outcome measures. Spinal Cord 45, 206-221.
6. Tator, C.H. (2006). Review of treatment trials in human spinal cord injury: issues, difficulties, and recommendations. Neurosurgery 59, 957-982.
7. Maas, A.I.R., Menon, D.K., Lingsma, H.F., Pineda, J.A., Sandel, M.E., and Manley, G.T. (2012). Re-orientation of clinical research in traumatic brain injury: report of an international workshop on comparative effectiveness research. J. Neurotrauma 29, 32-46.
8. 1998 Neuroprotection as initial therapy in acute stroke. Third Report of an Ad Hoc Consensus Group Meeting. The European Ad Hoc Consensus Group. Cerebrovasc. Dis. 8, 59-72.
9. Steyerberg, E.W., Bossuyt, P.M., and Lee, K.L. (2000). Clinical trials in acute myocardial infarction: should we adjust for baseline characteristics? Am. Heart J. 139, 745-751.
10. Lee, R.S.R., Noonan, V.K., Batke, J., Ghag, A., Paquette, S.J., Boyd, M.C., Fisher, C.G., Street, J., Dvorak, M.F., and Kwon, B.K. (2012). Feasibility of patient recruitment into clinical trials of experimental treatments for acute spinal cord injury. J. Clin. Neurosci. 19, 338-343.
11. Anderson, K.D. (2004). Targeting recovery: priorities of the spinal cord-injured population. J. Neurotrauma 21, 1371-1383.
12. Scivoletto, G., Tamburella, F., Laurenza, L., and Molinari, M. (2013). Distribution-based estimates of clinically significant changes in the international standards for neurological classification of spinal cord injury motor and sensory scores. Eur. J. Phys. Rehabil. Med. 49, 373-384.
13. Kirshblum, S.C., Burns, S.P., Biering-Sorensen, F., Donovan, W., Graves, D.E., Jha, A., Johansen, M., Jones, L., Krassioukov, A., Mulcahey, M.J., Schmidt-Read, M., and Waring, W. (2011). International standards for neurological classification of spinal cord injury (Revised 2011). J. Spinal Cord Med. 34, 535-546.
14. Tuszynski, M.H., Steeves, J.D., Fawcett, J.W., Lammertse, D., Kalichman, M., Rask, C., Curt, A., Ditunno, J.F., Fehlings, M.G., Guest, J.D., Ellaway, P.H., Kleitman, N., Bartlett, P.F., Blight, A.R., Dietz, V., Dobkin, B.H., Grossman, R., and Privat, A.; International Campaign for Cures of Spinal Cord Injury Paralysis. (2007). Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP Panel: clinical trial inclusion/exclusion criteria and ethics. Spinal Cord 45, 222-231.
15. Steeves, J.D., Kramer, J.K., Fawcett, J.W., Cragg, J., Lammertse, D.P., Blight, A.R., Marino, R.J., Ditunno, J.F. Jr., Coleman, W.P., Geisler, F.H., Guest, J., Jones, L., Burns, S., Schubert, M., and van Hedel, H.J., Curt, A.; EMSCI Study Group. (2011). Extent of spontaneous motor recovery after traumatic cervical sensorimotor complete spinal cord injury. Spinal Cord 49, 257-265.
16. Fawcett, J.W., Curt, A., Steeves, J.D., Coleman, W.P., Tuszynski, M.H., Lammertse, D., Bartlett, P.F., Blight, A.R., Dietz, V., Ditunno, J., Dobkin, B.H., Havton, L.A., Ellaway, P.H., Fehlings, M.G., Privat, A., Grossman, R., Guest, J.D., Kleitman, N., Nakamura, M., Gaviria, M., and Short, D. (2007). Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: spontaneous recovery after spinal cord injury and statistical power needed for therapeutic clinical trials. Spinal Cord 45, 190-205.
17. Lammertse, D., Tuszynski, M.H., Steeves, J.D., Curt, A., Fawcett, J.W., Rask, C., Ditunno, J.F., Fehlings, M.G., Guest, J.D., Ellaway, P.H., Kleitman, N., Blight, A.R., Dobkin, B.H., Grossman, R., Katoh, H., Privat, A., and Kalichman, M.; International Campaign for Cures of Spinal Cord Injury Paralysis. (2007). Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: clinical trial design. Spinal Cord 45, 232-42.
18. Geisler, F.H.F., Dorsey, F.C.F., and Coleman, W.P.W. (1991). Recovery of motor function after spinal-cord injury-a randomized, placebo-controlled trial with GM-1 ganglioside. N. Engl. J. Med. 324, 1829-1838.
19. Coleman, W.P. and Geisler, F.H. (2004). Injury severity as primary predictor of outcome in acute spinal cord injury: retrospective results from a large multicenter clinical trial. Spine J. 4, 73-78.
20. Al-Habib, A.F., Attabib, N., Ball, J., Bajammal, S., Casha, S., and Hurlbert, R.J. (2011). Clinical predictors of recovery after blunt spinal cord trauma: systematic review. J. Neurotrauma 28, 1431-1443.
21. Steeves, J., Fawcett, J., and Tuszynski, M. (2004). Report of International Clinical Trials Workshop on Spinal Cord Injury February 20-21, 2004, Vancouver, Canada. Spinal Cord 42, 591-597.
22. Geisler, F.H., Coleman, W.P., Grieco, G., and Poonian, D.; Sygen Study Group. (2001). The Sygen multicenter acute spinal cord injury study. Spine 26(24 Suppl), S87-S98.
23. Fehlings, M.G., Vaccaro, A., Wilson, J.R., Singh, A.W., Cadotte, D., Harrop, J.S., Aarabi, B., Shaffrey, C., Dvorak, M., Fisher, C., Arnold, P., Massicotte, E.M., Lewis, S., and Rampersaud, R. (2012). Early versus delayed decompression for traumatic cervical spinal cord injury: results of the Surgical Timing in Acute Spinal Cord Injury Study (STASCIS). PLoS ONE. 7, e32037.
24. Blight, A.R. and Tuszynski, M.H. (2006). Clinical trials in spinal cord injury. J. Neurotrauma 23, 586-593.
25. Noonan, V.K., Kwon, B.K., Soril, L., Fehlings, M.G., Hurlbert, R.J., Townson, A., Johnson, M., Dvorak, M.F.; RHSCIR Network. (2011). The Rick Hansen Spinal Cord Injury Registry (RHSCIR): a national patient-registry. Spinal Cord 50, 22-27.
26. Furlan, J.C., Noonan, V., Singh, A., and Fehlings, M.G. (2011). Assessment of impairment in patients with acute traumatic spinal cord injury: a systematic review of the literature. J. Neurotrauma 28, 1445-1477.
27. Geisler, F.H., Coleman,W.P., Grieco, G., and Poonian, D.; Sygen Study Group. (2001). Measurements and recovery patterns in a multicenter study of acute spinal cord injury. Spine 26(24 Suppl), S68-S86.
28. Fehlings, M.G., Theodore, N., Harrop, J., Maurais, G., Kuntz, C., Shaffrey, C.I., Kwon, B.K., Chapman, J., Yee, A., Tighe, A., and McKerracher, L. (2011). A phase I/IIa clinical trial of a recombinant rho protein antagonist in acute spinal cord injury. J. Neurotrauma 28, 787-796.
29. Casha, S., Zygun, D., McGowan, M.D., Bains, I., Yong, V.W., and Hurlbert, R.J. (2012). Results of a phase II placebo-controlled randomized trial of minocycline in acute spinal cord injury. Brain 135, 1224-1236.
30. Lammertse, D.P., Jones, L.A., Charlifue, S.B., Kirshblum, S.C., Apple, D.F., Ragnarsson, K.T., Falci, S.P., Heary, R.F., Choudhri, T.F., Jenkins, A.L., Betz, R.R., Poonian, D., Cuthbert, J.P., Jha, A., Snyder, D.A., and Knoller, N. (2012). Autologous incubated macrophage therapy in acute, complete spinal cord injury: results of the phase 2 randomized controlled multicenter trial. Spinal Cord 50, 661-671.
31. Bracken, M.B., Shepard, M.J., Collins, W.F., Holford, T.R., Young, W., Baskin, D.S., Eisenberg, H.M., Flamm, E., Leo-Summers, L., Maroon, J., Marshall, L.F., Perot, P.L., Jr., Piepmeier, J., Sonntag, V.K.H., Wagner, F.C., Wilberger, J.E., and Winn, H.R. (1990). A randomized, controlled trial of methylprednisolone or naloxone in the treatment of acute spinal-cord injury: results of the Second National Acute Spinal Cord Injury Study. N. Engl. J. Med. 322, 1405-1411.
32. Marino, R.J. and Graves, D.E. (2004). Metric properties of the ASIA motor score: subscales improve correlation with functional activities. Arch. Phys. Med. Rehab. 85, 1804-1810.
33. Kingwell, S.P., Noonan, V.K., Fisher, C.G., Graeb, D.A., Keynan, O., Zhang, H., and Dvorak, M.F. (2010). Relationship of neural axis level of injury to motor recovery and health-related quality of life in patients with a thoracolumbar spinal injury. J. Bone Joint Surg. Am. 92, 1591-1599.
34. Pollard, M.E. and Apple, D.F. (2003). Factors associated with improved neurologic outcomes in patients with incomplete tetraplegia. Spine 28, 33-39.
35. Schuld, C., Wiese, J., Franz, S., Putz, C., Stierle, I., Smoor, I., and Weidner, N.; EMSCI Study Group, Rupp R. (2013). Effect of formal training in scaling, scoring and classification of the International Standards for Neurological Classification of Spinal Cord Injury. Spinal Cord 51, 282-288.