| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
(Stroke. 2000;31:1429.)
© 2000 American Heart Association, Inc.
Comments, Opinions, and Reviews |
Outcome Measures in Acute Stroke Trials
A Systematic Review and Some Recommendations to Improve Practice
From the Center on Aging (P.W.D.), University of Kansas Medical Center, Kansas City; Rivermead Rehabilitation Centre (D.T.W.), Oxford, England; the Department of Neurology (H.S.J.), Bispebjerg Hospital, Copenhagen, Denmark; and the Department of Veterans Affairs Medical Center (P.W.D.), Kansas City, Mo.
Correspondence to Pamela W. Duncan, PhD, FAPTA, Center on Aging, University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160-7117. E-mail pduncan{at}kumc.edu
Background—There is little consistency in the measurement of outcome in acute stroke trials, and this may complicate interpretation of the results and reduce the likelihood of detecting worthwhile drug effects. This study aims to investigate empirically the measures used to date and to give recommendations for future studies.
Summary of Comment—A systematic review of all published randomized studies of acute stroke drug intervention was undertaken, and the measures used were recorded. Fifty-one studies involving 57 214 subjects were identified. These studies used 14 different measures of impairment, 11 different measures of activity, 1 measure of "quality of life," and 8 miscellaneous other measures. Timing of outcome assessments varied from 1 week to 1 year, with the modal time being 3 months. Many studies used ordinal measures but dichotomized results for analysis. Of the 51 studies included in the review, only 21 demonstrated benefit with the defined primary outcome measure. In several studies, however, post hoc analysis using varied outcome measures or varied cut points for dichotomizing outcomes resulted in positive results, whereas the primary study analysis failed to do so.
Conclusions—There is no consensus on the level of outcome to be used, the method of measurement to be used, or the most appropriate timing of the assessment. It is recommended that future studies should include extended/instrumental activities and advanced mobility as components of the primary outcome measure, with outcome assessment being undertaken at 6 months. New initiatives in developing stroke-specific outcomes may address some of the current problems in the assessment of stroke outcomes
Key Words: outcome • stroke
This article has been cited by other articles:
 |
|
 |
|
  N. J. Donovan, D. L. Kendall, S. C. Heaton, S. Kwon, C. A. Velozo, and P. W. Duncan Conceptualizing Functional Cognition in Stroke Neurorehabil Neural Repair, April 1, 2008; 22(2): 122 - 135. [Abstract] [PDF]
|
|
|
|
|
|
N. Yozbatiran, L. Der-Yeghiaian, and S. C. Cramer A Standardized Approach to Performing the Action Research Arm Test Neurorehabil Neural Repair, February 1, 2008; 22(1): 78 - 90. [Abstract] [PDF]
|
|
|
|
 |
|
 T. J. Quinn, J. Dawson, J. S. Lees, T.-P. Chang, M. R. Walters, K. R. Lees, and for the GAIN and VISTA Investigators Time Spent at Home Poststroke: "Home-Time" a Meaningful and Robust Outcome Measure for Stroke Trials Stroke, January 1, 2008; 39(1): 231 - 233. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
E. MacDonald, H. Van der Lee, D. Pocock, C. Cole, N. Thomas, P. M. VandenBerg, R. Bourtchouladze, and J. A. Kleim A Novel Phosphodiesterase Type 4 Inhibitor, HT-0712, Enhances Rehabilitation-Dependent Motor Recovery and Cortical Reorganization After Focal Cortical Ischemia Neurorehabil Neural Repair, December 1, 2007; 21(6): 486 - 496. [Abstract] [PDF]
|
|
|
|
 |
|
 A.-K. Welmer, M. von Arbin, V. Murray, L. W. Holmqvist, and D. K Sommerfeld Determinants of Mobility and Self-care in Older People With Stroke: Importance of Somatosensory and Perceptual Functions Physical Therapy, December 1, 2007; 87(12): 1633 - 1641. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
T. J. Quinn, K. R. Lees, H.-G. Hardemark, J. Dawson, and M. R. Walters Initial Experience of a Digital Training Resource for Modified Rankin Scale Assessment in Clinical Trials Stroke, August 1, 2007; 38(8): 2257 - 2261. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. L. Saver Hemorrhage After Thrombolytic Therapy for Stroke: The Clinically Relevant Number Needed to Harm Stroke, August 1, 2007; 38(8): 2279 - 2283. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. Schmid, P. W. Duncan, S. Studenski, S. M. Lai, L. Richards, S. Perera, and S. S. Wu Improvements in Speed-Based Gait Classifications Are Meaningful Stroke, July 1, 2007; 38(7): 2096 - 2100. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M.-Y. Tseng, P. J. Hutchinson, M. Czosnyka, H. Richards, J. D. Pickard, and P. J. Kirkpatrick Effects of Acute Pravastatin Treatment on Intensity of Rescue Therapy, Length of Inpatient Stay, and 6-Month Outcome in Patients After Aneurysmal Subarachnoid Hemorrhage Stroke, May 1, 2007; 38(5): 1545 - 1550. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M.-H. Chen, C.-L. Hsieh, H.-F. Mao, and S.-L. Huang Differences between patient and proxy reports in the assessment of disability after stroke Clinical Rehabilitation, April 1, 2007; 21(4): 351 - 356. [Abstract] [PDF]
|
|
|
|
|
|
M. Eriksson, P. Appelros, B. Norrving, A. Terent, and B. Stegmayr Assessment of Functional Outcome in a National Quality Register for Acute Stroke: Can Simple Self-Reported Items Be Transformed Into the Modified Rankin Scale? Stroke, April 1, 2007; 38(4): 1384 - 1386. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 C. M. Boyd, C. O. Weiss, J. Halter, K. C. Han, W. B. Ershler, and L. P. Fried Framework for Evaluating Disease Severity Measures in Older Adults With Comorbidity J. Gerontol. A Biol. Sci. Med. Sci., March 1, 2007; 62(3): 286 - 295. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. Chamorro, M. Vargas, and J. Mensa Response to Letter by Kwan et al Stroke, July 1, 2006; 37(7): 1657 - 1657. [Full Text] [PDF]
|
|
|
|
|
|
J. Kwan, H. C. Roberts, and N. Englyst Do We Really Understand the Pathophysiology and Clinical Impact of Poststroke Infection? Stroke, July 1, 2006; 37(7): 1656 - 1656. [Full Text] [PDF]
|
|
|
|
|
|
F. Song, C. Jerosch-Herold, R. Holland, M. d. L. Drachler, K. Mares, and I. Harvey Statistical methods for analysing Barthel scores in trials of poststroke interventions: a review and computer simulations Clinical Rehabilitation, April 1, 2006; 20(4): 347 - 356. [Abstract] [PDF]
|
|
|
|
 |
|
 C. A. Anderson, D. B. Arciniegas, and C. M. Filley Treatment of Acute Ischemic Stroke: Does It Impact Neuropsychiatric Outcome? J Neuropsychiatry Clin Neurosci, November 1, 2005; 17(4): 486 - 488. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
F. B. Young, C. J. Weir, K. R. Lees, and for the GAIN International Trial Steering Committe Comparison of the National Institutes of Health Stroke Scale With Disability Outcome Measures in Acute Stroke Trials Stroke, October 1, 2005; 36(10): 2187 - 2192. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. Uyttenboogaart, R. E. Stewart, P. C.A.J. Vroomen, J. De Keyser, and G.-J. Luijckx Optimizing Cutoff Scores for the Barthel Index and the Modified Rankin Scale for Defining Outcome in Acute Stroke Trials Stroke, September 1, 2005; 36(9): 1984 - 1987. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. M. Ferro, P. Canhao, M.-G. Bousser, J. Stam, F. Barinagarrementeria, and for the ISCVT Investigators Cerebral Vein and Dural Sinus Thrombosis in Elderly Patients Stroke, September 1, 2005; 36(9): 1927 - 1932. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 C. Foerch, O. C. Singer, T. Neumann-Haefelin, R. du Mesnil de Rochemont, H. Steinmetz, and M. Sitzer Evaluation of Serum S100B as a Surrogate Marker for Long-term Outcome and Infarct Volume in Acute Middle Cerebral Artery Infarction Arch Neurol, July 1, 2005; 62(7): 1130 - 1134. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
S. E. Lord and L. Rochester Measurement of Community Ambulation After Stroke: Current Status and Future Developments Stroke, July 1, 2005; 36(7): 1457 - 1461. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. T. L. Wilson, A. Hareendran, A. Hendry, J. Potter, I. Bone, and K. W. Muir Reliability of the Modified Rankin Scale Across Multiple Raters: Benefits of a Structured Interview Stroke, April 1, 2005; 36(4): 777 - 781. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. H. Kim, C. L. Haney, and G. Van Ginhoven Utility of Outcome Measures After Treatment for Intracranial Aneurysms: A Prospective Trial Involving 520 Patients Stroke, April 1, 2005; 36(4): 792 - 796. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 T. A. Glass, L. F. Berkman, E. F. Hiltunen, K. Furie, M. M. Glymour, M. E. Fay, and J. Ware The Families In Recovery From Stroke Trial (FIRST): Primary Study Results Psychosom Med, November 1, 2004; 66(6): 889 - 897. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. L. Saver Number Needed to Treat Estimates Incorporating Effects Over the Entire Range of Clinical Outcomes: Novel Derivation Method and Application to Thrombolytic Therapy for Acute Stroke Arch Neurol, July 1, 2004; 61(7): 1066 - 1070. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 L. Kalra, A. Evans, I. Perez, A. Melbourn, A. Patel, M. Knapp, and N. Donaldson Training carers of stroke patients: randomised controlled trial BMJ, May 8, 2004; 328(7448): 1099. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
I-P. Hsueh, W.-C. Wang, C.-F. Sheu, and C.-L. Hsieh Rasch Analysis of Combining Two Indices to Assess Comprehensive ADL Function in Stroke Patients Stroke, March 1, 2004; 35(3): 721 - 726. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 G. H. Danton and W. D. Dietrich The Search for Neuroprotective Strategies in Stroke AJNR Am. J. Neuroradiol., February 1, 2004; 25(2): 181 - 194. [Full Text] [PDF]
|
|
|
|
 |
|
 N. S. Ward, M. M. Brown, A. J. Thompson, and R. S. J. Frackowiak Neural correlates of motor recovery after stroke: a longitudinal fMRI study Brain, November 1, 2003; 126(11): 2476 - 2496. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
F. B. Young, K. R. Lees, and C. J. Weir Strengthening Acute Stroke Trials Through Optimal Use of Disability End Points Stroke, November 1, 2003; 34(11): 2676 - 2680. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
PROGRESS Effects of a Perindopril-Based Blood Pressure-Lowering Regimen on Disability and Dependency in 6105 Patients With Cerebrovascular Disease: A Randomized Controlled Trial Stroke, October 1, 2003; 34(10): 2333 - 2338. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 B. Als-Nielsen, W. Chen, C. Gluud, and L. L. Kjaergard Association of Funding and Conclusions in Randomized Drug Trials: A Reflection of Treatment Effect or Adverse Events? JAMA, August 20, 2003; 290(7): 921 - 928. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
N. S. Ward, M. M. Brown, A. J. Thompson, and R. S. J. Frackowiak Neural correlates of outcome after stroke: a cross-sectional fMRI study Brain, June 1, 2003; 126(6): 1430 - 1448. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. Fisher Recommendations for Advancing Development of Acute Stroke Therapies: Stroke Therapy Academic Industry Roundtable 3 Stroke, June 1, 2003; 34(6): 1539 - 1546. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. L. Tirschwell, W.T. Longstreth Jr, K. J. Becker, R. E. Gammans Sr, L. A. Sabounjian, S. Hamilton, and L. B. Morgenstern Shortening the NIH Stroke Scale for Use in the Prehospital Setting Stroke, December 1, 2002; 33(12): 2801 - 2806. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. W. Sturm, R. H. Osborne, H. M. Dewey, G. A. Donnan, R. A.L. Macdonell, and A. G. Thrift Brief Comprehensive Quality of Life Assessment After Stroke: The Assessment of Quality of Life Instrument in the North East Melbourne Stroke Incidence Study (NEMESIS) Stroke, December 1, 2002; 33(12): 2888 - 2894. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
C.-L. Hsieh, C.-F. Sheu, I-P. Hsueh, and C.-H. Wang Trunk Control as an Early Predictor of Comprehensive Activities of Daily Living Function in Stroke Patients Stroke, November 1, 2002; 33(11): 2626 - 2630. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J.T. L. Wilson, A. Hareendran, M. Grant, T. Baird, U. G.R. Schulz, K. W. Muir, and I. Bone Improving the Assessment of Outcomes in Stroke: Use of a Structured Interview to Assign Grades on the Modified Rankin Scale Stroke, September 1, 2002; 33(9): 2243 - 2246. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. J. Gladstone, S. E. Black, and A. M. Hakim Toward Wisdom From Failure: Lessons From Neuroprotective Stroke Trials and New Therapeutic Directions Stroke, August 1, 2002; 33(8): 2123 - 2136. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. Garratt, L. Schmidt, A. Mackintosh, and R. Fitzpatrick Quality of life measurement: bibliographic study of patient assessed health outcome measures BMJ, June 15, 2002; 324(7351): 1417 - 1417. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. Sulch, A. Melbourn, I. Perez, and L. Kalra Integrated Care Pathways and Quality of Life on a Stroke Rehabilitation Unit Stroke, June 1, 2002; 33(6): 1600 - 1604. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. J. Eng, K. S. Chu, A. S. Dawson, C.M. Kim, and K. E. Hepburn Functional Walk Tests in Individuals With Stroke: Relation to Perceived Exertion and Myocardial Exertion Stroke, March 1, 2002; 33(3): 756 - 761. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. Evans, F. Harraf, N. Donaldson, and L. Kalra Randomized Controlled Study of Stroke Unit Care Versus Stroke Team Care in Different Stroke Subtypes Stroke, February 1, 2002; 33(2): 449 - 455. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
P. W. Duncan, R. D. Horner, D. M. Reker, G. P. Samsa, H. Hoenig, B. Hamilton, B. J. LaClair, T. K. Dudley, and M. Kelly-Hayes Adherence to Postacute Rehabilitation Guidelines Is Associated With Functional Recovery in Stroke * Editorial Comment Stroke, January 1, 2002; 33(1): 167 - 178. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. G. Celani, T. A. Cantisani, E. Righetti, L. Spizzichino, and S. Ricci Different Measures for Assessing Stroke Outcome: An Analysis From the International Stroke Trial in Italy Stroke, January 1, 2002; 33(1): 218 - 223. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. Spedding Letters to the Editor: Reasons Why Stroke Trials Underestimate the Neuroprotective Effects of Drugs Stroke, January 1, 2002; 33(1): 324 - 325. [Full Text] [PDF]
|
|
|
|
 |
|
 C. Schmitz and E. H. Blackstone International Council of Emboli Management (ICEM) Study Group results: risk adjusted outcomes in intraaortic filtration Eur. J. Cardiothorac. Surg., November 1, 2001; 20(5): 986 - 991. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 D. J. Gladstone and S. E. Black Update on intravenous tissue plasminogen activator for acute stroke: from clinical trials to clinical practice Can. Med. Assoc. J., August 1, 2001; 165(3): 311 - 317. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
C. S. Kidwell, D. S. Liebeskind, S. Starkman, and J. L. Saver Trends in Acute Ischemic Stroke Trials Through the 20th Century Stroke, June 1, 2001; 32(6): 1349 - 1359. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
K. Uchino, D. Billheimer, and S. C. Cramer Entry Criteria and Baseline Characteristics Predict Outcome in Acute Stroke Trials Stroke, April 1, 2001; 32(4): 909 - 916. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. L. Saver, C. S. Kidwell, D. S. Liebeskind, S. Starkman, and P. W. Duncan Acute Ischemic Stroke Trials Response Stroke, January 1, 2001; 32 (1): 275 - 278. [Full Text] [PDF]
|
|