What Should Be Defined As Good Outcome in Stroke Trials; a Modified Rankin Score of 0-1 or 0-2?

Overview

Journal J Neurol

Specialty Neurology

Date 2008 Mar 14

PMID 18338195

Citations 64

Authors

N Weisscher

M Vermeulen

Y B Roos

R J de Haan

Affiliations

Soon will be listed here.

Abstract

Background And Purpose: Good outcome in stroke trials has been defined as a modified Rankin scale (mRs) score of 0-1 or 0-2. The aim of this study was to investigate the clinical meaning of these two dichotomies.

Methods: We studied 152 patients six months post stroke using the mRs and a new disability measure the AMC Linear Disability Scale (ALDS) item bank. Descriptive statistics were used to show the ALDS scores by the levels of the mRs. To investigate the clinical meaning of the different definitions of good outcome, the mean probability to perform activities of daily life (ADL) of all mRs grades and these two dichotomies was calculated.

Results: The ability to perform difficult ALDS items declined gradually with increasing mRs grade. When favourable outcome is defined as mRs 0-1, 15 % of the cohort has a good outcome; of these patients 84 % were likely to perform outdoor activities. If good outcome is defined as mRs 0-2, the percentage of patients with good outcome increased to 37 %, whereas 66 % of these patients were likely to perform outdoor activities.

Conclusion: If good outcome is defined as the ability to perform outdoor activities mRs 0-1 should be chosen. If complex ADL are considered as good outcome mRs 0-2 is the outcome measure of choice. Independent of which outcome measure is chosen, the treatment effect in clinical trials must be large before good outcome is achieved. Therefore, it is likely that clinically important treatment effects can be missed in clinical trials with both these mRs endpoints.

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References

Banks J, Marotta C . Outcomes validity and reliability of the modified Rankin scale: implications for stroke clinical trials: a literature review and synthesis. Stroke. 2007; 38(3):1091-6. DOI: 10.1161/01.STR.0000258355.23810.c6. View

Saver J . Clinical impact of NXY-059 demonstrated in the SAINT I trial: derivation of number needed to treat for benefit over entire range of functional disability. Stroke. 2007; 38(5):1515-8. DOI: 10.1161/01.STR.0000263135.47779.9e. View

Bergner M, Bobbitt R, Carter W, Gilson B . The Sickness Impact Profile: development and final revision of a health status measure. Med Care. 1981; 19(8):787-805. DOI: 10.1097/00005650-198108000-00001. View

Broderick J, Lu M, Kothari R, Levine S, Lyden P, HALEY E . Finding the most powerful measures of the effectiveness of tissue plasminogen activator in the NINDS tPA stroke trial. Stroke. 2000; 31(10):2335-41. DOI: 10.1161/01.str.31.10.2335. View

Jennett B, Bond M . Assessment of outcome after severe brain damage. Lancet. 1975; 1(7905):480-4. DOI: 10.1016/s0140-6736(75)92830-5. View

Wilson J, Hareendran A, Hendry A, Potter J, Bone I, Muir K . Reliability of the modified Rankin Scale across multiple raters: benefits of a structured interview. Stroke. 2005; 36(4):777-81. DOI: 10.1161/01.STR.0000157596.13234.95. View

van Swieten J, Koudstaal P, Visser M, Schouten H, van Gijn J . Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988; 19(5):604-7. DOI: 10.1161/01.str.19.5.604. View

Weimar C, Kurth T, Kraywinkel K, Wagner M, Busse O, Haberl R . Assessment of functioning and disability after ischemic stroke. Stroke. 2002; 33(8):2053-9. DOI: 10.1161/01.str.0000022808.21776.bf. View

Adams Jr H, Bendixen B, Kappelle L, Biller J, Love B, Gordon D . Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter clinical trial. TOAST. Trial of Org 10172 in Acute Stroke Treatment. Stroke. 1993; 24(1):35-41. DOI: 10.1161/01.str.24.1.35. View

10.

Hacke W, Kaste M, Fieschi C, von Kummer R, Davalos A, Meier D . Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischaemic stroke (ECASS II). Second European-Australasian Acute Stroke Study Investigators. Lancet. 1998; 352(9136):1245-51. DOI: 10.1016/s0140-6736(98)08020-9. View

11.

Weisscher N, Wijbrandts C, de Haan R, Glas C, Vermeulen M, Tak P . The Academic Medical Center Linear Disability Score item bank: psychometric properties of a new generic disability measure in rheumatoid arthritis. J Rheumatol. 2007; 34(6):1222-8. View

12.

MAHONEY F, BARTHEL D . FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965; 14:61-5. View

13.

Holman R, Glas C, de Haan R . Power analysis in randomized clinical trials based on item response theory. Control Clin Trials. 2003; 24(4):390-410. DOI: 10.1016/s0197-2456(03)00061-8. View

14.

Koziol J, Feng A . On the analysis and interpretation of outcome measures in stroke clinical trials: lessons from the SAINT I study of NXY-059 for acute ischemic stroke. Stroke. 2006; 37(10):2644-7. DOI: 10.1161/01.STR.0000241106.81293.2b. View

15.

Sulter G, Steen C, De Keyser J . Use of the Barthel index and modified Rankin scale in acute stroke trials. Stroke. 1999; 30(8):1538-41. DOI: 10.1161/01.str.30.8.1538. View

16.

Young F, Lees K, Weir C . Improving trial power through use of prognosis-adjusted end points. Stroke. 2005; 36(3):597-601. DOI: 10.1161/01.STR.0000154856.42135.85. View

17.

Bonita R, Beaglehole R . Recovery of motor function after stroke. Stroke. 1988; 19(12):1497-500. DOI: 10.1161/01.str.19.12.1497. View

18.

Holman R, Lindeboom R, Vermeulen M, de Haan R . The AMC Linear Disability Score project in a population requiring residential care: psychometric properties. Health Qual Life Outcomes. 2004; 2:42. PMC: 514531. DOI: 10.1186/1477-7525-2-42. View

19.

Roberts L, Counsell C . Assessment of clinical outcomes in acute stroke trials. Stroke. 1998; 29(5):986-91. DOI: 10.1161/01.str.29.5.986. View

20.

Holbrook M, Skilbeck C . An activities index for use with stroke patients. Age Ageing. 1983; 12(2):166-70. DOI: 10.1093/ageing/12.2.166. View