(Stroke. 1999;30:1538-1541.)
© 1999 American Heart Association, Inc.
Original Contributions |
Use of the Barthel Index and Modified Rankin Scale in Acute Stroke Trials
From the Department of Neurology, Academisch Ziekenhuis Groningen, Groningen, Netherlands.
Correspondence to Professor J. De Keyser, Department of Neurology, Academisch Ziekenhuis Groningen, PO Box 30.001, 9700 RB Groningen, Netherlands. E-mail j.h.a.de.keyser{at}neuro.azg.nl
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Abstract |
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Background and Purpose—The Barthel Index (BI) and the Modified Rankin Scale (MRS) are commonly used scales that measure disability or dependence in activities of daily living in stroke victims. The objective of this study was to investigate how these scales were used and interpreted in acute stroke trials.
Methods—We identified from MEDLINE the major efficacy trials with neuroprotective drugs, thrombolytic drugs, and anticoagulants in acute ischemic stroke published between January 1995 and December 1998. We selected those trials that used the BI and/or MRS as outcome parameters.
Results—Fifteen trials fulfilling the inclusion criteria
were identified. The BI was used in 13 and the MRS in 8. In 4 trials
mean and median scores of the BI were used, and in 1 trial median
scores of the MRS were compared. Primary end points included the BI in
7, the MRS in 6, and both the BI and MRS in 3. With regard to the BI, a
variety of sum scores between 50 and 95 were used as cutoff scores to
define favorable outcome. Favorable outcome on the MRS was defined as
either 
1 or 2.
Conclusions—Among the efficacy trials in acute stroke, we found remarkable differences in the choice of primary end points and in the definition of favorable outcome on both the BI and MRS. This lack of consensus strongly hinders the design, interpretation, and comparison of acute stroke trials. In general, it may be easier to define poor outcome instead of favorable outcome. Poor outcome could be defined if any of the following end points are reached: death, institutionalization due to stroke, MRS >3, or BI <60.
Key Words: disability evaluation • outcome • stroke trials
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Introduction |
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Substantial efforts are being made to develop drug treatments that may minimize brain damage and improve outcome in patients with ischemic stroke. In clinical trials, the Barthel Index (BI) and the Modified Rankin Scale (MRS) are commonly used scales to assess outcome.
The BI was developed in 19651 and later modified by
Granger and coworkers2 as a scoring technique that
measures the patient's performance in 10 activities of daily
life. The BI is considered a reliable disability scale for stroke
patients.3 The items can be divided into a group that is
related to self-care (feeding, grooming, bathing, dressing, bowel and
bladder care, and toilet use) and a group related to mobility
(ambulation, transfers, and stair climbing). The maximal score is 100
if 5-point increments are used, indicating that the patient is fully
independent in physical functioning. The lowest score is 0,
representing a totally dependent bedridden state. The MRS
measures independence rather than performance of specific
tasks.4 In this way, mental as well as physical
adaptations to the neurological deficits are incorporated. The scale
consists of 6 grades, from 0 to 5, with 0 corresponding to no symptoms
and 5 corresponding to severe disability (Table 1
).
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Although both scales are easy to use and have an acceptable degree of reliability,3 4 there is apparently no consensus on how these scales should be used to determine outcome in clinical trials. The aim of our study was to investigate how both scales were used and interpreted in recently published clinical drug trials in acute ischemic stroke.
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Methods |
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We searched through MEDLINE for the major pivotal randomized trials (phase III trials) in acute stroke in which the efficacy of either thrombolytics, neuroprotective drugs, or antithrombotic compounds was investigated and the final results were published between January 1995 and December 1998. We selected those trials that used the BI and/or MRS either as primary or secondary end point. We assessed how the scores obtained from these scales were presented and interpreted.
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Results |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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We identified 15 trials that together enrolled 9082 patients (Table 2
). There were a variety of
primary end points, including stroke scales, mortality, BI, MRS, and
the Glasgow Outcome Scale (GOS). Four trials defined >1 primary end
point. Assessment of the primary end points occurred at 3 months in 10
studies. In 1 study patients were scored at 1 month; in 4 other trials
they were scored at 6 months.
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The BI was used in 13 trials and served as primary outcome measure in 7
trials. Two trials compared mean scores, and 2 others used median
scores. In regard to definition of a favorable outcome, sum scores of
50, 60, 75, 85, and 95 were used. Three trials used a
so-called combined BI/Rankin Scale, giving a sum score of 110 for
patients showing complete recovery. In some trials, the BI was
subdivided into different categories, of which the number varied from 3
to 6 categories (Table 3).
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The MRS was used in 8 trials and was a primary outcome
parameter in 6. In 1 trial median scores of the MRS were
compared between the 2 treatment groups. Favorable outcome on the MRS
was defined in 3 trials as a score 1 and in 5 trials as a score 2.
In the second European Cooperative Acute Stroke Study (ECASS II) trial,
the proportion of patients with a 3-months MRS of 1 was used to
assess efficacy of recombinant tissue plasminogen
activator (r-tPA).15 There was no
statistically significant difference with placebo. However, by shifting
MRS grades from 1 to 2 (not a predefined end point) to indicate
favorable outcome, a significant result in favor of r-tPA was
obtained.
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Discussion |
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Over the last 4 years, a number of pivotal acute stroke trials with thrombolytics, anticoagulants, and neuroprotective drugs were published. All failed to demonstrate a significant clinical beneficial effect on predefined primary end points, except for the National Institute of Neurological Disorders and Stroke (NINDS) and Fraxiparine in Ischemic Stroke Study (FISS) trials.12 16 Remarkably, the criteria by which outcome was measured and the measuring instruments that were used differed considerably between the trials. The lack of consensus regarding what should be considered a clinically meaningful effect on outcome in stroke patients strongly hinders the design, interpretation, and comparison of acute stroke trials.
The BI was the most commonly used scale for assessing activities
of daily living. However, the criteria for classifying patients with a
favorable outcome varied substantially from trial to trial; a variety
of sum scores from 50 to 95 were used. In fact, many of the cutoff
scores were arbitrarily chosen and have never been validated.
Curiously, although the BI is widely used, few studies have been
conducted on the clinical relevance of the sum scores. Granger and
coworkers2 found that a score of 60 was a pivotal score at
which patients move from assisted independence to dependence. In
practical terms, with a score of 60, most patients were independent
for essential personal care, such as moving around unassisted,
sphincter control, eating, and personal toilet. A score of 85 usually
corresponded to independence with minimal assistance.2
This means that the majority of patients were able to get dressed and
to move from armchair to bed unassisted. Kay and
coworkers20 and Dennis and colleagues21
also found that a score of <85
corresponded to a state in which patients reported needing help in
performing activities of daily living, with a sensitivity of 94% to
95% and a specificity of 80% to 86%. Therefore, it is difficult to
defend why in the NINDS and ECASS II trials a BI of 95 (defined as
minimal or no disability) was chosen to define favorable
outcome.15 16 Why not use a score of 85, which has been
shown to correspond to an acceptable level of autonomy in the majority
of patients, or a score of 100 if one predicts that the therapy should
result in complete recovery? Some investigators have even invented a
combined BI/Rankin Scale with a sum score of 110, although such a
scoring system has also not been functionally
justified.6 14 15 The BI is an ordinal (noncontinuous)
scale. Therefore, parametric statistical methods cannot be
used. We found it cumbersome that prestigious journals accepted the
presentation of results in mean or median BI
values,6 14 15 17 which are completely inappropriate
statistical end points. A number of studies distinguished between
different categories of disability on the BI.6 8 9 11 16
This may allow assessment of a global shift toward independence in
subsequent categories of scores rather than reliance on a single score
that dichotomizes outcome into favorable or poor. However, the cutoff
scores used to define these different categories should also be
validated and not arbitrarily chosen.
In contrast to the BI, we found fewer variations between the trials in
use of the MRS. Only 2 cutoff scores were used: 1 in 3 trials
investigating r-tPA and 2 in 5 other trials. A striking example of
how data can be differently interpreted by post hoc analyses
was recently demonstrated in the ECASS II trial.15 It was
possible, simply by shifting the cutoff score from the predefined 1
grades to 2 grades on the MRS, to obtain a statistically significant
effect in favor of r-tPA. At first glance, a cutoff score of 2 (able
to look after own affairs without assistance) appears to be more
meaningful than a score of 1 in terms of independence (Table 1
). Kay et al20 found that self-reported dependence
had a sensitivity of 85% and specificity of 87% against the MRS
dichotomized at 2 and a sensitivity of 94% and specificity of 70%
against the MRS dichotomized at 3.
Concordance between outcome parameters is also important in the evaluation of trial results. Although cutoff scores were chosen on a pragmatic basis, this was one of the strengths of the NINDS trial, in which each of the 4 outcome parameters (BI, MRS, National Institutes of Health Stroke Scale, GOS) showed consistency in the degree of benefit with r-tPA.16 Some investigators advocate the use of self-reported dependence as a valid means of dichotomizing stroke patients for the purpose of clinical trials.20 21 We should be careful with this definition of dependence. Many factors unrelated to the intervention, such as psychological and socioeconomic factors, may influence this subjective statement. For example, a wheelchair-bound patient may have a level of income or a health insurance system that allows the acquisition of expensive technical aids to compensate for restrictions to perform desired activities, thereby making the patient "independent." The BI and MRS are reliable measures that provide a more objective assessment of functional recovery after stroke.
Another important issue is that in the analysis of the trials, different types of stroke were mixed together. Bamford and coworkers22 showed that the 6-month combined outcome of being dead or dependent (defined as MRS score >2) differed greatly between patients with total anterior circulation infarcts and those with lacunar or partial anterior circulation infarcts. Efficacy in a controlled trial should cover the entire study population. However, although effective randomization should ensure a good balance of stroke subtypes in the treated and placebo groups, it would also be appropriate to analyze outcome separately in function of stroke subtypes. If patients with anterior circulation lesions are selected, one should distinguish between total anterior circulation infarction, partial anterior circulation infarction, and lacunar infarction.22
Instead of trying to define favorable outcome, for which there will be no consensus, we believe that it may be easier to define poor outcome. Rather than using a single scale, we suggest a definition of poor outcome if any of the following occurs: death, institutionalization due to stroke, MRS >3, or BI <60. Whereas there is no consensus regarding the definition of favorable outcome, there will be less disagreement that each of these 4 conditions corresponds to an unfavorable outcome, and it is a more objective instrument than self-reported dependence.
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Acknowledgments |
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This study was supported by a grant from the Academic Hospital Groningen (to Dr Sulter).
Received January 28, 1999; revision received May 3, 1999; accepted May 3, 1999.
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D. G. Nabavi, S. P. Kloska, E.-M. Nam, M. Freund, C. G. Gaus, E. Klotz, W. Heindel, and E. B. Ringelstein MOSAIC: Multimodal Stroke Assessment Using Computed Tomography: Novel Diagnostic Approach for the Prediction of Infarction Size and Clinical Outcome Stroke, December 1, 2002; 33(12): 2819 - 2826. [Abstract] [Full Text] [PDF]
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 G. Szatmary, V. Biousse, and N. J. Newman Can Swedish Interactive Thresholding Algorithm Fast Perimetry Be Used as an Alternative to Goldmann Perimetry in Neuro-ophthalmic Practice? Arch Ophthalmol, September 1, 2002; 120(9): 1162 - 1173. [Abstract] [Full Text] [PDF]
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C. Weimar, T. Kurth, K. Kraywinkel, M. Wagner, O. Busse, R. L. Haberl, and H.-C. Diener Assessment of Functioning and Disability After Ischemic Stroke Stroke, August 1, 2002; 33(8): 2053 - 2059. [Abstract] [Full Text] [PDF]
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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]
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D. Leys, L. Bandu, H. Henon, C. Lucas, F. Mounier-Vehier, P. Rondepierre, and O. Godefroy Clinical outcome in 287 consecutive young adults (15 to 45 years) with ischemic stroke Neurology, July 9, 2002; 59(1): 26 - 33. [Abstract] [Full Text] [PDF]
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O. O. Zaidat, J. I. Suarez, C. Santillan, J. L. Sunshine, R. W. Tarr, V. H. Paras, W. R. Selman, D. M.D. Landis, and D. D. Tong Response to Intra-Arterial and Combined Intravenous and Intra-Arterial Thrombolytic Therapy in Patients With Distal Internal Carotid Artery Occlusion * Editorial Comment Stroke, July 1, 2002; 33(7): 1821 - 1827. [Abstract] [Full Text] [PDF]
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S.-M. Lai, S. Studenski, P. W. Duncan, and S. Perera Persisting Consequences of Stroke Measured by the Stroke Impact Scale Stroke, July 1, 2002; 33(7): 1840 - 1844. [Abstract] [Full Text] [PDF]
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M. Castellanos, J. Castillo, M. M. Garcia, R. Leira, J. Serena, A. Chamorro, and A. Davalos Inflammation-Mediated Damage in Progressing Lacunar Infarctions: A Potential Therapeutic Target Stroke, April 1, 2002; 33(4): 982 - 987. [Abstract] [Full Text] [PDF]
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A. Iranzo, J. Santamaria, J. Berenguer, M. Sanchez, and A. Chamorro Prevalence and clinical importance of sleep apnea in the first night after cerebral infarction Neurology, March 26, 2002; 58(6): 911 - 916. [Abstract] [Full Text] [PDF]
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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]
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J Kuipers-Upmeijer, A E J de Jager, J M Hew, J W Snoek, and T W van Weerden Primary lateral sclerosis: clinical, neurophysiological, and magnetic resonance findings J. Neurol. Neurosurg. Psychiatry, November 1, 2001; 71(5): 615 - 620. [Abstract] [Full Text] [PDF]
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 R. L. Sacco, J. T. DeRosa, E. C. Haley Jr, B. Levin, P. Ordronneau, S. J. Phillips, T. Rundek, R. G. Snipes, J. L. P. Thompson, and for the GAIN Americas Investigators Glycine Antagonist in Neuroprotection for Patients With Acute Stroke: GAIN Americas: A Randomized Controlled Trial JAMA, April 4, 2001; 285(13): 1719 - 1728. [Abstract] [Full Text] [PDF]
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D. E. Briggs, R. A. Felberg, M. D. Malkoff, P. Bratina, and J. C. Grotta Should Mild or Moderate Stroke Patients Be Admitted to an Intensive Care Unit? Stroke, April 1, 2001; 32(4): 871 - 876. [Abstract] [Full Text] [PDF]
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C. McKevitt, R. Dundas, and C. Wolfe Two Simple Questions to Assess Outcome After Stroke : A European Study Stroke, March 1, 2001; 32(3): 681 - 686. [Abstract] [Full Text] [PDF]
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D. Bereczki, M. Liu, G. F. d. Prado, and I. Fekete Cochrane Report : A Systematic Review of Mannitol Therapy for Acute Ischemic Stroke and Cerebral Parenchymal Hemorrhage Stroke, November 1, 2000; 31(11): 2719 - 2722. [Abstract] [Full Text] [PDF]
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N. Ahmed, P. Nasman, and N. G. Wahlgren Effect of Intravenous Nimodipine on Blood Pressure and Outcome After Acute Stroke Stroke, June 1, 2000; 31(6): 1250 - 1255. [Abstract] [Full Text] [PDF]
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P. W. Duncan, H. S. Jorgensen, and D. T. Wade Outcome Measures in Acute Stroke Trials : A Systematic Review and Some Recommendations to Improve Practice Stroke, June 1, 2000; 31(6): 1429 - 1438. [Abstract] [Full Text] [PDF]
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J. Castillo, R. Rama, and A. Davalos Nitric Oxide-Related Brain Damage in Acute Ischemic Stroke Stroke, April 1, 2000; 31(4): 852 - 857. [Abstract] [Full Text] [PDF]
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