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(Stroke. 2000;31:231-a.)
© 2000 American Heart Association, Inc.

Letters to the Editor

Measuring Outcome in Acute Stroke Trials

C. S. Gray, MD, FRCP; J. F. Scott, MB, MRCP J. E. O’Connell, MB, FRCP

Newcastle University Department of Geriatrics

A. J. Hildreth, MSc

Department of Statistics, Sunderland Royal Hospital, Sunderland, UK

Key Words: disability evaluation • outcome • stroke trials

	Introduction

 
To the Editor:

We welcome the article of Sulter and colleagues¹ in the August edition of your journal, in which they investigate the use of the Barthel Index (BI) and Modified Rankin scale (MRS) in acute stroke trials.¹ The lack of objectivity in defining what is a favorable outcome lends itself to redefining the primary end point should the results of a clinical trial not meet with expectations. The temptation to move the goal posts (MRS <1 to <2) is a clear indication of the ambiguity of the end point.

In the event of a safe, simple, and effective treatment for stroke being discovered, it is likely that this will be given to patients with significant levels of comorbidity and preexisting disability—stroke related or otherwise. In this situation it will be much more difficult to evaluate the clinical effectiveness of the treatment, and use of "poor outcome" as a clinical end point becomes much more relevant. It could be further argued that since the principal objective of stroke treatment is to reduce disability and dependency, it is the avoidance of this poor outcome that is of paramount importance. The clinical relevance of a stroke treatment trial inevitably reflects the trial population; if a highly selected group of patients with no previous disability is selected (MRS=0), it is impossible to be sure what a favourable outcome for such an individual would be. Conversely, we believe there would be little doubt among patients and their carers what a poor outcome would be: . . . [Full Text of this Article]