From the Department of Clinical Neurosciences, Western General Hospital,
Edinburgh, Scotland.
Correspondence to Dr Carl Counsell, Department of Neurology, Austin & Repatriation Medical Centre, Repatriation Campus, Banksia St, West Heidelberg 3081, Victoria, Australia.
Background and Purpose—Adequate
outcome assessment is crucial to randomized trials. We wished to assess
the types of outcomes used in acute stroke trials and the
appropriateness of these outcomes and their analyses.
Methods—Acute stroke trials from the Cochrane Stroke Group's
database were included from 1955 to 1995 if they were published in full
text in English. For each trial we collected year of publication,
number of patients randomized, blinding of outcome assessment, the
specific outcome instruments used, the statistical methods used for
analysis, and the significance of the results. The validity and
reliability of each outcome measure were assessed by review of the
literature.
Results—Our study included 174 trials. Outcomes were assessed
blindly in 69%. Death was recorded in only 76% of trials,
impairment in 76%, disability in 42%, and handicap or quality of life
in only 2%. Of the trials that measured impairment, 35% used a
measure of established validity or reliability. For disability and
handicap, the proportions with valid or reliable measures were 70% and
25%, respectively. Impairment and handicap measures were primarily
analyzed as continuous variables, while disability was
mainly analyzed as a dichotomous variable. Continuous data
were usually analyzed with inappropriate parametric
statistics. There was no relationship between the method of
analysis, the type of outcome, and the statistical significance
of results.
Conclusions—Most acute stroke trials up to 1995 have used
clinical outcome measures that were inadequate in terms of their
content, reliability, validity, blinded assessment, and statistical
analysis. This has important implications for future stroke
research.
© 1998 American Heart Association, Inc.
Original Contributions
Assessment of Clinical Outcomes in Acute Stroke Trials
Key Words: clinical trials • outcome assessment • stroke, acute
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