Article type
Year
Abstract
Introduction:
Objectives: Choosing proper outcome measures is important for producing reliable results in clinical trials and systematic reviews. We analysed outcome measures used in Chinese acute stroke trials to see if appropriate clinically relevant outcomes were used.
Methods: Randomised controlled trials (RCTs) on acute stroke published before 1997 from the Chinese Stroke Trials Register were included. For each trial, we recorded types of outcome measures used, year of publication, sample size, blinding of outcome assessment, statistical methods used for analysis and the significance of the results. Types of outcomes used were classified as four levels: 1. Pathology. 2. Impairment. 3. Disability. 4. Handicap/quality of life.
Results: Sixty RCTs were included in this analysis. 40% (24/60) of the trials used outcomes in pathology level, 80% (48/60) in impairment level, 8% (5/60) in disability level and none in quality of life level. Only 23% (14/60) of the trials reported number of death but none of them used death as an outcome measure. Results in 95% (57/60) of the trials were favorable to the tested interventions.
Discussion: In Chinese acute stroke trials, outcome measures used were mainly in pathology and impairment levels and very few trials used functional outcome or death. The proportion of positive results in these trials was high. More clinically relevant outcomes should be used in future Chinese stroke trials.
Objectives: Choosing proper outcome measures is important for producing reliable results in clinical trials and systematic reviews. We analysed outcome measures used in Chinese acute stroke trials to see if appropriate clinically relevant outcomes were used.
Methods: Randomised controlled trials (RCTs) on acute stroke published before 1997 from the Chinese Stroke Trials Register were included. For each trial, we recorded types of outcome measures used, year of publication, sample size, blinding of outcome assessment, statistical methods used for analysis and the significance of the results. Types of outcomes used were classified as four levels: 1. Pathology. 2. Impairment. 3. Disability. 4. Handicap/quality of life.
Results: Sixty RCTs were included in this analysis. 40% (24/60) of the trials used outcomes in pathology level, 80% (48/60) in impairment level, 8% (5/60) in disability level and none in quality of life level. Only 23% (14/60) of the trials reported number of death but none of them used death as an outcome measure. Results in 95% (57/60) of the trials were favorable to the tested interventions.
Discussion: In Chinese acute stroke trials, outcome measures used were mainly in pathology and impairment levels and very few trials used functional outcome or death. The proportion of positive results in these trials was high. More clinically relevant outcomes should be used in future Chinese stroke trials.