Article type
Year
Abstract
Background: One of the key principles of The Cochrane Collaborations work is to strive for relevance, by promoting the assessment of healthcare interventions using outcomes that matter to people making choices in health care.
Objective: This study analysed methods of outcome assessment in Chinese stroke trials to learn if clinically relevant outcomes and appropriate methods were used, and to identify the gaps between Chinese acute stroke trials and the principle of the Cochrane review in outcome assessment. The resolution was also suggested.
Methods: Randomised and quasi-randomised controlled (reported by authors) acute stroke trials published before March 2003 from six Chinese neurological journals were included. We mainly evaluated types of outcome measures, blinding of outcome assessment, duration of follow up, statistical methods used for data analysis and the significance of the results. Types of outcomes were classified as death and four levels: 1. Pathology. 2. Impairment. 3. Disability. 4. Handicap/quality of life.
Results: Two hundreds and ten trials were included in this analysis. 57% of the trials used outcomes in pathology level, 77% in impairment level, 12% in disability level and none in quality of life level. No dichotomous data was analyzed in these trials used disability measures and no trials used relative risk (RR) or odds ratio (OR) and their confidence interval (CI) to show the effects. Most trials used t test for statistical analysis. Only 16% of the trials reported number of death but few of them designed death as an outcome measure. Duration of follow up ranged from 3h to 3 years (median 17 days, interquartile range 14-30 days). Only 2% of trials reported data of lost to follow up. Most trials (97%) did not report whether outcomes were assessed blindly. Results in 95% of the trials were favourable with statistical significance to the tested interventions.
Conclusions: Very few Chinese acute stroke trials used functional outcomes or death, such as death or dependency , which were regarded as relevant to patients to assess the effects of interventions; In most included trials, the methods of outcome assessment did not meet the principle of the Cochrane Collaboration generally. Compared to the number of stroke trials published in China, few data of these trials could be included in Cochrane reviews and the above problems in outcome assessment might be some explanations. More training, education and promotion work in Chinese Cochrane Centre were required to bridge these gaps.
Objective: This study analysed methods of outcome assessment in Chinese stroke trials to learn if clinically relevant outcomes and appropriate methods were used, and to identify the gaps between Chinese acute stroke trials and the principle of the Cochrane review in outcome assessment. The resolution was also suggested.
Methods: Randomised and quasi-randomised controlled (reported by authors) acute stroke trials published before March 2003 from six Chinese neurological journals were included. We mainly evaluated types of outcome measures, blinding of outcome assessment, duration of follow up, statistical methods used for data analysis and the significance of the results. Types of outcomes were classified as death and four levels: 1. Pathology. 2. Impairment. 3. Disability. 4. Handicap/quality of life.
Results: Two hundreds and ten trials were included in this analysis. 57% of the trials used outcomes in pathology level, 77% in impairment level, 12% in disability level and none in quality of life level. No dichotomous data was analyzed in these trials used disability measures and no trials used relative risk (RR) or odds ratio (OR) and their confidence interval (CI) to show the effects. Most trials used t test for statistical analysis. Only 16% of the trials reported number of death but few of them designed death as an outcome measure. Duration of follow up ranged from 3h to 3 years (median 17 days, interquartile range 14-30 days). Only 2% of trials reported data of lost to follow up. Most trials (97%) did not report whether outcomes were assessed blindly. Results in 95% of the trials were favourable with statistical significance to the tested interventions.
Conclusions: Very few Chinese acute stroke trials used functional outcomes or death, such as death or dependency , which were regarded as relevant to patients to assess the effects of interventions; In most included trials, the methods of outcome assessment did not meet the principle of the Cochrane Collaboration generally. Compared to the number of stroke trials published in China, few data of these trials could be included in Cochrane reviews and the above problems in outcome assessment might be some explanations. More training, education and promotion work in Chinese Cochrane Centre were required to bridge these gaps.