Ottenbacher K J, Jannell S
Department of Ocupational Therapy, School of Health Related Professions, State University of New York, Buffalo 14214.
Arch Neurol. 1993 Jan;50(1):37-44. doi: 10.1001/archneur.1993.00540010033014.
RESEARCH PROBLEM AND METHODS: There are currently 1.5 million stroke survivors in the United States. More than half of these individuals have significant residual physical disability and functional impairment. Survivors of stroke constitute the largest group of patients receiving rehabilitation services in this country. We examined existing clinical trials investigating the effectiveness of stroke rehabilitation programs to improve functional outcomes and discharge destination. One hundred twenty-four research reports were initially identified. From this sample, 36 trials meeting selected criteria were evaluated by the methods of meta-analysis.
A total of 3717 patients participated in the 36 clinical trials included in the meta-analysis. The results revealed a mean d-index of 0.40 +/- 0.33. This effect size index was converted to a U3 value of 65.5, indicating that the average patient receiving a program of focused stroke rehabilitation performed better than approximately 65.5% of those patients in comparison groups (95% confidence interval, 63.6% to 67.3%). The results also revealed a significant interaction between type of research design and method of recording the outcome of a clinical trial. Blind recording of the outcome measure appears to be an essential design characteristic in clinical trials that do not randomize patients to conditions.
Programs of focused stroke rehabilitation may improve functional performance for some patients who have experienced a stroke. The improvement in performance appears related to early initiation of treatment, but not to the duration of intervention. Improvements are also associated with the patient's age and the type of design. Research design should be considered an important moderator variable in planning and interpreting future clinical trials of treatment effectiveness in stroke rehabilitation.
研究问题与方法：美国目前有150万中风幸存者。其中超过一半的人有严重的身体残疾和功能障碍。中风幸存者是该国接受康复服务的最大患者群体。我们审查了现有的临床试验，这些试验调查了中风康复计划改善功能结局和出院目的地的有效性。最初识别出124篇研究报告。从这个样本中，采用荟萃分析方法对36项符合选定标准的试验进行了评估。
共有3717名患者参与了荟萃分析中纳入的36项临床试验。结果显示平均d指数为0.40±0.33。这个效应量指数转换为U3值为65.5，表明接受针对性中风康复计划的平均患者比对照组中约65.5%的患者表现更好（95%置信区间，63.6%至67.3%）。结果还显示研究设计类型与记录临床试验结果的方法之间存在显著交互作用。在未将患者随机分组的临床试验中，对结局指标进行盲法记录似乎是一项关键的设计特征。
针对性中风康复计划可能会改善一些中风患者的功能表现。表现的改善似乎与早期开始治疗有关，但与干预持续时间无关。改善还与患者年龄和设计类型有关。在规划和解释未来中风康复治疗效果的临床试验时，应将研究设计视为一个重要的调节变量。
