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一种康复程序标准化方法:用于肢体约束诱导疗法评估多中心随机对照试验。

A method for standardizing procedures in rehabilitation: use in the extremity constraint induced therapy evaluation multisite randomized controlled trial.

作者信息

Morris David M, Taub Edward, Macrina David M, Cook Edwin W, Geiger Brian F

机构信息

Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.

出版信息

Arch Phys Med Rehabil. 2009 Apr;90(4):663-8. doi: 10.1016/j.apmr.2008.09.576.

DOI:10.1016/j.apmr.2008.09.576
PMID:19345784
Abstract

OBJECTIVE

An enduring problem in the field of rehabilitation has been the lack of standardization in the protocols of treatments and tests. To develop a process evaluation method to standardize the administration of rehabilitation procedures used in the Extremity Constraint Induced Therapy Evaluation (EXCITE) Trial, a randomized controlled trial of upper-extremity constraint-induced therapy implemented across 7 sites.

DESIGN

Process evaluation.

SETTING

Research laboratory.

PARTICIPANTS

Convenience sample or research personnel.

INTERVENTIONS

Not applicable.

MAIN OUTCOME MEASURES

Checklist scoring sheets were developed to rate videotapes using systematic application of prescribed steps for each of 5 procedures across 3 time periods. Time periods were immediately after training, and 1 and 2 years later. A performance score of at least 90% was required before individual research personnel were allowed to participate in the trial.

RESULTS

Overall performance scores ranged from 85.8% to 95% of performance items correctly executed. There was a significant improvement in standard performance of procedures between the first time period (immediately after training) and each of the subsequent time periods for all but 1 procedure. The scoring of standardized performance when carried out with routine participant testing and training did not differ significantly from scoring from videotaped sessions submitted for standardization rating for 2 of the procedures, suggesting adequate validity of scoring from videotape.

CONCLUSIONS

The present method was successful in assessing protocol fidelity for the EXCITE research personnel and represents 1 means of addressing the longstanding problem in rehabilitation of the lack of standardization in administering different treatments and tests.

摘要

目的

康复领域长期存在的一个问题是治疗和测试方案缺乏标准化。为制定一种过程评估方法,以规范在肢体约束诱导疗法评估(EXCITE)试验中使用的康复程序的实施,该试验是一项在7个地点开展的上肢约束诱导疗法随机对照试验。

设计

过程评估。

设置

研究实验室。

参与者

便利样本或研究人员。

干预措施

不适用。

主要观察指标

制定了清单评分表,通过在3个时间段内对5种程序中的每一种系统地应用规定步骤来对录像带进行评分。时间段分别为训练后立即进行,以及1年后和2年后。在允许个体研究人员参与试验之前,要求其表现得分至少达到90%。

结果

总体表现得分在正确执行的表现项目的85.8%至95%之间。除1种程序外,在第一个时间段(训练后立即进行)与随后的每个时间段之间,程序的标准表现有显著改善。对于其中2种程序,在常规参与者测试和训练时进行的标准化表现评分与提交用于标准化评级的录像环节评分之间没有显著差异,这表明录像评分具有足够的效度。

结论

本方法成功地评估了EXCITE研究人员的方案保真度,是解决康复领域在实施不同治疗和测试时缺乏标准化这一长期问题的一种手段。

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