多中心随机临床试验中单侧脑瘫婴儿干预疗效的传递准确性。
Fidelity of Delivery in a Multisite Randomized Clinical Trial of Intervention Efficacy for Infants With Unilateral Cerebral Palsy.
机构信息
Department of Physical Therapy (Dr Scott), Creighton University, Omaha, Nebraska; Queensland Cerebral Palsy and Rehabilitation Research Centre (Drs Sakzewski and Boyd), Child Health Research Centre, Faculty of Medicine, and School of Health and Rehabilitation Sciences (Dr Ziviani), The University of Queensland, Brisbane, Queensland, Australia; Division of Physical Therapy (Dr Heathcock), The Ohio State University, Columbus, Ohio.
出版信息
Pediatr Phys Ther. 2023 Oct 1;35(4):458-466. doi: 10.1097/PEP.0000000000001038.
PURPOSE
To investigate the reliability of a measure of fidelity of therapist delivery, quantify fidelity of delivery, and determine factors impacting fidelity in the Rehabilitation EArly for Congenital Hemiplegia (REACH) clinical trial.
METHODS
Ninety-five infants (aged 3-9 months) with unilateral cerebral palsy participated in the REACH clinical trial. The Therapist Fidelity Checklist (TFC) evaluated key intervention components. Video-recorded intervention sessions were scored using the TFC.
RESULTS
Inter- and intrarater reliability was percentage agreement 77% to 100%. Fidelity of delivery was high for 88.9% of sessions and moderate for 11.1% of sessions. Sessions with moderate scores included infants receiving infant-friendly bimanual therapy and occurred at the intervention midpoint or later. No significant relationships were found for TFC scores and infant age, manual ability, or parent engagement.
CONCLUSIONS
Fidelity of delivery was high for the REACH trial in most intervention sessions. Standardized therapist training with intervention manuals and monthly peer-to-peer support likely contributed to these results.
目的
研究治疗师实施的可信度度量的可靠性，量化实施的可信度，并确定影响康复早期治疗先天性偏瘫（REACH）临床试验中可信度的因素。
方法
95 名患有单侧脑瘫的婴儿（3-9 个月大）参加了 REACH 临床试验。治疗师可信度检查表（TFC）评估了关键干预因素。使用 TFC 对录像干预课程进行评分。
结果
组内和组间的可靠性为 77%到 100%的百分比一致性。88.9%的课程实施可信度高，11.1%的课程实施可信度中等。实施中等评分的课程包括接受婴儿友好型双手治疗的婴儿，并且发生在干预的中点或之后。TFC 评分与婴儿年龄、手动能力或父母参与度之间未发现显著关系。
结论
REACH 试验中大多数干预课程的实施可信度都很高。标准化的治疗师培训、干预手册和每月的同行支持可能促成了这些结果。
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