儿童治疗网络试验的敏感性分析：一项针对有特殊医疗需求儿童的综合服务与常规护理的随机对照试验。
A sensitivity analysis of the Children's Treatment Network trial: a randomized controlled trial of integrated services versus usual care for children with special health care needs.
机构信息
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, On, Canada ; Biostatistcs Unit, St Joseph's Healthcare Hamilton, McMaster University, Hamilton, On, Canada.
出版信息
Clin Epidemiol. 2013 Sep 23;5:373-85. doi: 10.2147/CLEP.S48870. eCollection 2013.
BACKGROUND
The value of integrated care through comprehensive, coordinated, and family-centered services has been increasingly recognized for improving health outcomes of children with special health care needs (CSHCN). In a randomized controlled trial (RCT), the integrated care provided through the Children's Treatment Network (CTN) was compared with usual care in improving the psychosocial health of target CSHCN. In this paper, we aimed to estimate the effect of CTN care by conducting multiple analyses to handle noncompliance in the trial.
METHODS
The trial recruited target children in Simcoe County and York Region, ON, Canada. Children were randomized to receive CTN or usual care and were followed for 2 years. The CTN group received integrated services through multiple providers to address their specific needs while the usual care group continued to receive care directed by their parents. The outcome was change in psychosocial quality of life at 2 years. We conducted intention-to-treat, as-treated, per-protocol, and instrumental variable analyses to analyze the outcome.
RESULTS
The trial randomized 445 children, with 229 in the intervention group and 216 in the control group. During follow-up, 52% of children in the intervention group did not receive complete CTN care for various reasons. At 2 years, we did not find a significant improvement in psychosocial quality of life among the children receiving CTN care compared with usual care (intention-to-treat mean difference 1.50, 95% confidence interval -1.49 to 4.50; P = 0.32). Other methods of analysis yielded similar results.
CONCLUSION
Although the effect of CTN care was not significant, there was evidence showing benefits of integrated care for CSHCN. More RCTs are needed to demonstrate the magnitude of such an effect. The CTN study highlights the key challenges in RCTs when assessing interventions involving integrated care, and informs further RCTs including similar evaluations.
背景
通过综合、协调和以家庭为中心的服务进行整合护理，已逐渐被认可可改善有特殊健康需求儿童（CSHCN）的健康结果。在一项随机对照试验（RCT）中，通过儿童治疗网络（CTN）提供的整合护理与常规护理相比，可改善目标 CSHCN 的心理健康。在本文中，我们旨在通过进行多次分析来处理试验中的不依从性，以估计 CTN 护理的效果。
方法
该试验在加拿大安大略省的 Simcoe 县和 York 地区招募了目标儿童。儿童被随机分配接受 CTN 或常规护理，并随访 2 年。CTN 组通过多个提供者提供整合服务，以满足他们的特定需求，而常规护理组则继续接受其父母指导的护理。结果是 2 年后的社会心理生活质量变化。我们进行了意向治疗、实际治疗、方案内和工具变量分析来分析结果。
结果
该试验随机分配了 445 名儿童，其中干预组 229 名，对照组 216 名。在随访期间，由于各种原因，干预组中有 52%的儿童未接受完整的 CTN 护理。在 2 年时，我们没有发现接受 CTN 护理的儿童与接受常规护理的儿童相比，社会心理生活质量有显著改善（意向治疗平均差异 1.50，95%置信区间-1.49 至 4.50；P = 0.32）。其他分析方法得出了相似的结果。
结论
尽管 CTN 护理的效果不显著，但有证据表明综合护理对 CSHCN 有益。需要更多的 RCT 来证明这种效果的幅度。CTN 研究强调了在评估涉及整合护理的干预措施的 RCT 中面临的关键挑战，并为进一步的 RCT 提供了信息，包括类似的评估。
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