针对儿童、青少年及其家庭进行慢性疼痛管理干预临床试验的特殊考量。
Special considerations in conducting clinical trials of chronic pain management interventions in children and adolescents and their families.
作者信息
Palermo Tonya M, Kashikar-Zuck Susmita, Friedrichsdorf Stefan J, Powers Scott W
机构信息
Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, WA, USA.
Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.
出版信息
Pain Rep. 2018 Apr 10;4(3):e649. doi: 10.1097/PR9.0000000000000649. eCollection 2019 May-Jun.
INTRODUCTION
Disabling chronic pain is a common experience for children and adolescents. However, the evidence base for chronic pain interventions for youth is extremely limited, which has hindered the development of evidence-based practice guidelines for most pediatric chronic pain conditions.
OBJECTIVES
To review and provide recommendations on clinical trial design and evaluation in children and adolescents with chronic pain.
METHODS
In this article, we summarize key issues and provide recommendations for addressing them in clinical trials of chronic pain interventions in children and adolescents and their families.
RESULTS
To stimulate high-quality trials of pediatric chronic pain management interventions, attention to key issues including sample characterization, trial design and treatment administration, outcome measurement, and the ethics of intervening with children and adolescents, as opposed to adults with chronic pain, is needed.
CONCLUSION
Future research to develop interventions to reduce or prevent childhood chronic pain is an important priority area, and requires special considerations in implementation and evaluation in clinical trials.
引言
慢性疼痛致残是儿童和青少年常见的经历。然而，针对青少年慢性疼痛干预措施的证据基础极为有限，这阻碍了针对大多数儿科慢性疼痛病症制定循证实践指南。
目的
对慢性疼痛儿童和青少年的临床试验设计与评估进行综述并提供建议。
方法
在本文中，我们总结了关键问题，并针对在儿童、青少年及其家庭的慢性疼痛干预措施临床试验中解决这些问题提供建议。
结果
为推动高质量的儿科慢性疼痛管理干预措施试验，需要关注关键问题，包括样本特征、试验设计与治疗实施、结果测量，以及与成年慢性疼痛患者相比，对儿童和青少年进行干预的伦理问题。
结论
未来开展旨在减少或预防儿童慢性疼痛的干预措施研究是一个重要的优先领域，在临床试验的实施和评估中需要特别考虑。
Zotero 插件