A Core Outcome Set for Neonatal Opioid Withdrawal Syndrome
A Core Outcome Set for Neonatal Opioid Withdrawal Syndrome
复制标题
DOI：
10.1542/peds.2020-0018
复制
发表时间：
2020-07-01
期刊：
影响因子：
8
通讯作者：
Offringa, Martin
中科院分区：
文献类型：
--
作者：
Kelly, Lauren E.;Shan, Flora;Offringa, Martin
背景：随着新生儿阿片类药物戒断率的增加，评估新治疗方法的研究需求也在增长。目前文献报道的健康结局存在较大的异质性。我们的目标是开发一个循证和共识为基础的核心成果集在新生儿阿片类药物戒断综合征（NOWS-COS）的研究和临床practice.METHODS：一个国际多学科指导委员会成立。进行了一项系统性综述和3轮德尔菲，对每个结局的重要性进行了开放式和基于评分的评估，以告知新生儿阿片类药物戒断的临床管理。与父母和/或照顾者进行了访谈结果的重要性。最后，与不同的利益相关者举行了一次共识会议，审查所有数据来自所有来源，并建立了一套核心的成果definitions.RESULTS：NOWS-COS被告知47发表的研究，41德尔菲参与者，和6家长访谈。共评估了63个结果。最终的核心结局包括（1）药物治疗，（2）阿片类药物治疗的总剂量，（3）治疗持续时间，（4）辅助治疗，（5）喂养困难，（6）安慰性，（7）充分控制症状的时间，（8）父母-婴儿结合，（9）新生儿住院时间，（10）母乳喂养，（11）出院时体重增加，（12）因退出而再次入院，（13）神经发育。结论：我们开发了一个循证和共识为基础的核心结果集。这一核心结果集的实施将减少研究之间的异质性并促进基于证据的决策。今后的研究将传播所有调查结果，并在更多的国家和人口中对NOWS-COS的有效性进行试点测试，以提高普及性和影响力。
BACKGROUND:As rates of neonatal opioid withdrawal are increasing, the need for research to evaluate new treatments is growing. Large heterogeneity exists in health outcomes reported in current literature. Our objective is to develop an evidence-informed and consensus-based core outcome set in neonatal opioid withdrawal syndrome (NOWS-COS) for use in studies and clinical practice.METHODS:An international multidisciplinary steering committee was established. A systematic review and a 3-round Delphi was performed with open-ended and score-based assessments of the importance of each outcome to inform clinical management of neonatal opioid withdrawal. Interviews were conducted with parents and/or caregivers on outcome importance. Finally, a consensus meeting with diverse stakeholders was held to review all data from all sources and establish a core set of outcomes with definitions.RESULTS:The NOWS-COS was informed by 47 published studies, 41 Delphi participants, and 6 parent interviews. There were 63 outcomes evaluated. Final core outcomes include (1) pharmacologic treatment, (2) total dose of opioid treatment, (3) duration of treatment, (4) adjuvant therapy, (5) feeding difficulties, (6) consolability, (7) time to adequate symptom control, (8) parent-infant bonding, (9) duration of time the neonate spent in the hospital, (10) breastfeeding, (11) weight gain at hospital discharge, (12) readmission to hospital for withdrawal, and (13) neurodevelopment.CONCLUSIONS:We developed an evidence-informed and consensus-based core outcome set. Implementation of this core outcome set will reduce heterogeneity between studies and facilitate evidence-based decision-making. Future research will disseminate all the findings and pilot test the validity of the NOWS-COS in additional countries and populations to increase generalizability and impact.