Department of Pediatrics and Child Health, Max Rady College of Medicine, University of Manitoba, Winnipeg, Canada;
Clinical Trials Platform, George and Fay Yee Centre for Healthcare Innovation, Winnipeg, Canada.
Pediatrics. 2020 Jul;146(1). doi: 10.1542/peds.2020-0018. Epub 2020 Jun 3.
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.
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.
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.
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.
由于新生儿阿片类戒断的发生率不断增加，因此需要研究来评估新的治疗方法。目前文献中报告的健康结果存在很大的异质性。我们的目标是为新生儿阿片类戒断综合征（NOWS-COS）制定一个基于证据和共识的核心结局集，用于研究和临床实践。
成立了一个国际多学科指导委员会。进行了系统评价和 3 轮 Delphi 研究，对每个结局在新生儿阿片类戒断的临床管理中的重要性进行了开放式和评分评估。对父母和/或照顾者进行了有关结局重要性的访谈。最后，举行了一次有不同利益相关者参加的共识会议，以审查所有来源的所有数据，并确定一个核心结局集及其定义。
NOWS-COS 得到了 47 篇已发表的研究、41 位 Delphi 参与者和 6 位家长访谈的信息。共评估了 63 个结局。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）安慰程度，（7）达到充分症状控制的时间，（8）父母-婴儿的联系，（9）新生儿在医院住院的时间，（10）母乳喂养，（11）出院时的体重增加，（12）因戒断而再次住院，（13）神经发育。
我们制定了一个基于证据和共识的核心结局集。实施这个核心结局集将减少研究之间的异质性，并促进基于证据的决策。未来的研究将在其他国家和人群中传播所有发现，并试点测试 NOWS-COS 的有效性，以提高其普遍性和影响力。
