Department of Pediatric and Child Health, University of Manitoba, 405 Chown, 753 McDermot Ave., Winnipeg, MB, R3E0T6, Canada.
School of Health and Social Care, Edinburgh Napier University, Edinburgh, UK.
Trials. 2020 Mar 12;21(1):262. doi: 10.1186/s13063-020-4183-9.
Neonatal withdrawal secondary to in utero opioid exposure is a growing global concern stressing the psychosocial well-being of affected families and scarce hospital resources. In the ongoing search for the most effective treatment, randomized controlled trials are indispensable. Consistent outcome selection and measurement across randomized controlled trials enables synthesis of results, fostering the translation of research into practice. Currently, there is no core outcome set to standardize outcome selection, definition and reporting. This study identifies the outcomes currently reported in the literature for neonates experiencing withdrawal following opioid exposure during pregnancy.
A comprehensive literature search of MEDLINE, EMBASE and Cochrane Central was conducted to identify all primary research studies (randomized controlled trials, clinical trials, case-controlled studies, uncontrolled trials, observational cohort studies, clinical practice guidelines and case reports) reporting outcomes for interventions used to manage neonatal abstinence syndrome between July 2007 and July 2017. All "primary" and "secondary" neonatal outcomes were extracted by two independent reviewers and were assigned to one of OMERACT's core areas of "pathophysiological manifestation", "life impact", "resource use", "adverse events", or "death".
Forty-seven primary research articles reporting 107 "primary" and 127 "secondary" outcomes were included. The most frequently reported outcomes were "duration of pharmacotherapy" (68% of studies, N = 32), "duration of hospital stay" (66% of studies, N = 31) and "withdrawal symptoms" (51% of studies, N = 24). The discrepancy between the number of times an outcome was reported and the number of articles was secondary to the use of composite outcomes. Frequently reported outcomes had heterogeneous definitions or were not defined by the study and were measured at different times. Outcomes reported in the literature to date were mainly assigned to the core areas "pathophysiologic manifestations" or "resource use". No articles reported included parent or former patient involvement in outcome selections.
Inconsistent selection and definition of primary and secondary outcomes exists in the present literature of pharmacologic and nonpharmacologic interventions for managing opioid withdrawal in neonates. No studies involved parents in the process of outcome selection. These findings hinder evidence synthesis to generate clinically meaningful practice guidelines. The development of a specific core outcome set is imperative.
由于胎儿期暴露于阿片类药物而导致的新生儿戒断，是一个日益受到关注的全球性问题，这对受影响家庭的社会心理健康和稀缺的医院资源构成了压力。在不断寻找最有效的治疗方法的过程中，随机对照试验是不可或缺的。在随机对照试验中，一致的结果选择和测量可以促进结果的综合，推动研究成果转化为实践。目前，尚无标准的核心结局集来规范结局选择、定义和报告。本研究旨在确定目前文献中报道的，与妊娠期间暴露于阿片类药物后经历戒断的新生儿相关的结局。
对 MEDLINE、EMBASE 和 Cochrane Central 进行全面文献检索，以确定所有在 2007 年 7 月至 2017 年 7 月期间报告了用于治疗新生儿戒断综合征的干预措施的主要研究（随机对照试验、临床试验、病例对照研究、非对照试验、观察性队列研究、临床实践指南和病例报告）的所有“主要”和“次要”新生儿结局。两名独立评审员提取所有“主要”和“次要”新生儿结局，并将其分配到 OMERACT 的核心领域之一：“病理生理表现”、“生活影响”、“资源利用”、“不良事件”或“死亡”。
纳入了 47 篇主要研究文章，报告了 107 项“主要”和 127 项“次要”结局。报告最多的结局是“药物治疗持续时间”（68%的研究，N=32）、“住院时间”（66%的研究，N=31）和“戒断症状”（51%的研究，N=24）。报告结局的次数与文章数量之间的差异是由于使用了综合结局。经常报告的结局定义不明确或未在研究中定义，且测量时间也不同。迄今为止，文献中报告的结局主要分配到核心领域“病理生理表现”或“资源利用”。没有文章报告包括父母或前患者参与结局选择。
目前关于管理新生儿阿片类戒断的药理学和非药理学干预的文献中，存在主要和次要结局选择和定义不一致的情况。没有研究让父母参与结局选择过程。这些发现阻碍了证据综合，无法生成有临床意义的实践指南。制定特定的核心结局集是当务之急。
