Outcome reporting in neonates experiencing withdrawal following opioid exposure in pregnancy: a systematic review

Abstract Background 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. Methods 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”. Results 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. Conclusions 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.

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PID https://www.doi.org/10.6084/m9.figshare.c.4892745.v1
PID https://www.doi.org/10.6084/m9.figshare.c.4892745
URL http://dx.doi.org/10.6084/m9.figshare.c.4892745.v1
URL http://dx.doi.org/10.6084/m9.figshare.c.4892745
URL http://hdl.handle.net/1765/125640
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Author Shan, Flora
Author MacVicar, Sonya
Author Allegaert, Karel
Author Offringa, Martin
Author Jansson, Lauren M.
Author Simpson, Sarah
Author Moulsdale, Wendy
Author Kelly, Lauren E., 0000-0001-7567-0816
Contributor Erasmus MC: University Medical Center Rotterdam
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Collected From Datacite; NARCIS
Hosted By Erasmus University Institutional Repository; figshare
Publication Date 2020-03-12
Publisher figshare
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Country Netherlands
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Source https://science-innovation-policy.openaire.eu/search/other?orpId=dedup_wf_001::c8e69901e1254b6fb420c6f167915ca0
Author jsonws_user
Last Updated 19 December 2020, 14:27 (CET)
Created 19 December 2020, 14:27 (CET)