A core outcome set for neonatal abstinence syndrome: study protocol for a systematic review, parent interviews and a Delphi survey.

Lauren E Kelly,Sarah Simpson,Loretta Finnegan,Paula Williamson,Jodi Pereira,Henry Roukema,Lisa Askie,Wendy Moulsdale,Karel Allegaert,Lauren M Jansson,Jonathan M Davis,Martin Offringa,Astrid Guttman,Thierry Lacaze

doi:10.1186/s13063-016-1666-9

Abstract

BackgroundThe prevalence of neonatal abstinence syndrome (NAS) is increasing globally resulting in an increased incidence of adverse neonatal outcomes and health system costs. Evidence regarding the effectiveness of NAS prevention and management strategies is very weak and further research initiatives are critically needed to support meta-analysis and clinical practice guidelines. In NAS research, the choice of outcomes and the use of valid, responsive and feasible measurement instruments are crucial. There is currently no consensus and evidence-based core outcome set (COS) for NAS.Methods/designThe development of the NAS-COS will include five stages led by an international Multidisciplinary Steering Committee: (1) qualitative interviews with parents/families and a systematic review (SR) to identify items for inclusion in a COS. The SR will also identify participants for the Delphi survey, (2) a three-round Delphi survey to gain expert opinion on the importance of health outcomes influencing NAS management decisions, (3), a consensus meeting to finalize the items and definitions with experts and COS users, (4) feasibility and pilot testing, development of the COS and explanatory document and (5) implementation planning.DiscussionSince standardized outcome measurement and reporting will improve NAS clinical research consistency, efficacy and impact, this COS will reflect the minimum set of health outcomes which should be measured in trials evaluating interventions for preventing or treating NAS.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1666-9) contains supplementary material, which is available to authorized users.

Highlights

The prevalence of neonatal abstinence syndrome (NAS) is increasing globally resulting in an increased incidence of adverse neonatal outcomes and health system costs
Since standardized outcome measurement and reporting will improve NAS clinical research consistency, efficacy and impact, this core outcome set (COS) will reflect the minimum set of health outcomes which should be measured in trials evaluating interventions for preventing or treating NAS
According to the Canadian Pediatric Society (CPS) there is no best practice for managing newborns with NAS in Canada or in other parts of the world

Summary

Introduction

The prevalence of neonatal abstinence syndrome (NAS) is increasing globally resulting in an increased incidence of adverse neonatal outcomes and health system costs. The “opioid epidemic” has seen a dramatic increase in the prevalence of opioid use [1, 2] driven primarily by prescription drugs and relatively inexpensive heroin. In 2010, the use of prescription opioids during pregnancy was estimated at 14 % in the US [3]. The rise in opioid use during pregnancy has caused a dramatic increase in the NAS is a multisystem disorder characterized by disturbances in the central and autonomic nervous systems, the gastrointestinal tract and the respiratory system. NAS can cause death resulting from seizures, respiratory instability and/or fluid loss and may

Objectives

Methods

Findings

Conclusion