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

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.

Core outcome sets in women's and newborn health: a systematic review

“…Seven published protocols were identified: endometriosis, termination of pregnancy, pre‐eclampsia, diabetes in pregnancy, neonatal abstinence syndrome, gastroschisis, and autologous fat grafting (Table S1). The protocols were published in 2015 ( n = 1), 2016 ( n = 5), or January 2017 ( n = 1). Five protocols described core outcome sets funded by international funders, World Health Organization, national funders, including Health Research Board (Ireland), National Institute of Health Research (UK), and Royal College of Obstetricians and Gynaecologists (UK), or regional funders such as Barts Health Charity (London, UK) .…”

“…Five protocols described core outcome sets funded by international funders, World Health Organization, national funders, including Health Research Board (Ireland), National Institute of Health Research (UK), and Royal College of Obstetricians and Gynaecologists (UK), or regional funders such as Barts Health Charity (London, UK) . The scope of the core outcome set was clearly stated in five protocols . All protocols described systematic reviews to identify potential core outcomes.…”

Neonatal Abstinence Syndrome: Update on Diagnostic and Therapeutic Strategies

“…Support research initiatives aimed at defining high‐quality, evidence‐based clinical practice guidelines for NAS. A large international trial was recently designed to develop a consensus‐based core outcome set for NAS . This trial will be the starting point for designing large multicenter trials and systematic reviews with the aim of improving research quality.…”

Akılcı ilaç kullanımı ilkeleri doğrultusunda diş hekimliğinde kişisel analjezik listesi oluşturulması

“…Opioid analjeziklerin gebelik kategorisi ise "C"dir. Hamilelik döneminde opioid analjezik kullanan kadınların bebeklerinde neonatal yoksunluk sendromu görülme ihtimali bulunmaktadır (44).…”