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

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

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Abstract

Background: The 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/design: The 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. Discussion: Since 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.

Original languageEnglish (US)
Article number536
JournalTrials
Volume17
Issue number1
DOIs
StatePublished - Nov 8 2016

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ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Kelly, L. E., Jansson, L. M., Moulsdale, W., Pereira, J., Simpson, S., Guttman, A., Allegaert, K., Askie, L., Roukema, H., Lacaze, T., Davis, J. M., Finnegan, L., Williamson, P., & Offringa, M. (2016). A core outcome set for neonatal abstinence syndrome: Study protocol for a systematic review, parent interviews and a Delphi survey. Trials, 17(1), [536]. https://doi.org/10.1186/s13063-016-1666-9