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



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.



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.
Child Health and Evaluative Sciences, the Hospital for Sick Children, Toronto, ON, Canada. lauren.elyse.kelly@gmail.com.
Lauren E
LE
Kelly
Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Lauren M
LM
Jansson
Neonatal Intensive Care Unit, Aubrey and Marla Dan Program for High Risk Mothers and Babies, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
Wendy
W
Moulsdale
Women's and Infant's Program, St. Joseph's Healthcare, Hamilton, ON, Canada.
Jodi
J
Pereira
Women's and Infant's Program, St. Joseph's Healthcare, Hamilton, ON, Canada.
Sarah
S
Simpson
Department of Pediatrics, the Hospital for Sick Children, Toronto, ON, Canada.|Institute for Clinical Evaluative Sciences, Toronto, ON, Canada.
Astrid
A
Guttman
Intensive Care and Department of Surgery, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.|Department of Development and Regeneration, KU Leuven, Leuven, Belgium.
Karel
K
Allegaert
NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
Lisa
L
Askie
Faculty of Medicine and Dentistry, Department of Paediatrics, Western University, London, ON, Canada.
Henry
H
Roukema
Department of Pediatrics, Alberta Health Services and the Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
Thierry
T
Lacaze
Department of Pediatrics, The Floating Hospital for Children at Tufts Medical Center and the Tufts Clinical and Translational Science Institute, Boston, MA, USA.
Jonathan M
JM
Davis
College on Problems of Drug Dependence, Philadelphia, PA, USA.
Loretta
L
Finnegan
Department of Biostatistics, University of Liverpool, Liverpool, England.
Paula
P
Williamson
Child Health and Evaluative Sciences, the Hospital for Sick Children, Toronto, ON, Canada.|Faculty of Medicine, Department of Pediatrics, University of Toronto, Toronto, ON, Canada.
Martin
M
Offringa
D002985:Clinical Protocols; D003697:Delphi Technique; D006801:Humans; D007231:Infant, Newborn; D009357:Neonatal Abstinence Syndrome / Q000517:prevention & control*; D017063:Outcome Assessment, Health Care; D000078202:Systematic Reviews as Topic