TY - JOUR
T1 - A core outcome set for neonatal abstinence syndrome
T2 - Study protocol for a systematic review, parent interviews and a Delphi survey
AU - Kelly, Lauren E.
AU - Jansson, Lauren M.
AU - Moulsdale, Wendy
AU - Pereira, Jodi
AU - Simpson, Sarah
AU - Guttman, Astrid
AU - Allegaert, Karel
AU - Askie, Lisa
AU - Roukema, Henry
AU - Lacaze, Thierry
AU - Davis, Jonathan M.
AU - Finnegan, Loretta
AU - Williamson, Paula
AU - Offringa, Martin
N1 - Funding Information:
The authors would like to thank Alanna Marson a reference and instruction librarian with the Library and Archives Services at the Hospital for Sick Children for her assistance in developing and validating the SR search strategy., No funding for this project has been obtained at the time of publication.
Publisher Copyright:
© 2016 The Author(s).
PY - 2016/11/8
Y1 - 2016/11/8
N2 - 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.
AB - 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.
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U2 - 10.1186/s13063-016-1666-9
DO - 10.1186/s13063-016-1666-9
M3 - Article
C2 - 27821184
AN - SCOPUS:84994452848
SN - 1745-6215
VL - 17
JO - Trials
JF - Trials
IS - 1
M1 - 536
ER -