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A core outcome set for neonatal abstinence syndrome: study protocol for a systematic review, parent interviews and a
Lauren E Kelly1, Lauren M Jansson2, Wendy Moulsdale3
1Child Health and Evaluative Sciences, the Hospital for Sick Children, Toronto, ON, Canada. lauren.elyse.kelly@gmail.com.
Insights
A core outcome set (COS) is needed to standardize Neonatal Abstinence Syndrome (NAS) research. This project will develop a consensus-based COS to improve clinical trial consistency and impact.
Area of Science:
- Neonatal Abstinence Syndrome (NAS) research
- Clinical trial methodology
- Outcome measurement standardization
Background:
- Global increase in Neonatal Abstinence Syndrome (NAS) prevalence
- Rising adverse neonatal outcomes and healthcare costs
- Weak evidence for NAS prevention and management strategies
Purpose of the Study:
- To develop an evidence-based Core Outcome Set (COS) for Neonatal Abstinence Syndrome (NAS)
- Establish consensus on essential health outcomes for NAS clinical research
- Improve consistency and impact of NAS clinical trials
Main Methods:
- Systematic review and qualitative interviews to identify potential outcomes
- Three-round Delphi survey with experts
- Consensus meeting with experts and stakeholders
- Feasibility and pilot testing of the COS
Main Results:
- Development of a standardized Core Outcome Set (COS) for NAS research
- Identification of critical health outcomes for NAS management trials
- Establishment of consensus among international experts
Conclusions:
- Standardized outcome measurement is crucial for NAS clinical research
- The NAS-COS will enhance research consistency, efficacy, and impact
- Implementation of the COS will support meta-analysis and clinical practice guidelines
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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