A Core Outcome Set for Neonatal Opioid Withdrawal Syndrome

BACKGROUND:As rates of neonatal opioid withdrawal are increasing, the need for research to evaluate new treatments is growing. Large heterogeneity exists in health outcomes reported in current literature. Our objective is to develop an evidence-informed and consensus-based core outcome set in neonatal opioid withdrawal syndrome (NOWS-COS) for use in studies and clinical practice.

METHODS:An international multidisciplinary steering committee was established. A systematic review and a 3-round Delphi was performed with open-ended and score-based assessments of the importance of each outcome to inform clinical management of neonatal opioid withdrawal.Interviews were conducted with parents and/or caregivers on outcome importance. Finally,a consensus meeting with diverse stakeholders was held to review all data from all sources and establish a core set of outcomes with definitions.

RESULTS:The NOWS-COS was informed by 47 published studies, 41 Delphi participants, and6 parent interviews. There were 63 outcomes evaluated. Final core outcomes include(1) pharmacologic treatment, (2) total dose of opioid treatment, (3) duration of treatment,(4) adjuvant therapy, (5) feeding difficulties, (6) consolability, (7) time to adequate symptom control, (8) parent-infant bonding, (9) duration of time the neonate spent in the hospital,(10) breastfeeding, (11) weight gain at hospital discharge, (12) readmission to hospital for withdrawal, and (13) neurodevelopment.

CONCLUSIONS:We developed an evidence-informed and consensus-based core outcome set.Implementation of this core outcome set will reduce heterogeneity between studies and facilitate evidence-based decision-making. Future research will disseminate all the findings and pilot test the validity of the NOWS-COS in additional countries and populations to increase generalizability and impact.

Contributors

Lauren E. Kelly, Flora Shan, Sonya MacVicar, Emily Czaplinksi, Wendy Moulsdale, Sarah Simpson, Karel Allegaert, Lauren M. Jansson and Martin Offringa

Publication

Journal: Pediatrics
Volume:
Issue:
Pages: -
Year: 2020
DOI: 10.1542/peds.2020-0018

Further Study Information

Current Stage: Completed
Date: January 2016 - January 2017
Funding source(s): The systematic review for the development of a core outcome set was funded by the Dr Paul H.T. Thorlakson Foundation Fund awarded to Dr Kelly at the University of Manitoba.


Health Area

Disease Category: Neonatal care, Pregnancy & childbirth

Disease Name: Neonatal Abstinence Syndrome

Target Population

Age Range: Unknown

Sex: Either

Nature of Intervention: Drug, Nonpharmacological

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Researchers
- Journal editors
- Pharmaceutical industry representatives
- Regulatory agency representatives

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Consensus meeting
- Delphi process
- Interview
- Systematic review

An international multidisciplinary steering committee was established. A systematic
review and a 3-round Delphi was performed with open-ended and score-based assessments of the importance of each outcome to inform clinical management of neonatal opioid withdrawal.

Interviews were conducted with parents and/or caregivers on outcome importance.

Finally,a consensus meeting with diverse stakeholders was held to review all data from all sources and establish a core set of outcomes with definitions.