COMET Initiative | Identifying outcomes and outcome measures in neonatal family-centered care trials: a systematic review

Identifying outcomes and outcome measures in neonatal family-centered care trials: a systematic review

Background
A wide range of outcomes for infants and parents has been reported in clinical trials testing FCC interventions. This systematic review aimed to identify outcomes, outcome measures, and time-points reported in experimental studies testing FCC interventions in neonatal care units.

Methods
This review included experimental studies investigating FCC interventions in neonatal settings. Database searches were conducted in MEDLINE, EMBASE, CINAHL, Cochrane, PsycINFO, Scopus, JBI, Lilacs, and SciELO, completed in December 2022 and updated in November 2023. Critical appraisal was performed using the JBI checklist for randomized controlled trials, and a narrative synthesis process was used. Outcomes were categorized into the Comet Taxonomy core areas.

Results
The search identified 8787 papers; 42 studies were included in the analysis. Totally, 60 outcomes were identified: 42 infant and 18 parents’ outcomes. Outcomes were clustered into 12 domains for infants and five domains for parents and measured by 97 outcome measures. The included studies reported 25 and 27 different time-points for infants and parents, respectively.

Conclusion
This review of studies testing FCC interventions identified heterogeneity and inconsistency of outcomes, outcome measures, and time-points measuring the outcomes. Developing a core outcome set for FCC studies is warranted to benchmark the evidence and identify best-practices.

Aim

This systematic review aimed to identify outcomes, outcome measures, and time-points reported in experimental studies testing FCC interventions in neonatal care units.

Contributors

Cansel Kocakabak, Agnes van den Hoogen, Melissa Rothfus, Marsha Campbell-Yeo, Johanna Kostenzer, Anna Axelin, Patricia Schofield & Jos M. Latour

Publication

Journal: Pediatric Research
Volume:
Issue:
Pages: -
Year: 2024
DOI: 10.1038/s41390-024-03293-2

Further Study Information

Current Stage: Completed
Date:
Funding source(s): This work was partially funded by the Republic of Turkey Ministry of National Education. The first author, Cansel Kocakabak, received a PhD studentship of the Republic of Turkey Ministry of National Education.

Health Area

Disease Category: Neonatal care

Disease Name: Neonatal care

Target Population

Age Range: 0 - 1

Sex: Either

Nature of Intervention: Management of care

Stakeholders Involved

Study Type

- Systematic review of outcome measures/measurement instruments
- Systematic review of outcomes measured in trials

Method(s)

- Systematic review

Databases included Medline (Ovid), Embase (Elsevier), CINAHL (EBSCO), the Cochrane Library, PsycINFO (EBSCO), Scopus (Elsevier), JBI EBP Database, LILACS (VHL), and SciELO (VHL). Database were searched from inception up to 14 December 2022