TY - JOUR
T1 - Identifying outcomes and outcome measures in neonatal family-centered care trials
T2 - a systematic review
AU - Kocakabak, Cansel
AU - van den Hoogen, Agnes
AU - Rothfus, Melissa
AU - Campbell-Yeo, Marsha
AU - Kostenzer, Johanna
AU - Axelin, Anna
AU - Schofield, Patricia
AU - Latour, Jos M.
N1 - Publisher Copyright:
© The Author(s), under exclusive licence to the International Pediatric Research Foundation, Inc 2024.
PY - 2025/1
Y1 - 2025/1
N2 - 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. Impact: This systematic review identified inconsistency of outcomes, outcome measures, and time-points reported in quantitative studies testing family-centered care interventions in neonatal care settings. The lack of standardized outcomes and outcome measures reported in clinical trials makes it difficult to synthesize data to provide conclusive recommendations. This systematic review will contribute to the development of a core outcome set for research testing family-centered care interventions in neonatal care settings.
AB - 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. Impact: This systematic review identified inconsistency of outcomes, outcome measures, and time-points reported in quantitative studies testing family-centered care interventions in neonatal care settings. The lack of standardized outcomes and outcome measures reported in clinical trials makes it difficult to synthesize data to provide conclusive recommendations. This systematic review will contribute to the development of a core outcome set for research testing family-centered care interventions in neonatal care settings.
UR - http://www.scopus.com/inward/record.url?scp=85195395721&partnerID=8YFLogxK
U2 - 10.1038/s41390-024-03293-2
DO - 10.1038/s41390-024-03293-2
M3 - Review article
C2 - 38849484
SN - 0031-3998
VL - 97
SP - 56
EP - 66
JO - Pediatric Research
JF - Pediatric Research
IS - 1
M1 - 89
ER -