Kocakabak Cansel, van den Hoogen Agnes, Rothfus Melissa, Campbell-Yeo Marsha, Kostenzer Johanna, Axelin Anna, Schofield Patricia, Latour Jos M
School of Nursing and Midwifery, Faculty of Health, University of Plymouth, Plymouth, UK.
Department Women and Baby, Neonatology, Wilhelmina Children's Hospital, University Medical Centre Utrecht, The Netherlands, Utrecht University, Utrecht, The Netherlands.
Pediatr Res. 2025 Jan;97(1):56-66. doi: 10.1038/s41390-024-03293-2. Epub 2024 Jun 7.
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.
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.
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.
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.
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.
在测试家庭参与式护理（FCC）干预措施的临床试验中，已报告了一系列针对婴儿及家长的结果。本系统评价旨在确定在新生儿重症监护病房测试FCC干预措施的实验研究中所报告的结果、结果测量指标及时间点。
本评价纳入了在新生儿环境中调查FCC干预措施的实验研究。于2022年12月在MEDLINE、EMBASE、CINAHL、Cochrane、PsycINFO、Scopus、JBI、Lilacs和SciELO中进行数据库检索，并于2023年11月更新。使用JBI随机对照试验清单进行批判性评价，并采用叙述性综合分析方法。结果被归类为Comet分类法的核心领域。
检索共识别出8787篇论文；42项研究纳入分析。总共确定了60项结果：42项婴儿结果和18项家长结果。结果被聚类为婴儿的12个领域和家长的5个领域，并通过97项结果测量指标进行测量。纳入研究分别报告了婴儿和家长25个及27个不同的时间点。
本对测试FCC干预措施的研究的评价发现，在结果、结果测量指标以及测量结果的时间点方面存在异质性和不一致性。有必要为FCC研究制定一套核心结局指标，以规范证据并确定最佳实践。
本系统评价发现，在新生儿护理环境中测试以家庭为中心的护理干预措施的定量研究中，所报告的结果、结果测量指标和时间点存在不一致性。临床试验中缺乏标准化的结果和结果测量指标，使得难以综合数据以提供确凿的建议。本系统评价将有助于为在新生儿护理环境中测试以家庭为中心的护理干预措施的研究制定一套核心结局指标。
