Table 1_Translation, cultural adaptation, and validation of the German EMPATHIC-30G questionnaire for use in the neonatal intensive care setting.docx

BackgroundParental satisfaction is a key quality indicator in neonatal intensive care units (NICUs). While the EMPATHIC-30 questionnaire is widely used internationally, no validated German version exists for NICU settings. This study aimed to translate, culturally adapt, and validate the EMPATHIC-30G for use in German-speaking NICUs.
MethodsA structured Delphi process involving multidisciplinary experts and parents guided the translation and cultural adaptation, including forward-backward translation and cognitive debriefing. The German version was validated in a prospective observational study at a Swiss NICU. Parents of infants hospitalized for ≥24 h completed the questionnaire at discharge.
ResultsA total of 228 questionnaires were completed (138 by mothers, 89 by fathers, 1 by another caregiver). Exploratory factor analysis identified six latent factors for mothers and four for fathers, explaining ∼70% of variance. Internal consistency was excellent (McDonald's omega/Cronbach's alpha: 0.97/0.96 for mothers, 0.98/0.97 for fathers). Construct validity was supported by moderate to strong correlations with global satisfaction indicators; discriminant validity was confirmed by low correlation with unrelated variables. At the domain level, ceiling effects exceeded the 15% threshold across all five domains, though inter-item correlations remained acceptable. Several items showed substantial non-response due to being marked “not applicable” reflecting variability in clinical experiences.
ConclusionThe EMPATHIC-30G is a reliable and valid instrument for assessing parent satisfaction in German-speaking NICUs. However, ceiling effects may limit its sensitivity in high-satisfaction settings. Further evaluation in multicenter samples is recommended.

研究背景
家长满意度是新生儿重症监护病房（Neonatal Intensive Care Unit, NICU）的核心质量评价指标。尽管EMPATHIC-30调查问卷已在国际范围内广泛应用，但目前尚无适用于NICU场景的经过验证的德语版本。本研究旨在针对德语区NICU，对EMPATHIC-30调查问卷进行翻译、文化调适，并验证其德语版本EMPATHIC-30G的适用性。

研究方法
翻译与文化调适环节采用结构化德尔菲法，邀请多学科专家与患儿家长参与，涵盖正反向翻译及认知访谈流程。该德语版本的有效性通过瑞士一家NICU开展的前瞻性观察研究进行验证：住院时长≥24小时的新生儿家长在患儿出院时填写该问卷。

研究结果
最终共回收有效问卷228份，其中母亲填写138份，父亲填写89份，其余1份由其他照料者填写。探索性因子分析结果显示，母亲组问卷析出6个潜在因子，父亲组析出4个潜在因子，累计解释约70%的方差变异。内部一致性表现优异：母亲组的麦克唐纳欧米茄系数（McDonald's omega）与克朗巴赫α系数（Cronbach's alpha）分别为0.97与0.96，父亲组则为0.98与0.97。结构效度得到支持，该问卷与总体满意度指标呈中等到强相关；区分效度则通过与无关变量的低相关性得以验证。在维度层面，全部5个维度的天花板效应均超过15%的阈值，但条目间相关性仍处于可接受范围。部分条目因被标记为"不适用"而出现大量无应答情况，这反映了不同临床经历的差异。

研究结论
EMPATHIC-30G是一款适用于德语区NICU家长满意度评估的可靠且有效的测评工具。但天花板效应可能会限制其在高满意度场景中的灵敏度。建议在多中心样本中开展进一步评估。