Characteristics of the study infants.

BackgroundAnkyloglossia may restrict newborn infant’s tongue movements, complicating breastfeeding. However, due to lacking evidence-based guidelines, patient selection for early frenotomy has remained a challenge. The present prospective, observation study validated a scoring aimed to detect infants who required early tongue-tie treatment. It is a part of the Lingual Frenulum in Newborn Infants (LINNE) project, investigating tongue-tie epidemiology along with a randomized treatment trial.MethodsHealthy mother-infant-dyads were assessed by independent and mutually blinded study physicians and midwives. They used the LINNE scoring, including: 1. Infant examination using a picture assessment tool for tongue-tie in breastfed babies (TABBY); 2. Maternal breastfeeding experience scoring (MBES), a psychometric testing on acute breastfeeding symptoms; 3. Three anamnestic factors associated with tongue-ties and breastfeeding problems. Validation tests were conducted using the Cronbach alpha for the whole LINNE scoring, and for the subscorings: 1. TABBY: areas under the curve (AUC), multi-rater Fleiss kappa; 2. MBES: content and construct validity and responsiveness tests; 3. Anamnesis: accuracy studies for diagnostic tests.ResultsOf the studied 556 mother-infant-dyads, 72 (12.9%) infants fulfilled the early tongue-tie treatment criteria. The overall LINNE scoring’s internal consistency was acceptable (alpha = 0.723). The pooled TABBY scoring (n = 1094) accurately detected the need for treatment (AUC = 0.914, 95%CI 0.891–0.938) with moderate inter-rater agreement (kappa = 0.441, 95%CI 0.406–0.477). MBES responsiveness, content, and construct validities reached the required levels. Anamnestic factors had high specificity but fair sensibility for the tongue-tie causing breastfeeding symptoms.ConclusionThe LINNE scoring demonstrated moderate inter-rater agreement; however, the accuracy of the TABBY tool was very good with AUC 0.9 for ankyloglossia needing early treatment.Background 舌系带过短（ankyloglossia）可能限制新生儿的舌部活动，使母乳喂养过程变得复杂。但由于缺乏循证指南，早期舌系带切开术的患者筛选一直是临床难题。本项前瞻性观察研究开发并验证了一套用于识别需早期舌系带治疗患儿的评分体系。该研究属于新生儿舌系带（Lingual Frenulum in Newborn Infants, LINNE）研究项目的一部分，该项目旨在探究舌系带过短的流行病学特征，并同步开展随机对照治疗试验。 Methods 研究由独立且相互设盲的医师与助产士执行，对健康母婴对开展评估。评估采用LINNE评分体系，包含以下三部分：1. 婴儿检查：使用母乳喂养婴儿舌系带过短图片评估工具（TABBY）；2. 母亲母乳喂养体验评分（MBES）：一种针对急性母乳喂养症状的心理测量学评估工具；3. 三项与舌系带过短及母乳喂养问题相关的回忆性因素。 本研究对整体LINNE评分及各子量表开展信效度检验：1. TABBY量表：采用受试者工作特征曲线下面积（AUC）、多评分者Fleiss kappa值进行评估；2. MBES量表：开展内容效度、结构效度及反应效度检验；3. 回忆性因素：开展诊断试验准确性研究。 Results 本研究共纳入556对母婴对，其中72名（12.9%）婴儿符合早期舌系带治疗标准。整体LINNE评分的内部一致性良好（克朗巴赫α=0.723）。合并后的TABBY评分（n=1094）可准确识别治疗需求（AUC=0.914，95%置信区间0.891~0.938），评分者间一致性为中等水平（kappa=0.441，95%置信区间0.406~0.477）。MBES量表的反应效度、内容效度及结构效度均达到预设标准。回忆性因素对舌系带过短相关母乳喂养症状的诊断特异性较高，但灵敏度一般。 Conclusion LINNE评分的评分者间一致性为中等水平；但针对需早期治疗的舌系带过短患儿，TABBY工具的诊断准确性极佳，AUC达0.9。