Abstract：
OBJECTIVE: Objective and practical biomarkers to determine the need for gastrostomy in patients with amyotrophic lateral sclerosis (ALS) are lacking. Tongue pressure (TP) is a promising biomarker because it is associated with bulbar dysfunction. The aims of this study were to evaluate the association of TP with the need for gastrostomy, and to determine its optimal cut-off value.
METHODS: This prospective observational study included participants with ALS taking nutrition orally. TP was evaluated using the Iowa Oral Performance Instrument. Need for gastrostomy as determined by a multidisciplinary team during a 12-month follow up period was recorded. Associations between TP and need for gastrostomy placement were performed. ROC curve analysis determined the optimal cut-off value of TP to predict gastrostomy.
RESULTS: Of 208 screened participants, 119 were included. Gastrostomy was indicated in 45% (53), in a 12-month follow up period. TP of ≤20 kPA was a strong predictor of gastrostomy indication (OR 11.8, CI 95% [4.61, 34.7], p < .001). The association persisted even after adjustment for weight loss, pneumonia, prolonged feeding duration, Revised ALS Functional Rating Scale score, and American Speech-Language-Hearing Association scale score (OR 4.51, CI 95% [1.50, 14.9], p = .009). By receiver operating characteristic curve analysis, 20 kPA represented the optimal cut-off value (sensitivity 0.75, specificity 0.89).
CONCLUSIONS: TP is a strong independent predictor of gastrostomy indication in the subsequent 12 months in patients with ALS, with good sensitivity and specificity at a cutoff value of ≤20 kPA, suggesting that it may be a promising biomarker in clinical practice.
METHODS: This prospective observational study included participants with ALS taking nutrition orally. TP was evaluated using the Iowa Oral Performance Instrument. Need for gastrostomy as determined by a multidisciplinary team during a 12-month follow up period was recorded. Associations between TP and need for gastrostomy placement were performed. ROC curve analysis determined the optimal cut-off value of TP to predict gastrostomy.
RESULTS: Of 208 screened participants, 119 were included. Gastrostomy was indicated in 45% (53), in a 12-month follow up period. TP of ≤20 kPA was a strong predictor of gastrostomy indication (OR 11.8, CI 95% [4.61, 34.7], p < .001). The association persisted even after adjustment for weight loss, pneumonia, prolonged feeding duration, Revised ALS Functional Rating Scale score, and American Speech-Language-Hearing Association scale score (OR 4.51, CI 95% [1.50, 14.9], p = .009). By receiver operating characteristic curve analysis, 20 kPA represented the optimal cut-off value (sensitivity 0.75, specificity 0.89).
CONCLUSIONS: TP is a strong independent predictor of gastrostomy indication in the subsequent 12 months in patients with ALS, with good sensitivity and specificity at a cutoff value of ≤20 kPA, suggesting that it may be a promising biomarker in clinical practice.
摘要：
目的：缺乏确定肌萎缩侧索硬化症（ALS）患者是否需要胃造口术的客观和实用的生物标志物。舌压（TP）是一种有前途的生物标志物，因为它与延髓功能障碍有关。这项研究的目的是评估TP与胃造口术的需要的相关性，并确定其最佳截止值。
方法：这项前瞻性观察性研究包括接受口服营养的ALS患者。使用Iowa口腔性能仪器评估TP。记录了由多学科小组在12个月的随访期内确定的对胃造口术的需求。进行了TP与胃造口术需要之间的关联。ROC曲线分析确定了TP预测胃造瘘术的最佳临界值。
结果：在经过筛选的208名参与者中，119包括在内。胃造口术占45％（53），在12个月的随访期。TP≤20kPA是胃造口术指征的强预测因子(OR11.8,CI95%[4.61,34.7],p<.001)。即使在调整了减肥后，这种关联仍然存在，肺炎,延长喂食时间，修订后的ALS功能评定量表评分，和美国言语-语言-听力协会量表评分(OR4.51，CI95%[1.50，14.9]，p=.009）。通过接收机工作特性曲线分析,20kPA代表最佳临界值(灵敏度0.75,特异性0.89)。
结论：TP是ALS患者随后12个月胃造瘘术指征的独立预测指标，在≤20kPA的截止值下具有良好的敏感性和特异性，这表明它可能是临床实践中一个有前途的生物标志物。
方法：这项前瞻性观察性研究包括接受口服营养的ALS患者。使用Iowa口腔性能仪器评估TP。记录了由多学科小组在12个月的随访期内确定的对胃造口术的需求。进行了TP与胃造口术需要之间的关联。ROC曲线分析确定了TP预测胃造瘘术的最佳临界值。
结果：在经过筛选的208名参与者中，119包括在内。胃造口术占45％（53），在12个月的随访期。TP≤20kPA是胃造口术指征的强预测因子(OR11.8,CI95%[4.61,34.7],p<.001)。即使在调整了减肥后，这种关联仍然存在，肺炎,延长喂食时间，修订后的ALS功能评定量表评分，和美国言语-语言-听力协会量表评分(OR4.51，CI95%[1.50，14.9]，p=.009）。通过接收机工作特性曲线分析,20kPA代表最佳临界值(灵敏度0.75,特异性0.89)。
结论：TP是ALS患者随后12个月胃造瘘术指征的独立预测指标，在≤20kPA的截止值下具有良好的敏感性和特异性，这表明它可能是临床实践中一个有前途的生物标志物。
