卒中后吞咽障碍患者改良钡餐吞咽损害剖面（MBSImP）咽部总分的临床最小重要差值

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中文摘要

背景： 改良钡餐吞咽损害剖面（MBSImP）广泛用于视频透视吞咽评估中量化吞咽生理，但其咽部总分在卒中后吞咽障碍中的临床最小重要差值（MCID）仍不明确。本研究旨在估算住院康复期间MBSImP咽部总分改善的MCID。方法：这项前瞻性多中心观察性研究纳入卒中后2周至3个月因吞咽障碍入院接受住院康复的卒中存活者。基线和10天随访评估包括MBSImP咽部总分、功能性经口摄食量表（FOIS）、渗透-误吸量表（PAS）和患者总体变化印象（PGIC）。以FOIS作为主要锚定指标，PAS和PGIC作为次要锚定指标。采用平均变化、变化差值、线性回归和受试者工作特征分析计算基于锚定的估计值。分布法估计值和最小可检测变化用作解释基于锚定估计值的补充背景。使用更严格或合并的锚定定义进行敏感性分析，包括合并FOIS类别、FOIS改善≥2级、合并PAS类别以及更严格的PGIC阈值。探索性交互分析进一步检验与FOIS恰好改善1级相比恰好改善2级相关的MBSImP变化是否随基线FOIS水平而变化。结果：共纳入161名参与者。MBSImP咽部总分从中位数[9.00（7.00，11.00）]降至[4.00（2.00，6.00）]。用于基于锚定MCID估计的平均改善为4.27分。MBSImP咽部总分的变化与FOIS、PAS和PGIC显著相关（r > 0.3）。在预设锚定定义下，合并的平均变化和变化差值估计值分别为2.977分和2.004分。在更严格或基于类别的锚定定义下，平均变化估计值增至4.633-5.141分，而变化差值估计值相对稳定在1.731-2.554分。ROC推导的截断值在预设定义下为2-3分，在更严格定义下为5分。在探索性FOIS分析中，没有证据表明恰好改善1级与恰好改善2级之间的对比随基线FOIS水平而变化（交互作用P = 0.776）；限制于基线FOIS 2-5级时结果相似（P = 0.503）。结论：MBSImP咽部总分的临床重要变化取决于锚定定义和预期解释。在预设锚定定义下，平均变化估计值约为3分，而更严格的功能或吞咽安全性改善定义显示估计值接近5分。相比之下，变化差值估计值在不同锚定定义下相对稳定在约2分。

英文摘要

The Modified Barium Swallow Impairment Profile (MBSImP) is widely used to quantify swallowing physiology during videofluoroscopic swallowing assessment, but the minimal clinically important difference (MCID) for its pharyngeal total score in post-stroke dysphagia remains unclear. This study estimated the MCID for improvement in the MBSImP pharyngeal total score during inpatient rehabilitation. This prospective multicenter observational study included stroke survivors with dysphagia admitted for inpatient rehabilitation 2 weeks to 3 months after stroke onset. Baseline and 10-day follow-up assessments included the MBSImP pharyngeal total score, Functional Oral Intake Scale (FOIS), Penetration-Aspiration Scale (PAS), and Patient Global Impression of Change (PGIC). The FOIS was used as the primary anchor, while the PAS and PGIC were secondary anchors. Anchor-based estimates were calculated using average change, change difference, linear regression, and receiver operating characteristic analyses. Distribution-based estimates and minimal detectable change were used as complementary context for interpreting the anchor-based estimates. Sensitivity analyses were performed using stricter or collapsed anchor definitions, including collapsed FOIS categories, ≥ 2-level FOIS improvement, collapsed PAS categories, and a stricter PGIC threshold. An exploratory interaction analysis additionally examined whether the MBSImP change associated with exactly 1-level versus exactly 2-level FOIS improvement varied according to baseline FOIS level. A total of 161 participants were included. The MBSImP pharyngeal total score decreased from a median of [9.00 (7.00, 11.00)] to [4.00 (2.00, 6.00)]. The mean improvement, used for anchor-based MCID estimation, was 4.27 points. Changes in the MBSImP pharyngeal total score were significantly correlated with the FOIS, PAS, and PGIC (r > 0.3). The pooled average-change and change-difference estimates under the prespecified anchor definitions were 2.977 and 2.004 points, respectively. Under stricter or category-based anchor definitions, average-change estimates increased to 4.633-5.141 points, whereas change-difference estimates remained comparatively stable at 1.731-2.554 points. ROC-derived cutoffs were 2-3 points under the prespecified definitions and 5 points under the stricter definitions. In the exploratory FOIS analysis, there was no evidence that the contrast between exactly 1-level and exactly 2-level improvement varied by baseline FOIS level (P for interaction = 0.776); findings were similar when restricted to baseline FOIS levels 2-5 (P = 0.503). Clinically important change in the MBSImP pharyngeal total score depended on the anchor definition and intended interpretation. Under the prespecified anchor definitions, average-change estimates were approximately 3 points, whereas stricter functional or swallowing-safety improvement definitions showed estimates close to 5 points. In contrast, change-difference estimates were comparatively stable at approximately 2 points across anchor definitions.