Cambridge Ear Institute, University of Cambridge, Cambridge, United Kingdom.
Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, United Kingdom.
PLoS One. 2018 Nov 8;13(11):e0206946. doi: 10.1371/journal.pone.0206946. eCollection 2018.
Eustachian tube dysfunction (ETD) is a commonly diagnosed disorder of Eustachian tube opening and closure, which may be associated with severe symptoms and middle ear disease. Currently the diagnosis of obstructive and patulous forms of ETD is primarily based on non-specific symptoms or examination findings, rather than measurement of the underlying function of the Eustachian tube. This has proved problematic when selecting patients for treatment, and when designing trial inclusion criteria and outcomes. This study aims to determine the correlation and diagnostic value of various tests of ET opening and patient reported outcome measures (PROMs), in order to generate a recommended diagnostic pathway for ETD.
Index tests included two PROMs and 14 tests of ET opening (nine for obstructive, five for patulous ETD). In the absence of an accepted reference standard two methods were adopted to establish index test accuracy: expert panel diagnosis and latent class analysis. Index test results were assessed with Pearson correlation and principle component analysis, and test accuracy was determined. Logistic regression models assessed the predictive value of grouped test results.
The expert panel diagnosis and PROMs results correlated with each other, but not with ET function measured by tests of ET opening. All index tests were found to be feasible in clinic, and acceptable to patients. PROMs had very poor specificity, and no diagnostic value. Combining the results of tests of ET function appeared beneficial. The latent class model suggested tympanometry, sonotubometry and tubomanometry have the best diagnostic performance for obstructive ETD, and these are included in a proposed diagnostic pathway.
ETD should be diagnosed on the basis of clinical assessment and tests of ET opening, as PROMs have no diagnostic value. Currently diagnostic uncertainty exists for some patients who appear to have intermittent ETD clinically, but have negative index test results.
咽鼓管功能障碍（ETD）是一种常见的咽鼓管开放和关闭功能障碍，可能与严重症状和中耳疾病有关。目前，对阻塞型和扩张型 ETD 的诊断主要基于非特异性症状或检查结果，而不是测量咽鼓管的潜在功能。这在选择治疗患者以及设计试验纳入标准和结果时带来了问题。本研究旨在确定咽鼓管开放的各种测试和患者报告的结果测量（PROMs）之间的相关性和诊断价值，以生成 ETD 的推荐诊断途径。
指标测试包括两个 PROMs 和 14 种咽鼓管开放测试（9 种用于阻塞性 ETD，5 种用于扩张性 ETD）。由于缺乏公认的参考标准，采用了两种方法来确定指标测试的准确性：专家小组诊断和潜在类别分析。使用 Pearson 相关性和主成分分析评估指标测试结果，并确定测试准确性。逻辑回归模型评估分组测试结果的预测价值。
专家小组诊断和 PROMs 结果相互关联，但与通过咽鼓管开放测试测量的咽鼓管功能无关。所有指标测试都在临床中被发现是可行的，并且可以被患者接受。PROMs 的特异性非常差，没有诊断价值。组合咽鼓管功能测试的结果似乎有益。潜在类别模型表明，鼓室压测量、声导管测量和管内压测量对阻塞性 ETD 具有最佳的诊断性能，这些都包含在建议的诊断途径中。
ETD 应基于临床评估和咽鼓管开放测试进行诊断，因为 PROMs 没有诊断价值。目前，一些临床上似乎间歇性 ETD 但指标测试结果为阴性的患者存在诊断不确定性。
