Abstract

Objective

To use 1) newly generated data, 2) existing evidence, and 3) expert opinion to create and validate a new cluster headache screening tool.

Methods

In phase 1 of the study, we performed a prospective study of an English translation of an Italian screen on 95 participants (45 with cluster headache, 17 with other trigeminal autonomic cephalalgias, 30 with migraine, and 3 with trigeminal neuralgia). In phase 2, we performed a systematic review in PubMed of all studies until September 2019 with diagnostic screening tools for cluster headache. In phase 3, a 6-person panel of cluster headache patients, research coordinators, and headache specialists analyzed the data from the first two phases to generate a new diagnostic screening tool. Finally, in phase 4 this new screen was validated on participants at a single headache center (all diagnoses) and through research recruitment (trigeminal autonomic cephalalgias only, as recruitment was essential but was otherwise low).

Results

In total, this study included 319 unique participants including 109 cluster headache participants (95 total participants/45 cluster headache participants in phase 1, and 224 total participants/64 cluster headache participants in phase 4). It also found 123 articles on potential screening tools in our systematic review. In phase 1, analysis of the English translation of an Italian screen generated 7 questions with high sensitivity and specificity against migraine, trigeminal neuralgia, and other trigeminal autonomic cephalalgias, but had grammatical and other limitations as a general screening tool. In phase 2, the systematic review revealed nine studies that met inclusion criteria as diagnostic screening tools for cluster headache, including four where sensitivity and specificity were available for individual questions or small groups of questions. In phase 3, this data was reviewed by the expert panel to generate a brief (6-item), binary (yes/no), written screening test. In phase 4, a total of 224 participants completed the new 6-item screening test (81 migraine, 64 cluster headache, 21 other trigeminal autonomic cephalalgias, 35 secondary headaches, 7 neuralgias, 5 probable migraine, and 11 other headache disorders). Answers to the 6 items were combined in a decision tree algorithm and three items had a sensitivity of 84% (confidence interval or 95% confidence interval 73–92%), specificity of 89% (95% confidence interval 84–94%), positive predictive value of 76% (95% confidence interval 64-85%), and negative predictive value of 93% (95% confidence interval 88–97%) for the diagnosis of cluster headache. These three items focused on headache intensity, duration, and autonomic features.

Conclusion

The 3-item Erwin Test for Cluster Headache is a promising diagnostic screening tool for cluster headache.

中文翻译：

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丛集性头痛的简要诊断屏幕：丛集性头痛欧文测试的创建和初步验证

 抽象的

 客观的

使用 1) 新生成的数据、2) 现有证据和 3) 专家意见来创建和验证新的丛集性头痛筛查工具。

 方法

在该研究的第一阶段，我们对 95 名参与者（45 名患有丛集性头痛，17 名患有其他三叉神经自主性头痛，30 名患有偏头痛，3 名患有三叉神经痛）的意大利语屏幕进行了前瞻性研究。在第二阶段，我们使用丛集性头痛的诊断筛查工具对 2019 年 9 月之前的所有研究在 PubMed 上进行了系统回顾。在第三阶段，由丛集性头痛患者、研究协调员和头痛专家组成的 6 人小组分析了前两个阶段的数据，以生成新的诊断筛查工具。最后，在第四阶段，这种新的筛查在单个头痛中心（所有诊断）的参与者中进行了验证，并通过研究招募（仅限三叉神经自主性头痛，因为招募是必要的，但在其他方面较低）。

 结果

这项研究总共包括 319 名参与者，其中包括 109 名丛集性头痛参与者（第 1 阶段总共 95 名参与者/45 名丛集性头痛参与者，第 4 阶段总共 224 名参与者/64 名丛集性头痛参与者）。我们的系统评价中还发现了 123 篇有关潜在筛选工具的文章。在第一阶段，对意大利语筛查的英文翻译进行分析，生成了 7 个针对偏头痛、三叉神经痛和其他三叉神经自主性头痛具有高敏感性和特异性的问题，但作为一般筛查工具存在语法和其他限制。在第二阶段，系统评价发现九项研究符合作为丛集性头痛诊断筛查工具的纳入标准，其中四项研究对个别问题或小组问题具有敏感性和特异性。在第 3 阶段，专家小组审查了这些数据，以生成简短（6 项）、二元（是/否）书面筛选测试。在第 4 阶段，共有 224 名参与者完成了新的 6 项筛查测试（81 名偏头痛、64 名丛集性头痛、21 名其他三叉神经自主性头痛、35 名继发性头痛、7 名神经痛、5 名可能偏头痛和 11 名其他头痛疾病）。 6 个项目的答案合并在决策树算法中，其中 3 个项目的敏感性为 84%（置信区间或 95% 置信区间 73-92%），特异性为 89%（95% 置信区间 84-94%），丛集性头痛诊断的阳性预测值为 76%（95% 置信区间 64-85%），阴性预测值为 93%（95% 置信区间 88-97%）。这三项重点关注头痛强度、持续时间和自主神经功能。

 结论

丛集性头痛三项欧文测试是一种很有前景的丛集性头痛诊断筛查工具。