Development and Validation of a Japanese-Language Questionnaire to Screen for Tension-Type Headaches and Migraines.

Introduction Migraine and tension-type headache (TTH) are chronic diseases associated with significant socioeconomic losses and social and psychological impact (current global prevalence: 10% and 38%, respectively). Thus, they require accurate identification and classification. In clinical practice, validated screening tools able to quickly determine migraine and TTH with high sensitivity and specificity help provide an objective and multifaceted understanding of patients' headache symptoms. However, no tool has been developed or validated yet in Japan to ask multifaceted questions about headache-related symptoms in order to identify migraine and TTH and understand these symptoms. This study aimed to develop a questionnaire for screening TTH and migraine. Methods The study was conducted from March to June 2022 at a medical institution in Osaka, Japan. The questionnaire - comprising 24 questions that were generated based on the 3rd edition of the International Classification of Headache Disorders - was used to screen for migraine and TTH, aiming for a deeper understanding of related symptoms. The participants were patients aged ≥18 years with at least one of the following diagnoses: migraine, TTH. The participants were asked to respond in writing or online. The inclusion criteria were age ≥18 years; headache patients attending a hospital; and diagnoses of at least one of the following: migraine, TTH. The informativeness and discriminating ability of the screening items were evaluated using the item response theory. Items with a calculated discrimination ≥1.35 (high or very high) were retained for screening purposes. Basic questions required to screen for primary headaches were retained, despite their limited computational discrimination power. Ultimately, nine and eight screening items were finalized for migraine and TTH, respectively. The previous neurologists' clinical diagnosis of each patient was used as the gold standard reference for calculating sensitivity, specificity, and positive and negative predictive values regarding the screening items. Cohen's kappa coefficients with 95% CIs were also calculated to determine the agreement between the neurologists' clinical diagnosis and the questionnaire results. Results The study population comprised 69 patients aged 19-89 years who were assisted at a hospital division specializing in headache medicine and diagnosed by neurologists. Of these, 22 patients had migraine, 30 had TTH, and 17 had migraine/TTH. Comparing the neurologists' clinical diagnosis with our screening questionnaire results, the sensitivity and specificity were 72.7% and 86.7% for migraine and 50.0% and 86.4% for TTH, respectively. Conclusions Our brief screening tool was highly specific for diagnosing migraine and TTH in individuals with headache symptoms but lacked sufficient sensitivity, especially for TTH. The high specificity for migraine and TTH suggests that the screening tool we developed in this study can correctly identify those who do not have migraine and TTH. The sensitivity was also relatively high for migraine, suggesting that the tool can correctly identify migraine-positive individuals. However, the sensitivity for TTH was low. This tool could help clinicians in providing detailed course assessment of migraine symptoms and TTH symptoms; however, the issue of low sensitivity for TTH needs to be addressed.