Development and validation of a web-based headache diagnosis questionnaire | Scientific Reports – Nature.com

Development of headache diagnosis module

We developed a questionnaire for the headache diagnosis based on the ICHD-3 criteria of migraine, PM, and TTH. Since both criteria of migraine without (code 1.1) and with aura (code 2.1) were composed of five criteria including the total number of attacks, duration of attacks, typical headache characteristics, accompanying symptoms, and a poor accountability by another headache diagnosis questionnaire, we constructed seven questions for the duration of attack, typical headache characteristics, and accompanying symptoms12. We included a question for headache attacks about typical attack duration. For typical headache characteristics and accompanying symptoms, we incorporated five questions regarding headache intensity, unilateral pain, pulsating quality, aggravation by routine physical activity, nausea, vomiting, photophobia, and phonophobia (Table 5 and Supplementary Table S2). A question for headache frequency was also included.

Table 5 Web-based questionnaire for the diagnosis of headache.

We did not consider criteria A and E for the total number of attacks and a poor accountability by another headache diagnosis questionnaire in migraine without aura and infrequent episodic TTH. Most individuals with headaches could not recall the exact number of headache attacks. Moreover, adult individuals with at least one attack of headache during the previous 1 year may have had experienced more than 10 headache attacks during their lifetime. Approximately 98% of individuals with headaches had primary headache disorders, and it is very difficult to diagnose headaches other than common primary or secondary headache disorders in epidemiological studies12,27.

Participants

We recruited participants for the present study via a mobile phone text invitation among the survey panels of Hankook Research. An invitation mobile phone text was sent with the title ‘a survey on headaches’. The invitation text messaging was not stratified by sex or age. The inclusion criteria were: (1) aged 20–59 years (2) having at least one headache attack during the previous 1 year, (3) able to participate in the web-based headache survey, and (4) agreed to participate in an additional telephonic interview by a doctor. Exclusion criteria were as follows: (1) aged < 20 or > 59, (2) did not experience any headache attack during the previous 1 year, and (3) did not agree to participate in an additional telephonic interview.

Web-based survey

After accepting the participation request, internet link for the web-based survey was sent to all the participants, and they were asked to complete the survey. The web-based survey was conducted from May 1 to May 10, 2021.

Validation interview

A semi-structured telephonic validation interview was performed by a neurologist with a special interest in headache medicine (MKC) using a case report form (Supplementary Table S2). All participants were asked about (1) the occurrence of headache during the previous 1 year, (2) duration of headache attacks, (3) intensity of headache, (4) typical headache characteristics including unilateral pain, pulsating quality, aggravation by routine physical activity, and (5) accompanying symptoms of nausea, vomiting, photophobia, and phonophobia. If the telephonic interview call was not connected, the interviewer tried to call up to three times. Validation interview was performed between May 14 to May 31, 2021.

Sample size calculation

Sample size calculation was based on the prevalence, confidence interval, and the estimated sensitivity and specificity of the questionnaire for diagnosing migraine, PM, and TTH. We set the estimated prevalence of migraine, PM, and TTH as 15%, 20%, and 60%, respectively among participants’ headaches based on the previous epidemiological studies28,29,30. To achieve a maximal error of 10%, the sample size for 90% sensitivity and 95% specificity for migraine, PM, and TTH was calculated as 230, 172, and 57, respectively31. Therefore, we set the target sample size as 230 in the present study.

Identification of the duration, intensity, characteristics, and accompanying symptoms of headache

We identified the duration, intensity, characteristics, and accompanying symptoms of headache based on the responses to the questionnaire (Table 5 and Supplementary Table S2). The duration and intensity of headache were determined based on the response to Q1 and Q3, respectively. Unilateral pain was considered by positive responses to (1), (2), or (5) of Q4. Pulsating quality was recognized by positive responses to (1) or (3) of Q5. Aggravation by routine physical activity was identified by a positive response to Q7. Nausea, vomiting, photophobia, and phonophobia were assigned when a positive response was recorded to (2), (3), (4), and (5) questions of Q6, respectively.

Diagnoses of migraine, PM, and TTH

Diagnoses of migraine, PM, and TTH in the web-based survey were performed based on the ICHD-3 criteria. If a participant’s headache fulfilled B-D criteria of migraine without aura (code 1.1), the participant was classified as having migraine. The participant who met all but one criterion of the migraine diagnostic criteria was classified as having PM (code 1.5). Since it is very difficult to accurately identify the presence of aura using questionnaire, we did not evaluate the presence of aura32. Therefore, participants with migraine in the present study included both migraine with and without aura. Similarly, PM included both PM with (code 1.5.2) and without (code 1.5.1) aura.

If a participant’s headache fulfilled all but one criteria of migraine, the participant was diagnosed as having PM. Diagnoses of TTH was based on criteria B through D for infrequent TTH (code 2.1) in ICHD-3. Participants who met all these criteria were considered to have TTH. We did not apply the frequency criterion (criterion A) in the diagnosis of TTH. Thus, the TTH evaluated in this study included infrequent TTH (code 2.1), frequent TTH (code 2.2), and chronic TTH (code 2.3). When a participant was diagnosed with TTH and PM simultaneously, a diagnosis of TTH was assigned12. If a participant’s headache did not fulfill the criteria for migraine, PM, and TTH, the participant was diagnosed with an UH.

During the validation interview, all headache diagnostic criteria for migraine (code 1.1, criteria A–E), PM (code 1.5, criteria A–C), and TTH (code 2.1, criteria A–E) were applied. Headache diagnoses other than migraine, PM, TTH, and UH were also allowed.

Ethical considerations

This study was approved by the institutional review board/ethics committee of Severance Hospital, Yonsei University (IRB No. 2021-0538-001). Written informed consent was obtained from each participant. All procedures involving human participants were performed in accordance with the ethical standards of the institutional and/or national research committee as well as the tenets of the 1964 Declaration of Helsinki and its later amendments, or comparable ethical standards.

Statistical analyses

Sensitivity, specificity, positive and negative predictive values, accuracy, and kappa coefficients with 95% confidence interval were calculated for different headache diagnoses based on the responses in the web-based questionnaire using a neurologist’s headache diagnoses as a gold standard. A kappa coefficient of ≤ 0.20 was considered as poor, between 0.21 and 0.40 as fair, between 0.41 and 0.60 as moderate, between 0.61 and 0.80 as good, and between 0.81 and 1.00 as a very good agreement33.

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