Development and validation of tools for the asssessment of the burden and disease-management of headache disorders in Europe

Headache, including migraine, is a common and disabling neurobiological disorder which is under-recognized, under-treated, commonly mismanaged and it imposes a substantial health burden. The principle aim of my dissertation was to develop and validate scientific instruments to improve the methodology and the scientific value of future headache impact studies on which headache disease-management recommendations at EU level will be based upon. My dissertation’s working objectives were: * To review the literature published between 1988 and 2007 for studies reporting the prevalence and impact of headache disorders and new relevant review papers at EU level from 2005-2007 * To develop and validate a first scientific instrument in a questionnaire format for gathering headache impact information from a representative multi-cultural population sample of migraine sufferers in Luxembourg * To develop and validate a second instrument in a questionnaire format for gathering headache prevalence and impact information in a standardized way from headache sufferers in Europe. In my first study I made a literature survey in order to summarize what is known on the subject, as a support for my future studies to assess the prevalence and impact of primary headache disorders in Europe with similar methodology and the same research instrument. The analysis revealed that according to a recent health economic survey in Europe migraine is the most costly among the neurological disorders. Several studies suggest that migraine and other disorders lead to widespread suffering, reduction of quality of life, and marked impairment of participation, both in work and social activities. Most studies have yielded relatively reliable data only for migraine, whereas the impact of tension-type headache is virtually unknown or only very incompletely known for most dimensions of headache impact. Some data do suggest, however, that this headache may be as important from a health economic and a public health perspective as migraine. These findings allowed me to analyze the gaps and to the collection of population-based data from various countries relevant for estimation of indirect (mostly absenteeism from work and reduced working efficiency when having headache) and direct costs (related to medication, consultations, investigations and hospitalisations). The impact on ability to get education and participate in the workforce should be taken into consideration as well as the impact on love life and family planning. To get a complete picture, one should also ask about the effect on the life of partners and children, and on the possible impact even when headache free (e.g. fear of the next attack). The quality of life of headache patients should be measured by validated instruments. In my second study we developed and validated a 77-item-self reporting questionnaire to run a pilot study to assess the burden of migraine (BURMIG), including headache characteristics, migraine associated disability, comorbidities, management, and the consequences on the patients’ lives. We translated BURMIG into 4 languages (French, Portuguese, German and English) and tested it in 130 headache patients (20 from pain clinics, 17 from primary care doctors and 93 from the general public) in Luxembourg. We performed a linguistic and a face-content validation and tested the questionnaire for its comprehensiveness, internal consistency and for its test-retest-reliability at an interval of one month (completion rates were 79.6%, and 76,4%, for test and retest, respectively). Retest-reliability for the different parts of the questionnaire varied between 0.6 to 1.0 (Kappa coefficient), with an intracorrelation coefficient of 0.7–1.0. The internal consistency was between 0.74 to 0.91 (Cronbach’s alpha). These findings allowed me to propose the BURMIG questionnaire to evaluate the burden of migraine in the multicultural population of Luxemburg in four languages English, German, French and Portuguese. Based on the results of my pilot study in Luxemburg with BURMIG questionnaire, we developed in my third study a 103-item-self reporting questionnaire (EUROLIGHT) to assess the burden of primary headache disorders on those affected by them including headache characteristics, associated disability, comorbidities, disease-management and quality of life. We validated the questionnaire in 5 languages with 426 headache patients (131 in UK, 60 in Italy, 107 in Spain, 83 in Germany/Austria, and 45 in France). After a linguistic and a face-content validation we tested the questionnaire for comprehensibility, internal consistency and test-retest reliability at an interval of one month. In the different countries, response rates were between 73% and 100%. Completion rates over 90% were 69% and 82%. Test-retest reliability varied between -0.27 to 1.0 depending of the nature of the expected agreement. The internal consistency was between 0.69 and 0.91. These findings allowed me to propose the EUROLIGHT questionnaire to evaluate the burden of primary headache disorders at European level. It can be used in English, German, French, Italian and Spanish. Further language validations have already been done for Portuguese, Dutch and Lithuanian. The studies show that primary headache disorders are disabling neurobiological disorders but under-recognized, under-treated and commonly mismanaged. With the support of major stakeholders we developed a first and then a second scientific instrument in a questionnaire format and we validated both instruments to gather qualitative as well as quantitative data that describe the clinical, economic and humanistic dimensions of primary headache disorders to produce systematic data to complement epidemiological evidence of the burden and disease management of primary headache disorders in Europe.