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Scientific Concept of the National Cohort (status ... - Nationale Kohorte

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A.2 <strong>Scientific</strong> background and rationale for study elements<br />

onset <strong>of</strong> migraine and tension-type headache. These studies, however, report inconsistent<br />

findings. Certain triggering factors for migraine and for tension-type headache have been<br />

identified 108, 109 and include alcohol consumption and physical activity 110, 111 . Modifications <strong>of</strong><br />

lifestyle habits might provide a sufficient, feasible, and cost-effective preventive strategy.<br />

Migraine is a common, primary headache disorder characterized by episodic, severe headache<br />

and, in about 25% <strong>of</strong> cases, transient neurologic symptoms known as migraine aura.<br />

It is a disorder <strong>of</strong> young and mid-age adulthood, and women are affected three to four times<br />

as <strong>of</strong>ten as men. Migraine, particularly migraine with aura, is associated with an unfavorable<br />

cardiovascular risk pr<strong>of</strong>ile and with an increased risk <strong>of</strong> major CVD. This risk is different according<br />

to aura <strong>status</strong>. Active migraine with aura is associated with a significantly increased<br />

risk <strong>of</strong> subsequent major cardiovascular events, ischemic stroke, MI, coronary revascularization,<br />

angina, and death due to ischemic CVD. In Germany, only few studies have investigated<br />

<strong>the</strong> frequency and impact <strong>of</strong> different headache types on an affected individual 110-113 . Tensiontype<br />

headache is even more common, affecting about one in four to one in three adults in<br />

12 months without any difference by gender. For both headache disorders, migraine and<br />

tension-type headache, prospective population-based studies are very rare and analytic risk<br />

factor analyses based on incident cases are lacking.<br />

Assessment <strong>of</strong> headache:<br />

Examinations and questionnaires (at baseline and during reassessment)<br />

Level 1: Questionnaire<br />

Active follow-up:<br />

Self-report <strong>of</strong> physician-diagnosed migraine and tension-type headache<br />

Restless legs syndrome: Standard criteria for <strong>the</strong> definition and diagnosis <strong>of</strong> restless legs<br />

syndrome (RLS) were published by <strong>the</strong> International Restless Legs Syndrome Study Group<br />

in 1995 114 . These criteria include <strong>the</strong> desire to move <strong>the</strong> limbs usually associated with pares<strong>the</strong>sia<br />

or dyses<strong>the</strong>sia <strong>of</strong> <strong>the</strong> legs, a motor restlessness, a worsening or exclusive presence<br />

<strong>of</strong> symptoms at rest (lying or sitting) with at least partial and temporary relief by activity and a<br />

worsening <strong>of</strong> <strong>the</strong> symptoms in <strong>the</strong> evening or during <strong>the</strong> night. RLS is a common disease with<br />

a prevalence <strong>of</strong> 8–15% in <strong>the</strong> general population 115 , affecting women twice as <strong>of</strong>ten as men.<br />

RLS is one <strong>of</strong> <strong>the</strong> few neurologic disorders that can be assessed by posing specific questions<br />

to participants in population-based studies. The etiology <strong>of</strong> RLS is still not known. Parity is a<br />

major factor in explaining <strong>the</strong> difference between <strong>the</strong> two genders. Few data on risk factors<br />

for RLS in <strong>the</strong> general population are known and all currently existing data come from crosssectional<br />

or case-control studies. RLS prevalence is related to age and cases have a higher<br />

prevalence <strong>of</strong> self-reported diabetes, a higher body mass index (BMI), perform less exercise,<br />

and consume less alcohol than non-cases. Cases with RLS report considerably reduced<br />

mental health and more depressed mood, ei<strong>the</strong>r self-reported or pr<strong>of</strong>essionally assessed, as<br />

well as more social isolation. Fur<strong>the</strong>r research, especially about <strong>the</strong> impact <strong>of</strong> health-related<br />

behaviors, e.g., physical activity, alcohol consumption, smoking, and diet and psychosocial<br />

factors, on <strong>the</strong> occurrence <strong>of</strong> RLS is needed since any potential association would be subject<br />

to preventive strategies.<br />

Assessment <strong>of</strong> RLS:<br />

Examinations and questionnaires (at baseline and during reassessment)<br />

Level 1: Questionnaire<br />

Active follow-up (and medical verification <strong>of</strong> self-reports):<br />

Self-report <strong>of</strong> physician-diagnosed RLS<br />

31<br />

A.2

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