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

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93<br />

A.3 Study design<br />

fluency (e.g., animal names), processing speed (e.g., letter digit substitution test), and executive<br />

functioning.<br />

Both established and more recently developed measures <strong>of</strong> cognitive functions which may<br />

be affected in diseases targeted by <strong>the</strong> <strong>National</strong> <strong>Cohort</strong> study will be examined during a<br />

feasibility study with <strong>the</strong> aim to derive a battery <strong>of</strong> feasible, age- and disease-sensitive measures<br />

<strong>of</strong> attention, executive function, and episodic memory. All tested instruments will be<br />

validated and simple to implement, even if applied by using a PC.<br />

Based on <strong>the</strong> results <strong>of</strong> <strong>the</strong> feasibility study, a set <strong>of</strong> instruments will be selected for <strong>the</strong><br />

<strong>National</strong> <strong>Cohort</strong> with a maximum total duration time <strong>of</strong> 15 min (10 min for testing and 5 min<br />

for touch screen).<br />

A.3.3.5 respiratory disease-related measures<br />

lung function: spirometry<br />

Spirometry is a well-established technique for assessing lung function and can easily be<br />

performed in terms <strong>of</strong> technical requirements and with minimal inconvenience to <strong>the</strong> study<br />

participant. Spirometry assesses lung function by measuring inhaled and exhaled volumes<br />

<strong>of</strong> air as a function <strong>of</strong> time. Parameters usually assessed are FEV1 and forced vital capacity<br />

(FVC) 202, 612-615 .<br />

Spirometry provides an integrative signal covering <strong>the</strong> mechanically relevant aspects <strong>of</strong><br />

lung structure by fully noninvasive means. The results demonstrate chronic repair and remodeling<br />

processes in <strong>the</strong> lung and <strong>the</strong>refore correspond with disease development and<br />

progression but also with loss <strong>of</strong> function due to organ aging. Spirometry is used to assess<br />

conditions such as asthma and COPD and to distinguish between obstructive and restrictive<br />

lung disease. In addition, spirometric data are considered to be a powerful predictor <strong>of</strong><br />

longevity and aging.<br />

Procedure <strong>of</strong> measurement:<br />

To guarantee valid results, cooperation between <strong>the</strong> participant and study nurse and patient<br />

effort are necessary. After adequate explanation <strong>of</strong> <strong>the</strong> maneuver, <strong>the</strong> participant will be<br />

asked to exhale several times as fast and hard as possible until three measurements without<br />

artifacts have been obtained 616 . It takes about 8 min to obtain a set <strong>of</strong> valid, reproducible data.<br />

Airway inflammation: NO in exhaled air (feNO)<br />

The analysis <strong>of</strong> exhaled NO provides information on presence and severity <strong>of</strong> allergic airway<br />

inflammation in airways disease such as allergic asthma and allergic rhinitis. Exhaled<br />

NO (FeNO) is <strong>the</strong> only currently available measure <strong>of</strong> specific airway inflammation that is<br />

rapid and easily accessible (noninvasive) and at <strong>the</strong> same time ra<strong>the</strong>r informative. Determination<br />

<strong>of</strong> exhaled NO at an expiratory flow rate <strong>of</strong> 50 mL/s is clinically established and<br />

accepted 617, 618 .<br />

Measurement <strong>of</strong> exhaled NO is simple, quick to perform, and shows good reproducibility 619-621 ,<br />

and thus has been applied in several epidemiologic studies 617, 622-624 . Available SOPs provide<br />

for highly standardized measurements 618 to be performed in a multicenter study setting.<br />

Procedure <strong>of</strong> measurement:<br />

The NIOX ® Flex (Aerocrine) device will be used to measure NO in exhaled air. After having<br />

placed <strong>the</strong> filter in <strong>the</strong> mouth, subjects will be asked to inhale to total lung capacity NO-free<br />

A.3

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