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

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A.3<br />

A.3 Study design<br />

<strong>the</strong> participants <strong>the</strong>mselves will not be possible. No oversampling <strong>of</strong> a specific population<br />

subgroup is planned.<br />

Selection <strong>of</strong> subjects for <strong>the</strong> calibration substudy<br />

At recruitment, all Level 2 participants will be asked whe<strong>the</strong>r <strong>the</strong>y are willing to take part in a<br />

repeated examination within 12 months (on average 6 months). According to <strong>the</strong> given sex<br />

and age distribution <strong>of</strong> <strong>the</strong> cohort, subjects agreeing to participate in <strong>the</strong> reassessment will<br />

be consecutively invited for examinations until <strong>the</strong> required numbers in each stratum and<br />

year (see Table 3.3) are reached.<br />

A.3.1.3 Participation rates<br />

Based on previous experience from population-based studies in Germany, it is estimated<br />

that at least 400,000 primary invitations must be mailed in order to recruit 200,000 subjects<br />

into <strong>the</strong> cohort, ultimately resulting in a participation proportion <strong>of</strong> about 50%, following a<br />

multistep invitation and recruitment process (see below). We aim for a high response proportion<br />

in order to obtain a reasonably representative sample <strong>of</strong> <strong>the</strong> underlying population.<br />

Measures to achieve high response rates<br />

The high participation proportion rate <strong>of</strong> 50% will be achieved by employing a comprehensive<br />

contacting and reminder program (see below). We will ensure that population subgroups<br />

with an expected low participation rate (e.g., subjects with a low SES) are well represented<br />

in <strong>the</strong> cohort by instituting a number <strong>of</strong> measures. For example, a public relations<br />

representative <strong>of</strong> <strong>the</strong> <strong>National</strong> <strong>Cohort</strong> responsible for general public relations activities will<br />

provide information on <strong>the</strong> cohort as a whole. In addition, each study region will authorize a<br />

communication expert who will organize public relations for <strong>the</strong> recruitment area. The aim<br />

is to implement a number <strong>of</strong> local public relations activities (adapted to local circumstances)<br />

that raise and maintain awareness <strong>of</strong> <strong>the</strong> <strong>National</strong> <strong>Cohort</strong>. These may involve:<br />

� Information and integration <strong>of</strong> local institutions and stakeholders such as local health<br />

authorities, general practitioners, pharmacies, mayors, etc.<br />

� Declaration <strong>of</strong> support by <strong>of</strong>ficial representatives <strong>of</strong> health organizations (e.g., Ministry<br />

<strong>of</strong> Health, Ministry <strong>of</strong> Education and Research) and <strong>the</strong> responsible data privacy<br />

commissioners by letters <strong>of</strong> support to be mailed with <strong>the</strong> invitation letters<br />

� Pr<strong>of</strong>essionally designed information and advertising material (flyer, postcards, posters,<br />

etc.)<br />

� A service telephone and a webpage to provide information on <strong>the</strong> <strong>National</strong> <strong>Cohort</strong><br />

� Media campaigns including coverage <strong>of</strong> issues related to <strong>the</strong> <strong>National</strong> <strong>Cohort</strong> in print<br />

media, radio, and television:<br />

– Features and reports in national and local press, radio and television<br />

– Press releases featuring interviews with members <strong>of</strong> <strong>the</strong> Epidemiologic Planning<br />

Committee, local principal investigators, local health ministers, and celebrities<br />

– The possibility that national and local reporters and film teams visit <strong>the</strong> study centers,<br />

create short movie clips, and interview study center staff as well as potential<br />

participants<br />

– Local and national press reports at certain dates (e.g., at <strong>the</strong> beginning <strong>of</strong> <strong>the</strong><br />

study, halftime, end <strong>of</strong> baseline recruitment)<br />

� Articles in <strong>the</strong> national scientific press (e.g., Ärzteblatt)<br />

Fur<strong>the</strong>rmore, <strong>the</strong> promotion campaign will be supported by national and regional organizations<br />

and representatives <strong>of</strong> medical research and health care systems, such as health insurances<br />

and scientific associations, e.g., <strong>the</strong> German Epidemiologic Association (DGEpi).<br />

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