Pneumonia Clinical Trial
Official title:
Collecting Health Outcomes and Economic Data on Hospitalized Community-Acquired Pneumonia - a Prospective Cohort Study
The purpose of this study is to collect additional data on hospitalized Community-Acquired Pneumonia (CAP) on health states, health outcomes and on (health) resources and estimate the differences in the quality of life and resources of elderly persons with and without CAP.
Within the study data on quality of life and various health and non-health resources and
their costs is collected with the help of questionnaires administered at different points in
time in different cohorts. Data collection is additional upon data collected in the main
CAPITA trial, such as incidence data, mortality estimates, use of some health care
resources, vaccine effectiveness and general background (socio-demographic) data.
In a first sub-study of CHO-CAP, the CAPITA participants are asked, via written information
distributed shortly after vaccination, to fill in once-only a short questionnaire describing
their health status (5 item EQ-5D instrument) and a few additional socio-demographic
background data. This is done in order to determine an EQ-5D baseline score (index value for
health status) - a prerequisite to match CAP patients and controls later, and as such an
inclusion criterion for the two (nested) cohorts that will be followed prospectively.
About 2,000 cases of CAP are expected to occur in the CAPITA cohort in the next two to three
years. Assuming a response rate of ~30% for the baseline questionnaire, we will have some
600 CAP cases out of the 2,000 expected patients for whom a baseline EQ-5D score is
available. These CAP patients will be asked to participate in a prospective cohort study.
Within CHO-CAP, these CAP cases will be followed for up to one year after their CAP episode.
For each CAP case included in the CAP cohort, two controls from the baseline population are
matched and included in a cohort of controls (non-CAP elderly with similar baseline health
status). Controls will also be followed for up to one year. The matches between CAP cases
and controls will be made based on age, sex and EQ-5D baseline score. This implies that
controls will only be recruited from the group that responded to the baseline measurement of
health status shortly after vaccination. For both cohorts, the CAP patients and the matched
controls, additional data on health care and non-health care resource use, on health status,
using EQ-5D and SF-36 questionnaires, and on selected health outcomes is collected at four
contact (at 0, 1, 6 and 12 months) moments within a period of 1 year. This will be done
using questionnaires, distributed during a home visit and by post.
;
Time Perspective: Prospective
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