Development of an instrument to measure quality of life in children with bronchopulmonary dysplasia

The new form of Bronchopulmonary Dysplasia (BPD) describes the effects of an
incomplete development of the lungs in (extreme) premature born children with
an underdeveloped microanatomical structure and a decrease in alveolairy
surface. There is a growing incidence because of the better survival of extreme
premature children. In the past years it was found repeatetly that children
with BPD are different from premature born children without BPD and normal
children, also at older age. There is no information available about the
influence of BPD on the quality of life. Measuring quality of life can be done
with a disease specific questionnaire. These are not available for BPD. But
with a good methodology it could be developed. A questionnaire for BPD can be
relevant to determine the impact of BPD between different patients, but also to
measure differences within a patient over time, for example in a treatment
course. This will be an important step forward on the way to developing an
evidence based treatment for BPD at older age.

The development of a disease specific questionnaire to measure the quality of
life in children with BPD at age 4-8, that can be answered by the parents.

This is a cohortstudy at the deparment of children pulmonology of the
Universitary Medical Centrum Groningen (UMCG). The development of a disease
specific questionnaire starts with the collection of items that are relevant.
This will be done by literature research, interviewing specialists on this
subject and interviewing patients and/or their parents. Then the list of items
will be reduced by asking a group of patients about the relevance of the items
idependently. After this, the list of questions needs to be validated. Because
there is no gold standard available, we need to use construct validation. This
means that an independent outcome, that is related to what you want to measure,
will be used to validate the strength of the questionnaire. There must be a
correlation between existing measurements and the questions developed. Only the
validated questions will be used in the final questionnaire.
Because the study concerns a population of children, the tests are chosen to be
of very common use, easy to perform and of no risk. Another reason to choose
commonly used tests is because the results will be easier to interpret. To
validate the questions about pulmonary problems a lung function test will be
performed, for feeding problems lenght and weight will be measured. To validate
problems concerning (pulmonary) hypertension, ecg and blood pressure will be
taken. To measure behaviour and development, some (already validated)
questionnaires will be used.

Filling in the questionnaires will be of no risk for the child. The tests that
are selected are known to be very safe and easy to perform. Also there is a lot
of experience with these kind of tests. The risk of unwanted side-effects is
therefore very low. According to the European guidelines a lung function test
like spirometry and making of an ecg is considered to have no risk. The tests
are picked to be of very low burden for the patient and will be performed like
that.
This study makes use of a population of children under 18 years old because a
disease specific questionnaire for these children is only usefull when it is
specifically designed in the same group. This is because the parameters for
quality of life at this age are not comparable to that of older children or
adults.
The important reason to select this group of children for to make a disease
specific questionnaire is because healthrelated problems that effect the
development can have long-term consequences at this age since it knows a big
development.