The objective of this study is to determine whether the dichotomization in good and poor outcome by the composite scale, corresponds better with the parents' and doctor's opinion on the outcome than the PSOM. The composite scale willl be…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. The Pediatric Stroke Outcome Measure (PSOM). At the completion of the
examination a deficit severity score ranging from 0 (no deficit) to 2 (severe
deficit) is assigned for each of five spheres: right sensorimotor (including
motor, visual, hearing and somatosensory function), left sensorimotor, language
production, language comprehension, and cognitive and behavioral performance.
The patient is assigned an overall Deficit Severity Score of normal (0=normal
function), mild (1/2=minimal to mild impairment, normal function), moderate
(1=decreased function), or severe (2=loss of function) for each assessment,
based on the combination of scores in the individual spheres of the PSOM.
2. A two- item parental questionnaire.
Question 1: *does your child need extra help with day-to-day activities
compared with other children of the same age?*
Question 2: *does your child attend special schooling?*
Outcome is, based on the PSOM score and on the questionnaire, classified into
two categories: *good* outcome and *poor* outcome.
Secondary outcome
1. Visual Analogue Scale: parent*s report (score 0-10).
2. Visual Analogue Scale: doctor*s report (score 0-10).
3. PedsQL: health related quality of life.
- Parent Reports for Ages 2-4, 5-7, 8-12, and 13-18 (Total score 0-100)
- Patient Self-Reports for Ages 5-7, 8-12, and 13-18 (Total score 0-100)
4. Modified Rankin Scale: degree of disability (score 0-6).
5. Short neuropsychological examination.
Background summary
Clinical research in childhood stroke requires a well-validated and
standardized childhood stroke outcome measure that allows a meaningful and
reliable dichotomization in *good* or *poor* outcome. Such a measure should
ideally cover several levels of functioning, and reflect both objective
neurological deficits and subjective quality of life. The PSOM is a frequently
used childhood stroke outcome measure. However, the PSOM has several
limitations: 1. cognitive functions after childhood stroke are not taken into
account; 2. there is a strict dichotomisation in the PSOM, in which children
with only mild deficits without restrictions in daily activities are classified
as 'poor outcome'.
This study will determine ischaemic stroke outcome in children by using a
composite measure. This composite measure, based on the Pediatric Stroke
Outcome Measure (PSOM), combines findings at neurological examination with a
two-item parental questionnaire. The two-item questionnaire includes a question
on school performance, since one third of the surviving patients attend a
school for special education in contrast to the 5% of children in the general
population who attend schools for special education. Outcome will be based on
the PSOM and the parental questionnaire and defined as *good* or *poor*. This
dichotomization will be compared with the results obtained from other outcome
measures, like the modified Rankin Scale, PedsQL and a short neuropsychological
examination.
The proposed study on the dichotomization of pediatric stroke outcome closely
relates to a research project starting in the near future. This research
project investigates the association between stroke outcome and perfusion
deficits in children and young adults with arterial ischaemic stroke. Since the
proposed study assesses a new composite scale, this might have influence on
defining the outcome measure of pediatric stroke in future stroke research
projects.
Study objective
The objective of this study is to determine whether the dichotomization in good
and poor outcome by the composite scale, corresponds better with the parents'
and doctor's opinion on the outcome than the PSOM. The composite scale willl be
compared with other frequently used outcome measures.
Study design
Outcome is, based on the PSOM and the parental questions, classified into good
outcome or poor outcome. The result of dichotomisation will be compared with
the result of dichotomisation, as used by DeVeber and Delsing.
Second, in order to test the accuracy of the composite score, it will be
compared with the following validated measures:
- Visual Analogue Scales (doctor*s report and parent*s report)
- PedsQL (child*s report and parent*s report)
- Modified Rankin Scale
- Short neuropsychological examination
Since these measures can not be regarded as the *gold standard*, the new
composite scale will not be validated in this study. Therefore, the proposed
study will be descriptive, and must be regarded as a first step towards a new
outcome measure for children after ischaemic stroke.
Study burden and risks
There are no risks for the patient and his/her parent(s) when participating in
this study. The patient and his/her parent(s) have to visit the hospital only
once. This visit will take only 2.5 hours.
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
- age 1 month - 18 years at the time of stroke
- age between 2 and 19 years at time of investigation
- the patients have been treated in the UMCU for ischaemic stroke (arterial ischaemic stroke or sinovenous trombosis) between 2000 and 2007
Exclusion criteria
none
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL19646.041.07 |