Assessing the reliability and variability of our skin prick tests at our ENT outpatient clinic.
ID
Source
Brief title
Condition
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Outcome of the first SPT
- Outcome of the repeat SPT
- Most common allergic symptoms + the discomfort they cause (via CARAT score
and VAS)
Secondary outcome
Analysing whether there is a correlation between a changed SPT outcome and
secondary endpoints:
- (Changes in) medication from the time of the first SPT to the repeat SPT
- Any other therapy (surgery) between the first and repeat SPT
- Influence of: age, gender, medication. Allergens that test positive in the
first or second test, presence of skin diseases that may complicate the
reading.
Background summary
Many patients undergo a one-time skin prick test (SPT) at our ENT outpatient
clinic (OPC) to identify sensitizations to aeroallergens. The results of this
test are used for treatment and research. However, there is little literature
describing the reliability and variability over time of a single SPT. We would
like to know how reliable such a single test is and to what extent the result
can change over time.
Study objective
Assessing the reliability and variability of our skin prick tests at our ENT
outpatient clinic.
Study design
prospective cohort study
Study burden and risks
The patient will undergo an SPT during a regular follow-up visit at the clinic,
and the CARAT questionnaire and VAS will be completed in the meantime. This
appointment will last 30 minutes longer then the regular visit due to the
repeat SPT. Additionally (if applicable), patients must stop taking oral
antiallergic medications, such as antihistamines and corticosteroids, at least
three days before the SPT, as these medications can suppress an allergic
reaction. This also applies to ointments with immunosuppressive agents at the
test site.
Instructions regarding the SPT can be found via Zenya/K2: Discontinuation of
medication for the skin test with inhalation allergens or food - patient
information (version 3) (iprova.nl).
The CARAT questionnaire will be used for correlation of SPT outcomes to
clinical allergy symptoms and consists of 10 questions.
The amount of allergen used in the solutions is minimal. Therefore, a reaction
elsewhere in the body is rare. If the patient is allergic to a particular
allergen, a red, maybe itchy, bump will develop at the test site. This
typically disappears after 30 minutes.
Patients will receive an update of their allergy status. Patients will invest
30 minutes of their time once to the SPT and CARAT-questionnaire, which will
help understand the reliability and changeability of the SPT at our ENT OPC. In
case of changed sensibilization it will help to identify possible correlated
factors. This might lead to information that benefits peers in the future.
See E4/E9 for further information.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Adult patients who underwent a skin prick test 6-18 months ago at our ENT
outpatient clinic and currently still are treated at our clinic.
Exclusion criteria
- Patients <18 years
- Patients without skin prick test in the past
- Patients with an skin prick test in the past, but who no longer need to come
to our outpatient clinic for check-ups.
- Patients with a (new) contraindication for a skin prick test.
Design
Recruitment
Medical products/devices used
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 | NL87249.018.24 |