Main objective: to validate a screening algorithm for PAD in a primary care setting in the Netherlands. Secondary objective: to improve the screening algorithm based on obtained results
ID
Source
Brief title
Condition
- Immunodeficiency syndromes
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of patients with an eventual PAD diagnosis identified with our screening
algorithm.
Secondary outcome
-Number of manually excluded patients and reasons for exclusion
-Characteristics of included patients: use of immunosuppressant medication,
incidence of malignancies, number of patients with aberrant laboratory results,
amount of points scored on ATC/ICPC codes and laboratory results, score on JMF
Early Warning Signs questionnaire
-Of the patients referred to a medical specialist the outcome of this referral
-Number of patients with a known immunodeficiency that were correctly
identified by the algorithm
Background summary
Primary antibody deficiencies (PAD) encompass a group of rare heterogeneous
diseases. The clinical presentation may vary widely, including infectious and
autoimmune symptoms and increased risk of malignancy. Due to the rarity of the
diseases and this wide array of symptoms there is often a delay in diagnosis,
of up to 12 years on average1-4. Timely diagnosis of PAD reduces morbidity,
mortality and health care costs as effective therapies are available. The
currently available screening systems for the broader group of primary
immunodeficiencies have been shown to have poor diagnostic performance5-10 and
are time consuming. We have thus developed an algorithm to screen patient
records in a primary care setting for risk factors specifically for PAD.
Patients with a high risk may undergo a laboratory assessment and referral if
necessary, thus reducing the diagnostic delay of PAD. The aim of the current
study is to validate this algorithm.
Study objective
Main objective: to validate a screening algorithm for PAD in a primary care
setting in the Netherlands.
Secondary objective: to improve the screening algorithm based on obtained
results
Study design
Monocentre cohort study based on regular care data
Study burden and risks
Around 100 patients with a high predicted risk of PAD will be invited for a
single laboratory assessment. Patients may be referred to a specialist clinic
by their general practitioner based on their laboratory results and an advice
from the UMC Utrecht. As this study aims to identify patients with a wide range
of complaints to diagnose a disease that is otherwise delayed or missed, we
expect a positive risk-benefit ratio from this study.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
We will include 100 patients with the highest algorithm scores, that meet the
following criteria:
• Age between 12 and 70 years
• A total algorithm score that is within the highest 0.66% of all the algorithm
scores within a single general practitioner*s clinic
• Signed informed consent
• Did not meet exclusion criteria during manual evaluation of the health care
record
Exclusion criteria
• Secondary causes of immunodeficiency as registered by ICPC codes for:
multiple myeloma, HIV-infection, anorexia nervosa, bulimia, cystic fibrosis,
leukemia.
• The presence of one of the following during manual screening of the health
care record by the research nurse: nephrotic syndrome, current systemic
chemotherapy and stage 3-4 liver cirrhosis will be excluded. This could not be
done by the algorithm as there is no ICPC code available.
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 | NL74944.041.20 |