Early detection of primary antibody deficiencies in primary care facilities by an algorithm driven selection of serologic testing in individuals at risk.

Early detection of primary antibody deficiencies in primary care facilities by an algorithm driven selection of serologic testing in individuals at risk. - GP-PADII

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54991

Enrollment

100

Registered

2021-03-03

Start date

2022-05-13

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PAD Primary antibody deficiency

Interventions

None listed

Eligibility

Age

12 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Number of patients with an eventual PAD diagnosis identified with our screening algorithm.	—

Secondary

Measure	Time frame
-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	—

Measure

Time frame

-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

—

Countries

Netherlands

Outcome results