The Incidence of Venous Thromboembolism in Atopic Dermatitis

Completed

Conditions: Allergy to Animal Dander
Venous Thromboembolism
Atopic Dermatitis
Pulmonary Embolism
Allergy to House Dust Mite
Allergic Rhinitis
Deep Vein Thrombosis
Food Allergy
Cows Milk Allergy

Interventions: Other: Exposure of venous thromboembolism

Registration Number: NCT04969653

Lead Sponsor: Momentum Data

Brief Summary: This study aims to investigate the incidence of venous thromboembolism in people who are diagnosed with atopic dermatitis.

Detailed Description: The aim of this study is to examine whether venous thromboembolism is higher in people with atopic dermatitis compared and those without and to explore the risk in particular subgroups of people with AD such as those with higher body mass index or using oestrogen containing contraceptives. Such insights will be valuable for clinicians in advising patients with atopic dermatitis regarding venous thromboembolism prevention and detection and when selecting atopic dermatitis treatments.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 754745

Inclusion Criteria

All eligible adult people (aged ≥ 18) registered with GP practices contributing data to OPCRD between January 1, 2010 and January 1, 2020, were eligible for inclusion in the study.

Exclusion Criteria

People with less than 5 years potential follow up. People with atopic dermatitis that was not active atopic dermatitis during the study period. People without atopic dermatitis but diagnosed with other skin conditions.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	Exposure of venous thromboembolism	Adults without atopic dermatitis or other skin conditions matched to cases by age, gender, and duration of practice registration.
Cases	Exposure of venous thromboembolism	All adults with an episode of active atopic dermatitis at any point between 1st Jan 2010 to 1st Jan 2015 will be included for analysis.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person.	10 years from index date	To describe the risk of venous thromboembolism (composite of pulmonary embolism and deep vein thrombosis) in people with active AD compared to a matched control population.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Diagnosis of Pulmonary Embolism After the Start of Follow-up for Each Person	10 years from index date	To describe the risk of pulmonary embolism in people with active AD compared to a matched control population.
Number of Participants With Diagnosis of Deep-vein Thrombosis After the Start of Follow-up for Each Person	10 years from index date	To describe the risk of deep-vein thrombosis in people with active AD compared to a matched control population.
Number of Male Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person	10 years from index date	To explore the risk of VTE stratified by the male sex at the baseline in people with active AD compared to a matched control population.
Number of Female Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person	10 years from index date	To explore the risk of VTE stratified by the female sex at the baseline in people with active AD compared to a matched control population.
Number of Participants Aged 18-44 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person	10 years from index date	To explore the risk of VTE stratified by those aged 18-44 at the baseline in people with active AD compared to a matched control population.
Number of Participants Aged 45-64 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person	10 years from index date	To explore the risk of VTE stratified by those aged 45-64 at the baseline in people with active AD compared to a matched control population.
Number of Participants Aged ≥65 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person	10 years from index date	To explore the risk of VTE stratified by those aged ≥65 at the baseline in people with active AD compared to a matched control population.
Number of Participants BMI <30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person	10 years from index date	To explore the risk of VTE stratified by those with a BMI \<30 at the baseline with active AD compared to a matched control population. Patients with active AD and missing BMI are excluded along with their related matched cases. Patients with active AD and no matched controls with BMI recorded are also excluded.
Number of Participants BMI ≥30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person	10 years from index date	To explore the risk of VTE stratified by those with a BMI ≥30 at the baseline in people with active AD compared to a matched control population. Patients with active AD and missing BMI are excluded along with their related matched cases. Patients with active AD and no matched controls with BMI recorded are also excluded.
Number of Female Participants Aged 18-44 Using Oestrogen Contraceptive With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person	10 years from index date	To explore the risk of VTE stratified by oestrogen contraceptive use in females aged 18-44 years at the baseline in people with active AD compared to a matched control population.
Number of Participants Having History of an Allergic Condition With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person	10 years from index date	To explore risk of VTE stratified by the presence, or absence of allergic conditions at baseline in people with active AD compared to a matched control population.. Allergic conditions will comprise common allergies; allergic rhinitis, allergy to dust mites or animal dander, and food allergies e.g., nut, fruit, shellfish, eggs and cows' milk allergies. Medication and other allergies will not be included.