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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This study aims to investigate the incidence of venous thromboembolism in people who are diagnosed with atopic dermatitis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | 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. |
| |
| Controls | Adults without atopic dermatitis or other skin conditions matched to cases by age, gender, and duration of practice registration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure of venous thromboembolism | Other | Composite of pulmonary embolism and deep vein thrombosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person. | 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. | 10 years from index date |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Diagnosis of Pulmonary Embolism After the Start of Follow-up for Each Person | To describe the risk of pulmonary embolism in people with active AD compared to a matched control population. | 10 years from index date |
| Number of Participants With Diagnosis of Deep-vein Thrombosis After the Start of Follow-up for Each Person |
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Inclusion Criteria:
Exclusion Criteria:
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This study will use routinely collected and collated data from OPCRD to provide a broadly representative sample of the population of the UK.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew McGovern, MD | Momentum Data Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Momentum Data Ltd | London | WC1X 8QT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37418627 | Result | Warren RB, Basey V, Lynam A, Curtis C, Ardern-Jones MR. The risk of venous thromboembolism in atopic dermatitis: a matched cohort analysis in UK primary care. Br J Dermatol. 2023 Sep 15;189(4):427-436. doi: 10.1093/bjd/ljad212. |
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OPCRD data can be accessed by bone fide researchers for specific research projects, subject to approval by Anonymised Data Ethics & Protocol Transparency (ADEPT) Committee. The data utilised for this study cannot be made available without such approval.
The data will be available subject to approvals for two years after the study publication date
Data sharing is subject to ADEPT committee approval
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| ID | Title | Description |
|---|---|---|
| FG000 | Cases | 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. Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis |
| FG001 | Controls | Adults without atopic dermatitis or other skin conditions matched to cases by age, gender, and duration of practice registration. Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cases | 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. Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis |
| BG001 | Controls |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person. | 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. | Posted | Count of Participants | Participants | 10 years from index date |
|
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All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cases | 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. Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Andrew McGovern | Momentum Data Ltd | 07531221970 | andy.mcgovern@momentumdata.co.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 5, 2021 | Mar 4, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D003876 | Dermatitis, Atopic |
| D011655 | Pulmonary Embolism |
| D020246 | Venous Thrombosis |
| D065631 | Rhinitis, Allergic |
| D000092542 | Dust Mite Allergy |
| D005512 | Food Hypersensitivity |
| D016269 | Milk Hypersensitivity |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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To describe the risk of deep-vein thrombosis in people with active AD compared to a matched control population. |
| 10 years from index date |
| Number of Male Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person | 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. | 10 years from index date |
| Number of Female Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person | 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. | 10 years from index date |
| Number of Participants Aged 18-44 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 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. | 10 years from index date |
| Number of Participants Aged 45-64 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 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. | 10 years from index date |
| Number of Participants Aged ≥65 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 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. | 10 years from index date |
| Number of Participants BMI <30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 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. | 10 years from index date |
| Number of Participants BMI ≥30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 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. | 10 years from index date |
| Number of Female Participants Aged 18-44 Using Oestrogen Contraceptive With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 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. | 10 years from index date |
| Number of Participants Having History of an Allergic Condition With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 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. | 10 years from index date |
Adults without atopic dermatitis or other skin conditions matched to cases by age, gender, and duration of practice registration. Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| GP visit in last 12 months | Count of Participants | Participants |
|
| BMI | Count of Participants | Participants |
|
| Smoking status | Count of Participants | Participants |
|
| Alcohol status | Count of Participants | Participants |
|
| Hospital admission | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With Diagnosis of Pulmonary Embolism After the Start of Follow-up for Each Person | To describe the risk of pulmonary embolism in people with active AD compared to a matched control population. | Posted | Count of Participants | Participants | 10 years from index date |
|
|
|
| Secondary | Number of Participants With Diagnosis of Deep-vein Thrombosis After the Start of Follow-up for Each Person | To describe the risk of deep-vein thrombosis in people with active AD compared to a matched control population. | Posted | Count of Participants | Participants | 10 years from index date |
|
|
|
| Secondary | Number of Male Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person | 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. | Posted | Count of Participants | Participants | 10 years from index date |
|
|
|
| Secondary | Number of Female Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person | 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. | Posted | Count of Participants | Participants | 10 years from index date |
|
|
|
| Secondary | Number of Participants Aged 18-44 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 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. | Posted | Count of Participants | Participants | 10 years from index date |
|
|
|
| Secondary | Number of Participants Aged 45-64 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 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. | Posted | Count of Participants | Participants | 10 years from index date |
|
|
|
| Secondary | Number of Participants Aged ≥65 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 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. | Posted | Count of Participants | Participants | 10 years from index date |
|
|
|
| Secondary | Number of Participants BMI <30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 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. | Posted | Count of Participants | Participants | 10 years from index date |
|
|
|
| Secondary | Number of Participants BMI ≥30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 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. | Posted | Count of Participants | Participants | 10 years from index date |
|
|
|
| Secondary | Number of Female Participants Aged 18-44 Using Oestrogen Contraceptive With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 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. | Posted | Count of Participants | Participants | 10 years from index date |
|
|
|
| Secondary | Number of Participants Having History of an Allergic Condition With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 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. | Posted | Count of Participants | Participants | 10 years from index date |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Controls | Adults without atopic dermatitis or other skin conditions matched to cases by age, gender, and duration of practice registration. Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis | 0 | 0 | 0 | 0 | 0 | 0 |
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| D012873 |
| Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D013927 | Thrombosis |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D012221 | Rhinitis, Allergic, Perennial |