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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| Oxford Royal College of General Practitioners Research and Surveillance Centre | UNKNOWN |
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Atopic dermatitis (AD), commonly called eczema, is one of the most frequently occurring skin conditions. It is estimated to affect around one fifth of children in developed countries and is also becoming increasingly common in less developed countries. Exact estimates of how common eczema is, vary considerably and there has not been an in-depth analysis of the number of people with eczema in the UK. It is also unclear which groups of people are most affected and which treatment options are being used.
Most people with eczema are managed by their general practitioner (GP) with only a few people requiring specialist care. GP records therefore provide an excellent opportunity to explore how common eczema is and which treatments are being used currently.
Objective
The study aims to describe the health care resource utilisation of patients with active AD in terms of prescription use, primary care appointments, and specialist referrals.
Method This study will define AD cases using a previously validated algorithm for case identification use clinical codes form primary care in the UK (Read codes). The study will analyse a cohort of prevalent active AD cases over a one year period (2018). The annual use of topical and oral medications used for the treatment of AD, primary care appointments, and specialist referrals will be reported.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active atopic dermatitis | People fulfilling the diagnostic criteria for active atopic dermatitis during the calendar year 2018, and meeting the inclusion criteria and registered with one of the study practices for one or more years during the study period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | Observational analysis of usual care only |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prescription Rates for Atopic Dermatitis Related Treatments: Emollients and Soap Substitutes | Proportion of the arm/group receiving at least one prescription for emollients and soap substitutes. | Jan - Dec 2018 inclusive |
| Prescription Rates for Atopic Dermatitis Related Treatments: Mild Topical Corticosteroids (TCS) | Proportion of the arm/group receiving at least one prescription for mild topical corticosteroids (atopic dermatitis related treatment) | Jan - Dec 2018 inclusive |
| Prescription Rates for Atopic Dermatitis Related Treatments: Moderate Topical Corticosteroids (TCS) | Proportion of the arm/group receiving at least one prescription for moderate topical corticosteroids (an atopic dermatitis related treatment) | Jan - Dec 2018 inclusive |
| Prescription Rates for Atopic Dermatitis Related Treatments: Potent Topical Corticosteroids (TCS) | Proportion of the arm/group receiving at least one prescription for potent topical corticosteroids (an atopic dermatitis related treatment) | Jan - Dec 2018 inclusive |
| Prescription Rates for Atopic Dermatitis Related Treatments: Very Potent Topical Corticosteroids (TCS) | Proportion of the arm/group receiving at least one prescription for very potent topical corticosteroid (an atopic dermatitis related treatment) | Jan - Dec 2018 inclusive |
| Prescription Rates for Atopic Dermatitis Related Treatments: Topical Calcineurin Inhibitors (TCI) | Proportion of the arm/group receiving at least one prescription for a topical Calcineurin Inhibitor (an atopic dermatitis related treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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Adults and children with atopic dermatitis identified from routinely collected healthcare records using a validated algorithm.
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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 |
|---|---|---|---|
| 33179341 | Derived | de Lusignan S, Alexander H, Broderick C, Dennis J, McGovern A, Feeney C, Flohr C. The epidemiology of eczema in children and adults in England: A population-based study using primary care data. Clin Exp Allergy. 2021 Mar;51(3):471-482. doi: 10.1111/cea.13784. Epub 2020 Nov 26. | |
| 33176023 | Derived | de Lusignan S, Alexander H, Broderick C, Dennis J, McGovern A, Feeney C, Flohr C. Patterns and trends in eczema management in UK primary care (2009-2018): A population-based cohort study. Clin Exp Allergy. 2021 Mar;51(3):483-494. doi: 10.1111/cea.13783. Epub 2020 Nov 23. |
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All individual patient data (IPD) can be made available to bone fide researchers subject to appropriate checks and approvals made by Momentum Data, the RCGP RSC, and the University of Surrey and subject to the completion of information governance training.
There is no pre-specified time-frame for data availability; this will be considered on an individual basis for each request.
As above
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Atopic Dermatitis | People fulfilling the diagnostic criteria for active atopic dermatitis (AD) during the calendar year 2018. Primary outcomes conducted within this single arm. No intervention: Observational analysis of usual care only |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Atopic Dermatitis | People fulfilling the diagnostic criteria for active atopic dermatitis during the calendar year 2018. Primary outcomes conducted within this single arm. No intervention: Observational analysis of usual care only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Prescription Rates for Atopic Dermatitis Related Treatments: Emollients and Soap Substitutes | Proportion of the arm/group receiving at least one prescription for emollients and soap substitutes. | Posted | Count of Participants | Participants | Jan - Dec 2018 inclusive |
|
|
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Death, serious adverse events, and other (non-serious adverse events) were not assessed for the study.
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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 | Active Atopic Dermatitis | People fulfilling the diagnostic criteria for active atopic dermatitis during the calendar year 2018. Primary outcomes conducted within this single arm. No intervention: Observational analysis of usual care only |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carsten Flohr | Guy's & St Thomas' NHS Foundation Trust | 020 7188 8884 | carsten.flohr@kcl.ac.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 | May 21, 2021 | Apr 17, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Jan - Dec 2018 inclusive |
| Prescription Rates for Atopic Dermatitis Related Treatments: Topical Antimicrobials | Proportion of the arm/group receiving at least one prescription for topical antimicrobials. | Jan - Dec 2018 inclusive |
| Prescription Rates for Atopic Dermatitis Related Treatments: Antihistamin | Proportion of the arm/group receiving at least one prescription for antihistamin. | Jan - Dec 2018 inclusive |
| Prescription Rates for Atopic Dermatitis Related Treatments: Systemic Immuno-modulatory Therapy | Proportion of the arm/group receiving at least one prescription for Systemic immuno-modulatory therapy | Jan - Dec 2018 inclusive |
| Prescription Rates for Atopic Dermatitis Related Treatments: Oral Corticosteroids | Proportion of the arm/group receiving at least one prescription for oral corticosteroids | Jan - Dec 2018 inclusive |
| Specialist Referrals | Specialist dermatology referral rate in 2018 | Jan - Dec 2018 inclusive |
| Primary Care Referrals | Annual rate of primary care consultations in 2018 | Jan - Dec 2018 inclusive |
| 32938595 | Derived | de Lusignan S, Alexander H, Broderick C, Dennis J, McGovern A, Feeney C, Flohr C. Epidemiology and management of atopic dermatitis in England: an observational cohort study protocol. BMJ Open. 2020 Sep 16;10(9):e037518. doi: 10.1136/bmjopen-2020-037518. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| IMD quintile | Index of Multiple Deprivation (IMD) is a UK national deprivation measure of deprivation which is based on the patient postcode. IMD has been stratified into quintiles with IMD 1 representing most deprived and IMD 5 being the least deprived. | Count of Participants | Participants |
|
| Rural-urban classification | Count of Participants | Participants |
|
|
| Primary | Prescription Rates for Atopic Dermatitis Related Treatments: Mild Topical Corticosteroids (TCS) | Proportion of the arm/group receiving at least one prescription for mild topical corticosteroids (atopic dermatitis related treatment) | Posted | Count of Participants | Participants | Jan - Dec 2018 inclusive |
|
|
|
| Primary | Prescription Rates for Atopic Dermatitis Related Treatments: Moderate Topical Corticosteroids (TCS) | Proportion of the arm/group receiving at least one prescription for moderate topical corticosteroids (an atopic dermatitis related treatment) | Posted | Count of Participants | Participants | Jan - Dec 2018 inclusive |
|
|
|
| Primary | Prescription Rates for Atopic Dermatitis Related Treatments: Potent Topical Corticosteroids (TCS) | Proportion of the arm/group receiving at least one prescription for potent topical corticosteroids (an atopic dermatitis related treatment) | Posted | Count of Participants | Participants | Jan - Dec 2018 inclusive |
|
|
|
| Primary | Prescription Rates for Atopic Dermatitis Related Treatments: Very Potent Topical Corticosteroids (TCS) | Proportion of the arm/group receiving at least one prescription for very potent topical corticosteroid (an atopic dermatitis related treatment) | Posted | Count of Participants | Participants | Jan - Dec 2018 inclusive |
|
|
|
| Primary | Prescription Rates for Atopic Dermatitis Related Treatments: Topical Calcineurin Inhibitors (TCI) | Proportion of the arm/group receiving at least one prescription for a topical Calcineurin Inhibitor (an atopic dermatitis related treatment) | Posted | Count of Participants | Participants | Jan - Dec 2018 inclusive |
|
|
|
| Primary | Prescription Rates for Atopic Dermatitis Related Treatments: Topical Antimicrobials | Proportion of the arm/group receiving at least one prescription for topical antimicrobials. | Posted | Count of Participants | Participants | Jan - Dec 2018 inclusive |
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|
| Primary | Prescription Rates for Atopic Dermatitis Related Treatments: Antihistamin | Proportion of the arm/group receiving at least one prescription for antihistamin. | Posted | Count of Participants | Participants | Jan - Dec 2018 inclusive |
|
|
|
| Primary | Prescription Rates for Atopic Dermatitis Related Treatments: Systemic Immuno-modulatory Therapy | Proportion of the arm/group receiving at least one prescription for Systemic immuno-modulatory therapy | Posted | Count of Participants | Participants | Jan - Dec 2018 inclusive |
|
|
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| Primary | Prescription Rates for Atopic Dermatitis Related Treatments: Oral Corticosteroids | Proportion of the arm/group receiving at least one prescription for oral corticosteroids | Posted | Count of Participants | Participants | Jan - Dec 2018 inclusive |
|
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| Primary | Specialist Referrals | Specialist dermatology referral rate in 2018 | Posted | Number | 95% Confidence Interval | Referrals per 100 person-years | Jan - Dec 2018 inclusive |
|
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| Primary | Primary Care Referrals | Annual rate of primary care consultations in 2018 | Posted | Number | 95% Confidence Interval | Consultations per 100 person-years | Jan - Dec 2018 inclusive |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |