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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| University of Oxford | OTHER |
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Alopecia areata (AA) is a common immune-mediated non-scarring alopecia often associated with substantial morbidity. There are however, limited population-based data on potential disparities in the burden of AA, including across people of different ethnicities and deprivation.
We aimed to provide the first large-scale, population-based estimate of lifetime risk of AA overall and by important sociodemographic subgroups. As AA is associated with an increased burden of mental health conditions and work-related outcomes (unemployment, time off work), a detailed understanding of the burden of disease in different sociodemographic groups is vital to plan resource provision.
The overall purpose of the study is to provide an estimate of the cumulative lifetime incidence of AA in the population overall and by important sociodemographic groups. Moreover, to do a subgroup analysis in the AA population to identify health-related disparities across people in different socioeconomic strata, geographical distribution, sex and ethnic groups. The disparities that will be considered are AA associated: Mental health conditions; healthcare utilisation; and work impact (time off work and unemployment).
The cumulative lifetime risk of AA was estimated at age 80 years (approximate life expectancy in the UK) using survival models, with age as the timescale and accounting for the competing risk of death.
The assessment of any associations with baseline characteristics and the outcomes of interest will be assessed using Cox proportional hazards models (time to event outcomes) and Poisson regression (repeated event outcomes) models.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People with Alopecia Areata | Children and adults aged 12+ with new onset Alopecia Areata registered with a contributing General practitioner (GP) practice during the study period. |
| |
| People without Alopecia Areata | Children and adults aged 12+ without Alopecia Areata registered with a contributing GP practice 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 |
|---|---|---|
| Likelihood of Depressive Episodes | Estimated using logistic regression and reported using adjusted odds ratios | Data was collected retrospectively, assessed prior to and up to two years following initial Alopecia Areata diagnosis for each participant |
| Likelihood of Recurrent Major Depressive Disorder | Estimated using logistic regression and reported using adjusted odds ratios | Data was collected retrospectively, assessed prior to and up to two years following initial Alopecia Areata diagnosis for each participant |
| Likelihood of Anxiety Disorder | Estimated using logistic regression and reported using adjusted odds ratios | Data was collected retrospectively, assessed prior to and up to two years following initial Alopecia Areata diagnosis for each participant |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Incidence of Primary Care Attendances | Estimated using negative binomial regression and reported as adjusted incidence rate ratio | Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant |
| Relative Incidence of Dermatology Referrals |
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Inclusion Criteria:
Exclusion Criteria:
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All individuals with new onset AA during the study period defined by the presence of at least one disease specific diagnostic code will be eligible for inlcusion in the AA cohort. Controls will be matched people without AA matched on age, sex, geography, ethnicity, socioeconomic status.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew McGovern, MD | Momentum Data | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Momentum Data Limited | London | United Kingdom |
Individual patient data is confidential but can be made available in an anonymised form to bone fide researchers subject to the required data protection training and other requirements. All data will remain behind a firewall and will only be available for access through a secured computer network.
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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People that did not develop Alopecia Areata but had a diagnosis of a nonspecific or alopecia alternative condition, or less than 12 months of follow-up available, were excluded from the study.
Of the 4,052,231 adults and children (aged 12+) in the final study population, 6,183 people who developed Alopecia Areata (AA) between 1 January 2009 and 31 December 2018 were matched to 24,718 people without AA.
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| ID | Title | Description |
|---|---|---|
| FG000 | People With Alopecia Areata | Children and adults aged 12+ with new onset Alopecia Areata registered with a contributing General practitioner (GP) practice during the study period. No intervention: Observational analysis of usual care only. |
| FG001 | People Without Alopecia Areata | Children and adults aged 12+ without Alopecia Areata registered with a contributing GP practice during the study period. No intervention: Observational analysis of usual care only. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | People With Alopecia Areata | Children and adults aged 12+ with new onset Alopecia Areata registered with a contributing General practitioner (GP) practice during the study period. No intervention: Observational analysis of usual care only. |
| BG001 | People Without Alopecia Areata |
| 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 | Likelihood of Depressive Episodes | Estimated using logistic regression and reported using adjusted odds ratios | Posted | Count of Participants | Participants | Data was collected retrospectively, assessed prior to and up to two years following initial Alopecia Areata diagnosis for each participant |
|
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Deaths, serious adverse events, and nonserious adverse events were not assessed for study participants.
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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 | People With Alopecia Areata | Children and adults aged 12+ with new onset Alopecia Areata registered with a contributing General practitioner (GP) practice during the study period. No intervention: Observational analysis of usual care only. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew G. Messenger | University of Sheffield | +44 114 222 2000 | a.g.messenger@sheffield.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: Study Protocol | Nov 2, 2022 | Jan 27, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
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Estimated using Cox proportional hazard regression and reported as Adjusted hazard ratio |
| Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant |
| Relative Incidence Psychological Therapy | Estimated using Cox proportional hazard regression and reported as adjusted hazard ratio | Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant |
| Relative Incidence of Unemployment | Unemployment identified by issue of IB113 or ESA113 forms for unemployment. Relative incidence estimated using Cox proportional hazard regression and reported as Adjusted hazard ratio | Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant |
| Relative Incidence of Time Off Work | Time off work identified by recorded issue of Med 3 certificate in primary care. Relative incidence estimated using Cox proportional hazard regression and reported as Adjusted hazard ratio | Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant |
Children and adults aged 12+ without Alopecia Areata registered with a contributing GP practice during the study period. No intervention: Observational analysis of usual care only. |
| 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 |
|
| Geographic area: Urban, Rural | Count of Participants | Participants |
|
| Index of multiple deprivation (IMD) | Index of Multiple Deprivation (IMD) is a United Kingdom (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 |
|
| Body Mass Index (BMI), Categorical | Count of Participants | Participants |
|
| Smoking status | Count of Participants | Participants |
|
| Alcohol status | Count of Participants | Participants |
|
| Geographical region | Count of Participants | Participants |
|
|
|
|
| Primary | Likelihood of Recurrent Major Depressive Disorder | Estimated using logistic regression and reported using adjusted odds ratios | Posted | Count of Participants | Participants | Data was collected retrospectively, assessed prior to and up to two years following initial Alopecia Areata diagnosis for each participant |
|
|
|
|
| Primary | Likelihood of Anxiety Disorder | Estimated using logistic regression and reported using adjusted odds ratios | Posted | Count of Participants | Participants | Data was collected retrospectively, assessed prior to and up to two years following initial Alopecia Areata diagnosis for each participant |
|
|
|
|
| Secondary | Relative Incidence of Primary Care Attendances | Estimated using negative binomial regression and reported as adjusted incidence rate ratio | Posted | Number | Count of primary care visits | Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant |
|
|
|
|
| Secondary | Relative Incidence of Dermatology Referrals | Estimated using Cox proportional hazard regression and reported as Adjusted hazard ratio | Posted | Number | Count of dermatology referrals | Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant |
|
|
|
|
| Secondary | Relative Incidence Psychological Therapy | Estimated using Cox proportional hazard regression and reported as adjusted hazard ratio | Posted | Number | Count of therapy visits | Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant |
|
|
|
|
| Secondary | Relative Incidence of Unemployment | Unemployment identified by issue of IB113 or ESA113 forms for unemployment. Relative incidence estimated using Cox proportional hazard regression and reported as Adjusted hazard ratio | Posted | Number | Count of unemployment forms issued | Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant |
|
|
|
|
| Secondary | Relative Incidence of Time Off Work | Time off work identified by recorded issue of Med 3 certificate in primary care. Relative incidence estimated using Cox proportional hazard regression and reported as Adjusted hazard ratio | Posted | Number | Count of Med 3 certificates issued | Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant |
|
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|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | People Without Alopecia Areata | Children and adults aged 12+ without Alopecia Areata registered with a contributing GP practice during the study period. No intervention: Observational analysis of usual care only. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D017437 |
| Skin and Connective Tissue Diseases |