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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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Vitiligo is an acquired, non contagious skin disorder characterised by depigmented patches of skin that may appear in a localised or very generalised distribution, and affecting 0.5-2.0% of the global population.There are however, limited population-based studies on the burden of vitiligo and disparities across people of different ethnicities and deprivation.
The overall purpose of this study is to provide an estimate of the lifetime risk of vitiligo in the population overall and by sociodemographic subgroups. Moreover, to do a subgroup analysis in the vitiligo population to identify health-related disparities across people in different sex, age, deprivation and ethnicity. A detailed understanding of the burden of disease in different sociodemographic groups is vital to plan resource provision.
This study will provide estimate of the cumulative lifetime risk of vitiligo in the population overall, and by important sociodemographic groups, including age, sex, ethnicity and deprivation, which will prevalent key data to show the relative burden of vitiligo across the aforementioned groups. These approaches allow creation of cumulative lifetime risk plots which provide an excellent and accessible way to display the relative disease burden across groups.
The cumulative lifetime risk of vitiligo will be estimated at age 80 years (approximate lifetime expectancy in the UK) using survival models, with age as the timescale and accounting for competing risk of death.
This study will also perform a subgroup analysis in the vitiligo population to identify health-related disparities across people in different deprivation, sex and ethnic groups. The disparities that will be considered are: Mental health conditions; healthcare utilisation; and work impact (time off work and unemployment),
The assessment of any associations with baseline characteristics and the outcome of interest will be used using Cox proportional hazards models (time to event outcomes) and generalised linear models.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People with Vitiligo | Children and adults with new onset Vitiligo registered with OPCRD during the study period. |
| |
| People without Vitiligo | Children and adults without Vitiligo registered with OPCRD 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 |
|---|---|---|
| Risk of Depression Within Patients With Vitiligo | Adjusted odds ratio calculated using logistic regression. | 2 years |
| Risk of Anxiety Within Patients With Vitiligo | Adjusted odds ratio calculated using logistic regression. | 2 years |
| Risk of Depression or Anxiety Within Patients With Vitiligo | Adjusted odds ratio of depression or anxiety in people with vitiligo calculated using logistic regression . | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Care Encounters | Describe any disparities in primary care usage (primary care visits) reported as adjusted incidence rate ratios | 2 years |
| Dermatology Referrals | Percentage of participants diagnosed with vitligo and having a recorded dermatology referral event wthin two year estimated using using the Kaplan-Meier method. |
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Inclusion Criteria:
Exclusion Criteria:
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Incident cases will be defined as people with a first ever diagnosis code of vitiligo during the study period. People with a diagnosis of vitiligo prior to the study period will be excluded. Each case will be assigned an index date at the time of their vitiligo diagnosis. Controls will be matched to people without Vitiligo matched on age, sex, ethnicity and deprivation.
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39018020 | Derived | Eleftheriadou V, Ahmed A, Nesnas J, Nagra R. The lifetime risk and impact of vitiligo across sociodemographic groups: a UK population-based cohort study. Br J Dermatol. 2024 Dec 23;192(1):63-71. doi: 10.1093/bjd/ljae282. |
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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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Participants with a diagnosis for an alternative depigmenting disorder or were diagnosed with vitiligo within 6 months of registering with their general practice (GP) were excluded.
All adults and children (aged ≥ 13 years) contributing to the Optimum Patient Care Research Database (OPCRD) between 1 January 2004 and 31 December 2020, without a diagnosis of vitiligo prior to1 January 2004 were eligible for inclusion.
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| ID | Title | Description |
|---|---|---|
| FG000 | People With Vitiligo | Children and adults with new onset Vitiligo registered with OPCRD during the study period. No intervention: Observational analysis of usual care only. |
| FG001 | People Without Vitiligo (Reference Group) | Children and adults without Vitiligo registered with OPCRD 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 Vitiligo | Children (≥ 13 years) and adults with new onset Vitiligo registered with Optimum Patient Care Research Database during the study period. No intervention: Observational analysis of usual care only. |
| BG001 | People Without Vitiligo |
| 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 | Risk of Depression Within Patients With Vitiligo | Adjusted odds ratio calculated using logistic regression. | Posted | Number | Events | 2 years |
|
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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 Vitiligo | Children and adults with new onset Vitiligo registered with OPCRD during the study period. No intervention: Observational analysis of usual care only. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ranjit Nagra | Pfizer Ltd | 01304 616161 | ranjit.nagra@pfizer.com |
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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 | Aug 25, 2023 | Oct 13, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 2 years |
| Mental Health Referrals | Describe any disparities in healthcare utilisation ( mental health referrals) reported as adjusted hazard ratios | 2 years |
| Unemployment | Describe any disparities in work-related impact (unemployment) reported as adjusted hazard ratios. | 2 years |
| Time Off Work | Describe any disparities in work-related impact (time off work) reported as adjusted hazard ratios. | 2 years |
| Sleep Disturbance | Describe any disparities in sleep disturbance reported as adjusted hazard ratios. | 2 years |
Children (≥ 13 years) and adults without Vitiligo registered with Optimum Patient Care Research Database 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 | Ethnicity categorized according to the UK's Office for National Statistics definitions of major UK ethnic groups | Count of Participants | Participants |
|
| Index of Multiple Deprivation | 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 |
|
| Body Mass Index, Categorical | Body Mass Index (BMI) is a based on a participants height and weight. | Count of Participants | Participants |
|
| Smoking status, Categorical | Count of Participants | Participants |
|
| Alcohol consumption, Categorical | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
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| Primary | Risk of Anxiety Within Patients With Vitiligo | Adjusted odds ratio calculated using logistic regression. | Posted | Number | Events | 2 years |
|
|
|
|
| Primary | Risk of Depression or Anxiety Within Patients With Vitiligo | Adjusted odds ratio of depression or anxiety in people with vitiligo calculated using logistic regression . | Posted | Number | Events | 2 years |
|
|
|
|
| Secondary | Primary Care Encounters | Describe any disparities in primary care usage (primary care visits) reported as adjusted incidence rate ratios | Posted | Number | Events | 2 years |
|
|
|
|
| Secondary | Dermatology Referrals | Percentage of participants diagnosed with vitligo and having a recorded dermatology referral event wthin two year estimated using using the Kaplan-Meier method. | Dermatology referrals were assessed only in patients with vitiligo | Posted | Number | 95% Confidence Interval | percentage of participants analyzed | 2 years |
|
|
|
| Secondary | Mental Health Referrals | Describe any disparities in healthcare utilisation ( mental health referrals) reported as adjusted hazard ratios | Posted | Number | Events | 2 years |
|
|
|
|
| Secondary | Unemployment | Describe any disparities in work-related impact (unemployment) reported as adjusted hazard ratios. | Subset of participants of working age | Posted | Number | Events | 2 years |
|
|
|
|
| Secondary | Time Off Work | Describe any disparities in work-related impact (time off work) reported as adjusted hazard ratios. | Subset of participants of working age | Posted | Number | Events | 2 years |
|
|
|
|
| Secondary | Sleep Disturbance | Describe any disparities in sleep disturbance reported as adjusted hazard ratios. | Posted | Number | Events | 2 years |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | People Without Vitiligo | Children and adults without Vitiligo registered with OPCRD during the study period No intervention: Observational analysis of usual care only. | 0 | 0 | 0 | 0 | 0 | 0 |
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