Vitiligo
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERNo intervention
Observational analysis of usual care only.
Sponsors
Pfizer
Momentum Data
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 95 Years
Inclusion criteria
* The cohort for the endpoint analysis will consist of all adults and adolescents (aged 13+) contributing to OPCRD during the study period (2004-2020). * The cohort for the lifetime risk analysis will consist of all people contributing to OPCRD during the study period. * The vitiligo cohort consists of people newly diagnosed with vitiligo at any point during the study period.
Exclusion criteria
* People with the alternative non-vitiligo diagnoses (other hypopigmenting conditions). * People with vitiligo diagnosis within 6 months of practice registration. * People without vitiligo with less than 1 year of follow up within the dataset. * People over the age of 95 (for those reaching age 95 during the follow up period follow up was censored at age 95). * People who have opted out of record sharing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk of Depression Within Patients With Vitiligo | 2 years | Adjusted odds ratio calculated using logistic regression. |
| Risk of Anxiety Within Patients With Vitiligo | 2 years | Adjusted odds ratio calculated using logistic regression. |
| Risk of Depression or Anxiety Within Patients With Vitiligo | 2 years | Adjusted odds ratio of depression or anxiety in people with vitiligo calculated using logistic regression . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unemployment | 2 years | Describe any disparities in work-related impact (unemployment) reported as adjusted hazard ratios. |
| Primary Care Encounters | 2 years | Describe any disparities in primary care usage (primary care visits) reported as adjusted incidence rate ratios |
| Sleep Disturbance | 2 years | Describe any disparities in sleep disturbance reported as adjusted hazard ratios. |
| Time Off Work | 2 years | Describe any disparities in work-related impact (time off work) reported as adjusted hazard ratios. |
| Dermatology Referrals | 2 years | Percentage of participants diagnosed with vitligo and having a recorded dermatology referral event wthin two year estimated using using the Kaplan-Meier method. |
| Mental Health Referrals | 2 years | Describe any disparities in healthcare utilisation ( mental health referrals) reported as adjusted hazard ratios |
Countries
United Kingdom
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7,890 |
| People Without Vitiligo 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. | 31,484 |
| Total | 39,374 |
Baseline characteristics
| Characteristic | People Without Vitiligo | People With Vitiligo | Total |
|---|---|---|---|
| Age, Continuous | 42 years | 43 years | 42.5 years |
| Age, Customized 13-17 years | 1915 Participants | 487 Participants | 2402 Participants |
| Age, Customized 18-29 years | 5471 Participants | 1370 Participants | 6841 Participants |
| Age, Customized 30-49 years | 12242 Participants | 3063 Participants | 15305 Participants |
| Age, Customized 50+ years | 11856 Participants | 2970 Participants | 14826 Participants |
| Alcohol consumption, Categorical Harmful | 463 Participants | 121 Participants | 584 Participants |
| Alcohol consumption, Categorical In excess of limits | 3685 Participants | 1005 Participants | 4690 Participants |
| Alcohol consumption, Categorical None | 10014 Participants | 2605 Participants | 12619 Participants |
| Alcohol consumption, Categorical Not recorded | 5946 Participants | 1246 Participants | 7192 Participants |
| Alcohol consumption, Categorical Within limits | 11376 Participants | 2913 Participants | 14289 Participants |
| Body Mass Index, Categorical 18.5-25 (normal weight) | 8504 Participants | 2324 Participants | 10828 Participants |
| Body Mass Index, Categorical < 18.5 (underweight) | 1054 Participants | 269 Participants | 1323 Participants |
| Body Mass Index, Categorical 25-30 (overweight) | 8938 Participants | 2386 Participants | 11324 Participants |
| Body Mass Index, Categorical 30-35 (class I obesity) | 4410 Participants | 1137 Participants | 5547 Participants |
| Body Mass Index, Categorical 35-40 (class II obesity) | 1654 Participants | 372 Participants | 2026 Participants |
| Body Mass Index, Categorical > 40 (class III obesity) | 940 Participants | 214 Participants | 1154 Participants |
| Body Mass Index, Categorical Not recorded | 5984 Participants | 1188 Participants | 7172 Participants |
| Index of Multiple Deprivation 1 (most deprived) | 6094 Participants | 1525 Participants | 7619 Participants |
| Index of Multiple Deprivation 2 | 5545 Participants | 1392 Participants | 6937 Participants |
| Index of Multiple Deprivation 3 | 5418 Participants | 1355 Participants | 6773 Participants |
| Index of Multiple Deprivation 4 | 6084 Participants | 1527 Participants | 7611 Participants |
| Index of Multiple Deprivation 5 (least deprived) | 5928 Participants | 1484 Participants | 7412 Participants |
| Index of Multiple Deprivation Not recorded | 2415 Participants | 607 Participants | 3022 Participants |
| Race/Ethnicity, Customized Asian | 4775 Participants | 1197 Participants | 5972 Participants |
| Race/Ethnicity, Customized Black | 708 Participants | 196 Participants | 904 Participants |
| Race/Ethnicity, Customized Mixed | 332 Participants | 80 Participants | 412 Participants |
| Race/Ethnicity, Customized Not recorded | 9555 Participants | 2392 Participants | 11947 Participants |
| Race/Ethnicity, Customized Other | 1220 Participants | 299 Participants | 1519 Participants |
| Race/Ethnicity, Customized White | 14894 Participants | 3726 Participants | 18620 Participants |
| Sex: Female, Male Female | 16492 Participants | 4131 Participants | 20623 Participants |
| Sex: Female, Male Male | 14992 Participants | 3759 Participants | 18751 Participants |
| Smoking status, Categorical Current smoker | 6114 Participants | 1229 Participants | 7343 Participants |
| Smoking status, Categorical Ex-smoker | 13435 Participants | 3642 Participants | 17077 Participants |
| Smoking status, Categorical Never smoked | 10000 Participants | 2709 Participants | 12709 Participants |
| Smoking status, Categorical Not recorded | 1935 Participants | 310 Participants | 2245 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Risk of Anxiety Within Patients With Vitiligo
Adjusted odds ratio calculated using logistic regression.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| People With Vitiligo | Risk of Anxiety Within Patients With Vitiligo | 708 Events |
| People Without Vitiligo | Risk of Anxiety Within Patients With Vitiligo | 2430 Events |
95% CI: [1.09, 1.3]
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 .
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| People With Vitiligo | Risk of Depression or Anxiety Within Patients With Vitiligo | 1614 Events |
| People Without Vitiligo | Risk of Depression or Anxiety Within Patients With Vitiligo | 6064 Events |
95% CI: [1.03, 1.17]
Primary
Risk of Depression Within Patients With Vitiligo
Adjusted odds ratio calculated using logistic regression.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| People With Vitiligo | Risk of Depression Within Patients With Vitiligo | 1412 Events |
| People Without Vitiligo | Risk of Depression Within Patients With Vitiligo | 5395 Events |
95% CI: [1.01, 1.15]
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.
Time frame: 2 years
Population: Dermatology referrals were assessed only in patients with vitiligo
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| People With Vitiligo | Dermatology Referrals | 20 percentage of participants analyzed |
Secondary
Mental Health Referrals
Describe any disparities in healthcare utilisation ( mental health referrals) reported as adjusted hazard ratios
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| People With Vitiligo | Mental Health Referrals | 311 Events |
| People Without Vitiligo | Mental Health Referrals | 1191 Events |
95% CI: [0.93, 1.2]
Secondary
Primary Care Encounters
Describe any disparities in primary care usage (primary care visits) reported as adjusted incidence rate ratios
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| People With Vitiligo | Primary Care Encounters | 134207 Events |
| People Without Vitiligo | Primary Care Encounters | 439633 Events |
95% CI: [1.26, 1.32]
Secondary
Sleep Disturbance
Describe any disparities in sleep disturbance reported as adjusted hazard ratios.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| People With Vitiligo | Sleep Disturbance | 318 Events |
| People Without Vitiligo | Sleep Disturbance | 1102 Events |
95% CI: [1.02, 1.31]
Secondary
Time Off Work
Describe any disparities in work-related impact (time off work) reported as adjusted hazard ratios.
Time frame: 2 years
Population: Subset of participants of working age
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| People With Vitiligo | Time Off Work | 746 Events |
| People Without Vitiligo | Time Off Work | 2472 Events |
95% CI: [1.06, 1.24]
Secondary
Unemployment
Describe any disparities in work-related impact (unemployment) reported as adjusted hazard ratios.
Time frame: 2 years
Population: Subset of participants of working age
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| People With Vitiligo | Unemployment | 111 Events |
| People Without Vitiligo | Unemployment | 436 Events |
95% CI: [0.76, 1.15]