Clinical trial NCT06097494: Investigating Healthcare Disparities in Vitiligo
Official title: Healthcare Disparities in Vitiligo: a Population-based Cohort Study in the UK
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitiligo
Lead sponsor: Momentum Data
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2023-10-24
Enrollment: 39374
Sex: ALL
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Risk of Depression Within Patients With Vitiligo
timeFrame: 2 years
measure: Risk of Anxiety Within Patients With Vitiligo
timeFrame: 2 years
measure: Risk of Depression or Anxiety Within Patients With Vitiligo
timeFrame: 2 years
Secondary outcomes:
measure: Primary Care Encounters
timeFrame: 2 years
measure: Dermatology Referrals
timeFrame: 2 years
measure: Mental Health Referrals
timeFrame: 2 years
measure: Unemployment
timeFrame: 2 years
measure: Time Off Work
timeFrame: 2 years
measure: Sleep Disturbance
timeFrame: 2 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Momentum Data Limited
Study officials:
affiliation: Momentum Data
name: Andrew McGovern, MD
role: STUDY_DIRECTOR
References: