Investigating Healthcare Disparities in Vitiligo

Healthcare Disparities in Vitiligo: a Population-based Cohort Study in the UK

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.

Study Overview

• Status: Completed
• Conditions: Vitiligo
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 39374

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Momentum Data Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
People with Vitiligo; Children and adults with new onset Vitiligo registered with OPCRD during the study period.	Other: No intervention; Observational analysis of usual care only.
People without Vitiligo; Children and adults without Vitiligo registered with OPCRD during the study period	Other: No intervention; Observational analysis of usual care only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Momentum Data
• Collaborators: Pfizer
• Investigators: Study Director: Andrew McGovern, MD, Momentum Data

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Actual): July 17, 2024
• Study Completion (Actual): July 17, 2024

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hypopigmentation; Pigmentation Disorders; Vitiligo
• Other Study ID Numbers: P084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: There is no pre-specified time-frame for data availability; this will be considered on an individual basis for each request.
• IPD Sharing Access Criteria: As above.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No