Palmoplantar Pustulosis and Generalized Pustular Psoriasis: A National Population-based Analysis of Prevalence

This study plans to calculate the prevalence and incidence of palmoplantar pustulosis and generalized pustular psoriasis based on the national medical insurance data and analyze the composition characteristics and some clinical features of patients, through taking into account of the research status of palmoplantar pustulosis and generalized pustular psoriasis and the characteristics of medical insurance data.

Study Overview

• Status: Unknown
• Conditions: Palmoplantar Pustulosis; Generalized Pustular Psoriasis
• Intervention / Treatment: Other: prevalence/incidence

• Study Type: Observational
• Enrollment (Anticipated): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study used the Urban Employee Basic Medical Insurance (UEBMI) data from 2012 to 2016 to calculate the epidemiological characteristics of palmoplantar pustulosis and generalized pustular psoriasis. The database includes basic medical insurance data for urban workers and basic medical insurance data for urban residents, which covers 31 provinces, municipalities and autonomous regions. By the end of 2016, the number of people participating in the national basic medical insurance exceeded 1.3 billion, and the coverage rate of the insurance was stable at over 95%.

The database is composed of an insurance coverage database and a reimbursement settlement database. The insurance coverage database involves demographic information, insurance information and payment information; and the reimbursement settlement database involves medical information, disease information and expense information.

Description

Inclusion Criteria:

• The insured population of the national urban employee basic medical insurance and the urban resident basic medical insurance from January 1, 2012, to December 31, 2016 (60 months) (the denominator)
• The patients have been diagnosed with palmoplantar pustulosis or generalized pustular psoriasis (including disease name, English abbreviation and ICD code)
• Both outpatient and inpatient patients are included

Exclusion Criteria:

• The individuals whose information is only contained in the reimbursement settlement database but not in the insurance coverage database will be considered as invalid reimbursement individuals and be excluded from the study (the denominator)
• The patients have been diagnosed with non-PPP and -GPP diseases, such as pustular psoriasis in palm and toe, pustular arthritis osteitis and SAPHO syndrome

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PPP and GPP; Palmoplantar pustulosis (PPP) and Generalized pustular psoriasis (GPP) are rare chronic inflammatory skin diseases, characterized by repeated episodes of sterile pustules in several months or years, associated with erythrokeratodermia generally. Both two diseases are easy to cause skin rupture, leading to bleeding and pain.	Other: prevalence/incidence; It is an observational study for prevalence/incidence, no intervention provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence of Palmoplantar pustulosis	Epidemiological characteristics of diseases: Mainly referring to indicators that could reflect the frequency related to the disease	From 2012 to 2016 in the Urban Employee Basic Medical Insurance (UEBMI) data of China
prevalence of Generalized pustular psoriasis	Epidemiological characteristics of diseases: Mainly referring to indicators that could reflect the frequency related to the disease	From 2012 to 2016 in the Urban Employee Basic Medical Insurance (UEBMI) data of China

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of Palmoplantar pustulosis	Epidemiological characteristics of diseases: Mainly referring to indicators that could reflect the frequency related to the disease	From 2012 to 2016 in the Urban Employee Basic Medical Insurance (UEBMI) data of China
incidence of Generalized pustular psoriasis	Epidemiological characteristics of diseases: Mainly referring to indicators that could reflect the frequency related to the disease	From 2012 to 2016 in the Urban Employee Basic Medical Insurance (UEBMI) data of China
Economic burden of Palmoplantar pustulosis	Mainly referring to the consumption of medical resources, including medical expenses of patients.	From 2012 to 2016 in the Urban Employee Basic Medical Insurance (UEBMI) data of China
Economic burden of Generalized pustular psoriasis	Mainly referring to the consumption of medical resources, including medical expenses of patients.	From 2012 to 2016 in the Urban Employee Basic Medical Insurance (UEBMI) data of China

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Siyan Zhan, PhD, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): December 1, 2016
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2020
• Last Update Submitted That Met QC Criteria: September 22, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Generalized pustular psoriasis; Palmoplantar pustulosis; Urban Employee Basic Medical Insurance (UEBMI) data; prevalence; incidence
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: BI13680065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No