Global consensus process to establish a core dataset for hidradenitis suppurativa registries

Area of Science:

• Dermatology
• Clinical Research Methodology
• Data Standardization

Background:

• Existing hidradenitis suppurativa (HS) registries in Europe and the USA lack a unified core dataset (CDS).
• Logistical and regulatory challenges hinder global HS registry collaboration due to dataset variations.
• A standardized CDS is crucial for enabling worldwide collaboration among HS registries.

Purpose of the Study:

• To define a globally applicable core dataset (CDS) for all hidradenitis suppurativa (HS) registries.
• The CDS encompasses demographic data, comorbidities, clinical findings, patient-reported outcomes, and treatments.

Main Methods:

• A four-round eDelphi process involving 20 experts and patient advocates from 8 countries.
• Literature reviews identified initial items, considering existing core sets like HiSTORIC.
• Anonymous feedback facilitated consensus-building among international participants.

Main Results:

• A consensus-based core dataset (CDS) comprising 48 items was established for global HS registries.
• The CDS is recommended for inclusion in all current and future hidradenitis suppurativa registries.

Conclusions:

• Routine adoption of the 48-item CDS will facilitate collaboration among international HS registries.
• This standardization will enable research initiatives requiring substantial patient cohorts.
• The established CDS is key to advancing global hidradenitis suppurativa research.