Core outcome domains in incontinence-associated dermatitis research

Area of Science:

• Dermatology
• Clinical Research Methodology
• Patient Care

Background:

• Incontinence-associated dermatitis (IAD) management is crucial for patient care.
• Lack of outcome comparability hinders evidence-based IAD prevention and treatment research.
• Core outcome sets can enhance the value of IAD clinical research.

Purpose of the Study:

• To establish a universal core set of outcome domains for clinical research on incontinence-associated dermatitis (IAD).
• To ensure consistency and comparability in IAD research outcomes across different geographical locations and populations.

Main Methods:

• Systematic literature review of 244 articles to identify outcome domains.
• Patient interviews and international steering committee consultations.
• A three-round Delphi consensus procedure with 57 international experts (healthcare providers, researchers, industry).

Main Results:

• 1,852 outcomes were extracted; 56 proposed by experts, 32 by patients.
• 58 outcome domains were rated by international panellists.
• The final core outcome set includes: erythema, erosion, maceration, IAD-related pain, and patient satisfaction.

Conclusions:

• Erythema, erosion, maceration, IAD-related pain, and patient satisfaction are essential outcome domains for IAD trials.
• This international consensus provides a foundation for standardizing IAD outcome measurement.
• Future research should focus on defining the methods for measuring these core domains.