Assessment of the Systemic Sclerosis-Associated Raynaud's Phenomenon Questionnaire: Item Bank and Short-Form...

Area of Science:

• Rheumatology and Immunology
• Patient-Reported Outcomes
• Psychometrics

Background:

• Systemic sclerosis (SSc) frequently causes Raynaud's phenomenon (RP), impacting patient quality of life.
• Existing measures may not fully capture the severity and functional impact of SSc-RP from the patient's perspective.

Purpose of the Study:

• To develop and validate a novel patient-reported outcome instrument for assessing SSc-RP.
• To create both long-form and short-form versions of the questionnaire for comprehensive and efficient assessment.

Main Methods:

• Item generation involved patient insight partners and qualitative testing.
• International multicenter study enrolled 420 SSc patients.
• Psychometric analyses, including item response theory, refined the questionnaire.

Main Results:

• A 27-item long-form ASRAP questionnaire was developed and calibrated.
• A 10-item short-form ASRAP questionnaire was created using adaptive testing simulations.
• Extensive patient input ensured content validity and relevance to lived experiences.

Conclusions:

• The ASRAP questionnaire, developed with patient input, offers strong content validity for SSc-RP.
• Advanced psychometric methods ensured item quality and relevance.
• Calibrated long- and short-form questionnaires are ready for formal validation.