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Development of the Cold Agglutinin Disease Symptoms and Impact Questionnaire (CAD-SIQ)

Florence Joly1, Pronabesh DasMahapatra2, Dana B DiBenedetti3

  • 1Sanofi, Chilly-Mazarin, France.

European Journal of Haematology
|May 2, 2023
PubMed

Insights

This study identified key symptoms and impacts of cold agglutinin disease (CAD) in patients. A new questionnaire was developed to measure these patient-reported outcomes for better CAD management.

Area of Science:

  • Hematology
  • Autoimmune Diseases
  • Patient-Reported Outcomes

Background:

  • Cold agglutinin disease (CAD) is a rare autoimmune hemolytic anemia.
  • Understanding patient-centered symptoms and impacts is crucial for managing CAD.
  • Existing measures may not fully capture the lived experience of CAD patients.

Purpose of the Study:

  • To identify disease-related symptoms and impacts significant to patients with CAD.
  • To develop and validate a novel, CAD-specific patient-reported outcome measure.

Main Methods:

  • Concept elicitation (CE) interviews were conducted with adult CAD patients to identify key symptoms and impacts.
  • Cognitive debriefing (CD) interviews were used to refine a draft item set.
  • Standard survey methodological principles guided item development and refinement.

Main Results:

  • 37 adults with CAD participated in interviews.
  • The most frequently reported symptoms were cold sensitivity and fatigue.
  • Negative impacts included limitations on daily and enjoyable activities, mood, and anxiety.

Conclusions:

  • A novel 11-item questionnaire, the CAD-Symptoms and Impact Questionnaire, was developed.
  • This measure captures symptoms and impacts important to patients with CAD.
  • The questionnaire provides a valuable tool for assessing the patient experience in CAD.
Abstract

Keywords:
cold agglutinin diseaseconceptual modelinstrument developmentpatient interviewspatient-reported outcome

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