Poster Presentation International Celiac Disease Symposium 2026

Adapting the Celiac Disease Symptom Diary v2.1 (CDSD) for Routine Clinical Practice: Preliminary Findings from Cognitive Interviews with Patients with Celiac Disease (#307)

Melinda Dennis 1 , Ciarán P. Kelly 1 , Daniel A Leffler 2 , Daniel C Adelman 3 , Kellee Howard 4
  1. Celiac Center, Beth Israel Deaconess Medical Center, Boston, MA, USA
  2. Chugai Pharma USA, Inc., Cambridge, MA, USA
  3. University of California, San Francisco, CA, USA
  4. Patient Centered Solutions, IQVIA, Montreal, QC, Canada

Background:

The Celiac Disease Symptom Diary v2.1 was developed and validated as a Patient Reported Outcome measure to quantify and monitor symptoms over 24 hours in celiac disease clinical trials. Tools developed for use in clinical trials may not be optimal for routine clinical care, creating a need for an instrument suitable for symptom assessment in clinical practice.

 

Aim:
This study explored patient feedback to inform adaptation of the CDSD as a clinician-administered tool to assess celiac disease symptoms in routine clinical practice.

 

Methods:  

The qualitative phase used a semi-structured interview to support adaptation of the CDSD. The initial cohort of subjects with celiac disease (n=4 women, n=3 men, all Caucasian, mean age 43.43 years, mean duration on a gluten-free diet: 6.63 years) completed the CDSD and provided feedback on item relevance, comprehension, response options, recall period and overall usability in a clinical care setting. The interviews included a socio-demographic form and concept elicitation questions reviewing the impact of celiac disease on subjects’ lives.

 

Results:

Using structured thematic coding, interview transcript analyses from the initial cohort showed that most participants found the instrument easy to understand and were able to select response options that reflected their symptom experiences. The analysis identified multiple factors impacting clinical usability of the CDSD, including difficulties related to the short recall period (changed to seven days for clinical use), comprehension of symptom definitions, and the cognitive load involved in reporting complex symptom data. Findings from the initial interview round will be used to inform refinement of symptom definitions and item wording in subsequent interviews.

 

Conclusion:
Our findings identify areas for modification to the CDSD to improve utility in clinical practice.  These include symptom definitions, response options, and recall period, and support adaptation of the CDSD for symptom assessment in routine clinical practice.

 

 

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