Evidence map›Paper›PMID 41710098›Full record

ArticlePatient related outcome measures2025

Psychometric Evaluation of the Celiac Disease Symptom Diary 2.1

Sonal Ghura, Dawn Wiese Adams, Marilyn G Geller, Daniel A Leffler, Edwin Liu, Lori D McLeod, Lisa M Meckley, Muna J Tahir, Ragy Saad, Nicholas J Rockwood

Registry-linked trialAbstract read
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In one paragraph

Article in Patient related outcome measures, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05309330 (Assessment of Symptom Patterns in Celiac Disease), which is not on this map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05309330 completednot on this map

Assessment of Symptom Patterns in Celiac Disease: A Prospective Longitudinal Survey

TypeobservationalSponsorTakedaRan2022 to 2023Enrolled480ConditionsCeliac DiseaseArmsNo Intervention
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Sonal GhuraTakeda Development Center Americas, Inc., Cambridge, MA, USA.
Dawn Wiese AdamsVanderbilt University Medical Center, Nashville, TN, USA.
Marilyn G GellerCeliac Disease Foundation, Woodland Hills, CA, USA.
Daniel A LefflerTakeda Development Center Americas, Inc., Cambridge, MA, USA.
Edwin LiuChildren's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO, USA.
Lori D McLeodRTI Health Solutions, Research Triangle Park, NC, USA.
Lisa M MeckleyTakeda Development Center Americas, Inc., Cambridge, MA, USA.
Muna J TahirTakeda Development Center Americas, Inc., Cambridge, MA, USA.
Ragy SaadTakeda Development Center Americas, Inc., Cambridge, MA, USA.
Nicholas J RockwoodRTI Health Solutions, Research Triangle Park, NC, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: Validated patient-reported outcome measures (PROMs) are required for use in clinical trials of celiac disease (CeD) therapies. The Celiac Disease Symptom Diary 2.1 Methods: Psychometric properties of CDSD 2.1 were evaluated using data from a 12-week US observational study, the Virtual Celiac Symptoms Study (NCT05309330), in patients with CeD maintaining a gluten-free diet. Participants completed CDSD 2.1 daily and other PROMs (Patient Global Impression of Severity [PGIS], Gastrointestinal Symptom Rating Scale [GSRS], and Celiac Symptom Index [CSI]) at specified time points to evaluate the reliability, validity, and responsiveness of CDSD 2.1. Results: Overall, 480 participants (338 adults, 142 adolescents) completed the study. Cronbach's alpha (baseline = 0.77 adults/adolescents) indicated high internal consistency reliability of weekly average gastrointestinal (GI; abdominal pain, bloating, nausea, diarrhea) CDSD 2.1 scores. An intraclass correlation coefficient of 0.89 (adults)/0.88 (adolescents) demonstrated high test-retest reliability among stable patients on PGIS. Moderate-to-strong correlations between weekly average GI CDSD 2.1 scores and GSRS domains at baseline and CSI at Week 3 confirmed construct validity (r = 0.44-0.76; Conclusion: This evaluation provides evidence to support the use of CDSD 2.1 in clinical trials as a reliable and responsive measure of CeD symptom severity.

Indexed as

celiac diseaseceliac disease symptom diarygastrointestinal symptomspatient-reported outcome measurepsychometric validationvirtual celiac symptoms study

Identifiers

PMID41710098
PMCPMC12912051

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