Evidence map›Paper›PMID 39461929›Full record

ArticleQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2024

Development of the celiac disease symptom diary version 2.1

Kellee Howard, Daniel Adelman, Sonal Ghura, Sarah Acaster, Sarah Clifford, Ciaran P Kelly, Susan A Martin, Lisa M Meckley, Daniel A Leffler

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In one paragraph

Article in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

9 authors.

Kellee HowardICON plc, San Fransisco, CA, USA.ORCID http://orcid.org/0009-0009-8608-3161
Daniel AdelmanUniversity of California, San Fransisco, CA, USA.ORCID http://orcid.org/0000-0002-0470-3235
Sonal GhuraTakeda Development Center Americas Inc, Cambridge, CA, USA.ORCID http://orcid.org/0009-0004-8615-9297
Sarah AcasterOxford Outcomes Ltd. (later acquired by ICON plc), Oxford, UK.ORCID http://orcid.org/0000-0003-1025-2546
Sarah CliffordICON plc, San Fransisco, CA, USA.ORCID http://orcid.org/0000-0002-6811-4691
Ciaran P KellyCeliac Center, Beth Israel Deaconess Medical Center, Harvard Medical School Celiac Research Program, Boston, MA, USA.ORCID http://orcid.org/0000-0002-8216-1240
Susan A MartinRTI Health Solutions, Ann Arbor, USA, MI.ORCID http://orcid.org/0000-0002-9594-5036
Lisa M MeckleyTakeda Development Center Americas Inc., Cambridge, MA, USA.ORCID http://orcid.org/0000-0002-4791-4294
Daniel A LefflerTakeda Development Center Americas Inc, Cambridge, CA, USA. daniel.leffler@takeda.com.ORCID http://orcid.org/0000-0002-0750-3386

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeFor patients with celiac disease (CeD), the only current management option is adherence to a strict gluten-free diet (GFD); however, many patients on a GFD continue to experience symptoms with a significant impact on quality of life. Potential new treatments for CeD are under development and a validated patient-reported outcome measure is required to evaluate their utility in clinical trials. The purpose of this article is to provide a history of the development of the Celiac Disease Symptom Diary (CDSD) 2.1

methodsQualitative and quantitative studies were conducted from 2010 to 2021, including concept elicitation and cognitive debriefing interviews with adult and adolescent participants with CeD (N = 93) diagnosed via biopsy and/or serology and input from eight interviews with CeD clinical experts. During these studies, different iterations of the CDSD were presented to the US Food and Drug Administration and the European Medicines Agency, and modifications were made in line with their feedback.

resultsThese studies ultimately led to the development of CDSD 2.1

conclusionCDSD 2.1

Indexed as

Celiac DiseaseDiet, Gluten-FreePatient Reported Outcome MeasuresQuality of LifeAdolescentAdultFemaleHumansMaleMiddle AgedPsychometricsQualitative ResearchSurveys and QuestionnairesYoung AdultCDSDCeliac diseaseCoeliac diseasePatient-reported outcomeSymptoms

Identifiers

PMID39461929
PMCPMC11599373

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.