Evidence map›Paper›PMID 34819137›Full record

ArticleOrphanet journal of rare diseases2021

Development and content validation of a symptom assessment for eosinophilic gastritis and eosinophilic gastroenteritis in adults and adolescents.

Calvin N Ho, Sean O'Quinn, Julie Bailey, Oren Meyers, Ashley F Slagle, Evan S Dellon, Catherine Datto

Open access · goldAbstract readValidation Study
In one paragraph

Article in Orphanet journal of rare diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.0field-weighted citation impact, top 22% of its field
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

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Eosinophilic gastrointestinal diseases.Nature reviews. Disease primers · 2026
    Review
  3. Article
  4. Review
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

7 authors at 4 institutions in 3 countries.

Calvin N HoAstraZeneca, Gaithersburg, MD, USA. calvin.ho@astrazeneca.com.ORCID 0000-0002-3360-9651
Sean O'QuinnAstraZeneca, Gaithersburg, MD, USA.
Julie BaileyIQVIA, Real World Solutions, Patient Centered Solutions, New York, NY, USA.
Oren MeyersIQVIA, Real World Solutions, Patient Centered Solutions, New York, NY, USA.
Ashley F SlagleAspen Consulting, Steamboat Springs, CO, USA.
Evan S DellonCenter for Esophageal Diseases and Swallowing, Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.
Catherine DattoAstraZeneca, Gaithersburg, MD, USA.
AstraZeneca (United States) · USIQVIA (United States) · USAstraZeneca (Netherlands) · NLUniversity of North Carolina at Chapel Hill · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA patient reported outcome (PRO) instrument with evidence of validity and reliability for assessing symptoms of eosinophilic gastritis (EG) and eosinophilic gastroenteritis (EGE) is needed to measure treatment benefit in clinical trials. The aim of this research is to develop an EG/EGE symptom PRO instrument for patients aged 12 and above.

methodsThe Symptom Assessment for Gastrointestinal Eosinophilic Diseases (SAGED) was developed through a literature review, discussions with expert clinicians, and concept elicitation and cognitive debriefing interviews with patients. Patients (n = 28) were recruited based on confirmed diagnosis and self-reported symptoms. The final instrument was translated and linguistically validated with additional cognitive debriefing interviews (n = 105).

resultsSAGED is a 24-h recall questionnaire consisting of eight items evaluating the core symptoms of EG and EGE (abdominal pain, nausea, bloating, early satiety, loss of appetite, vomiting, and diarrhea). Seven of the eight items are evaluated on an 11-point numerical rating scale ranging from 'none' to 'worst imaginable'. Cognitive debriefing interviews showed that adults and adolescents understand the content and are able to select a response that reflects their experience. The linguistic validation process produced 21 translations that are understandable to patients and conceptually equivalent to the source version.

conclusionsSAGED is suitable for measuring symptom improvement in adult and adolescent patients with EG and/or EGE. The content validity of SAGED has been established through best practices in qualitative research for PRO instrument development. The psychometric properties of SAGED will be evaluated in a future study.

Indexed as

EnteritisGastritisSymptom AssessmentAdolescentAdultChildEosinophiliaHumansReproducibility of ResultsSurveys and QuestionnairesTranslationsEosinophilic duodenitisEosinophilic gastritisEosinophilic gastroenteritisPatient reported outcomes

Identifiers

PMID34819137
PMCPMC8611867
OpenAlexW3215665711

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.