Gastrointestinal Symptom Questionnaire Validation

Assessment of a new gastrointestinal symptom questionnaire in comparison to 2 well established and validated questionnaires that do not fully fit the requirements of an investigator concerned about gastrointestinal side effects in a patient without primary gastrointestinal disease.

Study Overview

• Status: Withdrawn
• Conditions: Those With and Without Gastrointestinal Disorders
• Intervention / Treatment: Other: Questionnaire

Detailed Description

210 subjects Healthy (n=70), ill with non-GI disease (n=70), with GI disease (n=70) Age above 18 COnsent after full explanation Each subject completes 3 questionnaires Glasgow Dyspepsia Score Gastrointestinal Symptom Rating Scale New score This is a total of 48 questions Analysis will seek to validate the new score. There is no other intervention and no risks are anticipated.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

As above

Description

Inclusion Criteria:

• As above Either healthy or GI disease or non-GI disease

Exclusion Criteria:

• Unable to provide informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy; Volunteers over 18 years	Other: Questionnaire; Form filling only
Gastrointestinal disorders; Over 18 and with any gastrointestinal or liver disorder	Other: Questionnaire; Form filling only
Non-gastrointestinal disorders; Over 18 and with any medical condition requiring hospital attention in which there is no primary gastrointestinal or liver disease	Other: Questionnaire; Form filling only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Construct validity measured by Validation of new score	Validation of new score	18 months

Collaborators and Investigators

• Sponsor: University of East Anglia
• Investigators: Study Chair: Alastair Forbes, MD, UEA

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Actual): November 3, 2020
• Study Completion (Actual): November 3, 2020

Study Registration Dates

• First Submitted: July 31, 2015
• First Submitted That Met QC Criteria: July 31, 2015
• First Posted (Estimate): August 3, 2015

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: 150725

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED