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Protocol - Assessment of Functional Gastrointestinal Disorders (Adult)

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Description:

This questionnaire is based on the Rome III symptoms-based diagnostic criteria for the functional gastrointestinal disorders (FGIDs). It can be self-administered and takes about 15 minutes to complete. Response formats for questions include yes/no responses, a five-point ordinal response scale for conditional questions (never or rarely to always), a seven-point ordinal response scale for frequency questions (never to every day), and a few other response scales specific to an item not fitting these (e.g., questions 76, 77, and 79). A series of "red flag" or alarm symptom questions are included at the end of the questionnaire (questions 82 to 93). Although these are not part of the diagnostic criteria, they are helpful in determining whether other diagnostic studies are needed to exclude other conditions/diseases that may explain symptoms captured in this questionnaire. A positive answer to any of these questions suggests a possibility of a diagnosis other than functional gastrointestinal disorder. This questionnaire (with its coding system) is intended for research and may be used to aid diagnosis. However, it is not meant as an instrument for self-diagnosis nor does it obviate the need for medical evaluation including history, physical examination, and limited laboratory and endoscopic testing of individual patients. The questionnaire is followed by a coding system that identifies provisional (or possible) diagnoses from the responses to the questions. The presence of an "alarm" symptom does not negate a diagnosis of an FGID, but it may indicate further inquiry or testing to rule out other conditions/diseases. Similarly, an indication of psychosocial difficulties will not alter the diagnosis but should prompt health care professionals to collect more information and possibly offer appropriate treatment. In the absence of biological markers and confirmatory tests for FGIDs, their diagnosis depends on applying these criteria, performing limited testing, and judiciously excluding other conditions/diseases (e.g., with other studies).

Protocol:

Summary of the Rome III Adult Questionnaire

The purpose of the questionnaire is to learn more about the health problems that people sometimes have with their stomach and intestines. Respondents are asked to answer each question by filling in the circle directly to the left of the correct answer. Sections of the Rome III questionnaire include symptoms in the esophagus, symptoms in the stomach and intestines, symptoms in the gallbladder or pancreas, symptoms in the rectum or anal canal, and other questions.

Scoring Algorithm

The diagnostic criteria for each of the functional gastrointestinal disorders (FGIDs) are available as part of the questionnaire. Following each criterion there is bold and italicized text to indicate (a) the questions in the Rome III Diagnostic Questionnaire that capture this information and (b) the frequency threshold that defines a clinically significant frequency of occurrence for this symptom. For example, for heartburn, "question 8 > 3" means that the frequency should be more than that for response 3 or at least 1 day a week.

Copyright © 2006 by Douglas A. Drossman, Enrico Corazziari, Michel Delvaux, Robin C. Spiller, Nicholas J. Talley, W. Grant Thompson, William E. Whitehead.

Protocol Name from Source:

This section will be completed when reviewed by an Expert Review Panel.

Availability:

Publicly available

Personnel and Training Required
None
Equipment Needs
None
Requirements
Requirement CategoryRequired
Major equipment No
Specialized training No
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration

Self-administered questionnaire

Life Stage:

Adult

Participants:

The Rome III Adult Questionnaire should be administered to adults aged 18 and older. There are separate questionnaires for adolescents and the parents of children and toddlers.

Specific Instructions:
Because there are no available tests to confirm the diagnosis of functional gastrointestinal disorders (FGIDs), the Gastrointestinal Working Group suggests that limited investigation be performed to exclude other conditions/diseases that may explain the reported gastrointestinal (GI) symptoms. These should include complete blood count, erythrocyte sedimentation rate and/or C-reactive protein, electrolytes, and liver function tests. In addition, it is recommended that serology for celiac sprue be completed for patients with diarrhea, a colonoscopy be completed for patients aged 50 years old or older with functional bowel symptoms, and an upper endoscopy be completed for patients aged 50 or older with upper GI symptoms. Additional tests should be considered based on presence of alarm symptom and clinical judgment of the provider. Many clinical scientists may prefer to study only one or a few of the FGIDs. To serve such a purpose, the questionnaire may be subdivided into question and coding modules for each of the disorders of interest: esophageal, gastroduodenal, gallbladder/sphincter of Oddi, bowel, chronic abdominal pain, and anorectal disorders.
Selection Rationale

This questionnaire is based on the commonly used Rome III symptom-based diagnostic criteria for these disorders, which was developed by consensus from an international group of experts in the field of functional gastrointestinal disorders (FGIDs).

Language

English

Standards
StandardNameIDSource
Common Data Elements (CDE) Adult Gastrointestinal Disorder Assessment Score 3163043 CDE Browser
Logical Observation Identifiers Names and Codes (LOINC) Assess func GI disorders adult proto 62951-9 LOINC
Derived Variables

None

Process and Review

This section will be completed when reviewed by an Expert Review Panel.

Source

Drossman, D. A., Corazziari, E., Delvaux, M., Spiller, R. C., Talley, N. J., Thompson, W. G., & Whitehead, W. E. (2006). The Rome III adult questionnaire. McLean, VA: The Rome Foundation/Degnon Associates. Available at http://www.romecriteria.org/

The Rome III questionnaires are available to view online at: http://www.romecriteria.org/questionnaires/

For copyright policy and licensing fee schedules for translations and usage of the Rome III questionnaires, please contact Michele Pickard at: mpickard@theromefoundation.org

General References

Drossman, D. A. (2006). Rome III: The functional gastrointestinal disorders (3rd ed.). McLean, VA: Degnon Associates.

Drossman, D. A. (2006). The functional gastrointestinal disorders and the Rome III process. Gastroenterology, 130, 1377–1390.

Protocol ID:

190101

Variables:
Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX190101000000 Protocol 190101 - proprietary. Check DCW for contact. 4 N/A
Research Domain Information
Measure Name:

Assessment of Functional Gastrointestinal Disorders

Release Date:

December 13, 2010

Definition

Questionnaire that asks about gastrointestinal symptoms to help identify the presence of functional gastrointestinal disorders (FGIDs) and their subtypes.

Purpose

This measure is used to help determine the presence of functional gastrointestinal disorders (FGIDs), such as functional bowel disorders (e.g., irritable bowel syndrome, functional constipation, functional diarrhea, functional abdominal pain, and functional bloating), functional gastroduodenal disorders (e.g., functional dyspepsia, functional nausea, functional vomiting), functional esophageal disorders (e.g., functional heartburn, functional dysphagia), and others.

Keywords

Gastrointestinal disorders, FGID, functional gastrointestinal disorder, Rome III criteria, dysphagia, constipation, dyspepsia, heartburn, IBS, irritable bowel syndrome, reflux, vomiting, pain, stomach, intestines, esophagus, gallbladder, rectum, proprietary, Gastrointestinal