The Rome Foundation research and education materials are increasingly in demand internationally by a number of agencies and individuals. Such agencies include pharmaceutical companies, clinical research organizations and medical education providers, including universities and colleges. Individual users may include academicians undertaking investigator-initiated research studies. In view of the extensive resources invested by the Rome Foundation in the creation of these materials, and their important intellectual property, it is necessary to maintain a formal copyright policy.
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Current Rome Foundation copyright education and research materials:
All instruments available in English unless otherwise marked.
Rome IV Questionnaires
All Questionnaires listed below are available by license from Rome Foundation.| Name of Instrument | Description of Instrument |
|---|---|
| Rome IV Book Rome IV | Two volume textbook of all Rome IV content that contains appendices with all Rome IV questionnaires. Appendices: A) Rome IV Diagnostic Criteria, B) Comparison Table of Rome III and Rome IV Adult and Pediatric criteria,C) Rome IV Diagnostic Questionnaire for Adult FGIDs, D) Rome IV Psychosocial Alarm Questionnaire for FGIDs, E) Psychosocial Assessment of FGIDs flowchart, F) Rome IV Diagnostic Questionnaire for Pediatric FGIDs (Children and adolescent and Neonate and toddler questionnaires) |
| Rome IV Diagnostic Questionnaire for Adult FGIDs R4DQ | The Rome IV Diagnostic Questionnaire for Functional Gastrointestinal Disorders in Adults (R4DQ) translates the Rome IV diagnostic criteria into questions that can be understood and reported by patients and research subjects. The intended uses of the R4DQ are (1) to provide inclusion criteria for clinical research studies, (2) to serve as case definitions for epidemiological surveys, and (3) to assist clinicians in arriving at a provisional diagnosis. Diagnostic questionnaires were also developed for pediatric FGIDs. |
| Rome IV Psychosocial Guidelines and Flags for Referring to a Mental Health Provider R4 Psychosocial Alarm Red Flags | Provides a checklist of 9 key questions (“red flags”) that would alert the clinician to seek mental health consultation. A white flag considers to seek mental health involvement and a red flag indicates to involve them quickly. Question items relate to anxiety, depression, suicidality, sexual or physical abuse, severe pain, somatic symptom anxiety, impairment and drug or alcohol abuse. |
| Rome IV Diagnostic Questionnaire on Pediatric Functional Gastrointestinal Disorders– Child R4PDQ | Child: Self-report form for Children and Adolescents (10 years and older) |
| Rome IV Diagnostic Questionnaire on Pediatric Functional Gastrointestinal Disorders– Child R4PDQ-child | Parent-report form for Children (4 years and older) |
| Rome IV Diagnostic Questionnaire for Pediatric Functional Gastrointestinal Disorders-Toddler R4PDQ-toddler | Parent-report form for Neonates and Toddlers (0-3 years) |
| Rome III Book Rome III | |
| Questionnaires for Adults and Children | Adult and Pediatric Rome III Questionnaires are available on request. Contact Mark Schmitter at mschmitter@theromefoundation.org |
Questionnaires for Research and Clinical Practice
All Questionnaires listed below are available by license from Rome Foundation.| Name of Instrument | Description of Instrument |
|---|---|
| Bristol Stool Form Scale BSFS | To assess stool consistency based on seven stool types from pellets to liquid. The stool form correlates with colonic transit time (r=0.7). Types 1 and 2 define constipation and types 6 and 7 define diarrhea. Note, five stool type pediatric scale is also available. |
| Irritable Bowel Syndrome- Symptom Severity Scale IBS-SSS | This is the most frequently used severity measure for evaluating IBS severity. Items relate to pain, bowel dysfunction and overall well-being. It is commonly used as an outcome measure in clinical trials because it is highly responsive to change with treatment. Two versions are available with scoring based on a visual analog scale and a numerical scale. |
| Irritable Bowel Syndrome- Quality of Life survey IBS-QOL | The IBS-QOL is currently the most validated and highly responsive self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. The IBS-QOL was developed using a needs based model. There are three validation studies done in English and several other international publications. |
| Celiac Disease- Quality of Life Survey CD-QOL | The final CD-QOL has 20 items across four clinically relevant subscales (Limitations, Dysphoria, Health Concerns, and Inadequate Treatment). The CD-QOL has high internal consistency, reliability, and psychometric validation indicates both convergent and discriminate validity. The CD-QOL is a reliable and valid measure of celiac disease related QOL. As a disease-specific instrument, it is likely to be a useful tool for evaluating patients with this disorder. |
| Functional Bowel Disorders Severity Index FBDSI | This instrument quantifies the illness severity of patients with painful functional bowel disorders (IBS, CAPS, painful constipation). It was validated using 4 sites in the US, Canada and the UK where pain severity measures were correlated to physician rating of severity. The measure relies heavily on pain severity and health care utilization scores. Therefore, the instrument is useful for selection and stratification of patients for research but is not responsive to change. |
| IBS Patient-Physician Relationship Survey Short Form (PPRS-SF) - Patient version | This is a shortened form of the Patient-Physician Relationship Survey (PPRS) Patient Version. It was developed from a study of patients to correlate the PPRS with patient satisfaction (SAT-37). Exploratory Factor Analysis and Regression Analysis yielded a brief 12-item Scale that explained 63% of the variance in patient satisfaction with their care. This new PPRS-SF version is a convenient tool for clinicians to use in practice or for research. |
| IBS Patient-Physician Relationship Survey (PPRS) - Patient version | This is a measure of patient assessment of the clinical interaction with the physician. It contains 32 items with a 7-item response scale. Themes included interpersonal features, clinical care expectations, and aspects of communication. One thousand fifty-four eligible individuals completed the survey. Concurrent validity was established by it's correlation with the Communication Assessment Tool - CAT- 15 (r=40, P<.001) and the Patient Doctor Relationship Scale PDRQ-9 (r=30, P<.001). This instrument can be used clinically in conjunction with the physician version, and for future studies on physician evaluation and training. |
| IBS Patient-Physician Relationship Survey (PPRS) - Physician version | This is a measure of physician assessment of the clinical interaction with the patient. It contains 35 questions with a 7-item response scale. Themes include interpersonal and psychosocial features considered desirable or undesirable in physician relationships with their patients. It was developed from focus groups of physicians and quantitatively developed from evaluating over 1,000 physicians. It was modified by content experts and usability testing and validated by gastroenterology experts and it showed a high correlation with the Jefferson Scale of Physician Empathy. This instrument can be used clinically in conjunction with the patient version and for future studies on physician evaluation and training. |
| Recent Physical Symptom Questionnaire RPSQ | This is an empirically derived questionnaire to measure non-gastrointestinal symptoms and disorders that co-exist with IBS. It was developed from a systematic review of the world literature that identified non GI-symptoms and diagnoses known to have excess frequency in IBS patients. The psychometric properties of the questionnaires were assessed in two studies of IBS patients. It is a measure that can be used to evaluate non-GI somatic symptoms and medical comorbidities in IBS. |
| Post Infection IBS Scale PI-IBS | The Post-Infection IBS Scale was developed by consensus using a Delphi Approach by experts in DGBI who were commissioned by the Rome Foundation to develop criteria for diagnosis that could be used in research. A diagnosis of PI-IBS requires meeting Rome IV IBS criteria and evidence for an earlier gastrointestinal infection prior to symptom development. |
| Pictogram for Bloating and Scoring System | This is a generic pictogram for the evaluation of bloating, visible abdominal distention, combination of both categories, and normalcy or absence of these symptoms/signs. These pictograms were published by Rome IV as an example of this type of instrument that can be used in cultures and languages where there are no expressions for bloating and distention such as Spanish, Italian or Chinese. |
| Global Improvement Scale GIS | The Global Improvement Scale (GIS) has been used in several versions. This is a questionnaire that Dr. Drossman developed for his NIH treatment trial and picked up by the FDA for their IBS Guidance document. It is a response measure based on comparing current IBS symptoms measures to the previous week: “How would you rate your IBS signs and symptoms overall for the past 7 days”. There are 7 response items from significantly relieved to significantly worse. |
| Rating form of Inflammatory Bowel Disease Patient Concerns RFIPC | This is a frequently used 25 item health status assessment of perceived health status for IBD (UC and Patient Concerns Crohn’s disease). It evaluates the worries and concerns associated with IBD and its treatments. The questionnaire has a single item summary score as well as several health status indices (impact of disease, complications of disease, body stigma, and sexual intimacy). The instrument has concurrent validation as it is highly correlated with several measures of poor daily function. This standardized measure of worries and concerns of persons with IBD may be used in clinical care to evaluate the effects of interventions on IBD patient outcomes. |
| Comorbid Medical Conditions Questionnaire CMCQ | This is an empirically derived questionnaire to measure non-gastrointestinal symptoms that co-exist with Irritable Bowel Syndrome (IBS). Factor analysis of IBS patient symptoms were used to develop the scale and the instrument is rated with 4 subscales: one for psychiatric disorders and 3 for different types of somatic disorders. Concurrent validity was shown with strong correlations with the Cornell Medical Index and the Brief Symptom Inventory – 18. |
| Satisfaction with Care Scale SAT-37, IBS-SAT | This scale evaluates patient satisfaction with care. Although it was developed and validated with patients having irritable bowel syndrome (IBS), the items are generic to perceived care and thus can be used for other GI conditions. The IBS-SAT has 37 items across five clinically relevant subscales (connection with provider, Education, Benefits of visit, Office attributes and access to care). It has extremely high internal consistency and reliability and shows convergent validity with global satisfaction with care as well as with the Physician Satisfaction Questionnaire. Discriminant (known groups) validity was also established. |
| Trauma Questionnaire Trauma | This is the first validated (by interview and self-report) questionnaires to assess physical and sexual abuse. The answers are scaled for adults and children based on presumed severity of physical and/or sexual abuse related to threat, contact (touching) or penetration (vaginal or rectal). |
| Ulcerative Colitis and Crohn's Disease Health Status Scales UC-CD | This self-report health status scale can be used for patients with ulcerative colitis or Crohn’s Disease. It was developed from a large database of 991 patients belonging to the Crohn’s and Colitis Foundation. The items were derived from factor analysis of symptoms and health status measures. Validation of the items were achieved through strong correlations with general well-being, health status and pain as independent measures. By design, this questionnaire was a better predictor of health status than the CDAI. |
| Patient Education Needs Questionnaire PEQ | The IBS-Patient Education Questionnaire (IBS-PEQ) was developed using patient focus groups and cognitive item reduction. Questions were administered to a national sample of 1,242 IBS patients via mail and online. Frequencies of item endorsements were obtained and categorized. Content areas covered included attitudes and perceptions of causes and exacerbating factors related to IBS, treatments, lifestyle modifications and items patients would like to learn more of. This instrument can be used to survey patients with IBS about interests and preferences. |
| Recent Physical Symptom Questionnaire RPSQ | This is an empirically derived questionnaire to measure non- gastrointestinal symptoms and disorders that co-exist with IBS. It was developed from a systematic review of the world literature that identified non GI-symptoms and diagnoses know to have excess frequency in IBS patients. The psychometric properties of the questionnaires were assessed in two studies of IBS patients. It is a measure that can be used to evaluate non-GI somatic symptoms and medical comorbidities in IBS. |
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