Development of the Diary for Irritable Bowel Syndrome Symptoms to Assess Treatment Benefit in Clinical Trials: Foundational Qualitative Research

Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain and alterations in bowel habits. Three subtypes are defined on the basis of stool patterns: diarrhea-predominant IBS, constipation-predominant IBS, and alternating or mixed IBS. To develop patient-r...

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Veröffentlicht in:Value in health Jg. 20; H. 4; S. 618 - 626
Hauptverfasser: Fehnel, Sheri E., Ervin, Claire M., Carson, Robyn T., Rigoni, Gianna, Lackner, Jeffrey M., Coons, Stephen Joel
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States Elsevier Inc 01.04.2017
Elsevier Science Ltd
Schlagworte:
Abdominal pain
Abdominal Pain - etiology
Abdominal Pain - physiopathology
Abdominal Pain - therapy
Adult
Aged
Bowel habits
Chronic pain
Clinical research
Clinical trials
Clinical Trials as Topic - methods
Cognition
Cognitive ability
Constipation
Constipation - etiology
Constipation - physiopathology
Constipation - therapy
content validity
Criteria
Debriefing
Defecation
Diarrhea
Diarrhea - etiology
Diarrhea - physiopathology
Diarrhea - therapy
Discomfort
Elicitation
Female
Food quality
Habits
Health Status
Health Status Indicators
Humans
Internal Medicine
Interviews
Interviews as Topic
Intestine
Irritable bowel syndrome
Irritable Bowel Syndrome - complications
Irritable Bowel Syndrome - diagnosis
Irritable Bowel Syndrome - physiopathology
Irritable Bowel Syndrome - therapy
Male
Medical Records
Medical treatment
Middle Aged
Pain
Pain Measurement
Patient Reported Outcome Measures
Patients
Pilot projects
Qualitative Research
Quantitative psychology
Reproducibility of Results
Research Design
Scores
Subtypes
Symptoms
Treatment Outcome
United States
Urgency
Young Adult
symptoms
content validity
irritable bowel syndrome
patient-reported outcome measures
ISSN:1098-3015, 1524-4733, 1524-4733
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Zusammenfassung:Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain and alterations in bowel habits. Three subtypes are defined on the basis of stool patterns: diarrhea-predominant IBS, constipation-predominant IBS, and alternating or mixed IBS. To develop patient-reported outcome measures for qualification by the Food and Drug Administration to support product approvals and labeling in IBS; the article focuses on the qualitative research that provided the foundation for the new measures. Forty-nine concept elicitation and 42 cognitive debriefing interviews were conducted with subjects meeting Rome III criteria; additional criteria were imposed to yield a sample representative of the target patient population. Although incomplete bowel movements, abnormal stool frequency and consistency, and abdominal pain, discomfort, and bloating were reported most frequently across concept elicitation interviews, the relative importance of specific symptoms varied by subtype. Among their five symptoms most important to treat, diarrhea-predominant and alternating or mixed IBS subjects frequently identified urgency, loose/watery stools, abdominal pain, and cramping, whereas constipation-predominant IBS subjects commonly included infrequent and incomplete bowel movements, bloating, and abdominal pain. The cognitive debriefing interviews facilitated refinement of each item set, supported minor modifications following translatability assessment, and suggested improvements to the electronic interface. Furthermore, subjects reported that every item was relevant and no concepts of importance were missing. Results support the content validity of the IBS patient-reported outcome measures. A pilot study was recently initiated to inform item reduction, develop scoring algorithms, and provide preliminary psychometric information. Comprehensive psychometric evaluation and responder definition development will follow.
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ObjectType-Feature-2
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ISSN:1098-3015
1524-4733
1524-4733
DOI:10.1016/j.jval.2016.11.001