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Qualitative Development of a Patient-Reported Outcome Symptom Measure in Diarrhea-Predominant Irritable Bowel Syndrome

OBJECTIVES: Despite a documented clinical need, no patient reported outcome (PRO) symptom measure meeting current regulatory requirements for clinically relevant end points is available for the evaluation of treatment benefit in diarrhea-predominant IBS (IBS-D). METHODS: Patients (N=113) with IBS-D...

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Autores principales: Marquis, P, Lasch, K E, Delgado-Herrera, L, Kothari, S, Lembo, A, Lademacher, C, Spears, G, Nishida, A, Tesler, Waldman L, Piault, E, Rosa, K, Zeiher, B
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4077041/
https://www.ncbi.nlm.nih.gov/pubmed/24964994
http://dx.doi.org/10.1038/ctg.2014.7
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author Marquis, P
Lasch, K E
Delgado-Herrera, L
Kothari, S
Lembo, A
Lademacher, C
Spears, G
Nishida, A
Tesler, Waldman L
Piault, E
Rosa, K
Zeiher, B
author_facet Marquis, P
Lasch, K E
Delgado-Herrera, L
Kothari, S
Lembo, A
Lademacher, C
Spears, G
Nishida, A
Tesler, Waldman L
Piault, E
Rosa, K
Zeiher, B
author_sort Marquis, P
collection PubMed
description OBJECTIVES: Despite a documented clinical need, no patient reported outcome (PRO) symptom measure meeting current regulatory requirements for clinically relevant end points is available for the evaluation of treatment benefit in diarrhea-predominant IBS (IBS-D). METHODS: Patients (N=113) with IBS-D participated in five study phases: (1) eight concept elicitation focus groups (N=34), from which a 17-item IBS-D Daily Symptom Diary and four-item IBS-D Symptom Event Log (Diary and Event Log) were developed; (2) one-on-one cognitive interviews (N=11) to assess the instrument's comprehensiveness, understandability, appropriateness, and readability; (3) four data triangulation focus groups (N=32) to confirm the concepts elicited; (4) two hybrid (concept elicitation and cognitive interview) focus groups (N=16); and (5) two iterative sets of one-on-one cognitive interviews (N=20) to further clarify the symptoms of IBS-D and debrief a revised seven-item Diary and four-item Event Log. RESULTS: Of thirty-six concepts initially identified, 22 were excluded because they were not saturated, not clinically relevant, not critical symptoms of IBS-D, considered upper GI symptoms, or too broad or vaguely defined. The remaining concepts were diarrhea, immediate need (urgency), bloating/pressure, frequency of bowel movements, cramps, abdominal/stomach pain, gas, completely emptied bowels/incomplete evacuation, accidents, bubbling in intestines (bowel sounds), rectal burning, stool consistency, rectal spasm, and pain while wiping. The final instrument included a daily diary with separate items for abdominal and stomach pain and an event log with four items completed after each bowel movement as follows: (1) a record of the bowel movement/event and an assessment of (2) severity of immediacy of need/bowel urgency, (3) incomplete evacuation, and (4) stool consistency (evaluated using the newly developed Astellas Stool Form Scale). Based on rounds of interviews and clinical input, items considered secondary or nonspecific to IBS-D (rectal burning, bubbling in intestines, spasms, and pain while wiping) were excluded. CONCLUSIONS: The IBS-D Symptom Diary and Event Log represent a rigorously developed PRO instrument for the measurement of the IBS-D symptom experience from the perspective of the patient. Its content validity has been supported, and future work should evaluate the instrument's psychometric properties.
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spelling pubmed-40770412014-07-01 Qualitative Development of a Patient-Reported Outcome Symptom Measure in Diarrhea-Predominant Irritable Bowel Syndrome Marquis, P Lasch, K E Delgado-Herrera, L Kothari, S Lembo, A Lademacher, C Spears, G Nishida, A Tesler, Waldman L Piault, E Rosa, K Zeiher, B Clin Transl Gastroenterol Functional GI Disorders OBJECTIVES: Despite a documented clinical need, no patient reported outcome (PRO) symptom measure meeting current regulatory requirements for clinically relevant end points is available for the evaluation of treatment benefit in diarrhea-predominant IBS (IBS-D). METHODS: Patients (N=113) with IBS-D participated in five study phases: (1) eight concept elicitation focus groups (N=34), from which a 17-item IBS-D Daily Symptom Diary and four-item IBS-D Symptom Event Log (Diary and Event Log) were developed; (2) one-on-one cognitive interviews (N=11) to assess the instrument's comprehensiveness, understandability, appropriateness, and readability; (3) four data triangulation focus groups (N=32) to confirm the concepts elicited; (4) two hybrid (concept elicitation and cognitive interview) focus groups (N=16); and (5) two iterative sets of one-on-one cognitive interviews (N=20) to further clarify the symptoms of IBS-D and debrief a revised seven-item Diary and four-item Event Log. RESULTS: Of thirty-six concepts initially identified, 22 were excluded because they were not saturated, not clinically relevant, not critical symptoms of IBS-D, considered upper GI symptoms, or too broad or vaguely defined. The remaining concepts were diarrhea, immediate need (urgency), bloating/pressure, frequency of bowel movements, cramps, abdominal/stomach pain, gas, completely emptied bowels/incomplete evacuation, accidents, bubbling in intestines (bowel sounds), rectal burning, stool consistency, rectal spasm, and pain while wiping. The final instrument included a daily diary with separate items for abdominal and stomach pain and an event log with four items completed after each bowel movement as follows: (1) a record of the bowel movement/event and an assessment of (2) severity of immediacy of need/bowel urgency, (3) incomplete evacuation, and (4) stool consistency (evaluated using the newly developed Astellas Stool Form Scale). Based on rounds of interviews and clinical input, items considered secondary or nonspecific to IBS-D (rectal burning, bubbling in intestines, spasms, and pain while wiping) were excluded. CONCLUSIONS: The IBS-D Symptom Diary and Event Log represent a rigorously developed PRO instrument for the measurement of the IBS-D symptom experience from the perspective of the patient. Its content validity has been supported, and future work should evaluate the instrument's psychometric properties. Nature Publishing Group 2014-06 2014-06-26 /pmc/articles/PMC4077041/ /pubmed/24964994 http://dx.doi.org/10.1038/ctg.2014.7 Text en Copyright © 2014 American College of Gastroenterology http://creativecommons.org/licenses/by-nc-sa/3.0/ This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/3.0/
spellingShingle Functional GI Disorders
Marquis, P
Lasch, K E
Delgado-Herrera, L
Kothari, S
Lembo, A
Lademacher, C
Spears, G
Nishida, A
Tesler, Waldman L
Piault, E
Rosa, K
Zeiher, B
Qualitative Development of a Patient-Reported Outcome Symptom Measure in Diarrhea-Predominant Irritable Bowel Syndrome
title Qualitative Development of a Patient-Reported Outcome Symptom Measure in Diarrhea-Predominant Irritable Bowel Syndrome
title_full Qualitative Development of a Patient-Reported Outcome Symptom Measure in Diarrhea-Predominant Irritable Bowel Syndrome
title_fullStr Qualitative Development of a Patient-Reported Outcome Symptom Measure in Diarrhea-Predominant Irritable Bowel Syndrome
title_full_unstemmed Qualitative Development of a Patient-Reported Outcome Symptom Measure in Diarrhea-Predominant Irritable Bowel Syndrome
title_short Qualitative Development of a Patient-Reported Outcome Symptom Measure in Diarrhea-Predominant Irritable Bowel Syndrome
title_sort qualitative development of a patient-reported outcome symptom measure in diarrhea-predominant irritable bowel syndrome
topic Functional GI Disorders
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4077041/
https://www.ncbi.nlm.nih.gov/pubmed/24964994
http://dx.doi.org/10.1038/ctg.2014.7
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