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Content validation of a daily patient-reported outcome measure for assessing symptoms in patients with Small Intestinal Bacterial Overgrowth
PURPOSE: The aim of this study was to generate evidence supporting the development and content validity of a new PRO instrument, the Small Intestinal Bacterial Overgrowth (SIBO) Symptom Measure (SSM) daily diary. The SSM assesses symptom severity in SIBO patients, with the ultimate goal of providing...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10393850/ https://www.ncbi.nlm.nih.gov/pubmed/37212941 http://dx.doi.org/10.1007/s11136-023-03407-z |
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author | Durgam, Neha Dashputre, Ankur A. Moshkovich, Olga Rezaie, Ali Martinez, Nicholas Enayati, Pedram Stansbury, James Joseph, George |
author_facet | Durgam, Neha Dashputre, Ankur A. Moshkovich, Olga Rezaie, Ali Martinez, Nicholas Enayati, Pedram Stansbury, James Joseph, George |
author_sort | Durgam, Neha |
collection | PubMed |
description | PURPOSE: The aim of this study was to generate evidence supporting the development and content validity of a new PRO instrument, the Small Intestinal Bacterial Overgrowth (SIBO) Symptom Measure (SSM) daily diary. The SSM assesses symptom severity in SIBO patients, with the ultimate goal of providing a fit for purpose PRO for endpoint measurement. METHODS: Qualitative research included 35 SIBO patients in three study stages, using a hybrid concept elicitation (CE)/cognitive interview (CI) method with US patients, ≥ 18 years. Stage 1 included a literature review, clinician interviews, and initial CE interviews with SIBO patients to identify symptoms important to patients for inclusion in the SSM. Stage 2 included hybrid CE/CI to learn more about patients’ SIBO experience and test the draft SSM. Finally, stage 3 used CIs to refine the instrument and test its content validity. RESULTS: In stage 1 (n = 8), 15 relevant concepts were identified, with items drafted based on the literature review/clinician interviews and elicitation work. Within stage 2 (n = 15), the SSM was refined to include 11 items; with wording revised for three items. Stage 3 (n = 12) confirmed the comprehensiveness of the SSM, as well as appropriateness of the item wording, recall period, and response scale. The resulting 11-item SSM assesses the severity of bloating, abdominal distention, abdominal discomfort, abdominal pain, flatulence, physical tiredness, nausea, diarrhea, constipation, appetite loss, and belching. CONCLUSIONS: This study provides evidence supporting the content validity of the new PRO. Comprehensive patient input ensures that the SSM is a well-defined measure of SIBO, ready for psychometric validation studies. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11136-023-03407-z. |
format | Online Article Text |
id | pubmed-10393850 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-103938502023-08-03 Content validation of a daily patient-reported outcome measure for assessing symptoms in patients with Small Intestinal Bacterial Overgrowth Durgam, Neha Dashputre, Ankur A. Moshkovich, Olga Rezaie, Ali Martinez, Nicholas Enayati, Pedram Stansbury, James Joseph, George Qual Life Res Article PURPOSE: The aim of this study was to generate evidence supporting the development and content validity of a new PRO instrument, the Small Intestinal Bacterial Overgrowth (SIBO) Symptom Measure (SSM) daily diary. The SSM assesses symptom severity in SIBO patients, with the ultimate goal of providing a fit for purpose PRO for endpoint measurement. METHODS: Qualitative research included 35 SIBO patients in three study stages, using a hybrid concept elicitation (CE)/cognitive interview (CI) method with US patients, ≥ 18 years. Stage 1 included a literature review, clinician interviews, and initial CE interviews with SIBO patients to identify symptoms important to patients for inclusion in the SSM. Stage 2 included hybrid CE/CI to learn more about patients’ SIBO experience and test the draft SSM. Finally, stage 3 used CIs to refine the instrument and test its content validity. RESULTS: In stage 1 (n = 8), 15 relevant concepts were identified, with items drafted based on the literature review/clinician interviews and elicitation work. Within stage 2 (n = 15), the SSM was refined to include 11 items; with wording revised for three items. Stage 3 (n = 12) confirmed the comprehensiveness of the SSM, as well as appropriateness of the item wording, recall period, and response scale. The resulting 11-item SSM assesses the severity of bloating, abdominal distention, abdominal discomfort, abdominal pain, flatulence, physical tiredness, nausea, diarrhea, constipation, appetite loss, and belching. CONCLUSIONS: This study provides evidence supporting the content validity of the new PRO. Comprehensive patient input ensures that the SSM is a well-defined measure of SIBO, ready for psychometric validation studies. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11136-023-03407-z. Springer International Publishing 2023-05-22 2023 /pmc/articles/PMC10393850/ /pubmed/37212941 http://dx.doi.org/10.1007/s11136-023-03407-z Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Article Durgam, Neha Dashputre, Ankur A. Moshkovich, Olga Rezaie, Ali Martinez, Nicholas Enayati, Pedram Stansbury, James Joseph, George Content validation of a daily patient-reported outcome measure for assessing symptoms in patients with Small Intestinal Bacterial Overgrowth |
title | Content validation of a daily patient-reported outcome measure for assessing symptoms in patients with Small Intestinal Bacterial Overgrowth |
title_full | Content validation of a daily patient-reported outcome measure for assessing symptoms in patients with Small Intestinal Bacterial Overgrowth |
title_fullStr | Content validation of a daily patient-reported outcome measure for assessing symptoms in patients with Small Intestinal Bacterial Overgrowth |
title_full_unstemmed | Content validation of a daily patient-reported outcome measure for assessing symptoms in patients with Small Intestinal Bacterial Overgrowth |
title_short | Content validation of a daily patient-reported outcome measure for assessing symptoms in patients with Small Intestinal Bacterial Overgrowth |
title_sort | content validation of a daily patient-reported outcome measure for assessing symptoms in patients with small intestinal bacterial overgrowth |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10393850/ https://www.ncbi.nlm.nih.gov/pubmed/37212941 http://dx.doi.org/10.1007/s11136-023-03407-z |
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