Content validation of a daily patient-reported outcome measure for assessing symptoms in patients with Small Intestinal Bacterial Overgrowth
© 2023. The Author(s)..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:32 |
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| Enthalten in: |
Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation - 32(2023), 9 vom: 22. Sept., Seite 2573-2585 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Durgam, Neha [VerfasserIn] |
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| Links: |
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| Themen: |
Cognitive interviewing |
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| Anmerkungen: |
Date Completed 02.08.2023 Date Revised 04.08.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1007/s11136-023-03407-z |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM357154177 |
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| 520 | |a © 2023. The Author(s). | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Review | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Cognitive interviewing | |
| 650 | 4 | |a Content validity | |
| 650 | 4 | |a Patient-reported outcome | |
| 650 | 4 | |a Questionnaire development | |
| 650 | 4 | |a SIBO | |
| 650 | 4 | |a Small intestinal bowel overgrowth | |
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| 700 | 1 | |a Martinez, Nicholas |e verfasserin |4 aut | |
| 700 | 1 | |a Enayati, Pedram |e verfasserin |4 aut | |
| 700 | 1 | |a Stansbury, James |e verfasserin |4 aut | |
| 700 | 1 | |a Joseph, George |e verfasserin |4 aut | |
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