Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2023 Sep;32(9):2573-2585.
doi: 10.1007/s11136-023-03407-z. Epub 2023 May 22.

Content validation of a daily patient-reported outcome measure for assessing symptoms in patients with Small Intestinal Bacterial Overgrowth

Neha Durgam  1 , Ankur A Dashputre  2 , Olga Moshkovich  1 , Ali Rezaie  3 , Nicholas Martinez  4 , Pedram Enayati  3 , James Stansbury  1 , George Joseph  5
Affiliations
Review

Content validation of a daily patient-reported outcome measure for assessing symptoms in patients with Small Intestinal Bacterial Overgrowth

Neha Durgam et al. Qual Life Res. 2023 Sep.

Abstract

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.

Keywords: Cognitive interviewing; Content validity; Patient-reported outcome; Questionnaire development; SIBO; Small intestinal bowel overgrowth.

PubMed Disclaimer

Conflict of interest statement

GJ and AAD are employees of Bausch Pharma US, LLC. ND, OM, and JS are employed by ICON plc, of whom were commissioned by Bausch Pharma US, LLC to perform the study and develop this manuscript.

Figures

Fig. 1
Fig. 1
Study flow. This study comprised of 3 stages which consisted of various interview waves, feedback from clinicians, and guidance from the FDA. This work resulted in a content valid measure, the Small Intestinal Bacterial Overgrowth Symptom Measure (SSM). CE concept elicitation, CI cognitive interviews, FDA US Food and Drug Administration, SSM Small Intestinal Bacterial Overgrowth Symptom Measure
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Bures J, Cyrany J, Kohoutova D, Förstl M, Rejchrt S, Kvetina J, Vorisek V, Kopacova M. Small intestinal bacterial overgrowth syndrome. World Journal of Gastroenterology. 2010;16(24):2978–2990. doi: 10.3748/wjg.v16.i24.2978. - DOI - PMC - PubMed
    1. Rezaie A, Buresi M, Lembo A, Lin H, McCallum R, Rao S, Schmulson M, Valdovinos M, Zakko S, Pimentel M. Hydrogen and methan-based breath testing in gastrointestinal disorders: The North American consensus. American Journal of Gastroenterology. 2017;112:775–784. doi: 10.1038/ajg.2017.46. - DOI - PMC - PubMed
    1. Shah SC, Day LW, Somsouk M, Sewell JL. Meta-analysis: Antibiotic therapy for small intestinal bacterial overgrowth. Alimentary Pharmacology & Therapeutics. 2013;38(8):925–934. doi: 10.1111/apt.12479. - DOI - PMC - PubMed
    1. Dukowicz AC, Lacy BE, Levine GM. Small intestinal bacterial overgrowth: A comprehensive review. Gastroenterology & Hepatology. 2007;3(2):112–122. - PMC - PubMed
    1. Takakura W, Pimentel M. Small intestinal bacterial overgrowth and irritable bowel syndrome—An update. Frontiers in psychiatry. 2020;11:664. doi: 10.3389/fpsyt.2020.00664. - DOI - PMC - PubMed

LinkOut - more resources