{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T04:50:22Z","timestamp":1793767822542,"version":"4.6.1"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"9","license":[{"start":{"date-parts":[[2023,5,22]],"date-time":"2023-05-22T00:00:00Z","timestamp":1684713600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,5,22]],"date-time":"2023-05-22T00:00:00Z","timestamp":1684713600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100014565","name":"Bausch Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100014565","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Qual Life Res"],"published-print":{"date-parts":[[2023,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Purpose<\/jats:title>\n                <jats:p>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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Qualitative research included 35 SIBO patients in three study stages, using a hybrid concept elicitation (CE)\/cognitive interview (CI) method with US patients,\u2009\u2265\u200918\u00a0years. 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\u2019 SIBO experience and test the draft SSM. Finally, stage 3 used CIs to refine the instrument and test its content validity.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>In stage 1 (<jats:italic>n<\/jats:italic>\u2009=\u20098), 15 relevant concepts were identified, with items drafted based on the literature review\/clinician interviews and elicitation work. Within stage 2 (<jats:italic>n<\/jats:italic>\u2009=\u200915), the SSM was refined to include 11 items; with wording revised for three items. Stage 3 (<jats:italic>n<\/jats:italic>\u2009=\u200912) 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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>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.\n<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s11136-023-03407-z","type":"journal-article","created":{"date-parts":[[2023,5,22]],"date-time":"2023-05-22T14:02:31Z","timestamp":1684764151000},"page":"2573-2585","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Content validation of a daily patient-reported outcome measure for assessing symptoms in patients with Small Intestinal Bacterial Overgrowth"],"prefix":"10.1007","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4371-7525","authenticated-orcid":false,"given":"Neha","family":"Durgam","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0898-959X","authenticated-orcid":false,"given":"Ankur A.","family":"Dashputre","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6464-8533","authenticated-orcid":false,"given":"Olga","family":"Moshkovich","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0106-372X","authenticated-orcid":false,"given":"Ali","family":"Rezaie","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicholas","family":"Martinez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pedram","family":"Enayati","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Stansbury","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George","family":"Joseph","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,5,22]]},"reference":[{"issue":"24","key":"3407_CR1","doi-asserted-by":"publisher","first-page":"2978","DOI":"10.3748\/wjg.v16.i24.2978","volume":"16","author":"J Bures","year":"2010","unstructured":"Bures, J., Cyrany, J., Kohoutova, D., F\u00f6rstl, M., Rejchrt, S., Kvetina, J., Vorisek, V., & Kopacova, M. 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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.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All procedures performed in studies involving human patients were in accordance with the ethical standards of the institutional and\/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The ethics bodies that approved the study at the four clinical sites were WCG IRB.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Informed consent was obtained from all individual patients included in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}}]}}