{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,2]],"date-time":"2026-04-02T01:05:19Z","timestamp":1775091919036,"version":"3.50.1"},"reference-count":33,"publisher":"Public Library of Science (PLoS)","issue":"2","license":[{"start":{"date-parts":[[2022,2,3]],"date-time":"2022-02-03T00:00:00Z","timestamp":1643846400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000664","name":"health technology assessment programme","doi-asserted-by":"publisher","award":["17\/32\/04"],"award-info":[{"award-number":["17\/32\/04"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Objective<\/jats:title>\n<jats:p>The success of pharmacological randomised controlled trials (RCTs) depends on the recruitment of the required number of participants. Recruitment to RCTs for patients with cirrhosis and small oesophageal varices raises specific additional challenges. The objectives of the study were 1) to explore patient perspectives on factors that influence RCT recruitment, 2) to understand factors that influence the success of recruitment from a staff perspective, and 3) to identify opportunities for tailored interventions to improve trial recruitment in this context.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods<\/jats:title>\n<jats:p>The qualitative study was embedded in a multi-centre blinded RCT (BOPPP trial) and was conducted alongside site opening. Semi-structured interviews were conducted with patients who enrolled to participate in the trial (n = 13), patients who declined to take part (n = 5), and staff who were responsible for recruiting participants to the trial (n = 18). An open approach to data collection and analysis was adopted and the Theoretical Domains Framework (TDF) was used to provide a theoretical lens through which to view influences on behaviour. Data was analysed using thematic analysis.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Results<\/jats:title>\n<jats:p>The findings consist of 5 overarching themes that outline trial recruitment influences at the patient, staff, team, organisational and trial levels: i) <jats:italic>patient risks and benefits<\/jats:italic> ii) <jats:italic>staff attitudes<\/jats:italic>, <jats:italic>knowledge and capacity<\/jats:italic>, iii) <jats:italic>team-based approach<\/jats:italic>, iv) <jats:italic>organisational context<\/jats:italic> and v) <jats:italic>Trial collective<\/jats:italic>. Patient-generated themes map onto thirteen of the fourteen TDF domains and staff-generated themes map onto all TDF domains. The overarching themes are not mutually exclusive; with evidence of direct interactions between patient and staff-level themes that influence recruitment behaviours.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Conclusions<\/jats:title>\n<jats:p>This study uses a theory-informed approach to gain new insights into improving clinical trial recruitment for patients with cirrhosis and small oesophageal varices. Although people with cirrhosis often display decreased healthcare-seeking behaviours, we found that patients used research to empower themselves to improve their health. Pragmatic trials involving unpredictable populations require staff expertise in building trust, and a deep knowledge of the patient group and their vulnerabilities. RCT recruitment is also more successful when research visits align with what staff identified as the natural rhythm of care.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec005\">\n<jats:title>Trial registration<\/jats:title>\n<jats:p>ISRCTN10324656; <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/\" xlink:type=\"simple\">https:\/\/clinicaltrials.gov\/<\/jats:ext-link>.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0263288","type":"journal-article","created":{"date-parts":[[2022,2,3]],"date-time":"2022-02-03T18:42:11Z","timestamp":1643913731000},"page":"e0263288","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":8,"title":["Using a theory-informed approach to explore patient and staff perspectives on factors that influence clinical trial recruitment for patients with cirrhosis and small oesophageal varices"],"prefix":"10.1371","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3665-0315","authenticated-orcid":true,"given":"Clair","family":"Le Boutillier","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claire","family":"Snowdon","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6616-3628","authenticated-orcid":true,"given":"Vishal","family":"Patel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"McPhail","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christopher","family":"Ward","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ben","family":"Carter","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ruhama","family":"Uddin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ane","family":"Zamalloa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vanessa","family":"Lawrence","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2022,2,3]]},"reference":[{"issue":"9961","key":"pone.0263288.ref001","doi-asserted-by":"crossref","first-page":"1953","DOI":"10.1016\/S0140-6736(14)61838-9","article-title":"Addressing liver disease in the UK: a blueprint for attaining excellence in health care and reducing premature mortality from lifestyle issues of excess consumption of alcohol, obesity, and viral hepatitis","volume":"384","author":"R Williams","year":"2014","journal-title":"Lancet"},{"issue":"1","key":"pone.0263288.ref002","doi-asserted-by":"crossref","first-page":"155","DOI":"10.1016\/j.jhep.2014.03.014","article-title":"Inflammation and portal hypertension\u2014the undiscovered country","volume":"61","author":"G Mehta","year":"2014","journal-title":"Journal of Hepatology"},{"issue":"10","key":"pone.0263288.ref003","doi-asserted-by":"crossref","first-page":"1787","DOI":"10.1038\/ajg.2011.173","article-title":"Effectiveness of combined pharmacologic and ligation therapy in high-risk patients with acute esophageal variceal bleeding","volume":"106","author":"S Augustin","year":"2011","journal-title":"The American Journal of Gastroenterology"},{"issue":"7","key":"pone.0263288.ref004","doi-asserted-by":"crossref","first-page":"1111","DOI":"10.1136\/gutjnl-2013-306502","article-title":"Non-selective \u03b2-blockers are associated with improved survival in patients with ascites listed for liver transplantation","volume":"64","author":"JA Leithead","year":"2015","journal-title":"Gut"},{"key":"pone.0263288.ref005","doi-asserted-by":"crossref","first-page":"238","DOI":"10.1016\/j.psym.2019.12.004","article-title":"Confronting the Crisis of Comorbid Alcohol Use Disorder and Alcohol-Related Liver Disease With a Novel Multidisciplinary Clinic","volume":"61","author":"GS Winder","year":"2020","journal-title":"Psychosomatics"},{"issue":"12","key":"pone.0263288.ref006","doi-asserted-by":"crossref","first-page":"1143","DOI":"10.1016\/S0895-4356(99)00141-9","article-title":"Barriers to Participation in Randomised Controlled Trials","volume":"52","author":"S Ross","year":"1999","journal-title":"A Systematic Review. 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