{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,12]],"date-time":"2026-06-12T04:54:46Z","timestamp":1781240086974,"version":"3.54.1"},"reference-count":26,"publisher":"BMJ","issue":"4","license":[{"start":{"date-parts":[[2023,4,20]],"date-time":"2023-04-20T00:00:00Z","timestamp":1681948800000},"content-version":"unspecified","delay-in-days":19,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment Programme","doi-asserted-by":"publisher","award":["131136"],"award-info":[{"award-number":["131136"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,3,7]]},"published-print":{"date-parts":[[2023,4]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>This mixed-methods feasibility study aimed to explore parents\u2019 and medical practitioners\u2019 views on the acceptability and design of a clinical trial to determine whether routine prophylactic proton pump inhibitors (PPI) reduce the incidence of anastomotic stricture in infants with oesophageal atresia (OA).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Semi-structured interviews with UK parents of an infant with OA and an online survey, telephone interviews and focus groups with clinicians. Data were analysed using reflexive thematic analysis and descriptive statistics.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants and setting<\/jats:title>\n                    <jats:p>We interviewed 18 parents of infants with OA. Fifty-one clinicians (49 surgeons, 2 neonatologists) from 20\/25 (80%) units involved in OA repair completed an online survey and 10 took part in 1 of 2 focus groups. Interviews were conducted with two clinicians whose survey responses indicated they had concerns about the trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Outcome Measures<\/jats:title>\n                    <jats:p>Parents and clinicians ranked the same top four outcomes (\u2018Severity of anastomotic stricture\u2019, \u2018Incidence of anastomotic stricture\u2019, \u2018Need for treatment of reflux\u2019 and \u2018Presence of symptoms of reflux\u2019) as important to measure for the proposed trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>All parents and most clinicians found the use, dose and duration of omeprazole as the intervention medication, and the placebo control, as acceptable. Parents stated they would hypothetically consent to their child\u2019s participation in the trial. Concerns of a few parents and clinicians about infants suffering with symptomatic reflux, and the impact of this for study retention, appeared to be alleviated through the symptomatic reflux treatment pathway. Hesitant clinician views appeared to change through discussion of parental support for the study and by highlighting existing research that questions current practice of PPI treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Our findings indicate that parents and most clinicians view the proposed Treating Oesophageal Atresia with prophylactic proton pump inhibitors to prevent STricture (TOAST) trial to be feasible and acceptable so long as infants can be given PPI if clinicians deem it clinically necessary. This insight into parent and clinician views and concerns will inform pilot phase trial monitoring, staff training and the development of the trial protocol.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2022-066070","type":"journal-article","created":{"date-parts":[[2023,4,20]],"date-time":"2023-04-20T12:33:33Z","timestamp":1681994013000},"page":"e066070","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":5,"title":["Mixed-methods feasibility study to inform a randomised controlled trial of proton pump inhibitors to reduce strictures following neonatal surgery for oesophageal atresia"],"prefix":"10.1136","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0014-8016","authenticated-orcid":false,"given":"Tracy Karen","family":"Mitchell","sequence":"first","affiliation":[{"name":"Department of Public Health, Policy and Systems, Faculty of Health and Life Sciences, Institute of Population Health, University of Liverpool, Liverpool, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8570-9374","authenticated-orcid":false,"given":"Nigel J","family":"Hall","sequence":"additional","affiliation":[{"name":"University Surgery Unit, Faculty of Medicine, University of Southampton, Southampton, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6928-2267","authenticated-orcid":false,"given":"Iain","family":"Yardley","sequence":"additional","affiliation":[{"name":"Evelina Children's Hospital, Guy's & St. Thomas's NHS Foundation Trust, London, UK"},{"name":"Faculty of Life Sciences and Medicine, King\u2019s College, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8798-2136","authenticated-orcid":false,"given":"Christina","family":"Cole","sequence":"additional","affiliation":[{"name":"National Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2937-8368","authenticated-orcid":false,"given":"Pollyanna","family":"Hardy","sequence":"additional","affiliation":[{"name":"National Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5180-7179","authenticated-orcid":false,"given":"Andy","family":"King","sequence":"additional","affiliation":[{"name":"National Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9010-2905","authenticated-orcid":false,"given":"David","family":"Murray","sequence":"additional","affiliation":[{"name":"National Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5092-7643","authenticated-orcid":false,"given":"Elizabeth","family":"Nuthall","sequence":"additional","affiliation":[{"name":"National Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7965-4637","authenticated-orcid":false,"given":"Charles","family":"Roehr","sequence":"additional","affiliation":[{"name":"National Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield 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