Mixed-methods feasibility study to inform a randomised controlled trial of proton pump inhibitors to reduce strictures following neonatal surgery for oesophageal atresia


Mitchell, Tracy Karen ORCID: 0000-0003-0014-8016, Hall, Nigel J, Yardley, Iain, Cole, Christina, Hardy, Pollyanna, King, Andy, Murray, David, Nuthall, Elizabeth, Roehr, Charles, Stanbury, Kayleigh et al (show 3 more authors) (2023) Mixed-methods feasibility study to inform a randomised controlled trial of proton pump inhibitors to reduce strictures following neonatal surgery for oesophageal atresia. BMJ Open, 13 (4). e066070-e066070.

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3. Supplementary file 3 TOAST Parent interview topic guide.pdf - Supporting information
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9. Supplementary file 9 Parent and clinician suggested edits to existing outcomes.pdf - Supporting information
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TOAST final accepted version 18.4.2023.docx - Author Accepted Manuscript
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8. Supplementary file 8a and b Edits to symptomatic reflux treatment pathway.pdf - Supporting information
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6. Supplementary file 6 Symptomatic reflux treatment pathway.pdf - Supporting information
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7. Supplementary file 7 Outcomes.pdf - Supporting information
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4. Supplementary file 4 ISSM_COREQ_Checklist.pdf - Supporting information
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1. Supplementary file 1 TOAST Feasibility Study PIS (Parent) v1.0 - 21-Jan-2021.pdf - Supporting information
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5. Supplementary file 5 Proposed TOAST (Parent) PIL Leaflet v0.4 - 28-Jun-2021.pdf - Supporting information
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2. Supplementary file 2 TOAST Practitioner Survey.pdf - Supporting information
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Abstract

<jats:sec><jats:title>Objectives</jats:title><jats:p>This mixed-methods feasibility study aimed to explore parents’ and medical practitioners’ 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></jats:sec><jats:sec><jats:title>Design</jats:title><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></jats:sec><jats:sec><jats:title>Participants and setting</jats:title><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></jats:sec><jats:sec><jats:title>Outcome Measures</jats:title><jats:p>Parents and clinicians ranked the same top four outcomes (‘Severity of anastomotic stricture’, ‘Incidence of anastomotic stricture’, ‘Need for treatment of reflux’ and ‘Presence of symptoms of reflux’) as important to measure for the proposed trial.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><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’s 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></jats:sec><jats:sec><jats:title>Conclusions</jats:title><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></jats:sec>

Item Type: Article
Uncontrolled Keywords: qualitative research, paediatric gastroenterology, statistics & research methods, neonatology, neonatal intensive & critical care
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Population Health
Depositing User: Symplectic Admin
Date Deposited: 21 Apr 2023 10:56
Last Modified: 19 Sep 2023 12:40
DOI: 10.1136/bmjopen-2022-066070
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3169838
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