PMID- 37080617
OWN - NLM
STAT- MEDLINE
DCOM- 20230502
LR  - 20230502
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 13
IP  - 4
DP  - 2023 Apr 20
TI  - Mixed-methods feasibility study to inform a randomised controlled trial of proton 
      pump inhibitors to reduce strictures following neonatal surgery for oesophageal 
      atresia.
PG  - e066070
LID - 10.1136/bmjopen-2022-066070 [doi]
LID - e066070
AB  - OBJECTIVES: 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). 
      DESIGN: 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. 
      PARTICIPANTS AND SETTING: 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. OUTCOME MEASURES: 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. 
      RESULTS: 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. CONCLUSIONS: 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.
CI  - (c) Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published 
      by BMJ.
FAU - Mitchell, Tracy Karen
AU  - Mitchell TK
AUID- ORCID: 0000-0003-0014-8016
AD  - Department of Public Health, Policy and Systems, Faculty of Health and Life 
      Sciences, Institute of Population Health, University of Liverpool, Liverpool, UK 
      Tracy.Mitchell@Liverpool.ac.uk.
FAU - Hall, Nigel J
AU  - Hall NJ
AUID- ORCID: 0000-0001-8570-9374
AD  - University Surgery Unit, Faculty of Medicine, University of Southampton, 
      Southampton, UK.
FAU - Yardley, Iain
AU  - Yardley I
AUID- ORCID: 0000-0002-6928-2267
AD  - Evelina Children's Hospital, Guy's & St. Thomas's NHS Foundation Trust, London, 
      UK.
AD  - Faculty of Life Sciences and Medicine, King's College, London, UK.
FAU - Cole, Christina
AU  - Cole C
AUID- ORCID: 0000-0002-8798-2136
AD  - National Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield Department 
      of Population Health, University of Oxford, Oxford, UK.
FAU - Hardy, Pollyanna
AU  - Hardy P
AUID- ORCID: 0000-0003-2937-8368
AD  - National Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield Department 
      of Population Health, University of Oxford, Oxford, UK.
FAU - King, Andy
AU  - King A
AUID- ORCID: 0000-0001-5180-7179
AD  - National Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield Department 
      of Population Health, University of Oxford, Oxford, UK.
FAU - Murray, David
AU  - Murray D
AUID- ORCID: 0000-0001-9010-2905
AD  - National Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield Department 
      of Population Health, University of Oxford, Oxford, UK.
FAU - Nuthall, Elizabeth
AU  - Nuthall E
AUID- ORCID: 0000-0002-5092-7643
AD  - National Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield Department 
      of Population Health, University of Oxford, Oxford, UK.
FAU - Roehr, Charles
AU  - Roehr C
AUID- ORCID: 0000-0001-7965-4637
AD  - National Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield Department 
      of Population Health, University of Oxford, Oxford, UK.
FAU - Stanbury, Kayleigh
AU  - Stanbury K
AUID- ORCID: 0000-0002-8726-2411
AD  - National Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield Department 
      of Population Health, University of Oxford, Oxford, UK.
FAU - Williams, Rachel
AU  - Williams R
AUID- ORCID: 0000-0002-5872-1690
AD  - National Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield Department 
      of Population Health, University of Oxford, Oxford, UK.
FAU - Pearce, John
AU  - Pearce J
AD  - TOFS, Nottingham, UK.
FAU - Woolfall, Kerry
AU  - Woolfall K
AUID- ORCID: 0000-0002-5726-5304
AD  - Department of Public Health, Policy and Systems, Faculty of Health and Life 
      Sciences, Institute of Population Health, University of Liverpool, Liverpool, UK.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230420
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
RN  - 0 (Proton Pump Inhibitors)
RN  - KG60484QX9 (Omeprazole)
SB  - IM
MH  - Humans
MH  - Infant, Newborn
MH  - Constriction, Pathologic/etiology/prevention & control
MH  - *Esophageal Atresia/complications/surgery
MH  - Feasibility Studies
MH  - Gastroesophageal Reflux/etiology/prevention & control
MH  - *Proton Pump Inhibitors/administration & dosage/therapeutic use
MH  - *Esophageal Stenosis/etiology/prevention & control
MH  - Chemoprevention
MH  - Health Care Surveys
MH  - Parents
MH  - Physicians
MH  - *Randomized Controlled Trials as Topic/methods
MH  - *Omeprazole/administration & dosage/therapeutic use
MH  - Patient Acceptance of Health Care
MH  - Attitude of Health Personnel
MH  - Adult
PMC - PMC10124212
OTO - NOTNLM
OT  - neonatal intensive & critical care
OT  - neonatology
OT  - paediatric gastroenterology
OT  - qualitative research
OT  - statistics & research methods
COIS- Competing interests: National Institute for Health Research (NIHR) Health 
      Technology Assessment (HTA) Programme grant payments to support the conduct of 
      this study were made to the institutions of all authors (except JP). TKM and EN 
      employment roles were funded by the NIHR HTA programme grant payment made to 
      their institutions.
EDAT- 2023/04/21 00:42
MHDA- 2023/04/24 06:42
PMCR- 2023/04/20
CRDT- 2023/04/20 20:53
PHST- 2023/04/24 06:42 [medline]
PHST- 2023/04/21 00:42 [pubmed]
PHST- 2023/04/20 20:53 [entrez]
PHST- 2023/04/20 00:00 [pmc-release]
AID - bmjopen-2022-066070 [pii]
AID - 10.1136/bmjopen-2022-066070 [doi]
PST - epublish
SO  - BMJ Open. 2023 Apr 20;13(4):e066070. doi: 10.1136/bmjopen-2022-066070.