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@article{Lammons:2021:10.1136/bmjpo-2021-001112,
author = {Lammons, W and Moss, R and Battersby, C and Cornelius, V and Babalis, D and Modi, N},
doi = {10.1136/bmjpo-2021-001112},
journal = {BMJ Paediatrics Open},
title = {Incorporating parent, former patient, and clinician perspectives in the design of a national UK double-cluster, randomised controlled trial addressing uncertainties in preterm nutrition},
url = {http://dx.doi.org/10.1136/bmjpo-2021-001112},
volume = {5},
year = {2021}
}

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TY  - JOUR
AB  - Background: Comparative effectiveness randomised controlled trials are powerful tools to resolve uncertainties in existing treatments and care processes. We sought parent and patient perspectives on the design of a planned national, double-cluster randomised controlled trial (COLLABORATE) to resolve two longstanding uncertainties in preterm nutrition.Methods: We used qualitative focus groups and interviews with parents, former patients and clinicians. We followed the Consolidated Criteria for Reporting Qualitative Research checklist and conducted framework analysis, a specific methodology within thematic analysis.Results: We identified support for the trial’s methodology and vision, and elicited themes illustrating parents’ emotional needs in relation to clinical research. These were: relieving the pressure on mothers to breastfeed; opt-out consent as reducing parent stress; the desire for research to be a partnership between clinicians, parents and researchers; the value of presenting trial information in a collaborative tone; and in a format that allows assimilation by parents at their own pace. We identified anxiety and cognitive dissonance among some clinicians in which they recognised the uncertainties that justify the trial but felt unable to participate because of their strongly held views.Conclusions: The early involvement of parents and former patients identified the centrality of parents’ emotional needs in the design of comparative effectiveness research. These insights have been incorporated into trial enrolment processes and information provided to participants. Specific outputs were a two-sided leaflet providing very brief as well as more detailed information, and use of language that parents perceive as inclusive and participatory. Further work is warranted to support clinicians to address personal biases that inhibit trial participation.
AU  - Lammons,W
AU  - Moss,R
AU  - Battersby,C
AU  - Cornelius,V
AU  - Babalis,D
AU  - Modi,N
DO  - 10.1136/bmjpo-2021-001112
PY  - 2021///
SN  - 2399-9772
TI  - Incorporating parent, former patient, and clinician perspectives in the design of a national UK double-cluster, randomised controlled trial addressing uncertainties in preterm nutrition
T2  - BMJ Paediatrics Open
UR  - http://dx.doi.org/10.1136/bmjpo-2021-001112
UR  - http://hdl.handle.net/10044/1/90175
VL  - 5
ER  -

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