Incorporating parent, former patient and clinician perspectives in the design of a national UK double-cluster, randomised controlled trial addressing uncertainties in preterm nutrition.

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.
Competing Interests: Competing interests: CB reports grants and personal awards funded by the NIHR, NM reports grants from Medical Research Council, grants from National Institute for Health Research, grants from Prolacta Life Sciences, grants from Chiesi International, grants from Westminster Children’s Research Trust, grants from European Health Data and Evidence Network, grants from HCA International, grants from Health Data Research UK, grants from Shire Pharmaceuticals, grants from March of Dimes, outside the submitted work; CB is deputy chair of the NIHR Health Technology Assessment Prioritisation Committee for Hospital based care, NM is a member of the Nestle International Scientific Advisory Board (accepts no personal remuneration for this role).
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