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

Abstract

BackgroundComparative 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.MethodsWe 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.ResultsWe 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.ConclusionsThe 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.

A report on parent involvement in planning a randomised controlled trial in neonatology and lactation – insights for current and future research

“…Patient and Public Involvement had a far-reaching influence on the study during the planning and design phase, which reinforces the importance of PPI at the earliest stages of the research cycle [4]. The online questionnaire format elicited an unexpectedly deep and broad pool of insights to influence trial design and the number of people involved was much larger than other published PPI reports [5,26,27]. However a known weakness of using social media to recruit participants [46] is that it is less effective at including marginalised voices, for example, families from ethnic minorities and communities with lower socioeconomic status.…”

“…Some actions resulting from Patient and Public Involvement in this trial are similar to the conclusions from other neonatal and paediatric PPI conducted while planning RCTs [26,27]. For example, providing participant information in short formats to cater for parents with different information needs, a focus on compassionate language when describing low volumes of maternal milk [26] and giving participants the opportunity to describe their experiences more freely, rather than being constrained to validated questionnaires and numerical responses [27].…”

“…PPI reports should cover short term outcomes (what was said and learnt), medium term outcomes (changes resulting from this learning) and long term impacts, for example on the future research agenda, as these can all be used by the wider research community [7]. Such reports are becoming more frequent [23,26,27].…”

“…Qualitative literature and published PPI were used as another way to hear the voice of parents of very preterm infants [16,17,26,[28][29][30][31][32] and co-produced research prioritisation exercises [33] were consulted. All of these factors inform an understanding of parental experiences, priorities and values that can be used as a springboard for formal PPI planning.…”

“…For example, providing participant information in short formats to cater for parents with different information needs, a focus on compassionate language when describing low volumes of maternal milk [26] and giving participants the opportunity to describe their experiences more freely, rather than being constrained to validated questionnaires and numerical responses [27]. However the broad, foundational questions asked in the online questionnaire, and the very large number of responses at an early stage, meant that this PPI process has resulted in a deeper and wider set of transferrable insights than most reports [5,26,27]. Thus, in addition to practical changes to trial design, a wide range of future research topics that parents want answers to has been presented, which can be a springboard for the research community.…”