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A report on parent involvement in planning a randomised controlled trial in neonatology and lactation - insights for
Ilana Levene1, Fiona Alderdice1, Beth McCleverty2
1National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Insights
Patient and Public Involvement (PPI) significantly influenced a neonatal trial for preterm infants. This iterative process improved study design, focusing on reducing participant distress and informing future research in lactation and prematurity.
Area of Science:
- Neonatal research
- Clinical trials
- Patient and Public Involvement (PPI)
Background:
- Patient and Public Involvement (PPI) is crucial for research planning, design, execution, and dissemination.
- Effective communication of PPI findings maximizes the utilization of contributions.
- This report details an extended, iterative PPI process within a neonatal randomized controlled trial focused on breast milk expression after very preterm birth.
Purpose of the Study:
- To describe and evaluate an extended, iterative Patient and Public Involvement (PPI) process.
- To demonstrate the impact of PPI on the design and outcomes of a neonatal randomized controlled trial.
- To highlight strategies for increasing PPI engagement, particularly from under-reached populations.
Main Methods:
- A seven-stage iterative PPI approach was employed, starting with informal engagement and progressing to online questionnaires, charity partnerships, and advisory roles.
- Online panels and interactive exercises were used to refine study design and intervention.
- Strategies were implemented to ensure diversity and involve parents from under-reached groups.
Main Results:
- Six hundred and seventy-five participants responded to the online questionnaire (Stage 2).
- PPI directly influenced the study question, outcomes, and generated future research questions.
- The PPI process led to modifications in study design, emphasizing reduced participant distress and burden related to lactation.
Conclusions:
- Patient and Public Involvement (PPI) profoundly impacted the planning and design phases of the neonatal trial.
- The online questionnaire yielded extensive insights valuable for future research in lactation and prematurity.
- Successful strategies for engaging under-reached populations in PPI are feasible even with limited resources.
Background:
Patient and Public Involvement (PPI) is a rich and valuable part of the process of planning, designing, carrying out and disseminating research. It is important to communicate PPI findings in detail so that the contributions of those involved are fully utilised and disseminated. The extended and iterative PPI process used within a neonatal randomised controlled trial related to the expression of breastmilk after very preterm birth is reported here.
Methods:
Seven iterative stages of PPI were used. Stage 1 was informal PPI using historical interaction with parents and publicly available resources. Stage 2 was an online questionnaire open to parents of premature babies and advertised via a charity collaborator. Stage 3 was partnership with a charity collaborator. Stage 4 was a set of online panels focusing on study design and documents. Stage 5 was an interactive exercise to modify the trial intervention. Stage 6 is the presence of PPI contributors on the trial steering committee. Stage 7 is a dissemination panel. At each stage attention was paid to the diversity of participants involved, with strategies to increase the involvement of parents from under-reached groups.
Results:
Six hundred and seventy-five participants responded at Stage 2, six parents were involved at Stage 4 and 12 parents at Stage 5. PPI contributed to the choice of study question, outcomes and produced a set of questions for future research. PPI impacted on the study design, with specific emphasis on reducing participant distress related to lactation, and reducing the burden of being involved in research at a time of significant stress.
Conclusions:
PPI had a far-reaching influence on this neonatal randomised controlled trial during the planning and design phase, which reinforces the importance of PPI at the earliest stages of the research cycle. The online questionnaire format elicited an unexpectedly deep and broad pool of transferable insights, which will have an impact on future research focus and design in the area of lactation and prematurity. Approaches to increasing PPI involvement from under-reached populations are important and can be successful despite resource constraints.
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