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

Abstract

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.

Relaxation Therapy and Human Milk Feeding Outcomes

“…Database searches identified 236 individual records (after removal of duplicates), and 1 record was added by a topic expert . Nineteen of 34 full-text reports assessed were excluded due to ineligible format, ineligible outcome, ineligible intervention and ineligible population or study design . Three protocols are designated as reports of included studies.…”

“…The studies were from a wide variety of countries (China, India, Iran, Malaysia, Spain, Thailand, Turkey, UK, and US). The contextual congruence of the intervention is likely to affect adherence; eg, parents report that mindfulness tracks designed for normal birth may be distressing for those experiencing traumatic birth and with sick or preterm infants . The potential impact of these factors is difficult to assess as each study has a unique cultural context and relevant information about attitudes to relaxation and modifications to the intervention are infrequently reported.…”

The Effect of Individual Learning Programs on Self-Efficacy and Learning Motivation of Students With Special Needs at Inclusive Schools

“…Individualized learning programs can positively affect the self-efficacy and learning motivation of special education pupils (Love et al, 2020). This is because PPI can help children with special needs overcome their anxiety and feelings of inadequacy in inclusive education (Levene, et al, 2022;Street & Cooper, 2023). In typical classrooms, children with special needs do not feel discriminated against and are not discriminated against by their peers (Mayori et al, 2021).…”

The relationship of milk expression pattern and lactation outcomes after very premature birth: A cohort study

“…The participant log template for one site is provided as S1 Fig . Single recording days were selected, over a continuous log, because of parent involvement and recommendations on reducing the burden on participants (described fully elsewhere [ 33 ]). Days 4, 14 and 21 specifically were chosen as the recording days because of previous literature examining days 4 and 14 [ 37 , 38 ] and a desire for a later timepoint than day 14.…”

“…There is low concordance with expressing frequency recommendations in practice, with most studies reporting a median expressing frequency of six times per day and some as low as three [ 28 – 32 ]. Parents want to know more personalised and quantitative information to balance the benefits of frequent expression for lactation outcomes against the risks to physical and mental health [ 17 , 33 ]. For example, in our preparatory study asking parents what questions they have about milk expression, these included “How often to express is actually okay—10 times a day seemed impossible”, “Do you really have to wake up every 3 hours at night” and “how often to express and what time of day is best?” [ 33 ] specific quotations personal communication]…”