Sarah Anne Redsell

Background. How outcomes are measured in studies can influence recruitment, retention, and data quality. This study examined characteristics of outcome measurement instruments influencing caregivers’ data provision in child health studies. Methods. An online mixed-methods cross-sectional survey including 22 closed-ended and one open-ended question(s) about outcome measurement instrument related factors influencing data provision in child health studies. Quantitative data were descriptively analyzed; qualitative data were analyzed using content analysis. Results. The survey was conducted with 490 caregivers of a child ≤12 years. The most important characteristics influencing caregivers’ provision of data were potential risk or discomfort to their child, ease of data provision, and perception of potential benefit to others. Caregivers ranked online data provision as their highest preference (M 1.23, SD 0.53; lower score indicates higher preference). Caregivers’ highest preferences were for healthcare professional data collection (M 2.50, SD 1.29), providing data in their own time (M 1.68, SD 1.27), and in their own homes (M 1.38, SD 0.88). Qualitative data indicated that trust, time and ease, perceived research value, and child comfort and safety were important to caregivers. Conclusions. Enhancing child comfort/safety, caregiver understanding/trust, and ease of data collection in child health studies is vital to maximize data provision and quality. Doing so, can improve evaluation of treatments and interventions, and improve child health outcomes.

Background What, when, and how infants are fed in the first year of life can influence their growth and development. Establishing optimal infant feeding behaviours is therefore crucial. However, trials of infant feeding interventions for early childhood obesity prevention have shown inconsistent results, potentially related to heterogeneity in what and how outcomes are measured. This heterogeneity limits evidence synthesis and the evaluation of intervention effectiveness. A Core Outcome Set (COS) including 26 infant feeding outcomes was previously developed to address this issue. The next step is to establish a Core Outcome Measurement Set (COMS) that specifies how these outcomes can be best measured. Evidence from work to date has informed a draft COMS. The primary aim of this study is to finalise the COMS with key stakeholders to support standardised measurement across research, policy, and practice. The secondary aim is to develop implementation strategies to facilitate uptake of the COMS and identify areas for future research. Methods This multi-method study will involve parents/caregivers, healthcare practitioners, researchers, and policymakers. Guided by the Generative Co-Design Framework for Healthcare Innovation, it will include two distinct phases. Phase 1 will consist of online meetings to finalise the COMS including structured voting to reach agreement on measurement recommendations. Phase 2 will involve one online co-design workshop to develop implementation strategies and identify priorities for future research. Both phases will be recorded, transcribed, and analysed using inductive content analysis (Phase 1) and thematic analysis (Phase 2). Participant demographic data and voting results will be analysed descriptively. Findings from both phases will inform the finalised COMS and implementation recommendations. Discussion This study represents the final stage of the Standardised measurement for Childhood Obesity Prevention (SCOPE) Project (www.eiascope.com). Findings from this study will strengthen the design, conduct, and evaluation of interventions to promote optimal infant feeding and growth.

Acute pain management in children and young people (CYP) attended by ambulance services is a significant challenge due to the complex nature of pain, the variation of approach needed across the age range, and the unpredictability of the environment. We aimed to understand how ambulance clinicians can provide improved prehospital acute pain management for CYP. A realist review was conducted and reported in accordance with the Realist And Meta-narrative Evidence Syntheses: Evolving Standards (RAMESES) guidance. We developed an initial programme theory (PT) using key stakeholder input, searched the major bibliographic databases MEDLINE, CINAHL Complete and PsycINFO, and other sources from January 2000 to February 2024, screened and assessed relevance and rigour in duplicate, and performed synthesis and programme theory refinement. We developed an initial PT that focussed on the preparedness of staff and the expectations of CYP and parents/carers, along with key outcomes such as pain score severity, fear and anxiety. The subsequent search strategy yielded 1503 documents, of which 95 were included, representing empirical research articles, reviews, theses, book chapters and clinical guidelines. The initial PT was tested and refined throughout the synthesis to produce a PT underpinned by 34 context-mechanism-outcome configurations. The PT portrayed positive (e.g. presence of parents, focussed education and training, building trust) and negative (e.g. misinformation, fear and anxiety, long-term consequences) effects on prehospital acute pain management for CYP. This PT was mapped to the Behaviour Change Wheel to provide a clinically relevant behaviour change model for improvement. This realist review has provided a clinically focussed model to guide the improvement of prehospital acute pain management in children and young people attended by ambulance. The programme theory lays a foundation on which future empirical testing can be conducted to effect behaviour change in practice. Registration: CRD42024505978.

Background How, what and when infants are fed in the first year of life influences their health and development. Interventions to improve infant feeding demonstrate inconsistent findings, highlighting a need for standardisation of what and how outcomes are measured. A core outcome set of infant feeding outcomes for use in childhood obesity prevention interventions has previously been developed, and scoping reviews have been conducted to identify what outcome measurement instruments are currently used to measure these outcomes. The aim of this review is to evaluate the measurement properties of the identified outcome measurement instruments that measure outcomes included in the infant feeding core outcome set. Methods A systematic review will be conducted following the COSMIN Initiative guidance. PubMed, EMBASE, CINAHL and PsycINFO databases will be searched from inception to present. To be eligible for inclusion studies must include infants ≤ 1 year of age. Studies must also report the development and/or evaluation of one or more measurement property of the outcome measurement instruments identified in our previous reviews, or other relevant outcome measurement instruments identified by the study team. Study screening and selection will be conducted independently in duplicate. The COSMIN Risk of Bias checklist will be used to evaluate the methodological quality of each study, and measurement properties will be evaluated one-by-one based on the COSMIN Initiative guidance. Confidence in the final ratings will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Working Group approach. Results will be presented in narrative and tabular format. Discussion Evaluating measurement properties of outcome measurement instruments to measure outcomes included in the infant feeding core outcome set will inform development of a core outcome measurement set. This will standardise measurement in trials of infant feeding interventions to prevent childhood obesity, thus improving evidence synthesis and reducing research waste.

Summary: Background: Complex interventions that include responsive infant feeding components can potentially prevent childhood obesity. To develop a replicable responsive feeding intervention, an understanding of the most effective behavior change techniques (BCTs) and theory is needed.Objective: To identify the BCTs and theories used in interventions with responsive feeding components for caregivers of children ≤2 years.Methods: PsycINFO, CINAHL, Cochrane Library, EMBASE, and MIDIRS were searched from inception to May 2023. Studies of obesity prevention interventions with a responsive feeding component were included. BCT Taxonomy Version 1 and Michie and Prestwich theory coding method were applied.Findings: Eighteen interventions were identified; the number of BCTs ranged from 3 to 11 (mean = 5.5). The most used BCTs were “Instruction on how to perform a behaviour” (17/18) and “Adding objects to the environment” (13/18), which were commonly used in the nine trials demonstrating higher responsive feeding behaviours and the four trials reporting reduced likelihood of overweight or obesity, or rapid weight gain. Fifteen trials reported use of theory.Conclusion: BCT use was low in interventions with responsive feeding components. BCTs are replicable; their use in interventions, alongside theory, will ensure that key determinants of responsive feeding behavior are included in future obesity prevention interventions.

Background Trials of interventions to prevent illness and/or improve health outcomes in children play a crucial role in the advancement of paediatric healthcare, research, and policy. It is important for researchers and trialists involved in such trials to understand factors which are important to parents/caregivers when deciding to participate and provide data about their child. There is little evidence to date surrounding the impact of outcome measurement instruments (OMIs) on parents/caregivers’ decisions about participation and provision of data in trials. The aim of this project is to examine what characteristics of OMIs are important in parents/caregivers’ decisions to engage with and participate in trials of interventions to prevent childhood illness and/or improve child health outcomes. Methods An online cross-sectional survey is being conducted. Survey recruitment began July 2024 and will be completed in October 2024. Parents/caregivers are eligible to participate if they have at least one child up to 12 years of age; there are no restrictions based on factors such as gender or nationality. Survey participants are being recruited using convenience sampling via social media, parenting websites, and online forums. This survey includes questions about parents/caregivers’ preferences for how, when, where, and with whom data is collected in child health research, as well as the types of OMIs parents/caregivers would be most comfortable using. Data will be analysed using descriptive statistics. Conclusions Findings from this study will address the current gap in knowledge related to preferences of parents/caregivers in how data are collected in trials of interventions to improve health outcomes in children. Study findings will inform trialists in the design and conduct of child health research in the future. Implementation of study findings in future trials can also improve experiences of children and their caregivers engaged in research and enhance the quality and quantity of data being collected.

Background Childhood obesity is a significant global public health challenge, with significant adverse effects on both mental and physical health outcomes. During the period from birth to one-year, modifiable caregiver behaviours, such as what, how and when infants are fed, can influence obesity development and prevention. The Choosing Healthy Eating for Infant Health (CHErIsH) intervention was developed to support healthy infant feeding practices to prevent childhood obesity in the first year. A feasibility study examined acceptability and feasibility of the CHErIsH intervention in primary care and identified key challenges and possible areas for refinement of the intervention and trial processes. The current project aims to refine delivery of the CHErIsH intervention and trial processes to maximise the likelihood of successful future implementation and evaluation. Methods This study will utilise a mixed-methods approach and will be conducted in three phases. In Phase 1 potential refinements to the CHErIsH intervention delivery and trial processes will be developed from a review of the feasibility study findings and input from the multidisciplinary team. An online mixed-methods survey will be conducted in Phase 2 to evaluate caregiver attitudes about the proposed refinements from Phase 1. Participants will be pregnant women, their partners, and/or parents/primary caregivers of infants up to 2-years of age, based in Ireland. Participants will be recruited using convenience and snowball sampling. In Phase 3 a stakeholder consensus meeting, using the nominal group technique, will be conducted to agree the refined intervention and trial processes. Stakeholders will include healthcare professionals, researchers, policymakers, and parents/caregivers, who will discuss and rate refinements in terms of preference. Conclusions Findings from this study will address uncertainties in the intervention delivery and trial processes of the CHErIsH intervention, with the potential to maximise the likelihood of successful future implementation and evaluation of a primary-care based obesity prevention intervention.

Background Two core outcome sets for childhood obesity prevention have been developed; standardised sets of outcome measurement instruments for these core outcome sets are currently being developed. Core outcome sets and standardised measurement sets can reduce heterogeneity and improve evidence syntheses for trials of interventions to prevent childhood obesity and/or interventions to improve child health behaviours related to childhood obesity. Such benefits are only realised if core outcome sets and standardised measurement sets are used in trials. The aims of this study are 1) to examine trialists’ awareness and attitudes towards the two existing core outcome sets and factors influencing their use; 2) to explore the characteristics of outcome measurement instruments that trialists currently use; and 3) to better understand how trialists choose outcome measurement instruments and the factors that influence those choices. Methods A cross-sectional online survey will be conducted with researchers involved in the design and/or conduct of trials of interventions to prevent childhood obesity and/or to improve child health behaviours related to childhood obesity, in children aged 0 to 5 years (trialists). Trialists will be recruited using purposive sampling, and will complete a 22-item survey examining trialist characteristics, awareness of the existing core outcome sets, factors influencing use of the existing core outcome sets, characteristics of measurement instruments, how trialists choose measurement instruments, and factors influencing choice of measurement instrument. Quantitative data will be analysed descriptively; responses to open-ended questions will be analysed using qualitative content analysis. Conclusions Findings from this study will inform approaches to maximising use of core outcome sets and standardised measurement sets for childhood obesity prevention. Use of standardised approaches to what and how outcomes are measured in this area will reduce heterogeneity and research waste and enhance evidence syntheses to better determine intervention effects.