Lessons Learned Recruiting and Retaining Pregnant and Postpartum Individuals in Digital Trials (Preprint)

UNSTRUCTURED In an increasingly connected world and in the midst of a global pandemic, digital trials offer numerous advantages over traditional trials that rely on physical study sites. Digital trials have the potential to improve access to research and clinical treatments for the most vulnerable and minoritized, including pregnant and postpartum individuals. However, digital trials are underutilized in maternal and child health research, and there is limited evidence to inform the design and conduct of digital trials. Our research collaborative, consisting of five research teams in the U.S. and Australia, aimed to address this gap. We collaborated to share lessons learned from our experiences recruiting and retaining pregnant and postpartum individuals in digital trials of social and behavioral interventions. We first discuss the promise of digital trials in improving participation in research during the perinatal period as well as the unique challenges they pose. Second, we present lessons learned from 12 completed and ongoing digital trials that have used platforms such as Ovia, Facebook, and Instagram to recruitment. Our trials have evaluated interventions for breastfeeding, prenatal and postpartum depression, insomnia, decision-making, and chronic pain. We focus on challenges and lessons learned in three key areas 1) rapid recruitment of large samples with a diversity of minoritized identities; 2) retention of study participants in longitudinal studies; and 3) preventing fraudulent enrollment. We offer concrete strategies that we have pilot tested to address these challenges. Strategies presented in this commentary can be incorporated into as well as formally evaluated in future studies.

Priorities for child health research across the UK and Ireland

BackgroundThe General and Adolescent Paediatric Research Network in the UK and Ireland (GAPRUKI) was established in 2016. The aims of GAPRUKI are to unite general paediatricians around the UK and Ireland, to develop research ideas and protocols, and facilitate delivery of multicentre research.ObjectivesTo undertake a research prioritisation exercise among UK and Ireland general paediatricians.MethodsThis was a four-phase study using a modified Delphi survey. The first phase asked for suggested research priorities. The second phase developed ideas and ranked them in priority. In the third phase, priorities were refined; and the final stage used the Hanlon Prioritisation Process to agree on the highest priorities.ResultsIn phase one, there were 250 questions submitted by 61 GAPRUKI members (66% of the whole membership). For phase two, 92 priorities were scored by 62 members and the mean Likert scale (1–7) scores ranged from 3.13 to 5.77. In a face-to-face meeting (phases three and four), 17 research questions were identified and ultimately 14 priorities were identified and ranked. The four priorities with the highest ranking focused on these three respiratory conditions: asthma, bronchiolitis and acute wheeze. Other priorities were in the diagnosis or management of constipation, urinary tract infection, fever, gastro-oesophageal reflux and also new models of care for scheduled general paediatric clinics.ConclusionResearch priorities for child health in the UK and Ireland have been identified using a robust methodology. The next steps are for studies to be designed and funded to address these priorities.

78 Asking, listening, understanding: Establishing parent and youth priorities in child health research

Primary Subject area Advocacy Background A growing body of literature supports the active involvement of stakeholders in the prioritization and dissemination of evidence-based health care information. However, in child health related research, the perspectives of parents and youth are rarely acknowledged. Objectives To engage parents and youth in identifying and developing priority lists of research topics that are most relevant and important to youth and their families. Design/Methods We engaged parents and youth across Alberta in a modified James Lind Alliance priority setting exercise. Two lists, containing 27 topics were developed and modified in consultation with local parent and youth advisory groups. The respective lists were sent to parents and youth via online surveys. The anonymous surveys asked parents and youth to rank the topics by rating the degree (5-point Likert scale) to which they agreed the topic was a priority for child health research. All topics rated “Agree” or “Strongly Agree” by ≥ 70% of respondents were retained for discussion. Online focus groups (utilizing deliberative dialogue) to discuss priority topics were held with parents and youth, separately. Focus group discussions were analyzed using thematic analysis; resultant themes and subthemes were used to produce representative research questions. These were then sent via a second online survey to all participating parents and youth, who were asked to rank their ‘top 10’ most important child health research topics. Ethics approval was received from our institutional ethics board, and all participants gave informed consent or assent, prior to any data collection. Results Initial surveys were completed by 273 parents and 344 youth. This resulted in 5 highly rated health research topics for parents (behaviour, learning, and developmental disorders; mental health; food, environment and lifestyle; quality of health care; and vaccines) and 4 for youth (brain and nerve health, mental health, quality of health care, and vaccines), respectively. The research questions stemming from four parent (n=12) and six youth (n=21) focus group discussions were ranked in a second survey, completed by 43 parents and 62 youth. Parents’ highest ranked research topic was “effect of screen time on children’s neurodevelopment”, while the highest ranked topic from youth was “early signs of anxiety and depression in children and youth” (Tables 1 & 2). Conclusion Utilizing the knowledge and experience of Albertan parents and youth, relevant lists of priority topics in child health research were developed. These lists highlight the areas where funding and research should be directed to improve child health outcomes and patient care experiences that are important to parents and youth.

Endocrine-Disrupting Chemicals and Child Health

While definitions vary, endocrine-disrupting chemicals (EDCs) have two fundamental features: their disruption of hormone function and their contribution to disease and disability. The unique vulnerability of children to low-level EDC exposures has eroded the notion that only the dose makes the thing a poison, requiring a paradigm shift in scientific and policy practice. In this review, we discuss the unique vulnerability of children as early as fetal life and provide an overview of epidemiological studies on programming effects of EDCs on neuronal, metabolic, and immune pathways as well as on endocrine, reproductive, and renal systems. Building on this accumulating evidence, we dispel and address existing myths about the health effects of EDCs with examples from child health research. Finally, we provide a list of effective actions to reduce exposure, and subsequent harm that are applicable to individuals, communities, and policy-makers. Expected final online publication date for the Annual Review of Pharmacology and Toxicology, Volume 62 is January 2022. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

Forming a Parent And Clinician Team (PACT) in a cohort of healthy children

Background Engaging parents in child health research can facilitate choosing relevant research questions, recruiting participants who reflect the diversity of large communities, and disseminating study results to communities in accessible ways. Main body Primary care well-child visit systems present a foundation for trusting relationships between families and clinicians, lending itself well to a system where health research is embedded into the delivery of health care. We provide an example of a practice-based research network called TARGet Kids!, which is a longitudinal cohort study of children from birth to adolescence. Researchers and clinicians have partnered with parents of children participating in TARGet Kids! to ensure child health research is centred on family values and preferences. A Parent And Clinician Team (PACT) was formed to set research priorities, co-design research protocols, troubleshoot issues, and communicate research to knowledge users. Conclusion This partnership will facilitate child health research which is feasible, relevant and inclusive for improving children’s health care and public health policy.

Development of the patient-oriented research curriculum in child health (PORCCH)

Background The Canadian Institutes for Health Research launched a national ‘Strategy for Patient-Oriented Research’ (SPOR) in 2011. Patient-oriented research is defined as a continuum of research that engages patients as partners, focuses on patient-identified priorities, and improves patient outcomes. Capacity development is a core element of SPOR. Barriers to patient-oriented research include unfamiliarity with the research process for patients and families and unfamiliarity with the methods of patient and family engagement for researchers. Methods The aim of the Patient-Oriented Research Curriculum in Child Health (PORCCH) is to build capacity in patient-oriented research in child health among patients and families, researchers, healthcare professionals, decision-makers, and trainees through a curriculum delivered via a series of interactive online modules (e-learning). A multi-disciplinary, multi-stakeholder steering committee, which included patients and families, guided the development of the curriculum and provided feedback on individual modules. The content, design, and development of each module were co-led by a parent and researcher in an equal partnership. Results PORCCH consists of a series of five modules. All modules are interactive and include video vignettes and knowledge comprehension questions. Access to the modules is free and each module takes approximately 30 min to complete. The five modules are: Research 101 (an Introduction to Patient-Oriented Research, parts 1 and 2), Patient Engagement 101 (an Introduction to Patient Engagement in Child Health Research, parts 1 and 2), and Research Ethics 101. Conclusions PORCCH was developed specifically to overcome recognized barriers to the engagement of patients and families in child health research. The aim of the curriculum is to build capacity in patient-oriented research in child health. The goal is for PORCCH to be a useful resource for all stakeholders involved in patient-oriented research: patients and families, researchers, healthcare professionals, decision-makers, and trainees.

P value and Bayesian analysis in randomized-controlled trials in child health research published over 10 years, 2007 to 2017: a methodological review protocol

Background There is an unresolved debate about the reliability of the interpretation of P value. Some investigators have suggested that an alternative Bayesian method is preferred in conducting health research. As randomized-controlled trials (RCTs) are important in generating research evidence, we decided to investigate the extent, if any, the inferential statistical framework in published RCTs in child health research have changed over 10 years. We aim to examine the change in P value and Bayesian analysis in RCTs in child health research papers published from 2007 to 2017. Methods We will search the Cochrane Central Register of Controlled Trials (Wiley) to identify relevant citations. We will leverage a pre-existing sample of child health RCTs published in 2007 (n=300) used in our previous study of reporting quality of pediatric RCTs. Using the same strategy and study selection methods, we will identify a comparable random sample of child health RCTs published in 2017 (n=300). Eligible studies will include RCTs in health research among individuals aged 21 years and below. One reviewer will select studies for inclusion and extract the data and another reviewer will verify these. Disagreements will be resolved by a discussion between reviewers or by involving another reviewer. We will perform a descriptive analysis of 2007 and 2017 samples and analyze the results using both the frequentist and Bayesian methods. We will present specific characteristics of the clinical trials from 2007 and 2017 in tabular and graphical forms. We will report the difference in the proportion of P value and Bayesian analysis between 2007 and 2017 to assess the 10-year change. Clustering around P values of significance, if observed, will be reported. Discussion This review will present the difference in the proportion of trials that reported on P value and Bayesian analysis between 2007 and 2017 to assess the 10-year change. The implications for future clinical research will be discussed and this research work will be published in a peer-reviewed journal. This review has the potential to help inform the need for a change in the methodological approach from the null hypothesis significance test to Bayesian methods. Systematic review registration Open Science Framework https://osf.io/aj2df

Developing a national birth cohort for child health research using a hospital admissions database in England: The impact of changes to data collection practices

Background National birth cohorts derived from administrative health databases constitute unique resources for child health research due to whole country coverage, ongoing follow-up and linkage to other data sources. In England, a national birth cohort can be developed using Hospital Episode Statistics (HES), an administrative database covering details of all publicly funded hospital activity, including 97% of births, with longitudinal follow-up via linkage to hospital and mortality records. We present methods for developing a national birth cohort using HES and assess the impact of changes to data collection over time on coverage and completeness of linked follow-up records for children. Methods We developed a national cohort of singleton live births in 1998–2015, with information on key risk factors at birth (birth weight, gestational age, maternal age, ethnicity, area-level deprivation). We identified three changes to data collection, which could affect linkage of births to follow-up records: (1) the introduction of the “NHS Numbers for Babies (NN4B)”, an on-line system which enabled maternity staff to request a unique healthcare patient identifier (NHS number) immediately at birth rather than at civil registration, in Q4 2002; (2) the introduction of additional data quality checks at civil registration in Q3 2009; and (3) correcting a postcode extraction error for births by the data provider in Q2 2013. We evaluated the impact of these changes on trends in two outcomes in infancy: hospital readmissions after birth (using interrupted time series analyses) and mortality rates (compared to published national statistics). Results The cohort covered 10,653,998 babies, accounting for 96% of singleton live births in England in 1998–2015. Overall, 2,077,929 infants (19.5%) had at least one hospital readmission after birth. Readmission rates declined by 0.2% percentage points per annual quarter in Q1 1998 to Q3 2002, shifted up by 6.1% percentage points (compared to the expected value based on the trend before Q4 2002) to 17.7% in Q4 2002 when NN4B was introduced, and increased by 0.1% percentage points per annual quarter thereafter. Infant mortality rates were under-reported by 16% for births in 1998–2002 and similar to published national mortality statistics for births in 2003–2015. The trends in infant readmission were not affected by changes to data collection practices in Q3 2009 and Q2 2013, but the proportion of unlinked mortality records in HES and in ONS further declined after 2009. Discussion HES can be used to develop a national birth cohort for child health research with follow-up via linkage to hospital and mortality records for children born from 2003 onwards. Re-linking births before 2003 to their follow-up records would maximise potential benefits of this rich resource, enabling studies of outcomes in adolescents with over 20 years of follow-up.