Collaboration: protocol for a systematic review with individual participant data meta-analysis of behavioural interventions for the prevention of early childhood obesity.

Introduction Behavioural interventions in early life appear to show some effect in reducing childhood overweight and obesity. However, uncertainty remains regarding their overall effectiveness, and whether effectiveness differs among key subgroups. These evidence gaps have prompted an increase in very early childhood obesity prevention trials worldwide. Combining the individual participant data (IPD) from these trials will enhance statistical power to determine overall effectiveness and enable examination of individual and trial-level subgroups. We present a protocol for a systematic review with IPD meta- analysis to evaluate the effectiveness of obesity prevention interventions commencing antenatally or in the first year after birth, and to explore whether there are differential effects among key subgroups. Methods and analysis Systematic searches of Medline, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycInfo and trial registries for all ongoing and completed randomised controlled trials evaluating behavioural interventions for the prevention of early childhood obesity have been completed up to March 2021 and will be updated annually to include additional trials. Eligible trialists will be asked to share their IPD; if unavailable, aggregate data will be used where possible. An IPD meta-analysis and a nested prospective meta- analysis will be performed using methodologies recommended by the Cochrane Collaboration. The primary outcome will be body mass index z-score at age 24±6 months using WHO Growth Standards, and effect differences will be explored among prespecified individual and trial-level subgroups. Secondary outcomes include other child weight-related measures, infant feeding, dietary intake, physical activity, sedentary behaviours, sleep, parenting measures and adverse events. 73) and Flinders University Social and Behavioural Research Ethics Committee (HREC CIA2133- 1). Results will be Department. eminated via publications, presentations and media releases

Recruitment strategies in randomised controlled trials of men aged 50 years and older: a systematic review

Objectives: To identify and review evaluations of strategies to recruit men aged 50 years and over to randomised controlled trials (RCTs). Design: Systematic review and narrative synthesis. Data Sources: MEDLINE, EMBASE, CINAHL and ORRCA databases were searched to 1 December 2017. Eligibility Criteria: Studies using quantitative methods to evaluate recruitment strategies to RCTs of men aged 50 years and older. Data Extraction and Synthesis: A single reviewer extracted data (for each strategy, number of participants approached, screened and randomised, and cost). Study quality was assessed using National Heart, Lung and Blood Institute Quality Assessment Tools and considered study design, description of interventions, description and measurement of outcomes, completeness of outcome reporting, performance of statistical testing and consideration of confounders. Recruitment strategies were categorised by the recruitment stage they addressed. Results: Sixteen studies (n >14 000) were included: one good quality, ten fair quality and five poor quality. Studies evaluated strategies to identify prospective participants, and to improve the processes for assessing participant eligibility, providing participant information and seeking consent. In good and fair quality studies, the most effective strategies for identifying participants were referral from an affiliated health service provider (two studies), mass mailing (five studies) and media coverage (two studies). Community outreach activities such as displaying posters and attending local community events were not effective (two studies). Trial-specific training of site recruitment staff, developed using qualitative analysis of recruitment visits (two studies), and provision of study information to prospective participants at a multidisciplinary, group information session (one study) both improved recruitment. Conclusion: Improved engagement of men aged 50 years and older in RCTs is needed. A gender-sensitised approach to RCT recruitment may help to address this need. We have identified several promising recruitment strategies that merit further evaluation.Karen Bracken, Lisa Askie, Anthony C Keech, Wendy Hague, Gary Witter

Surfactant status and respiratory outcome in premature infants receiving late surfactant treatment.

BACKGROUND:Many premature infants with respiratory failure are deficient in surfactant, but the relationship to occurrence of bronchopulmonary dysplasia (BPD) is uncertain. METHODS:Tracheal aspirates were collected from 209 treated and control infants enrolled at 7-14 days in the Trial of Late Surfactant. The content of phospholipid, surfactant protein B, and total protein were determined in large aggregate (active) surfactant. RESULTS:At 24 h, surfactant treatment transiently increased surfactant protein B content (70%, p < 0.01), but did not affect recovered airway surfactant or total protein/phospholipid. The level of recovered surfactant during dosing was directly associated with content of surfactant protein B (r = 0.50, p < 0.00001) and inversely related to total protein (r = 0.39, p < 0.0001). For all infants, occurrence of BPD was associated with lower levels of recovered large aggregate surfactant, higher protein content, and lower SP-B levels. Tracheal aspirates with lower amounts of recovered surfactant had an increased proportion of small vesicle (inactive) surfactant. CONCLUSIONS:We conclude that many intubated premature infants are deficient in active surfactant, in part due to increased intra-alveolar metabolism, low SP-B content, and protein inhibition, and that the severity of this deficit is predictive of BPD. Late surfactant treatment at the frequency used did not provide a sustained increase in airway surfactant

A core outcome set for neonatal abstinence syndrome: Study protocol for a systematic review, parent interviews and a Delphi survey

Background: The prevalence of neonatal abstinence syndrome (NAS) is increasing globally resulting in an increased incidence of adverse neonatal outcomes and health system costs. Evidence regarding the effectiveness of NAS prevention and management strategies is very weak and further research initiatives are critically needed to support meta-analysis and clinical practice guidelines. In NAS research, the choice of outcomes and the use of valid, responsive and feasible measurement instruments are crucial. There is currently no consensus and evidence-based core outcome set (COS) for NAS. Methods/design: The development of the NAS-COS will include five stages led by an international Multidisciplinary Steering Committee: (1) qualitative interviews with parents/families and a systematic review (SR) to identify items for inclusion in a COS. The SR will also identify participants for the Delphi survey, (2) a three-round Delphi survey to gain expert opinion on the importance of health outcomes influencing NAS management decisions, (3), a consensus meeting to finalize the items and definitions with experts and COS users, (4) feasibility and pilot testing, development of the COS and explanatory document and (5) implementation planning. Discussion: Since standardized outcome measurement and reporting will improve NAS clinical research consistency, efficacy and impact, this COS will reflect the minimum set of health outcomes which should be measured in trials evaluating interventions for preventing or treating NAS

Repeat prenatal corticosteroid prior to preterm birth: a systematic review and individual participant data meta-analysis for the PRECISE study group (prenatal repeat corticosteroid international IPD study group: assessing the effects using the best level of evidence) - study protocol

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.BACKGROUND The aim of this individual participant data (IPD) meta-analysis is to assess whether the effects of repeat prenatal corticosteroid treatment given to women at risk of preterm birth to benefit their babies are modified in a clinically meaningful way by factors related to the women or the trial protocol. METHODS/DESIGN The Prenatal Repeat Corticosteroid International IPD Study Group: assessing the effects using the best level of Evidence (PRECISE) Group will conduct an IPD meta-analysis. The PRECISE International Collaborative Group was formed in 2010 and data collection commenced in 2011. Eleven trials with up to 5,000 women and 6,000 infants are eligible for the PRECISE IPD meta-analysis. The primary study outcomes for the infants will be serious neonatal outcome (defined by the PRECISE International IPD Study Group as one of death (foetal, neonatal or infant); severe respiratory disease; severe intraventricular haemorrhage (grade 3 and 4); chronic lung disease; necrotising enterocolitis; serious retinopathy of prematurity; and cystic periventricular leukomalacia); use of respiratory support (defined as mechanical ventilation or continuous positive airways pressure or other respiratory support); and birth weight (Z-scores). For the children, the primary study outcomes will be death or any neurological disability (however defined by trialists at childhood follow up and may include developmental delay or intellectual impairment (developmental quotient or intelligence quotient more than one standard deviation below the mean), cerebral palsy (abnormality of tone with motor dysfunction), blindness (for example, corrected visual acuity worse than 6/60 in the better eye) or deafness (for example, hearing loss requiring amplification or worse)). For the women, the primary outcome will be maternal sepsis (defined as chorioamnionitis; pyrexia after trial entry requiring the use of antibiotics; puerperal sepsis; intrapartum fever requiring the use of antibiotics; or postnatal pyrexia). DISCUSSION Data analyses are expected to commence in 2011 with results publicly available in 2012.Caroline A Crowther ... Tanya K Bubner ... Philippa F Middleton ... Lisa Yelland ... Sasha Zhang ... et al

Emerging collaborative research platforms for the next generation of physical activity, sleep and exercise medicine guidelines : the Prospective Physical Activity, Sitting, and Sleep consortium (ProPASS)

Galileo Galilei’s quote “measure what is measurable, and make measurable what is not so” has particular relevance to health behaviours, such as physical activity (PA), sitting and sleep, whose measurement during free living is notoriously difficult. To date, much of what we know about how these behaviours affect our health is based on self-report by questionnaires which have limited validity, are prone to bias, and inquire about selective aspects of these behaviours. Although self-reported evidence has made great contributions to shaping public health and exercise medicine policy and guidelines until now1, the ongoing advancements of accelerometry-based measurement and evidence synthesis methods are set to change the landscape. The aim of this editorial is to outline new directions in PA and sleep related epidemiology that open new horizons for guideline development and improvement; and to describe a new research collaboration platform: the Prospective Physical Activity, Sitting, and Sleep consortium (ProPASS)

Latest update of the clinical trials landscape in Australia (2006 – 2020)

The latest update of the clinical trials landscape in Australia (2006 – 2020) uses trial registration data to gain an understanding of the clinical trials occurring in Australia. This report is an update of the original report covering 2006-2015 and includes new data from 2016 to 2020. These data are sourced from the Australian New Zealand Clinical Trials Registry (ANZCTR) and US-based ClinicalTrials.gov registry. The purpose of this report is to provide a comprehensive outline of the key characteristics of clinical trials over time. Reporting on clinical trial activity is a crucial step in understanding where improvements may be needed in the clinical trials sector. This report can be used as a reference point when promoting Australian clinical trial activity at national or international forums. It is intended to be used by all those working in or with clinical trials including clinical trial investigators, researchers, funders, industry, policymakers, trial participants and the public. Previous reports analysing trial activity in Australia have helped to identify research gaps and prioritise funding schemes and to inform the design of new national infrastructure that facilitates clinical trial data sharing. We hope this updated report will be of similar use and help to inform the health research agenda in government and industry

Latest update of the clinical trials landscape in Australia (2006 – 2020)

The latest update of the clinical trials landscape in Australia (2006 – 2020) uses trial registration data to gain an understanding of the clinical trials occurring in Australia. This report is an update of the original report covering 2006-2015 and includes new data from 2016 to 2020. These data are sourced from the Australian New Zealand Clinical Trials Registry (ANZCTR) and US-based ClinicalTrials.gov registry. The purpose of this report is to provide a comprehensive outline of the key characteristics of clinical trials over time. Reporting on clinical trial activity is a crucial step in understanding where improvements may be needed in the clinical trials sector. This report can be used as a reference point when promoting Australian clinical trial activity at national or international forums. It is intended to be used by all those working in or with clinical trials including clinical trial investigators, researchers, funders, industry, policymakers, trial participants and the public. Previous reports analysing trial activity in Australia have helped to identify research gaps and prioritise funding schemes and to inform the design of new national infrastructure that facilitates clinical trial data sharing. We hope this updated report will be of similar use and help to inform the health research agenda in government and industry

Oxygen saturation and outcomes in preterm infants

BACKGROUN