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Deferred (also known as delayed) cord clamping can improve survival of infants born preterm (before 37 weeks of gestation), but the optimal duration of deferral remains unclear. We conducted a systematic review and individual participant data network meta-analysis with the aim of comparing the effectiveness of umbilical cord clamping strategies with different timings of clamping or with cord milking for preterm infants. We searched medical databases and trial registries from inception until Feb 24, 2022 (updated June 6, 2023) for randomised controlled trials comparing cord clamping strategies for preterm infants. Individual participant data were harmonised and assessed for risk of bias and quality. Interventions were grouped into immediate clamping, short deferral (≥15 s to <45 s), medium deferral (≥45 s to <120 s), long deferral (≥120 s), and intact cord milking. The primary outcome was death before hospital discharge. We calculated one-stage, intention-to-treat Bayesian random-effects individual participant data network meta-analysis. This study was registered with PROSPERO, CRD42019136640. We included individual participant data from 47 trials with 6094 participants. Of all interventions, long deferral reduced death before discharge the most (compared with immediate clamping; odds ratio 0·31 [95% credibility interval] 0·11–0·80; moderate certainty). The risk of bias was low for 10 (33%) of 30 trials, 14 (47%) had some concerns, and 6 (20%) were rated as having a high risk of bias. Heterogeneity was low, with no indication of inconsistency. This study found that long deferral of clamping leads to reduced odds of death before discharge in preterm infants. In infants assessed as requiring immediate resuscitation, this finding might only be generalisable if there are provisions for such care with the cord intact. These results are based on thoroughly cleaned and checked individual participant data and can inform future guidelines and practice. Australian National Health and Medical Research Council.

Umbilical cord clamping strategies at preterm birth have the potential to affect important health outcomes. The aim of this study was to compare the effectiveness of deferred cord clamping, umbilical cord milking, and immediate cord clamping in reducing neonatal mortality and morbidity at preterm birth. We conducted a systematic review and individual participant data meta-analysis. We searched medical databases and trial registries (from database inception until Feb 24, 2022; updated June 6, 2023) for randomised controlled trials comparing deferred (also known as delayed) cord clamping, cord milking, and immediate cord clamping for preterm births (<37 weeks' gestation). Quasi-randomised or cluster-randomised trials were excluded. Authors of eligible studies were invited to join the iCOMP collaboration and share individual participant data. All data were checked, harmonised, re-coded, and assessed for risk of bias following prespecified criteria. The primary outcome was death before hospital discharge. We performed intention-to-treat one-stage individual participant data meta-analyses accounting for heterogeneity to examine treatment effects overall and in prespecified subgroup analyses. Certainty of evidence was assessed with Grading of Recommendations Assessment, Development, and Evaluation. This study is registered with PROSPERO, CRD42019136640. We identified 2369 records, of which 48 randomised trials provided individual participant data and were eligible for our primary analysis. We included individual participant data on 6367 infants (3303 [55%] male, 2667 [45%] female, two intersex, and 395 missing data). Deferred cord clamping, compared with immediate cord clamping, reduced death before discharge (odds ratio [OR] 0·68 [95% CI 0·51–0·91], high-certainty evidence, 20 studies, n=3260, 232 deaths). For umbilical cord milking compared with immediate cord clamping, no clear evidence was found of a difference in death before discharge (OR 0·73 [0·44–1·20], low certainty, 18 studies, n=1561, 74 deaths). Similarly, for umbilical cord milking compared with deferred cord clamping, no clear evidence was found of a difference in death before discharge (0·95 [0·59–1·53], low certainty, 12 studies, n=1303, 93 deaths). We found no evidence of subgroup differences for the primary outcome, including by gestational age, type of delivery, multiple birth, study year, and perinatal mortality. This study provides high-certainty evidence that deferred cord clamping, compared with immediate cord clamping, reduces death before discharge in preterm infants. This effect appears to be consistent across several participant-level and trial-level subgroups. These results will inform international treatment recommendations. Australian National Health and Medical Research Council.

In evidence synthesis, assessing risk of bias (ROB) of eligible studies is crucial to inform interpretation of findings. Standardized tools like Cochrane's ROB-1 or ROB-2 traditionally rely on published information to inform assessments, but this is often incomplete or unclear. Availability of raw individual participant data (IPD) enables more in-depth assessments; however, guidance on how to use IPD in ROB assessments is lacking. We aim to develop preliminary guidance on how to use IPD to inform ROB assessments of randomized controlled trials (RCTs) for three case studies. In stage 1, we reviewed relevant literature, consulted our networks, and drew on previous experience to compile items on how IPD may inform ROB assessment for each domain. We discussed feasibility and potential usefulness of each item with an international, interdisciplinary expert advisory group and developed preliminary guidance, which was piloted in two IPD meta-analyses (MAs) (65 RCTs) using ROB-1. In stage 2, the guide was adapted for ROB-2 and applied to another IPD-MA (34 RCTs). All assessments were conducted in duplicate by two independent reviewers. In stage 3, we conducted an evaluation workshop to further refine each item, and capture important lessons. To assess the impact of IPD-informed assessments, we compared them to existing ROB-1 assessments performed with published information alone for 33 trials. We identified 12 items across the ROB domains. IPD provided opportunities to enhance ROB assessments by enabling additional checks for selection bias (ie, testing randomization) and attrition bias (ie, more granular assessment of incomplete data at various time points). We also identified domains for which availability of IPD enabled reduction of ROB, for instance, by mitigating selective outcome reporting bias or by reincluding excluded participants in intention-to-treat analyses. Applying IPD-informed assessments led to changes in ROB judgment in 25 of 33 studies, most commonly, resolution of domains previously marked as “unclear”. Our preliminary guidance for IPD-informed ROB assessments may be applied in IPD-MAs to increase the accuracy of ROB assessments and in some cases reduce ROB to create a more reliable evidence base informing policy and practice. When making decisions about how to treat a patient in clinical practice, it is important to consider the results of all relevant studies. Usually, combined analyses of multiple clinical trials rely on published reports, in which researchers summarize their findings. However, looking at the original data from these studies, instead of just the published reports, can improve the quality of analyses. Access to these underlying data also allows for more thorough assessment of the studies' quality and any potential for bias. This is important for understanding the results properly and for making the most appropriate treatment decisions for patients. Here, we present guidance on how to assess risk of bias of trials using these original datasets. [Display omitted] Key findings•Using Individual participant data (IPD) to inform risk of bias (ROB) assessments may reduce uncertainty, and in some cases reduce ROB.What this adds to what is known?•Standard methods of assessing ROB in a systematic review and meta-analysis (MA) rely on published information alone. IPD allow additional checks to be performed across several domains during ROB assessment.What is the implication, what should change now?•Our preliminary guidance for IPD-informed ROB assessments may be applied in IPD-MAs to create a more reliable evidence base informing policy and practice.

Childhood obesity is a global public health issue, which has prompted governments to invest in prevention programmes. We aimed to investigate the effectiveness of parent-focused early childhood obesity prevention interventions globally. We did a systematic review and individual participant data meta-analysis. We searched databases and trial registries (MEDLINE, Embase, CENTRAL, CINAHL, PsycInfo, ClinicalTrials.gov, and WHO International Clinical Trials Registry Platform) from inception until Sept 30, 2024, for randomised controlled trials commencing before 12 months of age examining parent-focused behavioural interventions to prevent obesity in children, compared with usual care, no intervention, or attention control. Individual participant data were checked, harmonised, and assessed for integrity and risk of bias. We excluded trials that were quasi-randomised, investigated pregnancy-only interventions, or did not collect any child weight-related outcomes. The primary outcome was BMI Z score at age 24 months (±6 months). We did an intention-to-treat, two-stage, random effects meta-analysis to examine effects overall and for prespecified subgroups. We assessed certainty of evidence using Grading of Recommendations Assessment, Development, and Evaluation. This study is registered with PROSPERO, CRD42020177408. Of 19 990 identified records, 47 (0·24%) trials were completed and eligible. Of these, 18 (38%) assessed our primary outcome, BMI Z score. We obtained individual participant data for 17 (94%; n=9128) of these 18 trials (n=9383), representing 97% of eligible participants. Of these 9128 participants, 4549 (50%) were boys, 4415 (48%) were girls, and 164 (2%) had unknown sex. We found no evidence of an effect of interventions on BMI Z score at age 24 months (±6 months; mean difference –0·01 [95% CI –0·08 to 0·05]; high certainty evidence, τ2=0·01; n=6505; 2623 missing). Findings were robust to prespecified sensitivity analyses (eg, different analysis methods and missing data), and we found no evidence of differential intervention effects for prespecified subgroups including priority populations and trial-level factors. These findings indicate that examined parent-focused behavioural interventions are insufficient to prevent obesity at age 24 months (±6 months). This evidence highlights a need to re-think childhood obesity prevention approaches. Australian National Health and Medical Research Council.

Background Early childhood obesity prevention interventions that aim to change parent/caregiver practices related to infant (milk) feeding, food provision and parent feeding, movement (including activity, sedentary behaviour) and/or sleep health (i.e. target parental behaviour domains) are diverse and heterogeneously reported. We aimed to 1) systematically characterise the target behaviours, delivery features, and Behaviour Change Techniques (BCTs) used in interventions in the international Transforming Obesity Prevention for CHILDren (TOPCHILD) Collaboration, and 2) explore similarities and differences in BCTs used in interventions by target behaviour domains. Methods Annual systematic searches were performed in MEDLINE, Embase, Cochrane (CENTRAL), CINAHL, PsycINFO, and two clinical trial registries, from inception to February 2023. Trialists from eligible randomised controlled trials of parent-focused, behavioural early obesity prevention interventions shared unpublished intervention materials. Standardised approaches were used to code target behaviours, delivery features and BCTs in both published and unpublished intervention materials. Validation meetings confirmed coding with trialists. Narrative syntheses were performed. Results Thirty-two trials reporting 37 active intervention arms were included. Interventions targeted a range of behaviours. The most frequent combination was targeting all parental behaviour domains (infant [milk] feeding, food provision and parent feeding, movement, sleep health; n[intervention arms] = 15/37). Delivery features varied considerably. Most interventions were delivered by a health professional ( n  = 26/36), included facilitator training ( n  = 31/36), and were interactive ( n  = 28/36). Overall, 49 of 93 unique BCTs were coded to at least one target behaviour domain. The most frequently coded BCTs were: Instruction on how to perform a behaviour (n[intervention arms, separated by domain] = 102), Behavioural practice and rehearsal ( n  = 85), Information about health consequences ( n  = 85), Social support (unspecified) ( n  = 84), and Credible source ( n  = 77). Similar BCTs were often used for each target behaviour domain. Conclusions Our study provides the most comprehensive description of the behaviour change content of complex interventions targeting early childhood obesity prevention available to date. Our analysis revealed that interventions targeted multiple behaviour domains, with significant variation in delivery features. Despite the diverse range of BCTs coded, five BCTs were consistently identified across domains, though certain BCTs were more prevalent in specific domains. These findings can be used to examine effectiveness of components and inform intervention development and evaluation in future trials. Trial registration PROSPERO registration no. CRD42020177408.

IntroductionBehavioural 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 analysisSystematic 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.Ethics and disseminationApproved by The University of Sydney Human Research Ethics Committee (2020/273) and Flinders University Social and Behavioural Research Ethics Committee (HREC CIA2133-1). Results will be relevant to clinicians, child health services, researchers, policy-makers and families, and will be disseminated via publications, presentations and media releases.PROSPERO registration numberCRD42020177408.

IntroductionLittle is known about how early (eg, commencing antenatally or in the first 12 months after birth) obesity prevention interventions seek to change behaviour and which components are or are not effective. This study aims to (1) characterise early obesity prevention interventions in terms of target behaviours, delivery features and behaviour change techniques (BCTs), (2) explore similarities and differences in BCTs used to target behaviours and (3) explore effectiveness of intervention components in preventing childhood obesity.Methods and analysisAnnual comprehensive systematic searches will be performed in Epub Ahead of Print/MEDLINE, Embase, Cochrane (CENTRAL), CINAHL, PsycINFO, as well as clinical trial registries. Eligible randomised controlled trials of behavioural interventions to prevent childhood obesity commencing antenatally or in the first year after birth will be invited to join the Transforming Obesity in CHILDren Collaboration. Standard ontologies will be used to code target behaviours, delivery features and BCTs in both published and unpublished intervention materials provided by trialists. Narrative syntheses will be performed to summarise intervention components and compare applied BCTs by types of target behaviours. Exploratory analyses will be undertaken to assess effectiveness of intervention components.Ethics and disseminationThe study has been approved by The University of Sydney Human Research Ethics Committee (project no. 2020/273) and Flinders University Social and Behavioural Research Ethics Committee (project no. HREC CIA2133-1). The study’s findings will be disseminated through peer-reviewed publications, conference presentations and targeted communication with key stakeholders.PROSPERO registration numberCRD42020177408.

IntroductionTiming of cord clamping and other cord management strategies may improve outcomes at preterm birth. However, it is unclear whether benefits apply to all preterm subgroups. Previous and current trials compare various policies, including time-based or physiology-based deferred cord clamping, and cord milking. Individual participant data (IPD) enable exploration of different strategies within subgroups. Network meta-analysis (NMA) enables comparison and ranking of all available interventions using a combination of direct and indirect comparisons.Objectives(1) To evaluate the effectiveness of cord management strategies for preterm infants on neonatal mortality and morbidity overall and for different participant characteristics using IPD meta-analysis. (2) To evaluate and rank the effect of different cord management strategies for preterm births on mortality and other key outcomes using NMA.Methods and analysisSystematic searches of Medline, Embase, clinical trial registries, and other sources for all ongoing and completed randomised controlled trials comparing cord management strategies at preterm birth (before 37 weeks’ gestation) have been completed up to 13 February 2019, but will be updated regularly to include additional trials. IPD will be sought for all trials; aggregate summary data will be included where IPD are unavailable. First, deferred clamping and cord milking will be compared with immediate clamping in pairwise IPD meta-analyses. The primary outcome will be death prior to hospital discharge. Effect differences will be explored for prespecified participant subgroups. Second, all identified cord management strategies will be compared and ranked in an IPD NMA for the primary outcome and the key secondary outcomes. Treatment effect differences by participant characteristics will be identified. Inconsistency and heterogeneity will be explored.Ethics and disseminationEthics approval for this project has been granted by the University of Sydney Human Research Ethics Committee (2018/886). Results will be relevant to clinicians, guideline developers and policy-makers, and will be disseminated via publications, presentations and media releases.Registration numberAustralian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12619001305112) and International Prospective Register of Systematic Reviews (PROSPERO, CRD42019136640).

There is a lack of community-based rehabilitation for stroke in the Philippines, and research on this topic is limited. Different challenges may be encountered in urban and rural settings. The aim of the Tulong, Ugnayan ng Lingap At gabaY (TULAY) project is to develop a context-appropriate, community-based stroke support programme, consisting of self-management and training resources to augment the rehabilitation and recovery process. An important stage in the development of this programme is to qualitatively explore the experiences and needs of all stakeholders. Using co-designed and evidence-based topic guides, in-depth semi-structured interviews will be conducted with people living with stroke, household carers and care providers. We will aim to gain a representation of different regions (within Luzon, Visayas, and Northern Mindanao), socioeconomic levels, and urban and rural locations. For people with stroke and household carers, interviews will be supplemented by auto-photography and visual elicitation to widen access for those that prefer to share their experiences visually or have communication problems. An interpretivist paradigm will be applied across all interview data and the consolidated criteria for reporting qualitative research (COREQ) will be followed. Thematic analysis will be undertaken using guidance by Braun and Clarke. To our knowledge, this study is the first of its kind in the Philippines. It has several methodological strengths, including the capture of perspectives from multiple stakeholders in diverse settings, the inclusion of people with communication difficulties, use of visual methods, and analysis in the native language. The findings will have various applications, including the potential to influence policy, practice and guidelines, and to inform the development of the TULAY stroke support programme.