Himanshu Popat

Prevalence and incidence are fundamental metrics with numerous applications in epidemiology. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline lacks specific items for reporting studies of disease prevalence or incidence. To address this gap, the STROBE Enhanced Prevalence and Incidence Criteria (STROBE EPIC) extension was developed in accordance with established methods for reporting guideline development. The authors generated an initial list of reporting items, conducted a modified Delphi process, and convened a face-to-face consensus meeting to confirm the need for a STROBE extension and to generate an early version of the checklist. They conducted 2 further Delphi surveys, first extending from typhoid and other invasive salmonelloses to all infectious diseases, and then to noncommunicable diseases and injuries. Finally, experts piloted the checklist on relevant manuscripts to critically assess if it was clear, concise, complete, and free of errors. An executive group curated the checklist after every survey round. The STROBE EPIC checklist comprises 47 items in the domains of title (1 item), abstract (2 items), introduction (1 item), methods (25 items), results (6 items), discussion (7 items), and other information (5 items). STROBE EPIC items address reporting of study design, adjustment factors for underreporting and underdiagnosis, denominator population estimation, case ascertainment methods, factors producing artefactual changes to observed disease prevalence or incidence, limitations of incomplete surveillance coverage, generalizability of short-duration studies, and data availability. The authors anticipate that the STROBE EPIC extension will be used by researchers, authors, modelers, burden-of-disease researchers, peer reviewers, and journal editors to optimize the presentation of epidemiologic evidence to support diverse health policy decisions.

Infants undergoing surgery experience postoperative pain beyond acute short‐lasting procedural pain and have variable analgesic needs. Assessing pain in this nonverbal population presents challenges for clinicians and parents. Given the short‐ and long‐term effects of pain and its treatment, timely and accurate assessment of pain is vital. The aim of this scoping review was to map pain assessment methods used by clinicians and parents to assess postoperative pain in infants aged 0 to 12 months and describe their psychometric properties. The review was guided by Arksey and O'Malley's (2005) five‐stage framework. We searched Embase, Medline, PsycINFO, Scopus, Cochrane, CINAHL from January 2014 to March 2026 to retrieve eligible studies. Thirty‐five studies (four systematic reviews, eight trials, and 23 original research studies) were included. We identified 20 different pain assessment methods used by clinicians. Postoperative pain categorization was inconsistent and lacked clear differentiation. There were inconsistencies in the duration, frequency, and documentation of pain scores. Several studies highlighted a discordance between pain scores, clinical judgment, and treatment decisions. Some tools had been used without being validated for postoperative pain or the age group studied. We found no studies of formal pain assessment methods used by parents. Observational subjectivity, the lack of current validity testing and standardization in methods, together with the multi‐faceted nature of pain reflects the need for a multidimensional approach to assess pain. Research is warranted on continuous monitoring of postoperative pain in infants and family involvement in pain assessment.

{4–5}: Background: The use of invasive mechanical ventilation in newborns has several risks, including ventilator-induced lung injury, ventilation-associated pneumonia, and hyperventilation leading to potential brain injury, prolonged hospitalisations, and increased mortality. The SafeBoosC-IIIv trial aims to assess the benefits and harms of treatment guided by cerebral oximetry monitoring in newborns receiving invasive mechanical ventilation within the first 28 days from birth. The SafeBoosC consortium is a global network of neonatologists from multiple neonatal intensive care units worldwide. Methods: The SafeBoosC-IIIv trial is an investigator-initiated, multinational, randomised, pragmatic, superiority phase III clinical trial. The trial will be conducted in two steps. This is a protocol for step one. The objective of step one is to assess if treatment guided by cerebral oximetry monitoring according to the SafeBoosC treatment guideline compared with usual care in newborns receiving invasive mechanical ventilation increases the number of hospital-free days. The participants will be newborns with a gestational age more than or equal to 28 + 0 weeks, postnatal age less than 28 days, expected to receive invasive mechanical ventilation (intubation) for at least 24 h, and a cerebral oximeter available so monitoring can be started within 6 h after initiation of invasive mechanical ventilation. Exclusion criteria will be suspicion of or confirmed brain injury or congenital heart malformation likely to require surgery. A total of 1,610 participants will be randomised 1:1 to treatment guided by cerebral oximetry monitoring or usual care. The primary outcome will be hospital-free days, and the secondary outcomes will be serious adverse events and invasive mechanical ventilation-free days. All outcomes will be assessed at 90 days after randomisation. Discussion: The SafeBoosC-IIIv trial has several strengths, including detailed predefined methodology, a high degree of external validity due to centres in several countries, and the trial will be built upon the already established SafeBoosC consortium and the experience from the previous SafeBoosC-II and SafeBoosC-III trials. The SafeBoosC-IIIv trial has limitations, including current lack of funding for step two, lack of blinding of the clinical staff, and the clinicians may have limited experience in using the device. Trial registration: ClinicalTrials.gov: NCT05907317, registered 8 June 2023, https://clinicaltrials.gov/study/NCT05907317?cond=NCT05907317&rank=1

Newborns requiring invasive mechanical ventilation are at high risk of neurodevelopmental impairment, prolonged hospitalisation, and increased mortality. T

Introduction: Delayed cord clamping (DCC) is an evidence-based intervention that reduces mortality, anaemia and disability in infants born Population ) infants Intervention ) the WAMM intervention (sharing of anonymised data on DCC60, together with a locally adapted quality improvement (QI) programme), compared with ( Control ) sharing of anonymised data on DCC60 alone, increase ( primary Outcome ) the proportion of infants receiving DCC60? At the end of 72 weeks, all sites will complete an 8-week period without the WAMM intervention to evaluate if implementation of DCC is sustained. Alongside the SW-CRT, an embedded process evaluation will assess the fidelity, acceptability, mechanisms of action and contextual barriers and enablers of the WAMM intervention. Discussion: Using the stepped wedged design and guided by an explicit implementation framework (i-PARIHS), WAMM will provide information on the effectiveness and transferability of a locally adapted QI method to improve DCC60. If proven effective, ultimately scaling up the WAMM intervention globally will greatly improve childhood anaemia, death, disability and long-term costs. Trial registration number: ACTRN12624000035527.

Background: There has been little decline in neonatal mortality rates over recent decades, and this is now further challenged by the rising prevalence of antimicrobial resistance. In Australia, the incidence of neonatal sepsis is low on a global scale, yet there are increasingly frequent outbreaks of multidrug-resistant (MDR) infections in neonatal intensive care units, alongside rising rates of colonisation with MDR bacteria. Methods: We analysed positive blood and cerebrospinal fluid cultures collected from infants (aged 0 to ≤180 days) across five clinical sites in Australia between 2010 and 2019, to determine evolving antimicrobial susceptibility profiles. Results: After excluding presumed contaminants, we analysed 743 pathogenic bacterial isolates cultured from 624 neonates and infants with early-onset (≤72 hours), late-onset (>72 hours to ≤28 days) and very late-onset (>28 days to ≤180 days) infections. Escherichia coli (37%) and Streptococcus agalactiae (31%) were the primary pathogens responsible for early-onset bloodstream infections, while coagulase-negative staphylococci, E. coli and Staphylococcus aureus were responsible for most infections in older neonates and infants. Antimicrobial susceptibility to currently recommended empiric regimens remains high; however, gram-negative bacteria—including MDR bacteria—were responsible for an increasing proportion of very late-onset infections over the study period (22% in 2010–2014 vs 34% in 2015–2019; p=0.07). Conclusions: Although empiric antimicrobial regimens remain adequate for most pathogens causing infections in neonates and infants in Australia, there is an increasing burden of invasive infections caused by gram-negative bacteria. Ongoing surveillance is necessary to ensure empiric antimicrobial guidelines remain efficacious and appropriate.

Mesenchymal stromal cells (MSCs) have been under clinical investigation for the treatment of cerebral palsy (CP) for over a decade. However, the field has been limited by study heterogeneity and variable reports of efficacy. We conducted a scoping review of published and registered reports of MSC treatment for CP, with meta-analysis of Gross Motor Function Measure (GMFM) outcomes to summarize research and provide future recommendations. Thirty published reports and 10 registered trials were identified, including 1292 people with CP receiving MSCs. Most received ≥2 doses (72%) of umbilical cord tissue MSCs (75%), intrathecally (40%) or intravenously (38%), and 31% were treated via compassionate/Expanded access. MSC treatment was safe and meta-analyses demonstrated that MSCs conferred significant improvements in GMFM at 3 − (1.05 (0.19–1.92), p = 0.02), 6 − (0.97 (0.30–1.64), p = 0.005) and 12 months (0.99 (0.30–1.67), p = 0.005) post-treatment. Whilst MSCs are safe and improve GMFM outcomes in CP with large effect sizes, study and participant variability continues to confound data interpretation and limits subgroup analyses. With no published Phase 3 trials and high rates of compassionate access, the field would benefit from well-designed trials with unified outcomes. Additionally, data sharing to enable Individual Participant Data Meta-Analysis would support the determination of optimal source, route and dose to progress towards regulatory approval.