Early detection of Australian Aboriginal and Torres Strait Islander infants at high risk of adverse neurodevelopmental outcomes at 12 months corrected age: LEAP-CP prospective cohort study protocol

IntroductionNeurodevelopmental disorders (NDD), including cerebral palsy (CP), autism spectrum disorder (ASD) and foetal alcohol spectrum disorder (FASD), are characterised by impaired development of the early central nervous system, impacting cognitive and/or physical function. Early detection of NDD enables infants to be fast-tracked to early intervention services, optimising outcomes. Aboriginal and Torres Strait Islander infants may experience early life factors increasing their risk of neurodevelopmental vulnerability, which persist into later childhood, further compounding the health inequities experienced by First Nations peoples in Australia. The LEAP-CP prospective cohort study will investigate the efficacy of early screening programmes, implemented in Queensland, Australia to earlier identify Aboriginal and Torres Strait Islander infants who are ‘at risk’ of adverse neurodevelopmental outcomes (NDO) or NDD. Diagnostic accuracy and feasibility of early detection tools for identifying infants ‘at risk’ of a later diagnosis of adverse NDO or NDD will be determined.Methods and analysisAboriginal and/or Torres Strait Islander infants born in Queensland, Australia (birth years 2020–2022) will be invited to participate. Infants aged <9 months corrected age (CA) will undergo screening using the (1) General Movements Assessment (GMA); (2) Hammersmith Infant Neurological Examination (HINE); (3) Rapid Neurodevelopmental Assessment (RNDA) and (4) Ages and Stages Questionnaire-Aboriginal adaptation (ASQ-TRAK). Developmental outcomes at 12 months CA will be determined for: (1) neurological (HINE); (2) motor (Peabody Developmental Motor Scales 2); (3) cognitive and communication (Bayley Scales of Infant Development III); (4) functional capabilities (Paediatric Evaluation of Disability Inventory-Computer Adaptive Test) and (5) behaviour (Infant Toddler Social and Emotional Assessment). Infants will be classified as typically developing or ‘at risk’ of an adverse NDO and/or specific NDD based on symptomology using developmental and diagnostic outcomes for (1) CP (2) ASD and (3) FASD. The effects of perinatal, social and environmental factors, caregiver mental health and clinical neuroimaging on NDOs will be investigated.Ethics and disseminationEthics approval has been granted by appropriate Queensland ethics committees; Far North Queensland Health Research Ethics Committee (HREC/2019/QCH/50533 (Sep ver 2)-1370), the Townsville HHS Human Research Ethics Committee (HREC/QTHS/56008), the University of Queensland Medical Research Ethics Committee (2020000185/HREC/2019/QCH/50533) and the Children’s Health Queensland HHS Human Research Ethics Committee (HREC/20/QCHQ/63906) with governance and support from local First Nations communities. Findings from this study will be disseminated via peer-reviewed publications and conference presentations.Trial registration numberACTRN12619000969167.

O Perfil dos Acadêmicos de Engenharia de uma IES Pública e suas Potencialidades para a Evasão

ResumoA desistência é uma problemática que afeta, atualmente, muitas Instituições de Ensino Superior. As origens dessas evasões vêm sendo investigadas, por muitos pesquisadores, com o intento de compreendê-las e elaborar, a partir das observações feitas, ações que mitiguem essa realidade. O objetivo do estudo foi conhecer o perfil dos alunos de Engenharia da Computação e Engenharia de Automação do IFMT – Campus Cuiabá, também, compreender quais fatores podem estar contribuindo para que estes estejam desejosos ou pré-dispostos a abandonarem o curso. Por se tratar de uma pesquisa com seres humanos, foi necessária a submissão e aprovação de projeto pelo Comitê de Ética de Pesquisa do IFMT e se baseou em um questionário que, depois de aplicado aos alunos, foi posteriormente submetido à análise de suas respostas. Em suma, percebeu-se que as principais causas que, a priori, estejam relacionadas às desistências podem ser: a necessidade de alguns alunos terem que trabalhar para ajudar no sustento da família; as poucas horas de estudo extraclasse destinadas ao curso e, por último, uma falta de afinidade com a Graduação, tendo em vista que esta não era sua primeira opção de escolha profissional. Palavras-chave: Questionário. Evasão. Engenharias. Abstract Dropout is a problem that affects many higher education institutions today. The origins of such evasions have been investigated by many researchers with the intention of understanding them and elaborating, based on the observations made, actions that mitigate this reality. The objective of the study was to know the students’ profile of Computer Engineering and Automation Engineering at IFMT - Campus Cuiabá, also, to understand what factors may be contributing for them to be willing or ready to abandon the course. As it is a research with human beings, it was necessary to submit and approve the project by the IFMT Research Ethics Committee and it was based on a questionnaire which, after being applied to students, was subsequently submitted for analysis of their responses. In short, it was noticed that the main causes that, a priori, are related to dropouts can be: the need for some students to have to work to help support the family; the few hours of extra-class study aimed at the course and, lastly, a lack of affinity with undergraduate degree, considering that this was not his or her first professional choice. Keywords: Questionnaire, Evasion, Engineering.

nSeP: immune and metabolic biomarkers for early detection of neonatal sepsis—protocol for a prospective multicohort study

IntroductionDiagnosing neonatal sepsis is heavily dependent on clinical phenotyping as culture-positive body fluid has poor sensitivity, and existing blood biomarkers have poor specificity.A combination of machine learning, statistical and deep pathway biology analyses led to the identification of a tripartite panel of biologically connected immune and metabolic markers that showed greater than 99% accuracy for detecting bacterial infection with 100% sensitivity. The cohort study described here is designed as a large-scale clinical validation of this previous work.Methods and analysisThis multicentre observational study will prospectively recruit a total of 1445 newborn infants (all gestations)—1084 with suspected early—or late-onset sepsis, and 361 controls—over 4 years. A small volume of whole blood will be collected from infants with suspected sepsis at the time of presentation. This sample will be used for integrated transcriptomic, lipidomic and targeted proteomics profiling. In addition, a subset of samples will be subjected to cellular phenotype and proteomic analyses. A second sample from the same patient will be collected at 24 hours, with an opportunistic sampling for stool culture. For control infants, only one set of blood and stool sample will be collected to coincide with clinical blood sampling. Along with detailed clinical information, blood and stool samples will be analysed and the information will be used to identify and validate the efficacy of immune-metabolic networks in the diagnosis of bacterial neonatal sepsis and to identify new host biomarkers for viral sepsis.Ethics and disseminationThe study has received research ethics committee approval from the Wales Research Ethics Committee 2 (reference 19/WA/0008) and operational approval from Health and Care Research Wales. Submission of study results for publication will involve making available all anonymised primary and processed data on public repository sites.Trial registration numberNCT03777670

Challenges During Review of COVID-19 Research Proposals: Experience of Faculty of Medicine, Ain Shams University Research Ethics Committee, Egypt

The COVID-19 pandemic resulted in an overwhelming increase in research studies submitted to research ethics committees (RECs) presenting many ethical challenges. This article aims to report the challenges encountered during review of COVID-19 research and the experience of the Faculty of Medicine, Ain Shams University Research Ethics Committee (FMASU REC). From April 10, 2020, until October 13, 2020, the FMASU REC reviewed 98 COVID-19 research protocols. This article addressed the question of how to face an overwhelming amount of research submitted to the REC while applying the required ethical principles. Ethical challenges included a new accelerated mode of review, online meetings, balance of risks vs. benefits, measures to mitigate risks, co-enrolment in different studies, protection of a vulnerable COVID-19 population, accelerated decisions, online research, how to handle informed consent during the pandemic, and justification of placebo arm.

Oxford Understanding Relationships, Sex, Power, Abuse and Consent Experiences (OUR SPACE) cross-sectional survey: a study protocol

IntroductionSexual violence among higher education students is a public health concern, threatening the general safety of students, often with significant physical and mental health implications for victims. Establishing the prevalence estimates of sexual violence at higher education institutions (HEIs) is essential for designing and resourcing responses to sexual violence, including monitoring the effectiveness of prevention initiatives and institutional programmes. Yet, to date, there have been no rigorous studies assessing prevalence of sexual violence at HEIs in the UK.Methods and analysisInformed by guidance from Universities UK, the University of Oxford administration and the related student advocacy groups working within the University, Oxford Understanding Relationships, Sex, Power, Abuse and Consent Experiences is a cross-sectional survey of all undergraduate and graduate students over the age of 18 enrolled at the University of Oxford, UK. The survey design uses a complete sampling approach and measures adapted from previous campus climate surveys in the USA as well as the Sexual Experiences Survey (USA). The analysis will estimate the prevalence of sexual harassment and sexual violence perpetration and victimisation, and will examine whether ethnicity, gender identity, and sexual orientation are associated with these primary outcomes.Ethics and disseminationEthical approval was obtained by the Social Sciences and Humanities Interdivisional Research Ethics Committee at the University of Oxford which is a subcommittee of the Central University Research Ethics Committee (ref no.: R73805/RE001). The research team will disseminate findings through peer-reviewed journal articles and conference presentations. A report cowritten by authors and stakeholders will be shared with Oxford University students.

Human Research Ethics Committee Experiences and Views About Children’s Participation in Research: Results From the MESSI Study

As part of a larger study, Australian Human Research Ethics Committee (HREC) members and managers were surveyed about their decision-making and views about social research studies with child participants. Responses of 229 HREC members and 42 HREC managers are reported. While most HREC members had received ethical training, HREC training and guidelines specific to research involving children were rare. Most applications involving children had to go through a full ethical review, but few adverse events were reported to HRECs regarding the conduct of the studies. Revisions to study proposals requested by HRECs were mostly related to consent processes and age-appropriate language. One-third of HREC members said that they would approve research on any topic. Most were also concerned that the methodology was appropriate, and the risks and benefits were clearly articulated. Specific training and guidance are needed to increase HREC members’ confidence to judge ethical research with children.

A situation analysis of competences of research ethics committee members regarding review of research protocols with complex and emerging study designs in Uganda

Background Over the past two decades, Uganda has experienced a significant increase in clinical research driven by both academia and industry. This has been combined with a broader spectrum of research proposals, with respect to methodologies and types of intervention that need evaluation by Research Ethics Committees (RECs) with associated increased requirement for expertise. We assessed the competencies of REC members regarding review of research protocols with complex and emerging research study designs. The aim was to guide development of a training curriculum to improve the quality of scientific and ethical review. Methods This was a cross-sectional study design, with quantitative data collection methods. Research Ethics Committee members completed a structured pre-coded questionnaire on current competence with complex and emerging study design. REC members were asked to outline a list of additional topics for which they needed training. Data from coded questions were entered into Epidata Version 3.1 and then exported to STATA Version14.1 for analysis. Descriptive analysis was performed and findings are presented using percentages and frequencies. Results We enrolled 55 REC members from 6 RECs who have a total of 97 members. The majority of whom were males (56.4%, n = 31/55). The level of competence for review of selected study design was lowest for Controlled Human Infection Model (10.9%, n = 6) and reverse pharmacology design (10.9%, n = 6), and highest for cluster randomized study design (52.7%, n = 29) and implementation science research (52.7%, n = 29). Conclusion Competence for review of research protocols with complex and emerging study design was low among participating REC members. We recommend prioritising training of REC members on complex and emerging study designs to enhance quality of research protocol review.

Socio-Demographic Profile and Prevalence of Tuberculosis (TB) Treatment Outcomes among Tuberculosis/Human Immunodeficiency Virus (TB/HIV) Co-Infected Patients in Kelantan

In Kelantan, the prevalence of Tuberculosis (TB) treatment success rate among TB/HIV co-infection is still below the success target of the World Health Organisation (WHO). Our objective was to assess the socio-demographic profile and determine the prevalence of TB treatment outcomes among TB/HIV co-infected patients in Kelantan. The cross-sectional study involved secondary data from the MyTB online system from January 2014 to December 2018, carried out at TB/Leprosy Sector, State Health Department of Kelantan. The data were analysed using SPSS version 25.0 and STATA version 14. The ethics approval was obtained from the UniSZA Human Research Ethics Committee (UHREC) and Medical Research Ethics Committee (MREC) of Ministry of Health (MOH). There were 6,313 TB cases in Kelantan. Of these, 703 (11.1%) cases were TB/HIV co-infection. However, 36 cases were excluded, and 667 cases were evaluated based on inclusion and exclusion criteria. The mean (SD) age was 38.7 (7.9) years, and the mean duration of TB treatment was 202.8 (131.27) days. The prevalence of successful treatment was 57.1%, with 19.8% cases were cured, and another 37.3% cases were completed treatment. While the unsuccessful were 42.9%, with 10.1% cases were defaulted, and 32.8% cases died. The successful outcomes were significantly associated with the educational level, the anatomy of TB location, smoking status, DOTS by health care providers, source of notification, the place of treatment and method of detection. This study provides the basic data of patient’s socio-demographic profiles, and the prevalence of TB treatment success in Kelantan is under international target by WHO of ≥ 90.0%.