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

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Evaluation of two population screening programmes for BRCA1/2 founder mutations in the Australian Jewish community: a protocol paper

BMJ Open ◽

10.1136/bmjopen-2020-041186 ◽

2021 ◽

Vol 11 (6) ◽

pp. e041186

Author(s):

Nicole E Cousens ◽

Jane Tiller ◽

Bettina Meiser ◽

Kristine Barlow-Stewart ◽

Simone Rowley ◽

...

Keyword(s):

Research Ethics ◽

Population Based ◽

Ethics Committee ◽

Founder Mutations ◽

Human Research ◽

Research Ethics Committee ◽

Human Research Ethics ◽

Pathogenic Variants ◽

Increased Risk ◽

Study Results

IntroductionPeople of Ashkenazi Jewish (AJ) ancestry are more likely than unselected populations to have a BRCA1/2 pathogenic variant, which cause a significantly increased risk of breast, ovarian and prostate cancer. Three specific BRCA1/2 pathogenic variants, referred to as BRCA-Jewish founder mutations (B-JFM), account for >90% of BRCA1/2 pathogenic variants in people of AJ ancestry. Current practice of identifying eligible individuals for BRCA testing based on personal and/or family history has been shown to miss at least 50% of people who have one of these variants. Here we describe the protocol of the JeneScreen study—a study established to develop and evaluate two different population-based B-JFM screening programmes, offered to people of Jewish ancestry in Sydney and Melbourne, Australia.Methods and analysisTo rmeasure the acceptability of population-based B-JFM screening in Australia, two screening programmes using different methodologies have been developed. The Sydney JeneScreen programme provides information and obtains informed consent by way of an online tool. The Melbourne JeneScreen programme does this by way of community sessions attended in person. Participants complete questionnaires to measure clinical and psychosocial outcomes at baseline, and for those who have testing, 2 weeks postresult. Participants who decline testing are sent a questionnaire regarding reasons for declining. Participants with a B-JFM are sent questionnaires 12-month and 24-month post-testing. The questionnaires incorporate validated scales, which measure anxiety, decisional conflict and regret, and test-related distress and positive experiences, and other items specifically developed or adapted for the study. These measures will be assessed for each programme and the two population-based B-JFM screening methods will be compared.Ethics and disseminationInstitutional Human Research Ethics Committee approval was obtained from the South Eastern Area Health Service Human Research Ethics Committee: HREC Ref 16/125.Following the analysis of the study results, the findings will be disseminated widely through conferences and publications, and directly to participants in writing.

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Prevalence and characteristics of polycystic ovary syndrome in Brazilian women: protocol for a nation-wide case–control study

BMJ Open ◽

10.1136/bmjopen-2019-029191 ◽

2019 ◽

Vol 9 (10) ◽

pp. e029191 ◽

Cited By ~ 2

Author(s):

Poli Mara Spritzer ◽

Lucas B Marchesan ◽

Betânia R Santos ◽

Felipe V Cureau ◽

Karen Oppermann ◽

...

Keyword(s):

Polycystic Ovary Syndrome ◽

Research Ethics ◽

Polycystic Ovary ◽

Ethics Committee ◽

Control Group ◽

Public Healthcare ◽

Ovary Syndrome ◽

Large Country ◽

Research Ethics Committee ◽

Study Results

IntroductionBrazil is a large country, with a population of mixed ethnic background and broad variation in dietary and physical activity traits across its five main regions. Because data on Brazilian women with polycystic ovary syndrome (PCOS) are still scarce, a nation-wide collaborative study was designed to determine the prevalence of metabolic and reproductive abnormalities and the presence of anxiety and depression in Brazilian women with PCOS. In addition, the study aims at describing how these characteristics are distributed across PCOS phenotypes and at detecting associations with regional demographic and lifestyle aspects, genetic variants, and epigenetic markers.Methods and analysisThe Brazilian PCOS study is being conducted in the outpatient clinics of eight university hospitals within the public healthcare network (Unified Health System) across the country. Additional centres will be included following completion of the research ethics approval process. The sample includes women with PCOS according to Rotterdam criteria at inclusion in the study and a control group of healthy women matched by age, socioeconomic status and geographical region. Data will be collected in each centre and incorporated into a unified cloud database. Clinical, demographic, socioeconomic, psychological, metabolic, epigenetic and genotypic variables will be evaluated. The data resulting from this study will be useful to guide specific public strategies for primary and secondary prevention of metabolic and reproductive comorbidities in the PCOS population of Brazil.Ethics and disseminationThe study protocol was approved by each local Research Ethics Committee. Written informed consent will be obtained from each participant. During data collection, analysis and publication, care will be taken to ensure confidentiality of participant information. Study results will be published in peer-reviewed journals and disseminated at international conferences. This research protocol was registered with the Research Ethics Committee of HCPA, through Plataforma Brasil.Trial registration numberCAAE 18082413.9.1001.5327

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Citizens, Research Ethics Committee Members and Researchers’ Attitude Toward Information and Consent for the Secondary Use of Health Data: Implications for Research Within Learning Health Systems

Journal of Empirical Research on Human Research Ethics ◽

10.1177/1556264621992214 ◽

2021 ◽

pp. 155626462199221

Author(s):

Annabelle Cumyn ◽

Roxanne Dault ◽

Adrien Barton ◽

Anne-Marie Cloutier ◽

Jean-François Ethier

Keyword(s):

Research Ethics ◽

Health Systems ◽

Ethics Committee ◽

Health Data ◽

Data Reuse ◽

Fundamental Importance ◽

Research Ethics Committee ◽

Secondary Use ◽

Public Perspectives ◽

Advance Knowledge

A survey was conducted to assess citizens, research ethics committee members, and researchers’ attitude toward information and consent for the secondary use of health data for research within learning health systems (LHSs). Results show that the reuse of health data for research to advance knowledge and improve care is valued by all parties; consent regarding health data reuse for research has fundamental importance particularly to citizens; and all respondents deemed important the existence of a secure website to support the information and consent processes. This survey was part of a larger project that aims at exploring public perspectives on alternate approaches to the current consent models for health data reuse to take into consideration the unique features of LHSs. The revised model will need to ensure that citizens are given the opportunity to be better informed about upcoming research and have their say, when possible, in the use of their data.

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Developing a policy to reduce the salt content of food consumed outside the home in Malaysia: protocol of a qualitative study

BMJ Open ◽

10.1136/bmjopen-2020-044628 ◽

2021 ◽

Vol 11 (7) ◽

pp. e044628

Author(s):

Mhairi Karen Brown ◽

Suzana Shahar ◽

Yee Xing You ◽

Viola Michael ◽

Hazreen Abdul Majid ◽

...

Keyword(s):

Medical Research ◽

Research Ethics ◽

Salt Intake ◽

Salt Content ◽

Ethics Committee ◽

Salt Reduction ◽

Reduction Strategy ◽

Research Ethics Committee ◽

School Canteen ◽

Medical Research Ethics

IntroductionCurrent salt intake in Malaysia is high. The existing national salt reduction policy has faced slow progress and does not yet include measures to address the out of home sector. Dishes consumed in the out of home sector are a known leading contributor to daily salt intake. This study aims to develop a salt reduction strategy, tailored to the out of home sector in Malaysia.Methods and analysisThis study is a qualitative analysis of stakeholder views towards salt reduction. Participants will be recruited from five zones of Malaysia (Western, Northern, Eastern and Southern regions and East Malaysia), including policy-makers, non-governmental organisations, food industries, school canteen operators, street food vendors and consumers, to participate in focus group discussions or in-depth interviews. Interviews will be transcribed and analysed using thematic analysis. Barriers will be identified and used to develop a tailored salt reduction strategy.Ethics and disseminationEthical approval has been obtained from the Universiti Kebangsaan Malaysia Medical Research Ethics Committee (UKM PPI/1118/JEP-2020–524), the Malaysian National Medical Research Ethics Committee (NMRR-20-1387-55481 (IIR)) and Queen Mary University of London Research Ethics Committee (QMERC2020/37) . Results will be presented orally and in report form and made available to the relevant ministries for example, Ministry of Health, Ministry of Education and Ministry of Trade to encourage adoption of strategy as policy. The findings of this study will be disseminated through conference presentations, peer-reviewed publications and webinars.

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Early Moves: a protocol for a population-based prospective cohort study to establish general movements as an early biomarker of cognitive impairment in infants

BMJ Open ◽

10.1136/bmjopen-2020-041695 ◽

2021 ◽

Vol 11 (4) ◽

pp. e041695

Author(s):

Catherine Elliott ◽

Caroline Alexander ◽

Alison Salt ◽

Alicia J Spittle ◽

Roslyn N Boyd ◽

...

Keyword(s):

At Risk ◽

Cohort Study ◽

Cognitive Impairment ◽

Research Ethics ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

Ethics Committee ◽

Research Ethics Committee ◽

National Implementation ◽

General Movements

IntroductionThe current diagnostic pathways for cognitive impairment rarely identify babies at risk before 2 years of age. Very early detection and timely targeted intervention has potential to improve outcomes for these children and support them to reach their full life potential. Early Moves aims to identify early biomarkers, including general movements (GMs), for babies at risk of cognitive impairment, allowing early intervention within critical developmental windows to enable these children to have the best possible start to life.Method and analysisEarly Moves is a double-masked prospective cohort study that will recruit 3000 term and preterm babies from a secondary care setting. Early Moves will determine the diagnostic value of abnormal GMs (at writhing and fidgety age) for mild, moderate and severe cognitive delay at 2 years measured by the Bayley-4. Parents will use the Baby Moves smartphone application to video their babies’ GMs. Trained GMs assessors will be masked to any risk factors and assessors of the primary outcome will be masked to the GMs result. Automated scoring of GMs will be developed through applying machine-based learning to the data and the predictive value for an abnormal GM will be investigated. Screening algorithms for identification of children at risk of cognitive impairment, using the GM assessment (GMA), and routinely collected social and environmental profile data will be developed to allow more accurate prediction of cognitive outcome at 2 years. A cost evaluation for GMA implementation in preparation for national implementation will be undertaken including exploring the relationship between cognitive status and healthcare utilisation, medical costs, health-related quality of life and caregiver burden.Ethics and disseminationEthics approval has been granted by the Medical Research Ethics Committee of Joondalup Health Services and the Health Service Human Research Ethics Committee (1902) of Curtin University (HRE2019-0739).Trial registration numberACTRN12619001422112.

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A Call for Better, Not Faster, Research Ethics Committee Reviews in the Covid‐19 Era

Ethics & Human Research ◽

10.1002/eahr.500104 ◽

2021 ◽

Vol 43 (5) ◽

pp. 42-44

Author(s):

Leonardo Tamariz ◽

Fred J. Hendler ◽

John M. Wells ◽

Annette Anderson ◽

Stephen Bartlett

Keyword(s):

Research Ethics ◽

Ethics Committee ◽

Research Ethics Committee

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Implementation of the StandingTall programme to prevent falls in older people: a process evaluation protocol

BMJ Open ◽

10.1136/bmjopen-2020-048395 ◽

2021 ◽

Vol 11 (7) ◽

pp. e048395

Author(s):

Morag E Taylor ◽

Chris Todd ◽

Sandra O'Rourke ◽

Lindy M Clemson ◽

Jacqueline CT Close ◽

...

Keyword(s):

Older People ◽

Research Ethics ◽

Process Evaluation ◽

Ethics Committee ◽

Community Dwelling ◽

Innovative Technology ◽

Local Health ◽

Research Ethics Committee ◽

Personal Impact ◽

The Uk

IntroductionOne in three people aged 65 years and over fall each year. The health, economic and personal impact of falls will grow substantially in the coming years due to population ageing. Developing and implementing cost-effective strategies to prevent falls and mobility problems among older people is therefore an urgent public health challenge. StandingTall is a low-cost, unsupervised, home-based balance exercise programme delivered through a computer or tablet. StandingTall has a simple user-interface that incorporates physical and behavioural elements designed to promote compliance. A large randomised controlled trial in 503 community-dwelling older people has shown that StandingTall is safe, has high adherence rates and is effective in improving balance and reducing falls. The current project targets a major need for older people and will address the final steps needed to scale this innovative technology for widespread use by older people across Australia and internationally.Methods and analysisThis project will endeavour to recruit 300 participants across three sites in Australia and 100 participants in the UK. The aim of the study is to evaluate the implementation of StandingTall into the community and health service settings in Australia and the UK. The nested process evaluation will use both quantitative and qualitative methods to explore uptake and acceptability of the StandingTall programme and associated resources. The primary outcome is participant adherence to the StandingTall programme over 6 months.Ethics and disseminationEthical approval has been obtained from the South East Sydney Local Health District Human Research Ethics Committee (HREC reference 18/288) in Australia and the North West- Greater Manchester South Research Ethics Committee (IRAS ID: 268954) in the UK. Dissemination will be via publications, conferences, newsletter articles, social media, talks to clinicians and consumers and meetings with health departments/managers.Trial registration numberACTRN12619001329156.

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