The Potentially Protective Effects of Anti-Lipid, Hypoglycemic, and Anti-Hypertensive Agents for Perioperative Mortality in Geriatric Group

Background Great efforts were made to collect information and identify risk factors in predicting post-anesthetic mortality. In this study, we use national health insurance data base, including medications, underlying comorbidities and surgical factors to assess the relationship between these factors and mortality after surgery. Methods This is a retrospective, population based study. The study population who underwent general anesthesia (GA) were retrieved from the National Health Insurance Research Database in Taiwan between January 1, 2005 and December 31, 2013. We classified the study patients into 4 major comparison groups by surgical procedures, including major organ transplantation (heart, liver, lung, kidney, or pancreas), CV surgery, major neurosurgery, and others according to the diagnostic codes of the international classification of diseases, ninth revision, clinical modification (ICD-9-CM) codes. We proposed a logistic regression model with valuable variables which can significantly predicts the post-anesthesia mortality. We also designed different models for 4 subgroups according the results. Results A total of 833,685 subjects were included in this study, and the most common comorbidity was hypertension. Age was an important determinant associated with post-operation mortality among different surgical types. Perioperative prescription could reduce risks of operation. The prediction model based on the preliminary training group also performed well in the validation group (AUROC=0.8753 for in-hospital mortality; AUROC= 0.8767 for 30-days mortality). A reliable predicting model can help anesthesiologists to decide the anesthesia method or monitors, as well as helping physicians to take care of their patients after operation. Conclusions While GA is commonly used for the majority of the patients undergoing operations, the prediction model that we proposed from this nationwide study could identify the predictors for post-operation mortality. The potentially protective effects of anti-lipid, hypoglycemic, and anti-hypertensive agents were encouraging in geriatric preoperative group. It is expected that applying this prediction model and prescription into clinical practice could improve surgical risk stratification and further improve patient outcomes. Trial registration The protocol of this study was approved by the National Taiwan University Hospital Research Ethics Committee (Trial Registration 201411078RINC). Informed consent was waived by the National Taiwan University Hospital Research Ethics Committee due to the retrospective and anonymous nature of the claims data.

Operationalising a real-time research ethics approach: supporting ethical mindfulness in agriculture-nutrition-health research in Malawi

Background There have been notable investments in large multi-partner research programmes across the agriculture-nutrition-health (ANH) nexus. These studies often involve human participants and commonly require research ethics review. These ANH studies are complex and can raise ethical issues that need pre-field work, ethical oversight and also need an embedded process that can identify, characterise and manage ethical issues as the research work develops, as such more embedded and dynamic ethics processes are needed. This work builds on notions of ‘ethics in practice’ by developing an approach to facilitate ethical reflection within large research programmes. This study explores the application of a novel ‘real-time research ethics approach’ (RTREA) and how this can support ethical mindfulness. This involves embedding ethical analysis and decision-making within research implementation, with a continuous dialogue between participants and researchers. The aim is to improve ethical responsiveness and participant experience, which in turn may ethically support adherence and retention. In this case study, a bioethics team (BT) was embedded in a community-based randomised, controlled trial conducted in rural Malawi, titled the ‘Addressing Hidden Hunger with Agronomy’. To identify ethical issues, the researchers conducted ten focus group discussions, fourteen in-depth interviews with key informants, two workshops, observed two sensitisation and three activity meetings conducted by the trial team, and analysed fifteen reports from pre-trial to trial implementation. Results The RTREA facilitated the identification of social and ethical concerns and made researchers aware of participants’ ‘lived research experience’. To address concerns and experiences, the BT worked with researchers to facilitate conversation spaces where social and ethical issues were discussed. Conversation spaces were designed to create partnerships and promote participatory methods to capture trial participants’ (TPs) perspectives and experiences. Conclusions The use of RTREA showed the value of real-time and continuous engagement between TPs and researchers. These real-time processes could be embedded to complement traditional ethical guidance and expert opinions. A deeper engagement appeared to support greater operationalising of principles of inclusion, empowerment, and participant autonomy and supported researchers ‘ethical mindfulness’ which in turn may support instrumental outcomes of high recruitment, retention, and adherence levels.

Seeking Approval from Universities to Research the Views of Their Staff. Do Gatekeepers Provide a Barrier to Ethical Research?

A “gatekeeper” controls access to an organization; “gatekeeper approval” is often needed before external research can take place within an organization. We explore the need for gatekeeper approval for research with university staff employing, as a case study, a project which collected data in Australia. This case study addresses known issues, seemingly rarely addressed in the literature. The Human Research Ethics Committee (HREC)'s requirement for approval from individual universities to approach their staff brought significant consequences, exacerbated by the lack of university procedures for such approvals. Simultaneously, since invitations could legitimately be distributed via other avenues, such approval was superfluous. We recommend the HREC's blanket requirement for institutional approval instead be considered on a case-by-case basis depending on the risk of the research, and perhaps waived for low-risk research where participants are able to provide informed consent, and that universities establish processes to deal with requests from external researchers.

Research Ethics in the Social Sciences

The formulation of Charts for research ethics and Codes of conduct has been growing in the last few decades, on the one hand due to a renewed awareness of the ethical dimensions of research governance and the relationship between regulators and researchers, and on the other hand for the expansion of possibilities achieved by innovation in information and communication technologies. The voluntary involvement of research participants, risk management and prevention, data protection, community engagement, reflexivity of researchers are some of the centres of gravity of a debate that involves researchers, institutions, and citizens.

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.