This study aims to calculate the global warming potential, in carbon dioxide (CO2) equivalent emissions, from all in-scope activities involved in a phase-1 clinical study.
Retrospective analysis.
Internal data held by Janssen Pharmaceuticals.
Janssen-sponsored TMC114FD1HTX1002 study conducted between 2019 and 2021.
Measure CO2 equivalents (CO2e) for in-scope clinical trial activities calculated according to intergovernmental panel on climate change 2021 impact assessment methodology.
The CO2e emissions generated by the trial were 17.65 tonnes. This is equivalent to the emissions generated by driving an average petrol-fueled family car 71 004 km or roughly 1.8 times around the circumference of the Earth. Commuting to the clinical site by the study participants generated the most emissions (5419 kg, 31% of overall emissions), followed by trial site utilities (2725 kg, 16% of overall emissions) and site staff travel (2560 kg, 15% of overall emissions). In total, the movement of people (participant travel, site staff travel and trial site staff travel) accounted for 8914 kg or 51% of overall trial emissions.
Decentralised trial models which seek to bring clinical trial operations closer to the participant offer opportunities to reduce participant travel. The electrification of sponsor vehicle fleets and society’s transition towards electric vehicles may result in further reductions.
Physical activity (PA) has beneficial effects on brain health and cardiovascular disease (CVD) risk. Yet, we know little about whether PA-induced changes to physiological mediators of CVD risk influence brain health and whether benefits to brain health may also explain PA-induced improvements to CVD risk. This study combines neurobiological and peripheral physiological methods in the context of a randomised clinical trial to better understand the links between exercise, brain health and CVD risk.
In this 12-month trial, 130 healthy individuals between the ages of 26 and 58 will be randomly assigned to either: (1) moderate-intensity aerobic PA for 150 min/week or (2) a health information control group. Cardiovascular, neuroimaging and PA measurements will occur for both groups before and after the intervention. Primary outcomes include changes in (1) brain structural areas (ie, hippocampal volume); (2) systolic blood pressure (SBP) responses to functional MRI cognitive stressor tasks and (3) heart rate variability. The main secondary outcomes include changes in (1) brain activity, resting state connectivity, cortical thickness and cortical volume; (2) daily life SBP stress reactivity; (3) negative and positive affect; (4) baroreflex sensitivity; (5) pulse wave velocity; (6) endothelial function and (7) daily life positive and negative affect. Our results are expected to have both mechanistic and public health implications regarding brain–body interactions in the context of cardiovascular health.
Ethical approval has been obtained from the University of Pittsburgh Institutional Review Board (IRB ID: 19020218). This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule.
The inaugural expert consensus and guidance for Nutrition Interventions in Adults with Diabetic Foot Ulcers (DFU) have been welcomed by clinicians internationally. This short report aimed to determine how the macronutrient and micronutrient status of individuals living with DFU compared to the American Limb Preservation Society Nutrition Interventions in Adults with DFU expert consensus and guidance. Descriptive analysis was conducted as a secondary analysis of an existing dataset. Mean (SD) dietary intake, the proportion meeting the nutrition recommendations and the proportion exceeding the upper limit (UL) for specific vitamins and minerals were reported. Most individuals with DFU do not meet current consensus guidelines for optimal dietary intake for wound healing, with inadequacies evident for fibre, zinc, protein, vitamin E and vitamin A. Future iterations of the consensus guideline should consider using evidence-informed recommendations for clinical practice, with the inclusion of all nutrients that are essential for wound healing in DFU.
Busyness as a construct within modern healthcare is complex and multidimensional. To date, few studies have sought to explore how busyness influences family-centred care. This study explored the influence of busyness on the delivery of family-centred care for nurses and parents.
Ethnography was selected as the research design. The study site was a metropolitan tertiary hospital inpatient paediatric unit in Sydney, Australia. Semi-structured interview and non-participant observation techniques were used for data collection. Ten paediatric nurses and 10 parents were interviewed and 40 h of non-participant observations were undertaken. The COREQ was used to report the study.
The findings are presented as three key themes: (i) ‘Supporting family-centred care’ in which participants detail beliefs about the nurse-parent relationships and how despite busyness nurses sought out moments to engage with parents; (ii) ‘Being present at the bedside’ identified the challenges in optimising safety and how parents adapted their way of being and interacting on the unit; and (iii) ‘The emotional cost of busyness’ and how this influenced nurse-parent interactions, care delivery and family-centred care.
The ethnography has given shape to social understandings of busyness, the complexities of paediatric nursing and family-centred care. The culture of care changed in moments of busyness and transformed parent and nursing roles, expectations and collaborative care that at time generated internal emotional conflict and tension.
Given the increasing work demands across health systems, new agile ways of working need to ensure maintenance of a family-centred approach. Strategies need to be developed during periods of busyness to better support collaborative connections and the well-being of paediatric nurses and parents. At an organisational level, fostering a positive workplace culture that shares a vision for family-centred care and collaboration is essential.
Parents of sick children admitted to an acute paediatric inpatient ward were invited to be a participant in a single interview. Parents were aware of the study through ward advertisement and informal discussions with the researchers or senior clinical staff. Engagement with parents was important as healthcare delivery in paediatrics is focused on the delivery of family-centred care. To minimise the risk of child distress and separation anxiety, children were present during the parent interview. Whist children and young people voices were not silenced during the interview process, for this study the parent's voice remained the focus. While important, due to limited resources, parents were not involved in the design analysis or interpretation of the data or in the preparation of this manuscript.
The data that support the findings of this study are available from the corresponding author upon reasonable request.