Conectar
Cystic fibrosis (CF) is a genetic condition of impaired membrane electrolyte transport and is characterised by defects in the production and function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein. Ground-breaking CFTR modulator therapy has resulted in a notable shift in the clinical presentation and progressive nature of CF, across both pulmonary and extrapulmonary systems. Access to CFTR modulator therapies in people with CF is occurring in a staged, descending age process, with clinical trials focusing primarily on safety and efficacy. There is a lack of robust, real-world longitudinal data on CFTR modulator therapy in infants and young children where extrapulmonary outcomes such as growth, micronutrient status and pancreatic function are the key focus.
Pancreatic, nutritional and clinical outcomes in children 0–5 years with CF during the first 2 years of CFTR modulator therapy (PaNC) is a prospective cohort study involving all eight tertiary paediatric CF centres in Australia. Infants and children 4 months to 5 years of age who are eligible for elexacaftor/tezacaftor/ivacaftor (ETI) or ivacaftor (IVA) meet the inclusion criteria for PaNC, with a total eligible cohort of 303 children at the commencement of recruitment. The primary outcomes are change in weight-for-length/body mass index z score and change in serum micronutrient status, at 6–12 monthly intervals, during the first 2 years of treatment with ETI or IVA. Secondary outcomes include change in exocrine pancreatic function, measured by faecal elastase-1, change in the use and dose of pancreatic enzyme replacement therapy, nutritional and gastrointestinal therapies and change in sweat chloride levels. Linear mixed modelling will be used to analyse primary and secondary endpoints. This protocol is reported in accordance with ‘The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement’ reporting guidelines.
Overarching governance and ethics approval has been granted by Monash Health Human Research Ethics Committee, in addition to all eight sites receiving site-specific authorisation approvals prior to the commencement of recruitment. Opportunities for CF consumers to be involved in targeted dissemination plans will be initiated via CF Australia at the completion of the study period. Additionally, a summary of non-identifiable results will be provided to CF consumers and CF healthcare providers via scientific and lay conferences and via peer-reviewed journals.
ACTRN12624001185550; Pre-results.
Venous thromboembolism (VTE) occurs when a blood clot forms in a vein. It is comprised of deep vein thrombosis (DVT) and pulmonary embolism and can be potentially life-threatening. Patients undergoing surgery are at increased risk of developing VTE within hospital admission and 90 days after hospital discharge are collectively known as hospital-acquired thrombosis (HAT). Without the use of thromboprophylaxis, the untreated risk of VTE is reported to be as high as 40–60% in those undergoing major orthopaedic procedures and around 15–40% in the general surgical population.
HAT accounts for around 12 000 deaths per year in the UK. For patients undergoing surgery, there is good evidence for the use of thromboprophylaxis to prevent VTE.
Thromboprophylaxis is available in both pharmacological and mechanical forms. While there is a huge body of evidence demonstrating that pharmacological thromboprophylaxis significantly reduces VTE by 30–65%, the benefit of graduated compression stockings (GCS) has been called into question. The GRACE study (Graduated Compression stocking as an adjunct to Extended duration pharmacological thromboprophylaxis for venous thromboembolism prevention) aims to evaluate the adjuvant benefit of GCS in addition to extended duration pharmacological thromboprophylaxis (EDPTP) for elective surgical patients at highest risk of VTE.
GRACE is a pragmatic, multicentre randomised trial of adults undergoing surgery who are at high risk of VTE. Participants are randomised into a 1:1 ratio to either EDPTP and compression stockings (control arm) or EDPTP (intervention arm). Following randomisation, participants will undergo surgery and be followed up centrally at 7, 21–35 and 90 days after their procedure. All participants will be offered a bilateral full lower limb duplex scan at 21–35 days post procedure to capture any asymptomatic DVT.
The trial aims to randomise 8608 participants from around 50 National Health Service (NHS) and non-NHS sites in the UK over a 24-month period. The primary endpoint is any imaging-confirmed incidence of VTE within 90 days of surgery.
On 20 December 2023, GRACE received favourable ethical approval from the Wales Research Ethics Committee 3 Cardiff (23/WA/0350) and the Health Research Authority (IRAS 333539). The results of the study will be disseminated via peer-reviewed publications, presentation at national and international conferences and to study participants via electronic newsletter and social media channels.
This observational cohort study explored lymphoedema development following a cancer diagnosis and whether demographic factors impacted the time to lymphoedema development. We identified cases through the Secure Anonymised Information Linkage (SAIL) Databank. We used cancer diagnostic codes to identify a cohort of six broad cancer ‘types’. We independently used lymphoedema diagnostic codes to identify a cohort who developed lymphoedema. We linked these two cohorts to develop a single cohort of cases and describe the number of cases who went on to develop lymphoedema after a cancer diagnosis, and the time to lymphoedema diagnosis. We used Cox regression models to calculate hazard ratios and produced survival curves to explore whether pre-defined factors (gender, age, deprivation, cancer type) had any impact on time to lymphoedema development. We identified 7538 cases of lymphoedema development after a cancer diagnosis, relating to 7279 people. There was considerable variation in the time to diagnosis, with a mean and standard deviation of 483.3 (701.8) days. Cancer type was the single most important factor in explaining time to lymphoedema diagnosis. Time to lymphoedema was shortest in breast cancer. A large number of breast cancer cases have undergone surgery, and this may account for the earlier development of lymphoedema. Consideration should be made of risk factors for lymphoedema development in order to allow for more targeted treatment plans that could improve health-related quality of life for patients.
Simulation offers a feasible modality to prepare nurses for challenges communicating with patients with dementia. Elderspeak communication is speech that sounds like baby talk and can lead to rejection of care by patients with dementia. However, it is unknown if simulation can be used to capture elderspeak communication in dementia care. The purpose of this mixed-methods study was to determine if simulation accurately captures elderspeak communication by nursing staff in hospital dementia care.
A 3-part mixed-methods design in which (1) three dementia care simulations were designed and validated by a panel of experts, (2) communication by nursing staff completing each simulation was quantitatively compared to communication during actual patient care, and (3) views on the realism were explored using within- and across-case coding.
Three simulations using different modalities (manikin, role-play, and standardised patient) were designed and validated with eight experts using the Lynn Method. Ten nursing staff were audio-recorded and their communication was coded for elderspeak communication. Results for each simulation were compared using Wilcoxon signed-rank test to recordings taken during actual dementia care encounters. Debriefings were coded for realism and results were converged.
The average time using elderspeak during naturalistic care was 29.9% (SD = 20.9%) which did not differ from the average amount of elderspeak used across the three simulations modalities which ranged from 29.1% to 30.4%. Qualitative results suggested a lack of realism with the manikin condition and the nursing staff indicated preference for the simulation with the standardised patient.
Communication elicited in the dementia care simulations was congruent to communication produced in actual dementia care but preference was for the standardised patient.
Elderspeak communication can be accurately produced in the simulated environment which indicates that simulation is a valid method for person-centred communication training in nursing staff.
Simulation offers a feasible modality to prepare nurses for challenges communicating with patients with dementia. Elderspeak communication is speech that sounds like baby talk and can lead to rejection of care by patients with dementia. However, it is unknown if simulation can be used to capture elderspeak communication in dementia care. Elderspeak communication captured in the simulated environment was congruent to communication nursing staff use during actual patient care to hospitalised persons living with dementia. This study empirically identifies that communication is elicited in similar patterns by nursing staff in the simulated environment compared to the naturalistic care environment which demonstrates that simulation can be used as a valid tool for education and research on person-centred communication.
STROBE.
No Patient or Public Contribution.
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