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Inadequate production of the essential stress hormone, cortisol, results in adrenal insufficiency (AI), which is associated with significant morbidity and mortality. The current standard diagnostic test for AI is the Short Synacthen Test (SST), but this is both invasive and resource-intensive, involving cannulation and blood sampling. A novel formulation, Nasacthin, has been developed in which the same Active Pharmaceutical Ingredient can be delivered intranasally, with the resultant glucocorticoid levels either measured in serum, or in saliva samples to render the test non-invasive, thus creating a potentially more cost-effective test. The Salivary Test of Adrenal Response to Liquid Intranasal Tetracosactide (STARLIT-3) study aims to determine the diagnostic utility of the test in patients with AI.
STARLIT-3 is a randomised 2-way crossover trial which aims to collect data from 32 AI patients allocated to receive both Synacthen and Nasacthin in a random order across two study visits. Paired blood and saliva samples will be collected from participants at baseline, and then at 30 and 60 min after drug administration. Glucocorticoid levels in study samples will be quantified with the aim to determine whether the Nasacthin test is able to correctly diagnose patients with AI by estimating the positive percent agreement with the standard SST using serum cortisol at 30 and 60 min. Data on any reported harms and on the acceptability, usability and tolerability of the Nasacthin test will also be collected.
The study and subsequent amendments have been reviewed and approved by South Central—Hampshire A Research Ethics Committee. Results will be published in peer-reviewed journals and presented at national and international conferences. Plans for dissemination of results to trial participants will be developed in collaboration with patient and public involvement and engagement groups.
Open femoral vessel access is commonly performed in vascular surgery, but surgical site complications (SSCs) occur frequently. The aim of this study is to evaluate the incidence and identify potential risk factors by applying a new standardised definition and grading of various types of groin wound complications. This retrospective analysis includes 201 consecutive patients with 219 vertical groin incisions to expose the femoral vessels for different vascular interventions. A prophylactic drain was placed intraoperatively in almost all incisions (91%). Groin SSCs were defined and graded into four categories according to a modified Clavien-Dindo classification. Potential risk factors were evaluated using univariable analysis. For multivariable analysis, a multiple logistic regression was performed. Cutoff values were determined through ROC analysis. According to the proposed definition, regular postoperative course grade 0 (no SSC) occurred in 163 patients (74.4%), grade 1 (minor SSC) in 10 (4.6%), grade 2 (moderate SSC) in 14 (6.4%), and grade 3/4 (major or life-threatening SSC) in 32 (14.6%) incisions. The incidence of clinically relevant SSCs (grade 2–4) was 21%. Drainage volume was an independent parameter that predicted relevant SSCs with a threshold value of 70 mL/24 h on postoperative day 4 (sensitivity 100%; specificity 67%; AUC = 0.835; p = 0.0004). Groin wound complications following vascular procedures are common. Lymphatic leakage appears to be the most significant, potentially preventable condition associated with relevant SSCs. Prophylactic or early therapeutic interventions should focus on reducing lymphatic morbidity.
by Carmen Villagrasa, Giorgio Baiocco, Zine-El-Abidine Chaoui, Michael Dingfelder, Sébastien Incerti, Pavel Kundrát, Ioanna Kyriakou, Yusuke Matsuya, Takeshi Kai, Alessio Parisi, Yann Perrot, Marcin Pietrzak, Jan Schuemann, Hans Rabus
Biological effects induced by diverse types of ionizing radiation are known to show important variations. Nanodosimetry is suitable for studying the link between these variations and the patterns of radiation interactions within nanometer-scale volumes, using experimental techniques complemented by Monte Carlo track structure (MCTS) simulations. However, predicted nanodosimetric quantities differ among MCTS codes, primarily because each code employs distinct molecular-scale particle interaction models. This multi-code study examines these variations for low-energy electrons (20–10,000 eV), which play a critical role in energy deposition and biological effects by virtually all types of ionizing radiation. Specifically, the hypothesis tested in this work is that inter-code variability in nanodosimetry results is mainly caused by differences in assumptions regarding total interaction cross sections. Ionization cluster size distributions and derived nanodosimetric parameters were simulated with seven MCTS codes (PARTRAC, PHITS-TS, MCwater, PTra, and three Geant4-DNA options) in liquid water as a surrogate for biological tissue. Significant inter-code differences were observed, especially at the lowest energies. They were substantially reduced upon replacing the original cross sections in each code with a common, averaged dataset, created ad-hoc for this study and not based on theoretical assumptions. For example, for 50 eV electrons in 8 nm spheres, the variability in the predicted mean ionization numbers decreased from 23% to 5%, and in the probability of inducing two or more ionizations from 34% to 7% (relative standard deviations). This quantification demonstrates that total interaction cross sections are the primary source of uncertainty at low electron energies. A sensitivity test using DNA damage simulations with the PARTRAC code revealed that cross section variations notably affect biological outcome predictions. Replacing the code’s original cross sections with the averaged ones increased the predicted double-strand break yield by up to 15%. These findings underscore the urgent need for improved characterization of low-energy electron interaction cross sections to reduce uncertainties in MCTS simulations and enhance mechanistic understanding of radiation-induced biological effects.This study aimed to assess construct validity against commonly used patient-reported outcome measures (PROMs), test–retest reliability and responsiveness of seven Dutch-Flemish Patient-Reported Outcomes Measurement Information System (PROMIS) computerised adaptive testing (CATs) in Dutch adults with type 2 diabetes (T2D), and assess their acceptability in healthcare providers and people with T2D.
A cross-sectional observational study in people with T2D and qualitative study involving both people with T2D and healthcare professionals.
Participants with T2D were recruited from the ongoing Hoorn Diabetes Care System cohort in the West-Friesland area of the Netherlands. Additionally, people with T2D and advanced chronic kidney disease were recruited at the outpatient clinics of Amsterdam University Medical Centre and ‘Niercentrum aan de Amstel’, both in the Amsterdam area of the Netherlands. The healthcare professionals involved in the qualitative part were recruited at the Amsterdam University Medical Centre.
314 people with T2D (age 64.0±10.8 years, 63.7% men).
Participants completed seven PROMIS CATs (assessing (1) Physical Function, (2) Pain Interference, (3) Fatigue, (4) Sleep Disturbance, (5) Anxiety, (6) Depression and (7) Ability to Participate in Social Roles and Activities), and PROMs measuring similar constructs. After 2 weeks and 6 months, participants completed the CATs measures again, together with seven Global Rating Scales (GRS) on perceived change in each domain. Construct validity was assessed using Pearson’s correlations. Test–retest reliability was assessed by the intraclass correlation coefficient (ICC). Measurement error was assessed by the standard error of measurement (SEM) and minimal detectable change (MDC). Responsiveness was assessed by correlations between change scores on the PROMIS CAT and GRS. Acceptability was assessed through focus groups and interviews in healthcare providers and people with T2D.
Except for Fatigue, all PROMIS CAT domains demonstrated sufficient construct validity, since ≥75% of the results was in accordance with a priori hypotheses. All seven PROMIS CATs showed sufficient test–retest reliability (ICCs 0.73–0.91). SEM and MDC ranged from 2.1 to 2.7 and from 5.7 to 7.4, respectively. Responsiveness was rated as insufficient in this study design as there was almost no change in participants’ own rating of their health compared with 6 months ago according to a global rating of change.
During the focus groups and interviews, healthcare providers and people with T2D agreed that CATs could serve as a conversation starter in routine care, but should never replace personal consultations with a doctor. If implemented, participants would be willing to spend 15 min to complete the PROMIS CATs.
The PROMIS CATs showed sufficient construct validity and test–retest reliability in most domains in people with T2D. Responsiveness needs to be evaluated in a population with poorer diabetes control or in a study design with longer follow-up. The CATs are well accepted to be used in care to identify relevant topics, but should not replace personal contact with the doctor.
To identify and synthesise nursing interventions directed at family caregivers of patients with end-stage renal disease undergoing haemodialysis.
A convergent-integrated mixed-methods systematic review.
A comprehensive search was conducted in EBSCOHost databases (Academic Search Complete, CINAHL Complete, MEDLINE with Full Text, MedicLatina, ERIC) and the PubMed database. Studies were appraised using the Mixed-Methods Appraisal Tool (MMAT), and interventions were classified using the Cochrane Effective Practice and Organisation of Care taxonomy.
Quantitative data were narratively synthesised and transformed into textual descriptions to enable integration with qualitative findings. A thematic synthesis was conducted to group similar concepts.
Twenty-three studies met the inclusion criteria. Most were quantitative or mixed methods with moderate-to-high methodological quality. Interventions were primarily classified as disease management (n = 10) or self-management support (n = 9). Common components included education, coping strategies, empowerment, and psychosocial support. Positive effects were observed on caregiver quality of life, anxiety, depression, and self-efficacy. Caregiver burden outcomes were mixed, potentially influenced by time and intervention intensity. Additional benefits were noted from relaxation techniques and intradialytic exercise. Qualitative data revealed culturally embedded coping strategies such as spiritual practices, time management and seeking social support.
Educational and empowerment-based nursing interventions—particularly those supporting dyadic coping and family-centred care—can improve caregiver outcomes. Frameworks such as the Roy Adaptation Model and the ‘Timing it Right’ approach enhance intervention design and relevance.
By addressing caregiver needs through structured education, psychosocial support and contextually sensitive approaches, nurses can mitigate caregiver burden and promote long-term caregiver well-being and patient adherence to treatment.
Although patients and caregivers were not directly involved, this review contributes to improving nursing care for family caregivers of individuals with ESRD, aiming to enhance their quality of life.
Commentary on: Douglas C, Alexeev S, Middleton S, Gardner G, Kelly P, McInnes E, et al. Transforming nursing assessment in acute hospitals: A cluster randomised controlled trial of an evidence-based nursing core assessment (the ENCORE trial). International Journal of Nursing Studies. 2024. 2024;151:104690.
Implications for practice and research Introducing training to enhance manual nursing assessment and surveillance has the potential to improve outcomes for hospitalised patients with multimorbidity. Further research is needed to establish which aspects of nursing assessment and surveillance are essential to improving recognition and response to clinical deterioration.
Failure to identify and respond to deteriorating patients is a significant and complex clinical safety issue. There is a growing body of international research evidence which has identified the importance of system and human factors in ‘failure to rescue’ events.
Commentary on: Drennan J, Murphey A, McCarthy VJC, Ball J, Duffield C, Crouch R, Kelly G, Loughnane C, Murphey A, Hegarty J, Brady N, Scott A & Griffiths P. The association between nurse staffing and quality of care in emergency departments: A systematic review. Int J Nurs Stud 2024 153, 104 706.
Implications for practice and research Healthcare leaders should place high importance on ensuring adequate levels of nursing staff in emergency departments to reduce serious adverse outcomes. Further research is needed to ascertain safe nurse staffing levels in emergency departments.
There is a substantial body of international evidence, which demonstrates that inadequate nurse staffing is associated with increased mortality and poor patient outcomes in medical and surgical settings.
To explore the feasibility and acceptability of pain management (transcutaneous electrical nerve stimulation (TENS)) and patient education (PE) to increase physical activity in people with peripheral arterial disease and intermittent claudication (IC).
Feasibility randomised controlled trial with embedded process evaluation.
One secondary care UK vascular centre.
56 community-dwelling adults with a history of stable IC and ankle-brachial pressure index ≤0.9 were recruited via claudication clinics.
Participants randomised to 6 weeks of: TENS+PE, TENS, Placebo TENS+PE or Placebo TENS. PE was a 3-hour workshop plus three follow-up phone calls. The TENS machine was worn during walking (TENS: 120 Hz, 200 μs, intensity ‘strong but comfortable’; Placebo TENS: intensity below sensation threshold).
Primary feasibility outcomes included rates of recruitment, retention and adherence. Acceptability of the intervention and trial procedures was explored with semistructured interviews. Measures of walking capacity, walking behaviour, quality of life, disease perception and pain were recorded at baseline, end of intervention (6 weeks) and follow-up (3 months).
56 participants were randomised from 95 who completed baseline screening. Of the 39 excluded, 97% (38/39) had >20% variability in absolute claudication distance. All participants received their allocated intervention. Outcome completion was 91% at 6 weeks and 80% at 3 months. Attendance at group education was 96% with 63% taking follow-up phone calls. Compliance with TENS was 70% according to participant-completed logs. Interviewed participants (n=9) were generally positive about the acceptability of the interventions and trial procedures; however, experience of TENS use was mixed. Some participants were dissatisfied with the size of the device and electrode wires.
The PrEPAID (Pain management and Patient Education for Physical Activity in Intermittent claudication) trial was feasible to run; however, 40% of potential participants were excluded at screening due to issues of research fidelity rather than participant suitability or willingness to participate. A future definitive trial should consider a revised primary outcome measure and smaller wireless TENS machines.
ClinicalTrials.gov, NCT03204825. Registered on 2 July 2017.
Chief Scientist Office, Scottish Government. Translational grant award (TCS/16/55).
Commentary on: Roussel M, Teissandier D, Yordanov Y, et al. Overnight stay in the emergency department and mortality in older patients. JAMA Intern Med. 2023 Dec 1;183(12):1378-1385.
Healthcare leaders should place high importance on organisational solutions to prioritise the admission of older patients from emergency departments (EDs) to wards to reduce risks associated with overnight stays. Further evidence is needed to understand if increased risks to older patients in ED also occur at other times and to establish the most effective interventions to mitigate risks.
Crowding and access block in emergency departments (EDs) are pervasive problems of international concern.
FreshRSS 