Conectar
To report on the unique perspectives of senior nursing leaders on the value proposition of the Clinical Nurse Specialist (CNS) role, their organisational experience and the barriers and facilitators to optimise and promote the long-term sustainability.
A qualitative sub-study of a larger multi-method study focused on informing policy recommendations to optimise the CNS workforce, informed by integrated knowledge translation.
Chief Nursing Officers (CNOs) and other senior leaders in all health authorities in British Columbia, Canada, were invited to participate in semi-structured interviews via video call between August–December 2023. We recruited 13 participants from diverse health regions, including 5 CNOs.
Leaders collectively conveyed a renewed interest in the CNS role to support nursing and multidisciplinary teams to better meet patient and system needs, and a sense of urgency to optimise the role in diverse settings. The overarching theme of “success by design” was supported by three thematic priorities: (1) understanding the CNS role, (2) a role that needs protection and connections and (3) moving forward together. Views were aligned to co-construct implementation-ready policy recommendations to guide provincial strategies.
Senior leaders reported a common understanding of the value-add of the CNS workforce and had a shared experience of barriers to optimisation. Contemporary policy guidance is needed to equip health systems to address this gap.
Across international regions, the role of CNSs is not fully optimised. This is a wasted opportunity to address the pressing need for nursing practice leaders to transform health systems and improve outcomes. This study provides new knowledge about the perspectives of Chief Nursing Officers and other nursing leaders to shape comprehensive and targeted policy recommendations and address enduring and new challenges to realise the full impact of the CNS workforce.
We have adhered to COREQ reporting guidelines (See supplemental file).
This study did not include patient or public involvement in its design, conduct, or reporting.
To examine whether self-reported thriving at work is associated with biomarkers of stress, inflammation, neuroplasticity and neurodegeneration in nurses.
A cross-sectional study.
An online questionnaire measuring thriving at work was administered to nurses in a teaching hospital in Michigan, U.S. over 5 weeks in 2024. A subsample of 100 questionnaire respondents provided blood samples for biomarker analysis. Multiple regression was used to identify self-reported and biomarker predictors of nurse thriving. Cluster analysis was used to distinguish between nurses with high and low levels of thriving based on a combination of self-report and biomarker data.
Higher self-reports of individual and work-related resources predicted higher thriving. Cortisol, a stress hormone, was significantly and inversely associated with thriving. No blood-based biomarkers of inflammation or neuroplasticity predicted thriving. Neurofilament light chain, a marker of neurodegeneration, was not a direct predictor but modified the effects of interpersonal and work resources on thriving.
Biological markers do play a role in nurses' thriving at work and may contribute important complementary information to that provided by nurse self-reports.
Nurses thrive in a work situation characterised by positive reports of individual, interpersonal and work resources and lower levels of stress. Efforts to enhance thriving could positively impact nurses' well-being and conditions for providing high-quality patient care.
This study addressed the question of whether self-reported thriving at work among nurses is reflected in biomarkers of stress, inflammation, and neurocognitive health. A profile of high self-reported work-related resources and low cortisol distinguished higher levels of nurses' thriving from lower levels. Organisational efforts to enhance nurses' thriving can positively impact nurses' health, their work environment, and patient care.
We followed the STROBE checklist in reporting this study.
No Patient or public contribution.
Glaucoma is one of the leading causes of irreversible blindness and is characterised by progressive loss of retinal ganglion cells. While therapies to lower intraocular pressure slow the progression of the disease in most patients, a significant subset still shows progression despite treatment. Transcorneal electrical stimulation (TES) may potentially activate neuroprotective pathways and slow the progression of visual field defects. The OkuStim 2 System is a medical device for TES which was originally developed for the treatment of retinitis pigmentosa and similar retinal dystrophies and shall now be tested for the treatment of glaucoma. Stimulation of the diseased retina with weak currents can activate signalling pathways and the release of substances that have a protective effect on the retinal cells. This neuroprotective effect might preserve physiological functions of the retina for longer and slow down its gradual degeneration. Long-term use is required to maintain this effect. The TES-GPS study is investigating the safety and efficacy of TES in open-angle glaucoma.
TES-GPS (short title for glaucoma pilot study) is a prospective, randomised, double-blind, sham-controlled, single-centre pilot study at the University Medical Center Mainz. 50 patients with progressive visual field loss due to open-angle glaucoma will be randomised 1:1 to receive either TES with the OkuStim 2 System or sham stimulation. The primary endpoint is the change in visual field sensitivity (Humphrey mean deviation) after 18 months. Secondary endpoints include changes in visual acuity, intraocular pressure, optical coherence tomography (OCT) parameters and quality of life (National Eye Institute Visual Function Questionnaire 25, NEI-VFQ 25). The intervention consists of weekly 30 min TES sessions, which are conducted in the patient’s home after initial training in the clinic. The study comprises up to 13 scheduled visits over 18 months.
The study is conducted in accordance with ISO14155, Medical Device Regulation (EU) 2017/745, International Council for Harmonisation Good Clinical Practice and the Declaration of Helsinki. Approval was obtained from the Ethics Committee of the Landesaerztekammer Rheinland-Pfalz in Mainz and from Bundesinstitut fuer Arzneimittel und Medizinprodukte. Results will be published in peer-reviewed journals and presented at scientific conferences.
Within the UK there are 33 deaths every day from prostate cancer, second only to lung cancer as the most common cause of cancer death in males in the UK. Of the 55 000 new cases each year, up to 50% of these patients will receive radiotherapy either alone or after prostatectomy. Although there have been significant improvements in the accuracy of radiotherapy delivery leading to better tumour targeting and a reduction in dose to normal tissues, significant permanent genito-urinary or gastrointestinal-related side effects are all too common. With nearly 80% of patients with prostate cancer surviving for 10 years or more, minimising life-limiting radiation damage to normal tissues is vitally important. However, at present, it is not possible to identify which patients will suffer a poorer outcome after radiotherapy. The aim of this study, improving radiotherapy in PROState cancer using EleCtronic population-based healthCAre data (PROSECCA), is to do this by using the existing information in a patient’s digital healthcare record. By linking primary, secondary and tertiary clinical data, including digital image information, with radiotherapy treatment plans and outcome data, the PROSECCA study will identify de novo predictive biomarkers of radiation response and provide clinicians with a tool to individualise a radiotherapy dose and plan to maximise cure and minimise toxicity.
The PROSECCA study is a large multidisciplinary project, the purpose of which is to analyse healthcare records from up to 15 000 patients with prostate cancer who underwent radiotherapy in the treatment of their cancer in Scotland between 2010 and 2022. Through the linkage of data obtained specifically for radiotherapy and data held within each patient’s unique electronic health record (EHR), the factors that indicate why some patients have a poor response to treatment, or an increased risk of side effects from radiation, will be identified. This will be made possible by the use of artificial intelligence and machine learning (AL/ML), which will help to identify at-risk patients earlier and allow adaptation of their treatment accordingly.
The study is being conducted in accordance with the ethical principles set out in the Declaration of Helsinki and Good Clinical Practice that respects and protects the rights, and maintains confidentiality, of all trial participants. The study protocol (V.1.0) was reviewed by the South Central Oxford A Research Ethics Committee (REC) on 13 December 2021 and received a favourable opinion subject to each National Health Service (NHS) organisation confirming permission for patients treated within their area. Approval for the use of unconsented healthcare record data for patients included in the study and treated at one of the five Scottish Cancer Centres required an application to the NHS Scotland Public Benefit and Privacy Panel for Health and Social Care (HSC-PBPP). Full approval from the HSC-PBPP panel was received on 1 July 2024, which covered the use of pseudoanonymised EHR data for all patients participating in the study. The study is publicly listed on the NHS Health Research Authority site, with IRAS ID 306245 and REC reference 21/SC/0402. Dissemination of the study findings will take place through field-leading cancer, radiation oncology and medical physics journals. All manuscripts will be approved by the main study team and authorship determined by mutual agreement.
The Cancer Behaviour Inventory–Brief Version was designed to assess cancer-coping self-efficacy in clinical and research settings where minimising patient burden is essential. However, there is no evidence of its longitudinal validity. Although widely used in cancer research, the lack of evidence for longitudinal invariance significantly undermines its validity in studies spanning multiple time points. Establishing longitudinal invariance enables valid comparisons over time, enhancing our confidence in applying it in longitudinal research.
To examine the factor structure of the measurement and test its longitudinal invariance across four time points in cancer patients experiencing moderate-to-high symptoms during curative cancer treatment.
A longitudinal psychometric evaluation.
This is a secondary data analysis of a randomised controlled trial in patients with moderate-to-high symptoms undergoing cancer treatment (N = 534). We conducted longitudinal invariance tests for the measurement using four time points. Other psychometric tests included confirmatory factor analysis, reliability analyses and correlations.
Our confirmatory factor analysis supported the four-factor, 12-item structure for the Cancer Behaviour Inventory–Brief Version. Items 1 and 6 were found to be moderately correlated. The resulting 12-item measure demonstrated good internal consistency, with convergent and divergent validity supported by correlations with selected instruments. Finally, longitudinal invariance was tested, which revealed strict measurement invariance across four time points (CFI = 0.930, RMSEA = 0.045, SRMA = 0.056).
We found that the factor structure of the Cancer Behaviour Inventory–Brief Version remained stable over four time points in a sample of patients having moderate to high symptoms under cancer treatment. This supports its accountability for examining the changes in cancer-coping self-efficacy among cancer patients over time in longitudinal studies.
This study confirms that Cancer Behaviour Inventory–Brief Version has adequate internal consistency and demonstrated evidence of construct validity. Our conclusion of strict longitudinal invariance supports its credibility for continuous assessment of cancer-coping self-efficacy to evaluate patient outcomes and intervention processes over time in clinical and research settings.
No patient or public contribution.
Quality improvement is a well-known and commonly utilized approach to improving care and outcomes that is built on process improvement methods but not practice improvement methods. Because quality care includes both process and practice elements, process improvement alone cannot ensure quality outcomes will be achieved. This calls for a new approach.
To share an innovative, synergistic, and collaborative quality framework: Evidence-based Quality in Practice and Process: The EQUiPP Framework.
The EQUiPP Framework's intent is to provide structure for collaborative efforts to effectively identify best practices/processes, implement and sustain change, and improve outcomes. The framework provides guidance to decrease the frequency of implementing ineffective changes by deriving effective solutions … the first time, every time.
A team of experts used a consensus approach to develop the framework.
A precursor to this framework, the Practice and Process Improvement = Quality (PPQ) Model, was evaluated by individual expert review and a two-day beta test workshop. Feedback was obtained during the workshop when participants applied the model in activities reflecting real-world healthcare scenarios. When used in both DNP student work and real-world health systems, fundamental flaws were identified which resulted in the necessity to develop a different conceptualization. The framework described here is a new approach to improving quality care.
The EQUiPP Framework is a tool that provides the synergistic integration of both practice improvement (EBP) and process improvement methodologies to successfully implement and sustain best practices to achieve and sustain quality outcomes.
The EQUiPP Framework aligns EBP and process improvement, allowing clinicians and students to work collaboratively to identify and effectively, as well as efficiently, implement and sustain best practices to deliver quality outcomes.
Patient participation improves patient outcomes, but factors that predict participation in pressure injury prevention (PIP) are relatively unknown. This study aimed to identify patient-related factors predictive of patient participation in pressure injury prevention (PPPIP) in hospitalised medical and surgical patients and to assess the psychometric properties of the PPPIP scale. This observational substudy recruited consenting adults at risk of pressure who participated in a parent trial. The seven-item PPPIP scale was administered within 48 h of recruitment, with higher scores reflecting more participation. Multiple regression was used to identify patient-related factors predictive of patient participation. The scale's psychometric properties were assessed using confirmatory factor analysis and Cronbach's alpha. In total, usable data were obtained from 856 patients. Mean PPPIP scale scores were relatively high, with 571 (66.7%) scores reflecting agreement or strong agreement. The Cronbach's alpha was 0.81, and most confirmatory factor analysis criteria for construct validity were met. Only the use of mobility aids was statistically significant in the model, but it predicted a small amount of variability in PPPIP score (adjusted R 2 = 0.017; p < 0.001). Targeting patients with limited mobility may be a useful strategy when trying to engage patients in PIP if resources are limited.
Major haemorrhage is the leading cause of preventable death in trauma, and prehospital blood transfusion may improve survival and outcomes for patients with prolonged out-of-hospital times. Globally, there is increasing interest in the use of whole blood in the prehospital environment, with randomised controlled trials ongoing. However, the results of these studies may not be generalisable to the longer out-of-hospital times seen in the Canadian trauma environment. The aim of this trial is to determine the feasibility of performing a randomised clinical trial evaluating the use of leukocyte-reduced whole blood transfusion compared with component blood transfusion in the Canadian prehospital environment. The secondary objective is to explore whether whole blood transfusion is better in reducing the proportion of patients who die or require massive transfusion within 24 hours.
This is a multi-centre, open-label, randomised controlled feasibility trial. Patients aged 16 years or older will be eligible if they have suffered a major traumatic haemorrhage, are attended by the provincial air ambulance service and require a prehospital blood transfusion. The primary outcome is feasibility as measured by the following metrics: proportion of patients enrolled with full data collection, proportion of patients who received at least one prehospital transfusion prior to arriving at the receiving trauma centre, proportion of patients who completed transfusion of all assigned blood units, number of patients unable to be enrolled due to lack of whole blood availability and number of whole blood units produced for the study that were wasted or expired. The secondary outcome is a composite outcome of death (all-cause mortality) or receipt of massive transfusion (receipt of 10 units of blood or more) within the first 24 hours from randomisation. We plan to recruit 60 patients, with an anticipated post-randomisation exclusion of ~10 patients for traumatic cardiac arrest or who do not meet eligibility criteria.
Provincial ethics approval was obtained (Clinical Trials Ontario REB ID: CTO-4921). An opt-out consent model will be employed for participants. The SWiFT Canada trial will recruit 60 patients through the provincial air ambulance organisation in Ontario who are transported to one of the six participating lead trauma centres. It will investigate the feasibility of a pre-hospital transfusion clinical trial in Canada to compare the effectiveness of whole blood compared with component blood therapy in a future definitive trial.
ClinicalTrials.gov: NCT06495294 (
To evaluate nurses' perspectives on factors influencing the acceptability and practicality of comfort rounding, focussing on personalised nutritional and mobility care.
Mixed-methods feasibility study.
Focus group interviews with nurses were conducted before, during and at the end of the implementation period (2022–2023). A questionnaire assessed acceptability and practicality among nurses at the end of the implementation. Data were analysed using directed content analyses and descriptive statistics.
Comfort rounding's acceptability and practicality were influenced by nurses' attitudes, knowledge and skills, patient characteristics and the nurse–patient relationship. Barriers included workload, time pressure, team culture and the extensive, rigid design of comfort rounding. Questionnaire responses demonstrated nurses perceived added value of comfort rounding and frequently engaged patients in activities related to nutrition and mobility. However, it was not performed as originally intended.
Nurses considered personalised nutritional and mobility care important and frequently provided it during ‘usual care’. However, nurses were critical of comfort rounding's acceptability and practicality and did not perform it as intended.
Comfort rounding's concept does not align well with current nursing practice. Greater tailoring to nurses' preferences or alternative approaches to structuring personalised nutritional and mobility care are recommended.
What problem did the study address: Hospitalised patients often receive suboptimal nutritional care and are largely inactive. The challenge is to integrate personalised nutritional and mobility care effectively into standard nursing practice to enhance patient safety and well-being. Comfort rounding could improve patient safety and satisfaction; however, there is no research evaluating the feasibility of comfort rounding in relation to personalised nutritional and mobility care. What were the main findings: Comfort rounding was generally perceived as valuable and aligned with existing care routines, but its rigid structure was often considered impractical. Comfort rounding was not performed as originally intended due to the influence of individual, social and organisational factors. Flexibility in execution emerged as a critical factor for successful integration. Where and on whom will the research have an impact?: Comfort rounding can enhance attention to nutrition, mobility and patient participation when adapted to local contexts and delivered with flexibility. Policymakers and nurse leaders should avoid rigid protocols and instead support tailored implementation strategies alongside the practical delivery of locally tailored interventions.
Consolidated criteria for reporting qualitative research and Checklist for Reporting of Survey studies.
Nurses were involved in all stages of the study, contributing through focus group interviews and completing a questionnaire to help develop and evaluate comfort rounding.
PaNaMa Research Management System, number 112832
The role of the interprofessional evidence-based practice (EBP) mentor is critical to integrate best practices into healthcare and academic environments to improve outcomes and reduce costs for patients, families, providers, students, and faculty. This study aimed to validate the knowledge, skills, and attitudes/beliefs (KSAs) needed for the EBP mentor. This role delineation study (RDS) assessed knowledge about the EBP mentor role and tasks as related to the steps and competencies of EBP.
Interprofessional EBP experts participated in an advisory panel. Focus groups were conducted with the advisory panel members to identify the KSAs needed for expert EBP mentors. The steps of EBP were broken into 11 domains to align with the processes and strategies needed for EBP methodology. The focus group data were analyzed to identify the KSAs for each domain. A role delineation survey was developed. Interprofessional experts were invited to complete the survey to validate the KSAs needed for the EBP mentor role. The online survey included demographic information and 11 sections that aligned with the steps of EBP and the 107 KSA items needing to be validated.
A total of 251 interprofessional EBP experts completed the survey (232 nurses, 19 interprofessionals). Healthcare providers comprised 82.5% of the sample, academic/researchers 15.5%, and “worked in both settings” 2%. The results reported strong inter-rater reliability (ranging from 0.836 to 0.955) and strong validity for each of the 11 domains and KSAs.
Findings from this study support the EBP mentor role and will guide interprofessional EBP education and EBP mentor positions in healthcare systems. The study showed that the tasks of the EBP mentor were consistent across settings, educational degrees, and professional roles. Validity for the tasks/role for an interprofessional Evidence-based Practice Certification was clear and outlined expectations for the EBP mentor role.
Military personnel are a unique population with heightened vulnerability to sexually transmitted infections (STIs), often exhibiting higher prevalence rates than civilians due to demographic, environmental and occupational factors. These vulnerabilities underscore the need for global prevalence estimates to guide effective, evidence-based interventions. This study aims to quantify the global burden of STIs among military personnel, providing a comprehensive and up-to-date assessment.
This systematic review will follow the Preferred Reporting Items for Systematic Review and Meta-Analysis Guidelines (2020). Using the CoCoPop (Condition, Context, and Population) framework, a comprehensive search strategy will be conducted in MEDLINE, Embase, Global Health and Scopus to retrieve peer-reviewed records published between January 2010 and June 2025. Eligible studies will report numerical STI prevalence data among military personnel. Studies with insufficient information to calculate prevalence or those relying on self-reported STI data will be excluded. Data extraction will include study details, military descriptors, STI prevalence and diagnostic methods. Risk of bias will be assessed using the Joanna Briggs Institute critical assessment tool for prevalence and incidence studies. Prevalence estimates with 95% CIs will be reported for each STI and, where appropriate, pooled for curable STIs. Subgroup analyses will stratify prevalence by geographic region, service status, deployment status and socioeconomic factors. Heterogeneity will be evaluated within predefined subgroups using the I² statistic. Data will be presented in comprehensive tables and visualised with graphical tools, including forest plots for subgroup analyses and pooled estimates.
Ethical approval is not required for this review. The results will be disseminated through a peer-reviewed publication and conference presentations.
CRD42023472113.
The Cohort of Health-Related Outcomes in Chronic Illness Care in General Practice was established using data collected as part of a cluster-randomised trial. This aims to support the trial’s follow-up and enable further examination of the interplay between chronic disease, multimorbidity (MM), polypharmacy (PP) and quality of life (QoL) in a Danish general practice setting.
The cohort comprises 35 977 adult patients from 250 general practices participating in a cluster-randomised trial and had a response rate of 22.4%. Participants were either registered as chronic care patients or had attended an annual chronic disease consultation. They completed a comprehensive questionnaire on self-reported chronic conditions, medication use, QoL, treatment burden and patient-centred care. Additionally, 431 general practitioners (GPs) from the participating practices completed a questionnaire about managing patients with complex MM.
Among participants, 51.9% were female, the mean age was 65.6 (SD 12.9) years, 93.1% had education beyond basic schooling, and half were retired. Conditions from more than one organ system-based disease group were reported by 82.2%, and 94.6% used one or more prescription medications. The main challenges reported by the participating GPs in managing patients with complex MM were keeping time and obtaining an overview of the patient’s health status.
Cohort data will be linked with Danish registries to improve the detection and treatment of chronic conditions and PP in general practice.
The cluster randomised trial (MM600) is registered with ClinicalTrials.gov ID: NCT05676541.
Data quality in epidemiological studies is a basic requirement for good scientific research. The aim of this study was to examine an important indicator of data quality, data completeness, by investigating predictors of missing data.
Baseline data of a cohort study, the population-based Hamburg City Health Study, were used. Missingness was investigated at the levels of a whole research unit, on the two segments of health service utilisation and psychosocial variables, and two sensitive items (income and number of sexual partners). Predictors for missingness were sociodemographic variables, cognitive abilities and the mode of data collection. Associations were estimated using binary and multinomial logistic regression models.
Of 10 000 participants (mean age=62.4 years; 51.1% women), 32.9% had complete data at the unit level, 66.8% had partially missing data and 0.3% missed all items. The highest proportions of missing values were found for income (27.8%) and the number of sexual partners (36.7%). At both the unit, segment and item level, older age, female sex, low education, a foreign mother language and cognitive impairment were significant predictors for missingness.
For analysing population-based data, dealing with missingness is equally important at all levels of analysis. During the design and conduct of the study, the identified groups may be targeted to reach higher levels of data completeness.
Preventable hospital patient harm events disproportionally affect certain patient populations. For some, harm extends beyond physical injury to include cultural, emotional or spiritual impacts. While these disparities are linked to socio-demographics (eg, race, education), they are driven by structural factors (eg, procedures and policies). Patient safety monitoring systems (eg, incident reporting, patient concerns) were not originally designed to identify equity-related harms and may inadvertently obscure or reinforce the injustices they should address. This study will examine how equity is currently considered within hospital incident reporting and patient concerns systems across Canada and will identify opportunities to strengthen these systems’ responsiveness to inequities in patient safety.
This 3-year exploratory sequential mixed-method study began in September 2024. Phase one involves qualitative interviews with patient safety and equity leads, patients/families/caregivers and leaders of innovative initiatives to explore current practices, gaps and innovations in how equity-related factors are identified and addressed within incident reporting and patient concerns systems. Findings will inform Phase 2, a modified Delphi process with patient safety and equity experts and persons with lived experience of equity-related harm events to refine and reach consensus on key equity-promoting features, considerations and recommendations for these systems. In Phase 3, consensus items will be used to develop a national cross-sectional survey assessing the extent to which equity is integrated into hospital incident reporting and patient concerns systems in Canada. A patient advisory committee will inform data collection, interpretation of findings and dissemination.
Ethics approval has been received for Phase 1, with subsequent approvals to be sought for later phases. Dissemination plans include peer-reviewed publications, presentations at international conferences and knowledge exchange activities to inform patient engagement, the design of incident reporting and patient concerns systems and policy development.
There is only a little research on anticipated stigma in the general population, despite evidence of negative consequences with regard to underutilisation of medical testing or treatment. While a lot of instruments focus on the interpersonal dimension of public stigma (i.e., societal attitudes), fewer assess the intrapersonal dimension of anticipated stigma, a belief that stigmatising attitudes will be directed at the self in the future. The objective of this study was to test the applicability and the psychometric properties of an anticipated stigma scale in a population survey on beliefs about irritable bowel syndrome (IBS).
Analyses are based on telephone interviews in a random population sample of 1205 adult individuals in Germany. They were presented with a vignette describing a person with symptoms suggestive of IBS, followed by 10 items assessing anticipated stigma based on a modified version of the Perceived Stigma Scale of IBS.
Results indicate that individuals expected others not to have enough knowledge about symptoms and may ascribe their aetiology to personal behaviour. A first exploratory factor analysis (EFA) yielded two factors. Examination of scree plot and content considerations justified a second EFA specifying a one-factorial solution with Cronbach’s α of 0.80 and satisfactory discriminatory power and mean inter-item correlations.
The applicability of the scale to assess anticipated IBS stigma in the general population using a vignette design was demonstrated. Such assessments can be used as the basis for tailored anti-stigma measures, for example, the communication of specific facts about the development of IBS symptoms.
Total diet replacements (TDRs) and weight loss medications (WLMs) have proven effective in producing substantial weight loss for individuals with obesity. Evidence is lacking on whether combining these treatments is effective and cost-effective in primary care for adults with obesity class I (body mass index (BMI) 30–34.9) or uncomplicated obesity class II or higher (BMI≥35 without obesity-related disease).
LightCARE is a 2-year 1:1 randomised, parallel-group, clinical superiority trial with blinded outcome assessment evaluating the benefits and harms of an intensive weight loss (IWL) intervention compared with usual care for adults with obesity in Denmark and the UK. The trial will include 400 participants aged 18–60 years with obesity class I or uncomplicated obesity class II or higher. The IWL programme aims to achieve and maintain a weight loss of ≥20% through a flexible and individualised combination of TDR, behavioural support, including physical activity and sleep guidance, and WLM if needed and will continue for 2 years. The control group will receive usual care offered in each country, typically consisting of brief behavioural support for weight loss. The primary outcome is body weight 2 years after randomisation. Secondary outcomes will include the proportion of participants achieving ≥20% weight loss, Short-Form-36 Mental Component Score, 4-m gait speed and Metabolic Syndrome Severity-Z score. Serious adverse events, the incidence of eating disorders and bone mineral density will be evaluated as safety outcomes. We will also examine the cost-effectiveness of the intervention, within the trial and in the longer term through modelling. We will conduct a process evaluation to inform any future implementation.
Ethical approval was granted in Denmark (December 2023, H-23051332) and the UK (August 2024, 24/SC/0210). Findings from the trial will be disseminated through peer-reviewed journals and scientific conferences.
The Cardiometabolic function in Offspring, Mother and Placenta after Assisted Reproductive Technology (COMPART) study is a prospective cohort study aiming to explore health outcomes in mothers and children following assisted reproductive technology (ART), with a particular focus on frozen embryo transfer (FET) versus fresh embryo transfer (fresh-ET). The increasing prevalence of ART and FET emphasises the need to assess potential health risks associated with the procedures, both in pregnancy, such as pre-eclampsia and large for gestational age offspring, and in the children, such as obesity and cardiometabolic dysfunction.
The cohort will include 600 pregnant women, their potential partner and their offspring in a 1:1:1 ratio of pregnancies achieved after ART with FET, ART with fresh-ET and women who conceived naturally. The study will involve extensive data collection from electronic medical records; parental questionnaires; biochemical, genetic and epigenetic analyses in blood, urine and placental tissue; and medical imaging (fetal ultrasound and PEA POD scan) and clinical examinations. Outcomes are grouped into six work packages (WPs) related to fetal growth (WP1), pregnancy (WP2), placenta (WP3), offspring (WP4), genetics (WP5) and epigenetics (WP6).
The COMPART study aims to provide valuable insights into the impact of ART and FET on maternal and offspring health and the underlying mechanisms responsible. The study seeks to advance reproductive medicine, shape clinical practice and guidelines and ultimately ensure maternal-fetal health following ART. The study has been approved by the Danish Ethics Committee (H-23071266; February 2024).
Physicians are increasingly interested in part-time employment. However, the impact of part-time work on efficiency and quality of care of inpatients is unknown.
To investigate the association between part-time clinical work of hospitalists in General Internal Medicine (GIM) and resource utilisation and short-term patient outcomes.
Retrospective study.
GIM wards of 3 Swiss teaching hospitals.
Each inpatient was categorised as having received care mainly (>50%) by part-time or full-time hospitalists. Part-time clinical work was defined as employment of
Primary outcome was length of hospital stay, secondary outcomes included 30-day readmission, in-hospital mortality, hospitalisation cost and time to completion of the discharge letter. We assessed the association between both groups and outcomes using generalised estimating equations, clustering for individual patients and adjusting for patient and hospitalist characteristics.
There was no statistically relevant difference in length of stay in cases cared for mainly by part-time (mean 7.3 days, 95% CI 7.1 to 7.6) compared with full-time hospitalists (mean 7.6 days, 95% CI 7.3 to 7.8; p=0.18). Time to completion of the discharge letter was longer in the part-time (mean 11.4 days, 95% CI 11.0 to 11.8) versus full-time group (mean 10.9 days, 95% CI 10.6 to 11.2, p=0.049). There was no statistically significant difference between groups for the other outcomes.
We found no evidence that part-time clinical work of hospitalists negatively affects resource utilisation and short-term patient outcomes compared with full-time work.
Procedure-related pain should be minimised to prevent psychological trauma and the potential negative consequences on body physiology. Dressing changes in paediatric patients with burn injuries are frequently performed with analgesics alone where sedation is not indicated, especially in minor and superficial burns. It is hypothesised that distraction methods can be used in addition to pain alleviating medication to reduce the experience of pain in these patients.
With this research project, we aim to assess the effectiveness of a simple, inexpensive, non-electronic distraction method, a kaleidoscope, to reduce acute pain experienced in paediatric patients undergoing dressing changes in the outpatient clinic.
A randomised controlled trial will be performed at the Ngwelezana Tertiary Hospital, Empangeni, South Africa. Paediatric patients between the ages of 5 years and 12 years with minor and superficial partial thickness burn injuries who require dressing changes in the outpatient clinic, without sedation, will be randomised into two groups with a 1:1 allocation ratio. Fixed randomisation will be performed by a computer random number generator. The control group will receive standard practice of care which concerns a dressing change without any distraction methods, and the intervention group will receive distraction by use of a kaleidoscope as an additional method for potential pain alleviation. Patients in both groups will receive paracetamol or non-steroidal anti-inflammatory drugs when indicated according to hospital protocol. The primary outcome will be the change in pain score from pre-procedural to pain score during the dressing change and will be analysed with a linear regression analysis. Additionally, subanalyses will be performed to evaluate potentially modifying factors on the treatment effect. This will also be evaluated with a linear regression analysis and correlated with caregiver and healthcare worker observational pain scores. Participants and assessors are not blinded to group assignment due to the nature of the intervention. To achieve a power of 80% and a level of significance of 5% for detecting at least a 1-point difference in change in pain scores between the intervention and control group, a sample size of 50 patients in each group is required.
This study evaluates a non-invasive adjunct to reduce pain in children who undergo a painful procedure. Ethical approval has been granted from the University of Kwazulu-Natal’s biomedical research and ethics committee and the ethics and research committee of Ngwelezana Tertiary Hospital prior to recruitment (ref no. BREC/00005194/2023). Written informed consent will be acquired from all study participants’ caregivers. Study findings will be presented orally to staff at the paediatric burn unit of Ngwelezana Tertiary Hospital (study location). The research methodology and results will be presented at scientific conferences and will be submitted for publication in a peer-reviewed journal.
Patients with stage III non-small cell lung cancer (NSCLC) are at high risk of developing post-treatment recurrences (50–78%) during follow-up. As more effective treatments are now available, especially for patients with oligometastatic disease, earlier detection of recurrences may prolong survival and health-related quality of life (HRQOL). With the use of 2'-deoxy-2'-[18F]fluoroglucose positron emission tomography/CT ([18F]FDG PET/CT) during follow-up, recurrences may be detected earlier. Therefore, the primary objective of this study is to compare the 3-year overall survival of patients with stage III NSCLC during follow-up surveillance with [18F]FDG PET/CT versus follow-up with conventional CT (usual care). Secondary objectives address the number, location and timing of recurrences, as well as HRQOL, cost-effectiveness and patient experiences of PET/CT scans.
In this multicentre randomised controlled clinical trial, 690 patients with stage III NSCLC (8th edition International Association for the Study of Lung Cancer (IASLC) Tumor, Nodes, Metastasis (TNM) classification) who completed curative intended treatment and started follow-up care (which may include adjuvant therapy) will be randomised 1:1 to either the intervention ([18F]FDG PET/CT) or the control group (CT). Patients will undergo follow-up scans during visits at 6, 12, 18, 24 and 36 months. Data will be collected using validated questionnaires, electronic case report forms and data extractions from the electronic health records. Additionally, blood samples will be collected, and interviews will be conducted.
The study protocol has been approved by the Medical Ethical Committee of the Radboudumc and review boards of all participating centres. Written informed consent will be obtained from all participants. Study results will be published in international peer-reviewed scientific journals and presented at relevant scientific conferences. Data will be published in a data repository or other online data archive.
FreshRSS 