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Weight stigma and internalised weight bias are associated with poor mental, social and physical health. Weight-neutral approaches prioritise well-being and sustainable health behaviours. However, the feasibility and acceptability of weight-neutral interventions remain uncertain.
Weight-Neutral Health Intervention (WIN) is an investigator-initiated single-arm feasibility study enrolling 56 adults with body mass index ≥30 kg/m2 in the Capital Region of Denmark. The study investigates a codesigned weight-neutral health intervention. The 6-month intervention comprises 1 preparatory session and 11 group sessions led by trained practitioners, focusing on intuitive eating, body acceptance and self-compassion; optional components include support-network events, up to three individual online sessions and access to ‘size-inclusive yoga’ and ‘body competence’ courses. The primary feasibility outcome is follow-up completion. Recruitment proportion and adherence are secondary feasibility outcomes. These will be assessed using a set of predefined ‘traffic-light’ stop/go progression criteria. Exploratory feasibility outcomes include data completeness for other outcomes and participant engagement with the intervention. Exploratory clinical outcomes include questionnaire data (quality of life, depression, weight bias internalisation, eating behaviours, self-esteem, body image, stress and life satisfaction), clinical measures (weight, heart rate and blood pressure), biomarkers (blood samples and hair cortisol), 7-day actigraphy (physical activity and sleep) and serious adverse events. Qualitative interviews, focus groups and fieldnotes will be used to explore acceptability and contextual factors. If progression criteria are met, the study will inform the design of a pragmatic, multicentre, randomised trial. The exploratory outcomes will inform outcome selection, setting, sample size and procedures.
Approved by the Regional Ethics Committee of the Capital Region of Denmark (H-25013213). Results will be disseminated through peer-reviewed publications, conferences and public platforms.
Effective treatment for clinical obesity is available but is rarely offered by healthcare systems, which often treat complications without treating the underlying cause. The LightWAY trial will investigate the clinical benefits and harms as well as cost-effectiveness of an intensive weight loss intervention compared with existing weight management programmes for people with clinical obesity.
LightWAY is an investigator-initiated, international, randomised, parallel-group clinical superiority trial with blinded outcome assessment. Six hundred people seeking treatment for clinical obesity (body mass index ≥35 kg/m2 with comorbidities) will be recruited in centres in the UK and Denmark and randomised 1:1 to one of two groups. The experimental group will be offered a 2-year intensive weight loss programme providing support and advice to follow a total diet replacement programme, followed by gradual transition to an energy-reduced diet in combination with increased physical activity and if needed, prescription of weight loss medication. The control group will receive usual care, typically comprising brief behavioural support for weight loss and treatment of the complications of obesity or occasionally referral to specialist weight management services. The two co-primary outcomes are cardiometabolic risk, assessed with metabolic syndrome severity Z-score, and body weight assessed at 2 years. The secondary outcomes include the Short Form-36 mental component scale, 4-metre gait speed and proportion of participants achieving ≥20% weight loss. The key adverse effects will be the proportion of participants with at least one serious adverse event, incidence of eating disorders and disproportional loss of bone mass. Incremental cost-effectiveness will be assessed over the trial period and over the lifetime through modelling.
Ethical approval was granted in the UK (August 2024, 24/SC/0211) and Denmark (December 2023, H-23065222). Findings will be disseminated through peer-reviewed journals and scientific conferences and to participants in the trial and clinicians.
To identify barriers and facilitators to implementing an electronic shared decision-making tool for managing anticoagulant-related drug-drug interactions that affect bleeding risk in routine clinical care.
Preimplementation qualitative study using semistructured interviews.
Three academic medical centres in the southeastern and western USA. Interviews were conducted between 27 March and 25 September 2024.
36 participants, including 19 clinicians involved in prescribing or managing anticoagulants and seventeen patients prescribed anticoagulants, were recruited using purposive and convenience sampling.
Participants identified multiple barriers and facilitators to tool implementation. Common barriers included limited visit time, challenges integrating the tool into existing workflows, role and scope-of-practice constraints, and variation in patient digital literacy. Facilitators included clear visualisation of bleeding risk, access to supporting evidence, familiar interface design and perceived potential to support patient engagement and shared decision-making. Several determinants functioned as both barriers and facilitators, depending on clinical context and user role.
This preimplementation qualitative study identified context-specific determinants that influence the adoption of an electronic shared decision-making tool for anticoagulant-related drug–drug interactions. Findings highlight the importance of early attention to workflow integration, role alignment and usability to support uptake in routine care. Addressing these factors during design and implementation may inform strategies to support adoption and future evaluation in real-world clinical settings.
This community-led research study protocol emphasises placing black youth impacted by the legal system, their families and their communities at the forefront of substance use treatment development research and decision-making. The study, the Cultural Adaptation of a Substance Use Treatment (CAST) Project, challenges traditional top-down approaches to treatment creation, advocating for a grassroots model that centres community knowledge, values and active participation.
The CAST project is a US-based mixed-methods study with an exploratory design that examines the impact of racial discrimination on substance use in black youth impacted by the legal system. The study participants are black youth impacted by the legal system (N=15), parents of black youth impacted by the legal system (N=10) and community members who serve black youth (N=10) (total N=35 study participants). Study participants from each group (youth, parents and community members) will participate in three separate focus groups, respectively, to provide feedback on the culturally responsive content needed to best support black youth impacted by the legal system around substance use and mental health. The eight-step Assess, Decision, Adaptation, Production, Topical Expert, Integration, Training, Testing framework will be used as a guide to inform adaptations to the Motivational Enhancement Therapy and Cognitive Behavioural Therapy (MET/CBT12) for black youth impacted by the legal system. Once the cultural adaptation process has been completed, the study will conclude with an open feasibility and accessibility trial of the culturally adapted MET/CBT12 manual. The primary outcomes of this study are the feasibility and acceptability of the culturally adapted manual, measured by treatment attendance and participant feedback. Secondary outcomes include reductions in substance use and discrimination distress, and improvements in mental health symptoms.
This study was approved by the Institutional Review Board (IRB) at the University of California, San Francisco (IRB Protocol Number: 23-40126). All study procedures will be conducted in accordance with the ethical standards outlined by the institutional review board. The results from this study will be shared through peer-reviewed publications, academic conferences, community forums and policy briefs to support broader implementation of culturally adapted adolescent substance use interventions that address discrimination-related stress and substance use among black individuals impacted by the legal system.
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.
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 (
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.
Specialised outpatient palliative care (SOPC) is an important element of the palliative care concept in Germany. The aim of this study is to compare patient characteristics, care processes and outcomes of patients with heart failure (HF) and oncological diseases, using the latter as a reference group to identify disease-specific needs and support the adaptation of SOPC to non-oncological conditions such as HF.
In this cross-sectional study (22 SOPC providers), clinical data of all palliative care patients who were treated between 2017 and 2021 were retrospectively analysed.
Survival was estimated by Kaplan-Meier analysis. To further examine the relationship between patient survival time and various variables, a Cox proportional hazards model was used. Differences in symptom burden were tested for statistical significance using the McNemar test.
Data from 48 882 patients were analysed, with 5387 (11.0%) identified as having a primary HF diagnosis. This cohort was compared against a large oncological group consisting of 34 287 (70.1%) patients.
For HF patients, the mean number of days spent in SOPC was 30.5±67.7 days and for oncological patients 44.1±72.0 days. A significantly higher proportion of oncological patients died in hospices (14.0%) and hospitals (6.9%) compared with HF (2.9% and 2.2%). Age-adjusted Charlson Comorbidity Index at admission into SOPC was 9.4±3.1 in oncological patients compared with 6.7±1.7 in HF (p
HF patients in SOPC exhibit a different clinical profile compared with oncological patients, characterised by significant symptom burden and shorter survival times. These results emphasise the necessity for tailored palliative interventions to address the specific needs of HF patients.
FreshRSS 