Acute febrile illness is a major cause of morbidity and healthcare seeking in sub-Saharan Africa, including Mozambique. However, few studies have explored the perceptions and practices related to clinical management of acute febrile illness. Our aim was to understand the perceptions, knowledge and practices of healthcare professionals and community members regarding the management of acute febrile illness.
A qualitative study was conducted using a thematic analysis approach. Eight focus group discussions (FGDs) and three in-depth interviews (IDIs) were conducted in two Mozambican provinces across four healthcare facilities. Purposive sampling was used to select participants, comprising both healthcare professionals and community members. Data were analysed thematically through manual coding, applying inductive and deductive approaches, in line with established qualitative analytical frameworks.
The study included a total of 60 participants, 28 healthcare professionals who participated in FGDs (25) and IDIs (3) and 32 community members who participated in FGDs. Major causes of fever, according to healthcare professionals, were upper and lower respiratory infections, malaria, diarrhoeal diseases and COVID-19. The diagnostic approach for febrile patients primarily included screening, malaria testing and other non-specific investigations depending on availability at health facilities. Antibiotics and antipyretics were the most commonly prescribed treatments. The healthcare professionals reported a decrease in prescribing antimalarials due to extensive training on malaria case management. In contrast, community members reported relying primarily on home-based and traditional practices to treat acute febrile illness before seeking care at health facilities. These practices are related to sociocultural habits, such as the use of traditional medicine and self-medication. The main barriers to seeking care at health facilities were the perception of poor quality of care, long waiting times, cultural beliefs and lack of medicines.
Proper management of non-malarial febrile illness remains a major challenge for both healthcare professionals and communities. Training, adherence to case management protocols and efforts to change behaviours to mitigate harmful sociocultural practices are urgently necessary to improve febrile illness management.
Patients on low-dose prednisolone may develop adrenal insufficiency causing reduced health-related quality of life (HRQoL) and increased risk of adrenal crisis. This study examines whether supplemental hydrocortisone during mild to moderate stress improves HRQoL in patients with polymyalgia rheumatica/giant cell arteritis (PMR/GCA) with adrenal insufficiency on low-dose prednisolone.
A multicentre, randomised, double-blinded, placebo-controlled, clinical trial including patients with PMR/GCA receiving ongoing prednisolone ≤5 mg/day. Eligible patients undergo an adrenocorticotropic hormone (ACTH) test, and 250 patients with a stimulated cortisol
The study is approved by the Ethics Committee of the Capital Region of Denmark and the Danish Medicines Agency. Recruitment began June 2022. The last patient’s last visit is expected in 2026. Results will be disseminated via peer-reviewed publication and conference presentations.
EudraCT:2021-002528-18, CTIS:2024-518272-30-00, NCT05435781.
To identify subgroups with similar social determinants of health (SDOH) characteristics using latent class analysis (LCA) and examine their associations with physical and mental health, cognitive function and missed workdays at 3 and 6 months post-SARS-CoV-2 infection. We hypothesised that intersecting SDOH factors would differentially influence COVID-19-related health outcomes across subgroups.
Prospective cohort study from the Innovative Support for Patients with SARS-CoV-2 Infections Registry (INSPIRE), with longitudinal data collection and cross-sectional analyses at baseline, 3-month and 6-month follow-ups.
Multicentre registry across eight US academic medical centres (Chicago, Dallas, Houston, Los Angeles, New Haven, Philadelphia, San Francisco and Seattle).
Adults aged ≥18 years, fluent in English or Spanish, with self-reported acute COVID-19 symptoms and a confirmed positive SARS-CoV-2 test within 42 days before enrolment (9 December 2020 to 12 August 2022), and access to an internet-connected device. Exclusions included incarceration, inability to provide informed consent, lack of confirmed SARS-CoV-2 infection or no internet access. Of 3791 eligible participants with complete baseline data, 2897 (76.4%) completed the 3-month follow-up and 2666 (70.3%) completed the 6-month follow-up; most were aged 18–49 years (74–75%), female (66–67%), white (86.6–87.5%) and non-Hispanic (86.6–87.5%).
Prespecified primary outcomes were physical and mental health (Patient-Reported Outcomes Measurement Information System (PROMIS)-29 V.2.1 T-scores for depression, anxiety, fatigue, sleep disturbance, pain interference, physical function and social participation), cognitive function (PROMIS Cognitive Function Short Form 8 T-scores) and missed workdays due to illness (binary: >1 week vs ≤1 week, from a single-item survey). All measures were self-reported and collected at baseline, 3 months and 6 months; no changes from protocol.
LCA identified a 4-class model as optimal (lowest Bayesian Information Criterion (BIC) after evaluating 1–7 class models; significant demographic differences (2 p
In this US prospective cohort, SDOH-based subgroups showed persistent disparities in health outcomes post-SARS-CoV-2 infection. Findings highlight the urgent need for intersectional approaches to address systemic inequities in post-COVID-19 recovery.
by Robert Parisien, Alexander Drost, Amin Razi, Sina Ramtin, David Ring, Stein J. Janssen
ObjectivesTo inform efforts to promote regular and normalized Bayesian reasoning, we studied factors associated with the degree to which surgeons use Bayesian reasoning to navigate uncertainty across different clinical scenarios.
MethodsScience of Variation Group members (153; 58% North America, 30% Europe, 69% over 15 years of experience) completed an online survey reading 8 scenarios of test and treatment decisions and chose one of 4 answer options with higher scores indicating more Bayesian reasoning. Internal consistency of the survey was assessed using Cronbach alpha.
ResultsThe average Bayesian reasoning score across all scenarios was 3.0 (IQR 2.7–3.2) on a 4-point scale, indicating a relative context-dependent variability. Completely non-Bayesian reasoning was selected least often (8.6%, 90 of 1,044) and fully Bayesian reasoning represented 29% (301 of 1,044) of responses. Most surgeons showed mixed patterns (defined as reasoning in which prior probability is acknowledged but underweighted, without explicit probabilistic updating): 85% (121 of 142) used fully Bayesian reasoning at least once (121 of 142) while 42% (60 of 142) used completely non-Bayesian reasoning at least once. The Cronbach alpha was 0.43 suggesting the scenarios measured different aspects of clinical reasoning rather a unified construct.
ConclusionsThe finding that surgeons use relatively context-dependent reasoning suggests an opportunity for surgeons to develop and practice Bayesian reasoning strategies both in training programs and in practice.
Crohn's disease (CD) is primarily characterised by chronic gastrointestinal inflammation; however, its systemic nature frequently leads to musculoskeletal complications. Among these, clinically significant foot pathologies can impair mobility and negatively impact patients' overall quality of life. Despite their relevance, the specific influence of podiatric manifestations on health-related quality of life in individuals with CD remains insufficiently explored, underscoring a critical gap in current disease management. The aim of this study was to assess the extent to which foot-related health issues affect the quality of life in people living with CD compared with a healthy population. This multicenter observational case–control study was conducted across five provinces in southern Spain—Málaga, Granada, Jaén, Sevilla, and Cádiz—between January 2024 and February 2025. The study included 110 participants, evenly divided between individuals diagnosed with CD (n = 55) and healthy controls (n = 55), matched for age, sex, and body mass index. All participants completed the validated Spanish version of the Foot Health Status Questionnaire (SFHSQ), which assesses four foot-specific domains and four general health domains. Due to the non-normal distribution of the data, non-parametric statistical methods were applied, with the Mann–Whitney U test used to evaluate differences between groups. Participants with CD exhibited significantly lower scores across all domains of the SFHSQ, with the exception of the Footwear domain, which showed no statistically significant difference (p = 0.406). Compared with healthy controls, individuals in the CD group reported greater impairments in foot pain, foot function, general foot health, and in broader health-related domains including general health, physical activity, and social capacity (p < 0.01 for all). CD significantly compromises foot-related QoL. These results highlight the need to include podiatric evaluations as part of comprehensive, multidisciplinary care approaches aimed at enhancing mobility, functional capacity, and general well-being in affected individuals.
To examine the impact of the COVID-19 pandemic on body mass index (BMI) and obesity status among Canadian residents and explore how this association varied by sociodemographic and health status.
Prospective cohort study.
Canada.
41 302 adults, aged 45–85 at baseline, participating in the Canadian Longitudinal Study on Aging.
BMI and BMI-defined obesity were measured at baseline, follow-up 1 and follow-up 2 (FUP2), with 33% of FUP2 data (n=13 444) gathered after 16 March 2020, when COVID-19 restrictions began. Correction factors were applied for self-reported BMI and weighted generalised estimating equations assessed BMI changes before and during the pandemic.
We found a significant interaction between follow-up time and timing of FUP2 data collection (before or during the pandemic). Participants measured during the pandemic had an excess BMI increase of 0.21 kg/m² (95% CI 0.15 to 0.28) and 1.06 times higher odds of obesity (95% CI 1.03 to 1.09) compared with prepandemic trends. Increases were more pronounced among females, middle-aged adults and those without diabetes.
The COVID-19 pandemic was associated with a modest increase in BMI and obesity among Canadian adults. Ongoing research is needed to assess long-term trends.
Fibromyalgia is a polysymptomatic central sensitisation disorder characterised by widespread pain, fatigue, sleep disturbances and neuropsychiatric features. Hyperbaric oxygen therapy modulates neuroinflammation, mitochondrial function and neuroplasticity, thereby yielding analgesic and functional benefits.
Evaluate the efficacy and optimal timing of hyperbaric oxygen therapy as an adjunct to standard care for fibromyalgia.
This single-centre, randomised, cross-over group, assessor-blinded clinical trial was conducted in the Department of Rheumatology at the University Hospital of the Federal University of Juiz de Fora, Juiz de Fora, Brazil, and adhered to Consolidated Standards of Reporting Trials (CONSORT) guidelines. Women (18–70 years) with a diagnosis of fibromyalgia for ≥2 years were randomised 1:1 to early hyperbaric oxygen therapy plus standard care or standard care alone (delayed group). Intention-to-treat (ITT) analysis was conducted with all 56 participants (mean age: 51.0±9.8 years; mean body mass index: 30.5±5.1 kg/m²).
Standardised care (education, exercise and pharmacotherapy) plus hyperbaric oxygen therapy was delivered at 2.3 atmospheres absolute for 90 min, five times per week, over 8 weeks (total 32–40 sessions). The early group received hyperbaric oxygen therapy during weeks 0–8, while the delayed group received it during weeks 8–16, following the same protocol.
Primary endpoints included the Fibromyalgia Impact Questionnaire-Brazilian Portuguese (FIQR-Br), the pain visual analogue scale (VAS) and the Symptoms Assessment Scale-40 (EAS-40) for psychopathology. Secondary endpoints included the 12-Item Short-Form Health Survey (SF-12) physical and mental components and adverse effects. Assessments were conducted at baseline, 8 weeks and 16 weeks, and analysed using a mixed-design 2x3 analysis of variance (group: early vs delayed; time: baseline, 8 weeks and 16 weeks) with Greenhouse-Geisser corrections as needed, followed by Bonferroni post hoc tests. Missing data were assessed using Little’s missing completely at random (MCAR), and considering the ITT analysis, the means imputed for missing data were estimated through expectation maximisation. Effect sizes were reported as partial ² and Cohen’s d with α=0.05.
44 participants completed the study, and the overall withdrawal rate was 21.4% with no baseline between-group differences. Significant time effects were observed for all primary outcomes and the SF-12 outcome (pxtime interactions were significant for FIQR-Br, VAS, EAS-40 and SF-12 physical and mental (p≤0.02; interaction ² up to 0.23), indicating improvements during active hyperbaric oxygen therapy exposure. Compared with standard care alone over 8 weeks, combined treatment achieved greater gains: FIQR-Br, –31.1% vs –14.4%; VAS, –54.0% vs –33.5%; EAS-40, –28.4% vs –3.7%; SF-12 physical, +39.1% vs +14.8%; SF-12 mental, +57.4% vs +31.9%. Large within-group effect sizes were observed (eg, VAS d=2.5–2.7; FIQR-Br d=1.4–1.7). Efficacy was equivalent regardless of time started, and the benefits converged by the end of each hyperbaric oxygen therapy phase. After stopping hyperbaric oxygen therapy, the FIQR-Br and SF-12 mental component scores regressed towards standard care levels, whereas residual improvements persisted for up to 8 weeks in VAS, EAS-40 and SF-12 physical component scores. Adverse events were infrequent; one case of otalgia required extended management. Withdrawals were primarily due to non-compliance or intolerance to chamber confinement. No serious or unexpected safety concerns were reported.
Hyperbaric oxygen therapy, delivered under a standardised protocol, is an effective and well-tolerated adjunct to multimodal fibromyalgia care. Timing can be individualised: early initiation for rapid relief or stepped introduction after optimised usual care, with comparable overall efficacy. The durability of the benefit appears to be exposure dependent, and maintenance or booster schedules merit further evaluation.
RBR-6prps8g.
To understand healthcare professionals' perspectives of what works well and what can be improved in the supply and administration of anticipatory medications at the end of life in the community.
Qualitative interpretive study using focus groups.
Semi-structured focus groups included healthcare professionals with experience of using anticipatory medications, and public contributors with lived experiences of relatives' end-of-life care. Participants' demographic information was elicited in a brief questionnaire. Transcripts were analysed inductively using thematic analysis. Data were collected in September 2022.
Eight focus groups involved 58 UK-based participants. Each group included people with a variety of professional roles from diverse geographical areas, and public contributors with relevant lived experiences.
The administration of anticipatory prescriptions was widely perceived to be a valuable intervention, but extensive operational challenges were identified, with three interconnected themes arising from the data: (a) Communication between healthcare teams; (b) Intuitive documentation; (c) Accessibility of medications. Addressing these challenges was perceived to be onerous, particularly for nurses and families.
Operational barriers to the timely and appropriate administration of anticipatory medications risk were perceived as adversely affecting patient care and patients' and families' experiences.
System-level improvements are needed to streamline care processes and ensure equitable, appropriate, and timely access to end-of-life symptom control medications in the community.
This study adheres to relevant EQUATOR guidelines and follows the appropriate Standards for Reporting Qualitative Research (SRQR).
Our Public and Clinician Advisory Group helped shape questions and commented on findings. Focus groups included public participants with lived experience of end-of-life care in the community.
Mental health problems among undergraduate medical students are a major global public health concern that emerge early during training and are shaped by demanding educational environments, emotional stressors and organisational pressures. Although research has expanded rapidly, the literature remains fragmented across themes, regions and methods. This scoping review aims to map the global quantitative literature on medical students’ mental health and identify gaps in scope, geography, methodology and equity.
This scoping review will be conducted in accordance with the Joanna Briggs Institute methodological guidance and reported in accordance with PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. We will include quantitative studies assessing mental health among undergraduate medical students. MEDLINE (Ovid), Web of Science (Clarivate), the Cochrane Library (Wiley) and PsycINFO (Ovid) will be searched without date or language restrictions using a keyword-based search strategy. Two reviewers will independently screen titles, abstracts and full texts and extract data using a standardised form. Data will include publication year, country, study design, sample size, mental health measures, thematic domains and patterns of collaboration. Mental health domains will be classified using an a priori thematic framework encompassing psychological symptoms and distress, psychological resources, academic environment, social support and physical health and lifestyle factors. Equity-related variables (sex, gender identity, sexual orientation, race/ethnicity, socioeconomic status) will be operationalised based on analytical use. Results will be synthesised descriptively using tables and visualisations.
Ethical approval is not required. Findings will be disseminated through publication and presentations. The dataset and code will be openly available on publication.
Protocol registration will be made available online via the Open Science Framework (doi:10.17605/OSF.IO/2EHNU).
Vision reduction is linked to reduced quality of life, self-care capacity, increased fall risk, cognitive decline and depression. Prevalence increases with age. In response, WHO recommends regular vision assessment at primary care level, such as general practice (GP), for adults +50 years. However, research on detection of age-related vision reduction in GP is limited. The objective is to assess the feasibility and clinical utility of implementing vision screening in Danish general practice following an annual control consultation for patients aged ≥70 years with minimum one chronic condition.
Complex health intervention in a Danish general practice setting. Testing a patient baseline questionnaire with 18 items on self-reported vision and quality of life in combination with three vision tests: Colenbrander Mixed Contrast Card Test for near vision, Amsler Grid test and Confrontational Visual Field Test. 18–20 GP clinics and 450 patients are planned to be included. After GP consultation, all patients visit a collaborating optometrist for a comprehensive vision assessment including refraction, intraocular pressure measurement, fundus photography and optical coherence tomography (OCT). Data and pictures from the optometrist are evaluated by an ophthalmologist, who refers to further follow-up and/or treatment if deemed necessary.
Feasibility outcomes: patient recruitment rate, patient adherence, as well as patients’ and health providers’ experiences with the intervention. Clinical outcomes: GP staff assessment of patient vision and patient-reported assessment compared with ophthalmologic assessment. This includes identifying the need for new glasses and detecting eye diseases that require further evaluation, monitoring or treatment. This study will provide evidence on the feasibility of integrating vision screening into routine general practice, potentially helping expedient referrals and improving detection and access to primary eye-health care for older adults.
The study is registered and approved by Danish Research Ethics and Data Protection, VEK F-23070033 and in ClinicalTrials.gov: NCT07015034. Findings will be disseminated in peer-review journals, academic conferences and with the public through patient organisations and public health events.
ClinicalTrials.gov; identifier: NCT07015034.
Older patients admitted under surgical care have longer length of stay (LOS) and are at risk of functional decline, hospital-acquired complications and geriatric syndromes. Embedded specialist geriatrician models within surgical care teams can reduce length of stay and perioperative complications. Evidence gaps remain regarding the implementation of these models of care and their impact on patient outcomes. This study aims to measure hospital, patient and implementation outcomes of an embedded perioperative geriatric service in a large Australian tertiary referral hospital.
This hybrid type 1 effectiveness-implementation trial involves four services (emergency general, elective general, urology and vascular surgery), with a predicted reach of >2000 patients over 24 months. The intervention consists of a proactive geriatrician-led service providing a comprehensive geriatric assessment and ongoing review during the acute admission. Service evaluation will be via (1) traditional hospital outcomes (primary outcome LOS); (2) implementation outcomes; and (3) patient reported outcomes across three 6 month phases: (1) prior to service implementation; (2) during service implementation and (3) continued service but without active implementation. Data analysis will include descriptive statistics of patient demographics, clinical characteristics and implementation outcomes; cost-effectiveness; univariate and multivariate analysis of outcomes against demographic and clinical characteristics and thematic analysis of qualitative data.
This trial has been approved by the Hunter New England Research Ethics Committee (2024_ETH023259). The findings will be disseminated via peer-reviewed publications and conference presentations. The research team will facilitate adoption more broadly within the health service.
Australian New Zealand Clinical Trials Registry (ACTRN12625000404426)
Chronic musculoskeletal pain is an occupational health concern among surgeons, with spinal pain being commonly reported. Exercise-based physiotherapy is recommended for reducing chronic spinal pain; however, the treatment effects are modest and may vary across clinical subgroups. Mechanical Diagnosis and Therapy (MDT) is a classification-based approach that uses a standardised clinical examination to guide exercise-based interventions and self-management strategies, and may offer advantages over non-direction-specific generalised exercise in selected patients.
This pragmatic, two-arm, parallel-group randomised controlled superiority trial will compare MDT with generalised exercise in surgeons with chronic spinal pain and a confirmed directional preference, with a planned recruitment of 62 participants (31 per group). Participants will be randomised 1:1 using a computer-generated allocation sequence in Research Electronic Data Capture (REDCap), with stratification by sex and permuted blocks of undisclosed size. Interventions will be delivered in routine physiotherapy practice with flexible scheduling within predefined boundaries (maximum six supervised sessions; most expected within the first 12 weeks), with a follow-up period of 26 weeks.
The primary outcome is the between-group difference in average pain intensity over the preceding 7 days at 12 weeks, measured using the Numeric Pain Rating Scale and adjusted for baseline pain intensity.
The secondary and exploratory outcomes include functional limitations, health-related quality of life, fear of movement, pain catastrophising, pain self-efficacy, therapeutic alliance, exercise adherence and patient global impression of change, assessed at baseline and at 4, 12 and 26 weeks (where applicable). Treatment effects will be analysed using linear mixed-effects models under the intention-to-treat principle.
Ethical approval has been obtained from the North Denmark Region Committee on Health Research Ethics (N-20240046). The findings will be disseminated through peer-reviewed publications and conference presentations.
To identify key factors influencing the implementation of technology-enabled virtual wards (VWs), also known as hospital at home, drawing on the qualitative accounts of stakeholders involved in implementation, using the updated Consolidated Framework for Implementation Research (CFIR) as a guiding analytical framework.
Qualitative semi-structured interviews with implementation leads. All interviews were conducted online, using MS Teams or Zoom, between January–June 2024, and audio-recorded with consent. Audio-recordings were transcribed, anonymised and exported to NVivo V.12 Pro software for data management. The updated CFIR was used to guide thematic analysis of interview data.
Adult VW services in one regional health and social care system in North West England, UK.
Service implementation leads from 11 hospital sites providing adult VW services. Job titles and roles varied across sites and included both operational and clinical service leads.
20 interviews were conducted with 22 participants. Four implementation themes were identified: (1) complexity and adaptability: the ability to adapt the service to local conditions was valued by leads, but also contributed to wide variation in operational, clinical, workforce and digital components of VW models; (2) resource and infrastructure: workforce capacity was identified as a key implementation challenge along with information technology system capability and interoperability; (3) performance demands: leads were concerned that an excessive focus on bed numbers and occupancy levels, without accounting for patient acuity, could negatively affect implementation, straining the service and staff capacity; and (4) readiness for change: organisational and professional readiness for change was considered crucial for increasing referrals and enabling successful implementation, yet leads reported that the level of behavioural and cultural change required had been underestimated.
Implementation of a national VWs programme has resulted in wide service variation in one UK region, which raises questions about service equity and poses challenges for wider programme evaluation. Despite this variation, common factors found to help or hinder implementation have been identified. This study provides greater understanding of the factors that influence the implementation of VW services and outlines actionable insights to help refine VW strategies. These insights can support future planning and sustainability of technology-enabled inpatient-level care at home more widely.
by Jakob Brandstetter, Lea Goldstein, Tim Schreiber, Rupert Palme, Tobias Lindner, Markus Joksch, Bernd Krause, Brigitte Vollmar, Simone Kumstel
Pancreatic cancer is the third leading cause of cancer-related death, with a 5-year survival rate of only 10%. Preclinical studies remain essential for identifying novel therapeutic strategies, discovering biomarkers, and deepening the understanding of disease biology. The most frequent driver mutation in pancreatic cancer is the G12D mutation in the KRAS gene, present in approximately 90% of the tumors. A recent study demonstrated complete regression of KRAS-driven pancreatic cancer upon systemic ablation up- and downstream signaling proteins EGFR and C-RAF. Building on these findings, we investigated the therapeutic benefit of combining the EGFR inhibitor erlotinib with the novel pan-RAF inhibitor LXH-254. The anticancer effects of this combination were assessed in vitro in murine and human pancreatic cancer cell lines by evaluating cell proliferation, cell death and phosphorylation of key signaling proteins. Subsequent in vivo studies were performed in an orthotopic murine pancreatic cancer model and in genetically engineered KPC mice, using daily oral administration of LXH-254 (35 mg/kg) and erlotinib (75 mg/kg). While the treatment robustly inhibited MAPK signaling and caused significant anti-proliferative effects in vitro, it did not improve survival or reduce tumor burden in either in vivo model. hese results contrast with previous reports of efficacy from monotherapies in xenograft models, highlighting the limitations of current preclinical approaches. Our findings underscore the need to develop more effective pathway-targeted inhibitors, and preclinical models that predict clinical outcomes more accurately.Chronic wounds cause a significant burden to affected patients and to society. Effective and objective diagnostic and monitoring methods are needed in wound care, and artificial intelligence offers one promising alternative. In this study, real-world wound images were used to train a convolutional neural network to automatically segment wound area and wound tissues on an image. The study included altogether 362 images of venous, arterial, vasculitis and pyoderma gangrenosum wounds. The model was based on a convolutional neural network architecture U-Net, and fully supervised learning was utilised during the training phase. Wound area reached a Dice Similarity Coefficient (DSC) of 0.927 and Intersection over Union (IoU) of 0.868 using an augmented dataset with pretraining. Fibrinous exudate and granulation performed fairly well with DSC 0.750 and 0.696, and with IoU 0.659 and 0.601, respectively. Necrosis present in only 56 images achieved lower performance with DSC 0.503 and IoU 0.502. In conclusion, this study suggested that it is possible to train a neural network to perform well with images taken for purely clinical purposes. Besides wound area, several wound structures can be identified, but wound structure identification performance is dependent on the number of images featuring the structure.
In cluster randomised trials (CRT), groups (rather than individuals) are randomised to intervention and control conditions. Since the publication of the Ottawa Statement on the Ethical Design and Conduct of CRTs, the accurate identification of research participants has continued to challenge researchers and research ethics committees.
In this article, we focus on CRTs involving healthcare providers and provide a practical framework for applying Ottawa Statement criteria for identifying research participants. We illustrate key lessons with example CRTs.
Study procedures should be analysed in relation to the study objective. A study intervention confers research participant status on healthcare providers if the study objective is to evaluate its effect and it is delivered to or targeted at healthcare providers. A data collection procedure confers research participant status on healthcare providers if it informs a study outcome used to achieve the study objective and it involves interactions between researchers and healthcare providers to collect their data, or the collection of healthcare providers’ identifiable private information.
In CRTs, healthcare providers may be research participants because of study interventions, data collection procedures, or both; conversely, they may simply be research collaborators. Some study interventions confer research participant status on both healthcare providers and patients. Collecting data on healthcare provider behaviour may confer research participant status on healthcare providers.
Accurately identifying research participants in CRTs is essential to their ethical conduct. When healthcare providers are research participants, their rights and welfare should be protected in accordance with research ethics guidelines.
While adverse childhood experiences (ACEs) have been consistently linked to poorer cognitive outcomes in later life, far less is known about ACEs’ contribution to dementia and cognitive ageing risk in low-income and middle-income countries (LMICs), despite their growing and disproportionate share of global Alzheimer’s disease and related dementias (ADRD) burden. This study aimed to systematically review existing evidence on the association between individual ACEs and cognitive outcomes among adults aged 40 years and older in LMIC settings.
Systematic review and narrative synthesis.
We searched Medline, Embase, PsycINFO and CINAHL from the inception of each database to January 2026.
Observational studies examining the association between individual ACEs and cognitive outcomes among adults aged 40 and older in LMICs.
Two reviewers independently screened each record, assessed risk of bias using the Joanna Briggs Institute critical appraisal tool and extracted data. Results were illustrated using descriptive forest plots and a narrative synthesis.
Our systematic review included 14 studies, primarily from upper-middle-income countries, that assessed the relationship between individual ACEs and cognitive impairment (n=4) and function (n=10). 10 studies reported significant associations between ACEs and poorer cognitive function and increased risk of cognitive impairment. No study assessed the association between ACEs and ADRD. Parental death, neglect and mental health issues in the family showed consistent associations with cognitive outcomes, whereas experiencing hunger and poor health in childhood showed inconsistent associations.
Our review corroborated evidence from high-income countries that exposure to ACEs is associated with a long-term risk of poorer cognitive outcomes among older populations in LMICs. However, the available literature remains limited, with most studies originating from upper-middle-income countries, few examining cognitive impairment and none assessing ADRD. These findings underscore substantial gaps in knowledge and highlight the need for research across diverse LMIC settings to clarify the role of broader psychosocial and contextual childhood experiences in shaping cognitive ageing and dementia risk.
CRD42024501816.
To estimate the proportion of Italian nurse managers (NMs) intending to leave (ITL) their positions and to identify associated socio-demographic, job-related, and psychosocial factors.
Cross-sectional study.
Between September and November 2023, 464 NMs from 19 public hospitals completed a case-report form and the short version of the Copenhagen Psychosocial Questionnaire II (COPSOQ II). Latent Class Analysis (LCA) identified ITL profiles, and multiple logistic regression assessed factors associated with ITL.
284 NMs (61.2%; 95% CI 57–66) reported an intention to leave within 12 months. LCA identified two classes: (1) Low-ITL (54%)—mainly outpatient NMs from Central regions with strong relationships with management, good support, work–life balance, and autonomy (55.9% probability of being unlikely to leave). (2) High-ITL (46%)—mainly surgical or critical-care NMs, often from Northern regions, marked by poor management relations, low support and high work–family conflict (80.9% probability of being likely to leave). Multiple regression confirmed that stronger management relations reduced ITL (OR 0.60, 95% CI 0.46–0.79) whereas high job demands and work–health conflict increased it (OR 1.56, 95% CI 1.19–2.04). Northern location also predicted higher ITL (OR 1.58, 95% CI 1.03–2.44). Demographics, education, and clinical setting were not significantly associated.
These findings suggest that healthcare organizations should prioritize managerial and organizational strategies targeting modifiable work-related factors to reduce nurse managers' intention to leave. Interventions aimed at improving organizational support, work environment, and job satisfaction may contribute to workforce retention at the managerial level. Future research should evaluate the effectiveness of targeted organizational interventions in sustaining nurse manager retention.
by Gift Treighcy Banda-Mtaula, Ibrahim Simiyu, Sangwani Nkhana Salimu, Stephen A. Spencer, Nateiya M. Yongolo, Marlen Chawani, Hendry Sawe, Jamie Rylance, Ben Morton, Adamson S. Muula, Eve Worall, Felix Limbani, Miriam Taegtmeyer, Rhona Mijumbi, on behalf of the Multilink consortium
Multimorbidity, the presence of multiple chronic health conditions, is a leading cause of death globally. In Malawi, chronic noncommunicable and communicable diseases such as HIV frequently co-exist, putting pressure on an under-resourced system. However, the health system is primarily structured around disease-specific [vertical] programs, which hinders person-centred care approaches to multimorbidity. Our study focuses on multimorbidity care and explores the perceptions of healthcare workers on the patient pathways and service organisation throughout the patient’s interaction with the health facilities. This cross-sectional qualitative study took an interpretivist approach. We conducted 13 days of clinical observations at Queen Elizabeth Central Hospital and Chiradzulu District Hospital. We also conducted 13 days of clinical observations and semi-structured in-depth interviews with different cadres of purposively sampled healthcare workers (n = 22) at Queen Elizabeth Central Hospital and Chiradzulu District Hospital. Through thematic analysis, we identified an understanding of the organisation of care and healthcare workers’ perspectives on the delivery of services. Findings showed both hospitals provided services for inpatients and outpatients with multimorbidity, including screening, management, prevention of secondary conditions and rehabilitation. Patient diagnosis and management for multimorbidity were often delayed due to frequent stockouts of medication and consumables necessary for diagnostic testing for NCDs at the hospital level. Some healthcare workers were not equipped with the knowledge, skills, or guidelines to manage multimorbidity. As HIV care is currently better resourced than other chronic conditions, healthcare facilities may strengthen the supply chain, healthcare workers’ training sessions and monitoring and evaluation tools to ensure NCDs are well managed, learning from HIV programmes.