Acute respiratory distress syndrome (ARDS) is a major public health problem, accounting for 23% of intubated patients and associated with high mortality rates. Although lifesaving, invasive mechanical ventilation can worsen lung injury when ventilator settings are poorly adjusted to lung physiology. We hypothesise that individualising ventilator settings via (1) the bedside assessment of lung recruitability using a one-breath derecruitment manoeuvre and measurement of airway opening pressure to set positive end-expiratory pressure (PEEP), (2) controlling the distending pressure and (3) controlling respiratory drive improves ARDS outcomes.
The CAreful Ventilation In ARDS trial is an investigator-led multicentre (33 centres in eight countries), open-label, randomised controlled basket trial comparing two ventilation strategies in two subpopulations of moderate-to-severe ARDS: induced or not by COVID-19. A total of 740 patients will be randomised (370 in each substudy) in a 1:1 ratio to individualised ventilator settings or to using traditional PEEP to inspired fraction of oxygen tables for PEEP setting. Indications for proning and weaning strategies are similar in both arms. The primary outcome is all-cause mortality at day 60. Secondary outcomes include duration of mechanical ventilation, duration of intensive care unit (ICU) and hospital stay, organ dysfunction, barotrauma and mortality in ICU, at day 28 and in hospital.
Ethics approval has been obtained for all participating centres: Unity Health Toronto Research Ethics Board (for three centres: St Michael’s Hospital, Toronto General Hospital and Toronto Western Hospital); Comité de Ética de Investigación con Medicamentos del Hospital Universitari Vall d’Hebron; Comité de protection des personnes Ile de France III; Comité d'Ética de la Investigatción con Medicamentos de la Fundació de Gestió Sanitària del Hospital de la Santa Creu i Sant Pau; Comitato Etico—Fondazione Policlinico Gemelli; Comitato Etico di Area Vasta Emilia Centro; NYU Langone Health Institutional Review Board; Comité Ético Científico de Ciencias de la Salud; Il Comitato Etico Area 1 dell’Azienda Ospedaliero-Universitaria ‘Ospedali Riuniti’ di Foggia; HIGA ‘Eva Perón’ Comité de Bioética; Comité de Revisión Institucional del Hospital Británico Comité de Ética en Investigación; Complejo Médico Churruca-Visca Comité de Ética Biomédica; Comité de Ética SATI Comité de Ética en Investigación; Comité de Ética en Investigación del CEMIC; Comité de Ética SATI Comité de Ética en Investigación; Medical Research Ethics Committees United. Findings will be disseminated in peer review journals and conference presentations.
To assess the levels of knowledge, attitudes and practices (KAP) toward skin cancer prevention among Malaysian adults and to examine differences in KAP across socio-demographic groups.
Cross-sectional online survey.
Community-based study conducted in Malaysia using social media recruitment.
A total of 386 adults aged ≥18 years residing in Malaysia. Most participants were young adults (86.3%), female (55.4%) and of Chinese ethnicity (65.5%). Healthcare professionals were excluded.
Primary outcomes were levels of knowledge, attitude and preventive practices toward skin cancer, measured using the validated KAP-SC-Q (Knowledge, Attitude and Practice of Skin Cancer Questionnaire) and categorised as poor, moderate or good. Secondary outcomes included differences in KAP across socio-demographic and clinical characteristics, analysed using independent t-tests and 2 tests.
Over half of participants demonstrated poor knowledge of skin cancer (56.0%) and the vast majority showed inadequate preventive practices (84.2%), while attitudes toward skin cancer were predominantly positive (62.4%). Significant differences in mean KAP scores and categorical levels were observed across several socio-demographic variables. Participants with tertiary education had higher knowledge (14.32 vs 12.61) and attitude scores (20.01 vs 15.95; p
Malaysian adults exhibited limited knowledge and very poor preventive practices toward skin cancer despite generally positive attitudes. These findings highlight substantial gaps between awareness and behaviour and support the need for targeted public health interventions to correct misconceptions, improve risk perception especially in high-risk groups and promote effective ultraviolet protection behaviours.
Primary healthcare (PHC) workforce shortages remain a critical global and national challenge, threatening progress toward Universal Health Coverage. Limited research has examined career-stage-specific motivations and deterrents. This study explores how perceptions of PHC careers differ between final-year medical students and current PHC providers, offering insights for targeted recruitment and retention strategies.
We conducted semi-structured face-to-face and online interviews (November 2023 to December 2024) with final-year medical students and primary healthcare providers (PCPs) from Greater Bay Area institutions. Participants were purposively sampled to ensure diversity in key characteristics. Interviews continued until thematic saturation was reached. Data were analysed thematically using Braun and Clarke’s six-step framework.
Interviews with 17 PCPs and 13 students identified five themes: systemic and institutional factors, education and training, professional development, community perceptions and personal motivations and trade-offs. The analysis identified common barriers across the participant groups, including inadequate resources, fragmented health information systems, unstructured career pathways and inequitable pay-for-performance mechanisms. Career-stage differences were notable: students associated success with hospital-based specialisation and viewed PHC as a fallback option, influenced by limited PHC training exposure, unclear advancement pathways and prevailing stigma. In contrast, PCPs described professional fulfilment through developing niche expertise and fostering continuity of care, increasingly perceiving PHC as an innovative platform for specialised practice. PCPs with prior hospital experience described their transition from hospital settings as motivated by burnout and the pursuit of better work–life balance, an opportunity often overlooked in workforce planning.
Career-stage-specific recruitment strategies are essential to strengthen the PHC workforce. Policies that address early-career and mid-career needs, establish structured development pathways and enhance the societal value of PHC will be critical to building a resilient primary care system. Findings offer practical implications for health system reforms in China and other countries advancing toward Universal Health Coverage.
Concentration of care and collaborations between hospitals increasingly reorganise oncological care into Comprehensive Cancer Networks (CCNs), aiming to improve care outcomes and reduce costs. This study aims to evaluate the effect of four CCNs on healthcare cost and outcomes for patients with colon or pancreatic cancer.
We performed a retrospective cohort study based on claims data in the Netherlands. Data included patient characteristics, health insurance claims and healthcare activities. All costs were indexed to Euro 2023. We performed propensity score matching per CCN and applied regression models with a difference-in-difference design, adjusting for non-linear trends before the start of a CCN.
The study was conducted within the Dutch healthcare system, analysing claims data representative of hospital-based cancer care.
A total of 92 309 patients with colon cancer and 25 630 patients with pancreatic cancer were included. Patients were identified through health insurance claims between January 2013 and June 2021.
Implementation of four CCNs, which included structured collaboration between healthcare organisations. Follow-up duration was 2 years post-diagnosis.
Primary outcomes included 2-year oncological healthcare costs and 2-year mortality rate. Secondary outcomes involved care process indicators: referral rates and double diagnostics (an identical diagnostic activity performed within 4 weeks after referral to a secondary hospital).
For colon cancer, one CCN showed a significant decrease in 2-year oncological costs (–1899). One CCN showed a significant decrease in referrals (–3.6%) and one a significant increase (+4.4%). No significant effect on 2-year mortality and double diagnostic activities was found. For pancreatic cancer, one CCN showed a significant decrease in 2-year oncological costs (–3747) and one CCN showed a significant increase in double diagnostic activities (+8.6%). No significant effect on referrals and 2-year mortality was found.
CCNs do not consistently reduce costs or affect referral patterns or redundant diagnostics. No impact on mortality was found. Additional insights into determinants of CCN success are required before broad implementation is warranted.
As people age, frailty becomes increasingly prevalent and is associated with adverse outcomes, including higher risks of hospitalisation, institutionalisation and mortality. Early identification of frailty in ambulance and emergency department (ED) settings may support clinical decision-making and help predict outcomes for older patients. However, there is currently no consensus on how frailty should be assessed in these settings, and the clinical usefulness of available tools remains uncertain. This protocol outlines the methods for a planned scoping review that aims to identify frailty screening tools used for older adults (age ≥65 years) in the ambulance and ED settings and to evaluate existing evidence on their clinical usefulness.
This protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for Protocols, and the final review will follow the Joanna Briggs Institute methodology and is reported in accordance with the PRISMA extension for Scoping Reviews guidelines. Studies will be included if they examine the use of frailty screening or assessment tools in individuals aged 65 years or older in ambulance and/or ED settings and report on aspects of clinical usefulness, such as feasibility, predictive validity or influence on clinical decisions. A comprehensive literature search will be conducted in PubMed, Embase, CINAHL, Scopus and Web of Science for studies published in English between January 2014 and December 2025. To refine the search strategy, an initial systematic pre-search was performed in PubMed using Medical Subject Headings terms, followed by a pilot study. A sample pilot screening of 101 references identified in the pre-search was conducted as a support for finalising the search. Ten of the papers in the pre-screening were furthermore used as a support for testing and validating the data extraction variables and quality assessment procedures. In the full scoping review, study selection and data extraction will be independently conducted by two reviewers using the Covidence software (Veritas Health Innovation, Melbourne, Australia), with any discrepancies resolved by a third reviewer. Extracted data will be summarised in tabular format and analysed through narrative synthesis. The methodological quality of included studies will be evaluated using the quality assessment tool of the National Heart, Lung, and Blood Institute for cohort studies.
Ethical approval is not required as no primary data will be collected. Findings will be disseminated through publication in a peer-reviewed journal, conference presentations and summaries shared with relevant clinical and research-related stakeholders.
Endometriosis is a common, benign, chronic inflammatory disease with multiple consequences, from chronic pain to systemic comorbidities and poor quality of life. As it usually affects people of reproductive age, one of the most distressing consequences is infertility, which can be only partly overcome by medically assisted reproduction. Poor outcomes are, in fact, frequent adverse events. As no definitive therapy exists for endometriosis-related infertility, affected women often tend to try either complementary and alternative medicine or self-management strategies to improve their quality of life, with the hope of also enhancing their fertility. Among available options, dietary interventions are commonly explored, even if no robust evidence is available on the optimal type of diet and its effects on reproductive outcomes. This trial will investigate whether an anti-inflammatory dietary intervention can improve fertility outcomes in women affected by endometriosis undergoing in vitro fertilisation (IVF).
The DietAry interveNtion in ameliorating fertiliTy parameters in women with Endometriosis undergoing IVF (DANTE) study is a single-centre, randomised, controlled, non-pharmacological interventional trial in patients living with endometriosis who are infertile and require IVF. Participants will be allocated to either a 12-week intervention based on an anti-inflammatory diet or no diet before the beginning of controlled ovarian stimulation. Following baseline assessment, 438 participants aged
The study has received ethics approval from Comitato Etico Territoriale Lombardia 3 (#5587_18.12.2024). Results will be presented in peer-reviewed journals and at international conferences.
There is a global rise in the burden of childhood obesity, increasing the risk of early onset adult obesity. Most developing countries face the double burden of malnutrition; overnutrition as overweight/obesity and undernutrition.
To determine the current burden and determinants of childhood thinness, overweight and obesity using national survey data.
Data from a cross-sectional survey conducted in 2022 were used.
Data from the seventh Demographic Health Survey conducted in Ghana were used.
The participants included 4417 children ≤59 months.
The seventh Ghana Demographic Health Survey in 2022 employed a two-stage stratified cluster sampling design, selecting 618 clusters to create a nationally representative sample. Weight and height were measured using the SECA 874U scale and Shorrboard, respectively. Children’s heights were measured recumbent (24 months). Multivariate logistic regression was used to assess the relationship between thinness and obesity, as well as the independent factors.
The outcome variable was obesity, determined by a WHZ of >+2SD.
The weighted prevalence of overweight/obesity and thinness in children under 5 years is 9.9% and 5.2%, respectively. Children who were overweight or obese had a mean age of 23.11 months, those who were thin or severely thin had a lower mean age of 21.02 months, and those with normal nutritional status were relatively older, with a mean age of 28.41 months. The Upper West, Northeast and Northern regions had the lowest densities of obesity. In the multivariate logistic regression model, children residing in Ashanti, Oti, Northern, North East and Upper East regions had significantly reduced odds of being obese compared with those in the Ahafo region. The average haemoglobin for those overweight/obese was 10.8 g/dL, and 10.7 g/dL for those who were normal and marginally reduced, 10.5 g/dL for those who were thin.
Regional disparities, maternal nutritional status, socioeconomic conditions and unsafe water sources were significant determinants of child nutrition outcomes. These findings call for targeted, multipronged interventions that integrate maternal-child nutrition, safe water, sanitation and regional context.
To identify the key characteristics required for hypothetical diagnostic tests to be cost-effective for diagnosing giant cell arteritis (GCA).
Combined decision tree and Markov cohort state-transition models were used to evaluate the cost-utility of new diagnostic tests compared with the standard pathways of biopsy and clinical judgement, with and without ultrasound. Input parameters were derived from secondary data and expert opinions. The analysis adopted a lifetime horizon and the UK National Health Service (NHS) perspective, using a willingness-to-pay threshold of £20 000 per quality-adjusted life year (QALY). Bivariate deterministic sensitivity analyses identified the maximum test price at varying diagnostic performance levels, and probabilistic sensitivity analyses over 5000 simulations provided 95% CIs.
UK.
Patients with symptoms suggestive of GCA.
Percentage of GCA-related and glucocorticoid-related complications avoided, maximum test price and incremental QALYs at each sensitivity and specificity combination.
A biomarker test incorporated into a hypothetical diagnostic pathway with perfect accuracy (100% sensitivity and specificity) can be priced up to £7245 (95% CI £5763 to £8727) and remain cost-effective compared with a standard pathway of temporal artery biopsy and clinical judgement. Against a standard pathway including ultrasound, the biomarker test can be priced up to £8606 (£6741 to £10 471). The test’s value was more strongly influenced by improvements in specificity than in sensitivity. The maximum prices decreased with earlier starting age, lower clinician adherence, shorter time horizons and shorter durations of glucocorticoid-related effects.
The study highlights the potential for hypothetical tests to improve GCA diagnosis and reduce glucocorticoid toxicity, while demonstrating their market viability for use within the NHS. It also illustrates how early-stage economic models can provide valuable insights into potential cost-effectiveness to inform the test development process.
The Maharashtra Anaemia Study 3 (MAS 3) aims to (1) Investigate the nutritional, environmental, and economic impacts on haemoglobin concentration/anaemia, (2) Identify the underlying micronutrient causes of anaemia and (3) Investigate the association between anaemia and physical and cognitive development of Indian children during their first 18 years of life. This paper introduces the MAS 3 cohort, which consists of data collected from the participants in the prospective Pune Maternal Nutrition Study from the antenatal period to children at 18 years of age (1996–2014) in the Maharashtra state, India.
Recruitment of 2466 married non-pregnant women, and their husbands, took place between June 1994 and April 1996 in six villages, approximately 50 km from Pune city in India. Women were followed up monthly to identify those who became pregnant. A total of 797 pregnant women were followed up for data collection at or near gestational week 18 and 28, with further data collection for women and children occurring within 72 hours of delivery, for both live and stillbirths. Of the 797 women, 710 were included in the MAS 3 cohort, and long-term follow-up of children occurred at 6 years, 12 years and 18 years of age.
In the MAS 3 cohort, most mothers (73%) were aged between 18 and 25 years at the time of their final prepregnancy visit (baseline), and half (55%) belonged to families of middle-upper socioeconomic status (SES). At the children’s baseline (birth) visit, children had a mean birth weight of 2630 g (SD: 376), with one third (31%) of low birth weight. At the 6-year, 12-year and 18-year follow-up visits, data were available for 706 (99%), 689 (97%) and 694 (98%) children.
MAS 3 will be used to address a number of research objectives, including (1) Trends of haemoglobin and anaemia-related micronutrients from age 6 to 18 years, (2) Micronutrient causes of anaemia during childhood, (3) Prevalence and risk factors for maternal anaemia and childhood anaemia, (4) Impact of maternal anaemia on immediate birth outcomes and (5) Intergenerational risk factors associated with anaemia.
The SupportBack 2 randomised controlled trial (RCT) compared the clinical and cost-effectiveness of an internet intervention supporting self-management versus usual primary care in reducing low back pain (LBP)-related disability. In this study, we aimed to identify and understand key processes and potential mechanisms underlying the impact of the intervention.
This was a nested qualitative process evaluation of the SupportBack 2 RCT (ISRCTN: 14736486 pre-results).
Primary care in the UK (England).
46 trial participants experiencing LBP without indicators of serious spinal pathologies (eg, fractures, infection) took part in telephone interviews at either 3 (n=15), 6 (n=14) or 12 months (n=17) post randomisation. Five physiotherapists who provided telephone support for the internet intervention also took part in telephone interviews.
An internet intervention ‘SupportBack’ supporting self-management of LBP primarily through physical activity and exercise delivered in addition to usual care, with and without physiotherapist telephone support.
Data were analysed thematically, applying a realist logic to develop context-mechanism-outcome configurations.
Four explanatory themes were developed, with five context-mechanism-outcome configurations. Where benefit was reported, SupportBack appeared to work by facilitating a central associative process where participants linked increases in physical activity or exercise with improvements in LBP, then continued to use physical activity or exercise as key regulatory strategies. Participants who reported little or no benefit from the intervention appeared to experience several barriers to this associative process, including negative expectations, prohibitive beliefs about the cause of LBP or functional limitations preventing engagement. Physiotherapists appeared to provide accountability and validation for some; however, the remote telephone support that lacked physical assessment was viewed as limiting its potential value.
Digital interventions targeting physical activity and exercise to support LBP self-management may rely on mechanisms that are easily inhibited in complex, heterogeneous populations. Future research should focus on identifying and removing barriers that may limit the effectiveness of digital self-management support for LBP.
The transition from hospital to home can be challenging for parents of premature infants due to a lack of education on specific care. This may lead to both higher readmission rates and healthcare costs. Telehealth interventions can improve the quality of care specific to premature and critically ill newborns. This protocol outlines the WELCOME study and evaluates its feasibility and effectiveness of this approach.
This two-centre randomised control trial (RCT) will assign 240 families with premature and critically ill newborns to an intervention or control group. The study has a parallel group design and an exploratory framework. The control group will receive standard postdischarge care. The intervention group will additionally receive scheduled video consultations, digital assessments and 24/7 access to educational resources. Primary outcomes will focus on 30-day readmission and emergency care use. Secondary outcomes will include child development and parental health. The intervention is expected to be feasible, with high acceptance and minimal drop-out. It will aim to improve parents’ self-efficacy and health literacy. If successful, insights from this multimethod telehealth study will inform standard care.
Results will be published in anonymised and summarised form in international and national journals and symposia. The study received ethical approval from the Ethics Committee of the Ludwig-Maximilians-University Munich (No. 25-0028) and was registered in the German Clinical Trials Register on 6 March 2025 (DRKS00034422).
DRKS00034422.
Cancer has impacted patients’ quality of life (QoL). Qigong, a type of mind-body exercise, has been adopted by some patients with cancer to improve their QoL. However, various lengthy questionnaires were used to assess Qigong’s effects which made data synthesis difficult. Therefore, a simplified Qigong QoL Questionnaire (3Q instrument) has been developed to assess cancer patients’ QoL when they practise Qigong. This study aims to validate this instrument and contribute to the standardisation and simplification of the outcome measures for the studies on Qigong.
A total of 173 patients with cancer practising Qigong in Australia and China will be recruited to evaluate QoL using the 3Q instrument and Functional Assessment of Cancer Therapy–General (FACT-G) questionnaire. SPSS Statistics V.29 software will be used for data analyses. Exploratory factor analysis will be conducted to identify the factor structures of the 3Q instrument. The internal consistency of the 3Q instrument will be evaluated by Cronbach’s alpha. Test–retest reliabilities will be confirmed by intraclass correlations. Content validity will be assessed by the Spearman’s correlation coefficient. Construct validity will be established through confirmatory factor analysis. Criterion validity will be assessed against FACT-G, and Spearman’s correlation coefficient will be adopted to calculate their correlations.
This study has been approved by the RMIT University Human Research Ethics Committee (HREC26229). The findings from the present study will be submitted to peer-reviewed journals for publication and/or presented at conferences.
Mental health issues such as depression and anxiety are highly and disproportionally prevalent among university students. Beyond the academic rigour, stressors imposed by a new environment result in them being vulnerable to the onset and manifestation of mental health symptomatology. Leveraging smartphones and wearables for digital phenotyping capabilities is an innovative approach for monitoring and intervening in the mental health conditions of university students. This provides a unique opportunity to collect and identify digital and behavioural biomarkers, subsequently enabling the development of predictive models to identify university students at risk.
This study—Brightline—will employ an observational study design over a 6-month period, recruiting 500 students from a major public university in Singapore. Passive data collection will occur continuously throughout the monitoring period through a wearable device (Fitbit Charge 6) and smartphone sensors via the Brightline app, which uses a digital phenotyping data collection platform. Active data collection will consist of self-report questionnaires to be completed at the beginning of the study and follow-up assessments at 1, 3 and 6 months after. The passive and active data collected will be analysed to identify the digital biomarkers associated with depression, anxiety, stress, loneliness and affect among university students. Predictive models of these mental health issues will also be developed.
This study was approved by the Nanyang Technological University Institutional Review Board (IRB-2023-894). Findings from this study will be published in peer-reviewed journals and presented at academic conferences.
Increasing physical activity and effectively managing stress can positively impact immunity and may reduce the duration of respiratory tract infections (RTIs). As part of a larger trial, participants accessed a digital behavioural change intervention that encouraged physical activity and stress management to reduce RTIs. We aimed to understand the barriers and facilitators to engaging in physical activity and stress reduction.
A qualitative process analysis from semistructured interviews of the behavioural intervention in a randomised control trial.
Primary care in the UK.
34 participants (aged 18–82 years) in the behavioural intervention arm.
The larger trial involved four interventions: a gel-based antiviral nasal spray; a saline water-based nasal spray; a behavioural intervention; usual care. In this study, we focused on participants allocated to the behavioural intervention. The behavioural intervention included two components: one to increase physical activity (getting active) and another for stress management techniques (healthy paths) to reduce RTIs.
We analysed the interviews using thematic analysis with a critical realist perspective (focusing on). We developed five themes: digital intervention engagement, views on intervention allocation, the role of getting active, the role of healthy paths and benefits reinforcing behaviour. Participants’ views on the relevance and benefit of the behavioural intervention shaped their engagement with the intervention website and behaviour. Facilitators of intervention engagement included awareness of inactivity, goal setting, increasing immunity, positive outcome expectations and benefits from changing behaviour. Barriers to engagement included negative outcome expectations, such as around efficacy of the behaviours.
Overall, the results highlighted the importance of positive expectations for a digital intervention promoting physical activity and stress management for RTI reduction. Future interventions should consider how to clearly communicate a broad range of perceived benefits to users.
The trial was prospectively registered with International Standard Randomized Controlled Trial Number (ISRCTN) registry (17936080).
The COVID-19 pandemic dramatically affected schools. However, there are insufficient data on the chronic physical and mental health consequences of the pandemic in school workers.
To determine the prevalence and the functional and mental health impact of pandemic-related chronic health symptoms among school workers towards the end of the COVID-19 pandemic.
Cross-sectional analysis of health questionnaires and serology testing data (nucleocapsid, N antibodies) collected between January and April 2023, within a cohort of school workers.
Three large school districts (Vancouver, Richmond, Delta) in the Vancouver metropolitan area, Canada (representing 186 elementary and secondary schools in total).
Active school staff employed in these three school districts.
COVID-19 infection history by self-reported viral and/or nucleocapsid antibody testing.
Self-reported, new-onset pandemic-related chronic health symptoms that started within the past year, lasting at least 3 months, after a positive viral test among those with a known infection.
Of 1128 school staff enrolled from 185/186 (99.5%) schools, 1086 (96.3%) and 998 (88.5%) staff completed health questionnaires and serology testing, respectively. The N-seroprevalence adjusted for clustering by school and test sensitivity and specificity was 84.7% (95% Credible Interval (95% CrI): 79.2% to 91.8%) compared with 85.4% (95% CrI: 81.6% to 90.3%) in a community-matched sample of blood donors. Overall, 31.1% (95% CI: 28.4% to 34.0%) staff reported new-onset chronic symptoms. These symptoms were more frequently reported in staff with viral test-confirmed infections (38.0% (95% CI: 34.3% to 41.9%)) compared with those with positive serology who were unaware that they had COVID-19 (14.3% (95% CI: 7.6% to 23.6%); p
The pandemic had major health impacts on school workers. To our knowledge, this study is among the first to concurrently quantify a broad range of chronic physical and mental health impacts, highlighting the need for further research and targeted health programmes to address this significant burden.