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☐ ☆ ✇ BMJ Open

Early-stage cost-utility analysis of novel diagnostic tests for giant cell arteritis: a modelling study in UK secondary care

Por: Yang · M. · Cocco · P. · Mackie · S. L. · Morgan · A. W. — Noviembre 14th 2025 at 06:04
Objective

To identify the key characteristics required for hypothetical diagnostic tests to be cost-effective for diagnosing giant cell arteritis (GCA).

Design

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.

Setting

UK.

Participants

Patients with symptoms suggestive of GCA.

Main outcome measure

Percentage of GCA-related and glucocorticoid-related complications avoided, maximum test price and incremental QALYs at each sensitivity and specificity combination.

Results

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.

Conclusions

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.

☐ ☆ ✇ BMJ Open

Cohort profile: the Maharashtra Anaemia Study 3 (MAS 3)--a maternal-child cohort study up to age 18 years in India

Por: Benavente · M. T. · Geifman · N. · Bath · S. C. · Ahmadi · K. R. · Fogarty · A. W. · Marshall · C. · Ray · S. · Tata · L. J. · Yajnik · C. · Ahankari · A. — Octubre 28th 2025 at 18:00
Purpose

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.

Participants

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.

Findings to date

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.

Future plans

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.

☐ ☆ ✇ BMJ Open

Understanding internet-supported self-management for low back pain in primary care: a qualitative process evaluation of the SupportBack 2 randomised controlled trial

Por: Geraghty · A. W. A. · Hughes · S. · Roberts · L. · Hill · J. C. · Foster · N. E. · Hay · E. · Mansell · G. · White · M. · Davies · F. · Steele · M. · Little · P. · Yardley · L. — Octubre 21st 2025 at 08:30
Objective

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.

Design

This was a nested qualitative process evaluation of the SupportBack 2 RCT (ISRCTN: 14736486 pre-results).

Setting

Primary care in the UK (England).

Participants

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.

Intervention

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.

Analysis

Data were analysed thematically, applying a realist logic to develop context-mechanism-outcome configurations.

Results

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.

Conclusions

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.

☐ ☆ ✇ BMJ Open

WELCOME: Digital transition of premature and newborn infants with special care needs to postdischarge care - study protocol for a randomised controlled duo-centred study

Por: Sehn · L. · Otter · M. · Will · J. · Visscher · R. M. S. · Kus · S. · Coenen · M. · Flemmer · A. W. · Schouten · E. · Tannen · A. · Fischer · U. — Octubre 15th 2025 at 09:50
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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).

Trial registration number

DRKS00034422.

☐ ☆ ✇ PLOS ONE Medicine&Health

Conformation of HLA-E/peptide complex guides interaction with two novel HLA-E receptors: Stabilin 1 and 2

by Tom A. W. Schoufour, Linda Voogd, Kees L.M.C. Franken, Tom H.M. Ottenhoff, Ruud H.M. Wijdeven, Simone A. Joosten

Human leukocyte antigen E (HLA-E) communicates cellular health to natural killer (NK) cells through presentation of peptides derived from the leader sequence of classical major histocompatibility complex class I (MHC-I), inhibiting NK cell activation and lysis of healthy cells. Besides this canonical role, HLA-E can also present peptides from pathogens such as Mycobacterium tuberculosis (Mtb) to T cells and can inhibit phagocytosis by engaging with LILRB1/2. To identify additional HLA-E binding surface molecules, we utilized a CRISPR/Cas9 activation screen with HLA-E tetramers, which identified Stabilin (STAB)1 and STAB2 as novel interactors. This interaction depended on the nature of the peptide/HLA-E complex, whereby high affinity peptides did not permit the interaction while low affinity peptides did. Functionally, expression of STAB1 or STAB2 on THP-1 monocytes increased phagocytic uptake of HLA-E coated microbeads. These results provide the first evidence of an interaction between Stabilin receptors and specific HLA-E conformations.
☐ ☆ ✇ BMJ Open

Validation of a Qigong quality of life questionnaire (3Q instrument) in patients with cancer: a study protocol

Por: Xu · J. · Li · H. · Stylianou · S. · Sze · D. M.-y. · Chan · V. W. S. · Yang · A. W. H. — Septiembre 29th 2025 at 07:52
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

☐ ☆ ✇ BMJ Open

Harnessing digital phenotyping to advance university student mental health (Brightline) in Singapore: study protocol for a prospective observational study

Por: Ito · S. · Ang · C.-S. · Kampman · O. P. · Rokde · K. · Buddhika · T. · Heaukulani · C. · Tan · Z.-W. · Dewanti · F. A. · Au · E. W. M. · Huan · V. S. · Morris · R. J. · Khong · A. W. H. · Ho · A. H. Y. — Septiembre 23rd 2025 at 03:05
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

NCT06770075.

☐ ☆ ✇ BMJ Open

Experiences of using a physical activity and exercise digital intervention to reduce respiratory tract infections: a qualitative process evaluation

Por: Dennis · A. · Joseph · J. · Greenwell · K. · Miller · S. · Vennik · J. · Dennison · L. · Holt · S. · Bradbury · K. · Ainsworth · B. · Yardley · L. · Little · P. · Geraghty · A. W. A. — Septiembre 10th 2025 at 05:45
Objectives

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.

Design

A qualitative process analysis from semistructured interviews of the behavioural intervention in a randomised control trial.

Setting

Primary care in the UK.

Participants

34 participants (aged 18–82 years) in the behavioural intervention arm.

Interventions

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.

Results

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.

Conclusions

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.

Trial registrations

The trial was prospectively registered with International Standard Randomized Controlled Trial Number (ISRCTN) registry (17936080).

☐ ☆ ✇ BMJ Open

Chronic health consequences of the COVID-19 pandemic on school workers: a cross-sectional post-pandemic analysis

Por: Watts · A. W. · Pitblado · M. · Li · S. · Irvine · M. A. · Golding · L. · Coombs · D. · OReilly · C. · OBrien · S. F. · Goldfarb · D. M. · Masse · L. C. · Lavoie · P. — Julio 29th 2025 at 06:15
Importance

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.

Objectives

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.

Design

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.

Setting

Three large school districts (Vancouver, Richmond, Delta) in the Vancouver metropolitan area, Canada (representing 186 elementary and secondary schools in total).

Participants

Active school staff employed in these three school districts.

Exposure

COVID-19 infection history by self-reported viral and/or nucleocapsid antibody testing.

Main outcomes

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.

Results

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

Conclusions

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.

☐ ☆ ✇ Journal of Clinical Nursing

Leadership practices that enable healthful cultures in clinical practice: A realist evaluation

Por: Caroline A. W. Dickson · Joy Merrell · Sonja Mcilfatrick · Liz Westcott · Nigel Gleeson · Brendan McCormack — Diciembre 7th 2023 at 06:43

Abstract

Aim

To generate, test and refine programme theories that emerged from a rapid realist review investigating practising UK Nurses' and Midwives' experiences of effective leadership strategies during the COVID-19 pandemic.

Background

The realist review of literature generated six tentative theories of healthful leadership practices reflecting, working with people's beliefs and values; being facilitative; multiple means of communication and; practical support. The review yielded little insight into the actual impact of the leadership approaches advocated.

Methods

A realist study, informed by person-centredness using mixed-methods. Online survey (n = 328) and semi-structured interviews (n = 14) of nurses and midwives across the UK in different career positions/specialities. Quantitative data analysed using descriptive statistics and exploratory factor analysis. Framework analysis for qualitative data using context (C), mechanism (M), outcome (O) configurations of the tentative theories.

Results

Three refined theories were identified concerning: Visibility and availability; embodying values and; knowing self. Healthful leadership practices are only achievable within organisational cultures that privilege well-being.

Conclusions

Leaders should intentionally adopt practices that promote well-being. ‘Knowing self’ as a leader, coaching and mentoring practice development is important for leadership development.

Implications for Clinical Practice

Nurses who feel valued, heard, cared for and safe are more likely to remain in clinical practice. Job satisfaction and being motivated to practice with confidence and competence will impact positively on patient outcomes.

Impact

The study addresses the role of leadership in developing healthful workplace cultures. The main findings were six leadership practices that promote healthful cultures. The research will have an impact on strategic and clinical leaders, nurses and midwives.

Reporting Method

This study used EQUATOR checklist, RAMASES II as reporting standards for realist evaluations.

Patient or Public Contribution

No patient or public contribution.

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