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☐ ☆ ✇ BMJ Open

Cross-sectional observational study evaluating social brain health in HIV using a research domain criteria-based approach: a protocol

Por: Vance · D. E. · Brennan-Ing · M. · Lambert · C. C. · Hellemann · G. · Zeng · X. · Lee · J. — Marzo 3rd 2026 at 13:40
Introduction

Some people with HIV (PWH) experience brain changes that affect neurocognition, but little is known about how HIV impacts social cognition or related brain regions. Social cognition, the ability to perceive, understand and respond to social information, is important for maintaining relationships and quality of life. This article provides the protocol for the first comprehensive study examining social brain function in PWH and people without HIV (PWoH). With three aims, this study will: (1) examine neural circuits related to social cognition; (2) examine social cognitive performance across two social cognitive domains and (3) examine the role of social cognition in everyday social functioning.

Methods and analysis

Referred to as Social Brain Health Study in HIV Study, this cross-sectional study will enrol 105 PWH and 105 demographically matched PWoH aged 18–65 years. The study administers a comprehensive assessment battery across two visits within a 2-week period. Visit 1 includes behavioural measures of social cognition (Perceiving Social Cues and Understanding Others), neurocognition and social functioning (social network size and loneliness). Visit 2 involves functional MRI procedures with three social cognitive tasks designed to activate key brain regions (ie, fusiform face area, superior temporal gyrus, temporo-parietal junction, dorsal medial prefrontal cortex).

Ethics and dissemination

This study was funded by the National Institute of Mental Health (MH139613) and approved by the Institutional Review Board of the University of Alabama at Birmingham (IRB-300013394). Data collection is ongoing. The first results are expected to be submitted for publication in 2030. Findings of this study will be published in peer-reviewed journals and presented at local, national and international conferences as well as patient organisations such as AIDS service organisations and community talks.

☐ ☆ ✇ BMJ Open

Implementing multi-component intervention to reduce antibiotic prescribing in primary care of rural China: a qualitative process evaluation of the trial

Por: Zhang · T. · Shen · X. · Chai · J. · Liu · R. · Wang · D. · Yardley · L. · Lambert · H. · Cabral · C. — Enero 16th 2026 at 18:44
Objectives

The overuse of antibiotics for respiratory tract infections in primary healthcare in rural China is a particular challenge and is highly related to antibiotic resistance. Our research team designed a multi-component intervention focusing predominantly on health practitioners to reduce antibiotic prescriptions in rural communities of China. The effects of the intervention were evaluated through a randomised controlled trial. This study was conducted alongside the trial to develop a contextualised understanding of the implementation of the intervention and related influencing factors.

Design

Qualitative process study nested in a randomised controlled trial, including observation and semi-structured interviews.

Setting

Primary healthcare in rural China.

Participants

27 health practitioners from township health centres assigned to the intervention arm.

Intervention

A complex intervention to reduce antibiotic prescriptions in rural communities of China, which includes the following components: training for health practitioners, a public letter of commitment, patient leaflets, a decision support system and a peer support group.

Primary and secondary outcome measures

Not applicable.

Analysis

Data were analysed using thematic analysis.

Results

The overall multi-component intervention was described as useful in reducing antibiotic prescribing, with a particularly high acceptance and use of patient leaflets and the public letter of commitment among health practitioners. There were mixed views on the decision support system and peer support group. Practitioners reported usability-related barriers to using the decision support system during consultations. Practitioners did not understand the role or benefits of the peer support group and found it difficult to initiate group discussions, due to the lack of any existing clinical team at the primary care level.

Conclusions

The multi-component intervention appears to be acceptable and useful in primary healthcare in rural China. Successful implementation requires a comprehensive understanding of the contextual characteristics of the setting. Interventions to reduce antibiotic prescribing in China in the future could consider wider stakeholders including patients, retail pharmacies and health authorities.

Trial registration number

ISRCTN30652037 (01/12/2020).

☐ ☆ ✇ BMJ Open

Understanding psoriasis care costs and the impact of comorbidities: a time-driven activity-based costing analysis in an integrated practice unit

Por: Borzee · J. · Cardoen · B. · Roodhooft · F. · Vyvey · E. · Lambert · J. — Enero 9th 2026 at 14:17
Objectives

The study aims to evaluate the cost of managing psoriasis and its comorbidities across multiple medical departments and to identify cost determinants based on patient, disease and treatment characteristics. Additionally, it compares the cost of care with reimbursements under the fee-for-service (FFS) system to assess how well they reflect patient-specific care needs.

Design

Seven-step, time-driven activity-based costing (TD-ABC) analysis based on direct observations and interviews to generate patient-level cost estimates over the full cycle of care for participants prospectively enrolled in a clinical trial.

Setting

An integrated practice unit (IPU) at a Belgian University Hospital, centred around the treatment of psoriasis, including the management of associated comorbidities.

Participants

A total of 52 patients meeting the trial’s inclusion criteria, enrolled between January 2023 and November 2023, undergoing treatment within the IPU.

Results

The individual cost of care over a 6-month period ranged from 169.78 to 1454.97, highlighting significant variability. Major cost drivers included mental health status and disease severity. Additionally, the presence of one or more comorbidities had a substantial impact on care costs, affecting not only expenses directly related to comorbidity management but often also those associated with dermatological care. Finally, a comparison between the TD-ABC cost variability and reimbursement tariffs variability revealed disparities, indicating that current tariffs do not sufficiently account for patient-specific cost differences.

Conclusions

Healthcare delivery and costing studies often adopt a fragmented approach, limiting cost insights into the full cycle of care for a medical condition. The TD-ABC methodology can address this gap by generating detailed, patient-level cost estimates for both primary illness management and related comorbidities. Our findings underscore the importance of including comorbidity-related costs when discussing a condition’s overall economic burden while also revealing significant cost variability among patients with the same disease. Notably, these variations are not sufficiently addressed by the current FFS reimbursement system.

Trial registration number

NCT05480917 (ClinicalTrials.gov).

☐ ☆ ✇ PLOS ONE Medicine&Health

Integrated knowledge translation (iKT) in preclinical research: A scoping review protocol

by Georgia Black, Reena Besa, Daniel Blumberger, Heather Brooks, Graham Collingridge, John Georgiou, Evelyn K. Lambe, Clement Ma, Bernadette Mdawar, Tarek K. Rajji, Sanjeev Sockalingam, Cara Sullivan, Quincy Vaz, Zhengbang Yao, Branka Agic

Introduction

Integrated knowledge translation (iKT) is a collaborative research approach that emphasizes the meaningful and active participation of knowledge users throughout the research process. Evidence suggests that integrated knowledge translation has the potential to increase the relevance, applicability, and use of research findings. This approach has been increasingly utilized in health research in recent years. However, the extent to which it has been applied in preclinical research and its effectiveness are unknown. To address this gap, we will conduct a scoping review to map the current use, potential benefits, and challenges of iKT in preclinical research.

Methods

Guided by a modified Arksey and O’Malley’s scoping review framework, we will systematically search reference lists and key research databases including Medline, Embase, PsycINFO, Cochrane CENTRAL, Cochrane Database of Systematic Reviews, and Web of Science. Peer-reviewed articles written or translated in English that focus on iKT or approaches that align with iKT within the context of preclinical research will be included. This review will be conducted as part of the Improving Neuroplasticity through Spaced Prefrontal intermittent-Theta-Beta-Stimulation REfinement in Depression (INSPiRE-D) project, which features preclinical research from mouse models to human work (Grant number CAMH File No.22-060). The project’s multidisciplinary team and knowledge user advisory committee will be consulted at key points throughout the scoping review process. A person with lived experience co-chairs the project advisory committee, co-authored this manuscript, and will be routinely included in the decision-making process of the scoping review.

☐ ☆ ✇ BMJ Open

Effectiveness of a home-based physical exercise intervention in patients with fragility fractures on functional independence and hospital readmissions: a protocol for a randomised controlled trial

Por: Segura-Ruiz · R. · Ruiz-Canete · M. · Munoz-Alonso · A. · Rivas-Cruces · C. · Serrano-Lazaro · P. · Armenteros-Ortiz · P. J. · Hidalgo-Lopezosa · P. · Lamberti · N. · Manfredini · F. · Lopez-Soto · P. J. — Noviembre 4th 2025 at 13:13
Introduction

Patients with fragility fractures are two times as likely to suffer future fractures as their peers who have not suffered a fracture. In addition, 40% of those who suffer fragility fractures do not recover their level of functioning in terms of activities of daily living after 1 year. The present study aims to verify the hypothesis that a semipersonalised home-based exercise intervention may improve patients’ independence and reduce the number of hospital admissions compared with usual care for a population that suffers fragility fractures.

Methods and analysis

This parallel-arm single-blinded randomised-controlled trial will take place at the University of Cordoba (Spain) between September 2022 and September 2024. Patients aged >50 years old who have undergone surgery for a fragility hip fracture and who were prefracture independent (Barthel index (BI)>60) will be invited to participate. Patients will be excluded if they present a different type of fracture, mild or greater cognitive impairment or contraindication to exercise training. Patients will then be randomised into exercise or usual care group. The former will receive a daily walking appointment (number of steps to be completed inside home, interspersed with sit-to-stand movements) with the total volume increasing weekly. The latter will receive the usual care. The outcomes, collected at baseline, at the end of training (3 months) and at follow-up (6 months) by blinded operators will include the BI and number of readmissions (primary outcomes) and quality of life, exercise capacity, strength, cognitive status, bone mineral density and laboratory biomarkers (secondary outcomes). Variables related to quality of life, cognitive status, laboratory markers and densitometry will also be analysed.

Ethics and dissemination

The research ethics committee of the province of Cordoba approved the project (number 326; date 28 July 2021). Patients who meet the eligibility criteria will receive a patient information document and the consent form and will be encouraged to ask any questions. The proposed research respects the fundamental principles of the Declaration of Helsinki, the Council of Europe Declaration on Human Rights and Biomedicine, the UNESCO Universal Declaration on the Human Genome and Human Rights, and the Oviedo Council on Human Rights and Biomedicine. The data obtained in this study will be confidential. They will be treated by the Organic Law 3/2018, of 5 December, on the Protection of Personal Data and Guarantee of Digital Rights, keeping it strictly confidential and not accessible to unauthorised third parties, and the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on Data Protection (RGPD). Written informed consent will be obtained from all the participants. The study’s results will be published in peer-reviewed journals and presented at scientific congresses worldwide. The results will also be disseminated through patient advocacy group newsletters and social media platforms. Patient partners will help select the appropriate channels and develop plain-language summaries tailored to their communities’ needs.

Trial registration number

ClinicalTrials.gov ID: NCT04934358 (registration date: 14 June 2021).

☐ ☆ ✇ BMJ Open

Real-world waitlist randomised controlled trial of gameChange VR to treat severe agoraphobic avoidance in patients with psychosis: a study protocol

Por: Freeman · D. · Jones · J. · Prouten · E. · Sainsbury · J. · Morrison · A. · Chapman · K. · Cousins · E. · Altoft · V. · Peel · H. · Kabir · T. · Myrick · J. · Rovira · A. · Rouse · N. · Waite · F. · Lambe · S. · Leal · J. · Yu · L.-M. — Agosto 17th 2025 at 08:12
Introduction

Many people with psychosis find the world very frightening. It can be difficult for them to do everyday things—for example, walking down a busy street, travelling on a bus or going to the shops. Sometimes, the fears are so great that individuals rarely leave their homes. gameChange virtual reality therapy is designed to reduce this agoraphobic avoidance. In gameChange, users practise going into computerised immersive versions of ordinary situations. A virtual therapist guides users through the programme. A mental health worker also supports people. People normally do six sessions of gameChange, but now they can do more as headsets can be left with many people. We originally tested gameChange with 346 patients with psychosis. People saw a significant reduction in their fears. People with the most severe problems made the biggest improvements. This led to gameChange receiving National Institute for Health and Care Excellence (NICE) Early Value Assessment (EVA) approval for its use with patients with psychosis who have severe agoraphobic avoidance. NICE EVA approval is conditional on further evidence generation. We aim to carry out a real-world trial of gameChange used in the NHS. The overall aim is to gather evidence on the four essential areas (clinical benefits on agoraphobia, level of engagement and adherence, healthcare resource use, adverse effects) and the two further supporting areas (health-related quality of life, generalisability) identified in the NICE evidence generation plan for gameChange.

Methods and analysis

200 patients with psychosis and severe agoraphobic avoidance will be randomised (1:1) to receive gameChange in addition to treatment as usual (TAU) or to a waitlist control group receiving TAU. Assessments will be conducted blind to group allocation at baseline, 8 weeks (end of treatment) and 26 weeks (follow-up). The trial will be embedded in services in at least seven National Health Service (NHS) trusts across England. The primary outcome is agoraphobic avoidance at 26 weeks assessed with the Oxford Agoraphobic Avoidance Scale. The secondary clinical outcomes are agoraphobic distress, paranoia and social contacts. There will be tests of moderation of the main clinical outcome. Treatment acceptability, adverse effects and cost-effectiveness will also be assessed. The target estimand is the treatment policy estimand and all primary and secondary analyses will be carried out incorporating data from all participants including those who do not complete treatment.

Ethics and dissemination

The trial has received ethical approval from the NHS Health Research Authority and Health and Care Research Wales (25/WA/0081). A key output will be the evidence needed for a NICE guidance update on gameChange and a clear recommendation concerning future routine use in the NHS.

Trial registration number

ISRCTN79060696.

☐ ☆ ✇ BMJ Open

Effects of antibiotic prescribing for respiratory tract infection on future consultations in primary care: a systematic review and meta-analysis

Por: Adamu · I. · Lambert · A. · Bello · S. · Abdulmalik · F. A. · Marshall · T. — Julio 28th 2025 at 11:15
Objectives

Prescribing antibiotics may reinforce patients’ beliefs that antibiotics are needed and increase future consultations for similar symptoms. This review determines the effect of antibiotic prescribing for respiratory infections in primary care on future reattendance.

Design

A systematic review and meta-analysis of randomised controlled trials (RCTs) and cohort studies and reported following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Participants were adults or children presenting with respiratory infection in primary care.

Data sources

MEDLINE (Ovid), PubMed, Embase, the Cochrane Central Register of Controlled Trials, clinical trial registries and grey literature sources were searched from inception until 6 February 2024.

Eligibility criteria

Eligible studies included open-label RCTs or cohort studies of antibiotics compared with no antibiotics in adults or children with respiratory infections. The outcome of interest was reattendance at least 28 days after the initial consultation.

Data extraction and synthesis

Two reviewers independently screened, selected, assessed the quality and extracted data. Separate meta-analyses were presented for RCT and cohort studies and a combined meta-analysis of all studies.

Results

We identified 2128 records and reviewed 48 full texts, of which five met the inclusion criteria. These reported three RCTs (1207 randomised to antibiotics, 672 controls) and three cohort studies (209 138 exposed to antibiotics, 46 469 controls). In the meta-analysis of RCTs, relative risk (RR) of reattendance with antibiotics was 1.10 (95% CI: 0.99 to 1.23), and in cohort studies, RR was 1.21 (95% CI: 0.94 to 1.49). An important limitation is that most studies were in UK primary care.

Conclusion

Evidence suggests prescribing antibiotics for acute respiratory tract infections in primary care probably modestly increases future reattendance for similar conditions. Reducing antibiotic prescribing may help decrease demand for primary care.

PROSPERO registration number

CRD42023470731.

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