To translate and culturally adapt six self-report measures for depression, anxiety, post-traumatic stress disorder (PTSD) and somatic symptom disorder into Hindi and determine their diagnostic accuracy against a diagnostic clinical interview.

Cross-sectional validation study.

Rural Kangra, Himachal Pradesh, northern India.

480 perinatal (pregnant or within 12 months postpartum) and non-perinatal (not currently pregnant and not given birth within 12 months) women at one tertiary hospital and district-level Anganwadi (community health) centres.

Symptom endorsement; and discriminant validity, sensitivity, specificity, positive and negative predictive values and area under the receiver operating characteristic curve (AUROC) of the Kessler Scale of Psychological Distress (K10), Patient Health Questionnaire (PHQ9), Edinburgh Postnatal Depression Scale (EPDS), Generalised Anxiety Disorder Scale (GAD7), Perinatal Anxiety Screening Scale (PASS), PTSD Checklist (PCL-5) and Scale for the Assessment of Somatic Symptoms (SASS).

Complete data were available for 443 participants. Tiredness and body weakness were the most commonly endorsed symptoms among participants with common mental disorders. Among perinatal participants, the AUROC was highest for the GAD7 (0.88, 95% CI 0.79 to 0.96) and SASS (0.84, 95% CI 0.71 to 0.96). Among non-perinatal participants, the AUROC was highest for the SASS (0.92, 95% CI 0.88 to 0.97) and PHQ9 (0.91, 95% CI 0.86 to 0.96).

Measures which assess for fatigue, tiredness and somatic symptoms may help to identify women experiencing common mental disorders in this setting. Small numbers of participants with clinically diagnosed mental disorders in our sample mean results must be interpreted cautiously.

NCT05485701.

Anaphylaxis is a sudden onset multiorgan allergic reaction that infrequently but regularly causes fatalities which may be preventable with appropriate organ support. There is limited data about the type of organ failure leading to death or near-fatal episodes resulting in permanent neurological disability. To assist clinicians facing anaphylaxis in diverse clinical settings, we aimed to quantify the frequency of organ failure type contributing to death or neurological disability from anaphylaxis according to allergen trigger.

Systematic review of published peer-reviewed literature.

Three databases were searched to January 2025: MEDLINE from 1946, Embase from 1947 and Web of Science from 1900.

Studies were eligible if they contained data about the type of clinical deterioration during anaphylaxis resulting in death or permanent neurological disability. No language restriction was implemented. Exclusion criteria were: hydatid anaphylaxis; five or more stings from an insect; death from acute atheromatous myocardial infarction and where anaphylaxis was only a differential diagnosis.

We extracted information using pre-specified criteria to determine the primary organ failure involved: either upper airway obstruction, lower respiratory obstruction (bronchospasm) or cardiovascular failure. Baseline demographics including age and asthma status were collected along with the allergen trigger, time course and treatment. We reported frequencies according to allergen trigger for case reports and a narrative analysis of case series weighted by risk of bias assessment.

277 case studies and 14 case series were identified reporting 896 deaths and 28 disabilities. There were no other study types. Separate case series and case report analyses produced similar findings despite varying quality of published clinical data. Respiratory failure was the most common primary organ failure in case reports (73.4%), whereas primary cardiovascular failure was reported in 26.6% of case reports. Primary organ failure type differed in frequency by allergen trigger and was primarily caused by: respiratory failure when food was the allergen trigger (95%); respiratory failure in 65% of cases of drug allergen triggers; cardiovascular failure in 65% venom allergen triggers.

In this review, respiratory failure (primarily bronchospasm) is the most common primary physiological event leading to decompensation in fatal anaphylaxis, particularly for food and drug allergen deaths. Emphasising the significance of respiratory involvement, particularly from bronchospasm, in both patient and clinician facing anaphylaxis treatment guidelines may help further reduce the risk of fatalities. Prospective anaphylaxis management registries or whole population data are needed to better capture primary organ failure present in fatal anaphylaxis to validate this finding.

CRD42023434206.

Within the UK there are 33 deaths every day from prostate cancer, second only to lung cancer as the most common cause of cancer death in males in the UK. Of the 55 000 new cases each year, up to 50% of these patients will receive radiotherapy either alone or after prostatectomy. Although there have been significant improvements in the accuracy of radiotherapy delivery leading to better tumour targeting and a reduction in dose to normal tissues, significant permanent genito-urinary or gastrointestinal-related side effects are all too common. With nearly 80% of patients with prostate cancer surviving for 10 years or more, minimising life-limiting radiation damage to normal tissues is vitally important. However, at present, it is not possible to identify which patients will suffer a poorer outcome after radiotherapy. The aim of this study, improving radiotherapy in PROState cancer using EleCtronic population-based healthCAre data (PROSECCA), is to do this by using the existing information in a patient’s digital healthcare record. By linking primary, secondary and tertiary clinical data, including digital image information, with radiotherapy treatment plans and outcome data, the PROSECCA study will identify de novo predictive biomarkers of radiation response and provide clinicians with a tool to individualise a radiotherapy dose and plan to maximise cure and minimise toxicity.

The PROSECCA study is a large multidisciplinary project, the purpose of which is to analyse healthcare records from up to 15 000 patients with prostate cancer who underwent radiotherapy in the treatment of their cancer in Scotland between 2010 and 2022. Through the linkage of data obtained specifically for radiotherapy and data held within each patient’s unique electronic health record (EHR), the factors that indicate why some patients have a poor response to treatment, or an increased risk of side effects from radiation, will be identified. This will be made possible by the use of artificial intelligence and machine learning (AL/ML), which will help to identify at-risk patients earlier and allow adaptation of their treatment accordingly.

The study is being conducted in accordance with the ethical principles set out in the Declaration of Helsinki and Good Clinical Practice that respects and protects the rights, and maintains confidentiality, of all trial participants. The study protocol (V.1.0) was reviewed by the South Central Oxford A Research Ethics Committee (REC) on 13 December 2021 and received a favourable opinion subject to each National Health Service (NHS) organisation confirming permission for patients treated within their area. Approval for the use of unconsented healthcare record data for patients included in the study and treated at one of the five Scottish Cancer Centres required an application to the NHS Scotland Public Benefit and Privacy Panel for Health and Social Care (HSC-PBPP). Full approval from the HSC-PBPP panel was received on 1 July 2024, which covered the use of pseudoanonymised EHR data for all patients participating in the study. The study is publicly listed on the NHS Health Research Authority site, with IRAS ID 306245 and REC reference 21/SC/0402. Dissemination of the study findings will take place through field-leading cancer, radiation oncology and medical physics journals. All manuscripts will be approved by the main study team and authorship determined by mutual agreement.

NCT06714630.

Statins are a cornerstone of cardiovascular disease prevention yet remain underused among eligible patients. Clinical decision support systems embedded in electronic health records (EHRs) are commonly used to encourage guideline-concordant prescribing. Interruptive reminders (eg, pop-ups) may be effective but interfere with clinical workflows and contribute to alert fatigue. Non-interruptive alerts are less intrusive, but their effectiveness remains unclear. The Interruptive versus Non-Interruptive Reminders for Statin tHerApy in Primary Care (INIRSHA-PC) trial is designed to evaluate the comparative effectiveness of interruptive and non-interruptive reminders on statin-prescribing rates.

INIRSHA-PC is a single-centre, pragmatic, three-arm, parallel-group randomised controlled trial embedded in the EHR at Vanderbilt University Medical Center. The trial will enrol adults aged 18–74 seen in primary care who are eligible for, but not currently prescribed, statin therapy. The planned sample size is 3000 patients (1000 per arm). Enrolled patients will be randomised 1:1:1 to (1) interruptive reminder, (2) non-interruptive reminder or (3) no reminder (usual care). The primary outcome is statin prescription within 24 hours of enrolment. Secondary outcomes are statin prescribing within 12 months and low-density lipoprotein cholesterol levels measured between 30 days and 12 months after enrolment. Enrolment began on 14 August 2024. The study is expected to be completed on 19 November 2025.

The trial has been approved by the Vanderbilt University Medical Center Institutional Review Board with waiver of patient informed consent (IRB number: 240419). Results will be disseminated through peer-reviewed publication and presentation at scientific conferences.

NCT06456658.

Suboptimal feeding practices in children under five remain a critical concern, particularly in low- and middle-income countries. Integrated Supplementary Feeding programmes (SFPs) combined with Social and Behaviour Change Communication (SBCC) interventions have shown potential, yet global evidence on their design and effectiveness remains scattered across diverse settings and varies widely in scope and quality. This review aims to map global evidence on integrated SFP and SBCC interventions for children aged 6–59 months, assessing their impact on anthropometric, biochemical, nutritional, health, developmental, functional, microbiological and infant and young child feeding (IYCF) outcomes, and to identify contextual factors, evidence gaps and successful strategies. The review will also aim to document cost effectiveness and economic outcomes of this integrated intervention.

The review will follow Joanna Briggs Institute (JBI) methodology, applying the Population–Concept–Context framework and the review title has been registered in Open Science Framework (OSF) (https://doi.org/10.17605/OSF.IO/ZJ5BG). Eligible studies published between 2000 and 2025 will include community-based interventions for children under five that combine SFP and SBCC. The review will focus on SFP interventions delivered through community-based or public health platforms, including but not limited to take home ration, hot cooked meal, micronutrient powders, coupled with SBCC modalities such as home visits, mobile health and mass media campaigns. Comprehensive searches will be conducted in MEDLINE (PubMed), Cochrane CENTRAL, Google Scholar and organisational websites. Two independent reviewers will screen, extract and appraise studies using Covidence and JBI tools. Data will be analysed using descriptive statistics to summarise study characteristics, intervention types and reported outcomes, helping understand patterns across time and settings. Qualitative findings will be synthesised through descriptive content analysis involving coding and theme development. Expected outcomes include a range of study designs from different settings across the globe, covering diverse delivery models of integrated SFP and SBCC with reported outcomes including dietary indicators, anthropometry, nutritional biomarkers, caregiver practices and cost-effectiveness.

This review is part of a larger cluster randomised controlled trial (NECCTAR) which has received ethical approval from the independent institutional ethics committee of all the participating institutes. The current review will involve only publicly available literature and does not have a separate institutional ethics committee approval. Findings will be disseminated through academic conferences and publications in peer-reviewed journals.

The review title has been registered in OSF (https://doi.org/10.17605/OSF.IO/ZJ5BG).

The objective of this study was to test whether an airtime reward increased tuberculosis (TB) Check screening uptake. This served as a feasibility study for the planned Phase 2, which aimed to test behavioural messaging to boost take-up of TB testing among users who were advised to get tested by TB Check.

The study was a randomised controlled trial with a parallel design.

This study assessed mHealth support to boost TB testing in high-burden Cape Town clinics.

Patients aged 18 or above with a valid mobile phone number that had been added within the last 5 years were invited by the Western Cape Department of Health and Wellness through unsolicited text messages to screen for TB using TB Check.

Patients in the intervention group (n=1250) were additionally offered R15 airtime for completing the screening and participating in the research study. Patients were allocated to the intervention or control group through parallel randomisation with equal group size.

The primary outcome was the number of TB Check screenings completed within 1 week of the SMS invitation being sent.

Messages were successfully delivered to 616 patients in the control group and 633 patients in the intervention group. Uptake of the invitation by the intended recipients was very low. Eight users in the control group and 20 users in the intervention group initiated a self-screening (1.3% vs 3.2% of delivered messages; 95% CI of difference (0.2 to 3.5)), but only three users in the control group and seven users in the intervention group successfully completed a self-screening (0.49% vs 1.11% of delivered messages; 95% CI of difference (–0.4 to 1.6)). Low delivery of text message invitations (50.0%) and low completion of users who started the screening (35.7%) posed additional challenges. No adverse events were recorded.

The addition of a small airtime participation reward to unsolicited text message invitations did not appear to be an effective tool to reach targeted individuals in this context. The results of Phase 1 reported here suggested that Phase 2 would not be feasible, so we did not proceed with the planned Phase 2. However, uptake of incentivised self-screening was unexpectedly high among users who were not originally invited (presumably known contacts of the original invitees). Within 5 days of the invitations being sent, 1962 unique self-screenings had taken place using the incentive code; only 7 of these users were originally invited. The lessons learnt from this study can help to inform future efforts to promote TB self-screening, mHealth initiatives and attempts to engage with patients via text message. 

The study was pre-registered with the South African National Clinical Trials Registry (Phase 1 trial no DOH-27-112023-9045, Phase 2 trial no DOH-27-112023-4944) and the Pan African Clinical Trials Registry (Phase 1 trial no PACTR202311529334858).

To evaluate the incremental diagnostic value and sub-phenotyping capability of Cardiovascular Magnetic Resonance (CMR) compared with Transthoracic Echocardiography (TTE) in patients with elevated left ventricular filling pressure (LVFP).

Prospective registry study. [Results from ClinicalTrials.gov ID NCT05114785]

A single NHS hospital in the UK.

The primary outcome was the rate of diagnostic discordance between TTE and CMR. Secondary outcomes included the characterisation of specific pathologies identified by CMR where TTE was normal, non-diagnostic or provided a non-specific diagnosis.

CMR demonstrated diagnostic discordance with TTE in 74% (n=194) of cases. In patients with a normal TTE (n=54), CMR identified heart failure with preserved ejection fraction (HFpEF) in 46% (n=25) and ischaemic heart disease (IHD) in 19% (n=10). For non-diagnostic TTE cases (n=15), CMR detected HFpEF in 53.3% (n=8) and IHD in 26.7% (n=4). Among those with non-specific left ventricular hypertrophy on TTE (n=47), CMR revealed HFpEF in 45% (n=21) and hypertrophic cardiomyopathy in 34% (n=16).

CMR markedly improves diagnostic precision and sub-phenotyping in patients with elevated LVFP, identifying key conditions like HFpEF, IHD and specific cardiomyopathies that TTE frequently misses. These findings highlight CMR’s critical role as a complementary imaging tool for refining diagnoses and informing management strategies in cardiovascular conditions.

With growing interest in applying artificial intelligence (AI) to population breast cancer screening, the evidence base has expanded rapidly. This systematic review aims to systematically review and summarise the published evidence on the use of AI in breast cancer screening.

We conducted a systematic review of primary studies assessing AI for screening mammography, extracting test-accuracy metrics (sensitivity, specificity, recall and cancer detection rates) and workflow outcomes.

We searched the Cochrane Breast Cancer Group Specialised Register, Cochrane CENTRAL, PubMed, Embase (Elsevier), Scopus, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform from January 2012 to June 2025; we also screened reference lists of included studies and relevant reviews. No language restrictions were applied.

Primary studies evaluating AI for screening mammography (digital mammography or digital breast tomosynthesis) in asymptomatic women, assessing AI as a standalone reader or AI-assisted radiologist workflows versus radiologists alone. Eligible designs included randomised trials, prospective paired reader studies, real-world implementation/registry cohorts, retrospective cohorts and multireader-multicase reader studies conducted in population-based or opportunistic screening settings. Key outcomes included diagnostic accuracy metrics (eg, sensitivity, specificity, Area Under the Curve (AUC) and/or programme metrics (cancer detection rate (CDR), recall/abnormal interpretation rate, positive predictive value, arbitration/workload). We excluded protocols, pilot/feasibility studies, case reports, editorials and studies without relevant accuracy or screening outcomes.

Two independent reviewers extracted data and assessed risk of bias. Study quality was appraised with Quality Assessment of Diagnostic Accuracy Studies-2 and an AI-specific critical appraisal tool, and findings were synthesised narratively with stratification by study design and AI integration role.

31 studies met the inclusion criteria, encompassing randomised controlled trials, prospective paired-reader studies, registry-based implementations and retrospective simulations, representing more than two million screening examinations across Europe, Asia, North America and Australia. When used as a second reader or within double-reading workflows, AI generally maintained or modestly increased sensitivity (up to +9 percentage points (PP)) while preserving or improving specificity. Triage and decision-referral configurations delivered the greatest operational benefit, reducing reading volumes by 40–90% while maintaining non-inferior cancer detection when thresholds were conservatively calibrated. Stand-alone AI achieved AUC values comparable to radiologists and similar cancer detection in real-world, non-enriched cohorts, although interval-cancer follow-up remains incomplete in several datasets. In prospective randomised evidence, including the Mammography Screening with Artificial Intelligence trial (MASAI) trial, AI-supported screening achieved higher CDRs (6.4 versus 5.0 per 1000; p=0.0021) with stable or reduced false-positive and recall rates. Across implementation and simulation settings, integration of AI reduced radiologist workload substantially, with triage and band-pass approaches reducing the number of reads by approximately 40–90%. Overall certainty is limited by heterogeneity across study designs, reliance on enriched datasets for some accuracy estimates and incomplete interval-cancer follow-up in several major studies.

Contemporary AI systems show diagnostic performance that is broadly comparable to radiologists and can substantially reduce reading workload, particularly when used as a second reader or triage tool. Emerging prospective evidence supports their safe integration in these roles, although transparent reporting, standardised evaluation and long-term population studies are still required before considering AI as a stand-alone reader. AI may improve workflow efficiency and possibly cancer detection, but definitive evidence on safety, especially interval cancer outcomes, remains essential.

Spiritual well-being (SpWB) is a critical yet often underexplored component of holistic care for patients with advanced cancer. This study aimed to assess the SpWB and quality of life (QOL) levels and examine their correlation among patients receiving palliative care at a tertiary cancer centre in Kerala, India.

Institution-based cross-sectional observational study among patients with advanced cancer conducted between August 2023 and December 2024.

The outpatient department of a major tertiary-level, autonomous cancer centre under the Government of Kerala, India.

398 patients with advanced cancer aged 18 and above.

SpWB and QOL were measured using validated Malayalam versions of the Functional Assessment of Chronic Illness Therapy–Spiritual well-being Expanded Version and European Organisation for Research and Treatment of Cancer, Quality of Life Core 30 questionnaires, respectively. Data collection included patient self-reports or assistance by a medical social worker.

The median (IQR) age of participants was 59 (51–65) years; most were married (94.5%) and from an upper-lower socioeconomic background (55%). Hinduism was the predominant religion (67.1%). Almost all patients (99%) were aware of their diagnosis, but only 62.3% knew their prognosis. The median (IQR) SpWB score was 67.5 (57–76), significantly higher in females (p=0.02). The median (IQR) QOL score was 50 (41.7–66.7). SpWB was positively correlated with QOL (r=0.766, p

SpWB showed a strong positive correlation with QOL among patients with advanced cancer. Enhancing SpWB may play a pivotal role in improving overall QOL in palliative care settings.

This study aimed to evaluate the feasibility of delivering a vocational rehabilitation intervention (Return to Work After Trauma—ROWTATE), remotely to individuals recovering from traumatic injuries. The primary objectives were to assess therapists’ training and competence, adapt the intervention and training for remote delivery and assess the feasibility and fidelity of remote delivery to inform a definitive randomised controlled trial.

A mixed-methods feasibility study incorporating (1) telerehabilitation qualitative literature review, (2) qualitative interviews preintervention and postintervention with therapists and patients, (3) a team objective structured clinical examination to assess competency, (4) usefulness of training, attitudes towards (15-item Evidence-Based Practice Attitude Scale) and confidence in (4-item Evidence Based Practice Confidence Scale) evidence-based practice, intervention delivery confidence (8-bespoke questions) and intervention behaviour determinants (51-items Theoretical Domains Framework) and (5) single-arm intervention delivery feasibility study.

The study was conducted in two UK Major Trauma Centres. The intervention and training were adapted for remote delivery due to the COVID-19 pandemic.

Therapists: Seven occupational therapists (OTs) and clinical psychologists (CPs) were trained, and six participated in competency assessment. Seven OTs and CPs participated in preintervention interviews and surveys; six completed post-intervention interviews and four completed post-training surveys. Patients: 10 patients were enrolled in the single-arm feasibility study and 4 of these participated in postintervention qualitative interviews. Inclusion criteria included therapists involved in vocational rehabilitation delivery and patients admitted to major trauma centres. Exclusion criteria included participation in other vocational rehabilitation trials or those who had returned to work or education for at least 80% of preinjury hours. Intervention: The ROWTATE vocational rehabilitation intervention was delivered remotely by trained OTs and CPs. Training included competency assessments, mentoring and adaptation for telerehabilitation. The intervention was delivered over multiple sessions, with content tailored to individual patient needs.

Therapists found the training useful, reported positive attitudes (Evidence-Based Practice Attitude Scale mean=2.9 (SD 0.9)) and high levels of confidence in delivering evidence-based practice (range 75%–100%) and the ROWTATE intervention (range 80%–100%). Intervention barriers identified pretraining became facilitators post-training. Half the therapists needed additional support post-training through mentoring or additional training. The intervention and training were successfully adapted for remote delivery. High levels of fidelity (intervention components delivered: OTs=84.5%, CPs=92.9%) and session attendance rates were found (median: OT=97%, CP=100%). Virtually all sessions were delivered remotely (OT=98%, CP=100%). The intervention was acceptable to patients and therapists; both considered face-to-face delivery where necessary was important.

The ROWTATE intervention was delivered remotely with high fidelity and attendance and was acceptable to patients and therapists. Definitive trial key changes include modifying therapist training, competency assessment, face-to-face intervention delivery where necessary and addressing lower fidelity intervention components.

ISRCTN74668529.

A ‘7-1-7’ timeliness metric, developed for hastening the response to infectious disease outbreaks/pandemics, was adapted to improve screening and managing household contacts (HHCs) of pulmonary tuberculosis (TB) patients. The feasibility, enablers, challenges and utility of implementing this modified metric through TB Champions (TB survivors) for HHC management were assessed.

This was an explanatory mixed-methods study with a cohort design (quantitative) followed by a descriptive design with focus group discussions (qualitative).

The study was conducted within routine programmatic settings in public health facilities in six districts from three states of India.

In total, 595 drug-susceptible index pulmonary TB patients registered for treatment in the selected health facilities, and their listed 2108 HHCs were included in the study between December 2022 and August 2023. All 17 TB Champions involved in implementation participated in the focus group discussions.

The primary outcome measures were the percentage of eligible participants receiving the desired service within the ‘7-1-7’ timeliness metric and challenges in achieving the timeliness metrics.

In 89% of 595 index patients, their HHCs were line-listed within 7 days of initiating anti-TB treatment (‘First-7’). In 90% of 2108 HHCs, screening outcomes were ascertained within 1 day of line-listing (‘Next-1’). In 42% of 2073 HHCs eligible for further evaluation, anti-TB treatment, TB preventive treatment (TPT) or a decision to not receive medication were made within 7 days of screening (‘Second-7’). Barriers to TPT uptake included lack of money and daily wage losses for travelling to clinics, reluctance of asymptomatic contacts to take medication and fear of adverse events. TB Champions felt timeliness metrics improved performance in the systematic and timely management of HHCs.

TB Champions found ‘7-1-7’ timeliness metrics were feasible and useful, and national TB programmes should consider their operationalisation.

The ROWTATE intervention helps people experiencing trauma to return to work (RTW) through vocational rehabilitation (VR) support from occupational therapists (OTs) and clinical psychologists (CPs). This study aims to explore and understand the acceptability of VR after traumatic injury for patients, therapists and employers.

Qualitative interviews in eight major trauma regions, UK.

Interviews were undertaken with a range of stakeholders—15 patients, 15 therapists and 6 employers. Data were analysed using the theoretical framework of acceptability.

Stakeholders understood the aim of the intervention was to support people to RTW and perceived it as effective in achieving this. Patients and therapists understood the benefits of working with a combination of occupational therapy and clinical psychology. The intervention fits with the values of patients wanting to recover, therapists wanting to offer support and line managers wanting to meet employer and employee needs.

Patients reported they could not have achieved RTW without the intervention, and their therapist helped them feel less alone. Therapists felt that their work was rewarding, effective and had good outcomes. Patients perceived remote delivery as less burdensome than attending in person. Therapists felt they wasted time on non-patient activity, such as (re-)arranging appointments.

Employers discussed the difficulty of balancing employer and employee needs and managing uncertainty. Some workplace policies lacked flexibility, and without the ROWTATE intervention, employers lacked confidence in supporting employees RTW.

A VR intervention delivered remotely by OTs and CPs is acceptable to patients, therapists and employers.

ISRCTN43115471.