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Stereotactic ablative radiotherapy versus video-assisted lobectomy for operable stage I non-small-cell lung cancer: study protocol for an emulated target trial

Por: Bedir · A. · Hassan · L. · Wittenberg · I. · Müller · J. A. · Oesterling · F. · Walles · T. · Stang · A. · Vordermark · D. · Medenwald · D.
Introduction

Video-assisted thoracoscopic surgery (VATS) lobectomy is a commonly employed surgical technique for the management of operable early stage non-small cell lung cancer (NSCLC). This procedure, however, is dependent on the patient’s ability to tolerate surgery. In light of this, stereotactic ablative radiotherapy (SABR) has emerged as a viable alternative treatment strategy for patients who are inoperable or who refuse surgery. Considering the lack of randomised controlled trials and the increased risk of bias in observational cohort studies, this study protocol proposes an emulated target trial design to investigate the causal effect of SABR, in comparison to VATS, on overall survival in operable early stage NSCLC patients.

Methods and analysis

Data on NSCLC patients will be collected from routinely collected university hospital records linked with German cancer registry data. This study protocol was developed using the target trial methodology outlined by Hernan et al. The protocol establishes specific parameters for key trial components in order to mitigate bias in the analysis of observational data and to facilitate the calculation of causal estimands. The target trial design that would be emulated is a multicentre open-label two-parallel arm superiority randomised trial. Mediators and confounding variables were determined through the use of a directed acyclic graph. The statistical analysis aims to measure the per-protocol and intention to treat effect of SABR versus VATS within 3 months of diagnosis, on survival, through the difference in restricted mean survival times, using weighted non-parametric Kaplan-Meier curves.

Ethics and dissemination

The Ethics Committee of the Medical Faculty of Martin Luther University Halle-Wittenberg with an approved addendum with Dnr 2023–112 has approved this study. The study uses anonymised routinely collected hospital and cancer registry data in accordance with applicable data protection regulations. Results will be disseminated through peer-reviewed publications and presentations at scientific conferences.

Health worker capacity-building interventions and quality of primary healthcare delivery in sub-Saharan Africa: a systematic review protocol

Por: Amu · H. · Dzadza · A. E. L. A. · Glover · R. M. · Akpene · D. A. · Tiah · J. A. Y. · Agula · C. · Bawah · A. A.
Background

Achieving high-quality primary healthcare (PHC) remains essential to improving health systems performance and advancing progress towards attainment of universal health coverage, particularly in sub-Saharan Africa (SSA), where gaps in service delivery persist. Capacity-building interventions, such as mentorship, in-service training and supportive supervision, have been widely employed to improve the quality of PHC delivery. The evidence base is, however, fragmented across diverse settings, intervention types and outcome measures. This systematic review will examine the evidence on how capacity-building interventions improve the quality of PHC services in SSA, with a focus on the domains of effectiveness, safety, people-centredness, timeliness, equity, integration and efficiency as propounded by the WHO.

Methods

We will conduct a systematic review using established evidence synthesis methods and report the findings in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines. Eligible studies will include peer-reviewed and grey literature published in English between 2000 and 2025, focusing on capacity-building interventions aimed at improving PHC quality in SSA. We will search databases including PubMed, Embase, Web of Science, Scopus, Google Scholar and the African Journals Online. Study selection will follow the Population (PHC providers), Exposure (capacity-building interventions) and Outcome (quality of PHC delivery across WHO domains) framework. Quality assessment will use the Mixed Methods Appraisal Tool (MMAT). Data will be narratively synthesised using Atlas.ti software.

Ethics and dissemination

Ethical approval is not required because there will be no collection of primary data. Only published studies/records available on peer-reviewed literature and grey sources will be included. Findings will be disseminated through a peer-reviewed journal, academic conferences and stakeholder platforms in SSA.

Registration

The protocol has been registered in PROSPERO (CRD420251131534) and reported according to PRISMA-P guidelines.

Combining structured exercise with a low-energy diet to attenuate lean mass loss in South Asian adults living with type 2 diabetes: the COMBINE randomised trial protocol

Por: Arsenyadis · F. · Henson · J. · McCarthy · M. · Papamargaritis · D. · King · J. A. · Redman · E. · Whelehan · G. · Wilkinson · T. · Sargeant · J. · Rowlands · A. · Boule · N. · Dasgupta · K. · McCann · G. P. · Davies · M. J. · Khunti · K. · Choudhary · P. · Yates · T.
Introduction

The global prevalence of type 2 diabetes (T2D) is rising and disproportionately affects South Asian adults, including those in the United Kingdom. South Asians develop T2D at a higher rate and at a younger age than their white British counterparts, at a lower body mass index. Active efforts to reduce adiposity can improve glycaemic control and in some cases achieve T2D remission. However, a substantial proportion of lean mass is lost while achieving weight loss, which may have physiological and metabolic consequences, affecting long-term health outcomes and quality of life for people living with T2D and obesity. We are examining the impact of a combined low energy diet and supervised exercise intervention versus a low energy diet alone for the preservation of lean mass in an understudied South Asian population living with T2D and excess adiposity.

Methods and analysis

This prospective, randomised, two-arm parallel-group, open-label, blinded-endpoint trial is being conducted in Leicester, UK. 36 South Asian adults aged 40–65 years within 10 years of T2D diagnosis and not on insulin therapy will be enrolled. Both intervention arms will receive an 800–900 kcal/day low energy diet for 12 weeks. Those randomised to the exercise group will additionally receive a mixture of supervised and home-based resistance and aerobic exercise training three times per week. The primary outcome is the difference in the change of lean mass between groups measured using dual-energy X-ray absorptiometry at baseline and 12 weeks and will be analysed using linear regression modelling.

Ethics and dissemination

The trial was approved by the NHS research ethics service (23/WM/0201). All participants will provide informed consent prior to enrolment, and the study will be conducted in accordance with the Declaration of Helsinki. Findings will be shared widely (publications, presentations, press releases, social media platforms) and will inform an effectiveness trial.

Trial registration number

ISRCTN11175684.

Deaths with preceding hospitalisations within 180 days in eight countries in sub-Saharan Africa and South Asia: A secondary descriptive analysis of the Child Health and Mortality Prevention Surveillance (CHAMPS) network

Por: Varo · R. · Cole · K. · Madewell · Z. J. · Iglesias · J. F. · Igunza · K. A. · Akelo · V. · Mugah · C. · Onyango · D. · Were · J. A. · Madhi · S. A. · Dangor · Z. · Johnstone · S. · Lala · S. G. · Ruder · T. · Mandomando · I. · Kincardett · M. · Xerinda · E. G. · Scott · J. A. G. · Assefa
Objectives

To describe (1) the proportion of deaths that were in recently hospitalised children and (2) causes of mortality among deceased children aged 0–59 months with preceding hospitalisations who enrolled in a mortality surveillance programme.

Design

Descriptive study using prospectively collected data.

Setting

Eight Child Health and Mortality Prevention Surveillance (CHAMPS) community and healthcare sites in sub-Saharan Africa and South Asia.

Participants

Deaths among children aged 0–59 months enrolled in CHAMPS 2016–2023.

Interventions

None.

Primary and secondary outcome measures

Deaths with antecedent hospitalisations within 180 days of death. Causes of death determined by expert panels who reviewed clinical data and histopathologic and microbiologic results from postmortem minimally invasive tissue sampling.

Results

CHAMPS enrolled 8548 deaths; we excluded 3688 neonates who died before discharge or ≤24 hours of birth and 482 with unclear information on antecedent hospitalisations. Out of the 4378 remaining deaths, 16.7% (95% CI 15.7% to 17.9%) were deaths that occurred within 180 days of a hospitalisation (n=733/4378). Of these, 55.7% (95% CI 52.0% to 59.3%) occurred outside healthcare facilities. Among included deaths with minimally invasive tissue sampling completed (n=337), lower respiratory tract infections (41.2%, 95% CI 36.0% to 46.7%), sepsis (39.8%, 95% CI 34.5% to 45.2%) and undernutrition (n=92, 27.3%, 95% CI 22.7% to 32.4%) were most common causes of death among cases with antecedent hospitalisations. The greatest proportion of deaths with antecedent hospital admissions occurred among cases aged 1–11 months (48.0%, 95% CI 44.4% to 51.7%), compared with those aged 0–1 months (21.7%, 95% CI 18.8% to 24.9%) and those aged 1–5 years (30.3%, 95% CI 27.0% to 33.8%). Moreover, the greatest proportion of deaths with antecedent hospital admissions occurred among infants/children with weight-for-age Z-score of

Conclusions

We observed a high proportion of deaths with antecedent hospitalisations within 180 days among young children across eight sites in sub-Saharan Africa and Asia. Among those deaths, children aged 1–11 months and undernourished infants were over-represented, suggesting early follow-up as a potential point to focus targeted support and future research.

Effectiveness of manual diaphragmatic techniques in adults with non-specific low back pain: a systematic review and meta-analysis protocol

Introduction

Non-specific low back pain (NSLBP) is one of the leading causes of disability worldwide. Emerging evidence suggests that altered diaphragmatic function may be associated with lumbar pain, impaired trunk stabilisation and functional disability. Manual diaphragmatic techniques have been proposed as an intervention to modulate diaphragmatic tension, mobility and neuromyofascial relationships; however, their effectiveness has not yet been synthesised using rigorous systematic review methods.

Methods and analysis

This protocol follows Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidance and has been prospectively registered in PROSPERO. Randomised controlled trials evaluating manual techniques specifically applied to the diaphragm in adults with NSLBP will be eligible. The primary outcomes will include pain intensity and functional disability; secondary outcomes will include lumbar mobility, respiratory function, quality of life and adverse events. Searches will be performed in PubMed/MEDLINE, Cochrane CENTRAL, PEDro, CINAHL, Scopus, Embase and clinical trial registries without language or date restrictions. Two reviewers will independently perform study selection, data extraction and risk-of-bias (RoB) assessment using the Cochrane RoB 2 tool. Where appropriate, a random-effects meta-analysis will be conducted; the certainty of evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluation approach. Substantial clinical and methodological heterogeneity is anticipated across trials, which may limit the feasibility of quantitative data pooling.

Ethics and dissemination

As this study uses data from previously published trials, ethical approval is not required. Findings will be disseminated through peer-reviewed publication, conference presentations and a plain-language summary for clinical stakeholders.

PROSPERO registration

CRD420251172616.

How to measure the effectiveness of healthcare providers acting as an 'anchor institution: a case study of the NHS in Greater Manchester, England

Por: Wattal · V. · Camacho · C. · Gkiouleka · A. · Ford · J. A. · Munford · L. A.
Objectives

To improve social determinants of health, healthcare organisations can support societal and economic goals in their role as anchor institutions (large organisations with an important presence and ties to a place). In England, the National Health Service (NHS) Long Term Plan highlighted the role of the NHS as an Anchor. Despite a clear policy mandate on this, less is known about specific indicators to measure and benchmark anchor performance. A set of metrics was developed to quantify anchor activity using the Greater Manchester (GM) region in England as a case study.

Design

Descriptive cross-sectional study.

Setting

Data were received on employment and procurement for the financial year 2022/2023 from NHS trusts located in GM.

Primary and secondary outcome measures

Performance against two anchor metrics, local spending and employment, was assessed. ‘Local’ was defined as the Integrated Care Board (ICB) footprint in which the trusts are located. The proportion of procurement spend to the local economy was derived from procurement data. Employment data was aggregated by ethnicity codes and deprivation levels and compared with ICB-level ethnicity and deprivation profiles using the Index of Multiple Deprivation based on 2021 Census data.

Results

The included trusts employed 65 597 residents of GM and spent £389 million on local procurement, demonstrating their importance as anchor organisations. Considerable variation was observed between trusts in local spending, ranging from 6.4% (95% CI 6.4% to 6.41%) to 52.7% (95% CI 52.69% to 52.72%) (with the mean at 21%). The percentage of locally employed staff ranged from 82.7% (95% CI 81.45% to 83.90%) to 89.5% (95% CI 89.12% to 89.95%). All trusts demonstrate strong workforce representation from minoritised ethnic groups, but most employed a lower proportion of staff from the most deprived areas than expected based on the local population profile.

Conclusions

It is feasible to quantify aspects of anchor activity using routine NHS data, and meaningful variation exists across trusts, even within a single health system. GM provides a useful case study, but further work is needed to embed anchor metrics in routine reporting and to extend measurement to other domains such as estates and sustainability.

MULTIsite feasibility of MUSIc therapy to address Quality Of Life in Sickle cell disease (MULTI-MUSIQOLS): protocol for a mixed-methods randomised controlled trial at two US medical centres

Por: Rodgers-Melnick · S. N. · Gorthi · V. · Foss · A. · Erande · A. · DiFrancesco · K. · Owusu-Ansah · A. · Anim · S. · Bretz · S. · Ketter · P. · Fuqua · T. · Anderson · A. R. · Karasz · A. · Bailey · L. · Ezenwa · M. · Jenerette · C. · Dusek · J. A.
Introduction

Accessible, person-centred, non-pharmacologic modalities are needed to address chronic pain and health-related quality of life (HRQoL) among individuals with sickle cell disease (SCD). Building off prior single-site pilot studies of music therapy (MT) in SCD, the purpose of this study is to (1) examine the data collection processes and intervention implementation overall and across two sites and (2) evaluate the implementation of the MT and health education interventions using quantitative and qualitative data.

Methods and analysis

This three-arm, two-site, feasibility randomised controlled trial will include 90 individuals ≥14 years who have SCD, chronic pain and access to a mobile device who are not currently engaged in mind-body pain management interventions under the supervision of a healthcare professional. Participants will be randomised to six sessions over 8 weeks of either: (1) in-person MT, (2) hybrid (one in-person, five virtual) MT or (3) hybrid health education. Patient-reported outcome measures of HRQoL and self-efficacy will be assessed at baseline, post-intervention and 6 weeks post-intervention. 24 participants (eight per arm) and 20 stakeholders (eg, haematologists, music therapists, nurses) will be invited to complete semi-structured interviews to further examine intervention acceptability, perceived benefits and implementation. Sessions will be monitored for fidelity, and participants lacking access to home internet or videoconferencing technology will be provided tablets to engage in virtual sessions. Feasibility will be determined by rates of data completion, recruitment, retention, session attendance and home practice.

Ethics and dissemination

This study was approved by the University Hospitals Cleveland Medical Center Institutional Review Board (STUDY20231055). The dissemination plan includes presenting findings at national and international scientific conferences and publishing in peer-reviewed journals. All activities will be conducted in collaboration with SCD community stakeholders.

Trial registration number

NCT06853158.

Organ failure type in fatal and near-fatal anaphylaxis: a systematic review

Por: McKenzie · B. · Marshall · S. D. · Sanci · L. · Poonian · J. · Nair · R. · J Selman · C. · Douglass · J. A.
Objectives

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.

Design

Systematic review of published peer-reviewed literature.

Data sources

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

Eligibility criteria

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.

Data extraction and synthesis

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.

Results

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.

Conclusion

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.

PROSPERO registration number

CRD42023434206.

Harm reduction and pharmacy practice: a scoping review of services for people who use drugs provided by pharmacy staff

Por: Navarrete · J. · Berg · E. · Hughes · C. · Salokangas · E. · Taylor · M. · Kung · J. Y. · Johnson · J. A. · Hyshka · E.
Objectives

The roles of pharmacy staff have expanded to include public health functions, such as delivering harm reduction services for people who use drugs (PWUD), particularly unregulated substances and non-medical drug use, in response to an ongoing drug overdose crisis. Nonetheless, their involvement across the full spectrum of harm reduction services remains underexplored. This study mapped existing research describing or evaluating the implementation of harm reduction services for PWUD provided by pharmacy staff.

Design

Scoping review.

Data sources

MEDLINE, EMBASE, CINAHL, Web of Science, Scopus and Cochrane Library (inception to July 2025).

Study selection

Studies reporting on the description or evaluation of harm reduction services for PWUD provided by pharmacy staff.

Data extraction

Two team members screened studies for eligibility and extracted the data. The data were analysed primarily to describe harm reduction services and the role of pharmacy staff.

Results

43 articles were included. The most frequently reported harm reduction services were sexually transmitted and blood-borne infection care (33%), needle and syringe programmes (21%), naloxone distribution (19%) and medication treatment for opioid use disorder (19%). Pharmacy staff were integrated into multidisciplinary teams (79%), with their roles varying from education to medication prescribing. Included studies reported harm reduction services for PWUD delivered by pharmacy staff as effective, feasible and safe. However, implementations were not tailored to equity-deserving populations. Services primarily addressed opioid-related harms, while strategies focusing on the use of non-opioid substances were limited.

Conclusion

This scoping review highlights the diverse roles pharmacy staff play in delivering harm reduction services for PWUD. Positioned at the intersection of accessibility and healthcare delivery, pharmacy staff are ideally situated to expand access to equitable care. To fully harness this potential, future research and practice should embed harm reduction as a core philosophy, extending beyond individual interventions to support the creation of person-centred, non-judgmental and low-barrier services.

ALARUM: Active One Health surveillance in LMICs to monitor and predict Antimicrobial Resistance Using Metagenomics - a cross-sectional study protocol

Por: van der Sande · M. A. B. · Valia · D. · Tigoi · C. · Stoesser · N. · Stamm · L. · Marten · A. · Riems · B. · Musyimi · R. · Sibidou · Y. · Schurch · A. C. · Tiendrebeogo · E. W. · Mwaringa · S. · Kohns Vasconcelos · M. · Ingelbeen · B. · Tinto · H. · Bielicki · J. A. · Cooper · B. S. · B
Background

In rural sub-Saharan Africa (sSA), the burden of antimicrobial resistance (AMR) remains high. As AMR continues to rise, there is a strong need for practical, implementable surveillance to monitor and mitigate risks, as well as inform timely, evidence-based clinical decision-making. Emerging evidence points to possible community-level drivers, such as transmission between human, animal and environmental reservoirs as contributing factors, yet microbiological surveillance or opportunities for wastewater-based surveillance are often limited and insufficient in these settings. Therefore, alternative sustainable and affordable approaches are needed. We intend to build on the demonstrated potential of metagenomic profiling of pooled faecal material, which accurately predicted population-level AMR prevalence in invasive Enterobacterales infections.

Methods and analysis

We aim to validate this metagenomic pooled approach on additional populations, and to evaluate whether AMR patterns could be similarly predicted from surveillance of community One Health reservoirs. We will assemble existing data from hospital-based microbiology diagnostic laboratories in rural Burkina Faso and Kenya, and determine to what extent community-level metagenomic data, and/or faecal material of patients on hospital admission, can predict AMR in clinical isolates. We will perform community-level surveys in eight clusters per country, randomly selecting 15 households per cluster. We will systematically sample suspected environmental AMR exposure sites in and around households (soil, drinking water, latrines, chicken faeces) and collect data on community-level antibiotic use, hygiene practices, contact with domestic animals and sanitary facilities. Samples and data will be collected twice: during the dry and during the rainy season.

In addition to evaluating the accuracy of predicting resistance in clinical isolates, we will quantify community-level exposure risks. We will conduct metagenomic profiling on pooled DNA extracts from human stool samples (hospital and community-level) and from household environments. Bayesian statistical models will quantify relationships between AMR gene abundance in the environment and in human stool, and invasive bacteria identified among clinical patients, accounting for geography and seasonality. A cost-utility analysis will determine under what circumstances the use of pooled metagenomic data to inform empirical antibiotic policies would represent an efficient use of resources.

Ethics and dissemination

The proposed surveillance protocol is developed in partnership with local communities and local and international researchers and has received ethical approval in Kenya and Burkina Faso. It will assess whether intermittent, pooled-sample metagenomics provides a viable, low-cost and practical approach for population-level AMR surveillance in settings that—like many in rural sSA—lack systematic microbiological diagnostics and where sewage systems for wastewater-based surveillance are absent. By providing an alternative to routine microbiological-based surveillance where this proves challenging to implement, this approach may help improve treatment outcomes, contribute to equity and public health. Findings will be disseminated through peer-reviewed publications and academic conferences and will contribute to the recently proposed WHO AMR surveillance strategy, which combines survey-based approaches with routine AMR surveillance.

'Its never one size fits all: a qualitative exploration of vision-impaired patients preferences for mental health support

Por: Scott · J. A. · Gillard · J. · Vasconcelos e Sa · D. · Oliver · A. · Hawkins · R. · Pardhan · S.
Introduction

It is widely known that a diagnosis of visual impairment has significant mental health impacts. Proposed approaches to addressing these include cognitive behavioural, problem-solving and stepped care solutions.

Objectives

Limited research has focused specifically on vision-impaired patients’ preferences for mental health support following diagnosis. This study aimed to address this gap.

Design

The study was qualitative and cross-sectional, involving thematic analysis of semistructured interviews with patients diagnosed with vision impairment.

Participants

Twenty vision-impaired patients, aged from 20 to 84 years old and with a range of diagnoses, were interviewed regarding their experience of and recommendations for mental health support at the point of diagnosis and thereafter.

Results

Three main themes were identified: (1) Mapping the Journey: The Critical Role of Accessible Information, (2) Navigating the Emotional Impact: Help-Seeking Attitudes and Experiences and (3) Tailored Mental Health Support: Timing, Delivery and Preferred Providers. Each theme had three subthemes.

Conclusions

It was concluded that clear information about diagnosis, prognosis and available supports is fundamental to promoting and maintaining mental health for vision-impaired patients. Person-centred and/or peer support is highly valued. To be maximally effective, specific mental health support should be informed by knowledge of vision impairment, with standardised treatment programmes not being valued highly. The study results strongly suggest that mental health support needs to be tailored to the unique needs of each individual, and therefore, a stepped care approach may be most helpful, encompassing clear information, practical advice and ongoing peer and professional support.

Epidemiological investigation of perinatal depression among pregnant and postpartum women: findings from a cross-sectional survey in the Philippines

Por: Filoteo · J. A. · Maravilla · J. C. · Mamaat · J. E. · Flores · A. D. · Jumamil · A. N. · Cardenas · R. L. · Quijencio · W. · Bayani · M. A. · Santos · N. · Acena · J. L. · Alfonso · A. L. · Rivera · M. · Guarino · R. · Sarmiento · R. · Flenady · V. · Boyle · F. M. · Loughnan · S. A. · T
Objective

This study investigated perinatal depressive symptoms among pregnant and postpartum Filipino women.

Design

Cross-sectional survey.

Setting

The Philippines.

Participants

Participants were recruited online and face-to-face from maternal care facilities.

Primary outcome measure

Perinatal depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS) score, with prevalence calculated based on ≥13 cut-off, indicating clinically significant symptoms of depression. Patterns of depressive symptoms were examined by demographics, perinatal time period and other obstetric information using adjusted regression coefficients (ab) and risk ratios (aRR).

Results

A total of 856 women participated in the study, comprising 356 pregnant and 500 postpartum women. EPDS scores were, on average, similar between pregnant (14.4) and postpartum women (14.1). Using the locally validated cut-off of ≥13 revealed that 69.1% of pregnant and 62.0% of postpartum women reported clinically significant depressive symptoms. Consistent EPDS scores and prevalence were observed across pregnancy trimesters and within 12 months postpartum and beyond. Women who received adequate prenatal care were less likely to experience antenatal (ab=–1.59, 95% CI –3.13 to –0.05) and postpartum (ab=–1.30, 95% CI –2.48 to –0.12) depressive symptoms. Postpartum EPDS scores and depressive symptom prevalence (EPDS score ≥13) were higher among 18–24-year olds (ab=1.96, 95% CI 0.30 to 3.61; aRR=1.23, 95% CI 1.03 to 1.47) and single mothers (ab=3.46, 95% CI 0.22 to 6.71; aRR=1.42, 95% CI 1.07 to 1.90), compared with older and married mothers, respectively.

Conclusions

At least 60% Filipino mothers experienced clinically significant perinatal depressive symptoms, which exceeds the established global average of 25%. Younger and single postpartum women were at greater risk, while pregnant and postpartum women who attended adequate prenatal visits were less likely to report depressive symptoms. Our study underscores the need for further research to uncover the true burden of poor perinatal mental health and calls for targeted early interventions and integrative public health strategies to support at-risk mothers, particularly those from socially disadvantaged backgrounds.

Feasibility and efficacy of virtual reality rehabilitation for upper extremity impairment in ischaemic stroke patients: an open-label, parallel-group, randomised controlled trial

Por: Sylaja · P. N. · PR · S. · Paul · R. · Chakravarthy · S. · Sinha · A. · Bapi · R. S. · Kesavadas · C. · Bharath · R. D. · Sarma · P. S. · Elango · S. · Hafsath · S. · Darshini · D. · F · A. J. A. · Dhasan · A. · Sambath · S. · Amal · M. G. · R S · A. · Akhil · S. · Devan · H. S. · Anjana Mad
Objective

The study evaluated the feasibility and efficacy of a non-immersive virtual reality (VR) system on upper extremity (UE) recovery in ischaemic stroke patients in comparison to a conventional physiotherapy.

Design

An open-label, parallel-group, randomised controlled trial randomly assigned the participants to two groups, VR intervention or conventional physiotherapy.

Setting

Two tertiary stroke care centres in South India participated in the study.

Participants

Sixty first-ever ischaemic stroke patients (1–6 months of stroke onset) having spasticity grades of 1 or 1+ as per Modified Ashworth scale and Brunnstrom recovery stages of 3, 4 or 5 in the UE were included in the intention-to-treat analysis.

Intervention

High-intensity non-immersive VR-based comprehensive rehabilitation gaming system with a duration of 12 weeks (3 days/week) was compared with equally intensive conventional physiotherapy.

Primary and secondary outcome measures

The feasibility outcome was the compliance with the treatment. The primary efficacy outcome was the improvement in the motor function assessed by the Fugl-Meyer assessment (FMA) and Wolf motor function test (WMFT). The secondary outcomes included the performance in activities of daily living by the Barthel index (BI) and the quality of life by the 36-item short form health survey (SF-36).

Results

The treatment compliance was similar in two groups (p=0.19). Both groups improved in motor performance, activities of daily living and quality of life. However, there were no significant differences in the FMA (p=0.58), WMFT (functional ability scale, p=0.33; performance time, p=0.44), BI (p=0.84) and SF-36 (physical, p=0.87; mental, p=0.99) scores between the groups.

Conclusions

The non-immersive VR system was feasible, effective and safe; however, it was not found to be superior to conventional physiotherapy. The trial was stopped early and did not reach its proposed sample size and hence, the findings are to be interpreted cautiously.

Trial registration number

Clinical trial registry India: CTRI/2021/11/038339 (https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NTc1OTI=&Enc=&userName=CTRI/2021/11/038339).

Protocol for a biomarker discovery study to identify correlates of risk for future tuberculosis disease progression in South African children (INTREPID)

Por: Hamilton · M. S. · Derks · I. P. · Kaforou · M. · Dunbar · R. · McNamara · R. P. · Fortune · S. M. · Basu-Roy · R. · van Deventer · A. · Bosch · C. · Dunican · C. · van der Zalm · M. M. · Levin · M. · Schaaf · H. S. · Altin · J. A. · Hesseling · A. C. · Seddon · J. A.
Introduction

Young children and children living with HIV are at high risk of progressing to tuberculosis (TB) disease following Mycobacterium tuberculosis (Mtb) exposure and infection, and also of developing severe forms of disease and TB-related mortality. Identifying children who have very early (sub-clinical) TB disease, prior to progression to clinically apparent TB, would mean that TB preventive treatment (TPT) could be more efficiently targeted to this group. Identifying biomarker changes on drug therapy in children with Mtb infection or very early disease could pave the way for the development of tests that can identify which children have viable bacilli and are therefore at increased risk of disease progression.

Methods and analysis

The INTREPID study will use already collected samples taken from well-phenotyped paediatric cohorts in three clinical studies conducted in South Africa in children Mtb exposure to disease and from children treated for Mtb infection and early TB disease, as well as targeted Mtb antibody analysis. Data on viral co-infections and relevant clinical and epidemiological parameters will be integrated and evaluated to identify the optimal biosignatures that can predict future progression to clinically overt disease in children below 5 years of age, including those living with HIV.

Ethics and dissemination

The study protocol received ethical approval from the Stellenbosch University Health Research Ethics Committee (N23/03/025). The study findings will be disseminated through peer-reviewed publications, scientific conferences and formal presentations to healthcare professionals and to local communities, in collaboration with the Desmond Tutu TB Centre Community Advisory Board.

Perioperative intravenous fluid management in paediatric surgery: a scoping review protocol

Por: Sanchez · V. L. · Pinzon Rodas · V. · Cabra-Bautista · G. · Florez · I. D. · Klimek · M. · Calvache · J. A.
Introduction

Intravenous fluids are essential components of perioperative care, supporting intravascular volume, acid–base balance and electrolyte homeostasis. Despite extensive research in adult surgical populations, paediatric-specific evidence remains limited, and clinical practice frequently relies on extrapolated adult-based recommendations. This gap is particularly relevant in paediatric non-cardiac surgery, where fluid choice may influence key physiological outcomes such as acid–base status, electrolyte balance, renal function and haemodynamic stability. Given the heterogeneity of study designs, perioperative phases, age groups and reported outcomes in the paediatric literature, a comprehensive synthesis of the existing evidence is needed before a systematic review can be undertaken.

Methods and analysis

We will conduct this scoping review following the methodological guidance of the Joanna Briggs Institute Manual for Evidence Synthesis, and the reporting will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guideline.

This scoping review will map existing evidence on perioperative intravenous fluid management in paediatric patients (

Eligibility is framed using participants, concept and context: paediatric patients (

Ethics and dissemination

This scoping review involves no primary data collection and relies exclusively on published literature; therefore, formal ethical approval is not required. The protocol received administrative approval from the Comité de Ética para la Investigación Científica of Universidad del Cauca (approval no. 6553, 11 June 2025). Findings will be disseminated through peer-reviewed publications, conference presentations and targeted communication with paediatric anaesthesia and surgical communities.

Causal language jumps and non-alignments between clinical practice guidelines and original studies: a systematic evaluation of diabetes guidelines and their cited evidence

Por: Wang · K. · Wei · C. · Labrecque · J. A.
Objectives

Clinical practice guidelines are designed to guide clinical practice and often make causal claims when making recommendations. Sometimes, guidelines make or require stronger causal claims than supplied in the original studies, a phenomenon we call ‘causal language jump’. We aimed to evaluate the strength of expressed causation in guidelines and the evidence they reference to assess the pattern of jumps, taking diabetes as an illustrative example.

Design

This is a systematic evaluation of guidelines and original studies cited by them, using scoping review design with deviations.

Data source

Randomly sampled 300 guideline statements (narrative sentences describing evidence to support recommendations) from four selected diabetes guidelines.

Eligibility criteria

The eligible guidelines should focus on non-pharmacological treatments or preventive strategies for adult type 2 diabetes mellitus management and related complications. The eligible action recommendations and guideline statements should intend to support non-pharmacological treatments or preventive strategies of type 2 diabetes or in a general diabetic context.

Data extraction and synthesis

We rated the causation strength in the statements and the dependence on causation in recommendations supported by these statements using existing scales. Among the causal statements, the cited original studies were similarly assessed. We then evaluated jumps by checking if the causal claims in guideline statements were stronger than in original studies, and if the causation-dependence in guideline recommendations was stronger than supplied in guideline statements. We also assessed how well they report target trial emulation (TTE) components as a proxy for reliability.

Results

Of the 300 statements, 114 (38.0%) were causal, and 76 (66.7%) expressed strong causation. 27.2% (31/114) of causal guideline statements stated stronger causation than any of their references and demonstrated ‘causal language jump’; 34.9% (29/83) of guideline recommendations required stronger causation than provided in statements. Of the 53 eligible studies for TTE rating, most did not report treatment assignment and causal contrast in detail. The prevalence of these jumps could be partially attributed to the suboptimal use of causal and associational words.

Conclusions

Causal language jumps were common among diabetes guidelines. While these jumps are sometimes inevitable, they should always be justified by good causal inference practices.

Direct healthcare costs associated with sickle cell disease complications: a retrospective cohort study using routinely collected healthcare data in England

Por: Barcelos · G. T. · Besser · M. · Davidson · J. A. · Filonenko · A. · Telfer · P. · Joao Carvalho · S. · Jiang · L. · Wirz · R. · Rice · C. T.
Objectives

Due to the multisystemic nature of sickle cell disease (SCD), complications can occur together and thus discerning costs associated with individual complications requires a methodology that can estimate the costs of a given complication while accounting for the presence of other complications. In this study, we aimed to estimate period-based incremental costs associated with specific chronic complications in patients with SCD in England while accounting for multimorbidity.

Design/setting

All-cause primary and secondary care healthcare resource utilisation (HCRU) was obtained for a retrospective cohort of patients with SCD using Clinical Practice Research Datalink (CPRD) Aurum linked to Hospital Episode Statistics (HES) datasets. Annualised HCRU and costs were calculated, dividing patient-level events by patient-level time (in years) to obtain per person per year estimates. A series of generalised linear models were used with adjustment for demographic factors and proportion of follow-up time with each complication to estimate the costs associated with 10 chronic SCD-related complications of interest. For these costs, annual equivalent costs can be obtained by dividing by the median follow-up time of 4.74 years.

Participants

Patients with a diagnosis of SCD, with or without complications, in CPRD or HES with at least 12 months follow-up.

Outcome measures

Period-based all-cause direct healthcare costs.

Results

Of the 1271 patients with SCD included in the study, 49.9% (n=634) had at least one complication and of these 41.3% (n=262) had two or more complications either at baseline or during follow-up. Patients with complications had higher all-cause healthcare costs compared with patients without complications (mean (SD) annualised cost £16 058 (£21 488) vs £4399 (£6635)). Patients with complications had four times the number of annualised inpatient admissions (6.1 vs 1.5 admissions) and more than double the number of annualised bed days in hospital (8.3 vs 3.8 days) over a median 4.74 years of follow-up. Of the complications evaluated, end-stage renal disease had the highest estimated incremental cost of £252 083 (95% CI £214 478 to £283 745) over 4.74 years; this is in addition to the £18 547 period-based cost among patients with SCD without complications. Osteonecrosis was the most common complication with an estimated incremental cost of £27 399 (95% CI £6417 to £43 319) over the same period.

Conclusion

Estimating the cost of complications, while accounting for multimorbidity, is essential to determine the true direct cost of SCD. The modelling method presented in our study provides period-based estimates of cost and hospital admissions for individual complications in patients with SCD, accounting for multimorbidity. This approach can be used and extended to other diseases with multisystemic complications to estimate the direct HCRU and costs of individual complications.

Generating actionable insights to support point-of-care suicide risk decision-making in a safety-net healthcare system: a machine learning approach to predicting dynamic risk of intentional self-harm

Por: Sarkar · J. · Ghosh · A. · Liu · S. · Martinez · B. · Teigen · K. · Rush · J. A. · Blackwell · J.-M. · Shaikh · S. · Claassen · C.
Background

Suicide rates have increased over the last couple of decades globally, particularly in the United States and among populations with lower economic status who present at safety-net healthcare systems. Recently, predictive models for suicide risk have shown promise; however, a model for this specific population does not exist.

Objective

To develop a predictive risk model of suicide and intentional self-harm (ISH) for patients presenting at the psychiatric emergency department (ED) of JPS Health Network, a safety net medical and mental healthcare system in Texas.

Methods

The study used structured and unstructured electronic medical record (EMR) data (2015–2019) and local medical examiner data (2015–2020) to create predictors and outcome variables. All psychiatric ED notes during calendar years 2018 and 2019 were reviewed using natural language processing to identify presentations for any level of self-harm and subsequent manual review of identified visits to accurately classify ED presentations for treatment of an act of intentional self-harm meeting study criteria. Data from 15 987 patients were used to develop and validate a machine learning-based predictive model that leverages rolling window methodology to predict risk repeatedly across a patient’s trajectory. Feature engineering played a prominent role in defining new predictors.

Findings

The best model (XGBoost) achieved the area under the receiver operating characteristic curve of 0.81 for 30-day predictions and demonstrated concentration of ISH and suicide attempt events in high-risk quantiles of risk (65% had events in top 0.1% quantile). The predicted risk can be translated into a propensity of events (80% at the highest predicted risk) to facilitate clinical interpretation.

Conclusions

Machine learning-based models can be used with standard EMRs to identify patients presenting at the psychiatric ED with a high risk of ISH and suicide attempts within the next 30 days.

Clinical implications

Integration of a predictive model can significantly aid clinical decision-making in safety-net psychiatric EDs.

Agreement testing of AMSTAR-PF, a tool for quality appraisal of systematic reviews of prognostic factor studies

Por: Henry · M. L. · OConnell · N. E. · Riley · R. D. · Moons · K. G. M. · Shea · B. J. · Hooft · L. · Wallwork · S. B. · Damen · J. A. A. G. · Skoetz · N. · Appiah · R. P. · Berryman · C. · Crouch · S. M. · Ferencz · G. A. · Grant · A. R. · Henry · K. M. · Herman · A. M. · Karran · E. L. · K
Objectives

To test the agreement and usability of a novel quality appraisal tool: A MeaSurement Tool to Assess systematic Reviews of Prognostic Factor studies (AMSTAR-PF).

Design

Observational study.

Participants

14 appraisers of varied experience levels and backgrounds, including undergraduate, master’s and PhD students, postgraduate researchers, research fellows and clinicians.

Study procedure

Eight systematic reviews were rated by all reviewers using AMSTAR-PF.

Outcome measures

Planned measures included intrapair and inter-pair agreement using Cohen’s and Fleiss’ kappa, time of use and time to reach consensus. Interrater agreement was an added measure, and Gwet’s agreement coefficient was calculated and presented due to its greater stability across agreement levels. The percentage of intrapair agreements identical or one category apart was also presented.

Results

Interrater agreement averaged 0.59 (range 0.21–0.90), inter-pair agreement 0.61 (range 0.24–0.91) and intrapair agreement 0.75 (range 0.45–0.95) across the domains, with agreement for the overall rating 0.46 (95% CI 0.30 to 0.62) for interrater agreement, 0.46 (95% CI 0.17 to 0.74) for inter-pair agreement and 0.68 (range of averages 0.22–1.00) for intrapair agreement. The majority (60.7%) of intrapair ratings were identical, with 94.6% of final ratings either identical or only one category different for the overall appraisal. The time taken to appraise a study with AMSTAR-PF improved with use and averaged around 34 min after the first two appraisals.

Conclusions

Despite some variance in agreement for different domains and between different appraisers, the testing results suggest that AMSTAR-PF has clear utility for appraising the quality of systematic reviews of prognostic factor studies.

Rationale and design of the REMECHOQUE multicentre registry protocol: evaluating therapeutic trends in cardiogenic shock

Introduction

Cardiogenic shock (CS) is a complex syndrome characterised by primary cardiac dysfunction. Despite advances in therapeutic options such as mechanical cardiac support, it remains associated with high mortality. Although previous registries have described heterogeneous populations and outcomes across different centres, contemporary real-world data on management practices remain limited. This gap is particularly evident in low- and middle-income countries, where there is no robust registry that clearly defines the current state of CS management. Therefore, a multicentre registry is needed to better characterise current practices and outcomes. Our study aims to gain insight into current therapeutic trends in Mexico, a low- to middle-income country with a significant cardiovascular disease burden.

Methods and analysis

The Mexican Registry of Cardiogenic Shock is a quality initiative that aims to identify therapeutic trends, demographic characteristics and clinical presentations. It also aims to evaluate outcomes, including mortality and cognitive function at in-hospital and 1-year follow-ups, and to identify areas for improvement in the care process across the broad spectrum of CS.

Ethics and dissemination

Ethical approval for this multicentre study was obtained from the local research ethics committees of all participating institutions. The study results will be disseminated to all participating institutions in the form of summary reports and presentations on completion of the analysis.

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