FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerTus fuentes RSS

Development and acceptability of a patient decision aid for people with degenerative cervical myelopathy: an international mixed-methods study

Por: Gamble · A. R. · Anderson · D. B. · McKay · M. J. · Davies · B. · Macpherson · S. · Van Gelder · J. · Hoffmann · T. · McCaffery · K. · Stevens · S. X. · Ammendolia · C. · Chauhan · R. V. · Zipser · C. M. · Boerger · T. F. · Tetreault · L. A. · Fehlings · M. G. · Dustan · E. · Nugent · C
Objectives

To develop and user-test a patient decision aid for people diagnosed with degenerative cervical myelopathy and who are considering surgery.

Design

Mixed-methods study describing the development of a patient decision aid.

Setting

A draft decision aid was developed by a multidisciplinary steering group (including study authors with degenerative cervical myelopathy, health professionals and researchers) informed by the best available evidence, authorship consensus and existing patient decision aids.

Participants

Patient-participants and health professional-participants who manage people with degenerative cervical myelopathy were recruited through social media and the steering group’s research and practice network. Quantitative questionnaires were used to gather baseline data, descriptive feedback, refine the decision aid and assess its acceptability. Qualitative semi-structured interviews were conducted online to gather feedback on the decision aid and were analysed using reflexive thematic analysis.

Results

We conducted 32 interviews: 19 patient-participants and 13 health professional-participants who manage people with degenerative cervical myelopathy (neurosurgeons, neurologists, physiotherapists, orthopaedic surgeons, general practitioners, rehabilitation and pain specialists and consultant occupational physicians and chiropractors). Participants were from 10 countries (Australia, Canada, Cyprus, Germany, Ireland, New Zealand, Sweden, Switzerland, United Kingdom and USA). Most participants rated the decision aid’s acceptability as good-to-excellent and agreed with most aspects of the decision aid (eg, defining degenerative cervical myelopathy, management recommendations, potential benefits and harms, questions to consider asking a health professional).

Conclusion

Our patient decision aid was rated as an acceptable tool by both health professional-participants who treat degenerative cervical myelopathy and patient-participants with lived experience of degenerative cervical myelopathy. This decision aid can be used by clinicians and people with degenerative cervical myelopathy to help with shared decision making following a diagnosis of degenerative cervical myelopathy. A study testing the potential benefits of this decision aid in a clinical setting is recommended.

Sick leave and engagement as workforce well-being proxies in hospital departments: a cross-sectional study of routinely collected organisational data in a Dutch academic hospital

Por: Bazuin · T. · Oerbekke · M. S. · Bontjer · S. · Reijmerink · I. M. · Dongelmans · D. A. · Franx · A. · Wietasch · J. K. G. · Hooft · L. · van der Laan · M. J.
Objectives

Well-being of healthcare professionals (HCPs) is vital for care quality, staff retention and overall healthcare system effectiveness. This study aims to identify the organisational and workplace variables associated with sick leave and measures of engagement of HCPs on department level within a single Dutch academic hospital.

Design

Cross-sectional study using routinely collected organisational data.

Setting

A tertiary-care academic hospital in the Netherlands.

Participants

25 clinical departments were included. Department level variables were derived from routinely collected hospital databases. Availability of data varied across variables. Analysis included information on patient population, human resources, care processes, quality of care and employee and patient experiences to assess differences, correlations and predictors for sick leave and engagement.

Primary and secondary outcome measures

Primary outcome measures were (1) sick leave (%) and (2) engagement, assessed through two staff-survey items (vitality and connectedness; 0–10 Numeric Rating Scale). Both outcomes were analysed at department level.

Results

Employee population data showed the most consistent patterns across analyses. Departments with higher staffing capacity had higher sick leave and lower engagement in group comparisons (p=0.009, p=0.030, respectively). In multivariable models, higher staffing capacity remained associated with increased sick leave (B=1.38, 95% CI 0.53 to 2.23, p=0.003). Engagement was positively associated with higher inflow (B=0.92, 95% CI 0.06 to 1.77, p=0.037) and negatively associated with outflow (B = –1.36, 95% CI –2.08 to –0.63, p=0.001). No consistent associations were found with patient population and patient experience measures.

Conclusions

Workforce-related factors, particularly staffing capacity and inflow and outflow, are strongly linked to sick leave and engagement. Routinely collected hospital data can be used to identify at-risk departments and inform targeted strategies for improving workforce sustainability. Future studies should explore more granular, team-level data to better support staff well-being and care quality.

Sex and gender reporting and differences in trials evaluating patient decision aids: a secondary analysis of systematic review with meta-analysis

Por: Stacey · D. · Legare · F. · Lewis · K. B. · Smith · M. · Carley · M. E. · Barry · M. J. · Bennett · C. · Bravo · P. · Steffensen · K. D. · Finderup · J. · Gendler · Y. · Gogovor · A. · Gunderson · J. · Kelly · S. E. · Pacheco-Brousseau · L. · Trenaman · L. · Trevena · L. · Volk · R. J. · G
Objectives

Patient decision aids (PtDAs) are effective interventions to support patient involvement in health decisions and have the potential to impact favourably on health inequities by reducing gender bias in clinical practice. The aim was to explore sex and gender reporting and differences in randomised controlled trials (RCTs) evaluating PtDAs for adults making treatment or screening decisions.

Design

Secondary analysis of the Cochrane review of PtDAs of RCTs that reported sex and/or gender. The original review searched MEDLINE, Embase, PsychINFO and EBSCO from journal inception to March 2022. Two team members independently screened citations, extracted data and assessed risk of bias. For this secondary analysis, we only included primary outcomes from the original review. We assessed appropriate use of terminology for sex (biological attribute) and gender (social construct). When terms were used interchangeably, it was considered inaccurate. Findings were synthesised descriptively, and we used meta-analysis when two or more RCTs were conducted with females/women or males/men using similar outcome measures.

Primary and secondary outcome measures

Informed values-choice congruence and the quality of the decision-making process (eg, knowledge, accurate risk perceptions, feeling informed, clear values, participation in decision making, undecided) and adverse events (eg, decision regret, emotional distress) by sex and gender.

Results

Of 209 RCTs in the original review, 206 reported sex and/or gender, with 35 (17%) using accurate terminology. Of 206 RCTs, 70 were with females/women only, 27 males/men only, 12 analysed by sex/gender and 97 RCTs did not disaggregate findings by sex or gender. Meta-analysis comparing RCTs for females/women to usual care and RCTs for males/men only compared with usual care showed similar mean differences in knowledge scores (10.84 vs 9.38 out of 100; p=0.44). Males/men had significantly higher self-reported participation in decision making compared with females/women (RR 3.16 vs 0.95; p

Conclusions

In PtDA RCTs, sex and gender terms are used interchangeably and 6% analysed outcomes by sex or gender. Meta-analysis of males/men only given PtDAs showed higher self-reported decision making participation in clinical practice compared to usual care versus females/women only compared with usual care. Researchers must improve reporting sex and gender in PtDA RCTs to assess how it influences health inequities.

Beyond the debate: centring people in conversations about dying

Por: Tatterton · M. J. · Hayes · A.

Assisted dying is changing. Countries around the world, including the UK,1 are considering changing the law, or have legalised assisted death.2 This editorial does not focus on legal, moral or ethical issues that surround assisted dying, but on the people at the centre of the debate: people with life-limiting conditions and their families.

The opportunity to write this editorial could not be more timely, having recently been invited to join the Independent Expert Panel of the UK Government’s Health and Social Care Committee, evaluating the state of palliative care in England.3 Our focus was palliative and end of life care, and not assisted dying; however, during discussions, we did talk about the importance of death literacy, specifically the lack of our willingness to talk about death and dying, even by and with people who have life-limiting conditions.

There is a wealth of research...

Priorities for the development of a new rapid diagnostic test for patients with fever: a cross-sectional online survey among hospital physicians across Europe

Por: Bonnet · G. · Nielsen · M. J. · Foss · A. M. · Lewin · A. · Nijman · R. G. · Fitchett · E. · Carrol · E. · Yeung · S. · the DIAMONDS consortium · Bonnet · Nielsen · Foss · Lewin · Nijman · Fitchett · Carrol · Yeung
Objective

This study aimed to understand hospital doctors’ priorities (target use cases and aetiologies) for the development of a new rapid diagnostic test for patients with fever.

Design

A cross-sectional online survey.

Setting

Europe-wide.

Participants

Secondary and tertiary care doctors involved in patient assessment and diagnosis across Europe.

Intervention

Online survey from April to September 2024.

Main outcome measures

Importance of developing a new test on a scale of 1–10 for up to 19 ‘use cases’ (types of febrile presentations in specific demographic groups): use case scores and ranks and differences across subgroups of respondents, with free text to capture additional suggestions; respondents’ preferences (multiple choice) regarding which aetiologies should be included in a new test.

Results

265 respondents from 30 European countries (out of 270 starting the survey) were included in the analysis. Top priorities included febrile immunocompromised patients and fever without a focus for both paediatric and adult use cases, and 1–3 months old febrile infants. Rankings were similar across clinician subgroups despite some differences in average scores. 92% (243/263), 95% CI 89% to 95%, of respondents would find a ‘generic’ test for bacterial aetiology useful, even if it does not differentiate between Gram-positive and Gram-negative aetiologies. 54% (63/116), 95% CI 45% to 63%, of respondents would find a ‘generic’ test for inflammatory aetiology useful when seeking to diagnose children for whom Kawasaki’s disease (KD) is on the differential, even in the absence of any KD-specific test, 83% (96/116), 95% CI 75% to 89%, would find such a ‘generic’ test useful if they could use it alongside a KD test when desired.

Conclusion

Clinicians prioritise the most vulnerable patients (because of age or comorbidities) and unclear presentations (fever without a focus) for the development of a new fever diagnostic test. Even relatively simple (eg, bacterial, inflammatory) tests could provide added value to most clinicians.

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.

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.

Is occupational exposure to radiofrequency electromagnetic fields associated with glioma risk? An Australian population-based family case-control study

Por: Mate · R. · Benke · G. · Loughran · S. P. · Abramson · M. J. · Vjadic · C. · Turner · M. · Turuban · M. · Cardis · E. · Karipidis · K.
Objectives

This study investigated occupational exposure to radiofrequency electromagnetic fields (RF EMF) using two job-exposure matrices (JEMs) and risk of glioma.

Design

Population-based family case–control study.

Setting

Cases were recruited from participating hospitals in the Australian states of New South Wales, Queensland, Tasmania, Western Australia and Victoria between January 2013 and November 2017.

Participants

The study population consisted of 467 cases of glioma and 367 family controls recruited for the Australian Genomics and Clinical Outcomes of Glioma case–control study between 2013 and 2017. Participants completed questionnaires on demographic and other information, including a detailed occupational history.

Exposures

Exposure to RF EMF was estimated using both the multicountry case–control study INTEROCC JEM and the Canadian JEM (CANJEM).

Primary outcome measures

ORs and 95% CIs were calculated from logistic regression models adjusted for relatedness between cases and controls, sex, age, ethnicity, education level, smoking status and alcohol consumption.

Results

There was no statistically significant positive association overall for risk of glioma when applying either JEM. For the highest compared with the lowest quartile of lifetime exposure, results using the INTEROCC JEM showed an OR of 0.74 (95% CI 0.47 to 1.15) for electric fields and 0.92 (95% CI 0.58 to 1.45) for magnetic fields, while the CANJEM showed an OR of 0.85 (95% CI 0.54 to 1.32). We also did not observe associations when applying different assumptions regarding latency or time windows or with glioma grade.

Conclusion

Overall, this study found no evidence of an association between occupational RF EMF exposure and glioma. Future research should focus on refining occupational RF EMF exposure assessment.

Stimulating amyloid-{beta} clearance in cerebral amyloid angiopathy with low-sodium oxybate and/or non-invasive vagus nerve stimulation (Clear-Brain): study protocol for a randomised pre-post trial

Por: Schriemer · S. E. · Hirschler · L. · van Etten · E. S. · van Zwet · E. W. · Lammers · G. J. · Liebler · E. J. · van Walderveen · M. A. A. · Slats · A. M. · van Es · A. C. G. M. · Verbeek · M. M. · van Osch · M. J. P. · Wermer · M. J. H. · Fronczek · R.
Introduction

Cerebral amyloid angiopathy (CAA) is caused by the accumulation of amyloid-beta (Aβ) in the cerebrovasculature. The glymphatic system is thought to be involved in the clearance of cerebral waste products, including Aβ. Stimulation of the glymphatic system through enhancing deep sleep with low-sodium oxybate (LXB) or inhibition of cortical spreading depolarisations via non-invasive vagus nerve stimulation (nVNS) could potentially increase clearance of Aβ and hence improve disease course.

Methods and analysis

We will perform a pre-post trial to assess whether treatment with LXB, nVNS or a combination of both interventions can enhance the clearance of Aβ in patients with CAA. A total of 60 participants, 30 with sporadic CAA and 30 with Dutch-type CAA, will be randomly assigned to receive either LXB, nVNS or both interventions, resulting in three groups (20 in each group: LXB, nVNS and both). The study spans 6 months, comprising a 3-month observational phase and a 3-month intervention phase. The primary outcome measure will be the morning levels of Aβ40 and Aβ42 in cerebrospinal fluid (CSF) before and after the intervention. We will assess possible disease progression with (non-)haemorrhagic imaging markers on 7-Tesla MRI at baseline, before and after intervention, as a secondary outcome. Additionally, the activity of the glymphatic system by means of fluid dynamics will be assessed with CSF-Selective T2-weighted Readout with Acceleration and Mobility encoding (CSF-STREAM) on 7-Tesla MRI.

Ethics and dissemination

The study was reviewed and approved by the Medical Research Ethics Committee Leiden The Hague Delft (P23.100) on 8 April 2024. The first participant was enrolled on 27 March 2025. Study results will be published in peer-reviewed journals and presented at scientific conferences. Additionally, study updates and results will be shared with participants via our newsletter twice a year.

Trial registration

EU CT number 2023–5 06 128-10-00, Universal Trial Number U1111-1295-1113, ClinicalTrials.gov NCT06421532.

Socioeconomic inequalities in the self-reported use of antibiotics in the European Union, 2009-2022: a repeated cross-sectional analysis

Por: Patel · M. J. · Filippidis · F. T.
Objectives

This study aims to explore trends in the use of antibiotics, in the context of the COVID-19 pandemic, across the European Union (EU), focusing on socioeconomic inequalities.

Design

Repeated cross-sectional analysis.

Setting

26 EU member states.

Participants

Analyses were conducted using data from five waves of the Eurobarometer survey (2009–2022, n=1 27 299).

Primary and secondary outcome measures

We used multilevel logistic regression, stratified by financial difficulty, to examine changes in the past-year use of antibiotics and in obtaining antibiotics inappropriately over time, adjusting for gender, age, type of community, children under 10 years in the household and antibiotic-related knowledge.

Results

We found that the odds of self-reported use of antibiotics decreased between 2009 and 2022 in those with (OR=0.59, 95% CI 0.55–0.63) and without financial difficulties (OR=0.53, 95% CI 0.50 to 0.56), with a substantial reduction between 2018 and 2022. However, a relatively higher proportion of Europeans who used antibiotics in the past year were obtaining them inappropriately in those with (OR=2.03, 95% CI 1.68 to 2.45) and without financial difficulties (OR=1.83, 95% CI 1.53 to 2.19) in 2022. Among those with financial difficulties, higher self-reported use of antibiotics and inappropriately obtaining antibiotics were associated with lesser knowledge about antibiotics.

Conclusion

Despite notable progress made in the EU in reducing antibiotic use, current efforts fall short in addressing the issue of inappropriate antibiotic use. A targeted approach prioritising outreach to vulnerable populations to advance attitudes and behaviours related to appropriate antibiotic use may be required to achieve further progress.

Associations between age, gender and health deterioration in caregivers aged 75 and older in Spain: an observational study

Por: Bernal-Alonso · A. · Ayala · A. · Kirvalidze · M. · Calderon-Larranaga · A. · Forjaz · M. J. · Rodriguez-Blazquez · C.
Objective

This study aims to explore how age and gender are associated with health deterioration related to caregiving among caregivers aged 75 and older in Spain.

Design

Observational, descriptive, cross-sectional study.

Setting

Nationwide survey in Spain: 2020 Survey on Disability, Personal Autonomy and Situations of Dependency.

Participants

All non-professional caregivers identified by the survey (3746): 3166 caregivers younger than 75 (CG75–) and 580 caregivers 75 years old or older (CG75+).

Primary outcome measure

Self-reported caregivers’ health deterioration, as a categorical variable (present or absent).

Results

The majority of caregivers in both groups were women (63.2% of CG75– and 57.0% of CG75+, p=0.011). CG75+ provided care 16 hours/day (vs 14.1 hours/day of CG75–, p=0.032). Over half of CG75+ reported health deterioration (53.0%), compared with 43.5% of CG75– (p

Conclusions

In Spain, older caregivers have a specific socio-demographic profile, provide high-intensity care and report a higher caregiving-related health deterioration. However, the association between older age and health deterioration was found only in women. Public health interventions must prioritise older female caregivers.

Promoting active outdoor play and healthy dietary behaviours through the co-creation of supporting physical and social environments for and with primary school-aged children living in underserved neighbourhoods in Europe: the protocol of the B-Challenged

Por: Altenburg · T. M. · Pawlowski · C. S. · Ahrens · W. · Brand · T. · Buck · C. · Börnhorst · C. · Dzielska · A. · Klaufus · L. · De Miguel-Etayo · P. · Moreno · L. · Okulicz-Kozaryn · K. · Vrijkotte · T. G. M. · Wink · R. · Belmon · L. S. · Chinapaw · M. J. M.
Introduction

An alarmingly low number of children meet public health guidelines for physical activity and dietary behaviours and, therefore, are at increased risk of developing lifestyle-related diseases. This paper describes the protocol of the B-Challenged project, which aims to co-create systemic actions to promote active outdoor play and healthy dietary behaviours before, during or after their outdoor play together with children themselves.

Methods and analysis

In five European countries, child-centred Participatory Action Research (PAR)—combined with systems dynamics methods—was conducted with 15–20 child co-researchers (aged 9–12 years) and 15–20 adult actors (eg, youth workers, local policy makers). In the first phase, the main drivers of children’s active outdoor play and related dietary behaviours were mapped by (1) analysing existing cohort data, and (2) conducting child-centred PAR. In the second phase, systemic actions targeting the local physical and social environments will be co-created and implemented by child co-researchers and adult actors to promote children’s active outdoor play and related healthy dietary behaviours. A mixed-methods design will be used to evaluate (1) if actions positively contributed to systems change and 6- to 12-year-olds’ outdoor play and related dietary behaviours (140 children per country); (2) the process of conducting multi-actor, child-centred PAR and implementing the co-created actions and (3) if the child-centred PAR positively contributed to child co-researchers’ feelings of empowerment.

Ethics and dissemination

Ethics approval for the mapping phase was obtained and approval for implementation and evaluation will be obtained from the five local research institutions. Participating children, one of their parents/caregivers and adult actors had given informed consent before participating in the project. Throughout the project, child-friendly methods, materials and language will be applied, and ethical challenges and potential solutions will be discussed. Project results will be disseminated locally and internationally through various channels and activities among the scientific community, professionals—for example, in health and policy making, children and other citizens.

Trial registration number

NCT07136376.

Establishing criteria for emergency department-based episode of care definitions: a modified Delphi study

Por: Kocher · K. E. · Myers · A. D. · Urech · T. H. · Asch · S. · Admon · A. · Fuehrlein · B. S. · Gettel · C. J. · Patel · N. · Pines · J. M. · Potochny · N. S. · Sabbatini · A. K. · Vanneman · M. · Ward · M. J. · Vashi · A.
Objective

Design

Traditional encounter-based analyses overlook downstream costs and complications that follow emergency department (ED) care. To enable more comprehensive evaluations, we developed standardised episode of care definitions for five common, high-cost conditions: chest pain, congestive heart failure (CHF), pneumonia, chronic obstructive pulmonary disease (COPD) and suicidality.

A two-round modified Delphi panel study was conducted following a literature review and evidence synthesis. Using structured surveys with anonymous feedback, panellists rated candidate criteria. To be retained in the final episode definitions, criteria were required to meet a predefined validity threshold without panellist disagreement. Data were analysed descriptively, and meeting deliberations were recorded and reviewed thematically.

Setting

Virtual, supported by an online survey platform.

Participants

A multidisciplinary panel of 11 experts in emergency medicine and relevant clinical specialties with 9 members participating in each round.

Outcomes

Criteria to determine inclusion, exclusion (including pre-trigger, post-trigger and event exclusion) and risk-adjustment standards for constructing ED-based episodes of care.

Results

Candidate criteria were presented to the panel by condition: 30 for chest pain, 54 for CHF, 30 for COPD, 79 for pneumonia and 375 for suicidality. Following deliberations and re-rating, the number of valid criteria was reduced, primarily in the episode exclusion category. Thematic analysis highlighted trade-offs between episode exclusion criteria and the use of risk adjustment to account for heterogeneity.

Conclusions

Operational definitions for ED-based episodes of care for five conditions were established. These may support healthcare administrators, policymakers and researchers in evaluating variation in ED care delivery and its downstream cost and outcomes.

Common mental health outcomes among children in conflict with the law in Africa: a systematic review protocol

Por: Maotoana · M. · Phalane · K. · Ndlovu · S. M. · Rapau · M. · Quarshie · E. N.-B. · Ntho · T. A. · Sepadi · M. D. · Oppong Asante · K. · Sodi · T. · Themane · M. J.
Introduction

Common mental health outcomes among children in conflict with the law in correctional facilities in Africa are an under-researched area with significant public health implications. This review will synthesise available and accessible evidence on the prevalence and associated factors of common mental health outcomes among children in conflict with the law in Africa.

Methods and analysis

Comprehensive electronic searches will date from 01 January 2015 to 31 December 2025 and will be conducted in PubMed, Sabinet, Scopus, EBSCOhost, Web of Science and PsycINFO. Articles will be screened using defined inclusion and exclusion criteria and assessed for eligibility by three independent reviewers. Discrepancies will be reviewed by a ninth reviewer. The selection process of included articles will be reported by using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses will be used. The Mixed Methods Appraisal Tool will assess study quality, and data will be synthesised using meta-analysis or a narrative synthesis approach, depending on heterogeneity levels.

Ethics and dissemination

This study will not require ethical approval from an institutional review board, as it does not entail the direct collection of data from children in conflict with the law, nor does it pose any risk to their privacy. Once finalised, the full review report will be submitted for publication in a peer-reviewed journal. The key findings will also be shared at both local and international conferences, highlighting common mental health outcomes among children in conflict with the law.

PROSPERO registration number

CRD420251011484.

Mechanisms of SGLT inhibitor action and physiological mediators: systematic review and protocol for the MOSAIC collaborative meta-analysis

Por: Kugathasan · L. · Nardone · M. · Muskiet · M. · Diaz Martinez · J. P. · Lovblom · L. E. · Orchanian-Cheff · A. · Nielsen · S. · Rotbain · V. · Kazup · A. · Cersosimo · E. · Gullaksen · S. · Vernstrom · L. · van Baar · M. J. B. · van Bommel · E. · Kannenkeril · D. · Scholtes · R. · Hesp
Introduction

Sodium-glucose cotransporter (SGLT) inhibitors have shown substantial benefit in reducing cardiovascular and kidney events across diverse clinical populations, but the underlying physiological mechanisms remain unclear. However, existing mechanistic studies on renal and cardiovascular haemodynamics show variability in design, have limited statistical power and yield inconsistent outcomes, thus limiting the ability to draw generalisable conclusions. To address this gap, we conducted a systematic review and proposed the first meta-analysis to aggregate individual participant-level data from mechanistic studies to identify consistent physiological patterns and enhance understanding of the therapeutic effects of SGLT inhibition.

Methods and analysis

Gold-standard measured glomerular filtration rate (mGFR) was selected as the primary outcome for this systematic review, which aimed to identify all completed mechanistic studies investigating the effects of SGLT inhibition. Electronic databases including Ovid MEDLINE; Ovid Embase; Cochrane Database of Systematic Reviews; and Cochrane Central Register of Controlled Trials were searched using a detailed search strategy. In total, 24 studies (n=1296) were identified. This systematic review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Key variables including demographics, medical history, concomitant medications, vital signs, mGFR, renal haemodynamics, urine and plasma biochemistry, tubular sodium handling, echocardiography, cardiac output monitoring, arterial stiffness and fluid volume will be extracted. A one-stage individual participant data meta-analysis under a Bayesian framework will be conducted, using hierarchical models to simultaneously analyse data from all eligible studies. The risk of bias due to missing results will be assessed. Sensitivity analyses and subgroup evaluations will be incorporated to explore sources of heterogeneity and assess robustness of findings.

Ethics and dissemination

Ethics approval was obtained from University Health Network, Toronto, Canada. Findings from the Mechanisms of SGLT Inhibitor Action and Physiological Mediators (MOSAIC) meta-analysis will be published in peer-reviewed journals and results will be disseminated at scientific conferences.

PROSPERO registration number

CRD420251001413.

Effectiveness, acceptability and oral health-related quality of life of silver diamine fluoride compared with atraumatic restorative treatment for the management of early childhood caries: protocol of a pragmatic randomised clinical trial

Por: Munoz Millan · P. · Pineda · P. · Fontana · M. · Freyhofer · V. A. · Ormeno · A. · Munoz · K. · Martinez-Zapata · M. J. · Zaror · C.
Introduction

Early childhood caries (ECC) continues to be a public health problem. The application of silver diamine fluoride (SDF) is a simple, non-invasive procedure. This study aims to evaluate SDF’s effectiveness, acceptability and oral health-related quality of life (OHRQoL) compared with atraumatic restorative treatment in managing ECC.

Methods and analysis

An open-label parallel superiority randomised clinical trial will be conducted involving children aged 2–5 years. Participants will include children with at least one active cavitated lesion (ICDAS 5+) of their primary teeth, with no signs of pulp involvement. The trial will occur at preschools in the La Araucanía and Metropolitan Regions of Chile from 2025 to 2027. The primary outcome variable will be the caries lesion arrest, acceptability and OHRQoL. We will also determine the presence of any adverse effects. Evaluations will be carried out at 6 and 12 months. A sample of 234 teeth with carious lesions per group is estimated. The primary inferential analysis will be performed on an intention-to-treat basis; a per-protocol analysis will be conducted for adverse effects. For caries lesion arrest, a multilevel logistic regression model adjusted for significant covariates will be used to account for within-child clustering. The acceptability will be assessed through quantitative and qualitative methods. The magnitude of change in OHRQoL between baseline and follow-up will be quantified using effect size estimates derived from the early childhood health impact scale survey data.

Ethics and dissemination

This study’s implementation benefits the study population, and the ethical principles of research have been considered and approved by the Science Committee of the University, Resolution N°049_19. The results and conclusions of the clinical trial will be published in academic conferences and peer-reviewed journals.

Trial registration number

NCT06786975.

Osseointegration Group of Australia Accelerated Protocol-3 (OGAAP-3): protocol for a stratified approach to surgical technique and rehabilitation in lower limb amputees

Por: Al Muderis · M. · Oomatia · A. · Al-Maawi · Q. M. J. · Tetsworth · K.
Introduction

The Osseointegration Group of Australia Accelerated Protocol-3 (OGAAP-3) presents the latest iteration of a structured, prospective, clinical-based protocol for single-stage osseointegration surgery in lower limb amputees. Building on the foundational work of OGAAP-1 and OGAAP-2, this protocol incorporates a decade of institutional experience and over 1000 cases using the Osseointegrated Prosthetic Limb system. OGAAP-3 introduces stratified rehabilitation categories—immediate, standard, slow and delayed loading—based on intraoperative findings, residual limb characteristics and patient-specific physiological factors. The surgical approach remains a single-stage procedure, with modifications described for transfemoral and transtibial levels, including primary amputation with simultaneous implant placement. The aim is to enhance safety, optimise functional outcomes and broaden access to osseointegration.

Methods and analysis

OGAAP-3 is a prospective registry-based protocol enrolling approximately 50 patients annually at the Osseointegration Group of Australia and affiliated centres, with data collection ongoing since mid-2023 and planned until 2027. Eligibility criteria include adults (aged 18 years or over) with unilateral or bilateral transfemoral or transtibial amputations, as well as primary amputees undergoing concurrent osseointegration. All patients receive osseointegrated implants which are press-fitted into the residual bone. Functional and quality-of-life outcome measures are recorded preoperatively and at defined postoperative follow-up intervals up to 2 years. Postoperative adverse events are also recorded. The preoperative and postoperative values will be compared for each outcome measure, and the outcomes of the OGAAP-3 procedure will be compared with the results of the OGAAP-1 and OGAAP-2 protocol.

Ethics and dissemination

This study has received ethics approval by Macquarie University, Sydney, Australia. The study outcomes will be disseminated by publications in peer-reviewed academic journals and presentations at relevant clinical and orthopaedic conferences with final outcome analyses planned following completion of 2-year follow-up in 2027.

Cross-sectional epidemiological assessment of lymphatic filariasis situation in areas under post-mass drug administration surveillance and the associated risk of transmission in the context of migrants in India: a study protocol

Por: Srividya · A. · Dinesh · R. J. · M M · M. J. · Kishanthini · M. · Dogra · V. · Tripathi · B. · Sharma · R. · Jain · T. · Rahi · M.
Introduction

India targets to eliminate lymphatic filariasis (LF) in alignment with the global goals. By 2024, 106 out of a total of 345 endemic districts have passed all three serial transmission assessment surveys (TAS) and are under post-mass drug administration (MDA) surveillance for a variable period. However, the current epidemiological situation of LF is not known in these districts. With increased mobility of population from the endemic districts currently under MDA to these post-MDA areas, resurgence of LF in these areas cannot be ruled out. Therefore, a study is planned to understand the current LF status in areas under post-MDA surveillance with the following objectives: (1) To assess the epidemiological situation of LF in terms of human and vector infection prevalence in selected evaluation units (EUs) under different durations of post-MDA phase and (2) to estimate the filarial infection (in terms of filarial antigen and microfilaria) among migrants (from endemic districts) in these EUs.

Methods and analysis

This cross-sectional study will measure the filarial infection in (1) adult population aged ≥20 years (following the WHO 2025 protocol for monitoring and evaluation of MDA) among general population (n=3150 per EU), (2) migrant population (aged 2 years and above) in the post-MDA area originating from endemic areas (n=1000 per EU) and (3) vectors (n=7500 per EU) using molecular xenomonitoring (MX) to confirm sustenance of transmission interruption or identify any potential risk of resurgence in three EUs under post-MDA phase. In one MDA-naive EU that shares borders with endemic districts, filarial infection status will be assessed in (1) school children aged 9–14 years (as per WHO mini-TAS protocol, n=480), (2) migrants (aged 2 years and above) from endemic areas (n=1000) and (3) vectors (n=7500). EU-wide prevalence of microfilaria, circulating filarial antigen and vector infection rates with 95% CIs will be estimated. Multivariate logistic regression analysis will be carried out to find factors associated with LF positivity. In addition, knowledge, attitude and practice surveys will also be conducted among the adult migrants (n=1000 per EU). Thirty in-depth interviews will be conducted among the migrants, local community and health workers (in each EU) and the results will be suitably analysed and triangulated. The study results will enable the national programme to confirm sustenance of transmission interruption or assist in taking a decision to reinitiate MDA in these areas under post-MDA surveillance. It will also enable devising specific strategies to treat migrants.

Ethics and dissemination

This study has been approved by the institutional ethics committee (IHEC 03-0824/N/F). A workshop will be held with all stakeholders to disseminate the study findings.

Understanding opioid use within the substance use journeys of adults receiving treatment: a qualitative study protocol of the participant-led timeline mapping approach

Por: Estrella · M. J. · Wells · S. · Foy · R. · Quilty · L. · Bozinoff · N. · Buckley · L. · Lincoln · S. · Patenaude · S. · Ali · F.
Introduction

The opioid crisis remains a significant public health emergency. Key contributors to this crisis include an increasingly toxic drug supply and inadequate health policies that rely on strategies to address opioid-related harms and underutilise primary prevention and early intervention approaches. To inform comprehensive prevention and early intervention strategies, research is needed to explore pathways involving hazardous opioid use (ie, daily opioid use that results in, and may arise from, disruptions to health, relationships, work or social functioning) and the individual, social and structural factors that shape such pathways. This qualitative study aims to address this research gap by exploring the substance use journeys of adults with lived or living experiences of hazardous opioid use who are receiving substance use treatment at a large Canadian mental health hospital.

Methods and analysis

A qualitative descriptive study informed by the life course perspective will be conducted. Data will be collected using participant-led timeline mapping in combination with semistructured interviews. Participants will include 20–30 adults who are receiving or have received substance use treatment from the hospital where the study is being conducted. Timelines and interviews will be analysed using thematic analysis. A brief demographic questionnaire will also be administered to describe characteristics of the sample.

Ethics and dissemination

Ethical approval was granted on 1 October 2025 by the Centre for Addiction and Mental Health Research Ethics Board (Protocol no. 2025/026). Findings will be reported through peer-reviewed publications, lay language reports and/or academic conferences on mental health and substance use health research.

Building a functional resonance analysis method (FRAM) in healthcare: a systematic review on how steps are reported, defined and supported by data

Por: Luijcks · N. M. · Bazuin · T. · Adriaensen · A. · Visser · A. · Dongelmans · D. · Groeneweg · J. · van der Laan · M. J. · Marang-van de Mheen · P.
Objectives

The functional resonance analysis method (FRAM) is increasingly used to analyse healthcare processes. FRAM uses four steps to analyse a process and its potential variability. We systematically reviewed studies using FRAM in healthcare on how the four steps in FRAM are reported, defined and supported by data.

Design

Systematic review following the preferred reporting items for systematic reviews and meta-analyses 2020 guidelines.

Data sources

Web of Science, PubMed, Embase, Scopus, PsycINFO, Dimensions and Lens were searched up to December 2025.

Eligibility criteria for selecting studies

All peer-reviewed studies using FRAM in a healthcare context that presented a FRAM visualisation were included. The papers had to be written in English.

Data extraction and synthesis

Two independent reviewers screened titles and abstracts, and subsequently the full text of selected papers. Data was extracted reporting on the steps of FRAM, how functions were supported by data, and the functions and couplings of the visualisations.

Results

Sixty-eight papers were included, of which 20 (29%) reported at least one aspect of all four steps in FRAM. While most studies (85%) described how functions were supported by data, the methods used varied widely. Terminology was interpreted differently concerning variability, the output of variability and the effect of combined variability.

Conclusion

Most FRAM studies in healthcare do not report all steps of FRAM, and interpretations of key terms differ. FRAM studies should more clearly describe which steps of the method are conducted, and how data is collected and analysed. Refinement of FRAM guidelines, particularly on data use and terminology, would enhance consistency and comparability across studies.

PROSPERO registration number

CRD42024592858.

❌