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AnteayerBMJ Open

Acceptability and adoption of a multiparameter point-of-care testing (POCT) device in primary healthcare for non-communicable diseases in resourced-limited communities in Peru

Por: Huayanay-Espinoza · C. A. · Moran · D. · Albitres-Flores · L. · Bernabe-Ortiz · A. · Cahuana-Hurtado · L. · Vetter · B. · Safary · E. · Lazo-Porras · M.
Objectives

To assess the acceptability and adoption of multiparameter point-of-care testing (POCT) devices for the diagnosis and management of non-communicable diseases (NCDs) at the primary healthcare level in a resource-limited region of Peru.

Design

Qualitative case-control process evaluation.

Setting

Eight primary healthcare facilities in northern Peru, including both urban and rural centres, where routine chronic care and laboratory services are provided.

Participants

Sixty-three participants: 36 patients, 12 laboratory technicians, 10 healthcare professionals and five facility heads. Eligible patients were ≥18 years, residing in the catchment area, with or without prior NCD diagnoses. Healthcare workers, including physicians, nurses, laboratory staff and facility managers.

Interventions

Multiparameter POCT devices were installed in four intervention facilities, accompanied by staff training and community awareness activities, while four control facilities continued with conventional laboratory diagnostics.

Primary and secondary outcome measures

Primary outcome: perceptions of patients and healthcare workers regarding the acceptability and adoption of POCT devices. Secondary outcomes: identification of facilitators and barriers to implementation, including infrastructure, supply chains and training gaps.

Results

(1) Individuals: POCT was valued for speed and comfort, but concerns over accuracy were mentioned. (2) Intervention characteristics: laboratory staff valued POCT’s practicality in emergencies, but noted limitations in handling multiple samples. (3) Outer setting: urban centres outperformed rural facilities, with more staff and longer operating hours. (4) Inner setting: calibration gaps impacted POCT and conventional test reliability, requiring quality control and training. (5) Process: clear staff communication boosted patient confidence in POCT, but inconsistent training could lead to reliability doubts.

Conclusions

Multiparameter POCT devices show promise for enhancing NCD care in resource-limited primary healthcare settings, particularly in rural areas. However, their sustainability depends on broader health system reforms, including reliable supply chains, expanded training and stronger quality assurance mechanisms. Further research should examine strategies for embedding POCT within national regulatory and policy frameworks.

Lower versus standard dose-intensity continuous renal replacement therapy: a protocol for a systematic review and meta-analysis

Por: Lumlertgul · N. · Kusirisin · P. · Kung · J. Y. · Duquette · D. · Fujii · T. · Zarbock · A. · Wald · R. · Bagshaw · S. M.
Introduction

The 2012 Kidney Diseases Improving Global Outcomes clinical practice guideline recommends prescribing continuous renal replacement therapy (CRRT) doses in patients with acute kidney injury (AKI) between 20 and 25 mL/kg/hour, with a need to consider further augmentation to 25–30 mL/kg/hour. Observational data have shown that lower-dose CRRT (

Methods and analysis

Ovid MEDLINE, Ovid Embase, CINAHL and Cochrane Library will be searched for studies from inception to present. We will evaluate the risk of bias using the modified Cochrane tool for randomised controlled trials and the Cochrane Risk of Bias In Non-randomised Studies—of Interventions tool for cohort studies. Two reviewers will independently complete study selection, data extraction and bias assessment. Inclusion criteria will be randomised controlled trials and observational studies (cohort) including patients with AKI receiving CRRT. The exposure will be lower dose-intensity CRRT (

Ethics and dissemination

Ethics approval is not required as primary data will not be collected. Findings of this review will be disseminated through peer-related publication.

PROSPERO registration number

CRD420251135606.

Protective factors for maternal mental health and life satisfaction during the COVID-19 pandemic: a longitudinal analysis

Por: Johannessen · P. M. · Madsen · C. · Hart · R. K. · Lund · I. O. · Pettersen · J. H. · Gustavson · K. · Roysamb · E. · Nesvag · R. · Brandlistuen · R. E. · Ask · H.
Objective

Mothers’ mental health and life satisfaction may have been negatively affected due to challenges during the COVID-19 pandemic. Given the risk of future crises, knowledge of possible mitigating factors in this population is essential. This study aims to examine whether the pandemic affected the level of protective factors such as social support, physical activity and employment situation, and how these factors are associated with mental distress and life satisfaction.

Design

Longitudinal cohort study.

Outcome measures

Primary outcomes were mental distress (measured by the eight-item version of the Hopkins Symptom Checklist) and life satisfaction (measured by the Satisfaction With Life Scale). As the first step, we investigated changes in the levels of social support (defined by the number and frequency of social contact), physical activity (average hours of physical activity during a week), employment situation (actively working vs sick leave or unemployed), alcohol consumption (measured by the Alcohol Use Disorders Identification Test-Consumption) and relationship satisfaction (measured by the five-item version of the Relationship Satisfaction Scale).

Methods

We analysed data from two waves of the Norwegian Mother, Father and Child Cohort Study (n=~18 000 mothers); one pre-pandemic wave and one wave where half of the sample responded after the onset of the pandemic, with pandemic exposure being defined by questionnaire response timing rather than cohort recruitment. To assess changes in protective factors over time and pandemic exposure, we used difference-in-differences analyses and regression discontinuity design. Associations between protective factors with mental distress and life satisfaction, and possible moderation by pandemic exposure, were investigated using multiple regression models with interaction terms adjusted for potential confounders.

Results

Apart from physical activity, which declined less across time in the pandemic group (B=0.09, 99% CI 0.05 to 0.12), protective factors did not change during the pandemic. Social support, employment situation and relationship satisfaction were associated with mental distress and life satisfaction, whereas physical activity showed a unique relationship with mental distress. Most associations were similar across pandemic exposure groups, except employment situation which appeared to have a stronger protective effect in the pandemic group (β=–0.12, 99% CI –0.24 to –0.00).

Conclusions

Changes over time in self-reported levels of protective factors were generally consistent among mothers independent of the pandemic. These factors appear to play an equally important role for mental distress and life satisfaction both under ordinary circumstances and during public health crises. Our findings enhance the understanding of how potential protective factors among mothers are associated with mental distress and life satisfaction in the context of a global stressor. Future studies should investigate additional mitigating factors that may be particularly relevant during global crises and explore the causal relationship between protective factors, mental health and life satisfaction.

Evaluating the impact of a national brain health education course for older adults with intellectual and developmental disabilities and caregivers: Brain Health-IDD Program protocol

Por: Lunsky · Y. · Bobbette · N. · Chiu · M. · Thakur · A. · Patel · P. · Volpe · T. · Balogh · R. · Baskin · A. · Beaudoin · M.-J. · Dever · M. J. · Durbin · A. · Fogle · A. · Kelly · C. · Lake · J. · Lefkowitz · G. · Mallett · H. · McCabe · J. · Noonan · J. · Selick · A. · Shooshtari · S. · Socka
Introduction

Adults with intellectual and/or developmental disabilities (IDD) experience higher rates of age-related health concerns, including dementia, than adults without disabilities. Despite this, current efforts to support brain health in ageing have often excluded this population. To address this gap, we will codesign, codeliver and evaluate a national virtual brain health education programme, Brain Health-IDD, for ageing individuals with IDD, family caregivers and health and social care providers.

Methods and analysis

This study will evaluate the Brain Health-IDD Program, an interactive virtual psychoeducation course codesigned and coled by an interdisciplinary team of clinicians and people with lived experience. Three participant groups will be recruited from across Canada: adults with IDD, aged 40 years and older; family caregivers who have a family member with IDD aged 40 years and older or who are themselves aged 60 years and older; and health or social service providers who support adults with IDD aged 40 years and older. Outcomes will be measured at baseline, postcourse and 3-month follow-up. Data will be collected through structured surveys, including both closed and open-ended questions, and focus group interviews.

Primary outcomes are participation, satisfaction and changes in knowledge and self-efficacy related to brain health among the three participant groups. Secondary outcomes for both adults with IDD and family caregivers include changes in health-related behaviours (social connections, sleep hygiene and physical activity), physical health, mental wellbeing, resilience and whether cognitive screening is initiated for adults with IDD and for caregivers. For health and social service providers, secondary outcomes include changes in brain health promotion practices and whether cognitive screening for older adults with IDD is initiated.

Analysis of open-text survey responses and qualitative data from focus group interviews will explore the experiences of participants with the Brain Health-IDD Program.

Ethics and dissemination

Institutional ethics approval was obtained from the Centre for Addiction and Mental Health Research Ethics Board. Programme findings and resources will be shared with advocacy groups, disability agencies, family caregiver organisations, clinicians and policymakers in the fields of disability, health and ageing at the provincial, national and international levels.

Retrospective validation of an artificial intelligence system for diagnostic assessment of prostate biopsies on the ProMort cohort: study protocol

Por: Ji · X. · Zelic · R. · Aspegren · O. · Mulliqi · N. · Fiorentino · M. · Giunchi · F. · Molinaro · L. · Boman · S. E. · Szolnoky · K. · Liu · L. X. · Pettersson · A. · Vincent · P. H. · Eklund · M. · Akre · O. · Kartasalo · K.
Introduction

Prostate cancer diagnosis and treatment planning depend on accurate histopathological assessment of needle biopsies, particularly through the Gleason scoring system. The inherently subjective nature of the grading creates variability between pathologists, potentially resulting in suboptimal patient management decisions. These reproducibility challenges extend beyond Gleason scoring to encompass other critical diagnostic and prognostic markers, including cancer volume quantification and detection of cribriform morphology patterns and perineural invasion. Artificial intelligence (AI) applications in digital pathology have emerged as promising solutions for enhancing diagnostic consistency and accuracy, with recent research demonstrating that automated systems can match expert-level performance in prostate biopsy evaluation. Nevertheless, comprehensive validation studies have revealed concerning limitations in model generalisability when deployed across different clinical environments and patient populations. Recent systematic reviews revealed widespread risk-of-bias limitations and insufficient external validation in AI diagnostic studies, highlighting critical needs for accumulated evidence supporting generalisability before clinical implementation. Rigorous external validation with preregistered protocols using independent datasets from diverse clinical settings remains essential to establish the reliability and safety of AI-assisted prostate pathology systems.

Methods and analysis

This study protocol establishes a framework for the retrospective external validation of an AI system developed for prostate biopsy assessment, to be conducted on the case-control samples of the National Prostate Cancer Register of Sweden, ProMort study (1998-2015). The primary aim is to evaluate the AI model’s diagnostic accuracy and Gleason grading performance using completely independent datasets separate from any model development or previously used validation cohorts. The diversity of the validation samples, spanning multiple geographic regions, temporal collection periods and reference standards, allows evaluation of model robustness across varied clinical contexts. Secondary aims encompass evaluating AI performance in cancer length estimation and detection of cribriform patterns and perineural invasion. This protocol delineates procedures for data collection, reference standard clarification and prespecified statistical analyses, ensuring comprehensive validation and reliable performance assessment. The study design conforms to established reporting guidelines Checklist for Artificial Intelligence in Medical Imaging (CLAIM) and Standards for Reporting Diagnostic Accuracy Studies using Artificial Intelligence (STARD-AI), and recognised best practices for AI validation in medical imaging.

Ethics and dissemination

Data collection and usage were approved by the Swedish Regional Ethics Review Board and the Swedish Ethical Review Authority (permits 2012/1586-31/1, 2016/613-31/2, 2019-01395, 2019-05220). The study adheres to the Declaration of Helsinki principles, and findings will be made available in open access peer-reviewed publications.

Virtual reality-based cognitive rehabilitation programme to support employment in patients with breast cancer: protocol for the Cog-RV pilot study

Por: Vieira Jales · I. · Hummel · E. · Clarisse · B. · Gouranton · V. · Cogne · M. · Lecuyer · A. · Leconte · A. · Lequesne · J. · Ahmed-Lecheheb · D. · Morel · A. · Fernette · M. · Joly · F. · Lange · M.
Introduction

Cancer-related cognitive impairment is frequently reported by patients with breast cancer after chemotherapy. These difficulties can hinder return to work. It is therefore particularly important to assess and manage these impairments, especially to facilitate employment. We propose the Cog-VR pilot study to assess patient adherence to a virtual reality (VR)-based cognitive rehabilitation programme to support employment.

Methods and analysis

This prospective interventional pilot study aims to assess adherence to a VR-based cognitive rehabilitation programme in patients with breast cancer (n=23) treated by chemotherapy reporting cognitive complaints following cancer and its treatments. The programme consists of six weekly individual sessions (1 hour/week), including cognitive training, psychoeducation and VR immersion (10–15 min). VR tasks train executive functions, attention, memory and processing speed. The primary endpoint is the programme adherence, defined as completing at least five out of six VR sessions, each lasting a minimum of 5 min. The main secondary endpoints are objective cognitive tests and patient-reported outcomes (subjective cognitive functioning (Functional Assessment of Cancer Therapy—Cognitive Scale), anxiety/depression (Hospital Anxiety and Depression Scale) and fatigue (Functional Assessment of Chronic Illness Therapy—Fatigue)) assessed before and after the programme. Furthermore, cyber sickness (Simulator Sickness Questionnaire) at each session, VR usability (System Usability Scale—third session) and patient satisfaction to the programme will also be assessed.

Ethics and dissemination

The study was approved by the local ethics committee (French Ouest II personal protection committee no. ID RCB: 2023-A02163-42) on January 2024. It was validated by the review board of the participating center. An individual participant data-sharing statement is not planned. Written informed consent will be obtained from all patients before any study procedure. The results of this pilot study will be disseminated through peer-reviewed journals and conference presentations.

Trial registration number

NCT06267014.

How can midwives in Germany be supported in advising on early childhood allergy prevention in a health literacy-responsive way? Protocol for a mixed-methods study to co-design and evaluate an educational intervention following the Medical Research Council

Por: von Sommoggy · J. · Steinmann · J. R. · Lander · J. · Bitzer · E. M. · Pawellek · M. · Brandstetter · S. · Apfelbacher · C. · Fillenberg · B. D.
Introduction

Health literacy (HL) is essential for making informed health-related decisions, for example enabling parents to reduce their child’s allergy risk. Health literacy does not, however, rely solely on an individual’s capacities, but is strongly influenced by external factors. Midwives provide important health advice to families, particularly since their relationship is close during a time of significant transition. This offers them a unique opportunity to positively influence the HL of parents, which in turn may support the health and well-being of the whole family. The aim of this study is to develop and evaluate an intervention that can support midwives in providing allergy prevention advice in a way that is in line with the concept of HL.

Methods and analysis

In accordance with the recommendations of the Medical Research Council framework in the first phase of this study, we will survey midwives (target sample size=379) in Germany regarding their practices, the potential barriers they face and enabling factors in providing advice on early childhood allergy prevention in an HL-responsive way. The data will be subjected to descriptive statistical analysis. Two co-design workshops will then be conducted with various stakeholders in two regions (Rhineland-Palatinate and Saxony) of Germany. Following the protocol proposed by the Stanford Design Thinking School, we will use design thinking to collect ideas for the intervention. Based on these ideas and our previous qualitative and quantitative study, we will develop an intervention in collaboration with didactic experts. The intervention will be piloted in three groups (midwives=10–15, midwives working as practice supervisors=5–10, students of midwifery=10–20). For the process evaluation, we will use observation protocols of the intervention conduct and qualitative interviews. For the outcome evaluation, we will use a questionnaire and observations in simulation laboratories with students of midwifery.

Ethics and dissemination

This study protocol was approved by the Ethics Committee of the University of Regensburg (ID 23-3441-101) and is in compliance with the Declaration of Helsinki. Participation in the study will only be possible after informed consent has been given. Our results will be presented at national and international conferences and published in scientific journals. Additionally, once it has been finalised, we will make the intervention available to educational institutions for (future) midwives.

Preferences and predictors driving opioid-involved polysubstance use profiles and trajectories: a prospective cohort study protocol

Por: Campbell · M. · Lafayette · J. I. · Vallejo Vasquez · K. · Rivard · A. · Diamond · J. · Nguyen · C. · Caputo · D. · Lothumalla · S. · Rodriguez · C. R. · Tomlinson · D. C. · Bonar · E. E. · Goldstick · J. E. · Walton · M. · Lee · S. · Menke · N. · Lin · L. · Coughlin · L. N.
Introduction

Polysubstance use (PSU), particularly opioid-involved and stimulant-involved PSU, is a growing issue in the USA. PSU increases the risk of negative health consequences, including infectious diseases, worsening physical and mental health conditions, and overdose-related deaths. These consequences occur in the context of varying health risk behaviours, substance-related preferences, and treatment engagements among people with PSU. To inform improvements in prevention, harm reduction, and substance use disorder (SUD) treatment, additional research is needed to comprehensively understand the current context and drivers of PSU preferences, motivations, and behaviours.

Methods and analysis

Herein, we describe the protocol for a prospective cohort study designed to capture detailed patterns, profiles, and trajectories of PSU, with the aim of comprehensively examining the drivers of PSU behaviours and SUD treatment utilisation. Adults (ages 18–75; n=400) who engage in PSU will be recruited from healthcare institutions, an established participant database maintained by an adjacent SUD research team, and online advertisements. Study assessments will capture dynamic patterns, choice preferences, and motivators of PSU via behavioural economic (BE) measures, detailed Timeline Follow-Back (TLFB) interviews, and self-administered surveys. The assessment timeline will include a baseline survey and TLFB interview, weekly TLFB interviews for 4 weeks post-baseline, and follow-up surveys and TLFB interviews at 4-, 8-, and 12-months post-baseline.

Ethics and dissemination

The study is funded through the National Institutes of Health Helping to End Addiction Long-term (HEAL) initiative and was approved by the University of Michigan Medical Institutional Review Board. Findings will be disseminated to academic, clinical, and community partners through the Michigan Innovations in Addiction Care through Research and Education programme. Results from this study will inform actionable and practical insights relevant to the delivery of personalised care in the context of PSU.

Prevalence of sexually transmitted infections among military personnel: a systematic review protocol

Por: Shoemaker · E. S. · Sandstrom · E. · Dangerfield · C. D. · Linton · J. · Cholette · F. · McClarty · L. M. · Lazarus · L. · Herpai · N. · Pavlova · D. · Pickles · M. · Becker · M.
Introduction

Military personnel are a unique population with heightened vulnerability to sexually transmitted infections (STIs), often exhibiting higher prevalence rates than civilians due to demographic, environmental and occupational factors. These vulnerabilities underscore the need for global prevalence estimates to guide effective, evidence-based interventions. This study aims to quantify the global burden of STIs among military personnel, providing a comprehensive and up-to-date assessment.

Methods and analysis

This systematic review will follow the Preferred Reporting Items for Systematic Review and Meta-Analysis Guidelines (2020). Using the CoCoPop (Condition, Context, and Population) framework, a comprehensive search strategy will be conducted in MEDLINE, Embase, Global Health and Scopus to retrieve peer-reviewed records published between January 2010 and June 2025. Eligible studies will report numerical STI prevalence data among military personnel. Studies with insufficient information to calculate prevalence or those relying on self-reported STI data will be excluded. Data extraction will include study details, military descriptors, STI prevalence and diagnostic methods. Risk of bias will be assessed using the Joanna Briggs Institute critical assessment tool for prevalence and incidence studies. Prevalence estimates with 95% CIs will be reported for each STI and, where appropriate, pooled for curable STIs. Subgroup analyses will stratify prevalence by geographic region, service status, deployment status and socioeconomic factors. Heterogeneity will be evaluated within predefined subgroups using the I² statistic. Data will be presented in comprehensive tables and visualised with graphical tools, including forest plots for subgroup analyses and pooled estimates.

Ethics and dissemination

Ethical approval is not required for this review. The results will be disseminated through a peer-reviewed publication and conference presentations.

PROSPERO registration number

CRD42023472113.

Adherence to Choosing Wisely Africa recommendations in breast cancer care: a cross-sectional study across three Sub-Saharan African centres

Por: Rubagumya · F. · Rugengamanzi · E. · Nyagabona · S. K. · Ndumbalo · J. · Kwizera · V. · Uwimbabazi · A. · Celyna · K. · Ayettey · H. · Vanderpuye · V. · Hopman · W. M. · Hammad · N. · Booth · C. M.
Objective

The expenses associated with cancer treatment are increasing at a rapid pace. The financial strain of providing care is experienced worldwide, but is particularly pronounced in low and middle-income countries (LMICs). This has resulted in a growing acknowledgement of the importance of value-based cancer care. Choosing Wisely Africa (CWA) is an initiative aimed at reducing the excessive use and expenses associated with cancer treatment. In this study, we assessed adherence to CWA recommendations for the treatment of breast cancer in three high-volume cancer centres in Sub-Saharan Africa (SSA).

Design

A cross-sectional study across Rwanda, Ghana and Tanzania was conducted, involving a review of medical records to assess adherence to five measurable CWA practices in breast cancer care. The study used inferential statistics, such as 2 tests, to compare adherence among these countries.

Settings

This study was conducted in three cancer centres (Ocean Road Cancer Institute, Rwanda Military Hospital and Korle Bu Teaching Hospital) in three countries (Tanzania, Rwanda and Ghana, respectively).

Participants

A total of 542 patients were recruited. Eligible patients were those with a breast cancer diagnosis and complete data as pertaining to five CWA recommendations.

Results

A total of 542 participants with a mean age of 51 years were included. Participants were well distributed across Ghana (37%), Rwanda (34%) and Tanzania (29%). Female patients represented 97% of the study cohort. Half (51%) of the participants had some form of insurance. The study observed high adherence to cancer staging (94%) before treatment and histological confirmation (91%) before breast lump removal across all sites. Hypofractionation was used in 0% of cases in Rwanda, 42% in Ghana and 70% in Tanzania.

Conclusion

This study provides critical insights into the implementation of CWA recommendations in breast cancer care in SSA. It highlights the disparities in adherence to CWA recommendations across different centres, showing the need for policy-driven changes and healthcare infrastructure improvement to standardise cancer care practices in LMICs.

Examining the care priorities, service needs and lived experiences of rural people with cognitive impairment and dementia in Canada: a scoping review protocol

Por: Bacsu · J.-D. R. · Berlinguette · C. · Smith · M. · Stone · C. · Vazquez · C. · Singer · J. · Rahemi · Z. · Funk · M. · Abudu-Birresborn · D. · Chai · H. W.
Introduction

Older age is one of the greatest risk factors of dementia, and the rural demographic is ageing in Canada. Compared with their urban counterparts, rural older adults often face unique challenges in accessing cognitive healthcare, which is exacerbated by a shortage of healthcare specialists, public transportation, finances, education, services and dispersed geography. This scoping review protocol outlines the methodology that will be used to examine the literature about the care priorities, service needs and lived experiences from the perspectives of rural older adults living with cognitive impairment and dementia in Canada.

Methods and analysis

Our scoping review protocol will follow the guidance of Arksey and O’Malley and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extensions for Scoping Reviews checklist. Our search strategy will identify relevant peer-reviewed literature in databases including Cumulated Index in Nursing and Allied Health Literature (CINAHL), EMBASE, PsycINFO, PubMed, Web of Science and Scopus. The database search dates for this scoping review will be from 1 January 2015 to 1 January 2025. The data will be charted by two reviewers using a standardised data extraction table. Inductive content analysis will be performed using a three-step process.

Ethics and dissemination

Given this scoping review will be an examination of the published literature, human subjects will not be included in this research. Therefore, ethics approval is not required. Knowledge mobilisation and dissemination strategies will include peer-reviewed journal articles, conference presentations, community workshops, newsletter articles and webinars. This study may provide valuable information for healthcare practitioners, community leaders and policymakers working to support people living with cognitive impairment and dementia in rural communities.

Effect of music therapy on vital signs and heart rate variability of paediatric patients during the extubation process in the paediatric intensive care unit: a multicentre randomised clinical trial protocol

Por: Beltran · Y. M. · Charum · D. P. · Zuluaga · C. A. · Vega · M. A. · Benavides-Cruz · J. · Amarillo · M. · Canon · E. · Alvarez · I. · Ramirez-Moreno · J. · Paez · L. · Garzon · M. C. · Calderon · P. D. · Quintero · T. C. · Moreno · J. · Ettenberger · M.
Introduction

A successful extubation process is critical for the future health outcomes of paediatric patients, as it tests the functioning of the respiratory system without the support of mechanical ventilation. However, extubation can cause stress, pain, anxiety or discomfort in patients, which may sometimes lead to an increased likelihood of reintubation. Music-based interventions and therapies have been shown to be effective in reducing anxiety and stress levels in ventilated patients in the paediatric intensive care unit (PICU), but studies evaluating the effect of music therapy during the extubation process in the PICU are scarce.

Methods and analysis

This is a pragmatic multicentre randomised clinical trial with two parallel arms. The intervention group will receive standard care + music therapy during the extubation process, and the control group will receive standard care alone. The main outcome measure is heart rate, which will be measured every minute for 5 min pre-extubation, during the extubation process and up to 10 min postextubation. Secondary outcome measures are: oxygen saturation, respiratory rate, blood pressure and heart rate variability. A total of 82 patients will be randomised.

Ethics and dissemination

This study was approved by the Research Ethics Committee of the Fundación Universitaria Sanitas (CEIFUS 1356-24, date of approval: 3 May 2024). All parents or legal guardians of patients will sign a written informed consent, and if applicable, assent from participants will be sought. The results will be disseminated through publications in peer-reviewed journals, conferences and presentations at the hospitals’ clinical committees.

Protocol version

Version 1.0, 18 December 2024.

Trial registration number

NCT06591533, trial registration date: 10 September 2024.

Development of a case definition for polycystic ovary syndrome using administrative health data: a validation study

Por: Salem · J. N. · Vettese · R. · Yamamoto · J. M. · Koshy · S. · Harrison · T. · Stephenson · N. · Ronksley · P. E. · Metcalfe · A. · Brennand · E. A. · Benham · J. L.
Objectives

To develop and validate a polycystic ovary syndrome (PCOS) case definition using administrative health data sources.

Design

A validation study.

Setting

Secondary care centre outpatient gynaecology clinic in Calgary, Alberta, Canada.

Participants

3951 electronic health records of women aged 18–45 years who presented to a gynaecology clinic in Calgary, Canada, between January 2014 and December 2019 were reviewed. We identified 180 patients with PCOS using the Rotterdam criteria. Participants were excluded if they were biologically male, pregnant at the time of the consultation, did not meet the date criteria or if their consultation note was missing. The chart data were connected to the Practitioner Claims and the Discharge Abstract Database by personal health number.

Primary and secondary outcome measures

Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of 68 case definitions for PCOS were estimated. Case definition performance was graded.

Results

Of the 68 case definitions tested, none had high validity. The best performing case definitions were: (1) ≥3 instances of International Classification of Diseases-9 code 256.4 (polycystic ovaries) with exclusion codes (sensitivity 23.89%, specificity 99.59%, PPV 74.14%, NPV 96.35%) and (2) 626.X (irregular menstruation), 704.1 (hirsutism) and ≥3 instances of code 256.4 with exclusion codes (sensitivity 2.78%, specificity 99.97%, PPV 83.33%, NPV 95.40%).

Conclusions

We identified several case definitions for PCOS of moderate validity with high PPV (>70%) for case ascertainment in PCOS research in jurisdictions with similar administrative health data. These case definitions are limited by low sensitivity, which should be considered when interpreting research findings.

Neurogranin in cerebrospinal fluid as a marker of synaptic dysfunction in hip fracture patients with delirium: a multicentre cross-sectional study

Por: Hella · M. N. P. · Halaas · N. B. · Soennesyn · H. · Bergland · A. K. · Hetland · H. B. · Blennow · K. · Zetterberg · H. · Vik-Mo · A. O. · Idland · A.-V. · Pollmann · C. T. · Myrstad · M. · Neerland · B. E. · Aarsland · D. · Watne · L. O.
Objectives

Neurogranin (Ng) has a role in synaptic plasticity and is considered a biomarker of synaptic dysfunction, a process hypothesised to be important in delirium. Few studies examining Ng in delirium exist, with mixed findings. This study aimed to investigate associations between cerebrospinal fluid (CSF) Ng concentrations and delirium in acutely admitted hip fracture patients.

Design

Cross-sectional study.

Setting

Acutely admitted orthopaedic patients with hip fracture recruited from four participating hospitals in eastern Norway, representing secondary and tertiary care settings.

Participants

This study included 392 hip fracture patients. All admitted hip fracture patients operated in spinal anaesthesia were, regardless of age, considered for inclusion.

Methods

An in-house ELISA was used to measure CSF Ng concentration in patients acutely admitted with a hip fracture (n=392). Delirium status was evaluated daily according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Editions criteria independently by two experienced geriatricians. A value > 3.44 on The Informant Questionnaire on Cognitive Decline in the Elderly was used as a surrogate marker of probable dementia.

Results

180 patients (46 %) developed delirium and 70% of these had dementia. CSF Ng concentration did not differ significantly between those with and without delirium (176 pg/mL vs 164 pg/mL), with an estimated difference in medians of 12 (95% CI –5.8 to 29.8), p=0.185. Analyses adjusted for age, gender and dementia status did not show a statistically significant difference in Ng concentrations between the patients.

Conclusions

We did not find an association between delirium and CSF concentrations of Ng. This could imply that synaptic dysfunction and degeneration, involving Ng, are not key processes in the development of delirium. Further studies on other synaptic proteins are warranted to better explore synaptic dysfunction’s potential role in the pathophysiology of delirium.

Effects of deprescribing from inhaled corticosteroids in people with cystic fibrosis: protocol for a target trial emulation using the UK CF Registry

Por: McClenaghan · E. · Rouette · J. · Granger · E. · Davies · G. · Keogh · R. H. · Tazare · J.
Introduction

Observational data are increasingly used to study and draw causal inferences about the effects of treatments. Target trial emulation (TTE) is a framework for mitigating biases in causal investigations through specification of an observational study, targeting a specific causal research question, based on a real or hypothetical randomised controlled trial. Investigations into the effects of treatment discontinuation are of growing interest and particularly relevant in cystic fibrosis (CF), where treatment burden is high and new transformative therapies are becoming widespread. We aim to use the TTE framework to investigate the effect of discontinuation of inhaled corticosteroids (ICS) on clinical outcomes in people with CF. Our observational emulation will be based on the CF WISE (Withdrawal of Inhaled Steroids Evaluation) trial (PMID:16556691).

Methods and analysis

Two study designs proposed for investigating treatment effects using observational data are the prevalent new-user design and the sequential trials design. Each design uses different but related methods to address similar causal questions; however, the comparability between them remains uncertain. We will conduct a population-based cohort study using data from the UK CF Registry between January 2016 and June 2018 and apply these designs. We will specify the target trial protocol for each study design. Estimates for the causal effects of discontinuing ICS will be obtained and compared with those from the CF-WISE trial.

Ethics and dissemination

This study has received approval from the UK CF Registry Research Committee for both the research and access to data. Ethical approval has also been granted by the LSHTM Ethics Committee. The UK CF Registry has NHS Research Ethics Committee approval (REC reference: 24/EE/0012). The findings from this project will be submitted to peer-reviewed journals and presented at academic conferences.

Associations between prior and subsequent sickness absence before and during the COVID-19 pandemic: a Swedish prospective cohort study of 306 933 blue-collar workers in the retail and wholesale industry

Por: Cybulski · L. · Pettersson · E. · Alexanderson · K. · Farrants · K.
Objectives

The length and frequency of previous sickness absence (SA) spells have been shown to be associated with future SA. The aim was to examine if this pattern persisted during the COVID-19 pandemic among workers in retail and sales.

Design

We used pseudonymised, individual-level data from three nationwide Swedish administrative registers to conduct a prospective cohort study.

Setting

Sweden.

Participants

All 306 933 blue-collar workers in retail and wholesale, aged 18–67 in Sweden in 2019.

Outcomes

Likelihood and length of SA.

Methods

We used a Negative Binomial Hurdle model to estimate incidence rate ratios (IRR) and odds ratios (ORs) to determine if SA patterns differed in 2020–2021 compared with 2018–2019. We examined how these patterns varied according to the length and frequency of SA in the preceding year. Only SA spells >14 days were included.

Results

54 993 (18.5%) workers had SA during 2020–2021, an increase from 46 024 (15.6%) in 2018–2019. We observed a dose-response association between the number of prior SA days and the likelihood and length of future SA days, both before and during the pandemic. The likelihood of subsequent SA was higher in 2020–2021 compared with 2018–2019 among individuals with up to 180 prior SA days. Individuals with no prior SA had a lower average number of subsequent SA days during the pandemic (IRR (95% CI) 0.96 (0.94–0.98)) than in 2018–2019, while those with 1–30, 31–90 or 181–365 prior SA days had a higher average number of SA days during 2020–2021.

Conclusion

Individuals with many SA days prior to the pandemic were at particularly high risk of lengthy SA during the pandemic years.

Mobilising global knowledge to strengthen the integration of community health workers (CHWs) in high-income countries with universal healthcare systems: a scoping review protocol

Por: Steenbeek · A. · Rothfus · M. · Doucette · N. · {-} · S. · Indar · A. · Sarkar · S. · Khan · F. · Rani · S.
Introduction

Community health workers (CHWs) are trained lay people and trusted members of communities worldwide who play crucial roles in bridging healthcare gaps in low–middle-income countries yet remain underused and not well integrated within high-income countries like Canada. The objective of this scoping review is to map out available evidence on the integration of CHWs in high-income countries with universal healthcare systems.

Methods and analysis

This scoping review will include all available literature involving CHWs, or similar designations, and their integration into universal health systems within high-income countries. Literature will be excluded if it does not involve CHWs, universal healthcare systems, address integration or is conducted in low–middle-income countries. This review will include all available literature (including those that show null or negative results) that examines the integration of CHWs in high-income countries with a universal healthcare system. Documents describing integration may include, but are not limited to: tools, policies, models, frameworks, programmes or organisational features that seek to promote positive integration. Peer-reviewed and grey literature examining CHW integration in high-income countries with universal healthcare systems will be eligible for inclusion. Databases/sources to be searched (from inception until November 2025) will include: Medline (Ovid), Embase (Elsevier), Scopus (Elsevier), CINAHL (EBSCO), PsycINFO (EBSCO), Academic Search Premier (EBSCO), Business Source Complete (EBSCO), ProQuest Dissertations and Theses Global. Retrieval of full-text, all language studies (and other literature), data extraction, synthesis and mapping will be performed independently by two reviewers, following Joanna Briggs Institute methodology. Findings will be organised and presented according to the Levesque conceptual framework for healthcare access.

Ethics and dissemination

Ethics approval is not required for this scoping review and literature search will start in October 2025 or on acceptance of this protocol. The findings of the scoping review will be available (February 2026) and will be published in a peer-reviewed journal.

Surrogacy in Ghana: a qualitative study exploring recruitment processes, eligibility criteria, stigma and postnatal care experiences among surrogate mothers

Por: Amarteifio · D. A. · Hiadzi · R. A. · Tetteh · P. M. · Boafo · I. M.
Objective

Surrogacy has become a vital reproductive option for individuals and couples who are unable to conceive naturally. This study explores the experiences of surrogate mothers in Ghana, focusing on recruitment pathways, eligibility criteria, societal stigma and postnatal care experiences.

Design

Qualitative phenomenological research design was used, and data were collected through semi-structured interviews and analysed using thematic content analysis.

Setting

Three private agencies that source surrogate mothers for assisted reproduction facilities in Accra, Ghana. Data were collected between December 2020 and June 2021.

Participants

Twenty-one surrogate mothers aged 20–40 years who were either pregnant (gestational age ≥16 weeks) or had delivered within the past 2 years were recruited from three private agencies in Accra.

Results

Thematic analysis generated four themes: (1) recruitment pathways into surrogacy, (2) eligibility criteria and assessments, (3) experiences of stigma and concealment and (4) postnatal care and recovery. These themes illustrate how surrogate mothers in Ghana navigate recruitment processes, psychosocial and medical evaluations, societal stigma and challenges with discharge and follow-up care.

Conclusion

These findings underscore the need for systemic changes, including enhanced postnatal care, structured psychological evaluations and culturally sensitive interventions to reduce stigma.

Study protocol for the DISTINCT trial: inDividual, targeted thrombosIS prophylaxis versus the standard 'one-size-fits-all approach in patients undergoing Total hIp or total kNee replaCemenT - a national, multicentre, randomised, multiarm, open-label trial

Por: Kok · R. Y. · van Bodegom-Vos · L. · Ettema · H. B. · Groenwold · R. H. H. · van den Hout · W. B. · Huisman · M. V. · Klok · F. A. · Nelissen · R. G. H. H. · van Rein · N. · van Veen · M. · Vehmeijer · S. B. W. · Wiegerinck · J. J. I. · Cannegieter · S. C. · Nemeth · B.
Introduction

Patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA) are considered to have a symptomatic venous thromboembolism (VTE) risk of 1.0%–1.5% despite thromboprophylaxis. Fast-track treatment protocols have substantially lowered the VTE risk in most patients. Hence, the majority of patients may be unnecessarily exposed to the burden and risk of thromboprophylaxis. On the contrary, there are still patients with a high VTE risk who develop VTE despite thromboprophylaxis. Thus, tailored thromboprophylaxis treatment may potentially reduce both VTE and bleeding risk.

Methods and analysis

The DISTINCT (inDividual, targeted thrombosIS prophylaxis versus the standard ‘one-size-fits-all’ approach in patients undergoing Total hIp or total kNee replaCemenT) trial is a national, multicentre, randomised, multiarm, open-label trial. The main objective is to study whether tailored thromboprophylaxis reduces the occurrence of symptomatic VTE (primary outcome) and major bleeding (primary safety outcome) within 90 days after THA/TKA in comparison with standard thromboprophylaxis. Patients with a low, intermediate or high predicted VTE risk (based on the Thrombosis Risk Prediction following total hip and knee arthroplasty score (TRiP(plasty) score)) will be included in the DISTINCT-1, DISTINCT-2 or DISTINCT-3 studies, respectively. In the DISTINCT-1 trial, 3478 patients will be randomly allocated to receive either in-hospital thromboprophylaxis or standard prophylaxis. In the DISTINCT-2 cohort study, 2500 patients will receive standard prophylaxis. In the DISTINCT-3 trial, 4100 patients will be randomly allocated to receive either 6 weeks of high-dose thromboprophylaxis or standard prophylaxis. Standard prophylaxis consists of a low dose of any approved thromboprophylactic agent for 4 weeks. We hypothesise that (1) the efficacy of in-hospital only thromboprophylaxis is non-inferior in preventing VTE and equally safe compared with standard prophylaxis in patients with a low VTE risk (DISTINCT-1) and (2) prolonged high-dose thromboprophylaxis is superior in preventing VTE as compared with standard prophylaxis in patients with a high VTE risk (DISTINCT-3). Patients with intermediate VTE risk will be observed to evaluate VTE and bleeding rates (DISTINCT-2).

Ethics and dissemination

The protocol has been approved by the Medical Research Ethics Committee Leiden-Den Haag-Delft, EU-trial-number 2023-510186-98. Study results will be disseminated through peer-reviewed journals and during international conferences.

Trial registration number

NCT06581965.

Evaluation of natriuresis-guided depletion after cardiac surgery: protocol for a single-centre, open-label, randomised controlled trial--the EASY-CS study

Por: Beyls · C. · Mollet · N. · Gibert · L. · Huette · P. · Khamari · M. · Meynier · J. · Abou-Arab · O. · Mahjoub · Y.
Introduction

Fluid overload (FO) is a common complication following cardiac surgery with cardiopulmonary bypass (CPB) and is associated with increased morbidity and mortality. Loop diuretics, particularly furosemide, are widely used to promote sodium and water excretion, but their postoperative use remains largely empirical. International guidelines recommend early assessment of diuretic response using spot urinary sodium concentration, traditionally measured by automated laboratory analysers. Recent advances now enable bedside measurement of natriuresis using point-of-care (POC) urinary sodium sensors. This trial aims to determine whether real-time bedside natriuresis monitoring using a POC device can guide safer and more effective diuretic strategies in the postoperative management of FO.

Materials and methods

The EASY-CS trial is a prospective, single-centre, open-label, randomised controlled trial designed to evaluate whether a natriuresis-guided furosemide titration protocol improves diuresis within 48 hours following cardiac surgery with CPB. A total of 102 adult patients undergoing elective cardiac surgery with CPB and requiring postoperative intravenous (IV) furosemide for FO will be randomised in a 1:1 ratio to either standard care (n=51; furosemide titration based on clinical judgement) or a natriuresis-guided arm (n=51), in which furosemide dosing is adjusted according to urinary sodium concentration. All patients will receive an initial 20 mg dose of IV furosemide. In the intervention group, urinary sodium will be measured every 6 hours using a POC sodium sensor (LAQUAtwin Na+ metre, Horiba, Japan). If the spot urinary sodium is

Secondary outcomes include urinary sodium concentration and urine output at 24 hours, natriuresis at 48 hours, and the venous excess ultrasound score at 48 hours, as determined by transthoracic echocardiography. The study will also assess total loop diuretic dose administered, cumulative fluid balance over 48 hours and the incidence of postoperative complications at day 30, including cardiovascular, renal, respiratory and gastrointestinal events. Safety endpoints include the presence of hypotension, hypokalaemia or acute kidney injury before each diuretic administration. Randomisation will be stratified by EuroSCORE II (

Ethics and dissemination

Ethical approval has been obtained from the Institutional Review Board (IRB) of Amiens University hospital (IRB-ID: 2025-A00925-44). The study’s results will be disseminated through peer-reviewed publications and presentations at national and international conferences.

Trial registration number

ClinicalTrials.gov Identifier: NCT07077772.

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