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Hoy — Diciembre 16th 2025Tus fuentes RSS

Adapting the CanMEDS framework to develop an advanced practice nursing competency framework in Belgium

Por: Racine · L. · Luimes · J.

Commentary on: Van Hecke A, et al. Development of a competency framework for advanced practice nurses: a co-design process. J Adv Nurs 2024; 1-13. doi.org/10.1111/jan.16174

Implications for practice and research

  • A CanMEDS-derived APN (Advanced Practice Nurse) competency framework informs APNs’ personal and professional development and guides APNs’ practices within educational and healthcare settings in Belgium.

  • Further research is required to validate this competency framework and determine its usability in education and practice.

  • Context

    Advanced practice nursing (APN) refers to an expanded scope of practice beyond the generalist level to provide direct healthcare services, including prevention, diagnosis, therapeutics and illness management.1 2 APNs require roles and levels of practice based on measurable competencies.1 Competency frameworks can be used to develop APN graduate programmes and serve for quality improvement. A change in the legal framework for APNs’ roles and...

    High-protein diets reduce plasma pro-inflammatory cytokines following lipopolysaccharide challenge in Swiss Albino mice

    by Hellen W. Kinyi, Charles Kato Drago, Lucy Ochola, Gertrude N. Kiwanuka

    Macronutrients serve as principal sources of energy, structural components, and regulators of physiological processes. However, the optimal macronutrient combination for health remains unclear. While previous studies indicate that dietary macronutrient composition influences immune function, many have examined individual nutrients in isolation, failing to reflect the interactive effects of macronutrients. This study addresses this gap by examining how varying ratios of dietary carbohydrates, proteins, and lipids modulate serum cytokine responses to lipopolysaccharide challenge in Swiss albino mice. Male and female Swiss albino mice (n = 6 per group), aged 6–8 weeks, were randomly assigned to six purified isocaloric diets with differing macronutrient ratios for 15 weeks. Body weights were monitored to assess nutritional status. Serum levels of TNF-α, IL-6, IL-1β, and IL-10 were measured in unchallenged mice and after three hours of intraperitoneal LPS administration. Mice fed high-carbohydrate, low-protein diets had the highest weight (33.1 g ± 1.1), while those on high-lipid, low-protein diets had the lowest (28.3 g ± 0.6). Plasma levels of TNF-α and IL-10 varied significantly (p 

    Investigating risk factors of hemorrhagic fever of renal syndrome (HFRS) in Qingdao, Shandong province, China

    by Ying Li, Jing Jia, Runze Lu, Liyan Dong, Lizhu Fang, Litao Sun, Zongyi Zhang, Qing Duan, Lijie Zhang, Kunzheng Lv, Huilai Ma

    Background

    Qingdao, a historically high-risk area for hemorrhagic fever with renal syndrome (HFRS) in China, is undergoing agricultural mechanization and urbanization. However, the specific risk factors for HFRS in this context remain unclear. This study sought to determine the risk factors for HFRS in Qingdao.

    Methods

    Community-based, 1:2 case-control study. Each case was matched with two healthy neighborhood controls based on biological sex, age, and the same neighborhood or village. Univariate and multivariate conditional logistic regression analyses were performed. Furthermore, stratified analyses were performed to explore risk factor heterogeneity between the peak season for Hantaan virus (HTNV) type HFRS (October-January) and other months.

    Results

    93 cases (73.2%, 93/127) reported from January 2022 to September 2023 and 186 controls completed this questionnaire. Farmers accounted for the highest proportion (68.8%, 64/93). In multivariate logistic regression analysis, there were three significant risk factors for HFRS: piles of firewood and/or grain in residential yards (odds ratio [OR]=3.75, 95% CI: 2.14–6.55), mite and/or flea bites (OR=1.83, 95% CI: 1.06–3.18) and contacting with rats and/or their excreta (OR=1.73, 95% CI: 1.09–2.74); three variables represented significant protective factors for HFRS: frequency of sun exposure for quilts and bedding (OR=0.41, 95% CI: 0.19–0.90), rodent control measures at home (OR=0.50, 95% CI: 0.30–0.81) and knowing the main sources of HFRS transmission (OR=0.58, 95% CI: 0.36–0.90). Stratified analysis revealed that the influence of these factors varied by season, with rodent contact and control measures being particularly salient during the HTNV peak season.

    Conclusion

    This study provides the first comprehensive evidence of risk and protective factors for HFRS in Qingdao, highlighting the role of rodent control, promoting comprehensive health education, environmental management, and personal protection. However, the results should be interpreted considering the study’s limitations, including a 73.2% response rate and the potential for recall bias.

    Cyclodextrin reduces cholesterol crystal uptake by circulating monocytes in patients undergoing coronary angiography

    by Nikola Lübbering, Alexander Krogmann, Felix Jansen, Eicke Latz, Georg Nickenig, Sebastian Zimmer

    Background

    Atherosclerosis is a chronic inflammatory disease driven by endothelial dysfunction, cholesterol accumulation, and immune activation leading to thrombosis and vascular stenosis. While LDL-lowering therapies are firmly established, targeting the underlying inflammation is still an emerging strategy. Cholesterol crystals (CC) contribute to inflammation by activating the NLRP3 inflammasome in monocytes and promoting disease progression. Cyclodextrin (CD), an FDA-approved drug carrier, has shown atheroprotective effects by enhancing cholesterol metabolism and reducing inflammation in preclinical models. This study investigated whether CC-uptake in human monocytes, a prerequisite for inflammasome activation, is also influenced by CD pretreatment.

    Methods

    Human peripheral mononuclear cells were isolated from whole blood samples provided by 76 patients undergoing coronary angiography at the University Hospital Bonn between November 2017 and February 2018. After separation, peripheral mononuclear cells were stimulated with 2-Hydroxypropyl-γ-Cyclodextrin and CC. CC-uptake by monocytes was analyzed using flow cytometry.

    Results

    CC-uptake by monocytes varied greatly between patients (8–37%), with lower uptake observed in patients with elevated leukocytes (p = 0.0058) and diabetes mellitus (p = 0.0448). CD-pretreatment significantly reduced CC-uptake (20.1% ± 0.8% vs. 15.0% ± 0.6%, p p = 0.0316), requirement for percutaneous coronary intervention (PCI) (p = 0.0030), and elevated leucocyte levels (p = 0.0135) had lower CCΔCD, suggesting a link between systemic inflammation and attenuated CD efficacy.

    Conclusion

    We demonstrated that CD significantly reduced CC-uptake in patients undergoing coronary angiography, which supports its role in inhibiting CC-phagocytosis and promoting cholesterol efflux. Interestingly, patient response to CD varied, with those exhibiting greater systemic inflammation or CAD showing a less pronounced reduction in CC-uptake. Our findings provide insight into the atheroprotective mechanisms of CD and suggest its potential utility in evaluating individual cardiovascular risk and monitoring CD-based therapeutic interventions in humans.

    Study on the release pattern of Zn in soil of ionic rare earth mining areas under different leaching conditions

    by Zhongqun Guo, Qiangqiang Liu, Feiyue Luo, Shaojun Xie, Tianhua Zhou

    The acidic leachate injected during the mining process of ion-type rare earth ores can damage the environmental characteristics of the soil, thereby triggering the activation and release of associated heavy metals. Severe Zn contamination has been found in the environment of ion-type rare earth mining areas, but the activation and release of Zn in the soil during the leaching process have not been fully understood. This study investigated the activation and release patterns and mechanisms of Zn in soil under different leaching agents ((NH4)2SO4, MgSO4, Al2(SO4)3) and varying concentrations of Al2(SO4)3 (1%, 3%, 5%, 7%) using a simulated leaching experimental system. The results show that the activation and release patterns of Zn in the soil vary significantly under the influence of the three leaching agents. During the entire leaching cycle, the peak Zn concentration in the leachate was highest under MgSO4 leaching, while the residual Zn content in the soil under Al2(SO4)3 leaching approached the high-risk environmental threshold. The high-concentration systems (5%, 7%) of Al2(SO4)3 significantly enhanced the activation and release efficiency of Zn in the soil compared to the low-concentration systems (1%, 3%) of Al2(SO4)3. (NH4)2SO4 mainly promotes the activation and release of Zn through ion exchange between NH4+ and Zn2+ and the acidification effect; Al2(SO4)3, on the other hand, dominates the activation and release of Zn by providing a strongly acidic environment and dissolving and damaging the mineral lattice; while MgSO4 not only exchanges ions between Mg2+ and Zn2+, but also alters the soil colloidal structure, facilitating Zn activation and release. The promoting effects of the three leaching agents on the transformation of Zn in soil follow the order of Al2(SO4)3> (NH4)2SO4 > MgSO4, with the environmental risk assessment index (RAC) being highest after Al2(SO4)3 leaching, indicating the greatest potential environmental risk. Compared to the other three concentrations (1%, 5%, 7%) of Al₂(SO4)3, the 3% concentration of Al2(SO4)3 had the most significant promoting effect on the transformation of Zn in soil. This study provides a theoretical basis for optimizing the green mining process of ion-type rare earth ores and preventing heavy metal pollution, and offers scientific support for revealing pollution mechanisms and formulating remediation and risk assessment strategies.

    High-dose intermittent theta burst stimulation targeting the individualised frontoparietal cognitive network for post-stroke cognitive impairment: protocol for a randomised sham-controlled trial in China

    Por: Han · K. · Zhou · Y. · Huang · J. · Ren · J. · Lu · H. · Liao · X. · Zhu · Y. · Zhang · H. · Liu · H.
    Introduction

    Cognitive impairment is a common consequence after stroke. Intermittent theta burst stimulation (iTBS) has emerged as a promising cognitive therapy. However, traditional iTBS typically employs lower doses and one-size-fits-all stimulation targets, which may not fully capitalise on the potential of this therapy and warrants further evaluation for both efficacy and safety. This study aims to evaluate the efficacy and safety of high-dose iTBS targeting the individualised frontoparietal cognitive network (FCN) identified by precision functional neuroimaging for post-stroke cognitive impairment (PSCI).

    Methods and analysis

    This is a prospective, double-blind, sham-controlled, parallel-group randomised controlled trial. 60 eligible participants with PSCI will be randomly assigned (1:1) to an active iTBS or a sham-controlled group. The active group will receive high-dose iTBS (3600 pulses/day) at 80% resting motor threshold targeting the left individualised FCN, guided by a real-time neuronavigation system. The sham group will follow identical procedures using a sham coil. Both groups will also undergo conventional computerised cognitive training. The intervention will be administered on workdays over a period of 3 weeks, totalling 15 workdays. The primary outcome is the change in Montreal Cognitive Assessment scores from baseline to immediately post-treatment. Secondary outcomes include long-term change in global cognition, activities of daily living and specific cognitive domains (assessed by a comprehensive neuropsychological battery covering memory, attention, executive function and language), as well as mood. Assessments occur at baseline, post-treatment and 3-month follow-up. Safety outcomes, specifically the number of adverse events related to iTBS, will be monitored and recorded throughout the trial.

    Ethics and dissemination

    This study has been approved by the Medical Ethics Committee of the China Rehabilitation Research Center. The results of this study will be published in peer-reviewed scientific journals and disseminated at academic conferences.

    Trial registration number

    NCT05953415.

    Nomogram for suicidal ideation and non-suicidal self-injury risk assessment in Dehong District nursing staff: a cross-sectional study

    Por: Li · G. · Ding · C. · Duan · Z. · Luo · W.
    Objectives

    This study aimed to identify and validate risk factors for suicidal ideation (SI) and non-suicidal self-injury (NSSI) among nursing staff through the development and application of a risk model and nomogram.

    Design

    A cross-sectional online survey was conducted in Dehong District to collect relevant data.

    Participants

    A total of 1774 Chinese nursing staff members were enrolled in this study.

    Results

    Multiple factors were independently associated with SI among nursing staff. These included divorce or other non-marital status (OR=2.42, 95% CI 1.07 to 5.44), drinking frequency (OR=1.34, 95% CI 1.001 to 1.79), loneliness (OR=1.26, 95% CI 1.11 to 1.44), depressive symptoms (OR=1.13, 95% CI 1.09 to 1.18), childhood trauma (OR=1.03, 95% CI 1.02 to 1.05) and life quality satisfaction (OR=0.63, 95% CI 0.49 to 0.80). Similarly, for NSSI among nursing staff, independent risk factors were identified, such as smoking frequency (OR=1.37, 95% CI 1.01 to 1.85), drinking frequency (OR=1.42, 95% CI 1.05 to 1.91), loneliness (OR=1.21, 95% CI 1.05 to 1.39), depressive symptoms (OR=1.13, 95% CI 1.09 to 1.18) and childhood trauma (OR=1.03, 95% CI 1.01 to 1.05). A nomogram for assessing SI/NSSI was established and demonstrated good calibration, with a Concordance Index of 0.82 (95% CI 0.79 to 0.86) for SI and 0.81 (95% CI 0.78 to 0.85) for NSSI.

    Conclusion

    The findings of this study can be used to identify nursing staff at risk of developing SI/NSSI. By using the developed nomograms for self-assessment, individuals might gain a better understanding of their occupational stress levels while performing routine work tasks. However, it should be noted that the study lacks external validation, which limits the generalisability of the findings at this stage.

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    Translation and content validity of the Arabic Communication and Symbolic Behaviour Scales Developmental Profile (CSBS DP) Infant-Toddler Checklist

    Por: Al-Bluwi · G. S. M. · Masuadi · E. · Marquis · A. · Al-Rifai · R. H. · Elbarazi · I. · Ahmed · L. A.
    Objective

    The Communication and Symbolic Behaviour Scales Developmental Profile Infant–Toddler Checklist (CSBS DP ITC) is a screening tool designed to identify early deficits in social communication, expressive speech/language and symbolic functioning in children aged 6–24 months. This study aimed to translate and content validate the CSBS DP ITC into Modern Standard Arabic.

    Design

    Methodological study involving translation and content validation.

    Setting

    The study was conducted in the United Arab Emirates.

    Participants

    The translation process involved five bilingual translators and one monolingual Arabic language expert. Ten experts participated in the content validation phase, and 10 parents of young children participated in the face validity assessment.

    Outcome measures

    Content Validity Indices (CVIs), including the Item-level CVI (I-CVI), the Scale-level CVI by Average (S-CVI/Ave) and the S-CVI by Universal Agreement (S-CVI/UA), along with modified kappa statistics, were calculated to assess item-level and scale-level clarity, relevance and comprehensiveness.

    Results

    Expert panel ratings showed high clarity (I-CVI: 0.8–1, S-CVI/Ave: 0.98, S-CVI/UA: 0.88) and similar relevance scores. Face validity assessments yielded clarity I-CVI scores of 0.9–1, with S-CVI/Ave at 0.98 and S-CVI/UA at 0.8. The modified kappa statistic ranged from 0.89 to 1, indicating strong agreement among parents.

    Conclusions

    The CSBS DP ITC was effectively translated and content validated into Modern Standard Arabic. The calculated CVI values ranged from excellent to acceptable. This step establishes a foundation before proceeding to full psychometric testing of the instrument, paving the way for a reliable and culturally appropriate tool to identify early communication delays for use across the Arab-speaking population.

    Channels and countermeasures of the COVID-19 pandemic’s impact on urban economic resilience: Lessons from China

    by Xianxiang Lu, Yangrui Duan

    Resilience is a crucial ability of an economy to withstand sudden events and uncertain shocks. Using the entropy method, this study measures the economic resilience of 281 Chinese cities (prefecture-level and above) from 2017 to 2022, and empirically examines the impact of COVID-19 on this resilience, as well as its transmission channels. The results show that COVID-19 adversely affected overall urban economic resilience, with contrasting effects across its sub-dimensions: an insignificant negative impact on shock resistance, a significant negative impact on adaptive recovery, and an insignificant positive impact on innovative transformation. Transmission channels analysis reveals COVID-19 impaired urban economic resilience through the channels of employment structure, consumption, investment, and unrelated diversification, with consumption identified as the predominant one. Heterogeneity analysis reveals that the economic resilience of cities in both the high and low manufacturing specialization groups was more adversely affected by COVID-19 than that of cities in the medium group. Regarding services specialization, the economic resilience of cities with a medium degree of services specialization were more negatively affected by COVID-19 than that of cities with low services specialization. Furthermore, the economic resilience of cities with a higher degree of related diversification was less negatively affected by COVID-19. This study provides a replicable analytical framework and empirical evidence for enhancing urban economic resilience in China and other countries in post-pandemic era.

    Uncovering age-related differences in communication by people with persistent pain when interacting with a pain history assessment chatbot in Australia: an exploratory mixed-methods study using a comparative analysis

    Por: Hay · E. · Ireland · D. · Claus · A. · Rose · T. · Strong · J. · Westerman · D. · Schlumpf · M. · Vijayakumar · P. · Burvill · L. · Andrews · N.
    Objectives

    There is limited research exploring the age-related difference in communication when describing pain experiences. This project aimed to identify key differences between adolescents’, young adults’ and adults’ (i) preferred communication method, (ii) language content and (iii) lexical amount and variety when discussing their persistent pain experience using chatbot technology.

    Design

    An exploratory concurrent nested mixed-methods design using a comparative analysis.

    Setting

    Participants were recruited through a convenience sampling strategy from two tertiary multidisciplinary pain centres in Australia.

    Participants

    20 adolescents, 20 young adults and 20 adults completed a pain history assessment using the Dolores application. The inclusion criteria for this study were (i) persistent non-cancer pain for at least 3 months, (ii) 10 years of age and over and (iii) adequate expressive and receptive language skills to complete the required tasks in English, as determined by clinicians in the treating team.

    Results

    Drawn, voice and typed responses provided by participants during the chatbot interaction were analysed using content analysis. Fisher’s exact tests and 2 tests were used to examine differences between age groups. Strong effect size estimates generated from comparative analyses suggested that adolescents were the most likely age group to utilise drawing (p=0.153, Cramer’s V=0.268), preferred typing over speaking (p==0.007, Cramer’s V=0.433). Young adults used the greatest number and variety of words in response to chatbot questions including evaluative language (p=0.097, Cramer’s V=0.296). Adults tended to use more metaphors (p=0.085, Cramer’s V=0.305) and had a strong preference for speaking over typing (p=

    Conclusions

    The results of this study provide insights into age-related differences in communication and preferences when using technology to communicate about persistent pain. Future research exploring individualised age-related approaches to pain assessment, supported by the findings of this study, in comparison to current standardised assessments administered by clinicians are warranted.

    Study protocol for a multi-site case study evaluation of a Canadian quality improvement collaborative to improve Baby-Friendly practices in community health services

    Por: Turner · S. E. · Enns · J. E. · Seager · E. · LeDrew · M. · Benoit · B. · Semenic · S. · Snelgrove-Clarke · E. · Shittu · B. · Gordon Pappas · D. · CBFI-C Implementation and Evaluation Team · Nickel · N. C. · Campbell-Yeo · Frittenburg · Haiek · McClure · Rashid · Swan · Abbass-Di
    Introduction

    In Canada, many families want to breastfeed, but there are several common challenges they may encounter. Currently, 91% of Canadian families initiate breastfeeding after giving birth, yet only 38% of babies are breastfed exclusively to 6 months. In 1991, the Breastfeeding Committee for Canada (BCC) was established to implement the World Health Organization’s Ten-Step Baby-Friendly Hospital Initiative, a series of evidence-based in-hospital practices to support families to breastfeed. Then, in recognition of the need to support breastfeeding beyond the hospital setting, the BCC expanded the Baby-Friendly Initiative (BFI) to apply the Ten Steps to both hospitals and community health settings. However, uptake of the BFI Ten Steps in community settings has been low and methodology on how to optimise implementation of the Ten Steps in community is not well developed. Therefore, the objective of this project is to develop and evaluate a quality improvement collaborative with 25 community health services from across Canada to learn how to best support the implementation of the BFI Ten Steps in community, with the ultimate goal of improving breastfeeding outcomes.

    Methods and analysis

    This protocol describes the activities of the Community Baby-Friendly Initiative Collaborative (CBFI-C) and the methods used to evaluate its effectiveness. We will use the Institute for Healthcare Information Breakthrough Series (IHI-BTS) model, a proven quality improvement model that has been widely used in clinical settings, but is not yet widely used in community settings. The IHI-BTS combines three virtual learning sessions with action cycles that allow the participating sites time to test and track small practice changes. Sites will be asked to track care indicator and breastfeeding outcome data, engage in monthly webinars, receive coaching from trained mentors, participate in focus groups and participate in a final summative workshop. We will use a multi-site case study approach, combining aggregate care indicator data and qualitative data from webinars, focus groups and workshops to evaluate how the CBFI-C model supports community sites in the process of implementing the BFI Ten Steps.

    Ethics and dissemination

    Ethics approval for this evaluation was obtained from the CHIPER Health Research Ethics Board (Number HS26947-H2025:157)). The results of the CBFI-C evaluation will be shared in a report, peer-reviewed publications and presentations to government and academic audiences. The findings will inform effective quality improvement strategies to enhance uptake of the BFI in community health settings.

    Effects of glucagon-like peptide-1 analogues on hard binary outcomes for patients at increased risk of cardiovascular events: a protocol for a systematic review with network meta-analysis and Trial Sequential Analysis

    Por: Sillassen · C. D. B. · Faltermeier · P. · Petersen · J. J. · Kamp · C. B. · Grand · J. · Dominguez · H. · Frolich · A. · Gaede · P. H. · Gluud · C. · Mathiesen · O. · Jakobsen · J. C.
    Background

    Cardiovascular diseases, overweight, type 2 diabetes and chronic kidney disease increase the risk of cardiovascular events.

    Glucagon-like peptide-1 analogues are recommended by the European Society of Cardiology and the American College of Cardiology to lower the risk of death and progression of cardiovascular disease in patients with cardiovascular disease and type 2 diabetes. Semaglutide, tirzepatide and liraglutide are approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of type 2 diabetes mellitus and overweight. CagriSema is currently not approved, but several phase III trials are ongoing.

    No previous systematic review has investigated the effects of semaglutide, tirzepatide, CagriSema and liraglutide, which may not be disease-specific, on hard binary outcomes for all trial populations at increased risk of cardiovascular events.

    Methods and analyses

    We will conduct a systematic review and search major medical databases (Cochrane Central Register of Controlled Trials, Medical Literature Analysis and Retrieval System Online, Excerpta Medica database, Latin American and Caribbean Health Sciences Literature, Science Citation Index Expanded, Conference Proceedings Citation Index—Science) and clinical trial registries from their inception and onwards to identify relevant randomised trials. We expect to perform the literature search in December 2025. Two review authors will independently extract data and assess the risk of bias. We will include randomised trials assessing the effects of semaglutide, tirzepatide, CagriSema and/or liraglutide in participants with an increased risk of cardiovascular events. The primary outcome will be all-cause mortality. Secondary outcomes will be myocardial infarction, stroke and all-cause hospitalisation. Data will be synthesised by aggregate data meta-analyses, Trial Sequential Analyses and network meta-analysis, risk of bias will be assessed with Cochrane Risk of Bias tool V. 2, and the certainty of the evidence will be assessed by Grading of Recommendations, Assessment, Development and Evaluations and the Confidence in Network Meta-Analysis approach.

    Ethics and dissemination

    This protocol does not present any results. Findings of this systematic review will be published in international peer-reviewed scientific journals.

    PROSPERO registration number

    CRD42024623312.

    Effect of peri-interventional music on postictal agitation in electroconvulsive therapy patients (MUSE): protocol for an open-label multicentre randomised controlled trial in the Netherlands

    Introduction

    Postictal agitation (PIA) is a common adverse effect following electroconvulsive therapy (ECT). Current pharmacological treatments for PIA have undesirable side effects, and interventions to prevent PIA are unsatisfactory. The aim of this study is to assess the effect of peri-interventional music on PIA for patients undergoing ECT. Additionally, the study will assess the impact of music on pretreatment anxiety and post-treatment cognitive impairment.

    Methods and analysis

    This multicentre, open-label, parallel randomised controlled trial (RCT) aims to include 92 patients from two centres in Rotterdam, the Netherlands. Participants will be randomised into two groups: a music intervention group and a control group. The music group listens to recorded music 30 min before and 12 min after each of the first six ECT sessions of the full ECT course, while the control group will receive standard care. The primary outcome is the presence of PIA, measured using the Richmond Agitation-Sedation Scale (RASS). Secondary outcomes include the severity and duration of PIA, pretreatment anxiety, recovery duration, peri-treatment medication requirements, cognitive impairment and depression severity. Data will be analysed according to an intention-to-treat principle.

    Ethics and dissemination

    This study protocol has been approved by the Medical Ethical Review Committee of the Erasmus Medical Centre on 28 January 2025 (MEC-2024–0467) and subsequently received local approval at Antes Parnassia group. The trial will be carried out following the Declaration of Helsinki principles. Study results will be reported in a peer-reviewed journal according to the Consolidated Standards of Reporting Trials guidelines.

    Trial registration number

    NCT06817330.

    Increasing the pneumonia treatment coverage among children under 5 years old through 'Enhanced Management of Pneumonia in the Community: implementation research protocol

    Por: Nsona · H. · Golombe · E. · Zulu · U. · Magombo · C. · Twaibu · H. · Mbemba · P. · Msowoya · C. · Chagoma · E. · Sadala · A. · Dedza · C. · Mangwilisa · A. · Banda · R. · Chizani · N. · Mpezeni · W. · Qazi · S. A. · Nisar · Y. B.
    Introduction

    Pneumonia remains a leading cause of under-5 mortality in sub-Saharan Africa, accounting for approximately 14% of deaths in this age group. In Malawi, pneumonia accounts for 12% of under-5 deaths, with recent data revealing a concerning trend of over 110 000 new cases reported in 6 months. The Malawi government has made significant strides in reducing childhood mortality through the Integrated Community Case Management (iCCM) strategy, resulting in an 11% reduction in under-5 mortality over a 5-year period. However, the current iCCM strategy does not include the management of chest indrawing pneumonia in children aged 2–59 months and fast-breathing pneumonia in infants aged up to 2 months. This implementation research aims to increase pneumonia treatment coverage for under-5 year-old children in Kasungu District, Malawi, by expanding the community-based management of pneumonia by the iCCM-trained Health Surveillance Assistants (HSAs).

    Methods and analysis

    The current implementation research using both qualitative and quantitative data collection methods will assess the feasibility and acceptability of iCCM-trained HSAs managing chest indrawing pneumonia and fast-breathing pneumonia in children under 5 with oral amoxicillin at the community level in district Kasungu using the existing district health system. The study will employ a district health system model, leveraging existing trained iCCM HSAs to enrol and manage infants aged 7–59 days with fast-breathing pneumonia and 2–59-month-old children with chest indrawing pneumonia in the community with 7-day and 5-day oral amoxicillin, respectively. HSAs will also use pulse oximetry to identify hypoxaemic children for prompt referral to a hospital for further care. Sociodemographic features of enrolled children will be documented. Enrolled children will be followed up on treatment compliance using follow-up forms. The pneumonia treatment coverage will be assessed using baseline, midline and end-line surveys using both qualitative and quantitative data collection methods.

    Ethical and dissemination

    Ethical approval was obtained from the National Health Research Sciences Committee and the WHO Ethics Committee. The implementation research findings will be disseminated to national-level stakeholders and specifically targeted at District Health Offices, which are responsible for implementing the interventions.

    Intelligent voice-interactive tailored communication system (ScreenTalk) to improve colorectal cancer screening uptake among first-degree relatives of colorectal cancer patients: study protocol for a cluster-randomised type I hybrid effectiveness-implemen

    Por: Lin · S. · Luo · B. · Cai · L. · Qiu · L. · Li · H. · Liu · W. · Luo · Y. · Yuan · Y. · Peng · Z. · Bai · Y.
    Introduction

    First-degree relatives of colorectal cancer (CRC) patients have a twofold to fourfold increased risk of CRC. Tailored communication interventions have shown efficacy in improving their risk awareness and screening participation. While computer-based tailoring systems offer convenience, they often overlook the integration of healthcare professionals’ verbal input, potentially limiting effectiveness and long-term impact. To address this gap, we developed ScreenTalk, an intelligent voice-interactive tailored communication system that employs intelligent speech interaction to automate the tailoring process, enhance message credibility and improve scalability within CRC screening workflows.

    Methods and analysis

    This study is a two-arm, cluster-randomised controlled trial with a hybrid type I design involving 314 participants across three tertiary general hospitals in Guangzhou, China. Participants in both groups will receive usual care. Additionally, the intervention group will receive a 1-month tailored intelligent voice-interactive intervention, whereas the control group will receive unrelated health education to control for attention. Screening uptake (primary outcomes) and health beliefs (secondary outcomes) are measured at baseline and at 3 months, 6 months, 9 months and 12 month post the intervention. Implementation outcomes including reach, implementation, adoption and maintenance will be assessed through questionnaire, qualitative interviews and tailored system record.

    Ethics and dissemination

    The trial has been approved by the Ethics Committee of the Sun Yat-sen University (IRB No. L2024SYSU-HL-054). Information on the purpose and process of this study will be provided to the participants before recruitment, and written signatures will be collected from all participants to ensure their voluntary participation and protection of their rights and privacy.

    Trial registration

    NCT06710860 on ClinicalTrials.gov. Registered 26 November 2024. Date and version: 3.0, 14 July 2025.

    Development and validation of a postoperative risk calculator (POP-score) for patients undergoing cardiac surgery: a retrospective cohort study

    Por: Pölzl · L. · Sutter · C. · Lohmann · R. · Eder · J. · Ioannou-Nikolaidou · M. · Engler · C. · Graber · M. · Naegele · F. · Hirsch · J. · Maier · S. · Ulmer · H. · Mathis · S. · Reinstadler · S. J. · Grimm · M. · Bonaros · N. · Holfeld · J. · Gollmann-Tepeköylü · C.
    Objectives

    This study aimed to identify intraoperative and perioperative factors influencing 30-day mortality after cardiac surgery and to develop a risk score (POP-score) for its prediction.

    Design

    Retrospective cohort study with multivariable regression analysis.

    Setting

    A tertiary care cardiac surgery centre in Austria; data from consecutive patients undergoing cardiac surgery between 2010 and 2020 were analysed.

    Participants

    A total of 8072 patients were included. The cohort was randomly divided into a derivation cohort (75%) and a validation cohort (25%).

    Outcome measures

    The primary outcome measure was 30-day mortality. We analysed associations between intraoperative and perioperative variables and 30-day mortality, assessed via multivariable regression analysis.

    Results

    Several factors were significantly associated with 30-day mortality, including intraoperative RBC transfusion (OR 3.407 (95% CI 2.124–5.464)), postoperative high-sensitive cardiac troponin T cut-off levels (OR 2.856 (95% CI 1.958 to 4.165)), need for dialysis/haemofiltration (OR 2.958 (95% CI 2.013 to 4.348)) and temporary extracorporeal membrane oxygenation support (OR 5.218 (95% CI 3.329 to 8.179)) (p

    Conclusions

    The validated POP-score provides an improved tool for predicting 30-day mortality after cardiac surgery by incorporating intraoperative and perioperative factors alongside the EuroSCORE II. Although model performance was evaluated using 7-day peak troponin data, the score can be calculated within the first 72 hours postoperatively in most patients, supporting its clinical applicability for early decision-making, resource allocation and patient counselling. Further research is warranted to assess its clinical utility in diverse populations.

    Efficacy and moderators of mindfulness-based cognitive therapy (MBCT) in 'Difficult to Treat depression: protocol for a systematic review and individual participant data meta-analysis of randomised controlled trials

    Por: Barnhofer · T. · Niemi · M. · Michalak · J. · Velana · M. · Williams · J. M. G. · Chiesa · A. · Eisendrath · S. · Delucchi · K. · Segal · Z. · Cladder-Micus · M. · Speckens · A. · Foroughi · A. A. · Garcia-Toro · M. · Montero-Marin · J. · Dunn · B. · Strauss · C. · Ruths · F. A. · Ryan
    Introduction

    About 30% of depressed patients suffer from a protracted course in which the disorder continues to cause significant burden despite treatment efforts. While originally developed for relapse prevention, mindfulness-based cognitive therapy (MBCT) has increasingly been investigated in depressed patients with such ‘difficult-to-treat’ courses. This is a protocol for an individual participant data (IPD) meta-analysis aiming to determine efficacy and potential moderators of MBCT treatment effects in this group based on evidence from randomised controlled trials.

    Methods and analysis

    Systematic searches in PubMed, Web of Science, Scopus, PsycINFO, EMBASE and the Cochrane Controlled Trials Register for randomised controlled trials were completed on 17 June 2024. Authors of identified studies have contributed IPD, and data extractions have been completed. An update search will be conducted immediately before the start of data analyses. We will investigate the following outcomes: (a) self-reported and observer-reported severity of depression symptomatology, (b) remission and (c) clinically meaningful improvement and deterioration. One-stage and two-stage IPD-MA will be conducted with one-stage models using the observed IPD from all studies simultaneously as the primary approach. One-stage IPD models will include stratified study intercepts and error terms as well as random effects to capture between-study heterogeneity. Moderator analyses will test treatment-covariate interactions for both individual patient-level and study-level characteristics.

    Ethics and dissemination

    The results will inform understanding of the use of MBCT in patients with current ‘difficult-to-treat’ depression and will contribute to arguments in favour of or against implementing MBCT as a treatment for this group. They will be published in a peer-reviewed journal and made available to stakeholders in accessible formats. No local ethical review was necessary following consultation with the Ethics and Governance Board of the University of Surrey. Guidance on patient data storage and management will be adhered to throughout.

    PROSPERO registration number

    CRD42022332039.

    Patient experiences with a smartwatch 1L-ECG versus traditional Holter monitoring for ambulatory cardiac rhythm monitoring: a qualitative study

    Por: Karregat · E. P. M. · Vooijs · P. · Wierda · E. · Harskamp · R. · Lucassen · W. · Himmelreich · J. C. L. · Moll van Charante · E. P.
    Objective

    To explore patients’ experiences and perspectives on using a direct-to-consumer smartwatch with single-lead electrocardiography (1L-ECG) for ambulatory rhythm diagnostics in primary care.

    Design

    Qualitative study using semi-structured interviews and thematic analysis.

    Setting

    Primary care patients referred for ambulatory rhythm monitoring in a diagnostic centre.

    Participant

    Eighteen adults with paroxysmal palpitations, of whom nine were female patients (50%), aged 32–85 (median 66) years.

    Intervention

    Participants simultaneously wore a smartwatch with 1L-ECG capability (Withings ScanWatch) and a conventional Holter monitor for 7 days.

    Outcome measures

    Patient experiences and perceived barriers and facilitators to smartwatch use for rhythm monitoring, reported after the monitoring period.

    Results

    Patients found the smartwatch more user-friendly and feasible than the Holter monitor. Difficulties included uncertainty about when to initiate recordings, challenges capturing brief episodes and anxiety triggered by automated algorithm outputs. Participants emphasised the importance of accessible healthcare support for interpretation and reassurance.

    Conclusions

    This study shows that smartwatch-based 1L-ECG monitoring is feasible and acceptable for ambulatory rhythm diagnostics in primary care. Prior to routine implementation, it is crucial to address the identified challenges: particularly anxiety related to algorithm results, uncertainty about when to record and accessible clinician support.

    Preconception health risk profiles among women planning pregnancy in northern Ethiopia: a latent class analysis

    Por: Gebretsadik · G. G. · Biratu · A. K. · Kahsay · A. B. · Mulugeta · A. · Gessessew · A. · S Lassi · Z.
    Objectives

    Although the WHO and the Centers for Disease Control and Prevention (CDC) classify preconception health risks (PCHRs) into biomedical, behavioural and social categories, this classification remains theoretical, mainly inconsistent and lacks a scientifically robust framework. Data-driven clustering techniques may help clarify this complexity for policymakers and healthcare providers. This study aimed to assess the status of PCHRs and identify latent classes of these risks among women preparing for pregnancy.

    Design and methods

    This community-based cross-sectional study was conducted from 31 July to 16 August 2024 in Tigray, Ethiopia, among 865 married women planning to conceive within the next 6 months. Data were gathered through face-to-face interviews using a structured questionnaire. Risk factor indicators covering lifestyle behaviours, substance use, nutritional risks and related factors were developed based on guidelines from the WHO, the CDC and national recommendations. Latent class analysis (LCA) was employed to identify distinct classes of PCHRs, with the optimal number of classes determined using statistical fit indices, adequacy criteria and interpretability. The study also evaluated the overall distribution of PCHRs among participants.

    Setting and participants

    The study took place in Tigray, Ethiopia, among married women intending to become pregnant within 6 months.

    Outcome

    Burden of PCHRs and identified distinct latent classes of these risks within the participants.

    Results

    All participants were exposed to at least four PCHRs, with 84.2% experiencing between 6 and 12 risk factors. The optimal LCA model identified four distinct classes of PCHRs: lifestyle behavioural risks (n=458, 52.9%), reproductive health risks and chronic medical conditions (n=106, 12.25%), nutritional risks and environmental exposure (n=149, 17.23%) and social determinants of health (n=152, 17.57%).

    Conclusions

    Our study reveals a high baseline level of PCHRs, with all participants exhibiting multiple risk factors for adverse pregnancy outcomes. The identification of four distinct risk profiles underscores the need for tailored risk-specific interventions, particularly in conflict-affected settings. Our findings point out the need for targeted preconception care and risk stratification in national health strategies to improve maternal and child health outcomes.

    Positive health programme for British South Asian women with postnatal depression: a multiperspective qualitative study

    Por: Miah · J. · Bee · P. E. · Lunat · F. · McPhillips · R. · Taylor · A. K. · Aseem · S. · Sharma · D. · Husain · N. · Chew-Graham · C.
    Objectives

    To explore the views and perspectives of British South Asian (BSA) women and Positive Health Programme (PHP) facilitators on the usefulness and experiences of the PHP intervention for managing postnatal depression (PND) in primary care settings.

    Design

    Qualitative study with semi-structured interviews to explore perceptions of acceptability and implementation. A patient and public involvement group provided their insights and feedback on study topic guides, analysis and outcomes.

    Setting and participants

    We sampled trial participants from the PHP intervention database to ensure variation in geographic setting, age, socioeconomic status and ethnicity. PHP facilitators involved in the trial were also invited to participate in an interview.

    Interviews with study participants were conducted at participants’ homes, and community centres, or via phone. Interviews with PHP facilitators were conducted via phone or online. Interview recordings were transcribed verbatim and analysed using thematic analysis and subsequently the Theoretical Framework of Acceptability (TFA) was applied. Recruitment took place between February 2017 and March 2020.

    Results

    Thirty interviews were conducted—19 trial participants and 11 PHP facilitators. The PHP intervention was viewed positively, with appreciation of its therapeutic content and components such as childcare and refreshments that facilitated engagement. Participants reported improved confidence and well-being and supported their needs. Participants understood the intervention’s purpose. Both intervention participants and facilitators noted strengthened self-efficacy.

    Some participants experienced difficulties balancing childcare and attendance, implying a need for logistical assistance. Stigma about mental health in the BSA community was viewed as persistent, recommending future programmes efforts on strategies to reduce stigma and develop supportive environment.

    Conclusion

    This study demonstrates the possibility of PHP intervention being integrated into routine care by providing culturally tailored support for BSA women with PND, primarily through family engagement and facilitator support. Future research on scalability, alongside community engagement efforts, will strengthen its acceptability and broader applicability.

    Trial registration number

    ISRCTN10697380.

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