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Mental Health First Aid training for Chile and Argentina: protocol for a cluster randomised controlled trial

Por: Agrest · M. · Encina-Zuniga · E. · Ardila-Gomez · S. · Fernandez · M. A. · Gabriel · R. · Bargamian · J. · Alvarado · R. · Morgan · A. J. · Kelly · C. M. · Reavley · N.
Introduction

Community support for individuals with mental health problems is a global public health issue. Poor mental health literacy and high levels of stigmatising attitudes among the general population can hinder both help-seeking behaviours and limit the capacity of community members to provide support to people experiencing mental health challenges. The Mental Health First Aid (MHFA) training course was created to educate community members to provide initial help towards a person developing a mental health problem. MHFA training has spread to high-income countries, but there is relatively little research on cultural adaptation to lower-resource settings. This study aims to fill that gap and is the first cluster randomised controlled trial (cRCT) assessing the effectiveness of MHFA training in Chile and Argentina.

Methods and analysis

The study involves a two-arm wait-list cRCT with 240 participants (120 in each country). The study will be conducted in three settings in each of Chile and Argentina (eg, universities, health services and workplaces). Two clusters per setting in each country will be paired and randomly allocated to the intervention (the MHFA training for Chile and Argentina) or the wait-list control group. Participants in the intervention arm will be asked to complete questionnaires at baseline (T1), after training completion (T2) and 6 months after completion (T3), with control arm participants completing data collection at corresponding time points. The primary outcome will be intended support towards someone experiencing a mental health problem or experiencing a mental health crisis. Secondary outcome measures will include the ability to recognise depression and psychosis in vignettes; beliefs about the helpfulness of different types of interventions and helping actions, confidence in providing MHFA and stigmatising attitudes towards a person with depression or psychosis. Findings will demonstrate whether the culturally adapted MHFA training for Chile and Argentina can effectively enhance intended support, knowledge, attitudes and supportive actions towards other individuals within the community.

Ethics and dissemination

Ethics approval has been granted by the Human Research Ethics Committee at the University of Melbourne (Australia), Proyecto Suma (Argentina) and the University of Chile (Chile). Dissemination will be via academic publications and conference presentations. These will also be made available to participants and other interested parties on request.

Trial registration number

ISRCTN63724445.

Exploring the Roles and Regulatory Challenges of Advanced Practice Nurses in Acute Pain Management: A Scoping Review

ABSTRACT

Aim

To explore the roles and training of advanced practice nurses specialised in acute pain management, as reported in the current literature.

Design

Scoping review.

Data Sources

We searched PubMed, Scopus and CINAHL in December 2023 to identify relevant studies published from 1996.

Methods

Relevant literature was identified, screened, and analysed using a structured scoping review process. Two reviewers independently selected and extracted data from eligible studies, with a third reviewer resolving any disagreements.

Results

A total of 1682 records were screened, and 36 studies met the inclusion criteria. Four main themes emerged: job titles, roles, training, and barriers. The review revealed substantial variation in job titles and role descriptions across clinical settings and geographic regions, with more comprehensive role definitions found in countries like the United States and the United Kingdom. Training pathways, including postgraduate qualifications and certification, varied significantly and many low- and middle-income countries lacked structured training frameworks. Barriers identified included regulatory limitations, insufficient educational infrastructure and lack of legal authority to practice.

Conclusion

This review highlights significant international variation in the definition, training and regulation of advanced practice nurses in acute pain management. There is an urgent need to develop global standards, including unified competencies and certification pathways, to ensure consistent and effective care.

Implications for the Profession

Standardising competencies and training will support role recognition, improve consistency in clinical practice and promote high-quality care for individuals experiencing acute pain.

Impact

This review addresses the global inconsistency in role definition and training of advanced practice nurses in acute pain management. Findings may inform educators, health professionals, policymakers and regulators, particularly in resource-limited settings.

Reporting Method

This review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR).

Patient or Public Contribution

No patient or public contribution.

A Remote Nursing‐Guided Secondary Prevention Programme in Acute Coronary Syndrome. The SPRING Randomised Controlled Trial

ABSTRACT

Aim

To assess the impact of a nurse-led remote secondary cardiovascular prevention programme versus usual follow-up in patients who have suffered an acute coronary syndrome in terms of major adverse clinical events (MACE), diet, physical exercise, smoking, emotional state, adherence to medical treatment, cardiometabolic profile and anthropometric parameters within one year of discharge.

Design

Prospective, randomised, open-label, evaluator-blinded, multicentre trial.

Methods

Between October 17, 2017, and February 5, 2023, patients were randomly assigned to either a usual follow-up of two cardiology visits over 12 months or the nurse-led remote secondary cardiovascular prevention programme, which also included 5 nursing visits (one face-to-face and four remote).

Results

At 12 months, the nurse-led remote prevention programme group (interventional group) had lower smoking rates, greater adherence to medication, greater adherence to the Mediterranean diet, more physical activity, and better perceived health status compared to the usual follow-up group. The interventional group demonstrated a reduction in major adverse clinical events (20.7%) compared to the usual follow-up group (12.4%). This reduction was observed particularly in Acute Coronary Syndrome recurrence, all-cause hospitalisation, and hospitalisation for cardiovascular causes.

Conclusions

Patients randomised to the nurse-led remote prevention programme showed a significant reduction of the MACE, improved lifestyle, and medication adherence at 12 months compared to the usual follow-up group.

Implications for the Profession and/or Patient Care

This study illustrates the feasibility and efficacy of a remote secondary cardiovascular prevention programme led by advanced practice nurses in patients who have suffered an Acute Coronary Syndrome.

Reporting Method

CONSORT.

Patient or Public Contribution

None.

Trial Registration

The study was prospectively registered at www.clinicaltrials.gov: NCT03234023

Care Needs of Community‐Dwelling Older Adults Living in Poverty and Their Relationship With Other Biopsychosocial Variables: A Cross‐Sectional Study

ABSTRACT

Aim

To assess the care needs of older adults living in poverty in a high-income country and to analyse their relationship with other outcome variables.

Design

A cross-sectional study.

Method

Data were collected between September 2022 and February 2024 from 384 older adults in southeastern Spain. Descriptive statistics were calculated to assess older adults' care needs. A multiple linear regression analysis was carried out to determine the percentage by which the socio-demographic or outcome variables could explain the number of met care needs among older adults in poverty.

Results

Around 20% of the care needs amongst older adults living in poverty were unmet. The most frequently unmet care need was related to money (53.6%). Almost 30% of participants were at risk of malnutrition, 18% felt lonely, and 80% perceived a low level of social support. Age, history of falls, emergency room visits, functionality, perceived social support, quality of life and nutritional status significantly predicted the number of needs met.

Conclusion

The health conditions of older adults living in poverty are suboptimal and may negatively influence their care needs. Nurses should consider these factors when designing, implementing and evaluating interventions to promote the biopsychosocial health of this population.

Implications for the Profession and/or Patient Care

Nursing interventions to promote health amongst older adults living in poverty should focus on identifying unmet care needs, particularly those related to financial and social support. Interventions should prioritise improving nutritional status, enhancing social support networks and addressing loneliness.

Impact

Living in poverty increases older adults' vulnerability due to unmet financial, nutritional and social support needs. These unmet needs can negatively affect older adults' physical and mental health.

Reporting Method

The study has been reported following the STROBE guidelines.

Patient or Public Contribution

The study's participants only participated in the data collection process.

Palliative Care for People With Very Severe to Extreme Behavioural and Psychological Symptoms of Dementia (BPSD): A Scoping Review

ABSTRACT

Aim

To explore current evidence regarding the provision of palliative care for individuals with very severe to extreme behavioural and psychological symptoms of dementia (BPSD) in a hospital setting.

Design

Scoping review.

Reporting Method

The PRISMA-ScR reporting guideline.

Methods

The JBI guidelines for scoping reviews were followed. A data extraction form assisted in the identification of key findings via a process of content analysis.

Data Sources

Studies were obtained from bibliographic databases of PubMed, CINAHL, and PsycINFO.

Results

This review included six articles, and nine categories emerged from the findings. Symptom assessment and management, pain assessment challenges, atypical presentation of end-stage dementia, complex prescribing and treatment practices, principles of person-centred care, collaboration; training for health care professionals; emotional impact on staff; and family and caregivers.

Conclusions

This scoping review highlighted a significant gap in the literature regarding palliative care for people living with very severe to extreme BPSD in hospital settings. This review highlighted key differences in the presentation of people with BPSD needing palliative care. There is a need for tailored models of care, specialised training and education for health professionals, families, and carers, and recognition of dementia as a terminal illness.

Implications for the Profession and/or Patient Care

The results of this review provide valuable insights into the level of understanding about the unique palliative care needs for people experiencing very severe to extreme BPSD, making an important contribution to the planning and development of future models of care.

Impact

Mapping the available literature highlights a paucity of research in palliative care for people with very severe to extreme BPSD in hospital settings. There is a need for rigorous research studies and models of care developed and informed by the evidence for this small population necessitating unique care needs.

Patient or Public Contribution

No patient or public contribution.

Surgery versus conservative management for severe pectus excavatum (RESTORE): protocol for a multicentre, randomised, controlled superiority trial

Por: Maier · R. · Dunning · J. · Wason · J. · Chadwick · T. · Bryant · A. · Fernandez-Garcia · C. · Vale · L. · Danjoux · G. R. · Wallace · G. · Levett-Renton · A. · Naidu · B. · Pryor · C. · McCulloch · P. · Thursfield · R. · Wyllie · J. · Chang · L. · Marsay · L. · Akowuah · E.
Introduction

Severe pectus excavatum (PE) may impair cardiopulmonary and physical function. The effectiveness of surgical treatment to correct PE and restore physical function is widely debated due to a lack of high-quality comparative evidence. The RESTORE trial aims to determine the clinical and cost-effectiveness of corrective surgery for severe PE compared with conservative management for the first time in a randomised controlled trial (RCT).

Methods and analysis

RESTORE is a pragmatic, multicentre, RCT with an embedded observational cohort. 200 participants aged ≥12 years with severe PE will be recruited at around 12 National Health Service cardiothoracic surgical centres in England. Participants will be randomised 1:1 to receive either surgery within 3 months of randomisation (intervention arm) or no surgery until after the primary outcome measurement at 1 year (comparator arm). The primary outcome is change in physical functioning from baseline to 1 year as measured by the Short Form Health Survey (SF-36v2) physical function score. The primary economic outcome is cost-effectiveness. The key secondary outcome is change in % predicted VO2peak at 1 year measured by cardiopulmonary exercise test (CPET). Outcomes will be assessed at 1 year post-randomisation in the comparator arm and 1 year post-surgery in the intervention arm. The primary analyses will be undertaken on an intention-to-treat population using a linear mixed-effects model, adjusted for stratification variables via a binary covariate. Other secondary outcomes will include change from baseline of cardiopulmonary function (CPET and spirometry), health-related quality of life using the EuroQol 5 Dimension 5 Level (EQ-5D-5L) and SF-36v2 questionnaires, Hospital Anxiety and Depression Scale and disease specific symptoms (Phoenix Comprehensive Assessment for Pectus Excavatum Symptoms and Pectus Excavatum Evaluation Questionnaire). Adverse events, complications from surgery and operative technical success (Haller and Compression Indices from preoperative and postoperative CT scans) will also be assessed. Health economic analysis will estimate the incremental cost per quality adjusted life year at 1 year.

Ethics and dissemination

The trial was approved by East of Scotland Research and Ethics Service (24/ES/0034). Participants who are ≥16 years of age will be required to provide written informed consent. For participants

Trial registration number

ISRCTN11359779.

The Journey to First‐Line Nursing Management: A Qualitative Study in a Spanish University Hospital

ABSTRACT

Aim

To explore nurse managers' perceptions at first-line, middle and executive levels regarding their transition to first-line management in two divisions of a highly specialised university hospital in Spain.

Design

A qualitative descriptive study.

Method

A purposive sampling technique was employed to conduct four focus groups and two semi-structured interviews with 31 nurse managers across three hierarchical levels in two divisions of a highly specialised university hospital in Spain. Participants included two Chief Nursing Officers, four Nursing Directors and 25 first-line nurse managers. Data were analysed thematically.

Results

Three themes emerged: ‘Bridging the Readiness Gap: Training, Role Clarity, and Institutional Alignment’, revealing the lack of structured transition plans, role ambiguity and gaps in managerial skills, such as human resources, financial management and leadership; ‘Fighting Loneliness: A Common Challenge in Care Management’, highlighting the isolation of first-line nurse managers due to the absence of structured mentorship and peer support; ‘Clinical Expertise as a Cornerstone: The Role of Prior Experience in Nurse Management’, examining how clinical expertise facilitates leadership transitions but also presents challenges, particularly for managers promoted within their teams, where authority negotiation and role redefinition become critical.

Conclusions

Findings underscore the need for structured training and mentorship to address role ambiguity, enhance managerial competencies and support nurse managers' transitions through targeted education.

Implications for Profession and Patient Care

Structured transition programmes focusing on role clarity, training and institutional alignment can ease transitions, boost leadership confidence and enhance peer collaboration. Providing mentoring and training tailored to first-line nurse managers can improve team dynamics, support professional integration and strengthen organisational cohesion.

Impact

Tailored educational interventions are essential in supporting nurse managers' transitions. Structured mentorship and targeted training enhance leadership readiness, adaptability and institutional alignment, strengthening healthcare leadership, efficiency and patient care quality.

Patient and Public Contribution

No patient or public contribution.

Influence of Social Determinants of Health on Adherence to Lifestyle Modifications in Individuals With Prediabetes: A Mixed Methods Study

ABSTRACT

Aim

To explore the relationship between social determinants of health and adherence to lifestyle recommendations, and how these determinants can help explain contextual and interpersonal factors contributing to adherence among individuals with prediabetes.

Design

Explanatory sequential mixed methods study integrating a cross-sectional quantitative analysis with an ethnomethodological qualitative approach grounded in critical social paradigm.

Methods

The quantitative phase used data from the intervention arm (n = 86) of the PREDIPHONE trial, a randomised controlled study evaluating the effectiveness of a nurse-led telephone intervention for lifestyle changes in glycaemic control. Adherence was measured using a composite index, analysed as both a continuous and categorical variable. Correlation analysis examined adherence and age. Chi-square and ANOVA tests were used to analyse differences in participant characteristics across adherence quartiles. The qualitative phase included individual semi-structured interviews and a focus group with participants showing high or low adherence. Thematic content and discourse analysis were employed, ensuring validity through triangulation, reflexivity and discourse saturation.

Results

Employment status was identified as a significant factor, with unemployed or retired participants showing better adherence. Although no statistical differences in adherence were found by social class or gender, lower social class participants reported financial barriers to healthy eating and time constraints limiting physical activity (PA). Women reported facing greater challenges due to caregiving responsibilities, whereas men benefited from household support.

Conclusions

Employment status emerged as a determinant of time availability for self-care, alongside social class and gender in adherence to lifestyle modifications. Women, especially those from lower social classes, experienced heightened barriers to adherence, underscoring the need for tailored, gender-sensitive and equity-focused interventions.

Implications

Addressing social determinants is essential for effective lifestyle advice among individuals with prediabetes.

Impact

The study highlights the role of social class and gender in adherence.

Reporting Method

STROBE and COREQ guidelines.

Patient Contribution

Through interviews and focus group.

Reducing decisional conflict in COVID-19 vaccination in ethnocultural communities through sensemaking: a participatory action mixed-methods study

Objective

To examine how cultural health brokers, as trusted intermediaries between formal systems and diverse ethnocultural communities, help navigate decisional conflict and misinformation regarding COVID-19 vaccination and to identify how their work contributes to system resilience in crisis contexts.

Design

A community-based participatory action sensemaking research project to capture the real-time work of cultural health brokers in helping people navigate decisional conflict for vaccination.

Setting, participants

Multicultural Health Broker Cooperative in Edmonton, Alberta where brokers speak 54 languages and serve more than 10 000 people from diverse ethnolinguistic communities. 28 cultural health brokers (9 male; experience 4–25 years) contributed to data collection and analysis between 16 September 2021 and 16 December 2021.

Data collection and analysis

The brokers captured real-time reflections and self-interpretations in the SenseMaker platform through a theoretically informed, codesigned, mixed-method data collection tool. The team engaged in 13 weekly, 90 minute, audio-recorded and transcribed sessions: seven focused on understanding and action planning and five reflecting on the SenseMaker data, the focus of the thematic analysis. Data were managed in NVivo (QSR International, Version 12, 2018).

Results

Brokers collected 277 narratives and conducted 13 sensemaking sessions. Understanding and purpose were identified in 68% of narratives as key to achieving coherence; 81% of narratives highlighted trust as crucial to what was needed for action; 62% of narratives reflected on a potential risk, with loss of trust a concern in 70% of them. A rich understanding of the sources of decisional conflict and misinformation was achieved and managed through outreach. There were four entwined components to navigation of the evolving complexity of COVID-19 vaccination: (1) building and sustaining trust; (2) strengthening relationships; (3) creating safe spaces for collective sensemaking and solution finding; and (4) leveraging cultural and social capital to address barriers. Through these mechanisms, brokers reduced decisional conflict and misinformation, supporting informed, values-congruent decisions.

Conclusions

Cultural health brokers, embedded within communities and linked to formal systems, play a critical role in crisis response by fostering trust, mobilising resources and enabling collective sensemaking. This study demonstrates how these intermediaries’ contextually and culturally attuned work provides a model for building system resilience for future crisis response.

State of Ohio Adversity and Resilience (SOAR) study protocol: a comprehensive, multimodal, family-based, longitudinal observational investigation of risk and resilience in mental health and substance use disorders

Por: King · A. P. · Langenecker · S. · Gorka · S. M. · Turner · J. · Wang · L. · Wastler · H. · Gonzalez · M. · Christian · L. M. · Keck · C. · Olsen · R. · Kim · H. · Klamer · B. · Fernandez · S. · Adler · C. · Andari · E. · Barrenger · S. L. · Bonfine · N. · Bozzay · M. · Brown · S. L. · Browni
Introduction

Deaths related to drug overdose and suicide in the USA have increased 500% and 35%, respectively, over the last two decades. The human and economic costs to society associated with these ‘deaths of despair’ are immense. Great efforts and substantial investments have been made in treatment and prevention, yet these efforts have not abated these increasing trajectories of deaths over time. The COVID-19 pandemic has exacerbated and highlighted these problems. Notably, some geographical areas (eg, Appalachia, farmland) and some communities (eg, low-income persons, ‘essential workers’, minoritised populations) have been disproportionately affected. Risk factors have been identified for substance use and suicide deaths: forms of adversity, neglect, opportunity indexes and trauma. Yet, the biological, psychological and social mechanisms driving risk are not uniform. Notably, most people exposed to risk factors do not become symptomatic and could broadly be considered resilient. Achieving a better understanding of biological, psychological and social mechanisms underlying both pathology and resilience will be crucial for improving approaches for prevention and treatment and creating precision medicine approaches for more efficient and effective treatment.

Methods and analysis

The State of Ohio Adversity and Resilience (SOAR) study is a prospective, longitudinal, multimodal, integrated familial study designed to identify biological, psychological and social risk and resilience factors and processes leading to mental health disorders, substance use disorders, substance overdose, suicide and associated psychological/medical comorbidities which reduce life expectancy and quality of life. It includes two nested longitudinal samples: (1) WD Survey: an address-based random population epidemiological sample of 15 000 individuals (unique households) representative of the state of Ohio assessed for psychosocial, psychiatric, behavioural health and substance use factors and (2) Brain Health Study: a family-based, multimodal, deep-phenotyping study conducted in 1200 families (up to 3600 persons aged 12–72 years) including MRI, electroencephalography, blood biomarkers and psychiatric diagnostic interviews, as well as neuropsychological, psychosocial functioning and family/community history, dynamics and support assessments. SOAR is designed to discover, develop and deploy advanced predictive analytics and interventions to transform mental health prevention, diagnosis, treatment and recovery.

Ethics and dissemination

All participants will provide written informed consent (or parental permission and assent for minors). The study was approved by The Ohio State University Institutional Review Board (study numbers 2023H0316 (Brain Health) and 2023H0350 (Wellness Survey). The Brain Health study was also approved by institutional review boards at each partnering institution involved in conducting participant assessments. Findings will be disseminated to academic peers, clinicians and healthcare consumers, policymakers and the general public, using local and international academic channels (academic journals, evidence briefs and conferences) and outreach (workshops and seminars).

Use and reporting of intervention mapping for adaptation: a systematic review protocol

Por: Kang · E. · Sanchez-Blas · H. R. · Obekpa · E. O. · Fernandez · M. E.
Introduction

Intervention adaptation is likely to occur to some extent when implementing interventions in new implementation contexts. Using systematic frameworks can guide intentional and effective adaptation processes. Intervention Mapping for Adaptation (IM-ADAPT) is a framework that offers step-by-step guidance for systematic, theory-based intervention adaptation. Despite the increasing use of IM-ADAPT, there is limited understanding of the contexts in which it has been applied and how effectively it is used and reported. Addressing this knowledge gap can improve current adaptation practices and inform future enhancements of the IM-ADAPT framework and the broader science of intervention adaptation. This review aims to (1) determine the context in which IM-ADAPT is used, (2) assess how studies apply IM-ADAPT tasks and (3) evaluate how these studies report their IM-ADAPT findings.

Methods and analysis

This protocol followed the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. The eligibility criteria include original peer-reviewed English articles that used Intervention Mapping or IM-ADAPT to adapt interventions. We searched PubMed/Medline, Web of Science, Embase and the Intervention Mapping literature library, and conducted forward citation searches using two landmark articles from inception to 19 July 2024. At least two independent coders will screen the records to determine eligibility and extract data from the included articles. Any discrepancies will be resolved through regular co-author meetings or in consultation with a senior author. The study protocol was registered on the Open Science Framework (https://doi.org/10.17605/OSF.IO/D5TCP).

Ethics and dissemination

As this systematic review only used published data, no ethics approval was required. We will disseminate the findings of this review through open-access channels and journals.

The Association Between Nursing Work Environment and Evidence‐Based Practice

ABSTRACT

Introduction

Evidence-based practice (EBP) is essential for improving the quality of care and health outcomes in healthcare organizations. This study aimed to analyze the association between the nursing work environment and EBP elements, including attitude, training, implementation and quality of care.

Methods

A multicenter, cross-sectional study was conducted with 1022 registered nurses from 57 primary care centers and four public hospitals in northern Spain. The Practice Environment Scale of the Nursing Work Index (PES-NWI) was used to assess the nursing work environment. Data collection also included the Health Sciences Evidence-Based Practice (HS-EBP) questionnaire to evaluate attitudes toward EBP, and self-reported measures of EBP training, EBP implementation, and overall quality of care. Odds ratios (OR) and 95% confidence intervals for the association between the nursing work environment and EBP elements were calculated using logistic regression adjusted for sociodemographic and occupational characteristics.

Results

Compared to nurses who reported working in unfavorable environments (n = 220; 21.5%), those working in favorable environments (n = 437; 42.8%) exhibited a positive attitude toward EBP (OR = 2.89; 95% CI [2.00, 4.18]), EBP implementation (OR = 2.30; 95% CI [1.52, 3.39]) and higher quality of care (OR = 2.35; 95% CI [1.61, 3.44]). Using a composite measure that considered all EBP elements, favorable environments were associated with overall EBP engagement (OR = 3.47; 95% CI [2.38, 5.07]). The most influential environmental dimensions were adequate staffing and strong nursing foundations.

Linking Evidence to Action

A favorable nursing work environment was strongly associated with a positive attitude toward EBP, the implementation of EBP, and a commitment to providing high-quality care. Key strategies to promote EBP should involve healthcare and academic institutions working together to establish a healthy work environment with appropriate staffing and care foundations rooted in nursing theory.

Impact of mental health status and clinical factors on health-related quality of life in patients undergoing haemodialysis: a multicentre cross-sectional study

Objectives

This study aimed to investigate the factors influencing health-related quality of life (HRQoL) in patients undergoing haemodialysis, focusing on the association between HRQoL dimensions and sociodemographic variables, clinical parameters, mental health status and biochemical indicators.

Design

A multicentre cross-sectional study conducted over 30 months.

Setting

The study was carried out in secondary care centres across multiple locations in the Community of Extremadura, Spain.

Participants

A total of 150 patients undergoing haemodialysis were recruited between March 2022 and September 2023. Inclusion criteria required patients to be diagnosed with chronic kidney disease (CKD) and undergoing haemodialysis. Patients unable to provide informed consent or with severe cognitive impairment were excluded.

Primary and secondary outcome measures

HRQoL was assessed using the Kidney Disease Quality of Life 36-item Short Form scale. Mental health parameters, specifically anxiety and depression, were evaluated using the Hospital Anxiety and Depression Scale. Biochemical markers such as haemoglobin and haematocrit levels, as well as sociodemographic and clinical data, were analysed for their influence on HRQoL.

Results

Symptoms of anxiety and depression were prevalent among patients undergoing haemodialysis. Anxiety had the greatest negative effect on HRQoL, being significantly associated with lower scores in the mental component summary (MCS) (β = –2.06; 95% CI –2.78 to –1.33; R² = 0.106; p

Conclusions

Depression and anxiety, along with older age, were identified as key factors negatively affecting HRQoL of patients undergoing haemodialysis. Management of mental health, alongside optimisation of clinical care to minimise complications, could enhance the HRQoL in this patient population. Further research is recommended to develop targeted interventions addressing anxiety and other modifiable factors influencing HRQoL in haemodialysis patients.

Determinants of the optimal selection of vascular access devices: A systematic review underpinned by the COM‐B behavioural model

Abstract

Background

Optimal selection of vascular access devices is based on multiple factors and is the first strategy to reduce vascular access device-related complications. This process is dependent on behavioural and human factors. The COM-B (Capability, Opportunity, Motivation, Behaviour) model was used as a theoretical framework to organize the findings of this systematic review.

Methods/Aims

To synthesize the evidence on determinants shaping the optimal selection of vascular access devices, using the COM-B behavioural model as the theoretical framework.

Design

Systematic review of studies which explore decision-making at the time of selecting vascular access devices.

Data Sources

The Medline, Web of Science, Scopus and EbscoHost databases were interrogated to extract manuscripts published up to 31 December 2021, in English or Spanish.

Results

Among 16 studies included in the review, 8/16 (50%) focused on physical capability, 8/16 (50%) psychological capability, 15/16 (94%) physical opportunity, 12/16 (75%) social opportunity, 1/16 (6%) reflective motivation and 0/16 (0%) automatic motivation. This distribution represents a large gap in terms of interpersonal and motivational influences and cultural and social environments. Specialist teams (teams created for the insertion or maintenance of vascular access devices) are core for the optimal selection of vascular access devices (75% physical capability, 62% psychological capability, 80% physical opportunity and 100% social opportunity).

Conclusion

Specialist teams predominantly lead all actions undertaken towards the optimal selection of vascular access devices. These actions primarily centre on assessing opportunity and capability, often overlooking motivational influences and social environments.

Implications for the Profession and/or Patient Care

A more implementation-focused professional approach could decrease inequity among patients and complications associated with vascular access devices.

Impact

Optimal selection of vascular access devices is the primary strategy in mitigating complications associated with these devices. There is a significant disparity between interpersonal and motivational influences and the cultural and social environments. Furthermore, specialized teams play a pivotal role in facilitating the optimal selection of vascular access devices. The study can benefit institutions concerned about vascular access devices and their complications.

Reporting Method

This review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.

Patient or public contribution

No Patient or Public Contribution.

What does this article contribute to the wider global clinical community?

Optimal selection of vascular devices remains a growing yet unresolved issue with costly clinical and patient experience impact. Interventions to improve the optimal selection of vascular devices have focused on training, education, algorithms and implementation of specialist vascular teams; alas, these approaches do not seem to have substantially addressed the problem. Specialist vascular teams should evolve and pivot towards leading the implementation of quality improvement interventions, optimizing resource use and enhancing their role.

New regimens of benznidazole for the treatment of chronic Chagas disease in adult participants in indeterminate form or with mild cardiac progression (NuestroBen study): protocol for a phase III randomised, multicentre non-inferiority clinical trial

Por: Marques · T. · Forsyth · C. · Barreira · F. · Lombas · C. · Blum de Oliveira · B. · Laserna · M. · Molina · I. · Bangher · M. d. C. · Javier Fernandez · R. · Lloveras · S. · Fernandez · M. L. · Scapellato · P. · Patterson · P. · Garcia · W. · Ortiz · L. · Schijman · A. · Moreira · O. C.
Introduction

Chagas disease (CD) is one of the most neglected diseases in the world. In Latin America, CD is endemic in 21 countries, with an estimated 70 million people at risk of infection. Current treatments are limited to two nitroheterocyclic compounds: nifurtimox and benznidazole (BZN). Each has significant limitations, including long duration and safety concerns. However, data from recently completed studies suggest that reduced-duration regimens may be equally effective while enhancing safety.

Methods and analysis

NuestroBen is a phase III, randomised, multicentre clinical trial designed to assess whether shorter (2- and 4-week) regimens of BZN are non-inferior to the standard 8-week treatment. A total of 540 adult participants with no evidence of organ damage (the indeterminate form) or with mild cardiac progression (mild electrocardiographic alterations and without systolic dysfunction or symptoms), all in the chronic phase of CD, will be recruited at six study sites in Argentina and two study sites in Bolivia. Participants will be randomised to receive one of the two shortened regimens of BZN (300 mg per day for 2 or 4 weeks) or standard treatment (300 mg per day for 8 weeks). The primary endpoint is sustained elimination of parasitaemia from the end of treatment through 12 months of follow-up. Secondary endpoints will assess sustained clearance of parasitaemia at 1, 4, 6 and 8 months of follow-up from the end of treatment, drug tolerability and adherence to treatment. NuestroBen will also evaluate whether two shortened regimens of BZN improve drug tolerability and treatment adherence compared with the current standard treatment while maintaining efficacy in participants with the indeterminate form of CD or with mild cardiac involvement.

Ethics and dissemination

In Argentina, this study was approved by Fundación de Estudios Farmacológicos y Medicamentos ‘Luis M. Zieher’ for its conduct at the Instituto de Cardiología de Corrientes ‘Juana Francisca Cabral’ (reference: NuestroBen-2020/2021) and the Instituto Nacional de Parasitología ‘Dr. Mario Fatala Chaben’ (reference: NuestroBen-2020/2021) by Comité Institucional de Ética de Investigación en Salud for the Centro de Chagas y Patología Regional de Santiago del Estero (reference: NuestroBen-2020-088/2021), by Comité de Ética en Investigación for the Hospital de Infecciosas F.J. Muñiz (reference: NuestroBen-2020–4037) and the Hospital General de Agudos D.F. Santojanni (reference: NuestroBen-2020–4039) and by Comité de Bioética for the Fundación Huésped (reference: NuestroBen-2020/2021). In Bolivia, it was approved by Comité de Ética en Investigación en Salud from the Universidad Autónoma Juan Misael Saracho (reference: NuestroBen-2020/2025). All participants are asked to provide written informed consent to participate. Recruitment processes started in July 2023, and as of 15 June 2025, 140 participants have been recruited. Findings will be shared with Argentinian and Bolivian public health officials and with the Chagas and tropical medicine communities via international conferences. Findings will also be published in medical journals.

Trial registration number

NCT04897516.

Effectiveness of an Online Training Program on Brief Tobacco Intervention (BTI) for Nurses: A Quasi‐Experimental Study. The E‐Learning BTI Project

ABSTRACT

Introduction

Smoking is the leading cause of preventable deaths. The training of professionals on brief tobacco interventions (BTIs) increases the effectiveness of these interventions.

Objective

To assess the effectiveness of an online training program on BTI based on the 5As and 5Rs model in acquiring anti-tobacco brief advice competencies among nurses.

Method

Quasi-experimental study with a pre-test and post-test design, with a control group and without random assignment. In the experimental group (EG), online training was provided in three sections: BTI theoretical content and methodology, clinical scenario videos, and feedback. Each scenario assessed the 5As and 5Rs as a validated instrument (BTI-Prof(C)). The control group (CG) only assessed the three videos of clinical scenarios. In both groups, competence was measured at the following points in time: T0 (before the training), T1 (at the end of the training), and T2 (after 90 days). The efficacy of the intervention was measured through a two-way ANOVA, and the variation rate was calculated from T0 to T1 and from T0 to T2.

Results

236 nurses participated (157 EG; 79 CG). The mean age was 42.9 years, and 76.7% were women. There was a significant group*time interaction in the three cases, indicating that the online BTI training increases the competence of these professionals in clinical scenario 1 (F = 10.210; p ≤ 0.001; η 2 = 0.081), clinical scenario 2 (F = 6.235; p = 0.002; η 2 = 0.051), and clinical scenario 3 (F = 11.271; p ≤ 0.001; η 2 = 0.090).

Conclusion

A brief, asynchronous, and online intervention using standardized video-based cases is effective in improving nurses' BTI competence. This type of training can be a useful option for the National Health System as part of a global and continuous strategy for nurses to perform BTI.

Clinical Relevance

An asynchronous online training program provides nurses with standardized, evidence-based tools to implement brief tobacco interventions in routine care, offering a scalable and practical solution to strengthen preventive strategies in health systems.

Consensus on the definition, components, timeframe and grading of composite outcome of postoperative pulmonary complication--protocol for an international mixed-method consensus study (PrECiSIOn)

Por: Nasa · P. · Yurttas · T. · Battaglini · D. · Blot · S. · Fernandez-Bustamante · A. · Gama de Abreu · M. · van Meenen · D. M. · Myatra · S. N. · Serpa Neto · A. · Oppong · R. · Paulus · F. · Renukappa · S. · Schultz · M. J. · Slutsky · A. S. · Hemmes · S. N. T. · for the PrECiSIOn-gro
Introduction

Postoperative pulmonary complications (PPCs) represent a significant cause of postoperative morbidity and even mortality. However, there is a lack of consensus regarding this composite endpoint, the definition of the individual components, classification and optimal outcome measures. This study aims to refine the PPCs composite framework by evaluating its construct validity, assessing the necessity and risks of a composite measure and exploring the feasibility of differentiating severity categories.

Methods

A Delphi consensus process will be conducted, engaging an international multidisciplinary group of 30–40 panellists, including clinicians, researchers, patients, public representatives and health economists. Through iterative rounds, the study will seek agreement on the individual components of the PPCs composite. Additionally, consensus will establish a framework for a composite outcome measure based on a standardised severity classification, appropriate timeframes and weighted grading of PPCs.

Analysis

Consensus, defined by ≥75% concurrence in multiple choice questions or on Likert–scale statements, will be evaluated from round 2 onwards. Delphi rounds will be continued until all statements have reached stability of responses evaluated by 2 tests or the Kruskal-Wallis test.

Ethics and dissemination

The study will be conducted in strict compliance with the principles of the Declaration of Helsinki and will adhere to ACCORD guidance for reporting. Ethics approval has been obtained for this study from the University of Wolverhampton, UK (SOABE/202425/staff/3). Informed consent will be obtained from all panellists before the commencement of the Delphi process. The results of the study will be published in a peer–reviewed journal with the authorship assigned in accordance with ICMJE requirements.

Trial registration number

NCT06916598 (clinicaltrials.gov).

Association of nociceptive, neurocognitive, psychological and genetic profile on conditioned pain modulation in women with migraine: protocol for a case-control study

Introduction

Migraine is a primary headache showing a multifactorial component that includes altered pain processing, psychological/emotional problems, neurocognitive and executive function deficits, all with a possible genetic association. The aim of the current study will be to evaluate the association between sensitisation, psychological/emotional, neurocognitive and genetic profile on conditioned pain modulation (CPM) in women with migraine from a multidisciplinary perspective.

Methods and analysis

A cross-sectional observational case–control study including 90 women with chronic migraine, 90 women with episodic migraine and 90 women without migraine (as controls) will be conducted. Clinical variables (disability, pain), processing (sensitisation-associated, neuropathic-like symptoms), psychological/emotional (anxiety, depression, sleep quality, catastrophising), neurocognitive (attention), executive functions (memory, mental inhibition, speed processing) and genetics (Val158Met polymorphism rs4680 gene) will be assessed in all subjects by healthcare professionals. Subsequently, CPM will be evaluated with the cold-pressor test paradigm by assessing changes obtained in mechanical and thermal stimuli. The association of each group of variables on CPM will be analysed with multivariate analyses (OMNIBUS analysis of variance). A network model will also be created to identify those variables showing the greatest key measure of centrality with the rest of the severity indicators (strength, intermediation and closeness) to establish the potentially therapeutic targets in patients with migraine from a multidisciplinary point of view.

Ethics and dissemination

The protocol of the current study has been approved by the Ethics Committee of all involved institutions (Hospital Universitario Fundación Alcorcón 24–117, Universidad Rey Juan Carlos 010220240912024). All procedures will be conducted following the Declaration of Helsinki. Participants will be informed of the aims and procedures of the study and will receive the informed written consent which should be signed before their inclusion. Study results will be disseminated through peer-reviewed publications and presentations at scientific meetings.

Exposure to suppressive antibiotic therapy in women with recurrent urinary tract infections and severity of infections: a retrospective population-based cohort study

Por: Llor · C. · Ouchi · D. · Fernandez-Garcia · S. · Giner-Soriano · M. · Moragas · A. · Morros · R.
Background

Women with recurrent urinary tract infections (UTIs) often undergo intensive antibiotic exposure, especially with suppressive therapies. Suppressive therapy is recommended for women with three UTIs in the past year or two in the last 6 months. However, the collateral long-term effects of this have been poorly studied.

Objectives

To assess whether suppressive therapy for recurrent UTIs increases the incidence and severity of future infections compared with episodic UTI treatment.

Design

Retrospective cohort study.

Setting and Participants

The study was conducted using data from the Information System for Research in Primary Care database, including 5.8 million people in Catalonia. Two groups of women with recurrent UTIs (≥3 episodes/year) were compared: those on suppressive antibiotic therapy for ≥6 months and those treated episodically. Primary outcomes were hospitalisations due to pyelonephritis, septicaemia, COVID-19, influenza, pneumonia and mortality by these infections, over a 100-month follow-up period.

Results

Among 36 170 women, 2898 (8%) were treated with continuous suppressive therapy. Overall, 6.9% of the population experienced severe infections, with a higher incidence in women on suppressive therapy (12.6%) compared with those without (6.4%), with a HR of 1.50 (95% CI 1.33 to 1.68). Pyelonephritis presented the greatest difference (HR, 1.95 (95% CI 1.64 to 2.33)), followed by septicaemia (HR, 1.34 (95% CI 1.13 to 1.59)) and COVID-19 (HR 1.23 (95% CI 1.01 to 1.50)).

Conclusions

Suppressive antibiotic therapy in women with recurrent UTIs is associated with a higher incidence and severity of future infections. Future research should focus on clarifying causal relationships and identifying the potential mechanisms involved.

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