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Ayer — Octubre 2nd 2025Tus fuentes RSS

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.

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Efficacy of virtual reality in reducing pain, anxiety and fear in hospitalised children: a systematic review and meta-analysis protocol

Introduction

Paediatric hospitalisation, encompassing the period from admission to discharge, often involves feelings of pain, fear and anxiety, primarily due to clinical diagnoses and, more significantly, discomfort and stress-inducing procedures. Numerous methodologies and interventions have been investigated and implemented to alleviate these phenomena during paediatric hospitalisation. Virtual reality (VR), for example, has demonstrated efficacy in pain relief for hospitalised children in recent studies. This systematic review, therefore, aims to identify and evaluate the effectiveness of VR in alleviating pain, fear and anxiety in hospitalised children undergoing painful procedures.

Method and analysis

This systematic review and meta-analysis will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols guidelines. A systematic search will be conducted in March and April 2025 across the following databases, with no restrictions on language or publication year: PubMed, Embase, Scopus, Web of Science, Cumulated Index in Nursing and Allied Health Literature, ClinicalTrials.gov and the Cochrane Central Register of Controlled Trials. Eligible studies will include randomised and quasi-randomised clinical trials involving children (aged 2–10 years) and adolescents (aged 10–18 years) who received VR interventions during painful procedures. Data will be managed and analysed using Review Manager software (RevMan 5.2.3). In cases of significant heterogeneity (I² > 50%), a random-effects model will be employed to combine studies and calculate the OR with a 95% CI. The methodological quality of the included studies will be assessed using the Cochrane Risk of Bias 2.0 tool, and the certainty of the evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluations framework.

Ethics and dissemination

This study will solely review published data; thus, ethical approval is not required. This systematic review is expected to provide subsidies, evidence and insights into the use of VR. It is also anticipated that the results will directly impact the improvement of care for these patients and the qualification of professional care.

PROSPERO registration number

CRD42024568297.

Effectiveness of aromatherapy in pain relief postcardiac surgery: a systematic review and meta-analysis protocol

Introduction

Acute pain in the postoperative period of cardiac surgery is mostly treated with opioid analgesics. However, with the risk of adverse reactions and complications, strategies which do not involve opioid analgesics can be considered, such as aromatherapy. This systematic review aims to analyse the effectiveness of aromatherapy in relieving pain in post-cardiac surgery patients.

Methods and analysis

Two researchers will independently and simultaneously conduct searches and select studies from the following databases: PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Latin American and Caribbean Literature on Health Sciences, Scopus, Web of Science, Cochrane (Library) and clinical trial registries (clinicaltrials.com), with no language or publication date restrictions. Randomised and quasi-randomised clinical trials on the use of aromatherapy for pain relief in postcardiac surgery patients will be included. Then, two researchers will independently examine the studies based on inclusion criteria, extract data from the included studies and assess the risk of bias using the Risk of Bias 2 tool and the Risk of Bias in Non-randomized Studies of Interventions tool from Cochrane. Data will be synthesised using Review Manager software. The strength of the evidence will be evaluated using the Grading of Recommendation Assessment, Development and Evaluation approach. The literature search, study selection, review and meta-analysis stages will be conducted from early October 2025 to April 2026.

Ethics and dissemination

This study is based on secondary data, and therefore ethical approval from a research ethics committee was not required. The results will be disseminated through publication in a peer-reviewed scientific journal.

PROSPERO registration number

CRD42024568532.

Are we closing the gender gap in academic oncology? An observational study of gender disparities in participant engagement at the ASCO 2024 annual meeting

Por: Puhr · H. C. · Cammarota · A. · Ettaieb · M. · Flierman · I. · Gisinger · T. · Glas · A. · Guven · D. C. · Siebenhüner · A. · Steindl · A. · Szydlik · V. · Valpione · S. · Yip · M. · van Laarhoven · H. W. M.
Objective

Despite global efforts, gender disparities in oncology may persist. Understanding these disparities within the context of major conferences can inform strategies to promote gender inclusiveness in the field. This study evaluates the participation of women and men at the American Society of Clinical Oncology (ASCO) 2024 congress, focusing on chairs, speakers and audience questioners.

Design

Observational study.

Setting

152 recorded sessions of the ASCO 2024 annual meeting, one of the largest conferences in the field of oncology, available on the ASCO website.

Participants

Individuals serving as chairs, speakers and audience members who asked questions.

Primary and secondary outcome measures

In this observational study, gender for chairs, speakers and audience questioners across 152 sessions of the ASCO 2024 congress was assessed by two independent reviewers using audio and video recordings. Speaking times for questions and responses were also evaluated. Statistical analyses, including 2 and unpaired t-tests, were conducted to analyse the data.

Results

Women were well represented as chairs (n=124) and speakers (n=402) in 66% and 95% of sessions, respectively. However, only 21% of questions from the audience were posed by women, while 37% of questions were asked by men and 42% online or by chairs/speakers. Women were more likely to pose questions when the sessions were chaired by women (71% vs 53%; p=0.047). There were no statistically significant gender disparities concerning speaking time (questions: p=0.30; responses: 0.53). The response dynamics indicated a pattern of gender homogeneity, with individuals more frequently responding to questions from their own gender.

Conclusions

While the balanced representation of women in leadership roles at the ASCO 2024 congress reflects positive development in gender equality, disparities in active participation persist. These findings underscore the need for strategies that not only promote women in visible roles but also foster an environment that supports their active engagement in scientific discussions.

Cardioprotective and mentally protective effects of the Mediterranean-dietary approaches to stop hypertension intervention for neurodegenerative delay diet combined with forest bathing among adults with elevated blood cholesterol: a parallel group randomi

Por: Law · P. S. Q. · Yau · K.-Y. · Wong · D. C. · Yuen · K.-S. · Yu · C.-P. · Loke · A. Y.
Introduction

The prevalence of cardiovascular diseases (CVDs) is rapidly increasing across Asia, with the burden particularly high among individuals aged ≥50 years. Elevated low-density lipoprotein cholesterol (LDL-C) level is a well-established causal risk factor for CVDs. Mediterranean-Dietary Approaches to Stop Hypertension Intervention for Neurodegenerative Delay (MIND) diet is a cardioprotective diet, which is rich in plant-based foods. Combining it with stress-reducing practices, including forest bathing (FB), which involves immersive exposure to forest environments, has been shown to reduce LDL-C levels and other cardiovascular risk factors by modulating pro-inflammatory responses. However, existing evidence is limited due to small sample sizes and poor study design. Therefore, this study aims to investigate whether the MIND diet combined with FB can reduce CVD risks among Chinese adults in Hong Kong. It also compares the effects of the MIND diet combined with FB on cardiovascular and mental health.

Methods and analysis

A single-blind, randomised controlled trial involving three groups will be used to assess the impact of the MIND diet combined with FB on LDL-C levels in adults aged 50–75 years with elevated LDL-C levels. Participants (n=273) from local community centres will be randomly assigned to the MIND-plus-FB (who will receive nutrition education, follow the MIND diet for 12 weeks and participate in regular FB sessions), MIND-alone (who will receive nutrition education and follow the MIND diet for 12 weeks) or routine care (who will continue their usual activities and receive a general health talk along with pamphlets on cardiovascular risks) group. The change in LDL-C levels will be measured at weeks 4 and 12 (primary outcome). Additionally, changes in high-density lipoprotein cholesterol level, triglyceride level, glucose level, systolic blood pressure, waist circumference, body mass index, anxiety levels and emotional state will also be assessed at weeks 4 and 12. Statistical analyses will include intent-to-treat, 2 test, analysis of variance and generalised estimating equations.

Ethics and dissemination

This study has been approved by the Research Ethics Committee of Tung Wah College, Hong Kong (reference number: REC2023164). Research findings will be disseminated through publication in peer-reviewed journals and presentations at academic and primary healthcare conferences.

Trial registration number

ClinicalTrials.gov ID: NCT06222632, registered on 25 January 2024. The ClinicalTrials.gov data are available at: https://clinicaltrials.gov/study/NCT06222632?term=NCT06222632&rank=1&a=2&tab=history

Establishing a framework of measurement for use in Long COVID research and practice: protocol for a scoping review involving evidence review and consultation

Por: McDuff · K. · Bhereur · A. · Kadakia · Z. · Corrales-Medina · V. F. · Gross · D. P. · Janaudis-Ferreira · T. · Lam · G. · Naik · H. · Paterson · T. S. E. · Sanchez-Ramirez · D. C. · Sasseville · M. · Sekar · A. · Vohra · S. · Bayley · M. · Birch · S. · Busse · J. W. · Cameron · J. I. · K
Introduction

Our aim is to develop a Framework of Measurement for people living with Long COVID and their caregivers for use in Long COVID research and clinical practice. Specifically, we will characterise evidence pertaining to outcome measurement and identify implementation considerations for use of outcome measures among adults and children living with Long COVID and their caregivers.

Methods and analysis

We will conduct a scoping study involving: (1) an evidence review and (2) a two-phased consultation, using methodological steps outlined by the Arksey and O’Malley Framework and Joanna Briggs Institute. We will answer the following question: What is known about outcome measures used to describe, evaluate or predict health outcomes among adults and children living with Long COVID and their caregivers? Evidence review: we will review peer review published and grey literature to identify existing outcome measures and their reported measurement properties with people living with Long COVID and their caregivers. We will search databases including MEDLINE, Embase, CINAHL, PsycINFO and Scopus for articles published since 2020. Two authors will independently review titles and abstracts, followed by full text to select articles that discuss or use outcome measures for Long COVID health outcomes, pertain to adults or children living with Long COVID and/or their caregivers and are based in research or clinical settings. We will extract data including article characteristics, terminology and definition of Long COVID, health outcomes assessed, characteristics of outcome measures, measurement properties and implementation considerations. We will collate and summarise data to establish a preliminary Framework of Measurement. Consultation phase 1: we will conduct an environmental scan involving a cross-sectional web-based questionnaire among individuals with experience using or completing outcome measures for Long COVID, to identify outcome measures not found in the evidence review and explore implementation considerations for outcome measurement in the context of Long COVID. Consultation phase 2: we will conduct focus groups to review the preliminary Framework of Measurement and to highlight implementation considerations for outcome measurement in Long COVID. We will analyse questionnaire and focus group data using descriptive and content analytical approaches. We will refine the Framework of Measurement based on the focus group consultation using community-engaged approaches with the research team.

Ethics and dissemination

Protocol approved by the University of Toronto Health Sciences Research Ethics Board (protocol #46503) for the consultation phases of the study. Outcomes will include a Framework of Measurement, to enhance measurement of health outcomes in Long COVID research and clinical practice. Knowledge translation will also occur in the form of publications and presentations.

Remote ischaemic conditioning for efficacy in patients with aneurysmal subarachnoid haemorrhage (REPAIR): protocol for a multicentre, randomised, double-blind, sham-controlled, parallel-group trial

Por: Jin · T. · Niu · H. · Liu · L. · Yin · Y. · Zhao · W. · Feng · X. · Xu · L. · Hess · D. C. · Liu · A. · Ji · X.
Introduction

A large number of basic and clinical studies have demonstrated that remote ischaemic conditioning (RIC) has neuroprotective effects. Recently, RIC has made gratifying progress in the field of ischaemia stroke treatment. A considerable number of basic and clinical studies have also revealed the possible therapeutic effects of RIC on subarachnoid haemorrhage. However, the neuroprotective effect of RIC on subarachnoid haemorrhage is still lacking convincing evidence and deserves further study.

Aim

To explore the efficacy and safety of RIC for aneurysmal subarachnoid haemorrhage.

Methods and analysis

An investigator-initiated, multicentre, randomised, double-blind, sham-controlled, parallel-group trial to evaluate the effect of RIC intervention compared to sham RIC intervention for the neurological function improvement of patients with aneurysmal subarachnoid haemorrhage.

Ethics and dissemination

The protocol was approved by the IRB of Beijing Tiantan Hospital, Capital Medical University (KY2024-080-03). Progress and safety of the trial are monitored by an independent Data and Safety Monitoring Board. Study results will be published in peer-reviewed medical journals. Written informed consent will be obtained from all participants.

Trial registration number

NCT06711302.

Patient-reported outcome measures for fatigue in patients with chronic kidney disease: a systematic review

Por: Hughes · A. · Ju · A. · Cazzolli · R. · Howell · M. · Guha · C. · Levin · A. · Manera · K. · Teixeira-Pinto · A. · Torrisi · L. G. · Wheeler · D. C. · Wong · G. · Wu · R. · Jaure · A.
Objective

Fatigue is a common and debilitating symptom that is associated with an increased risk of mortality, dialysis initiation and hospitalisation among patients with chronic kidney disease (CKD). The aim of this study was to identify the characteristics, content and psychometric properties of patient-reported outcome measures (PROMs) used to measure fatigue in patients with CKD not requiring kidney replacement therapy (KRT).

Design

Systematic review. The characteristics, dimensions of fatigue and psychometric properties of these measures were extracted and analysed.

Data sources

We searched MEDLINE, Embase, PsycINFO and CINAHL from database inception to February 2023.

Eligibility criteria for selecting studies

All studies that reported fatigue in patients with CKD stages 1–5 not receiving KRT.

Results

We identified 97 studies (20 (21%) randomised trials, 2 (2%) non-randomised trials and 75 (77%) observational studies). 27 different measures were used to assess fatigue, of which three were author-developed measures. The 36-Item Short Form Health Survey (SF-36) and Kidney Disease Quality of Life – Short Form (KDQOL-SF) were the most frequently used measures (41 (42%) and 24 (25%) studies, respectively). Six (22%) measures were specific to fatigue (Chalder Fatigue Questionnaire, Functional Assessment of Chronic Illness Therapy – Fatigue Scale, Functional Assessment of Cancer Therapy-Fatigue, Fatigue Severity Scale, and author developed Chen & Ku 1998, and Hao et al 2021) while 21 (78%) included a fatigue subscale or item within a broader construct for example, quality of life. Various content domains assessed included tiredness, ability to think clearly, level of energy, muscle weakness, ability to concentrate, verbal abilities, motivation, memory, negative emotions and life participation. Only two measures (Chronic Kidney Disease Symptom Index – Sri Lanka, Kidney Symptom Questionnaire) were developed specifically for CKD, but they were not specific to fatigue. Six measures (Chronic Kidney Disease Symptom Index – Sri Lanka, Functional Assessment of Cancer Therapy – Anemia, Revised Illness Perception Questionnaire, Kidney Symptom Questionnaire, Short Form 6 Dimension and 36-Item Short Form Health Survey) had been validated in patients with CKD not requiring KRT.

Conclusion

PROMs used to assess fatigue in patients with CKD vary in content and few were specific to fatigue in patients with CKD not requiring KRT. Data to support the psychometric robustness of PROMs for fatigue in CKD were sparse. A validated and content-relevant measure to assess fatigue in patients with CKD is needed.

Chatbot-delivered structured psychological intervention (SPI-Bot) for teenagers with adolescent idiopathic scoliosis in Hong Kong: protocol for a pilot randomised controlled trial

Por: Li · J. · Zhang · T. · Cheung · J. P. Y. · Meng · N. · Wu · Z. · Ma · D. C. F. · Chan · E. A. · Yu · L. · Cao · Y. · Li · Y.
Introduction

Adolescent idiopathic scoliosis (AIS) often imposes a significant psychological burden on teenagers. Cognitive and behavioural strategies have demonstrated the potential to alleviate these challenges. Chatbots, with their real-time interaction capabilities, provide a promising and accessible approach to delivering psychological interventions for young people.

Method and analysis

This pilot trial will evaluate a chatbot-delivered, structured psychological intervention (SPI-Bot) incorporating cognitive and behavioural strategies for teenagers with AIS. Conducted as a single-centre, parallel-group randomised controlled trial, the study aims to assess the feasibility, acceptability and preliminary effectiveness of SPI-Bot. Fifty-two teenagers with AIS and mild to moderate psychological symptoms will be block-randomised into two groups. The intervention group will complete an 8-week, evidence-based SPI-Bot programme, while the control group will engage in casual conversations with another chatbot that does not include specific psychological health content. Assessments will be conducted at baseline, postintervention (8 weeks) and follow-up (12 weeks). Primary outcomes include feasibility and acceptability, measured through recruitment rates, adherence rates, attrition rates, engagement, working alliance, usability, user experience and adverse events. Secondary outcomes focus on effectiveness, including psychological distress, psychological well-being, perceived social support and quality of life. Participants in the intervention group will be purposively sampled for semistructured interviews to explore their perceptions of the intervention process.

Ethics and dissemination

This study has been approved by the Institutional Review Board of the Hong Kong Polytechnic University (Reference: HSEARS20240919007). The results of this pilot study will be disseminated through peer-reviewed journals and conference presentations.

Trial registration number

NCT06698952

Telenursing practice in the care of patients with surgical cancer: a scoping review

Por: Mozer · C. A. d. N. · Goncalves · J. d. C. · Rozetti · C. M. T. · Carvalho · R. d. · Fiorin · B. H. · Furieri · L. B. · Fioresi · M.
Objectives

Surgical oncology patients often experience doubts and uncertainties in the preoperative and postoperative periods, which can be addressed remotely through telenursing. Expanding telenursing services could contribute to more comprehensive perioperative care. We conducted a scoping review to characterise these telenursing services, identify their outcome indicators and examine the content of the care delivered.

Design

A scoping review was conducted in accordance with the Joanna Briggs Institute (JBI) recommendations.

Data sources

MEDLINE (PubMed), EMBASE, CINAHL, SCOPUS, Web of Science and Virtual Health Library (VHL), with searches performed up to 5 May 2025.

Eligibility criteria for selecting studies

We included studies that implemented telenursing interventions in the preoperative or postoperative period in adult oncology patients.

Data extraction and synthesis

Two independent reviewers used a standardised search to select and extract data from the included studies. Study characteristics were presented descriptively using absolute and relative frequencies, and the content of telenursing interventions was organised into a circular thematic matrix.

Results

A total of 37 studies were included, published between 1996 and 2024, conducted in 12 countries and primarily focused on postoperative telenursing via telephone or video calls. Preoperative care focused on psychosocial support and guidance related to surgical preparation. Postoperative topics included surgical wound care; handling of devices such as drains, ostomy bags and catheters; instructions for returning to work and support groups for financial and social assistance. Outcome indicators were primarily related to care, including levels of anxiety, stress, depression and quality of life.

Conclusions

Oncologic surgical telenursing remains primarily focused on postoperative care and the delivery of personalised support. Reporting on the protocols used, frequency and duration of sessions, nurse training and profiles, integration with in-person care workflows and operational cost data could strengthen the knowledge base for perioperative telenursing in oncology.

Patient-Reported Experience Measures in Vascular Surgery Enhancement (PREMIERE) study: protocol for a mixed-methods study to develop and validate a vascular surgery-specific patient-reported experience measure

Por: Darwish · M. · Palmer · R. · Coulson · J. · Bosanquet · D. C. · Withers · K.
Introduction

Patient-reported experience measures (PREMs) capture patients’ healthcare journey experiences. No validated PREMs are specific to vascular surgery patients. This study aims to develop and validate a vascular surgery-specific PREM to assess patient experience and satisfaction.

Methods and analysis

Patient Reported Experience Measures In Vascular Surgery Enhancement Study is a two-phase multisite sequential mixed-methods study. The qualitative phase will develop a draft PREM; the quantitative phase will validate it. The study will be conducted across three major vascular units in Wales. Up to 40 patients and healthcare professionals will participate in the qualitative phase. Approximately 150–200 patients will be recruited for the quantitative validation. Inclusion criteria are: (1) age ≥18; (2) recent vascular procedure; (3) inpatient vascular care; (4) not cognitively impaired; (5) consent to participate and (6) English or Welsh proficiency. Primary outcomes will be construct validity and reliability. Secondary outcomes will include patient engagement, healthcare provider perspectives and health system impacts. Thematic analysis will be conducted using NVivo. Psychometric validation will include item analysis, internal consistency testing and factor analysis.

Ethics and dissemination

The study was approved by the London—Camberwell St Giles Research Ethics Committee, coordinated by the Health Research Authority and Health and Care Research Wales (REC reference: 24/PR/0522).

Trial registration number

NCT06363175.

Association of multiple symptoms with sleep quality and duration: a cross-sectional population-based study of older men in Sweden

Por: Zeaiter · M. · Olsson · M. · Kochovska · S. · Currow · D. C. · Ekström · M.
Objective

To evaluate any association of the presence and severity of nine major symptoms (pain, tiredness, drowsiness, nausea, appetite, breathlessness, depression, anxiety, and perceived well-being) with sleep quality and duration in elderly men.

Design and setting

Cross-sectional analysis within the population-based VAScular and Chronic Obstructive Lung disease study (VASCOL) conducted in southern Sweden in 2019.

Participants

A total of 838 older men aged 73 years.

Measures

Severity of the symptoms was self-reported between 0 and 10 on a numerical rating scale. Breathlessness was also assessed using the Multidimensional Dyspnoea Profile and Dyspnoea-12. Sleep quality was reported on a 5-point Likert scale from ‘very well’ to ‘very bad’and sleep duration on a 7-point scale from ‘less than 4 hours’ to ‘more than 10 hours’. Associations of each symptom score with having worse sleep quality (‘bad’ or ‘very bad’) and/or shorter sleep duration (

Results

Of 838 men analysed, 11% had worse sleep quality, 8% had shorter sleep duration and 5% had both. Higher severity of each symptom was associated with worse sleep quality (adjusted odds ratios (aOR) ranging 1.12–1.61) and shorter sleep duration (aORs ranging 1.10–1.49).

Conclusions

A wide range of symptoms is associated with worse sleep quality and shorter sleep duration in elderly men, suggesting that clinicians should assess sleep when these symptoms are present and vice versa.

Studies on cognitive performance among older people living with HIV in eastern Europe and central Asia: a scoping review

Por: Imerlishvili · E. · Gustafson · D. R. · Pashalishvili · M. · Ompad · D. C. · Djibuti · M.
Background

Despite the growth of the population of older people living with HIV (PLWH), data on cognitive disorders among older PLWH, particularly in low- and middle-income countries, are scarce. These data are especially underrepresented in the literature from eastern Europe and central Asia (EECA).

Objectives

This scoping review aimed to describe the peer-reviewed literature on cognitive health among PLWH in the EECA region.

Eligibility criteria

We selected articles from peer-reviewed journals that reported on cognitive assessments or the prevalence and characteristics of cognitive disorders among adult (≥18 years) PLWH in EECA countries (Armenia, Azerbaijan, Belarus, Estonia, Georgia, Kazakhstan, Kyrgyzstan, Latvia, Lithuania, Moldova, Russia, Tajikistan, Turkmenistan, Ukraine and Uzbekistan). Studies assessing cognition among PLWH related to traumatic brain injury, brain tumours, COVID-19, meningitis, neurosyphilis and/or other central nervous system infections were excluded.

Source of evidence

We searched for relevant data published up to March 2025 using four online databases (PubMed, CINAHL, Web of Science and PsycINFO).

Charting methods

Covidence, a web-based collaborative software platform, was used for data screening and extraction. Two independent reviewers screened abstracts and full texts, resolving disagreements through consensus. The data were extracted based on the predefined data extraction criteria.

Results

A total of 1388 peer-reviewed articles were identified; 295 articles were removed due to duplication; and 1053 and 25 articles were excluded based on the abstract/title and full-text screenings, respectively. Finally, 15 articles met the inclusion criteria. All 15 studies used different neuropsychological assessments to measure cognitive performance by domain and/or cognitive disorders among various subgroups of PLWH. One cross-sectional study focused on older populations (≥40 years old), using standardised cognitive performance assessment tests. However, it neither provided information about the prevalence estimate of cognitive disorders nor identified risk factors.

Conclusion

Existing literature on cognitive disorders among older PLWH in the EECA region is limited and insufficient to estimate prevalence, or identify risk factors, and ultimately develop appropriate policy addressing the needs of older PLWH in this region. This scoping review underscores the urgent need for large-scale, longitudinal studies employing standardised, culturally adapted neuropsychological batteries and adherence to rigorous reporting standards.

Prehospital antibiotics and intravenous fluids for patients with sepsis: protocol for a 2x2 factorial randomised controlled trial

Por: Scales · D. C. · Rogowsky · A. · Burry · L. · Christenson · J. · Daneman · N. · Drennan · I. R. · Hillier · M. · Jenneson · S. · Klein · G. · Mazzulli · T. · Moran · P. · Morris · A. M. · Morrison · L. J. · Pinto · R. · Rubenfeld · G. D. · Seymour · C. W. · Stenstrom · R. · Verbeek · P. R
Introduction

Prompt recognition and treatment of patients with sepsis improve survival. Patients transported to hospital with sepsis often do not receive treatment until they are assessed in emergency departments. Initiation of treatments by paramedics at the point of first contact may improve outcomes for these patients.

Methods and analysis

The study design involves two randomised controlled trials (RCTs) conducted using a 2x2 factorial design comparing use of (1) early intramuscular ceftriaxone versus placebo and (2) an early liberal intravenous fluid strategy (up to 2 L normal saline) versus usual care resuscitation guided by paramedic medical directives. Patients who are ≥18 years of age will be eligible for inclusion if they have sepsis, defined as (1) paramedic suspicion of infection, (2) fever (temperature ≥38.0°C measured by paramedic or history of fever during the previous 24 hours), and (3) hypotension: SBP 250 mL) within 24 hours of hospital arrival; total amount of crystalloid infused during transport and first 24 hours of hospitalisation; and proportion of enrolled patients not suspected to have sepsis or infection by emergency department physicians. Safety outcomes include the proportion of patients with pulmonary oedema during transport to hospital and on initial chest X-ray and the proportion of patients with anaphylaxis or suspected allergic reactions to study medication.

Ethics and dissemination

This study has been approved through Clinical Trials Ontario’s streamlined ethics review process (board of record, Sunnybrook Health Sciences Centre). It will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and regulatory requirements. The final results will be disseminated to participating paramedic services through educational materials, presentations and interactive training. We anticipate our trial will achieve wide dissemination through publication in a peer-reviewed medical journal and presentation at international conferences targeting the fields of prehospital and emergency medicine, resuscitation and critical care.

Trial registration number

NCT03068741.

Prevalence of extrapulmonary tuberculosis in Indonesia: protocol for systematic review and meta-analysis

Background

Extrapulmonary tuberculosis (EPTB) is a significant public health issue in Indonesia, a country with a high tuberculosis burden. EPTB accounts for 15%–20% of global TB cases, with the proportion rising in populations co-infected with HIV. In Indonesia, estimates of EPTB prevalence vary significantly due to inconsistencies in diagnostic criteria, population demographics and methodologies. These variations highlight the need for a systematic review to synthesise existing evidence and provide a comprehensive understanding of EPTB’s epidemiology in Indonesia. This study aims to consolidate findings from various studies to identify prevalence trends, inform public health strategies and address knowledge gaps in diagnosing and managing EPTB.

Methods

This systematic review will follow Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines and has been registered with PROSPERO (Registration Number: CRD42024601175). A comprehensive search will be conducted in databases including PubMed, Google Scholar, ScienceDirect, Scopus and Southeast Asian Index Medicus to identify studies published between 2005 and 2024. Inclusion criteria include observational studies reporting EPTB prevalence in Indonesia based on clinical, microbiological or radiological diagnoses. Two independent reviewers will conduct study selection, data extraction and quality assessments using the Newcastle-Ottawa Scale. Data will be analysed using a random-effects model to estimate pooled prevalence, and subgroup analyses will explore variability by region, age and clinical setting. The study selection process will be documented using a Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram, and potential publication bias will be evaluated with funnel plots and the trim-and-fill method.

Ethics and dissemination

As this review involves secondary analysis of published data, no ethical approval is required. Findings will be disseminated through peer-reviewed journal publications and conference presentations.

Random capillary blood glucose in the diagnosis of diabetes: a cross-sectional study in Bangladesh

Por: Bhowmik · B. · Siddiquee · T. · Munir · S. B. · Parvin · S. · Ahmed · T. · Afsana · F. · Pathan · M. F. · Qureshi · N. K. · Mir · A. S. · Islam · R. · Milon · M. S. U. · Chowdhury · R. I. · Ozaki · R. · Ray · D. C. · Chowdhury · S. R. · Aufi · S. S. · Akhtar · S. · Afroz · T. · Samad · M. A
Objective

To assess the effectiveness of random capillary blood glucose as a diagnostic tool for type 2 diabetes and determine optimal cut-off values for adults in Bangladesh.

Design

Cross-sectional diagnostic accuracy study.

Setting

16 diabetes centres were selected randomly from all eight administrative divisions of Bangladesh.

Participants

A total of 3200 adults aged 18 years and older were recruited using systematic random sampling between May and September 2022.

Primary and secondary outcome measures

The primary outcome was the diagnostic accuracy of random capillary blood glucose compared to fasting plasma glucose, 2-hour plasma glucose after a 75-gram glucose load and glycated haemoglobin. Secondary outcomes included sensitivity, specificity, area under the curve and agreement with the other diagnostic tests.

Results

Random capillary blood glucose showed a strong positive correlation and high concordance with fasting plasma glucose, 2-hour plasma glucose and glycated haemoglobin. A cut-off value of ≥8.7 mmol/L demonstrated improved diagnostic performance compared with the currently used cut-off of ≥11.1 mmol/L. This new threshold yielded higher sensitivity, specificity, area under the curve and agreement with other standard diagnostic tests. Notably, hyperglycaemic symptoms were not required for diagnosis. The number needed to screen to identify one case of type 2 diabetes using the ≥8.7 mmol/L cut-off was 2.74, lower than that for fasting plasma glucose (2.86) and random capillary blood glucose ≥11.1 mmol/L (4.68).

Conclusions

Random capillary blood glucose may be an effective and affordable diagnostic tool for type 2 diabetes in resource-limited settings. The proposed cut-off of ≥8.7 mmol/L offers improved diagnostic accuracy and reflects the population’s glucose distribution pattern.

Evaluating the impact of patient blood management implementation: a protocol for a quasiexperimental study in a Portuguese tertiary care setting

Por: Pauperio · D. C. · Coelho · H. · Jorge · S. · Rabello · G. · Sphan · D. R. · Firmino-Machado · J.
Introduction

Patient blood management (PBM), an evidence-based, patient-centred approach for optimising blood health, faces significant implementation challenges despite regulatory support, and this study explores its adoption within a Portuguese hospital to enhance education, develop tailored protocols and address healthcare system complexities, thereby contributing a unique perspective to the global discourse on PBM in Portuguese-speaking countries. This study will evaluate the clinical outcomes and cost-effectiveness of implementing a PBM programme in elective surgical patients at a tertiary Portuguese hospital, with secondary objectives focusing on preoperative anaemia prevalence and aetiology, PBM protocol adherence, transfusion practices guided by viscoelastic tests and the impact of cell salvage techniques.

Methods

A baseline evaluation will be conducted in 2018, and postintervention assessments will follow from 2019 to 2024. The control group comprised patients who underwent selected elective surgeries—including cardiac, general, orthopaedic, urological and gynaecological procedures—during 2018 without exposure to targeted PBM interventions. The intervention group consisted of patients scheduled for the same elective surgeries, who were referred for preanaesthesia evaluation to identify the need for PBM interventions. These interventions, where indicated, were implemented during the preoperative phase and extended to the intraoperative and postoperative periods to ensure a comprehensive and standardised approach to PBM application. Data will be extracted from pseudoanonymised medical records, ensuring full compliance with ethical standards and data protection regulations. Statistical analyses will be performed using robust methods suitable for categorical and continuous variables, enabling the evaluation of temporal trends and the overall effectiveness of PBM interventions in improving clinical outcomes.

Ethics and dissemination

Our research has been ethically approved by the Vila Nova de Gaia/Espinho Hospital Centre’s Ethical Health Committee (approval number 196/2023–1). We plan to disseminate our findings through posters, lectures at conferences and in scientific journals.

Australian immigration detention health study protocol: a prospective, mixed-methods cohort study examining the physical and mental health of refugees and asylum seekers

Por: Sherif · B. · Hocking · D. C. · Asghari-Jafarabadi · M. · Rees · S. · Sundram · S.
Introduction

Globally, studies have consistently demonstrated the harmful mental and physical health impacts of immigration detention, with high levels of distress documented among detained asylum seekers and refugees (ASR). However, the consequences of immigration detention over time on the psychological and physical health of ASR are unclear and poorly quantified.

Methods and analysis

This prospective, mixed-methods cohort study will recurrently assess and describe the health profiles of adult ASR with an experience of Australian Government-sponsored immigration detention greater than 28 days. ASR ≥18 years old released from immigration detention will be assessed at 0, 3, 6 and 12 months and annually thereafter for up to 10 years, contingent on resourcing. Five self-report scales and a structured psychiatric interview will assess the primary outcome of depression, anxiety, post-traumatic stress, pain intensity and severity, somatic symptoms, functional impairment, physical health conditions associated with detention and engagement in available treatment of this cohort. Additionally, pre-existing health records will be accessed to identify current and previous health status and assess changes in these health indices. Quantitative findings will be triangulated with a qualitative phenomenological thematic analysis of interviews to determine additional psychosocial factors associated with the outcomes.

Ethics and dissemination

The study protocol was approved by the Monash Health Human Research Ethics Committee (HREC/73614/MonH-2021-251322). Results will be reported at conferences, in peer-reviewed publications and to all relevant stakeholder groups.

Cost savings of a nationwide project preventing healthcare-associated infections in adult, paediatric and neonatal critical care settings in Brazil: a micro-costing study

Por: Bass · L. M. · de Meireles · L. H. F. · Kiriyama · E. J. · dos Santos · N. O. · de Sousa · A. H. F. · Silva · K. C. d. C. D. · de Moura · R. M. · Prandini · C. M. · Santos · G. C. S. D. · dos Santos · R. G. · Franco · F. F. · Petenate · A. J. · Cristalda · C. M. R. · de Barros · C
Objective

To provide evidence of the cost savings of a quality improvement (QI) initiative preventing healthcare-associated infections (HAIs) in critical care settings.

Design

A micro-costing study focused on financial data related to a nationwide multicentric project preventing central line-associated bloodstream infection (CLABSI), ventilator-associated pneumonia (VAP) and catheter-associated urinary tract infection (CAUTI).

Setting

Brazilian public healthcare system.

Participants

Adult, paediatric and neonatal intensive care units (ICUs) participating in the QI initiative.

Intervention

This collaborative QI project implemented a multifaceted strategy to enhance infection-control measures. Participating ICUs reported the number of patients with and without HAIs and information on each HAI’s aggregate average cost (AC), which was analysed following the Brazilian Ministry of Health’s micro-costing guidelines. The 1-year preintervention period evidenced an aggregated AC in adult, paediatric and neonatal ICUs, respectively, of Intl$21 763.5 (95% CI 20 683.6 to 22 843.0), Intl$34 062.4 (95% CI 25 819.6 to 42 304.9) and Intl$32 903.2 (95% CI 29 203.6 to 36 602.4) for CLABSI; Intl$25 202.5 (95% CI 24 276.6 to 26 127.8), Intl$44 753.6 and Intl$17 238.4 for VAP and Intl$19 166.3 (95% CI 17 676.2 to 20 656.1) and Intl$55 873.3 (95% CI 43 563.1 to 68 183.1) for CAUTI (not included neonatal ICUs).

Primary outcome

The cost savings were estimated using the HAIs prevented—expenses avoided—during the QI intervention period from September 2021 to December 2023. The HAIs prevented were estimated using the difference between observed and predicted infections based on the aggregated preintervention baseline.

Results

Of the 188 participating ICUs, 31 voluntarily completed and provided the requested financial data with 100% accuracy. Considering the prevented 7342 HAIs for adult, paediatric and neonatal ICUs, respectively: 1647, 86 and 205 CLABSI; 3775, 114 and 118 VAP; and 1377 and 20 CAUTI, we estimated a saving of Intl$175.3 million (95% CI 153.2 to 180.9 million) to the Brazilian unified health system and a resultant estimated return on investment (ROI) of 890%.

Conclusion

This QI collaborative is a value-based initiative preventing HAIs in adult, paediatric and neonatal ICUs in South American settings. The substantial cost savings and a remarkable ROI underscore the economic viability of investing in comprehensive QI infection prevention strategies.

Ageism directed at older nurses in the workplace: a scoping review protocol

Introduction

In the context of global population ageing, there is a continuous and significant increase in the average age of nursing professionals. However, evidence indicates that age bias may hinder older workers’ access to the necessary support to remain active in the workforce.

Method and analysis

This scoping review aims to map and characterise the scientific literature on age bias directed at older nursing professionals in the workplace, conducted using the Joanna Briggs Institute methodology for scoping reviews and aligned with the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. Databases include MEDLINE (PubMed), CINAHL (EBSCOhost), LILACS, Scopus, APA PsycInfo and grey literature in Google Scholar. Two independent reviewers will screen titles and abstracts, followed by a full-text review of potentially relevant articles. Another reviewer will reconcile discrepancies. Two independent reviewers will extract data from the included articles using a data extraction tool developed for this review. The results will be tabulated and presented in a diagram and/or tables and summarised to explicitly address the review’s objective.

Ethics and dissemination

Findings will be disseminated through professional networks, conference presentations and publication in a scientific journal.

Registration details

https://doi.org/10.17605/OSF.IO/TR5ZK.

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