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Australian research priorities for inherited retinal diseases: a James Lind Alliance priority setting partnership

Por: Robertson · E. G. · Hetherington · K. · Prain · M. · Ma · A. · Ayton · L. N. · Jamieson · R. V. · Shepard · E. · Boyd · L. · Hall · J. · Boyd · R. · Karandrews · S. · Feller · H. · Simunovic · M. P. · Grigg · J. R. · Yamamoto · K. · Wakefield · C. E. · Gonzalez-Cordero · A.
Objectives

Inherited retinal diseases (IRDs) are a broad range of diseases associated with abnormalities/degeneration of retinal cells. We aimed to identify the top 10 Australian research priorities for IRDs to ultimately facilitate more meaningful and potentially cost-effective research.

Design

We conducted a James Lind Alliance priority setting partnership that involved two Australian-wide surveys and online workshops.

Setting

Australia-wide.

Participants

Individuals aged 16 years or older were eligible to participate if they had an IRD, were caregivers of an individual with an IRD or were health professionals providing care to this community.

Outcome measure

In Survey 1, we gathered participants’ unanswered questions about IRDs. We grouped these into summary questions and undertook a literature review to verify if they were truly unanswered (ie, evidence uncertainties). In Survey 2, participants voted for the uncertainties that they considered a priority. Top-ranked uncertainties progressed for discussion and final prioritisation in two workshops.

Results

In Survey 1, we collected 223 questions from 69 participants. We grouped these into 42 summary questions and confirmed 41 as evidence uncertainties. In Survey 2, 151 participants voted, with the 16 uncertainties progressing to final prioritisation. The top 10 priorities, set by the 24 workshop participants, represented (1) treatment/cure; (2) symptoms and disease progression; (3) psychosocial well-being and (4) health service delivery. The #1 priority was for treatment to prevent, slow down or stop vision loss, followed by the #2 priority to address the psychological impact of having an IRD.

Conclusion

The top 10 research priorities highlight the need for IRD research that takes a whole-person, systems approach. Collaborations to progress priorities will accelerate the translation of research into real-world benefits.

Investigating facilitators and barriers of university-based administrative staff, residents and researchers to implement an active breaks intervention: a mixed-methods study

Por: Pinelli · E. · Masini · A. · Scoppolini Massini · M. · Dallolio · L. · Bragonzoni · L.
Objective

This study aims to analyse the barriers and facilitators towards an implementation of active breaks (ABs) intervention inside the workplace.

Methods

This study used a mixed-methods approach, incorporating virtual focus groups and an online questionnaire, conducted among the workers of Alma Mater Studiorum - University of Bologna (Italy). A total of 30 participants (N=30), including administrative and academic staff, PhD candidates, specialised trainees and research fellows, were involved in the study. Key themes and subthemes related to the barriers and facilitators of ABs interventions at the university were identified and categorised according to the three levels of the socio-ecological model.

Results

The most commonly reported barriers are: lack of time, lack of motivation (intrapersonal level); lack of influence, lack of awareness (social level); physical space, organisational support (environmental level). The most commonly reported facilitators are: access to information, flexible work hours (intrapersonal level); group support, awareness programmes (social level); adequate spaces, organisational structure (environmental level). A significant majority (81.48%) recognised the problem of sedentary time at work, with strong interest (92.59%) in workplace interventions to reduce it. Flexibility in timing for ABs (44.44%) was preferred over fixed schedules, with preference for dedicated areas (37.04%) and outdoor spaces (29.63%). The majority (62.96%) preferred taking ABs in small groups open to all, with a qualified kinesiologist (40.74%) leading the management.

Conclusions

This study identified barriers and facilitators to an ABs intervention from the perspective of administrative staff, residents and researchers. These findings could help institutions foster an environment that promotes physical activity, reduces sedentary behaviour and promotes the well-being and safety of workers through an integrated and individual-centred approach.

Better Living with Non-memory-led Dementia: study protocol for a randomised controlled trial of a web-based caregiver educational programme (BELIDE trial)

Por: Suarez-Gonzalez · A. · Brotherhood · E. · John · A. · Hayes · O. · Rossi-Harries · S. · Zimmermann · N. · Mansfield · V. · Brand · A. · Hoare · Z. · Fitzsimmons · D. · Cullen · K. · Crutch · S. · Stott · J.
Introduction

Carers of people with non-memory-led dementias such as posterior cortical atrophy (PCA), primary progressive aphasia (PPA) and behavioural variant frontotemporal dementia (bvFTD) face unique challenges. Yet, little evidence-based support and guidance are available for this population. To address this gap in services, we have developed a novel, web-based educational programme: the Better Living with Non-memory-led Dementia programme (BELIDE). BELIDE was co-designed with people with lived experience of non-memory-led dementia and a previous pilot study confirmed its feasibility as an online intervention. This protocol outlines the randomised controlled trial (RCT) to evaluate the clinical and cost-effectiveness of BELIDE.

Methods and analysis

This is a parallel-group, single-blind, RCT of 238 unpaid caregivers of people diagnosed with PCA, PPA or bvFTD recruited internationally among members of the UK-based organisation Rare Dementia Support. The intervention (BELIDE programme) consists of six structured online educational modules tailored to each phenotype, a virtual onboarding session, real-life practice tasks and up to two follow-up facilitation sessions. The group receiving the intervention will be given access to the programme, while the control group will receive treatment as usual and be placed on a wait-list to receive access to the programme once they complete their participation in the trial. The allocation ratio will be 1:1 stratified by dementia diagnosis and gender. The primary outcome is reduction in caregiver depressive symptoms. Secondary outcomes include stress, anxiety, self-efficacy, quality of life and caregiver-patient relationship quality. Data will be collected online via Qualtrics surveys at baseline, 8 weeks and 6 months post-randomisation. A mixed-method process evaluation with a subgroup of intervention participants will explore barriers and facilitators for engagement. A health economics evaluation will also be conducted to assess cost-effectiveness. If effective, this programme could improve access to caregiver support for non-memory-led dementias by providing scalable, tailored education.

Ethics and dissemination

Ethical approval has been granted by University College London Research Ethics Committee (8545/007). The results will be disseminated via peer-reviewed publications, conferences, stakeholder events and open-access resources.

Trial registration

This trial has been registered prospectively on the Clinical Trials registry, first posted on 5 February 2024 under registration number NCT06241287.

Trends in diabetes monitoring and control among Aboriginal and Torres Strait Islander Peoples attending general practice in urban and rural locations in Australia: a repeated cross-sectional study using data from a national general practice database (Medi

Por: Liddell · A. · Pink · N. · Baldim Jardim Nobre · F. · Bernardo · C. · Williams · S. · Stocks · N. · Gonzalez-Chica · D.
Objective

To determine the proportion of Aboriginal and/or Torres Strait Islander Peoples with diabetes who were monitored according to recommended national guidelines and had their clinical parameters within recommended targets. We also examined trends over time (2013–2022) and compared urban and rural areas.

Design

A repeated cross-sectional study using data from a national general practice database (MedicineInsight, 2013–2022).

Setting

De-identified electronic health records (EHR) of people attending 427 mainstream general practices across Australia.

Participants

This study included all Aboriginal and/or Torres Strait Islander adults (18+ years) diagnosed with diabetes mellitus who were regular patients (attended at least once a year in three consecutive years) within the MedicineInsight database.

Outcome measures

Outcomes measured were (i) monitoring of blood glucose, lipids, blood pressure (BP), renal function and Body Mass Index (BMI)/waist circumference (WC) and (ii) achieving recommended targets: glycosylated haemoglobin (HbA1c) ≤7.0%, fasting glucose 4–7 mmol/L, random glucose 5–10 mmol/L, total cholesterol ≤4.0 mmol/L, low-density lipoprotein 60 mL/min/1.73 m2, urine albumin-creatinine ratio (uACR) 2, WC

Results

Between 70% and 90% of individuals were monitored for the clinical parameters above, except for BMI/WC (55%–75%). Trends in monitoring over time were similar across remoteness areas, increasing slightly in 2013–2014 and declining from 2019. Among those monitored, 53%–86% achieved targets for blood glucose, lipids and renal function; 32%–42% for BP; and

Conclusion

The risk of diabetes complications among Aboriginal and/or Torres Strait Islander Peoples could be reduced by improving management of blood pressure and overweight/obesity in all areas, and blood glucose and lipids in rural areas.

From unconditionality to disenchantment among primary healthcare professionals during the COVID-19 pandemic: a qualitative study from Madrid, Spain

Objectives

To explore the experience of primary healthcare (PHC) professionals in their professional role during the pandemic and to describe collective coping strategies.

Design

We conducted a qualitative study using interviews, focus groups and photovoice techniques from February to September 2021. The qualitative data were transcribed, aggregated and analysed, from a hermeneutic perspective, using applied thematic analysis and ethnographic approaches.

Setting

Primary Care Health Madrid region (Spain).

Participants

Convenience sampling was used to select 71 multidisciplinary primary care professionals who were working in 12 PHCs representing diverse socioeconomic, social vulnerability and COVID impact levels in the Madrid region (Spain).

Results

Findings from this study show how lack of protection in the early days, uncertainty about how the disease would evolve and the daily challenges they faced have had an impact on the participants’ perceptions of their professional role. Nuanced differences in impact were found between men and women, age groups, professional roles and territories. The questioning of the basic foundations of primary care and the lack of prospects led to a feeling of demotivation. They perceive a wide gap between their levels of involvement and commitment, the recognition they receive and the attention to resources they need to do their work to a high standard. The support of their colleagues was seen as the most valuable resource for coping with the crisis.

Conclusions

The practitioners’ discourses offer knowledge that could help to face new global health threats; they also identify an urgent need to restore the role and motivation of PHC professionals as part of a wider regeneration of health systems.

Misinformation on cardiovascular disease spreads through social networks: a scoping review protocol

Por: Bhandari · B. · Zafra-Tanaka · J. H. · Mahapatra · P. · Njelekela · M. · Infante-Garcia · M. M. · Ramalingam · S. · Gonzalez-Rivas · J. P.
Introduction

Misinformation about cardiovascular health has the potential to negatively impact public health outcomes. Understanding the nature and spread of such misinformation is crucial for developing effective interventions to mitigate this potential risk. However, despite the critical importance of this issue, there is a gap in comprehensive reviews mapping the existing literature on cardiovascular health misinformation. This scoping review aims to map the existing literature on cardiovascular health misinformation, identifying its spread, prevalence, impact and strategies for correction across diverse populations and settings.

Methods

This review will follow the Joanna Briggs Institute guidelines for conducting a scoping review. A comprehensive search will be conducted across multiple databases, including MEDLINE, EMBASE, SCOPUS and Web of Science, along with grey literature sources. The last date of search was January 2025. The review will include studies without date that involve individuals affected by cardiovascular disease (CVD) misinformation, examine the spread, prevalence, impact or correction of misinformation related to cardiovascular health, and capture various cultural, geographic or setting-specific factors. The exclusion criteria include studies that do not directly address misinformation related to CVD. All identified records will be imported into Covidence systematic review software. Two reviewers will independently screen titles and abstracts, followed by full-text reviews of potentially relevant studies. Discrepancies will be resolved through discussion or by consulting a third reviewer. Data extraction will be conducted by two reviewers using a pre-piloted tool, and a descriptive presentation of the findings will be done. Both inductive and deductive content analysis methods will be employed for objectives related to the impact and strategies to combat misinformation.

Ethics and dissemination

Given that the study involves synthesising data from existing published literature, ethical approval is not required. The findings will be disseminated through international conference presentations, published in a peer-reviewed journal and shared with public health organisations and policymakers.

Development and retrospective validation of an artificial intelligence system for diagnostic assessment of prostate biopsies: study protocol

Por: Mulliqi · N. · Blilie · A. · Ji · X. · Szolnoky · K. · Olsson · H. · Titus · M. · Martinez Gonzalez · G. · Boman · S. E. · Valkonen · M. · Gudlaugsson · E. · Kjosavik · S. R. · Asenjo · J. · Gambacorta · M. · Libretti · P. · Braun · M. · Kordek · R. · Łowicki · R. · Hotakainen · K. · Vä
Introduction

Histopathological evaluation of prostate biopsies using the Gleason scoring system is critical for prostate cancer diagnosis and treatment selection. However, grading variability among pathologists can lead to inconsistent assessments, risking inappropriate treatment. Similar challenges complicate the assessment of other prognostic features like cribriform cancer morphology and perineural invasion. Many pathology departments are also facing an increasingly unsustainable workload due to rising prostate cancer incidence and a decreasing pathologist workforce coinciding with increasing requirements for more complex assessments and reporting. Digital pathology and artificial intelligence (AI) algorithms for analysing whole slide images show promise in improving the accuracy and efficiency of histopathological assessments. Studies have demonstrated AI’s capability to diagnose and grade prostate cancer comparably to expert pathologists. However, external validations on diverse data sets have been limited and often show reduced performance. Historically, there have been no well-established guidelines for AI study designs and validation methods. Diagnostic assessments of AI systems often lack preregistered protocols and rigorous external cohort sampling, essential for reliable evidence of their safety and accuracy.

Methods and analysis

This study protocol covers the retrospective validation of an AI system for prostate biopsy assessment. The primary objective of the study is to develop a high-performing and robust AI model for diagnosis and Gleason scoring of prostate cancer in core needle biopsies, and at scale evaluate whether it can generalise to fully external data from independent patients, pathology laboratories and digitalisation platforms. The secondary objectives cover AI performance in estimating cancer extent and detecting cribriform prostate cancer and perineural invasion. This protocol outlines the steps for data collection, predefined partitioning of data cohorts for AI model training and validation, model development and predetermined statistical analyses, ensuring systematic development and comprehensive validation of the system. The protocol adheres to Transparent Reporting of a multivariable prediction model of Individual Prognosis Or Diagnosis+AI (TRIPOD+AI), Protocol Items for External Cohort Evaluation of a Deep Learning System in Cancer Diagnostics (PIECES), Checklist for AI in Medical Imaging (CLAIM) and other relevant best practices.

Ethics and dissemination

Data collection and usage were approved by the respective ethical review boards of each participating clinical laboratory, and centralised anonymised data handling was approved by the Swedish Ethical Review Authority. The study will be conducted in agreement with the Helsinki Declaration. The findings will be disseminated in peer-reviewed publications (open access).

What are the expectations of patients regarding the communication of nuclear imaging results? Insights from a French national survey of 723 patients

Por: Gonzalez · S. · Le coz · P. · Israël · J.-M. · Comte · F. · Rezungles · F. · Benjelloun · H. · Mancini · J. · Taieb · D.
Objectives

There are still some controversies regarding the role of nuclear medicine practitioners in delivering imaging findings to the patients as well as content and magnitude of information to be delivered. The aim of the study was to identify the expectations of patients regarding the communication of results from a nuclear imaging examination.

Design

A national survey was conducted among patients who underwent a nuclear imaging examination. In each participating centre, a questionnaire was administered to the patients.

Setting

Primary care in France.

Participants

The study involved 723 patients from 12 French Nuclear Medicine departments (university hospitals, general hospitals, comprehensive cancer centres and private centres).

Outcome measure

The primary endpoint was to determine the proportion of patients expressing a wish to consult a nuclear medicine physician at the end of the imaging session and to assess the rationale underlying this preference.

Results

Our results indicate that a significant majority (73.2%) of patients prefer to meet primarily with the nuclear medicine physician to receive an explanation of the imaging findings. Concerning the disclosure of these results, 66.1% of the patients prefer to receive an explanation from the nuclear medicine physician, either alongside or instead of the requesting physician alone. Furthermore, nearly all patients (96.1%) who wish to meet with the nuclear medicine physician also indicate their willingness to receive the examination results, even if they are unfavourable.

Conclusions

This study underscores the clear preference of patients to interact with nuclear medicine specialists and benefit from their expertise, irrespective of whether the results are positive or negative. This emphasises the critical need for implementing standardised recommendations across countries and ensuring adequate training for nuclear physicians to actually meet this demand. This aspect is likely to distinguish a nuclear medicine physician from a scan interpreter.

Patient-Reported Incident Measure (PRIM) tools for reporting patient safety incidents: protocol for a scoping review

Por: Osorio · D. · Plana · M. N. · Rubio-Valera · M. · Munoz-Miguel · J. · Bolibar · I. · Franco · M. T. · Secanell-Espluga · M. · Soler-Font · M. · Fernandez-Torres · P. · Suclupe · S. · Salas-Gama · K. · Torres-Lopez · D. · Ferreira-Gonzalez · I. · FIS-PRIMs Research Group · Castillo
Introduction

Patient safety incidents during healthcare cause a high burden and mortality, but many go unreported. Involving patients and caregivers in the identification and reporting of safety incidents would add value to the current incident reporting systems used by health professionals. Identifying and analysing patient safety incidents is essential to prevent future events, allowing organisations to apply a learning-from-error approach and to implement improvement plans. Patient-Reported Incident Measures are tools for patients and caregivers to report safety issues related to their healthcare. In accordance with WHO’s patient safety taxonomy, the term patient safety incidents is used throughout this protocol to encompass events that do and do not reach the patient, including what are commonly referred to as near misses and adverse events. We aim to identify and describe the published literature about tools for patients or caregivers to report patient safety incidents in healthcare.

Methods and analysis

We will conduct a scoping review. We have developed inclusion criteria using the PCC (population, concept and context) format, where population includes adult patients or caregivers; concept refers to documents describing formal tools used to report patient safety incidents; and context includes any healthcare setting, such as hospitals or mental health centres, during or immediately after care. The scoping review will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines. Evidence sources include primary research, systematic reviews, meta-analyses, conference abstracts, letters, guidelines, as well as policy documents, reports, blogs and websites, without language restriction. An initial database search in Medline, Embase, CINAHL, and Cochrane Library from database inception up to June 2023 identified 4500 initial citations, of which 4103 were selected for evaluation after duplicates were removed. We will supplement the search by checking the reference lists of included studies for additional sources of evidence and an additional search in Google to identify non-peer-reviewed documents. This initial search will be updated before completing the review. We will use a self-created data collection form for data extraction and perform a narrative synthesis to integrate and summarise the review findings. We will describe the general characteristics of the tool: setting, scope, format, content, type of patient safety incident and severity, the moment of notification, relation to patient safety incident reporting and learning systems, development process, testing, validation, or piloting, among other characteristics. As a result of this scoping review, we intend to provide an index of patient/caregiver-reported safety notification tools and a list of descriptive or evaluation studies.

Ethics and dissemination

We will only use published data. Approval from the human research ethics committee is not required. The results of this scoping review will be submitted for publication in an international peer-reviewed journal and scientific meetings. Findings will also be disseminated through digital science platforms and academic social media.

International Registry of thyroid cancer in Latin American (CaTaLiNA): epidemiology, clinical and follow-up study protocol in Latin American countries during the period 2023-2028

Por: Solis Pazmino · P. · Pilatuna · E. · Ron · M. · Ledesma · T. · Alvarado · B. · Rojas · T. · Pazmino · C. · Tite · B. · Figueroa · L. · Lincango · E. · Hernandez · V. · Salazar · J. · Garcia · C. · Rosero · D. · Guerrero · J. · Ruilova · L. · Imaicela · L. · Abad · H. · Paz-Ibarra · J. · Gonz
Introduction

Differentiated thyroid cancer (DTC) is the most common endocrine malignancy, with a high 5-year survival rate of approximately 98%. Despite advances in diagnosis and treatment, up to 20% of patients experience recurrence, adversely affecting their quality of life. Predictive models have been developed to assess recurrence risk and guide clinical decision-making, but these models often face limitations such as retrospective design, lack of diversity in study populations and absence of external validation. The primary aim is to externally validate existing predictive models for DTC recurrence using prospective data from a diverse Latin American cohort. The secondary aim is to explore opportunities for model recalibration to improve their performance in our population.

Methods and analysis

The CaTaLiNA study is a multicentre prospective observational study conducted across 10 hospitals in five Latin American countries, including Ecuador, Peru, Uruguay and Mexico. Patients aged 18 years or older receiving treatment for DTC, such as the first thyroid surgery, active surveillance or radiofrequency ablation will be included. Recruitment will occur from November 2023 to June 2025, with follow-up extending until June 2028. Data collection will include baseline clinical, surgical and histological characteristics, treatment details and follow-up outcomes. Statistical analysis will follow the Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis guidelines, using imputation strategies for missing data and evaluating calibration and discrimination of the prediction models. Calibration measures include the ratio of expected and observed events, calibration slope and calibration plot, while discrimination will be assessed using the C-index and area under the receiver operating characteristic curve.

Ethics and dissemination

This study protocol was approved by Comité de Ética de Investigación en Seres Humanos de la Universidad San Francisco de Quito USFQ ‘CEISH-USFQ’ APO-010–2023-CEIHS-USFQ Oficio No. 161-2023-CA-23030M-CEISH-USFQ. Results will be disseminated via peer-reviewed publications.

Effectiveness of the BioFire FilmArray for the rapid detection of bloodstream infection in haematological patients with febrile neutropenia (the ONFIRE study): study protocol of a prospective, multicentre observational study at three reference university

Por: Bergas · A. · Lopez de Egea · G. · Albasanz-Puig · A. · Machado · M. · Vinado · B. · Estevez-Prieto · A. · Maluquer · C. · Carro · I. · Perez-Gonzalez · A. · Regalado-Artamendi · I. · Gomez-Centurion · I. A. · Laporte-Amargos · J. · Sastre-Escola · E. · Badia-Tejero · A. M. · Garci
Introduction

Bloodstream infection (BSI) due to multidrug-resistant Gram-negative bacilli is a serious global health problem that has a profound impact on severely immunosuppressed neutropenic haematological patients. Prompt institution of appropriate antimicrobial therapy is crucial for improving outcomes in these patients, and in an era of multidrug resistance, antimicrobial stewardship programmes are mandatory. Blood cultures, the current gold standard for the diagnosis of BSI, present two main drawbacks: the prolonged time to results and their low sensitivity, especially if the patient has received antimicrobial treatment before blood extraction. The aim of this study is to determine whether a molecular technique, the BioFire FilmArray Blood Culture Identification 2 (BCID2) panel, achieves higher sensitivity and specificity than conventional blood cultures for the microbiological diagnosis of BSI in haematological patients with febrile neutropenia.

Methods and analysis

This multicentre, prospective, observational study will be conducted at three reference university hospitals in Spain. The population will comprise haematological patients scheduled to undergo diagnostic blood cultures as standard care for the microbiological diagnosis of the febrile neutropenia episode. The BioFire FilmArray panel will be performed in patients with positive blood cultures at the time of blood culture positivity and in patients with negative blood cultures at 48 hours of incubation. The primary endpoint will be the sensitivity and specificity of the BioFire FilmArray BCID2 panel compared with conventional blood cultures. The secondary endpoints will be this same comparison in the subgroup of patients with recent (

Ethics and dissemination

The study protocol has been approved by the Clinical Research Ethics Committee at Bellvitge Hospital (reference number ICPS029/22) and the Institutional Review Boards at each participating site. All patients’ personal data will be processed, disclosed and transferred in accordance with Organic Law 3/2018 of 5 December 2018 and Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016. All data will be collected, stored and processed anonymously. Results will be reported at conferences and in peer-reviewed publications regardless of whether the hypothesis is demonstrated. Any formal presentation or publication of data collected from this study will be considered as a joint publication by the participating investigators and will follow the recommendations of the International Committee of Medical Journal Editors.

Discussion

The aim of this study is to assess the impact of the BCID2 panel on the diagnostic yield of BSI in haematological patients with febrile neutropenia. Unlike previous studies, which focused on patients with documented BSI, our research will include all patients with febrile neutropenia.

Trials registration number

NCT06787326.

Prevalence of chronic wounds in hospitalised patients in Catalonia, Spain: a multicentre cross-sectional descriptive observational study

Por: Lopez-Jimenez · M. M. · Romero-Garcia · M. · Adamuz · J. · Berbis-Morello · C. · Pons-Prats · M. · Tapia-Perez · M. · Zuriguel Perez · E. · Castro-Navarro · T. · Juve-Udina · M.-E. · Gonzalez-Samartino · M.
Background

Few studies have investigated the prevalence of chronic wounds and the clinical and sociodemographic characteristics of hospitalised patients affected by them. Understanding these characteristics within the inpatient setting can support improved follow-up, inform care strategies, enhance quality and safety and reduce associated healthcare costs. This study aimed to determine the prevalence and the sociodemographic profile of adult inpatients with chronic wounds admitted to the eight hospitals of the Catalan Institute of Health between 2016 and 2020.

Methods

A descriptive, observational, cross-sectional and retrospective multicentre study was conducted using routinely collected clinical data from 1 January 2016 to 31 December 2020. The study encompassed hospital wards, step-down units and home hospitalisation services across eight public hospitals managed by the Catalan Institute of Health, the main public healthcare provider in Catalonia, Spain. The study included all patients aged 18 years or older who were hospitalised with chronic wounds during the study period. The main variables were nursing diagnoses of chronic wound types: pressure injuries (PIs), arterial ulcers (AUs), venous ulcers (VUs), mixed ulcers and diabetic foot ulcers (DFUs), as recorded in nursing electronic health records. Secondary variables included age, sex, reason for admission, unit of admission, hospital type, source of admission and discharge destination. A descriptive and comparative analysis was performed.

Results

Among 796 698 hospitalised patients, 16 935 (2.1%) presented with at least one chronic wound. The most common types of chronic wounds were PIs and AUs. A slight decline in the prevalence of chronic wounds was observed over the study period. Cardiovascular and respiratory conditions were the leading causes of admission among these patients. AUs and DFUs were more prevalent in men, whereas VUs were more frequently observed in women. Patients with PIs had longer hospital stays, higher rates of intensive care unit admissions and increased in-hospital mortality. In contrast, patients with vascular ulcers more often required continued care after discharge (p

Conclusions

Chronic wounds continue to represent a significant healthcare challenge. It is essential to consider the clinical characteristics and health outcomes of hospitalised patients with chronic wounds in order to improve care quality and safety. Further research is warranted to explore the relationship between patient care complexity and the type of chronic wounds present.

An adaptive multiarm randomised trial of biomedical and psychosocial interventions to improve convalescence following severe acute malnutrition in sub-Saharan Africa: Co-SAM trial protocol

Por: Bwakura-Dangarembizi · M. · Amadi · B. · Singa · B. O. · Muyemayema · S. · Ngosa · D. · Mwalekwa · L. · Ngao · N. · Kazhila · L. · Mutasa · B. · Mpofu · E. · Mudawarima · L. · Gonzales · G. B. · Mudzingwa · S. · Mutenda · M. · Keter · L. K. · Mutasa · K. · Njunge · J. M. · Jones · H. · Phi
Introduction

Children discharged from hospital following management of complicated severe acute malnutrition (SAM) have a high risk of mortality, readmission and failed nutritional recovery. Current management approaches fail to sufficiently promote convalescence after inpatient nutritional rehabilitation. Novel interventions during the post-discharge period could enhance convalescence to help children survive and thrive.

Methods and analysis

The Co-SAM trial is an adaptive, multicountry, phase III, individually randomised clinical trial, based on the principles that (i) interacting biological and social factors drive multimorbidity in children with SAM, and (ii) both medical and psychosocial interventions may therefore ameliorate underlying causal pathways to reduce morbidity and mortality and improve recovery. Children aged 6–59 months with complicated SAM, who have stabilised and started the transition to ready-to-use therapeutic food (RUTF), will be enrolled and randomised to one of five trial arms (standard-of-care alone; antimicrobials; reformulated RUTF; psychosocial support; or a combination of all strategies). Standard-of-care, which is provided in all trial arms, includes RUTF until nutritional recovery (defined as weight-for-height Z-score >–2, mid-upper arm circumference >12.5 cm and oedema-free since the last study visit), and other management recommended in WHO guidelines. The 12-week antimicrobial package provides daily co-formulated rifampicin and isoniazid (with pyridoxine) and 3 days of azithromycin monthly. The reformulated RUTF, which incorporates medium-chain triglycerides and hydrolysed protein to increase nutrient bioavailability and reduce metabolic stress, is provided at the same dose and duration as standard RUTF. The 12-week psychosocial package includes caregiver problem-solving therapy, educational modules, peer support groups and child play. The combined arm includes all interventions. Children start their intervention package prior to hospital discharge, with follow-up data collection in study clinics at 2, 4, 6, 8, 12 and 24 weeks. The primary composite outcome is death, hospitalisation or failed nutritional recovery within 24 weeks post-randomisation. An interim analysis will allow unpromising arms to be dropped, while the final analysis will be conducted when 1266 children have completed the study. Embedded process evaluation and laboratory substudies will explore the mechanisms of action of the interventions.

Ethics and dissemination

The trial has been approved by ethics committees in Zimbabwe, Zambia, Kenya and UK. Dissemination will be via community advisory boards in each country; Ministries of Health; and dialogue with policymakers including UNICEF.

Trial registration number

Clinicaltrials.gov: NCT05994742; Pan African Clinical Trials Registry: PACTR202311478928378.

Prospective study of continuous rhythm monitoring in patients with early post-infarction systolic dysfunction: clinical impact of arrhythmias detected by an implantable cardiac monitoring device with real-time transmission--the TeVeO study protocol

Introduction

Updated primary prevention strategies are needed for post-infarction sudden cardiac death (SCD) based on implantable cardioverter-defibrillator (ICD). Current recommendations, based on left ventricular systolic function and functional class, may be obsolete because they are derived from ancient studies that do not incorporate the potential benefit of either current comprehensive treatment of ischaemic heart disease or modern device programming. Among patients with post-infarction left ventricular dysfunction, modern implantable cardiac monitoring devices (ICM) allow a unique opportunity to determine in real-time the burden of non-sustained ventricular tachycardias and their relationship to the subsequent occurrence of sustained or symptomatic events.

Methods and analysis

Approximately 200 patients with left ventricular ejection fraction (LVEF) equal to or less than 40% after acute myocardial infarction will be included in the study. They will be implanted with a Confirm RX, an ICM with real-time remote connection via a smartphone. At 6 months, LVEF and functional status will be re-evaluated and cardiac morpho-functional characterisation will be performed by MRI. At this time, and following current European guidelines, patients with an indication will receive an ICD; the others will continue to be monitored using an ICM for a minimum of 2 years. Patients are expected to be followed up for 4 years after the index event. More than 20 000 remote transmissions are expected to be analysed. The study will focus on the relationship between the detection of non-sustained ventricular tachycardias by ICMs (defined as at least 8 R-R intervals at 160 beats per minute) and the subsequent occurrence of symptomatic arrhythmic events. An advanced statistical analysis will be performed using machine and deep learning techniques to determine the clinical variables, those that are derived from monitoring and imaging tests and related to mid-term prognosis.

Ethics and dissemination

The study was approved by the Ethical Committee of the University Hospital of Salamanca (protocol number PI 2019 03 246) on 30 April 2020. Each patient will be informed about the study in both oral and written form by a physician and will be included in the study after written consent is obtained.

For the first time, a study will provide real-time information on the arrhythmic burden of patients with post-infarction ventricular dysfunction and its prognostic implications in the medium term. Several publications in scientific journals are planned.

Trial registration number

NCT04765943.

Cost drivers and feasibility of a hospital-at-home programme for geriatric care in northeastern Mexico: a retrospective observational study

Objective

The primary objective was to evaluate factors influencing the cost of a ‘hospital at home’ (HAH) for geriatric patients in a Northeastern Mexican hospital. Secondarily to evaluate the per capita global cost-effectiveness compared with traditional hospital care.

Design

This retrospective analysis examined the costs incurred by geriatric patients in an HAH programme from February to December 2022

Setting

We collected data from clinical records and assessed medication and procedure costs through the hospital’s financial department. Costs for traditionally hospitalised patients were reviewed for comparison.

Participants

Subjects of both genders aged 70 and older who were treated in HAH during 2022 and hospitalised subjects with the same age and gender treated in the same period.

Intervention: NA

Primary and secondary outcome measures

Primary outcome: factors that influence costs in HAH. Secondary, global per capita cost comparison between HAH and hospital care.

Results

We examined the expenses associated with 416 home visits to 49 patients in the HAH programme. The main factors influencing the programme’s overall cost were medical care and procedure-related disorders (β=0.333, p=0.002), sleep-regulators (β=0.561, p

Conclusions

This study highlights that the main factors influencing the HAH programme’s costs include medical care and procedure-related disorders, as well as medication extensively used in the elderly population. Additionally, we demonstrated the cost-effectiveness of the HAH programme, which produces substantial savings and is a financially viable alternative to traditional hospital care.

HER2-low prevalence among Hispanic/Latino women with breast cancer: A systematic review and meta-analysis

by Daniel Felipe Mendivelso-González, Daniel Clavijo Cabezas, Luisa Montoya, Merideidy Plazas Vargas, Patricia López-Correa, Eugenia Colón, Rafael Parra-Medina

Purpose

HER2-low has garnered significant attention for the treatment of HER2-negative breast cancer. We aimed to determine the prevalence of HER2-low expression in Hispanic/Latino women with breast cancer (BC).

Methods

We searched in Embase, LILACS, and Medline databases for articles reporting the expression of HER2 immunohistochemistry with scores reported as 0, 1+, 2+, or 3+, with equivocal cases (2+) confirmed through in situ hybridization (ISH).

Results

A total of 12 articles were finally included, comprising 73,467 individuals. The prevalence of HER2-zero, HER2-low and HER2 positive cases among all BC (0, 1+, 2+/ISH-, 2+/ISH+ and 3+), was 45.0%, 32.0%, and 23.0%, respectively. The prevalence of HER2-zero and HER2-low expression among negative cases (0, 1+ and 2+/ISH-), was 53.0% and 47.0%, respectively.

Conclusion

There is an important percentage of Hispanic/Latino individuals who would benefit from HER2-targeted therapies, even in HER2 negative cases. Additional research on the prevalence of HER2-low tumors across a wider range of Latin American countries is required to better understand the molecular epidemiology of this biomarker within the Hispanic/Latino population.

Dynamic optical coherence tomography for imaging acute wound healing

Abstract

The aim of this study was to investigate acute wound healing with dynamic optical coherence tomography (D-OCT). From 22 patients with 23 split skin graft donor sites, vessels at four wound edges, the wound bed, and adjacent and unaffected skin of the contralateral leg were measured by D-OCT at six time points from surgery to 4 weeks of healing. Changes in vessel orientation, density, diameter, morphology and pattern in horizontal, vertical and 3D images were analysed for wound healing and re-epithelialization. At 300 μm depth, there were significant differences of blobs and serpiginous vessels between normal and wounded skin. The wound had significantly more vertically oriented vessels, a higher degree of branching, vessel density and diameter compared with healthy skin. 3D images showed increased angiogenesis from healthy skin towards the wound centre, significantly higher vessel density at the wound than at normal skin and the highest at the interface. During wound healing blobs, coils and serpiginous vessels occurred significantly more frequently in lesional than healthy skin. Vessel density was greatest at the beginning, decreased and then increased by 4 weeks post-surgery. D-OCT helps to evaluate acute wound healing by visualizing and quantifying blood vessel growth in addition to re-epithelialization.

Exploring the effect of wound related pain on psychological stress, inflammatory response, and wound healing

Abstract

Aims and Objectives

The relationship between pain and poor healing is intricate, potentially mediated by psychological stress and aberrations in inflammatory response. The purpose of this study was to examine the biopsychosocial model of pain by assessing the relationships between pain, stress, inflammation and healing in people with chronic wounds.

Design

This was a 4-week prospective observational study to explore the relationship of pain, stress, inflammation and wound healing in a convenience sample of patients with chronic wounds in a chronic care hospital in Canada.

Methods

Only subjects over 18 with chronic wounds were recruited into the study. Chronic wounds were defined by the duration of wounds for more than 4 weeks of various aetiologies including wounds caused by pressure injuries, venous disease, arterial insufficiency, surgery or trauma and diabetic neuropathy. Participants were evaluated for pain by responding to the Brief Pain Inventory-Short Form, the McGill Pain Questionnaire-Short Form and the Leeds Assessment of Neuropathic Symptoms and Signs scale. Stress was measured by the Perceived Stress Scale (PSS). All wounds were assessed with the Pressure Ulcer Scale for Healing tool. The levels of matrix metalloproteinases were analysis by obtaining wound fluid from all participants.

Results

A total of 32 individuals with chronic wounds participated in the study. Correlation analysis indicated pain severity was positively and significantly related to pain interference, McGill Pain Questionnaire scores, neuropathic pain and matrix metalloproteinase levels. Logistic regression was used to determine the predictors for high or low perceived stress. The only significant variable that contributed to the stress levels was BPI-I. Results suggested that participants who experienced higher levels of pain interference also had an increased odds to report high level of stress by 1.6 times controlling for all other factor in the model.

Conclusion

Pain is a complex biopsychosocial phenomenon affecting quality of life in people with chronic wounds. Results of this study identified a significant relationship between pain, stress and wound healing.

Changes in the quality of life of adults with an ostomy during the first year after surgery as part of the Best Practice Spotlight Organisation® Programme

Abstract

The aim was to analyse changes in the perceived quality of life of patients with an ostomy during the first year after surgery at two or three follow-ups. This is a prospective study of a cohort of 55 patients who were ostomised between June 2021 and September 2022 and cared for under the recommendations set out in the Registered Nurses' Association of Ontario® best practice guideline Supporting Adults Who Anticipate or Live with an Ostomy as part of the Best Practice Spotlight Organisation® (BPSO®) programme. The Stoma Quality of Life tool was used. A univariate analysis was performed to identify variables associated with a non-improvement in quality of life. Variables showing p < 0.1 were included in a multivariate model. Patients with an ostomy exhibited a moderate-to-good perception of quality of life in both the personal and social dimensions, with no worsening over the first year. Being female (OR = 10.32) and being younger (OR = 0.89) were associated with a higher risk of no improvement in quality of life. The most frequent complications were urinary leakage (p = 0.027) and dermatitis (p = 0.052) at first follow-up; and parastomal hernia (p = 0.009) and prolapse (p = 0.05) at third follow-up. However, they did not lead to a worsening of quality of life, suggesting that these patients were adequately supported under the BPSO® programme.

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