Conectar
There is an absence of real-world evidence, especially from low- and middle-income countries (LMICs), on the implementation successes and challenges of COVID-19 Test and Treat (T&T) programmes. In 2022, nirmatrelvir/ritonavir was provided as standard of care for mild to moderate COVID-19 treatment in eight LMICs (Ghana, Kenya, Laos, Malawi, Nigeria, Rwanda, Uganda and Zambia). This manuscript describes a research protocol to study novel drug introduction during the COVID-19 health emergency, with implications and learnings for future pandemic preparedness. The goal of the study is to provide simultaneous programme learnings and improvements with programme rollout, to fill a gap in real-world implementation data on T&T programmes of oral antiviral treatment for COVID-19 and inform programme implementation and scale-up in other LMICs.
This multiple methods implementation research study is divided into three components to address key operational research objectives: (1) programme learnings, monitoring and evaluation; (2) patient-level programme impact; and (3) key stakeholder perspectives. Data collection will occur for a minimum of 6 months in each country up to the end of grant. Quantitative data will be analysed using descriptive statistics for each country and then aggregated across the programme countries. Stakeholder perspectives will be examined using the Consolidated Framework for Implementation Research implementation science framework and semistructured interviews.
This study was approved by the Duke University Institutional Review Board (Pro00111388). The study was also approved by the local institutional review boards in each country participating in individual-level data collection (objectives 2 and 3): Ghana, Malawi, Rwanda, Nigeria and Zambia. The study’s findings will be published in peer-reviewed journals and disseminated through dialogue events, national and international conferences and through social media.
Child malnutrition remains a pressing public health challenge in sub-Saharan Africa (SSA), where approximately 148 million children are stunted and 45 million are wasted. Although often conceptualised as a persistent condition, evidence indicates that malnutrition among children under 5 years frequently follows seasonal patterns shaped by agricultural cycles, climatic variability and socioeconomic conditions. Current interventions have paid limited attention to the food system dynamics that underpin these fluctuations. Adopting a system perspective, this scoping review will synthesise existing evidence on the food system determinants of seasonal malnutrition in children under 5 years in SSA.
The review will be conducted in accordance with the Joanna Briggs Institute methodological framework for scoping reviews and reported following Preferred Reporting Items for Systematic Reviews and Meta-Analyses - Extension for Scoping Reviews (PRISMA-ScR) guidelines. A comprehensive search will be undertaken across electronic databases (Google Scholar, ProQuest Central, PubMed, Scopus and African Index Medicus) for literature published from 2015 onwards. Grey literature will also be sought from institutional repositories of the WHO, United Nations Children’s Fund, Food and Agriculture Organization and World Food Programme. Screening of titles, abstracts and full texts will be performed independently by two reviewers using predefined eligibility criteria. Data extraction will capture study characteristics and food system determinants of seasonal malnutrition at micro, meso and macro levels. The Food Insecurity and Vulnerability Information and Mapping Systems framework will guide the analysis and synthesis.
As this review involves analysis of previously published data, ethical approval is not required. Findings will be disseminated through a peer-reviewed publication and social media engagements. Results will inform the development of integrated system-based approaches to address seasonal malnutrition in children under five in SSA. The full study protocol, datasets and supplementary forms will be published in an open-access repository in compliance with the Findability, Accessibility, Interoperability and Reuse principles.
This scoping review protocol is registered with the Open Science Framework (https://doi.org/10.17605/OSF.IO/RU4ZX).
The emergency department (ED) often serves as a crucial pathway for cancer diagnosis. However, little is known about the management of patients with new suspected cancer diagnoses in the ED. The objective of this study was to explore emergency physicians’ experiences in managing patients with a newly suspected cancer diagnosis in the ED.
Between January and April 2024, we conducted a qualitative descriptive study. Interviews were conducted by trained research personnel using a semistructured interview guide. Interviews were conducted until thematic saturation was achieved. The interview transcripts were coded and thematic analysis was used to uncover key themes.
Emergency physicians practising in Ontario, Canada.
20 emergency physicians were interviewed. Four themes around the management of patients with new suspected cancer diagnoses in the ED were identified: (1) healthcare system-level factors that impact suspected cancer diagnosis through the ED, (2) institutional and provider-level challenges associated with managing patients with a suspected cancer diagnosis in the ED, (3) patient-level characteristics and experiences of receiving a cancer diagnosis in the ED and (4) the need for care coordination for patients with suspected cancer in the ED.
Physicians experienced several unique challenges in managing patients with a suspected cancer diagnosis in the ED. Overall, the findings of this study suggest these challenges often make the ED a difficult environment in which to deliver a suspected cancer diagnosis.
Postoperative pulmonary complications (PPCs) represent a significant cause of postoperative morbidity and even mortality. However, there is a lack of consensus regarding this composite endpoint, the definition of the individual components, classification and optimal outcome measures. This study aims to refine the PPCs composite framework by evaluating its construct validity, assessing the necessity and risks of a composite measure and exploring the feasibility of differentiating severity categories.
A Delphi consensus process will be conducted, engaging an international multidisciplinary group of 30–40 panellists, including clinicians, researchers, patients, public representatives and health economists. Through iterative rounds, the study will seek agreement on the individual components of the PPCs composite. Additionally, consensus will establish a framework for a composite outcome measure based on a standardised severity classification, appropriate timeframes and weighted grading of PPCs.
Consensus, defined by ≥75% concurrence in multiple choice questions or on Likert–scale statements, will be evaluated from round 2 onwards. Delphi rounds will be continued until all statements have reached stability of responses evaluated by 2 tests or the Kruskal-Wallis test.
The study will be conducted in strict compliance with the principles of the Declaration of Helsinki and will adhere to ACCORD guidance for reporting. Ethics approval has been obtained for this study from the University of Wolverhampton, UK (SOABE/202425/staff/3). Informed consent will be obtained from all panellists before the commencement of the Delphi process. The results of the study will be published in a peer–reviewed journal with the authorship assigned in accordance with ICMJE requirements.
NCT06916598 (clinicaltrials.gov).
To evaluate inhaler sustainability in asthma and Chronic Obstructive Pulmomary Disease (COPD) by analysing how inhaler design typology, prescribing and usage patterns, disposal and recycling practices influence human health and environmental outcomes, using a People-Process-Product (PPP) framework to identify actionable opportunities for improvement.
A systematic review was conducted in May 2024, with reporting structured around the PPP framework using narrative synthesis.
MEDLINE, Scopus, Cochrane Library and relevant grey literature were searched for publications over the period from April 2014 to April 2024.
Studies were included if published between 2014 and 2024, involved patients with asthma or COPD and healthcare professionals and specifically examined aspects of inhaler sustainability, including patient behaviours, healthcare provider prescribing practices and environmental impacts.
Two independent reviewers screened and extracted data from 63 studies. Due to diverse methodologies, quality assessment focused on research design robustness, completeness of outcome reporting and potential biases. Findings were synthesised narratively to address each research question using the PPP framework.
33% of included studies focused on two or more domains of the PPP framework as both primary and/or secondary outcomes. Studies mapped to the ‘People’ domain (n=34) showed limited awareness among patients and clinicians regarding the environmental impact of inhaler prescription patterns, use patterns and disposal methods, with over 75% of patients discarding inhalers in household waste. In the ‘Process’ domain (n=11), switching from pressurised metered-dose inhalers (pMDIs) to dry powder inhalers (DPIs) or soft mist inhalers (SMIs) was associated with improved inhaler adherence and asthma control, though uptake of new inhalers was influenced by patients’ prior experience, competence, proficiency and perceived usability. The ‘Product’ domain (n=41) showed that DPIs and SMIs consistently had lower carbon footprints than pMDIs, with short-acting beta-agonists (SABAs) pMDIs having the highest emissions due to prescription, use patterns and disposal.
Improving patient education on sustainable inhaler use and disposal and providing healthcare professionals with focused training on low-carbon prescribing are critical steps towards achieving significant clinical benefits and supporting environmental sustainability in asthma and COPD management.
CRD42024541927.
Cutaneous anthrax is a zoonotic bacterial infection that mostly involves the head, neck, and upper extremities. Periorbital involvement of cutaneous anthrax is a rare presentation that can lead to severe irreversible complications. Herein, we describe a 2.5-year-old girl with periorbital anthrax cellulitis. She presented with a severe swelling on the right side of her face and an ulceronecrotic lesion above the right eyebrow. After receiving an appropriate antibiotic regimen, her condition improved and she was discharged without any intraocular complications.
Breast cancer is the most commonly diagnosed cancer among women worldwide. Survivors often experience physical and psychological effects arising from breast cancer and its treatment, which can last months and years, adversely impacting quality of life. As the number of early breast cancer survivors increases, models of specialist-led follow-up care in hospital settings are not sustainable and evidence suggests that they may not meet survivors’ needs. Nurse-enabled, shared-care, follow-up models between cancer specialist and primary care teams have potential to address this need.
The proposed research is a multicentre, prospective, pragmatic, stepped-wedge cluster-randomised trial designed to test the effectiveness and implementation of IBIS-Survivorship, a follow-up care model for patients with early breast cancer who have completed primary treatment. The IBIS-Survivorship intervention involves a nurse-led consultation, development of a Survivorship Care Plan and case-conferencing between a breast care nurse and the patient’s primary care provider. This study seeks to recruit 1079 breast cancer survivors across six cancer centres (clusters) in Australia. Health-related quality of life at 12 months assessed by the Functional Assessment of Cancer Therapy - Breast Cancer questionnaire will be the primary endpoint, along with a range of patient-reported outcomes, safety indicators and cost-effectiveness measures as secondary endpoints. General and generalised linear mixed models will be used to assess the effectiveness of the intervention versus usual care. Implementation and process outcomes will be assessed using the Reach Effectiveness Adoption Implementation Maintenance framework.
Ethical approval was provided by the Metro South Hospital and Health Service Human Research Ethics Committee (HREC/2020/QMS/59892) and reciprocally across the other five trial sites under National Mutual Acceptance arrangements. Results will be disseminated through peer-reviewed academic journal publications and presentations at national and international conferences.
Australia and New Zealand Clinical Trials Registry (ANZCTR) Trial ID: ACTRN12621000188831.
This study set forth to investigate the efficacy of Quality and Quantity mononuclear cells (QQMNCs) for promoting wound healing and limb salvage in a severe ischemic wound model using diabetic mice. Female BALB/c nude mice induced with diabetes were used to create ischemic limb models in a controlled experimental design. Intramuscular injections of human QQMNCs were compared to phosphate-buffered saline (PBS) and peripheral blood mononuclear cells (PBMNCs) relative to their effects on wound healing and limb salvage. In vitro analysis demonstrated that the QQMNC group had significantly higher median percentages of CD34+ cells, CD34+CD133+ cells, CD206+ cells, and FOXP3+ cells compared to the PBMNC group (all p < 0.05), which suggests an enhanced regenerative and immunomodulatory profile. Kaplan–Meier survival analysis showed a significantly higher number of completely healed wounds in the QQMNC group than in the PBMNC group (p = 0.044). The histological evaluation showed that the QQMNC group had a significantly thinner epithelial thickness than the PBMNC (p = 0.032) and PBS groups (p = 0.002), and a significantly greater T cell density than the PBS group (p = 0.033), which suggests more efficient tissue repair. Moreover, the QQMNC group exhibited the highest percentage of minor tissue loss (57% for forefoot and toe gangrene), and the lowest incidence of severe limb loss (0% for lower leg gangrene). The findings of this study highlight the effectiveness of QQMNCs for promoting wound healing and limb salvage in diabetic ischemic animal model; however, clinical trials are needed to further assess their efficacy in this clinical context.
Toxic epidermal necrolysis (TEN) is a severe skin reaction caused by extensive epidermal and mucosal necrosis. This clinical phenomenon is known as an acute syndrome of apoptotic pan-epidermolysis (ASAP). The ASAP phenomenon is observed in conditions that mimic TEN, highlighting the challenge in distinguishing these conditions. While TEN is a well-recognized entity, distinguishing it from other TEN-like conditions presents significant diagnostic and treatment challenges. These conditions include drug rash with eosinophilia and systemic symptoms (DRESS), generalized bullous fixed drug eruption (GBFDE), acute generalized exanthematous pustulosis (AGEP), TEN-like methotrexate toxicity, mustard gas toxicity, pseudoporphyria, mycoplasma-induced rash and mucositis (MIRM), multisystem inflammatory syndrome in children (MIS-C), graft versus host disease (GVHD), and acute cutaneous lupus erythematosus and subacute cutaneous lupus erythematosus. This review explores these ten separate entities and debates their clinical features, pathophysiology, diagnosis and management.
In preclinical studies, topical oxygen treatment (TOT) was shown to enhance wound healing by applying supplemental oxygen topically to the surface of a moist wound at normobaric conditions. The objective of this systematic review and meta-analysis is to provide a thorough evaluation of published RCTs and observational studies that compare supplemental TOT with standard wound care. A total of 1077 studies were obtained from a variety of databases, including PubMed, ScienceDirect, Web of Science, ProQuest, Scopus, ClinicalTrials.gov, EU Clinical Trial Registers, and Preprints.org. The Jadad scale was employed to assess the reliability of RCT studies, while the Newcastle-Ottawa Scale (NOS) was employed to assess the quality of observational studies. Seven RCT studies (n = 692) and two controlled observational studies (n = 111) were analysed. The rate of healed wounds was 25.8% in the control group and 43.25% in the adjuvant TOT group, which shows the use of TOT significantly increased the number of healed wounds (RR = 1.77; 95% CI 1.18–2.64; p = 0.005). A significant decrease in the percentage of wound area was found in the TOT group in RCT studies (mean difference = 15.64; 95% CI 5.22–26.06; p = 0.003). In observational studies, the rate of healed wounds was 37.5% in the standard care group and 80.95% in the adjuvant TOT group, which shows a significant increase in the number of healed wounds in the adjuvant TOT group (RR = 2.15; 95% CI 1.46–3.15; p < 0.00001). Topical oxygen therapy is considered a great adjuvant therapy for chronic wound healing, particularly wounds with vascular compromise such as diabetic ulcers and pressure ulcers. Further studies on this topic are still needed as there are a lot of potential uses for this technology in various types of wounds.
To assess the prevalence of malnutrition in hospitalised adult patients, and to evaluate the accuracy of the most commonly used nutritional screening tools for identifying individuals at risk of malnutrition.
A prospective cross-sectional study was conducted on a total of 248 hospitalised patients in internal medicine wards (mean age: 75.2 years; 39.5% females). Nutritional screening was performed within 48 h of admission using the following tools: Malnutrition Universal Screening Tool (MUST), Nutrition Risk Screening Tool (NRS-2002), Malnutrition Screening Tool (MST), Short Nutritional Assessment Questionnaire (SNAQ), and Mini Nutritional Assessment Short Form (MNA-SF). The criteria of the European Society for Clinical Nutrition and Metabolism (ESPEN) were used as the gold standard for defining malnutrition. Patients were also evaluated using the Subjective Global Assessment (SGA) and the Global Leadership Initiative on Malnutrition (GLIM) criteria. Accuracy was determined by examining sensitivity, specificity, and positive and negative predictive values, and diagnostic agreement was determined by calculation of Cohen's kappa (κ). The study is reported as per the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.
The ESPEN criteria classified 20.2% of the hospitalised patients as malnourished. Overall, the MUST had the highest sensitivity (80.0%), specificity (74.7%) and positive predictive value (44.4%). For the subgroup of patients aged >65 years, the MNA-SF had high sensitivity (94.4%) but low specificity (39.0%). Based on Cohen's κ, the SGA and GLIM criteria showed low agreement with the ESPEN criteria.
The MUST was the most accurate nutritional screening tool, through the MST is more easily applied in many clinical settings. A comprehensive assessment of malnutrition that considers muscle mass is crucial for the reliable diagnosis of malnutrition.
The present findings underscore the importance of accurate assessment of the malnutrition status of hospitalised patients and the need for a reliable screening tool.
No patient or public contribution.
This study aimed to develop atorvastatin-loaded emulgel and nano-emulgel dosage forms and investigate their efficiency on surgical wound healing and reducing post-operative pain. This double-blind randomized clinical trial was conducted in a surgical ward of a tertiary care hospital affiliated with university of medical sciences. The eligible patients were adults aged 18 years or older who were undergoing laparotomy. The participants were randomized in a 1:1:1 ratio to one of three following groups of atorvastatin-loaded emulgel 1% (n = 20), atorvastatin-loaded nano-emulgel 1% (n = 20), and placebo emulgel (n = 20) twice a day for 14 days. The primary outcome was the Redness, Edema, Ecchymosis, Discharge, and Approximation (REEDA) scores to determine the rate of wound healing. The Visual Analogue Scale (VAS) and quality of life were the secondary outcomes of this study. A total of 241 patients assessed for eligibility; of them, 60 patients completed the study and considered for final evaluation. A significant decrease in REEDA score was observed on Days 7 (63%) and 14 (93%) of treatment with atorvastatin nano-emulgel (p-value < 0.001). A significant decrease of 57% and 89% in REEDA score was reported at Days 7 and 14, respectively, in atorvastatin the emulgel group (p-value < 0.001). Reduction in pain VAS in the atorvastatin nano-emulgel was also recorded at Days 7 and 14 of the intervention. The results of the present study suggested that both topical atorvastatin-loaded emulgel and nano-emulgel 1% were effective in acceleration of wound healing and alleviation of pain of laparotomy surgical wounds, without causing intolerable side effects.
FreshRSS 