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Hoy — Diciembre 16th 2025Tus fuentes RSS

<i>Mycobacterium tuberculosis</i> complex lineages and drug resistance patterns among tuberculosis patients with or without diabetes mellitus in southern Ghana

by Emelia Konadu Danso, Prince Asare, Amanda Yaa Tetteh, Phillip Tetteh, Augustine Asare Boadu, Ivy Naa Koshie Lamptey, Augustina Angelina Sylverken, Kwasi Obiri-Danso, Jane Sandra Afriyie-Mensah, Abraham Adjei, Dorothy Yeboah-Manu

Drug-resistant (DR) tuberculosis (TB) and diabetes mellitus (DM) are intersecting epidemics that complicate management of both diseases and worsen patient outcomes. We conducted a prospective cohort study of 758 GeneXpert-confirmed pulmonary TB patients, of whom 75 had DM. Demographic, clinical, radiographic, and anthropometric data were collected at baseline. Sputum samples were cultured for mycobacterial isolation, and the obtained isolates were characterized for Mycobacterium tuberculosis complex (MTBC) lineage and drug-susceptibility testing using spoligotyping and microplate alamar blue assay. The TB-diabetes (TB-DM) comorbid cohort was older [TB-DM: 53/75 (70.7%) vs. 241/683 (35.3%) aged 41–60 years) (p 
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Fast-track pathway for giant cell arteritis: Improved visual outcomes and reduced healthcare costs

by Loïc Duron, Thibaud Chazal, Thomas Sene, Julien Savatovsky, Augustin Lecler

Background

Giant cell arteritis (GCA) is the leading vasculitis threatening vision in adults aged ≥ 50 years; permanent vision loss may occur within the first few days after symptom onset. We assessed the impact of a fast-track pathway (FTP) for early diagnosis and treatment of giant cell arteritis in terms of hospitalization patterns and cost-effectiveness.

Methods

We conducted a retrospective, single-center medico-economic study of consecutive patients referred to a neuro-ophthalmology tertiary center between Nov 1, 2016, and Dec 31, 2022. GCA was defined by ≥ 3 American College of Rheumatology criteria plus a positive temporal-artery biopsy or vascular imaging. An FTP—24/7 access to internal medicine specialists, priority magnetic-resonance imaging, and protocol-driven corticosteroid initiation—was launched on Nov 1, 2018. Demographic, clinical, biological, care-pathway, and cost data were compared before (pre-FTP) and after (post-FTP) implementation. Continuous variables were analyzed with two-sample t tests or Wilcoxon rank–sum tests; categorical variables with χ² or Fisher’s exact test.

Findings

We included 135 patients (mean age 76 ± 8 years, 61% women): 23 pre-FTP and 112 post-FTP. Baseline characteristics were similar between groups. Compared with the pre-FTP period, the FTP reduced full hospitalizations (62% [69/112] vs 96% [22/23]; p  Interpretation

A dedicated fast-track pathway for suspected GCA enables prompt, largely ambulatory care, halves unnecessary full hospitalizations, speeds treatment initiation, improves visual prognosis, and lowers overall expenditure. These findings support wider adoption of imaging-driven FTPs to mitigate the growing clinical and economic burden of GCA.

Ozoile‐Stable Ozonides, Derived From Organic Extravirgin Olive Oil, Enhance Wound Healing Process in Patients With Diabetic Chronic Ulcers

ABSTRACT

The article describes the outcomes of a single-centre investigation on the use of OZOILE to improve the healing process in patients with chronic diabetic ulcers. This is a non-randomised interventional study which aims to assess the differences between two groups (total 200 patients) by evaluating healing time at 15, 30, 45, 60, 75 and 90 days. Pain assessment with VAS scale at 15, 30 and 45 days, biofilm test and tissue regeneration by histological evaluation were also taken into consideration. The outcomes show faster healing, reduced pain, control of local infection, aesthetically pleasing and qualitatively better healing. Our treatment strategy involves applying OZOILE detergent without rinsing, Ozoile spray oil and Ozoile cream followed by a non-adherent dressing (paraffin gauze). This integrated protocol shows a safe and effective treatment for diabetic chronic wound healing in a cost-effective manner. The group treated with the Rigenoma/Ozoile protocol demonstrated significantly superior outcomes compared to the control group, including accelerated healing, reduced pain levels, effective management of unpleasant odour, and high levels of compliance from both patients and surgeons. Overall, Ozoile markedly reduced healing time compared with standard care, with results robust across multiple analytical approaches.

Optimising healthcare workforce training and deployment: qualitative experiences from stakeholders in Tanzania

Por: Nyongole · O. V. · Sirili · N. · Mwakilasa · M. T. · Temba · P. · Mkoka · D. A. · Akoko · L. · August · F. · Kiwango · G. · Kaale · E. · Kamori · D. · Mbawala · H. · Sangeda · R. Z. · Mbugi · E. V. · Balandya · E. · Kamuhabwa · A. A. R. · Kakoko · D.
Objective

To explore the experiences of different stakeholders on the balance of package training and deployment of highly skilled Human Resources for Health for specialised services in Tanzania.

Design

An exploratory qualitative case study was used as part of a larger tracer study conducted by Muhimbili University of Health and Allied Sciences (MUHAS) for its postgraduate programmes being a requirement for quality assurance. Semi-structured interview guides were used for in-depth interviews (IDIs) and focus group discussions (FGDs). Qualitative content analysis was adopted to analyse the data.

Setting

The trace study was carried out in all seven geopolitical zones of the Tanzania mainland and Unguja in Zanzibar.

Participants

We conducted 14 FGDs and 301 IDIs. Participants included alumni, immediate supervisors at employment sites, MUHAS faculty, continuing students at MUHAS and management of professional councils in Tanzania.

Results

Key findings revealed variations in demands and recognition within the scheme of services, even after registration by professional councils. Five main themes emerged from the qualitative interviews: Package training to improve service provision, Unprofessional collegial relationships or issues related to professionalism within interdisciplinary teams, Silence of scheme services on super specialisation in the medical cadre, Silence of scheme services on specialisation in the nursing cadre, Integrated scheme of services for specialties in pharmacy.

Conclusion

The findings highlight the demand for specialised training, challenges with professionalism and inconsistencies in the recognition and remuneration of specialists across medical, nursing and pharmacy cadres within existing service schemes. There is a need for harmonisation between specialisation/super specialisation and the scheme of services. This harmonisation is crucial to ensure the provision of quality healthcare services. Furthermore, harmonisation requires multistakeholder engagement to realise universal health coverage strategies.

Implementation contexts and strategies for alternative peripherally inserted central catheter material and design selection: A qualitative exploration using CFIR/ERIC approach

Abstract

Aim

To explore the implementation contexts and strategies that influence the uptake and selection of alternative peripherally inserted central catheter (PICC) materials and design.

Design

Qualitative evaluation of end user perspectives within a randomized control trial of different PICC materials and design.

Methods

Semi-structured interviews with key stakeholders were undertaken via an adapted, rapid-analytic approach using the Consolidated Framework for Implementation Research. Outcomes were mapped against the Expert Recommendations for Implementing Change (ERIC) tool for strategies to guide innovation in PICC practice.

Results

Participants (n = 23) represented a combination of users and inserters/purchasers, from adult and paediatric settings. Dominant themes included intervention characteristics (intervention source), inner setting (structural characteristics) and individuals involved (self-efficacy). Strategies emerging to support a change from ERIC mapping (n = 16) included promotion of intervention adaptability, inclusion of staff and consumer perspectives and sufficient funding. Implementation contexts such as inner setting and individuals involved equally impacted PICC success and implementation effectiveness and enabled a greater understanding of barriers and facilitators to intervention implementation in this trial.

Conclusion

Trial evidence is important, but healthcare decision-making requires consideration of local contexts especially resourcing. Implementation contexts for Australian healthcare settings include a practical, strategic toolkit for the implementation of alternative PICC materials and designs.

Reporting Method

This study adhered to COREQ guidelines.

Patient or Public Contribution

No patient or public contribution.

Challenges of using and managing medication: a meta-ethnography of the experiences and perceptions of people with intellectual disability and people who support them

Por: Ghosh · I. · Adams · D. · Auguste · P. · Brown · A. · Chaplin · E. · Flynn · S. · Gauly · J. · Gill · P. · Langdon · P. E. · Mahon · D. · Martin · K. · Patterson · S. · Sutherland · D. · Tromans · S. J. · Chen · Y.-F. · Seers · K. · Supporting Medication use In people with a LEarning d
Objective

To explore the challenges experienced by people with intellectual disability, their carers and health and social care professionals when using and managing medication.

Design

A synthesis of qualitative research using meta-ethnography.

Data source

We searched seven databases: MEDLINE, Embase, CINAHL, Science, Social Science and Conference Proceedings Citation Indices (Web of Science), Cochrane Library, PsycINFO and Proquest Dissertations and Theses from inception to September 2022 (updated in July 2023).

Eligibility criteria for selecting studies

We included studies exploring the challenges and perceptions of people with intellectual disability, their carers and health and social care professionals regarding medication management and use.

Results

We reviewed 7593 abstracts and 475 full texts, resulting in 45 included papers. Four major themes were identified: (1) Medication-related issues, (2) navigating autonomy and relationships, (3) knowledge and training needs and (4) inequalities in the healthcare system. We formulated a conceptual framework centred around people with intellectual disability and described the interconnectedness between them, their carers and health and social care professionals in the process of managing and using medication. We identified challenges that could be associated with the person, the medication and/or the context, along with a lack of understanding of these challenges and a lack of capability or resources to tackle them. We developed an overarching concept of ‘collective collaboration’ as a potential solution to prevent or mitigate problems related to medication use in people with intellectual disability.

Conclusions

The effective management of medication for people with intellectual disability requires a collaborative and holistic approach. By fostering person-centred care and shared decision-making, providing educational and practical support, and nurturing strong relationships between all partners involved to form a collective collaboration surrounding people with intellectual disability, improved medication adherence and optimised therapeutic outcomes can be achieved.

PROSPERO registration number

CRD42022362903.

How to Interpret Quality of Life Assessment of Patients With Chronic Wounds Using the Wound‐QoL

ABSTRACT

The Wound-QoL assesses patients' health-related quality of life. Quick and valid interpretation of the results is crucial, but no thresholds have yet been established. Additionally, counting top box responses might be a quick approximation to the Wound-QoL score itself. The aim of this study was to develop Wound-QoL bands (i.e., thresholds) and to analyse top box responses. Patients from European countries completed the Wound-QoL and a global question. We grouped patients' Wound-QoL scores and mapped these on the global question score. Upon this, we developed sets of Wound-QoL bands and calculated the weighted kappa (κ) coefficient of agreement for each set. Moreover, we analysed the correlation of the sum of top box responses with patients' Wound-QoL. The 305 patients (mean age: 68.5 years; 52.8% male) had most frequently leg ulcers (49.2%). The final set of Wound-QoL bands with the highest κ coefficient (0.564 and 0.550) was 0–0.25, not at all/rarely impaired; > 0.25 to 1, a little; > 1 to 2, moderately; > 2 to 3, quite a lot; > 3 to 4, very much. Top box responses showed strong correlation with the Wound-QoL scores (0.961–0.961). We are confident that the Wound-QoL bands will facilitate interpretation of Wound-QoL data in routine care as well as in research.

European, multicentre, prospective observational phase IV clinical study to assess the impact of lebrikizumab on health-related well-being and control of skin manifestations in patients with moderate-to-severe atopic dermatitis (ADTrust): study protocol

Por: Augustin · M. · Bewley · A. · Brüggen · M.-C. · de Bruin-Weller · M. S. · Ezzedine · K. · Ferrucci · S. M. · Gkalpakiotis · S. · Herranz · P. · Johansson · E. K. · Kampe · T. · Lapeere · H. · Legat · F. J. · Rehbinder · E. M. · Szepietowski · J. C. · Torres · T. · Vestergaard · C.
Introduction

Atopic dermatitis (AD) is a chronic, relapsing, heterogeneous skin disease affecting 2%–7% of adults, with roughly 30% having moderate-to-severe disease. AD symptoms, like intense itching and skin pain, carry a substantial disease burden that negatively impacts patients’ quality of life (QoL) and psychosocial well-being. Lebrikizumab is a novel, high-affinity monoclonal antibody that selectively binds to and neutralises interleukin-13 with high potency. Three clinical trials with lebrikizumab (ADvocate 1 and 2; ADhere) demonstrated significant clinical benefit in patients with AD, while the 3-year long-term extension study of lebrikizumab (ADjoin) further demonstrated long-term efficacy and safety in patients with AD. The ADTrust study will evaluate patient well-being, their relationship with their skin, long-term effectiveness, and safety of lebrikizumab, treatment satisfaction, and long-term effect of lebrikizumab treatment on different aspects of patients’ lives, including itch, pain, sleep, fatigue, work impairment and overall QoL among adult patients with moderate-to-severe AD in a real-world setting.

Methods and analysis

This non-interventional, prospective, observational, real-world evidence study will involve approximately 150 sites across Europe and approximately 1200 adults with moderate-to-severe AD treated with lebrikizumab for 2 years. The primary endpoint is patient well-being assessed by the 5-item WHO Well-Being Index (WHO-5) questionnaire. Key secondary endpoints include clinical effectiveness (Eczema Area and Severity Index and Investigator’s Global Assessment Scale), disease symptomatology and control (Patient-Oriented Eczema Measure, 24-hour peak pruritus, skin pain, fatigue and sleep quality Numerical Rating Scale, and safety and tolerability. Other validated endpoints will evaluate physician-reported and patient-reported QoL and treatment satisfaction (Dermatology Life Quality Index, Treatment Satisfaction Questionnaire-9), patients’ work productivity and impairment (Work Productivity and Activity Impairment (WPAI)-AD) and disease control (AD Control Tool). Novel experimental endpoints will also be evaluated with the aim to assess patients’ relationship with their skin (SkinLove questionnaire), disease control (intensity and frequency of flares) and an Effectiveness Diary (a brief monthly survey on a voluntary basis with the aim to assess the long-term impact of lebrikizumab on three fundamental aspects of the patients’ life: the well-being (WHO-5), the itch intensity (24 hours peak pruritus) and the frequency and intensity of flares). Statistical analyses will be descriptive and explorative and based on observed cases. Missing data imputation may be used to handle missing data for primary endpoints and secondary effectiveness endpoints.

Ethics and dissemination

This study will be conducted according to the protocol, which has ethics committee approval (Hamburg Ethic Committee in Germany: 2024-101358-BO-ff), and all applicable laws and regulatory requirements for each participating country. The results will be disseminated through scientific publications and congress presentations.

Trial registration number

NCT06815380 (Pre-results).

Cutaneous non-volar melanoma dermoscopy and histopathology correlation: a systematic review protocol

Por: Bouceiro Mendes · R. · Henrique · M. · Augusto-Simoes · P. · Argenziano · G.
Introduction

Dermoscopy has a proved validity in the diagnosis of cutaneous melanoma, which is one of the most aggressive forms of skin cancer. Although some studies have demonstrated a relationship between specific dermoscopic and pathologic melanoma features, there is no solid evidence allowing reliable conclusions. This study will evaluate the evidence regarding this association.

Methods and analysis

Observational studies eligible for our systematic review will enrol adults with histological cutaneous non-volar melanoma diagnosis and with dermoscopy image analysis. We will search the following databases: PubMed, Embase, Web of Science, MEDLINE and Cochrane Library. We will not impose any language or date restrictions. Outcomes of interest include the association of at least one of the melanoma dermoscopy features (irregular pigmentation, blue-white veil, atypical network, multicomponent pattern, atypical dots and/or globules, regression, peripheral tan structureless area, negative network, shiny white structures, atypical vessels and streaks/pseudopods), with melanoma Breslow index or other histopathology characteristics (melanoma subtype, mitotic index and presence of ulceration). Two reviewers will independently screen and search results, extract data from eligible studies and assess risk of bias. The evidence derived by this study will elucidate the possible link between melanoma dermoscopy and histopathology. If we could predict melanoma thickness based on dermoscopy, we would be able to anticipate melanoma treatment with impact on survival.

Ethics and dissemination

Ethical approval is not required because this is a literature-based study. It will be published in scientific Pubmed indexed open access journals to ensure its accessibility.

PROSPERO registration number

CRD42024564919.

Randomised controlled trial comparing low doses of aspirin in the prevention of pre-eclampsia (ASAPP): a study protocol

Por: Khander · A. · Matthews · K. · Christos · P. · Thomas · C. · Alam · T. · Alcus · C. · Bush · L. · Edusei · E. · August · P. · Malha · L.
Introduction

Pre-eclampsia (PEC) is a morbid and potentially lethal complication of pregnancy and is more common in women with risk factors such as hypertension, diabetes, autoimmune disease, kidney disease or multifetal pregnancies. Low dose aspirin (ASA) is currently the only prophylactic therapy known to decrease PEC in this patient population. However, currently, there is no prospective literature comparing various low-dose ASA formulations in the risk reduction of PEC. In the USA, the currently available low-dose ASA is over-the-counter and found in 81 mg tablets. Therefore, when clinicians initiate low-dose ASA therapy, they may prescribe one or two tablets of 81 mg per day without comparative evidence to guide their decision. Our objective is to prospectively compare pregnant patients on 81 mg vs 162 mg of ASA and determine a possible dose response in the prevention of PEC.

Methods and analysis

We designed a pragmatic phase 3 prospective randomised open label blinded-end point clinical trial with parallel assignment between two groups of pregnant people at high risk for PEC, as defined by the US Preventive Services Task Force and American College of Obstetricians and Gynecologists (ACOG). The primary outcome is the incidence of preterm (

Ethics and dissemination

Our research protocol and safety monitoring protocol have been approved by the Weill Cornell Medicine institutional review board (IRB) and the Office of Human Research Protection. Evaluation for adverse events will be monitored throughout the study period. Adverse events will be assessed at each study visit.

Trial registration number

NCT04070573

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