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Objetivo: identificar las necesidades humanas básicas de las embarazadas de alto riesgo hospitalizadas con base en la Teoría de Wanda Horta. Método: investigación asistencial realizada con dieciséis gestantes de alto riesgo hospitalizadas en una maternidad de referencia en Ceará entre septiembre y noviembre de 2019. Se recolectó información a través de diario de campo y ficha de caracterización de las gestantes y registros de necesidades humanas básicas. Los resultados se analizaron mediante estadística descriptiva simple y un enfoque integral a la luz del marco de Wanda Horta. Resultados: las gestantes presentaron necesidades psicobiológicas, psicosociales y psicoespirituales, siendo prevalentes: ausencia de actividades de ocio, inseguridad emocional, escaso conocimiento, sueño y descanso perjudicados, y actividades físicas restringidas por indicación de descanso. Consideraciones finales: se cree que el razonamiento crítico y el juicio clínico de los enfermeros se centraron en la individualidad de las gestantes, identificando necesidades en los tres niveles propuestos por la teoría, apuntando caminos para cualificar el cuidado de enfermería a las gestantes de alto riesgo.
Community health workers are essential to front-line health outreach throughout low-income and middle-income countries, including programming for early childhood immunisation. Understanding how community health workers are engaged for successful early childhood vaccination among countries who showed success in immunisation coverage would support evidence-based policy guidance across contexts.
We employed a multiple case study design using qualitative research methods.
We conducted research in Nepal, Senegal and Zambia.
We conducted 207 interviews and 71 focus group discussions with 678 participants at the national, regional, district, health facility and community levels of the health systems of Nepal, Senegal and Zambia, from October 2019 to April 2021. We used thematic analysis to investigate contributing factors of community health worker programming that supported early childhood immunisation within each country and across contexts.
Implementation of vaccination programming relied principally on the (1) organisation, (2) motivation and (3) trust of community health workers. Organisation was accomplished by expanding cadres of community health workers to carry out their roles and responsibilities related to vaccination. Motivation was supported by intrinsic and extrinsic incentives. Trust was expressed by communities due to community health worker respect and value placed on their work.
Improvements in immunisation coverage was facilitated by community health worker organisation, motivation and trust. With the continued projection of health worker shortages, especially in low-income countries, community health workers bridged the equity gap in access to vaccination services by enabling wider reach to underserved populations. Although improvements in vaccination programming were seen in all three countries—including government commitment to addressing human resource deficits, training and remuneration; workload, inconsistency in compensation, training duration and scope, and supervision remain major challenges to immunisation programming. Health decision-makers should consider organisation, motivation and trust of community health workers to improve the implementation of immunisation programming.
Effective communication can help optimise healthcare interactions and patient outcomes. However, few interventions have been tested clinically, subjected to cost-effectiveness analysis or are sufficiently brief and well-described for implementation in primary care. This paper presents the protocol for determining the effectiveness and cost-effectiveness of a rigorously developed brief eLearning tool, EMPathicO, among patients with and without musculoskeletal pain.
A cluster randomised controlled trial in general practitioner (GP) surgeries in England and Wales serving patients from diverse geographic, socioeconomic and ethnic backgrounds. GP surgeries are randomised (1:1) to receive EMPathicO e-learning immediately, or at trial end. Eligible practitioners (eg, GPs, physiotherapists and nurse practitioners) are involved in managing primary care patients with musculoskeletal pain. Patient recruitment is managed by practice staff and researchers. Target recruitment is 840 adults with and 840 without musculoskeletal pain consulting face-to-face, by telephone or video. Patients complete web-based questionnaires at preconsultation baseline, 1 week and 1, 3 and 6 months later. There are two patient-reported primary outcomes: pain intensity and patient enablement. Cost-effectiveness is considered from the National Health Service and societal perspectives. Secondary and process measures include practitioner patterns of use of EMPathicO, practitioner-reported self-efficacy and intentions, patient-reported symptom severity, quality of life, satisfaction, perceptions of practitioner empathy and optimism, treatment expectancies, anxiety, depression and continuity of care. Purposive subsamples of patients, practitioners and practice staff take part in up to two qualitative, semistructured interviews.
Approved by the South Central Hampshire B Research Ethics Committee on 1 July 2022 and the Health Research Authority and Health and Care Research Wales on 6 July 2022 (REC reference 22/SC/0145; IRAS project ID 312208). Results will be disseminated via peer-reviewed academic publications, conference presentations and patient and practitioner outlets. If successful, EMPathicO could quickly be made available at a low cost to primary care practices across the country.
Diffuse intrinsic pontine glioma (DIPG) and paediatric high-grade glioma (pHGG) are aggressive glial tumours, for which conventional treatment modalities fall short. Dendritic cell (DC)-based immunotherapy is being investigated as a promising and safe adjuvant therapy. The Wilms’ tumour protein (WT1) is a potent target for this type of antigen-specific immunotherapy and is overexpressed in DIPG and pHGG. Based on this, we designed a non-randomised phase I/II trial, assessing the feasibility and safety of WT1 mRNA-loaded DC (WT1/DC) immunotherapy in combination with conventional treatment in pHGG and DIPG.
10 paediatric patients with newly diagnosed or pretreated HGG or DIPG were treated according to the trial protocol. The trial protocol consists of leukapheresis of mononuclear cells, the manufacturing of autologous WT1/DC vaccines and the combination of WT1/DC-vaccine immunotherapy with conventional antiglioma treatment. In newly diagnosed patients, this comprises chemoradiation (oral temozolomide 90 mg/m2 daily+radiotherapy 54 Gy in 1.8 Gy fractions) followed by three induction WT1/DC vaccines (8–10x106 cells/vaccine) given on a weekly basis and a chemoimmunotherapy booster phase consisting of six 28-day cycles of oral temozolomide (150–200 mg/m2 on days 1–5) and a WT1/DC vaccine on day 21. In pretreated patients, the induction and booster phase are combined with best possible antiglioma treatment at hand. Primary objectives are to assess the feasibility of the production of mRNA-electroporated WT1/DC vaccines in this patient population and to assess the safety and feasibility of combining conventional antiglioma treatment with the proposed immunotherapy. Secondary objectives are to investigate in vivo immunogenicity of WT1/DC vaccination and to assess disease-specific and general quality of life.
The ethics committee of the Antwerp University Hospital and the University of Antwerp granted ethics approval. Results of the clinical trial will be shared through publication in a peer-reviewed journal and presentations at conferences.
The aim of this study was to assess the impact of high-quality evidence supporting surgical treatment of lumbar disc herniation (LDH) on healthcare practice in the Netherlands by examining changes in healthcare utilisation, including the timing of surgery, and the healthcare costs for patients with LDH.
A retrospective, cross-sectional study was performed using population-based, longitudinal data obtained from the Dutch Healthcare Authority (2007–2020) and NIVEL’s primary care (2012–2020) administrative databases.
The study was conducted within the healthcare system of the Netherlands.
We included adults (≥18 years) who visited a Dutch hospital or a general practitioner (GP) for lumbar degenerative disc disease. Patients with LDH were identified based on registered diagnosis code, type of surgery (discectomy) and age (
The primary outcome measure was the difference in the annual number of LDH procedures following the publication of evidence-based guidelines in 2009 (comparing the periods 2007–2009 to 2017–2019). Secondary outcome measures focused on the timing of surgery and associated healthcare costs. To validate the outcomes, secondary outcomes also include the number of discectomies and the number of procedures in the younger age group (discectomies, laminectomies, and fusion surgery).
The number of patients suffering from LDH increased from 55 581 to 68 997 (+24%) between 2007 and 2019. A decrease was observed in the annual number of LDH procedures (–18%), in the number of discectomies (–22%) and in the number of procedures for patients aged
Healthcare utilisation for LDH changed tremendously in the Netherlands between 2007 and 2020 and seemed to be associated with the publication and implementation of evidence-based guidelines. The observed decrease in the number of procedures has been accompanied by a corresponding reduction in healthcare costs. These findings underscore the importance of adhering to evidence-based guidelines to optimise the management of patients with LDH.
To determine the association between nurse and institutional characteristics and perceived professional nurse knowledge and self-efficacy of reporting child abuse and neglect.
A sample of N = 166 nurses were recruited to respond to the Reporting of Suspected Child Abuse and Neglect (RSCAN) survey.
A multiple linear regression examined whether nurse characteristics and institutional characteristics were associated with the two RSCAN survey domain scores.
Perceived knowledge of a workplace child abuse and neglect protocol was associated with the knowledge subscale. Education and child abuse and neglect expertise were significant predictors of the self-efficacy subscale. Nurses with a master's or higher degree and those who identified as being either forensic, paediatric or Emergency Department nurses, had less perceived institutional barriers to self-efficacy of reporting child abuse and neglect.
This study provides a preliminary insight into the institutional barriers and facilitators of nurses as child abuse and neglect mandated reporters.
To encourage innovative education and collaborations to support nurses as fully informed child abuse and neglect mandated reporters.
This research identifies the gaps and facilitators of nurses as child abuse and neglect mandated reporters to inform healthcare professionals and academic institutions on the importance of nurse education and experience in nurse knowledge and self-efficacy in reporting suspected child abuse and neglect.
The authors of this study have adhered to relevant EQUATOR guidelines: STROBE.
There is no patient or public contribution as the study only looked at nurses.
To assess visitors' perceptions of the benefits and challenges related to engaging in a remote visit intervention, which was designed to address the loneliness of people living with moderate to severe dementia in care homes.
A qualitative descriptive study.
Twenty-four people living with dementia in care homes in Canada and their family and friends (i.e., remote visitors) took part in facilitated remote visits in 2021. Each person living with dementia received scheduled visits for 30–60 min per week for 6 weeks. Participants chose to complete one longer visit, or multiple shorter visits, per week. Twenty remote visitors participated in semi-structured interviews after six weeks to discuss their perspectives on the effectiveness, benefits and challenges of the program in relation to addressing experiences of loneliness of the person living with dementia. Conventional content analysis was used to analyze the data.
We describe three themes and several sub-themes. Themes support the use of remote visits to enhance, rather than replace, in-person visits; the benefits of remote visits for the person living with dementia and their remote visitors; and the conditions that lead to a successful remote visit.
Remote visitors reported that facilitated visits had positive effects for both visitors and people living with dementia with respect to loneliness, communication, relationships, and social connection.
Clinicians can consider the factors that contributed to positive experiences of remote visits. The factors include individualized, facilitated visits that were flexible, and the use of reliable technology in a supportive, distraction-free environment.
Loneliness and social isolation are growing health concerns. When experienced by people living with dementia residing in long-term care homes, loneliness and social isolation can result in lower levels of quality of life and well-being, and higher levels of anxiety and responsive behaviours. Remote visitors perceived that facilitated remote visits have the potential to address loneliness and improve quality of life for people living with dementia and also offer social support to remote visitors. The findings can impact clinician practice by guiding the use of remote visits in care homes, and inform future intervention research to evaluate the effectiveness of remote visits for people living with dementia and their remote visitors.
This manuscript adheres to the relevant EQUATOR guidelines (the Consolidated criteria for reporting qualitative research or COREQ).
No patient or public contribution.
Workplace stress can negatively impact healthcare providers' professionalism and quality of care. One source of workplace stress is the experience of workplace mistreatment. Drawing on the Job Demands-Resources theory, this study aimed to (a) investigate the impact of mistreatment frequency experienced by healthcare workers from insider sources (i.e. co-workers, supervisors) and outsider sources (i.e. patients, visitors) on affective ill-being and (b) the potential moderating role of trait resilience and trait self-efficacy, as personal resources, in the mistreatment–ill-being relationship.
Lagged design.
We collected data from 153 Irish healthcare workers between January 2018 and June 2019 via three surveys, separated by 1-week intervals. Personal resources were measured at Time 1, frequency of mistreatment from the two sources was assessed at Time 2 and affective ill-being was assessed at Time 3. We used moderated regression analyses to evaluate the association of mistreatment frequency from the two sources and affective ill-being and the moderating effect of personal resources.
Only insider mistreatment frequency was positively related to affective ill-being. Furthermore, the positive impact of insider mistreatment on affective ill-being was moderated by self-efficacy (but not by trait resilience). In contrast to our expectations, the relationship was stronger at high levels compared to low levels of self-efficacy.
Mistreatment from co-workers and supervisors is linked to higher levels of affective ill-being. Additionally, healthcare workers with high self-efficacy were more vulnerable to the negative consequences of co-worker and supervisor mistreatment as it impacted their affective ill-being.
These findings extend the literature on workplace mistreatment by integrating insider and outsider perpetrators of mistreatment and examining their differential impact on the employees' affective ill-being. It also highlights mistreatment from organizational insiders as a significant factor in the relationship between mistreatment and affective ill-being.
No patient or public contribution.
The findings underscore the detrimental impact of workplace mistreatment on the well-being of healthcare professionals. The study findings of higher frequency of insider mistreatment being associated with increased affective ill-being call for action, with line managers and supervisors being critical to achieving respective changes in healthcare workers' environment. The findings have implications for policymakers interested in developing a framework to support healthcare professionals in addressing workplace mistreatment, enabling them to effectively fulfil their role as care providers.
Management controversy and clinical equipoise exist in treatments of long bone fractures and traumatic hip dislocation in paediatric patients due to the lack of high-quality clinical evidence. This protocol describes the effort of a large prospective global multicentre cohort study (registry) aiming at providing quality data to assist evidence-based treatment decision-making.
Eligible paediatric patients (N=750–1000) with open physes suffering from proximal humerus fractures, distal humerus fractures, proximal radius fractures, forearm shaft fractures, traumatic hip dislocations, femoral neck fractures or tibial shaft fractures will be recruited over a period of 24–36 months. Hospitalisation and treatment details (including materials and implants) will be captured in a cloud-based, searchable database. Outcome measures include radiographic assessments, clinical outcomes (such as range of motion, limb length discrepancies and implant removal), patient-reported outcomes (Patient Reported Outcomes Of Fracture, Patient-Reported Outcomes Measurement Information System (PROMIS) and EuroQol-5D (EQ-5D-Y)) and adverse events.
Aside from descriptive statistics on patient demographics, baseline characteristics, types of fractures and adverse event rates, research questions will be formulated based on data availability and quality. A statistical analysis plan will be prepared before the statistical analysis.
Ethics approval will be obtained before patients are enrolled at each participating site. Patient enrolment will follow an informed consent process approved by the responsible ethics committee. Peer-reviewed publication is planned to disseminate the study results.
Sickle cell disease (SCD) poses a significant global health burden, particularly affecting individuals in developing countries with constrained healthcare resources. While research on self-management in the context of SCD is emerging, it has predominantly focused on primary studies, and there is a notable dearth of evidence synthesis on SCD self-management in developing countries. This scoping review aims to identify and map self-management needs of individuals living with SCD, the strategies they employed to meet those needs, and the support systems available to them.
The review will be conducted following the Arksey and O’Malley’s (2005) 29 framework to comprehensively examine the landscape of SCD self-management research. Searches will be performed in PubMed, Scopus, Embase and Dimensions AI, with additional searches in other databases and grey literature. Indexed literature published in English from inception to January 2024 will be included. Reference list from included studies will also be searched manually. Two teams will be constituted to independently screen titles, abstracts and full text against the eligible criteria. Data will be extracted from included studies onto a customised data extraction form.
Ethical approval is not required for this review due to the fact that it synthesises information from available publications. The findings will be disseminated through publication in a peer-reviewed journal. Also, the findings will possibly be presented at relevant international and national conferences. This protocol has already been registered with the Open Science Framework. The study characteristics such as design and setting will be descriptively analysed and presented as graphs, tables and figures. Thematic analysis will also be conducted based on the study objectives and presented as a narrative summary.
Chronic autoimmune (type 1 diabetes and coeliac disease) and metabolic/cardiovascular (type 2 diabetes, dyslipidaemia, hypertension) diseases are highly prevalent across all age ranges representing a major public health burden. Universal screening for prediction/early identification of these conditions is a potential tool for reducing their impact on the general population. The aim of this study is to assess whether universal screening using capillary blood sampling is feasible at a population-based level.
This is a low-risk interventional, single-centre, pilot study for a population-based screening programme denominated UNISCREEN. Participants are volunteers aged 1–100 who reside in the town of Cantalupo (Milan, Italy) undergoing: (1) interview collecting demographics, anthropometrics and medical history; (2) capillary blood collection for measurement of type 1 diabetes and coeliac disease-specific autoantibodies and immediate measurement of glucose, glycated haemoglobin and lipid panel by point-of-care devices; (3) venous blood sampling to confirm autoantibody-positivity; (4) blood pressure measurement; (5) fulfilment of a feasibility and acceptability questionnaire. The outcomes are the assessment of feasibility and acceptability of capillary blood screening, the prevalence of presymptomatic type 1 diabetes and undiagnosed coeliac disease, distribution of glucose categories, lipid panel and estimate of cardiovascular risk in the study population. With approximately 3000 inhabitants, the screened population is expected to encompass at least half of its size, approaching nearly 1500 individuals.
This protocol and the informed consent forms have been reviewed and approved by the San Raffaele Hospital Ethics Committee (approval number: 131/INT/2022). Written informed consent is obtained from all study participants or their parents if aged
If proven feasible and acceptable, this universal screening model would pave the way for larger-scale programmes, providing an opportunity for the implementation of innovative public health programmes in the general population.
by Lukáš Vejřík, Ivana Vejříková, Zuzana Sajdlová, Luboš Kočvara, Tomáš Kolařík, Daniel Bartoň, Tomáš Jůza, Petr Blabolil, Jiří Peterka, Martin Čech, Mojmír Vašek
Stable isotope analysis (SIA) is widely used to study trophic ecology and food webs in aquatic ecosystems. In the case of fish, muscle tissue is generally preferred for SIA, and the method is lethal in most cases. We tested whether blood and fin clips can be used as non-lethal alternatives to muscle tissue for examining the isotopic composition of two freshwater predatory fish, European catfish (Silurus glanis) and Northern pike (Esox lucius), species of high value for many freshwater systems as well as invasive species in many others. Blood samples from the caudal vein, anal fin clips, and dorsal muscle obtained by biopsy punch were collected from four catfish and pike populations (14–18 individuals per population). Subsequently, these samples were analyzed for δ13C and δ15N. The effects of alternative tissues, study site, and fish body mass on the isotopic offset were investigated. Both species showed a correlation between the isotopic offset and the tissue type, as well as the study site, but no significant relationship with the body mass. The isotopic offsets between tissues were used to calculate the conversion equations. The results demonstrated that both blood and fin clips are suitable and less invasive alternative to muscle in SIA studies focused on European catfish and Northern pike. Blood provided better correspondence to muscle isotope values. However, our results clearly demonstrated that isotopic offsets between tissues vary significantly among populations of the same species. Therefore, obtaining a muscle biopsy from several individuals in any population is advisable to gain initial insights and establish a possible population-specific inter-tissue conversion.
To estimate the cost-effectiveness of using a removable boot versus a cast following ankle fracture from the National Health Service and Personal Social Services (NHS+PSS) payer and societal perspectives and explore the impact of both treatments on participants’ activities of daily living.
Cost-effectiveness analyses and qualitative interviews performed alongside a pragmatic multicentre randomised controlled trial.
Eight UK NHS secondary care trusts.
243 participants (60.5% female, on average 48.2 years of age (SD 16.4)) with ankle fracture. Qualitative interviews with 16 participants. Interventions removable air boot versus plaster cast 2 weeks after surgery weight bearing as able with group-specific exercises.
Quality-adjusted life years (QALYs) estimated from the EQ-5D-5L questionnaire, costs and incremental net monetary benefit statistics measured 12 weeks after surgery, for a society willing-to-pay £20 000 per QALY.
Care in the boot group cost, on average, £88 (95% CI £22 to £155) per patient more than in the plaster group from the NHS+PSS perspective. When including all societal costs, the boot saved, on average, £676 per patient (95% CI –£337 to £1689). Although there was no evidence of a QALY difference between the groups (–0.0020 (95% CI –0.0067 to 0.0026)), the qualitative findings suggest participants felt the boot enhanced their quality of life. Patients in the boot felt more independent and empowered to take on family responsibilities and social activities.
While the removable boot is slightly more expensive than plaster cast for the NHS+PSS payer at 12 weeks after surgery, it reduces productivity losses and the need for informal care while empowering patients. Given that differences in QALYs and costs to the NHS are small, the decision to use a boot or plaster following ankle surgery could be left to patients’ and clinicians’ preferences.
ISRCTN15497399, South Central—Hampshire A Research Ethics Committee (reference 14/SC/1409).
This study aimed to evaluate the prospective cost-effectiveness of the Identification and Referral to Improve Safety plus (IRIS+) intervention compared with usual care using feasibility data derived from seven UK general practice sites.
A cost–utility analysis was conducted to assess the potential cost-effectiveness of IRIS+, an enhanced model of the UK’s usual care. IRIS+ assisted primary care staff in identifying, documenting and referring not only women, but also men and children who may have experienced domestic violence/abuse as victims, perpetrators or both. A perpetrator group programme was not part of the intervention per se but was linked to the IRIS+ intervention via a referral pathway and signposting. A Markov model was constructed from a societal perspective to estimate mean incremental costs and quality-adjusted life years (QALYs) of IRIS+ compared with to usual care over a 10-year time horizon.
The IRIS+ intervention saved £92 per patient and produced QALY gains of 0.003. The incremental net monetary benefit was positive (£145) and the IRIS+ intervention was cost-effective in 55% of simulations at a cost-effectiveness threshold of £20 000 per QALY.
The IRIS+ intervention could be cost-effective or even cost saving from a societal perspective in the UK, though there are large uncertainties, reflected in the confidence intervals and simulation results.
Rotator cuff calcific tendinopathy (RCCT) involves calcific deposits in the rotator cuff. Non-surgical interventions such as extracorporeal shockwave therapy (ESWT) and ultrasound-guided percutaneous irrigation of calcific tendinopathy (US-PICT) are recommended for its early management. Exercise therapy (ET) has shown to be an effective intervention for people with rotator cuff tendinopathy, but it has not been formally tested in RCCT. The main objective of this study is to compare the effectiveness of an ET programme with ESWT and US-PICT in people with RCCT. As a secondary aim, this study aims to describe the natural history of RCCT.
A randomised, single-blinded four-group clinical trial will be conducted. Adults from 30 to 75 years diagnosed with RCCT who accomplish eligibility criteria will be recruited. Participants (n=116) will be randomised into four groups: ET group will receive a 12-week rehabilitation programme; ESWT group will receive four sessions with 1 week rest between sessions during 1 month; US-PICT group will receive two sessions with 3 months of rest between sessions; and (actual) wait-and-see group will not receive any intervention during the 12-month follow-up. The primary outcome will be shoulder pain assessed with the Shoulder Pain and Disability Index at baseline, 2 weeks, 4 months, 6 months and 12 months from baseline. The primary analysis will be performed at 12 months from baseline. Secondary outcomes will include pain, range of motion, patient satisfaction and imaging-related variables. Moreover, the following psychosocial questionnaires with their corresponding outcome measure will be assessed: Central Sensitization Inventory (symptoms related to central sensitization); Pain Catastrophizing Scale (pain catastrophizing); Tampa Scale for Kinesiophobia 11 items (fear of movement); Fear Avoidance Belief Questionnaire (fear avoidance behaviour); Hospital Anxiety and Depression Scale (anxiety and depression); Pittsburgh Sleep Quality Index (sleep quality); and the EuroQol-5D (quality of life). An intention-to-treat analysis will be performed to reduce the risk of bias using a worst-case and best-case scenario analysis.
Ethics committee approval for this study has been obtained (reference number: 1718862). The results of the main trial will be submitted for publication in a peer-reviewed journal.
Preterm birth is a leading cause of perinatal morbidity and mortality. During the COVID-19 pandemic, reduction in rates of preterm birth in women exposed to viral mitigation measures was reported by multiple studies. In addition, others and we observed a more pronounced reduction of preterm birth in women who had previously experienced a preterm birth. The aim of this pilot study is to establish the feasibility of a lifestyle intervention based on viral mitigation measures in high-risk pregnancies, with the ultimate aim to reduce the incidence of preterm birth.
One hundred pregnant women, enrolled in antenatal clinics at two tertiary maternity centres in Melbourne, Australia, who have had a previous preterm birth between 22 and 34 weeks gestation will be recruited. This is a two-arm, parallel group, open-label randomised controlled feasibility trial: 50 women will be randomised to the intervention group, where they will be requested to comply with a set of lifestyle changes (similar to the viral mitigation measures observed during the pandemic). Another 50 women will be randomised to the control group, where they will undergo standard pregnancy care. The primary outcome of this trial is feasibility, which will be assessed by measuring patient eligibility rate, recruitment rate, compliance rate and data completion rate. Secondary outcomes include incidence of preterm birth, maternal satisfaction, maternal quality of life and other pregnancy outcomes. Standard methods in statistical analysis for randomised controlled trials on an intention to treat basis will be followed.
This trial has been approved by the Monash Human Research Ethics Committee; approval reference number RES-22-0000-122A. Study findings will be reported and submitted to peer-reviewed journals for publication, and presentation at conferences.
ACTRN12622000753752; Pre-results.
A limited understanding of the pathology underlying chronic wounds has hindered the development of effective diagnostic markers and pharmaceutical interventions. This study aimed to elucidate the molecular composition of various common chronic ulcer types to facilitate drug discovery strategies. We conducted a comprehensive analysis of leg ulcers (LUs), encompassing venous and arterial ulcers, foot ulcers (FUs), pressure ulcers (PUs), and compared them with surgical wound healing complications (WHCs). To explore the pathophysiological mechanisms and identify similarities or differences within wounds, we dissected wounds into distinct subregions, including the wound bed, border, and peri-wound areas, and compared them against intact skin. By correlating histopathology, RNA sequencing (RNA-Seq), and immunohistochemistry (IHC), we identified unique genes, pathways, and cell type abundance patterns in each wound type and subregion. These correlations aim to aid clinicians in selecting targeted treatment options and informing the design of future preclinical and clinical studies in wound healing. Notably, specific genes, such as PITX1 and UPP1, exhibited exclusive upregulation in LUs and FUs, potentially offering significant benefits to specialists in limb preservation and clinical treatment decisions. In contrast, comparisons between different wound subregions, regardless of wound type, revealed distinct expression profiles. The pleiotropic chemokine-like ligand GPR15L (C10orf99) and transmembrane serine proteases TMPRSS11A/D were significantly upregulated in wound border subregions. Interestingly, WHCs exhibited a nearly identical transcriptome to PUs, indicating clinical relevance. Histological examination revealed blood vessel occlusions with impaired angiogenesis in chronic wounds, alongside elevated expression of genes and immunoreactive markers related to blood vessel and lymphatic epithelial cells in wound bed subregions. Additionally, inflammatory and epithelial markers indicated heightened inflammatory responses in wound bed and border subregions and reduced wound bed epithelialization. In summary, chronic wounds from diverse anatomical sites share common aspects of wound pathophysiology but also exhibit distinct molecular differences. These unique molecular characteristics present promising opportunities for drug discovery and treatment, particularly for patients suffering from chronic wounds. The identified diagnostic markers hold the potential to enhance preclinical and clinical trials in the field of wound healing.
by Tinne Gils, Mashaete Kamele, Thandanani Madonsela, Shannon Bosman, Thulani Ngubane, Philip Joseph, Klaus Reither, Moniek Bresser, Erika Vlieghe, Tom Decroo, Irene Ayakaka, Lutgarde Lynen, Alastair Van Heerden
During TB-case finding, we assessed the feasibility of implementing the advanced HIV disease (AHD) care package, including VISITECT CD4 Advanced Disease (VISITECT), a semiquantitative test to identify a CD4≤200cells/μl. Adult participants with tuberculosis symptoms, recruited near-facility in Lesotho and South-Africa between 2021–2022, were offered HIV testing (capillary blood), Xpert MTB/RIF and Ultra, and MGIT culture (sputum). People living with HIV (PLHIV) were offered VISITECT (venous blood) and Alere tuberculosis-lipoarabinomannan (AlereLAM, urine) testing. AHD was defined as a CD4≤200cells/μl on VISITECT or a positive tuberculosis test. A CD4≤200cells/μl on VISITECT triggered Immy cryptococcal antigen (Immy CrAg, plasma) testing. Participants were referred with test results. To evaluate feasibility, we assessed i) acceptability and ii) intervention delivery of point-of-care diagnostics among study staff using questionnaires and group discussions, iii) process compliance, and iv) early effectiveness (12-week survival and treatment status) in PLHIV. Predictors for 12-week survival were assessed with logistic regression. Thematic content analysis and triangulation were performed. Among PLHIV (N = 676, 48.6% of 1392 participants), 7.8% were newly diagnosed, 81.8% on ART, and 10.4% knew their HIV status but were not on ART. Among 676 PLHIV, 41.7% had AHD, 29.9% a CD4≤200cells/μl and 20.6% a tuberculosis diagnosis. Among 200 PLHIV tested with Immy CrAg, 4.0% were positive. The procedures were acceptable for study staff, despite intervention delivery challenges related to supply and the long procedural duration (median: 73 minutes). At 12 weeks, among 276 PLHIV with AHD and 328 without, 3.3% and 0.9% had died, 84.8% and 92.1% were alive and 12.0% and 7.0% had an unknown status, respectively. Neither AHD nor tuberculosis status were associated with survival. Implementing AHD care package diagnostics was feasible during tuberculosis-case finding. AHD was prevalent, and not associated with survival, which is likely explained by the low specificity of VISITECT. Challenges with CD4 testing and preventive treatment uptake require addressing.
Pulmonary tuberculosis (TB) is an infectious disease with high incidence in low-income countries (LICs); it remains one of the infectious diseases with the highest mortality in the world, especially in LICs. It is crucial to recognise and diagnose TB as soon as possible, but microbiological tests on sputum are not always sensitive enough. New methods for an early diagnosis of TB are needed. In this study, we will investigate the role of two different tests to detect TB in Ethiopia (where the prevalence of TB is high): molecular search for TB in stool samples with Xpert assay and detection of pulmonary TB signs on chest X-rays with CAD4TB technology.
A prospective diagnostic test accuracy study during TB active contact investigation will be conducted. In the referral hospital in Southwest Shoa Zone, Oromia Region, Ethiopia, patients with pulmonary TB and a sputum sample positive for Mycobacterium tuberculosis and household contacts of at least 4 years of age will be enrolled, with a target sample size of 231 patients. Trained staff will label household contacts as ‘possible TB’ cases or not according to their symptoms; when TB is possible, a stool Xpert and computer-aided detection on chest X-ray will be performed, alongside standard diagnostic methods, assessing the diagnostic accuracy of CAD4TB compared with Xpert MTB/RIF during TB contact investigation and the accuracy of stool Xpert compared with sputum Xpert.
This study has been approved by the Oromia Health Bureau Research Ethics Committee (ref no BFO/MBTFH/1-16/100023). All information obtained will be kept confidential. Selected investigators will have access to data, while international partners will sign a dedicated data protection agreement. Eligible participants will receive brief information about the study before being asked to participate and they will provide written informed consent. Results will be disseminated through peer-reviewed journals.
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