Conectar
Cognitive impairment is associated with people with diabetes-related foot ulcers (DFU). However, it is unclear if cognitive impairment is associated with the ulcer itself or other co-existing diabetes-related complications such as peripheral neuropathy. We aimed to investigate cognition in people with diabetes-related peripheral neuropathy and compare those with DFUs to those without DFUs. In this age- and sex-matched, multicentre, case-control, observational study of 89 participants with Type 2 diabetes and peripheral neuropathy, we compared 49 participants with DFUs (cases) to 40 without DFUs (controls). Global cognition scores were assessed using the Montreal Cognitive Assessment tool. Participants with DFUs had similar characteristics to those without DFUs (all, p > 0.05), except for lower body mass index (p = 0.028). Participants with active DFUs had significantly lower global cognition scores compared to those without DFUs (median [IQR] 24.0 [21.0–25.0], 26.0 [24.0–28.0]; p < 0.001). After adjusting for other diabetes-related complications, lower global cognition was independently associated with a DFU, peripheral artery disease, lower physical activity and no family history of diabetes (all, p ≤ 0.019). People with DFUs had lower cognitive scores than those without DFUs, suggesting that the DFU itself is independently associated with cognitive impairment. Future studies should explore causal pathways and targeted management strategies.
Hospital falls and associated injuries are a global issue associated with harm and significant costs to individuals and society, especially for older adults. Hospital standards specify the minimum level of care required to optimise patient safety, quality and outcomes. Standards are often used during hospital accreditation. This investigation analysed the content and quality of hospital falls standards across the globe.
Hospital standards were located by searching online databases (PubMed, CINAHL, Google Scholar, MEDLINE), ChatGPT, the grey literature via internet search engines, and websites of accreditation agencies, government agencies, and other relevant organisations. We searched for standards from the 60 largest countries by population plus the 60 countries with the highest gross domestic product (n = 82 after accounting for duplicates). For inclusion, hospital standards had to mention ‘fall/s’. Data were analysed using a deductive framework synthesis and content analysis to identify emergent themes.
Forty-one standards used by at least 72 countries were identified from our search. Sixteen were excluded from detailed analysis because they did not mention falls and 3 could not be retrieved. A total of 22 standards were included in the final detailed analysis. Included standards showed wide variations in content and quality. Seven were assessed as high quality, 12 medium quality, and 3 were deemed to be of low quality. Some lacked details on hospital falls screening, assessment, prevention, and management. Consumer engagement in development, implementation, or evaluation was not mentioned in all standards. Procedures for falls data collection and reporting were seldom documented. Hospital standards infrequently referred readers to contemporary research or clinical practice guidelines.
There are variations in the quality and content of standards on hospital falls. International collaboration is recommended to increase the consistency and validity of hospital falls standards across nations, in order to optimise healthcare outcomes.
The findings of this global analysis of hospital falls standards have the potential to impact falls rates and fall-related injuries in hospital patients by providing data to inform the content, evidence base and use of hospital standards to optimise the safety and quality of care delivery. The findings inform the review, design and implementation of hospital accreditation procedures to improve patient outcomes, patient experiences, and service quality.
To assess anaesthesia capacity and practice in Sierra Leone by enumerating the anaesthesia workforce by volume, training level and distribution across urban and rural areas and facility ownership; estimating the prevalence of anaesthesia methods used for common surgical procedures by provider category; and evaluating hospital infrastructure and the availability of essential anaesthesia-related medications and equipment.
A nationwide, cross-sectional, facility-based study combining structured questionnaires administered through face-to-face interviews with facility leads and retrospective review of surgical and anaesthesia logbooks.
Public and private hospitals and clinics in Sierra Leone providing surgical care with general, regional or local anaesthesia within an operating theatre.
69 of 78 eligible surgical facilities nationwide were included. Facilities providing surgical services between September 2022 and August 2023 were eligible; facilities without registries or declining participation were excluded.
Across participating facilities, the anaesthesia workforce comprised 198 full-time positions, predominantly non-physician providers, with only 40.4% (80/198) trained to administer anaesthesia independently. Ketamine-based and spinal anaesthesia were most common, while general anaesthesia with a protected airway accounted for just 5.0% (415/8339) of procedures. Anaesthesia practices varied by provider training level. Essential infrastructure, equipment and medications fell below international minimum standards, with shortages most pronounced in rural facilities.
Severe shortages of certified anaesthesia providers, limited anaesthesia techniques and inadequate material resources remain major barriers to safe anaesthesia and surgical care in Sierra Leone. Targeted investments in workforce development, infrastructure and resource allocation—particularly in rural areas—are required to improve the safety, quality and equity of anaesthesia care nationwide.
by David A. Green, Jesse M. Maestas, Jessica N. Sanchez, Nathan C. Nieto, Andrew S. Bridges, David K. Garcelon
The San Clemente Island fox (Urocyon littoralis clementae) is classified as a focal species for conservation management by the US Navy. They are considered vulnerable to a variety of vector-borne diseases due to their relatively high population density and low genetic diversity. During the dry (July–November) and wet (December–February) seasons of 2017–2018 we live-trapped 95 foxes and collected ectoparasites to test for the presence of pathogens. We found a significant difference in ectoparasite abundance on foxes between seasons, but no differences associated with sex or age. We found that foxes carried two species of flea (Echidnophaga gallinacea and Orchopeas howardi) and two tick species (Ixodes pacificus and Ixodes jellisoni). No evidence of Borrelia burgdorferi, Anaplasma phagocytophilum, or Borrelia miyamotoi bacteria were found. This paper is the first account of ectoparasite species identification, quantification, and pathogen testing for the San Clemente Island fox subspecies.Suboptimal feeding practices in children under five remain a critical concern, particularly in low- and middle-income countries. Integrated Supplementary Feeding programmes (SFPs) combined with Social and Behaviour Change Communication (SBCC) interventions have shown potential, yet global evidence on their design and effectiveness remains scattered across diverse settings and varies widely in scope and quality. This review aims to map global evidence on integrated SFP and SBCC interventions for children aged 6–59 months, assessing their impact on anthropometric, biochemical, nutritional, health, developmental, functional, microbiological and infant and young child feeding (IYCF) outcomes, and to identify contextual factors, evidence gaps and successful strategies. The review will also aim to document cost effectiveness and economic outcomes of this integrated intervention.
The review will follow Joanna Briggs Institute (JBI) methodology, applying the Population–Concept–Context framework and the review title has been registered in Open Science Framework (OSF) (https://doi.org/10.17605/OSF.IO/ZJ5BG). Eligible studies published between 2000 and 2025 will include community-based interventions for children under five that combine SFP and SBCC. The review will focus on SFP interventions delivered through community-based or public health platforms, including but not limited to take home ration, hot cooked meal, micronutrient powders, coupled with SBCC modalities such as home visits, mobile health and mass media campaigns. Comprehensive searches will be conducted in MEDLINE (PubMed), Cochrane CENTRAL, Google Scholar and organisational websites. Two independent reviewers will screen, extract and appraise studies using Covidence and JBI tools. Data will be analysed using descriptive statistics to summarise study characteristics, intervention types and reported outcomes, helping understand patterns across time and settings. Qualitative findings will be synthesised through descriptive content analysis involving coding and theme development. Expected outcomes include a range of study designs from different settings across the globe, covering diverse delivery models of integrated SFP and SBCC with reported outcomes including dietary indicators, anthropometry, nutritional biomarkers, caregiver practices and cost-effectiveness.
This review is part of a larger cluster randomised controlled trial (NECCTAR) which has received ethical approval from the independent institutional ethics committee of all the participating institutes. The current review will involve only publicly available literature and does not have a separate institutional ethics committee approval. Findings will be disseminated through academic conferences and publications in peer-reviewed journals.
The review title has been registered in OSF (https://doi.org/10.17605/OSF.IO/ZJ5BG).
Case reports (CRs) are essential in physiotherapy, yet reporting remains heterogeneous and insufficiently standardised. The 2013 CAse REport (CARE) guideline improves transparency but lacks physiotherapy-specific detail. This study aimed to develop a consensus-driven extension of the CARE reporting guideline to support structured reporting of physiotherapy CRs, encompassing physiotherapy-specific assessments and interventions.
An e-Delphi consensus process study following the ACcurate COnsensus Reporting Document (ACCORD) guidelines.
Online.
Forty-four international experts in physiotherapy practice, research and education, along with six core committee members.
Experts objectively scored items for relevance (5-point Likert scale) and provided open-ended responses for each item of the drafts. Scores and responses were analysed to facilitate iterative refinement of the Physiotherapy CAse REport (PhyCARE) reporting guidelines. Consensus was predetermined at over 70% agreement.
Round 1 had the majority of items achieving ≥70% agreement, except two items that did not meet the threshold were revised and replaced with an alternative. Five new items addressing physiotherapy-specific reporting needs were added, and 10 items were relocated. In round 2, all 35 items across 13 domains achieved 84%–100% agreement. The nomenclature of one domain was revised to ‘Outcomes and Follow-up’. Following two e-Delphi rounds, consensus was achieved, and suggestions from online meeting, piloting led to item rephrasing, after which the PhyCARE guidelines were finalised.
The PhyCARE guidelines have the potential to provide a physiotherapy-specific extension of CARE to support structured, transparent and reproducible reporting of physiotherapy CRs.
To describe obstacles and ideas for improvement for the delivery of cardiopulmonary resuscitation and basic life support to wheelchair users.
A descriptive qualitative study underpinned by constructivism was conducted.
Semi structured interviews were completed with 26 participants from three cohorts: formal and informal carers, wheelchair users and healthcare professionals. Data were collected via online and in person interviews between February and June 2024. All participants were located in Australia, with the exception of one who was located in the United Kingdom. Data were analysed using thematic analysis.
Two major themes were identified: (1) obstacles to providing cardiopulmonary resuscitation and basic life support to a wheelchair user and (2) aspirations for improving cardiopulmonary resuscitation and basic life support for wheelchair users.
Participants shared ideas for how to improve emergency care for wheelchair users, highlighting a need for further research, testing and development of an education intervention.
Improving knowledge about providing emergency care to a wheelchair user could improve outcomes, save lives and reduce the life expectancy gap experienced by people with disability.
Approximately 2% of the global population use a wheelchair. Wheelchair use complicates the delivery of cardiopulmonary resuscitation and basic life support. There are currently no guidelines informing emergency care for wheelchair users available globally. Recognition of common symptoms of distress exhibited by wheelchair users, and options for the delivery of practical emergency care are required for wheelchair users.
The paper adheres to the EQUATOR reporting guidelines utilising the SRQR checklist.
Patients and the public were the driving force in recognising the gap in knowledge regarding the delivery of CPR to wheelchair users. Questions from patients and the public shaped the aims and methodological choices for this study.
To determine the prevalence of burnout and back pain in homecare workers in Switzerland and assess their associations with psychosocial work environment factors.
National multicentre cross-sectional study.
Using paper-pencil questionnaires, data were collected from January 2021 to September 2021 from employees of 88 homecare agencies across Switzerland. Respondents who identified themselves as administrators, apprentices, or trainees, who were in leadership positions, or who were not involved in the provision of care or housekeeping were excluded from this analysis. Burnout was assessed with the Copenhagen Burnout Inventory Scale (possible score range 0–100) and back pain with a single item from the Federal Statistical Office's Swiss Health Survey. Multilevel regression analyses were used to assess burnout and back pain's associations with psychosocial work environment factors.
We included 2514 homecare workers. More than two-thirds (68.6%) reported back pain in the past 4 weeks. The overall mean burnout score was 36.0 (SD 18.3). Poorer work-life balance, higher perceived workload and verbal aggression from clients were positively associated with both outcomes. Better leadership and social support from colleagues were negatively associated with burnout. Higher role conflict levels correlated with higher burnout levels.
Our findings indicate that the psychosocial work environment should be considered when designing interventions to reduce the prevalence of burnout and back pain among homecare workers.
The high reported burnout and back pain prevalences among homecare workers highlight an urgent need to design and implement psychosocial work environment-improving interventions. In addition to contributing to homecare employees' long-term attraction and retention, protecting and promoting their health and well-being will likely not only benefit them, but also contribute to patient safety, quality of care and homecare sustainability.
The study reports the prevalence of burnout and back pain among homecare workers and their associations with psychosocial work environment factors. The results indicate that six psychosocial work environment factors—work-life balance, perceived workload, leadership quality, levels of social support from colleagues, role conflict levels, and verbal aggression from clients—all correlate with burnout and/or back pain in homecare workers. For policy makers, researchers, healthcare managers, and homecare agencies, this study's findings will inform the development of interventions to enhance homecare work environments, leading to improvements both in workers' health and in the quality of their care.
We have adhered to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting checklist for cross-sectional studies.
Our stakeholder group included patient representatives, policy makers, researchers, clinicians and representatives of professional associations. Throughout the study, all provided support and input on topics including questionnaire development, result interpretation and the design of strategies to improve response rates.
The substantial case detection gap in the field of child tuberculosis (TB) disease is largely driven by inadequate diagnostic tools and approaches. Chest radiographs (CXRs) remain a key component in the evaluation of children and young adolescents (0–15 years) with presumptive TB, aiding clinicians in making the diagnosis and discriminating children with TB from those with other diseases. Widespread use and optimal interpretation of CXR is hampered by a lack of access to well-trained specialists to interpret images. Artificial intelligence CXR interpretation software, termed computer-aided detection (CAD), is now well developed for adults, yet few products have been evaluated in children. The CXR features of child TB are different from those of adults, and as a result, the performance of these CAD algorithms, largely developed for use in adults, will be suboptimal when used in children. Adapting, or fine-tuning adult CAD algorithms, using CXR images from children with presumptive TB, could allow optimisation of these products for use in children. We, therefore, set out to develop a large image and data repository collected from children evaluated for TB (called Catalysing Artificial Intelligence for Paediatric Tuberculosis Research, CAPTURE) with the purpose of evaluating current CAD products and then working with developers and other partners to optimise CAD algorithms for use in children.
We identified approximately 20 studies, from which potentially up to 11 000 CXRs could be used for the proposed project. CXRs and data were eligible for inclusion in the CAPTURE repository if collected from high-quality child TB diagnostic studies that enrolled children with presumptive TB and if CXRs were obtained as part of the baseline assessment. All lead investigators of these studies are members of the CAPTURE consortium. The images and metadata contributed are centrally collated and the key variable of TB case classification as confirmed, unconfirmed or unlikely TB, using an established consensus case definition, is available. All CXRs included in the CAPTURE repository have a consensus radiological interpretation allocated by a panel of independent expert child TB CXR readers who have classified them as ‘unreadable’, ‘normal’, ‘abnormal typical of TB’ or ‘abnormal not typical of TB’. To determine diagnostic performance of existing CAD products, we will evaluate these against a primary composite clinical reference standard (confirmed TB and unconfirmed TB vs unlikely TB), as well as other secondary microbiological and radiological reference standards. A subset of images will be subsequently allocated to a ‘training set’ and made available to developers, academic groups or other parties to either develop novel paediatric CAD products or fine-tune existing adult ones, which will then be re-evaluated by the CAPTURE team using an image subset (‘validation set’) that is independent of the training set.
The CAPTURE study has been approved by Stellenbosch University Health Research Ethics Committee (N22/09/113), with additional ethics approval or waivers by relevant local authorities obtained by consortium members contributing data if required. The final pooled, harmonised and cleaned dataset, as well as the deidentified, renamed CXR images, is stored on a secure cloud-based server. All analyses of existing CAD products, as well as the paediatric-optimised products, will be published in peer-reviewed publications and shared with other stakeholders like the WHO and donor and procurement organisations to guide policy updates and procurement pathways to ensure widespread uptake.
by Donato Koyalta, Zita Aleyo Nodjikouambaye, Jonathan Muwonga Tukisadila, Hachim Djamal Abdoulaye Bargo, Suitombaye Noubaramadji Yamti, Amine Akouya, Ralph-Sydney Mboumba Bouassa, Laurent Belec
BackgroundHigh-risk (HR) human papillomavirus (HPV) infection remains a great concern in sub-Saharan Africa in men who have sex with men (MSM). The prevalence of anal shedding of HPV and associated risk factors was estimated for the first time in a cross-sectional observational study covering MSM living in N’Djamena, the capital city of Chad.
MethodsMSM were recruited from the community in 21 sites in neighborhoods of 5 districts randomly selected in N’Djamena by respondent-driven sampling (RDS) method. Anal Collector V-Veil UP2™ device was used for anal canal self-sampling. Manual silica-extracted DNA was subjected for HPV detection and genotyping using BMRT Human Papillomavirus Genotyping Real Time PCR assay (Jiangsu Bioperfectus Technologies Co., Ltd., Taizhou, China). HIV serostatus was assessed using two rapid tests in series.
ResultsA total of 70 MSM (mean age: 29.9 years; range, 18–50) were included. The overall acceptability to practice veil-based anal self-sampling was 95.9%. The usability of the veil collector device was high (92.3%), with easy understandable instructions for use and correct placement in the anal canal. Satisfaction questionnaire reported high overall feeling, intimacy respect and lack of shame. The majority of MSM (44/70, 62.8%) showed anal shedding of HPV DNA, with HR-HPV frequently detected (38,70, 54.3%), including HPV-33 (30/70, 42.9%) HPV-68 (16/70, 22.9%), HPV-18 (4/70, 5.7%), HPV-35 (3/70, 4.3%), HPV-58 (2/70, 2.9%), and HPV-45 (1/70, 1.4%). The distribution of genotypes in HR-HPV DNA-positive MSM revealed that HPV-33 (30/70; 42.9%) was the predominant genotype, followed by the HPV-68 (16/70; 22.9%), HPV-18 (4/70; 5.7%), HPV-35 (3/70; 4.3%), HPV-58 (2/70; 2.9%), and HPV-45, HPV-51 and HPV-56 (each type, 1/70;1.4%).Among all HPV detected, only 42 HPV (36.8%) were covered by Gardasil-9® vaccine, including the HR-HPV-33, −18, −58 and −45, and the low risk-HPV-6 (5.7%) and HPV-11 (1.4%). The majority of detected HPV were non-covered by Gardasil-9® vaccine (63.1%). Overall HIV prevalence was 5.7%.
ConclusionsTaken together, these observations point the MSM population in N’Djamena as a very particular core group of HIV and HPV transmission. HIV prevalence was higher than that of general adult population, but limited to only one MSM of twenty. The RDS method of recruitment allowed to include MSM likely belonging to the same sexual network of HPV transmission leading to the selection of an atypical and specific profile of anal HPV distribution. The potential efficacy of HPV prophylactic vaccination in this population can be estimated at relatively weak.
by Mary O’Keeffe, Nathan Skidmore, Arianna Bagnis, Przemysław Bąbel, Elżbieta A. Bajcar, Alessandra De Palma, Andrea W.M. Evers, Eveliina Glogan, Julia W. Haas, Stefanie H. Meeuwis, Marek Oleszczyk, Antonio Portolés, Johan W.S. Vlaeyen, Katia Mattarozzi, on behalf of PANACEA Consortium
BackgroundPlacebo and nocebo effects significantly influence health outcomes, yet healthcare professionals receive limited training and guidance on their mechanisms and clinical application, creating a gap in education and practical understanding. Conducted within the European PANACEA Consortium, this study evaluated healthcare professionals’ knowledge, attitudes, and practices regarding placebo and nocebo effects, and assessed their needs in further education.
MethodsAn online cross-sectional survey among a European multi-country convenience sample of healthcare professionals collected data assessing participants’ knowledge, perceptions, and experiences regarding placebo and nocebo effects; their application and ethical considerations in clinical practice; and investigated educational needs and interest in further training. Quantitative data were analyzed using descriptive statistics, and thematic analysis was applied to the free-text responses.
ResultsAmongst 807 participants, 71.7% reported taking advantage of placebo effects in their practice, and over half of participants (55.8%) observing nocebo effects. Participants reported feeling somewhat confident (53.3%) in harnessing placebo effects with 47.5% feeling confident in preventing nocebo effects. The majority of respondents had not received formal training on placebo and nocebo effects, with most expressing an interest in further training in areas such as healthcare education, emphasizing communication skills to enhance placebo effects, and knowledge to recognize and reduce nocebo effects.
ConclusionsThere is a significant need for more comprehensive training on placebo and nocebo effects, particularly in early health professional education. These findings informed the development of educational resources and best practice recommendations developed as part of the outcomes from the PANACEA Consortium, improving the understanding and application of these effects among healthcare professionals across Europe.
by Fezile Wagner, Unathi Kolanisi, Ryan G. Wagner, Lerato P. Makuapane, Mxolisi Masango, Francesc Xavier Gómez-Olivé
The COVID-19 pandemic exacerbated hunger levels in South Africa, with an increase from 10% pre-pandemic to 23% during the pandemic. Pre-pandemic national and global research identified university students to be more vulnerable to hunger compared to the general population. This elevated risk is commonly associated with prevalent financial mismanagement in this group. However, research investigating the prevalence of hunger during the pandemic among this at-risk group is limited. This cross-sectional study aimed to assess the prevalence and determinants of hunger among students at a South African university during the COVID-19 lockdown, with particular focus on the effect of returning home. An online, self-administered survey produced a sample of 596 students. The Household Hunger Scale (HHS) was used to assess hunger. Most students (84%) who resided in on- or off-campus residences before the lockdown returned home during the lockdown. The weighted prevalence of hunger during lockdown was 16.4% (95%CI 13.6%, 19.6%). Bivariate analyses found living alone to be significantly associated with hunger, while multivariate analyses found that first-generation students (adjusted odds ratio (aOR) = 1.78; 95%CI: 1.04, 3.07, p = 0.015), financial aid recipients (aOR = 2.69; 95%CI: 1.47, 4.91, p = 0.001), and those experiencing financial stress/worry (aOR = 3.38; 95%CI: 1.85, 6.18, pAnalyse the concept of expertise among practicing clinical nurses in hospital settings.
The generational loss of expert clinical nurses was exacerbated globally by the novel coronavirus. This ongoing loss combined with the increased complexity of hospitalised patients has prompted an urgent need to understand expertise among clinical nurses who practice in hospital settings.
Walker and Avant's concept analysis method was used. PubMed, Medline, CINAHL and Access Medicine were searched (1982–2025) for research studies and literature reviews published in English that addressed clinical nursing expertise in hospitals.
Expertise is the knowledge and skills that are enculturated from immersion in a domain. Common attributes include obtaining salient information from different sources, interpreting patient situations rapidly and holistically, and performing actions that are individualised, immediate and appear instinctive. Common antecedents include deliberate accumulation of relevant experience and contextual connections within the hospital. Facilitating improved outcomes and facilitating improved outcomes are common consequences.
The attributes, antecedents and consequences of clinical nursing expertise are complementary and cross specialties. Experts' apparently instinctive actions are not intuitive but rather related to relevant past experiences, pattern recognition and skilled know-how. The requirements to develop expertise have evolved with the increased volume of available knowledge.
Expertise requires cultivating relevant experiences through active engagement with patients and creating contextual connections with others regarding hospital systems and processes. Experts should be formally included when developing processes and guidelines. Low-fidelity proxy measures like years of experience should be replaced with psychometrically validated instruments to measure expertise.
This concept analysis addresses the ambiguity of clinical nursing expertise by synthesising over 40 years of literature and provides insights for clinical nurses and researchers regarding the importance of context and the growing complexity of care delivery.
No patient or public involvement.
Metabolic dysfunction-associated steatotic liver disease (MASLD) and gestational diabetes mellitus (GDM) are prevalent metabolic disorders in pregnancy, posing significant risks to maternal and fetal health. This study evaluates the effectiveness of metformin, in combination with lifestyle modifications, compared with lifestyle modifications alone, in reducing the incidence of diabetes, pro-inflammatory liver markers, adverse maternal and neonatal outcomes and total gestational weight gain in pregnant women diagnosed with MASLD in the first trimester.
This parallel-arm, randomised controlled trial will recruit pregnant women (≤14 weeks of gestation) with confirmed MASLD from antenatal clinics of tertiary care public hospitals in Puducherry, India. Participants will be consecutively enrolled until a sample size of 296 is reached. Block randomisation will ensure balanced group allocation, with allocation concealment maintained using sequentially numbered opaque sealed envelopes. The intervention group will receive oral metformin (500 mg two times per day) alongside structured lifestyle modification counselling, while the control group will receive lifestyle modification counselling alone. Primary outcomes include GDM incidence, changes in pro-inflammatory markers, MASLD grading (assessed via liver function tests and ultrasound) and adverse maternal outcomes such as hypertensive disorders, polyhydramnios, genitourinary infections, caesarean delivery and postpartum haemorrhage. Neonatal outcomes assessed include macrosomia, stillbirth, intrauterine death, birth injury, shoulder dystocia, respiratory distress and neonatal hypoglycaemia. The secondary outcome is total gestational weight gain. Participants will be followed at 24–28 weeks, 34–36 weeks and post partum (within 6 weeks of delivery). Data collection will be conducted using a pretested structured questionnaire, with data entry and management performed using REDCap software. Statistical analysis will be conducted using STATA V.4, applying both intention-to-treat and per-protocol analyses. Effect sizes will be reported as proportions and relative risks with 95% CIs, ensuring robust statistical inference.
This study provides a rigorous framework to assess metformin’s role in managing MASLD and preventing GDM, thereby promoting favourable maternal and neonatal outcomes. Findings will contribute to improved clinical management, public health strategies and policy recommendations.
The study was approved by the JIPMER Institutional Ethics Committee (JIP/AEC/2023/01/011), and the findings will be disseminated through peer-reviewed journals and academic conferences.
CTRI/2023/12/060930.
Although multiple studies have offered self-collection for human papillomavirus (HPV)-based cervical screening in community settings, there are no randomised controlled trials (RCTs) that have compared implementation outcomes of programme approaches for self-collection. This trial will compare two such approaches in low-resource settings in the states of Tamil Nadu and Mizoram, India.
A cluster RCT will be conducted over a year, offering self-collection to 3000 women aged 30–49 from 28 clusters (average size 101) in selected districts. Clusters in tribal, rural and urban low-income settings will be randomised to two arms. The intervention arm, co-designed with multiple stakeholders, will involve campaigns to offer self-collection in the community. The comparison arm will be offered self-collection at the nearest health facilities.
HPV-based cervical screening will be performed at central laboratories using clinically validated screening assays that can identify the highest risk carcinogenic HPV types (Group 1a–c - HPV16/18/31/33/45/52/58, ±35). Ablative treatment will be based on positivity with this extended genotyping triage, while those with any of the lower carcinogenic HPV types (Group 1d - 39, 51, 56, 59, ±35, Groups 2a/b - 66, 68) will undergo further assessment with visual inspection with acetic acid. Outcomes will be evaluated quantitatively and qualitatively using RE-AIM and the Theoretical Framework of Acceptability.
The primary outcome will be percentage of women well-managed (screened and appropriately treated) in both arms, with secondary outcomes including proportion screened, proportion treated, acceptability (willingness to screen, rescreen, and/or recommend to others) to women, community and healthcare providers, adoption (by providers), implementation fidelity, costs, sustainability assessment and systematically identified implementation barriers and facilitators. The reach, effectiveness and acceptability of community-based self-collection and the use of extended genotyping for triage in resource-constrained, hard-to-reach populations will be assessed, with lessons that can inform future statewide and national programmes.
Ethics approval has been obtained from the Institutional Review Board (IRB) and Ethics Committee of the Christian Medical College Vellore, Tamil Nadu, India (IRB Min. No 14314; INTERVEN), the Alfred Hospital Ethics Committee (HREC Ref 80134, Local Reference: project 601/21), Melbourne, Australia, the IARC Ethics Committee (IEC 21-32), Lyon, France, the Salem Polyclinic Institutional Ethics Committee (SPCIEC/2022/June/01/02), Tamil Nadu, India and the Institutional Ethics Committee, Civil Hospital, Aizawl, Mizoram, India (No.B.12018/1/13-CHA(A)/IEC/115). The study is also approved by the State Scientific Advisory Committee, Directorate of Public Health and Preventive Medicine, Chennai, Tamil Nadu (R. No. 011575/HEB/A2/2023). The Alfred Hospital Approval, as an authorised Australian ethics committee for national mutual recognition, is recognised and registered with the University of Melbourne Human Research Ethics Committee (2024-25255-57650-1). Written informed consent will be obtained from participants. The results of the trial will be disseminated through a peer-reviewed medical journal, and also through workshops, reports and conferences.
The trial has been registered with the Clinical Trials Registry - India: CTRI/2022/04/042327.
Respiratory infections like influenza and SARS-CoV-2 pose significant global health risks due to their high transmissibility and severity. SARS-CoV-2 has caused over 7 million deaths worldwide, and the Lancet Commission estimates a >20% chance of a similar respiratory virus pandemic within a decade. Schools, often poorly ventilated, are high-risk settings for transmission. While COVID-19 school closures may have reduced transmission, they likely caused learning loss, mental health issues and increased burdens on parents and caregivers. Air purifiers with High Efficiency Particulate Air (HEPA) filters may offer a non-disruptive mitigation strategy, but the evidence to support their effectiveness in reducing viral transmission is weak. This protocol describes a cluster-randomised, parallel, two-arm, group sequential superiority trial with an interim analysis—to allow early stopping for efficacy or futility—to estimate the effect of portable air purifiers with HEPA filters in primary school classrooms on student absenteeism.
This group sequential trial will randomise schools (clusters) 1:1 to intervention or control arms in two stages: winter 2025/2026 (N=32 schools; ~736 students) and winter 2026/2027 (N=30 schools; ~690 students). The study setting is Norway. Eligible schools must have classrooms suitable for portable air purifiers, >10 students in grades 5–7 (typically aged 10–13 years) and principal consent. Intervention and control classrooms will each receive two portable air purifiers with HEPA filters operating at a performance equivalent to 3.0 and 0.3 air changes per hour, respectively, with control purifiers acting as shams. Outcomes will be measured during and at the end of a 12-week period. The primary outcome is student absenteeism, measured as full child days of absence aggregated at the class level. An interim analysis is planned at the end of the first stage, with error-spending O’Brien-Fleming stopping boundaries that are binding for efficacy and non-binding for futility. The primary estimand is the marginal incidence rate ratio of student absences, estimated using generalised estimating equations with a negative binomial model to account for overdispersion. Prespecified stopping boundaries will determine stopping, with efficacy boundaries being binding. Treatment effects will be estimated using cluster-bootstrapped CIs adjusted to provide strong control on overall type I and II error probabilities, and a bias correction will be applied if the trial is stopped early for efficacy. All analyses will follow the intention-to-treat principle. The primary question is whether installing and operating air purifiers with HEPA filters (intervention) reduces student absenteeism due to sickness (primary outcome) compared with sham air purifiers (control). Secondary questions examine whether the intervention reduces teacher absenteeism due to respiratory infections, rate and 12-week risk of self-reported respiratory infections among teachers, and teachers’ perceptions of air quality, compared with sham air purifiers. If the trial estimates a statistically significant effect for the primary outcome, a cost-consequence analysis will evaluate the direct and indirect costs associated with operating air purifiers against the potential benefits of reduced student and teacher absenteeism. A process evaluation will explore mechanisms of effect.
The trial has been approved by the Regional Committees for Medical and Health Research Ethics and the National Research Ethics Committee (ref. 737650). Absence data, routinely collected and fully anonymised at the class level, will serve as the primary outcome and does not require informed consent. Informed consent will be obtained from teachers participating in weekly surveys or interviews. Results will be disseminated to stakeholders, participants and the public through peer-reviewed journals, scientific meetings and social media.
To describe the organisation of nurse-led clinics and the factors facilitating or hindering their implementation based on experiences in five countries.
Descriptive multimethod study.
We analysed policy documents, nursing competency profiles and scientific literature and conducted 27 semi-structured interviews with stakeholders from the Netherlands, Ontario, Ireland, France and Finland between April and June 2023. We summarised relevant information on nurse-led clinic organisation in categories and mapped contextual factors following the Context and Implementation of Complex Interventions framework.
In the Netherlands, Ontario and France, nurse-led clinics are implemented in all care settings. In all regions, clinics are led by nurses with varied educational backgrounds, but master-trained advanced practice nurses have more autonomy than bachelor-trained nurses. In France and Ireland, expanded scope of nursing practice is expected to be formally documented in a practice agreement or protocol. In all regions, nurses can prescribe medication under specific conditions. Interviewees stressed the relevance of continuous education for nurses and clear role delineation to facilitate the implementation of nurse-led clinics and collaboration with physicians. Organisational readiness, practical support and research to demonstrate quality, safety and cost-effectiveness of nurses' expanded roles were drivers of successful nurse-led clinic integration.
Nurse-led clinics operate across various care settings and are staffed with nurses from diverse educational backgrounds, requiring adequate training and experience for autonomous practice. Successful implementation depends on clear role delineation, close collaboration with healthcare professionals, and supportive educational, legal and financial frameworks to ensure sustainable integration.
Our comprehensive description of the organisation of nurse-led clinics—including legal, financial, educational and practical aspects— along with our analysis of contextual factors supporting their implementation, provides guidance to policymakers and healthcare organisations considering the successful and sustainable adoption of this model of care within their healthcare system.
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