by Andrea C. Aplasca, Peter B. Johantgen, Christopher Madden, Kilmer Soares, Randall E. Junge, Vanessa L. Hale, Mark Flint
Amphibian skin is integral to promoting normal physiological processes in the body and promotes both innate and adaptive immunity against pathogens. The amphibian skin microbiota is comprised of a complex assemblage of microbes and is shaped by internal host characteristics and external influences. Skin disease is a significant source of morbidity and mortality in amphibians, and increasing research has shown that the amphibian skin microbiota is an important component in host health. The Eastern hellbender (Cryptobranchus alleganiensis alleganiensis) is a giant salamander declining in many parts of its range, and captive-rearing programs are important to hellbender recovery efforts. Survival rates of juvenile hellbenders in captive-rearing programs are highly variable, and mortality rates are overall poorly understood. Deceased juvenile hellbenders often present with low body condition and skin abnormalities. To investigate potential links between the skin microbiota and body condition, we collected skin swab samples from 116 juvenile hellbenders and water samples from two holding tanks in a captive-rearing program. We used 16s rRNA gene sequencing to characterize the skin and water microbiota and observed significant differences in the skin microbiota by weight class and tank. The skin microbiota of hellbenders that were housed in tanks in close proximity were generally more similar than those housed physically distant. A single taxa, Parcubacteria, was differentially abundant by weight class only and observed in higher abundance in low weight hellbenders. These results suggest a specific association between this taxa and Low weight hellbenders. Additional research is needed to investigate how husbandry factors and potential pathogenic organisms, such as Parcubacteria, impact the skin microbiota of hellbenders and ultimately morbidity and mortality in the species.Non-specific chronic low back pain is a leading cause of disability-adjusted life-years (DALYs) with a lifetime prevalence of 80%–85%. Although many modalities of treating chronic low back pain are available, pharmacotherapy remains a very important treatment modality, according to many recognised guidelines. Each of these pharmacological agents has evidence supporting its efficacy in treating chronic low back pain, and each of them is associated with side effects. At present, no study has unified these two outcomes or ranked them from the most effective to the least effective. Thus, this study aims to identify pharmacological agents that rank best by conducting multivariate bivariate network meta-analysis.
Four databases (Medline/Pubmed, Cochrane Central Register for Controlled Trials, Cochrane Database for Systematic Reviews and CINAHL) will be systematically searched from their inception to 31 July 2024 for randomised control trials that meet the inclusion criteria. Appropriate data will be extracted from the relevant studies, including the two outcomes of interest: the pain intensity score and the proportion of patients who withdrew from the study because of adverse events. A bivariate Bayesian network meta-analysis will be used to combine the two outcomes of interest to form a single probability that will rank the pharmacotherapy agents from the most effective and safe to the least. The studies will be assessed for risk of bias, and their evidence will be graded using the Grading of Recommendations Assessment, Development, and Evaluation assessment tool. Inconsistency, which is a key assumption of network meta-analysis, will be assessed using both local and global methods.
This systematic review is based on already published data, so it does not require ethical approval. The findings from the review, after completion, will be disseminated via peer-reviewed publications.
CRD42024569192.
The TRAjectory of knee heaLth in runners (TRAIL) study is a prospective cohort study investigating the long-term knee health trajectories of runners with and without a heightened osteoarthritis risk. This study aims to describe the recruitment results and baseline characteristics of the TRAIL cohort.
Runners aged 18–50 years and running ≥3 times and ≥10 km per week on average in the past 6 months were eligible. Participants were recruited via running podcasts, running clubs and social media between July 2020 and August 2023. Data were collected at study enrolment and at a face-to-face baseline testing session, which occurred a median of 33 weeks (IQR 18 to 86 weeks) after enrolment. Follow-up data collection is ongoing.
Out of 462 runners who completed an online registration form, 268 runners enrolled, of which 135 had a history of knee surgery (46% females) and 133 were non-surgical controls (50% females). 60% of the surgery group had undergone anterior cruciate ligament reconstruction, 33% meniscus and/or cartilage surgery, and 7% other knee surgery. 54 participants previously enrolled were unable to continue in the study before attending baseline data collection. Of the 214 runners who remained in the study and attended baseline data collection, 108 had a history of knee surgery (49% females) and 106 did not have a history of knee surgery (51% females).
Participants will be followed for 10 years through ongoing patient-reported outcomes and continuous monitoring of training loads using wearable devices. At baseline, 4- and 10-year follow-up, knee MRI and knee-health patient-reported outcomes will be collected to evaluate structural and symptomatic knee osteoarthritis progression. Data will inform guidelines for safe running practices and rehabilitation post-knee surgery.
Limited evidence exists regarding the effectiveness of learning approaches in supporting interprofessional wound care education transnationally. The aim of this pilot study was to explore the feasibility and preliminary impact of an international, online interprofessional masterclass in supporting baccalaureate health students' learning about wound care. Data were collected using multiple methods including quantitative survey, qualitative focus groups, and interviews with baccalaureate nursing, pharmacy, dietetics, podiatry and paramedicine students from two universities based in Australia and Northern Ireland. A retrospective pre-test design was used. A survey retrospectively assessed students' self-reported confidence and understanding before and after the masterclass, while qualitative methods explored students' experiences of interprofessional learning and wound care. Self-reported improvements in students' understanding of wound assessment and management, as well as heightened awareness of interprofessional contributions to patient care indicated the potential value of this interprofessional and international collaboration in supporting wound care education. Qualitative analysis identified four themes: recognising a wound is a person's wound; comparing international healthcare practices; fostering learner engagement; interprofessional recognition, acknowledgment, and understanding of each profession's roles, contributions and expertise. This pilot study has highlighted key issues to be addressed in future research examining the impact of a collaborative online international initiative on baccalaureate students' interprofessional learning about wound care.
by Sishir Poudel, Laxman Wagle, Tara Prasad Aryal, Binay Adhikari, Sushan Pokharel, Dipendra Adhikari, Kshitiz Bhandari, Kshitiz Rijal, Jyoti Bastola Paudel
BackgroundMultidrug-resistant tuberculosis (MDR-TB) continues to be a major public health concern, especially in high-burden countries like Nepal. While individual risk factors are known, the cumulative impact of cardiometabolic factors on MDR-TB is not well understood.
MethodsA health-facility-based, age- and sex-matched 1:2 case-control study was conducted at MDR-TB treatment centers in Gandaki Province, Nepal. MDR-TB patients (cases) and drug-sensitive tuberculosis (DS-TB) patients (controls) were enrolled. Cases were defined as adults (≥18 years) with confirmed MDR-TB; controls were adults with sputum-positive DS-TB. Data on sociodemographics, cardiometabolic risk factors (alcohol, tobacco, abnormal body mass index, hypertension, diabetes), TB literacy, and treatment history were collected using a structured, pretested questionnaire by trained medical officers. Data were analyzed using Stata v13.0. Binary logistic regression was used to assess associations between risk factors and MDR-TB. Ethical approval was obtained from the Nepal Health Research Council and written informed consent was obtained from all participants.
ResultsA total of 183 participants (61 cases, 122 controls) were included. Mean age of participants was 42.5 years (SD = 18.5); 73.8% were male. Most participants were from urban areas (74.9%), and 66.7% were unemployed. Cardiometabolic risk factors were present in 79.2% of participants. Alcohol and tobacco use were reported by 59.6% and 45.9%, respectively; 9.8% had diabetes and 7.1% had hypertension. Known TB contact and prior TB history were reported by 26.8% and 31.1% respectively. In multivariate analysis, unemployment (AOR: 5.24, 95% CI: 1.33–20.64), and known TB contact (AOR: 8.89, 95% CI: 2.46–32.15) were significantly associated with MDR-TB. Cardiometabolic risk factors were not significantly associated.
ConclusionKnown TB contact and unemployment were significantly associated with MDR-TB, while the cumulative effect of cardiometabolic risk factors showed no significant impact, indicating that interventions should prioritize established TB-related risk factors.
by Muluken Chanie Agimas, Mekuriaw Nibret Aweke, Berhanu Mengistu, Lemlem Daniel Baffa, Elsa Awoke Fentie, Ever Siyoum Shewarega, Aysheshim Kassahun Belew, Esmael Ali Muhammad
IntroductionMalaria is a global public health problem, particularly in sub-Saharan African countries. It is responsible for 90% of all deaths worldwide. To reduce the impact and complications associated with delayed treatment of malaria among children under five, comprehensive evidence about the magnitude and determinants of delayed treatment for malaria could be the solution. But there are no national-level studies in the Horn of Africa for decision-makers.
ObjectiveTo assess the prevalence and associated factors of delay in seeking malaria treatment among under-five children in the Horn of Africa.
MethodPublished and unpublished papers were searched on Google, Google Scholar, PubMed/Medline, EMBASE, SCOPUS, and the published articles’ reference list. The search mechanism was established using Medical Subject Heading (MeSH) terms by combining the key terms of the title. Joana Brigg’s Institute critical appraisal checklist was used to assess the quality of articles. A sensitivity test was conducted to evaluate the heterogeneity of the studies. The visual funnel plot test and Egger’s and Begg’s statistics in the random effect model were done to evaluate the publication bias and small study effect. The I2 statistics were also used to quantify the amount of heterogeneity between the included studies.
ResultsThe pooled prevalence of delayed treatment for malaria among under-five children in the Horn of Africa was 48% (95% CI: 34%–63%). History of child death (OR =2.5, 95% CI: 1.73–3.59), distance >3000 meters (OR = 2.59, 95% CI: 2.03–3.3), drug side effect (OR = 2.94, 95% CI: 1.86–4.67), formal education (OR = 0.69, 95% CI: 0.49–0.96), middle income (OR = 0.42, 95% CI: 0.28–0.63), expensiveness (OR = 4.39, 95% CI: 2.49–7.76), and affordable cost (OR = 2.13, 95% CI: 1.41–3.2) for transport were factors associated with malaria treatment delay among children.
Conclusion and recommendationsAbout one out of two parents in the Horn of Africa put off getting their kids treated for malaria. High transportation expenses, long travel times (greater than 3,000 meters) to medical facilities, and anxiety about drug side effects were major risk factors that contributed to this delay. On the other hand, a middle-class income was found to be protective of treatment delays. These results highlight how crucial it is to improve access to healthcare services, both financially and physically, to minimize delays in treating malaria in the area’s children.
To assess the feasibility of delivering the swallowing prehabilitation intervention known as Swallowing Intervention Package: Self-Monitoring, Assessment and Rehabilitation Training (SIP SMART) within the National Health Service (NHS) head and neck cancer care pathway.
Two-arm cluster-randomised pilot trial: SIP SMART2 trial.
Adults newly diagnosed with stage II–IV head and neck cancer receiving curative treatment within a multidisciplinary team who agree to participate.
Six hospitals were randomised. Trained clinicians at the intervention sites delivered the manualised SIP SMART intervention, while standard care was provided at care as usual (CAU) sites. The intervention included two 45-minute consultations incorporating an X-ray swallow assessment, tailored exercises/advice and specific behaviour change strategies while CAU involved a single consultation of information giving and provision of a generic exercise sheet.
Study outcomes related to feasibility of the cluster-randomised design, recruitment of both sites and patients and completeness of clinical and health economic data collected at baseline, 4 weeks, 12 weeks and 24 weeks after treatment.
12 hospitals expressed interest and six were randomised (50%) and provided data to the point of study completion. Patient recruitment across all sites (n=76) reached the target, although two sites fell short of their individual targets. The proportion of people with HNC recruited versus those eligible for each arm was 39% (95% CI 29 to 49) for SIP SMART group and 55% (95% CI 43 to 66) for CAU. The end point data at 24 weeks were completed for 50% (95% CI 33 to 67) for SIP SMART and 78% (95% CI 62 to 89) for CAU. Adherence to the intervention was above 50% at all time points. No harms related to the intervention were reported.
It is feasible to deliver the SIP SMART intervention embedded within the NHS cancer care pathway using a cluster-randomised design. A future trial will be optimised for efficiency in set-up and follow-up data collection based on these findings and learnings from the accompanying process evaluation study.
Interest in workplace bullying (WPB) has been steadily growing with a focus on understanding its consequences as well as prevalence rates in different occupations and across different countries with varying cultural contexts. Research in the Middle East remains limited, especially in Lebanon. The scarcity of data from the Lebanese healthcare sector underscores the need to better understand WPB in this unique sociocultural and organisational environment.
The primary aim of this study is to investigate the prevalence of WPB among healthcare providers and hospital staff in Greater Beirut. The secondary aim is to investigate the relationship between WPB, psychological well-being, burnout and sick leaves in the Lebanese cultural context.
A cross-sectional study design was conducted.
Seven hospitals in Greater Beirut took part in the study, including six private hospitals and one public hospital.
A total of 958 participants aged 18–64 were recruited using stratified proportionate non-random sampling. Stratification by hospital size and department aimed to ensure broad representation of nursing and support staff across institutions. The participants included nursing and supporting staff, of which 26.3% were males and 73.7% were females. Those employed for less than 6 months were excluded.
The Arabic versions of each of the Negative Acts Questionnaire-Revised (NAQ-R), the General Health Questionnaire (GHQ-12) and the Copenhagen Burnout Inventory (CBI) were administered. These instruments were selected for their established reliability and widespread use in cross-cultural occupational health research. Surveys were administered via paper-and-pencil (six hospitals) and online (one hospital). Prevalence of bullying using the NAQ-R cut-off scores was first calculated and then their respective thresholds identified using receiver operating characteristic analysis. Pearson’s correlation coefficient was used to evaluate the relationship between the NAQ-R and the GHQ-12, CBI and number of sick leaves.
Using the lower threshold as a cut-off on the NAQ-R, 35.1% of participants were classified as bullied. When applying the higher threshold as a cut-off, the percentage was slightly lower but remained comparable at 32.4%. Results showed that across the two outcomes, those who were bullied both when using a lower threshold and upper threshold were significantly more distressed and burnt out (pt(df) = –8.43, p±1.96; Upper threshold: ² (4, N=902)=9.963, p=0.019, Standardised residual for 6–10 days=2.2>±1.96).
Findings yielded lower prevalence rates of WPB among nurses and the entire sample as compared with research carried out in the Arab region. Our study further supports the impact of culture on the perpetuation of WPB and the uniqueness of Lebanon’s culture on influencing this prevalence. Results indicated that participants who were bullied were significantly more distressed, more burnt out and reported taking up more sick leaves. These findings highlight the need to consider local workplace culture when addressing bullying and reinforce the significant psychological and occupational toll bullying takes on affected individuals. Healthcare institutions are encouraged to implement and reinforce clear antibullying policies, WPB prevention strategies and confidential reporting mechanisms. Future research should explore longitudinal patterns of bullying, obtain a more nationally representative sample and examine the effectiveness of targeted interventions to create safer, more supportive work environments.
To estimate the frequency of antidiabetic prescriptions in type 2 diabetes mellitus (T2DM) in Spain and describe changes in prescription patterns between 2018–2022 and 2023-2024.
Observational study.
Patients from primary care centres newly diagnosed with T2DM in 2018–2022 and 2023–2024.
In each period, the prescription frequency of an antidiabetic medication at the diagnosis of T2DM was calculated and subsequently subdivided into monotherapy and combination therapy. The prescription frequency of the most common antidiabetic drugs was also calculated. Calculations were made for the entire group of subjects and stratified by sex and age (under 60 years and 60 years or older). Comparison of the frequencies between the two periods was performed using the chi-square test.
In 2018–2022 and 2023–2024, 78.4% and 88.9% of patients, respectively, were prescribed an antidiabetic medication. The prescription frequencies for monotherapy and combination therapy were 66.1% and 33.9% in the first period and 57.4% and 42.6% in the second. The prescription frequencies for metformin as monotherapy and combination therapy were 57.4% and 27.8% in the first period and 46.6% and 39.8% in the second. Prescribing metformin with sodium-glucose cotransporter-2 inhibitors (SGLT2i) and/or glucagon-like peptide receptor 1 agonists (GLP1a) was the most frequent combination therapy: 12.8% in 2018–2022 and 29.5% in 2023–2024. With a few exceptions, the prescribing pattern was similar by sex and age. The difference between the prescribing distributions in the two periods is significant.
Antidiabetic medication prescribing at the diagnosis of T2DM was high. Most prescriptions contained metformin. Monotherapy decreased in 2023–2024 compared with 2018–2022, while combination therapy increased due to increased prescriptions of metformin with SGLT2i and/or GLP1a.
by Ismat Tasnim, Md. Asif Iqbal, Ismat Ara Begum, Mohammad Jahangir Alam, Morten Graversgaard, Paresh Kumar Sarma, Kiril Manevski
Food insecurity and agriculture in South Asia, including Bangladesh, pose significant threats to the well-being and livelihoods of its people. Building adaptive capacities and resilient food systems is crucial for sustainable livelihoods. This study employs the Resilience Index Measurement and Analysis II framework to construct a Resilience Capacity Index (RCI) and analyze its relationship with food security using data from the Bangladesh Integrated Household Survey 2018. The study applies Exploratory Factor Analysis and Structural Equation Modeling to examine the impact of key resilience components such as Access to Basic Services, Adaptive Capacity, and Assets on household resilience. The findings reveal that access to basic services, land assets, and farm equipment positively influences households’ resilience capacity. However, the presence of livestock assets has a negative impact, potentially due to market volatility, climate vulnerability, and disease outbreaks. Additionally, adaptive capacity has a positive but insignificant influence on RCI, suggesting that without enhancing economic opportunities, institutional support, and inclusive development strategies, adaptive capacity could not be enough to foster resilience. However, resilient capacity enhances food security metrics such as the Food Consumption Score and Expenditure. These findings underscore the importance of policies that focus on increasing and maintaining access to basic services, promoting sustainable land management practices, and strengthening social safety nets. This study emphasizes the importance of focusing on livestock assets to ensure their sustainability by stabilizing the livestock market, improving veterinary services, and providing subsidies to reduce maintenance costs.Different malaria control measures are deployed simultaneously in endemic settings globally, with varying impacts on malaria burden. In sub-Saharan Africa, which bears the greatest burden of malaria, evidence on the impact of implementing various control interventions on malaria immunity remains unknown. This systematic review seeks to collate evidence on the extent of progression from uncomplicated to severe malaria among populations in sub-Saharan Africa settings receiving concurrent deployment of various malaria control measures.
The review will use a priori criteria contained in the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. An experienced librarian (AAK) will independently search for articles from the following databases: PubMed, Web of Science, Embase, Scopus and Google Scholar. Boolean operators ‘AND’ and ‘OR’ will be used in the article search. Identified articles will be managed using EndNote. Article screening for inclusion and data extraction will be done in duplicate by two reviewers (EJO, and BM). Data extraction tools will be developed and customised in Excel. Data will be analysed using both narrative and quantitative synthesis. The level of heterogeneity between study outcomes will be measured using the I2 statistic. Subgroup analysis will be conducted to explore heterogeneity and establish the impact of different control interventions on progression from uncomplicated to severe malaria. A full systematic review and meta-analysis is expected to be ready for dissemination by the end of December 2025.
This study did not involve human participants and so ethical approval was not sought. A full review and a meta-analysis will be published in a peer-reviewed journal and presented at national and international conferences.
CRD 42024619945.
Pelvic organ prolapse (POP) is the descent of one or more pelvic organs through the vaginal canal, including the vagina, uterus, rectum, bladder, cervix, posthysterectomy vaginal cuff, and small or large bowel, which compromises a woman’s physical, mental and social well-being.
This study aimed to explore how women with POP experience their living and its impact on their quality of life (QoL).
This was a qualitative study using interpretive phenomenological analysis, following in-depth structured interviews. Analysis was undertaken to identify superordinate themes relating to how women are living with POP.
3 public hospitals and 3 woredas in Gurage zone, Central Regional State, Ethiopia.
A purposive sample of 12 women who were diagnosed with POP was recruited.
Five core themes with subthemes were identified; general health judgement, POP symptom, life situation related to POP, feeling about POP and limitation in daily life/activity. The majority of respondents expressed concern that the prolapse had negatively impacted their general health and voiced hope that pelvic floor reconstruction would improve their general well-being. The majority of the informants stated that disclosing to others might significantly lower their QoL and that having the condition was extremely embarrassing. The women were most affected by the actual physical symptoms of prolapse (bulge, back pain, heaviness, bowel problems, urinary incontinence) as well as by the impact prolapse has on their sexual function.
Women with POP should be offered psychosocial support, early care and counselling because they have physical, personal, emotional, social and sleep/energy problems. Healthcare providers should take the initiative in educating women regarding prolapse and to make them aware that it is a treatable condition which can improve their QoL.
The development of effective vaccines targeting human papillomavirus (HPV) has significantly contributed to disease prevention, highly relevant in immunosuppressed patients who have higher incidence of HPV-related cancers than their non-immunosuppressed counterparts. However, the acceptance and uptake of the HPV vaccine among immunosuppressed individuals pose unique challenges. Immunocompromised patients’ acceptance of the HPV vaccine is influenced by multifaceted factors, including concerns about safety and effectiveness, interactions with immunosuppressive medications and uncertainties due to their compromised immunity. This systematic review aims to identify the main factors influencing HPV vaccine acceptance among immunosuppressed patients.
A comprehensive search strategy will be executed across databases such as MEDLINE/PubMed, Embase, Scopus, Web of Science, ScienceDirect, Latin American and Caribbean Literature in Health Sciences, Cumulative Index to Nursing and Allied Health Literature and Cochrane Database. The review will encompass the three WHO-endorsed HPV vaccines (quadrivalent, bivalent and nonavalent) and will consider studies related to HPV vaccines and their administration. The scope includes study focusing on immunosuppressed patients who received organ transplants, cancer treatments or are HIV-positive. No temporal restrictions will be applied, and searches will be conducted until December 2025. Observational studies, including retrospective/prospective cohorts, case–control and cross-sectional studies, reporting factors influencing HPV vaccination in immunosuppressed populations will be included. Studies with overlapping patient populations will be excluded. Data extraction will include study details, demographics, vaccine type, risk/protective factors, outcomes and medical history. Validation and cross-verification will ensure data accuracy. Risk of bias will be assessed using ROBINS-I (Risk Of Bias In Non-randomised Studies of Interventions), and GRADE (Grading of Recommendations Assessment, Development and Evaluation) will rate evidence certainty. Meta-analysis, guided by Cochrane and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, will employ fixed/random-effects models, assessing heterogeneity using I² statistics.
This research will analyse previously published data, so ethical approval is not required. The results of the systematic review will be submitted for publication in a peer-reviewed journal.
CRD42023452537.
To assess factors associated with the adoption of the WHO Package of Essential Non-Communicable Diseases (PEN) Protocol 1 at primary healthcare (PHC) facilities in Nepal after healthcare workers received training.
Cross-sectional study.
PHC facilities across various provinces in Nepal.
A total of 180 healthcare workers trained in PEN, recruited from a random selection of 105 basic healthcare facilities.
The adoption of PEN Protocol 1 components: blood pressure measurement, blood glucose screening, 10-year cardiovascular disease (CVD) risk assessment using WHO/International Society of Hypertension risk charts and body mass index (BMI) assessment. Factors associated with protocol adoption were assessed using generalised estimating equations for ORs.
Among participants, 100% reported measuring blood pressure, while 56% measured blood sugar, 28% assessed CVD risk and 27% assessed BMI. The adoption of the CVD risk prediction chart was positively associated with the availability of amlodipine (adjusted OR (aOR) 3.00; 95% CI 1.09 to 8.27). The adoption of BMI assessment was positively associated with access to a stadiometer (aOR 3.23; 95% CI 1.26 to 8.30) and a glucometer (aOR 3.07; 95% CI 1.12 to 8.40), and negatively associated with lack of motivation/inertia of previous practice (aOR 0.60; 95% CI 0.42 to 0.87) and environmental factors such as lack of time and resources (aOR 0.57; 95% CI 0.37 to 0.89). Blood glucose level measurements were positively associated with being at a PHC centre (aOR 7.34; 95% CI 2.79 to 19.3) and the availability of metformin (OR 2.40; 95% CI 1.08 to 5.29).
Adoption of PEN Protocol 1 varied by component and was influenced by resource availability, provider motivation and system barriers. Addressing these factors is key to optimising implementation in low-resource settings.
Oral HIV pre-exposure prophylaxis (PrEP) is a highly effective biomedical intervention for HIV prevention, but its access and utilisation are challenging, especially in high-burden settings such as Kenya. For potential PrEP users, long delays and repeated consultations with several providers are obstacles to both PrEP uptake and continuation. The One-Stop PrEP Care project aims to promote the use of PrEP among clients in the health system and enhance client satisfaction by reducing the waiting time.
We are conducting a 1:1 cluster-randomised trial to evaluate whether One-Stop PrEP Care achieves equivalent or better PrEP outcomes compared with the standard of care model in 12 high-volume HIV clinics in Kisumu County, Kenya. In the One-Stop model, all core PrEP components, including HIV risk evaluation, HIV testing and PrEP dispensing, are provided by one provider in a single consultation room. Programme data from ≥2400 new PrEP clients will be abstracted for 12 months each to obtain primary endpoints of PrEP initiation and continuation. Adherence will be assessed via blood drug level testing. A nested cohort of up to 300 PrEP clients will be enrolled and followed every 3 months to provide in-depth data on individual HIV prevention behaviour, risk perception and how they align PrEP use with perceived risk. We will also evaluate programme costs.
Ethical approval was obtained from the University of Washington Institutional Review Board (IRB) on 8 July 2022 (IRB ID: STUDY00015873) and the Kenya Medical Research Institute Scientific and Ethics Review Unit (SERU) with a letter dated 4 May 2023 (Ref: 4697). Project findings will be shared with stakeholders, including the Ministry of Health, County health officials and participants. Results will be disseminated through manuscripts, policy briefs and health meetings.
Plans for communicating important protocol modifications include timely notifications to all study team members and training on the changes, and updates to relevant stakeholders, including the two IRBs, through protocol amendment submissions.
V. 2.0 dated 21 May 2024.
Low-income adults with disabilities experience disproportionately high rates of food insecurity and preventable healthcare utilisation. The Supplemental Nutrition Assistance Program (SNAP) can reduce food insecurity and improve health, but there are accessibility gaps in the SNAP enrolment process. Existing outreach and enrolment assistance programmes have been shown to boost SNAP enrolment, but their health effects are understudied. This study estimates the effects of a SNAP outreach and enrolment assistance programme on health outcomes among low-income adults with disabilities.
The study pragmatically evaluates a programme that provided outreach and SNAP enrolment assistance for low-income households. The study leverages a random process that selected households for one of two types of outreach, including an information-only arm and an information plus enrolment assistance arm, which formed a control group by default. The study will estimate the effect of this programme among low-income adults with disabilities using Medicaid and SNAP administrative data. Study outcomes include emergency department, hospital and long-term nursing home utilisation. SNAP enrolment and benefit amounts are secondary study outcomes and will be tested as a mediating mechanism of action. The study will test effect heterogeneity based on race, ethnicity, age and chronic conditions.
The study, which relies on deidentified data, was determined to be exempt as human subjects research by the Institutional Review Boards at Johns Hopkins Medicine and the Michigan Department of Health and Human Services. The study is being conducted in ongoing consultation with an Advisory Group of experts in food advocacy and disability advocacy. In addition to disseminating findings in peer-reviewed publications, findings will be disseminated to state decision-makers and the community in partnership with an advisory group.
Pulmonary embolism (PE) is a life-threatening condition with significant morbidity and mortality. The relationship between psychiatric disorders and PE outcomes is complex and not well understood. This study aimed to determine the impact of psychiatric disorders on PE outcomes by comparing patients with and without these conditions.
Using the National Inpatient Sample database, we analysed 725 725 adult patients hospitalised with PE between 2016 and 2019. Patients were stratified based on the presence or absence of psychiatric disorders. Multivariable logistic regression models were used to examine associations between psychiatric disorders and in-hospital outcomes, adjusting for baseline differences.
Of the patients studied, 26.6% had psychiatric disorders. These patients were younger (59.80 vs 63.91 years, p
Psychiatric disorders are associated with distinct management and outcomes in PE. Recognising these unique characteristics may help optimise care for this population; further research is needed to clarify the best management strategies.
Carers of people with non-memory-led dementias such as posterior cortical atrophy (PCA), primary progressive aphasia (PPA) and behavioural variant frontotemporal dementia (bvFTD) face unique challenges. Yet, little evidence-based support and guidance are available for this population. To address this gap in services, we have developed a novel, web-based educational programme: the Better Living with Non-memory-led Dementia programme (BELIDE). BELIDE was co-designed with people with lived experience of non-memory-led dementia and a previous pilot study confirmed its feasibility as an online intervention. This protocol outlines the randomised controlled trial (RCT) to evaluate the clinical and cost-effectiveness of BELIDE.
This is a parallel-group, single-blind, RCT of 238 unpaid caregivers of people diagnosed with PCA, PPA or bvFTD recruited internationally among members of the UK-based organisation Rare Dementia Support. The intervention (BELIDE programme) consists of six structured online educational modules tailored to each phenotype, a virtual onboarding session, real-life practice tasks and up to two follow-up facilitation sessions. The group receiving the intervention will be given access to the programme, while the control group will receive treatment as usual and be placed on a wait-list to receive access to the programme once they complete their participation in the trial. The allocation ratio will be 1:1 stratified by dementia diagnosis and gender. The primary outcome is reduction in caregiver depressive symptoms. Secondary outcomes include stress, anxiety, self-efficacy, quality of life and caregiver-patient relationship quality. Data will be collected online via Qualtrics surveys at baseline, 8 weeks and 6 months post-randomisation. A mixed-method process evaluation with a subgroup of intervention participants will explore barriers and facilitators for engagement. A health economics evaluation will also be conducted to assess cost-effectiveness. If effective, this programme could improve access to caregiver support for non-memory-led dementias by providing scalable, tailored education.
Ethical approval has been granted by University College London Research Ethics Committee (8545/007). The results will be disseminated via peer-reviewed publications, conferences, stakeholder events and open-access resources.
This trial has been registered prospectively on the Clinical Trials registry, first posted on 5 February 2024 under registration number NCT06241287.
Coronary artery bypass grafting (CABG) remains one of the most commonly performed cardiac surgeries worldwide. Despite surgical advancements, a significant proportion of patients experience psychological distress following surgery, with depression being particularly common. Current evidence regarding the effectiveness of preoperative psychological interventions in improving postoperative mental health outcomes remains inconclusive. There is a critical need for predictive models that can identify patients at risk of developing clinically significant depressive symptoms (CSDSs) and related psychological conditions after CABG. This multicentre observational study aims to develop and validate prognostic models for predicting CSDSs and other psychological outcomes, including anxiety, post-traumatic stress symptoms and quality of life, 6 weeks after elective CABG surgery.
The study will recruit 300 adult patients undergoing elective CABG (with or without valve intervention) across two Swiss hospitals. Data collected will include demographic, clinical, psychometric, inflammation-related and interoceptive variables. A training set (n=200) will be used to develop predictive models using machine learning, while a held-out test set (n=100) will be used for model validation. The primary outcome prediction will focus on CSDSs, assessed using the Patient Health Questionnaire-9 (PHQ-9), with analyses conducted both categorically (PHQ-9 total score ≥10) and continuously as complementary approaches. Secondary models will address anxiety, using the General Anxiety Disorder Scale-7, post-traumatic stress, using the post-traumatic stress disorder checklist for Diagnostic and Statistical Manual of Mental Disorders-5 and health-related quality of life, using the 12-item Short Form Survey. A simplified ‘light solution’ model with fewer predictors will also be developed for broader applicability. This study will address an important gap in perioperative mental healthcare by identifying key predictors of psychological morbidity following CABG, particularly CSDSs. The resulting models may inform future screening and preventive strategies and improve postsurgical outcomes through early identification and intervention in high-risk individuals.
The responsible ethics committee has reviewed and approved this project (Kantonale Ethikkommission Zürich, BASEC number: 2023-02040). The study minimises participant burden by integrating brief validated instruments and limiting psychiatric interviews to relevant outcomes, while ensuring ethical safeguards and respect for participant rights (including written consent). Results will be shared through peer-reviewed publications, conference presentations and stakeholder meetings involving clinicians and mental health professionals. Findings will also be communicated to participating centres and patient communities in accessible formats.
To assess the incidence of delirium and its predictors among adult patients admitted to the intensive care units of comprehensive specialised hospitals in the Amhara region of northwest Ethiopia from 18 October 2024 to 20 February 2025.
A multicentre prospective observational study was conducted.
Four comprehensive specialised hospitals in the Amhara region of northwest Ethiopia, from 18 October 2024 to 20 February 2025.
A total of 351 patients were included in the final analysis during the study period.
The primary outcome measure of this study was the incidence of delirium. Additionally, the study investigated the factors associated with delirium incidence among adult patients admitted to intensive care units.
The incidence of delirium among adult patients in intensive care units was 42.17% (95% CI: 37.08 to 47.42). Pain (adjusted HR (AHR) = 4.74; 95% CI: 2.38 to 9.44), mechanical ventilation (AHR = 2.96; 95% CI: 1.56 to 5.63), age 65 years or older (AHR = 2.18; 95% CI: 1.48 to 3.21) and agitation (Richmond Agitation-Sedation Scale (RASS) ≥1) (AHR = 3.26; 95% CI: 2.09 to 5.09) were statistically significant factors associated with delirium.
In the present study, more than one-third of patients developed delirium. Pain, mechanical ventilation, age 65 or older and agitation (RASS≥1) were significantly associated with delirium occurrence. To reduce the incidence of delirium, the current study recommends treating or preventing pain and agitation. Additionally, special attention should be given to patients receiving mechanical ventilation and those aged 65 or older during care.