bluuebunny/crossref_metadata_2025_split huggingface dataset:
Azithromycin to prevent post-discharge morbidity and mortality in Kenyan children: a protocol for a randomised, double-blind, placebo-controlled trial (the Toto Bora trial)
Authors: Pavlinac Patricia B , Singa Benson O , John-Stewart Grace C , Richardson Barbra A , Brander Rebecca L , McGrath Christine J , Tickell Kirkby D , Amondi Mary , Rwigi Doreen , Babigumira Joseph B , Kariuki Sam , Nduati Ruth , Walson Judd L 
Published: May 2024

IntroductionChild mortality due to infectious diseases remains unacceptably high in much of sub-Saharan Africa. Children who are hospitalised represent an accessible population at particularly high risk of death, both during and following hospitalisation. Hospital discharge may be a critical time point at which targeted use of antibiotics could reduce morbidity and mortality in high-risk children.Methods and analysisIn this randomised, double-blind, placebo-controlled trial (Toto Bora Trial), 1400 children aged 1–59 months discharged from hospitals in Western Kenya, in Kisii and Homa Bay, will be randomised to either a 5-day course of azithromycin or placebo to determine whether a short course of azithromycin reduces rates of rehospitalisation and/or death in the subsequent 6-month period. The primary analysis will be modified intention-to-treat and will compare the rates of rehospitalisation or death in children treated with azithromycin or placebo using Cox proportional hazard regression. The trial will also evaluate the effect of a short course of azithromycin on enteric and nasopharyngeal infections and cause-specific morbidities. We will also identify risk factors for postdischarge morbidity and mortality and subpopulations most likely to benefit from postdischarge antibiotic use. Antibiotic resistance inEscherichia coliandStreptococcus pneumoniaeamong enrolled children and their primary caregivers will also be assessed, and cost-effectiveness analyses will be performed to inform policy decisions.Ethics and disseminationStudy procedures were reviewed and approved by the institutional review boards of the Kenya Medical Research Institute, the University of Washington and the Kenyan Pharmacy and Poisons Board. The study is being externally monitored, and a data safety and monitoring committee has been assembled to monitor patient safety and to evaluate the efficacy of the intervention. The results of this trial will be published in peer-reviewed scientific journals and presented at relevant academic conferences and to key stakeholders.Trial registration numberNCT02414399.
What is the relationship between physical activity and cardiovascular risk factors in stroke survivors post completion of rehabilitation? Protocol for a longitudinal study
Authors: Fini Natalie A , Bernhardt Julie , Holland Anne E 
Published: May 2024

IntroductionPhysical activity (PA) can modify cardiovascular and other health risks in people with stroke, but we know little about long-term PA in this group. This study aims to describe PA levels and investigate relationships between PA, cardiovascular risk factors, mobility and participant characteristics (eg, age, mood and fatigue) in the 2 years following rehabilitation discharge after first stroke.Methods and analysisThis is a longitudinal observational study with follow-up at 6, 12 and 24 months after rehabilitation discharge. Inclusion criteria are broad; excluding only those with previous stroke, palliative diagnosis, living more than 2 hours from the centre or admitted less than 5 days.The primary outcome of interest is duration of moderate to vigorous PA (min/day) measured by the Sensewear MF Armband (SWAB). Secondary outcomes include other PA measures measured with the SWAB; cardiovascular risk factors (eg, systolic blood pressure, fasting lipid profile and smoking status), mobility (10 m walk test), the Hospital Anxiety and Depression Scale and the Fatigue Severity Scale. All outcomes, except blood tests, are gathered at each time point.The target sample size is 77. We will explore associations between PA levels, cardiovascular risk factors, mobility and participant characteristics at baseline compared with 6, 12 and 24 months using random-effects regression modelling.The long-term PA of stroke survivors is largely unknown. We hope to identify factors that influence PA and cardiovascular risk in this population, which may help health professionals target the stroke survivors most at risk and implement appropriate treatment, preventative strategies and education.Ethics and disseminationApproval was granted from Alfred Hospital and La Trobe University Research Ethics Committees. The study results will be disseminated in a number of ways including journal publication and international conference presentations.Trial registration numberACTRN12613000196741.
Protocol for a feasibility study and randomised pilot trial of a low-intensity psychological intervention for depression in adults with autism: the Autism Depression Trial (ADEPT)
Authors: Russell Ailsa , Cooper Kate , Barton Stephen , Ensum Ian , Gaunt Daisy , Horwood Jeremy , Ingham Barry , Kessler David , Metcalfe Chris , Parr Jeremy , Rai Dheeraj , Wiles Nicola 
Published: May 2024

IntroductionHigh rates of co-occurring depression are reported in autism spectrum disorder (ASD), a neurodevelopmental condition characterised by social communication impairments and repetitive behaviours. Cognitive-behavioural interventions adapted for ASD have been effective for anxiety problems. There have been evaluation studies of group cognitive-behavioural therapy for co-occurring depression, but no randomised trials investigating low-intensity psychological interventions as recommended in clinical guidelines for mild-moderate depression.Methods and analysisA feasibility study comprising a randomised controlled trial (RCT) and nested qualitative evaluation is under way as preparation for a definitive RCT. Participants (n=70) will be randomised to Guided Self-Help: a low-intensity psychological intervention based on behavioural activation adapted for ASD or treatment as usual. Outcomes including depression symptoms, anxiety, social function and service use will be measured at 10, 16 and 24 weeks postrandomisation and will be blind to group allocation for measures that are not self-administered. The analysis will aim to establish the rates of recruitment and retention for a larger-scale RCT as well as the most appropriate measure of depression to serve as primary outcome. The qualitative study will purposively sample up to 24 participants from each treatment group to consider the acceptability and feasibility of the intervention and the trial design.Ethics and disseminationEthical approval has been received from WALES REC 3 (IRAS project ID: 191558) and the Health Research Authority with R&D approval from Avon and Wiltshire Mental Health Partnership and Northumberland, Tyne and Wear Foundation NHS Trusts. To our knowledge, this is the first study of a low-intensity intervention for depression in adults with autism. The results will inform the design of a definitive RCT. Dissemination will include peer-reviewed journal publications reporting the quantitative and qualitative research findings of the study and presentations at national and international conferences.Trial registration numberISRCTN54650760; Pre-results.
Patterns of routine primary care for osteoarthritis in the UK: a cross-sectional electronic health records study
Authors: Jackson Holly , Barnett Lauren A , Jordan Kelvin P , Dziedzic Krysia S , Cottrell Elizabeth , Finney Andrew G , Paskins Zoe , Edwards John J 
Published: May 2024

ObjectiveTo determine common patterns of recorded primary care for osteoarthritis (OA), and patient and provider characteristics associated with the quality of recorded care.DesignAn observational study nested within a cluster-randomised controlled trial.SettingEight UK general practices who were part of the Management of Osteoarthritis in Consultations study.ParticipantsPatients recorded as consulting within the eight general practices for clinical OA.Primary outcomesAchievement of seven quality indicators of care (pain/function assessment, information provision, exercise/weight advice, analgesics, physiotherapy), recorded through an electronic template or routinely recorded in the electronic healthcare records, was identified for patients aged ≥45 years consulting over a 6-month period with clinical OA. Latent class analysis was used to cluster patients based on care received. Clusters were compared on patient and clinician-level characteristics.Results1724 patients (median by practice 183) consulted with clinical OA. Common patterns of recorded quality care were: cluster 1 (38%,High) received most quality indicators of care; cluster 2 (11%,Moderate) had pain and function assessment, and received or were considered for other indicators; cluster 3 (17%,Low) had pain and function assessment, and received or were considered for paracetamol or topical non-steroidal anti-inflammatory drugs; cluster 4 (35%,None) had no recorded quality indicators. Patients with higher levels of recorded care consulted a clinician who saw more patients with OA, consulted multiple times and had less morbidity. Those in theHighcluster were more likely to have recorded diagnosed OA and have knee/hip OA.ConclusionsPatterns of recorded care for OA fell into four natural clusters. Appropriate delivery of core interventions and relatively safe pharmacological options for OA are still not consistently recorded as provided in primary care. Further research to understand clinical recording behaviours and determine potential barriers to quality care alongside effective training for clinicians is needed.Trial registration numberISRCTN06984617; Results.
Risk analysis of noise-induced hearing loss of workers in the automobile manufacturing industries based on back-propagation neural network model: a cross-sectional study in Han Chinese population
Authors: Ruan Yanmei , Huang Guanhao , Zhang Jinwei , Mai Shiqi , Gu Chunrong , Rong Xing , Huang Lili , Zeng Wenfeng , Wang Zhi 
Published: May 2024

ObjectivesThis study aims to predict the risk of noise-induced hearing loss (NIHL) through a back-propagation neural network (BPNN) model. It provides an early, simple and accurate prediction method for NIHL.DesignPopulation based, a cross sectional study.SettingHan, China.ParticipantsThis study selected 3266 Han male workers from three automobile manufacturing industries.Primary outcome measuresInformation including personal life habits, occupational health test information and occupational exposure history were collected and predictive factors of NIHL were screened from these workers. BPNN and logistic regression models were constructed using these predictors.ResultsThe input variables of BPNN model were 20, 16 and 21 important factors screened by univariate, stepwise and lasso-logistic regression. When the BPNN model was applied to the test set, it was found to have a sensitivity (TPR) of 83.33%, a specificity (TNR) of 85.92%, an accuracy (ACC) of 85.51%, a positive predictive value (PPV) of 52.85%, a negative predictive value of 96.46% and area under the receiver operating curve (AUC) is: 0.926 (95% CI: 0.891 to 0.961), which demonstrated the better overall properties than univariate-logistic regression modelling (AUC: 0.715) (95% CI: 0.652 to 0.777). The BPNN model has better predictive performance against NIHL than the stepwise-logistic and lasso-logistic regression model in terms of TPR, TNR, ACC, PPV and NPV (p<0.05); the area under the receiver operating characteristics curve of NIHL is also higher than that of the stepwise and lasso-logistic regression model (p<0.05). It was a relatively important factor in NIHL to find cumulative noise exposure, auditory system symptoms, age, listening to music or watching video with headphones, exposure to high temperature and noise exposure time in the trained BPNN model.ConclusionsThe BPNN model was a valuable tool in dealing with the occupational risk prediction problem of NIHL. It can be used to predict the risk of an individual NIHL.
What is current care for people with Long COVID in England? A qualitative interview study
Authors: Sunkersing David , Ramasawmy Mel , Alwan Nisreen A , Clutterbuck Donna , Mu Yi , Horstmanshof Kim , Banerjee Amitava , Heightman Melissa 
Published: May 2024

ObjectiveTo investigate current care for people with Long COVID in England.DesignIn-depth, semistructured interviews with people living with Long COVID and Long COVID healthcare professionals; data analysed using thematic analysis.SettingNational Health Service England post-COVID-19 services in six clinics from November 2022 to July 2023.Participants15 healthcare professionals and 21 people living with Long COVID currently attending or discharged (18 female; 3 male).ResultsHealth professionals and people with lived experience highlighted the multifaceted nature of Long COVID, including its varied symptoms, its impact on people’s lives and the complexity involved in managing this condition. These impacts encompass physical, social, mental and environmental dimensions. People with Long COVID reported barriers in accessing primary care, as well as negative general practitioner consultations where they felt unheard or invalidated, though some positive interactions were also noted. Peer support or support systems proved highly valuable and beneficial for individuals, aiding their recovery and well-being. Post-COVID-19 services were viewed as spaces where overlooked voices found validation, offering more than medical expertise. Despite initial challenges, healthcare providers’ increasing expertise in diagnosing and treating Long COVID has helped refine care approaches for this condition.ConclusionLong COVID care in England is not uniform across all locations. Effective communication, specialised expertise and comprehensive support systems are crucial. A patient-centred approach considering the unique complexities of Long COVID, including physical, mental health, social and environmental aspects is needed. Sustained access to post-COVID-19 services is imperative, with success dependent on offering continuous rehabilitation beyond rapid recovery, acknowledging the condition’s enduring impacts and complexities.
Challenges and support experienced by family caregivers seeking antiretroviral therapy services for children living with HIV/AIDS: a phenomenological study in Ghana
Authors: Yiryuo Lilian , Kpekura Stephen , Osman Wahab , Kukeba Margaret Wekem , Mumuni Najart Deborah , Mwinbam Mavis Mallory , Dery Anthony 
Published: May 2024

BackgroundFamily caregivers of children living with HIV/AIDS in most cases are found to be overwhelmed and under-resourced, yet they are believed to be the primary source of support for children living with HIV/AIDS. Family caregivers experience different challenges that affect their children’s antiretroviral therapy (ART) adherence.AimThis study explored the lived experiences of family caregivers of children living with HIV/AIDS who sought ART services for these children at the St Joseph’s Hospital of Jirapa, Ghana.MethodUsing a qualitative phenomenology design and a semistructured in-depth interview guide and using purposive sampling, data were gathered from 13 family caregivers of children living with HIV/AIDS receiving ART treatment at St Joseph’s Hospital, Jirapa following ethical approval. All interviews were audio-taped and transcribed verbatim. Reflexive thematic analysis was used to analyse the transcribed data.FindingsSix themes were generated: five challenges and one support. Family caregivers of children living with HIV/AIDS experienced: (1) Financial challenges, (2) Human-related challenges, (3) Challenges at HIV testing and counselling (HTC) centres, (4) Challenges with transportation, (5) Challenges in disclosing children’s HIV status to them and (6) Support received from HTC and their family members.Conclusion and recommendationFamily caregivers of children living with HIV/AIDS experience daunting challenges in their quest to care for their children. Governmental and non-governmental HIV/AIDS programme support should include small business skills training and acquisition including capital to help set up small-scale businesses for such caregivers to reduce their financial challenges. Access to ART at clinics closer to caregivers is also key to promoting adherence. Family and community support has been recognised as key to enhancing ART adherence. Education of caregivers on policy regarding disclosure of the HIV/AIDS status of children, the need to work to reduce the time spent by caregivers at HTC, and ensuring privacy by limiting access to HTCs to only caregivers and their children, are important to enhancing adherence.
Process evaluation of a Structured E-parenting Support (STEPS) in the OPTIMA randomised controlled trial: a protocol
Authors: Hedstrom Ellen , Kostyrka-Allchorne Katarzyna , French Blandine , Glazebrook Cristine , Hall Charlotte Lucy , Kovshoff Hanna , Lean Nancy , Sonuga-Barke Edmund 
Published: May 2024

IntroductionStructured E-parenting Support(STEPS) is a digital application (app) designed to help parents manage behaviour of their children who are referred to mental health services and are waiting for an assessment or treatment. STEPS is currently being evaluated in the Online Parent Training for the Initial Management of Attention-Deficit/Hyperactivity Disorder randomised controlled trial. Alongside the examination of STEPS’ clinical and cost-effectiveness, we are conducting a process evaluation to better understand the contextual factors that may influence study outcomes. The purpose of this protocol is to describe the aims, objectives and methodology of the process evaluation prior to it taking place to add to the fidelity and rigour of the trial process and outcomes. Our goal is to adapt STEPS to optimise its benefits in future applications.MethodsIn line with the Medical Research Council guidelines for evaluating complex interventions, the process evaluation will adopt a mixed method design using qualitative data collected from clinicians and parent interviews and app usage data from participants assigned to the intervention arm.AnalysisQualitative data from semistructured interviews and free text box responses included in trial questionnaires will be analysed thematically using framework analysis to better understand how parents use STEPS, how it works and key factors that could aid or hinder its effective implementation in routine clinical practice.EthicsThe application for ethical approval for the study was submitted to the North West—Liverpool Central Research Ethics Committee and received a favourable opinion on further information on 26 November 2021, reference number 21/NW/0319.DisseminationThe process evaluation aims to explore how a digital app might support parents in managing their child’s behaviour. Implications for policy and research will be explored and the clinical implications of offering the app to a wider audience to address the lack of support to parents as highlighted in this paper. We plan to publish findings in international, peer-reviewed journals as well as present at conferences.Trial registration numberThe trial has been prospectively registered on 18 November 2021;ISRCTN816523503.https://www.isrctn.com/ISRCTN16523503.
Comparison of outcomes from tunnelled femorally inserted central catheters and peripherally inserted central catheters: a propensity score-matched cohort study
Authors: McManus Craig , Mifflin Nicholas , Rivera Renz , Vause Sophie , Tran Ton , Ostroff Matthew , Harrowell Lorenza , Frost Steven , Alexandrou Evan 
Published: May 2024

ObjectivesTo compare catheter-related outcomes of individuals who received a tunnelled femorally inserted central catheter (tFICC) with those who received a peripherally inserted central catheter (PICC) in the upper extremities.DesignA propensity-score matched cohort study.SettingA 980-bed tertiary referral hospital in South West Sydney, Australia.ParticipantsIn-patients referred to the hospital central venous access service for the insertion of a central venous access device.Primary and secondary outcome measuresThe primary outcome of interest was the incidence of all-cause catheter failure. Secondary outcomes included the rates of catheters removed because of suspected or confirmed catheter-associated infection, catheter dwell and confirmed upper or lower extremity deep vein thrombosis (DVT).ResultsThe overall rate of all-cause catheter failure in the matched tFICC and PICC cohort was 2.4/1000 catheter days (95% CI 1.1 to 4.4) and 3.0/1000 catheter days (95% CI 2.3 to 3.9), respectively, and when compared, no difference was observed (difference −0.63/1000 catheter days, 95% CI −2.32 to 1.06). We found no differences in catheter dwell (mean difference of 14.2 days, 95% CI −6.6 to 35.0, p=0.910); or in the cumulative probability of failure between the two groups within the first month of dwell (p=0.358). No significant differences were observed in the rate of catheters requiring removal for confirmed central line-associated bloodstream infection (difference 0.13/1000 catheter day, 95% CI −0.36 to 0.63, p=0.896). Similarly, no significant differences were found between the groups for confirmed catheter-related DVT (difference −0.11 per 1000 catheter days, 95% CI −0.26 to 0.04, p=1.00).ConclusionThere were no differences in catheter-related outcomes between the matched cohort of tFICC and PICC patients, suggesting that tFICCs are a possible alternative for vascular access when the veins of the upper extremities or thoracic region are not viable for catheterisation.
Development and validation of a nomogram for predicting the occurrence of renal dysfunction after treatment of immune checkpoint inhibitor: a retrospective case–control study
Authors: Su Jianan , Chen Pengwei , Yang Yaping , Gao Ziqing , Bi Zhuofei , Feng Min 
Published: May 2024

PurposeThe administration of immune checkpoint inhibitors (ICIs) may lead to renal adverse events, notably including renal dysfunction. To early predict the probability of renal dysfunction after ICIs therapy, a retrospective case–control study was conducted.MethodsClinical information on ICIs-treated patients was collected. Multivariable logistic regression was applied to identify risk factors for renal dysfunction after ICIs treatment. Moreover, a nomogram model was developed and validated internally.ResultsA total of 442 patients were included, among which 35 (7.9%) experienced renal dysfunction after ICIs treatment. Lower baseline estimated glomerular filtration rate (eGFR) (OR 0.941; 95% CI 0.917 to 0.966; p<0.001), concurrent exposure of platinum(OR 4.014; 95% CI 1.557 to 10.346; p=0.004), comorbidities of hypertension (OR 3.478; 95% CI 1.600 to 7.562; p=0.002) and infection (OR 5.402; 95% CI 1.544 to 18.904; p=0.008) were found to be independent associated with renal dysfunction after ICIs treatment. To develop a predictive nomogram for the occurrence of renal dysfunction after ICIs treatment, the included cases were divided into training and validation groups in a ratio of 7:3 randomly. The above four independent risk factors were included in the model. The area under the receiver operating characteristic curves of the predictiive model were 0.822 (0.723–0.922) and 0.815 (0.699–0.930) in the training and validation groups, respectively.ConclusionsLower baseline eGFR, platinum exposure, comorbidities of hypertension and infection were predictors of renal dysfunction in ICIs-treated patients with cancer. A nomogram was developed to predict the probability of renal dysfunction after ICIs treatment, which might be operable and valuable in clinical practice.