Conectar
Countries face challenges in maternal and newborn care (MNC) regarding costs, workforce and sustainability. Organising integrated care is increasingly seen as a way to address these challenges. The evidence on the optimal organisation of integrated MNC in order to improve outcomes is limited.
(1) To study associations between organisational elements of integrated care and maternal and neonatal health outcomes, experiences of women and professionals, healthcare costs and care processes and (2) to examine how the different dimensions of integrated care, as defined by the Rainbow Model of Integrated Care, are reflected in the literature addressing these organisational elements.
We included 288 papers and identified 23 organisational elements, grouped into 6 categories: personal continuity of care; interventions to improve interdisciplinary collaboration and coordination; care by a midwife; alternative payment models (non-fee-for-service); place of birth outside the obstetric unit and woman-centred care. Personal continuity, care by a midwife and births outside obstetric units were most consistently associated with improved maternal and newborn outcomes, positive experiences for women and professionals and potential cost savings, particularly where well-coordinated multidisciplinary care was established. Positive professional experiences of collaboration depended on clear roles, mutual trust and respectful interdisciplinary behaviour. Evidence on collaboration interventions and alternative payment models was inconclusive. Most studies emphasised clinical and professional aspects rather than organisational integration, with implementation barriers linked to prevailing biomedical system orientations.
Although the literature provides substantial evidence of organisational elements that contribute to improved outcomes, a significant gap remains in understanding how to overcome the barriers in sustainable implementation of these elements within healthcare systems. Interpreted through a systems and transition science lens, these findings suggest that strengthening integrated maternity care requires system-level changes aligning with WHO policy directions towards midwifery models of person-centred care.
by Kennedy M. Peter-Marske, Annie Green Howard, Kelly R. Evenson, Sara Jones Berkeley, Joanna Maselko, Mario Sims, Stuart D. Russell, Anna Kucharska-Newton, Kevin J. Sullivan, Wayne D. Rosamond
We assessed whether social isolation (SI), social support (SS), and subtypes of SS were associated with self-rated health trajectories and clinical heart failure (HF) outcomes among participants with incident HF hospitalizations. We included 2967 Atherosclerosis Risk in Communities study participants with incident HF hospitalization after Visit 2 (1990–1992). SI, SS, and subtypes of SS were measured at Visit 2. We identified incident HF hospitalization as ICD-9 code 428 and physician adjudicated events; on average HF occurred 17 (SD 8) years after Visit 2. We assessed associations with trajectories of annually measured self-rated health in the 4 years prior to and after incident HF hospitalization (excellent/good self-rated health on a 0–100 scale), using linear mixed effects models. We calculated hazard ratios (HR) and 95% confidence intervals (CIs) for associations with time to first all-cause rehospitalization and all-cause mortality using Cox proportional hazard models. Low overall SS had a 5.8 point (95% CI 7.8, 3.8) lower self-rated health value over time than high SS; associations of subtypes of SS with this outcome were similar. Low belonging SS was associated with greater days to first rehospitalization (HR 0.85; 95% CI 0.79, 0.96) compared to the highest tertile; however, belonging SS was not associated with mortality (HR 1.05; 95% CI 0.95, 1.17). Being socially isolated/high risk for SI was associated with greater hazard of all-cause mortality among females (HR 1.57; 95% CI 1.20, 2.06) but not males (HR 0.95; 95% CI 0.75, 1.19), compared to low SI. SI and SS were not associated with number of hospitalizations in the first year or percent of first year spent at home.The incidence of anal carcinoma is increasing, with the current gold standard treatment being chemoradiotherapy. There is currently a wide range in the radiotherapy dose used internationally which may lead to overtreatment of early-stage disease and potential undertreatment of locally advanced disease.
PLATO is an integrated umbrella trial protocol which consists of three trials focused on assessing risk-adapted use of adjuvant low-dose chemoradiotherapy in anal margin tumours (ACT3), reduced-dose chemoradiotherapy in early anal carcinoma (ACT4) and dose-escalated chemoradiotherapy in locally advanced anal carcinoma (ACT5), given with standard concurrent chemotherapy.
The primary endpoints of PLATO are locoregional failure (LRF)-free rate for ACT3 and ACT4 and LRF-free survival for ACT5. Secondary objectives include acute and late toxicities, colostomy-free survival and patient-reported outcome measures. ACT3 will recruit 90 participants: participants with removed anal tumours with margins ≤1 mm will receive lower dose chemoradiotherapy, while participants with anal tumours with margins >1 mm will be observed. ACT4 will recruit 162 participants, randomised on a 1:2 basis to receive either standard-dose intensity modulated radiotherapy (IMRT) in combination with chemotherapy or reduced-dose IMRT in combination with chemotherapy. ACT5 will recruit 459 participants, randomised on a 1:1:1 basis to receive either standard-dose IMRT in combination with chemotherapy, or one of two increased-dose experimental arms of IMRT with synchronous integrated boost in combination with chemotherapy.
This study has been approved by Yorkshire & The Humber – Bradford Leeds Research Ethics Committee (ref: 16/YH/0157, IRAS: 204585), July 2016. Results will be disseminated via national and international conferences, peer-reviewed journal articles and social media. A plain English report will be shared with the study participants, patients’ organisations and media.
by Alex Berke, Dana Calacci, Alex Pentland, Kent Larson
We leverage a recently published dataset of Amazon purchase histories, crowdsourced from thousands of US consumers, to study changes in online purchasing behaviors over time, how changes vary by demographics, the impact of COVID-19, and relationships between online and offline retail. This work provides a case study in how consumer-level purchases data can reveal purchasing trends beyond those available from aggregate metrics. For example, in addition to analyzing spending behavior, we develop new metrics to quantify changes in consumers’ online purchase frequency and the diversity of products purchased, to better reflect the growing ubiquity of online retail. Between 2018 and 2022 these consumer-level metrics grew on average by more than 85%, peaking in 2021. We find a steady upward trend in individuals’ online purchasing prior to COVID-19, with a significant increase in the first year of COVID, but without a lasting effect. Purchasing behaviors in 2022 were no greater than the result of the pre-pandemic trend. We also find changes in purchasing significantly differ by demographics, with different responses to the pandemic. We further use the consumer-level data to show substitution effects between online and offline retail in sectors where Amazon heavily invested: books, shoes, and grocery. Prior to COVID we find year-to-year changes in the number of consumers making online purchases for books and shoes negatively correlated with changes in employment at local bookstores and shoe stores. During COVID we find online grocery purchasing negatively correlated with in-store grocery visits. This work demonstrates how crowdsourced, open purchases data can enable economic insights that may otherwise only be available to private firms.Cardiovascular events (CVEs), in particular acute coronary syndrome (ACS), complicate the course of a significant number of patients hospitalised for community-acquired pneumonia (CAP) or influenza. Emerging evidence suggests that this increased risk of CVEs could be mitigated by the use of acetylsalicylic acid (aspirin). The ASCAP study investigates whether the addition of aspirin to standard therapy in hospitalised patients with moderate-to-severe CAP or influenza can reduce the incidence of CVEs.
The ASCAP study is a multicentre, double-blind, placebo-controlled randomised trial in 16 university and general hospitals in the Netherlands, in which patients are randomised to acetylsalicylic acid or matching placebo for 90 days. Eligible patients are adults hospitalised for moderate-to-severe CAP or influenza. Patients with antithrombotic or anticoagulant drugs, or those with contraindications for aspirin, are excluded. The primary outcome is the incidence of ACS up to day 180. Secondary outcomes include the incidence of 4-point major adverse cardiovascular events up to day 180, as well as the incidence of major bleeding and clinically relevant non-major bleeding events up to day 90, all-cause mortality up to day 180 and quality of life and societal costs up to day 180. Survival time will be analysed by the log-rank test, stratified for CAP and influenza, with a two-sided alpha of 0.05. Assuming an average baseline ACS risk of 7.5% over 180 days with up to 30% variation across strata, and a 60% hazard reduction due to aspirin, the required sample size to achieve 80% power is 760 patients. Currently, 114 patients are enrolled in the study.
This study is approved by the Medical Ethics Committee Amsterdam UMC (Amsterdam, The Netherlands) under reference number 2023.0741 and registered under EU trial number 2023-504553-12-01 in the EU portal CTIS (Clinical Trials Information System). Results of the study will be published in a peer-reviewed journal.
EU CTIS: 2023-504553-12-01.
by Hoc Tran, Olaf Berke, Nicole Ricker, Zvonimir Poljak
BackgroundH3 influenza A viruses (IAV) have been shown to frequently cross the species barrier which can be an important factor in sustained transmission and spread. Machine learning methods have been widely explored for host prediction of IAV using genomic data; however, this is often done using data from only one of the eight IAV segments or by using all available IAV data to predict broad categories of hosts.
ObjectiveThe objective of this study was to combine machine learning algorithms with H3 IAV sequence data from all eight segments to train predictive machine learning models for distinct host prediction and validate model performance.
MethodsModels were trained on both k-mers and amino acid properties alongside machine learning algorithms that included random forest and XGBoost for each of the eight IAV genome segments. Models were then validated on a test dataset through analytics of model class predicted probabilities and subsequently used to investigate between-species transmission patterns within case studies including canine H3N8, swine H3N2 2010.2, and duck H3 sequences.
ResultsModels demonstrated strong performance in host prediction across all eight segments on the test dataset, with overall accuracies and κ (kappa) values ranging from 0.995–0.997, 0.984–0.990, respectively. Misclassified test dataset sequences with high predicted probabilities (> 90%) were validated using available literature and were identified to be frequently associated with between-species transmission events. Between-species transmission patterns within case study model class predicted probabilities were also identified to be consistent with the literature in cases of both correct and incorrect classification.
ConclusionsThese models allow for rapid and accurate host prediction of H3 IAV datasets from any of the eight IAV segments and provide a solid framework that allows for identification of variants with higher than typical between-species transmission potential. However, results obtained on selected case studies suggest further improvements of the training and validation processes should be considered.
Heart failure with reduced ejection fraction (HFrEF) remains a significant cause of morbidity and mortality worldwide, particularly in patients who remain symptomatic despite guideline-directed medical therapy (GDMT). Preliminary data suggest that a single fraction low-dose whole-heart external beam radiotherapy (EBRT) may improve cardiac function by modulating inflammatory and fibrotic processes. This trial aims to evaluate the preliminary efficacy of a single fraction 5 Gy whole-heart EBRT to improve left ventricular ejection fraction (LVEF) in patients with HFrEF on GDMT. Secondary objectives will assess safety, cardiac biomarkers and patient-reported outcomes.
Single-centre, single-arm, prospective interventional trial aiming to enrol 40 patients with HFrEF (LVEF≤35%) on maximal GDMT, New York Heart Association (NYHA) classes II–IV, and stable for ≥6 months prior to enrolment, without recent heart failure admissions or GDMT changes. All participants are required to have cardiac implantable electronic devices. Recruitment will be balanced with 20 patients with ischaemic and 20 with non-ischaemic aetiology. Eligible patients will receive a single fraction of 5 Gy whole-heart EBRT guided by a non-contrast enhanced primary planning CT. Follow-up assessments will be conducted at baseline, 6 weeks, 12 weeks and 6 months. The primary outcome is an improvement in LVEF of ≥5% at 6 months, assessed by transthoracic echocardiography. This is an open-label trial with blinded ascertainment of the primary outcome. Secondary outcomes include acute and late toxicity, overall survival, hospital admission for heart failure, patient-reported quality of life, cardiac biomarkers and device-reported arrhythmia burden.
The trial has been approved by the Ethics Committee Research UZ/KU Leuven, Belgium (S69569). The study results will be shared through peer-reviewed journals and presentations at academic conferences.
Hepatitis C virus (HCV) remains a leading cause of infectious disease-related morbidity in the USA, disproportionately affecting people who inject drugs and people who are incarcerated. Despite the availability of highly effective, highly tolerated direct-acting antivirals, treatment uptake in jails remains limited due to short stays, unpredictable release dates and system-level barriers. The original MINMON trial demonstrated that a low barrier ‘minimal monitoring"’ model can achieve high cure rates in community settings. This study, MINMON-J, aims to adapt and evaluate a modified version of the MINMON model for use in a jail setting, addressing the urgent need for scalable, low-barrier treatment approaches among justice-involved individuals.
MINMON-J is a single-arm, hybrid effectiveness-implementation pilot study protocol planned to recruit at the Rhode Island Department of Corrections. 40 people who are incarcerated with positive HCV RNA, who are treatment-naïve, without cirrhosis and awaiting trial, will receive 12 weeks of sofosbuvir/velpatasvir with no required lab monitoring during treatment. If released before treatment completion, participants will receive their remaining medication at discharge. Community health workers will provide post-release support. Mixed-methods evaluation will be guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance/Practical, Robust Implementation and Sustainability Model framework. Primary outcomes include feasibility, acceptability and adherence. Data will be collected through administrative records, surveys (Acceptability of Intervention Measure, Feasibility of Intervention Measure, Brief Adherence Rating Scale) and qualitative interviews with participants and other relevant parties. This study was reviewed and approved by the Brown University Health Institutional Review Board (2240400) and the Rhode Island Department of Corrections Medical Research Advisory Group.
This study was reviewed and approved by the Brown University Health Institutional Review Board (2240400) and the Rhode Island Department of Corrections (RIDOC) Medical Research Advisory Group. All participants will provide written informed consent prior to enrolment. People who are incarcerated will be assured that participation is voluntary, will not impact their clinical care and that they may withdraw at any time without penalty. Study procedures follow ethical principles outlined in the Declaration of Helsinki and comply with federal regulations regarding research involving vulnerable populations.
Dissemination of findings will include peer-reviewed publications and presentations at national conferences focused on infectious diseases, implementation science and/or correctional health. Lay summaries will be shared with RIDOC leadership and community partners. De-identified data and associated metadata may be archived in a publicly accessible repository in accordance with National Institutes of Health data sharing policies, contingent on final institutional review board approval and participant protections.
Current treatments for alcohol use disorders (AUD) have limited efficacy. A previous 28-day pilot trial of N-acetyl cysteine (NAC) vs placebo found NAC to be feasible and safe, with evidence of improvement on some measures of alcohol consumption. Thus, the primary aim of the NAC-AUD study is to examine the therapeutic and cost-effectiveness of NAC vs placebo in improving treatment outcomes for AUD. We will also examine the (i) effect of NAC vs placebo on mood, markers of liver injury, cognition and hangover symptoms; and (ii) predictors of any response.
This double-blind trial will randomise participants with AUD to a 12-week regimen of either NAC (2400 mg/day) or placebo. All participants will receive medical management. The primary drinking outcome will be the number of heavy drinking days (HDDs) per week, validated by phosphatidylethanol (PEth). Secondary alcohol-related outcomes will include standard drinks per drinking day (SDDD) per week and absence of any HDDs. Other secondary outcomes will include markers of liver injury, depression, anxiety, craving, hangover symptoms, cognition and blood oxidative stress markers. We will also examine the cost-efficacy of NAC vs placebo.
Ethics approval for the study has been granted by The Sydney Local Health District Ethics Review Committee (X21-0342& HREC2021/ETH11614). There are no restrictions on publication from the sponsor or other parties.
Patients with stage III non-small cell lung cancer (NSCLC) are at high risk of developing post-treatment recurrences (50–78%) during follow-up. As more effective treatments are now available, especially for patients with oligometastatic disease, earlier detection of recurrences may prolong survival and health-related quality of life (HRQOL). With the use of 2'-deoxy-2'-[18F]fluoroglucose positron emission tomography/CT ([18F]FDG PET/CT) during follow-up, recurrences may be detected earlier. Therefore, the primary objective of this study is to compare the 3-year overall survival of patients with stage III NSCLC during follow-up surveillance with [18F]FDG PET/CT versus follow-up with conventional CT (usual care). Secondary objectives address the number, location and timing of recurrences, as well as HRQOL, cost-effectiveness and patient experiences of PET/CT scans.
In this multicentre randomised controlled clinical trial, 690 patients with stage III NSCLC (8th edition International Association for the Study of Lung Cancer (IASLC) Tumor, Nodes, Metastasis (TNM) classification) who completed curative intended treatment and started follow-up care (which may include adjuvant therapy) will be randomised 1:1 to either the intervention ([18F]FDG PET/CT) or the control group (CT). Patients will undergo follow-up scans during visits at 6, 12, 18, 24 and 36 months. Data will be collected using validated questionnaires, electronic case report forms and data extractions from the electronic health records. Additionally, blood samples will be collected, and interviews will be conducted.
The study protocol has been approved by the Medical Ethical Committee of the Radboudumc and review boards of all participating centres. Written informed consent will be obtained from all participants. Study results will be published in international peer-reviewed scientific journals and presented at relevant scientific conferences. Data will be published in a data repository or other online data archive.
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