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Healthcare systems are undergoing major transformation driven by technological progress, growing patient involvement, workforce shortages, complex care needs, and rising costs. Against this backdrop, value-based healthcare has gained traction, yet the notion of ‘value’ remains ambiguously defined.
To clarify the concept of ‘value’ in value-based healthcare.
We conducted a concept analysis using Walker & Avant's eight-step method: (1) Select a concept; (2) Determine the aims; (3) Identify uses; (4) Define the concept's attributes; (5) Identify the model case(s); (6) Identify additional cases; (7) Identify antecedents and consequences; and (8) Define empirical referents. Data Sources: Scoping review methods following the Joanna Briggs Institute (JBI) recommendations were used to introduce rigour in locating, screening, and extracting data. We used a deductive thematic analysis for data analysis.
We selected the concept of value in value-based healthcare because it lacked conceptual clarity to support healthcare systems transformations. We propose that value arises when outcomes-to-costs ratios (empirical referents) are considered in processes (uses) addressing healthcare systems transformations, characterised by more informed and engaged patients and rising costs (antecedents). Model case included consideration for all components (health, non-health outcomes, and direct, indirect, social costs) of the ratio, whereas additional cases showed that consideration for most, not all, or none of these components led to partial or no value creation. Value is used from individual to collective dimensions and at clinical, organisational and system levels (attributes) to improve patient experience, care team well-being, health equity, and population health, and to reduce costs (consequences).
A shared understanding of ‘value’ can guide its design, measurement, and implementation to support successful transformations toward value-based healthcare. Implications: Our conceptual proposition of ‘value’ within value-based healthcare establishes a framework for a common understanding of ‘value’ that enables the successful transformation of health systems toward value-based healthcare.
by Natalia Mach, Julien Polleux, Lea Heinrich, Lukas Lechner, Iryna Levytska, Cornelia Lass-Flörl, Susanne Perkhofer
Aspergillus terreus is an opportunistic fungal pathogen associated with high mortality rates and intrinsic resistance to amphotericin B. Its ability to persist within host tissues without inducing strong immune responses was suggested to contribute to poor clinical outcomes. The cellular mechanisms underlying A. terreus interactions with host cells remain largely unexplored. In this study, we have used a micropattern-based infection model to investigate the early interactions between A. terreus conidia and alveolar epithelial cells, focusing on the role of Arp2/3-dependent actin remodeling. This system allows quantitative analysis of conidia-cell interactions under defined spatial conditions. We show that A. terreus conidia rapidly bind to micropatterned A549 cell islands, with conidial numbers increasing over time. Conidia were found in actin- and Lamp1-positive vesicles already after one hour of infection. Inhibition of the Arp2/3 complex significantly impaired conidial binding and disrupted the formation of actin-positive vesicles, confirming the essential role of Arp2/3-mediated actin remodeling in early stages of conidial uptake. A subset of conidia was localized to Lamp1-positive phagolysosomes and accumulated over time. Interestingly, we have identified a small but consistent population of Lamp1-positive vesicles decorated with actin structures, potentially resembling actin flashes. These structures were entirely abolished upon Arp2/3 inhibition, indicating active cytoskeletal remodeling at the phagolysosomal interface. Our findings provide the first mechanistic insights into A. terreus internalization by alveolar epithelial cells and establish Arp2/3-mediated actin dynamics as a key process in early host-pathogen interactions. This cellular pathway may further contribute to intracellular trafficking and help understand the delayed onset of A. terreus infections.Neurodevelopmental impairments in congenital heart disease (CHD) are the most frequent long-term morbidity. Adverse neurodevelopmental outcomes may start in the prenatal period. Maternal mental health may be a potentially modifiable risk factor for the optimisation of neurodevelopment in CHD. We propose to assess the impact of prenatal maternal mental health on 1-year neurodevelopmental outcomes in complex CHD.
Neuro-Moms CHD is a national multi-centre, prospective study of prenatal maternal mental health and neurodevelopmental outcomes in children with complex CHD who undergo neonatal open-heart surgery. Participants (n=87 mother-child dyads) will be recruited from five major French paediatric cardiology centres (Necker Children’s Hospital in Paris, Bordeaux Cardiology Hospital, Marseille Children’s Hospital, Montpellier University Hospital and Saint-Pierre Institute). Expecting women who receive a prenatal diagnosis of fetal complex cyanotic CHD that requires a neonatal open-heart surgery for the newborn are eligible to participate. They will complete self-reports on mental health, anxiety, depression and coping skills and will participate in a semi-structured psychological interview. Mothers will provide information on medical, sociodemographic and lifestyle factors. They will be enrolled during the third trimester of pregnancy and will participate at three time points: prenatal, T1; after the newborn’s cardiac surgery, T2; and between 12 and 18 months after birth of the child with CHD, T3. Children with CHD will undergo a standardised neurodevelopmental assessment when they turn 12–18 months old. The father or co-parent of the child with CHD will also participate in T1 and will complete mental health self-reports. We will use a structural equation model to estimate simultaneously the relationships among maternal mental health, prenatal factors and child neurodevelopment outcomes.
This study is sponsored by the French National Institute of Health and Medical Research. It was approved by the Ethics Committee on 5 November 2024 and is registered in a public trials registry (NCT06711666). Neuro-Moms CHD targets a public health question with important societal implications. Results are expected to be broadly communicated with the scientific community and the lay public. Dissemination of findings will be in the form of scientific articles in peer-reviewed journals and presentations at conferences. Any publication or communication will comply with the international recommendations: ‘Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals’ (http://www.icmje.org/recommendations). All participants will give written informed consent or assent to participate. The anonymised data to be collected in this study will be available within the manuscripts published.
NCT06711666; pre-results.
Current pharmacological treatment options for painful diabetic neuropathy (PDN) often fail to provide adequate pain relief. However, in the recent SENZA-PDN study, high-frequency 10 kHz spinal cord stimulation (SCS) demonstrated significant long-term improvements in lower limb pain and health-related quality of life (HRQoL) in a PDN population. Furthermore, more than half of 10 kHz SCS recipients showed improved sensory function based on non-blinded clinical assessments in post hoc analysis. We report the design of the PDN-Sensory study, which aims to evaluate changes in pain and neurological function with 10 kHz SCS in the treatment of PDN. The study will include objective measures of neurological function, including the modified Toronto Clinical Neuropathy Score (mTCNS) and intraepidermal nerve fibre density (IENFD).
This multicentre, prospective, randomised controlled trial will compare conventional medical management (CMM) with 10 kHz SCS+CMM in individuals with diabetes and chronic, intractable lower limb pain due to PDN. Participants will be randomised 1:1 to CMM alone or 10 kHz SCS+CMM, with optional crossover at 6 months. The primary outcome is the proportion of participants at 6 months achieving ≥50% pain relief from baseline. The key secondary endpoint is the proportion of participants at 6 months with a reduction in mTCNS of ≥3 points from baseline (excluding changes in foot pain). Additional endpoints at 6 and 12 months include changes from baseline in mTCNS, IENFD, 7-day averaged pain score, pain-related interference, HRQoL, sleep, psychological outcomes, functional status and metabolic parameters.
The study protocol received central approval from the Western Institutional Review Board (IRB #20230954). Local IRB approval will be required before initiation of the study at each participating clinical site. The study complies with Good Clinical Practice guidelines (ISO 14155), the Declaration of Helsinki, and all applicable national, federal and local regulatory requirements. Dissemination plans include presentations at national and international conferences and publication in a peer-reviewed journal with open access.
Stroke volume is a major determinant of tissue perfusion and, therefore, a key parameter to monitor in patients with haemodynamic instability and hypoperfusion. Left ventricular outflow tract (LVOT) velocity-time integral (VTI) measurement using pulsed-wave Doppler is widely used as an estimation of stroke volume and should be a competence required for every intensive care unit (ICU) physician. Artificial intelligence (AI) applied to ultrasound facilitates the acquisition of adequate images. The aim of the present study is to evaluate the interchangeability of LVOT VTI measurements obtained by minimally trained operators and expert physicians, both guided by AI.
This is a prospective multicentre randomised controlled trial. ICU patients in whom fluid administration is considered necessary will be included. A minimally trained operator and an expert will independently measure LVOT VTI, guided by the UltraSight AI software to obtain the best five-chamber view, before and after a 250 mL fluid challenge. The order of acquisition between each operator will be randomised. 100 patients will be included.
The primary endpoint is the relative difference in LVOT VTI between operators. Secondary outcomes include the concordance of the therapeutic decision made by the blinded physician in charge of the patient based on the measures obtained by each operator, and the agreement between absolute values of LVOT VTI obtained by minimally trained and expert operators.
The study has been reviewed and approved by a regional ethics committee (Comité de Protection des Personnes—Ile de France II—n°24.00671.000291). An information note will be given to the participant before he or she participates in the study. The present study will be disseminated through peer-reviewed publications and academic and medical conferences.
Non-communicable diseases (NCDs), such as diabetes, cardiovascular diseases and cancer, are major global public health concerns. Diet quality—particularly the consumption of ultra-processed foods—has been associated with increased risk of NCDs. Traditional cohort studies are often expensive and logistically complex. The NutriNet-Brasil cohort leverages a web-based approach, offering a cost-effective and practical solution for comprehensive data collection and long-term follow-up.
Recruitments began in January 2020 through mass media, social media campaigns and collaborations with health organisations. Eligible participants are adults (aged ≥18 years) living in Brazil with internet access. Participants complete self-administered online questionnaires covering dietary intake, health status and other health determinants. Dietary assessment is based on the Nova classification system, which categorises foods by their level of processing.
Over 88 000 participants have completed the initial questionnaire. The cohort is predominantly women (79.9%) and highly educated (67.9% had completed higher education). The web-based design enabled the development and application of innovative dietary assessment tools, including the Nova24h and the Nova24hScreener, specifically designed to evaluate food processing levels. These tools have shown good performance in capturing dietary patterns and are central to the cohort’s aim. The online platform facilitates efficient recruitment, data collection and participant retention.
NutriNet-Brasil is pioneering the development of web-based cohort methodologies and instruments tailored to food processing research. Future work includes leveraging collaborations with national and international research centres to conduct multidisciplinary analyses and inform public health policies.
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