Aims Cardiovascular magnetic resonance (CMR) 4-dimensional (4D) intraventricular flow analysis quantifies volume and kinetic energy (KE) of direct flow (DF), and residual volume (ReV) components, illustrating heart failure (HF) haemodynamic changes. Study aims were (1) compare volume and KE indexed (KEi) of DF and ReV between groups. (2) Assess relationship between 4D-flow parameters with CMR parameters. Methods and results 187 subjects (63.0 ± 17.1 years; 101 males) comprising 78 controls, 47 HF with preserved ejection fraction (HFpEF), 25 HF with mildly reduced ejection fraction (HFmrEF), 37 HF with reduced ejection fraction (HFrEF) were included. Volume and KEi of DF, and ReV were obtained from 4D flow CMR images. Controls had highest DF volume and systolic KEi (control 35.0% and 54.7 µJ/mL), followed by HFpEF (22.7% and 61.4 µJ/mL), HFmrEF (13.1% and 43.3 µJ/mL), HFrEF (5.2% and 33.1 µJ/mL) (P < 0.001). ReV and diastolic KEi were lowest in controls (26.0% and 7.9 µJ/mL), and higher across HFpEF (31.8% and 7.8 µJ/mL), HFmrEF (41.6% and 10.8 µJ/mL), HFrEF (49.5% and 11.5 µJ/mL) (P < 0.001). DF volume correlated positively with left ventricular ejection fraction (LVEF) (r = 0.794), but negatively with LV-end-diastolic volume indexed (EDVi) (r = −0.563) (all P < 0.001). ReV correlated negatively with LVEF (r = −0.737) but positively with LV-EDVi (r = 0.602) (all P < 0.001). Loss of two diastolic peaks in KE time curves for HF patients were shown. Conclusion CMR 4D DF and ReV with their KEi showed haemodynamic changes and KEi time curve pattern distortions in HF.
Background and Objective: Over the past decade substantial government and market-driven efforts focused on the use of real-world evidence (RWE) to improve healthcare decision-making. A successful strategy has been mounted by specialty societies and their registries that have created RWE through a model known as the Coordinated Registry Network (CRN), which has accelerated innovation, improved care quality, addressed the safety and efficacy of medical products, and supported medical research. This three-part manuscript works to understand how the CRNs have succeeded by applying organizational sociology and the theory of Systemic Coordinated Inter-Organizational Networks (SCIONs). Methods: We describe CRNs as organizations that evolved from the traditional registries of clinical specialty societies. We present the SCIONs theory, a network of organizations that deploy a coordination strategy based on trust and cooperation to solve complex problems. By applying sociological concepts, we identified key characteristics and functions that can inform the development of CRNs, providing practical guidance for their implementation. Results: Our analysis reveals that CRNs offer a unique mode of coordination that can address complex healthcare challenges, leveraging traditional market and government efforts. CRNs can support the vision of a learning health system and evidence-based medicine by harnessing the power of RWE, transforming, and improving healthcare delivery. Conclusion and Implications for Translation: CRNs have the potential to transform evidence generation in healthcare by curating and integrating multiple data sources that can address the data needs of multiple CRN partners. This American solution to the provision of evidence for supporting decision-making in healthcare builds on professional society relationships; the CRN model has demonstrated success in large national registries and warrants expansion to other specialty areas. By understanding the organizational sociology of CRNs, we can unlock their full potential to drive innovation, efficiency, and quality improvement in healthcare.
Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. In the phase 3b/4 PSORIATYK SCALP trial, deucravacitinib was superior to placebo at Week 16 in patients with moderate to severe scalp psoriasis, including those with less extensive overall psoriasis (total body surface area [BSA] involvement ≥3%). This analysis evaluates the time to meaningful improvement in patient-reported outcomes (PROs) in patients treated with deucravacitinib vs placebo in the PSORIATYK SCALP trial. Methods: Patients aged ≥18 years with moderate to severe scalp psoriasis were randomized 1:2 to once-daily placebo or deucravacitinib 6 mg. Evaluated PROs included scalp-specific itch, pain and flaking, and whole-body itch numeric rating scales (NRS), Scalpdex, and Dermatology Life Quality Index (DLQI). Times to meaningful improvement in these PROs (≥4-points reduction from baseline for NRS measures and DLQI; ≥20-point reduction for Scalpdex) were estimated using Kaplan-Meier methods. Cox regression models were used to calculate hazard ratios (HRs) and confidence intervals (CIs) for response up to 16 weeks. Results are reported for the overall population and for subgroups of patients with baseline BSA 3%–10% and BSA >10% at baseline. Results: In the overall population (placebo: n = 51; deucravacitinib: n = 103), patients treated with deucravacitinib had a shorter median time to meaningful improvement and were significantly more likely to achieve response by Week 16 for all PROs compared with patients receiving placebo (P < 0.05). In patients treated with deucravacitinib, the median time (95% CI) to meaningful improvement was 9.0 (8.0, 16.3), 8.7 (2.6, 15.7), 8.0 (4.1, 8.1), 8.3 (4.1, 15.7), and 2.1 (1.4, 4.3) weeks for scalp-specific itch, pain, and flaking NRS, whole-body itch NRS, and DLQI, respectively. The median time to meaningful improvement was also shorter with deucravacitinib vs placebo for all PROs in both the BSA 3%–10% and BSA <10% subgroups. Conclusion: Deucravacitinib was associated with a shorter time to meaningful improvement vs placebo across evaluated PROs in the overall population and in BSA subgroups.
Introduction: In the phase 3b/4 PSORIATYK SCALP trial, deucravacitinib achieved superiority vs placebo for the primary and all key secondary endpoints at Week 16 in patients with moderate to severe scalp psoriasis. Patient-reported outcomes (PROs) provide additional information on treatment efficacy by capturing patients’ experiences and impact on their quality of life (QoL). This analysis evaluated the association between PROs and clinician-reported outcomes (CROs) in patients treated with deucravacitinib vs placebo. Methods: This ad hoc analysis evaluated the associations between PROs (scalp-specific itch, pain, and flaking numeric rating scale [NRS], Scalpdex, and Dermatology Life Quality Index [DLQI]) and CROs (scalp-specific Physician Global Assessment [ss-PGA] and Psoriasis Scalp Severity Index [PSSI]) using Spearman’s correlation coefficients for absolute scores at baseline and Week 16. Descriptive analyses of PRO changes from baseline and response rates by CRO response groups were also calculated for deucravacitinib-treated patients. Results: Baseline severity, scalp-specific symptoms, and QoL were similar between treatment groups, yet correlations were weak between PRO and CRO absolute values. At Week 16, correlations between PROs and CROs were stronger in deucravacitinib-treated patients vs placebo. The strongest correlations in deucravacitinib-treated patients were for itch and flaking NRS and Scalpdex symptoms (≥0.6; P<0.0001). QoL was moderately correlated with CROs (<0.6; P<0.0001) in deucravacitinib-treated patients. At Week 16, clinically meaningful improvements in scalp-specific itch, pain, and flaking and DLQI were reported by 76.2%, 89.5%, 88.4%, and 82.6% of patients who achieved ss-PGA 0/1 and by 72.7%, 66.7%, 91.7%, and 83.3% of those achieving PSSI 90, respectively. A 20-point reduction in Scalpdex total score was also reported by 75.6% and 66.7% of deucravacitinib-treated patients who achieved ss-PGA 0/1 and PSSI 90, respectively. Conclusion: In deucravacitinib-treated patients, there was a strong correlation between patient-reported scalp symptoms and scalp-specific CROs, confirming the treatment benefit from the patient perspective. Moderate QoL/scalp-specific CRO correlations indicate that PROs provide complementary information about treatment benefits.
This article examines the provision of digital resilience in public governance through the lens of synthesising Ukraine's experience of “forced innovation” with European regulatory standards in the context of technological evolution. Based on an analysis of the Municipal Dispatch Service ‘1562’in Kharkiv during 2023- 2025, which demonstrated remarkable operational resilience indicators under full-scale war conditions (97.3% availability whilst processing over 1.2 million requests), the author identifies a unique phenomenon whereby extreme conditions stimulate technological innovations that outpace traditional regulatory mechanisms. The research reveals the evolution of EU-Ukraine cooperation in digital transformation through the EU4DigitalUA, DT4UA programmes and GovTech dialogue, demonstrating a transformation from a ‘donor-recipient’ model to a strategic partnership for exchanging innovative practices. A comparative analysis of the Ukrainian adaptive response model and the European regulatory DORA (Digital Operational Resilience Act) model reveals their complementarity across five key dimensions: ICT risk management, ease of implementation, scalability, viability under threats, and resource efficiency. The author proposes a theoretical ‘Cascading Resilience’ model – an adaptive system with three levels of operational readiness for each functional block, combining the rapid reactivity of the Ukrainian model with DORA's structured approach through decentralised Web 3.0 technologies. The model envisages not automatic switching between modes, but conscious decisions supported by algorithmic assistance, ensuring functionality even with 60% infrastructure loss. The research raises critical ethical and methodological questions regarding the use of ‘survival data’ from combat zones for training AI systems in other cities, as well as the limitations of simulating real crises. The conclusions emphasise the necessity of synthesising Ukrainian anti-fragility with European systematicity to create a new paradigm of digital resilience adequate to the challenges of an era of global turbulence.
