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Practice patterns and 90-day treatment-related morbidity in early-stage cervical cancer

To evaluate the impact of the Laparoscopic Approach to Cervical Cancer (LACC) Trial on patterns of care and surgery-related morbidity in early-stage cervical cancer

GEN-RWD Sandbox:Bridging the Gap Between Hospital Data Privacy and External Research Insights with Distributed Analytics

Background: Artificial intelligence (AI) has become a pivotal tool in advancing contemporary personalised medicine, with the goal of tailoring treatments to individual patient conditions. This has heightened the demand for access to diverse data from clinical practice and daily life for research, posing challenges due to the sensitive nature of medical information, including genetics and health conditions. Regulations like the Health Insurance Portability and Accountability Act (HIPAA) in the U.S. and the General Data Protection Regulation (GDPR) in Europe aim to strike a balance between data security, privacy, and the imperative for access.Results: We present the Gemelli Generator - Real World Data (GEN-RWD) Sandbox, a modular multi-agent platform designed for distributed analytics in healthcare. Its primary objective is to empower external researchers to leverage hospital data while upholding privacy and ownership, obviating the need for direct data sharing. Docker compatibility adds an extra layer of flexibility, and scalability is assured through modular design, facilitating combinations of Proxy and Processor modules with various graphical interfaces. Security and reliability are reinforced through components like Identity and Access Management (IAM) agent, and a Blockchain-based notarisation module. Certification processes verify the identities of information senders and receivers.Conclusions: The GEN-RWD Sandbox architecture achieves a good level of usability while ensuring a blend of flexibility, scalability, and security. Featuring a user-friendly graphical interface catering to diverse technical expertise, its external accessibility enables personnel outside the hospital to use the platform. Overall, the GEN-RWD Sandbox emerges as a comprehensive solution for healthcare distributed analytics, maintaining a delicate equilibrium between accessibility, scalability, and securit

Impact of microcirculatory video quality on the evaluation of sublingual microcirculation in critically ill patients

We aimed to assess the impact of image quality on microcirculatory evaluation with sidestream dark-field (SDF) videomicroscopy in critically ill patients and explore factors associated with low video quality. This was a retrospective analysis of a single-centre prospective observational study. Videos of the sublingual microcirculation were recorded using SDF videomicroscopy in 100 adult patients within 12 h from admittance to the intensive care unit and every 24 h until discharge/death. Parameters of vessel density and perfusion were calculated offline for small vessels. For all videos, a quality score (-12 = unacceptable, 1 = suboptimal, 2 = optimal) was assigned for brightness, focus, content, stability, pressure and duration. Videos with a total score ≤8 were deemed as unacceptable. A total of 2455 videos (853 triplets) was analysed. Quality was acceptable in 56 % of videos. Lower quality was associated with worse microvascular density and perfusion. Unreliable triplets (≥1 unacceptable or missing video, 65 % of total) showed lower vessel density, worse perfusion and higher flow heterogeneity as compared to reliable triplets (p 8, p < 0.001) or requiring mechanical ventilation (18.0 ± 4.5 vs. 17.2 ± 3.8 mm/mm(2) in not mechanically ventilated patients, p = 0.059). We concluded that SDF video quality depends on both the operator's experience and patient's cooperation. Low-quality videos may produce spurious data, leading to an overestimation of microvascular alterations

Changes in the sublingual microcirculation following aortic surgery under balanced or total intravenous anaesthesia: a prospective observational study

In vascular surgery with aortic cross-clamping, ischemia/reperfusion injury induces systemic haemodynamic and microcirculatory disturbances. Different anaesthetic regimens may have a varying impact on tissue perfusion. The aim of this study was to explore changes in microvascular perfusion in patients undergoing elective open abdominal aortic aneurysm repair under balanced or total intravenous anaesthesia

Plasma Free Hemoglobin and Microcirculatory Response to Fresh or Old Blood Transfusions in Sepsis

<div><p>Background</p><p>Free hemoglobin (fHb) may induce vasoconstriction by scavenging nitric oxide. It may increase in older blood units due to storage lesions. This study evaluated whether old red blood cell transfusion increases plasma fHb in sepsis and how the microvascular response may be affected.</p><p>Methods</p><p>This is a secondary analysis of a randomized study. Twenty adult septic patients received either fresh or old (<10 or >15 days storage, respectively) RBC transfusions. fHb was measured in RBC units and in the plasma before and 1 hour after transfusion. Simultaneously, the sublingual microcirculation was assessed with sidestream-dark field imaging. The perfused boundary region was calculated as an index of glycocalyx damage. Tissue oxygen saturation (StO₂) and Hb index (THI) were measured with near-infrared spectroscopy and a vascular occlusion test was performed.</p><p>Results</p><p>Similar fHb levels were found in the supernatant of fresh and old RBC units. Despite this, plasma fHb increased in the old RBC group after transfusion (from 0.125 [0.098–0.219] mg/mL to 0.238 [0.163–0.369] mg/mL, p = 0.006). The sublingual microcirculation was unaltered in both groups, while THI increased. The change in plasma fHb was inversely correlated with the changes in total vessel density (r = -0.57 [95% confidence interval -0.82, -0.16], p = 0.008), De Backer score (r = -0.63 [95% confidence interval -0.84, -0.25], p = 0.003) and THI (r = -0.72 [95% confidence interval -0.88, -0.39], p = 0.0003).</p><p>Conclusions</p><p>Old RBC transfusion was associated with an increase in plasma fHb in septic patients. Increasing plasma fHb levels were associated with decreased microvascular density.</p><p>Trial Registration</p><p>ClinicalTrials.gov <a href="https://www.clinicaltrials.gov/ct2/show/NCT01584999" target="_blank">NCT01584999</a></p></div

Impact of microcirculatory video quality on the evaluation of sublingual microcirculation in critically ill patients

We aimed to assess the impact of image quality on microcirculatory evaluation with sidestream dark-field (SDF) videomicroscopy in critically ill patients and explore factors associated with low video quality. This was a retrospective analysis of a single-centre prospective observational study. Videos of the sublingual microcirculation were recorded using SDF videomicroscopy in 100 adult patients within 12 h from admittance to the intensive care unit and every 24 h until discharge/death. Parameters of vessel density and perfusion were calculated offline for small vessels. For all videos, a quality score (-12 = unacceptable, 1 = suboptimal, 2 = optimal) was assigned for brightness, focus, content, stability, pressure and duration. Videos with a total score ≤8 were deemed as unacceptable. A total of 2455 videos (853 triplets) was analysed. Quality was acceptable in 56 % of videos. Lower quality was associated with worse microvascular density and perfusion. Unreliable triplets (≥1 unacceptable or missing video, 65 % of total) showed lower vessel density, worse perfusion and higher flow heterogeneity as compared to reliable triplets (p 8, p < 0.001) or requiring mechanical ventilation (18.0 ± 4.5 vs. 17.2 ± 3.8 mm/mm(2) in not mechanically ventilated patients, p = 0.059). We concluded that SDF video quality depends on both the operator's experience and patient's cooperation. Low-quality videos may produce spurious data, leading to an overestimation of microvascular alteration

Hematologic, hemodynamic and gas exchange variables in the two groups (baseline and 1 hour after transfusion).

<p>^aThese data have been already presented in [<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0122655#pone.0122655.ref016" target="_blank">16</a>] as “non-leukodepleted group”.</p><p>^bpre vs. post, Wilcoxon matched-pairs signed rank test.</p><p>^c between-group comparison of delta [after-before] values, Mann-Whitney U test.</p><p>^ddp<0.01</p><p>^dddp<0.001, vs. fresh RBCs group at the same time point, Mann-Whitney U test.</p><p>Data are expressed as median (interquartile range).</p><p>RBCs = red blood cells; Hb = haemoglobin; Hct = haematocrit; HR = heart rate; MAP = mean arterial pressure; T = body temperature; WBC = white blood cell count; PLT = platelet count; BE = base excess; Lac = arterial lactate levels.</p><p>Hematologic, hemodynamic and gas exchange variables in the two groups (baseline and 1 hour after transfusion).</p

Patient characteristics for the two groups.

<p>RBCs = red blood cells; SAPS II = Simplified Acute Physiology Score II; ICU = Intensive Care Unit; SOFA = Simplified Organ Failure Assessment.</p><p>Data are expressed as median (interquartile range) unless stated otherwise. Sepsis, severe sepsis, septic shock are reported as independent categories.</p><p>^aThese data have been already presented in [<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0122655#pone.0122655.ref016" target="_blank">16</a>] as “non-leukodepleted group”.</p><p>^bnumber of patients; dose in μg/kg*min [median (interquartile range)].</p><p>Patient characteristics for the two groups.</p