Investigator-Reported Versus Adjudicated Clinical Events

2021 ◽  
Vol 78 (15) ◽  
pp. 1538-1540
Author(s):  
Stephen J. Greene ◽  
Javed Butler
Keyword(s):  
1976 ◽  
Vol 36 (02) ◽  
pp. 411-423 ◽  
Author(s):  
Nicholas Lekas ◽  
J. C Rosenberg

SummaryHuman platelets labeled with 51Cr were used to determine the contribution made by platelet lysis to the platelet release reaction and platelet aggregation induced by rabbit antihuman platelet serum (APS) and equine antihuman thymocyte globulin (ATG). Platelets were tested in both plasma (PRP) and non-plasma containing media. Antibodies directed against platelets, either as APS or ATG, induced significant amounts of platelet release and aggregation, as well as some degree of lysis, in the absence of complement. The presence of complement increased platelet lysis and aggregation, but not the release reaction. Non-immune horse gamma globulin produced different responses depending upon whether platelets were investigated in PRP or non-plasma containing media. Aggregation was seen in the latter but not the former. These differences can be explained by the presence of plasma components which prevent non-specific immune complexes from causing platelet aggregation. Since platelets in vivo are always in a plasma medium, one must be wary of utilizing data from platelet studies in synthetic plasma-free media as the basis of explaining clinical events. These observations demonstrate at least two, and possibly three, different mechanisms whereby ATG could activate platelets causing thrombotic complications and thrombocytopenia, i.e., via 1) specific and, 2) non-specific non-lytic pathways and 3) a lytic pathway.


2020 ◽  
Vol 132 (6) ◽  
pp. 1952-1960 ◽  
Author(s):  
Seung-Bo Lee ◽  
Hakseung Kim ◽  
Young-Tak Kim ◽  
Frederick A. Zeiler ◽  
Peter Smielewski ◽  
...  

OBJECTIVEMonitoring intracranial and arterial blood pressure (ICP and ABP, respectively) provides crucial information regarding the neurological status of patients with traumatic brain injury (TBI). However, these signals are often heavily affected by artifacts, which may significantly reduce the reliability of the clinical determinations derived from the signals. The goal of this work was to eliminate signal artifacts from continuous ICP and ABP monitoring via deep learning techniques and to assess the changes in the prognostic capacities of clinical parameters after artifact elimination.METHODSThe first 24 hours of monitoring ICP and ABP in a total of 309 patients with TBI was retrospectively analyzed. An artifact elimination model for ICP and ABP was constructed via a stacked convolutional autoencoder (SCAE) and convolutional neural network (CNN) with 10-fold cross-validation tests. The prevalence and prognostic capacity of ICP- and ABP-related clinical events were compared before and after artifact elimination.RESULTSThe proposed SCAE-CNN model exhibited reliable accuracy in eliminating ABP and ICP artifacts (net prediction rates of 97% and 94%, respectively). The prevalence of ICP- and ABP-related clinical events (i.e., systemic hypotension, intracranial hypertension, cerebral hypoperfusion, and poor cerebrovascular reactivity) all decreased significantly after artifact removal.CONCLUSIONSThe SCAE-CNN model can be reliably used to eliminate artifacts, which significantly improves the reliability and efficacy of ICP- and ABP-derived clinical parameters for prognostic determinations after TBI.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Tzikas ◽  
A Samaras ◽  
A Kartas ◽  
D Vasdeki ◽  
G Fotos ◽  
...  

Abstract Background Oral anticoagulation (OAC) is paramount to effective thromboprophylaxis; yet adherence to OAC remains largely suboptimal in patients with atrial fibrillation (AF). Purpose We aimed to assess the impact of an educational, motivational intervention on the adherence to OAC in patients with non-valvular AF. Methods Hospitalised patients with non-valvular AF who received OAC were randomly assigned to usual medical care or a proactive intervention, comprising motivational interviewing and tailored counseling on medication adherence. The primary study outcome was adherence to OAC at 1-year, evaluated as Proportion of Days Covered (PDC) by OAC regimens and assessed through nationwide prescription registers. Secondary outcomes included the rate of persistence to OAC, gaps in treatment, proportion of VKA-takers with labile INR (defined as time to therapeutic range<70%) and clinical events. Results A total of 1009 patients were randomised, 500 in the intervention group and 509 in the control group. At 1-year follow-up, 77.2% (386/500) of patients in the intervention group had good adherence (PDC>80%), compared with 55% (280/509) in the control group (adjusted odds ratio 2.84, 95% confidence interval 2.14–3.75; p<0.001). Mean PDC±SD was 0.85±0.26 and 0.75±0.31, respectively (p<0.001). Patients that received the intervention were more likely to persist in their OAC therapy at 1 year, while usual medical care was associated with more major (≥3 months) treatment gaps [Figure]. Among 212 VKA-takers, patients in the intervention group were less likely to have labile INR compared with those in the control group [21/120 (17.1%) vs 34/92 (37.1%), OR 0.33 95% CI 1.15–0.72, p=0.005]. Clinical events over a median follow-up period of 2 years occurred at a numerically lower, yet non-significant, rate in the intervention group [Table]. Conclusions In patients receiving OAC therapy for non-valvular AF, a motivational intervention significantly improved patterns of medication adherence, without significantly affecting clinical outcomes. Primary and secondary outcomes Funding Acknowledgement Type of funding source: None


2021 ◽  
Vol 22 (11) ◽  
pp. 5564
Author(s):  
Ronald M. Sánchez-Ávila ◽  
Natalia Vázquez ◽  
Manuel Chacón ◽  
Mairobi Persinal-Medina ◽  
Agustín Brea-Pastor ◽  
...  

The purpose of this work is to describe the use of Fibrin-Plasma Rich in Growth Factors (PRGF) membranes for the treatment of a rabbit alkali-burn lesion. For this purpose, an alkali-burn lesion was induced in 15 rabbits. A week later, clinical events were evaluated and rabbits were divided into five treatment groups: rabbits treated with medical treatment, with a fibrin-PRGF membrane cultured with autologous or heterologous rabbit Limbal Epithelial Progenitor Cells (LEPCs), with a fibrin-PRGF membrane in a Simple Limbal Epithelial Transplantation and with a fibrin-PRGF membrane without cultured LEPCs. After 40 days of follow-up, corneas were subjected to histochemical examination and immunostaining against corneal or conjunctival markers. Seven days after alkali-burn lesion, it was observed that rabbits showed opaque cornea, new blood vessels across the limbus penetrating the cornea and epithelial defects. At the end of the follow-up period, an improvement of the clinical parameters analyzed was observed in transplanted rabbits. However, only rabbits transplanted with cultured LEPCs were positive for corneal markers. Otherwise, rabbits in the other three groups showed positive staining against conjunctival markers. In conclusion, fibrin-PRGF membrane improved the chemically induced lesions. Nonetheless, only fibrin-PRGF membranes cultured with rabbit LEPCs were able to restore the corneal surface.


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