scholarly journals INDIRECT CALORIMETRY AS AN OBJECTIVE TECHNIQUE FOR ASSESSING ENERGY NEEDS OF PATIENTS IN CRITICAL STATES

2020 ◽  
Vol 23 (6) ◽  
pp. 329-334
Author(s):  
E. S. Glebova ◽  
E. V. Ivanova-Davidova ◽  
Valery G. Amcheslavsky
Keyword(s):  
Clinical Trials ◽  
Intensive Care ◽  
Clinical Practice ◽  
Indirect Calorimetry ◽  
Narrow Range ◽  
Published Data ◽  
Pediatric Practice ◽  
Metabolic Monitoring ◽  
Energy Needs ◽  
Current Calculation

Background. Nutrition is one of the most important aspects of intensive care. While working over the nutritive program, one should take into account patient’s energy needs, which lie in a narrow range - to avoid under- or overfeeding. Purpose. To compare modern approaches to metabolic rate assessment in patients in ICU and to find the most effective one. Material and methods. The researchers have analyzed published data of clinical trials on metabolic monitoring in Russia and abroad. Results. After the scientific articles had been analyzed, it became evident that current calculation approaches cannot be considered reliable in pediatric clinical practice, especially in ICU. Thus, the indirect calorimetry, as an objective technique for calculating energy needs in patients, should be used in pediatric practice.

scholarly journals Continuous Glucose Monitoring Use in Clinical Trials for On-Market Diabetes Drugs

2021 ◽  
Author(s):  
Bradley Q. Fox ◽  
Peninah F. Benjamin ◽  
Ammara Aqeel ◽  
Emily Fitts ◽  
Spencer Flynn ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Continuous Glucose Monitoring ◽  
Diabetes Care ◽  
Glucose Monitoring ◽  
Published Data ◽  
Start Date ◽  
Treatment Of Diabetes ◽  
Pharmacologic Agents ◽  
Over Time

Despite the growing momentum behind a movement to augment adoption of continuous glucose monitoring (CGM) in clinical practice and investigation, to the best of our knowledge, there are no published data on the historical and recent use of CGM in clinical trials of pharmacologic agents used in the treatment of diabetes. We analyzed 2,032 clinical trials of 40 diabetes therapies currently on the market with a study start date between 1 January 2000 and 31 December 2019. According to ClinicalTrials.gov listings, 119 (5.9%) of these trials used CGM. CGM usage in clinical trials has increased over time, rising from <5% before 2005 to 12.5% in 2019. However, it is still low given its inclusion in the American Diabetes’s Association’s latest guidelines and known limitations of A1C for assessing ongoing diabetes care.

scholarly journals How May Ramucirumab Help Improve Treatment Outcome for Patients with Gastrointestinal Cancers?

Cancers ◽  
2021 ◽  
Vol 13 (14) ◽  
pp. 3536
Author(s):  
Ming-Huang Chen ◽  
Sheng-Nan Lu ◽  
Chien-Hung Chen ◽  
Peng-Chan Lin ◽  
Jeng-Kai Jiang ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Treatment Outcome ◽  
Clinical Practice ◽  
Safety Data ◽  
Published Data ◽  
Similar Data ◽  
Phase 3 ◽  
Improve Treatment ◽  
Improve Treatment Outcome ◽  
Gi Cancers

GI cancers are characterized by high recurrence rates and a dismal prognosis and there is an urgent need for new therapeutic approaches. This is a narrative review designed to provide a summary of the efficacy as measured by overall survival, progression free survival, and safety data from phase 3 randomized controlled GI clinical trials of ramucirumab including those from important pre-specified patient subgroups and evidence from real clinical practice worldwide. Quality of life (QOL) is discussed where data are available. Our aim was to summarize the efficacy and safety of ramucirumab in the treatment of GI cancers using these existing published data with a view to demonstrating how ramucirumab may help improve treatment outcome for patients with GI cancers. The data indicate that ramucirumab is efficacious, safe, and tolerable across the intent-to-treat patient populations as a whole and across several pre-specified subgroups, even those whose disease is traditionally more difficult to treat. Furthermore, survival outcomes observed in real-world clinical practice demonstrate similar data from phase 3 clinical trials even in patients with complications, suggesting that the benefits of ramucirumab translate in actual clinical practice.

Antithrombin III Concentrates-Are they Clinically Useful?

1995 ◽  
Vol 73 (03) ◽  
pp. 340-348 ◽  
Author(s):  
K Lechner ◽  
P A Kyrle
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Randomized Clinical Trials ◽  
Antithrombin Iii ◽  
Animal Experiments ◽  
Published Data ◽  
Thromboembolic Complications ◽  
At Iii ◽  
Antithrombin Iii Deficiency ◽  
Theoretical Considerations

SummaryTreatment with AT III concentrates is a good example for the discrepancy between the optimistic expectations based on theoretical considerations or animal experiments and the result of clinical studies. 15 years after the introduction into clinical practice, a benefit for patients treated with AT III concentrates has not been proven. In hereditary antithrombin III deficiency, randomized clinical trials are completely lacking and only few and small sized randomized studies were performed in patients with acquired AT III deficiency. In none of these trials, a significant clinical benefit with regard to reduction of morbidity or mortality was detectable. Based on the published data, one can state that AT III concentrates may be beneficial in some special clinical situations in patients with hereditary antithrombin III deficiency (such as delivery, acute serious thromboembolic complications and postoperative thromboprophylaxis). In acquired AT III deficiency, there is no proven indication for the use of AT III concentrates.

scholarly journals Synthesis of qualitative research studies regarding the factors surrounding UK critical care trial infrastructure

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e030815 ◽  
Author(s):  
Natalie Pattison ◽  
Nishkantha Arulkumaran ◽  
Geraldine O'Gara ◽  
Bronwen Connolly ◽  
Sally Humphreys ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Critical Care ◽  
Intensive Care ◽  
Clinical Practice ◽  
Patient Care ◽  
Human Study ◽  
Qualitative Synthesis ◽  
Research Activity ◽  
Patient Consent ◽  
The Uk

Conducting clinical trials in critical care is integral to improving patient care. Unique practical and ethical considerations exist in this patient population that make patient recruitment challenging, including narrow recruitment timeframes and obtaining patient consent often in time-critical situations. Units currently vary significantly in their ability to recruit according to infrastructure and level of research activity.AimTo identify variability in the research infrastructure of UK intensive care units and their ability to conduct research and recruit patients into clinical trials.DesignWe evaluated factors related to intensive care patient enrolment into clinical trials in the UK. This consisted of a qualitative synthesis carried out with two datasets of in-depth interviews (distinct participants across the two datasets) conducted with 27 intensive care consultants (n=9), research nurses (n=17) and trial coordinators (n=1) from 27 units across the UK. Primary and secondary analyses of two datasets (one dataset had been analysed previously) were undertaken in the thematic analysis.FindingsThe synthesis yielded an overarching core theme of normalising research, characterised by motivations for promoting research and fostering research-active cultures within resource constraints, with six themes under this to explain the factors influencing critical care research capacity: organisational, human, study, practical resources, clinician and patient/family factors. There was a strong sense of integrating research in routine clinical practice, and recommendations are outlined.ConclusionsThe central and transferable tenet of normalising research advocates the importance of developing a culture where research is inclusive alongside clinical practice in routine patient care and is a requisite for all healthcare individuals from organisational to direct patient contact level.

scholarly journals Continuous Glucose Monitoring Use in Clinical Trials for On-Market Diabetes Drugs

2021 ◽  
Author(s):  
Bradley Q. Fox ◽  
Peninah F. Benjamin ◽  
Ammara Aqeel ◽  
Emily Fitts ◽  
Spencer Flynn ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Continuous Glucose Monitoring ◽  
Diabetes Care ◽  
Glucose Monitoring ◽  
Published Data ◽  
Start Date ◽  
Treatment Of Diabetes ◽  
Pharmacologic Agents ◽  
Over Time

Despite the growing momentum behind a movement to augment adoption of continuous glucose monitoring (CGM) in clinical practice and investigation, to the best of our knowledge, there are no published data on the historical and recent use of CGM in clinical trials of pharmacologic agents used in the treatment of diabetes. We analyzed 2,032 clinical trials of 40 diabetes therapies currently on the market with a study start date between 1 January 2000 and 31 December 2019. According to ClinicalTrials.gov listings, 119 (5.9%) of these trials used CGM. CGM usage in clinical trials has increased over time, rising from <5% before 2005 to 12.5% in 2019. However, it is still low given its inclusion in the American Diabetes’s Association’s latest guidelines and known limitations of A1C for assessing ongoing diabetes care.

Controlling Hypertension and Stroke Prevention – From Guideline to Clinical Practice

2011 ◽  
Vol 3 (1) ◽  
pp. 30
Author(s):  
Anding Xu ◽  
Zefeng Tan ◽  
◽  
Keyword(s):  
Risk Factors ◽  
Blood Pressure ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Stroke Prevention ◽  
Modifiable Risk Factors ◽  
Cerebrovascular Events

Hypertension is the most important of the prevalent and modifiable risk factors for stroke. Based on evidence, blood pressure (BP) lowering is recommended in guidelines for the prevention of stroke. However, there are still some uncertainties in the guidelines for controlling BP and preventing stroke in patients with previous cerebrovascular events, such as the goal BP, who to treat and which class of BP-lowering drugs to use. This article discusses these questions by reviewing guidelines and corresponding clinical trials, with the aim of reducing the gap between guidelines and clinical practice.

ANTIBODY-DRUG CONJUGATES FOR TARGETED CANCER THERAPY

2019 ◽  
Vol 65 (6) ◽  
pp. 777-784
Author(s):  
David Korman
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Gemtuzumab Ozogamicin ◽  
Brentuximab Vedotin ◽  
Cytostatic Agent ◽  
Cytostatic Agents ◽  
Drug Conjugates ◽  
Natural Substances ◽  
Intracellular Release ◽  
High Antitumor Activity

Monoclonal antibody (MAB) conjugates with cytostatic agents (ADC) are intended for selective delivery of a cytostatic agent to a tumor cell. Three ADC have been approved for clinical use (gemtuzumab ozogamicin, brentuximab vedotin, trastuzumab-DM1); a few dozens of other ADC are undergoing clinical trials. Several derivatives of natural substances (antibiotics and inhibitors of microtubules) having a high antitumor activity are used as cytostatic agents included in ADC. They are inapplicable in clinical practice as self-sustained drugs due to their considerable toxicity. Of great importance for the implementation of the ADC effect is the character of a linker connecting MAB with a cytostatic agent and ensuring selective intracellular release after ADC internalization. The structure, mechanisms of action, and the results of clinical trials of a number of ADC are considered here as an illustration (by way of example). The development of ADC can help introduce new effective cytostatic agents into clinical practice.

Nurses’ Perceptions of a Care Plan Information Technology Solution With Hundreds of Clinical Practice Guidelines in Adult Intensive Care Units: Survey Study (Preprint)

2018 ◽  
Author(s):  
Azizeh Khaled Sowan ◽  
Meghan Leibas ◽  
Albert Tarriela ◽  
Charles Reed
Keyword(s):  
Intensive Care ◽  
Quality Of Care ◽  
Clinical Practice ◽  
Nursing Care ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Care Plan ◽  
System Use ◽  
Nurses Perceptions

BACKGROUND The integration of clinical practice guidelines (CPGs) into the nursing care plan and documentation systems aims to translate evidence into practice, improve safety and quality of care, and standardize care processes. OBJECTIVE This study aimed to evaluate nurses’ perceptions of the usability of a nursing care plan solution that includes 234 CPGs. METHODS A total of 100 nurses from 4 adult intensive care units (ICUs) responded to a survey measuring nurses’ perceptions of system usability. The survey included 37 rated items and 3 open-ended questions. RESULTS Nurses’ perceptions were favorable with more than 60.0% (60/100) in agreement on 12 features of the system and negative to moderate with 20.0% (20/100), to 59.0% (59/100) in agreement on 19 features. The majority of the nurses (80/100, 80.0% to 90/100, 90.0%) agreed on 4 missing safety features within the system. More than half of the nurses believed they would benefit from refresher classes on system use. Overall satisfaction with the system was just above average (54/100, 54.0%). Common positive themes from the narrative data were related to the system serving as a reminder for complete documentation and individualizing patient care. Common negative aspects were related to duplicate charting, difficulty locating CPGs, missing unit-specific CPGs, irrelevancy of information, and lack of perceived system value on patient outcomes. No relationship was found between years of system use or ICU experience and satisfaction with the system (P=.10 to P=.25). CONCLUSIONS Care plan systems in ICUs should be easy to navigate; support efficient documentation; present relevant, unit-specific, and easy-to-find information; endorse interdisciplinary communication; and improve safety and quality of care.

scholarly journals International teleproctoring in neurointerventional surgery and its potential impact on clinical trials in the era of COVID-19: legal and technical considerations

2020 ◽  
pp. neurintsurg-2020-017053
Author(s):  
Emanuele Orru' ◽  
Miklos Marosfoi ◽  
Neil V Patel ◽  
Alexander L Coon ◽  
Christoph Wald ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
High Resolution ◽  
Situational Awareness ◽  
Flow Diverter ◽  
Multiple Sources ◽  
Remote Supervision ◽  
Angiography Suite ◽  
The Us ◽  
Travel Restrictions

BackgroundExisting travel restrictions limit the mobility of proctors, significantly delaying clinical trials and the introduction of new neurointerventional devices. We aim to describe in detail technical and legal considerations regarding international teleproctoring, a tool that could waive the need for in-person supervision during procedures.MethodsInternational teleproctoring was chosen to provide remote supervision during the first three intracranial aneurysm treatments with a new flow diverter (currently subject of a clinical trial) in the US. Real-time, high-resolution transmission software streamed audiovisual data to a proctor located in Canada. The software allowed the transmission of images in a de-identified, HIPAA-compliant manner.ResultsAll three flow diverters were implanted as desired by operator and proctor and without complication. The proctor could swap between images from multiple sources and reported complete spatial and situational awareness, without any significant lag or delay in communication. Procedural times and radiologic dose were similar to those of uncomplicated, routine flow diversion cases at our institution.ConclusionsInternational teleproctoring was successfully implemented in our clinical practice. Its first use provided important insights for establishing this tool in our field. With no clear horizon for lifting the current travel restrictions, teleproctoring has the potential to remove the need for proctor presence in the angiography suite, thereby allowing the field to advance through the continuation of trials and the introduction of new devices in clinical practice. In order for this tool to be used safely and effectively, highly reliable connection and high-resolution equipment is necessary, and multiple legal nuances have to be considered.

scholarly journals Impact on actual clinical practice of the latest evidence for percutaneous closure of patent foramen ovale associated with stroke. A single center experience

2021 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
L Carnero Montoro ◽  
M Ruiz Ortiz ◽  
N Paredes Hurtado ◽  
M Delgado Ortega ◽  
A Rodriguez Almodovar ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Percutaneous Closure ◽  
Publication Date ◽  
Foramen Ovale ◽  
Complex Anatomy ◽  
The Mean ◽  
The Impact

Abstract Funding Acknowledgements Type of funding sources: None. Background and aims Since september 14th, 2017. Three large clinical trials demonstrated that, in selected patients, percutaneous closure of patent foramen ovale (PFO) was associated with lower recurrence in patients with cryptogenic stroke (CS). Our aim was to determine the impact of these findings on routine  clinical practice in a tertiary hospital. Methods Patients with percutaneous closure of PFO due to CS (January 2001-January 2020) were included. The clinical characteristics were analyzed individually and grouped in the RoPE score, before and after the publication date. Complex anatomy (CA) defined as interatrial septum aneurysm or basal wide bubble passage was evaluated in both periods. Results 293 patients were included. The mean age was 49 ± 11 years, 15% were older than 60 years, 60% men, 26% hypertensive, 28% smokers and 7%diabetics. The median RoPEscore was 6 [p25-75, 5-7] and 75% met CA criteria. Since september 14th, 2017, the frequency of CA and the mean age of the patients were significantly higher (89% vs. 69% p &lt;0.0005 and 51 ± 11 vs. 48 ± 11 years, p = 0.02, respectively), and RoPEscore, significantly lower (5 [5-7] vs. 6 [5-7], p = 0.02). Conclusion The publication of clinical trials wich demonstrated the benefit of percutaneous closure of PFO in CS had a significant impact on the daily clinical practice of our institution, with an increase in indications for CA, despite a clinical profile suggestive of lower causal probability of PFO.

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