scholarly journals Real-world clinical performance of SARS-CoV-2 point-of-care diagnostic tests: a systematic review of available trials as per April, 4, 2021

2021 ◽  
Author(s):  
Gabriel Hawthorne ◽  
Adam Harvey
Keyword(s):  
Clinical Practice ◽  
Clinical Performance ◽  
Point Of Care ◽  
Prospective Trial ◽  
Healthcare Providers ◽  
Real Life ◽  
Operating Conditions ◽  
The Real ◽  
Care Facilities ◽  
True Point

AbstractPoint-of-care assays offer a decentralised and fast solution to the diagnosis of SARS-CoV-2 and provide benefits for patients, healthcare workers, healthcare facilities and other environments. This technology has to potential to prevent outbreaks, enable faster adoption of life-changing measures and improve hospitalar workflow. While reviews regarding the performance of those assays exist, a review focused on the real-life clinical performance and point-of-care feasibility of those platforms was missing. Therefore, the objective of this study is to help end users (clinicians, healthcare providers and organisations) to understand the real-life performance of point-of-care assays, aiding in their implementation in decentralised, true point-of-care facilities, or inside hospitals. 871 studies were screened in 3 major databases and 51 studies were included, evaluating 20 antigen tests and 10 nucleic-acid amplification platforms. We excluded studies that used processed samples, pre-selected populations, archived samples and laboratory-only evaluations and strongly favored prospective trial designs in our inclusion criteria. We also investigated package inserts, instructions for use, comments on published studies and manufacturers websites in order to assess feasibility of POC placement and additional information of relevance to the end user. Apart from sensitivity and specificity, we present information on time to results, hands-on time, kit storage, machine operating conditions and regulatory status. To the best of our knowledge, this is the first review to systematically evaluate POC test performance in real-life clinical practice. We found the performance of tests in clinical practice to be markedly different from the manufacturers reported performance and laboratory-only evaluations in the majority of studies. Our findings may help in the decision-making process related to SARS-CoV-2 test in real-life clinical settings.Rationale for the reviewA review focused on the real-life clinical performance and point-of-care feasibility of SARS-CoV-2 diagnostic platforms was missing, impairing the ability of individuals, healthcare providers and test providers to make informed decisions on the adoption of such platforms.Objective(s) or question(s) the review addressesThe objective of this study is to help clinicians, healthcare providers and organisations to understand the real-life performance of point-of-care assays, aiding in their implementation in decentralised, true point-of-care facilities or in complex hospitalar environments.

P.0724 Vortioxetine in routine clinical practice: results from the real-life effectiveness of vortioxetine (RELIEVE) study

2021 ◽  
Vol 53 ◽  
pp. S529-S530
Author(s):  
G. Mattingly ◽  
H. Ren ◽  
M. Cronquist Christensen ◽  
K. Simonsen ◽  
L. Hammer-Helmich
Keyword(s):  
Clinical Practice ◽  
Real Life ◽  
Routine Clinical Practice ◽  
Life Effectiveness ◽  
The Real

Rivaroxaban Safety Threshold at 30 Ng/ml: Are a PT and/or a Aptt an Alternative to a Specific Test in the Real World?

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 5087-5087 ◽  
Author(s):  
Philippe Cauchie ◽  
Laurine Dierge ◽  
Courtois Isabelle ◽  
Alain Alewaeters ◽  
Bernard Chatelain
Keyword(s):  
Conflicts Of Interest ◽  
Point Of Care ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Real Life ◽  
Individual Variability ◽  
Bleeding Complications ◽  
Specific Test ◽  
The Real ◽  
Point Of Care System

Abstract The French Working Group on Perioperative Haemostasis (GIHP) published in March 2013 proposals for the management of major bleeding complications and emergency surgery in patients treated with direct oral anticoagulants, and especially the Rivaroxaban. This Direct Oral Anticoagulant (DOA) induces most of clotting tests, including Prothrombin Time (PT) and APTT. This led the GIHP to a degraded proposition for the institutions who does not propose the specific dosage of the molecule. This proposal assumes that the normality of the PT and aPTT exclude most patients with Rivaroxaban level >30 ng/ml. The aim of our evaluation is to verify the real-life practicability of this proposal. Samples from Rivaroxaban treated patients have been tested with 4 PT reagents: STA Neoplastine R (NeoR), STA Neoplastine CI+, Recombiplastine and Innovin. Four APTT reagents were also tested: STA-PTT automate, STA Cephascreen, Synthasil, Pathrontin SL. All reagents were tested on their specific analysers (STA-R, ACL TOP500, BCS XP). PT reagents were calibrated following manufacturer’s instructions (Stago, Instrumentation Laboratory, Siemens). Rivaroxaban prolongs PT but reagent’s sensitivity varies considerably and we observed a major individual variability, and this even at low Rivaroxaban concentrations. The NeoR presents the greatest sensitivity, the Innovin the lowest. For a normal PT (>70%), the NeoR alone can validly identify patients with Rivaroxaban level > 30ng/ml (sensitivity 93%). With the other reagents, from 42 to 51% of our patients with normal PT has Rivaroxaban level > 30 ng/ml. Two patients with Rivaroxaban > 150 ng/ml had normal PT with these 3 reagents. None of the APTT reagents has sufficient sensitivity to validly exclude these patients. In conclusion, none of the PT reagents can estimate Rivaroxaban concentration. The NeoR is the only reagent that allows distinguishing patients with residual Rivaroxaban level. For all other situations, specific test seems mandatory and the development of point-of-care system should be encouraged. Disclosures No relevant conflicts of interest to declare.

scholarly journals Chronic urticaria in the real‐life clinical practice setting in the UK: results from the noninterventional multicentre AWARE study

2020 ◽  
Vol 45 (8) ◽  
pp. 1003-1010
Author(s):  
S. Savic ◽  
L. Leeman ◽  
T. El‐Shanawany ◽  
R. Ellis ◽  
J.E. Gach ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Chronic Urticaria ◽  
Real Life ◽  
Practice Setting ◽  
The Real ◽  
Clinical Practice Setting ◽  
The Uk

Clinical Trials in Schizophrenia with Results for the Real World

CNS Spectrums ◽  
2006 ◽  
Vol 11 (S7) ◽  
pp. 9-13 ◽  
Author(s):  
Diana O. Perkins
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Real World ◽  
Clinical Decision Making ◽  
Treatment Options ◽  
Healthcare Providers ◽  
Clinical Decision ◽  
Clinical Practices ◽  
Treatment Protocols ◽  
The Real

AbstractMost clinical data for antipsychotics come from studies designed to test the efficacy and safety of the drugs under ideal conditions, in limited subgroups of patients. In contrast, practical clinical trials (PCTs) are designed to test the effectiveness of different treatment options under conditions that more accurately reflect actual clinical practice. Consequently, PCTs are able to provide information that can be utilized by healthcare providers and other decision makers. Characteristics of PCTs include a clinically relevant question, a representative sample of patients and practice settings, sufficient power to identify modest relevant effects, randomization to protect against bias, uncertainty regarding the outcome of treatment, assessment and treatment protocols that enact best clinical practices, simple and relevant outcomes, and limited subject and investigator burden. The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) research program is an example of a PCT. The CATIE study illustrates how PCTs, when properly designed, might be helpful in informing clinical decision making. Because the CATIE study was designed to reflect the effectiveness of antipsychotics under naturalistic clinical conditions, its results should have particular applicability to the arena of clinical practice. This article provides a discussion of the differences between efficacy and effectiveness studies. In assessing the practical utility of results from the CATIE study, much can be learned on how to shape future studies of effectiveness so as to better generate data that are applicable to the “real world.”

scholarly journals P-153 Regorafenib in the real-life clinical practice: data from the czech registry

2016 ◽  
Vol 27 ◽  
pp. ii45 ◽  
Author(s):  
T. Buchler ◽  
Z. Bortlicek ◽  
K. Hejduk ◽  
B. Melichar ◽  
P. Pokorna ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Real Life ◽  
The Real

scholarly journals Are clinical trial results transferable in the real life?

2016 ◽  
Vol 84 (1-2) ◽  
Author(s):  
Enrico Natale ◽  
Alfiera Marsocci
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Recurrent Events ◽  
Randomized Clinical Trials ◽  
Real Life ◽  
Recurrent Event ◽  
The Real ◽  
Number Of Patients ◽  
Clinical Trial Results

<p>Generally in the clinical practice patients are more complex in comparison with those included in the clinical trials. In this article, we discuss three relevant items, which may implement the transferability of the clinical trial results in the real world. The observational studies have fewer restrictions on the number of patients included, due to more relaxed inclusion and exlusion criteria than in randomized clinical trials. The absence of randomization however may lead to potential for bias. The recurrent event analysis may extend the positive results of clinical trials regarding the reductions of the first primary endpoint event to total events, including those beyond the first event. This analysis is of great interest in the clinical practice, where recurrent events are common. Finally the reliability of subgroup analysis is discussed. Pre-specified subgroup analyses are more credible and valuable than <em>post-hoc</em> analyses.</p><p><strong>Riassunto</strong></p><p>Nella pratica clinica i pazienti sono generalmente più complessi rispetto alle popolazioni studiate nei trial clinici. Si rendono necessari pertanto strumenti di analisi che integrino i trial clinici. In questo articolo vengono esaminati alcuni punti di rilevante importanza nella definizione di una corretta applicabilità dei risultati dei trial clinici al mondo reale. Il primo punto riguarda il ruolo e i limiti degli studi osservazionali. Il secondo tratta delle analisi degli eventi ricorrenti, una modalità di analisi dei trial clinici che rende i risultati più aderenti alla vita reale, nella consapevolezza che limitare i dati di outcome al primo evento sia riduttivo rispetto alla necessità di stabilire che l’intervento studiato nel trial confermi la sua efficacia anche sugli eventi successivi al primo. Il terzo punto riguarda la controversa questione delle analisi per sottogruppi, uno strumento utile per generare ipotesi, ma discutibile quando impiegato per rimediare a trial con risultati negativi o estendere i risultati di trial positivi a sottopopolazioni particolari di pazienti. </p>

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