scholarly journals Pharmacogenomics Biomarker Discovery and Validation for Translation in Clinical Practice

2020 ◽  
Author(s):  
Mariamena Arbitrio ◽  
Francesca Scionti ◽  
Maria Teresa Di Martino ◽  
Daniele Caracciolo ◽  
Licia Pensabene ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Biomarker Discovery ◽  
Pharmacogenomics Biomarker

scholarly journals Development, validation, and implementation of biomarker testing in cardiovascular medicine state-of-the-art: proceedings of the European Society of Cardiology—Cardiovascular Round Table

2020 ◽  
Author(s):  
Perry Elliott ◽  
Martin R Cowie ◽  
Jennifer Franke ◽  
André Ziegler ◽  
Charalambos Antoniades ◽  
...  
Keyword(s):  
Clinical Practice ◽  
New Technologies ◽  
Biomarker Discovery ◽  
Real Life ◽  
High Sensitivity ◽  
Standard Of Care ◽  
Round Table ◽  
Current Standard ◽  
Development Pathway ◽  
Regulatory Standards

Abstract Many biomarkers that could be used to assess ejection fraction, heart failure, or myocardial infarction fail to translate into clinical practice because they lack essential performance characteristics or fail to meet regulatory standards for approval. Despite their potential, new technologies have added to the complexities of successful translation into clinical practice. Biomarker discovery and implementation require a standardized approach that includes: identification of a clinical need; identification of a valid surrogate biomarker; stepwise assay refinement, demonstration of superiority over current standard-of-care; development and understanding of a clinical pathway; and demonstration of real-world performance. Successful biomarkers should improve efficacy or safety of treatment, while being practical at a realistic cost. Everyone involved in cardiovascular healthcare, including researchers, clinicians, and industry partners, are important stakeholders in facilitating the development and implementation of biomarkers. This article provides suggestions for a development pathway for new biomarkers, discusses regulatory issues and challenges, and suggestions for accelerating the pathway to improve patient outcomes. Real-life examples of successful biomarkers—high-sensitivity cardiac troponin, T2* cardiovascular magnetic resonance imaging, and echocardiography—are used to illustrate the value of a standardized development pathway in the translation of concepts into routine clinical practice.

scholarly journals State-of-the-Art Methods and Emerging Fluid Biomarkers in the Diagnostics of Dementia—A Short Review and Diagnostic Algorithm

Diagnostics ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. 788
Author(s):  
Eino Solje ◽  
Alberto Benussi ◽  
Emanuele Buratti ◽  
Anne M. Remes ◽  
Annakaisa Haapasalo ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Single Molecule ◽  
Biomarker Discovery ◽  
State Of The Art ◽  
Lewy Bodies ◽  
Diagnostic Algorithm ◽  
Short Review ◽  
Enzyme Linked Immunosorbent Assay ◽  
Non Invasive ◽  
History Of

The most common neurodegenerative dementias include Alzheimer’s disease (AD), dementia with Lewy bodies (DLB), and frontotemporal dementia (FTD). The correct etiology-based diagnosis is pivotal for clinical management of these diseases as well as for the suitable timing and choosing the accurate disease-modifying therapies when these become available. Enzyme-linked immunosorbent assay (ELISA)-based methods, detecting altered levels of cerebrospinal fluid (CSF) Tau, phosphorylated Tau, and Aβ-42 in AD, allowed the wide use of this set of biomarkers in clinical practice. These analyses demonstrate a high diagnostic accuracy in AD but suffer from a relatively restricted usefulness due to invasiveness and lack of prognostic value. In recent years, the development of novel advanced techniques has offered new state-of-the-art opportunities in biomarker discovery. These include single molecule array technology (SIMOA), a tool for non-invasive analysis of ultra-low levels of central nervous system-derived molecules from biofluids, such as CSF or blood, and real-time quaking (RT-QuIC), developed to analyze misfolded proteins. In the present review, we describe the history of methods used in the fluid biomarker analyses of dementia, discuss specific emerging biomarkers with translational potential for clinical use, and suggest an algorithm for the use of new non-invasive blood biomarkers in clinical practice.

The miR-21 potential of serving as a biomarker for liver diseases in clinical practice

2020 ◽  
Vol 48 (5) ◽  
pp. 2295-2305
Author(s):  
Jiawei Zhang ◽  
Dandan Li ◽  
Rui Zhang ◽  
Peng Gao ◽  
Rongxue Peng ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Liver Diseases ◽  
Hepatic Disease ◽  
Noninvasive Detection ◽  
Diagnosis And Prognosis ◽  
Expected Performance ◽  
Potential Biomarker ◽  
Disease Condition ◽  
Complex Regulatory Network

The role of miR-21 in the pathogenesis of various liver diseases, together with the possibility of detecting microRNA in the circulation, makes miR-21 a potential biomarker for noninvasive detection. In this review, we summarize the potential utility of extracellular miR-21 in the clinical management of hepatic disease patients and compared it with the current clinical practice. MiR-21 shows screening and prognostic value for liver cancer. In liver cirrhosis, miR-21 may serve as a biomarker for the differentiating diagnosis and prognosis. MiR-21 is also a potential biomarker for the severity of hepatitis. We elucidate the disease condition under which miR-21 testing can reach the expected performance. Though miR-21 is a key regulator of liver diseases, microRNAs coordinate with each other in the complex regulatory network. As a result, the performance of miR-21 is better when combined with other microRNAs or classical biomarkers under certain clinical circumstances.

Meeting the Best Practice for Hearing Aid Verification in Children: Challenges and Future Directions

2019 ◽  
Vol 28 (4) ◽  
pp. 877-894
Author(s):  
Nur Azyani Amri ◽  
Tian Kar Quar ◽  
Foong Yen Chong
Keyword(s):  
Clinical Practice ◽  
Hearing Aids ◽  
Best Practice ◽  
Hearing Aid ◽  
Evidence Based ◽  
Future Directions ◽  
Major Barrier ◽  
Klang Valley ◽  
Age Range ◽  
Fitting Hearing Aids

Purpose This study examined the current pediatric amplification practice with an emphasis on hearing aid verification using probe microphone measurement (PMM), among audiologists in Klang Valley, Malaysia. Frequency of practice, access to PMM system, practiced protocols, barriers, and perception toward the benefits of PMM were identified through a survey. Method A questionnaire was distributed to and filled in by the audiologists who provided pediatric amplification service in Klang Valley, Malaysia. One hundred eight ( N = 108) audiologists, composed of 90.3% women and 9.7% men (age range: 23–48 years), participated in the survey. Results PMM was not a clinical routine practiced by a majority of the audiologists, despite its recognition as the best clinical practice that should be incorporated into protocols for fitting hearing aids in children. Variations in practice existed warranting further steps to improve the current practice for children with hearing impairment. The lack of access to PMM equipment was 1 major barrier for the audiologists to practice real-ear verification. Practitioners' characteristics such as time constraints, low confidence, and knowledge levels were also identified as barriers that impede the uptake of the evidence-based practice. Conclusions The implementation of PMM in clinical practice remains a challenge to the audiology profession. A knowledge-transfer approach that takes into consideration the barriers and involves effective collaboration or engagement between the knowledge providers and potential stakeholders is required to promote the clinical application of evidence-based best practice.

Hybrid Telecoaching for Corporate Speech Training and Potential Applications to Clinical Practice

2019 ◽  
Vol 4 (2) ◽  
pp. 322-324
Author(s):  
Thomas F. Burke
Keyword(s):  
Clinical Practice ◽  
Engineering Teams ◽  
Corporate Strategies ◽  
Corporate Speech ◽  
Phone Calls ◽  
Future Clinical Practice ◽  
Fortune 100 ◽  
Potential Applications ◽  
Language Pathology ◽  
Development Engineering

Purpose The purpose of this article was to describe a model for “hybrid speech telecoaching” developed for a Fortune 100 organization and offer a “thought starter” on how clinicians might think of applying these corporate strategies within future clinical practice. Conclusion The author contends in this article that corporate telecommunications and best practices gleaned from software development engineering teams can lend credibility to e-mail, messaging apps, phone calls, or other emerging technology as viable means of hybrid telepractice delivery models and offer ideas about the future of more scalable speech-language pathology services.

What Does Evidence-Based Practice Mean to You? A Follow-Up Study Examining School-Based Speech-Language Pathologists' Perspectives on Evidence-Based Practice

2020 ◽  
Vol 29 (2) ◽  
pp. 688-704
Author(s):  
Katrina Fulcher-Rood ◽  
Anny Castilla-Earls ◽  
Jeff Higginbotham
Keyword(s):  
Clinical Practice ◽  
Research Evidence ◽  
Evidence Based Practice ◽  
Evidence Based ◽  
Clinical Expertise ◽  
Speech Language Pathologists ◽  
School Based ◽  
Research Findings ◽  
Ebp Implementation

Purpose The current investigation is a follow-up from a previous study examining child language diagnostic decision making in school-based speech-language pathologists (SLPs). The purpose of this study was to examine the SLPs' perspectives regarding the use of evidence-based practice (EBP) in their clinical work. Method Semistructured phone interviews were conducted with 25 school-based SLPs who previously participated in an earlier study by Fulcher-Rood et al. 2018). SLPs were asked questions regarding their definition of EBP, the value of research evidence, contexts in which they implement scientific literature in clinical practice, and the barriers to implementing EBP. Results SLPs' definitions of EBP differed from current definitions, in that SLPs only included the use of research findings. SLPs seem to discuss EBP as it relates to treatment and not assessment. Reported barriers to EBP implementation were insufficient time, limited funding, and restrictions from their employment setting. SLPs found it difficult to translate research findings to clinical practice. SLPs implemented external research evidence when they did not have enough clinical expertise regarding a specific client or when they needed scientific evidence to support a strategy they used. Conclusions SLPs appear to use EBP for specific reasons and not for every clinical decision they make. In addition, SLPs rely on EBP for treatment decisions and not for assessment decisions. Educational systems potentially present other challenges that need to be considered for EBP implementation. Considerations for implementation science and the research-to-practice gap are discussed.

Issues in Language Sample Collection and Analysis With Children Using AAC

2014 ◽  
Vol 23 (2) ◽  
pp. 65-74 ◽  
Author(s):  
Gail Van Tatenhove
Keyword(s):  
Clinical Practice ◽  
Augmentative And Alternative Communication ◽  
Language Production ◽  
Expressive Language ◽  
Sample Analysis ◽  
Alternative Communication ◽  
Sample Collection ◽  
Speech Language Pathologists ◽  
Language Sample Analysis ◽  
Language Sample

Language sample analysis is considered one of the best methods of evaluating expressive language production in speaking children. However, the practice of language sample collection and analysis is complicated for speech-language pathologists working with children who use augmentative and alternative communication (AAC) devices. This article identifies six issues regarding use of language sample collection and analysis in clinical practice with children who use AAC devices. The purpose of this article is to encourage speech-language pathologists practicing in the area of AAC to utilize language sample collection and analysis as part of ongoing AAC assessment.

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