scholarly journals Scientific Challenges and Implementation Barriers to Translation of Pharmacogenomics in Clinical Practice

2013 ◽  
Vol 2013 ◽  
pp. 1-17 ◽  
Author(s):  
Y. W. Francis Lam
Keyword(s):  
Clinical Practice ◽  
Drug Therapy ◽  
Drug Development ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Field Work ◽  
Current Approach ◽  
Therapeutic Area ◽  
Implementation Barriers ◽  
Public Expectation

The mapping of the human genome and subsequent advancements in genetic technology had provided clinicians and scientists an understanding of the genetic basis of altered drug pharmacokinetics and pharmacodynamics, as well as some examples of applying genomic data in clinical practice. This has raised the public expectation that predicting patients’ responses to drug therapy is now possible in every therapeutic area, and personalized drug therapy would come sooner than later. However, debate continues among most stakeholders involved in drug development and clinical decision-making on whether pharmacogenomic biomarkers should be used in patient assessment, as well as when and in whom to use the biomarker-based diagnostic tests. Currently, most would agree that achieving the goal of personalized therapy remains years, if not decades, away. Realistic application of genomic findings and technologies in clinical practice and drug development require addressing multiple logistics and challenges that go beyond discovery of gene variants and/or completion of prospective controlled clinical trials. The goal of personalized medicine can only be achieved when all stakeholders in the field work together, with willingness to accept occasional paradigm change in their current approach.

scholarly journals The use of multiple-criteria decision-making theory to measure students’ perceptions of high-fidelity simulation

2017 ◽  
Vol 3 (3) ◽  
pp. 88-93 ◽  
Author(s):  
Maureen Anne Jersby ◽  
Paul Van-Schaik ◽  
Stephen Green ◽  
Lili Nacheva-Skopalik
Keyword(s):  
Decision Making ◽  
Clinical Practice ◽  
Repeated Measures ◽  
Clinical Decision Making ◽  
Learning Experience ◽  
Clinical Decision ◽  
High Fidelity ◽  
High Fidelity Simulation ◽  
Initial Exposure ◽  
Repeated Measures Design

BackgroundHigh-Fidelity Simulation (HFS) has great potential to improve decision-making in clinical practice. Previous studies have found HFS promotes self-confidence, but its effectiveness in clinical practice has not been established. The aim of this research is to establish if HFS facilitates learning that informs decision-making skills in clinical practice using MultipleCriteria DecisionMaking Theory (MCDMT).MethodsThe sample was 2nd year undergraduate pre-registration adult nursing students.MCDMT was used to measure the students’ experience of HFS and how it developed their clinical decision-making skills. MCDMT requires characteristic measurements which for the learning experience were based on five factors that underpin successful learning, and for clinical decision-making, an analytical framework was used. The study used a repeated-measures design to take two measurements: the first one after the first simulation experience and the second one after clinical placement. Baseline measurements were obtained from academics. Data were analysed using the MCDMT tool.ResultsAfter their initial exposure to simulation learning, students reported that HFS provides a high-quality learning experience (87%) and supports all aspects of clinical decision-making (85%). Following clinical practice, the level of support for clinical decision-making remained at 85%, suggesting that students believe HFS promotes transferability of knowledge to the practice setting.ConclusionOverall, students report a high level of support for learning and developing clinical decision-making skills from HFS. However, there are no comparative data available from classroom teaching of similar content so it cannot be established if these results are due to HFS alone.

Clinical Conundrums When Integrating the QbTest into a Standard ADHD Assessment of Children and Young People

2021 ◽  
Author(s):  
Carsten Vogt
Keyword(s):  
Clinical Practice ◽  
Clinical Decision Making ◽  
Ecological Validity ◽  
Neuropsychological Test ◽  
Real Life ◽  
Clinical Decision ◽  
Hyperactivity Disorder ◽  
Standard Clinical Practice ◽  
Novel Method ◽  
The Impact

AbstractThe uptake of the QbTest in clinical practice is increasing and has recently been supported by research evidence proposing its effectiveness in relation to clinical decision-making. However, the exact underlying process leading to this clinical benefit is currently not well established and requires further clarification. For the clinician, certain challenges arise when adding the QbTest as a novel method to standard clinical practice, such as having the skills required to interpret neuropsychological test information and assess for diagnostically relevant neurocognitive domains that are related to attention-deficit hyperactivity disorder (ADHD), or how neurocognitive domains express themselves within the behavioral classifications of ADHD and how the quantitative measurement of activity in a laboratory setting compares with real-life (ecological validity) situations as well as the impact of comorbidity on test results. This article aims to address these clinical conundrums in aid of developing a consistent approach and future guidelines in clinical practice.

Between a logic of disruption and a logic of continuation: Negotiating the legitimacy of algorithms used in automated clinical decision-making

2021 ◽  
pp. 136345932199674
Author(s):  
Rikke Torenholt ◽  
Henriette Langstrup
Keyword(s):  
Decision Making ◽  
Clinical Practice ◽  
Patient Reported Outcomes ◽  
Patient Involvement ◽  
Clinical Decision Making ◽  
Diagnostic Procedures ◽  
Clinical Decision ◽  
Patient Reported ◽  
Pro Tools

In both popular and academic discussions of the use of algorithms in clinical practice, narratives often draw on the decisive potentialities of algorithms and come with the belief that algorithms will substantially transform healthcare. We suggest that this approach is associated with a logic of disruption. However, we argue that in clinical practice alongside this logic, another and less recognised logic exists, namely that of continuation: here the use of algorithms constitutes part of an established practice. Applying these logics as our analytical framing, we set out to explore how algorithms for clinical decision-making are enacted by political stakeholders, healthcare professionals, and patients, and in doing so, study how the legitimacy of delegating to an algorithm is negotiated and obtained. Empirically we draw on ethnographic fieldwork carried out in relation to attempts in Denmark to develop and implement Patient Reported Outcomes (PRO) tools – involving algorithmic sorting – in clinical practice. We follow the work within two disease areas: heart rehabilitation and breast cancer follow-up care. We show how at the political level, algorithms constitute tools for disrupting inefficient work and unsystematic patient involvement, whereas closer to the clinical practice, algorithms constitute a continuation of standardised and evidence-based diagnostic procedures and a continuation of the physicians’ expertise and authority. We argue that the co-existence of the two logics have implications as both provide a push towards the use of algorithms and how a logic of continuation may divert attention away from new issues introduced with automated digital decision-support systems.

Consent, Refusal, and Waivers in Patient-Centered Dysphagia Care: Using Law, Ethics, and Evidence to Guide Clinical Practice

2016 ◽  
Vol 25 (4) ◽  
pp. 453-469 ◽  
Author(s):  
Jennifer Horner ◽  
Maria Modayil ◽  
Laura Roche Chapman ◽  
An Dinh
Keyword(s):  
Health Care ◽  
Public Policy ◽  
Clinical Practice ◽  
Health Care Providers ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Care Providers ◽  
Patient Centered ◽  
Legal Advice ◽  
Medical Context

PurposeWhen patients refuse medical or rehabilitation procedures, waivers of liability have been used to bar future lawsuits. The purpose of this tutorial is to review the myriad issues surrounding consent, refusal, and waivers. The larger goal is to invigorate clinical practice by providing clinicians with knowledge of ethics and law. This tutorial is for educational purposes only and does not constitute legal advice.MethodThe authors use a hypothetical case of a “noncompliant” individual under the care of an interdisciplinary neurorehabilitation team to illuminate the ethical and legal features of the patient–practitioner relationship; the elements of clinical decision-making capacity; the duty of disclosure and the right of informed consent or informed refusal; and the relationship among noncompliance, defensive practices, and iatrogenic harm. We explore the legal question of whether waivers of liability in the medical context are enforceable or unenforceable as a matter of public policy.ConclusionsSpeech-language pathologists, among other health care providers, have fiduciary and other ethical and legal obligations to patients. Because waivers try to shift liability for substandard care from health care providers to patients, courts usually find waivers of liability in the medical context unenforceable as a matter of public policy.

scholarly journals Awareness, Knowledge, and Utility of RCT Data vs RWE: Results From a Survey of US Cardiologists: Real-world Evidence in Clinical Decision Making

2020 ◽  
Vol 14 ◽  
pp. 117954682095341 ◽  
Author(s):  
Todd C Villines ◽  
Mark J Cziraky ◽  
Alpesh N Amin
Keyword(s):  
Decision Making ◽  
Clinical Practice ◽  
Real World ◽  
Randomized Clinical Trials ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
The Body ◽  
Representative Sampling ◽  
Real World Evidence ◽  
Wide Range

Real-world evidence (RWE) provides a potential rich source of additional information to the body of data available from randomized clinical trials (RCTs), but there is a need to understand the strengths and limitations of RWE before it can be applied to clinical practice. To gain insight into current thinking in clinical decision making and utility of different data sources, a representative sampling of US cardiologists selected from the current, active Fellows of the American College of Cardiology (ACC) were surveyed to evaluate their perceptions of findings from RCTs and RWE studies and their application in clinical practice. The survey was conducted online via the ACC web portal between 12 July and 11 August 2017. Of the 548 active ACC Fellows invited as panel members, 173 completed the survey (32% response), most of whom were board certified in general cardiology (n = 119, 69%) or interventional cardiology (n = 40, 23%). The survey results indicated a wide range of familiarity with and utilization of RWE amongst cardiologists. Most cardiologists were familiar with RWE and considered RWE in clinical practice at least some of the time. However, a significant minority of survey respondents had rarely or never applied RWE learnings in their clinical practice, and many did not feel confident in the results of RWE other than registry data. These survey findings suggest that additional education on how to assess and interpret RWE could help physicians to integrate data and learnings from RCTs and RWE to best guide clinical decision making.

Treatment for Lexical Retrieval Impairments in Primary Progressive Aphasia: A Research Update with Implications for Clinical Practice

2018 ◽  
Vol 39 (03) ◽  
pp. 242-256 ◽  
Author(s):  
Karen Croot
Keyword(s):  
Clinical Practice ◽  
Clinical Decision Making ◽  
Primary Progressive Aphasia ◽  
Clinical Decision ◽  
Lexical Retrieval ◽  
Progressive Aphasia ◽  
Primary Progressive ◽  
Behavioral Studies ◽  
Long Term Treatment

AbstractLexical retrieval impairments (also known as anomia or word-finding deficits) are an early and prominent symptom in primary progressive aphasia (PPA), causing distress and frustration to individuals with PPA and their communication partners, and prompting research on lexical retrieval treatment. This paper reviews the research on lexical retrieval treatment in PPA from the earliest reports in the 1990s to early 2018 and considers the implications of this research for clinical practice. The number of published studies has increased markedly over the past decade, consisting primarily of behavioral studies, with rapid recent growth in noninvasive brain stimulation studies. Five general treatment techniques were identified in the behavioral studies, described here as standard naming treatment, Look, Listen, Repeat treatment, cueing hierarchies, semantically focused treatments, and lexical retrieval in context. Across techniques, behavioral studies targeting difficult-to-retrieve items typically report immediate gains, and there is evidence these gains can be maintained over months to years by some participants who continue with long-term treatment. There is also evidence that prophylactic treatment supports retrieval of treated items compared with untreated items. There is limited evidence for generalization of treatment to untreated items, suggesting the primary aim of lexical retrieval treatment in this population is to maintain retrieval of a core vocabulary for as long as possible. Language and cognitive assessment and piloting of the intended treatment can inform decisions about treatment selection and participant suitability for long-term lexical retrieval treatment. The paper concludes with some questions to guide clinical decision making about whether to implement or continue with a behavioral lexical retrieval treatment.

scholarly journals From sensitization to adoption? A qualitative study of the implementation of a digitally supported intervention for clinical decision making in polypharmacy

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Sara Söling ◽  
◽  
Juliane Köberlein-Neu ◽  
Beate Sigrid Müller ◽  
Truc Sophia Dinh ◽  
...  
Keyword(s):  
Decision Making ◽  
Formative Evaluation ◽  
Clinical Decision Making ◽  
Code Of Ethics ◽  
Controlled Trial ◽  
Implementation Process ◽  
Clinical Decision ◽  
Group Behavior ◽  
Control Group ◽  
Implementation Barriers

Abstract Objective Formative evaluation of the implementation process for a digitally supported intervention in polypharmacy in Germany. Qualitative research was conducted within a cluster randomized controlled trial (C-RCT). It focused on understanding how the intervention influences behavior-related outcomes in the prescription and medication review process. Methods/setting Twenty-seven general practitioners (GPs) were included in the study in the two groups of the C-RCT, the intervention, and the wait list control group. Behavior-related outcomes were investigated using three-step data analysis (content analytic approach, documentary method, and design of a model of implementation pathways). Results Content analysis showed that physicians were more intensely aware of polypharmacy-related risks, described positive learning effects of the digital technology on their prescribing behavior, and perceived a change in communication with patients and pharmacists. Conversely, they felt uncertain about their own responsibility when prescribing. Three main dimensions were discovered which influenced adoption behavior: (1) the physicians’ interpretation of the relevance of pharmaceutical knowledge provided by the intervention in changing decision-making situations in polypharmacy; (2) their medical code of ethics for clinical decision making in the context of progressing digitalization; and (3) their concepts of evidence-based medicine on the basis of professional experiences with polypharmacy in primary care settings. In our sample, both simple and complex pathways from sensitization to adoption were observed. The resulting model on adoption behavior includes a paradigmatic description of different pathways and a visualization of different observed levels and applied methodological approaches. We assumed that the GP habitus can weaken or strengthen interventional effects towards intervention uptake. This formative evaluation strategy is beneficial for the identification of behavior-related implementation barriers and facilitators. Conclusion Our analyses of the adoption behavior of a digitally supported intervention in polypharmacy revealed both simple and complex pathways from awareness to adoption, which may impact the implementation of the intervention and therefore, its effectiveness. Future consideration of adoption behavior in the planning and evaluation of digitally supported interventions may enhance uptake and support the interpretation of effects. Trial registration NCT03430336, 12 February 2018.

scholarly journals Ehlers-Danlos syndromes: state of the art on clinical practice guidelines

RMD Open ◽  
2018 ◽  
Vol 4 (Suppl 1) ◽  
pp. e000790 ◽  
Author(s):  
Alberto Sulli ◽  
Rosaria Talarico ◽  
Carlo Alberto Scirè ◽  
Tadej Avcin ◽  
Marco Castori ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Clinical Decision Making ◽  
Unmet Needs ◽  
Musculoskeletal Diseases ◽  
Clinical Decision ◽  
Current Evidence ◽  
Reference Network ◽  
Publication Type

ObjectiveTo report the effort of the European Reference Network for Rare and Complex CONnective tissue and musculoskeletal diseases NETwork working group on Ehlers-Danlos syndromes (EDS) and related disorders to assess current available clinical practice guidelines (CPGs) specifically addressed to EDS, in order to identify potential clinician and patient unmet needs.MethodsSystematic literature search in PUBMED and EMBASE based on controlled terms (MeSH and Emtree) and keywords of the disease and publication type (CPGs). All the published articles were revised in order to identify existing CPGs on diagnosis, monitoring and treatment of EDS.ResultsLiterature revision detected the absence of papers reporting good quality CPGs to optimise EDS patient care. The current evidence-based literature regarding clinical guidelines for the EDS was limited in size and quality, and there is insufficient research exploring the clinical features and interventions, and clinical decision-making are currently based on theoretical and limited research evidences.ConclusionsMany clinician and patient unmet needs have been identified.

scholarly journals P114: Barriers and facilitators affecting implementation of a decision aid for the diagnosis of acute aortic syndrome: a qualitative study

CJEM ◽  
2020 ◽  
Vol 22 (S1) ◽  
pp. S106-S106
Author(s):  
C. Dmitriew ◽  
R. Ohle
Keyword(s):  
Decision Making ◽  
Clinical Practice ◽  
Practice Guidelines ◽  
Resource Use ◽  
Decision Aid ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Barriers And Facilitators ◽  
Acute Aortic Syndrome ◽  
D Dimer

Introduction: Acute aortic syndrome (AAS) is an uncommon, life-threatening emergency that is frequently misdiagnosed. The Canadian clinical practice guidelines for the diagnosis of AAS were developed in order to reduce the frequency of misdiagnoses and number of diagnostic tests. As part of the guidelines, a clinical decision aid was developed in order to facilitate clinician decision-making based on practice recommendations. The objective of this study was to identify barriers and facilitators among physicians to implementation of the decision aid. Methods: We conducted semi-structured interviews with emergency room physicians working at 5 sites distributed between urban academic and rural settings. We used purposive sampling, contacting ED physicians until data saturation was reached. Interview questions were designed to understand potential barriers and facilitators affecting the probability of decision aid uptake and accurate application of the tool. Two independent raters coded interview transcripts using an integrative approach to theme identification, combining an inductive approach to identification of themes within an organizing framework (Theoretical Domains Framework), discrepancies in coding were resolved through discussion until consensus was reached. Results: A majority of interviewees anticipated that the decision aid would support clinical decision making and risk stratification while reducing resource use and missed diagnoses. Facilitators identified included validation and publication of the guidelines as well as adoption by peers. Barriers to implementation and application of the tool included the fact that the use of D-dimer and knowledge of the rationale for its use in the investigation of AAS were not widespread. Furthermore, scoring components were, at times, out of alignment with clinician practices and understanding of risk factors. The complexity of the decision aid was also identified as a potential barrier to accurate use. Conclusion: Physicians were amenable to using the AAS decision aid to support clinical decision-making and to reduce resource use, particularly within rural contexts. Key barriers identified included the complexity of scoring and inclusion criteria, and the variable acceptance of D-dimer among clinicians. These barriers should be addressed prior to implementation of the decision aid during validation studies of the clinical practice guidelines.

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