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.

scholarly journals Operationalization of the learned non-use phenomenon - A Delphi study

2020 ◽  
Author(s):  
Theresa Hirsch ◽  
Maria Barthel ◽  
Pauline Aarts ◽  
Yi-An Chen ◽  
Susanna Freivogel ◽  
...  
Keyword(s):  
Decision Making ◽  
Clinical Practice ◽  
Delphi Study ◽  
Clinical Decision Making ◽  
Negative Reinforcement ◽  
Brain Lesion ◽  
Clinical Decision ◽  
Diagnostic Process ◽  
Sources Of Information ◽  
Wide Range

AbstractThe discrepancy between residual functional capacity and reduced use of the contralesional hand, frequently observed after a brain lesion, has been termed Learned Non-Use (LNU) and is thought to depend on the interaction of neuronal mechanisms during recovery and learning-dependent mechanisms such as negative reinforcement. Despite the generally accepted existence of the LNU phenomenon among clinicians and researchers, no unequivocal and transdisciplinary definition exists to date. Furthermore, although therapeutic approaches are implemented in clinical practice to explicitly target LNU, no standardized diagnostic routine is described in the current literature.Based on a structured group communication following the Delphi method among clinical and scientific experts in the field of LNU, knowledge from both, the work with patient populations and with animal models, was synthesized and integrated to reach consensus regarding a transdisciplinary definition of the LNU phenomenon. Furthermore, the mode and strategy of the diagnostic process, as well as the sources of information and outcome parameters relevant for the clinical decision making, were described with a wide range showing the current lack of a consistent universal diagnostic approach. Building on these results, the need for the development of a structured diagnostic procedure and its implementation into clinical practice is emphasized. Moreover, it exists a striking gap between the prevailing hypotheses regarding the mechanisms underlying the LNU phenomenon and the actual evidence. Therefore, basic research is needed to bridge between bedside and bench and eventually improve clinical decision making and further development of interventional strategies beyond the field of stroke rehabilitation.

scholarly journals Use Of Real-World Evidence In Clinical Decision Making By Community Oncologists

2018 ◽  
Vol 21 ◽  
pp. S48
Author(s):  
J Kish ◽  
B Feinberg ◽  
D Hua ◽  
A Tchafa ◽  
Y Smith ◽  
...  
Keyword(s):  
Decision Making ◽  
Real World ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Real World Evidence

Rivaroxaban real-world evidence: Validating safety and effectiveness in clinical practice

2016 ◽  
Vol 116 (S 02) ◽  
pp. S13-S23 ◽  
Author(s):  
A. Camm ◽  
Craig Coleman ◽  
CAPT Tamayo ◽  
Jan Beyer-Westendorf
Keyword(s):  
Clinical Practice ◽  
Real World ◽  
Clinical Decision Making ◽  
Current Knowledge ◽  
Oral Anticoagulants ◽  
Clinical Decision ◽  
Routine Clinical Practice ◽  
Real World Data ◽  
Real World Evidence ◽  
Randomised Controlled

SummaryRandomised controlled trials (RCTs) are considered the gold standard of clinical research as they use rigorous methodologies, detailed protocols, pre-specified statistical analyses and well-defined patient cohorts. However, RCTs do not take into account the complexity of real-world clinical decision-making. To tackle this, real-world data are being increasingly used to evaluate the long-term safety and effectiveness of a given therapy in routine clinical practice and in patients who may not be represented in RCTs, addressing key clinical questions that may remain. Real-world evidence plays a substantial role in supporting the use of non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) in clinical practice. By providing data on patient profiles and the use of anticoagulation therapies in routine clinical practice, real-world evidence expands the current awareness of NOACs, helping to ensure that clinicians are well-informed on their use to implement patient-tailored clinical decisions. There are various issues with current anticoagulation strategies, including under- or overtreatment and frequent monitoring with VKAs. Real-world studies have demonstrated that NOAC use is increasing (Dresden NOAC registry and Global Anticoagulant Registry in the FIELD-AF [GARFIELD-AF]), as well as reaffirming the safety and effectiveness of rivaroxaban previously observed in RCTs (XArelto on preveNtion of sTroke and non-central nervoUS system systemic embolism in patients with non-valvular atrial fibrillation [XANTUS] and IMS Disease Analyzer). This article will describe the latest updates in real-world evidence across a variety of methodologies, such as non-interventional studies (NIS), registries and database analyses studies. It is anticipated that these studies will provide valuable clinical insights into the management of thromboembolism, and enhance the current knowledge on anticoagulant use and outcomes for patients.

scholarly journals A First Step Toward the Operationalization of the Learned Non-Use Phenomenon: A Delphi Study

2021 ◽  
pp. 154596832199906
Author(s):  
Theresa Hirsch ◽  
Maria Barthel ◽  
Pauline Aarts ◽  
Yi-An Chen ◽  
Susanna Freivogel ◽  
...  
Keyword(s):  
Decision Making ◽  
Clinical Practice ◽  
Delphi Study ◽  
Clinical Decision Making ◽  
Brain Lesion ◽  
Basic Research ◽  
Clinical Decision ◽  
Diagnostic Process ◽  
Sources Of Information ◽  
Wide Range

Background The negative discrepancy between residual functional capacity and reduced use of the contralesional hand, frequently observed after a brain lesion, has been termed Learned Non-Use (LNU) and is thought to depend on the interaction of neuronal mechanisms during recovery and learning-dependent mechanisms. Objective Albeit the LNU phenomenon is generally accepted to exist, currently, no transdisciplinary definition exists. Furthermore, although therapeutic approaches are implemented in clinical practice targeting LNU, no standardized diagnostic routine is described in the available literature. Our objective was to reach consensus regarding a definition as well as synthesize knowledge about the current diagnostic procedures. Methods We used a structured group communication following the Delphi method among clinical and scientific experts in the field, knowledge from both, the work with patient populations and with animal models. Results Consensus was reached regarding a transdisciplinary definition of the LNU phenomenon. Furthermore, the mode and strategy of the diagnostic process, as well as the sources of information and outcome parameters relevant for the clinical decision making, were described with a wide range showing the current lack of a consistent universal diagnostic approach. Conclusions The need for the development of a structured diagnostic procedure and its implementation into clinical practice is emphasized. Moreover, it exists a striking gap between the prevailing hypotheses regarding the mechanisms underlying the LNU phenomenon and the actual evidence. Therefore, basic research is needed to bridge between bedside and bench and eventually improve clinical decision making and further development of interventional strategies beyond the field of stroke rehabilitation.

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.

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.

scholarly journals Eccentric Exercise for Achilles Tendinopathy: A Narrative Review and Clinical Decision-Making Considerations

2019 ◽  
Vol 4 (2) ◽  
pp. 34 ◽  
Author(s):  
Dhinu J. Jayaseelan ◽  
John J. Mischke ◽  
Raymond L. Strazzulla
Keyword(s):  
Decision Making ◽  
Eccentric Exercise ◽  
Sports Medicine ◽  
Randomized Clinical Trials ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Health Condition ◽  
Achilles Tendinopathy ◽  
Narrative Review ◽  
Control Group

Background: Achilles tendinopathy is a common health condition encountered in the orthopedic and sports medicine settings. Eccentric exercise is a common intervention in the management of pain and limited function for this patient population, although contemporary evidence suggests additional exercise methods may be effective as well. Study design: Narrative review: Methods: A literature review was performed using the electronic databases Pubmed and PEDRO for articles through February 2019. Randomized clinical trials integrating eccentric exercise, with or without co-interventions, were evaluated. Outcomes related to pain and/or function were considered. A patient case is provided to highlight decision making processes related to clinical prescription of eccentrics for Achilles tendinopathy. Results: After screening titles and abstracts, seven studies were included for full review. Two articles compared eccentric exercise to a control group, four compared eccentrics to the use of modalities, while one used eccentric exercise as part of a multimodal intervention. In each case, eccentric exercise was effective in reducing pain and improving function. In comparison to other forms of exercise or additional interventions, eccentric exercise was frequently not more effective than other options. Discussion: Eccentric exercise has been associated with clinical benefit in improving pain and function for patients with Achilles tendinopathy. Despite the available evidence reporting effectiveness of eccentrics, other options may be equally useful. Appropriate load modification and exercise prescription for patients with Achilles tendinopathy requires systematic clinical reasoning and incorporation of patient values to optimize outcomes.

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