scholarly journals Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint

2021 ◽  
pp. 53-64
Author(s):  
Jennifer C. Goldsack ◽  
Ariel V. Dowling ◽  
David Samuelson ◽  
Bray Patrick-Lake ◽  
Ieuan Clay

To support the successful adoption of digital measures into internal decision making and evidence generation for medical product development, we present a unified lexicon to aid communication throughout this process, and highlight key concepts including the critical role of participant engagement in development of digital measures. We detail the steps of bringing a successful proof of concept to scale, focusing on key decisions in the development of a new digital measure: asking the right question, optimized approaches to evaluating new measures, and whether and how to pursue qualification or acceptance. Building on the V3 framework for establishing verification and analytical and clinical validation, we discuss strategic and practical considerations for collecting this evidence, illustrated with concrete examples of trailblazing digital measures in the field.

2018 ◽  
Vol 39 (7) ◽  
pp. 3072-3085 ◽  
Author(s):  
Florian Bitsch ◽  
Philipp Berger ◽  
Arne Nagels ◽  
Irina Falkenberg ◽  
Benjamin Straube

Author(s):  
Masoomeh Dadkhah ◽  
◽  
Abbas Ali Vafaei ◽  
Ali Rashidy-Pour ◽  
Parnia Trahomi ◽  
...  

Purpose: The basolateral amygdala (BLA) and infralimbic area (IL) of medial prefrontal cortex (mPFC) are two inter-connected brain structures that mediate both fear memory expression and extinction. Besides the well-known role of the BLA in the acquisition and expression of fear memory, projections from IL to BLA inhibit fear expression and have a critical role in fear extinction. However, the details of IL-BLA interaction remain unclear. Here, we aimed to investigate the role of functional reciprocal interactions between BLA and IL in mediating fear memory extinction. Methods: Using lidocaine (LID), male rats underwent unilateral or bilateral inactivation of the BLA and then unilateral intra-IL infusion of CORT, prior to extinction training of auditory fear conditioning paradigm. Freezing behavior was reported as an index for the measurement of conditioned fear. Infusions were performed before the extinction training, allowing to examine the effects on fear expression and also further extinction memory. Experiments 1-3 investigated the effects of left or right infusion of CORT into IL, and LID unilaterally into BLA on fear memory extinction. Results: Results showed that intra-IL infusion of CORT in the right hemisphere reduced freezing behavior when administrated before the extinction training. Auditory fear memory extinction was impaired by asymmetric inactivation of BLA and CORT infusion in the right IL; however, the same effect was not observed with symmetric inactivation of BLA. Conclusion: It is concluded that that the IL-BLA neural circuit may provide additional evidence to contribution of this circuit in auditory fear extinction. This study demonstrate dissociable roles for right or left BLA in subserving the auditory fear extinction. Our finding also raise the possibility that left BLA-IL circuitry may contribute in mediating auditory fear memory extinction via underlying mechanisms, however further research is required.


Author(s):  
José Rascão

This chapter investigates the key concepts of information systems, as well as the role of information in the information management activities, in terms of supporting decision making by different organizations' managers in the literature of information sciences and business sciences. The information has become, in the global economy, a source of value for organizations, assuming a key role in contributing to the development of the performance of the same. The relationship of information management with business management helps the process of decision making.


Author(s):  
Venesser Fernandes

This chapter provides a detailed literature review exploring the importance of data-driven decision-making processes in current Australian school improvement processes within a context of evidence-based organizational change and development. An investigation into the concept of decision-making and its effect on organizational culture is conducted as change and development are considered to be the new constants in the current discourse around continuous school improvement in schools. In a close examination of literature, this chapter investigates how key factors such as collaboration, communication, and organizational trust are achieved through data-driven decision-making within continuous school improvement processes. The critical role of leadership in sustaining data cultures is also examined for its direct impact on continuous school improvement processes based on evidence-based organizational change and development practices. Future implications of data-driven decision-making to sustain continuous school improvement and accountability processes in Australian schools are discussed.


Author(s):  
Jim Segers

This chapter looks at social transformation through the lens of ‘tough issues’. The perspective makes the vast challenges communities are faced with more practical, which in turns allows for progress in the right direction through small wins. Many citizen and community organisations with a background in environmental, peace and third world movements have roots in direct action. Over recent decades, they have been moving from opposing developments to proposing alternatives. We use the words of de Certeau (1984) to describe it as a shift from ‘résistance’ to ‘bricolage’. This shift has brought them closer to more institutionalised partners like government, business, civil society and research institutions. While this rapprochement has proven beneficial to each party involved – research methodologies such as Co-Creation prove that notions like horizontal decision-making, anti-authoritarianism and self-organisation are no longer the preoccupation of informal actors solely – the different stakeholders have not become interchangeable. The chapter argues for the role of a third actor in a social transformation process. This actor is not a stakeholder itself, but through a creative process (“prototyping” in the case of City Mine(d), arts creation in others) becomes tactically linked to the important stakeholders.


2019 ◽  
pp. bmjebm-2019-111247
Author(s):  
David Slawson ◽  
Allen F Shaughnessy

Overdiagnosis and overtreatment—overuse—is gaining wide acceptance as a leading nosocomial intervention in medicine. Not only does overuse create anxiety and diminish patients’ quality of life, in some cases it causes harm to both patients and others not directly involved in clinical care. Reducing overuse begins with the recognition and acceptance of the potential for unintended harm of our best intentions. In this paper, we introduce five cases to illustrate where harm can occur as the result of well-intended healthcare interventions. With this insight, clinicians can learn to appreciate the critical role of probability-based, evidence-informed decision-making in medicine and the need to consider the outcomes for all who may be affected by their actions. Likewise, educators need to evolve medical education and medical decision-making so that it focuses on the hierarchy of evidence and that what ‘ought to work’, based on traditional pathophysiological, disease-focused reasoning, should be subordinate to what ‘does work’.


Cells ◽  
2020 ◽  
Vol 9 (12) ◽  
pp. 2711
Author(s):  
Maria Mancini ◽  
Silvia Bassani ◽  
Maria Passafaro

During brain development, neurons need to form the correct connections with one another in order to give rise to a functional neuronal circuitry. Mistakes during this process, leading to the formation of improper neuronal connectivity, can result in a number of brain abnormalities and impairments collectively referred to as neurodevelopmental disorders. Cell adhesion molecules (CAMs), present on the cell surface, take part in the neurodevelopmental process regulating migration and recognition of specific cells to form functional neuronal assemblies. Among CAMs, the members of the protocadherin (PCDH) group stand out because they are involved in cell adhesion, neurite initiation and outgrowth, axon pathfinding and fasciculation, and synapse formation and stabilization. Given the critical role of these macromolecules in the major neurodevelopmental processes, it is not surprising that clinical and basic research in the past two decades has identified several PCDH genes as responsible for a large fraction of neurodevelopmental disorders. In the present article, we review these findings with a focus on the non-clustered PCDH sub-group, discussing the proteins implicated in the main neurodevelopmental disorders.


1990 ◽  
Vol 15 (4) ◽  
pp. 3-10
Author(s):  
Jayanth R Varma ◽  
N Venkiteswaran

The Indian capital market has shown signs of buoyancy and dynamism in the recent past. There is a very real need, therefore, to nurture and to give positive direction to the emerging trends in this sphere of economic activity. It is in this context that regulatory agencies have a critical role in providing the right kind of support to avoid bunching of issues as well as in protecting investors against manipulation by unscrupulous investors. Have Indian regulatory agencies risen to the occasion by formulating appropriate and adequate policies to facilitate the development of the capital markets in India? In this article, Varma and Venkiteswaran examine the role of Indian regulatory agencies and evaluate the methodology spelt out in the official guidelines for valuation of equity shares made public by the Government of India.


2019 ◽  
Vol 10 (1) ◽  
pp. 58-75
Author(s):  
Dale Stephens

Abstract International humanitarian law (ihl) primarily applies to govern the conduct of individuals in the most desperate time of human endeavour, namely armed conflict, in order to ameliorate violence. However, understanding how ihl is disseminated, trained and actually applied in the battlespace is, remarkably, a relatively underexplored area. There are countless volumes dedicated to analyzing and parsing the myriad of words and formulas that comprise this burgeoning body of law. However, there is very little empirical analysis undertaken on effective training strategies and even less on tracking nuanced compliance and decision-making processes in actual armed conflict. Against this background, the 2018 icrc study ‘The Roots of Restraint in War’ offers an insightful account of how to best frame training strategies and how to optimize compliance in the battlespace. It consciously adopts an inter-disciplinary approach. It accepts fully the role of social, ethical and moral factors that can orientate decision making in a manner that combines with the applicable law. The goal is restraint in war, of a type that comes not from clinical compliance with complex legal formulas and interpretative rectitude but is derived from a deeper sense of professional self-identity. It acknowledges the risks inherent in its approach and yet, compellingly, offers a blueprint for melding principles of ihl with a sense of personal commitment. Such an approach is to be celebrated for the audacity and courage that it exhibits.


1990 ◽  
Vol 28 (2) ◽  
Author(s):  
Gordon Wills ◽  
Sherril H. Kennedy ◽  
John Cheese ◽  
Angela Rushton

To achieve a full understanding of the role of marketing from plan to profit requires a knowledge of the basic building blocks. This textbook introduces the key concepts in the art or science of marketing to practising managers. Understanding your customers and consumers, the 4 Ps (Product, Place, Price and Promotion) provides the basic tools for effective marketing. Deploying your resources and informing your managerial decision making is dealt with in Unit VII introducing marketing intelligence, competition, budgeting and organisational issues. The logical conclusion of this effort is achieving sales and the particular techniques involved are explored in the final section.


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