scholarly journals Assessing human factors during simulation: The development and preliminary validation of the rescue assessment tool

Author(s):  
John Unsworth ◽  
Andrew Melling ◽  
Jaden Allan ◽  
Guy Tucker ◽  
Michael Kelleher
Head & Neck ◽  
2021 ◽  
Author(s):  
Nathan Yang ◽  
Érika Mercier ◽  
Louis Guertin ◽  
Eric Bissada ◽  
Apostolos Christopoulos ◽  
...  

Author(s):  
Katia M. Rojas ◽  
Leon Cosler ◽  
Daryl L. Santos

Since the FDA published guidance on the application of human factors engineering to medical devices and combination products, the concerns about the quality and success of human factors validation projects have put a strain on key stakeholders. Failed HF validation submissions can have serious negative impact not only on manufacturers and HF service providers, but also on the regulatory system and patients. Previously, we remarked on the need for alignment between key stakeholders, and strategies that increase the quality and success of HF validation projects. Leveraging the application of project management was recommended for that purpose. However, there is currently no research about characteristics, practices and critical success factors of these projects. An online survey instrument was developed tailored to this specific context to inform the development of an industry-focused project management maturity assessment tool (which will be Phase II of this research). In this opportunity, the high-level, preliminary findings are presented and briefly discussed. This effort contributes much needed literature regarding the current practices and factors that influence the quality and success of FDA HF validation projects.


SIMULATION ◽  
2011 ◽  
Vol 87 (10) ◽  
pp. 857-874 ◽  
Author(s):  
Agostino Bruzzone ◽  
Paolo Fadda ◽  
Gianfranco Fancello ◽  
Marina Massei ◽  
Enrico Bocca ◽  
...  

2021 ◽  
Author(s):  
Joseph Ciarrochi ◽  
Steven C. Hayes ◽  
Stefan G. Hofmann

The “protocols for syndromes” approach to evidence-based psychological intervention has failed the test of scientific progressivity. Process-based therapy provides an alternative model that is focused on treatment elements that target biopsychosocial processes of relevance to individual treatment goals. That shift in focus requires new, more integrative and idionomic models that identify key processes of change, using high temporal density measurement applied at the level of the person. Standard measurement validation approaches are inadequate to this challenge. The present study develops and provides a preliminary validation of a process-based assessment tool (PBAT) -- an item pool meant for intensive longitudinal clinical assessment. Developed using the Extended-Evolutionary Meta-Model of PBT and evaluated using an evolutionary algorithm appropriate for the evaluation of individual items, we administered the PBAT online to a representative sample of 598 participants (290 male; 302 female; 6 unidentified. Mage = 32.6). Analyses revealed that the PBAT distinguishes between positive and negative processes, links in theoretically coherent ways to need satisfaction and thwarting, and links to clinically relevant outcomes of sadness, anger, anxiety, stress, lack of social support, vitality, and health. The PBAT provides a beginning step towards developing a process-based tool that allows clinicians and researchers to select individual items or sets of items for individual-focused idionomic research and practice.


Author(s):  
Katia M. Rojas ◽  
Leon Cosler ◽  
Daryl L. Santos

As part of a comprehensive Quality System Regulation (QSR), the human factors (HF) validation requirement by the Food and Drug Administration (FDA) is a relatively recent topic. Multiple issues and bottlenecks have emerged since the publication of the draft guidance in 2011. The scientific literature on the topic of ‘FDA HF validation requirement’ is mostly focused on HF methods to ensure success from that perspective. However, the development of across-the-board strategies that can address other critical factors is necessary. No previous scientific research has outlined and addressed the problems considering the QSR and the needs of key stakeholders. For that purpose, this effort presents a narrative review of how the HF requirement for medical devices and combination products developed, as well as the issues and the interventions that have taken place to address the bottlenecks. Some essential considerations such as notorious knowledge-based and process-based gaps are discussed. Similarly, because of the demands of a changing QSR, attention is brought to the need to align key stakeholders, namely manufacturers and HF service providers (HFSPs). Also, the development of an industry (HFSPs) maturity assessment tool and future research for that purpose are proposed.


2012 ◽  
Vol 15 (7) ◽  
pp. A508
Author(s):  
P. Giraldo ◽  
A. Lopez ◽  
E. Rios ◽  
I. Gonzalez-Grande ◽  
M. Roset ◽  
...  

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