Regulatory aspects of insects in food in the United States and Europe

2016 ◽  
Author(s):  
Palma Ann Marone
Keyword(s):  
United States ◽  
The United States ◽  
Regulatory Aspects

scholarly journals Features, Functionality, and Acceptability of Internet-Based Cognitive Behavioral Therapy for Tinnitus in the United States

2020 ◽  
Vol 29 (3) ◽  
pp. 476-490
Author(s):  
Vinaya Manchaiah ◽  
George Vlaescu ◽  
Srinivas Varadaraj ◽  
Elizabeth Parks Aronson ◽  
Marc A. Fagelson ◽  
...  
Keyword(s):  
United States ◽  
Health Care ◽  
Cognitive Behavioral Therapy ◽  
Health Care Professionals ◽  
Behavioral Therapy ◽  
The United States ◽  
Cognitive Behavioral ◽  
Software Safety ◽  
Regulatory Aspects ◽  
The United Kingdom

Objective Although tinnitus is one of the most commonly reported symptoms in the general population, patients with bothersome tinnitus are challenged by issues related to accessibility of care and intervention options that lack strong evidence to support their use. Therefore, creative ways of delivering evidence-based interventions are necessary. Internet-based cognitive behavioral therapy (ICBT) demonstrates potential as a means of delivering this support but is not currently available in the United States. This article discusses the adaptation of an ICBT intervention, originally used in Sweden, Germany, and the United Kingdom, for delivery in the United States. The aim of this study was to (a) modify the web platform's features to suit a U.S. population, (b) adapt its functionality to comply with regulatory aspects, and (c) evaluate the credibility and acceptability of the ICBT intervention from the perspective of health care professionals and patients with bothersome tinnitus. Materials/Method Initially, the iTerapi ePlatform developed in Sweden was adopted for use in the United States. Functional adaptations followed to ensure that the platform's functional and security features complied with both institutional and governmental regulations and that it was suitable for a U.S. population. Following these adaptations, credibility and acceptance of the materials were evaluated by both health care professionals ( n = 11) and patients with bothersome tinnitus ( n = 8). Results Software safety and compliance regulatory assessments were met. Health care professionals and patients reported favorable acceptance and satisfaction ratings regarding the content, suitability, presentation, usability, and exercises provided in the ICBT platform. Modifications to the features and functionality of the platform were made according to user feedback. Conclusions Ensuring that the ePlatform employed the appropriate features and functionalities for the intended population was essential to developing the Internet-based interventions. The favorable user evaluations indicated that the intervention materials were appropriate for the tinnitus population in the United States.

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