scholarly journals Five Mitigations for the 10 Toxicities

2021 ◽  
pp. 237-246
Author(s):  
Eric D. Perakslis ◽  
Martin Stanley

Throughout the text we have discussed the necessity of sound and comprehensive medical benefit-risk assessment of digital health tools and have introduced the 10 Toxicities: privacy, security, misinformation, charlatanism, cybersecurity, overdiagnosis, cyberchondria, medical device deregulation, and user error. To many, these hazards appear new, evolving, and, possibly, overstated. The truth is, however, that there is preexisting precedent and numerous examples for all of them. This chapter presents five mitigations for these toxicities including awareness and education, a new regulatory paradigm, professionalism and workforce development, and new models of collaboration between health care and law enforcement. Fortunately, it is not too late to get ahead of the hazards of digital health and ensure optimized benefits and minimized risks.

2016 ◽  
Vol 50 (6) ◽  
pp. 823-832 ◽  
Author(s):  
Yasuo Sugitani ◽  
Yukio Udagawa ◽  
Shinichi Matsuda ◽  
Kana Yamada ◽  
Natsuko Miyawaki ◽  
...  

2020 ◽  
Vol 11 ◽  
pp. 204209862097695
Author(s):  
Marie-Laure Kürzinger ◽  
Ludivine Douarin ◽  
Ievgeniia Uzun ◽  
Chantal El-Haddad ◽  
William Hurst ◽  
...  

A favorable benefit–risk profile remains an essential requirement for marketing authorization of medicinal drugs and devices. Furthermore, prior subjective, implicit and inconsistent ad hoc benefit–risk assessment methods have rightly evolved towards more systematic, explicit or “structured” approaches. Contemporary structured benefit–risk evaluation aims at providing an objective assessment of the benefit–risk profile of medicinal products and a higher transparency for decision making purposes. The use of a descriptive framework should be the preferred starting point for a structured benefit–risk assessment. In support of more precise assessments, quantitative and semi-quantitative methodologies have been developed and utilized to complement descriptive or qualitative frameworks in order to facilitate the structured evaluation of the benefit–risk profile of medicinal products. In addition, quantitative structured benefit–risk analysis allows integration of patient preference data. Collecting patient perspectives throughout the medical product development process has become increasingly important and key to the regulatory decision-making process. Both industry and regulatory authorities increasingly rely on descriptive structured benefit–risk evaluation and frameworks in drug, vaccine and device evaluation and comparison. Although varied qualitative methods are more commonplace, quantitative approaches have recently been emphasized. However, it is unclear how frequently these quantitative frameworks have been used by pharmaceutical companies to support submission dossiers for drug approvals or to respond to the health authorities’ requests. The objective of this study has been to identify and review, for the first time, currently available, published, structured, quantitative benefit–risk evaluations which may have informed health care professionals and/or payor as well as contributed to decision making purposes in the regulatory setting for drug, vaccine and/or device approval. Plain language summary Quantitative evaluation of the benefit–risk balance for medicinal products The review of the benefits and the risks associated with a medicinal product is called benefit–risk assessment. One of the conditions for a medicinal product to receive marketing authorization is to demonstrate a positive benefit–risk balance in which the benefits outweigh the risks. In order to enhance the transparency and consistency in the assessment of benefit–risk balance, frameworks and quantitative methods have been developed for decision making purposes and regulatory approvals of medicinal products. This article considers published quantitative benefit–risk evaluations which may have informed health care professionals and/or payor as well as contributed to decision making purposes in the regulatory setting for drug, vaccine and/or device approval.


Author(s):  
I. Barsukova ◽  
I. Bagretsova

Development of a system for the delivery of emergency care in a hospital inevitably raises questions of its availability and quality. And, if the leading pathological syndrome which is a reason for hospitalization and posing a threat to the patient's life deserves priority attention, then the accompanying pathology often stays in the background. At the same time the accompanying pathology related to the field of dermatovenerology poses epidemiological threat. The aim of the study was to improve the organization of health care for patients with concomitant pathology related to dermatovenerology in an emergency hospital. Development of new models and principles of the organization of medical and diagnostic process, introduction of methods of express diagnostics is required; importance of a dermatovenerologist becomes obvious, it will increase the availability and quality of care for patients with dermatovenereological pathology in an emergency hospital.


2020 ◽  
Author(s):  
Gill Kazevman ◽  
Marck Mercado ◽  
Jennifer Hulme ◽  
Andrea Somers

UNSTRUCTURED Vulnerable populations have been identified as having higher infection rates and poorer COVID-19 related outcomes, likely due to their inability to readily access primary care, follow public health directives and adhere to self-isolation guidelines. As a response to the COVID-19 pandemic, many health care services have adopted new digital solutions, relying on phone and internet connectivity. Yet, persons who are digitally inaccessible, such as those struggling with poverty or homelessness, are often unable to utilize these services. In response to this newly highlighted social disparity known as “digital health inequity”, emergency physicians at the University Health Network, Toronto, initiated a program called “PHONE CONNECT”. This novel approach attempts to improve patients’ access to health care, information and social services, as well as improve their ability to adhere to public health directives (social isolation and contact tracing). While similar programs addressing the same emerging issues have been recently described in the media, this is the first time phones are provided as a health care intervention in an emergency department. This innovative ED point-of-care intervention may have a significant impact on improving the health outcomes for vulnerable people during the COVID-19 pandemic, and even beyond it.


2020 ◽  
Author(s):  
Abdulaziz A Alodhayani ◽  
Marwah Mazen Hassounah ◽  
Fatima R Qadri ◽  
Noura A Abouammoh ◽  
Zakiuddin Ahmed ◽  
...  

BACKGROUND There is growing evidence of the need to consider cultural factors in the design and implementation of digital health interventions. However, there is still inadequate knowledge pertaining to what aspects of the Saudi Arabian culture need to be considered in the design and implementation of digital health programs, especially in the context of home health care services for chronically and terminally ill patients. OBJECTIVE This study aims to explore the specific cultural factors relating to patients and their caregivers from the perspective of physicians, nurses, and trainers that have influenced the pilot implementation of Remotely Accessible Healthcare At Home (RAHAH); a connected health program in the Home Health Care Department at King Saud University Medical City, Riyadh, Saudi Arabia. METHODS A qualitative study design was adopted to conduct a focus group discussion (FGD) in July 2019 using a semi-structured interview guide with 3 female and 4 male participants working as nurses, family physicians, and information technologists. Qualitative data obtained were analyzed using a thematic framework analysis. RESULTS Two categories emerged from the FGD that influenced the experiences of digital health program intervention: (1) culture-related factors including language and communication, cultural views on using cameras during consultation, non-adherence to online consultations, and family role and commitment (2) caregiver characteristics in telemedicine that includes their skills and education and electronic literacy. Participants of this study revealed that indirect contact with the patients and their family members may work as a barrier to proper communication through RAHAH. CONCLUSIONS We recommend exploring the use of interpreters in digital health, creating awareness among the local population regarding privacy in digital health, and actively involving the direct family members with the healthcare providers.


2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
◽  

Abstract Health literacy (HL) has become an important topic in many countries. As HL - meaning the ability to access, understand, appraise and apply health information (Sørensen et al. 2012) - is important to make sound health decisions, to promote health and to take an active part in managing health and illness in everyday life and navigating the health care system. In the modern digital knowledge society, HL is also indispensable for orienting oneself in the abundance of mostly digital health information, including incorrect and false information, for locating reliable information and for assessing the trustworthiness and quality of information. However, available studies show that HL is insufficient in many countries. Low HL has - as many studies show - negative social consequences ranging from unhealthy behaviour, higher risk for diseases, less self-care and deficits in coping with illness and chronicity, to over- and misuse (extensive use) of health care. The promotion of HL is therefore an important public health task. An increasing number of population studies and policy documents currently underline this. The WHO has therefore included HL into many of its strategies, like the declarations of Shanghai (2016) and Astana (2018), and has published several publications focusing on HL, like the Solid Facts (2013), the 57th Health Evidence Network Report (2018) or the Roadmap for Implementing Health Literacy Activities (2019). In many countries, strategies and national action plans to improve HL have been developed in response to the political call for action, e.g. in Scotland, Germany and recently also in Portugal. Other countries and regions are currently working on the development of a HL action plan, e.g. Belgium and the WHO European Region action plan on HL. The development and especially the implementation strategies of action plans in different countries and the experiences gained will be discussed comparatively in the workshop. Following an introduction (10'), two countries, which already have action plans will introduce their implementation strategy in one presentation each: Germany and Portugal (30'). This will be followed by two presentations of countries/regions in which action plans are currently being developed: Belgium and WHO Europe (30'). Afterwards the participants will have the opportunity to ask questions and discuss on the different strategies (20'). The workshop will help other initiatives to successfully develop and implement policy plans and strategies in different fields of public health. Key messages Strategies and national action plans to improve HL have been developed in different countries/regions. It is important to reflect on the chosen development and implementation strategies and to discuss their effects, successes and barriers.


2020 ◽  
Vol 4 (1) ◽  
pp. 13-27 ◽  
Author(s):  
Lynn Rochester ◽  
Claudia Mazzà ◽  
Arne Mueller ◽  
Brian Caulfield ◽  
Marie McCarthy ◽  
...  

Health care has had to adapt rapidly to COVID-19, and this in turn has highlighted a pressing need for tools to facilitate remote visits and monitoring. Digital health technology, including body-worn devices, offers a solution using digital outcomes to measure and monitor disease status and provide outcomes meaningful to both patients and health care professionals. Remote monitoring of physical mobility is a prime example, because mobility is among the most advanced modalities that can be assessed digitally and remotely. Loss of mobility is also an important feature of many health conditions, providing a read-out of health as well as a target for intervention. Real-world, continuous digital measures of mobility (digital mobility outcomes or DMOs) provide an opportunity for novel insights into health care conditions complementing existing mobility measures. Accepted and approved DMOs are not yet widely available. The need for large collaborative efforts to tackle the critical steps to adoption is widely recognised. Mobilise-D is an example. It is a multidisciplinary consortium of 34 institutions from academia and industry funded through the European Innovative Medicines Initiative 2 Joint Undertaking. Members of Mobilise-D are collaborating to address the critical steps for DMOs to be adopted in clinical trials and ultimately health care. To achieve this, the consortium has developed a roadmap to inform the development, validation and approval of DMOs in Parkinson’s disease, multiple sclerosis, chronic obstructive pulmonary disease and recovery from proximal femoral fracture. Here we aim to describe the proposed approach and provide a high-level view of the ongoing and planned work of the Mobilise-D consortium. Ultimately, Mobilise-D aims to stimulate widespread adoption of DMOs through the provision of device agnostic software, standards and robust validation in order to bring digital outcomes from concept to use in clinical trials and health care.


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