scholarly journals Developing a Novel Measurement of Sleep in Rheumatoid Arthritis: Study Proposal for Approach and Considerations

2021 ◽  
pp. 191-205
Author(s):  
Michelle Crouthamel ◽  
Robert J. Mather ◽  
Suraj Ramachandran ◽  
Kai Bode ◽  
Godhuli Chatterjee ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Drug Development ◽  
Sleep Disturbances ◽  
Digital Health ◽  
The Novel ◽  
Tool Selection ◽  
Health Technologies ◽  
Study Approach ◽  
Digital Medicine ◽  
Regulatory Strategy

The development of novel digital endpoints (NDEs) using digital health technologies (DHTs) may provide opportunities to transform drug development. It requires a multidisciplinary, multi-study approach with strategic planning and a regulatory-guided pathway to achieve regulatory and clinical acceptance. Many NDEs have been explored; however, success has been limited. To advance industry use of NDEs to support drug development, we outline a theoretical, methodological study as a use-case proposal to describe the process and considerations when developing and obtaining regulatory acceptance for an NDE to assess sleep in patients with rheumatoid arthritis (RA). RA patients often suffer joint pain, fatigue, and sleep disturbances (SDs). Although many researchers have investigated the mobility of joint functions using wearable technologies, the research of SD in RA has been limited due to the availability of suitable technologies. We proposed measuring the improvement of sleep as the novel endpoint for an anti-TNF therapy and described the meaningfulness of the measure, considerations of tool selection, and the design of clinical validation. The recommendations from the FDA patient-focused drug development guidance, the Clinical Trials Transformation Initiative (CTTI) pathway for developing novel endpoints from DHTs, and the V3 framework developed by the Digital Medicine Society (DiMe) have been incorporated in the proposal. Regulatory strategy and engagement pathways are also discussed.

Evolution of Digital Technologies and Use of Virtual Assistants in Drug Development

2019 ◽  
pp. 1-20
Author(s):  
Manu Venugopal
Keyword(s):  
Drug Development ◽  
Digital Health ◽  
Critical Role ◽  
Life Sciences ◽  
Digital Technologies ◽  
Development Phase ◽  
Health Technologies ◽  
Daunting Task ◽  
The World

The drug development phase is one of the most time-consuming and expensive stages in the lifecycle of a drug. Marred by patent expirations, price regulations, complexities in disease conditions, life sciences companies are facing a daunting task to bring new molecular entities into the market. Digital health technologies are playing a critical role in addressing some of the challenges faced during drug development. In this chapter, the author talks about the challenges and key trends in the world of drug development, use of new digital health technologies, and the future of drug development. As an example, the author dives into a specific case study on the use of virtual assistants in clinical trials and the benefits of its usage on patients, healthcare professionals, and life sciences companies.

scholarly journals Social and Managerial Aspects of Using Digital Health Technologies

2021 ◽  
Author(s):  
Valery Igorevich Yudin
Keyword(s):  
Health Care ◽  
Information Technologies ◽  
Administrative Support ◽  
Digital Health ◽  
Health Sector ◽  
Digital Technologies ◽  
Critical Conditions ◽  
Maximum Information ◽  
Health Technologies ◽  
Digital Medicine

The development of the health sector around the world is linked to digital technologies, because there is a need to optimize the processes of medical care for the population. Every year there is an increase in this market by a quarter. The use of digital technologies helps to improve health care. The management and organization system implements unified effective systems using the technological capabilities of digitalization in the health care sector. The relevance of the study is related to the need to change the outdated health management system with access to a modern level of technical and administrative support for medical services.The actual tool of digital medicine is cooperative forms of network interaction. We are exploring the further development of digital medicine in the short term, what opportunities can be presented and what results can be obtained by residents. Network communications play an important role in uniting professional medical communities. More than 65% of people between the ages of 21 and 35 have become participants in network technologies, and their number is constantly increasing. Administrative and management staffs are most active in discussions (43%) on the Internet and all respondents have an idea about telemedicine. Patients have the opportunity to get advice by contacting doctors online. The next stage in the development of information technologies is associated with increasing the speed and volume of transmitted data, which will help to predict critical conditions that threaten the patient’s health as quickly as possible. Now there is a discussion about the possibility of not just consulting, but also making diagnoses when patients contact the doctor, discussing in which cases a personal meeting with the doctor is necessary and under what conditions it is enough to provide maximum information about the state of health for diagnosis. Keywords: digital healthcare, digital technologies, adaptation, medical specialists

scholarly journals Blockchain Enabled Tracking of Physician Burnout and Stressors During the COVID-19 Pandemic

2021 ◽  
Vol 3 ◽  
Author(s):  
Vikram Dhillon ◽  
Tailong Xu ◽  
Chirag Parikh
Keyword(s):  
Mental Health ◽  
Hot Spots ◽  
Healthcare Workers ◽  
Hot Spot ◽  
Digital Health ◽  
The Novel ◽  
Physician Burnout ◽  
Health Technologies ◽  
Hospital Systems ◽  
Novel Coronavirus

With more than 54 million cases worldwide, the novel coronavirus disease 2019 (COVID-19) has disrupted every aspect of public life and poses an ever-growing burden on an already strained healthcare system. The emergence of new COVID-19 hot-spots and super-spreader events are placing an immense amount of stress on hospital systems responding to the increased influx of critically ill patients. Healthcare workers and frontline physicians disproportionately bear the additional physical and psychological burdens associated with the appearance of a new hot-spot. However, the mental health implications of COVID-19 for physicians are not well understood. In this perspective piece, we discuss widespread effects of the ongoing pandemic on physician mental health and how blockchain infrastructure can enable digital health technologies in supporting data-driven fatigue mitigation interventions. This is particularly applicable to simplifying physician workflows in newly emerging hot-spots.

scholarly journals Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science

2020 ◽  
Vol 4 (1) ◽  
pp. 28-49
Author(s):  
Diane Stephenson ◽  
Robert Alexander ◽  
Varun Aggarwal ◽  
Reham Badawy ◽  
Lisa Bain ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Development ◽  
Parkinson Disease ◽  
Critical Path ◽  
Digital Health ◽  
Clinical Manifestations ◽  
Signs And Symptoms ◽  
Sensor Data ◽  
Regulatory Agencies ◽  
Health Technologies

Innovative tools are urgently needed to accelerate the evaluation and subsequent approval of novel treatments that may slow, halt, or reverse the relentless progression of Parkinson disease (PD). Therapies that intervene early in the disease continuum are a priority for the many candidates in the drug development pipeline. There is a paucity of sensitive and objective, yet clinically interpretable, measures that can capture meaningful aspects of the disease. This poses a major challenge for the development of new therapies and is compounded by the considerable heterogeneity in clinical manifestations across patients and the fluctuating nature of many signs and symptoms of PD. Digital health technologies (DHT), such as smartphone applications, wearable sensors, and digital diaries, have the potential to address many of these gaps by enabling the objective, remote, and frequent measurement of PD signs and symptoms in natural living environments. The current climate of the COVID-19 pandemic creates a heightened sense of urgency for effective implementation of such strategies. In order for these technologies to be adopted in drug development studies, a regulatory-aligned consensus on best practices in implementing appropriate technologies, including the collection, processing, and interpretation of digital sensor data, is required. A growing number of collaborative initiatives are being launched to identify effective ways to advance the use of DHT in PD clinical trials. The Critical Path for Parkinson’s Consortium of the Critical Path Institute is highlighted as a case example where stakeholders collectively engaged regulatory agencies on the effective use of DHT in PD clinical trials. Global regulatory agencies, including the US Food and Drug Administration and the European Medicines Agency, are encouraging the efficiencies of data-driven engagements through multistakeholder consortia. To this end, we review how the advancement of DHT can be most effectively achieved by aligning knowledge, expertise, and data sharing in ways that maximize efficiencies.

scholarly journals Leveraging Digital Health Technologies and Outpatient Sampling in Clinical Drug Development: A Phase I Exploratory Study

2018 ◽  
Vol 105 (1) ◽  
pp. 168-176 ◽  
Author(s):  
Marissa F. Dockendorf ◽  
Gowri Murthy ◽  
Kevin P. Bateman ◽  
Prajakti A. Kothare ◽  
Melanie Anderson ◽  
...  
Keyword(s):  
Drug Development ◽  
Phase I ◽  
Exploratory Study ◽  
Digital Health ◽  
Health Technologies ◽  
Clinical Drug Development ◽  
Clinical Drug

scholarly journals Digital medicine

JAHR ◽  
2019 ◽  
Vol 10 (1) ◽  
pp. 211-223 ◽  
Author(s):  
Elena Grebenshchikova
Keyword(s):  
Medical Information ◽  
Digital Health ◽  
Medical Documentation ◽  
Medical Care System ◽  
Health Technologies ◽  
Patient Interaction ◽  
Digital Medicine ◽  
Patient Relationships ◽  
The Impact

The digital health industry is developing rapidly: many new subjects are involved in the field of medicine; new opportunities for distant medical services, diagnostics, monitoring of patients’ health, and conducting medical research are emerging; electronic medical documentation is being developed, global medical information databases are being formed, etc. At the same time, the format of doctor-patient relationships is being transformed and new issues and challenges arise that require ethical evaluation. I identified three areas of digital medicine and analyzed issues of confidentiality, informed consent, autonomy and equity in each case. The impact of digital health technologies on the ethical contexts of medicine is uneven: telemedicine possesses the smallest revolutionary potential, which changes the mechanisms of doctor-patient interaction and actualizes issues of cultural differences. mHealth technologies significantly affect patient autonomy and change ways of sharing medical information. Artificial Intelligence (AI) is diverse in medicine, it can depersonalize relationships in medicine, radically change ideas about the role of the doctor and patient, lead to a radical restructuring of the medical care system in the center of which will be the new model of patient interaction with automated medical agents and systems.

scholarly journals PARE0008 MOBILE APPLICATION “MOJRA” FOR MONITORING PATIENTS WITH RHEUMATOID ARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1290.1-1290 ◽  
Author(s):  
N. Teodorovic ◽  
S. Djordjevic ◽  
L. Vranic
Keyword(s):  
Rheumatoid Arthritis ◽  
Health Care ◽  
Best Practice ◽  
Mobile Apps ◽  
Digital Health ◽  
Work Capacity ◽  
Learning Center ◽  
Approval Procedure ◽  
The Republic

Background:In Serbia, regular examinations with a rheumatologist are scheduled on average every 3 to 4 months. With this in mind, there is a real possibility that many patient data during this period may not be presented to the doctor during the examination, either because the patient forgets them or because they may focus on other issues and may not highlight key factsObjectives:To overcome this problem, the Association of Patients with Rheumatic Diseases of Serbia-ORS in cooperation with an IT firm developed the application “MojRA”, which was presented at the annual rheumatology congress of Serbia held in September 2019. The application “MojRA” is intended for patients suffering from rheumatoid arthritis - RA. The application enables efficient storage and systematization of data, allows doctors to monitor the condition of their patients between two examinations and have a medical history. “MojRA” is available for now from smartphones running the android operating system on the google play store. The privacy of patient information is guaranteed.Methods:Patients with RA will be able to record and store information about important moments during treatment in a simple and transparent way. At each subsequent visit they will be able to describe what happened to their illness in the meantime. The application can create different types of reports and views.At the same time, the doctor can use the app to inform the patient about her/his condition in real time, which will contribute to better and more meaningful communication. All this would improve the quality of health care, preserving work capacity and improving the quality of life.Results:In order to simplify biotherapy committee approval procedure for patients of RA, the “Charger” has been developed in association with ORS and URes. The “Charger” will connect data collected by MojRa to the registry of RA patients, making the whole approval procedure more efficient and transparent.Testing of the second version of this application is underway, meetings are held between the patients using the application and the IT company that created it.Plans are to expand the app to other types of arthritis in the near future, too, and will soon be completed for devices running Apple operating systems.Conclusion:In addition to being of great benefit to patients and doctors, it can in the future be of immeasurable importance for the savings in the overall health care system of the Republic of Serbia.References:[1]Mobile Apps for Rheumatoid Arthritis: Opportunities and Challenges, Mollard E, Michaud K, Rheum Dis Clin, May 2019, Volume 45, Issue 2, Pages 197–209[2]Apps for People With Rheumatoid Arthritis to Monitor Their Disease Activity: A Review of Apps for Best Practice and Quality, Rebecca Grainger, Hutt Hospital, JMIR Publications, Advancing Digital Health Research, Feb 27, 2017.[3]ACR Mobile Apps,https://www.rheumatology.org/Learning-Center/Apps,American College of Reumatology.Disclosure of Interests:None declared

scholarly journals The role of economic, educational and social resources in supporting the use of digital health technologies by people with T2D: a qualitative study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sophie Turnbull ◽  
Patricia J. Lucas ◽  
Alastair D. Hay ◽  
Christie Cabral
Keyword(s):  
Social Networks ◽  
Social Status ◽  
Digital Health ◽  
Self Care ◽  
Social Resources ◽  
Health Interventions ◽  
Structured Interviews ◽  
Health Technologies ◽  
Digital Skills ◽  
Care Support

Abstract Background Type 2 Diabetes (T2D) is a common chronic disease, with socially patterned incidence and severity. Digital self-care interventions have the potential to reduce health disparities, by providing personalised low-cost reusable resources that can increase access to health interventions. However, if under-served groups are unable to access or use digital technologies, Digital Health Technologies (DHTs) might make no difference, or worse, exacerbate health inequity. Study aims To gain insights into how and why people with T2D access and use DHTs and how experiences vary between individuals and social groups. Methods A purposive sample of people with experience of using a DHT to help them self-care for T2D were recruited through diabetes and community groups. Semi-structured interviews were conducted in person and over the phone. Data were analysed thematically. Results A diverse sample of 21 participants were interviewed. Health care practitioners were not viewed as a good source of information about DHTs that could support T2D. Instead participants relied on their digital skills and social networks to learn about what DHTs are available and helpful. The main barriers to accessing and using DHT described by the participants were availability of DHTs from the NHS, cost and technical proficiency. However, some participants described how they were able to draw on social resources such as their social networks and social status to overcome these barriers. Participants were motivated to use DHTs because they provided self-care support, a feeling of control over T2D, and personalised advice or feedback. The selection of technology was also guided by participants’ preferences and what they valued in relation to DHTs and self-care support, and these in turn were influenced by age and gender. Conclusion This research indicates that low levels of digital skills and high cost of digital health interventions can create barriers to the access and use of DHTs to support the self-care of T2D. However, social networks and social status can be leveraged to overcome some of these challenges. If digital interventions are to decrease rather than exacerbate health inequalities, these barriers and facilitators to access and use must be considered when DHTs are developed and implemented.

scholarly journals Digital Progression Biomarkers as Novel Endpoints in Clinical Trials: A Multistakeholder Perspective

2021 ◽  
pp. 1-7
Author(s):  
Diane Stephenson ◽  
Reham Badawy ◽  
Soania Mathur ◽  
Maria Tome ◽  
Lynn Rochester
Keyword(s):  
Disease Progression ◽  
Digital Health ◽  
Low Cost ◽  
Unmet Need ◽  
Disease Status ◽  
Standard Test ◽  
Imaging Biomarkers ◽  
Health Technologies ◽  
Therapeutic Development ◽  
The Rich

The burden of Parkinson’s disease (PD) continues to grow at an unsustainable pace particularly given that it now represents the fastest growing brain disease. Despite seminal discoveries in genetics and pathogenesis, people living with PD oftentimes wait years to obtain an accurate diagnosis and have no way to know their own prognostic fate once they do learn they have the disease. Currently, there is no objective biomarker to measure the onset, progression, and severity of PD along the disease continuum. Without such tools, the effectiveness of any given treatment, experimental or conventional cannot be measured. Such tools are urgently needed now more than ever given the rich number of new candidate therapies in the pipeline. Over the last decade, millions of dollars have been directed to identify biomarkers to inform progression of PD typically using molecular, fluid or imaging modalities). These efforts have produced novel insights in our understanding of PD including mechanistic targets, disease subtypes and imaging biomarkers. While we have learned a lot along the way, implementation of robust disease progression biomarkers as tools for quantifying changes in disease status or severity remains elusive. Biomarkers have improved health outcomes and led to accelerated drug approvals in key areas of unmet need such as oncology. Quantitative biomarker measures such as HbA1c a standard test for the monitoring of diabetes has impacted patient care and management, both for the healthcare professionals and the patient community. Such advances accelerate opportunities for early intervention including prevention of disease in high-risk individuals. In PD, progression markers are needed at all stages of the disease in order to catalyze drug development—this allows interventions aimed to halt or slow disease progression, very early, but also facilitates symptomatic treatments at moderate stages of the disease. Recently, attention has turned to the role of digital health technologies to complement the traditional modalities as they are relatively low cost, objective and scalable. Success in this endeavor would be transformative for clinical research and therapeutic development. Consequently, significant investment has led to a number of collaborative efforts to identify and validate suitable digital biomarkers of disease progression.

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