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.

Digital Health for Geriatric Oncology

2018 ◽  
pp. 1-12 ◽  
Author(s):  
Ramin Fallahzadeh ◽  
Seyed Ali Rokni ◽  
Hassan Ghasemzadeh ◽  
Enrique Soto-Perez-de-Celis ◽  
Armin Shahrokni
Keyword(s):  
Older Adults ◽  
State Of The Art ◽  
Digital Health ◽  
Unmet Need ◽  
Geriatric Oncology ◽  
Symptom Assessment ◽  
Health Technologies ◽  
Cancer Management ◽  
Study Protocols ◽  
Health Related

In this review, we describe state-of-the-art digital health solutions for geriatric oncology and explore the potential application of emerging remote health-monitoring technologies in the context of cancer care. We also discuss the benefits and motivations behind adopting technology for symptom monitoring of older adults with cancer. We provide an overview of common symptoms and of the digital solutions–designed remote symptom assessment. We describe state-of-the-art systems for this purpose and highlight the limitations and challenges for the full-scale adoption of such solutions in geriatric oncology. With rapid advances in Internet-of-things technologies, many remote assessment systems have been developed in recent years. Despite showing potential in several health care domains and reliable functionality, few of these solutions have been designed for or tested in older patients with cancer. As a result, the geriatric oncology community lacks a consensus understanding of a possible correlation between remote digital assessments and health-related outcomes. Although the recent development of digital health solutions has been shown to be reliable and effective in many health-related applications, there exists an unmet need for development of systems and clinical trials specifically designed for remote cancer management of older adults with cancer, including developing advanced remote technologies for cancer-related symptom assessment and psychological behavior monitoring at home and developing outcome-oriented study protocols for accurate evaluation of existing or emerging systems. We conclude that perhaps the clearest path to future large-scale use of remote digital health technologies in cancer research is designing and conducting collaborative studies involving computer scientists, oncologists, and patient advocates.

scholarly journals Digital Health for Patients With Multiple Myeloma: An Unmet Need

2021 ◽  
pp. 1096-1105
Author(s):  
Sundar Jagannath ◽  
Joseph Mikhael ◽  
Omar Nadeem ◽  
Noopur Raje
Keyword(s):  
Health Care ◽  
Multiple Myeloma ◽  
Health Care Providers ◽  
Randomized Clinical Trials ◽  
Digital Health ◽  
Unmet Need ◽  
Care Providers ◽  
Patient Journey ◽  
Health Technologies ◽  
Patient Reported

Multiple myeloma (MM) is associated with the highest symptom burden and lowest health-related quality of life (HRQoL) among patients with hematologic malignancies. HRQoL in MM is heterogeneous, varying over the course of disease, with the highest burden at diagnosis and relapse. Patients with MM are increasingly being treated with oral maintenance medications at home. As a result, longitudinal monitoring of medication adherence and patient-reported outcomes, including HRQoL, could inform on disease status, therapeutic tolerability, and satisfaction with care. Digital health technologies, including telemedicine, mobile health, and wearable devices, are poised to become an integral part of modern health care, in part due to the surge in telemedicine necessitated by the COVID-19 pandemic. Although the literature has many reports on the use of digital health technologies in other types of cancers, fewer studies report on their application to MM. In the current narrative review, we survey the applications of digital health for MM. Although there is evidence that some are associated with improved health outcomes, challenges exist that must be met to ensure more widespread adoption. These include the need for increased awareness by patients and health care providers, lack of access by the typical older patient with MM, absence of randomized clinical trials, and low integration with current workflows such as electronic health records. Following our summary of technologies that could benefit patients with MM, we end by describing our vision for how they can be integrated into each phase of the patient journey.

scholarly journals A Roadmap to Inform Development, Validation and Approval of Digital Mobility Outcomes: The Mobilise-D Approach

2020 ◽  
Vol 4 (1) ◽  
pp. 13-27 ◽  
Author(s):  
Lynn Rochester ◽  
Claudia Mazzà ◽  
Arne Mueller ◽  
Brian Caulfield ◽  
Marie McCarthy ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Health Care Professionals ◽  
Digital Health ◽  
Disease Status ◽  
Proximal Femoral Fracture ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Physical Mobility ◽  
High Level

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.

scholarly journals THU0070 DEFINING SYNOVIAL SIGNATURES IN THE RAT CIA MODEL: WHAT CAN WE LEARN ABOUT RA PROGRESSION?

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 247.2-248
Author(s):  
D. Ruelas ◽  
R. LI ◽  
C. Franci ◽  
V. Lira ◽  
D. Lopez ◽  
...  
Keyword(s):  
Disease Progression ◽  
Synovial Tissue ◽  
Current Knowledge ◽  
Severe Disease ◽  
Unmet Need ◽  
Poor Response ◽  
Multiple Time ◽  
Combination Therapies ◽  
Course Of Disease ◽  
Time Point

Background:Patients showing inadequate or no response to current therapies represent a key unmet need in rheumatoid arthritis (RA). To address this, novel or combination therapies are of high clinical interest. Identification of novel therapeutic targets requires a greater understanding of the pathogenic molecular drivers in the RA synovium. However, our current knowledge of human molecular patterns that emerge as a result of disease progression is complicated by patient-to-patient heterogeneity and access to synovial tissue.Objectives:Here we use the current knowledge of human synovial heterogeneity to conduct a longitudinal study of global molecular responses in the rat collagen-induced arthritis (CIA) model to better understand synovial biology, improve the preclinical modeling of human disease, and discover novel targets for RA.Methods:A rat CIA model was performed as previously described.1RNA-Seq was performed on 56 knee synovial tissues collected at multiple time points throughout the course of disease. Differential gene expression was determined at each individual time point and longitudinally with disease progression. Published human synovial datasets were used to categorize these genes into myeloid, lymphoid, fibroid, and low inflammatory signatures.2Differentially expressed genes (DEGs) at each time point were compared to human synovial datasets of RA patients before and after treatment. In addition, we compared disease-driven genes in CIA to genes in RA patients that are unchanged following therapy to identify possible combination therapies.Results:Disease pathology in the rat CIA natural history study progressed as expected: significant decreases were seen in body weight, as well as increases in ankle diameter, paw weight, and histopathology scores of joints in collagen-injected vs noninjected rats. There were 1900 DEGs identified between diseased and naïve rats over the course of disease, representing disease-induced gene signatures (Fig. 1). Comparing these DEGs to reported human RA synovial signatures, both the lymphoid and myeloid signatures were found to be highly upregulated. Interestingly, there were no significant DEGs representing the human fibroid and low inflammatory synovial signatures identified in the CIA rat model. This suggests that the rat CIA model most closely models RA patients with an immune synovial phenotype. In addition, we examined the overlap between disease-driven genes in CIA and genes in RA patients that are unchanged following therapy to identify signaling pathways that may be of utility in combination therapy. Of genes that were upregulated in CIA, 94% of genes that mapped to extracellular matrix-receptor pathways remained unchanged in the synovial tissue of RA patients following tocilizumab treatment.Conclusion:Previous studies have shown that nearly 30% of treatment-naïve early RA patients exhibit a strong fibroid phenotype that correlates with less severe disease and a relatively poor response to disease-modifying anti-rheumatic drugs.3These data indicate that the synovial biology associated with such patients (fibroid or pauci-immune) is not well captured in CIA, the most common preclinical RA model. To assess potential new therapies targeting these patients, it will be necessary to develop alternative animal models with more intact fibroid signatures. In addition to these findings, we also characterized the global molecular changes that occur with disease progression in the CIA rat and made a comparison to RA patients on treatment, providing an overall understanding of disease-relevant pathways in the synovium that may point to possible combination therapies.References:[1]Trentham DE, et al.J Exp Med. 1977;146(3):857-868.[2]Dennis G Jr, et al.Arthritis Res Ther. 2014;16(2):R90.[3]Humby F, et al.Ann Rheum Dis. 2019;78(6):761-772.Disclosure of Interests:Debbie Ruelas Employee of: Gilead, Ruidong Li Employee of: Gilead, Christian Franci Employee of: Gilead, Victor Lira Employee of: Gilead, David Lopez Employee of: Gilead, Li Li Employee of: Gilead, Gundula Min-Oo Employee of: Gilead, Julie A. Di Paolo Employee of: Gilead

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 A technology-assisted life of recovery from psychosis

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Dror Ben-Zeev ◽  
Benjamin Buck ◽  
Sarah Kopelovich ◽  
Suzanne Meller
Keyword(s):  
Early Detection ◽  
Symptom Management ◽  
Digital Health ◽  
Digital Technologies ◽  
Clinical Population ◽  
Illness Management ◽  
Illness Management And Recovery ◽  
Health Technologies ◽  
Health Innovations ◽  
Schizophrenia Spectrum

Abstract Developments in digital health technologies have the potential to expedite and strengthen the path towards recovery for people with psychosis. This perspective piece provides a snapshot of how a range of digital technologies can be deployed to support a young adult’s efforts to cope with schizophrenia-spectrum illness. In conjunction with a day in the life of this individual, we provide examples of innovations in digital health research designed for this clinical population, as well as brief summaries of the evidence supporting the usability, feasibility, or effectiveness of each approach. From early detection to ongoing symptom management and vocational rehabilitation, this day-in-the-life vignette provides an overview of the ways in which digital health innovations could be used in concert to augment, scaffold, and enhance schizophrenia-spectrum illness management and recovery.

Exclusion by Design: Lack of Information about Community Participation in COVID-19-related Mobile Apps and its Relationship to Digital Health Disparities (Preprint)

2021 ◽  
Author(s):  
Muhammed Yassin Idris ◽  
Maya Korin ◽  
Faven Araya ◽  
Sayeeda Chowdhury ◽  
Humberto Brown ◽  
...  
Keyword(s):  
Community Participation ◽  
Mobile Health ◽  
Medical Information ◽  
Mobile Apps ◽  
Digital Health ◽  
Community Based ◽  
Health Technologies ◽  
Community Needs ◽  
App Development ◽  
Communities Of Color

UNSTRUCTURED The rate and scale of transmission of COVID-19 overwhelmed healthcare systems worldwide, particularly in under-resourced communities of color that already faced a high prevalence of pre-existing health conditions. One way the health ecosystem has tried to address the pandemic is by creating mobile apps for telemedicine, dissemination of medical information, and disease tracking. As these new mobile health tools continue to be a primary format for healthcare, more attention needs to be given to their equitable distribution, usage, and accessibility. In this viewpoint collaboratively written by a community-based organization and a health app development research team, we present results of our systematic search and analysis of community engagement in mobile apps released between February and December 2020 to address the COVID-19 pandemic. We provide an overview of apps’ features and functionalities but could not find any publicly available information regarding whether these apps incorporated participation from communities of color disproportionately impacted by the pandemic. We argue that while mobile health technologies are a form of intellectual property, app developers should make public the steps taken to include community participation in app development. These steps could include community needs assessment, community feedback solicited and incorporated, and community participation in evaluation. These are factors that community-based organizations look for when assessing whether to promote digital health tools among the communities they serve. Transparency about the participation of community organizations in the process of app development would increase buy-in, trust, and usage of mobile health apps in communities where they are needed most.

scholarly journals Design and Development of a Low Cost Personal Computer Based ECG Monitor

2013 ◽  
Vol 4 (1) ◽  
pp. 115-125 ◽  
Author(s):  
K Siddique-e Rabbani ◽  
A Raihan Abir ◽  
AKM Bodiuzzaman
Keyword(s):  
Service Providers ◽  
Human Subjects ◽  
Medical Physics ◽  
Low Cost ◽  
Large Population ◽  
Telemedicine System ◽  
The Rich ◽  
Safety Features ◽  
The Third World ◽  
The Cost

ECG equipment is vital for diagnosis of cardiac problems. However, such equipment come from the rich Western countries at a huge cost in both procurement and maintenance, and therefore cannot offer services to a large population in the Third World countries. The only solution is to design and develop such equipment in individual countries by developing local expertise. With three decades of experience, the Dhaka University group has taken a step towards developing prototypes of ECG equipment for dissemination to the healthcare service providers. This paper presents the detailed design of an PC based ECG equipment where optimized choice of components and of the design have been made keeping the cost and maintenance in view, but not sacrificing the quality, and incorporating necessary safety features to protect the patient from known hazards. Both the hardware and the software have been developed locally and are detailed in this paper. Outputs obtained from human subjects are shown which are of reasonable good quality, and have been verified using standard ECG equipment. The PC based ECG system will allow digital post processing of signals for improved diagnosis through software. Besides, this can also become part of a nationwide telemedicine system. DOI: http://dx.doi.org/10.3329/bjmp.v4i1.14701 Bangladesh Journal of Medical Physics Vol.4 No.1 2011 115-125

Digital health technology enhances resilient behaviour: evidence from the ward

2019 ◽  
Vol 40 (1) ◽  
pp. 34-67 ◽  
Author(s):  
Iacopo Rubbio ◽  
Manfredi Bruccoleri ◽  
Astrid Pietrosi ◽  
Barbara Ragonese
Keyword(s):  
Patient Safety ◽  
Dynamic Capabilities ◽  
Digital Health ◽  
Digital Technologies ◽  
Healthcare Management ◽  
Content Type ◽  
Health Technologies ◽  
Management Domain ◽  
Operational Failure

PurposeIn the healthcare management domain, there is a lack of knowledge concerning the role of resilience practices in improving patient safety. The purpose of this paper is to understand the capabilities that enable healthcare resilience and how digital technologies can support these capabilities.Design/methodology/approachWithin- and cross-case research methodology was used to study resilience mechanisms and capabilities in healthcare and to understand how digital health technologies impact healthcare resilience. The authors analyze data from two Italian hospitals through the lens of the operational failure literature and anchor the findings to the theory of dynamic capabilities.FindingsFive different dynamic capabilities emerged as crucial for managing operational failure. Furthermore, in relation to these capabilities, medical, organizational and patient-related knowledge surfaced as major enablers. Finally, the findings allowed the authors to better explain the role of knowledge in healthcare resilience and how digital technologies boost this role.Practical implicationsWhen trying to promote a culture of patient safety, the research suggests healthcare managers should focus on promoting and enhancing resilience capabilities. Furthermore, when evaluating the role of digital technologies, healthcare managers should consider their importance in enabling these dynamic capabilities.Originality/valueAlthough operations management (OM) research points to resilience as a crucial behavior in the supply chain, this is the first research that investigates the concept of resilience in healthcare systems from an OM perspective, with only a few authors having studied similar concepts, such as “workaround” practices.

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