scholarly journals PMU95 CLINICAL TRIALS LANDSCAPE FOR DIGITAL HEALTH INTERVENTIONS: A DESCRIPTIVE ANALYSIS

2020 ◽  
Vol 23 ◽  
pp. S250
Author(s):  
G. Braileanu ◽  
J. Sa'id ◽  
C. Higgins ◽  
B. Rousseau
2018 ◽  
Vol 5 (1) ◽  
pp. 21-34
Author(s):  
Cheyenne E. Allenby ◽  
Eric S. Babiash ◽  
Patrick N. Blank ◽  
Marco D. Carpenter ◽  
Isabelle G. Lee ◽  
...  

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.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sophie Turnbull ◽  
Patricia J. Lucas ◽  
Alastair D. Hay ◽  
Christie Cabral

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.


2021 ◽  
Vol 4 (1) ◽  
Author(s):  
Anne M. Finucane ◽  
Hannah O’Donnell ◽  
Jean Lugton ◽  
Tilly Gibson-Watt ◽  
Connie Swenson ◽  
...  

AbstractDigital health interventions (DHIs) have the potential to improve the accessibility and effectiveness of palliative care but heterogeneity amongst existing systematic reviews presents a challenge for evidence synthesis. This meta-review applied a structured search of ten databases from 2006 to 2020, revealing 21 relevant systematic reviews, encompassing 332 publications. Interventions delivered via videoconferencing (17%), electronic healthcare records (16%) and phone (13%) were most frequently described in studies within reviews. DHIs were typically used in palliative care for education (20%), symptom management (15%), decision-making (13%), information provision or management (13%) and communication (9%). Across all reviews, mostly positive impacts were reported on education, information sharing, decision-making, communication and costs. Impacts on quality of life and physical and psychological symptoms were inconclusive. Applying AMSTAR 2 criteria, most reviews were judged as low quality as they lacked a protocol or did not consider risk of bias, so findings need to be interpreted with caution.


2020 ◽  
pp. 152483802096734
Author(s):  
Mengtong Chen ◽  
Ko Ling Chan

Digital technologies are increasingly used in health-care delivery and are being introduced into work to prevent unintentional injury, violence, and suicide to reduce mortality. To understand the potential of digital health interventions (DHIs) to prevent and reduce these problems, we conduct a meta-analysis and provide an overview of their effectiveness and characteristics related to the effects. We searched electronic databases and reference lists of relevant reviews to identify randomized controlled trials (RCTs) published in or before March 2020 evaluating DHIs on injury, violence, or suicide reduction. Based on the 34 RCT studies included in the meta-analysis, the overall random effect size was 0.21, and the effect sizes for reducing suicidal ideation, interpersonal violence, and unintentional injury were 0.17, 0.24, and 0.31, respectively, which can be regarded as comparable to the effect sizes of traditional face-to-face interventions. However, there was considerable heterogeneity between the studies. In conclusion, DHIs have great potential to reduce unintentional injury, violence, and suicide. Future research should explore DHIs’ successful components to facilitate future implementation and wider access.


10.2196/20158 ◽  
2020 ◽  
Vol 22 (12) ◽  
pp. e20158
Author(s):  
Dylan Gilbey ◽  
Helen Morgan ◽  
Ashleigh Lin ◽  
Yael Perry

Background Young people (aged 12-25 years) with diverse sexuality, gender, or bodily characteristics, such as those who identify as lesbian, gay, bisexual, transgender, intersex, or queer (LGBTIQ+), are at substantially greater risk of a range of mental, physical, and sexual health difficulties compared with their peers. Digital health interventions have been identified as a potential way to reduce these health disparities. Objective This review aims to summarize the characteristics of existing evidence-based digital health interventions for LGBTIQ+ young people and to describe the evidence for their effectiveness, acceptability, and feasibility. Methods A systematic literature search was conducted using internet databases and gray literature sources, and the results were screened for inclusion. The included studies were synthesized qualitatively. Results The search identified 38 studies of 24 unique interventions seeking to address mental, physical, or sexual health–related concerns in LGBTIQ+ young people. Substantially more evidence-based interventions existed for gay and bisexual men than for any other population group, and there were more interventions related to risk reduction of sexually transmitted infections than to any other health concern. There was some evidence for the effectiveness, feasibility, and acceptability of these interventions overall; however, the quality of evidence is often lacking. Conclusions There is sufficient evidence to suggest that targeted digital health interventions are an important focus for future research aimed at addressing health difficulties in LGBTIQ+ young people. Additional digital health interventions are needed for a wider range of health difficulties, particularly in terms of mental and physical health concerns, as well as more targeted interventions for same gender–attracted women, trans and gender-diverse people, and people with intersex variations. Trial Registration PROSPERO International Prospective Register of Systematic Reviews CRD42020128164; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=128164


Author(s):  
Geronimo Jimenez ◽  
David Matchar ◽  
Gerald Choon Huat Koh ◽  
Shilpa Tyagi ◽  
Rianne M. J. J. van der Kleij ◽  
...  

Abstract Background: The four primary care (PC) core functions (the ‘4Cs’, ie, first contact, comprehensiveness, coordination and continuity) are essential for good quality primary healthcare and their achievement leads to lower costs, less inequality and better population health. However, their broad definitions have led to variations in their assessment, in the innovations implemented to improve these functions and ultimately in their performance. Objectives: To update and operationalise the 4Cs’ definitions by using a literature review and analysis of enhancement strategies, and to identify innovations that may lead to their enhancement. Methods: Narrative, descriptive analysis of the 4Cs definitions, coming from PC international reports and organisations, to identify measurable features for each of these functions. Additionally, we performed an electronic search and analysis of enhancement strategies to improve these four Cs, to explore how the 4Cs inter-relate. Results: Specific operational elements for first contact include modality of contact, and conditions for which PC should be approached; for comprehensiveness, scope of services and spectrum of population needs; for coordination, links between PC and higher levels of care and social/community-based services, and workforce managing transitions and for continuity, type, level and context of continuity. Several innovations like enrolment, digital health technologies and new or enhanced PC provider’s roles, simultaneously influenced two or more of the 4Cs. Conclusion: Providing clear, well-defined operational elements for these 4Cs to measure their achievement and improve the way they function, and identifying the complex network of interactions among them, should contribute to the field in a way that supports efforts at practice innovation to optimise the processes and outcomes in PC.


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