Journal of Medical Internet Research

Traditionally, medical research is based on randomized controlled trials (RCTs) for interventions such as drugs and operative procedures. However, increasingly, there is a need for health research to evolve. RCTs are expensive to run, are generally formulated with a single research question in mind, and analyze a limited dataset for a restricted period. Progressively, health decision makers are focusing on real-world data (RWD) to deliver large-scale longitudinal insights that are actionable. RWD are collected as part of routine care in real time using digital health infrastructure. For example, understanding the effectiveness of an intervention could be enhanced by combining evidence from RCTs with RWD, providing insights into long-term outcomes in real-life situations. Clinicians and researchers struggle in the digital era to harness RWD for digital health research in an efficient and ethically and morally appropriate manner. This struggle encompasses challenges such as ensuring data quality, integrating diverse sources, establishing governance policies, ensuring regulatory compliance, developing analytical capabilities, and translating insights into actionable strategies. The same way that drug trials require infrastructure to support their conduct, digital health also necessitates new and disruptive research data infrastructure. Novel methods such as common data models, federated learning, and synthetic data generation are emerging to enhance the utility of research using RWD, which are often siloed across health systems. A continued focus on data privacy and ethical compliance remains. The past 25 years have seen a notable shift from an emphasis on RCTs as the only source of practice-guiding clinical evidence to the inclusion of modern-day methods harnessing RWD. This paper describes the evolution of synthetic data, common data models, and federated learning supported by strong cross-sector collaboration to support digital health research. Lessons learned are offered as a model for other jurisdictions with similar RWD infrastructure requirements.

Patient organizations (POs) play a crucial role in supporting individuals with health conditions. Their activities range from counseling to support groups to advocacy. The COVID-19 pandemic and its related public health measures prompted rapid digital transformation efforts across multiple sectors, including health care.

Mobile health (mHealth) refers to using mobile communication devices such as smartphones to support health, health care, and public health. mHealth interventions have their own nature and characteristics that distinguish them from traditional health care interventions, including drug interventions. Thus, randomized controlled trials (RCTs) of mHealth interventions present specific methodological challenges. Identifying and overcoming those challenges is essential to determine whether mHealth interventions improve health outcomes.

The last 25 years have seen enormous progression in digital technologies across the whole of the health service, including health education. The rapid evolution and use of web-based and digital techniques have been significantly transforming this field since the beginning of the new millennium. These advancements continue to progress swiftly, even more so after the COVID-19 pandemic.

The status of the digitalization of companies and institutions is usually measured using maturity models. However, the concept of maturity in general practice is currently unclear, and herewith we examine the question of how maturity can be measured. There is a lack of empirical work on the dimensions and subcategories of digital maturity that provide information on the assessment framework.

Obstructive sleep apnea (OSA) is a prevalent sleep disorder characterized by frequent pauses or shallow breathing during sleep. Polysomnography, the gold standard for OSA assessment, is time consuming and labor intensive, thus limiting diagnostic efficiency.

Acute kidney injury (AKI) is common in patients with community-acquired pneumonia (CAP) and is associated with increased morbidity and mortality.

With 1 in 3 adults globally living with chronic conditions and the rise in smartphone ownership, mobile health apps have become a prominent tool for managing lifestyle-related health behaviors and mental health. However, high rates of app abandonment pose challenges to their effectiveness.

The shift in medical care toward prediction and prevention has led to the emergence of digital health care as a valuable tool for managing health issues. Aiding long-term follow-up care for cancer survivors and contributing to improved survival rates. However, potential barriers to mobile health usage, including age-related disparities and challenges in user retention for commercial health apps, highlight the need to assess the impact of patients’ abilities and health status on the adoption of these interventions.

Pharmaceutical product development relies on thorough and costly clinical trials. Participant recruitment and monitoring can be challenging. The incorporation of cutting-edge technologies such as blockchain and artificial intelligence has revolutionized clinical research (particularly in the recruitment stage), enhanced secure data storage and analysis, and facilitated participant monitoring while protecting their personal information.

While numerous antimicrobial stewardship programs aim to decrease inappropriate antibiotic prescriptions, evidence of their positive impact is needed to optimize future interventions.

Long wait times for mental health treatments may cause delays in early detection and management of suicidal ideation and behaviors, which are crucial for effective mental health care and suicide prevention. The use of digital technology is a potential solution for prompt identification of youth with high suicidality.