The Synergy of Real-World Evidence and Digital Health Tools for Patient-Centric Outcomes
Valerie Henson, MPH; Michelle DiNicolas, PhD; Lalitha Priya Chandrashekhar, PFG MedComm, LLC, Somerset, NJ, USA
As patient centricity takes center stage in healthcare, the fusion of innovative digital health tools with real-world evidence (RWE) is revolutionizing how we understand and optimize patient outcomes, challenging age-old research and care delivery norms.
HEOR Overview
Health economics and outcomes research (HEOR) is vital for developing cost-effective and health-optimizing policies. Innovation in healthcare, whether through clinical studies or postmarket research, is an extensive and costly process. To maximize health outcomes and cost-efficiency, real-world evidence (RWE) has become a major focus of HEOR. RWE involves real-world data gathered from sources like electronic health records (EHR), mobile apps, claims data, and patient registries.1
The use of RWE marks a paradigm shift in HEOR, as it has the potential to reduce research costs and provide accurate clinical surveillance. Digital health tools such as mobile apps, wearable devices, and software are transforming the healthcare landscape, providing robust data sets from user activity. This provides a unique opportunity for emphasizing patient-centricity. In this article, we aim to explore the intersection of patient centricity in RWE with the use of digital health tools.
"The use of real-world evidence marks a paradigm shift in HEOR, as it has the potential to reduce research costs and provide accurate clinical surveillance."
Patient-Centric Care
Patient centricity involves engaging patients in healthcare innovation and processes.2 The value of pharmaceutical development and health interventions is reflected in the patient outcomes produced. Patient goals and principles should be a primary focus of healthcare providers and organizations. Patient-centered care empowers patients in their health decisions, fosters accountability, and focuses on patient priorities.3 As conflicting health information becomes widely available, establishing provider-patient trust is a vital aspect of patient care and treatment adherence.
One method of improving patient centricity in healthcare is through the utilization of RWE. Exploring the real-world outcomes of a drug or intervention can benefit every stakeholder in the healthcare ecosystem—from patients and caregivers to providers, healthcare systems, industry, and everyone in between. For example, clinical data of drug efficacy and safety can fill in the gaps within randomized controlled trials (RCTs). As Blonde et al4 highlights, the rigid structure of research settings and exclusion criteria can limit the generalizability of safety and efficacy outcomes. RWE can reveal the outcomes of an intervention from diverse, real-world medical practice without the cost and time required for RCTs.
"Over 90% of physicians believe these digital health tools are beneficial for patient care and can even reduce physician burnout."
The Rise of Digital Health Tools
Digital health tools such as mobile apps, wearable biosensors, and EHRs are becoming common practice for health-tracking and surveillance. Over 90% of physicians believe these digital health tools are beneficial for patient care and can even reduce physician burnout.5 Globally, mobile apps aimed at smoking cessation, fitness tracking, symptom monitoring, and nutrition counseling are becoming widely accessible. Real-time monitoring of patient vitals, symptoms, and treatment plans can deliver valuable information about treatment fidelity and efficacy.
Many digital health wearables can be conveniently worn throughout the day and track data automatically. This has been especially useful for passive tracking of symptoms which would normally require extensive time. With these wearables, tracking an individual’s blood sugar or heart rate has become as simple as checking their watch. In the era of digital health tools and telemedicine, RWE is becoming robust, accurate, and accessible.
The Synergy Between Patient-Centric Outcomes and Digital Health Tools
One of the main barriers to medical intervention or treatment adherence is access to care, especially in healthcare deserts. Digital health tools have the potential to bridge this gap and engage patients who would otherwise not have access. Collecting data from patients’ daily life can provide improved insight into the true impact of drugs or medical devices. Utilizing a mobile app that can remind volunteers to check in regarding their symptoms or pain level is a unique method for real-time patient engagement. Assessing real-time patient outcomes is helpful for analyzing trends over time and identifying emerging effects of interventions. The data obtained through digital health tools are extremely accessible, as researchers can quickly view patient data through cloud-based software. Additionally, there is an opportunity for significant cost savings by using RWE, in stark contrast to the millions of dollars required for RCTs.
Outside of access, monitoring the outcome of health interventions on varied and diverse patient populations by using digital health tools is a pillar of patient-centered care. Patient care for diverse populations must include evaluating efficacy and safety of medications or devices for individuals of various occupations, geographic locations, and lifestyles.
"Collecting data from patients’ daily life can provide improved insight into the true impact of drugs or medical devices."
Real-time data management is a useful tool to monitor patient conditions throughout clinical trials. For example, wearable devices that track heart rate and blood pressure changes can provide insight into the physiological changes in a way that is more objective than pain scales. Wearables utilized during sleep can provide valuable metrics to track medication and intervention effects outside of the lab. Mobile apps or wearable devices can also measure trends over time and the impact of certain patient environments, activities, and moods on various outcomes.
Challenges and Considerations
While digital-health tools can foster robust RWE, study researchers and participants will likely have concerns about their data privacy and security. When it comes to technology, especially artificial intelligence (AI)-based tech, garnering trust from the clinicians, payers, and even the general population can be difficult. Concerns surrounding privacy and consent are further escalated by the growing market of digital health, as social media platforms like Facebook may have access to users’ personal health information. In February of this year, GoodRx, a telemedicine platform offering drug pricing information, discount programs, and online prescriptions, faced allegations from the Federal Trade Commission (FTC) for illegally selling health information to Facebook.6 The FTC alleged that GoodRX patient data were used to target advertisements to users with certain health conditions based on their prescription history. Fitbit, a fitness-tracking wearable, also encountered recent controversy due to privacy concerns. The wearable company does not allow users to revoke consent for data sharing outside of the European Union (EU), breaching the EU General Data Privacy Regulation.7
The growing digital health market is ripe with opportunities for data breaches and patient privacy concerns. In a clinical trial setting, authentication concerns and data anonymization could be barriers to widespread use of this technology for research purposes. Policy makers and research stakeholders should carefully consider patient health data implications even in commercially available devices. In the aging population, issues with technological literacy are a barrier to widespread use of health-related digital tech.8 The aging population is increasing8 and continues to face significant chronic disease burden. Digital health tools could be useful for improving healthcare access for individuals who lack transportation or need continuous care for chronic conditions. Certain wearables can be lifesaving in the event of a seizure, stroke, or fall.8 However, a comprehensive understanding of health tech is crucial to accurate data collection and remote communication. Below-average technological literacy can make the use of wearables and other digital health tools less viable, especially in a research setting.
"The growing digital health market is ripe with opportunities for data breaches and patient privacy concerns."
According to research conducted by GoodRx, over 80% of counties in the United States are considered “medically underserved,” which translates to an estimated 121 million people.9 Digital health tools offer many opportunities to bring care to these populations in areas identified as healthcare deserts. However, the access limitations in these areas go beyond just healthcare to digital literacy and internet access. The successful implementation of digital health tools in healthcare deserts can be sustained only when there is corresponding expansion infrastructure, through initiatives such as community broadband networks and low-cost internet service options.10
Future Potential and Implications
Digital health technology will continue to evolve and integrate with most aspects of daily life. With the surge of mainstream AI-based software, at-home technology will become more accurate and capable. Long-term safety monitoring and symptom tracking can now be in the hands of patients through wearable devices and mobile surveillance reminders. Federal agencies, like the US Food and Drug Administration, are beginning to provide frameworks for the use of RWE as a decision-making tool for new indications of previously approved drugs. Notably, several surveys of patients, including those in underserved communities, have indicated that patients are ready for digital health tools.
While the use of digital health tools can offer huge value, there are still gaps for those populations without widespread access to the internet and economic limitations. Technological literacy of the aging population, a group with a high burden of chronic illness, is also a barrier to certain uses of digital health tools for RWE. Innovators of this technology should evaluate the accessibility of their products and account for potential safety concerns regarding user data. As solutions are created to overcome these challenges, RWE will undoubtedly be a promising tool with the potential to monitor and improve health outcomes, especially in conjunction with the accessibility of digital health tools.
References
1. Dang A. Real-world evidence: a primer. Pharm Med. 2023;37(1):25-36. doi:10.1007/s40290-022-00456-6
2. Yeoman G, Furlong P, Seres M, et al. Defining patient centricity with patients for patients and caregivers: a collaborative endeavour. BMJ Innov. 2017;3:76-83. https://innovations.bmj.com/content/3/2/76
3. World Health Organization. Patient Engagement. World Health Organization; 2016. Accessed October 13, 2023. https://iris.who.int/handle/10665/252269
4. Blonde L, Khunti K, Harris SB, Meizinger C, Skolnik NS. Interpretation and impact of real-world clinical data for the practicing clinician. Adv Ther. 2018;35(11):1763-1774. doi:10.1007/s12325-018-0805-y
5. Henry TA. 5 insights into how physicians view, use digital health tools. American Medical Association. Published October 17, 2022. Accessed October 13, 2023. https://www.ama-assn.org/practice-management/digital/5-insights-how-physicians-view-use-digital-health-tools
6. Adams K. GoodRx Illegally Sold Users’ Data to Google & Facebook, FTC Says. MedCity News. Published February 1, 2023. Accessed October 13, 2023. https://medcitynews.com/2023/02/goodrx-illegally-sold-users-data-to-google-facebook-ftc-says/
7. Mukherjee S. Privacy activist Schrems files complaints against Google’s Fitbit. Reuters. Accessed October 13, 2023. https://www.reuters.com/technology/privacy-activist-schrems-files-complaints-against-googles-fitbit-2023-08-31/
8. Chen C, Ding S, Wang J. Digital health for aging populations. Nat Med. 2023;29(7):1623-1630. doi:10.1038/s41591-023-02391-8
9. Marsh T. Mapping Healthcare Deserts. Accessed October 13, 2023. https://assets.ctfassets.net/4f3rgqwzdznj/6iU4VnrKD1eIDthc7i1hcl/2d42cfeb3e24e897f281eebfc7708eab/Healthcare_Deserts_Sept_2021.pdf
10. Loccoh EC, Nguyen A, Kim G, Warraich HJ. Geospatial analysis of access to health care and internet services in the US. JAMA Network Open. 2022;5(11):e2243792. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2798905
