Beyond the Package Insert: A Postmarket Digital Ethnographic Study of FDA-Cleared Prescription Digital Therapeutics.

Abstract

Introduction Prescription digital therapeutics (PDTs) are FDA-cleared software interventions designed to treat a variety of clinical conditions. Despite clinical validation through randomized controlled trials, PDTs face postmarket challenges that remain unmonitored through traditional surveillance. This study introduces a novel framework of digital ethnography, utilizing social media, specifically Reddit, to capture spontaneous, community-driven insights on PDT experiences beyond clinical trials. It seeks to explore the nuanced realities of user engagement, interface friction, emotional impact, and public perception. Methods We conducted a digital ethnographic analysis of Reddit posts collected from condition-specific and general health subreddits. We focused on 13 FDA-cleared PDTs. Posts containing first-person accounts or caregiver perspectives were included, and a thematic analysis was performed to identify recurrent themes related to user experience. Descriptive statistics were generated to support qualitative findings. Results The study revealed that Reddit communities offer rich, culturally-specific contexts that shape PDT experiences. A final sample of 65 posts, each containing first-person or caregiver perspectives, was analyzed, discussing 11 of the 13 PDTs. Five major domains emerging included ambivalence about efficacy (belief and skepticism), common patterns of engagement and dropout (motivation and frustration), usability challenges (technical friction), and structural barriers to access (insurance and affordability). Additionally, users frequently expressed emotional meaning-making as they navigated their therapeutic journeys. Differences in discussion tone were noted across subreddits: for example, r/ADHD focused on pragmatic usability, while r/depression engaged in deeper emotional reflection. Discussion This digital ethnographic study highlights the importance of integrating user-generated data from digital platforms like Reddit to understand the real-world impact of PDTs. While clinical trials offer limited insights, social media provides a broader, more diverse range of experiences that reveal common usability barriers, engagement patterns, and access challenges. Our findings suggest that the context in which PDTs are discussed, shaped by community norms, beliefs, and expectations, plays a critical role in shaping user outcomes and perceptions. Conclusion Postmarket digital ethnography offers valuable insights into the user experience of FDA-cleared PDTs, which are not captured in traditional clinical trials or regulatory processes. This study advocates for the inclusion of structured social media analysis as part of postmarket surveillance to improve the design, accessibility, and effectiveness of PDTs. Listening to the voice of the patient in informal spaces like Reddit is essential for ensuring the real-world success of digital therapeutics.