Opinion
Video
Clinical and Functional Outcomes With Prescription Digital Therapeutics
Panelists discuss the critical role of patient-reported outcomes in evaluating prescription digital therapeutics (PDTs), emphasizing how real-world usage patterns, symptom relief, and improvements in daily functioning inform clinical decisions and complement medication adherence, while sham-controlled studies help rigorously validate the true therapeutic effects of these digital interventions beyond placebo.
SWhen evaluating PDTs, patient-reported outcomes are crucial for understanding their real-world impact. Clinicians emphasize the importance of knowing how often patients use the apps, what triggers their usage, and the effects they experience during engagement. These insights can influence clinical decisions, such as adjusting medications if the digital tool provides notable symptom relief. For example, if a patient reports reduced anxiety episodes or fewer symptom flare-ups when using a PDT, it may signal that the app is offering significant benefit beyond pharmacological treatments. This feedback also helps identify if combined approaches, such as adding psychotherapy alongside the PDT, might better support the patient.
Functionality in daily life is another key measure of success. Beyond subjective feelings, improvements in real-world achievements, such as securing a new job or reaching personal goals, offer objective evidence of progress. Tracking how PDTs affect productivity, goal orientation, and overall functioning gives clinicians a more comprehensive view of patient well-being. These functional outcomes complement symptom reduction and highlight meaningful changes that affect patients’ quality of life. Additionally, adherence to medication and digital therapy is interconnected, influencing the overall effectiveness of treatment plans.
To rigorously assess PDTs, sham-controlled studies serve an important role similar to placebo controls in drug trials. Sham apps mimic the appearance and interaction of the real therapeutic software but omit active therapeutic elements. This control helps isolate the true effects of the intervention, distinguishing benefits from mere engagement with technology. For example, in one study, a sham version used shapes instead of faces in memory tasks to test whether cognitive improvement was due to specific therapeutic design or general brain exercise. Such research deepens our understanding of how PDTs function and validates their efficacy beyond placebo effects.
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