Background: Consumer technologies such as smartphones have the potential to transform large-scale population research - including pharmacoepidemiology (as evidenced by the new ISPE Digital Epidemiology SIG). Key ingredients of pharmacoepidemiology studies include medication use, its benefits and harms. Whilst symptom tracking apps are well-established allowing the measurement of treatment response, few tools exist that rapidly and easily allow patients to report coded, accurate information on drug side effects. Patient-centric apps can also open a hitherto blocked channel for feedback and iterative messaging.
Objectives: The aim of this workshop is to consider, together with the audience, the essential components for the design, development, testing and evaluation of a system to collect coded and structured data on adverse drug reactions direct from patients, focused on using smartphones. Through the workshop, we will co-design a research protocol for the development and testing of the side effect reporting app. This will be educational for the audience by describing and following a framework for digital health study design including validation, plus learning about patient reporting of medication side effects.
Description: Short presentations will describe- Current pharmacovigilance and pharmacoepidemiology data and gaps for patient involvement- Short videos from patients describing what they feel are key road blocks to reporting side effects- An initial outline plan for a study to design, develop, test and evaluate a smartphone app to collect patient-generated lay descriptions of side effects and convert to valid, coded data- Considerations in the design of a smartphone app to collect patient-generated health data, including opportunities for optimising patient engagement- Perspectives from different stakeholders for patient-generated health data about medication side effects to support pharmacovigilance and pharmacoepidemiology (timeliness; data quality; causality; volume of data)- Overview of experience from existing pharmacovigilance mobile apps- Experiences, opportunities and challenges in converting lay descriptions of experienced side effects into MedDRA etc., including on-going research combining NLP with vector-based representations of drugs and adverse eventsFollowing each presentation, we will update our study design to incorporate suggestions from the audience.We will close the workshop by summarising the refined study design and collecting interest in contributing to a pre-competitive consortium and study team that would support and deliver the study.