Ida Sim

This is the author(s)' response to peer review reports related to "Automating Individualized Notification of Drug Recalls to Patients: Complex Challenges and Qualitative Evaluation"

Background: Consumer-level drug recalls usually require action by individual patients. The Food and Drug Administration (FDA) has public-facing outlets to inform the public about drug safety information, including all recalls, but individual consumers may not be aware of them. And there is no system in place to notify individual prescribers which of their patients are affected by a specific recall. Objective: We aimed to leverage the FDA’s Healthy Citizen prototype web-based software platform, which provides users with information about recalls, to automatically notify patients of relevant recalls. Methods: We developed and evaluated an electronic notification system in the primary care and cardiology practices at a large, urban, academic medical center. The health care portal scanned the FDA Healthy Citizen application programming interface nightly to detect new recalls, identified patients who had those medications in their electronic health record (EHR) medication list, and sent them a message through the EHR patient portal with a link to a customized FDA information display. Using structured interviews, we assessed qualitative feedback on the system and portal messaging from a convenience sample of 9 patients. Results: The system was technically functional, but it was not possible to trace a medication prescription from the EHR to specific lot numbers dispensed to that patient by a community pharmacy. The qualitative feedback obtained from patients showed convergence of topics. Conclusions: Lack of an accurate electronic audit trail from prescription to dispensed medication precludes clinical deployment of automated drug recall notification.

Personalized Medicine was designed with a scientific framework that considered both the disease and the person with the disease. Here, we illustrate that the current approach to Personalized Medicine has neglected the person and offers a pathway to restoring the essential importance of the person’s lived experience.

The use of artificial intelligence (AI) in health care has significant implications for patient-clinician interactions. Practical and ethical challenges have emerged with the adoption of large language models (LLMs) that respond to prompts from clinicians, patients, and caregivers. With an emphasis on patient experience, this paper examines the potential of LLMs to act as facilitators, interrupters, or both in patient-clinician relationships. Drawing on our experiences as patient advocates, computer scientists, and physician informaticists working to improve data exchange and patient experience, we examine how LLMs might enhance patient engagement, support triage, and inform clinical decision-making. While affirming LLMs as a tool enabling the rise of the “AI patient,” we also explore concerns surrounding data privacy, algorithmic bias, moral injury, and the erosion of human connection. To help navigate these tensions, we outline a conceptual framework that anticipates the role and impact of LLMs in patient-clinician dynamics and propose key areas for future inquiry. Realizing the potential of LLMs requires careful consideration of which aspects of the patient-clinician relationship must remain distinctly human and why, even when LLMs offer plausible substitutes. This inquiry should draw on ethics and philosophy, aligned with AI imperatives such as patient-centered design and transparency, and shaped through collaboration between technologists, health care providers, and patient communities.

UNSTRUCTURED Use of generative artificial intelligence (AI) in healthcare presents a complex and evolving landscape with significant implications for patient-clinician interactions. Recognizing the new practical and ethical challenges raised by what may be referred to as “relational AI”–large language models (LLMs) able to “relate” to clinicians, patients and caretakers by generating human language–this paper examines the potential of generative AI to serve as a facilitator, interruptor, or both in patient-clinician relationships. Drawing on work as advocates of patient empowerment, students of computer science, and physician informaticists working to increase capacity for data exchange and mobile health, we recognize the potential for generative AI to enhance patient engagement, triage care, and support clinical decision-making. These same perspectives give us concern surrounding generative AI use and data privacy, algorithmic bias, moral injury, and the preservation of human connection. Considering the transformative power of LLMs on patient-clinician dynamics–and the still open questions about which direction that transformation will take–this paper outlines an analytic framework to understand the role and implications of generative AI in the patient-clinician relationship, and proposes an agenda for future research. Maximizing the positive potential of generative AI will require a thorough examination of which aspects of the patient-clinician relationship must remain human–and why–even if LLMs could provide a substitute. This inquiry will need to draw on ethics and philosophy to complement more traditional informatics imperatives such as patient-centered design, transparency on the use and limits of AI models, and collaboration between technologists, healthcare providers, and patient communities to shape the responsible integration of relational AI into clinical care.

Background: Falls are common in people with multiple sclerosis (MS), causing injuries, fear of falling, and loss of independence. Although targeted interventions (physical therapy) can help, patients underreport and clinicians undertreat this issue. Patient-generated data, combined with clinical data, can support the prediction of falls and lead to timely intervention (including referral to specialized physical therapy). To be actionable, such data must be efficiently delivered to clinicians, with care customized to the patient’s specific context. Objective: This study aims to describe the iterative process of the design and development of Multiple Sclerosis Falls InsightTrack (MS-FIT), identifying the clinical and technological features of this closed-loop app designed to support streamlined falls reporting, timely falls evaluation, and comprehensive and sustained falls prevention efforts. Methods: Stakeholders were engaged in a double diamond process of human-centered design to ensure that technological features aligned with users’ needs. Patient and clinician interviews were designed to elicit insight around ability blockers and boosters using the capability, opportunity, motivation, and behavior (COM-B) framework to facilitate subsequent mapping to the Behavior Change Wheel. To support generalizability, patients and experts from other clinical conditions associated with falls (geriatrics, orthopedics, and Parkinson disease) were also engaged. Designs were iterated based on each round of feedback, and final mock-ups were tested during routine clinical visits. Results: A sample of 30 patients and 14 clinicians provided at least 1 round of feedback. To support falls reporting, patients favored a simple biweekly survey built using REDCap (Research Electronic Data Capture; Vanderbilt University) to support bring-your-own-device accessibility—with optional additional context (the severity and location of falls). To support the evaluation and prevention of falls, clinicians favored a clinical dashboard featuring several key visualization widgets: a longitudinal falls display coded by the time of data capture, severity, and context; a comprehensive, multidisciplinary, and evidence-based checklist of actions intended to evaluate and prevent falls; and MS resources local to a patient’s community. In-basket messaging alerts clinicians of severe falls. The tool scored highly for usability, likability, usefulness, and perceived effectiveness (based on the Health IT Usability Evaluation Model scoring). Conclusions: To our knowledge, this is the first falls app designed using human-centered design to prioritize behavior change and, while being accessible at home for patients, to deliver actionable data to clinicians at the point of care. MS-FIT streamlines data delivery to clinicians via an electronic health record–embedded window, aligning with the 5 rights approach. Leveraging MS-FIT for data processing and algorithms minimizes clinician load while boosting care quality. Our innovation seamlessly integrates real-world patient-generated data as well as clinical and community-level factors, empowering self-care and addressing the impact of falls in people with MS. Preliminary findings indicate wider relevance, extending to other neurological conditions associated with falls and their consequences.

BACKGROUND Falls are common in people with multiple sclerosis (MS), causing injuries, fear of falling, and loss of independence. Although targeted interventions (physical therapy) can help, patients underreport and clinicians undertreat this issue. Patient-generated data, combined with clinical data, can support the prediction of falls and lead to timely intervention (including referral to specialized physical therapy). To be actionable, such data must be efficiently delivered to clinicians, with care customized to the patient’s specific context. OBJECTIVE This study aims to describe the iterative process of the design and development of Multiple Sclerosis Falls InsightTrack (MS-FIT), identifying the clinical and technological features of this closed-loop app designed to support streamlined falls reporting, timely falls evaluation, and comprehensive and sustained falls prevention efforts. METHODS Stakeholders were engaged in a double diamond process of human-centered design to ensure that technological features aligned with users’ needs. Patient and clinician interviews were designed to elicit insight around ability blockers and boosters using the capability, opportunity, motivation, and behavior (COM-B) framework to facilitate subsequent mapping to the Behavior Change Wheel. To support generalizability, patients and experts from other clinical conditions associated with falls (geriatrics, orthopedics, and Parkinson disease) were also engaged. Designs were iterated based on each round of feedback, and final mock-ups were tested during routine clinical visits. RESULTS A sample of 30 patients and 14 clinicians provided at least 1 round of feedback. To support falls reporting, patients favored a simple biweekly survey built using REDCap (Research Electronic Data Capture; Vanderbilt University) to support bring-your-own-device accessibility—with optional additional context (the severity and location of falls). To support the evaluation and prevention of falls, clinicians favored a clinical dashboard featuring several key visualization widgets: a longitudinal falls display coded by the time of data capture, severity, and context; a comprehensive, multidisciplinary, and evidence-based checklist of actions intended to evaluate and prevent falls; and MS resources local to a patient’s community. In-basket messaging alerts clinicians of severe falls. The tool scored highly for usability, likability, usefulness, and perceived effectiveness (based on the Health IT Usability Evaluation Model scoring). CONCLUSIONS To our knowledge, this is the first falls app designed using human-centered design to prioritize behavior change and, while being accessible at home for patients, to deliver actionable data to clinicians at the point of care. MS-FIT streamlines data delivery to clinicians via an electronic health record–embedded window, aligning with the 5 rights approach. Leveraging MS-FIT for data processing and algorithms minimizes clinician load while boosting care quality. Our innovation seamlessly integrates real-world patient-generated data as well as clinical and community-level factors, empowering self-care and addressing the impact of falls in people with MS. Preliminary findings indicate wider relevance, extending to other neurological conditions associated with falls and their consequences.