Design of a real-world, prospective, longitudinal, observational study to compare vortioxetine with other standard of care antidepressant treatments in patients with major depressive disorder: a PatientsLikeMe survey.

BACKGROUND: Major depressive disorder (MDD) is a recurrent psychiatric condition that presents challenges in responding to treatment and achieving long-term remission. To improve outcomes, a shared decision-making treatment approach with patient and healthcare practitioner (HCP) engagement is vital. PatientsLikeMe (PLM), a peer community of patients, provides information on MDD, symptoms, and treatment through forums and resources, helping patients stay engaged in their treatment journey. Data on PLM can be harnessed to gain insights into patient perspectives on MDD symptom management, medication switches, and treatment goals and measures. METHODS: This ongoing, decentralized, longitudinal, observational, prospective study is being conducted using the PLM platform in two parts, enrolling up to 500 patients with MDD in the United States aged ≥ 18 years to compare vortioxetine with other monotherapy antidepressants. The first qualitative component consists of a webinar and discussion forum with PLM community members with MDD, followed by a pilot for functionality testing to improve the study flow and questions in the quantitative survey. The quantitative component follows on the PLM platform, utilizing patient-reported assessments, over a 24-week period. Three surveys will be conducted at baseline and weeks 12 and 24 to collect data on patient global impression of improvement, depression severity, cognitive function, quality of life (QoL) and well-being, medication satisfaction, emotional blunting, symptoms of anhedonia and resilience, as well as goal attainment. Quantitative results will be compared between groups. The qualitative component is complete; patient recruitment is underway for the quantitative component, with results expected in late 2023. DISCUSSION: These results will help HCPs understand patient perspectives on the effectiveness of vortioxetine versus other monotherapy antidepressants in alleviating symptoms of MDD and improvements in QoL. Data from the PLM platform will support a patient goal-based treatment approach, as results can be shared by patients with their HCPs, providing them with insights on patient-centric goals, treatment management and adherence, as well as allowing them to observe changes in patient-related outcomes scores. Findings from the study will also help to optimize the PLM platform to build scalable solutions and connectivity within the community to better serve patients with MDD.

A Descriptive Study of the Caregiver's Experience of Managing Care for Children and Adolescents With Attention-Deficit/Hyperactivity Disorder During the COVID-19 Pandemic: The UNCOVER Study.

Objective: To assess the perceived impact of the COVID-19 pandemic on treatment and quality of life for children and adolescents in the United States who have attention-deficit/hyperactivity disorder (ADHD).Methods: An online survey of members of PatientsLikeMe was conducted via the health-tracking platform between March 10 and April 2, 2021. Participants were adult caregivers of dependents aged 6-18 years with diagnosed ADHD and who were taking or not taking prescription medication for ADHD.Results: The study enrolled 37 adult caregivers of 37 children/adolescents; 36 caregivers responded to treatment questions for children/adolescents. Twenty were caregivers to dependents currently being treated for ADHD. Compared with before the pandemic, there was a decrease in the percentage of children/adolescents using prescription ADHD medication from 65% to 54% during the pandemic. At least 1 switch in ADHD medication and a dosage change were reported by 5 and 8 caregivers, respectively. Seven caregivers reported their dependents had had difficulty adhering to their medication regimen during the pandemic, which caregivers ascribed to a lack of a structured routine. Telehealth visits for their dependents were reported by 13 caregivers. None of the caregivers of dependents taking ADHD medication reported a major impact of the pandemic on ADHD-related medical care. Irrespective of treatment status, 17 caregivers reported that their dependents had ADHD management goals and agreed that the pandemic had a negative impact on progress toward those goals.Conclusions: Many caregivers of children/adolescents with ADHD found it challenging to manage their dependents' symptoms and treatment during the pandemic.Prim Care Companion CNS Disord 2024;26(1):23m03587. Author affiliations are listed at the end of this article.

The Experience of Adults With Attention-Deficit/Hyperactivity Disorder in 2021 During the COVID-19 Pandemic: The UNCOVER Study.

Background: This study surveyed adults with attention-deficit/hyperactivity disorder (ADHD) to understand the impact of the COVID-19 pandemic on aspects of their disorder, quality of life, and treatment experience.Methods: A cross-sectional survey of US-resident members of PatientsLikeMe (PLM) was conducted through the PLM health tracking platform between March 10 and April 2, 2021. Adult participants with self-reported ADHD currently taking prescription medication (treated) and those not taking medication (untreated) were enrolled.Results: The study included 93 adults, of whom 48 patients were taking medication for ADHD. Most of the 45 untreated patients were not taking medication for reasons unrelated to the pandemic. Of the 47 treated patients who also completed the survey, 22 patients had ≥ 1 switch in ADHD medication type, and nearly half had a dosage change during the pandemic. Further, 29 treated patients reported a negative impact of the pandemic on their daily ADHD medication routine, primarily due to a "lack of schedule" and "changes to structured routine," and 16 patients reported "increased difficulty" adhering to prescribed ADHD medication during the pandemic compared with before the pandemic. Of the total study population, 52 patients reported having a telehealth visit during the pandemic, and 38 patients had an ADHD management goal. All but 1 patient with an ADHD management goal reported a negative impact of the pandemic on progress toward their goal. More treated patients than untreated adults reported having control over bothersome ADHD symptoms.Conclusions: Adults with ADHD reported increased difficulty in managing their symptoms during the COVID-19 pandemic.Prim Care Companion CNS Disord 2023;25(4):22m03474. Author affiliations are listed at the end of this article.

User-Centered Design of a Digitally Enabled Care Pathway in a Large Health System: Qualitative Interview Study.

BACKGROUND: Major depressive disorder (MDD) is a leading cause of disability worldwide. Management of chronic conditions such as MDD can be improved by enhanced patient engagement, measurement-based care (MBC), and shared decision-making (SDM). A user-centered design approach can improve the understanding of the patient journey and care team workflows and thus aid the development of digital health care innovations optimized for the needs of patients living with MDD and their primary care teams. OBJECTIVE: This study aims to use qualitative research methods for the user-centered design of a digitally enabled MDD care platform, PathwayPlatform, intended to enhance patient engagement, MBC, and SDM. METHODS: Insights were gathered through 2 stages of qualitative interviews by a study team with expertise in qualitative research and user-centered design methods. Thematic analysis was used to generate an overarching understanding of a set of shared experiences, thoughts, or behaviors across a broad qualitative data set, including transcripts of interviews, to allow both inductive and deductive insights to emerge. Thematic analysis of interviews was supported by Dedoose (SocioCultural Research Consultants, LLC), a qualitative data analysis software tool that enables systematized coding. Findings and insights were presented based on code frequency, salience, and relevance to the research project. RESULTS: In stage 1, interviews were conducted with 20 patients living with MDD and 15 health care providers from September 2018 to January 2019 to understand the experiences with and perceptions about the initial functionality of the Pathway app while also exploring the perceptions about potential additional features and functionality. Feedback about care team workflows and treatment approaches was collected in stage-2 interviews with 36 health care providers at 8 primary care sites. Inductive and deductive thematic analyses revealed several themes related to app functionality, patient-provider engagement, workflow integration, and patient education. Both patients and their care teams perceived the remote tracking of patient-reported outcomes via digital tools to be clinically useful and reliable and to promote MBC and SDM. However, there was emphasis on the need to enhance the flow of real-time data shared with the care team, improve trend visualizations, and integrate the data within the existing clinical workflow and educational programs for patients and their care teams. User feedback was incorporated into the iterative development of the Pathway app. CONCLUSIONS: Ongoing communication with patients living with MDD and their care teams provided an opportunity for user-centric developmental iterations of the Pathway Platform. Key insights led to further development of the patient-facing and care team-facing visit preparation features, collaborative goal-setting and goal-tracking features, patient-reported outcome summaries, and trend visualizations. The result is an enhanced digital platform with the potential to improve treatment outcomes and provide patients living with MDD additional support throughout their treatment journey.

Design and Implementation of a Digitally Enabled Care Pathway to Improve Management of Depression in a Large Health Care System: Protocol for the Implementation of a Patient Care Platform.

BACKGROUND: Major depressive disorder (MDD) is a serious public health concern worldwide. A treatment approach that incorporates measurement-based care (MBC) and shared decision-making between patients with MDD and their providers may foster patient engagement and improve clinical outcomes. While digital tools such as mobile apps show promise for expanding health interventions, these apps are rarely integrated into clinical practice. OBJECTIVE: The primary objective of this ongoing study is to determine whether implementation of a digital tool-the Pathway Platform-in primary care improves adherence to MBC practices; here, we present the study methods. METHODS: This large-scale, real-world implementation study is based on a pilot study of an earlier iteration of a mobile app (the Pathway app) that confirmed the feasibility of using the app in patients with MDD and showed a positive trend in patient engagement in the app arm. In addition, a user-centered design approach that included qualitative assessments from patients and providers was used to improve understanding of the patient journey and care team workflows. User feedback highlighted the need for enhanced features, education modules, and real-time data sharing via integration with the electronic health record. The current iteration of the Platform includes the newest version of the Pathway app, education modules for both patients and providers, and real-time patient-level data sharing with the electronic health record. The study takes place in primary care sites within the Advocate Aurora Health system in Illinois and includes adult patients with MDD who were recently prescribed monotherapy antidepressant medication (defined as a new start, medication switch, or dose change in the past 3 months). Clinical performance and selected patient outcomes will be compared before and after the implementation of the Platform. RESULTS: Patient recruitment was completed in July 2022, with initial results expected in mid-2023. CONCLUSIONS: This study will provide useful insights into real-world integration of a digital platform within a large health system. The methods presented here highlight the unique user-centric development of the Pathway Platform, which has resulted in an enhanced digital tool with the potential to foster MBC and shared decision-making, improve patient-provider communication, and ultimately lead to optimized treatment outcomes for patients with MDD. TRIAL REGISTRATION: ClinicalTrials.gov NCT04891224; https://clinicaltrials.gov/ct2/show/NCT04891224. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43788.