Real-world clinical outcomes and treatment patterns in patients with MDD treated with vortioxetine: a retrospective study.

BACKGROUND: This study included evaluation of the effectiveness of vortioxetine, a treatment for adults with major depressive disorder (MDD), using patient-reported outcome measures (PROMs) in a real-world setting. METHODS: This retrospective chart review analyzed the care experiences of adult patients with a diagnosis of MDD from Parkview Physicians Group - Mind-Body Medicine, Midwestern United States. Patients with a prescription for vortioxetine, an initial baseline visit, and ≥ 2 follow-up visits within 16 weeks from September 2014 to December 2018 were included. The primary outcome measure was effectiveness of vortioxetine on depression severity as assessed by change in Patient Health Questionnaire-9 (PHQ-9) scores ~ 12 weeks after initiation of vortioxetine. Secondary outcomes included changes in depression-related symptoms (i.e., sexual dysfunction, sleep disturbance, cognitive function, work/social function), clinical characteristics, response, remission, and medication persistence. Clinical narrative notes were also analyzed to examine sleep disturbance, sexual dysfunction, appetite, absenteeism, and presenteeism. All outcomes were examined at index (start of vortioxetine) and at ~ 12 weeks, and mean differences were analyzed using pairwise t tests. RESULTS: A total of 1242 patients with MDD met inclusion criteria, and 63.9% of these patients had ≥ 3 psychiatric diagnoses and 65.9% were taking ≥ 3 medications. PHQ-9 mean scores decreased significantly from baseline to week 12 (14.15 ± 5.8 to 9.62 ± 6.03, respectively; p < 0.001). At week 12, the response and remission rates in all patients were 31.0% and 23.1%, respectively, and 67% continued vortioxetine treatment. Overall, results also showed significant improvements by week 12 in anxiety (p < 0.001), sexual dysfunction (p < 0.01), sleep disturbance (p < 0.01), cognitive function (p < 0.001), work/social functioning (p = 0.021), and appetite (p < 0.001). A significant decrease in presenteeism was observed at week 12 (p < 0.001); however, no significant change was observed in absenteeism (p = 0.466). CONCLUSIONS: Using PROMs, our study results suggest that adults with MDD prescribed vortioxetine showed improvement in depressive symptoms in the context of a real-world clinical practice setting. These patients had multiple comorbid psychiatric and physical diagnoses and multiple previous antidepressant treatments had failed.

Parents' Desire to Change Phone Use: Associations with Objective Smartphone Use and Feelings About Problematic Use and Distraction.

We examined objective smartphone use (via a mobile sensing application) and self-reported desire to change phone use among a sample of 268 U.S. parents of infants. Using the Transtheoretical Stages of Change model as a conceptual foundation, we contextualized their attitudes and behaviors and explored how phone use and desire to change relate to perceptions of distraction and problematic phone use around their child. Latent profile analysis of parents' precontemplation, contemplation, and action scores revealed two classes-precontemplators (15%) and contemplators (85%). Contemplators-those considering or desiring change-showed more bedtime phone use and general social networking than precontemplors; however, there were no significant differences between groups on other objective use measures (e.g., total daily duration of phone use, phone use around child, etc.). Contemplators also showed greater perceptions of problematic use around their child and parenting distraction. Moreover, parents' problematic use and distraction were predictive of higher contemplation scores, even after controlling for demographic and objective phone use variables. Taken together, these results suggest that perceptions of phone use as problematic may be more important than actual phone habits, especially total phone use duration, for desire to change. Suggestions for future research and intervention are provided.

Naturalistic Decision Making in Everyday Self-care Among Older Adults With Heart Failure.

BACKGROUND: Every day, older adults living with heart failure make decisions regarding their health that may ultimately affect their disease trajectory. Experts describe these decisions as instances of naturalistic decision making influenced by the surrounding social and physical environment and involving shifting goals, high stakes, and the involvement of others. OBJECTIVE: This study applied a naturalistic decision-making approach to better understand everyday decision making by older adults with heart failure. METHODS: We present a cross-sectional qualitative field research study using a naturalistic decision-making conceptual model and critical incident technique to study health-related decision making. The study recruited 24 older adults with heart failure and 14 of their accompanying support persons from an ambulatory cardiology center. Critical incident interviews were performed and qualitatively analyzed to understand in depth how individuals made everyday health-related decisions. RESULTS: White, male (66.7%), older adults' decision making accorded with a preliminary conceptual model of naturalistic decision making occurring in phases of monitoring, interpreting, and acting, both independently and in sequence, for various decisions. Analyses also uncovered that there are barriers and strategies affecting the performance of these phases, other actors can play important roles, and health decisions are made in the context of personal priorities, values, and emotions. CONCLUSIONS: Study findings lead to an expanded conceptual model of naturalistic decision making by older adults with heart failure. In turn, the model bears implications for future research and the design of interventions grounded in the realities of everyday decision making.

Untold Stories in User-Centered Design of Mobile Health: Practical Challenges and Strategies Learned From the Design and Evaluation of an App for Older Adults With Heart Failure.

BACKGROUND: User-centered design (UCD) is a powerful framework for creating useful, easy-to-use, and satisfying mobile health (mHealth) apps. However, the literature seldom reports the practical challenges of implementing UCD, particularly in the field of mHealth. OBJECTIVE: This study aims to characterize the practical challenges encountered and propose strategies when implementing UCD for mHealth. METHODS: Our multidisciplinary team implemented a UCD process to design and evaluate a mobile app for older adults with heart failure. During and after this process, we documented the challenges the team encountered and the strategies they used or considered using to address those challenges. RESULTS: We identified 12 challenges, 3 about UCD as a whole and 9 across the UCD stages of formative research, design, and evaluation. Challenges included the timing of stakeholder involvement, overcoming designers' assumptions, adapting methods to end users, and managing heterogeneity among stakeholders. To address these challenges, practical recommendations are provided to UCD researchers and practitioners. CONCLUSIONS: UCD is a gold standard approach that is increasingly adopted for mHealth projects. Although UCD methods are well-described and easily accessible, practical challenges and strategies for implementing them are underreported. To improve the implementation of UCD for mHealth, we must tell and learn from these traditionally untold stories.

Patient decision-making personas: An application of a patient-centered cognitive task analysis (P-CTA).

Personas can be used to understand patterns of variation in patients' performance of cognitive work, particularly self-care decision making. In this study, we used a patient-centered cognitive task analysis (P-CTA) to develop self-care decision-making personas. We collected data from 24 older adults with chronic heart failure and 14 support persons, using critical incident and fictitious scenario interviews. Qualitative analyses produced three personas but revealed that individuals exemplify different personas across situations. The Rule-Following persona seeks clear rules, exercises caution under uncertainty, and grounds actions in confidence in clinician experts. The Researching persona seeks information to gain better understanding, invents strategies, and conducts experiments independently or with clinicians. The Disengaging persona does not actively seek rules or information and does not attempt to reduce uncertainty or conduct experiments. We discuss the situational nature of personas, their use in design, and the benefits of P-CTA for studying patient decision making.

Patient ergonomics: 10-year mapping review of patient-centered human factors.

Patient ergonomics is the application of human factors or related disciplines to study and improve patients' and other non-professionals' performance of effortful work activities in pursuit of health goals. We performed a mapping review of 212 full-text patient ergonomics publications in two conference proceedings, 2007-2017. The review revealed a robust and growing body of literature on patient ergonomics, particularly in the areas of aging and chronic disease, tools and technologies, and evaluations of patient-centered interventions on outcomes such as usability, user acceptance, and performance. Findings highlighted gaps deserving future research, including research with understudied populations such as children, informal caregivers, networks and collectives (groups), and marginalized populations; on topics such as health promotion and transitions of care; and using longitudinal and experimental study designs. The growth of patient-centeredness in general and of patient ergonomics in particular compel other more focused reviews, new primary research, and developing a roadmap for future patient ergonomics research.

Systematic review of smartphone-based passive sensing for health and wellbeing.

OBJECTIVE: To review published empirical literature on the use of smartphone-based passive sensing for health and wellbeing. MATERIAL AND METHODS: A systematic review of the English language literature was performed following PRISMA guidelines. Papers indexed in computing, technology, and medical databases were included if they were empirical, focused on health and/or wellbeing, involved the collection of data via smartphones, and described the utilized technology as passive or requiring minimal user interaction. RESULTS: Thirty-five papers were included in the review. Studies were performed around the world, with samples of up to 171 (median n = 15) representing individuals with bipolar disorder, schizophrenia, depression, older adults, and the general population. The majority of studies used the Android operating system and an array of smartphone sensors, most frequently capturing accelerometry, location, audio, and usage data. Captured data were usually sent to a remote server for processing but were shared with participants in only 40% of studies. Reported benefits of passive sensing included accurately detecting changes in status, behavior change through feedback, and increased accountability in participants. Studies reported facing technical, methodological, and privacy challenges. DISCUSSION: Studies in the nascent area of smartphone-based passive sensing for health and wellbeing demonstrate promise and invite continued research and investment. Existing studies suffer from weaknesses in research design, lack of feedback and clinical integration, and inadequate attention to privacy issues. Key recommendations relate to developing passive sensing strategies matching the problem at hand, using personalized interventions, and addressing methodological and privacy challenges. CONCLUSION: As evolving passive sensing technology presents new possibilities for health and wellbeing, additional research must address methodological, clinical integration, and privacy issues. Doing so depends on interdisciplinary collaboration between informatics and clinical experts.

Activity Theory Analysis of Heart Failure Self-Care.

The management of chronic health conditions such as heart failure is a complex process emerging from the activity of a network of individuals and artifacts. This article presents an Activity Theory-based secondary analysis of data from a geriatric heart failure management study. Twenty-one patients' interviews and clinic visit observations were analyzed to uncover eight configurations of roles and activities involving patients, clinicians, and others in the sociotechnical network. For each configuration or activity pattern, we identify points of tension and propose guidelines for developing interventions for future computer-supported healthcare systems.

User-Centered Evaluations with Older Adults: Testing the Usability of a Mobile Health System for Heart Failure Self-Management.

Many older adults living with heart failure struggle to follow recommended self-management routines. To help older adults with heart failure more effectively and efficiently self-manage their disease, we developed Engage, a mobile health application promoting the performance, logging, and sharing of routine self-management behaviors. This paper reports on the usability evaluation of the Engage system with 15 older adults with heart failure and informal caregivers. In two phases, participants used Engage during a task-based usability test (n=5) and a scenario-based usability test (n=10). Usability and performance data were assessed through video-recorded observation and the administration of the system usability scale (SUS) and NASA Task Load Index (TLX). We found that task-based testing was useful in quickly identifying problems within our application, but scenario-based testing elicited more valuable feedback from older adults. A comparison of the different evaluation methods used and the discussion of the challenges encountered provide multiple implications for the practice of usability testing of mobile health products with older adults.

Human factors analysis, design, and evaluation of Engage, a consumer health IT application for geriatric heart failure self-care.

Human factors and ergonomics (HFE) and related approaches can be used to enhance research and development of consumer-facing health IT systems, including technologies supporting the needs of people with chronic disease. We describe a multiphase HFE study of health IT supporting self-care of chronic heart failure by older adults. The study was based on HFE frameworks of "patient work" and incorporated the three broad phases of user-centered design: study or analysis; design; and evaluation. In the study phase, data from observations, interviews, surveys, and other methods were analyzed to identify gaps in and requirements for supporting heart failure self-care. The design phase applied findings from the study phase throughout an iterative process, culminating in the design of the Engage application, a product intended for continuous use over 30 days to stimulate self-care engagement, behavior, and knowledge. During the evaluation phase, we identified a variety of usability issues through expert heuristic evaluation and laboratory-based usability testing. We discuss the implications of our findings regarding heart failure self-care in older adults and the methodological challenges of rapid translational field research and development in this domain.