Longitudinal Assessment of Seasonal Impacts and Depression Associations on Circadian Rhythm Using Multimodal Wearable Sensing: Retrospective Analysis.

BACKGROUND: Previous mobile health (mHealth) studies have revealed significant links between depression and circadian rhythm features measured via wearables. However, the comprehensive impact of seasonal variations was not fully considered in these studies, potentially biasing interpretations in real-world settings. OBJECTIVE: This study aims to explore the associations between depression severity and wearable-measured circadian rhythms while accounting for seasonal impacts. METHODS: Data were sourced from a large longitudinal mHealth study, wherein participants' depression severity was assessed biweekly using the 8-item Patient Health Questionnaire (PHQ-8), and participants' behaviors, including sleep, step count, and heart rate (HR), were tracked via Fitbit devices for up to 2 years. We extracted 12 circadian rhythm features from the 14-day Fitbit data preceding each PHQ-8 assessment, including cosinor variables, such as HR peak timing (HR acrophase), and nonparametric features, such as the onset of the most active continuous 10-hour period (M10 onset). To investigate the association between depression severity and circadian rhythms while also assessing the seasonal impacts, we used three nested linear mixed-effects models for each circadian rhythm feature: (1) incorporating the PHQ-8 score as an independent variable, (2) adding seasonality, and (3) adding an interaction term between season and the PHQ-8 score. RESULTS: Analyzing 10,018 PHQ-8 records alongside Fitbit data from 543 participants (n=414, 76.2% female; median age 48, IQR 32-58 years), we found that after adjusting for seasonal effects, higher PHQ-8 scores were associated with reduced daily steps (ß=-93.61, P<.001), increased sleep variability (ß=0.96, P<.001), and delayed circadian rhythms (ie, sleep onset: ß=0.55, P=.001; sleep offset: ß=1.12, P<.001; M10 onset: ß=0.73, P=.003; HR acrophase: ß=0.71, P=.001). Notably, the negative association with daily steps was more pronounced in spring (ß of PHQ-8 × spring = -31.51, P=.002) and summer (ß of PHQ-8 × summer = -42.61, P<.001) compared with winter. Additionally, the significant correlation with delayed M10 onset was observed solely in summer (ß of PHQ-8 × summer = 1.06, P=.008). Moreover, compared with winter, participants experienced a shorter sleep duration by 16.6 minutes, an increase in daily steps by 394.5, a delay in M10 onset by 20.5 minutes, and a delay in HR peak time by 67.9 minutes during summer. CONCLUSIONS: Our findings highlight significant seasonal influences on human circadian rhythms and their associations with depression, underscoring the importance of considering seasonal variations in mHealth research for real-world applications. This study also indicates the potential of wearable-measured circadian rhythms as digital biomarkers for depression.

Examining the surgical stress effects (SSE) framework in practice: A qualitative assessment of perceived sources and consequences of intraoperative stress in surgical teams.

BACKGROUND: Surgical adverse events persist despite extensive improvement efforts. Emotional and behavioral responses to stressors may influence intraoperative performance, as illustrated in the surgical stress effects (SSE) framework. However, the SSE has not been assessed using "real world" data. METHODS: We conducted semi-structured interviews with all surgical team roles at one midwestern VA hospital and elicited narratives involving intraoperative stress. Two coders inductively identified codes from transcripts. The team identified themes among codes and assessed concordance with the SSE framework. RESULTS: Throughout 28 interviews, we found surgical stress was ubiquitous, associated with a variety of factors, including adverse events. Stressors often elicited frustration, anger, fear, and anxiety; behavioral reactions to negative emotions frequently were perceived to degrade individual/team performance and compromise outcomes. Narratives were consistent with the SSE framework and support adding a process outcome (efficiency) and illustrating how adverse events can feedback and acutely increase job demands and stress. CONCLUSION: This qualitative study describes narratives of intraoperative stress, finding they are consistent with the SSE while also allowing minor improvements to the current framework.

Barriers, opportunities, and potential costs of expanding HIV support services.

Experiencing housing instability, food insecurity, and financial stress can negatively impact retention in care and treatment adherence for people living with HIV. Expanding services that support socioeconomic needs could help improve HIV outcomes. Our objective was to investigate barriers, opportunities, and costs of expanding socioeconomic support programs. Semi-structured interviews were conducted with organizations serving U.S. Ryan White HIV/AIDS Program clients. Costs were estimated from interviews, organization documents, and city-specific wages. Organizations reported complex patient, organization, program, and system challenges as well as several opportunities for expansion. The average one-year per-person cost for engaging new clients was $196 for transportation, $612 for financial aid, $650 for food aid, and $2498 for short-term housing (2020 USD). Understanding potential expansion costs is important for funders and local stakeholders. This study provides a sense of magnitude for costs to scale-up programs to better meet socioeconomic needs of low-income patients living with HIV.

Barriers and facilitators to implementing pharmacist-provided comprehensive medication management in primary care transformation.

PURPOSE: How to effectively integrate pharmacists into team-based models of care to maximize the benefit they bring to patients and care teams, especially during times of primary care transformation (PCT), remains unknown. The objective of this study was to identify barriers and facilitators when integrating pharmacist-provided comprehensive medication management (CMM) services into a health system's team-based PCT using the Consolidated Framework for Implementation Research (CFIR). METHODS: Semistructured qualitative interviews were carried out with 22 care team members regarding their perceptions of the implementation of CMM in the PCT. Transcripts were coded to identify CMM implementation barriers and facilitators, and resulting codes were mapped to corresponding CFIR domains and constructs. RESULTS: Fifteen codes emerged that were labeled as either a barrier or a facilitator to implementing CMM in the PCT. Facilitators were the perception of CMM as an invaluable resource, precharting, tailored appointment lengths, insurance coverage, increased pharmacy presence, enhanced team-based care, location of CMM, and identification of CMM advocates. Barriers included limited clinic leadership involvement, a need for additional resources, CMM pharmacists not always feeling part of the core team, understanding of and training around CMM's role in the PCT, changing mindsets to utilize resources such as CMM more frequently, underutilization of CMM, and CMM scheduling. CONCLUSION: Clinical pharmacists providing CMM represent a valuable interdisciplinary care team member who can help improve healthcare quality and access to primary care. Identifying and addressing implementation barriers and facilitators early during PCT rollout is critical to the success of team-based services such as CMM and becoming a learning health system.

Remote Assessment of Disease and Relapse in Major Depressive Disorder (RADAR-MDD): recruitment, retention, and data availability in a longitudinal remote measurement study.

BACKGROUND: Major Depressive Disorder (MDD) is prevalent, often chronic, and requires ongoing monitoring of symptoms to track response to treatment and identify early indicators of relapse. Remote Measurement Technologies (RMT) provide an opportunity to transform the measurement and management of MDD, via data collected from inbuilt smartphone sensors and wearable devices alongside app-based questionnaires and tasks. A key question for the field is the extent to which participants can adhere to research protocols and the completeness of data collected. We aimed to describe drop out and data completeness in a naturalistic multimodal longitudinal RMT study, in people with a history of recurrent MDD. We further aimed to determine whether those experiencing a depressive relapse at baseline contributed less complete data. METHODS: Remote Assessment of Disease and Relapse - Major Depressive Disorder (RADAR-MDD) is a multi-centre, prospective observational cohort study conducted as part of the Remote Assessment of Disease and Relapse - Central Nervous System (RADAR-CNS) program. People with a history of MDD were provided with a wrist-worn wearable device, and smartphone apps designed to: a) collect data from smartphone sensors; and b) deliver questionnaires, speech tasks, and cognitive assessments. Participants were followed-up for a minimum of 11 months and maximum of 24 months. RESULTS: Individuals with a history of MDD (n = 623) were enrolled in the study,. We report 80% completion rates for primary outcome assessments across all follow-up timepoints. 79.8% of people participated for the maximum amount of time available and 20.2% withdrew prematurely. We found no evidence of an association between the severity of depression symptoms at baseline and the availability of data. In total, 110 participants had > 50% data available across all data types. CONCLUSIONS: RADAR-MDD is the largest multimodal RMT study in the field of mental health. Here, we have shown that collecting RMT data from a clinical population is feasible. We found comparable levels of data availability in active and passive forms of data collection, demonstrating that both are feasible in this patient group.

Clinic price reductions in a tiered total cost benefit design.

OBJECTIVES: To understand responses of primary care clinics to inclusion in a tiered total cost of care insurance benefit design. STUDY DESIGN: We used a qualitative design beginning with longitudinal analysis of administrative data on consumer clinic choice, clinic tier placement, and clinic actions, followed by in-depth interviews with key informants from clinics, administering health plans, and program administrators. METHODS: We collected data via semistructured interviews with purposively sampled key informants selected from clinics that prospectively reduced prices to move to, or remain in, a tier with lower cost sharing. Data from interview transcripts were coded using qualitative coding software and analyzed for thematic responses. RESULTS: Our findings suggest that clinics respond to the incentives in the tiered cost-sharing benefit design. Two motivations cited by clinics are (1) concern over developing a reputation as a high-cost clinic and (2) concern about the possible loss of patients due to higher cost sharing. Some clinics have agreed to price reductions or risk-sharing arrangements to move to, or remain in, a tier with lower cost sharing. Clinic informants reported that price reductions alone are not scalable. They sought greater transparency in tier assignment and increased data sharing to help them reduce costly or unnecessary utilization. CONCLUSIONS: Managers of primary care clinics respond to a tiered benefit design that holds them accountable for total cost of care. They respond by offering price discounts and expressing interest in reducing costly referrals and unnecessary use of services.

Age-friendly communities and perceived disconnectedness: the role of built environment and social engagement.

Objective: To examine the effect of access to outdoor space and buildings and social or community events on elders' perceived disconnectedness. Method: Data were from a representative survey conducted as part of an age-friendly community initiative in a large midwestern city in the United States. Hierarchical logistic regression was employed to examine the relationships between environment, engagement, and connection. Results: Having access to ramps to enter buildings reduced the odds of perceived disconnectedness by 79%, participation in social or community events reduced the odds of perceived disconnectedness by 83%. The odds of perceived disconnectedness for elders "not sure" of their access to public buildings were around 6 times that of those without access, holding all else constant. Discussion: Ensuring access to ramps to enter buildings, disseminating information about the accessibility of parks and buildings, and social or community events may reduce elders' perceived disconnectedness.

"It Has Changed My Life": An Exploration of Caregiver Experiences in Serious Illness.

BACKGROUND: Informal, unpaid caregivers shoulder much of the care burden for individuals with serious illness. As part of a project to create an innovative model of supportive care for serious illness, a series of user interviews were conducted, forming the basis for this article. OBJECTIVE: To understand both individual and interpersonal aspects of caregiving for serious illness. METHODS: Twelve semistructured group interviews were conducted with patients, families, and professionals as part of a larger study of late-life serious illness. Transcript data were analyzed with descriptive coding, and then coded material was analyzed to elicit major themes and subthemes. RESULTS: A total of 73 individuals participated in group interview sessions. Using descriptive coding, quotes were assigned to first-order codes of rewards, challenges, and a category of learnings and adaptations. Subthemes of reward included gratitude, a sense of accomplishment or mastery, and closeness in personal relationships. The most oft-cited challenges included emotional and physical stresses of caregiving and feeling unprepared or unsupported in caregiving. Reflecting on their experiences, caregivers cited new ways in which they had learned to be creative, to show assertiveness and advocacy, and to create personal balance in a demanding situation. CONCLUSIONS: The experience of caregiving is a life-altering journey as individuals rise to challenges and reflect on the rewards. Caregivers described intensive caregiving, often without acknowledgment or understanding of their role from the health-care system. This invisibility created its own iatrogenic caregiving challenge. The identified themes suggest avenues of meaningful caregiver support that bear further exploration.

Tracking The Changing Landscape Of Corporate Wellness Companies.

The corporate wellness industry is diversifying and now includes legacy wellness companies, divisions of health plans or delivery systems, and new technology-focused solution enterprises. We conducted in-depth interviews with leaders in the industry to understand the changes in its supply side, the drivers of these changes, future trends, and their implications for employers and policy makers. Three key trends emerged from the interviews: The industry is expanding and becoming increasingly diverse and competitive; wellness companies are redefining their business models to promote a culture of health; and the value proposition of employee wellness programs is shifting from a return on investment to a new idea: value on investment. Our findings clarify wellness companies' innovations, their contributions to population health improvement efforts, and the need for additional evidence to demonstrate the value of the new generation of wellness products and services.

Improving chronic disease care by adding laypersons to the primary care team: a parallel randomized trial.

BACKGROUND: Improving the quality and efficiency of chronic disease care is an important goal. OBJECTIVE: To test whether patients with chronic disease working with lay "care guides" would achieve more evidence-based goals than those receiving usual care. DESIGN: Parallel-group randomized trial, stratified by clinic and conducted from July 2010 to April 2012. Patients were assigned in a 2:1 ratio to a care guide or usual care. Patients, providers, and persons assessing outcomes were not blinded to treatment assignment. (ClinicalTrials.gov: NCT01156974). SETTING: 6 primary care clinics in Minnesota. PATIENTS: Adults with hypertension, diabetes, or heart failure. INTERVENTION: 2135 patients were given disease-specific information about standard care goals and asked to work toward goals for 1 year, with or without the help of a care guide. Care guides were 12 laypersons who received brief training about these diseases and behavior change. MEASUREMENTS: The primary end point for each patient was change in percentage of goals met 1 year after enrollment. RESULTS: The percentage of goals met increased in both the care guide and usual care groups (changes from baseline, 10.0% and 3.9%, respectively). Patients with care guides achieved more goals than usual care patients (82.6% vs. 79.1%; odds ratio, 1.31 [95% CI, 1.16 to 1.47]; P < 0.001); reduced unmet goals by 30.1% compared with 12.6% for usual care patients; and improved more than usual care patients in meeting several individual goals, including not using tobacco. Estimated cost was $286 per patient per year. LIMITATIONS: Providers' usual care may have been influenced by contact with care guides. Last available data in the electronic health record were used to assess end points. CONCLUSION: Adding care guides to the primary care team can improve care for some patients with chronic disease at low cost.

Assessment of a novel, capsid-modified adenovirus with an improved vascular gene transfer profile.

BACKGROUND: Cardiovascular disorders, including coronary artery bypass graft failure and in-stent restenosis remain significant opportunities for the advancement of novel therapeutics that target neointimal hyperplasia, a characteristic of both pathologies. Gene therapy may provide a successful approach to improve the clinical outcome of these conditions, but would benefit from the development of more efficient vectors for vascular gene delivery. The aim of this study was to assess whether a novel genetically engineered Adenovirus could be utilised to produce enhanced levels of vascular gene expression. METHODS: Vascular transduction capacity was assessed in primary human saphenous vein smooth muscle and endothelial cells using vectors expressing the LacZ reporter gene. The therapeutic capacity of the vectors was compared by measuring smooth muscle cell metabolic activity and migration following infection with vectors that over-express the candidate therapeutic gene tissue inhibitor of matrix metalloproteinase-3 (TIMP-3). RESULTS: Compared to Adenovirus serotype 5 (Ad5), the novel vector Ad5T*F35++ demonstrated improved binding and transduction of human vascular cells. Ad5T*F35++ mediated expression of TIMP-3 reduced smooth muscle cell metabolic activity and migration in vitro. We also demonstrated that in human serum samples pre-existing neutralising antibodies to Ad5T*F35++ were less prevalent than Ad5 neutralising antibodies. CONCLUSIONS: We have developed a novel vector with improved vascular transduction and improved resistance to human serum neutralisation. This may provide a novel vector platform for human vascular gene transfer.