The Digital Therapeutics Real-World Evidence Framework: An Approach for Guiding Evidence-Based Digital Therapeutics Design, Development, Testing, and Monitoring.

Digital therapeutics (DTx) are a promising way to provide safe, effective, accessible, sustainable, scalable, and equitable approaches to advance individual and population health. However, developing and deploying DTx is inherently complex in that DTx includes multiple interacting components, such as tools to support activities like medication adherence, health behavior goal-setting or self-monitoring, and algorithms that adapt the provision of these according to individual needs that may change over time. While myriad frameworks exist for different phases of DTx development, no single framework exists to guide evidence production for DTx across its full life cycle, from initial DTx development to long-term use. To fill this gap, we propose the DTx real-world evidence (RWE) framework as a pragmatic, iterative, milestone-driven approach for developing DTx. The DTx RWE framework is derived from the 4-phase development model used for behavioral interventions, but it includes key adaptations that are specific to the unique characteristics of DTx. To ensure the highest level of fidelity to the needs of users, the framework also incorporates real-world data (RWD) across the entire life cycle of DTx development and use. The DTx RWE framework is intended for any group interested in developing and deploying DTx in real-world contexts, including those in industry, health care, public health, and academia. Moreover, entities that fund research that supports the development of DTx and agencies that regulate DTx might find the DTx RWE framework useful as they endeavor to improve how DTxcan advance individual and population health.

Physical Therapists' Acceptance of a Wearable, Fabric-Based Sensor System (Motion Tape) for Use in Clinical Practice: Qualitative Focus Group Study.

BACKGROUND: Low back pain (LBP) is a costly global health condition that affects individuals of all ages and genders. Physical therapy (PT) is a commonly used and effective intervention for the management of LBP and incorporates movement assessment and therapeutic exercise. A newly developed wearable, fabric-based sensor system, Motion Tape, uses novel sensing and data modeling to measure lumbar spine movements unobtrusively and thus offers potential benefits when used in conjunction with PT. However, physical therapists' acceptance of Motion Tape remains unexplored. OBJECTIVE: The primary aim of this research study was to evaluate physical therapists' acceptance of Motion Tape to be used for the management of LBP. The secondary aim was to explore physical therapists' recommendations for future device development. METHODS: Licensed physical therapists from the American Physical Therapy Association Academy of Leadership Technology Special Interest Group participated in this study. Overall, 2 focus groups (FGs; N=8) were conducted, in which participants were presented with Motion Tape samples and examples of app data output on a poster. Informed by the Technology Acceptance Model, we conducted semistructured FGs and explored the wearability, usefulness, and ease of use of and suggestions for improvements in Motion Tape for PT management of LBP. FG data were transcribed and analyzed using rapid qualitative analysis. RESULTS: Regarding wearability, participants perceived that Motion Tape would be able to adhere for several days, with some variability owing to external factors. Feedback was positive for the low-profile and universal fit, but discomfort owing to wires and potential friction with clothing was of concern. Other concerns included difficulty with self-application and potential skin sensitivity. Regarding usefulness, participants expressed that Motion Tape would enhance the efficiency and specificity of assessments and treatment. Regarding ease of use, participants stated that the app would be easy, but data management and challenges with interpretation were of concern. Physical therapists provided several recommendations for future design improvements including having a wireless system or removable wires, customizable sizes for the tape, and output including range of motion data and summary graphs and adding app features that consider patient input and context. CONCLUSIONS: Several themes related to Motion Tape's wearability, usefulness, and ease of use were identified. Overall, physical therapists expressed acceptance of Motion Tape's potential for assessing and monitoring low back posture and movement, both within and outside clinical settings. Participants expressed that Motion Tape would be a valuable tool for the personalized treatment of LBP but highlighted several future improvements needed for Motion Tape to be used in practice.

Does a simplified algorithm and integrated HCV care model improve linkage to care, retention, and cure among people who inject drugs? A pragmatic quality improvement randomized controlled trial protocol.

BACKGROUND: As many as 2.4 million Americans are affected by chronic Hepatitis C Virus (HCV) in the United States.In 2018, the estimated number of adults with a history of HCV infection in San Diego County was 55,354 (95% CI: 25,411-93,329). This corresponded to a seroprevalence of 2.1% (95% CI: 2.1-3.4%). One-third of infections were among PWID. Published research has demonstrated that direct-acting antivirals (DAAs) have high efficacy and can now be used by primary care providers to treat HCV. In addition, limited evidence exists to support the effectiveness of simplified algorithms in clinical trial and real-world settings. Even with expanded access to HCV treatment in primary care settings, there are still groups, especially people who inject drugs (PWID) and people experiencing homelessness, who experience treatment disparities due to access and treatment barriers. The current study extends the simplified algorithm with a streetside 'one-stop-shop' approach with integrated care (including the offer of buprenorphine prescriptions and abscess care) using a mobile clinic situated adjacent to a syringe service program serving many homeless populations. Rates of HCV treatment initiation and retention will be compared between patients offered HCV care in a mobile clinic adjacent to a syringe services program (SSP) and homeless encampment versus those who are linked to a community clinic's current practice of usual care, which includes comprehensive patient navigation. METHODS: A quasi-experimental, prospective, interventional, comparative effectiveness trial with allocation of approximately 200 patients who inject drugs and have chronic HCV to the "simplified care" pathway (intervention group) or the "usual care" pathway (control group). Block randomization will be performed with a 1:1 randomization. DISCUSSION: Previous research has demonstrated acceptable outcomes for patients treated using simplified algorithms for DAAs and point-of-care testing in mobile medical clinics; however, there are opportunities to explore how these new, innovative systems of care impact treatment initiation rates or other HCV care cascade outcomes among PWID. TRIAL REGISTRATION: We have registered our study with ClinicalTrials.gov, a resource of the United States National Library of Medicine. This database contains research studies from United States and other countries around the world. Our study has not been previously published. The ClinicalTrials.gov registration identifier is NCT04741750.

Fatness but Not Fitness Linked to BrainAge: Longitudinal Changes in Brain Aging during an Exercise Intervention.

PURPOSE: Fitness, physical activity, body composition, and sleep have all been proposed to explain differences in brain health. We hypothesized that an exercise intervention would result in improved fitness and body composition and would be associated with improved structural brain health. METHODS: In a randomized controlled trial, we studied 485 older adults who engaged in an exercise intervention ( n = 225) or a nonexercise comparison condition ( n = 260). Using magnetic resonance imaging, we estimated the physiological age of the brain (BrainAge) and derived a predicted age difference compared with chronological age (brain-predicted age difference (BrainPAD)). Aerobic capacity, physical activity, sleep, and body composition were assessed and their impact on BrainPAD explored. RESULTS: There were no significant differences between experimental groups for any variable at any time point. The intervention group gained fitness, improved body composition, and increased total sleep time but did not have significant changes in BrainPAD. Analyses of changes in BrainPAD independent of group assignment indicated significant associations with changes in body fat percentage ( r (479) = 0.154, P = 0.001), and visceral adipose tissue (VAT) ( r (478) = 0.141, P = 0.002), but not fitness ( r (406) = -0.075, P = 0.129), sleep ( r (467) range, -0.017 to 0.063; P range, 0.171 to 0.710), or physical activity ( r (471) = -0.035, P = 0.444). With linear regression, changes in body fat percentage and VAT significantly predicted changes in BrainPAD ( ß = 0.948, P = 0.003) with 1-kg change in VAT predicting 0.948 yr of change in BrainPAD. CONCLUSIONS: In cognitively normal older adults, exercise did not appear to impact BrainPAD, although it was effective in improving fitness and body composition. Changes in body composition, but not fitness, physical activity, or sleep impacted BrainPAD. These findings suggest that focus on weight control, particularly reduction of central obesity, could be an interventional target to promote healthier brains.

Barriers and facilitators to self-measured blood pressure monitoring among US-resettled Arab refugees with hypertension: a qualitative study.

BACKGROUND: Minoritized communities including refugees are at an increased risk of poorly controlled hypertension. Evidence indicates that self-measured blood pressure monitoring (SMBP) is an effective method to improve blood pressure control in patients with hypertension. However, it has not been studied among refugee populations. The objective of this study is to examine barriers and facilitators to SMBP among Arab refugees resettled in the United States (US) with diagnosed hypertension. METHODS: A total of 109 participants were recruited through a Federally Qualified Health Center system that is a major provider of healthcare to refugees in San Diego, California. Participants completed a questionnaire and were interviewed using in-depth, semi-structured interviews. Interviews were transcribed and translated, and data were coded using inductive thematic analysis and organized based on the theory of care-seeking behavior. RESULTS: Several barriers to engaging in effective SMBP monitoring were identified. Clinical and sociodemographic barriers included reliance on public monitors and poor hypertension literacy. Psychosocial barriers of affect, norms, and habits included fear and anxiety from hypertension, cultural stigma of illness, and conditional SMBP with symptoms, respectively. Utility psychosocial barriers included lack of SMBP prioritization in treatment and perceived inaccuracy of home monitors. Family members' support with home monitoring served as an important facilitator to SMBP. CONCLUSIONS: There are several barriers to effective SMBP among the US-resettled Arab refugee population that may reflect unique cultural and care-seeking behaviors. Tailored public health and clinical interventions are needed to support refugee patients and providers to improve hypertension self-management behaviors for this unique population.

Effects of an mHealth physical activity intervention to prevent osteoporosis in premenopausal women. A randomized controlled trial.

OBJECTIVES: It is critical to develop prevention strategies for osteoporosis that reduce the burden fractures place on individuals and health systems. This study evaluated the effects of an mHealth intervention that delivered and monitored a non-supervised exercise program on bone mineral density (BMD). DESIGN: Randomized controlled trial. METHODS: 60 premenopausal women aged 35-50 years were divided into an intervention group (IG) and a control group (CG). The IG followed a 6-month intervention aimed at increasing osteogenic physical activity, guided by two daily goals: walking at least 10,000 steps and completing 60 impacts over 4 g of acceleration. These goals were monitored using a wearable accelerometer linked to an mHealth app. The CG maintained their regular lifestyle and wore the accelerometer without feedback. BMD was estimated using dual-energy X-ray absorptiometry (DXA) scans at baseline and after 6 months, with group-by-time analyses conducted using ANCOVA. The intervention's impact on physical fitness and activity habits was also evaluated. RESULTS: 46 participants completed the study (IG = 24; CG = 22). The IG showed significant improvements compared to the CG in femoral neck BMD (IG: +0.003 ±â€¯0.029 g/cm2 vs CG: -0.027 ±â€¯0.031 g/cm2), trochanter BMD (IG: +0.004 ±â€¯0.023 g/cm2 vs CG: -0.026 ±â€¯0.030 g/cm2), and total hip BMD (IG: +0.006 ±â€¯0.043 g/cm2 vs CG: -0.040 ±â€¯0.048 g/cm2). The IG also demonstrated significant improvements in physical fitness measures, including peak torque and power at various speeds and positions. No adverse events related to the intervention were reported. CONCLUSIONS: This non-supervised physical activity intervention delivered by wearable-technology and an mHealth app was effective in improving BMD, suggesting its potential for osteoporosis prevention.

Refugee Telehealth Utilization for Hypertension Management During the COVID-19 Pandemic.

Objectives: The COVID-19 pandemic limited refugees' access to healthcare. Increased use of telehealth could enable continuity of care but also create barriers to chronic disease management. This study explores refugees' experience with telehealth and hypertension management during the pandemic. Methods: We recruited 109 refugee participants diagnosed with hypertension. We conducted semi-structured interviews about their experience with telehealth during the COVID-19 pandemic. Interviews were transcribed, translated, and data was coded using inductive thematic analysis. Results: 86% used telehealth modalities at least once during the pandemic. Interviews highlighted three main themes: (1) Social isolation worsened mental health, affecting their motivation to manage their blood pressure; (2) telehealth alleviated discontinuity of care but posed logistical and cultural challenges; (3) participants relied on public blood pressure monitors that were not available during the pandemic which affected disease management. Conclusion: Refugees faced challenges managing their hypertension during the COVID-19 pandemic. Virtual community building may alleviate their stress and isolation. Telehealth must be adapted to account for language, cultural, and technological barriers. Communities with hypertension should increase access to personal or public blood pressure monitors.

Impact of United States refugee ban and discrimination on the mental health of hypertensive Arabic-speaking refugees.

Background: Hypertension is a global leading cause of death which disproportionately affects refugees. This chronic disease increases the risk of heart disease, stroke, brain, and other end-organ disease, if left uncontrolled. The 2017 United States travel or "Muslim" ban prevented immigrants and refugees from seven Muslim-majority countries from entering the United States, including Syria and Iraq; two major contributors to the global refugee population. As of 2020, the United States has admitted more than 133,000 and 22,000 Iraqi and Syrian refugees, respectively. Studies on the health effects of this policy on refugees are lacking. This study qualitatively explores the impact of the refugee ban on United States resettled Syrian and Iraqi refugees with hypertension. Methods: Participants were recruited through a federally qualified health center system that is the largest healthcare provider for refugees in San Diego, CA. All participants were Arabic-speaking refugees diagnosed with hypertension from Syria and Iraq. In-depth interviews took place between April 2021 and April 2022. Inductive thematic analysis was used to analyze data from semi-structured interviews. Results: Participants (N = 109) include 53 women and 56 men (23 Syrian, 86 Iraqi). The average age was 61.3 years (SD: 9.7) and stay in the United States was 9.5 years (SD 5.92). Four themes emerged linking the travel ban's impact on health, in line with the society to cells framework: (1) family factors: the refugee ban resulted in family separation; (2) physiological factors: the refugee ban worsened participants' mental health, exacerbating hypertension and perceived health outcomes; (3) community factors: perpetuation of Islamophobia, xenophobia, and perceived discrimination were structural barriers with links to poorer health; and (4) individual factors: trickle down consequences led to worsened participant self-image and self-perception within their host community. Discussion: The refugee ban negatively impacted the mental and physical health of United States resettled Arabic-speaking refugees through perceived discrimination, stress, and poor social integration. It continues to have long-lasting effects years after the ban was instated. Centering family reunification within the United States Refugee Admissions Program and tailoring interventions through the healthcare and public health systems are warranted to reduce hypertension disparities in this growing and overlooked population.

A technology-enabled multi-disciplinary team-based care model for the management of Long COVID and other fatiguing illnesses within a federally qualified health center: protocol for a two-arm, single-blind, pragmatic, quality improvement professional cluster randomized controlled trial.

BACKGROUND: The clinical burden of Long COVID, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), and other post-infectious fatiguing illnesses (PIFI) is increasing. There is a critical need to advance understanding of the effectiveness and sustainability of innovative approaches to clinical care of patients having these conditions. METHODS: We aim to assess the effectiveness of a Long COVID and Fatiguing Illness Recovery Program (LC&FIRP) in a two-arm, single-blind, pragmatic, quality improvement, professional cluster, randomized controlled trial in which 20 consenting clinicians across primary care clinics in a Federally Qualified Health Center system in San Diego, CA, will be randomized at a ratio of 1:1 to either participate in (1) weekly multi-disciplinary team-based case consultation and peer-to-peer sharing of emerging best practices (i.e., teleECHO (Extension for Community Healthcare Outcomes)) with monthly interactive webinars and quarterly short courses or (2) monthly interactive webinars and quarterly short courses alone (a control group); 856 patients will be assigned to participating clinicians (42 patients per clinician). Patient outcomes will be evaluated according to the study arm of their respective clinicians. Quantitative and qualitative outcomes will be measured at 3- and 6-months post-baseline for clinicians and every 3-months post assignment to a participating clinician for patients. The primary patient outcome is change in physical function measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)-29. Analyses of differences in outcomes at both the patient and clinician levels will include a linear mixed model to compare change in outcomes from baseline to each post-baseline assessment between the randomized study arms. A concurrent prospective cohort study will compare the LC&FIRP patient population to the population enrolled in a university health system. Longitudinal data analysis approaches will allow us to examine differences in outcomes between cohorts. DISCUSSION: We hypothesize that weekly teleECHO sessions with monthly interactive webinars and quarterly short courses will significantly improve clinician- and patient-level outcomes compared to the control group. This study will provide much needed evidence on the effectiveness of a technology-enabled multi-disciplinary team-based care model for the management of Long COVID, ME/CFS, and other PIFI within a federally qualified health center. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05167227 . Registered on December 22, 2021.

Digitally Based Blood Pressure Self-Monitoring Program That Promotes Hypertension Self-Management and Health Education Among Patients With Low-Income: Usability Study.

BACKGROUND: According to evidence-based clinical guidelines, adults with hypertension are advised to self-monitor their blood pressure (BP) twice daily. Self-measured BP monitoring is a recommended strategy for improving hypertension management. OBJECTIVE: We aimed to determine the feasibility and acceptability of a digitally based BP self-monitoring program that promotes hypertension self-management and health education among low-income patients. We hypothesized that the program would be highly feasible and acceptable and that at least 50% of the patients would use the monitor at the rate required for the reimbursement of the device's cost (16 days of measurements in any 30-day period). METHODS: Withings BPM Connect was deployed to patients at Family Health Centers of San Diego. Program elements included training, SMS text message reminders, and physician communication. Compliance, use, mean BP, and BP control status were calculated. A Kaplan-Meier time-to-event analysis was conducted to compare time to compliance between a strict definition (≥16 days in any rolling 30-day window) and a lenient definition (≥1 day per week for 4 consecutive weeks). A log-rank test was performed to determine whether the difference in time to compliance between the definitions was statistically significant. Mean systolic BP (SBP) and diastolic BP (DBP) before the intervention and after the intervention and mean change in SBP and DBP across patients were calculated. Paired sample t tests (2-tailed) were performed to assess the changes in SBP and DBP from before to after the intervention. RESULTS: A total of 179 patients received the monitors. The mean changes in SBP and DBP from before to after the intervention were +2.62 (SE 1.26) mm Hg and +3.31 (SE 0.71) mm Hg, respectively. There was a statistically significant increase in both SBP and DBP after the intervention compared with before the intervention (P=.04 and P<.001). At the first and last measurements, 37.5% (63/168) and 48.8% (82/168) of the patients had controlled BP, respectively. During the observation period, 83.3% (140/168) of the patients had at least 1 controlled BP measurement. Use decreased over time, with 53.6% (90/168) of the patients using their monitor at week 2 and only 25% (42/168) at week 11. Although only 25.6% (43/168) achieved the strict definition of compliance, 42.3% (71/168) achieved the lenient definition of compliance. The median time to compliance was 130 days for the strict definition and 95 days for the lenient definition. The log-rank test showed a statistically significant difference in time to compliance between the compliance definitions (P<.001). Only 26.8% (45/168) complied with the measurement rate that would result in device cost reimbursement. CONCLUSIONS: Few patients used the monitors at a rate that would result in reimbursement, raising financial feasibility concerns. Plans for sustaining costs among low-income patients need to be further evaluated.

Protocol for a Parallel Group Randomized Clinical Trial Comparing a Culturally Adapted Cognitive Behavioral Telerehabilitation Intervention to Usual Physical Therapy for Latino Patients With Chronic Spine Pain.

OBJECTIVE: Disparities exist in health care access, diagnosis, and treatment of chronic pain in Latino populations and other minority populations. Cognitive behavioral-based physical therapy (CBPT) interventions have been shown to be effective in predominantly non-Hispanic white populations with chronic spine pain. However, there is a need for culturally adapted CBPT interventions that focus on the conservative management of chronic spine pain. The primary purpose of the study described in this protocol is to test the efficacy of an adapted cognitive behavioral-based hybrid telerehabilitation intervention for Latino patients with chronic spine pain. METHODS: A single-blind, 2-arm parallel group, superiority randomized clinical trial is planned to compare an adapted CBPT intervention to Usual Care physical therapy. Goal Oriented Activity for Latinos with chronic Spine pain (GOALS/Metas) is an 8-week hybrid telerehabilitation intervention that integrates guideline-based physical therapy and pain management interventions using cognitive behavioral approaches and has been adapted for Latino patients with chronic spine pain. Usual Care physical therapy will be administered based on institutional standards at the referring health center. Outcome measures will be evaluated preintervention and at 1-week, 3-months, and 6-months postintervention. The primary outcome is pain-related disability 1-week postintervention using the Brief Pain Inventory Pain Interference subscale. Secondary outcome measures include behavioral measures of functional activity, social participation, physical activity, and sleep. Determinants of treatment effect, including pain-related psychological measures, posture and movement, self-efficacy, treatment expectancy, and therapeutic alliance, will be included in the secondary moderation and mediation analyses. IMPACT: This clinical trial will provide information on the extent to which an adapted CBPT hybrid telerehabilitation intervention is effective in reducing pain-related disability for Latino patients with chronic spine pain. This information will be useful for clinicians to integrate in their practice, given the growing population of Latino patients who experience disparities in health care management of chronic pain.

Process evaluation of Dulce Digital-Me: an adaptive mobile health (mHealth) intervention for underserved Hispanics with diabetes.

Type 2 diabetes disproportionately impacts ethnic minorities and individuals from low socioeconomic status. Diabetes self-management education and support has been shown to improve clinical outcomes in these populations, and mobile health (mHealth) interventions can reduce barriers to access. Dulce Digital-Me (DD-Me) was developed to integrate adaptive mHealth technologies to enhance self-management and reduce disparities in the high-risk, underserved Hispanic population. The objective of the present study was to evaluate reach, adoption, and implementation of an mHealth diabetes self-management education and support intervention in this underrepresented population. The present analysis is a multimethod process evaluation using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The study was effective in reaching a sample that was representative of the intended population; only modest but significant differences were observed in sex and age. The DD-Me health coach (HC) cited several important facilitators of intervention adoption, including outreach frequency and personalization, and the automated HC report. Implementation fidelity was high, with participants receiving >90% of intended interventions. Participants who received DD-Me with support from a HC were most engaged, suggesting utility and acceptability of integrating HCs with mHealth interventions. Perceptions of implementation among study participants were positive and consistent across study arms. This evaluation revealed the target population was successfully reached and engaged in the digital health interventions, which was implemented with high fidelity. Further studies should evaluate the efficacy and maintenance of the study following the RE-AIM model to determine whether this intervention warrants expansion to additional settings and populations.

Type 2 diabetes disproportionately impacts ethnic minorities, including Hispanic individuals; however, these populations are often underrepresented in clinical research, especially in studies using digital technologies. The Dulce Digital-Me study was developed to provide diabetes self-management education and support using mobile health technologies with the goal of improving clinical outcomes by reducing barriers to accessing support. This analysis revealed that the Dulce Digital-Me study was successful at reaching the target population and engaging them with the intervention, while also delivering the study intervention with high fidelity. This process evaluation provides critical context for understanding the study's clinical outcomes and the potential for further dissemination.

Identifying the behavior change techniques used in obesity interventions: An example from the EARLY trials.

Objective: The dissemination of effective obesity interventions requires the documentation of key elements of the intervention. But outcome papers and other published manuscripts often lack detail that allow the replication of the intervention. The Behavior Change Technique (BCT) Taxonomy (BCTTv1) is a widely used approach to identify key elements of an intervention study. This study compares the extent to which BCTs and domains identified in studies' intervention protocol are concordant with detail from corresponding intervention design and study outcome papers. Methods: Data come from four obesity interventions with complete intervention protocols as well as published intervention design and outcome papers. The number of domains and BCTs was calculated for each treatment arm and stratified by coding source. Emphasis of domains and BCTs was determined using an Analytical Hierarchy Process (AHP). Results: A review of each study's intervention protocol showed the mean number of domains and BCTs used in treatment arms as 11.8 and 26.7, respectively. Primary outcome papers had a mean loss of 34% of the reported domains and 43% of BCTS as compared with intervention protocl. Design papers showed a loss of 11% and 21% of domains and BCTs, respectively. Conclusions: The results confirm the limitations of using the BCTTv1 coding of outcome papers to describe obesity-related interventions. The results also highlight the need for mechanisms that allow for a full description of intervention content such as inclusion in a supplemental section of an online journal or the use of intervention-focused consort guidelines.

COVID-19 monoclonal antibody treatment impact on symptoms and post-COVID conditions among high-risk patients at a Federally Qualified Health Center.

BACKGROUND: Monoclonal antibody (mAb) treatment for COVID-19 is associated with improved clinical outcomes. However, there is limited information regarding the impact of treatment on symptoms and the prevalence of post-COVID Conditions (PCC). Understanding of the association between time to mAb infusion and the development of PCC is also limited. METHODS: This longitudinal study was conducted among patients with COVID-19 who received mAb infusions at a Federally Qualified Health Center in San Diego, CA. A series of telephone interviews were conducted at baseline and follow-up (14 days and 28+ days). A comprehensive symptom inventory was completed and physical and mental health status were measured using PROMIS-29 and PHQ-2. Pearson's Chi-squared tests and independent two-sample t-tests were performed to test for association between time to mAb infusion and outcomes at follow-up. A Poisson regression model was used to analyze whether time to mAb infusion predicts risk of developing PCC. RESULTS: Participants (N = 411) were 53% female, ranged in age from 16 to 92 years (mean 50), and a majority (56%) were Latino/Hispanic. Cross-sectional findings revealed a high symptom burden at baseline (70% of patients had cough, 50% had fever, and 44% had headache). The prevalence of many symptoms decreased substantially by the final follow-up survey (29% of patients had cough, 3% had fever, and 28% had headache). Longitudinal findings indicated that 10 symptoms decreased in prevalence from baseline to final follow-up, 2 remained the same, and 14 increased. The severity of symptoms and most patient-reported physical and mental health measure scores decreased over time. The prevalence of PCC was 69% when PCC was defined as ≥ 1 symptom at final follow-up. Time to mAb infusion was not significantly associated with any outcome at follow-up. Time to infusion was not associated with PCC status at final follow-up in the crude or adjusted Poisson regression models. CONCLUSIONS: The prevalence of PCC was high among this patient population following COVID-19 mAb treatment. Time to mAb infusion did not predict the development of PCC. Further research in these areas is essential to answer urgent clinical questions about effective treatments of COVID-19.

The core functions and forms paradigm throughout EPIS: designing and implementing an evidence-based practice with function fidelity.

There are numerous frameworks for implementing evidence-based practices (EBPs) in novel settings to achieve "fidelity." However, identifying appropriate referents for fidelity poses a challenge. The Core Functions and Forms paradigm offers a model that can inform adaptation decisions throughout all phases of the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. We applied the Core Functions-Forms paradigm throughout the Exploration and Preparation phases of EPIS in the design of two EBPs targeting family protective factors among Latinos in San Diego, as well as describe plans for its use in Implementation and Sustainment. We employed a distinct approach for each intervention element to contrast adaptation decisions that prioritize adherence to either form or function fidelity. We describe our application of the functions-forms paradigm within the EPIS framework, focusing on the Preparation phase. We also provide functions-forms matrices that map out the relationship between individual intervention components (forms) and the essential processes (functions) by which components are theorized to exert their impact. This case study of how the core functions-forms framework can be mapped onto EPIS can support a conceptual shift from prioritizing form fidelity to also focusing on function fidelity. This might allow interventionists to target appropriate fidelity referents when adapting an EBP, rather than defaulting to maintaining fidelity to forms as described in the protocol. We see great promise for using this framework for guiding actions throughout all EPIS phases and informing future applications of this paradigm to foster more robust fidelity to function.

Recommendations for Identifying Valid Wear for Consumer-Level Wrist-Worn Activity Trackers and Acceptability of Extended Device Deployment in Children.

BACKGROUND: Self-reported physical activity is often inaccurate. Wearable devices utilizing multiple sensors are now widespread. The aim of this study was to determine acceptability of Fitbit Charge HR for children and their families, and to determine best practices for processing its objective data. METHODS: Data were collected via Fitbit Charge HR continuously over the course of 3 weeks. Questionnaires were given to each child and their parent/guardian to determine the perceived usability of the device. Patterns of data were evaluated and best practice inclusion criteria recommended. RESULTS: Best practices were established to extract, filter, and process data to evaluate device wear, r and establish minimum wear time to evaluate behavioral patterns. This resulted in usable data available from 137 (89%) of the sample. CONCLUSIONS: Activity trackers are highly acceptable in the target population and can provide objective data over longer periods of wear. Best practice inclusion protocols that reflect physical activity in youth are provided.

Accuracy and Precision of Energy Expenditure, Heart Rate, and Steps Measured by Combined-Sensing Fitbits Against Reference Measures: Systematic Review and Meta-analysis.

BACKGROUND: Although it is widely recognized that physical activity is an important determinant of health, assessing this complex behavior is a considerable challenge. OBJECTIVE: The purpose of this systematic review and meta-analysis is to examine, quantify, and report the current state of evidence for the validity of energy expenditure, heart rate, and steps measured by recent combined-sensing Fitbits. METHODS: We conducted a systematic review and Bland-Altman meta-analysis of validation studies of combined-sensing Fitbits against reference measures of energy expenditure, heart rate, and steps. RESULTS: A total of 52 studies were included in the systematic review. Among the 52 studies, 41 (79%) were included in the meta-analysis, representing 203 individual comparisons between Fitbit devices and a criterion measure (ie, n=117, 57.6% for heart rate; n=49, 24.1% for energy expenditure; and n=37, 18.2% for steps). Overall, most authors of the included studies concluded that recent Fitbit models underestimate heart rate, energy expenditure, and steps compared with criterion measures. These independent conclusions aligned with the results of the pooled meta-analyses showing an average underestimation of -2.99 beats per minute (k comparison=74), -2.77 kcal per minute (k comparison=29), and -3.11 steps per minute (k comparison=19), respectively, of the Fitbit compared with the criterion measure (results obtained after removing the high risk of bias studies; population limit of agreements for heart rate, energy expenditure, and steps: -23.99 to 18.01, -12.75 to 7.41, and -13.07 to 6.86, respectively). CONCLUSIONS: Fitbit devices are likely to underestimate heart rate, energy expenditure, and steps. The estimation of these measurements varied by the quality of the study, age of the participants, type of activities, and the model of Fitbit. The qualitative conclusions of most studies aligned with the results of the meta-analysis. Although the expected level of accuracy might vary from one context to another, this underestimation can be acceptable, on average, for steps and heart rate. However, the measurement of energy expenditure may be inaccurate for some research purposes.

A multiple technology-based physical activity intervention for Latina adolescents in the USA: randomized controlled trial study protocol for Chicas Fuertes.

BACKGROUND: Latina adolescents in the USA report some of the lowest rates of physical activity of any demographic subgroup; this is paralleled by a markedly higher lifetime risk of obesity, type 2 diabetes, and other conditions related to inactivity. Despite this, to date, no fully powered clinical trials have tested physical activity interventions specifically for this population. High use of mobile technologies (including text messages, smartphone apps, and social media) suggests this could be an appropriate intervention channel, while also having potential for broad reach. This paper describes the protocol for Chicas Fuertes, a fully powered randomized trial of a mobile technology-based physical activity intervention for Latina adolescents. METHODS: We plan to recruit 200 Latina teens (age 13-18) in San Diego, CA, currently engaging in ≤ 150 min/week of moderate-to-vigorous physical activity (MVPA) to be assigned 1:1 to the intervention or control groups. Those randomly assigned to the intervention group receive a one-on-one goal setting session followed by 6 months of mobile technology-based intervention, including a personalized website, Fitbit activity tracker and app, individually tailored text messages based on Fitbit data, and daily intervention content on Instagram. Those randomized to the control group receive only a Fitbit activity tracker. The main outcome is change in weekly minutes of MVPA from baseline to 6 months, measured both objectively (ActiGraph accelerometers and Fitbit Inspire HR) and subjectively (7-Day Physical Activity Recall Interview). Additional outcomes are maintenance of activity change at 12 months and changes in psychosocial constructs, including social support and self-efficacy, engagement with mobile technology channels, and costs of intervention delivery. We are also examining the potential mediators and moderators of the intervention. The efficacy of the intervention is analyzed using a mixed effects regression model, adjusting for any potential confounders not balanced by randomization. All analyses of accelerometer measured MVPA are also adjusted for wear time. DISCUSSION: The Chicas Fuertes trial uses widely available mobile technologies to target critical health behavior, physical activity, in Latina teens, a population with a high lifetime risk of lifestyle-related diseases. The results will speak to the efficacy and acceptability of the intervention, which has the potential for broad dissemination. TRIAL REGISTRATION: ClinicalTrials.gov NCT04190225 . Registered on November 20, 2019.

Evaluation of Social Isolation, Loneliness, and Cardiovascular Disease Among Older Women in the US.

Importance: Social isolation and loneliness are increasing public health concerns and have been associated with increased risk of cardiovascular disease (CVD) among older adults. Objective: To examine the associations of social isolation and loneliness with incident CVD in a large cohort of postmenopausal women and whether social support moderated these associations. Design, Setting, and Participants: This prospective cohort study, conducted from March 2011 through March 2019, included community-living US women aged 65 to 99 years from the Women's Health Initiative Extension Study II who had no history of myocardial infarction, stroke, or coronary heart disease. Exposures: Social isolation and loneliness were ascertained using validated questionnaires. Main Outcomes and Measures: The main outcome was major CVD, which was physician adjudicated using medical records and included coronary heart disease, stroke, and death from CVD. Continuous scores of social isolation and loneliness were analyzed. Hazard ratios (HRs) and 95% CIs for CVD were calculated for women with high social isolation and loneliness scores (midpoint of the upper half of the distribution) vs those with low scores (midpoint of the lower half of the distribution) using multivariable Cox proportional hazards regression models adjusting for age, race and ethnicity, educational level, and depression and then adding relevant health behavior and health status variables. Questionnaire-assessed social support was tested as a potential effect modifier. Results: Among 57 825 women (mean [SD] age, 79.0 [6.1] years; 89.1% White), 1599 major CVD events occurred over 186 762 person-years. The HR for the association of high vs low social isolation scores with CVD was 1.18 (95% CI, 1.13-1.23), and the HR for the association of high vs low loneliness scores with CVD was 1.14 (95% CI, 1.10-1.18). The HRs after additional adjustment for health behaviors and health status were 1.08 (95% CI, 1.03-1.12; 8.0% higher risk) for social isolation and 1.05 (95% CI, 1.01-1.09; 5.0% higher risk) for loneliness. Women with both high social isolation and high loneliness scores had a 13.0% to 27.0% higher risk of incident CVD than did women with low social isolation and low loneliness scores. Social support was not a significant effect modifier of the associations (social isolation × social support: r, -0.18; P = .86; loneliness × social support: r, 0.78; P = .48). Conclusions and Relevance: In this cohort study, social isolation and loneliness were independently associated with modestly higher risk of CVD among postmenopausal women in the US, and women with both social isolation and loneliness had greater CVD risk than did those with either exposure alone. The findings suggest that these prevalent psychosocial processes merit increased attention for prevention of CVD in older women, particularly in the era of COVID-19.

Dulce Digital-Me: protocol for a randomized controlled trial of an adaptive mHealth intervention for underserved Hispanics with diabetes.

BACKGROUND: By 2034, the number of US individuals with diabetes is predicted to increase from 23.7 to 44.1 million, and annual diabetes-related spending is expected to grow from $113 to $336 billion. Up to 55% of US Hispanics born in the year 2000 are expected to develop diabetes during their lifetime. Poor healthcare access and cultural barriers prevent optimal care, adherence, and clinical benefit, placing Hispanics at disproportionate risk for costly diabetes complications. Mobile technology is increasingly prevalent in all populations and can circumvent such barriers. Our group developed Dulce Digital, an educational text messaging program that improved glycemic control relative to usual care. Dulce Digital-Me (DD-Me) has been tailored to a participant's individual needs with a greater focus on health behavior change. METHODS: This is a three-arm, parallel group, randomized trial with equal allocation ratio enrolling Hispanic adults with low income and poorly managed type 2 diabetes (N = 414) from a San Diego County Federally Qualified Health Center. Participants are randomized to receive Dulce Digital, Dulce Digital-Me-Automated, or Dulce Digital-Me-Telephonic. The DD-Me groups include Dulce Digital components plus personalized goal-setting and feedback delivered via algorithm-driven automated text messaging (DD-Me-Automated) or by the care team health coach (DD-Me-Telephonic) over a 12-month follow-up period. The study will examine the comparative effectiveness of the three groups in improving diabetes clinical control [HbA1c, primary outcome; low-density lipoprotein cholesterol (LDL-C), and systolic blood pressure (SBP)] and patient-provider communication and patient adherence (i.e., medication, self-management tasks) over 12 months and will examine cost-effectiveness of the three interventions. DISCUSSION: Our comparative evaluation of three mHealth approaches will elucidate how technology can be integrated most effectively and efficiently within primary care-based chronic care model approaches to reduce diabetes disparities in Hispanics and will assess two modes of personalized messaging delivery (i.e., automated messaging vs. telephonic by health coach) to inform cost and acceptability. TRIAL REGISTRATION: NCT03130699-All items from the WHO Trial Registration data set are available in https://clinicaltrials.gov/ct2/show/study/NCT03130699 .