Wearable Sensor-Based Detection of Influenza in Presymptomatic and Asymptomatic Individuals.

BACKGROUND: The COVID-19 pandemic highlighted the need for early detection of viral infections in symptomatic and asymptomatic individuals to allow for timely clinical management and public health interventions. METHODS: Twenty healthy adults were challenged with an influenza A (H3N2) virus and prospectively monitored from 7 days before through 10 days after inoculation, using wearable electrocardiogram and physical activity sensors. This framework allowed for responses to be accurately referenced to the infection event. For each participant, we trained a semisupervised multivariable anomaly detection model on data acquired before inoculation and used it to classify the postinoculation dataset. RESULTS: Inoculation with this challenge virus was well-tolerated with an infection rate of 85%. With the model classification threshold set so that no alarms were recorded in the 170 healthy days recorded, the algorithm correctly identified 16 of 17 (94%) positive presymptomatic and asymptomatic individuals, on average 58 hours postinoculation and 23 hours before the symptom onset. CONCLUSIONS: The data processing and modeling methodology show promise for the early detection of respiratory illness. The detection algorithm is compatible with data collected from smartwatches using optical techniques but needs to be validated in large heterogeneous cohorts in normal living conditions. Clinical Trials Registration. NCT04204493.

Systematic review of the validity and reliability of consumer-wearable activity trackers.

BACKGROUND: Consumer-wearable activity trackers are electronic devices used for monitoring fitness- and other health-related metrics. The purpose of this systematic review was to summarize the evidence for validity and reliability of popular consumer-wearable activity trackers (Fitbit and Jawbone) and their ability to estimate steps, distance, physical activity, energy expenditure, and sleep. METHODS: Searches included only full-length English language studies published in PubMed, Embase, SPORTDiscus, and Google Scholar through July 31, 2015. Two people reviewed and abstracted each included study. RESULTS: In total, 22 studies were included in the review (20 on adults, 2 on youth). For laboratory-based studies using step counting or accelerometer steps, the correlation with tracker-assessed steps was high for both Fitbit and Jawbone (Pearson or intraclass correlation coefficients (CC) > =0.80). Only one study assessed distance for the Fitbit, finding an over-estimate at slower speeds and under-estimate at faster speeds. Two field-based studies compared accelerometry-assessed physical activity to the trackers, with one study finding higher correlation (Spearman CC 0.86, Fitbit) while another study found a wide range in correlation (intraclass CC 0.36-0.70, Fitbit and Jawbone). Using several different comparison measures (indirect and direct calorimetry, accelerometry, self-report), energy expenditure was more often under-estimated by either tracker. Total sleep time and sleep efficiency were over-estimated and wake after sleep onset was under-estimated comparing metrics from polysomnography to either tracker using a normal mode setting. No studies of intradevice reliability were found. Interdevice reliability was reported on seven studies using the Fitbit, but none for the Jawbone. Walking- and running-based Fitbit trials indicated consistently high interdevice reliability for steps (Pearson and intraclass CC 0.76-1.00), distance (intraclass CC 0.90-0.99), and energy expenditure (Pearson and intraclass CC 0.71-0.97). When wearing two Fitbits while sleeping, consistency between the devices was high. CONCLUSION: This systematic review indicated higher validity of steps, few studies on distance and physical activity, and lower validity for energy expenditure and sleep. The evidence reviewed indicated high interdevice reliability for steps, distance, energy expenditure, and sleep for certain Fitbit models. As new activity trackers and features are introduced to the market, documentation of the measurement properties can guide their use in research settings.

Correlates of Adherence to Varenicline Among HIV+ Smokers.

INTRODUCTION: Low rates of adherence to smoking cessation pharmacotherapy may limit the effectiveness of treatment. However, few studies have examined adherence in smoking cessation trials thus, there is a limited understanding of factors that influence adherence behaviors. This brief report analyzes correlates of adherence to varenicline among people living with HIV/AIDS. METHODS: Study participants were recruited from three HIV care centers in New York City and enrolled in a three-arm randomized controlled pilot study in which all subjects received varenicline. At the 1-month study visit, there were no significant differences in adherence by study condition, therefore we combined treatment arms to examine correlates of adherence (n = 127). We used pill counts to assess varenicline adherence, defined as taking at least 80% of the prescribed dose. We conducted a multivariate path analysis to assess factors proposed by the information-motivation-behavioral skills model to predict adherence. RESULTS: Only 56% of smokers were at least 80% adherent to varenicline at 1 month. Adherence-related information, self-efficacy, a college degree, and non-Hispanic white race/ethnicity were associated with increased varenicline adherence. In path analysis, information and motivation were associated with increased adherence self-efficacy, and adherence self-efficacy was associated with increased adherence, but with marginal significance. These associations with adherence were no longer significant after controlling for race/ethnicity and education. CONCLUSIONS: Further exploration of the role of a modifiable correlates of adherence, such as adherence-related information, motivation and self-efficacy is warranted. Interventions are needed that can address disparities in these and other psychosocial factors that may mediate poor medication adherence.

Underdeveloped or underreported? Coverage of pretesting practices and recommendations for design of text message-based health behavior change interventions.

Text messaging interventions for health are becoming increasingly popular, but it is unclear how rigorously such interventions are developed and pretested before being implemented. Pretesting is important to the development of successful health communication interventions. This study reviewed the literature published on text messaging health behavior change interventions and examined pretesting practices. Results showed that pretesting is rarely mentioned in articles, although it is not clear as to why. Six articles mentioned pretesting practices conducted for their mobile intervention, and three articles were written specifically on the pretesting of an intervention. Most pretesting used qualitative methods. Recommendations are provided on pretesting best practices and pretesting reporting to help other researchers in the field of mobile health.

Formative Evaluation of a Text Messaging Intervention to Promote Varenicline Adherence Among Tobacco-Dependent Persons with HIV.

Few published studies describe processes in the development of mobile health interventions. This study reports data from a formative evaluation of a text messaging intervention being developed to increase adherence to smoking cessation medication (varenicline) among tobacco-dependent persons with HIV/AIDS. Four focus groups were conducted (N = 29) using a mixed-methods approach to assess: (a) beliefs and preferences regarding the use of varenicline, (b) preferences for receiving tobacco-related texts, and (c) the acceptability of draft text messages. Themes that emerged from the focus groups were that (a) participants were cautious and wanted to discuss varenicline carefully with health care providers, (b) participants preferred simple messages that were positive and encouraging, (c) messages should emphasize tobacco cessation and not varenicline adherence, and (d) texts would serve as a reminder about goals and foster support and connectedness with the health care team. Overall, 47 out of the 100 messages received a grade of C or less (rated on a 5-point grade scale: A, B, C, D, or F), the majority of which focused on medication adherence. All participants reported that they were likely to read the messages. The majority (64%) indicated that they preferred receiving 2 or more messages per day. Gathering systematic participant feedback provides critical input in intervention planning.

Social media: opportunities for quality improvement and lessons for providers-a networked model for patient-centered care through digital engagement.

Social media brings a new dimension to health care for patients, providers, and their support networks. Increasing evidence demonstrates that patients who are more actively involved in their healthcare experience have better health outcomes and incur lower costs. In the field of cardiology, social media are proposed as innovative tools for the education and update of clinicians, physicians, nurses, and medical students. This article reviews the use of social media by healthcare providers and patients and proposes a model of "networked care" that integrates the use of digital social networks and platforms by both patients and providers and offers recommendations for providers to optimize their use and understanding of social media for quality improvement.

Implementing an SMS-based intervention for persons living with human immunodeficiency virus.

This article describes a process evaluation conducted as part of a proof-of-concept study to develop, implement, and test a text messaging program to promote medication and appointment adherence, sexual and substance use risk reduction, general health and well-being, social support, and patient involvement. The text-messaging program was implemented in Chicago, Illinois, at an outpatient medical clinic that promotes the well-being of gay, lesbian, bisexual, and transgender persons. We collected and analyzed qualitative data from patients, providers, and research staff to answer the following questions: (1) What factors of the organizational context were important for implementation? (2) How are implementation policies and practices, organizational climate, and perceptions of implementation effectiveness described by intervention stakeholders? (3) What types of issues related to fidelity occurred during implementation? (4) What recommendations for improvement do stakeholders suggest? The study coordinator, providers, and the patients themselves confirmed that patients liked the messages and program overall. The program was implemented with high fidelity. The primary recommendations for improvements were to enhance confidentiality and implement strategies to lessen message fatigue. The findings from this process evaluation demonstrate the feasibility and acceptability of the intervention from the perspectives of patients, providers, and research staff. A larger-scale intervention study that incorporates these stakeholders' suggestions for improvement is warranted.

Beyond reminders: a conceptual framework for using short message service to promote prevention and improve healthcare quality and clinical outcomes for people living with HIV.

The availability of effective antiretroviral therapy has altered HIV from being an acute disease to being a chronic, manageable condition for many people living with HIV (PLWH). Because of their ubiquity and flexibility, mobile phones with short message service (SMS) offer a unique opportunity to enhance treatment and prevention for people managing HIV. To date, very few US studies using SMS for HIV self-management have been published. In this article, we review the published SMS-based intervention research that aimed to improve healthcare quality and outcomes for PLWH and other chronic health conditions, and propose a conceptual model that integrates the communication functionality of SMS with important psychosocial factors that could mediate the impact of SMS on health outcomes. We posit that an SMS-based intervention that incorporates the elements of interactivity, frequency, timing, and tailoring of messages could be implemented to encourage greater medication adherence as well as impact other mutually reinforcing behaviors and factors (e.g., increasing patient involvement and social support, reducing risk behaviors, and promoting general health and well-being) to support better healthcare quality and clinical outcomes for PLWH. We recommend that future studies explore the potential linkages between variations in SMS characteristics and these mediating factors to determine if and how they influence the larger outcomes.

Addressing HIV knowledge, risk reduction, social support, and patient involvement using SMS: results of a proof-of-concept study.

Men who have sex with men continue to be severely and disproportionately affected by the HIV/AIDS epidemic in the United States. Effective antiretroviral therapy has altered the HIV epidemic from being an acute disease to a chronic, manageable condition for many people living with HIV. The pervasiveness, low cost, and convenience of short message service suggests its potential suitability for supporting the treatment of conditions that must be managed over an extended period. The purpose of this proof-of-concept study was to develop, implement, and test a tailored short message service-based intervention for HIV-positive men who have sex with men. The messages focused on reducing risk-taking behaviors and enhancing HIV knowledge, social support, and patient involvement. Participants reported strong receptivity to the messages and the intervention. The authors detected a statistically significant increase in HIV knowledge and social support from baseline to follow-up. Among participants who received sexual risk reduction messages, the authors also detected a statistically significant reduction in reported risk behaviors from baseline to follow-up. Results confirm the feasibility of a tailored, short message service-based intervention designed to provide ongoing behavioral reinforcement for HIV-positive men who have sex with men. Future research should include a larger sample, a control group, multiple sites, younger participants, and longer term follow-up.

Consumer-Mediated Data Exchange for Research: Current State of US Law, Technology, and Trust.

A compendium of US laws and regulations offers increasingly strong support for the concept that researchers can acquire the electronic health record data that their studies need directly from the study participants using technologies and processes called consumer-mediated data exchange. This data acquisition method is particularly valuable for studies that need complete longitudinal electronic records for all their study participants who individually and collectively receive care from multiple providers in the United States. In such studies, it is logistically infeasible for the researcher to receive necessary data directly from each provider, including providers who may not have the capability, capacity, or interest in supporting research. This paper is a tutorial to inform the researcher who faces these data acquisition challenges about the opportunities offered by consumer-mediated data exchange. It outlines 2 approaches and reviews the current state of provider- and consumer-facing technologies that are necessary to support each approach. For one approach, the technology is developed and estimated to be widely available but could raise trust concerns among research organizations or their institutional review boards because of the current state of US law applicable to consumer-facing technologies. For the other approach, which does not elicit the same trust concerns, the necessary technology is emerging and a pilot is underway. After reading this paper, the researcher who has not been following these developments should have a good understanding of the legal, regulatory, technology, and trust issues surrounding consumer-mediated data exchange for research, with an awareness of what is potentially possible now, what is not possible now, and what could change in the future. The researcher interested in trying consumer-mediated data exchange will also be able to anticipate and respond to an anticipated barrier: the trust concerns that their own organizations could raise.

Supporting informed clinical trial decisions: Results from a randomized controlled trial evaluating a digital decision support tool for those with intellectual disability.

BACKGROUND: Informed consent requires that individuals understand the nature of the study, risks and benefits of participation. Individuals with intellectual disabilities (ID) have cognitive and adaptive impairments that may affect their ability to provide informed consent. New treatments and clinical trials for fragile X syndrome, the most commonly known inherited cause of ID, necessitate the development of methods to improve the informed consent process. The goal of this study was to compare the efficacy of a digital decision support tool with that of standard practice for informed consent and to examine whether the tool can improve decisional capacity for higher functioning individuals. METHODS: Participants (N = 89; mean age = 21.2 years) were allocated to the experimental group (consenting information provided via the digital decision support tool), or the comparison group (information provided via standard practice). Participants were assessed on four aspects of decisional capacity (Understanding, Appreciating, Reasoning, and Expressing a choice). We used regression analyses to test the impact of the tool on each outcome, repeating the analyses on the higher functioning subsample. RESULTS: No differences existed in any domain of decisional capacity for the sample in full. However, participants in the higher IQ subsample who used the tool scored better on Understanding after adjustment (ß = 0.25, p = 0.04), but not on Appreciating or Reasoning. No differences by experimental group existed in the decision to join the hypothetical trial for the full sample or higher functioning subsample. CONCLUSIONS: A decision support tool shows promise for individuals with fragile X syndrome with higher cognitive abilities. Future studies should examine the level of cognitive ability needed for sufficient understanding, whether these findings can be translated to other clinical populations, and the impact of the tool in larger trials and on trial retention.

Exposure to Potentially Harmful E-Cigarette Emissions via Vape Tricks: Protocol for a Mixed-Methods Study.

BACKGROUND: The number of adolescents and adults using e-cigarettes, referred to as vaping, has dramatically increased. E-cigarettes can be used to perform vape tricks by inhaling and exhaling the e-cigarette aerosol in patterns to create visual effects or large clouds. To create these effects, the puffing patterns associated with vape tricks may be different than standard ad-lib e-cigarette usage. The prevalence of vape tricks and the harm associated with exposure to e-cigarette emissions when performing vape tricks is currently unknown. OBJECTIVE: Our objectives are to characterize duration, heart rate, respiratory rate, tidal volume, minute volume, and physical activity metrics associated with the performance of vape tricks and to characterize the emission of e-cigarettes when performing vape tricks in a manner suitable to inform novel exposure modeling. METHODS: The study will recruit e-cigarette users with a history of performing vape tricks. Data collection will occur in two different sessions. In the first session, participants will be asked to puff on their e-cigarette as they normally would for 20 minutes. The second session will be a vape tricks session, where users will be asked to perform a series of up to five different vape tricks with their e-cigarette. Data will be collected through screener surveys, in-person interviews, video recordings, a personal exposure monitor, and a biometric garment. RESULTS: Data analysis is pending and scheduled to take place in the fall of 2019. CONCLUSIONS: This study will be used to assess the feasibility of using a biometric garment to complement environmental and observational data. The approach may provide greater insight into the health risks of performing vape tricks compared to typical e-cigarette use. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12304.

Implementing Web-Based Interventions in HIV Primary Care Clinics: Pilot Implementation Evaluation of Positive Health Check.

BACKGROUND: Web-based interventions can help people living with HIV achieve better clinical outcomes and behaviors, but integrating them into clinical practice remains challenging. There is a gap in understanding the feasibility of implementing these interventions in HIV clinic settings from the clinicians' perspective. OBJECTIVE: The goal of the research was to determine whether Positive Health Check (PHC)-a Web-based, tailored video counseling tool focused on increasing patient adherence and retention in care and reducing HIV risk among HIV-positive patients-was acceptable, appropriate, and feasible for HIV primary care clinic staff to implement in clinic workflows. METHODS: A multiple-case study design was used to evaluate the pilot implementation. Four primary care clinics located in the southeastern United States implemented PHC over a 1-month period. Nine clinic staff across the clinics participated in structured interviews before, during, and after the implementation. In total, 54 interviews were conducted. We used a framework analysis approach to code the data and identify themes related to implementation outcomes, including acceptability, appropriateness, and feasibility. We also analyzed patient intervention use metrics (n=104) to quantify patient intervention completion rates (n=68). RESULTS: Overall, clinicians viewed PHC as acceptable and appropriate. Themes that emerged related to these implementation outcomes include the ability for PHC to increase provider-patient communication and its ability to engage patients due to the tailored and interactive design. While generally feasible to implement, challenges to the clinic workflow and physical environment were areas that clinics needed to manage to make PHC work in their clinics. CONCLUSIONS: Findings from this pilot implementation suggest that clinical staff viewed PHC as acceptable and appropriate, especially as more patients used the intervention over the pilot period. Feasibility of implementation was challenging in some cases, and lessons learned from this pilot implementation can provide information for larger scale tests of the intervention that include assessment of both implementation outcomes and clinical outcomes.

Establishing Digital Biomarkers for Occupational Health Assessment in Commercial Salmon Fishermen: Protocol for a Mixed-Methods Study.

BACKGROUND: Commercial salmon fishing in Alaska is one of the most dangerous occupations in the United States. Between 1992 and 2008, the average annual industry mortality rate was 128 deaths per 100,000 workers, and despite an increase in industry regulations, there has not been a significant decrease in mortality rate since 2000. Unpredictable fishing openings and fierce competition for limited resources result in periods of intense sleep deprivation and physical strain during the short commercial salmon season in Alaska. OBJECTIVE: We hypothesize that the combined effect of sleep deprivation, intense physical workload, and significant short-term chronic stress may be deleterious to health in both the short- and long-term among commercial salmon drift gillnet fishermen in Alaska. The objective of this protocol is to determine the feasibility of the study design to test this hypothesis. METHODS: The study design uses mixed methods and includes biometric monitoring consisting of heart rate variability, respiration, and movement data collected via a personal, wearable biometric device. Additional methods include observational data on activity, including duration and quality of sleep, weather, catch, and financial gain, as well as the collection of salivary cortisol. As such, the study will provide a holistic assessment of individual stress on multiple simultaneous timescales: immediately and continuously through the personal wearable biometric device, on the minute-hour level through the multiple daily collections of salivary cortisol, and by the hour-day through the use of participant and environment observational data. RESULTS: Data collection was initiated in July 2017 and will extend through August 2019. Initial data collection has indicated that the methods outlined in this protocol are feasible and allow for effective collection of qualitative and quantitative data related to the psychological and physiological impact of Alaska commercial salmon fishing. CONCLUSIONS: We anticipate that the use of a biometric device will be crucial in establishing measures of stress and physical activity within a population and environment uniquely challenged by physical isolation, strong weather patterns, and the potential for significant financial gain by fishermen. The potential exists for individuals engaged long-term in the fishing industry, through repeated and extended exposure to periods of intense sleep deprivation and chronic stress, to be at increased risk of cardiovascular disease. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/10215.

A Digital Health App to Assess Decisional Capacity to Provide Informed Consent: Protocol for a Randomized Controlled Trial.

BACKGROUND: Any study with human subjects must have a robust consent process to ensure that participants understand the study and can decide whether they want to be involved. Investigators must determine whether a potential study participant is able to make an informed decision and what modifications or supports are needed to maximize participation in decision making. A variety of approaches have been used to modify consent forms and the consent process to increase the research participants' decisional capacity. This protocol describes a randomized controlled trial (RCT) of a digital health app to support decision making among individuals contemplating providing consent to participate in a clinical trial. OBJECTIVE: The objective of this RCT will be to determine if the use of a tablet-based app facilitates greater participation in and satisfaction with the consent process compared with standard practice and identify which individual factors are associated with better response to the decision aid. We hypothesize that the tablet-based version of the consent process will promote more informed decision making, including decisions that are more consistent with individual preferences and values expressed during qualitative data collection. METHODS: A two-arm RCT will be conducted in a sample of approximately 100 individuals with fragile X syndrome in their homes across the United States. RESULTS: Data analysis will be completed by late 2018. CONCLUSIONS: By developing and testing a novel consent decision aid, we will have a better understanding of whether and how technological support can optimize the fit between the decisional capacity and the decisional process. TRIAL REGISTRATION: ClinicalTrials.gov NCT02465931; https://clinicaltrials.gov/ct2/show/NCT02465931 (Archived by WebCite at http://www.webcitation.org/72Q3xJQAw). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/10360.

A Digital Decision Support Tool to Enhance Decisional Capacity for Clinical Trial Consent: Design and Development.

BACKGROUND: Challenges in the clinical and research consent process indicate the need to develop tailored, supportive interventions for all individuals, especially those with limited decisional capacity. We developed a tool to enhance shared decision making and the decisional capacity for individuals with fragile X syndrome engaged in the informed consent process for a clinical trial. OBJECTIVE: We describe the design and development process of a tablet-based decision support tool. METHODS: Our development process for the decision support tool employed a user-centered, feature-driven design approach. We began with an environmental scan to catalog relevant mobile apps, and we conducted interviews with people with a diagnosis of fragile X syndrome and clinicians at fragile X syndrome clinics. To develop content for the decision support tool, we extracted key concepts and elements from a real clinical trial consent form and rewrote it using plain-language principles. RESULTS: We used iterative testing to continuously evaluate and revise the decision support tool content. The tool was finalized in 2016 and contained a series of vignettes, quiz questions, and a sorting activity. A randomized controlled trial was then conducted to compare the efficacy of the decision support tool with a standard verbal presentation of material that mimicked typical informed consent practice. CONCLUSIONS: The informed consent process is primed to leverage digital health resources that promote increased understanding and engagement of research participants in the consent and research process. The process and experiences we describe may provide a model for other digital health design and development initiatives seeking to create more interactive and accessible decision support resources. TRIAL REGISTRATION: ClinicalTrials.gov NCT02465931; https://www.clinicaltrials.gov/ct2/show/NCT02465931 (Archived by WebCite at http://www.webcitation.org/6zx2KY9YW).

Virtual simulation-enhanced triage training for Iraqi medical personnel.

Triage, establishing the priority of care among casualties in disaster management, is generally practiced using constructive tabletop or live exercises. Actual disasters involving multiple casualties occur rarely, offering little opportunity for gaining experience and competency assessment. When they do occur, response needs to be rapid and well-learned. In the Iraqi medical education environment where the need for triage is immediate, but the ability to stage practice is nearly impossible, blending didactic learning with simulation-based triage offers an alternative training methodology.

A Mobile Clinical Decision Support Tool for Pediatric Cardiovascular Risk-Reduction Clinical Practice Guidelines: Development and Description.

BACKGROUND: Widespread application of research findings to improve patient outcomes remains inadequate, and failure to routinely translate research findings into daily clinical practice is a major barrier for the implementation of any evidence-based guideline. Strategies to increase guideline uptake in primary care pediatric practices and to facilitate adherence to recommendations are required. OBJECTIVE: Our objective was to operationalize the US National Heart, Lung, and Blood Institute's Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents into a mobile clinical decision support (CDS) system for healthcare providers, and to describe the process development and outcomes. METHODS: To overcome the difficulty of translating clinical practice guidelines into a computable form that can be used by a CDS system, we used a multilayer framework to convert the evidence synthesis into executable knowledge. We used an iterative process of design, testing, and revision through each step in the translation of the guidelines for use in a CDS tool to support the development of 4 validated modules: an integrated risk assessment; a blood pressure calculator; a body mass index calculator; and a lipid management instrument. RESULTS: The iterative revision process identified several opportunities to improve the CDS tool. Operationalizing the integrated guideline identified numerous areas in which the guideline was vague or incorrect and required more explicit operationalization. Iterative revisions led to workable solutions to problems and understanding of the limitations of the tool. CONCLUSIONS: The process and experiences described provide a model for other mobile CDS systems that translate written clinical practice guidelines into actionable, real-time clinical recommendations.

Establishing Linkages Between Distributed Survey Responses and Consumer Wearable Device Datasets: A Pilot Protocol.

BACKGROUND: As technology increasingly becomes an integral part of everyday life, many individuals are choosing to use wearable technology such as activity trackers to monitor their daily physical activity and other health-related goals. Researchers would benefit from learning more about the health of these individuals remotely, without meeting face-to-face with participants and avoiding the high cost of providing consumer wearables to participants for the study duration. OBJECTIVE: The present study seeks to develop the methods to collect data remotely and establish a linkage between self-reported survey responses and consumer wearable device biometric data, ultimately producing a de-identified and linked dataset. Establishing an effective protocol will allow for future studies of large-scale deployment and participant management. METHODS: A total of 30 participants who use a Fitbit will be recruited on Mechanical Turk Prime and asked to complete a short online self-administered questionnaire. They will also be asked to connect their personal Fitbit activity tracker to an online third-party software system, called Fitabase, which will allow access to 1 month's retrospective data and 1 month's prospective data, both from the date of consent. RESULTS: The protocol will be used to create and refine methods to establish linkages between remotely sourced and de-identified survey responses on health status and consumer wearable device data. CONCLUSIONS: The refinement of the protocol will inform collection and linkage of similar datasets at scale, enabling the integration of consumer wearable device data collection in cross-sectional and prospective cohort studies.