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.

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.

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.

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).

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.

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.

Biometrics and Policing: A Protocol for Multichannel Sensor Data Collection and Exploratory Analysis of Contextualized Psychophysiological Response During Law Enforcement Operations.

BACKGROUND: Stress experienced by law enforcement officers is often extreme and is in many ways unique among professions. Although past research on officer stress is informative, it is limited, and most studies measure stress using self-report questionnaires or observational studies that have limited generalizability. We know of no research studies that have attempted to track direct physiological stress responses in high fidelity, especially within an operational police setting. The outcome of this project will have an impact on both practitioners and policing researchers. To do so, we will establish a capacity to obtain complex, multisensor data; process complex datasets; and establish the methods needed to conduct idiopathic clinical trials on behavioral interventions in similar contexts. OBJECTIVE: The objective of this pilot study is to demonstrate the practicality and utility of wrist-worn biometric sensor-based research in a law enforcement agency. METHODS: We will use nonprobability convenience-based sampling to recruit 2-3 participants from the police department in Durham, North Carolina, USA. RESULTS: Data collection was conducted in 2016. We will analyze data in early 2017 and disseminate our results via peer reviewed publications in late 2017. CONCLUSIONS: We developed the Biometrics & Policing Demonstration project to provide a proof of concept on collecting biometric data in a law enforcement setting. This effort will enable us to (1) address the regulatory approvals needed to collect data, including human participant considerations, (2) demonstrate the ability to use biometric tracking technology in a policing setting, (3) link biometric data to law enforcement data, and (4) explore project results for law enforcement policy and training.

ActiviTeen: A Protocol for Deployment of a Consumer Wearable Device in an Academic Setting.

BACKGROUND: Regular physical activity (PA) can be an important indicator of health across an individual's life span. Consumer wearables, such as Fitbit or Jawbone, are becoming increasingly popular to track PA. With the increased adoption of activity trackers comes the increased generation of valuable individual-based data. Generated data has the potential to provide detailed insights into the user's behavior and lifestyle. OBJECTIVE: The primary objective of the described study is to evaluate the feasibility of individual data collection from the selected consumer wearable device (the Fitbit Zip). The rate of user attrition and barriers preventing the use of consumer wearable devices will also be evaluated as secondary objectives. METHODS: The pilot study will occur in two stages and employs a long-term review and analysis with a convenience sample of 30 students attending Research Triangle High School. For the first stage, students will initially be asked to wear the Fitbit Zip over the course of 4 weeks. During which time, their activity data and step count will be collected. Students will also be asked to complete a self-administered survey at the beginning and conclusion of the first stage. The second stage will continue to collect students' activity data and step count over an additional 3-month period. RESULTS: We are anticipating results for this study by the end of 2016. CONCLUSION: This study will provide insight into the data collection procedures surrounding consumer wearable devices and could serve as the future foundation for other studies deploying consumer wearable devices in educational settings.

Supporting Tablet Configuration, Tracking, and Infection Control Practices in Digital Health Interventions: Study Protocol.

BACKGROUND: Tablet-based health care interventions have the potential to encourage patient care in a timelier manner, allow physicians convenient access to patient records, and provide an improved method for patient education. However, along with the continued adoption of tablet technologies, there is a concomitant need to develop protocols focusing on the configuration, management, and maintenance of these devices within the health care setting to support the conduct of clinical research. OBJECTIVE: Develop three protocols to support tablet configuration, tablet management, and tablet maintenance. METHODS: The Configurator software, Tile technology, and current infection control recommendations were employed to develop three distinct protocols for tablet-based digital health interventions. Configurator is a mobile device management software specifically for iPhone operating system (iOS) devices. The capabilities and current applications of Configurator were reviewed and used to develop the protocol to support device configuration. Tile is a tracking tag associated with a free mobile app available for iOS and Android devices. The features associated with Tile were evaluated and used to develop the Tile protocol to support tablet management. Furthermore, current recommendations on preventing health care-related infections were reviewed to develop the infection control protocol to support tablet maintenance. RESULTS: This article provides three protocols: the Configurator protocol, the Tile protocol, and the infection control protocol. CONCLUSIONS: These protocols can help to ensure consistent implementation of tablet-based interventions, enhance fidelity when employing tablets for research purposes, and serve as a guide for tablet deployments within clinical settings.

Usability Testing and Adaptation of the Pediatric Cardiovascular Risk Reduction Clinical Decision Support Tool.

BACKGROUND: Cardiovascular disease (CVD) is 1 of the leading causes of death, years of life lost, and disability-adjusted years of life lost worldwide. CVD prevention for children and teens is needed, as CVD risk factors and behaviors beginning in youth contribute to CVD development. In 2012, the National Heart, Lung, and Blood Institute released their "Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents" for clinicians, describing CVD risk factors they should address with patients at primary care preventative visits. However, uptake of new guidelines is slow. Clinical decision support (CDS) tools can improve guideline uptake. In this paper, we describe our process of testing and adapting a CDS tool to help clinicians evaluate patient risk, recommend behaviors to prevent development of risk, and complete complex calculations to determine appropriate interventions as recommended by the guidelines, using a user-centered design approach. OBJECTIVE: The objective of the study was to assess the usability of a pediatric CVD risk factor tool by clinicians. METHODS: The tool was tested using one-on-one in-person testing and a "think aloud" approach with 5 clinicians and by using the tool in clinical practice along with formal usability metrics with 14 pediatricians. Thematic analysis of the data from the in-person testing and clinical practice testing identified suggestions for change in 3 major areas: user experience, content refinement, and technical deployment. Descriptive statistical techniques were employed to summarize users' overall experience with the tool. RESULTS: Data from testers showed that general reactions toward the CDS tool were positive. Clinical practice testers suggested revisions to make the application more user-friendly, especially for clinicians using the application on the iPhone, and called for refining recommendations to be more succinct and better tailored to the patient. Tester feedback was incorporated into the design when feasible, including streamlining data entry during clinical visits, reducing the volume of results displayed, and highlighting critical results. CONCLUSIONS: This study found support for the usability of our pediatric CVD risk factor tool. Insights shared about this tool may be applicable for designing other mHealth applications and CDS tools. The usability of decision support tools in clinical practice depends critically on receiving (ie, through an accessible device) and adapting the tool to meet the needs of clinicians in the practice setting.

Supporting Parental Decisions About Genomic Sequencing for Newborn Screening: The NC NEXUS Decision Aid.

Advances in genomic sequencing technology have raised fundamental challenges to the traditional ways genomic information is communicated. These challenges will become increasingly complex and will affect a much larger population in the future if genomics is incorporated into standard newborn screening practice. Clinicians, public health officials, and other stakeholders will need to agree on the types of information that they should seek and communicate to parents. Currently, few evidence-based and validated tools are available to support parental informed decision-making. These tools will be necessary as genomics is integrated into clinical practice and public health systems. In this article we describe how the North Carolina Newborn Exome Sequencing for Universal Screening study is addressing the need to support parents in making informed decisions about the use of genomic testing in newborn screening. We outline the context for newborn screening and justify the need for parental decision support. We also describe the process of decision aid development and the data sources, processes, and best practices being used in development. By the end of the study, we will have an evidenced-based process and validated tools to support parental informed decision-making about the use of genomic sequencing in newborn screening. Data from the study will help answer important questions about which genomic information ought to be sought and communicated when testing newborns.

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.

Increasing Patient Engagement in Pharmacovigilance Through Online Community Outreach and Mobile Reporting Applications: An Analysis of Adverse Event Reporting for the Essure Device in the US.

BACKGROUND: Preparing and submitting a voluntary adverse event (AE) report to the US Food and Drug Administration (FDA) for a medical device typically takes 40 min. User-friendly Web and mobile reporting apps may increase efficiency. Further, coupled with strategies for direct patient involvement, patient engagement in AE reporting may be improved. In 2012, the FDA Center for Devices and Radiologic Health (CDRH) launched a free, public mobile AE reporting app, MedWatcher, for patients and clinicians. During the same year, a patient community on Facebook adopted the app to submit reports involving a hysteroscopic sterilization device, brand name Essure®. METHODS: Patient community outreach was conducted to administrators of the group "Essure Problems" (approximately 18,000 members as of June 2015) to gather individual case safety reports (ICSRs). After agreeing on key reporting principles, group administrators encouraged members to report via the app. Semi-structured forms in the app mirrored fields of the MedWatch 3500 form. ICSRs were transmitted to CDRH via an electronic gateway, and anonymized versions were posted in the app. Data collected from May 11, 2013 to December 7, 2014 were analyzed. Narrative texts were coded by trained and certified MedDRA coders (version 17). Descriptive statistics and metrics, including VigiGrade completeness scores, were analyzed. Various incentives and motivations to report in the Facebook group were observed. RESULTS: The average Essure AE report took 11.4 min (±10) to complete. Submissions from 1349 women, average age 34 years, were analyzed. Serious events, including hospitalization, disability, and permanent damage after implantation, were reported by 1047 women (77.6 %). A total of 13,135 product-event pairs were reported, comprising 327 unique preferred terms, most frequently fatigue (n = 491), back pain (468), and pelvic pain (459). Important medical events (IMEs), most frequently mental impairment (142), device dislocation (108), and salpingectomy (62), were reported by 598 women (44.3 %). Other events of interest included loss of libido (n = 115); allergy to metals (109), primarily nickel; and alopecia (252). VigiGrade completeness scores were high, averaging 0.80 (±0.15). Reports received via the mobile app were considered "well documented" 55.9 % of the time, compared with an international average of 13 % for all medical products. On average, there were 15 times more reports submitted per month via the app with patient community support versus traditional pharmacovigilance portals. CONCLUSIONS: Outreach via an online patient community, coupled with an easy-to-use app, allowed for rapid and detailed ICSRs to be submitted, with gains in efficiency. Two-way communication and public posting of narratives led to successful engagement within a Motivation-Incentive-Activation-Behavior framework, a conceptual model for successful crowdsourcing. Reports submitted by patients were considerably more complete than those submitted by physicians in routine spontaneous reports. Further research is needed to understand how biases operate differently from those of traditional pharmacovigilance.

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.