Robert D. Furberg

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

BackgroundConsumer-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.MethodsSearches 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.ResultsIn 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)u2009>u2009=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.ConclusionThis 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.

Tailored text messaging intervention for HIV adherence: a proof-of-concept study.

OBJECTIVEnThis study sought to determine if dynamically tailored medication messages delivered to people living with HIV (PLWH) via text messaging would be well received and enhance adherence and clinical outcomes.nnnMETHODSnA preexperimental proof-of-concept study with 52 men who have sex with men (MSM) recruited from a health clinic focused on promoting the well-being of gay, lesbian, bisexual, and transgender people. Inclusion criteria were being an English speaking HIV-positive MSM, aged 25 or older. Participants also had to agree to allow access to their medical records, have a cell phone, and be able to receive text messages over the 3-month intervention period. Participants completed baseline surveys that assessed various demographic, social, and health questions; received text messages over 3 months; answered weekly adherence questions via two-way messaging; and completed a follow-up survey at the end of the intervention period. Clinical outcomes were abstracted from participants medical records at baseline and follow-up. Self-reported medication adherence and clinical outcomes, including CD4 counts and viral load.nnnRESULTSnParticipants were receptive to the text messaging intervention, and reported reading and liking the messages. Self-reported medication adherence significantly improved among participants who began the study as nonadherent and received tailored medication reminders. Overall viral load significantly decreased and CD4 count significantly increased from baseline to follow-up.nnnCONCLUSIONSnThe results demonstrate that using two-way text messaging to dynamically tailor adherence messages may enhance adherence and improve important clinical outcomes for PLWH.

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

Abstract 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.

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:

BackgroundPreparing and submitting a voluntary adverse event (AE) report to the US Food and Drug Administration (FDA) for a medical device typically takes 40xa0min. 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®.MethodsPatient 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.ResultsThe average Essure AE report took 11.4xa0min (±10) to complete. Submissions from 1349 women, average age 34xa0years, were analyzed. Serious events, including hospitalization, disability, and permanent damage after implantation, were reported by 1047 women (77.6xa0%). A total of 13,135 product–event pairs were reported, comprising 327 unique preferred terms, most frequently fatigue (nxa0=xa0491), 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 (44.3xa0%). Other events of interest included loss of libido (nxa0=xa0115); 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” 55.9xa0% of the time, compared with an international average of 13xa0% 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.ConclusionsOutreach 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.

Using screen-based simulation to improve performance during pediatric resuscitation.

OBJECTIVESnTo assess the ability of a screen-based simulation-training program to improve emergency medicine and pediatric resident performance in critical pediatric resuscitation knowledge, confidence, and skills.nnnMETHODSnA pre-post, interventional design was used. Three measures of performance were created and assessed before and after intervention: a written pre-course knowledge examination, a self-efficacy confidence score, and a skills-based high-fidelity simulation code scenario. For the high-fidelity skills assessment, independent physician raters recorded and reviewed subject performance. The intervention consisted of eight screen-based pediatric resuscitation scenarios that subjects had 4 weeks to complete. Upon completion of the scenarios, all three measures were repeated. For the confidence assessment, summary pre- and post-test summary confidence scores were compared using a t-test, and for the skills assessment, pre-scores were compared with post-test measures for each individual using McNemars chi-square test for paired samples.nnnRESULTSnTwenty-six of 35 (71.3%) enrolled subjects completed the institutional review board-approved study. Increases were observed in written test scores, confidence, and some critical interventions in high-fidelity simulation. The mean improvement in cumulative confidence scores for all residents was 10.1 (SD +/-4.9; range 0-19; p < 0.001), with no resident feeling less confident after the intervention. Although overall performance in simulated codes did not change significantly, with average scores of 6.65 (+/-1.76) to 7.04 (+/-1.37) out of 9 possible points (p = 0.58), improvement was seen in the administering of appropriate amounts of IV fluids (59-89%, p = 0.03).nnnCONCLUSIONSnIn this study, improvements in resident knowledge, confidence, and performance of certain skills in simulated pediatric cardiac arrest scenarios suggest that screen-based simulations may be an effective way to enhance resuscitation skills of pediatric providers. These results should be confirmed using a randomized design with an appropriate control group.

Technical implementation of a multi-component, text message-based intervention for persons living with HIV

Background Men who have sex with men (MSM) continue to be severely and disproportionately affected by the HIV/AIDS (human immunodeficiency virus/acquired immune deficiency syndrome) 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 (SMS) suggests its potential suitability for supporting the treatment of conditions that must be managed over an extended period. Objective The purpose of this proof-of-concept study was to develop, implement, and test a tailored SMS-based intervention for HIV-positive MSM. Prior studies do not routinely provide sufficiently detailed descriptions of their technical implementations, restricting the ability of subsequent efforts to reproduce successful interventions. This article attempts to fill this gap by providing a detailed description of the implementation of an SMS-based intervention to provide tailored health communication messages for HIV-positive MSM. Methods We used archives from the SMS system, including participant responses to messages and questions sent via SMS, as the data sources for results reported in this article. Consistent with the purpose of this article, our analysis was limited to basic descriptive statistics, including frequency distributions, means and standard deviations. Results During the implementation period, we sent a total of 7,194 messages to study participants, received 705 SMS responses to our two-way SMS questions of participants, and 317 unprompted SMS message acknowledgements from participants. Ninety two percent of participants on antiretroviral therapy (ART) responded to at least one of the weekly medication adherence questions administered via SMS, and 27% of those had their medication adherence messages changed over the course of the study based on their answers to the weekly questions. Participants who responded to items administered via SMS to assess satisfaction with and use of the messages reported generally positive perceptions, although response rates were low overall. Conclusions Results confirm the technical feasibility of deploying a dynamically tailored, SMS-based intervention designed to provide ongoing behavioral reinforcement for HIV-positive MSM. Lessons learned related to text programming, message delivery and study logistics will be helpful to others planning and implementing similar interventions.

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.

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.

Communicating risk of hereditary breast and ovarian cancer with an interactive decision support tool

OBJECTIVEnWomen with hereditary breast and ovarian cancer syndrome (HBOC) face a higher risk of earlier, more aggressive cancer. Because of HBOCs rarity, screening is recommended only for women with strong cancer family histories. However, most patients do not have accurate history available and struggle to understand genetic concepts.nnnMETHODSnCancer in the Family, an online clinical decision support tool, calculated womens HBOC risk and promoted shared patient-provider decisions about screening. A pilot evaluation (n=9 providers, n=48 patients) assessed the tools impact on knowledge, attitudes, and screening decisions. Patients used the tool before wellness exams and completed three surveys. Providers accessed the tool during exams, completed exam checklists, and completed four surveys.nnnRESULTSnPatients entered complete family histories (67%), calculated personal risk (96%), and shared risk printouts with providers (65%). HBOC knowledge increased dramatically for patients and providers, and many patients (75%) perceived tool results as valid. The tool prompted patient-provider discussions about HBOC risk and cancer family history (88%).nnnCONCLUSIONSnThe tool was effective in increasing knowledge, collecting family history, and sparking patient-provider discussions about HBOC screening.nnnPRACTICE IMPLICATIONSnInteractive tools can effectively communicate personalized risk and promote shared decisions, but they are not a substitute for patient-provider discussions.