Wear Time Research Articles

The effectiveness of a bespoke mobile application in improving adherence with removable orthodontic retention over 12 months: A randomized controlled trial

The primary aim was to analyze the effect of providing a mobile application (My Retainers) on adherence with removable retention. Eighty-four participants planned for thermoplastic retainers were randomly allocated to 2 groups. The intervention group was given access to a bespoke mobile application, while the control group was not given access. Baseline data were obtained at the removal of orthodontic appliances with follow-up at 3 months, 6 months, 9 months, and 12 months. The primary outcome was objectively assessed retainer wear recorded using a TheraMon microelectronic sensor (MC Technology GmbH, Hargelsberg, Austria). Secondary outcomes were stability and periodontal implications. The objectively assessed wear time at 12 months was low in both groups, being marginally higher in the intervention (median, 3.09 h/d; interquartile range, 8.1) than the control group (median, 1.44 h/d; interquartile range, 9.22) with no between-group statistical difference (P= 0.30, 95% confidence interval [CI], -3.91 to 1.19). No statistically significant difference was identified between the groups in terms of stability and periodontal outcomes. Improvement in plaque scores (P<0.0001; 95% CI, -0.20 to 0.15) and bleeding on probing (P<0.0001, 95% CI, -0.23 to-0.12) was noted over time with no periodontal attachment loss detected over the study period. Provision of the mobile application did not lead to improved adherence with thermoplastic retainer wear. Similarly, no benefit in respect of either occlusal stability or periodontal health was observed over the 12-month study period. Further novel approaches to improve adherence with retainer wear and oral hygiene measures are required. NCT03224481. Not published. This work was supported by funding from the European Orthodontic Society.

Abstract 13148: Cardiometabolic Risk Factors Partially Mediate the Association of Physical Inactivity With MRI Markers of Brain Aging

Introduction: Physical inactivity is associated with a higher risk of dementia, and has also been associated with unfavorable brain morphology. It is also clear that cardiometabolic risk factors accelerate the brain aging process. Hypothesis: Cardiometabolic risk factors mediate the association of physical inactivity with unfavorable brain morphology. Methods: Our investigation included participants from the Third Generation (exam 2) and Offspring (exam 9) cohorts of the Framingham Heart Study who wore an accelerometer for &amp;gte10 hours on &amp;gte3 days (to measure moderate to vigorous physical activity [MVPA] and steps walked per day), underwent brain MRI scans, and had no dementia, stroke, or missing cardiometabolic risk factor data (n=2416, 54% women, mean age 54.1 years). Higher levels of brain peak width of skeletonized mean (white matter) diffusivity, higher free water, and lower total cerebral brain volume were measured by MRI as markers of brain aging. We examined mediation by the 2017 revised version of the Framingham Stroke Risk Profile (FSRP, using weights for age, prevalent cardiovascular disease, atrial fibrillation, diabetes and smoking status, antihypertension medications and systolic blood pressure) and the homeostatic model of insulin resistance (HOMA-IR) in models of the association of MVPA and steps with brain volume, white matter diffusivity, and free water, adjusting for age, age-squared, sex, wear time, smoking status (for HOMA-IR mediation analysis only), cohort, time from exam to MRI, and season of exam. Results: The associations of lower MVPA and steps with lower brain volume, higher white matter diffusivity, and higher free water were partially mediated through FSRP, accounting for 14.1-25.7% (p&amp;lt0.05) of the total association of physical inactivity with brain aging. The association of fewer steps (but not MVPA) with lower brain volume was mediated by HOMA-IR (20.1% of the total association, p&amp;lt0.05). Conclusions: Our results suggest that the associations of physical inactivity with lower brain volume, poorer white matter microstructure and aggregation of free water in the extracellular compartments of the brain are partially mediated by cardiometabolic risk factors.

Abstract 11730: Data Quality and Monitoring Completion Rates Are Similar Between Clinic-Applied and Self-Applied Continuous ECG Monitoring Patches Prior to and During COVID-19

Introduction: Prior to COVID-19, ECG patches (ECGp) were applied almost exclusively in-clinic (CA) by technicians which required an office visit and fee. Since the pandemic, direct-to-patient, self-applied patch use (SA) has substantially increased, though the metrics surrounding SA are unknown. This study compares monitoring completion rates and data quality between CA and SA ECGp prior to and during COVID-19. Hypothesis: CA and SA ECGp have similar data quality and monitoring completion metrics. Methods: We performed a retrospective cohort analysis of patients prescribed an iRhythm Zio XT patch at Northwestern Memorial Hospital during the “pre-COVID” (3/1/2019-3/1/2020) and “COVID” (4/1/2020-4/1/2021) timeframes. Differences in ECGp with data available, actual vs prescribed wear time, and analyzable data between groups were assessed. ECGp without data was defined as devices which were not returned or not activated. Results: The cohort included 29,118 ECGp prescriptions; 13,180 pre-COVID (45%). The cohort was 56% female with mean age of 59.3 + 17.7 years. Palpitations (29%) and atrial fibrillation (19%) were the most common indications. In the pre-COVID cohort, there were no (0%) SA ECGp and data were available for 12,932 CA patches. In the COVID cohort, 34% of ECGp were SA; data were available for 10,231 CA ECGp and 4,902 SA ECGp. Average delay between prescription and SA ECGp activation was 8.1 ± 12.2 days. Comparisons between percent analyzable data, wear times, and ECGp with data available are shown in figure 1. Conclusions: COVID-19 resulted in a rapid adoption of SA ECGp use. Compared to CA, SA was associated with an inherent delay in ECGp application and a higher proportion of ECGp without data. However, there was no difference in actual vs prescribed wear time and a small but statistically significant decrease in percent analyzable data. These differences must be balanced with the additional cost and need for in-person visit for CA vs SA.

Abstract 9719: Structured Patient Education Improves Adherence with Wearable Cardiac Defibrillators

Background: The wearable-cardioverter defibrillator (WCD) tradename LifeVest has emerged as a temporary alternative to implantable cardioverter-defibrillator therapy. However, patient adherence can be variable. We sought to investigate if standardized device education and patient follow-up phone calls could lead to increased adherence. Methods: Patients prescribed a WCD from July 2017 to July 2018 comprised the pre-intervention group. The initial post-intervention group from January 2019 to May 2019 enrolled 32 patients. Each patient received standardized device education using a video presentation, and we sought to call each patient within 7 days of discharge to answer questions and administer a questionnaire. 14 patients comprised the second post-intervention group from March 2020 to May 2020, which received refined education with both a video presentation and 30-minute, standardized, hands-on training with the LifeVest representative, as well as similar follow-up phone calls for all patients within 7 days of discharge. Results: The pre-intervention group had a median wear time of 19.46 hours/day. In the first post-intervention group, all patients received standardized education; however, only 17 patients were contacted via phone due to time constraints. Patients with standardized education-only had a median wear time 21.55 hours/day, while patients who received both interventions had a median wear time of 23.01 hours/day. The increase in median wear time in pre-intervention compared to post-intervention groups was statistically significant (p= 0.0056) There was no significant difference between the two post-intervention groups (p=0.5485). In the second intervention group, median wear time significantly increased to 22.00 hours/day compared to the pre-intervention group (p=0.0244). Conclusions: Implementing standardized device education can improve median WCD wear time. The addition of post-discharge follow-up phone call did lead to improved mean and median wear times, but this was not statistically significant. Similar strategies could be cheaply and easily adopted at other centers in an effort to improve WCD adherence.

Abstract 13917: A Harmonized Meta-Analysis of the Associations of Steps per Day With Incident Cardiovascular Disease

Introduction: The goal of 10,000 steps/day is widely promoted. There is limited evidence, however, of the number of steps/day associated with risk of developing cardiovascular disease (CVD). Hypothesis: We hypothesize a dose-response association between higher device-measured steps/day with lower CVD incidence. Methods: The Steps for Health Collaborative conducted a meta-analysis of seven prospective studies with device-measured steps/day and followed participants for CVD events. Participants without CVD at baseline were included. CVD was defined as coronary heart disease, stroke, and/or heart failure. Data were analyzed at the study level. Study-specific associations of quartiles of steps/day with incident CVD was assessed using Cox proportional hazards regression models and summarized using random effects meta-analysis. Models were adjusted for age, race/ethnicity, sex, body mass index, device wear time, and study-specific indicators for education or income, smoking, alcohol intake, blood pressure, dysglycemia, and hyperlipidemia. Study heterogeneity was assessed using I2 statistic. Results: The meta-analysis included 16,906 adults (mean age 62 years; 51% women), with median follow-up of 6.3 years (limits 2.9-10.7 years) and 1370 (8.1%) CVD events. Medians of study-specific steps/day were 1,951 (first quartile, Q1), 3,823 (second quartile, Q2), 5,685 (third quartile, Q3), and 9,487 (fourth quartile, Q4). Compared with Q1, summary hazard ratios for CVD were 0.83 (Q2, 95% confidence interval 0.72-0.95), 0.68 (Q3, 0.58-0.80), and 0.60 (Q4, 0.47-0.78) (Figure). There was low to moderate heterogeneity; I2 values were 0% for Q2, 2% for Q3, and 37% for Q4. Conclusions: Higher steps/day were associated with progressively lower risk of CVD. Monitoring and promoting steps/day can be a simple, easy to interpret metric used for clinician-patient communication and population health to reduce the risk of CVD.

Abstract 11836: Higher Burden of Supraventricular Ectopy is Independently Associated With Greater Risk of Dementia in Older Adults Without Atrial Fibrillation: The Atherosclerosis Risk in Communities Study

Introduction: In older adults without atrial fibrillation (AF), it is unclear if higher burden of supraventricular ectopy (SVE) is associated with dementia risk independent of cardiovascular risk factors and clinically documented stroke. Hypothesis: In older adults without AF, higher burden of SVE including premature atrial contractions (PAC) and atrial tachycardias (AT) are associated with a higher risk of dementia. Methods: Among 2167 participants (mean age, 79 years, 60% female, 26% Black) without adjudicated dementia, stroke or AF, at baseline (2016-17), AT and PAC were measured over 2 weeks by an ambulatory, continuous electrocardiogram recorder (Zio XT patch, iRhythm Technologies, Inc.). We quantified burden of PACs and ATs as: 1) natural log of frequency (episodes/day) due to skewed distributions, and 2) a dichotomous frequency measure, split at the median. Additionally, we dichotomized duration of the longest AT episode at the median. Dementia was adjudicated based on cognitive assessments through 2019 using the Clinical Dementia Rating scale at study visits or by telephone cognitive interviews, informant interviews, and ongoing linkage to medical records. We calculated relative risk of incident dementia using Poisson regression with robust error variance. Results: At baseline, median Zio XT patch wear time was 13.8 days (interquartile interval 13-14 days). Over 2 years of follow-up, 66 (3.0%) participants developed dementia. Higher frequency of AT and PAC (continuous or dichotomous) were associated with a higher risk of dementia independent of incident AF, stroke, and cardiovascular risk factors (Table). Conclusions: In older adults without AF, higher burden of SVE is associated with a greater risk of dementia independent of incident AF, stroke, and cardiovascular risk factors. Future research should define underlying mechanisms and evaluate the effect of lowering SVE burden on the risk of dementia in older adults with a higher SVE burden.

Abstract 9886: Use of a Smartwatch and App Designed by Stroke Survivors for Atrial Fibrillation Detection in Older Adults After Stroke/Transient Ischemic Event: Preliminary Findings from an Ongoing Randomized Clinical Trial

Background: Atrial fibrillation (AF) is a common cause of ischemic stroke that, though critical to diagnose and treat, often goes undetected. Smartwatches are capable of AF detection, but little is known about their use among stroke survivors. In collaboration with stroke survivors and clinicians, we designed a smartphone-smartwatch system for AF detection. In our ongoing clinical trial, we are examining the performance and user experience of the system in older stroke survivors. Hypothesis: The system will be accurate for AF detection among stroke survivors compared to 14-day ECG patch monitoring; participants will find the system usable and will adhere to daily use over 30 days. Methods: The Pulsewatch study is an ongoing two-phased randomized controlled trial with randomization at two timepoints into control or intervention groups. Phase I (14 days) assesses accuracy and usability of the smartwatch and study app. Phase II (30 days) examines watch wear adherence. The intervention group receives a smartwatch with embedded AF detection and a smartphone app for rhythm and symptom tracking. Eligibility criteria are: &gt; 50 years old, ischemic stroke in the past decade, and no major contraindications to anticoagulation therapy. System accuracy for AF detection is compared to an ECG patch monitor, and usability is assessed via the System Usability Scale. Adherence is defined as daily watch wear time over the monitoring period. Results: To date, 69 participants have been randomized into phase I and 36 into phase II (mean age 65, 41% female, 87% White). The smartwatch system demonstrated a sensitivity of 66.7% (95% CI: 9.4 - 99.2) and specificity of 92.6% (95% CI: 82.1 - 97.9) for detection of 3 AF cases over the 14 day period (91.2% accuracy) compared to the ECG patch. The mean usability score was 65/100 and on average, participants wore the watch on 12/30 days for an average of 1.8 hours (SD 0.7) daily. Conclusion: A smartwatch and app dyad demonstrated reasonable accuracy for AF detection and high usability, though adherence was modest. Use of commercial wearables for AF detection among stroke patients shows promise, but additional data from the ongoing Pulsewatch clinical trial will continue to inform strategies to maximize adherence to these devices among older adults.

Effect of multi-grip myoelectric prosthetic hands on daily activities, pain-related disability and prosthesis use compared with single-grip myoelectric prostheses: A single-case study.

ObjectiveTo evaluate the effect of multi-grip myoelectric prosthetic hands on performance of daily activities, pain-related disability and prosthesis use, in comparison with single-grip myoelectric prosthetic hands.DesignSingle-case AB design.PatientsNine adults with upper-limb loss participated in the study. All had previous experience of single-grip myoelectric prostheses and were prescribed a prosthesis with multi-grip functions.MethodsTo assess the changes in daily activities, pain-related disability and prosthesis use between single-grip and multi-grip myoelectric prosthetic hands, the Canadian Occupational Performance Measure, Pain Disability Index, and prosthesis wearing time were measured at multiple time-points. Visual assessment of graphs and multi-level linear regression were used to assess changes in the outcome measures.ResultsAt 6 months' follow-up self-perceived performance and satisfaction scores had increased, prosthesis wearing time had increased, and pain-related disability had reduced in participants with musculoskeletal pain at baseline. On average, 8 of the 11 available grip types were used. Most useful were the power grip, tripod pinch and lateral pinch.ConclusionThe multi-grip myoelectric prosthetic hand has favourable effects on performance of, and satisfaction with, individually chosen activities, prostheses use and pain-related disability. A durable single-grip myoelectric prosthetic hand may still be needed for heavier physical activities. With structured training, a standard 2-site electrode control system can be used to operate a multi-grip myoelectric prosthetic hand.LAY ABSTRACTIndividuals with upper limb loss are often offered prosthetic hands during the rehabilitation process, to restore body balance and compensate for lack of grip ability. Prosthetic hands with multiple grip functions have been developed to facilitate fine motor skills and enable an ergonomic movement pattern. However, the impact of these hands on the users' daily life has been sparsely studied, and the results have been inconsistent. This study evaluates the effect of multi-grip hands on the performance of daily activities, pain-related disability and prosthesis use, compared to single-grip hands. Based on our results, a multi-grip hand was more useful than a single-grip model for performance of specific, individually chosen activities. Further, prosthesis use increased and pain-related disability was reduced by the use of a multi-grip hand. Multi-grip prosthetic hands seem to fill a gap in prosthetic rehabilitation and facilitate activity performance, and are something clinicians can recommend to their patients.

Carbon-Based Coatings in Medical Textiles Surface Functionalisation: An Overview

The COVID-19 pandemic has further highlighted the need for antimicrobial surfaces, especially those used in a healthcare environment. Textiles are the most difficult surfaces to modify since their typical use is in direct human body contact and, consequently, some aspects need to be improved, such as wear time and filtration efficiency, antibacterial and anti-viral capacity, or hydrophobicity. To this end, several techniques can be used for the surface modification of tissues, being magnetron sputtering (MS) one of [hose that have been growing in the last years to meet the antimicrobial objective. The current state of the art available on textile functionalisation techniques, the improvements obtained by using MS, and the potential of diamond-like-carbon (DLC) coatings on fabrics for medical applications will be discussed in this review in order to contribute to a higher knowledge of functionalized textiles themes.

Developing a Stabilizing Formulation of a Live Chimeric Dengue Virus Vaccine Dry Coated on a High-Density Microarray Patch.

Alternative delivery systems such as the high-density microarray patch (HD-MAP) are being widely explored due to the variety of benefits they offer over traditional vaccine delivery methods. As vaccines are dry coated onto the HD-MAP, there is a need to ensure the stability of the vaccine in a solid state upon dry down. Other challenges faced are the structural stability during storage as a dried vaccine and during reconstitution upon application into the skin. Using a novel live chimeric virus vaccine candidate, BinJ/DENV2-prME, we explored a panel of pharmaceutical excipients to mitigate vaccine loss during the drying and storage process. This screening identified human serum albumin (HSA) as the lead stabilizing excipient. When bDENV2-coated HD-MAPs were stored at 4 °C for a month, we found complete retention of vaccine potency as assessed by the generation of potent virus-neutralizing antibody responses in mice. We also demonstrated that HD-MAP wear time did not influence vaccine deposition into the skin or the corresponding immunological outcomes. The final candidate formulation with HSA maintained ~100% percentage recovery after 6 months of storage at 4 °C.

Joint association of aerobic physical activity and muscle-strengthening activities with metabolic syndrome : the Korean National Health and Nutrition Examination Survey 2014-2015

OBJECTIVESThe study aimed to examine whether simultaneously meeting the combined guidelines of accelerometer-assessed moderate to vigorous physical activity (MVPA) and self-reported muscle-strengthening activity (MSA) was associated with lower odds of metabolic syndrome (MetS) than meeting neither or 1 of the guidelines among the Koreans.METHODSThis cross-sectional analysis included 1,355 participants from the Korea National Health and Nutrition Examination Survey (2014-2015). Logistic regression was used to analyze the associations across groups of MVPA-MSA guideline adherence (meeting neither [reference]; meeting MVPA only; meeting MSA only; meeting both MVPS and MSA) with MetS components (abdominal obesity, hypertriglyceridemia, low high-density lipoprotein cholesterol [HDL-C], hypertension, and hyperglycemia). The odds ratios (ORs) were adjusted for covariates (e.g., sex, age, body mass index, and accelerometer wearing time).RESULTSMSA only significantly reduced the OR for abdominal obesity (OR, 0.34; 95% confidence interval [CI], 0.13 to 0.91). Meeting both MVPA and MSA reduced the OR for hypertriglyceridemia (OR, 0.59; 95% CI, 0.39 to 0.88) and low HDL-C (OR, 0.46; 95% CI, 0.31 to 0.68). Compared to meeting neither, MVPA only (OR, 0.63; 95% CI, 0.44 to 0.89) and both MVPA and MSA (OR, 0.46; 95% CI, 0.28 to 0.76) significantly reduced the OR for MetS.CONCLUSIONSCombined MVPA-MSA was more beneficially associated with MetS prevalence than MVPA only and MSA only. Considering that more than 85% of Korean adults do not meet both the MVPA and MSA guidelines, public health actions to promote adherence should be supported.

Comparison of chest- and wrist-based actigraphy in pulmonary arterial hypertension.

Activity trackers for clinical trials and remote monitoring are appealing as they provide objective data outside of the clinic setting. Algorithms determine physical activity intensity and count steps. Multiple studies show physical inactivity in pulmonary arterial hypertension (PAH). There are no studies comparing different activity trackers worn on different parts of the body in PAH. We had patients with PAH simultaneously wear two different accelerometers, compared measures between the two devices, and correlated the measures with standard clinical metrics in PAH. This was a single-centre, prospective observational study. Daily physical activity and daily total steps were measured using Actigraph GT9X Link and MC10 Biostamp nPoint for 5-10 days. Actigraph was worn on the non-dominant hand and the MC10 Biostamp nPoint was worn on the chest and leg with disposable adhesives. Twenty-two participants wore both accelerometers >12 h/day for an average 7.8 days. The average activity time measured by Actigraph was significantly higher than that measured by MC10 (251 ± 25 min vs. 113 ± 18 min, P = 0.0001). Actigraph's algorithm reported more time in light activity than moderate (190 ± 62 min vs. 60 ± 56 min, P = 0.0001). REVEAL 2.0 scores correlated highly with activity time measured using either device. Invasively measured haemodynamics within 7 days did not correlate with activity time or daily steps. Different activity trackers yield discordant results in PAH patients. Further studies are needed in determining the best device, optimal wear time, and different thresholds for activities in chronic diseases.

Daily use of nicotine replacement medications is related to daily smoking status: An ecological momentary assessment study

BackgroundFew studies have examined how daily adherence to nicotine replacement therapy (NRT) impacts daily smoking abstinence. MethodsData from a pilot randomized controlled trial of a smartphone-based smoking cessation intervention were used. Separate, generalized linear mixed models examined the association between ecological momentary assessments of NRT use and same-day and next day smoking status. Separate models examined the relationship between daily smoking status and (1) any use of NRT, (2) quantity of nicotine gum used, and (3) nicotine patch wear time. Reasons for medication non-adherence were also examined. ResultsParticipants (n = 77) were predominantly White (66.2%) and female (50.6%), 50.4 years old (SD=11.6) on average, and they smoked an average of 21.8 cigarettes per day (SD=11.0) at baseline. Daily NRT use was significantly associated with a lower likelihood of smoking both within that same day and the following day. While using the gum and patch together, and using the patch alone were associated with reduced odds of same-day and next-day smoking, using the gum alone was not significantly associated with reduced odds of smoking. The most commonly cited reasons for not using the patch or gum was “other” (43.3%), followed by “side effects” (27.1%), and “forgot” (18.9%). ConclusionDaily use of the patch or both the patch and gum was associated with a lower risk of daily smoking. Low levels of nicotine gum use alone may not be an effective cessation strategy. Future studies should further explore reasons for NRT non-compliance, and ways to increase NRT adherence.

Real-world experience with the wearable cardioverter defibrillator: clinical effectiveness and wear-time adherence in patients at high risk for sudden cardiac death.

Previous studies established arole for the wearable cardioverter defibrillator (WCD) to effectively and safely bridge temporary risk for sudden cardiac death (SCD) in patients with advanced heart failure. The prognostic relevance of the WCD remains controversial. The authors investigated adherence to, as well as the safety and effectiveness of, WCD use in areal-world cohort of patients at high risk for SCD. All consecutive patients (n = 83) receiving aWCD at aGerman tertiary care hospital between April 2012 and December 2019 were retrospectively included in this analysis. Patient characteristics were collected at the time of the index hospitalization. Using the Zoll® lifeVest® (ZOLL Medical Corporation, Chelmsford, MA, USA) network database, two separate investigators evaluated adherence to the WCD as well as arrhythmic events during WCD wear time. During 3680 wearing days (mean WCD wear time, 44days) with amedian daily wear time of 23.1 h, three arrhythmic events of relevance (sustained ventricular tachycardia, VT) occurred, one of which was sufficiently terminated by WCD shock. Another patient died from sudden cardiac death while pausing his WCD. Right bundle branch block correlated significantly with sustained VT occurrence (r = 0.3315; 95% CI -0.1265 to 0.3014; p = 0.0022). In 30patients (36.1%) acardioverter/defibrillator was implanted. In areal-life clinical setting, the use of WCD in patients at high risk for sudden cardiac death is effective and safe and adherence to the device is high. The event rate for VA was lower than in comparable patient cohorts. Adherence remains acrucial issue as one patient in the present series died while not wearing the device.

Wearable device signals and home blood pressure data across age, sex, race, ethnicity, and clinical phenotypes in the Michigan Predictive Activity & Clinical Trajectories in Health (MIPACT) study: a prospective, community-based observational study

Wearable technology has rapidly entered consumer markets and has health-care potential; however, wearable device data for diverse populations are scarce. We therefore aimed to describe and compare key wearable signals (ie, heart rate, step count, and home blood pressure measurements) across age, sex, race, ethnicity, and clinical phenotypes. In the Michigan Predictive Activity & Clinical Trajectories in Health (MIPACT) prospective observational study, we enrolled participants from Michigan Medicine, Ann Abor, MI, USA, and followed them up for at least 90 days. Patients were included if they were aged 18 years or older, were fluent in English, owned an iPhone 6 or newer model with a supported iOS version, and had regular access to the internet throughout the study period. All participants were provided with an Apple Watch Series 3 or 4, an Omron Evolv Wireless Blood Pressure Monitor, and the MyDataHelps study smartphone application. Participants were asked to wear their watch for 12 h per day or longer and to do daily or weekly tasks, including home blood pressure measurements and breathing tasks. Heart rate, blood pressure, step counts, and distance walked were collected. The study was divided into two phases: an intensive 45-day collection phase (phase 1); and a 3-year longitudinal monitoring phase (phase 2). Here we report the first 90 days of data for all participants, which includes all of phase 1 and the first 45 days of phase 2. Participants' electronic health records were used to establish clinical diagnoses for analysis. We enrolled 6765 eligible participants between Aug 14, 2018, and Dec 19, 2019, of whom 6454 participants from Michigan Medicine completed the phase 1 study protocol and were included in this analysis (3482 [54%] women and 2972 [46%] men; 3657 [57%] participants were White, with 1094 [17%] Asian and 1090 [17%] Black participants). On days when participants wore their smart watches, median daily watch wear time was 15·5 h (IQR 14-17). Participants contributed a total of 1 107 320 blood pressure and 202 198 347 heart rate measurements over 90 days, with 172 (SD 50) blood pressure and 31 329 (SD 24 620) heart rate measurements per participant. Mean systolic blood pressure was 122 mm Hg (SD 10) and mean diastolic blood pressure was 77 mm Hg (SD 8), with 167 312 (15%) measurements having a systolic blood pressure higher than 140 mm Hg or diastolic blood pressure higher than 90 mm Hg. Mean resting heart rate was 64 beats per min (SD 8). Blood pressure and resting heart rate varied by sex, age, race, and ethnicity, with higher blood pressures in males and lower heart rate in participants aged 65 years or older (p<0·0001). Participants took 7511 steps per day (SD 2805) and walked 6009 metres per day (SD 2608), varying across demographic and clinical subgroups. These data could inform clinical trial design, interpretation of wearable data in clinical practice, and health-care interventions. Apple, University of Michigan.

Physical Activity Patterns in Frail and Nonfrail Patients With End-Stage Liver Disease

Frailty commonly complicates cirrhosis and is associated with poorer outcomes. While patients with cirrhosis may be sedentary, there are few comprehensive descriptions of their physical activity (PA) patterns related to frailty. Our aim was to identify PA characteristics that may be used in interventions to improve PA and reduce frailty. In a cross-sectional cohort study, forty patients with cirrhosis (mean age 63; 30 nonfrail, 10 frail) wore an accelerometer/thermal sensing armband for 7 days. Postural status (e.g., upright movement, upright sedentary, lying down), Metabolic Equivalent of Tasks (METs) and active bouts were identified. Patients were highly sedentary most of the time (89±7% and 85±10% of the day, in frail and nonfrail cirrhotics, respectively). Compared with nonfrail cirrhotics, frail patients spent significantly shorter amountof time moving in an upright position (7%±5 vs. 12%±5, P= 0.013 in frail and nonfrail cirrhotics, respectively), had significantly fewer and shorter durations of active bouts per day (number of active bouts: 9±12 vs. 19±14; duration: 13.2±1.5min and 15.9±2.6min in frail and nonfrail cirrhotics, respectively), and had a lower amount of steps per wear time hours (41.7±37.1 vs. 116.8±85.4, P= 0.003 in frail and nonfrail, respectively). Traditional measures such as METs or aerobic bouts did not differ between groups. Active bout measures, as opposed to more traditional measures such as METs, differentiate between frail and nonfrail cirrhotics suggesting they may be used to assess changes resulting from targeted interventions to improve physical activity.

A Pilot Randomized Controlled Trial of a Fitbit- and Facebook-Based Physical Activity Intervention for Young Adult Cancer Survivors.

Purpose: Most young adult cancer survivors (YACS) do not meet physical activity (PA) guidelines. Although PA can improve health and quality of life (QOL), few randomized controlled trials (RCTs) of PA interventions for YACS exist. We conducted a pilot RCT to test feasibility of a PA intervention among YACS. Methods: We recruited 18-39-year-olds (≥1 and <5 years postcancer therapy) from Seattle Cancer Care Alliance. The 12-week intervention involved a wrist-worn PA-tracking device (Fitbit), a peer-based Facebook support group, step count goal setting, and a self-selected support "buddy." Controls received Fitbit only. Baseline assessments occurred before randomization; follow-up assessments occurred during intervention weeks 10-12. Feasibility criteria are listed below. Exploratory outcomes included PA, sedentary time (ST), QOL measures (e.g., fatigue), and self-determination theory (SDT) construct measures. Results: All feasibility criteria were met: We recruited 50 YACS, intervention participants wore the Fitbit on the majority of intervention days (82.9%), ≥75% of participants completed questionnaires at baseline (100%) and follow-up (93.9%). Exploratory analyses, adjusted for wave, accelerometer wear time, race, and income, showed significant group differences for change in ST (-52.4 vs. 2.5 minutes/day; p = 0.002) but no change in moderate-to-vigorous intensity PA (0.0 vs. -0.2 minutes/day; p = 0.40), comparing intervention participants to controls. The intervention (vs. control) group had a greater increase in fatigue interference (p = 0.03). No other significant differences in SDT or QOL measures were found. Conclusion: This Fitbit and Facebook-based PA intervention was feasible to YACS, with promising effects on reducing ST, and warrants a fully powered RCT. Clinical Trial Registration no.: NCT03233581.

Bio-tribological behavior of articular cartilage based on biological morphology

Artificial hemiarthroplasty is one of the effective methods for the treatment of hip joint diseases, but the wear failure of the interface between the hemi hip joint material and articular cartilage restricts the life of the prosthesis. Therefore, it is important to explore the damage mechanism between the interfaces to prolong the life of the prosthesis and improve the life quality of the prosthesis replacement. In this paper, the creep and bio-tribological properties of cartilage against PEEK, CoCrMo alloy, and ceramic were studied, and the tribological differences between “hard–soft” and “soft–soft” contact were analyzed based on biomorphology. The results showed that with the increase of time in vitro, the thickness of the cartilage membrane decreased, the surface damage was aggravated, and the anti-creep ability of cartilage was weakened. Second, the creep resistance of the soft–soft contact pair was better than that of the hard–soft contact pair. Also, the greater the load and the longer the wear time, the more serious the cartilage damage. Among the three friction pairs, the cartilage in PEEK/articular cartilage was the least damaged, followed by CoCrMo alloy/articular cartilage, and the most damage was found in ceramic/articular, indicating that the soft–soft friction pair inflicted the least damage to the cartilage.

‘It’s more than just a running leg’: a qualitative study of running-specific prosthesis use by children and youth with lower limb absence

Purpose The purpose of this study was to investigate the use of running-specific prostheses (RSPs) by children with lower limb absence (LLA) along with the benefits and challenges of RSPs. Materials and methods In this descriptive qualitative study, eight children (ages 8–20 years) and their parents participated in semi-structured interviews. The interviews were audio-recorded and transcribed. Coded data were the foundation for central theme development. Results Three main themes were generated. “Run faster, jump higher, do more” (the benefits of RSP use), “Every leg serves its purpose” (comparing functionality between daily use prostheses and RSPs), and “A lot more to think about” (additional considerations with RSP use). Conclusions RSPs have a positive impact in promoting children’s engagement in sports and physical activities. While some children used their RSP primarily for running, others wore it for a broader range of physical activities. Issues with balance and discomfort caused by leg length discrepancies and/or ill-fitting sockets limited daily wear time. Limitations related to current RSP designs and clinical implementation should be addressed to optimize the functional potential of children with unilateral or bilateral LLA. Implications for rehabilitation Running-specific prostheses (RSPs) positively impacted children’s ability to participate in some sports with peers promoting their physical and social well-being. The main issues that children faced were discomfort, difficulty balancing, and inability to use RSPs for certain sports, while parents’ issues focused on supporting prosthesis use and transport, and adjustments of different prostheses to keep up with their child’s growth. Clinicians should be aware of the challenges of RSP use to best support children and their families. Designers should focus on addressing limitations with current RSPs to facilitate the diverse needs of pediatric users.

A search for new options to manage fecal incontinence.

Fecal incontinence (FI) is a highly prevalent condition known to substantially impair a patient's quality of life. Although a non-invasive treatment option, currently available anal plugs are poorly tolerated, not significantly effective and therefore not often used. We present a new disposable device based on an innovative concept that renews the interest for non-invasive "external" control of bowel content for FI patients. The Contix™ (Forconti Medical Ltd, Cesarea, Israel) permits creation of temporary "artificial" fecal impaction to avoid bowel leakage while inserted high into the "non sensitive" rectum where it is not felt by the patient and therefore tolerated for 6- to 12- hour use. This European conformity (CE)-marked device has a unique design that allows insertion, usage and removal in a similar manner to a vaginal pad. It comes in 2 parts: a flexible silicone-based oval-shaped biocompatible balloon and an applicator in which the balloon is folded for self-insertion. An external tube allows for the balloon to be inflated with 60-100ml. of air. In doing this, small smooth tines deploy on its surface to help maintain the balloon in place. A pulling string with a ring stays out of the anal canal to deflate and withdraw the balloon inverted on itself at end of use. Device handling that includes rectal insertion and withdrawal feasibility, wear time, comfort at the different steps of use, safety and of course effectiveness of Contix™ have been tested in small trials yet to be published but pilot studies support its uses at greater scale in expert centers in Europe and the United States. In summary the Contix™ is a non-invasive device for FI management based on an innovative concept. Initial results support its spread to identify its role as an ancillary service to existing approaches.