Wear Time Research Articles

Experiences of Rural-Dwelling Children Wearing Physical Activity Trackers: An Exploratory Study.

Although there is a need for evidence-based physical activity programs in rural communities, evaluating such programs is often challenging due to access-related barriers and measurement tools that are not designed for rural contexts. This study aimed to explore and better understand the day-to-day experiences of rural-dwelling children using wrist-worn PA trackers as part of a study to develop a health promotion program. Ten caregivers and child dyads were enrolled (n = 20). The children wore accelerometers pre- and post-intervention. Semi-structured interviews were completed post-intervention and were audio recorded, transcribed, and summary reports were generated based on recurring themes. The children had a mean age of 8.7 (SD = 1.4) years and the majority were male (80%). The caregivers were female, white, and had a mean age of 43.6 (SD = 8.5) years, with an annual income of ≥USD 40,000. Factors contributing to device wear times included low caregiver burden, device functioning as a watch, and device interactivity. The children reported that the devices were acceptable, but may have changed their physical activity behaviors, with children regularly checking their step count. The caregivers preferred devices that monitored the children's activity levels without sharing location data. Identifying acceptable and feasible strategies to measure physical activity is vital to developing effective health promotion efforts. The lessons learned may help develop evaluation plans for implementing rural physical activity programming.

Lessons from the pandemic era: do we need new strategies to improve conservative treatment adherence in adolescent idiopathic scoliosis? A retrospective analysis.

This study aims to examine whether the COVID-19 pandemic affected the adherence to conservative AIS treatment. Adolescent Idiopathic Scoliosis (AIS) is characterized by a lateral curvature of the spine of at least 10 degrees. Compliance rates in conservative treatments are influenced by various factors. From a database of AIS patients, we selected 30 AIS patients who were assessed before, during, and after the COVID-19 pandemic. Data regarding Cobb's angle, brace prescription, prescribed brace wear time, brace wear compliance, and time dedicated to sports activities were collected over a six-year period from January 2018 to December 2023, divided into three 2-year time periods (before, during, and after COVID-19). There was an increased percentage of AIS patients prescribed with a brace during the pandemic. However, no significant differences in Cobb's angle were observed. Additionally, the prescribed wear time showed a significant decrease from the pre-COVID period to the post-COVID period (p-value = 0.03). Wear compliance exhibited a decreasing trend from pre- to during- and post-COVID-19 periods without reaching statistically significant differences, and the time dedicated to sports statistically significantly decreased. These differences were statistically significant when comparing the pre- vs. post- and pre- vs. during-COVID-19 periods (p-values 0.01, 0.04, respectively). Our study highlights changes in AIS conservative treatment during and after the COVID-19 pandemic. The increase in the number of patients prescribed with a brace during the pandemic, although not supported by an increase in Cobb's angle, may be attributed to the concerns about regular monitoring during the reduction of rehabilitation services. The observed decreases in brace compliance and involvement in sport activities, which persisted even in the post-pandemic period, emphasizes the lasting impact of the pandemic on AIS management, necessitating innovative approaches to address these ongoing concerns.

Digital Intervention Promoting Physical Activity in People Newly Diagnosed with Parkinson's Disease: Feasibility and Acceptability of the Knowledge, Exercise-Efficacy and Participation (KEEP) Intervention.

Exercise promotion interventions for people with Parkinson's disease (PD) are often offered on a face-to-face basis, follow a generic "one-size-fit-all" approach, and are not typically delivered at diagnosis. Considering PD's heterogenous nature, the existing evidence on the merits of exercise on symptom management and the expressed wishes of people living with PD for access to timely and tailored evidence-based information, there is a demand for interventions that are easily accessible, scalable and co-designed with people living with PD. Evaluate the feasibility and acceptability of a co-designed digital intervention promoting exercise and physical activity, in people newly diagnosed with PD. Thirty people living with PD for less than one year participated in an assessor-blinded randomized feasibility trial from June 2022 to April 2023. The intervention group received the 8-week Knowledge, Exercise Efficacy and Participation (KEEP) intervention comprising 6 interactive digital modules and 4 online live group discussions facilitated by a specialist physiotherapist. Assessments were performed at baseline, post intervention and at 6-month follow up. Thirty participants were recruited to target with a 64% recruitment rate (30/47). All but one participant completed the 6-month follow-up assessment. There was high retention (97%), module completion (91%), and online discussion attendance (88%). Outcome measure collection was feasible, including accelerometer data with a daily average wear time of 23.9 hours (SD:0.295). The KEEP intervention was feasible and acceptable in people newly diagnosed with PD. A larger trial is needed to assess intervention efficacy and correlation between knowledge, self-efficacy, and activity levels.

A systematic review on the use of transforming powder dressing for wound care.

The transforming powder dressing (Altrazeal®, Uluru Inc, Addison, TX, USA) is simple to use, painless to apply and has a wear time of up to 30 days. This study aims to review the current literature to elucidate the impact of transforming powder dressing on healing, pain management and overall patient outcomes. We conducted a systematic review following Preferred Reporting Items of Systematic Reviews and Meta-Analyses guidelines. Data including study characteristics, patient demographics and wound outcomes were extracted. Our systematic review included 26 articles (n = 175). Of these articles, 13 (50%) were case reports, 10 (38.5%) were case series, 2 (7.7%) were randomised controlled trials and 1 (3.8%) was a cohort study. Wound types included venous ulcer (23.9%), pressure sore (19.7%), burn (15.5%), skin graft (13.4%), diabetic foot ulcer (4.2%), Mohs defect (3.5%) and other (19.6%). Complete re-epithelialization occurred in 90.1% of the wounds. A total of 19 studies (73%) discussed pain, each of which reported reduced pain with the use of transforming powder dressing. The evaluated studies collectively suggest that transforming powder dressing offers a promising re-epithelialization rate and analgesic effect across various wound types.

Appropriate use of wearable defibrillators with multiparametric evaluation to avoid unnecessary defibrillator implantation

IntroductionWearable cardioverter-defibrillators (WCD) have emerged as a valuable tool in the management of patients at risk for life-threatening arrhythmias. These devices offer a non-invasive and temporary solution, providing continuous monitoring...

Effect of orthotic insole on symptomatic flexible flatfoot in school-age children: Meta-analysis and 1-year follow-up study

PurposeThis study aimed to investigate the efficacy of orthopedic insoles, specifically three-dimensional (3D)-printed orthopedic insoles, for treatment of symptomatic flexible flatfoot in school-age children. MethodsA systematic review of PubMed and China National Knowledge Infrastructure (CNKI) from database inception to March 2024 was conducted to determine additional studies. This single-center study included 38 participants, including 20 who chose ordinary orthopedic insoles and 18 who chose 3D printed orthopedic insoles, presented from January 2021 to December 2022. Pain symptom relief was compared between the two groups after 1 year of follow-up. ResultsA systematic review identified an additional six publications, involving 206 samples, and meta-analysis indicated that the force-bearing area, arch index, and heel valgus angle after treatment were 0.74 (95 ​% confidence interval [CI]: 0.65–1.01), 0.20 (95 ​% CI: 0.03–1.35), and 0.10 (95 ​% CI: 0.03–0.28) of those before treatment, respectively. The 1-year follow-up study revealed that because of its good comfort, 3D printed orthopedic insole can significantly improve the wearing time of both male (P ​< ​0.001) and overweight participants (P ​< ​0.001) and significantly reduce the pain score (P ​= ​0.032). ConclusionsOrthotic insoles are effective in helping the recovery of flexible flatfoot. Among them, the 3D-printed orthopedic insoles have a better effect on relieving pain symptoms and have a great development potential.

Spectacle Lenses With Highly Aspherical Lenslets for Slowing Axial Elongation and Refractive Change in Low-Hyperopic Chinese Children: A Randomized Controlled Trial

Purpose: Spectacle lenses with highly aspherical lenslets (HAL) have been shown to effectively retard myopia progression in myopic children. This study aimed to investigate the impact of spectacle lenses with HAL on refractive and axial length (AL) changes in Chinese children with low amount of hyperopia. Design: Randomized controlled trial Methods: A total of 108 Chinese children aged 6.0 to 9.9 years and spherical equivalent refractive error (SERE) from 0.00 to +2.00 D were randomly allocated into two groups: the HAL group and the single vision spectacle lens (SVL) group. Cycloplegic refraction, AL, and uncorrected visual acuity (UCVA) was measured at baseline, three months, six months, and 12 months after lens dispensing. The duration of spectacle lens wear was monitored using a wearable device attached to the spectacle frame and by questionnaire logs provided by participants at each follow up visit. Results: The one-year SERE change was -0.19 [-0.32, 0.03] D and −0.23 [-0.36, 0.05] D in the SVL and HAL groups (P=0.883). The one-year AL elongation was 0.24 [0.18, 0.34] mm and 0.19 [0.12, 0.27] mm in the SVL and HAL groups (P=0.057). In the HAL group, changes in AL and SERE were significantly correlated to lens wearing time (P<0.001 and P=0.024, respectively). Participants in the HAL group who wore their lenses for more than 30 hours per week had significantly slower AL elongation (0.11 [0.05, 0.17] mm) compared to their SVL counterparts (0.27 [0.21, 0.33] mm) (P<0.001). Conclusion: Spectacle lenses with HAL significantly reduced AL elongation in low hyperopic children who wore lenses for over 30 hours per week. A dose-response relationship was evident with longer lens wearing time associated with less AL change.

Performance of a Novel Continuous Glucose Monitoring Device in People With Diabetes.

In this multicenter study, performance of a novel continuous glucose monitoring (CGM) system was evaluated. Adult participants with diabetes were included in the study. They each wore three sensors of the CGM system on the upper arms for up to 14 days. During four in-clinic visits, frequent comparison measurements with capillary blood glucose (BG) samples were performed. The primary endpoint was the 20/20 agreement rate (AR): the percentage of CGM readings within ±20 mg/dL (at BG values <100 mg/dL) or ±20% (at BG values ≥100 mg/dL) of the comparator. Further evaluations included mean absolute relative difference (MARD) and 20/20 AR in different BG ranges and across the wear time. Data from 48 participants and 139 sensors were analyzed. During in-clinic sessions the 20/20 AR was 90.5% and the MARD was 9.2%. For BG ranges <70, 70-180, and >180 mg/dL, 20/20 AR was 94.3%, 89.0%, and 92.5%, respectively. At the beginning, middle, and end of sensor wear time, 20/20 AR was 92.8%, 91.5%, and 85.9%, respectively. The 14-day survival probability was 82.4%. Pain and bleeding after sensor insertion were within the expected range. Based on the study outcome, the use of the device is regarded as safe. The system showed a good performance compared to capillary BG measurements. This level of accuracy could be shown over the entire measurement range, especially in the low glycemic range, and the whole wear time of the sensors. The results of this study are supporting a non-adjunctive use of the device.

Prediction of wear properties of CaO and MgO doped stabilized zirconia ceramics produced with different pressing methods using adaptive neuro fuzzy inference systems

AbstractThe present paper describes the fabrication and wear behaviour of CaO and MgO added stabilized zirconia (ZrO2) ceramics produced by powder metallurgy method were examined and modelling with artificial neural networks was studied using the experimental data obtained. CaO/MgO added stabilized zirconia ceramics were fabricated by using a combined method of ball milling, cold pressing ‐ cold isostatic pressing and sintering. CaO and MgO in different amounts (0–8 %mole) were mixed with zirconia. These mixtures were prepared by mechanical alloying method. The green compacts were sintered at 1600 °C. The wear experimental results obtained were converted into data suitable for modelling with artificial neural networks. Wear Load, wear time, CaO and MgO data were used as artificial neural networks input variables. The amount of wear according to the pressing method was taken as the output variables of artificial neural networks. An artificial neural networks was established for the prediction of wear properties of zirconia pressed using the adaptive neuro fuzzy inference systems (ANFIS) learning technique. As a result, a high R2 value of 0.9187 for cold pressing samples and 0,9449 for cold isostatic pressing samples was achieved based on the approach of comparing the success of the model with the test data set and the result produced.

Fitting parameters in children with cochlear implants and severe additional disabilities.

The aim of this study was to investigate whether the fitting data of children with Cochlear implants (CI) and severe additional disabilities (CAD) differ compared to children with CI but without additional disabilities (CnonAD). In this retrospective analysis, 76 CI cases (fitted ears) from CAD were included and matched with 76 cases from CnonAD. The subjective set values, such as pulse width (PW), threshold (T) and most comfortable (MC) levels were recorded. Additionally, the response threshold values by means of aided soundfield threshold (AST), the values of the intracochlear electrode impedances, the eCAP thresholds and the daily wearing time by using data logging were recorded and analysed. The T and MC levels for the Medel implants were significantly lower in the sample than in the control group. A similar trend was evident for Cochlear® implants. The sample showed a positive correlation between the eCAP thresholds and the T level and MC level in case of the Cochlear implants. The CAD group showed a significantly higher aided soundfield threshold. In contrast to the CnonAD (0%), there was a total of 18% in the CAD with a reduced daily wearing time. When these were excluded, eCAP thresholds were significantly higher in the CAD group. In addition, there was a trend for eCAP thresholds to be higher if the contralateral ear was not also fitted with a CI. The significantly higher eCAPs in CAD may be explained by different neural survival but also by different fittings and MC levels. The audiuologist's subjectivity must be considered as a potential bias but also as potentially valuable input variable contributing to the variance in the fitting parameters and outcomes. Better fitting of T and MC levels focusing on behavioural and developmental responses may lead to a longer wearing time. To support the audiologist and the fitting process, it is necessary to interpret the response thresholds in the aided soundfield threshold against the background of the medical diagnosis and observations from everyday life should be considered. To ensure optimal development of CAD children according to their individual abilities, a multi-professional, family-centred intervention programme including videoanalyses should be implemented at an early stage, ideally from the decision process for a cochlear implant.

A single-centre RetrospeCtive sTudy Investigating patient-reported outcomeS of extended dressing wear time for incisional healing following orthopaedic surgery: the ARCTIS study.

Orthopaedic surgery is an effective intervention for treating the symptoms of degenerative joint disease or osteoarthritis (OA). Frequent wound dressing changes, unless clinically indicated, can disrupt the healing process and increase the occurrence of incision site contamination. Protection from contamination is critical for surgical incisions and, therefore, undisturbed wound healing (UWH) in surgical wound management is vital. This article describes a retrospective study reporting the clinical performance of a self-adherent, absorbent postoperative dressing, with a focus on dressing wear time. A single-centre, retrospective electronic medical record review of a convenience sample of adult patients treated with a dressing (Mepilex Border Post Op; Mölnlycke, Sweden) following elective hip or knee replacement was undertaken. Data relating to dressing wear time, rationale for dressing changes and patient-reported outcomes were extracted from a mobile health application moveUP Therapy (moveUP NV, Belgium). Health-related quality of life assessment was conducted using the EQ-5D-5L questionnaire and orthopaedic-specific quality of life (QoL) indicator tools. Of the 558 records reviewed, 151 respondents (27.1%) reported outcomes relating to dressing wear time and frequency of dressing change. The average wear time of the first dressing was 13.6 days (second dressing: 5.3 days). The proportion of patients who wore the first dressing for 1-7 days, 8-13 days and for ≥14 days was 17.2%, 13.2% and 69.5%, respectively. Data from the completed questionnaires revealed improvement in QoL over time. The results of this study are a good indicator of the suitability of the postoperative dressing for a 14-day wear time, in line with the principles of UWH.

Supervised machine learning to predict smoking lapses from Ecological Momentary Assessments and sensor data: Implications for just-in-time adaptive intervention development.

Specific moments of lapse among smokers attempting to quit often lead to full relapse, which highlights a need for interventions that target lapses before they might occur, such as just-in-time adaptive interventions (JITAIs). To inform the decision points and tailoring variables of a lapse prevention JITAI, we trained and tested supervised machine learning algorithms that use Ecological Momentary Assessments (EMAs) and wearable sensor data of potential lapse triggers and lapse incidence. We aimed to identify a best-performing and feasible algorithm to take forwards in a JITAI. For 10 days, adult smokers attempting to quit were asked to complete 16 hourly EMAs/day assessing cravings, mood, activity, social context, physical context, and lapse incidence, and to wear a Fitbit Charge 4 during waking hours to passively collect data on steps and heart rate. A series of group-level supervised machine learning algorithms (e.g., Random Forest, XGBoost) were trained and tested, without and with the sensor data. Their ability to predict lapses for out-of-sample (i) observations and (ii) individuals were evaluated. Next, a series of individual-level and hybrid (i.e., group- and individual-level) algorithms were trained and tested. Participants (N = 38) responded to 6,124 EMAs (with 6.9% of responses reporting a lapse). Without sensor data, the best-performing group-level algorithm had an area under the receiver operating characteristic curve (AUC) of 0.899 (95% CI = 0.871-0.928). Its ability to classify lapses for out-of-sample individuals ranged from poor to excellent (AUCper person = 0.524-0.994; median AUC = 0.639). 15/38 participants had adequate data for individual-level algorithms to be constructed, with a median AUC of 0.855 (range: 0.451-1.000). Hybrid algorithms could be constructed for 25/38 participants, with a median AUC of 0.692 (range: 0.523 to 0.998). With sensor data, the best-performing group-level algorithm had an AUC of 0.952 (95% CI = 0.933-0.970). Its ability to classify lapses for out-of-sample individuals ranged from poor to excellent (AUCper person = 0.494-0.979; median AUC = 0.745). 11/30 participants had adequate data for individual-level algorithms to be constructed, with a median AUC of 0.983 (range: 0.549-1.000). Hybrid algorithms could be constructed for 20/30 participants, with a median AUC of 0.772 (range: 0.444 to 0.968). In conclusion, high-performing group-level lapse prediction algorithms without and with sensor data had variable performance when applied to out-of-sample individuals. Individual-level and hybrid algorithms could be constructed for a limited number of individuals but had improved performance, particularly when incorporating sensor data for participants with sufficient wear time. Feasibility constraints and the need to balance multiple success criteria in the JITAI development and implementation process are discussed.

Long-term adherence to a wearable for continuous behavioural activity measuring in the SafeHeart implantable cardioverter defibrillator population.

Wearable health technologies are increasingly popular. Yet, wearable monitoring only works when devices are worn as intended, and adherence reporting lacks standardization. In this study, we aimed to explore the long-term adherence to a wrist-worn activity tracker in the prospective SafeHeart study and identify patient characteristics associated with adherence. This study enrolled 303 participants, instructed to wear a wrist-worn accelerometer day and night for 6 months. Long-term adherence was defined as valid days (≥22 h of wear time) divided by expected days, and daily adherence as mean hours of wear time per 24 h period. Optimal, moderate, and low long-term and daily adherence groups were defined as long-term adherence above or below 95 and 75% and daily adherence above or below 90 and 75%. Regression models were used to identify patient characteristics associated with long-term adherence. In total, 296 participants [median age 64 years; interquartile range (IQR) 57-72; 19% female] were found eligible, yielding 44 003 days for analysis. The median long-term adherence was 88.2% (IQR 74.6-96.5%). A total of 83 (28%), 127 (42.9%), and 86 (29.1%) participants had optimal, moderate, and low long-term adherence, and 163 (55.1%), 87 (29.4%), and 46 (15.5%) had optimal, moderate, and low daily adherence, respectively. Age and smoking habits differed significantly between adherence levels, and increasing changeover intervals improved the degree of long-term adherence. Long-term adherence to a wearable activity tracker was 88.2% over a 6-month period. Older age and longer changeover interval were positively associated with long-term adherence. This serves as a benchmark for future studies that rely on wearable devices. The National Trial Registration number: NL9218 (https://onderzoekmetmensen.nl/).

Agreement Between Apple Watch and Actical Step Counts in a Community Setting: Cross-Sectional Investigation From the Framingham Heart Study.

Step counting is comparable among many research-grade and consumer-grade accelerometers in laboratory settings. The purpose of this study was to compare the agreement between Actical and Apple Watch step-counting in a community setting. Among Third Generation Framingham Heart Study participants (N=3486), we examined the agreement of step-counting between those who wore a consumer-grade accelerometer (Apple Watch Series 0) and a research-grade accelerometer (Actical) on the same days. Secondarily, we examined the agreement during each hour when both devices were worn to account for differences in wear time between devices. We studied 523 participants (n=3223 person-days, mean age 51.7, SD 8.9 years; women: n=298, 57.0%). Between devices, we observed modest correlation (intraclass correlation [ICC] 0.56, 95% CI 0.54-0.59), poor continuous agreement (29.7%, n=957 of days having steps counts with ≤15% difference), a mean difference of 499 steps per day higher count by Actical, and wide limits of agreement, roughly ±9000 steps per day. However, devices showed stronger agreement in identifying who meets various steps per day thresholds (eg, at 8000 steps per day, kappa coefficient=0.49), for which devices were concordant for 74.8% (n=391) of participants. In secondary analyses, in the hours during which both devices were worn (n=456 participants, n=18,760 person-hours), the correlation was much stronger (ICC 0.86, 95% CI 0.85-0.86), but continuous agreement remained poor (27.3%, n=5115 of hours having step counts with ≤15% difference) between devices and was slightly worse for those with mobility limitations or obesity. Our investigation suggests poor overall agreement between steps counted by the Actical device and those counted by the Apple Watch device, with stronger agreement in discriminating who meets certain step thresholds. The impact of these challenges may be minimized if accelerometers are used by individuals to determine whether they are meeting physical activity guidelines or tracking step counts. It is also possible that some of the limitations of these older accelerometers may be improved in newer devices.

Retention efficacy and patient experience with customized clear retainer and wrap-around circumferential retainer among non-extraction orthodontic patients: A 12-month follow-up cohort study.

The aim of this study was to evaluate retention efficacy by assessing retention stability and patient perspectives according to type of circumferential retainer: the wrap-around circumferential retainer (WCR) and customized clear retainer (CCR). This cohort follow-up study involved 52 patients aged 18-62 who underwent fixed-appliance orthodontic treatment without extractions or orthognathic surgery. Following screening consenting participants were divided into WCR and CCR groups. All participants before follow-up received fixed retainers for the upper and lower anteriors and respective removable retainers within 2 weeks post-debond. Intraoral scans and lateral cephalograms were taken immediately after debonding (T0) and again 12 months later. Dentoalveolar changes in several measurements were compared to evaluate retention efficacy. Surveys were conducted at 1 month (T1) and 12 months (T2) post-debonding to assess changes in patient experiences. Outcome assessments were blinded. Paired T-tests and independent T-tests were used for intragroup and intergroup comparisons of dentoalveolar measurements, respectively. Survey responses were analysed using the Pearson Chi-Square test. The final assessment included 32 participants. Model analysis revealed no significant differences between the groups, except for maxillary intermolar width (p = .033). In the WCR group, the cephalometric analysis indicated a significant increase in the incisor mandibular plane angle (p = .002) and a decrease in the interincisal angle (p = .014), while changes in the CCR group were statistically non-significant. Patient attitude evaluation showed similar trends for wear time and overall satisfaction. However, a higher percentage of respondents in the WCR group reported irritation when wearing the retainers (p = .037) at T1 and discomfort related to speech (p = .038) at T2. CCR showed better retention efficacy in terms of lower incisor inclination. Patients experienced relatively less irritation and speech discomfort with CCRs.

The effect of thoraco-lumbo-sacral orthosis wear time and clinical risk factors on curve progression for individuals with adolescent idiopathic scoliosis

BACKGROUND CONTEXTThe effectiveness of bracing with a thoraco-lumbo-sacral orthosis (TLSO) for adolescent idiopathic scoliosis (AIS) has been studied extensively, with a growing body of evidence supporting TLSO use. In this study we examine the effect of wear time and other important causal factors affecting curve progression and develop a risk model that can be applied to individual patients and is based on important casual factors. PURPOSEUnderstand the impact of TLSO wear time and other risk factors in order to guide optimal treatment. STUDY DESIGN/SETTINGProspective, multi-center, cohort study Patient SampleIndividuals with a diagnosis of AIS, age of 10 to 16 years, primary Cobb angle of 20 to 45 degrees, Risser 0 to 2, <1 year post menarche if female, who were to be treated with a TLSO OUTCOME MEASURES(1) Rate of primary curve progression, (2) surgery recommendation during TLSO treatment METHODSWear time was monitored with thermochrons. Participants were followed until the end of growth. We examined the causal effects of wear time and baseline skeletal maturity as measured by triradiate cartilage (TRC) status, Cobb angle, and age. We then fit an outcome prediction model (logistic regression) based on important casual factors. RESULTSOur final cohort consisted of 145 individuals (baseline age 12.1–13.4 years). Wear time was an important cause of response to treatment, including an interaction with TRC status. Baseline Cobb angle and age were also meaningful causes of response. The prediction model was accurate (79%) and had good specificity (81%) and moderate sensitivity (68%) and an area under the receiver operating characteristic curve (AUC) of 0.81. Additionally, we were able to independently confirm previous estimates of treatment efficacy, with an odds ratio around 2.0. CONCLUSIONSOur study showed the explicit causal effects of wear time, and baseline skeletal maturity, Cobb angle and age. The risk model we developed can be used for counseling patients and their families regarding TLSO wear and expectations for outcome.

Design and rationale for a randomized clinical trial testing the efficacy of a lifestyle physical activity intervention for people with HIV and engaged in unhealthy drinking

BackgroundAmong people living with HIV (PLWH), unhealthy drinking presents an increased risk for negative outcomes. Physical inactivity and sedentariness raise additional health risks. Despite evidence that physical activity (PA) is associated with improved physical and mental functioning and reduced alcohol cravings, there have been no PA studies conducted with PLWH engaged in unhealthy drinking. We describe a study protocol of a remote lifestyle physical activity (LPA) intervention to increase PA and reduce alcohol consumption among PLWH. MethodsUsing online advertisements, 220 low-active PLWH engaged in unhealthy drinking will be recruited and randomized nationwide. After providing informed consent and completing a baseline interview, participants will receive a Fitbit. Participants will complete 15 days of ecologic momentary assessment through a phone application and up to 15 days of Fitbit wear time. Following this period, participants will be randomly assigned to a Fitbit-only control condition or a LPA and Fitbit intervention condition. Health counselors meet with control participants once (and have 6 subsequent brief check ins on Fibit use) and with intervention participants 7 times for PA counseling over a 12-week period. Follow-up assessments will be conducted at 3- and 6-months post-randomization. We hypothesize that individuals in the LPA and Fitbit condition will have lower rates of alcohol consumption and higher rates of PA at 6-month follow-up. ConclusionThe randomized controlled trial described in this paper investigates remote methods to influence multimorbidity among PLWH using a LPA approach for increasing PA and reducing alcohol consumption.

No beneficial use of the wearable cardioverter defibrillator among patients suffering from inherited and congenital heart disease: data from a European multicenter registry.

Data on the use of the wearable cardioverter defibrillator in patients suffering from inherited and congenital heart disease are limited. Consequently, evidence for guideline recommendations in this patient population is lacking. In total 1,675 patients were included in a multicenter registry of eight European centers. In the present cohort, we included 18 patients suffering from congenital and inherited heart disease. Nine patients (50%) were male with a mean age of 41.3 ± 16.4 years. Four patients suffered from hypertrophic cardiomyopathy (HCM), four patients suffered from non-compaction cardiomyopathy (NCCM), two patients were diagnosed with arrhythmogenic right ventricular cardiomyopathy (ARVC) and one patient suffered from muscular dystrophy of the limb-girdle type with cardiac involvement, secondary cardiomyopathy. Three patients presented with Brugada syndrome (BrS). One patient suffered from long-QT syndrome type 1 (LQTS1). Furthermore, two patients had congenital heart defects and one patient suffered from cardiac sarcoidosis (CS). There were no appropriate/inappropriate shocks with the WCD in this cohort. One patient had recurrent self-limiting sustained ventricular tachycardia during the wear time, but actively inhibited a shock and was hospitalized. The compliance rate in this cohort was 77.8% with a mean wear time of 45.3 ± 26.9 days with a mean follow-up time of 570 ± 734 days. 55.6% (10/18) of the patients received an ICD after WCD wear time. This retrospective study of patients with inherited and congenital heart disease shows that WCD use is not beneficial in the majority of patients with inherited and congenital heart disease.

Cranial Remolding Orthosis Study on the Use of a Temperature Sensor to Measure Wear Time

ABSTRACT Introduction The effectiveness of cranial remolding orthoses (CROs) in treating nonsynostotic deformational plagiocephaly (DP) is anecdotally related to adherence. Efficacy of CROs has been evaluated but lacks evidence regarding necessary wear time to achieve a positive outcome. A 23 hr/d wear schedule is generally prescribed regardless of presentation. The study compares daily wear time to treatment outcomes. Materials and Methods Subjects Infants aged 3–18 months diagnosed with DP were included with initial cranial vault asymmetry (CVA) &gt; 6 mm or cephalic ratio (CR) &gt; 0.90. Subjects were treated with an Orthomerica STARband CRO. A total of 106 subjects enrolled, with 69 completed. Apparatus A questionnaire assessed caregiver’s reported adherence with the CRO. Maximum Integrated’s iButton temperature loggers (iButtons) recorded objective wear time. Procedures 3D head shape measurements via Orthomerica STARScanner, caregivers’ questionnaires, and iButton data were collected every 5–8 weeks. Data Analysis Descriptive statistics were obtained, and data reported as mean ± SD or median [25th, 75th percentiles]. Nonparametric sign tests were used to assess differences from CRO fabrication scan to subsequent follow-ups. Spearman rank correlations and corresponding 95% confidence intervals and P values between average wear time and change of measurements were obtained. Results Self-reported wear time was 22 (22, 23) hrs/d. Measured wear time was 17–18 (12, 20) hrs/d. Longer average wear time was significantly associated with larger reductions in CVA (P = 0.0054), CR (P = 0.0080), and CVAI (P = 0.0059). Conclusions Results showed longer average daily wear increased effectiveness in CRO treatment of plagiocephaly. Increased sample sizing is required to determine if generalizable to brachycephalic and asymmetrical brachycephalic head shapes. Clinical Relevance A CRO wear schedule of 23 hrs a day is currently recommended, but difficult for families to adhere. The impact of the study may indicate a more realistic wear schedule that would improve adherence while achieving optimal outcomes.

Therapeutic Insulin Analogue Concentrations at Infusion Sites Enhanced the Pro-Inflammatory Response and Apoptosis in an In Vitro Macrophage-Material Interaction Model.

Continuous subcutaneous insulin infusion for Type 1 diabetes relies upon insulin infusion sets (IIS) to reliably deliver insulin to a subcutaneous depot, where it is absorbed into systemic circulation. However, IIS are plagued by short wear times and high failure rates, due in part to inconsistent insulin absorption that can arise over time. While emerging evidence suggests that the local inflammatory response to the IIS cannula may impact both wear times and unreliable insulin adsorption, the mechanisms are poorly understood. Here, we investigated the effects of local infused insulin concentrations on the biomaterial host response to better understand the underlying factors that limit the IIS performance. We first modeled the insulin concentration for a constant basal infusion rate to select a relevant insulin concentration range of 0.1-10 U/mL within the infusion site. We then examined the influence of a commercial insulin analogue (Humulin-N) using an in vitro macrophage-material model, which uses adsorbed fibroblast lysate (containing damage-associated molecular patterns) to activate macrophages and recapitulates macrophage responses on implanted biomaterials. RAW-Blue macrophages cultured on lysate-adsorbed surfaces had increased nuclear factor-κB (NF-κB) and activating protein 1 (AP-1) activity and intracellular reactive oxygen species (ROS) accumulation compared to control surfaces. Humulin-N concentration (0.5-10 U/mL) enhanced the NF-κB/AP-1 activity and ROS accumulation in macrophages on lysate-adsorbed surfaces. However, Humulin-N had no effect on NF-κB/AP-1 or ROS in the absence of the inflammatory stimulus. Additionally, high insulin concentrations arising from therapeutic doses induced macrophage apoptosis with and without adsorbed lysate. This study contributes to emerging evidence that infused insulin affects the tissue response to IIS.