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Background/AimsThis study assessed the feasibility of a novel contact lens device for intraocular pressure (IOP) and ocular pulse amplitude (OPA) continuous measurements over 24 hours.MethodsThis prospective, open-label, single-centre, non-randomised study included glaucoma and healthy subjects. IOP and OPA values acquired by the pressure-measuring contact lens (PMCL) device in one patient’s eye at the beginning of the measurement were compared with tonometry values (Goldman applanation tonometry (GAT) and dynamic contour tonometry (DCT)) in the same eye just before PMCL placement. Furthermore, IOP and OPA values measured with PMCL on the study eye during a water drinking test (WDT) were compared with DCT values in the fellow eye. Comparisons were performed using t-tests with 95% Confidence Intervals.ResultsTwenty-four-hour IOP and OPA curves were obtained for eight subjects. The mean IOP difference between PMCL and tonometry on the same eye was within ±5 mm Hg in 75% (GAT) and 87.5% (DCT) of subjects. IOP variations due to WDT were detected by PMCL and DCT, showing an average increase of 2.43 and 1.85 mm Hg, respectively. Differences between PMCL and DCT for IOP variations in fellow eyes were within ±5 mm Hg for 97.2% of time points. The difference between OPA in fellow eyes was within ±5 mm Hg for 85.5% of the time points.ConclusionsThis first-in-human study is a proof-of-concept for 24-hour continuous measurements of IOP and OPA with the PMCL. This device is non-invasive and has good comparability with standard tonometry.

Background Laparoscopic skills training has evolved over recent years. However, conveying a mentor’s directions using conventional methods, without realistic on-screen visual cues, can be difficult and confusing. To facilitate laparoscopic skill transference, an augmented reality telementoring (ART) platform was designed to overlay the instruments of a mentor onto the trainee’s laparoscopic monitor. The aim of this study was to compare the effectiveness of this new teaching modality to traditional methods in novices performing an intracorporeal suturing task. Methods Nineteen pre-medical and medical students were randomized into traditional mentoring ( n  = 9) and ART ( n  = 10) groups for a laparoscopic suturing and knot-tying task. Subjects received either traditional mentoring or ART for 1 h on the validated fundamentals of laparoscopic surgery intracorporeal suturing task. Tasks for suturing were recorded and scored for time and errors. Results were analyzed using means, standard deviation, power regression analysis, correlation coefficient, analysis of variance, and student’s t test. Results Using Wright’s cumulative average model ( Y  =  aX b ) the learning curve slope was significantly steeper, demonstrating faster skill acquisition, for the ART group ( b  = −0.567, r 2  = 0.92) than the control group ( b  = −0.453, r 2  = 0.74). At the end of 10 repetitions or 1 h of practice, the ART group was faster versus traditional (mean 167.4 vs. 242.4 s, p  = 0.014). The ART group also had fewer fails (8) than the traditional group (13). Conclusion The ART Platform may be a more effective training technique in teaching laparoscopic skills to novices compared to traditional methods. ART conferred a shorter learning curve, which was more pronounced in the first 4 trials. ART reduced the number of failed attempts and resulted in faster suture times by the end of the training session. ART may be a more effective training tool in laparoscopic surgical training for complex tasks than traditional methods.

IntroductionCardiac rehabilitation (CR) improves the outcomes of patients with chronic heart disease. However, participation in hospital-based programs is limited, partly because of accessibility issues. Notably, most CRs are performed unsupervised at home, making it challenging for healthcare providers and patients to monitor progress accurately or provide tailored feedback. Wearable devices are increasingly used to track physical activity; however, many require smartphone operations, which can be difficult for older adults. The purpose of this study is to evaluate whether a simple telemetry system for activity tracking and feedback could improve exercise tolerance in outpatients with chronic heart disease undergoing unsupervised CR at home.Methods and analysisThis open-label, multicentre, randomised controlled trial will include 140 patients with cardiovascular diseases aged ≥20 years with percent of peak oxygen uptake (%peak VO2) <80%. Eligible patients will undergo a 2–4-week observation period followed by cardiopulmonary exercise testing. Participants with <3% peak VO2 change over 6 months will be randomised in a 1:1 ratio to either the intervention (device) or control (no device) group. The intervention group will use a wearable device to track daily activities and receive exercise guidance based on these data every 4 weeks. The control group will not use the device or receive feedback. The primary outcome is the 12-week change in peak VO2 from baseline between the groups.Ethics and disseminationThis study was designed in accordance with the principles of the Declaration of Helsinki. Gifu University Graduate School of Medicine Ethics Committee approved this study (approval number: 2022–081), and all participants will sign an informed consent form.Trial registrationThis study has been registered at the Japan Registry of Clinical Trials (jRCT; registration number, 1042220058; URL, https://jrct.mhlw.go.jp/en-latest-detail/jRCT1042220058; date of registration, 26 August 2022).

For total knee replacement (TKR) patients, rehabilitation after the surgery is key toregaining mobility. This study proposes a sensor-based system for effectively monitoringrehabilitation progress after TKR. The system comprises a hardware module consisting of thetriaxial accelerometer and gyroscope, a microcontroller, and a Bluetooth module, and a softwareapp for monitoring the motion of the knee joint. Three indices, namely the number of swings, themaximum knee flexion angle, and the duration of practice each time, were used as metrics tomeasure the knee rehabilitation progress. The proposed sensor device has advantages such asusability without spatiotemporal constraints and accuracy in monitoring the rehabilitation progress.The performance of the proposed system was compared with the measured range of motion of theCybex isokinetic dynamometer (or Cybex) professional rehabilitation equipment, and the resultsrevealed that the average absolute errors of the measured angles were between 1.65° and 3.27° forthe TKR subjects, depending on the swing speed. Experimental results verified that the proposedsystem is effective and comparable with the professional equipment.

Purpose Telemonitoring might enhance continuous positive airway pressure (CPAP) adherence and save nursing time at the commencement of CPAP therapy. We tested wireless telemonitoring (ResTraxx Online System®, ResMed) during the habituation phase of the CPAP therapy in obstructive sleep apnea syndrome (OSAS). Methods In total, 111 consecutive OSAS patients were enrolled. After CPAP titration, patients were followed with the telemonitoring (TM, N  = 50) or the usual care (UC, N  = 61). The TM group used fixed pressure CPAP device with and the UC group similar device without wireless telemonitoring. Patients and study nurses were unblinded. The evaluated end-points were hours of CPAP use >4 h/day, mask leak <0.4 L/s, and AHI <5/h. Nursing time including extra phone calls, visits, and telemonitoring time was recorded during the habituation phase. CPAP adherence was controlled in the beginning and at the end of the habituation phase and after 1-year of use. Results TM and UC groups did not differ in terms of patient characteristics. The average length of the habituation phase was 4 weeks in the TM group and fixed 3 months in the UC group. Median nursing time was 39 min (range 12–132 min) in the TM group and shorter compared to that of 58 min (range 40–180 min) ( p  < 0.001) per patient in the UC group. Both treatment groups had high CPAP usage hours (>4 h/day) and the change in usage at the end of the habituation phase did not differ between the groups ( p  = 0.39). Patients in both groups were equally satisfied with the treatment protocol. CPAP adherence (6.4 h in TM vs. 6.1 h in UC group, p  = 0.63) and residual AHI (1.3 in TM vs. 3.2 in UC group, p  = 0.04) were good in both groups at 1-year follow-up. Conclusions Wireless telemonitoring of CPAP treatment could be relevant in closing the gap between the increasing demand and available health-care resources. It may save nursing time without compromising short- or long-term effectiveness of CPAP treatment in OSAS.

Background Cardiac rehabilitation has beneficial effects on morbidity and mortality in patients with coronary artery disease, but is vastly underutilised and short-term improvements are often not sustained. Telerehabilitation has the potential to overcome these barriers, but its superiority has not been convincingly demonstrated yet. This may be due to insufficient focus on behavioural change and development of patients’ self-management skills. Moreover, potentially beneficial communication methods, such as internet and video consultation, are rarely used. We hypothesise that, when compared to centre-based cardiac rehabilitation, cardiac telerehabilitation using evidence-based behavioural change strategies, modern communication methods and on-demand coaching will result in improved self-management skills and sustainable behavioural change, which translates to higher physical activity levels in a cost-effective way. Methods This randomised controlled trial compares cardiac telerehabilitation with centre-based cardiac rehabilitation in patients with coronary artery disease. We randomise 300 patients entering cardiac rehabilitation to centre-based cardiac rehabilitation (control group) or cardiac telerehabilitation (intervention group). The core component of the intervention is a patient-centred web application, which enables patients to adjust rehabilitation goals, inspect training and physical activity data, share data with other caregivers and to use video consultation. After six supervised training sessions, the intervention group continues exercise training at home, wearing an accelerometer and heart rate monitor. In addition, physical activity levels are assessed by the accelerometer for four days per week. Patients upload training and physical activity data weekly and receive feedback through video consultation once a week. After completion of the rehabilitation programme, on-demand coaching is performed when training adherence or physical activity levels decline with 50% or more. The primary outcome measure is physical activity level, assessed at baseline, three months and twelve months, and is calculated from accelerometer and heart rate data. Secondary outcome measures include physical fitness, quality of life, anxiety and depression, patient empowerment, patient satisfaction and cost-effectiveness. Discussion This study is one of the first studies evaluating effects and costs of a cardiac telerehabilitation intervention comprising a combination of modern technology and evidence-based behavioural change strategies including relapse prevention. We hypothesise that this intervention has superior effects on exercise behaviour without exceeding the costs of a traditional centre-based intervention. Trial registration Netherlands Trial Register NTR5156 . Registered 22 April 2015.

ObjectivesTo identify perspective of patients with osteoarthritis, in particular design requirements and mode of use, of wearable technology to support the rehabilitation pathway. This study is part of a user-centred design approach adopted to develop a rehabilitation tool for patients with osteoarthritis.DesignQualitative study using a focus group approach; data management via a thematic analysis of patients’ responses.Participants21 patients with osteoarthritis (age range 45–65 years) participated in 1 of the 4 focus groups. Recruitment continued until data saturation.SettingThe study was conducted in a university setting.ResultsMain determinants of user acceptance of a wearable technology were appearance and comfort during use. Patients were supportive of the use of wearable technologies during rehabilitation and could recognise their benefit as monitors for their progress, incentives to adhere to exercise, and tools for more informed interaction with clinicians.ConclusionsThis paper should encourage adoption and development of wearable technology to support rehabilitation of patients with osteoarthritis. It is pivotal that technological development takes into account patients’ views in that it should be small, light, discrete, not ‘appear medical’ or challenge the identity of the user. Derived data should be available to patients and clinicians. Furthermore, wearable technologies should be developed to operate in two modes: for exercise guidance and assessment only, and for unobtrusive everyday monitoring. The information obtained from this study should guide the design of new technologies and support their use in clinical practice.

Background In heart failure (HF) patients with implantable cardioverter defibrillators (ICD) or cardiac resynchronisation therapy defibrillators (CRT-D), remote monitoring has been shown to result in at least non-inferior outcomes relative to in-clinic visits. We aimed to provide further evidence for this effect, and to assess whether adding telephone follow-ups to remote follow-ups influenced outcomes. Methods InContact was a prospective, randomised, multicentre study. Subjects receiving quarterly automated follow-up only (telemetry group) were compared to those receiving personal physician contact. Personal contact patients were further divided into those receiving automated follow-up plus a telephone call (remote+phone subgroup) or in-clinic visits only. Results Two hundred and ten patients underwent randomisation (telemetry n  = 102; personal contact n  = 108 [remote+phone: n  = 53; visit: n  = 55]). Baseline characteristics were comparable between groups and subgroups. Over 12 months, 34.8% of patients experienced deterioration of their Packer Clinical Composite Response, with no significant difference between the telemetry group and personal care ( p  > 0.999), remote+phone ( p  = 0.937) or visit ( p  = 0.940) patients; predefined non-inferiority criteria were met. Mortality rates (5.2% overall) were comparable between groups and subgroups ( p  = 0.832/ p  = 0.645), as were HF-hospitalisation rates (11.0% overall; p  = 0.605/ p  = 0.851). The proportion of patients requiring ≥1 unscheduled follow-up was nominally higher in telemetry and remote+phone groups (42.2 and 45.3%) compared to the visit group (29.1%). Overall, ≥ 1 ICD therapy was delivered to 15.2% of patients. Conclusion In HF patients with ICDs/CRT-Ds, quarterly remote follow-up only over 12 months was non-inferior to regular personal contact. Addition of quarterly telephone follow-ups to remote monitoring does not appear to offer any clinical advantage. Trial registration clinicaltrials.gov: NCT01200381 (retrospectively registered on September 13th 2010).

Background In Denmark and other countries, there has been a shift in the management of patients with an implantable cardioverter defibrillator (ICD) with remote device monitoring largely replacing in-hospital visits. Less patient-nurse and patient-physician interaction may lead to gaps in patients’ quality of care and impede patients’ adaptation to living successfully with the ICD. A comprehensive eHealth intervention that include goal-setting, monitoring of symptoms of depression, anxiety, and quality of life, psychological treatment, information provision, supportive tools, online dialogues with nursing staff and access to an online community network, may help fill these gaps and be particularly beneficial to patients who suffer from anxiety and depression. This study will evaluate the effectiveness of the ACQUIRE-ICD care innovation, a comprehensive and interactive eHealth intervention, on patient-reported and clinical outcomes. Methods The ACQUIRE-ICD study is a multicenter, prospective, two-arm, unblinded randomised controlled superiority trial that will enroll 478 patients implanted with a first-time ICD or ICD with cardiac synchronisation therapy (CRT-D) from the six implanting centers in Denmark. The trial will evaluate the clinical effectiveness and cost-effectiveness of the ACQUIRE-ICD care innovation, as add-on to usual care compared with usual care alone. The primary endpoint, device acceptance, assessed with the Florida Patient Acceptance Survey, is evaluated at 12 months’ post implant. Secondary endpoints, evaluated at 12 and 24 months’ post implant, include patient-reported outcomes, return to work, time to first ICD therapy and first hospitalisation, mortality and cost-effectiveness. Discussion The effectiveness of a comprehensive and interactive eHealth intervention that relies on patient-centred and personalised tools offered via a web-based platform targeted to patients with an ICD has not been assessed so far. The ACQUIRE-ICD care innovation promotes and facilitates that patients become active participants in the management of their disease, and as such addresses the need for a more patient-centered disease-management approach. If the care innovation proves to be beneficial to patients, it may not only increase patient empowerment and quality of life but also free up time for clinicians to care for more patients. Trial registration The trial has been registered on https://clinicaltrials.gov/ct2/show/NCT02976961 on November 30, 2016 with registration number [ NCT02976961 ].

Telemetric core-temperature monitoring is becoming more widely used as a noninvasive means of monitoring core temperature during athletic events. To determine the effects of sensor ingestion timing on serial measures of core temperature during continuous exercise. Crossover study. Outdoor dirt track at an average ambient temperature of 4.4°C ± 4.1°C and relative humidity of 74.1% ± 11.0%. Seven healthy, active participants (3 men, 4 women; age  =  27.0 ± 7.5 years, height  =  172.9 ± 6.8 cm, body mass  =  67.5 ± 6.1 kg, percentage body fat  =  12.7% ± 6.9%, peak oxygen uptake [Vo(2peak)]  =  54.4 ± 6.9 mL•kg⁻¹•min⁻¹) completed the study. Participants completed a 45-minute exercise trial at approximately 70% Vo(2peak). They consumed core-temperature sensors at 24 hours (P1) and 40 minutes (P2) before exercise. Core temperature was recorded continuously (1-minute intervals) using a wireless data logger worn by the participants. All data were analyzed using a 2-way repeated-measures analysis of variance (trial × time), Pearson product moment correlation, and Bland-Altman plot. Fifteen comparisons were made between P1 and P2. The main effect of time indicated an increase in core temperature compared with the initial temperature. However, we did not find a main effect for trial or a trial × time interaction, indicating no differences in core temperature between the sensors (P1  =  38.3°C ± 0.2°C, P2  =  38.3°C ± 0.4°C). We found no differences in the temperature recordings between the 2 sensors. These results suggest that assumed sensor location (upper or lower gastrointestinal tract) does not appreciably alter the transmission of reliable and repeatable measures of core temperature during continuous running in the cold.