Implementing Wearable Sensors for Clinical Application at a Surgical Ward: Points to Consider before Starting.

Incorporating technology into healthcare processes is necessary to ensure the availability of high-quality care in the future. Wearable sensors are an example of such technology that could decrease workload, enable early detection of patient deterioration, and support clinical decision making by healthcare professionals. These sensors unlock continuous monitoring of vital signs, such as heart rate, respiration rate, blood oxygen saturation, temperature, and physical activity. However, broad and successful application of wearable sensors on the surgical ward is currently lacking. This may be related to the complexity, especially when it comes to replacing manual measurements by healthcare professionals. This report provides practical guidance to support peers before starting with the clinical application of wearable sensors in the surgical ward. For this purpose, the Non-Adoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework of technology adoption and innovations in healthcare organizations is used, combining existing literature and our own experience in this field over the past years. Specifically, the relevant topics are discussed per domain, and key lessons are subsequently summarized.

Determining the Reliable Measurement Period for Preoperative Baseline Values With Telemonitoring Before Major Abdominal Surgery: Pilot Cohort Study.

BACKGROUND: Preoperative telemonitoring of vital signs, physical activity, and well-being might be able to optimize prehabilitation of the patient's physical and mental condition prior to surgery, support setting alarms during in-hospital monitoring, and allow personalization of the postoperative recovery process. OBJECTIVE: The primary aim of this study was to evaluate when and how long patients awaiting major abdominal surgery should be monitored to get reliable preoperative individual baseline values of heart rate (HR), daily step count, and patient-reported outcome measures (PROMs). The secondary aim was to describe the perioperative course of these measurements at home. METHODS: In this observational single-center cohort study, patients used a wearable sensor during waking hours and reported PROMs (pain, anxiety, fatigue, nausea) on a tablet twice a day. Intraclass correlation coefficients (ICCs) were used to evaluate the reliability of mean values on 2 specific preoperative days (the first day of telemonitoring and the day before hospital admission) and randomly selected preoperative periods compared to individual reference values. Mean values of HR, step count, and PROMs per day were visualized in a boxplot from 14 days before hospital admission until 30 days after surgery. RESULTS: A total of 16 patients were included in the data analyses. The ICCs of mean values on the first day of telemonitoring were 0.91 for HR, 0.71 for steps, and at least 0.86 for PROMs. The day before hospital admission showed reliability coefficients of 0.76 for HR, 0.71 for steps, and 0.92-0.99 for PROMs. ICC values of randomly selected measurement periods increased over the continuous period of time from 0.68 to 0.99 for HR and daily step counts. A lower bound of the 95% CI of at least 0.75 was determined after 3 days of measurements. The ICCs of randomly selected PROM measurements were 0.89-0.94. Visualization of mean values per day mainly showed variable preoperative daily step counts (median 2409, IQR 1735-4661 steps/day) and lower postoperative daily step counts (median 884, IQR 474-1605 steps/day). In addition, pain was visually reduced until 30 days after surgery at home. CONCLUSIONS: In this prospective pilot study, for patients awaiting major abdominal surgery, baseline values for HR and daily step count could be measured reliably by a wearable sensor worn for at least 3 consecutive days and PROMs during any preoperative day. No clear conclusions were drawn from the description of the perioperative course by showing mean values of HR, daily step count, and PROM values over time in the home situation.

Feasibility and patient's experiences of perioperative telemonitoring in major abdominal surgery: an observational pilot study.

BACKGROUND: Telemonitoring during the perioperative trajectory may improve patient outcomes and self-management. The aim of this study is to assess the feasibility of and patient's experiences with telemonitoring before and after major abdominal surgery to inform future study design. METHODS: Patients planned for elective major abdominal surgery wore a sensor and answered well-being questions on a tablet daily for at least 2 weeks preoperatively up to 30-days postoperatively. Feasibility was assessed by participation and completion rate, compliance per day, weekly satisfaction scores, and reasons for nonscheduled contact. RESULTS: Twenty-three patients were included (participation rate of 54.5%) with a completion rate of 69.6%. Median compliance with the wearable sensor and well-being questions was respectively: 94.7% and 83.3% preoperatively at home; 100% and 66.7% postoperatively in-hospital; and 95.4% and 85.8% postoperatively at home. Median weekly satisfaction scores for both wearing the sensor and well-being questions were 5 (IQR, 4-5). Contact moments were related to absence of sensor data and technological issues (76.0%) or patient discomfort and insecurity (24.0%). CONCLUSIONS: In this study, telemonitoring showed high satisfaction and compliance during the perioperative trajectory. Future trial design regarding the effectiveness of telemonitoring requires embedding in clinical practice and support for patients, relatives, and healthcare personnel.

Continuous Monitoring of Vital Signs With Wearable Sensors During Daily Life Activities: Validation Study.

BACKGROUND: Continuous telemonitoring of vital signs in a clinical or home setting may lead to improved knowledge of patients' baseline vital signs and earlier detection of patient deterioration, and it may also facilitate the migration of care toward home. Little is known about the performance of available wearable sensors, especially during daily life activities, although accurate technology is critical for clinical decision-making. OBJECTIVE: The aim of this study is to assess the data availability, accuracy, and concurrent validity of vital sign data measured with wearable sensors in volunteers during various daily life activities in a simulated free-living environment. METHODS: Volunteers were equipped with 4 wearable sensors (Everion placed on the left and right arms, VitalPatch, and Fitbit Charge 3) and 2 reference devices (Oxycon Mobile and iButton) to obtain continuous measurements of heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), and temperature. Participants performed standardized activities, including resting, walking, metronome breathing, chores, stationary cycling, and recovery afterward. Data availability was measured as the percentage of missing data. Accuracy was evaluated by the median absolute percentage error (MAPE) and concurrent validity using the Bland-Altman plot with mean difference and 95% limits of agreement (LoA). RESULTS: A total of 20 volunteers (median age 64 years, range 20-74 years) were included. Data availability was high for all vital signs measured by VitalPatch and for HR and temperature measured by Everion. Data availability for HR was the lowest for Fitbit (4807/13,680, 35.14% missing data points). For SpO2 measured by Everion, median percentages of missing data of up to 100% were noted. The overall accuracy of HR was high for all wearable sensors, except during walking. For RR, an overall MAPE of 8.6% was noted for VitalPatch and that of 18.9% for Everion, with a higher MAPE noted during physical activity (up to 27.1%) for both sensors. The accuracy of temperature was high for VitalPatch (MAPE up to 1.7%), and it decreased for Everion (MAPE from 6.3% to 9%). Bland-Altman analyses showed small mean differences of VitalPatch for HR (0.1 beats/min [bpm]), RR (-0.1 breaths/min), and temperature (0.5 °C). Everion and Fitbit underestimated HR up to 5.3 (LoA of -39.0 to 28.3) bpm and 11.4 (LoA of -53.8 to 30.9) bpm, respectively. Everion had a small mean difference with large LoA (-10.8 to 10.4 breaths/min) for RR, underestimated SpO2 (>1%), and overestimated temperature up to 2.9 °C. CONCLUSIONS: Data availability, accuracy, and concurrent validity of the studied wearable sensors varied and differed according to activity. In this study, the accuracy of all sensors decreased with physical activity. Of the tested sensors, VitalPatch was found to be the most accurate and valid for vital signs monitoring.

Continuous monitoring of vital signs with the Everion biosensor on the surgical ward: a clinical validation study.

BACKGROUND: Wearable sensors enable continuous vital sign monitoring, although information about their performance on nursing wards is scarce. Vital signs measured by telemonitoring and nurse measurements on a surgical ward were compared to assess validity and reliability. METHODS: In a prospective observational study, surgical patients wore a wearable sensor (Everion, Biovotion AG, Zürich, Switzerland) that continuously measured heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), and temperature during their admittance on the ward. Validity was evaluated using repeated-measures correlation and reliability using Bland-Altman plots, mean difference, and 95% limits of agreement (LoA). RESULTS: Validity analyses of 19 patients (median age, 68; interquartile range, 62.5-72.5 years) showed a moderate relationship between telemonitoring and nurse measurements for HR (r = 0.53; 95% confidence interval, 0.44-0.61) and a poor relationship for RR, SpO2, and temperature. Reliability analyses showed that Everion measured HR close to nurse measurements (mean difference, 1 bpm; LoA, -16.7 to 18.7 bpm). Everion overestimated RR at higher values, whereas SpO2 and temperature were underestimated. CONCLUSIONS: A moderate relationship was determined between Everion and nurse measurements at a surgical ward in this study. Validity and reliability of telemonitoring should also be assessed with gold standard devices in future clinical trials.

Effectiveness of current perioperative telemonitoring on postoperative outcome in patients undergoing major abdominal surgery: A systematic review of controlled trials.

BACKGROUND: Perioperative telemonitoring of patients undergoing major surgery might lead to improved postoperative outcomes. The aim of this systematic review is to evaluate the effectiveness of current perioperative telemonitoring interventions on postoperative clinical, patient-reported, and financial outcome measures in patients undergoing major surgery. METHODS: For this systematic review, PubMed, CINAHL, and Embase databases were searched for eligible articles published between January 1, 2009 and March 15, 2021. Studies were eligible as they described: (P) patients aged 18 years or older who underwent major abdominal surgery, (I) perioperative telemonitoring as intervention, (C) a control group receiving usual care, (O) any type of postoperative clinical, patient-reported, or financial outcome measures, and (S) an interventional study design. RESULTS: The search identified 2958 articles of which 10 were eligible for analysis, describing nine controlled trials of 2438 patients. Perioperative telemonitoring comprised wearable biosensors (n = 3), websites (n = 3), e-mail (n = 1), and mobile applications (n = 2). Outcome measures were clinical (n = 8), patient-reported (n = 5), and financial (n = 2). Results show significant improvement of recovery time, stoma self-efficacy and pain in the early postoperative phase in patients receiving telemonitoring. Other outcome measures were not significantly different between the groups. CONCLUSION: Evidence for the effectiveness of perioperative telemonitoring in major surgery is scarce. There is a need for good quality studies with sufficient patients while ensuring that the quality and usability of the technology and the adoption in care processes are optimal.

A prospective cohort study evaluating screening and assessment of six modifiable risk factors in HPB cancer patients and compliance to recommended prehabilitation interventions.

INTRODUCTION: Despite improvements in perioperative care, major abdominal surgery continues to be associated with significant perioperative morbidity. Accurate preoperative risk stratification and optimisation (prehabilitation) are necessary to reduce perioperative morbidity. This study evaluated the screening and assessment of modifiable risk factors amendable for prehabilitation interventions and measured the patient compliance rate with recommended interventions. METHOD: Between May 2019 and January 2020, patients referred to our hospital for HPB surgery were screened and assessed on six modifiable preoperative risk factors. The risk factors and screening tools used, with cutoff values, included (i) low physical fitness (a 6-min walk test < 82% of patient's calculated norm and/or patient's activity level not meeting the global recommendations on physical activity for health). Patients who were unfit based on the screening were assessed with a cardiopulmonary exercise test (anaerobic threshold ≤ 11 mL/kg/min); (ii) malnutrition (patient-generated subjective global assessment ≥ 4); (iii) iron-deficiency anaemia (haemoglobin < 12 g/dL for women, < 13 g/dL for men and transferrin saturation ≤ 20%); (iv) frailty (Groningen frailty indicator/Robinson frailty score ≥ 4); (v) substance use (smoking and alcohol use of > 5 units per week) and (vi) low psychological resilience (Hospital Anxiety and Depression Scale ≥ 8). Patients had a consultation with the surgeon on the same day as their screening. High-risk patients were referred for necessary interventions. RESULTS: One hundred consecutive patients were screened at our prehabilitation outpatient clinic. The prevalence of high-risk patients per risk factor was 64% for low physical fitness, 42% for malnutrition, 32% for anaemia (in 47% due to iron deficiency), 22% for frailty, 12% for smoking, 18% for alcohol use and 21% for low psychological resilience. Of the 77 patients who were eventually scheduled for surgery, 53 (68.8%) needed at least one intervention, of whom 28 (52.8%) complied with 100% of the necessary interventions. The median (IQR) number of interventions needed in the 77 patients was 1.0 (0-2). CONCLUSION: It is feasible to screen and assess all patients referred for HPB cancer surgery for six modifiable risk factors. Most of the patients had at least one risk factor that could be optimised. However, compliance with the suggested interventions remains challenging.

Feasibility of Perioperative eHealth Interventions for Older Surgical Patients: A Systematic Review.

OBJECTIVES: EHealth interventions are increasingly being applied in perioperative care but have not been adequately studied for older surgical patients who could potentially benefit from them. Therefore, we evaluated the feasibility of perioperative eHealth interventions for this population. DESIGN: A systematic review of prospective observational and interventional studies was conducted. Three electronic databases (PubMed, EMBASE, CINAHL) were searched between January 1999 and July 2019. Study quality was assessed by Methodological Index for Non-Randomized Studies (MINORS) with and without control group. SETTING AND PARTICIPANTS: Studies of surgical patients with an average age ≥65 years undergoing any perioperative eHealth intervention with active patient participation (with the exception of telerehabilitation following orthopedic surgery) were included. MEASURES: The main outcome measure was feasibility, defined as a patient's perceptions of usability, satisfaction, and/or acceptability of the intervention. Other outcomes included compliance and study completion rate. RESULTS: Screening of 1569 titles and abstracts yielded 7 single-center prospective studies with 223 patients (range n = 9-69 per study, average age 66-74 years) undergoing oncological, cardiovascular, or orthopedic surgery. The median MINORS scores were 13.5 of 16 for 6 studies without control group, and 14 of 24 for 1 study with a control group. Telemonitoring interventions were rated as "easy to use" by 89% to 95% of participants in 3 studies. Patients in 3 studies were satisfied with the eHealth intervention and would recommend it to others. Acceptability (derived from consent rate) ranged from 71% to 89%, compliance from 53% to 86%, and completion of study follow-up from 54% to 95%. CONCLUSIONS AND IMPLICATIONS: Results of 7 studies involving perioperative eHealth interventions suggest their feasibility and encourage further development of technologies for older surgical patients. Future feasibility studies require clear definitions of appropriate feasibility outcome measures and a comprehensive description of patient characteristics such as functional performance, level of education, and socioeconomic status.

Predicting outcome in patients with moderate to severe traumatic brain injury using electroencephalography.

BACKGROUND: Better outcome prediction could assist in reliable quantification and classification of traumatic brain injury (TBI) severity to support clinical decision-making. We developed a multifactorial model combining quantitative electroencephalography (qEEG) measurements and clinically relevant parameters as proof of concept for outcome prediction of patients with moderate to severe TBI. METHODS: Continuous EEG measurements were performed during the first 7 days of ICU admission. Patient outcome at 12 months was dichotomized based on the Extended Glasgow Outcome Score (GOSE) as poor (GOSE 1-2) or good (GOSE 3-8). Twenty-three qEEG features were extracted. Prediction models were created using a Random Forest classifier based on qEEG features, age, and mean arterial blood pressure (MAP) at 24, 48, 72, and 96 h after TBI and combinations of two time intervals. After optimization of the models, we added parameters from the International Mission for Prognosis And Clinical Trial Design (IMPACT) predictor, existing of clinical, CT, and laboratory parameters at admission. Furthermore, we compared our best models to the online IMPACT predictor. RESULTS: Fifty-seven patients with moderate to severe TBI were included and divided into a training set (n = 38) and a validation set (n = 19). Our best model included eight qEEG parameters and MAP at 72 and 96 h after TBI, age, and nine other IMPACT parameters. This model had high predictive ability for poor outcome on both the training set using leave-one-out (area under the receiver operating characteristic curve (AUC) = 0.94, specificity 100%, sensitivity 75%) and validation set (AUC = 0.81, specificity 75%, sensitivity 100%). The IMPACT predictor independently predicted both groups with an AUC of 0.74 (specificity 81%, sensitivity 65%) and 0.84 (sensitivity 88%, specificity 73%), respectively. CONCLUSIONS: Our study shows the potential of multifactorial Random Forest models using qEEG parameters to predict outcome in patients with moderate to severe TBI.

Telemedicine in patients with peripheral arterial disease: is it worth the effort?

Introduction: For patients with peripheral arterial disease (PAD), the various components of telemedicine, such as telemonitoring, telecoaching, and teleconsultation, could be valuable in daily management. The objective of this review was to give an overview of the current use of telemedicine interventions in PAD. Areas covered: A literature search was performed for studies that evaluated patients with PAD of the aorto-pedal trajectory, who were monitored by telemedicine and acted upon accordingly. The primary outcome was health-related outcomes. The studies that were found focused mainly on wearable activity monitoring and telecoaching in PAD (n = 4) or wound monitoring after vascular surgery (n = 2). Main results indicate that telemedicine interventions are able to detect (post-operative) complications early, improve functional capacity and claudication onset time, and improve PAD patients' quality of life. Expert opinion: The use of telemedicine in PAD patients is still an under-explored area. Studies investigating the use of telemedicine in PAD are very limited and show varying results. Owing to its high potential in improving physical ability, lifestyle coaching, and timely detection of deterioration, future research should focus on proper implementation of telemedicine in PAD patients, including clinical and feasibility outcomes, effect on workload of nurses, and cost-efficiency.