Current Evidence for Continuous Vital Signs Monitoring by Wearable Wireless Devices in Hospitalized Adults: Systematic Review.

BACKGROUND: Continuous monitoring of vital signs by using wearable wireless devices may allow for timely detection of clinical deterioration in patients in general wards in comparison to detection by standard intermittent vital signs measurements. A large number of studies on many different wearable devices have been reported in recent years, but a systematic review is not yet available to date. OBJECTIVE: The aim of this study was to provide a systematic review for health care professionals regarding the current evidence about the validation, feasibility, clinical outcomes, and costs of wearable wireless devices for continuous monitoring of vital signs. METHODS: A systematic and comprehensive search was performed using PubMed/MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials from January 2009 to September 2019 for studies that evaluated wearable wireless devices for continuous monitoring of vital signs in adults. Outcomes were structured by validation, feasibility, clinical outcomes, and costs. Risk of bias was determined by using the Mixed Methods Appraisal Tool, quality assessment of diagnostic accuracy studies 2nd edition, or quality of health economic studies tool. RESULTS: In this review, 27 studies evaluating 13 different wearable wireless devices were included. These studies predominantly evaluated the validation or the feasibility outcomes of these devices. Only a few studies reported the clinical outcomes with these devices and they did not report a significantly better clinical outcome than the standard tools used for measuring vital signs. Cost outcomes were not reported in any study. The quality of the included studies was predominantly rated as low or moderate. CONCLUSIONS: Wearable wireless continuous monitoring devices are mostly still in the clinical validation and feasibility testing phases. To date, there are no high quality large well-controlled studies of wearable wireless devices available that show a significant clinical benefit or cost-effectiveness. Such studies are needed to help health care professionals and administrators in their decision making regarding implementation of these devices on a large scale in clinical practice or in-home monitoring.

Process Evaluation of a Wireless Wearable Continuous Vital Signs Monitoring Intervention in 2 General Hospital Wards: Mixed Methods Study.

BACKGROUND: Continuous monitoring of vital signs (CMVS) using wearable wireless sensors is increasingly available to patients in general wards and can improve outcomes and reduce nurse workload. To assess the potential impact of such systems, successful implementation is important. We developed a CMVS intervention and implementation strategy and evaluated its success in 2 general wards. OBJECTIVE: We aimed to assess and compare intervention fidelity in 2 wards (internal medicine and general surgery) of a large teaching hospital. METHODS: A mixed methods sequential explanatory design was used. After thorough training and preparation, CMVS was implemented-in parallel with the standard intermittent manual measurements-and executed for 6 months in each ward. Heart rate and respiratory rate were measured using a chest-worn wearable sensor, and vital sign trends were visualized on a digital platform. Trends were routinely assessed and reported each nursing shift without automated alarms. The primary outcome was intervention fidelity, defined as the proportion of written reports and related nurse activities in case of deviating trends comparing early (months 1-2), mid- (months 3-4), and late (months 5-6) implementation periods. Explanatory interviews with nurses were conducted. RESULTS: The implementation strategy was executed as planned. A total of 358 patients were included, resulting in 45,113 monitored hours during 6142 nurse shifts. In total, 10.3% (37/358) of the sensors were replaced prematurely because of technical failure. Mean intervention fidelity was 70.7% (SD 20.4%) and higher in the surgical ward (73.6%, SD 18.1% vs 64.1%, SD 23.7%; P<.001). Fidelity decreased over the implementation period in the internal medicine ward (76%, 57%, and 48% at early, mid-, and late implementation, respectively; P<.001) but not significantly in the surgical ward (76% at early implementation vs 74% at midimplementation [P=.56] vs 70.7% at late implementation [P=.07]). No nursing activities were needed based on vital sign trends for 68.7% (246/358) of the patients. In 174 reports of 31.3% (112/358) of the patients, observed deviating trends led to 101 additional bedside assessments of patients and 73 consultations by physicians. The main themes that emerged during interviews (n=21) included the relative priority of CMVS in nurse work, the importance of nursing assessment, the relatively limited perceived benefits for patient care, and experienced mediocre usability of the technology. CONCLUSIONS: We successfully implemented a system for CMVS at scale in 2 hospital wards, but our results show that intervention fidelity decreased over time, more in the internal medicine ward than in the surgical ward. This decrease appeared to depend on multiple ward-specific factors. Nurses' perceptions regarding the value and benefits of the intervention varied. Implications for optimal implementation of CMVS include engaging nurses early, seamless integration into electronic health records, and sophisticated decision support tools for vital sign trend interpretation.

Reoperation after colorectal surgery is an independent predictor of the 1-year mortality rate.

BACKGROUND: Comparative evaluation of surgical quality among hospitals must improve outcome and efficiency, and reduce medical costs. Reoperation after colorectal surgery is a consequence of surgical complications and therefore considered a quality-of-care indicator. With respect to the mortality rate, the 1-year mortality may be a more meaningful figure than in-hospital mortality, because it also reflects the impact of surgical complications beyond discharge. OBJECTIVE: The aim of our study was to evaluate the 1-year mortality after colorectal surgery and to identify predicting factors. DESIGN: This study was a retrospective analysis from our colorectal surgery database. PATIENTS: All patients who underwent elective colorectal surgery from 2005 to 2008 were included. MAIN OUTCOME MEASURES: Both univariate and multivariate analysis were performed to identify predicting factors. The following variables were analyzed: age, operative risk according to the ASA class, Charlson-Age Comorbidity Index, indication for and type of resection, primary anastomosis, tumor staging, anastomotic leakage, and reoperation. RESULTS: For 743 consecutive patients, the 1-year mortality rate was 6.9%. Patients were operated on mainly because of colorectal cancer (n = 537; 72%). The rate of reoperation and in-hospital mortality was 12.8% and 2.4%. Univariate survival analysis demonstrated that ASA class, age, Charlson-Age Comorbidity Index, reoperation, and stage of disease were independent predictors of 1-year mortality. Multivariate analysis showed that ASA class (P = .020; HR 1.69), age (P = .015; HR 2.08) and reoperation (P = .001; HR 2.72) are directly correlated with 1-year mortality. LIMITATIONS: Both patients with benign diseases and colorectal cancer are included. Furthermore, no clear guidelines on whether to perform a reoperation were available. CONCLUSION: One-year mortality after colorectal surgery is independently predicted by ASA class, age, and reoperation. Our results underline the value of the 1-year mortality rate and the reoperation rate as parameters for quality assessment in colorectal surgery.

Feasibility of continuous monitoring of vital signs in surgical patients on a general ward: an observational cohort study.

OBJECTIVE: To determine feasibility, in terms of acceptability and system fidelity, of continuous vital signs monitoring in abdominal surgery patients on a general ward. DESIGN: Observational cohort study. SETTING: Tertiary teaching hospital. PARTICIPANTS: Postoperative abdominal surgical patients (n=30) and nurses (n=23). INTERVENTIONS: Patients were continuously monitored with the SensiumVitals wearable device until discharge in addition to usual care, which is intermittent Modified Early Warning Score measurements. Heart rate, respiratory rate and axillary temperature were monitored every 2 min. Values and trends were visualised and alerts sent to the nurses. OUTCOMES: System fidelity was measured by analysis of the monitoring data. Acceptability by patients and nurses was assessed using questionnaires. RESULTS: Thirty patients were monitored for a median duration of 81 hours (IQR 47-143) per patient, resulting in 115 217 measurements per parameter. In total, 19% (n=21 311) of heart rate, 51% (n=59 184) of respiratory rate and 9% of temperature measurements showed artefacts (n=10 269). The system algorithm sent 972 alerts (median alert rate of 4.5 per patient per day), of which 90.3% (n=878) were system alerts and 9.7% (n=94) were vital sign alerts. 35% (n=33) of vital sign alerts were true positives. 93% (n=25) of patients rated the patch as comfortable, 67% (n=18) felt safer and 89% (n=24) would like to wear it next time in the hospital. Nurses were neutral about usefulness, with a median score of 3.5 (IQR 3.1-4) on a 7-point Likert scale, ease of use 3.7 (IQR 3.2-4.8) and satisfaction 3.7 (IQR 3.2-4.8), but agreed on ease of learning at 5.0 (IQR 4.0-5.8). Neutral scores were mostly related to the perceived limited fidelity of the system. CONCLUSIONS: Continuous monitoring of vital signs with a wearable device was well accepted by patients. Nurses' ratings were highly variable, resulting in on average neutral attitude towards remote monitoring. Our results suggest it is feasible to monitor vital signs continuously on general wards, although acceptability of the device among nurses needs further improvement.

Laparoscopic cholecystectomy in acute cholecystitis: C-reactive protein level combined with age predicts conversion.

INTRODUCTION: The aim was to enable prediction of risk for conversion in early laparoscopic cholecystectomy for acute cholecystitis. METHODS: Multivariate analysis and receiver operating characteristic curve analysis were used to define independent predictors for conversion and optimal cutoffs. Using those, a scoring system was created to predict conversion. RESULTS: In 261 patients, conversion to open cholecystectomy was necessary in 62 cases (24%). Multivariate analysis revealed age and C-reactive protein (CRP) level to be independent predictors for conversion (odds ratio 1.02; P=0.02 and odds ratio 1.01; P<0.001). Using cutoffs obtained by receiver operating characteristic curve analysis resulted in an useful scoring system to predict conversion risk (age>65 y=1+CRP value>165 mg/L=1): score 0=12%, 1=29%, 2=67% (P<0.001). CONCLUSIONS: Higher age and elevated CRP level are independent predictors for conversion. Surgery for acute cholecystitis in patients with age >65 years and/or CRP level >165 mg/L should be considered as high risk for conversion.