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.

ObjectiveTo determine feasibility, in terms of acceptability and system fidelity, of continuous vital signs monitoring in abdominal surgery patients on a general ward.DesignObservational cohort study.SettingTertiary teaching hospital.ParticipantsPostoperative abdominal surgical patients (n=30) and nurses (n=23).InterventionsPatients 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.OutcomesSystem fidelity was measured by analysis of the monitoring data. Acceptability by patients and nurses was assessed using questionnaires.ResultsThirty 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.ConclusionsContinuous 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.

It has been a standard practice to perform mechanical bowel preparation (MBP) prior to colorectal surgery to reduce the risk of colorectal anastomotic leakages (CAL). The latest Cochrane systematic review suggests there is no benefit for MBP in terms of decreasing CAL, but new studies have been published. The aim of this systematic review and meta-analysis is to update current evidence for the effectiveness of preoperative MBP on CAL in patients undergoing colorectal surgery. Consequently, PubMed, MEDLINE, Embase, CENTRAL and CINAHL were searched from 2010 to March 2017 for randomised controlled trials (RCT) that compared the effects of MBP in colorectal surgery on anastomotic leakages. The outcome CAL was expressed in odds ratios and analysed with a fixed-effects analysis in a meta-analysis. Quality assessment was performed by the cochrane risk of bias tool and grades of recommendation, assessment, development and evaluation (GRADE) methodology. Eight studies (1065 patients) were included. The pooled odds ratio showed no significant difference of MBP in colorectal surgery on CAL (odds ratio (OR) = 1.15, 95% CI = 0.68-1.94). According to GRADE methodology, the quality of the evidence was low. To conclude, MBP for colorectal surgery does not lower the risk of CAL. These results should, however, be interpreted with caution due to the small sample sizes and poor quality. Moreover, the usefulness of MBP in rectal surgery is not clear due to the lack of stratification in many studies. Future research should focus on high-quality, adequately powered RCTs in elective rectal surgery to determine the possible effects of MBP.

Background To support early recognition of clinical deterioration on a general ward continuous vital signs monitoring (CMVS) systems using wearable devices are increasingly being investigated. Although nurses play a crucial role in successful implementation, reported nurse adoption and acceptance scores vary significantly. In-depth insight into the perspectives of nurses regarding CMVS is lacking. To this end, we applied a theoretical approach for behaviour change derived from the Behaviour Change Wheel (BCW). Aim To provide insight in the capability, opportunity and motivation of nurses working with CMVS, in order to inform future implementation efforts. Methods A qualitative study was conducted, including twelve nurses of a surgical ward in a tertiary teaching hospital with previous experience of working with CMVS. Semi-structured interviews were audiotaped, transcribed verbatim, and analysed using thematic analysis. The results were mapped onto the Capability, Opportunity, Motivation – Behaviour (COM-B) model of the BCW. Results Five key themes emerged. The theme ‘Learning and coaching on the job’ linked to Capability. Nurses favoured learning about CVSM by dealing with it in daily practice. Receiving bedside guidance and coaching was perceived as important. The theme ‘interpretation of vital sign trends’ also linked to Capability. Nurses mentioned the novelty of monitoring vital sign trends of patients on wards. The theme ‘Management of alarms’ linked to Opportunity. Nurses perceived the (false) alarms generated by the system as excessive resulting in feelings of irritation and uncertainty. The theme ‘Integration and compatibility with clinical workflow’ linked to Opportunity. CVSM was experienced as helpful and easy to use, although integration in mobile devices and the EMR was highly favoured and the management of clinical workflows would need improvement. The theme ‘Added value for nursing care’ linked to Motivation. All nurses recognized the potential added value of CVSM for postoperative care. Conclusion Our findings suggest all parts of the COM-B model should be considered when implementing CVSM on general wards. When the themes in Capability and Opportunity are not properly addressed by selecting interventions and policy categories, this may negatively influence the Motivation and may compromise successful implementation.

Background Wireless continuous vital sign monitoring by wearable devices have recently become available for patients on general wards to promote timely detection of clinical deterioration. Many continuous monitoring systems use conventional threshold alarm settings to alert nurses in case of deviating vital signs. However, frequent false alarms often lead to alarm fatigue and inefficiencies in the workplace. The aim of this study was to determine the feasibility of continuous vital sign monitoring without the use of alarms, thereby exclusively relying on interval trend monitoring. Methods This explanatory sequential mixed methods study was conducted at an abdominal surgical ward of a tertiary teaching hospital. Heart rate and respiratory rate of patients were measured every minute by a wearable sensor. Trends were visualized and assessed six times per day by nurses and once a day by doctors during morning rounds. Instead of using alarms we focused exclusively on regular vital sign trend analysis by nurses and doctors. Primary outcome was feasibility in terms of acceptability by professionals, assessed by the Usefulness, Satisfaction and Ease of Use questionnaire and further explored in two focus groups, as well as fidelity. Results A total of 56 patients were monitored and in 80.5% (n = 536) of nurses’ work shifts the trends assessments were documented. All deviating trends (n = 17) were recognized in time. Professionals (N = 46) considered continuous monitoring satisfying (4.8±1.0 on a 1–7 Likert-scale) and were willing to use the technology. Although insight into vital sign trends allowed faster anticipation and action upon changed patient status, professionals were neutral about usefulness (4.4±1.0). They found continuous monitoring easy to use (4.7±0.8) and easy to learn (5.3±1.0) but indicated the need for gaining practical experience. Nurses considered the use of alarms for deviating vital signs unnecessary, when trends were regularly assessed and reported. Conclusion We demonstrated that continuous vital signs trend monitoring without using alarms was feasible in the general ward setting, thereby avoiding unnecessary alarms and preventing alarm fatigue. When monitoring in a general ward setting, the standard use of alarms may therefore be reconsidered.

Background Patients undergoing esophagectomy are at serious risk of developing postoperative complications. To support early recognition of clinical deterioration, wireless sensor technologies that enable continuous vital signs monitoring in a ward setting are emerging. Objective This study explored nurses’ and surgeons’ expectations of the potential effectiveness and impact of continuous wireless vital signs monitoring in patients admitted to the ward after esophagectomy. Methods Semistructured interviews were conducted at 3 esophageal cancer centers in the Netherlands. In each center, 2 nurses and 2 surgeons were interviewed regarding their expectations of continuous vital signs monitoring for early recognition of complications after esophagectomy. Historical data of patient characteristics and clinical outcomes were collected in each center and presented to the local participants to support estimations on clinical outcome. Results The majority of nurses and surgeons expected that continuous vital signs monitoring could contribute to the earlier recognition of deterioration and result in earlier treatment for postoperative complications, although the effective time gain would depend on patient and situational factors. Their expectations regarding the impact of potential earlier diagnosis on clinical outcomes varied. Nevertheless, most caregivers would consider implementing continuous monitoring in the surgical ward to support patient monitoring after esophagectomy. Conclusions Caregivers expected that wireless vital signs monitoring would provide opportunities for early detection of postoperative complications in patients undergoing esophagectomy admitted to the ward and prevent sequelae under certain circumstances. As the technology matures, clinical outcome studies will be necessary to objectify these expectations and further investigate overall effects on patient outcome.

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.

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.