Wearable wireless continuous vital signs monitoring on the general ward.

PURPOSE OF REVIEW: Wearable wireless sensors for continuous vital signs monitoring (CVSM) offer the potential for early identification of patient deterioration, especially in low-intensity care settings like general wards. This study aims to review advances in wearable CVSM - with a focus on the general ward - highlighting the technological characteristics of CVSM systems, user perspectives and impact on patient outcomes by exploring recent evidence. RECENT FINDINGS: The accuracy of wearable sensors measuring vital signs exhibits variability, especially notable in ambulatory patients within hospital settings, and standard validation protocols are lacking. Usability of CMVS systems is critical for nurses and patients, highlighting the need for easy-to-use wearable sensors, and expansion of the number of measured vital signs. Current software systems lack integration with hospital IT infrastructures and workflow automation. Imperative enhancements involve nurse-friendly, less intrusive alarm strategies, and advanced decision support systems. Despite observed reductions in ICU admissions and Rapid Response Team calls, the impact on patient outcomes lacks robust statistical significance. SUMMARY: Widespread implementation of CVSM systems on the general ward and potentially outside the hospital seems inevitable. Despite the theoretical benefits of CVSM systems in improving clinical outcomes, and supporting nursing care by optimizing clinical workflow efficiency, the demonstrated effects in clinical practice are mixed. This review highlights the existing challenges related to data quality, usability, implementation, integration, interpretation, and user perspectives, as well as the need for robust evidence to support their impact on patient outcomes, workflow and cost-effectiveness.

Novel Textbook Outcomes following emergency laparotomy: Delphi exercise.

BACKGROUND: Textbook outcomes are composite outcome measures that reflect the ideal overall experience for patients. There are many of these in the elective surgery literature but no textbook outcomes have been proposed for patients following emergency laparotomy. The aim was to achieve international consensus amongst experts and patients for the best Textbook Outcomes for non-trauma and trauma emergency laparotomy. METHODS: A modified Delphi exercise was undertaken with three planned rounds to achieve consensus regarding the best Textbook Outcomes based on the category, number and importance (Likert scale of 1-5) of individual outcome measures. There were separate questions for non-trauma and trauma. A patient engagement exercise was undertaken after round 2 to inform the final round. RESULTS: A total of 337 participants from 53 countries participated in all three rounds of the exercise. The final Textbook Outcomes were divided into 'early' and 'longer-term'. For non-trauma patients the proposed early Textbook Outcome was 'Discharged from hospital without serious postoperative complications (Clavien-Dindo ≥ grade III; including intra-abdominal sepsis, organ failure, unplanned re-operation or death). For trauma patients it was 'Discharged from hospital without unexpected transfusion after haemostasis, and no serious postoperative complications (adapted Clavien-Dindo for trauma ≥ grade III; including intra-abdominal sepsis, organ failure, unplanned re-operation on or death)'. The longer-term Textbook Outcome for both non-trauma and trauma was 'Achieved the early Textbook Outcome, and restoration of baseline quality of life at 1 year'. CONCLUSION: Early and longer-term Textbook Outcomes have been agreed by an international consensus of experts for non-trauma and trauma emergency laparotomy. These now require clinical validation with patient data.

Impact of wearable wireless continuous vital sign monitoring in abdominal surgical patients: before-after study.

BACKGROUND: Technological advances have enabled continuous monitoring of vital signs (CMVS) by wearable, wireless devices on general hospital wards to facilitate early detection of clinical deterioration, which could potentially improve clinical outcomes. However, evidence on the impact of these CMVS systems on patient outcomes is limited. This research aimed to explore the effect of CMVS on the clinical outcomes in major abdominal surgery patients in a general surgery ward. METHODS: A single-centre before-after study was conducted from October 2019 to June 2022. Patients in the intervention group received CMVS in addition to conventional intermittent vital sign monitoring (standard care for control group). With CMVS, heart rate and respiratory rate were measured every 5 min by a patch sensor. Proactive vital signs trends assessments and, when necessary, subsequent nursing activities were performed every nursing shift. The primary outcome of interest was the length of hospital stay (LOS); also, 12 patient-related outcomes were analysed. In the CMVS group, follow-up nursing activities of deviating vital signs trends were described and patient acceptability was measured. Post-hoc subgroup analysis was performed for colorectal and hepatopancreatobiliary surgery. RESULTS: A total of 908 patients were included (colorectal: n = 650; hepatopancreatobiliary: n = 257). Overall, median LOS was lower in the CMVS group (5.0 versus 5.5 days; P = 0.012), respectively. Post-hoc subgroup analysis showed this reduction in LOS was mostly observed in the colorectal group and not in the hepatopancreatobiliary group. Apart from a decrease in nurse-to-house-officer calls (from 15.3% to 7.7%; P = 0.007), all secondary clinical outcomes were similar in CMVS and control groups. However, a non-significant trend towards less-severe complications and reduced ICU LOS was observed in the CMVS group. In CMVS patients, 109 additional nursing activities were performed and 83% of patients indicated CMVS was acceptable. CONCLUSION: CMVS was associated with a significant reduction in LOS, while other clinical outcomes were unchanged. CMVS triggered additional nursing activities such as extra patient assessments and therapeutic interventions.

Usability of a digital health platform to support home hospitalization in heart failure patients: a multicentre feasibility study among healthcare professionals.

AIMS: Heart failure (HF) is a common cause of mortality and (re)hospitalizations. The NWE-Chance project explored the feasibility of providing hospitalizations at home (HH) supported by a newly developed digital health platform. The aim of this study was to explore the perceived usability by healthcare professionals (HCPs) of a digital platform in addition to HH for HF patients. METHODS AND RESULTS: A prospective, international, multicentre, single-arm interventional study was conducted. Sixty-three patients and 22 HCPs participated. The HH consisted of daily home visits by the nurse and use of the platform, consisting of a portable blood pressure device, weight scale, pulse oximeter, a wearable chest patch to measure vital signs (heart rate, respiratory rate, activity level, and posture), and an eCoach for the patient. Primary outcome was usability of the platform measured by the System Usability Scale halfway and at the end of the study. Overall usability was rated as sufficient (mean score 72.1 ± 8.9) and did not differ between the measurements moments (P = 0.690). The HCPs reported positive experiences (n = 7), negative experiences (n = 13), and recommendations (n = 6) for the future. Actual use of the platform was 79% of the HH days. CONCLUSION: A digital health platform to support HH was considered usable by HCPs, although actual use of the platform was limited. Therefore, several improvements in the integration of the digital platform into clinical workflows and in defining the precise role of the digital platform and its use are needed to add value before full implementation. REGISTRATION: clinicaltrials.gov NCT04084964.

Remote Home Monitoring of Continuous Vital Sign Measurements by Wearables in Patients Discharged After Colorectal Surgery: Observational Feasibility Study.

BACKGROUND: Hospital stays after colorectal surgery are increasingly being reduced by enhanced recovery and early discharge protocols. As a result, postoperative complications may frequently manifest after discharge in the home setting, potentially leading to emergency room presentations and readmissions. Virtual care interventions after hospital discharge may capture clinical deterioration at an early stage and hold promise for the prevention of readmissions and overall better outcomes. Recent technological advances have enabled continuous vital sign monitoring by wearable wireless sensor devices. However, the potential of these devices for virtual care interventions for patients discharged after colorectal surgery is currently unknown. OBJECTIVE: We aimed to determine the feasibility of a virtual care intervention consisting of continuous vital sign monitoring with wearable wireless sensors and teleconsultations for patients discharged after colorectal surgery. METHODS: In a single-center observational cohort study, patients were monitored at home for 5 consecutive days after discharge. Daily vital sign trend assessments and telephone consultations were performed by a remote patient-monitoring department. Intervention performance was evaluated by analyzing vital sign trend assessments and telephone consultation reports. Outcomes were categorized as "no concern," "slight concern," or "serious concern." Serious concern prompted contact with the surgeon on call. In addition, the quality of the vital sign data was determined, and the patient experience was evaluated. RESULTS: Among 21 patients who participated in this study, 104 of 105 (99%) measurements of vital sign trends were successful. Of these 104 vital sign trend assessments, 68% (n=71) did not raise any concern, 16% (n=17) were unable to be assessed because of data loss, and none led to contacting the surgeon. Of 62 of 63 (98%) successfully performed telephone consultations, 53 (86%) did not raise any concerns and only 1 resulted in contacting the surgeon. A 68% agreement was found between vital sign trend assessments and telephone consultations. Overall completeness of the 2347 hours of vital sign trend data was 46.3% (range 5%-100%). Patient satisfaction score was 8 (IQR 7-9) of 10. CONCLUSIONS: A home monitoring intervention of patients discharged after colorectal surgery was found to be feasible, given its high performance and high patient acceptability. However, the intervention design needs further optimization before the true value of remote monitoring for early discharge protocols, prevention of readmissions, and overall patient outcomes can be adequately determined.

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.

Bringing the hospital to home: Patient-reported outcome measures of a digital health-supported home hospitalisation platform to support hospital care at home for heart failure patients.

Background: Hospitalisations for heart failure are frequent and costly, linked with a lower quality of life, and lead to higher morbidity and mortality. Home hospitalisation interventions could be a substitute for in-hospital stays to reduce the burden on patients. The current study aims to investigate patient-reported satisfaction and usability in combination with the safety of a digital health-supported home hospitalisation intervention for heart failure patients. Methods: We conducted an international, multicentre, single-arm, interventional study to investigate the feasibility and safety of a digital health-supported home hospitalisation platform. Patients with acute decompensation of known and well-assessed chronic heart failure with an indication for hospital admission were included. The primary outcome was patient satisfaction. Secondary outcomes were usability, adherence, and safety. Results: A total number of 66 patients were included, of which the data of 65 patients (98.5%) was analysed. A total of 86.1% of patients reported being very satisfied or totally satisfied. No patients reported to be not satisfied with the home hospitalisation intervention. The patients reported a sufficient usability score (mean score: 75.8% of 100%) for the digital health-supported home hospitalisation platform. The adherence to the daily measurements of blood pressure and weight was very high, whereas the adherence to the daily interaction with the eCoach was lower (69.3%). In 7 patients (10.8%), a conversion from home hospitalisation to regular hospitalisation was needed. Furthermore, 6 patients (9.2%) had rehospitalisation within 30 days after the end of the home hospitalisation intervention. Conclusion: A digitally supported home hospitalisation intervention is feasible. This study demonstrates high patient satisfaction and sufficiently high usability scores. The safety outcomes are comparable with traditional heart failure hospitalisations. This indicates that digitally supported home hospitalisation could be an alternative to in-hospital care for all age groups, yet further research is needed to prove the (cost-) effectiveness.

Feasibility of wireless continuous monitoring of vital signs without using alarms on a general surgical ward: A mixed methods study.

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.

A Home Hospitalisation Strategy for Patients with an Acute Episode of Heart Failure Using a Digital Health-Supported Platform: A Multicentre Feasibility Study - A Rationale and Study Design.

BACKGROUND: Heart failure (HF) is a common cause of hospitalisation and mortality in elderly. The frequent rehospitalisations put a serious burden on patients, health-care budgets, and health-care capacity. Frequent hospital admissions are also associated with a substantial additional hazard for serious complications and reduced quality of life. The NWE-Chance project will explore the feasibility and scalability of providing home hospitalisation supported by a newly developed digital health-supported platform and daily visits of specialised nurses. METHODS/DESIGN: Hundred patients with chronic HF will be recruited over a 1-year period. The digital health-supported home hospitalisation strategy will be tested in 3 hospitals with different experience in delivering home hospitalisation: Isala Zwolle, Maastricht UMC+, both in The Netherlands, and Jessa Hospital, Hasselt in Belgium. The home hospitalisation intervention will have a maximal duration of 14 days. Feasibility will be measured with acceptability, satisfaction, and usability questionnaires for patients, nurses, and physicians. Furthermore, safety and costs will be assessed for 30 days after the start of the home hospitalisation intervention. DISCUSSION: The NWE-Chance project will be one of the first studies to examine the feasibility of a digital health-supported home hospitalisation platform for HF patients. It has the potential to augment current standard HF care and quality of life of HF patients and to innovate the standard HF care to potentially lower the hospitalisation-related complications, the burden of HF on health-care systems, and to potentially implement more patient-centred care strategies.

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.

Expectations of Continuous Vital Signs Monitoring for Recognizing Complications After Esophagectomy: Interview Study Among Nurses and Surgeons.

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.

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.

Effectiveness of mechanical bowel preparation versus no preparation on anastomotic leakage in colorectal surgery: a systematic review and meta-analysis.

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.