Dataset Information

Trial of remote continuous versus intermittent NEWS monitoring after major surgery (TRaCINg): a feasibility randomised controlled trial.

ABSTRACT: Background: Despite medical advances, major surgery remains high risk with up to 44% of patients experiencing postoperative complications. Early recognition of postoperative complications is crucial in reducing morbidity and preventing long-term disability. The current standard of care is intermittent manual vital signs monitoring, but new wearable remote monitors offer the benefits of continuous vital signs monitoring without limiting the patient's mobility. The aim of this study was to evaluate the feasibility, acceptability and clinical outcomes of continuous remote monitoring after major surgery.

Methods: The study was a randomised, controlled, unblinded, parallel group, feasibility trial. Adult patients undergoing elective major surgery were randomly assigned to receive continuous remote monitoring and normal National Early Warning Score (NEWS) monitoring (intervention group) or normal NEWS monitoring alone (control group). Continuous remote monitoring was achieved using the SensiumVitals® wireless patch which is worn on the patient's chest and monitors heart rate, respiratory rate and temperature continuously, and alerts the nurse when there is deviation from pre-set physiological norms. Feasibility was assessed by evaluating recruitment rate, adherence to protocol and randomisation and the amount of missing data. Clinical outcomes included time to antibiotics in cases of sepsis, length of hospital stay, number of critical care admissions and rate of hospital readmission within 30 days of discharge.

Results: One hundred and thirty-six patients were randomised between October 2018 and April 2019: 67 to the control group and 69 to the intervention group. Recruitment was completed prior to the 12 month target with a high rate of eligibility and consent. Missing data was limited only to questionnaire responses; no participants were lost to follow-up and only one participant was withdrawn due to loss of capacity. The number of patients classed as 'drop-out' due to design (8.1%) were less than anticipated, and there were no participants who crossed over into the alternative trial allocation group. Seventeen participants in the intervention group (28%) did not adhere to the monitoring protocol. No formal comparisons between arms was undertaken; however, participants had fewer unplanned critical care admissions (1 versus 5) and had a shorter average length of hospital stay (11.6 days (95% confidence interval 9.5-13.7 days) versus 16.2 days (95% confidence interval 11.3-21.2 days)) in the continuous vital signs monitoring group. The time taken to receive antibiotics in cases of sepsis was similar in both arms. A cost-utility analysis indicated that the remote monitoring system was cost-saving when compared to standard NEWS monitoring alone.

Conclusions: It is feasible to perform a large-scale randomised controlled trial of continuous remote monitoring after major surgery. Progression to a definitive multicentre randomised controlled trial would be appropriate, taking consideration of factors, such as patient adherence, that might mask the potential benefit of additional monitoring.

Trial registration: ISRCTN registry with study ID ISRCTN16601772 . Registered 30 August 2017.

SUBMITTER: Downey CL

PROVIDER: S-EPMC7684886 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Trial of remote continuous versus intermittent NEWS monitoring after major surgery (TRaCINg): a feasibility randomised controlled trial.

Downey C L CL Croft J J Ainsworth G G Buckley H H Shinkins B B Randell R R Brown J M JM Jayne D G DG

Pilot and feasibility studies 20201123 1

<h4>Background</h4>Despite medical advances, major surgery remains high risk with up to 44% of patients experiencing postoperative complications. Early recognition of postoperative complications is crucial in reducing morbidity and preventing long-term disability. The current standard of care is intermittent manual vital signs monitoring, but new wearable remote monitors offer the benefits of continuous vital signs monitoring without limiting the patient's mobility. The aim of this study was to ...[more]

PMID: 33292669

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Project description:OBJECTIVE:To validate whether a wearable remote vital signs monitor could accurately measure heart rate (HR), respiratory rate (RR) and temperature in a postsurgical patient population at high risk of complications. DESIGN:Manually recorded vital signs data were paired with vital signs data derived from the remote monitor set in patients participating in the Trial of Remote versus Continuous INtermittent monitoring (TRaCINg) study: a trial of continuous remote vital signs monitoring. SETTING:St James's University Hospital, UK. PARTICIPANTS:51 patients who had undergone major elective general surgery. INTERVENTIONS:The intervention was the SensiumVitals monitoring system. This is a wireless patch worn on the patient's chest that measures HR, RR and temperature continuously. The reference standard was nurse-measured manually recorded vital signs. PRIMARY AND SECONDARY OUTCOME MEASURES:The primary outcomes were the 95% limits of agreement between manually recorded and wearable patch vital sign recordings of HR, RR and temperature. The secondary outcomes were the percentage completeness of vital sign patch data for each vital sign. RESULTS:1135 nurse observations were available for analysis. There was no clinically meaningful bias in HR (1.85 bpm), but precision was poor (95% limits of agreement -23.92 to 20.22 bpm). Agreement was poor for RR (bias 2.93 breaths per minute, 95% limits of agreement -8.19 to 14.05 breaths per minute) and temperature (bias 0.82°C, 95% limits of agreement -1.13°C to 2.78°C). Vital sign patch data completeness was 72.8% for temperature, 59.2% for HR and 34.1% for RR. Distributions of RR in manually recorded measurements were clinically implausible. CONCLUSIONS:The continuous monitoring system did not reliably provide HR consistent with nurse measurements. The accuracy of RR and temperature was outside of acceptable limits. Limitations of the system could potentially be overcome through better signal processing. While acknowledging the time pressures placed on nursing staff, inaccuracies in the manually recorded data present an opportunity to increase awareness about the importance of manual observations, particularly with regard to methods of manual HR and RR measurements.

Project description:INTRODUCTION:Bronchiolitis is the most common reason for hospitalisation in infants in developed countries. The main focus of hospital care is on supportive care, such as monitoring for hypoxia and supplemental oxygen administration, as active therapies lack effectiveness. Pulse oximetry is used to monitor hypoxia in hospitalised infants and is used either intermittently or continuously. Observational studies have suggested that continuous pulse oximetry use leads to a longer length of hospital stay in stable infants. The use of continuous pulse oximetry may lead to unnecessary clinical intervention due to readings that are of little clinical significance, false-positive readings and less reliance on the clinical status. There is a lack of high-quality evidence to guide which pulse oximetry monitoring strategy, intermittent or continuous, is superior in infants hospitalised with bronchiolitis with respect to patient and policy-relevant outcomes. METHODS AND ANALYSIS:This is a multicentre, pragmatic randomised controlled trial comparing two strategies for pulse oximetry monitoring in infants hospitalised for bronchiolitis. Infants aged 1?month to 2 years presenting to Canadian tertiary and community hospitals will be randomised after stabilisation to receive either intermittent or continuous oxygen saturation monitoring on the inpatient unit until discharge. The primary outcome is length of hospital stay. Secondary outcomes include additional measures of effectiveness, acceptability, safety and cost. We will need to enrol 210 infants in order to detect a 12-hour difference in length of stay with a type 1 error rate of 5% and a power of 90%. ETHICS AND DISSEMINATION:Research ethics approval has been obtained for this trial. This trial will provide data to guide hospitals and clinicians on the optimal pulse oximetry monitoring strategy in infants hospitalised with bronchiolitis. We will disseminate the findings of this study through peer-reviewed publication, professional societies and meetings. TRIAL REGISTRATION NUMBER:NCT02947204.

Project description:Measuring blood pressure (BP) at home and remote monitoring can improve the patient's adherence to BP control and vascular outcomes. This study evaluated the feasibility of a trial regarding the effects of an intensive mobile BP management strategy versus usual care in acute ischemic stroke patients. A feasibility-testing, randomized, open-labeled controlled trial was conducted. Remote BP measurement, data transmission, storage, and centralized monitoring system were organized through a Bluetooth-equipped sphygmomanometer paired to the participants' smartphones. Participants were randomized equally into intensive management (behavioral intensification to measure BP at home by texting, direct telephone call, or breakthrough visit) and control (usual care) groups. The primary feasibility outcomes were: 1) recruitment time for the pre-specified number of participants, 2) retention of participants, 3) frequency of breakthrough visit calls, 4) response to breakthrough visit call, and 5) proportions satisfying BP measurement criteria. Sixty participants were randomly assigned to the intensive management (n = 31) and control (n = 29) groups, of which 57 participants were included in the primary analysis with comparable baseline characteristics. Recruitment time from the first to the last participant was 350 days, and 95% of randomized participants completed the final visit (intensive, 94%; control, 98%). Eight breakthrough visit calls were made to 7 participants (23%), with complete and immediate responses within 3 ± 4 days. The median of half-day blocks fulfilling the BP measurement criteria per patient were 91% in the intensive group and 83% in the control group (difference, 12.2; 95% confidence interval, 2.2-22.2). No adverse events related to the trial procedures were reported. The intensive monitoring, including remote BP measurement, data transfer, and centralized monitoring system, engaged with behavioral intensification was feasible if the patients complied with the intervention. However, the device utilized would need further improvement prior to a large trial.

Project description:ObjectiveTo evaluate effects of remote monitoring of adjuvant chemotherapy related side effects via the Advanced Symptom Management System (ASyMS) on symptom burden, quality of life, supportive care needs, anxiety, self-efficacy, and work limitations.DesignMulticentre, repeated measures, parallel group, evaluator masked, stratified randomised controlled trial.SettingTwelve cancer centres in Austria, Greece, Norway, Republic of Ireland, and UK.Participants829 patients with non-metastatic breast cancer, colorectal cancer, Hodgkin's disease, or non-Hodgkin's lymphoma receiving first line adjuvant chemotherapy or chemotherapy for the first time in five years.InterventionPatients were randomised to ASyMS (intervention; n=415) or standard care (control; n=414) over six cycles of chemotherapy.Main outcome measuresThe primary outcome was symptom burden (Memorial Symptom Assessment Scale; MSAS). Secondary outcomes were health related quality of life (Functional Assessment of Cancer Therapy-General; FACT-G), Supportive Care Needs Survey Short-Form (SCNS-SF34), State-Trait Anxiety Inventory-Revised (STAI-R), Communication and Attitudinal Self-Efficacy scale for cancer (CASE-Cancer), and work limitations questionnaire (WLQ).ResultsFor the intervention group, symptom burden remained at pre-chemotherapy treatment levels, whereas controls reported an increase from cycle 1 onwards (least squares absolute mean difference -0.15, 95% confidence interval -0.19 to -0.12; P<0.001; Cohen's D effect size=0.5). Analysis of MSAS sub-domains indicated significant reductions in favour of ASyMS for global distress index (-0.21, -0.27 to -0.16; P<0.001), psychological symptoms (-0.16, -0.23 to -0.10; P<0.001), and physical symptoms (-0.21, -0.26 to -0.17; P<0.001). FACT-G scores were higher in the intervention group across all cycles (mean difference 4.06, 95% confidence interval 2.65 to 5.46; P<0.001), whereas mean scores for STAI-R trait (-1.15, -1.90 to -0.41; P=0.003) and STAI-R state anxiety (-1.13, -2.06 to -0.20; P=0.02) were lower. CASE-Cancer scores were higher in the intervention group (mean difference 0.81, 0.19 to 1.43; P=0.01), and most SCNS-SF34 domains were lower, including sexuality needs (-1.56, -3.11 to -0.01; P<0.05), patient care and support needs (-1.74, -3.31 to -0.16; P=0.03), and physical and daily living needs (-2.8, -5.0 to -0.6; P=0.01). Other SCNS-SF34 domains and WLQ were not significantly different. Safety of ASyMS was satisfactory. Neutropenic events were higher in the intervention group.ConclusionsSignificant reduction in symptom burden supports the use of ASyMS for remote symptom monitoring in cancer care. A "medium" Cohen's effect size of 0.5 showed a sizable, positive clinical effect of ASyMS on patients' symptom experiences. Remote monitoring systems will be vital for future services, particularly with blended models of care delivery arising from the covid-19 pandemic.Trial registrationClinicaltrials.gov NCT02356081.

Project description:BACKGROUND:Misleading news claims can be detrimental to public health. We aimed to improve the alignment between causal claims and evidence, without losing news interest (counter to assumptions that news is not interested in communicating caution). METHODS:We tested two interventions in press releases, which are the main sources for science and health news: (a) aligning the headlines and main causal claims with the underlying evidence (strong for experimental, cautious for correlational) and (b) inserting explicit statements/caveats about inferring causality. The 'participants' were press releases on health-related topics (N?=?312; control?=?89, claim alignment?=?64, causality statement?=?79, both?=?80) from nine press offices (journals, universities, funders). Outcomes were news content (headlines, causal claims, caveats) in English-language international and national media (newspapers, websites, broadcast; N?=?2257), news uptake (% press releases gaining news coverage) and feasibility (% press releases implementing cautious statements). RESULTS:News headlines showed better alignment to evidence when press releases were aligned (intention-to-treat analysis (ITT) 56% vs 52%, OR?=?1.2 to 1.9; as-treated analysis (AT) 60% vs 32%, OR?=?1.3 to 4.4). News claims also followed press releases, significant only for AT (ITT 62% vs 60%, OR?=?0.7 to 1.6; AT, 67% vs 39%, OR?=?1.4 to 5.7). The same was true for causality statements/caveats (ITT 15% vs 10%, OR?=?0.9 to 2.6; AT 20% vs 0%, OR 16 to 156). There was no evidence of lost news uptake for press releases with aligned headlines and claims (ITT 55% vs 55%, OR?=?0.7 to 1.3, AT 58% vs 60%, OR?=?0.7 to 1.7), or causality statements/caveats (ITT 53% vs 56%, OR?=?0.8 to 1.0, AT 66% vs 52%, OR?=?1.3 to 2.7). Feasibility was demonstrated by a spontaneous increase in cautious headlines, claims and caveats in press releases compared to the pre-trial period (OR?=?1.01 to 2.6, 1.3 to 3.4, 1.1 to 26, respectively). CONCLUSIONS:News claims-even headlines-can become better aligned with evidence. Cautious claims and explicit caveats about correlational findings may penetrate into news without harming news interest. Findings from AT analysis are correlational and may not imply cause, although here the linking mechanism between press releases and news is known. ITT analysis was insensitive due to spontaneous adoption of interventions across conditions. TRIAL REGISTRATION:ISRCTN10492618 (20 August 2015).

Dataset Information

Trial of remote continuous versus intermittent NEWS monitoring after major surgery (TRaCINg): a feasibility randomised controlled trial.

Publications

Trial of remote continuous versus intermittent NEWS monitoring after major surgery (TRaCINg): a feasibility randomised controlled trial.

Similar Datasets

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