Background: The VItal siGns monItoring with continuous puLse oximetry And wireless cliNiCian notification aftEr surgery (VIGILANCE) study was a randomized controlled trial designed to assess the impact of continuous vital sign monitoring with alerts to nursing staff on the incidence of postoperative complications in surgical ward patients. Multiple factors interfered with the eHealth intervention implementation and conduct of the VIGILANCE study. Through examination of these challenges, the overall aim of this thesis was to help foster an understanding of the difficulties related to eHealth intervention implementation. The specific objectives were to identify issues related to implementation of intervention system of the VIGILANCE study, and to evaluate the influence of these issues on intervention adoption. Methods: During the VIGILANCE study, issues affecting the implementation of the intervention were documented on case report forms, alarm event forms, and a nursing feedback questionnaire. In this thesis, the issues were identified and evaluated using the Clinical Adoption Framework. Results: The key issues identified include nursing workflow changes, patient withdrawal, wireless network connectivity, false alarms, monitor malfunction, probe issues, and wireless network standards. These issues affected the service, system and information quality. As a result, these issues impacted ‘access’ through decreased ability of nurses to make complete use of the monitors; ‘care quality’ of the trial intervention through decreased effectiveness; and ‘productivity’ through interference in the coordination of care, and thus decreased clinical adoption of the monitoring system. Conclusion: Patient monitoring with eHealth technology in surgical wards has the potential to improve patient outcomes. However, proper planning that includes engagement of front-line nurses, installation of appropriate wireless network infrastructure, and use of comfortable cableless devices are required to maximize the potential of continuous monitoring. / Thesis / Master of Science (MSc) / The VIGILANCE study was a randomized controlled trial assessing the impact of continuous vital signs monitoring with alerts to nurses on the incidence of postoperative complications in surgical ward patients. This thesis identified and evaluated issues with implementation of wireless monitoring systems in the hospital. During VIGILANCE study issues affecting the intervention implementation were documented on case report forms, alarm event forms, and nursing questionnaires. Data related to these issues were explored using the Clinical Adoption Framework. Identified issues included nursing workflow changes, patient withdrawal, wireless network connectivity, false alarms, monitor malfunction, probe issues, and wireless network standards. The issues affected ‘access’ through decreased ability of nurses to make complete use of the monitors; ‘care quality’ of the intervention through decreased effectiveness; and ‘productivity’ by interfering in the care coordination. Future studies should aim to include front-line nurses, appropriate wireless network, and comfortable cableless devices in their planning.

Clinical trials involving digital health technologies are complex and challenging deployments. The SMArTVIEW trial (n=800), underway, combines remote automated patient monitoring (RAM) in hospital and virtual hospital-to-home nursing support, up to 30-days post-discharge, for patients who have undergone cardiac and major vascular surgery. Cardiac and vascular surgery patients are at risk for postoperative complications, as well as hospital readmission; SMArTVIEW aims to reduce hospital readmissions and emergency department visits. The purpose of this work was to conduct a process monitoring evaluation of the first 100 patients enrolled in order to examine the implementation, mechanisms, context, and specialized nursing role of the SMArTVIEW intervention. Six data sources were used to examine patient recruitment, daily nursing intervention workflows, RAM technology compliance, technical troubleshooting, patient education, and virtual nursing care. A content analysis was used to identify nursing advice, recommendations, and corrective actions for patients requiring intervention recovering at home. Fifty patients were allocated to the SMArTVIEW intervention; of these, 34 engaged in all intervention components, both in-hospital and at home. In-hospital RAM technology generated 194 notifications, drawing nurses to the beside for patient reassessment. Forty-two daily nurse reports and 926 virtual nursing care records were audited to determine technology implementation issues and nursing actions to support patient recovery at home. Process monitoring uncovered strengths and limitations in the initial days of intervention deployment. Strengths included the functionality of RAM technology, facilitating nurse compliance with required workflows, as well as a high degree of patient engagement in the program. SMArTVIEW nurses addressed multiple health concerns for patients, resulting in 1,865 nursing actions over the 30-day intervention course. Patient withdrawals and lack of standardized communication practices were areas requiring improvement. Results were used to refine and standardize intervention workflows in order to scale the intervention for deployment at a second site (United Kingdom). / Thesis / Master of Science (MSc)

The understanding of the mesorectal spread in rectal cancer has lead to wide acceptance of total mesorectal excision (TME) as the surgical technique of choice for carcinoma in the lower and mid rectum. While oncological results and survival have improved with TME-surgery, morbidity and mortality remain important issues. The most feared complication is symptomatic anastomotic leakage. The aim of this thesis was to focus on the role of the defunctioning stoma, risk factors, and postoperative monitoring in regard to anastomotic leakage in sphincter saving resection of the rectum. Intraoperative adverse events were analysed in a retrospective population based case-control study in which all patients who underwent elective anterior resection in Sweden between 1987 and 1995, and who died within 30 days or during the initial hospital stay (n=140), were compared with patients chosen at random (n=423) who underwent the same operation during the same period, but survived the operation. Intraoperative adverse events were more frequent in those who died, and reconstruction of an anastomosis judged unsatisfactory by the surgeon improved the outcome. In a population based retrospective case-control study, risk factors for symptomatic anastomotic leakage were investigated in randomly chosen sample of patients who underwent anterior resection in Sweden between 1987 and 1995 (n=432). Twelve per cent of the patients developed symptomatic leakage, and 25% of the patients with leakage ended up with a permanent stoma. In multivariate regression analysis, low anastomosis, preoperative radiotherapy, male gender and intraoperative adverse events were independent riskfactors for anastomotic leakage. In a randomised multicentre trial patients operated with sphincter saving TME¨surgery for rectal cancer were randomised to a defunctioning stoma (n=116) or not (n=118). The overall rate symptomatic leakage was 19%. Patienst without a defunctioning stoma leaked in 28% and patients with a defunctioing stoma in 10%, a statistically significant difference (p<0.001) not previously demonstrated in any randomised trial of adequate size. Postoperative monitoring with computed tomography scan (CT-scan) on postoperative day 2 and 7, and C-reactive protein (CRP) daily in 33 patients operated on with anterior resection of the rectum, demonstrated larger pelvic fluid collections in patients with leakage before the leakage was clinically diagnosed. CRP was increased from postoperative day 2 and onwards in patients in whom clinical leakage was diagnosed on median postoperative day 8. In 23 patients who underwent anterior resection of the rectum, intraperitoneal metabolism was investigated using microdialysis technique measuring the carbohydrate metabolites lactate, pyruvate and glucose. Intraperitoneal cytokines IL-6, IL-10 and TNF-α were collected through a pelvic drain and analysed. In patients who developed leakage, the latate/pyruvate ratio was increased near the anastomosis on postoperative day 5 and 6, as well as IL-6 and IL-10 which were increased postoperatively day 1 and 2, while TNF-α was higher on day 1.