A protocol on the effects of interactive digital assistance on engagement and perceived quality of care of surgery patients and self-efficacy and workload of staff.

Introduction: The workforce shortage in the healthcare context is a growing issue that exerts detrimental effects on employees (e.g., higher workload) and patients (e.g., suboptimal patient care). Since traditional approaches alone may not be enough to solve this problem, there is a need for complementary innovative digital health solutions, such as socially assistive robots. Hence, the proposed study aims to investigate the effects of gamified nursing education and physiotherapy delivered by a socially assistive robot on patient- (engagement, perceived quality of care) and employee-related outcomes (perceived self-efficacy, workload). Methods and analysis: Approximately 90 vascular and thoracic surgery patients will receive either standard care or standard care with additional robot interactions over the course of 3-5 days. Additionally, approximately 34 nursing and physiotherapeutic employees will fill out self-report questionnaires after weeks of not using a social robot and weeks of using a social robot. The main hypotheses will be tested with mixed-design analyses of variance and paired-samples t-tests. Discussion: While the proposed study has some limitations, the results will provide high-quality and comprehensive evidence on the effectiveness of socially assistive robots in healthcare. Ethics and dissemination: The study was approved by the Medical Ethics Commission of the University Medical Center and registered in the ISRCTN registry (ISRCTN96689284). The study findings will be summarized in international peer-reviewed scientific journals and meetings and communicated to relevant stakeholders.

A randomized controlled trial for evaluating the impact of integrating a computerized clinical decision support system and a socially assistive humanoid robot into grand rounds during pre/post-operative care.

Although clinical decision support systems (CDSSs) are increasingly emphasized as one of the possible levers for improving care, they are still not widely used due to different barriers, such as doubts about systems' performance, their complexity and poor design, practitioners' lack of time to use them, poor computer skills, reluctance to use them in front of patients, and deficient integration into existing workflows. While several studies on CDSS exist, there is a need for additional high-quality studies using large samples and examining the differences between outcomes following a decision based on CDSS support and those following decisions without this kind of information. Even less is known about the effectiveness of a CDSS that is delivered during a grand round routine and with the help of socially assistive humanoid robots (SAHRs). In this study, 200 patients will be randomized into a Control Group (i.e. standard care) and an Intervention Group (i.e. standard care and novel CDSS delivered via a SAHR). Health care quality and Quality of Life measures will be compared between the two groups. Additionally, approximately 22 clinicians, who are also active researchers at the University Clinical Center Maribor, will evaluate the acceptability and clinical usability of the system. The results of the proposed study will provide high-quality evidence on the effectiveness of CDSS systems and SAHR in the grand round routine.

Study protocol: a survey exploring patients' and healthcare professionals' expectations, attitudes and ethical acceptability regarding the integration of socially assistive humanoid robots in nursing.

INTRODUCTION: Population ageing, the rise of chronic diseases and the emergence of new viruses are some of the factors that contribute to an increasing share of gross domestic product dedicated to health spending. COVID-19 has shown that nursing staff represents the critical part of hospitalisation. Technological developments in robotics and artificial intelligence can significantly reduce costs and lead to improvements in many hospital processes. The proposed study aims to assess expectations, attitudes and ethical acceptability regarding the integration of socially assistive humanoid robots into hospitalised care workflow from patients' and healthcare professionals' perspectives and to compare them with the results of similar studies. METHODS/DESIGN: The study is designed as a cross-sectional survey, which will include three previously validated questionnaires, the Technology-Specific Expectation Scale (TSES), the Ethical Acceptability Scale (EAS) and the Negative Attitudes towards Robots Scale (NARS). The employees of a regional clinical centre will be asked to participate via an electronic survey and respond to TSES and EAS questionaries. Patients will respond to TSES and NARS questionaries. The survey will be conducted online. ETHICS AND DISSEMINATION: Ethical approval for the study was obtained by the Medical Ethics Commission of the University Medical Center Maribor. Results will be published in a relevant scientific journal and communicated to participants and relevant institutions through dissemination activities and the ecosystem of the Horizon 2020 funded project HosmartAI (grant no. 101016834). ETHICAL APPROVAL DATE: 06 May 2021. ESTIMATED START OF THE STUDY: December 2021.

Establishing an Expert Consensus on Key Indicators of the Quality of Life among Breast Cancer Survivors: A Modified Delphi Study.

(1) Background: The needs of cancer survivors are often not reflected in practice. One of the main barriers of the use of patient-reported outcomes is associated with data collection and the interpretation of patient-reported outcomes (PROs) due to a multitude of instruments and measuring approaches. The aim of the study was to establish an expert consensus on the relevance and key indicators of quality of life in the clinical practice of breast cancer survivors. (2) Methods: Potential indicators of the quality of life of breast cancer survivors were extracted from the established quality of life models, depicting survivors' perspectives. The specific domains and subdomains of quality of life were evaluated in a two-stage online Delphi process, including an international and multidisciplinary panel of experts. (3) Results: The first round of the Delphi process was completed by 57 and the second by 37 participants. A consensus was reached for the Physical and Psychological domains, and on eleven subdomains of quality of life. The results were further supported by the additional ranking of importance of the subdomains in the second round. (4) Conclusions: The current findings can serve to optimize the use of instruments and address the challenges related to data collection and interpretation as the facilitators of the adaption in routine practice.

Multilayered Polysaccharide Nanofilms for Controlled Delivery of Pentoxifylline and Possible Treatment of Chronic Venous Ulceration.

Local drug delivery systems made from nontoxic polysaccharide nanofilms have an enormous potential in wound care. A detailed understanding of the structural, surface, physicochemical, and cytotoxic properties of such systems is crucial to design clinically efficacious materials. Herein, we fabricated polysaccharide-based nanofilms onto either a 2D model (SiO2 and Au sensors) or on nonwoven alginate 3D substrates using an alternating assembly of N,N,N-trimethylchitosan (TMC) and alginic acid (ALG) by a spin-assisted layer-by-layer (LbL) technique. These TMC/ALG multilayered nanofilms are used for a uniform encapsulation and controlled release of pentoxifylline (PTX), a potent anti-inflammatory drug for treatment of the chronic venous ulceration. We show a tailorable film growth and mass, morphology, as well as surface properties (charge, hydrophilicity, porosity) of the assembled nanofilms through control of the coating during the spin-assisted assembly. The uniform distribution of the encapsulated PTX in the TMC/ALG nanofilms is preserved even with when the amount of the incorporated PTX increases. The PTX release mechanism from the model and real systems is studied in detail and is very comparable for both systems. Finally, different cell-based assays illustrated the potential of the TMC/ALG multilayer system in wound care (e.g., treatment chronic venous ulceration) applications, including a decrease of TNF-α secretion, a common indicator of inflammation.

Pancreaticoduodenectomy for ductal adenocarcinoma of the pancreatic head with venous resection.

BACKGROUND: Recent reports have shown that patients with vascular tumour invasion who undergo concurrent vascular resection can achieve long-term survival rates equivalent to those without vascular involvement requiring pancreaticoduodenectomy alone. There is no consensus about which patients benefit from the portal-superior mesenteric vein resection and there is no consensus about the best surgical technique of vessel reconstruction (resection with or without graft reconstruction). As published series are small the aim of this study was to evaluate our experience in pancreatectomies with en bloc vascular resection and reconstruction of vessels. METHODS: Review of database at University Clinical Centre Maribor identified 133 patients (average age 65.4 ± 8.6 years, 69 female patients) who underwent pancreatoduodenectomy between January 2006 and August 2014. Clinical data, operative results, pathological findings and postoperative outcomes were collected prospectively and analyzed. Current literature and our experience in pancreatectomies with en bloc vascular resection and reconstruction of portal vein are reviewed. RESULTS: Twenty-two patients out of 133 (16.5%) had portal vein-superior mesenteric vein resection and portal vein reconstruction (PVR) during pancreaticoduodenectomy. In fourteen patients portal vein was reconstructed without the use of synthetic vascular graft. In these series two types of venous reconstruction were performed. When tumour involvement was limited to the superior mesenteric vein (SPV) or portal vein (PV) such that the splenic vein could be preserved, and vessels could be approximated without tension a primary end-to-end anastomosis was performed. When tumour involved the SMV-splenic vein confluence, splenic vein ligation was necessary. In the remaining eight procedures interposition graft was needed. Dacron grafts with 10 mm diameter were used. There was no infection after dacron grafting. One patient had portal vein thrombosis after surgery: it was thrombosis after primary reconstruction. There were no thromboses in patients with synthetic graft interposition. There were no significant differences in postoperative morbidity, mortality or grades of complication between groups of patients with or without a PVR. Median survival time in months was in a group with vein resection 16.13 months and in a group without vein resection 15.17 months. Five year survival in the group without vein resection was 19.5%. Comparison of survival curves showed equal hazard rates with log-rank p = 0.090. CONCLUSIONS: Survival of patients with pancreatic cancer who undergo an R0 resection with reconstruction was comparable to those who have a standard pancreaticoduodenectomy with no added mortality or morbidity. Synthetic graft appeared to be an effective and safe option as an interposition graft for portomesenteric venous reconstruction after pancreaticoduodenectomy.

Revascularization of the superior mesenteric artery alone for treatment of chronic mesenteric ischemia.

BACKGROUND: Symptomatic patients with chronic mesenteric ischemia (CMI) should be treated without much delay because symptoms of CMI are present in 43% patients who present with acute mesenteric ischemia. There are few reported series with large numbers of patients undergoing surgery for CMI, and many controversies persist regarding the optimal surgical treatment. These controversies include the type of surgical repair (antegrade vs. retrograde bypass), and the number of arteries that should be treated (single- vs. multiple-vessel reconstruction). It was the aim of presented study to report our experience and long-term results with single-vessel bypass grafting from infrarenal aorta to superior mesenteric artery. METHODS: Patients who were admitted because of mesenteric ischemia at the surgical clinics of University Clinical Center Maribor between January 1999 and January 2009 were identified with a computerized medical data registry. Patients who underwent revascularization for CMI with retrograde synthetic aortomesenteric bypass were included in the study. Demographics, clinical characteristics, imaging, and operative data were obtained from the medical records. Significant superior mesenteric artery stenosis (> 70% diameter stenosis) was confirmed by spiral computed angiography. All patients underwent retrograde aortomesenteric arterial bypass with synthetic bypass graft originating from the infrarenal aorta. Doppler sonography combined with color Doppler was used to evaluate disease progression in patients at 3-month interval during the first year and from then at 6-month intervals. Endpoints of the study were occlusion of graft or death by any cause. RESULTS: Data are presented for a cohort of 19 women and 8 men with a mean age at admission 73 years (range 56-88 years). The mean duration of follow-up was 71 months (range 1-118 months). There was one early death (4%). Four patients died during the follow-up period, and three were lost for follow-up. None of the deaths was connected with mesenteric ischemia. During follow-up period none of the patients developed restenosis, and no occlusions were observed. There were no reinterventions. Symptom improvements were noted in 25 patients (93%). One patient (4%) referred to persistent pain despite successful revascularization, although during follow-up period weight gain was observed. At 71 months, freedom from recurrent symptoms, restenosis, and reinterventions was 78% ± 13.9%. CONCLUSIONS: Surgery for CMI can be safely performed with retrograde approach and single vessel anastomosis. Mortality rates and long-term survival compare favorably with other surgical approaches to treatment of CMI.

Towards a low-cost mobile subcutaneous vein detection solution using near-infrared spectroscopy.

Excessive venipunctures are both time- and resource-consuming events, which cause anxiety, pain, and distress in patients, or can lead to severe harmful injuries. We propose a low-cost mobile health solution for subcutaneous vein detection using near-infrared spectroscopy, along with an assessment of the current state of the art in this field. The first objective of this study was to get a deeper overview of the research topic, through the initial team discussions and a detailed literature review (using both academic and grey literature). The second objective, that is, identifying the commercial systems employing near-infrared spectroscopy, was conducted using the PubMed database. The goal of the third objective was to identify and evaluate (using the IEEE Xplore database) the research efforts in the field of low-cost near-infrared imaging in general, as a basis for the conceptual model of the upcoming prototype. Although the reviewed commercial devices have demonstrated usefulness and value for peripheral veins visualization, other evaluated clinical outcomes are less conclusive. Previous studies regarding low-cost near-infrared systems demonstrated the general feasibility of developing cost-effective vein detection systems; however, their limitations are restricting their applicability to clinical practice. Finally, based on the current findings, we outline the future research direction.

Treatment of primary infected juxtarenal aortic aneurysm with the multilayer stent.

PURPOSE: To report the use of multilayer uncovered stent to treat primary infected juxtarenal aortic aneurysm. CASE REPORT: A 50-year-old man was admitted to hospital for rapid onset of intractable abdominal pain and high fever. Computed tomographic scan showed 2 juxtarenal saccular aneurysms of abdominal aorta with morphologic and clinical changes compatible with infectious etiology. Patient was treated with multilayer flow-modulating stent. Follow-up imaging showed persistent aneurysm exclusion and continuous aneurysm shrinkage of the sac until complete regression to a normal aortic configuration was seen at 1 year. During follow-up (24 months), patient continued to do well, and there was no recurrence of infection. CONCLUSION: Multilayer stent appeared to be an acceptable treatment option for primary infected juxtarenal aortic aneurysms. Aneurysmal sac completely disappeared and visceral branches remained patent at 2-year follow-up. However, longer follow-up is necessary to evaluate the long-term patency of involved visceral arteries.

Delaying the superficial inferior epigastric artery flap: a solution to the problem of the small calibre of the donor artery.

BACKGROUND: Superficial inferior epigastric artery (SIEA) flap has a great advantage over other flaps of the area, that is, readily non-existent donor-site problems. The main reason why the SIEA flap has never been extensively used in breast reconstruction is the small diameter and variable anatomy of its donor artery. This study presents a possibility of enlarging the SIEA diameter using the delay-phenomenon mechanism. METHODS: A prospective clinical study of 26 patients was undertaken. Prior to surgery, ultrasound examinations were performed, measuring the diameter of SIEA and the velocity of blood flow in SIEA. The ipsilateral deep inferior epigastric artery (DIEA) was then ligated in all patients who had a measurable SIEA preoperatively. Two weeks later, measurements were repeated. The blood flow through SIEA was calculated and statistical analysis was applied. RESULTS: Twenty-one patients had an identifiable SIEA on preoperative measurements. On postoperative measurements, we confirmed ligation of DIEA in 19 patients, of these 17 patients had an augmentation in diameter (mean: 29%) and 18 in blood flow (mean: 127%). CONCLUSIONS: This study shows that ligating a single of the three main arteries (DIEA, SIEA and superficial circumflex iliac artery) irrigating skin/soft tissue of the lower abdomen, although the dominant one, results in widening of diameter and enlarging of blood flow of another artery (SIEA) supplying the same angiosome. The results of the present study might be used in future to increase the diameter and flow in SIEA when the vessel diameter found on preoperative imaging was too small for clinical microsurgical transfer. The drawback of the proposed delay procedure is the sacrifice of ipsilateral DIEA and an added operative procedure. STATEMENT: The clinical trial is registered with Clinical Trials (http://www.clinicaltrials.gov/). The clinical trial registration number is NCT01247129.

Isolated atherosclerotic aneurysm of the profunda femoris artery.

True aneurysms of the profunda femoris artery are extremely rare in comparison to pseudoaneurysms of the same artery. In most cases they are accompanied by aneurysms of the abdominal aorta or peripheral vessels. The most common reason for aneurysmic dilatation of vessels is a generalized vascular degenerative process. An isolated true aneurysm of the profunda femoris artery due to atherosclerosis is markedly unusual. These aneurysms have a high incidence of complication; therefore surgical management is mandatory for all diagnosed cases regardless of whether they are symptomatic or not. We describe a case of a 73-year-old man with a large isolated atherosclerotic aneurysm of the profunda femoris artery. He presented with an enlarging, progressively debilitating mass in his upper thigh. Ultrasound and computed tomography-angiography demonstrated a 15 x 14 cm large aneurysm of the profunda femoris artery. The patient was successfully treated by aneurysm neck ligation and sac decompression.

Infected femoral pseudoaneurysms from intravenous drug abuse in young adults.

Intravenous or parenteral drug abuse is the most common cause of infected femoral artery pseudoaneurysms (IFAP). This complication of intravenous drug abuse is not only limb threatening but can also be life threatening. The management of IFAP is difficult and controversial. Generally speaking, ligation and excision of the pseudoaneurysm without revascularization is accepted procedure in the majority of patients, with acceptable morbidity and low rate of limb loss. However, it is not an appropriate procedure for cases of acute interruption of the femoral artery flow, where a high probability of amputation is expected. We present four cases of young patients (average 19.5 years, range 17-24) with IFAP, where primary reconstruction was performed due to the absence of a Doppler signal over the pedal arteries after ligation of the common femoral artery. In two cases complications in the form of hemorrhage and repeated infection developed in the late postoperative period; in one case excision and ligation was performed, and in the last case reconstruction with a silver-impregnated dacron prosthesis. None of the patients required an amputation. Overall prognosis is uncertain because of the high incidence of postoperative drug injection despite aggressive drug rehabilitation.

Outcome of stenosis of the internal carotid artery after contralateral endarterectomy.

OBJECTIVES: The aim of the study was to evaluate clinical outcome and patterns of disease progression relating to stenosis of the internal carotid artery (ICA) opposite to the operated side, using ultrasonographic risk score of ICA plaques. METHODS: 150 patients who underwent ICA endarterectomy for transient ischemic attack (TIA) between January 1997 and December 2000 were studied prospectively. The progress (modified Strandness criteria) and ultrasonographic morphology of ICA plaques on the contralateral side were followed using digitally assisted plaque analysis. Parameters of the plaque image were analyzed and compared with neurologic events. RESULTS: Progression of contralateral stenosis from < 50% to 50-79% occurred in 11/105 patients (10.5%), all asymptomatic; from 50-79% to 80-99% in 10/31 patients (9.5%, one TIA). One patient progressed from the > 50% group to the 80-99% group and remained asymptomatic. After the progression of stenosis there were 32 patients with 50-79% stenosis and 25 with 80-99%. Among those with 50-79% stenosis, two patients developed symptoms (one TIA and one stroke). Among those with 80-99% stenosis, three patients developed symptoms (two TIAs and one stroke). Of the 105 patients who began with an initial contralateral stenosis of <50%, there remained 93; Seven developed symptoms appropriate to the contralateral carotid artery (four TIAs and three strokes). Life-table comparison (Cox's F test) of patients with < 50% stenosis (N = 93) and those with > 50% stenosis (N = 57, groups with > 50% stenosis taken together) showed no important statistical connection (F =1.71, p = 0.378). All plaques were heterogenous and there was no difference in global echogenicity. However, the activity index (AI) in patients with more than 50% stenosis (N=57, groups 50-79% and 80-99% together) was higher than 60 in 19 patients and lower than 60 in 38 patients. There were four neurologic events (three TIAs, one stroke) in the first group (AI > 60) and one neurologic event in the second (one stroke). Life-table comparison (Cox's F test) of the two groups based on the AI showed a significant difference (F=8.84, p=0.001). 18 patients were operated on the contralateral side on the basis of an elevated ultrasonographic AI. There was no morbidity or mortality in the operated group. CONCLUSIONS: Digitally assisted analysis of ultrasonographic ICA plaque morphology is unable to identify high-risk plaques in patients with less than 50% stenosis. In asymptomatic patients with more than 50% stenosis, an ultrasonographic plaque AI higher than 60 may contribute to a more objective selection of patients for operation.

The measurement of stenosis of the internal carotid artery: comparison of doppler ultrasound, digital subtraction angiography and the 3D CT volume rendering technique.

OBJECTIVES: To determine the variability of measurement of stenosis of the internal carotid artery (ICA) using Doppler ultrasound, digital subtraction angiography (DSA) and the three-dimensional volume rendering technique (3D CT) in the high-grade stenosis band (70-100%). DESIGN: A prospective study of preoperative findings in 64 patients. MATERIAL AND METHODS: Doppler ICA stenosis was assessed according to combined Doppler acoustic standard criteria (CDASC) and peak systolic velocity (PSV). DSA and 3D CT stenosis were measured using the NASCET method. The results were compared using kappa statistics and Pearson's correlation coefficient. RESULTS: Agreement on the degree of ICA stenosis was statistically very good for DSA and 3D CT (kappa = 0.81, CI 0.69-0.93): Pearson's correlation coefficient was 0.88 (CI 0.76-0.90). The comparison of Doppler ultrasound with DSA showed good agreement (kappa 0.70, CI 0.58-0.82): Pearson's correlation coefficient was 0.61 (CI 0.43-0.74). The disagreement rate on occlusion was 3% between DSA and 3D CT and was rather high (10.9%) between Doppler ultrasound and DSA. CONCLUSIONS: The clinical decision to operate on an ICA stenosis will be strongly influenced by the diagnostic method used. DSA and 3D CT correlate well, whereas Doppler ultrasound tends to differ at the high end of the high-grade stenosis band (90% occlusion), underestimating (compared with DSA) the degree of stenosis.

Reconstruction of the main portal vein for a large saccular aneurysm.

BACKGROUND: A large aneurysm of the main portal vein is rare, and the appropriate surgical procedure is uncertain. Reconstruction of a main portal vein affected by a large saccular aneurysm is described. CASE OUTLINE: Abdominal pain led to the diagnosis of a large saccular aneurysm of the main portal vein in a 58-year-old woman who had undergone cholecystectomy 10 years earlier. At laparotomy a dorsolateral approach to the hepatoduodenal ligament was performed with no attempt at extensive separate exposure of the anatomical structures in the hepatoduodenal ligament, so as to avoid the devascularisation of the common hepatic duct and additional weakening of the portal vein wall. The aneurysm was longitudinally incised, and the portal vein was reconstructed from the walls of the aneurysm with a longitudinal running suture. The rest of the aneurysmal wall was wrapped around the portal vein, leaving it normal in size and contour. Recovery was uneventful. Follow-up CT scan showed a patent portal vein in the region of the former aneurysm. DISCUSSION: Large saccular aneurysms can rupture, bleed and cause death. The potential hazards of manipulation of large portal vein aneurysms are negligible in comparison with the possible complications of the aneurysm itself. In our opinion the ease with which the main portal vein was dissected and reconstructed make an elective operation in such cases a reasonable approach.