Liability of Health Professionals Using Sensors, Telemedicine and Artificial Intelligence for Remote Healthcare.

In the last few decades, there has been an ongoing transformation of our healthcare system with larger use of sensors for remote care and artificial intelligence (AI) tools. In particular, sensors improved by new algorithms with learning capabilities have proven their value for better patient care. Sensors and AI systems are no longer only non-autonomous devices such as the ones used in radiology or surgical robots; there are novel tools with a certain degree of autonomy aiming to largely modulate the medical decision. Thus, there will be situations in which the doctor is the one making the decision and has the final say and other cases in which the doctor might only apply the decision presented by the autonomous device. As those are two hugely different situations, they should not be treated the same way, and different liability rules should apply. Despite a real interest in the promise of sensors and AI in medicine, doctors and patients are reluctant to use it. One important reason is a lack clear definition of liability. Nobody wants to be at fault, or even prosecuted, because they followed the advice from an AI system, notably when it has not been perfectly adapted to a specific patient. Fears are present even with simple sensors and AI use, such as during telemedicine visits based on very useful, clinically pertinent sensors; with the risk of missing an important parameter; and, of course, when AI appears "intelligent", potentially replacing the doctors' judgment. This paper aims to provide an overview of the liability of the health professional in the context of the use of sensors and AI tools in remote healthcare, analyzing four regimes: the contract-based approach, the approach based on breach of duty to inform, the fault-based approach, and the approach related to the good itself. We will also discuss future challenges and opportunities in the promising domain of sensors and AI use in medicine.

A Real-World Cost-Effectiveness Analysis of Rivaroxaban versus Vitamin K Antagonists for the Treatment of Symptomatic Venous Thromboembolism: Lessons from the REMOTEV Registry.

Background and objectives: Venous thromboembolism (VTE) represents a health and economic burden with consequent healthcare resource utilization. Direct oral anticoagulants (DOACs) have emerged as the mainstay option for VTE treatment but few data exist on their cost-effectiveness as compared to the standard therapy (vitamin K antagonists (VKAs)). This study aimed to assess the cost-effectiveness of rivaroxaban compared to VKAs in VTE treatment by calculating the incremental cost effectiveness ratio (ICER). Materials and methods: We conducted a prospective observational study based on the REMOTEV registry, including patients hospitalized for VTE from 23 October 2013 to 31 July 2015, to evaluate the impact of the anticoagulant treatment (DOACs versus VKAs) on 6-month complications: major or clinically relevant non-major bleeding, VTE recurrence and all-cause death. Rivaroxaban was the only DOAC prescribed in this study. The ICER was calculated as the difference in costs divided by the difference in effectiveness. Results: Among the 373 patients included, 279 were treated with rivaroxaban (63.1 ± 17.9 years old; 49% men) and 94 with VKAs (71.3 ± 16.6 years old; 46% men). The mean cost was EUR 5662 [95% CI 6606; 9060] for rivaroxaban and EUR 7721 [95% CI 5130; 6304] for VKAs, while effectiveness was 0.0586 95% CI [0.0114; 0.126] for DOACs and 0.0638 [95% CI 0.0208; 0.109] for VKAs. The rivaroxaban treatment strategy was dominant with costs per patient EUR 2059 lower [95% CI -3582; -817] and a higher effectiveness of 0.00527 [95% CI -0.0606; 0.0761] compared to VKAs. Conclusions: This study provides real-world evidence that rivaroxaban is not only an efficient and safe alternative to VKAs for eligible VTE patients, but also cost-saving.

A Real-World Cost-Effectiveness Study Evaluating Imaging Strategies for the Diagnostic Workup of Renal Colic in the Emergency Department.

Introduction Both non-contrast Computed Tomography (CT) and ultrasound (US) are used for the diagnosis of renal colic in the emergency department (ED). Although US reduces radiation exposure, its diagnostic accuracy is inferior to that of CT. In this context, data regarding the cost and organizational impact of these strategies represent essential elements in the choice of imaging; however, they remain poorly documented. Aim of the study The aim of this study was to compare the costs and effectiveness of diagnostic workup by US and CT for patients consulting with renal colic in the ED. Methods We conducted a monocentric real-life retrospective study of patients consulting for a renal colic in an ED between 1 July 2018 and 31 December 2018. We estimated length of stay (LOS), total hospital costs at 60 days including ED, and initial and repeat admissions. Patients with initial US in the ED were compared to patients with initial CT using inverse probability weighting of the propensity score calculated from demographic variables, vital parameters, and clinical presentation. We calculated the incremental cost effectiveness ratio as the difference in costs by the difference in LOS. The variability of the results was assessed using non-parametric bootstrapping. Results In this study, of the 273 patients included, 67 were patients assessed with US and 206 with CT. The average costs were €1159 (SD 1987) and €956 (SD 1462) for US and CT, respectively, and the ED LOS was 8.9 [CI 95% 8.1; 9.4] and 8.7 [CI 95% 7.9; 9.9] hours for US and CT, respectively. CT was associated with a decreased LOS by 0.139 [CI 95% -1.1; 1.5] hours and was cost-saving, with a €199 [CI 95% -745; 285] reduction per patient. Conclusion When imaging is required in the ED for suspected renal colic as recommended, there is real-life evidence that CT is a cost-effective strategy compared to US, reducing costs and LOS in the ED.

Organizational Benefits of Ultra-Low-Dose Chest CT Compared to Chest Radiography in the Emergency Department for the Diagnostic Workup of Community-Acquired Pneumonia: A Real-Life Retrospective Analysis.

Background and Objectives: Chest radiography remains the most frequently used examination in emergency departments (ED) for the diagnosis of community-acquired pneumonia (CAP), despite its poor diagnostic accuracy compared with ultra-low-dose (ULD) chest computed tomography (CT). However, although ULD CT appears to be an attractive alternative to radiography, its organizational impact in ED remains unknown. Our objective was to compare the relevant timepoints in ED management of CT and chest radiography. Materials and Methods: We conducted a retrospective study in two ED of a University Hospital including consecutive patients consulting for a CAP between 1 March 2019 and 29 February 2020 to assess the organizational benefits of ULD chest CT and chest radiography (length of stay (LOS) in the ED, time of clinical decision after imaging). Overlap weights (OW) were used to reduce covariate imbalance between groups. Results: Chest radiography was performed for 1476 patients (mean age: 76 years [63; 86]; 55% men) and ULD chest CT for 133 patients (mean age: 71 [57; 83]; 53% men). In the weighted population with OW, ULD chest CT did not significantly alter the ED LOS compared with chest radiography (11.7 to 12.2; MR 0.96 [0.85; 1.09]), although it did significantly reduce clinical decision time (6.9 and 9.5 h; MR 0.73 [0.59; 0.89]). Conclusion: There is real-life evidence that a strategy with ULD chest CT can be considered to be a relevant approach to replace chest radiography as part of the diagnostic workup for CAP in the ED without increasing ED LOS.

[Study of the links between type 2 diabetes and geriatric criteria]. / Étude des liens entre diabète de type 2 et critères gériatriques.

Type 2 diabetes in the elderly remains a major concern for all healthcare professionals and is itself considered a "global pandemic". Its prevalence is high and will continue to increase in years to come, becoming more and more prevalent in the elderly and very elderly. We offer a general summary of the work focusing on the links between type 2 diabetes and geriatric criteria.

Prognostic value of B lines detected with lung ultrasound in acute heart failure. A systematic review.

Pulmonary ultrasound is a simple diagnostic tool with immediate results for the assessment of pulmonary congestion in patients with heart failure (HF), allowing optimization of treatment by monitoring the dynamic changes identified. We aimed to evaluate the prognostic significance of the presence of B lines detected by lung ultrasound during hospitalization for heart failure. A search was conducted for scientific articles in PubMed, Embase, Google Scholar, and Cochrane databases including clinical trials, reviews, systematic reviews, and original articles that were related to the prognostic value of lung ultrasound in patients with HF in the last 5 years from 2016 to 2021. Studies including individuals aged ≥18 years evaluating the prognostic value of lung ultrasound in HF were included. Fourteen articles met inclusion criteria for analysis (three reviews, three systematic reviews with meta-analysis, six prospective studies, and two retrospective studies). The presence of more than 30-40 B lines at admission were considered a risk factor for readmission or mortality as was persistent pulmonary congestion with the presence of ≥15 B-lines. The presence of pulmonary congestion detected by lung ultrasound in acute heart failure has prognostic significance in terms of mortality and hospital readmission. Clinical trials are needed to evaluate whether diuretic therapy guided by lung ultrasound and the presence of B lines can reduce readmission and mortality in these patients.

The Conundrum of Occult Cancer Screening in Venous Thromboembolism: Lessons from the REMOTEV Registry.

(1) Background and Objectives: Venous thromboembolism (VTE) is strongly associated with cancer, and may be the first event revealing occult neoplasia. Nonetheless, the reasonable extent of the etiological assessment after an unprovoked VTE event remains debated. The main objective of this study was to evaluate the incidence of occult neoplasia one year after an episode of VTE, in consecutively hospitalized patients for VTE from the REMOTEV registry. The secondary objectives were to assess the performance of the various tests used for occult cancer screening in a real-life setting and analyze the risk factors associated with the discovery of cancer and the 1-year prognosis. (2) Methods: REMOTEV is a prospective, non-interventional cohort study of patients with acute VTE. Patients included in the registry from 23 October 2013 to 28 July 2018 were analyzed after a follow-up of 12 months. Cancer detection was performed according to local practices and consisted of a limited strategy to which an abdominal ultrasound was added. In the presence of suggestive clinical manifestations, further examinations were performed on an individual basis. (3) Results: A total of 993 patients were included in the study. At 1 year, the incidence of newly diagnosed cancer was low (5.3%). Half of the detected cancers were metastatic at discovery (51%) and had a poor global prognosis (32% of mortality at 1 year). Admission pulmonary CT scans as well as (thoracic)-abdomino-pelvic CT scans (when performed) were responsible for the majority of detected cancers. Age over 65 years and the concomitant presence of an unusual site and lower-limb deep vein thrombosis were the only factors associated with occult neoplasia in this cohort. After 1-year FU, mortality was higher in cancer patients (HR 6.0 (CI 95% 3.5−10.3, p < 0.0001)), and cancer evolution was the leading cause of death in the cancer group. (4) Conclusions: In REMOTEV, VTE-revealed occult cancer prevalence was low, but similar to recent reports and associated with higher age, multiple thrombotic sites and worse prognosis.

Interleukin 6 receptor inhibition in primary Sjögren syndrome: a multicentre double-blind randomised placebo-controlled trial.

OBJECTIVES: No immunomodulatory drug has been approved for primary Sjögren's syndrome, a systemic autoimmune disease affecting 0.1% of the population. To demonstrate the efficacy of targeting interleukin 6 receptor in patients with Sjögren's syndrome-related systemic complications. METHODS: Multicentre double-blind randomised placebo-controlled trial between 24 July 2013 and 16 July 2018, with a follow-up of 44 weeks, involving 17 referral centres. Inclusion criteria were primary Sjögren's syndrome according to American European Consensus Group criteria and score ≥5 for the EULAR Sjögren's Syndrome Disease activity Index (ESSDAI, score of systemic complications). Patients were randomised to receive either 6 monthly infusions of tocilizumab or placebo. The primary endpoint was response to treatment at week 24. Response to treatment was defined by the combination of (1) a decrease of at least 3 points in the ESSDAI, (2) no occurrence of moderate or severe activity in any new domain of the ESSDAI and (3) lack of worsening in physician's global assessment on a Visual Numeric Scale ≥1/10, all as compared with enrolment. RESULTS: 110 patients were randomised, 55 patients to tocilizumab (mean (SD) age: 50.9 (12.4) years; women: 98.2%) and 55 patients to placebo (54.8 (10.7) years; 90.9%). At 24 weeks, the proportion of patients meeting the primary endpoint was 52.7% (29/55) in the tocilizumab group and 63.6% (35/55) in the placebo group, for a difference of -11.4% (95% credible interval -30.6 to 9.0) (Pr[Toc >Pla]=0.14). CONCLUSION: Among patients with primary Sjögren's syndrome, the use of tocilizumab did not improve systemic involvement and symptoms over 24 weeks of treatment compared with placebo. TRIAL REGISTRATION NUMBER: NCT01782235.

Frostbite and Cold Agglutinin Disease: Coexistence of Two Entities Leading to Poor Clinical Outcomes.

An 83-year-old woman was admitted to the emergency department for a 7-day history of fatigue and progressive cyanosis in the feet and hands after cold exposure despite physical protective measures. Upon arrival, the patient presented with necrotic cutaneous lesions in both hands and distal lower extremities. Upon admission, hemoglobin was 7.6 g/dL and laboratory tests were consistent with cold agglutinin disease (CAD), the presence of monoclonal IgM, and flow cytometry consistent with lymphoplasmacytic lymphoma, but MYD88 L265P mutation was negative. The patient required blood transfusion, resulting in stabilized hemoglobin and a decrease in markers of hemolysis. Treatment with aspirin 250 mg daily and intravenous iloprost 0.5 mL/h was initiated with a poor clinical response at day 4. Amputation was required. Plasma exchange was performed and chemotherapy with rituximab and bendamustine was initiated. The clinical course was marked by further necrosis, prompting discussions regarding an additional amputation that was not performed considering the high surgical risk and refusal by the patient. Supportive treatment was initiated, and the patient expired one month after hospital admission.

Clinical Impact of the Time in Therapeutic Range on Early Hospital Readmission in Patients with Acute Heart Failure Treated with Oral Anticoagulation in Internal Medicine.

Background and objectives: Patients with heart failure (HF) often present with non-valvular atrial fibrillation and require oral anticoagulation with coumarin anticoagulants such as acenocoumarol. The objective of this study was to evaluate the relationship between time in therapeutic range (TTR) and the risk of early readmission. Materials and Methods: A retrospective descriptive study was carried out on hospitalized patients with a diagnosis of HF between 2014 and 2018 who had adverse effects due to oral anticoagulation with acenocoumarol (underdosing, overdosing, or hemorrhage). Clinical, analytical, therapeutic, and prognostic variables were collected. TTR is defined as the duration of time in which the patient's International Normalized Ratio (INR) values were within a desired range. Early readmission was defined as readmission within 30 days after hospital discharge. Patients were divided into two groups depending on whether or not they had a TTR less than 60% (TTR < 60%) over the 6 months prior to the adverse event. Results: In the cohort of 304 patients, the mean age was 82 years, 59.9% of the patients were female, and 54.6% had a TTR < 60%. Patients with TTR < 60% had a higher HAS-BLED score (4.04 vs. 2.59; p < 0.001) and INR (6 vs. 5.31; p < 0.05) but lower hemoglobin (11.67 vs. 12.22 g/dL; p < 0.05). TTR < 60% was associated with early readmission after multivariate analysis (OR: 2.05 (CI 95%: 1.16-3.61)). They also had a higher percentage of hemorrhagic events and in-hospital mortality but without reaching statistical significance. Conclusions: Patients with HF and adverse events due to acenocoumarol often have poor INR control, which is independently associated with a higher risk of early readmission.

Prognostic Value of the PROFUND Index for 30-Day Mortality in Acute Heart Failure.

Background and Objectives: The prevalence and incidence of heart failure (HF) have been increasing in recent years as the population ages. These patients show a distinct profile of comorbidity, which makes their care more complex. In recent years, the PROFUND index, a specific tool for estimating the mortality rate at one year in pluripathology patients, has been developed. The aim of this study was to evaluate the prognostic value of the PROFUND index and of in-hospital and 30-day mortality after discharge of patients admitted for acute heart failure (AHF). Materials and Methods: A prospective multicenter longitudinal study was performed that included patients admitted with AHF and ≥2 comorbid conditions. Clinical, analytical, and prognostic variables were collected. The PROFUND index was collected in all patients and rates of in-hospital and 30-day mortality after discharge were analyzed. A bivariate analysis was performed with quantitative variables between patients who died and those who survived at the 30-day follow-up. A logistic regression analysis was performed with the variables that obtained statistical significance in the bivariate analysis between deceased and surviving subjects. Results: A total of 128 patients were included. Mean age was 80.5 +/- 9.98 years, and women represented 51.6%. The mean PROFUND index was 5.26 +/- 4.5. The mortality rate was 8.6% in-hospital and 20.3% at 30 days. Preserved left ventricular ejection fraction was found in 60.9%. In the sample studied, there were patients with a PROFUND score < 7 predominated (89 patients (70%) versus 39 patients (31%) with a PROFUND score ≥ 7). Thirteen patients (15%) with a PROFUND score < 7 died versus the 13 (33%) with a PROFUND score ≥ 7, p = 0.03. Twelve patients (15%) with a PROFUND score < 7 required readmission versus 12 patients (35%) with a PROFUND score ≥ 7, p = 0.02. The ROC curve of the PROFUND index for in-hospital mortality and 30-day follow-up in patients with AHF showed AUC 0.63, CI: 95% (0.508-0.764), p <0.033. Conclusions: The PROFUND index is a clinical tool that may be useful for predicting short-term mortality in elderly patients with AHF. Further studies with larger simple sizes are required to validate these results.

[Prescribing inappropriate medication in the elderly: review of the main therapeutic scales]. / Prescription médicamenteuse inappropriée chez le sujet âgé : revue des principales échelles thérapeutiques.

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Report of a 'consensus' on the lines of therapy for primary immune thrombocytopenia in adults, promoted by the Italian Gruppo di Studio delle Piastrine.

Despite the publication in 2009 of a paper on 'terms and definitions of immune thrombocytopenia' (ITP), some unresolved issues remain and are reflected by the disagreement in the treatment suggested for primary ITP in adults. Considering that these disagreements could be ascribed to non-shared goals, we generated a 'consensus' on some terms, definitions, and assertions useful for classifying the different lines of treatment for primary ITP in adults according to their indications and goals. Agreement on the appropriateness of the single assertions was obtained by consensus for the following indicators: 1. classification of four 'lines of therapy'; 2. acceptance of the expression 'sequences of disease' for the indications of the respective four lines of treatment; 3I . practicability of splenectomy; 3Ib . acceptance, with only some exceptions, of a 'timing for elective splenectomy of 12 months'; and 4a-d . 'goals of the four lines of therapy.' On the basis of the consensus, a classification of four lines of treatment for primary ITP in adults was produced. In our opinion, this classification, whose validity is not influenced by the recently published new guidelines of the American Society of Hematology (ASH) and reviews, could reduce the disagreement that still exists regarding the treatment of the disease.

Anti-Ku syndrome with elevated CK and anti-Ku syndrome with anti-dsDNA are two distinct entities with different outcomes.

OBJECTIVE: To refine the spectrum of anti-Ku-associated disease, a condition that is equivocally described by current diagnostic criteria for connective tissue diseases. METHODS: Among 42 consecutive patients harbouring anti-Ku antibodies, subgroups with similar phenotypes and prognosis were delineated without an a priori diagnosis using hierarchical clustering analysis of the cumulative clinico-biological features recorded during the follow-up. Features present at baseline that most efficiently predicted the outcomes were then identified using a sensitivity-specificity sum maximisation approach. RESULTS: Clinico-biological features were clustered into three groups. Glomerulonephritis and ILD, the two fatal complications in this cohort, were unequally distributed between the three clusters that additionally differed on six clinico-biological features.Among features present at baseline, elevated serum level of creatine kinase (CK) and anti-dsDNA antibodies were generally mutually exclusive and most efficiently predicted the cluster belonging at last follow-up. Anti-Ku patients with elevated CK had a 22-fold higher risk of ILD while anti-Ku patients with anti-dsDNA antibodies had a 13-fold higher risk of glomerulonephritis CONCLUSION: "Anti-Ku with elevated CK" syndrome and "anti-Ku with anti-dsDNA" syndrome represent two distinct entities that are important to recognise in order to best tailor patient care.

[Geriatrics and e-technology in an institution]. / Gériatrie et e-technologie en Ehpad.

The objective of the GER-e-TEC™ project is to provide a personalised medical follow-up of residents in nursing homes with the aid of a telemedicine intelligent platform. It will assist the nursing staff by automatically processing information obtained from sensors and questionnaires in order to give an early warning about high-risk situations. This telemedicine tool will enable health professionals to optimise residents' care.

[Frailty scales to be used in emergency unit for elderly patients]. / Des échelles pour repérer la fragilité du sujet âgé aux urgences.

It is essential to carry it out in the emergency unit in order to improve the care of the elderly subject in a hospital setting. In this context, the role of nurse host organiser seems essential in order to optimize this care, reduce the duration of the hospital stay and anticipate possible risks of decompensation of geriatric syndromes.

[What to do before a hypervitaminia B12 in the elderly]. / Conduite à tenir devant une hypervitaminémie B12 chez le sujet âgé.

Hypervitanimia B12 is an early marker of serious pathologies. These include solid neoplasms, malignant blood diseases and acute/chronic hepatopathies. Hypervitaminemia B12 in geriatrics is thereby an indicator in the diagnosis and prognosis of these conditions.