Management of Medico-Legal Risks in Digital Health Era: A Scoping Review

Artificial intelligence needs big data to develop reliable predictions. Therefore, storing and processing health data is essential for the new diagnostic and decisional technologies but, at the same time, represents a risk for privacy protection. This scoping review is aimed at underlying the medico-legal and ethical implications of the main artificial intelligence applications to healthcare, also focusing on the issues of the COVID-19 era. Starting from a summary of the United States (US) and European Union (EU) regulatory frameworks, the current medico-legal and ethical challenges are discussed in general terms before focusing on the specific issues regarding informed consent, medical malpractice/cognitive biases, automation and interconnectedness of medical devices, diagnostic algorithms and telemedicine. We aim at underlying that education of physicians on the management of this (new) kind of clinical risks can enhance compliance with regulations and avoid legal risks for the healthcare professionals and institutions.

Visibility of Chinese ad hoc medical interpreters through text ownership: A case study

Professional interpreters’ visibility in the European context has been widely discussed in the field of community interpreting, but the visibility of untrained ad hoc interpreters in non-European contexts such as China has received little academic attention. By adopting the concept of “text ownership” proposed by Angelelli (2004a), this study examines Chinese ad hoc interpreters’ manifestations of visibility in an authentic medical setting. Based on field observations, audio recordings and interviews, the study reports on four types of visibility demonstrated by ad hoc interpreters: (a) replacing the interlocutor; (b) expressing affect towards a patient; (c) exploring answers; and (d) brokering comprehension. Other forms of visibility are also identified, such as omissions of doctors’ or patients’ remarks and small talk between doctor and interpreter. Interpreters’ deeply held views on social factors as well as the institutional and social norms they have been exposed to are believed to influence their manipulation of medical discourses. This study concludes that in a context where professional medical interpreting services are unavailable, ad hoc interpreters may act as linguistic facilitators by taking on various roles that go beyond mere interpreting. However, their excessive visibility may give rise to potential clinical risks, especially when direct doctor–patient communication is compromised. Attention is drawn to the importance of proper training as well as to the need for the professionalization of medical interpreting in China.

Managing clinical risk retrospectively and prospectively with a risk management framework in an acute care hospital in Singapore

Objective: To expound on the implementation of the clinical risk management framework in an acute care hospital to minimise clinical risks and improve patient safety on account of systemic and human risk factors and patterns.Methods: The clinical risk management framework involves a 2-pronged approach through retrospective and prospective methods. The 5 stages of the retrospective approach include data collection, data aggregation, risk assessment and prioritisation, risk mitigation, and lastly, risk monitoring. The prospective approach entails horizon scanning which aims to detect risks early and ensure controls are swiftly implemented to prevent harm from arising. When combined, the framework seeks to be responsive to reduce the possibility and severity of patient harm. The number of incidents and risk scores for top clinical risks from 2016 to 2019 were monitored and studied to assess the effectiveness of the newly implemented clinical risk management framework.Results: When the clinical risk management framework was implemented in 2017, the number of incidents as well as corresponding risk scores for many of the identified clinical incident types and root causes decreased over the years. Most notably, two top clinical risks, results not being reviewed or delayed, and staff inadequate skills and knowledge, saw major improvements in risk scores.Conclusions: The systematic workflow of the 2-pronged clinical risk management framework allows the campus to manage risks comprehensively and efficiently. While retrospective risk analysis examines and reacts to reported clinical incidents, amidst volatile circumstances and advancements of technology exposing unprecedented risks in healthcare, prospective risk analysis conducted through horizon scanning is useful in anticipating and acting before harm arises, ultimately resulting in improved patient safety.

Combinatorial approaches using an AI/ML-driven drug development platform targeting insulin resistance, lipid dysregulation, and inflammation for the amelioration of metabolic syndrome in patients

Dysregulations of key signaling pathways leading to metabolic syndrome (MetS) are complex eventually leading to cardiovascular events and type 2 diabetes. Dyslipidemia induces progression of insulin resistance and provokes release of proinflammatory cytokines resulting in chronic inflammation, acceleration of lipid peroxidation with further development of atherosclerotic alterations and diabetes. We have proposed a novel combinatorial approach using FDA approved compounds targeting IL-17a and DPP4 to ameliorate a significant portion of the clustered clinical risks in patients with MetS. As MetS is considered a multifactorial disorder, the treatment measures cannot be focused on the specific pathway because other metabolic changes keep the pathological processes in progression. In our present research we have modeled an outcomes of metabolic syndrome treatment using two distinct drug classes. Targets were chosen based on the clustered clinical risks in MetS; dyslipidemia, insulin resistance, impaired glucose control, and chronic inflammation. The AI/ML platform, BIOiSIM, was used in narrowing down two different drug classes with distinct mode of action and modalities. Preliminary studies demonstrated that the most promising drugs belong to DPP-4 inhibitors and IL-17A inhibitors. Alogliptin was chosen to be a candidate for regulating glucose control with long term collateral benefit of weight loss and improved lipid profiles. Secukinumab, IL-17A sequestering agent used in treating psoriasis, was selected as a candidate to address inflammatory disorders. Our analysis suggests this novel combinatorial approach has a high likelihood of ameliorating a significant portion of the clustered clinical risk in MetS.

Measurement of Electrical Impedance Tomography-Based Regional Ventilation Delay for Individualized Titration of End-Expiratory Pressure

Rationale: Individualized positive end-expiratory pressure (PEEP) titration might be beneficial in preventing tidal recruitment. To detect tidal recruitment by electrical impedance tomography (EIT), the time disparity between the regional ventilation curves (regional ventilation delay inhomogeneity [RVDI]) can be measured during controlled mechanical ventilation when applying a slow inflation of 12 mL/kg of body weight (BW). However, repeated large slow inflations may result in high end-inspiratory pressure (PEI), which might limit the clinical applicability of this method. We hypothesized that PEEP levels that minimize tidal recruitment can also be derived from EIT-based RVDI through the use of reduced slow inflation volumes. Methods: Decremental PEEP trials were performed in 15 lung-injured pigs. The PEEP level that minimized tidal recruitment was estimated from EIT-based RVDI measurement during slow inflations of 12, 9, 7.5, or 6 mL/kg BW. We compared RVDI and PEI values resulting from different slow inflation volumes and estimated individualized PEEP levels. Results: RVDI values from slow inflations of 12 and 9 mL/kg BW showed excellent linear correlation (R2 = 0.87, p < 0.001). Correlations decreased for RVDI values from inflations of 7.5 (R2 = 0.68, p < 0.001) and 6 (R2 = 0.42, p < 0.001) mL/kg BW. Individualized PEEP levels estimated from 12 and 9 mL/kg BW were comparable (bias −0.3 cm H2O ± 1.2 cm H2O). Bias and scatter increased with further reduction in slow inflation volumes (for 7.5 mL/kg BW, bias 0 ± 3.2 cm H2O; for 6 mL/kg BW, bias 1.2 ± 4.0 cm H2O). PEI resulting from 9 mL/kg BW inflations were comparable with PEI during regular tidal volumes. Conclusions: PEEP titration to minimize tidal recruitment can be individualized according to EIT-based measurement of the time disparity of regional ventilation courses during slow inflations with low inflation volumes. This sufficiently decreases PEI and may reduce potential clinical risks.

Low-Dose Antibiotic Prophylaxis Induces Rapid Modifications of the Gut Microbiota in Infants With Vesicoureteral Reflux

Background and Objectives: Maturation of the gut microbiota (GM) in infants is critically affected by environmental factors, with potential long-lasting clinical consequences. Continuous low-dose antibiotic prophylaxis (CAP) is the standard of care for children with vesicoureteral reflux (VUR), in order to prevent recurrent urinary tract infections. We aimed to assess short-term GM modifications induced by CAP in infants.Methods: We analyzed the GM structure in 87 infants (aged 1-5 months) with high-grade VUR, previously exposed or naïve to CAP. Microbial DNA was extracted from stool samples. GM profiling was achieved by 16S rRNA gene-based next-generation sequencing. Fecal levels of short- and branched-chain fatty acids were also assessed.Results: 36/87 patients had been taking daily CAP for a median time of 47 days, while 51/87 had not. In all patients, the GM was predominantly composed by Bifidobacteriaceae and Enterobacteriaceae. Subgroup comparative analysis revealed alterations in the GM composition of CAP-exposed infants at phylum, family and genus level. CAP-exposed GM was enriched in members of Enterobacteriaceae and Bacteroidetes, especially in the genera Bacteroides and Parabacteroides, and showed a trend toward increased Klebsiella, often associated with antibiotic resistance. In contrast, the GM of non-CAP children was mostly enriched in Bifidobacterium. No differences were found in fatty acid levels.Conclusions: In infants with VUR, even a short exposure to CAP definitely alters the GM composition, with increased relative abundance of opportunistic pathogens and decreased proportions of health-promoting taxa. Early low-dose antibiotic exposure might bear potential long-term clinical risks.

Patent Foramen Ovale—A Not So Innocuous Septal Atrial Defect in Adults

Patent foramen ovale (PFO) is a common congenital atrial septal defect with an incidence of 15%–35% in the adult population. The development of the interatrial septum is a process that begins in the fourth gestational week and is completed only after birth. During intrauterine life, the foramen ovale allows the passage of highly oxygenated blood from the right to the left atrium and into the systemic arteries, thus bypassing the pulmonary circulation. In 75% of the general population, the foramen ovale closes after birth, and only an oval depression, called fossa ovalis, remains on the right side of the interatrial septum. Patent foramen ovale can be associated with various clinically important conditions, including migraine and stroke, or decompression illness in divers. The aim of this review is to summarize the PFO developmental and anatomical features and to discuss the clinical risks associated with this atrial septal defect in adults.

Is it safe to remove central lines in patients with platelets less than 20,000/uL

Background: Patients with tunnelled CVL may develop blood stream infections which at times are difficult to control without line removal. Concomitant severe thrombocytopenia with platelet transfusion refractoriness is often considered a hard contraindication to any procedure involving a major blood vessel. There is very little literature on the actual clinical risks of tunnelled central line removal in febrile pancytopenic patients. Procedure: We analysed complications and outcomes in all or patients, a total of 52, who underwent CVL removal with platelets <20,000/uL. Results: No bleeding episodes or unplanned transfusions could be associated with CVL removal. No other complications were also reported. All patients had time to hemostasis within 5 minutes of catheter removal. A total 31 patients were febrile at the time of CVL removal, of which 17 became afebrile within 2 days. We found no difference in response when comparing those whose antibiotic therapy was change/escalation versus those who did not. Removal of CVL under local anaesthesia remained complication-free even at platelets counts less than 20.000/uL. With only RDP support 17 lines were pulled out without any complications when platelets were below 5.000. Conclusion: Our findings suggest that central lines can be safely removed with platelet counts less than 20.000/ul and that this may result in enhanced blood stream infection control. This might be particularly relevant to neutropenic patients in this day and age of MDR germs emergence and paucity of new effective antibiotics.

Sosialisasi Resiko Non Klinis Pernikahan Usia Anak di SMAN I Gerung

This community service activity aims to provide knowledge in child marriage which can cause bad risks, so it is necessary to do prevention by delaying the age of marriage, continuing studies and planning life to be able to carry it out better. Given the appeal from the government not to carry out activities that involve many people, this service program is carried out through socialization in limited classes to be able to maintain the Health protocol with a number of participants less than 20 pesetas. The steps in the implementation of this service include: (1) Providing gradual education to students about the non-clinical risks of child marriage and its prevention; Non-clinical risks of child marriage; planning for the future and further studies, and the importance of education to continue a better life. (2) Conduct a question and answer session at the end of the delivery of socialization materials. (3) Evaluation of child marriage risk socialization program activities and program sustainability plans. The result of this community service activity is that students understand the non-clinical risks of child marriage and can plan for the future, by continuing their studies or by doing entrepreneurship.