Acquisition and usage of robotic surgical data for machine learning analysis.

BACKGROUND: The increasing use of robot-assisted surgery (RAS) has led to the need for new methods of assessing whether new surgeons are qualified to perform RAS, without the resource-demanding process of having expert surgeons do the assessment. Computer-based automation and artificial intelligence (AI) are seen as promising alternatives to expert-based surgical assessment. However, no standard protocols or methods for preparing data and implementing AI are available for clinicians. This may be among the reasons for the impediment to the use of AI in the clinical setting. METHOD: We tested our method on porcine models with both the da Vinci Si and the da Vinci Xi. We sought to capture raw video data from the surgical robots and 3D movement data from the surgeons and prepared the data for the use in AI by a structured guide to acquire and prepare video data using the following steps: 'Capturing image data from the surgical robot', 'Extracting event data', 'Capturing movement data of the surgeon', 'Annotation of image data'. RESULTS: 15 participant (11 novices and 4 experienced) performed 10 different intraabdominal RAS procedures. Using this method we captured 188 videos (94 from the surgical robot, and 94 corresponding movement videos of the surgeons' arms and hands). Event data, movement data, and labels were extracted from the raw material and prepared for use in AI. CONCLUSION: With our described methods, we could collect, prepare, and annotate images, events, and motion data from surgical robotic systems in preparation for its use in AI.

Simulation-based assessment of robotic cardiac surgery skills: An international multicenter, cross-specialty trial.

Objective: This study aimed to investigate the validity of simulation-based assessment of robotic-assisted cardiac surgery skills using a wet lab model, focusing on the use of a time-based score (TBS) and modified Global Evaluative Assessment of Robotic Skills (mGEARS) score. Methods: We tested 3 wet lab tasks (atrial closure, mitral annular stitches, and internal thoracic artery [ITA] dissection) with both experienced robotic cardiac surgeons and novices from multiple European centers. The tasks were assessed using 2 tools: TBS and mGEARS score. Reliability, internal consistency, and the ability to discriminate between different levels of competence were evaluated. Results: The results demonstrated a high internal consistency for all 3 tasks using mGEARS assessment tool. The mGEARS score and TBS could reliably discriminate between different levels of competence for the atrial closure and mitral stitches tasks but not for the ITA harvesting task. A generalizability study also revealed that it was feasible to assess competency of the atrial closure and mitral stitches tasks using mGEARS but not the ITA dissection task. Pass/fail scores were established for each task using both TBS and mGEARS assessment tools. Conclusions: The study provides sufficient evidence for using TBS and mGEARS scores in evaluating robotic-assisted cardiac surgery skills in wet lab settings for intracardiac tasks. Combining both assessment tools enhances the evaluation of proficiency in robotic cardiac surgery, paving the way for standardized, evidence-based preclinical training and credentialing. Clinical trial registry number: NCT05043064.

Insulin-Based Infusion System: Advancing the Development.

BACKGROUND: Deviations in glucose control in critical care have been shown to increase mortality and morbidity. However, optimal glucose control through present technologies has shown to be a challenge. The insulin balanced infusion system (IBIS) is a new and emerging technology. METHODS: The closed loop system was tested in a stress trial to evaluate glucose stability in response to various conditions in nonrandomized people with type 1 diabetes mellitus (n=12). The prototype used in this trial was based on intermittent capillary measurements. RESULTS: Induced stresses in the study using unpredicted stimuli of intravenous or oral glucose and intravenous insulin boluses, was contained with glucose remaining in target 43.8% of the time. Mean increase in glucose concentration after glucose load was 17.4 mg/dl; after insulin bolus, no hypoglycemia (blood glucose less than 70 mg/dl) occurred. CONCLUSION: The use of IBIS proved safe and feasible under a wide range of conditions. The sensing and stress response of the IBIS demonstrated noticeable features.

Insulin-Based Infusion System: Preliminary Study.

BACKGROUND: Optimal glucose control has been shown to be useful in critical care as well as in other settings. Glucose concentrations in patients admitted to critical care are characterized by marked variability and hypoglycemia due to inadequate sensing and treatment technologies. METHODS: The insulin balanced infusion system (IBIS) is a closed-loop system that uses a system controller, two syringe pumps, and capillary glucose sensor intravenously infusing regular insulin and/or dextrose. The IBIS performance was evaluated in terms of glucose stability in response to various conditions in subjects with type 1 and insulin requiring type 2 diabetes mellitus (n = 15) with frequent intermittent capillary measurements, entered into the system and an adaptive algorithm adjusting the treatment modalities without other nursing intervention. RESULTS: Target glucose concentrations (80-125 mg/dl) were achieved from hyperglycemic levels in 2.49 hours in the first study with mean and standard deviation of 105.2 mg/dl and 11.5 mg/dl, respectively. CONCLUSION: Preliminary studies using a prototype closed-loop glucose control system for critical care produced noticeable results. Improvements were initiated within the system and further studies performed.

Diabetic ketoacidosis and diabetes associated with antipsychotic exposure among a previously diabetes-naive population with schizophrenia: a nationwide nested case-control study.

AIMS/HYPOTHESIS: Diabetic ketoacidosis (DKA) is a potentially fatal metabolic emergency of both type 1 and type 2 diabetes. Although there is a reduced risk of type 1 diabetes in schizophrenia, the incidence of DKA is tenfold higher than that of the general population. Thus, we aimed to investigate associations between exposure to antipsychotic medication (within 3 months prior to event) and DKA, type 1 diabetes and type 2 diabetes. We also reported related, clinically relevant outcomes. METHODS: Using a nested case-control study design, we identified cases of DKA, type 1 diabetes and type 2 diabetes in a previously diabetes-naive population with schizophrenia in Denmark from 1995 to 2014. Cases were matched (by age, sex and year of schizophrenia onset) 1:5 to schizophrenic control individuals who were alive and had not emigrated prior to event. Conditional logistic regression was used to compute ORs with 95% CIs. Other outcomes included diabetes aetiology of DKA, in-hospital mortality, DKA readmissions and temporal trends of use of insulin and oral glucose-lowering agents. RESULTS: Of 29,955 individuals with schizophrenia, we identified 28 individuals with DKA, 90 with type 1 diabetes and 2140 with type 2 diabetes. These were matched to 137, 410 and 9861 individuals in the control group, respectively. Antipsychotic exposure was associated with DKA (OR 2.60; 95% CI 1.06, 6.38) and type 2 diabetes (OR 1.64; 95% CI 1.48, 1.83). A trend towards increased risk of type 1 diabetes was found but remained insignificant (OR 1.38; 95% CI 0.84, 2.29). Diabetes aetiology of DKA was type 1 in eight cases and type 2 in 14 cases. Of the remaining six cases of DKA, aetiology could not be determined, as four were fatal within 8 days and for two, no prescriptions for insulin and oral glucose-lowering agents were redeemed. Of all DKA cases, six had more than one episode of DKA, and of all type 1 diabetes and type 2 diabetes cases, four and 11, respectively, had at least one episode. Use of insulin and oral glucose-lowering agents was higher among individuals with DKA relative to those with type 1 diabetes and type 2 diabetes. CONCLUSIONS/INTERPRETATION: Antipsychotic exposure was associated with DKA and type 2 diabetes in a previously diabetes-naive schizophrenia population. Antipsychotic-associated DKA is relevant not only for psychiatrists but also for other physicians who may manage and admit such patients.

Antipsychotic treatment of schizotypy and schizotypal personality disorder: a systematic review.

Schizotypal personality disorder (SPD) is characterised by thought disorders, experiences of illusions, obsessive ruminations, bizarre or eccentric behaviour, cognitive problems and deficits in social functioning - symptoms that SPD shares with schizophrenia. Efforts have been undertaken to investigate the relationship between these conditions regarding genetics, pathophysiology, and phenomenology. However, treatment of SPD with antipsychotics has received less scientific attention. Embase and PubMed databases were searched using all known generic names of antipsychotics as search terms in combination with the following diagnostic terms: latent schizophrenia, schizotypal disorder, latent type schizophrenia, or SPD. Studies were categorised according to evidence level on the basis of their methodology from A, being the best, to E, being the worst. Five hundred and nine studies were retrieved and scrutinised. Sixteen studies, from the period 1972 to 2012, on antipsychotic treatment of SPD were extracted. Four studies were categorised as evidence level A, two as level B, six as level C and three as level D, with one study level E. Only four randomised, double-blind, placebo-controlled trials, on subjects with well-defined diagnoses, exists. Only amisulpride, risperidone and thiothixene have been studied according to evidence level A. This result warrants further high quality studies of the effects of antipsychotic treatment of SPD.

Adverse events in children and adolescents treated with quetiapine: an analysis of adverse drug reaction reports from the Danish Medicines Agency database.

Quetiapine is a low-affinity dopamine D2 receptor antagonist, approved for the treatment of bipolar disorder and schizophrenia in children and adolescents by the Food and Drug Administration, but not by European Medicine Agency. Although knowledge of adverse drug reactions in children and adolescents is scarce, quetiapine is increasingly being used for youth in Denmark. The aim of this case study is to discuss adverse drug events (ADEs) spontaneously reported to the Danish Medicines Agency on quetiapine used in the pediatric population in relation to adversive drug reactions (ADRs) reported in the European Summary of Product Characteristics (SPCs). The ADE report database at Danish Medicines Agency was searched for all quetiapine ADRs involving individuals (<18 years) in the period 1997-2015. Fifteen ADE case reports were retrieved, scrutinized, and categorized. The average age was 14.8 years (range 10-17 years) and six patients were boys. The main reported ADEs were (i) endocrine, for example, hyperprolactinemia and hyperthyroidism, (ii) cardiac, for example, tachycardia and QT prolongation, (iii) neurological, for example, seizures and cerebral hemorrhage, and (iv) psychiatric, for example, hallucinations. As some of the reported ADEs are life threatening and not listed as ADRs in the SPCs, off-label use of quetiapine in children and adolescents gives rise to safety concerns.

Diabetic ketoacidosis in patients exposed to antipsychotics: a systematic literature review and analysis of Danish adverse drug event reports.

RATIONALE: Patients exposed to second-generation antipsychotics (SGAs) have approximately 10 times increased risk of diabetic ketoacidosis (DKA) compared with the general population. However, as DKA is a rare complication of type 2 diabetes mellitus, and susceptible patients exposed to antipsychotics may rapidly develop DKA independently of treatment duration and weight gain, this is rather suggestive of type 1 diabetes mellitus (T1DM) or latent autoimmune diabetes in adults. OBJECTIVES: We performed a systematic review of current studies regarding antipsychotic-associated DKA with type 1 etiology and analyzed Danish adverse drug event (ADE) reports (previously unpublished cases). METHODS: PubMed, Embase, and the Cochrane Library were searched for all relevant studies, and the Danish Medicines Agency retrieved ADE reports using the Danish ADE database (up to date as of June 28, 2016). Diagnosis of antipsychotic-associated DKA with type 1 etiology was either considered confirmed or possible depending on authors' conclusions in the studies and/or clinical aspects. In addition, clinico-demographic risk factors were extracted. RESULTS: A total of 655 records and 11 ADE reports were identified, and after screening for eligibility, we included 21 case reports/series and two ADE reports (n = 24). No relevant clinical studies were included. Although fatal cases were identified, these were excluded because of diagnostic uncertainties (n = 15). DKA occurred in 15 males (62.5 %) and nine females (37.5 %), with a mean age ± standard deviation of 34.8 ± 12.4 years. Median time to DKA was 5 months (interquartile range: 1.4-11 months). Associated antipsychotics were olanzapine (n = 9, 36 %), aripiprazole (n = 6, 24 %), risperidone (n = 6, 24 %), clozapine (n = 3, 12 %), and quetiapine (n = 1, 4 %). Nine patients (37.5 %) were confirmedly diagnosed with T1DM following DKA resolution, whereas 15 patients (62.5 %) had possible T1DM. In 22 patients (91.7 %), ongoing insulin treatment was required for glycemic control. CONCLUSIONS: Increased awareness of the potential risk of antipsychotic-associated DKA and subsequent T1DM diagnosis, with insulin requirements for glycemic control, is warranted. The underlying mechanisms are poorly understood but most probably multifactorial. Certainly, further studies are warranted. Clinicians must utilize appropriate monitoring in susceptible patients and consider the possibility of continuing antipsychotic treatment with appropriate diabetic care.