Autonomous surgical robotic systems and the liability dilemma.

Background: Advances in machine learning and robotics have allowed the development of increasingly autonomous robotic systems which are able to make decisions and learn from experience. This distribution of decision-making away from human supervision poses a legal challenge for determining liability. Methods: The iRobotSurgeon survey aimed to explore public opinion towards the issue of liability with robotic surgical systems. The survey included five hypothetical scenarios where a patient comes to harm and the respondent needs to determine who they believe is most responsible: the surgeon, the robot manufacturer, the hospital, or another party. Results: A total of 2,191 completed surveys were gathered evaluating 10,955 individual scenario responses from 78 countries spanning 6 continents. The survey demonstrated a pattern in which participants were sensitive to shifts from fully surgeon-controlled scenarios to scenarios in which robotic systems played a larger role in decision-making such that surgeons were blamed less. However, there was a limit to this shift with human surgeons still being ascribed blame in scenarios of autonomous robotic systems where humans had no role in decision-making. Importantly, there was no clear consensus among respondents where to allocate blame in the case of harm occurring from a fully autonomous system. Conclusions: The iRobotSurgeon Survey demonstrated a dilemma among respondents on who to blame when harm is caused by a fully autonomous surgical robotic system. Importantly, it also showed that the surgeon is ascribed blame even when they have had no role in decision-making which adds weight to concerns that human operators could act as "moral crumple zones" and bear the brunt of legal responsibility when a complex autonomous system causes harm.

Predictors of Citation Rates in High-Impact Glioblastoma Clinical Trials.

Clinical trials are at the top of research study designs and tend to attract high citation numbers. Glioblastoma multiforme (GBM) is a multidisciplinary disease that continues to be the subject of peak research interest. In general, the literature relating to the predictors of citation rates in clinical trials remains limited. This review aims to identify the factors that influence citation numbers in high-impact GBM clinical trials. The 100 most cited GBM trials of any phase published from 1975 to 2019 were selected and reviewed. The primary analysis correlated citation numbers of articles with various trial and publication-related predictors using the Pearson correlation coefficient. The secondary analysis compared the mean citation numbers for different subgroups using the mean difference test. The median (range) citation number for the selected 100 trials was 349 (135-16,384). The primary analysis showed a significant correlation between citation numbers of articles and the study population (P = 0.024), trial phase (I-III) (P = 0.0427), and the impact factor (IF) of the journal (P < 0.0001). The secondary analysis demonstrated significantly higher mean citation numbers in all trials with the following features: study population ≥115 (P = 0.0208), phase III (P = 0.0372), treatment protocol including radiotherapy (P = 0.0189), temozolomide (TMZ) therapy (P = 0.0343), IF of the journal ≥14.9 (P = 0.02), and general medical journals (P = 0.28). We conclude that the most significant predictors of citation rates in high-impact GBM trials were the study population, trial phase, and journal's IF. The treatment protocol was a positive predictor when it included the currently widely accepted treatment modalities (radiotherapy and TZM). Randomization, age of publication, as well as the numbers of arms, authors, centers, countries, and references were not significant predictors. Increasing awareness of the factors that could affect citations may help researchers undertaking clinical trials to enhance the academic impact of their work.

Placebo Effect of Sham Spine Procedures in Chronic Low Back Pain: A Systematic Review.

BACKGROUND: The literature lacks information about the characteristics of the placebo effect following sham spine procedures for chronic low back pain. We aim to evaluate the effect using pain score data from the sham arms of published trials. METHODS: Relevant trials were selected and reviewed. Baseline and post-procedure pain scores were collected. Each follow up pain score was considered an episode and compared to its baseline for significance. Patients and episodes were pooled and analyzed using three parameters: patient reported outcome measures (PROMs) (Oswestry Disability Index [ODI], Visual Analog Scale [VAS], Numerical Rating Scale [NRS] and Short Form-36 [SF]), anatomical targets (disc, facet, sacroiliac joint [SIJ], ramus communicans nerve [RCN], basivertebral nerve [BVN], and caudal) and follow up periods (early: 0-2, intermediate: >2-4 and late: >4-6) in months. The percentage of pooled patients in the episodes that had significant reduction in pain scores was termed placebo effect. The outcome was defining the magnitude of the placebo effect and determining if it was influenced by the three parameters. RESULTS: Seventeen studies that reported 535 patients and 55 pain scoring episodes were considered eligible. Significant reduction in pain scores was reported in 21 episodes. The overall placebo effect among the patients during the studied period was 53.2%. The rate ranged according to PROMs from 42.4% to 72.1%, anatomical targets from 11.1% to 100% and follow up periods from 47.9% to 59%. The placebo effect differed significantly between the various domains in the three parameters. CONCLUSION: Placebo effect was observed in nearly half of the patients during the first 6 months following a sham spine procedure. The effect was influenced by utilized PROMs, anatomical target and follow up period. The findings should be considered in the design of new sham spine procedure trials. Further research is required to delineate the effect of bias on the findings.

State of the art: leadless ventricular pacing : A national expert consensus of the Austrian Society of Cardiology.

BACKGROUND: Cardiac pacing has been shown to improve quality of life and prognosis of patients with bradycardia for almost 60 years. The latest innovation in pacemaker therapy was miniaturization of generators to allow leadless pacing directly in the right ventricle. There is a long history and extensive experience of leadless ventricular pacing in Austria. However, no recommendations of national or international societies for indications and implantation of leadless opposed to transvenous pacing systems have been published so far. RESULTS: A national expert panel of skilled implanters gives an overview on the two utilized leadless cardiac pacing systems and highlights clinical advantages as well as current knowledge of performance and complication rates of leadless pacing. Furthermore, a national consensus for Austria is presented, based on recent studies and current know-how, specifically including indications for leadless pacing, management of infection, suggestions for qualification, and training of the operators and technical standards. CONCLUSIONS: Leadless pacing systems can be implanted successfully with a low complication rate, if suggestions for indications and technical requirements are followed. An overview of the two utilized leadless cardiac pacing systems is given, specifically highlighting clinical advantages as well as current knowledge of performance and complication rates. Furthermore, a national consensus for Austria is presented, specifically including indications for leadless pacing, management of infection, and suggestions for qualification and technical standards.

Pilot Study of Endothelin Receptor Blockade in Heart Failure with Diastolic Dysfunction and Pulmonary Hypertension (BADDHY-Trial).

BACKGROUND: In this multi-centre, randomised, placebo-controlled pilot trial, we investigated the clinical and haemodynamic effects of the endothelin-receptor blocker Bosentan in patients with heart failure, preserved ejection fraction and pulmonary hypertension (PH-HFpEF). MATERIALS AND METHODS: Eligible patients received either 12 weeks of Bosentan therapy, or a placebo drug. Patients were thereafter followed for a further period of 12 weeks without the study medication. At three points during the study (study Commencement, Week 12 and Week 24), a six-minute walk test (6MWT), echocardiographic and laboratory assessments were performed, as well as a quality of life survey. Right heart catheterisation (RHC) was undertaken at commencement only. The study was aborted early, after an interim analysis favoured the placebo. RESULTS: Six-minute walk distance (6MWD) did not change in the Bosentan group (309.7±96.3m (Commencement), 317.0±126.1m (Week 12), 307.0±84.4m (Week 24); p=0.86), but almost reached statistical significance in the placebo group from 328.8±79.6m, to 361.6±98.2m and 384.0±74.9m (Week 24); p=0.075. In the placebo group, estimated systolic pulmonary artery pressure (measured via echocardiography) significantly decreased (from 62.3±16.7mmHg [Commencement], 45.3±13.9mmHg [Week 12], to 44.6±14.5mmHg [Week 24]; p=0.014) as did right atrial pressure (13.1±5.3 [Commencement], 10.0±3.8 [Week 12], to 9.4±3.2 [Week 24]; p=0.046). CONCLUSION: Despite this study's limited sample size and premature cessation, it nevertheless suggests that endothelin receptor blockade in patients with PH-HFpEF may have no beneficial effects and could even be detrimental in comparison to a placebo.

A new oscillometric method for pulse wave analysis: comparison with a common tonometric method.

In the European Society of Cardiology-European Society of Hypertension guidelines of the year 2007, the consequences of arterial stiffness and wave reflection on cardiovascular mortality have a major role. But the investigators claimed the poor availability of devices/methods providing easy and widely suitable measuring of arterial wall stiffness or their surrogates like augmentation index (AIx) or aortic systolic blood pressure (aSBP). The aim of this study was the validation of a novel method determining AIx and aSBP based on an oscillometric method using a common cuff (ARCSolver) against a validated tonometric system (SphygmoCor). aSBP and AIx measured with the SphygmoCor and ARCSolver method were compared for 302 subjects. The mean age was 56 years with an s.d. of 20 years. At least two iterations were performed in each session. This resulted in 749 measurements. For aSBP the mean difference was -0.1 mm Hg with an s.d. of 3.1 mm Hg. The mean difference for AIx was 1.2% with an s.d. of 7.9%. There was no significant difference in reproducibility of AIx for both methods. The variation estimate of inter- and intraobserver measurements was 6.3% for ARCSolver and 7.5% for SphygmoCor. The ARCSolver method is a novel method determining AIx and aSBP based on an oscillometric system with a cuff. The results agree with common accepted tonometric measurements. Its application is easy and for widespread use.

[Selected results of occupational psychological studies of nurses]. / Ausgewählte Ergebnisse arbeitspsychologischer Untersuchugen bei Krankenschwestern.

Investigations were carried out in 81 nurses by industrial psychological methods. The kind of load is different by nurses in intensive care unit, by surgical nurses and by nurses in geriatrics. Particularly pain in the back, the shoulder and the nape, ergasthenia and exhaustion were declared. Skin troubles were declared about 20 percent. A report is given to interpret these findings.