The therapeutic Delta-equivalence. The large sample case

Projet SYSTOLSeveral approaches are given in the literature for therapeutic equivalence (the two one-sided test approach, the power approach, the confidence and Westlake intervals approaches, the UMP test approach) yielding distinct definitions. This paper is aimed at passing beyond this heterogeneity in order to propose a standard definition of therapeutic equivalence. We firstly show that there can be no absolute definition, and that we have to define \Dvalence, where \Dis a thresholdrdrd that has to be chosen from clinical considerations. Then we study the links and inconsistenci- es of the different approaches in the case of large samples (which allows us to come back to calculations with normal distributions). From the obtained results, we are able to propose the two one-sided test definition as a standard definition. We replace the p-value computation by that of an a posteriori limit value of $\Ds standard -i- definition is simple, it is identical to the UMP test definition in case of one-sided equivalence, and it is close to it in case of two-sided equivalence. We finally propose a strategy for equivalence trials and we initiate the discussion on the medical areas where equivalence should be investigated

Robot-based tele-echography: clinical evaluation of the TER system in abdominal aortic exploration

OBJECTIVE: The TER system is a robot-based tele-echography system allowing remote ultrasound examination. The specialist moves a mock-up of the ultrasound probe at the master site, and the robot reproduces the movements of the real probe, which sends back ultrasound images and force feedback. This tool could be used to perform ultrasound examinations in small health care centers or from isolated sites. The objective of this study was to prove, under real conditions, the feasibility and reliability of the TER system in detecting abdominal aortic and iliac aneurysms. METHODS: Fifty-eight patients were included in 2 centers in Brest and Grenoble, France. The remote examination was compared with the reference standard, the bedside examination, for aorta and iliac artery diameter measurement, detection and description of aneurysms, detection of atheromatosis, the duration of the examination, and acceptability. RESULTS: All aneurysms (8) were detected by both techniques as intramural thrombosis and extension to the iliac arteries. The interobserver correlation coefficient was 0.982 (P < .0001) for aortic diameters. The rate of concordance between 2 operators in evaluating atheromatosis was 84% +/- 11% (95% confidence interval). CONCLUSIONS: Our study on 58 patients suggests that the TER system could be a reliable, acceptable, and effective robot-based system for performing remote abdominal aortic ultrasound examinations. Research is continuing to improve the equipment for general abdominal use

Towards Explainable Predictive Models for Electronic Health Records

Early identification of patients at risk of developing complications during their hospital stay is currently a challenging issue in healthcare. Complications include hospitalacquired infections, admissions to intensive care units, and in-hospital mortality. Being able to accurately predict the patients' outcomes is a crucial prerequisite for tailoring the care that certain patients receive, if it is believed that they will do poorly without additional intervention. We consider the problem of complication risk prediction, such as inpatient mortality, from the electronic health records of the patients. We study the question of making predictions on the first day at the hospital, and of making updated mortality predictions day after day during the patient's stay. We develop distributed models that are scalable and interpretable. Key insights include analysing diagnoses known at admission and drugs served, which evolve during the hospital stay. We leverage a distributed architecture to learn interpretable models from training datasets of gigantic size. We test our analyses with more than one million of patients from hundreds of hospitals, and report on the lessons learned from these experiments

Clinical impact of the disposable ventouse iCup® versus a metallic vacuum cup: a multicenter randomized controlled trial

Experimental Protocole. (DOCX 55 kb

Patient referral is influenced by dialysis centre structure in the Diamant Alpin Dialysis cohort study

Background. Late referral (LR) to the nephrologist of patients with progressing chronic kidney disease (CKD) has numerous deleterious effects and is observed in many countries. The contributing factors associated with LR are controversial and poorly defined. We hypothesized that these factors might be better identified by analysing patients starting dialysis in three distinct European countries within the same area. Method. The referral and progression of kidney failure patterns were analysed with demographic, clinical and biological data in 279 non-selected consecutive patients starting dialysis in eight centres of three adjacent regions in France, Italy and Switzerland. Results. Early referral (>6 months before the start of dialysis) was seen in 200 patients (71.6%), intermediate referral (1-6 months) in 42 (15.1%) and LR (<1 month) in 37 (13.3%). However inter-centre variations were between 2 and 19% for LR and 6-50% for combined late and intermediate referral. There were no differences at the national levels, but LR was more frequent in the large city centres than in the private or regional structures, with 31 out of 169 (18.3%), two out of 55 (5.4%) and four out of 55 (7.3%), respectively, of their patients (P<0.01). By multivariate analysis, it appears that, besides the presence of an active cancer and the CKD progression rate, the centre structure and the referring physician (primary care physicians and nephrologists are less responsible for LR than other medical specialists) play a significant role in the practice of LR. Conclusions. Within a dialysis cohort spread over adjacent regions of three countries, LR has the same global distribution pattern, indicating that different health and social security systems do not play a major role in inducing or preventing this practice. The contributing factors for LR that were identified are the type of the referring physician and the structure of the dialysis unit. Both factors are potential targets for an educational and collaborative approac

TER: A Robot for Remote Ultrasonic Examination: Experimental Evaluations

This chapter: o Motivates the clinical use of robotic tele-echography o Introduces the TER system o Describes technical and clinical evaluations performed with TE

Uptake of new treatment strategies for deep vein thrombosis: an international audit

Objective. Study of the uptake of new medical technologies provides useful information on the transfer of published evidence into usual practice. We conducted an audit of selected hospitals in three countries (Canada, France, and Switzerland) to identify clinical predictors of low-molecular-weight (LMW) heparin use and outpatient treatment, and to compare the pace of uptake of these new therapeutic approaches across hospitals. Design. Historical review of medical records. Setting and participants. We reviewed the medical records of 3043 patients diagnosed with deep vein thrombosis (DVT) in five Canadian, two French, and two Swiss teaching hospitals from 1994 to 1998. Measures. We explored independent clinical variables associated with LMW heparin use and outpatient treatment, and determined crude and adjusted rates of LMW heparin use and outpatient treatment across hospitals. Results. For the years studied, the overall rates of LMW heparin use and outpatient treatment in the study sample were 34.1 and 15.8%, respectively, with higher rates of use in later years. Many comorbidities were negatively associated with outpatient treatment, and risk-adjusted rates of use of these new approaches varied significantly across hospitals. Conclusion. There has been a relatively rapid uptake of LMW heparins and outpatient treatment for DVT in their early years of availability, but the pace of uptake has varied considerably across hospitals and countrie