0261: How to identify a risk for subsequent atrial fibrillation and higher risk of stroke in patients with hospitalization related to a cardiac cause?

A substantial part of ischemic strokes (IS) occurs in patients with atrial fibrillation (AF) and 20% of all strokes are attributed to AF. We aimed to identify patients with a cardiac condition without diagnosed AF at higher risk of having a subsequent diagnosis of AF.MethodsIn a French longitudinal cohort study based on the PMSI database covering hospital care for the entire population, we analyzed incidence rates of new onset AF.ResultsOf 1,081,969 patients with hospitalization due to a cardiac condition in 2009, 826,416 patients did not have AF in their history but had hypertension (51%), heart failure (24%), coronary artery disease (40%), rhythm or conduction disturbances with no AF (23%), and/or valve disease (9%). A total of 61,062 (7.4%) of these patients were diagnosed as having AF during a follow-up of 17±15 months (yearly AF incidence rate 5.19%). CHA2DS2-VASc score was higher in these patients (4.63±1.66 vs 2.83±1.98 in those with no AF during FU, p<0.0001). Among these 61,062 patients, 3,623 (5.9%) also suffered stroke during follow-up and CHA2DS2-VASc score was even higher in these patients (5.29±1.60 vs 4.59±1.65 in those with AF and no stroke during FU, p<0.0001). Among them, 967/3,623 (27%) had a stroke before AF was diagnosed.ConclusionA cardiac condition was associated with a substantial risk of AF (and stroke) during FU when CHA2DS2VASc score was higher

Utilization of 16S Ribosomal DNA Sequencing for Diagnosis of Septicemia Due to Neisseria elongata subsp. glycolytica in a Neutropenic Patient

Septicemia due to Neisseria elongata subsp. glycolytica occurs infrequently. We report a case of septicemia in a patient undergoing antimitotic chemotherapy. Gram-negative coccobacilli were isolated from blood cultures. The identity of the isolate by phenotypic methods was uncertain. In contrast, identity was confirmed by 16S ribosomal DNA sequencing, which appeared to be very useful for correct identification

Methodological expectations for demonstration of health product effectiveness by observational studies

International audienceThe issue of assessing the effectiveness of health technologies (drugs, devices, etc.) through observational studies is becoming increasingly important as registration and market access agencies consider them in their evaluation process. In this context, observational studies must be able to provide real demonstrations of a level of reliability comparable to those produced by the conventional randomized controlled trial (RCT) approach. The objective of the roundtable was to establish the acceptability criteria for an observational study (non-randomized, non-interventional study) to be able to provide these demonstrations, and possibly serve as a confirmatory study for registration and market access authorities, the construction of therapeutic strategies or the development of recommendations. In order to do this, the study must be a real confirmatory study respecting the hypothetical-deductive approach and guaranteeing the absence of HARKing and p-hacking by attesting to the establishment of a protocol and a statistical analysis plan, recorded before any inferential analysis. It must also be part of a formalized approach to causal inference and demonstrate that it correctly identifies the causal estimand sought. The study should ensure that there is no residual confusion bias by taking into account all confounding factors affecting the comparison, which should be determined by a formal approach (such as a graphical causality approach, DAGs). Residual confusion bias diagnoses by forgery and nullification analysis should be non-existent. The study shall be at low risk of bias, in particular selection bias, among others by using a target test emulation design. Overall type I error risk should be strictly controlled. The absence of selective publication of results and selection bias should be ensured

Patients With Ischemic Stroke and Incident Atrial Fibrillation

International audienceBackground and Purpose— A substantial part of ischemic strokes is attributed to atrial fibrillation (AF). We hypothesized that patients with ischemic stroke without prior diagnosed AF were at higher risk of having a subsequent diagnosis of AF, and this was associated with multiple risk factors. Methods— This French longitudinal cohort study was based on the national database covering hospital care from 2008 to 2012 for the entire population. Results— Of 65 807 patients with ischemic stroke in 2009, 48 992 did not have AF at baseline. A total of 4828 of these patients were diagnosed as having AF during a follow-up of 15±15 months (incidence rate 7.9 per 100 person-years). By comparison, the yearly rate of new-onset AF for the 826 416 patients with a cardiac hospitalization was 5.9%. CHADS 2 (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke/transient ischemic attack) and CHA 2 DS 2 -VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke/transient ischemic attack [doubled], vascular disease, age 65–75 years, and sex category [female]) scores were both associated with the risk of new-onset AF during follow-up (CHADS 2 : hazard ratio [HR] 1.70, 95% confidence interval [CI] 1.66–1.75; CHA 2 DS 2 -VASc: HR 1.45, 95% CI 1.42–1.48). The c statistics were 0.700 (95% CI 0.696–0.706) for CHADS 2 and 0.706 (95% CI 0.702–0.710) with CHA 2 DS 2 -VASc ( P =0.003 for comparison of the 2 scores). Independent predictors of subsequent diagnosis of AF were age 65 to 74 years (HR 2.29, 95% CI 2.06–2.54), age ≥75 years (HR 3.31, 95% CI 3.02–3.64), hypertension (HR 1.22, 95% CI 1.13–1.32), heart failure (HR 2.56, 95% CI 2.41–2.72), and vascular disease (HR 1.10, 95% CI 1.04–1.17). Conclusions— Ischemic stroke was associated with a substantially increased risk of incident AF, particularly among individuals with higher CHADS 2 or CHA 2 DS 2 -VASc scores. These risk scores seem to be simple tools for identifying patients at higher risk of incident AF after ischemic stroke

Real-life data and evidence in health technology assessment: when are they complementary, substitutes or the only source of data compared with clinical trials?

International audienceWithin the life-cycle assessment of health technologies, real-world data (RWD) have until now been of secondary importance to clinical trial data. The availability of massive, better quality RWD, particularly with the emergence of connected devices, the improvement of methods for characterizing populations, make it possible to have a better insight into the effects of treatment, sometimes on a national scale the importance of RWD is likely to progress in the eyes of health technology assessors, going from being traditionally complementary to possibly replacing clinical trial data. This is the fundamental question that the round table, involving experts from the academic and/or hospital, institutional, and industrial worlds, set out to answer. This work served first to establish the current role of RWD in health technology assessment, by distinguishing the main purposes of RWD, the timing of the evaluation in relation to the life cycle of the technology, and then according to the party commissioning or receiving the outcomes of RWD-based studies. Secondly, the round table proposed six general recommendations for more intensive and decisive use of RWD in the assessment and decision-making process