Abstract Background P2Y12-ADP receptor blockade during percutaneous coronary intervention (PCI) is critical to prevent thrombotic events. In patients under chronic P2Y12 blockers, the use of ...additional loading dose (LD) before an elective PCI is debated. We aimed to investigate the rate of high on-treatment platelet reactivity (HTPR) in patients undergoing elective PCI during chronic clopidogrel or ticagrelor therapy. Methods and Results. We performed a sub-group analysis of a randomized trial comparing ticagrelor and clopidogrel in acute coronary syndrome (ACS) patients undergoing PCI. Multi-vessel disease patients requiring a staged PCI one month after the ACS were included. The VASP (Vasodilatatory phosphoprotein) index, which is a specific and reproducible platelet assay to measure P2Y12-ADP receptor activity, was used to assess the biological efficacy of the maintenance dose (MD) of ticagrelor and clopidogrel before PCI. Forty-one patients in each group of randomization required a staged PCI. They were similar regarding the baseline demographic, clinical and angiographic characteristics. The mean VASP index in the ticagrelor group was 20.7 ± 8.8% compared to 51.8 ± 17% in the clopidogrel group (p < 0.001) before PCI. No patients had a VASP index ≥ 50% in the ticagrelor group compared to 56% in the clopidogrel group (p < 0.001). Following PCI the rate of peri-procedural MI was higher in the clopidogrel group (p = 0.02). Conclusions Unlike clopidogrel MD, ticagrelor MD achieves an optimal PR inhibition in all patients during a staged PCI.
Antiplatelet agents are critical to prevent thrombotic events in patients with acute coronary syndromes, particularly those who undergo percutaneous coronary intervention. Prasugrel is a potent P2Y12 ...–adenosine diphosphate receptor antagonist that is superior to clopidogrel in such patients. Previous studies have observed that nuisance and internal bleedings were relatively frequent in patients under clopidogrel therapy and were associated with noncompliance. Furthermore, premature drug discontinuation is associated with thrombotic recurrences. The aim of the present study was to investigate the rate of nuisance or internal bleedings in patients receiving prasugrel and its relation with compliance. This prospective multicenter study included 396 patients. Bleeding events were recorded and classified as alarming, nuisance, or internal according. Compliance with prasugrel therapy was assessed. Almost half of the patients (48.5%) were included for ST-segment elevation acute coronary syndromes. During the 1-month follow-up period, 54 patients (13.6%) had bleeding events. Most bleeding events were classified as internal or nuisance (96%). Internal and nuisance bleedings were associated with high rates of prasugrel discontinuation (16.6% and 14.7%, respectively). Nuisance and internal bleedings were significantly associated with prasugrel discontinuation in multivariate analysis (odds ratio 3.1, 95% confidence interval 1.01 to 9.2, p = 0.04). The rate of major adverse cardiovascular events was 2.3%. No relation was observed between minor bleeds, compliance, and major adverse cardiovascular events. In conclusion, in the present study, minor bleedings were common during the first month after percutaneous coronary intervention and were significantly associated with prasugrel withdrawal.
Abstract Background Two methods have been recently developed from a drug reimbursement database to provide useful indicators for public health authorities concerning the abuse potential of ...psychotropic drugs. The doctor-shopping indicator (DSI) measures the proportion of the drug obtained by doctor shopping among the overall quantity of the drug reimbursed and the clustering method reveals subgroups of deviant patients. Objective The objective of the study was to analyze and compare indicators resulting from these two methods, applied to High Dosage Buprenorphine (HDB) (a product well-known to be diverted in France), in order to determine which public health authorities needs they answer. Data analysis The patients with reimbursed HDB were grouped using the clustering method in terms of drug dispensations characteristics over a nine month period. The characteristics of the resulting subgroups, including their DSI, were then compared. Results 4787 Patients (73.4%) had no measurable doctor-shopping behaviour. But the comparison of the two methods demonstrated that the more a patient's profile was characterized by deviant behavior, the higher was the DSI: from 0.4% in a subgroup with a median profile to 72% in a subgroup with a deviant profile. Conclusion These two methods are useful surveillance tools for public health authorities: the clustering method may help devise pertinent intervention strategies to reduce prescription drug abuse while the DSI method provides quantitative information demonstrating whether these strategies are useful. We discuss the advantages and disadvantages of using these two methods as useful indicators for public health authorities.
This prospective study aimed to analyze determinants that can influence bone mineral density evolution in childhood acute leukemia survivors. Patients included were selected from the long‐term ...follow‐up LEA cohort and had dual energy radiograph absorptiometry scan between 10 and 18 years and after the age of 18. All scans were centrally reviewed. Bone mineral density was measured at the lumbar spine, femoral neck, total hip, and whole body, and expressed as z‐score. Eighty‐nine patients (female 39, lymphoblastic leukemia 68, relapse 25, hematopoietic stem cell transplantation 44, and mean age 15.4 and 20.1 years at the first and second scans, respectively) were studied. The first and second scan z‐scores were significantly correlated (P < 10−3). Mean femoral neck and total hip z‐scores improved significantly between the first and second scans, whereas no significant evolution occurred at the lumbar spine and whole‐body level. On the second evaluation, 14.6% of patients had z‐score <−2 at the lumbar spine and 4.3% at the femoral neck level. Gender, type of leukemia, transplantation, relapse, cumulative corticosteroid doses, or growth hormone deficiency did not have any significant impact on z‐score variation. Younger age at diagnosis (≤8.5 years) proved an unfavorable risk factor for z‐score evolution at the lumbar spine (P = 0.041); the trend did not reach statistical significance for metabolic syndrome (P = 0.054). At the femoral neck, both were associated with unfavorable z‐score evolution (P = 0.003 and 0.025, respectively). Patients treated at a younger age and those with metabolic syndrome seem to be at higher risk of bone mineral density decline and should benefit from specific interventions.
Does positive Chlamydia trachomatis serology have an impact on the cumulative live birth rate from IVF?
A retrospective matched cohort study compared women with positive Chlamydia trachomatis ...serology (group A) who underwent IVF treatment between January 2016 and December 2021 with a control group of women with negative Chlamydia trachomatis serology (group B). The main outcome measures were the cumulative live birth rate per IVF cycle and the live birth rate per embryo transfer. Secondary outcomes were the cumulative rates of clinical pregnancy, ectopic pregnancy and pregnancy loss calculated per IVF cycle and per embryo transfer.
A total of 151 women in group A were matched 1:2 to 302 women in group B, representing 220 and 440 IVF cycles, respectively. Women with a history of Chlamydia trachomatis infection had a significantly higher rate of tubal obstruction (P < 0.001), excluded or operated hydrosalpinx (P = 0.002) and/or history of chronic endometritis (P < 0.001). There were no statistically significant differences between the two groups in the mean number of mature oocytes retrieved, fertilization rate or implantation rate. The IVF cumulative live birth rate per cycle was similar in the two groups (36.7% in group A versus 34.9% in group B, P = 0.692). The cumulative rates of clinical pregnancy, pregnancy loss, biochemical pregnancy and ectopic pregnancy were comparable between the two groups.
Positive Chlamydia trachomatis serology has no impact on IVF pregnancy outcomes.
Objectives
Polyuria‐polydipsia syndrome (PPS) is a common presentation in children but the differential diagnosis rests on burdensome water deprivation tests. The aims of this study were to determine ...a copeptin threshold to distinguish patients with central diabetes insipidus from those with primary polydipsia and to estimate the normal range of copeptin concentrations in children.
Design
Single‐centre retrospective descriptive study.
Patients
Two hundred and seventy‐eight children aged 2 months to 18 years who consulted for PPS (N = 40) or other reasons (control group, N = 238) at La Timone University Hospital in Marseille, France, between April 2015 and September 2019 and had a copeptin assay.
Measurements
Ultrasensitive copeptin assays on blood samples.
Results
Among the children with PPS, the mean copeptin concentrations were 1.72, 55.2 and 15.7 pmol/l in those with central diabetes insipidus (N = 21), nephrogenic diabetes insipidus (N = 3), and primary polydipsia (N = 16), respectively. Copeptin levels lower than 3.53 pmol/l were diagnostic of central diabetes insipidus with 100% sensitivity and 87.4% specificity (p < .001). The 5th–95th copeptin percentile range in the control group was 2.53–21.03 pmol/L. Copeptin levels were significantly higher in boys than in girls but there was no association with age, pubertal stage, body mass index, or the reason for consulting.
Conclusions
Our results indicate copeptin assays may be valuable in the differential diagnosis of PPS in children. Larger prospective studies are required to establish their accuracy in everyday clinical practice.
Does moderate-to-severe endometriosis have an impact on cumulative live birth rates (cLBR) and IVF outcomes?
In this retrospective matched cohort study, women with moderate-to-severe endometriosis ...undergoing IVF or intracytoplasmic sperm injection treatment from January 2015 to December 2020 were matched 1:2 to women with other causes of infertility (control group). The main outcome was cLBR per cycle and per woman, and secondary outcomes were number of oocytes retrieved and number of mature oocytes, fertilization rate, total number of embryos and usable embryos, implantation rate, clinical pregnancy rate and miscarriage rate per cycle.
In total, 195 women with endometriosis were matched with 390 women without endometriosis (323 and 646 cycles, respectively). Women with endometriosis had significantly fewer oocytes retrieved than women in the control group (P=0.003) despite higher doses of gonadotropins, but had a similar number of mature oocytes, fertilization rate, and total number of embryos and usable embryos. cLBR per cycle and per women did not differ significantly between the endometriosis group and the control group (19.8% versus 24.3%, P = 0.12; 32.3% versus 37.2%, P = 0.24, respectively). In women with endometrioma, a history of cystectomy did not impact cLBR per cycle (28.3% versus 31.9%, P = 0.68). We did not observe any significant impact of tobacco use in the endometriosis group compared with the control group (16.4% versus 25.9%, P = 0.13).
This matched cohort study did not observe a significant impact of moderate-to-severe endometriosis on cLBR among women undergoing IVF. These data are reassuring for the counselling of infertile women with endometriosis before IVF.
To evaluate the evolution of endometriomas with or without medical treatment.
This retrospective observational study was performed at the Gynaecological Center, Hôpital La Conception (Assistance ...Publique Hopitaux de Marseille). We reviewed clinical data of patients with at least one endometrioma diagnosed by magnetic resonance imaging (MRI) and at least one other MRI exam after more than three months. Patients were divided into groups receiving medical treatment and without medical treatment (high-dose progestins, low-dose progestins or combined contraceptives). The primary objective was to evaluate the evolution of endometriomas with or without hormonal treatment. The primary evaluation criterion was the diameter of the endometriomas, and the secondary evaluation criterion was the number of endometriomas for each patient observed. The secondary objective was to evaluate whether different categories of hormonal treatment have different efficacity in the evolution of endometriomas.
We included 68 patients, 39 (57,4%) with hormonal treatment and 29 (42,6%) without hormonal treatment. There were 105 total endometriomas identified at the first MRI, 52 in patients with hormonal treatment and 53 in patients without treatment. The mean diameter of the endometriomas in patients with hormonal treatment was 31,48 ± 18,1 mm at the first MRI and 23,60 ± 15,3 mm at the second MRI. The mean diameter of the endometriomas in patients without treatment was 33,57 ± 19,7 mm at the first MRI and 40,11 ± 25,7 mm at the second MRI (statistically significant difference, p = 0.01). The mean number of endometriomas in patients with treatment was 1,79 ± 1,1 at the first MRI and 1,18 ± 0,9 at the second MRI, while the mean number of endometriomas in patients without hormonal treatment was 1,38 ± 0,6 at the first MRI and 1,97 ± 1,5 at the second MRI (difference not statistically significant, p = 0.38). The subgroup analysis differentiated by category of hormonal treatment did not show statistically significant results.
The present study shows that there is a positive effect of hormonal treatment on reducing the diameter of endometriomas and also a significative increase in endometrioma size in the absence of treatment. There is no evidence of an advantage of a single category of hormonal treatment on this effect on endometriomas. Thus, any medical treatment could be proposed as a first-line therapy for endometriomas that would reduce the size of the endometrioma and thereby help to avoid surgical intervention.
To determine the quality of life (QoL) of school-aged children who were born <28
weeks of gestation and who have no resultant major disabilities.
A cross-sectional multicentre study of extremely ...preterm (EPT) infants born <28
weeks, discharged alive and free from severe impairments (cerebral palsy, autism, major cognitive disabilities). Two generic, self-evaluation and hetero-evaluation (by parent) QoL measurement questionnaires (Kidscreen 10/VSP-A) were used and then compared with French population reference.
Clinical examination, an assessment of cognitive functions and QoL between 7 and 10 years of age.
40 (7.5%) severely disabled children were excluded. Among those 471 eligible, the lost to follow-up group (169 (36%)) paralleled those 302 (64%) included in the study. The mean gestational age was 26.2 (±0.8), birth weight was 879 (±181) g and the mean age was 8.4 (±0.87) years. 48% of participants had minor or moderate cognitive disabilities based on their Full-Scale Index Quotient. Working memory, attention and mental flexibility scored as low-average. Except for family relationships, the EPT QoL VSP-A and Kidscreen 10 assessment were significantly lower based on the children's and parent's perspectives. Children reported the most significant QoL decline as (1) friends' relationships, (2) self-esteem and (3) leisure, while parents indicated (1) psychological well-being, (2) schoolwork and (3) vitality.
The QoL of a school-age EPT child without severe impairment was lower relative to a reference population from both the parents' and child's points of view. This evaluation should help to better understand the long-term outcomes and to provide better support for them and their families.
NCT01675726, pre-results.
Developing a measuring tool for physician's performance anxiety during obstetrical procedures, as a self-administered questionnaire.
We used the Delphi method. First, we did a literature review to ...identify the items to submit for the first round. A panel of experts was asked to rate the relevance of items from one to six. For the first round of Delphi, items were retained if more than 70% of respondents assigned a five or six rating. Items were excluded if more than 70% of respondents assigned a one or two rating. All the other items, plus those suggested by the panel, were submitted to a second round of Delphi. The same item selection conditions were applied to the second round.
The overall response rate to the Delphi was 79% (19 respondents). At the end of the first round, 14 items were consensually relevant, no item was consensually irrelevant. For the second round, the 18 items that did not find consensus and seven new items suggested by the experts in the first round were submitted. At the end of the second round, nine items were retained by consensus as relevant.
This study defined by consensus 23 items for a self-questionnaire to measure specific performance anxiety in obstetrics divided into five dimensions: perceived stress, assessment of the risk of complications, medico-legal risk, impact of the healthcare team and peers, self-confidence and decision-making confidence. We intend to validate this tool in real population.
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