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Male and female drug prescription patterns and adverse drug reactions in chronic kidney disease.
No full textInternational audienceBackground: It is acknowledged that men and women differ with regard to pharmacological responses and adverse drug reactions (ADRs), and there is some evidence to suggest that ADR rates are higher in women. However, this topic has not been extensively explored in patients with chronic kidney disease (CKD). The objectives of the present study of a cohort of patients with CKD were to describe the types of drug prescriptions by sex and to examine potential differences between men and women in the incidence of ADRs.Methods: The French Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN) is a prospective cohort study including 3,011 nephrology outpatients with confirmed CKD (eGFR<60 mL/min/1.73 m²) and available data on drug prescriptions. Standard descriptive analyses were conducted to characterize drug prescriptions by gender through follow-up. ADRs were prospectively identified through hospitalization records, medical records, and patient interviews and adjudicated by expert pharmacologists using validated tools. Multivariable Cox proportional hazards model was used to explore the association between sex and ADRs.Results: Among the 3,011 included patients, 1,038 (34%) were women and 1,973 (66%) were men. Compared with men at baseline, women were younger (median [interquartile range] age: 69 [62-77] years vs 67 [58-76], respectively), and had a lower eGFR (mean ± standard deviation, 33.1±12.9 vs 34.7±13.2 mL/min/1.73 m²). Men and women presented some differences with regard to the types of drugs prescribed. Women were more often prescribed drugs for acid-related disorders, anemia, thyroid disorders, analgesics, and psychoactive drugs. Conversely, they were less often prescribed cardiovascular drugs and oral antidiabetics. During a median [interquartile range] follow-up period of 5.0 [3.6-5.2] years, 964 patients experienced a first ADR (incidence rates [95%CI]: 10.8 [9.6-11.9] per 100 person-years (PY) in women and 9.7 [9.0-10.5] in men). The most frequent ADRs were gastrointestinal disorders in women (n=59(17%)) and renal and urinary disorders in men (n=134 (22%)). The likelihood of a first ADR was higher in women than in men (adjusted HR [95%CI]: 1.17 [1.02;1.34]). However, the likelihood of a serious ADR did not differ by sex.Conclusions: In patients with CKD, significant differences between men and women were observed in drug prescriptions and ADR risks
OptiNeoCare: optimisation of routine care in the management of severe perinatal asphyxia in full-term or near-term newborns – study protocol for analysis of suboptimal care by confidential inquiries and e-self report
No full textInternational audienceIntroduction Severe perinatal asphyxia at term or near term remains a critical public health issue, associated with high risks of neonatal death and hypoxic-ischaemic encephalopathy (HIE). Despite improved clinical guidelines, suboptimal care persists in many cases, and previous audits have demonstrated that up to 50% of asphyxia cases could be associated with suboptimal care. OptiNeoCare is a French study which aims to assess the prevalence and determinants of suboptimal obstetric and neonatal care and evaluate its potential impact on neonatal outcomes. Materials and methods This prospective, population-based observational study will include newborns ≥36 weeks’ gestation with severe perinatal asphyxia across 12 French perinatal networks (213 maternity units). Inclusion criteria comprise neonatal death or moderate/severe HIE with confirmed biochemical markers of asphyxia. Data will be collected prospectively from labour wards, transport teams and neonatal intensive care units using an electronic case report form, and the in-situ team will be invited to complete a morbi-mortality review (MMR). Approximately 336 cases will be included over 12 months, with 25% randomly selected for confidential enquiry by two experts. The quality of care will be assessed based on a structured classification of medical errors (diagnostic, therapeutic, preventive and systemic) by a panel of experts including an obstetrician or midwife and a paediatrician. Root cause analysis will identify determinants of suboptimal care. A concordance analysis will compare findings from MMRs and confidential enquiries. Statistical analysis will include multivariable logistic regression to explore associations between care quality and neonatal outcomes. Ethics and dissemination Ethical approval was granted by the Ethics Committee for Research in Obstetrics and Gynaecology. Informed non-opposition is required from participants. Results will be shared with participating centres, healthcare professionals and through scientific dissemination. Trial registration number ClinicalTrials.gov ID: NCT06322732
Susceptibility Vessel Sign and Intravenous Alteplase in Stroke Patients Treated with Thrombectomy
No full textInternational audienceBackground: The susceptibility vessel sign (SVS) on baseline MRI in acute ischemic stroke patients has been associated with better outcomes post-thrombectomy. This study aimed to investigate whether the presence of the SVS modifies the treatment effect of intravenous thrombolysis plus endovascular thrombectomy (IVT + EVT) versus thrombectomy alone (EVT alone).Methods: In this secondary analysis of the SWIFT DIRECT trial, comparing IVT + EVT versus EVT alone, treatment effect and its heterogeneity were assessed with rates of pre-interventional reperfusion (eTICI 2a-3) and successful post-interventional reperfusion (eTICI of 2b-3) according to the SVS status using adjusted multivariable logistic regression. Secondary objectives were to analyze whether the presence of SVS or its individual characteristics (location, length, width, overestimation ratio, two-layered sign) were associated with outcomes.Results: 197 of the initial 408 trial participants were included in this secondary analysis, of which 52% received IVT + EVT. SVS was present in 92% of the participants (n = 181). There was no evidence for treatment effect heterogeneity regarding the post-interventional radiological and clinical effects of IVT + EVT versus EVT alone with strata of SVS. In SVS+ participants, IVT favored pre-interventional reperfusion (aOR 7.95, 95% CI 1.42-44.46), whereas in SVS-patients, it did not (P for interaction = 0.02). The individual SVS characteristics showed no significant associations with outcomes.Conclusion: Presence of SVS does not seem to modify the effect of IVT + EVT versus EVT alone. In SVS+ patients, IVT might improve pre-interventional reperfusion. There is insufficient evidence to recommend using SVS to inform IVT decisions prior to EVT
A Bundle of Interventions to Prevent Pressure Ulcers During Prone Position in Adult Patients With Acute Respiratory Distress Syndrome: Results of a French Stepped‐Wedge Randomized Controlled Trial
No full textInternational audienceBackground : In patients with moderate‐to‐severe acute respiratory distress syndrome, the frequency of pressure ulcers is higher in the prone position than in the supine position. Aim : To assess the effect of a bundle of interventions to prevent pressure ulcers in patients with acute respiratory distress syndrome prone. Study Design ESCARD is a stepped‐wedge prospective multicentre trial conducted in France that included patients with moderate‐to‐severe acute respiratory distress syndrome, intubated and with an indication for pronation. In the control period, patients received the routine means of each centre. In the experimental period, the bundle of specific standardized means included: eye protection with methylcellulose; strapped lower eyelids; 15° body inclination; specific cushions inserted between the mattress and head/thorax and knees/feet; head rotation every 4 h. The primary end‐point was the occurrence of a new pressure ulcer at any location and stage in the anterior part of the body 7 days after inclusion. It was assessed from pictures taken in the supine position and independently analysed by two experts blinded to the allocated period. Results From 16 April 2018 to 3 December 2020 (with an interruption between 12 March and 15 July 2020 because of COVID pandemic), a total of 160 patients were included in 9 centres; 156 were analysed. At the first proning session, all 6 specific preventive means were implemented in 1.2% of the patients in the control period and 91.8% in the experimental period. At Day 7, 53 patients (63.9%) in the control versus 40 (54.8%) in the experimental period had a new pressure ulcer at any location and of any stage (odds ratio = 0.92; 95% confidence interval [0.39; 2.18]). There was a 42.8% discrepancy between the two experts. Conclusions In this prospective multicentre stepped‐wedge trial, the bundle of interventions did not lead to a significant reduction in the frequency of new pressure ulcers in moderate‐to‐severe acute respiratory distress syndrome patients treated by prone position. Relevance to Clinical Practice The critical care nurses were able to manage patients enrolled in a complex trial up to its planned end. Even though negative, the study should encourage intensive care unit (ICU) nurses to better define the bundle of interventions including introducing other methods not used in the present study. ICU nurses should also assess the stage of pressure ulcers consistently over time. ICU nurses should consider further studies because pressure ulcer is a relevant issue of concern during the pronation in acute respiratory distress syndrome patients. If so, the new trial should include a larger number of ICUs. Trial Registration : The protocol was approved by an ethics committee (number 2017‐A01449‐44 on 7 October 2017) and was recorded in clinicaltrials.gov (NCT03125421
Bony alignment decisions affect patient‐specific laxity phenotype patterns significantly, independent of the deformity
No full textInternational audienceAbstract Purpose While bony alignment phenotype reconstruction became an important part of personalised knee arthroplasty, the knowledge on laxity phenotypes (LPs) is still limited. This study aimed to calculate individual LPs and assess their changes based on bony decisions from different alignment workflows. Methods Radiographs and computer‐assisted surgery data of 86 knees were imported into a validated knee alignment simulator. Individual bony parameters (medial proximal tibial angle, lateral distal femoral angle and posterior condyle axis) were first introduced. By that, the patient‐specific bony phenotype (B‐FKP) was implemented, and based on these simulations, the patient‐specific laxity phenotype (L‐FKP) was defined, calculated and analysed for the total group, as well as for all Coronal Plane Alignment of the Knee (CPAK) subgroups. CPAK I and IV were summarised as varus group; II and V as neutral, and III, VI and IX as valgus group. Identical calculations were then compared for the MA and L‐FKP of both workflows. LP was calculated in both extension (L‐FKPext) and flexion (L‐FKPflex), and a pattern matrix was constructed for all possible L‐FKP combinations, enabling a comprehensive distribution analysis. Statistical differences between subgroups and B‐FKP and mechanical alignment (MA) workflows were calculated. Results B‐FKP showed a minimal, non‐significant difference for L‐FKPext in all subgroups; however, a huge variability in L‐FKP pattern analysis. In contrast, MA showed a significant difference for L‐FKPext in all subgroups, with a high correlation between L‐FKPext and hip–knee–ankle angle. While in MA, 98% of knees showed lateral laxity (L‐FKPflex‐latlax), in B‐FKP, only 56% were L‐FKPflex‐latlax, with a large variability (31% L‐FKPflex‐neutr and 13% L‐FKPflex‐medlax). Conclusions Personalised bony resections reduce gap differences for LPext and LPflex independent of the deformity. MA showed a high correlation between deformity and LPext in extension and a uniform lateral laxity in flexion. L‐FKP analysis can help to understand the individuality of knees from a soft tissue aspect. Level of Evidence Level III
Is Carbohydrate Intolerance Associated With Carbohydrate Malabsorption in Disorders of Gut-Brain Interaction?
No full textInternational audienceINTRODUCTION: We aimed to explore the prevalence of carbohydrate (lactose and fructose) intolerance in patients with disorders of gut-brain interaction (DGBI) and to characterize those patients regarding gastrointestinal and nongastrointestinal symptoms. METHODS: Patients with DGBI who were referred to the physiology unit of our hospital between May 2022 and December 2023 for lactose (25 g) and fructose (25 g) breath tests were prospectively included. Patients were required to have a negative glucose breath test, before lactose and fructose breath tests, and to have completed the adult carbohydrate perception questionnaire during each breath test. Intolerance was defined as an increase of ≥20 mm in the Visual Analog Scale score from baseline in at least 1 of the 5 symptoms (pain, nausea, bloating, flatulence, and diarrhea) assessed with the adult Carbohydrate Perception Questionnaire. RESULTS: Among the 301 patients with DGBI included in our analysis, 178 (59.1%) had carbohydrate intolerance. Carbohydrate-intolerant patients were significantly more likely to be female ( P value < 0.001), to have 2 or more DGBI ( P value = 0.001), to have lactose maldigestion ( P value< 0.001) and fructose malabsorption ( P value = 0.023), higher irritable bowel syndrome and somatic symptom severity, and lower quality of life ( P value < 0.001) compared with patients without carbohydrate intolerance. The binary logistic regression showed that lactose maldigestion ( P value = 0.001), as well as somatic symptoms ( P value = 0.025), were independently associated with carbohydrate intolerance (Nagelkerke R Square = 0.206). DISCUSSION: Carbohydrate intolerance affects a substantial group of patients with DGBI, affecting their quality of life and symptom severity. Further research is needed to explore the underlying mechanisms in patients who do not have carbohydrate malabsorption/maldigestion
Severe scoliotic deformities: results of surgical treatment and complications in a multicentric series of children and young adults
No full textInternational audiencePurpose: The surgical management of severe spinal deformities (> 80°) in children and young adults remains challenging despite technical advances. Large, stiff curves with a short radius present a high complication rate, also in terms of acute or chronic spinal cord injury. There is a lack of consensus regarding the perioperative management of these curves, also due to the limited evidence available. This study aimed to review the strategies used in different hospitals for the surgical management of severe spinal deformities in young subjects and, in particular, to analyze the complication rate in a large series of patients.Methods: Multicentric, retrospective study on surgically treated patients younger than 25 with a coronal or sagittal deformity measuring at least 80°. Perioperative and radiographic data were collected. The rate of mechanical, neurologic, infectious, and other complications was analyzed, along with possible risk factors.Results: Data from 161 patients were analyzed. After surgery, there was a significant improvement of the deformity both on the coronal and sagittal plane. The overall complication rate was 25%. An increased angular ratio in the first postoperative X-ray was the main risk factor for the development of complications, along with a higher correction of the spinosacral angle. Performing a 3CO was associated with a higher risk of infections but not with a higher risk of mechanical complications. The use of an anterior approach did not increase the complication rate. A higher rate of non-mechanical and non-infectious complications was observed in patients who did not wear a brace or did not undergo halo traction before surgery.Conclusion: While spinal fusion is an effective treatment for the management of severe deformities, the rate of complications is still high
Comparison of induction with arsenic trioxide or chemotherapy in a real-world cohort of patients with high-risk acute promyelocytic leukemia
No full textInternational audienceFront-line treatment with all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) is superior to standard ATRA and chemotherapy (CHT) in patients with low-/intermediate-risk acute promyelocytic leukemia (APL). However, for high-risk (HR) patients (defined as those with a white blood cell count ≥ 10×10⁹/L), the role of ATRA-ATO is subject to debate, and study data are scarce. The objective for the present real-world cohort study was to assess the outcomes in 135 HR APL patients treated with ATRA-CHT or ATRA-ATO during induction at 12 French hospitals between 2010 and 2021. Of the 135 patients, 50 (37%) received ATRA-ATO as induction therapy (though combination with cytoreductive treatment was usually necessary), and 85 received standard ATRA-CHT ("CHT group"). The complete response rates were 90% in the ATRA-ATO group and 76% in the CHT group (p = 0.052). The five-year overall survival (OS) rate was significantly higher in the ATRA-ATO group (89.86% [95% confidence interval: 81.81-98.70]) than in the CHT group (72.69% [63.30-83.47]; p = 0.035). The combination of ATRA and ATO was effective and safe in this large, real-world cohort of HR APL patients. The forthcoming results of the APOLLO trial (a direct comparison of ATRA-ATO with ATRA-CHT) might validate our present findings
A “Trial within a Cohort” platform for pediatric clinical trials on idiopathic nephrotic syndrome: scope, objectives, and design of the retrospective-prospective cohort PIN’SNP
No full textInternational audienceBackground: Idiopathic nephrotic syndrome (INS) in children is the most common glomerular disease and is characterized by recurrent relapses. There is no community consensus on the treatment of relapsing forms of nephrotic syndrome in children, unlike that for the initial presentation. To date, available treatments only enable relapsing patients to be maintained in remission, rather than modifying the course of the disease; therefore, more therapeutic trials are needed. The Société de Néphrologie Pédiatrique (SNP) decided to implement within its French centers a national coordinated long-term clinical research program for children treated for INS based on a Trials within Cohorts (TwiCs) model. The aim of this paper is to describe the PIN'SNP cohort and research program as well as the TwiCs design adapted to INS research in the French regulatory system.Methods: This retrospective-prospective, multicenter research program will rely on a dynamic prospective cohort of children followed for an INS, known as the PIN'SNP cohort (i) to identify cases treated within SNP centers, (ii) to describe their clinical and epidemiological characteristics, and (iii) to provide a platform to nest prospective trials, and thus facilitate inclusion of patients in these future trials.Conclusions: The PIN'SNP cohort is the first French national pediatric platform dedicated to the implementation of randomized nested trials along with longitudinal and observational studies on INS in children. The adaptation of the TwiCs design to inform all eligible patients/parents to each nested trial will facilitate methodological robustness and ethical acceptability and reinforce communication between investigators and participants.Trial registration: number NCT04207580
Impact of excess weight on clinical features of psoriasis and efficacy of biologic therapies in children with severe psoriasis: Analysis of data from the BiPe cohorts
No full textInternational audienceBACKGROUND: Being overweight or obese is associated with both the occurrence of childhood psoriasis and increased severity thereof. We evaluated the impact of being overweight or obese on the clinical features of severe psoriasis in children treated with etanercept, adalimumab, or ustekinumab, and on the therapeutic effectiveness of these treatments using data from the BiPe cohorts. PATIENTS AND METHODS: Children from the BiPe cohorts with available baseline body mass index data were included. Data from two groups, "normal weight" and "overweight-to-obese" (OTO), and from two OTO subgroups, overweight and obese, were analyzed. RESULTS: Of the 134 children included, 98 (73.1%) were of normal weight, and 36 (26.9%) were OTO, including 21 (15.7%) overweight and 15 (11.2%) obese children. There were no between-group differences in age at psoriasis onset, family history, clinical features, or severity. Compared to the normal weight group, psoriatic arthritis was more frequent in the OTO group (5.1% versus 16.7% respectively; P = 0.03) and in the overweight and obese subgroups (5.1% versus 14.3% and 20.0%, respectively; P = 0.08). Analysis of PASI scores after 3 months of treatment suggested that biologic therapy efficacy was higher for the OTO group than the normal weight group. Drug continuation rates tended to be lower for the OTO group, particularly for adalimumab (P = 0.0002). DISCUSSION: OTO status was associated with a higher frequency of psoriatic arthritis in children with psoriasis. Except for lower rates of adalimumab continuation, overall biologic therapy efficacy was similar in the normal and OTO groups. Studies involving larger cohorts are needed to confirm these findings