Cost-effectiveness of endovascular thrombectomy for acute ischemic stroke with established large infarct in Germany: a decision tree and Markov model.

BACKGROUND: Recent studies, including the TENSION trial, support the use of endovascular thrombectomy (EVT) in acute ischemic stroke with large infarct (Alberta Stroke Program Early Computed Tomography Score (ASPECTS) 3-5). OBJECTIVE: To evaluate the cost-effectiveness of EVT compared with best medical care (BMC) alone in this population from a German healthcare payer perspective. METHODS: A short-term decision tree and a long-term Markov model (lifetime horizon) were used to compare healthcare costs and quality-adjusted life years (QALYs) between EVT and BMC. The effectiveness of EVT was reflected by the 90-day modified Rankin Scale (mRS) outcome from the TENSION trial. QALYs were based on published mRS-specific health utilities (EQ-5D-3L indices). Long-term healthcare costs were calculated based on insurance data. Costs (reported in 2022 euros) and QALYs were discounted by 3% annually. Cost-effectiveness was assessed using incremental cost-effectiveness ratios (ICERs). Deterministic and probabilistic sensitivity analyses were performed to account for parameter uncertainties. RESULTS: Compared with BMC, EVT yielded higher lifetime incremental costs (€24 257) and effects (1.41 QALYs), resulting in an ICER of €17 158/QALY. The results were robust to parameter variation in sensitivity analyses (eg, 95% probability of cost-effectiveness was achieved at a willingness to pay of >€22 000/QALY). Subgroup analyses indicated that EVT was cost-effective for all ASPECTS subgroups. CONCLUSIONS: EVT for acute ischemic stroke with established large infarct is likely to be cost-effective compared with BMC, assuming that an additional investment of €17 158/QALY is deemed acceptable by the healthcare payer.

Impact of the presence of a mediator on patient violent or uncivil behaviours in emergency departments: a cluster randomised crossover trial.

BACKGROUND AND IMPORTANCE: Several studies reported that violent behaviours were committed by patients against healthcare professionals in emergency departments (EDs). The presence of mediators could prevent or resolve situations of tension. OBJECTIVE: To evaluate whether the presence of mediators in EDs would have an impact on violent behaviours committed by patients or their relatives against healthcare professionals. Design, settings and participants A 6-period cluster randomised crossover trial was performed in 4 EDs during 12 months. Patients aged ≥18 and their relatives were included. INTERVENTION: In order to prevent or resolve situations of tension and conflict, four mediators were recruited.Outcome measure and analysis Using a logistic regression mixed model, the rate of ED visits in which at least one act of violence was committed by a patient or their relatives, reported by healthcare professionals, was compared between the intervention group and the control group. RESULTS: A total of 50 429 ED visits were performed in the mediator intervention group and 50 851 in the control group. The mediators reported 1365 interventions; >50% of the interventions were to answer questions about clinical management or waiting time. In the intervention group, 173 acts of violence were committed during 129 ED visits, and there were 145 acts of violence committed during 106 ED visits in the control group. The rate of ED visits in which at least one act of violence was committed, was 0.26% in the intervention group and 0.21% in the control group (OR = 1.23; 95% CI [0.73-2.09]); on a 4-level seriousness scale, 41.6% of the acts of violence were rated level-1 (acts of incivility or rudeness) in the intervention group and 40.0% in the control group. CONCLUSION: The presence of mediators in the ED was not associated with a reduction in violent or uncivil behaviours committed by patients or their relatives. However, the study highlighted that patients had a major need for information regarding their care; improving communication between patients and healthcare professionals might reduce the violence in EDs. TRIAL REGISTRATION: Clinicaltrials.gov (NCT03139110).

Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial.

BACKGROUND: Recent evidence suggests a beneficial effect of endovascular thrombectomy in acute ischaemic stroke with large infarct; however, previous trials have relied on multimodal brain imaging, whereas non-contrast CT is mostly used in clinical practice. METHODS: In a prospective multicentre, open-label, randomised trial, patients with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and a large established infarct indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3-5 were randomly assigned using a central, web-based system (using a 1:1 ratio) to receive either endovascular thrombectomy with medical treatment or medical treatment (ie, standard of care) alone up to 12 h from stroke onset. The study was conducted in 40 hospitals in Europe and one site in Canada. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days, assessed by investigators masked to treatment assignment. The primary analysis was done in the intention-to-treat population. Safety endpoints included mortality and rates of symptomatic intracranial haemorrhage and were analysed in the safety population, which included all patients based on the treatment they received. This trial is registered with ClinicalTrials.gov, NCT03094715. FINDINGS: From July 17, 2018, to Feb 21, 2023, 253 patients were randomly assigned, with 125 patients assigned to endovascular thrombectomy and 128 to medical treatment alone. The trial was stopped early for efficacy after the first pre-planned interim analysis. At 90 days, endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better outcome (adjusted common OR 2·58 [95% CI 1·60-4·15]; p=0·0001) and with lower mortality (hazard ratio 0·67 [95% CI 0·46-0·98]; p=0·038). Symptomatic intracranial haemorrhage occurred in seven (6%) patients with thrombectomy and in six (5%) with medical treatment alone. INTERPRETATION: Endovascular thrombectomy was associated with improved functional outcome and lower mortality in patients with acute ischaemic stroke from large vessel occlusion with established large infarct in a setting using non-contrast CT as the predominant imaging modality for patient selection. FUNDING: EU Horizon 2020.

Impact of a nurse education programme on oral feeding in a neonatal unit.

BACKGROUND: Premature neonates often experience feeding difficulties during their hospital stay, and evidence-based interventions have been shown to improve feeding outcomes. AIM: This study investigated whether an infant-cue based nurse educational feeding bundle accelerates the achievement of independent oral feeding in neonates in a neonatal intensive care unit. STUDY DESIGN: A quality improvement study with a pre, during and post intervention test design. All premature neonates admitted to the unit were eligible. The feeding programme included a four-month nurse training module and nurse coaching. RESULTS: A hundred and twenty-five nurses or nurse assistants attended the programme and 706 neonates were included. The median time to independent oral feeding (IOF) was 40, 36 and 37 days, respectively, for pre, during and post intervention. The reduction in time to IOF observed during the post-intervention period compared with the baseline period was significant (HR = 1.32, CI 95%: 1.01-1.74). No difference was noted in the length of hospital stay between the three study periods. CONCLUSIONS: An infant-cue based nurse educational feeding bundle can promote earlier achievement of IOF in preterm neonates. RELEVANCE TO CLINICAL PRACTICE: This quality improvement study demonstrates the impact that a nurse-driven intervention in neonatal care can have on improving practice. Feeding interventions involve the early introduction of oral feeding, non-nutritive sucking (NNS), and oral motor stimulation, and should be individualized for each neonate. These individualized feeding interventions applied by all nurses and assistant nurses, can facilitate the achievement of earlier independent oral feeding in preterm infants and should be included in neonatal critical care nurse education programs.

Co-design and evaluation of a patient-centred transition programme for stroke patients, combining case management and access to an internet information platform: study protocol for a randomized controlled trial - NAVISTROKE.

BACKGROUND: Stroke affects many aspects of life in stroke survivors and their family, and returning home after hospital discharge is a key step for the patient and his or her relatives. Patients and caregivers report a significant need for advice and information during this transition period. Our hypothesis is that, through a comprehensive, individualised and flexible support for patients and their caregivers, a patient-centred post-stroke hospital/home transition programme, combining an Internet information platform and telephone follow-up by a case manager, could improve patients' level of participation and quality of life. METHODS: An open parallel-group randomized trial will be conducted in two centres in France. We will recruit 170 adult patients who have had a first confirmed stroke, and were directly discharged home from the stroke unit with a modified Rankin score ≤3. Intervention content will be defined using a user-centred approach involving patients, caregivers, health-care professionals and social workers. Patients randomized to the intervention group will receive telephonic support by a trained case manager and access to an interactive Internet information platform during the 12 months following their return home. Patients randomized to the control group will receive usual care. The primary outcome is patient participation, measured by the "participation" dimension score of the Stroke Impact Scale 6 months after discharge. Secondary outcomes will include, for patients, quality of life, activation, care consumption, as well as physical, mental and social outcomes; and for caregivers, quality of life and burden. Patients will be contacted within one week after discharge, at 6 and 12 months for the outcomes collection. A process evaluation alongside the study is planned. DISCUSSION: Our patient-centred programme will empower patients and their carers, through individualised and progressive follow-up, to find their way around the range of available healthcare and social services, to better understand them and to use them more effectively. The action of a centralised case manager by telephone and the online platform will make it possible to disseminate this intervention to a large number of patients, over a wide area and even in cases of geographical isolation. TRIAL REGISTRATION: ClinicalTrials NCT03956160 , Posted: May-2019 and Update: September-2021.

A Positive Impact of an Observational Study on Breastfeeding Rates in Two Neonatal Intensive Care Units.

We aimed to investigate whether the participation in an observational study on breastfeeding (Doal) modified breastfeeding outcomes in enrolling neonatal intensive care units (NICUs). This bi-centric before-and-after study included neonates who were admitted during a 4-month period before and a 4-month period after the implementation of Doal. Breastfeeding intention and breastfeeding rates at discharge were compared between the two periods. The association between inclusion in Doal and breastfeeding at discharge was assessed among the infants fulfilling the inclusion criteria of Doal. The present study included 655 neonates. After adjustments, both breastfeeding (aOR 1.21, 95%CI [1.1; 1.4], p = 0.001) and exclusive breastfeeding (aOR 1.8, 95%CI [1.4; 2.3], p < 0.001) at discharge increased in the period after. Breastfeeding intention was higher in one center in the period after (79%) compared to before (59%, p = 0.019). Compared to the period before, neonates who were not included in Doal in the period after had a lower chance to be breastfed at discharge, whereas those included were more frequently exclusively breastfed. The participation in an observational study on breastfeeding was associated with an increase in breastfeeding outcomes in enrolling neonatal intensive care units (NICUs). Patients who are not included deserve attention as they are at risk to be disadvantaged regarding breastfeeding success.

VETCOSED study: efficacy of compressive garments for patients with hypermobile Ehlers-Danlos syndrome on shoulder stability and muscles strength.

PURPOSE: to assess the effect of wearing a compressive short-sleeve jacket on shoulder stability and rotator muscles in adult patients with a hypermobile subtype of Ehlers-Danlos syndrome. MATERIALS AND METHODS: a quasi-experimental study with "Pre/Post" design (4 weeks with versus 4 weeks without), open, conducted on a national cohort. Shoulder rotators were assessed with an isokinetic device at 180°/s and 90°/s; frequency of shoulder stability defects, pain (Visual Analogical Scale), and satisfaction (Quebec User Evaluation of Satisfaction with Assistive Technology) were reported. RESULTS: 36 patients (35 women), mean age 37.9 years, wore jackets for a meanly 7.8 h/day. >70% were satisfied with the effect on arthralgia, instability, or function. QUEST results were high (m = 4.1, SD = 0.7). After jacket wear, the power of external rotators at 180°/s was significantly increased (+1.29 W, CI95%: 0.31; 2.28; p = 0.0318). At 90°/s, no significant difference was found, either on power or strength. The on-off effect highlights a significant difference in external and internal rotators power, whatever the speed. The occurrence of subluxation (p = 0.0140) and dislocations (p = 0.0163) decreased. Pain decreased from 3.5/10 to 2.5/10, without significance (p = 0.0964). CONCLUSION: compressive CICATREX SED® jackets are well supported by patients, impact the power of external rotators at high speed (180°/s), and improve joint stability.IMPLICATIONS FOR REHABILITATIONCompressive garments made to measure are beneficial to patients with hypermobile Ehlers-Danlos syndrome.Compressive CICATREX SED® jackets clearly improve shoulder stability and help to promote muscle power in shoulder external rotators during high-speed movements.One month of jacket wearing seems to bring no lasting effect on shoulder-rotator power, so the jacket needs to be kept on for the benefits to be maintained.

HOMA indices as screening tests for cystic fibrosis-related diabetes.

BACKGROUND: We assessed the diagnostic performances of homeostasis model assessment indices (HOMA) of ß-cell function (HOMA-%ß) and of insulin resistance (HOMA-IR) for cystic fibrosis related diabetes (CFRD) screening. METHODS: Data were collected from a prospective cohort of 228 patients with CF (117 adults and 111 children). Fasting insulin and glucose levels were measured to calculate HOMA-%ß and HOMA-IR. HOMA-%ß <100 indicated insulin secretion deficiency and HOMA-IR >1 insulin resistance. Both were used to calculate sensitivity, specificity, and positive and negative predictive values (PPV and NPV). Two-hour oral glucose tolerance tests (2h-OGTT) defined CFRD. Analyses were conducted separately for children and adults. Performances of HOMA-%ß and HOMA-IR were calculated at inclusion, for each year of follow-up and for pooled data over the follow-up period. RESULTS: Sensitivity, specificity, NPV and PPV were respectively: 88%, 45%, 98% and 11% for HOMA-%ß and 42%, 48%, 91% and 6% for HOMA-IR in the pooled data of children; and 83%, 18%, 90% and 10% for HOMA-%ß, and 39%, 80%, 92% and 18% for HOMA-IR in the pooled data of adults. Combining HOMA-%ß and HOMA-IR did not improve performances. CONCLUSION: Within both age groups, HOMA-%ß <100 provided good sensitivity and NPV. HOMA-IR >1 had low sensitivity. Calculation of the HOMA-%ß could be an interesting first-line screening approach to exclude CFRD and thus avoid unnecessary OGTT in patients for whom value is ≥100. However, HOMA-%ß<100 does not support the diagnosis of CFRD and should be complemented by OGTT.

Efficacy of parent-mediated communication-focused treatment in toddlers with autism (PACT) delivered via videoconferencing: a randomised controlled trial study protocol.

INTRODUCTION: Intervention in the preschool period is currently recommended for autism spectrum disorder. Therapies delivered by parents are particularly suitable for young children. Preschool Autism Communication Trial (PACT) is a parent-mediated therapy that has shown a significant and sustained impact on autism symptom reduction. However, access to such evidence-based therapies for families is limited due to autism centres located in large urban areas. Using videoconferencing to deliver PACT training to parents may improve accessibility for families living in underserved areas. METHODS AND ANALYSIS: This single-blind randomised controlled trial, involving six sites in France, will investigate the efficacy of a telehealth, videoconferencing-based, parent-mediated PACT therapy on autism symptoms, over a 12-month period. It will compare PACT plus treatment as usual (TAU) against TAU only in a cohort of 238 toddlers (119 per group) aged 18-36 months at inclusion and living with their families more than 40 min away from the specialist centres for autism. Primary outcome will include change of overall autism score on the Autism Diagnostic Observation Scale (ADOS) at 12 months. Secondary outcomes will measure change in child skills, child functioning, impact on parents (stress, health, priorities) and implementation characteristics. Repeated measures analyses will be used to test the effect of PACT intervention on the overall ADOS module 1 score over the 12-month study period. Linear mixed models will be used with time, treatment allocation and the interaction between treatment and time as fixed effects and individual variation as random effect. ETHICS AND DISSEMINATION: This protocol (V.5, date: 25 October 2019) is approved by the French National Review Board (reference no 2018-A02516-49). The results will be disseminated via peer-reviewed journals TRIAL REGISTRATION NUMBER: NCT04244721.

Impact of 1h oral glucose tolerance test on the clinical status of adult cystic fibrosis patients over a 4-year period.

OBJECTIVE: To report the clinical profile associated with G60 and I60 over a 4-year prospective observational period in 2 large cohorts of adult patients with CF. METHODS: 319 patients were included (210 Canadian and 119 French) and classified according to their inclusion G60 (≥ or < 11.1 mmol/L) and the median inclusion I60 (≥ or < 24 mU/I). Forced expiratory volume in 1 second (FEV1), body mass index (BMI) were collected on OGTT days. Linear mixed regression models were used to assess the effect of G60 and I60. RESULTS: High G60 was not associated to a lower FEV1 at inclusion and the follow-up decline was not higher in the high G60 group (Coefficient [95% CI]: -3.4 [-7.4;0.6], p = 0.0995.). There was no significant association between BMI and G60. Patients with high I60 tended to have a higher mean BMI (+0.5 kg/m2 [0.0 to 1.1], p = 0.05) but no interaction over time was observed. CONCLUSIONS: High G60 is not associated with a lower lung function at inclusion nor its decline over a 4-year follow-up. High I60 is slightly associated to a higher weight at inclusion, but not with BMI evolution over time in adult patients.

Human Papilloma Virus Vaccination Among Female Patients Attending French Pediatric Cystic Fibrosis Centers.

STUDY OBJECTIVE: To describe human papilloma virus (HPV) vaccination practice among adolescent girls with cystic fibrosis (CF) and to identify reasons for non-vaccination. DESIGN: Cross-sectional multicentric study. SETTING AND PARTICIPANTS: Girls aged 9-17 years, attending 7 French pediatric CF centers, and their accompanying adult. INTERVENTIONS: Administration of a self-report questionnaire. MAIN OUTCOME MEASURES: The proportion of girls having received or receiving HPV vaccination, compliance with the vaccination schedule, factors associated with vaccination, and reasons for vaccination and for non-vaccination. RESULTS: A total of 113 girls and 104 accompanying adults participated. The mean age was 13.6 years (standard deviation 2.5; range 9-17). A total of 34 (30.9%) patients reported having received HPV vaccination. Among the 34 girls aged 15 years or older, 15 (44.1%) were vaccinated. Most patients (58.8%) started vaccination between 11 and 14 years of age (mean age 13.9). Most vaccine prescriptions (67.6%) were made by a CF center health care provider. Factors associated with vaccination were older age (odds ratio [OR] = 1.27, 95% confidence interval [CI] = 1.01-1.6, P = .037 for each year older), previous vaccination by the accompanying parent of one of their children for hepatitis B (OR = 8.01, 95% CI = 0.96-67.02), P = .055), and parental influence on decision-making (OR = 2.77, 95% CI = 0.97-7.95, P = .058). Health care providers' positive advice and fear of HPV-related disease were the main reasons given to justify vaccination decisions. Insufficient knowledge and concerns about potential side effects were the main barriers. CONCLUSION: HPV vaccination remains insufficient among girls with CF. CF health care providers may play a crucial role in HPV vaccination acceptance, and their sensitization to cervical cancer prevention is mandatory.

Narrow-band imaging versus Lugol chromoendoscopy for esophageal squamous cell cancer screening in normal endoscopic practice: randomized controlled trial.

BACKGROUND: Narrow-band imaging (NBI) is as sensitive as Lugol chromoendoscopy to detect esophageal squamous cell carcinoma (SCC) but its specificity, which appears higher than that of Lugol chromoendoscopy in expert centers, remains to be established in general practice. This study aimed to prove the superiority of NBI specificity over Lugol chromoendoscopy in the detection of esophageal SCC and high grade dysplasia (HGD) in current general practice (including tertiary care centers, local hospitals, and private clinics). METHODS: This prospective randomized multicenter trial included consecutive patients with previous or current SCC of the upper aerodigestive tract who were scheduled for gastroscopy. Patients were randomly allocated to either the Lugol or NBI group. In the Lugol group, examination with white light and Lugol chromoendoscopy were successively performed. In the NBI group, NBI examination was performed after white-light endoscopy. We compared the diagnostic characteristics of NBI and Lugol chromoendoscopy in a per-patient analysis. RESULTS: 334 patients with history of SCC were included and analyzed (intention-to-treat) from 15 French institutions between March 2011 and December 2015. In per-patient analysis, sensitivity, specificity, positive and negative likelihood values were 100 %, 66.0 %, 21.2 %, and 100 %, respectively, for Lugol chromoendoscopy vs. 100 %, 79.9 %, 37.5 %, and 100 %, respectively, for NBI. Specificity was greater with NBI than with Lugol (P = 0.002). CONCLUSIONS: As previously demonstrated in expert centers, NBI was more specific than Lugol in current gastroenterology practice for the detection of early SCC, but combined approaches with both NBI and Lugol could improve the detection of squamous neoplasia.

Impact of a paediatric-adult care transition programme on the health status of patients with sickle cell disease: study protocol for a randomised controlled trial (the DREPADO trial).

BACKGROUND: Thanks to advancements in medical care, a majority of patients with sickle cell disease (SCD) worldwide live beyond 18 years of age, and therefore, patients initially followed in paediatric departments are then transferred to adult departments. This paediatric-adult care transition is a period with an increased risk of discontinuity of care and subsequent morbidity and mortality. During this period, the patient will have to manage new interlocutors and places of care, and personal issues related to the period of adolescence. To take into consideration all these aspects, an interesting approach is to use the whole system approach to the patient, as presented in the biopsychosocial approach. The aim of this trial is to evaluate the impact of the proposed biopsychosocial paediatric-adult transition programme. METHODS: The DREPADO study is a multicentre randomised control trial comparing a control group (Arm A) to an interventional group with a paediatric-adult transition programme based on a biopsychosocial approach (Arm B). To be included, patients should have the SS, SC, or Sß form of sickle cell disease and be aged between 16 and 17 years. The randomisation in a 1:1 ratio assigns to Arm A or B. The primary outcome is the number of hospital admissions and emergencies for complications in the index hospital, in the 2 years after the first consultation in the adult department of care. Secondary outcomes consider the quality of life, but also include coping skills such as sense of self-efficacy and disease knowledge. To provide patient and parent knowledge and coping skills, the transition programme is composed of three axes: educational, psychological, and social, conducted individually and in groups. DISCUSSION: By providing self-care knowledge and coping skills related to SCD and therapeutics, helping empower patientsin relation to pain management and emotions, and facilitating the relationship to oneself, others, and care in Arm B of the DREPADO study, we believe that the morbidity and mortality of patients with SCD may be reduced after the proposed paediatric-adult transition programme. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03786549; registered on 17 December 2018; https://clinicaltrials.gov/.

Breastfeeding peer counselling for mothers of preterm neonates: protocol of a stepped-wedge cluster randomised controlled trial.

INTRODUCTION: Among preterm infants, mother's own milk feeding reduces neonatal morbidity and decreases the length of hospital stay. However, breastfeeding rates and duration are lower than among term infants. It is reported that peer counselling is effective in increasing breast feeding in term infants in low-income and middle-income countries, but results are mixed in high-income countries. We aim to investigate herein whether peer counselling may be a feasible and effective breastfeeding support among preterm infants in French-speaking high-income countries. METHODS AND ANALYSIS: Eight European centres will participate in this stepped-wedge cluster randomised controlled trial. We plan to include 2400 hospitalised neonates born before 35 gestational weeks. Each centre will begin with an observational period. Every 3 months, a randomised cluster (centre) will begin the interventional period with peer counsellors until the end of the study. The counsellors will be trained and supervised by the trained nurses. They will have a weekly contact with participating mothers, with a face-to-face meeting at least once every fortnight. During these meetings, peer counsellors will listen to mothers' concerns, share experiences and help the mother with their own knowledge of breast feeding. The main outcome is breastfeeding rate at 2 months corrected age. Secondary outcomes are breastfeeding rates at hospital discharge and at 6 months, breastfeeding duration and severe neonatal morbidity and mortality. The mental health of the mother, mother-infant bonding and infant behaviour will be assessed using self-report questionnaires. A neurodevelopmental follow-up, a cost-effectiveness analysis and a cost-consequence at 2 years corrected age will be performed among infants in a French subgroup. ETHICS AND DISSEMINATION: French, Belgian and Swiss ethics committees gave their agreement. Publications in peer-reviewed journals are planned on breast feeding, mental health and economic outcomes. TRIAL REGISTRATION NUMBER: NCT03156946.

Pregnancy outcome in women with cystic fibrosis and poor pulmonary function.

BACKGROUND: To investigate how poor pre-gestational pulmonary function influenced pregnancy outcome and clinical status evolution in women with cystic fibrosis. METHODS: Pregnancies in women without lung transplantation with a first delivery reported to the French cystic fibrosis registry between 2000 and 2012 were identified. Pregnancy outcomes and clinical trends (body mass index - BMI, and pulmonary function) over a 4-year follow-up in women with poor pre-gestational pulmonary function, defined as forced expiratory volume (FEV1) ≤ 50%, were compared to those in women with FEV1 ˃ 50%. RESULTS: A total of 149 women had a first delivery and 36 (24.2%) of these had pre-gestational FEV1 ≤ 50%. There was no significant difference in age or frequency of assisted conception between the 2 groups. The rate of cesarean section was significantly higher in women with FEV1 ≤ 50% (43.7% vs. 21.1%, p = .01). The frequency of preterm birth did not differ significantly between the two groups, but median infant birthweight was significantly lower in women with FEV1 ≤ 50% (2705 g; range: 650-3700 vs. 3044 g; range: 1590-3860, p = .003). Despite significantly lower FEV1 and BMI the year before pregnancy for women with poor pulmonary function, the decline in these parameters during the study period did not differ significantly between the two groups. CONCLUSION: Poor pre-gestational pulmonary function in women with cystic fibrosis was associated with a higher rate of cesarean section and a clinically significant impact on fetal growth, but was not associated with more important pulmonary and nutritional decline over the study period.

Quantifying Long-Term Changes in Lung Function and Exacerbations after Initiation of Azithromycin in Cystic Fibrosis.

Rationale: In cystic fibrosis, information on the efficacy of azithromycin past 12 months of treatment is still scarce.Objectives: The study sought to quantify the changes in lung function and the number of intravenous antibiotic courses (IVACs) after initiation of azithromycin in patients included in the French Cystic Fibrosis Registry.Methods: The study followed 1,065 children and 990 adults from 2 years before to 5 years after long-term azithromycin treatment initiated between 2001 and 2011. Mixed change-point models were used to quantify the changes in the forced expiratory volume (FEV) in 1 second and the yearly number of IVACs.Results: In the year of treatment initiation, the mean FEV was significantly higher than expected (+1.6%, P = 0.007 in children; +1.3%, P = 0.02 in adults). The decline of the FEV over time was less marked after than before treatment initiation (slope difference = +0.7% per year [P = 0.03] in children and +0.6% per year [P = 0.06] in adults). The mean increase in the yearly number of IVACs was lower after than before treatment initiation. The rate ratio quantifying the effect on the mean increase was 0.93 (95% confidence interval = [0.88-0.99]; P = 0.02) in children and 0.95 (95% confidence interval = [0.90-1.01]; P = 0.08) in adults.Conclusions: In children, long-term azithromycin treatment was associated with immediate and sustained beneficial changes in lung function and sustained beneficial changes in the frequency of pulmonary exacerbations. In adults, it was associated with immediate beneficial changes in lung function.

Using ESDM 12 hours per week in children with autism spectrum disorder: feasibility and results of an observational study.

BACKGROUND: Early intervention for Autism Spectrum Disorder (ASD) in France is heterogeneous and poorly evaluated to date. Early Start Denver Model (ESDM) is a developmental and behavioral model of intervention for toddlers with ASD which has already shown very interesting outcomes on the development of children with ASD in various studies with different settings. However, it is not possible with the current research to agree on the best setting. Thus, we implemented an ESDM program according to our context where children are often pre-schooling early from 30 months old. This therapy was applied by a multidisciplinary team working in close collaboration with parents and other partners. SUBJECTS AND METHODS: A prospective observational study including 19 toddlers with ASD was conducted. We evaluated improvement on the cognitive level of toddlers with ASD receiving therapist-delivered ESDM intervention for 12 hours per week. RESULTS: Significant improvements in verbal and nonverbal cognitive skills at the Mullen Scale of Early Learning were obtained after 10 months of intervention in our sample. The largest improvement was in receptive language development quotient with a mean improvement of 19.6 points. We also observed promising outcomes in daily adaptive behavior, with a slight improvement in communication at the Vineland Adaptive Behavioral Scale. These outcomes, when compared to the conclusions of previous studies, are leading us to the need for a therapy duration beyond 10 months. CONCLUSIONS: Our outcomes were very encouraging even with low cognitive and nonverbal children. These outcomes may be confirmed in a multicenter randomized controlled trial that is ongoing.

Adherence to long-term therapies in cystic fibrosis: a French cross-sectional study linking prescribing, dispensing, and hospitalization data.

BACKGROUND: Cystic fibrosis (CF) is a life-shortening genetic condition that usually affects several organs and involves significant treatment burden. Adherence to medication is important for successful CF management. OBJECTIVE: To describe medication adherence according to age, therapeutic class, and pharmaceutical form in adults and children followed in four regional CF centers in France. METHODS: We conducted a cross-sectional study with non-transplanted patients followed in two adult and two pediatric centers during 2015 who were covered by the French National Health Insurance (NHI). Sociodemographic, clinical, hospitalization, and prescription data were collected from patient medical records. Medication dispensations were extracted from the regional French NHI database. Adherence was calculated over 12 months using continuous medication availability (CMA) accounting for dose adjustments and hospitalizations. Drug-specific CMA was computed in R with the AdhereR package for each medication prescribed more than 3 months, which was averaged to obtain a composite CMA score (cCMA) for all treatments and per therapeutic class as well as pharmaceutical form for each patient. RESULTS: A total of 228 patients were included. The number of chronic medications increased with age (r=0.50, p<0.001): a median of 7 medications per patient were prescribed. The mean±SD cCMA was significantly different between age groups (p=0.0098): it was 0.71±0.20 for the 0-5 years age group, 0.73±0.16 for 6-11 years, 0.64±0.17 for 12-17 years, 0.57±0.23 for 18-25 years, and 0.65±0.20 for the over 25 years age group. cCMA varied significantly according to pharmaceutical forms: the mean±SD cCMA was 0.70±0.21 for oral medications and 0.54±0.28 for inhaled medications (p<0.001). CONCLUSION: This study suggests that adherence to medication regimens in CF patients remains suboptimal and varies substantially between age groups and pharmaceutical forms. These variations in adherence should be considered when developing effective strategies to improve adherence.

Impact of a comprehensive prevention programme aimed at reducing incivility and verbal violence against healthcare workers in a French ophthalmic emergency department: an interrupted time-series study.

OBJECTIVE AND SETTING: Primary prevention, comprising patient-oriented and environmental interventions, is considered to be one of the best ways to reduce violence in the emergency department (ED). We assessed the impact of a comprehensive prevention programme aimed at preventing incivility and verbal violence against healthcare professionals working in the ophthalmology ED (OED) of a university hospital. INTERVENTION: The programme was designed to address long waiting times and lack of information. It combined a computerised triage algorithm linked to a waiting room patient call system, signage to assist patients to navigate in the OED, educational messages broadcast in the waiting room, presence of a mediator and video surveillance. PARTICIPANTS: All patients admitted to the OED and those accompanying them. DESIGN: Single-centre prospective interrupted time-series study conducted over 18 months. PRIMARY OUTCOME: Violent acts self-reported by healthcare workers committed by patients or those accompanying them against healthcare workers. SECONDARY OUTCOMES: Waiting time and length of stay. RESULTS: There were a total of 22 107 admissions, including 272 (1.4%) with at least one act of violence reported by the healthcare workers. Almost all acts of violence were incivility or verbal harassment. The rate of violence significantly decreased from the pre-intervention to the intervention period (24.8, 95% CI 20.0 to 29.5, to 9.5, 95% CI 8.0 to 10.9, acts per 1000 admissions, p<0.001). An immediate 53% decrease in the violence rate (incidence rate ratio=0.47, 95% CI 0.27 to 0.82, p=0.0121) was observed in the first month of the intervention period, after implementation of the triage algorithm. CONCLUSION: A comprehensive prevention programme targeting patients and environment can reduce self-reported incivility and verbal violence against healthcare workers in an OED. TRIAL REGISTRATION NUMBER: NCT02015884.