Risultati per: Position paper della French Headache Society sul trattamento dell'emicrania

New England Journal of Medicine, Volume 391, Issue 24, Page 2361-2369, December 2024.

Background
Social determinants of health (SDH) impact the health status of individuals around the world. General practitioners (GPs) can take into account the social situation of patients in their care practice. To this end, the College of General Medicine (CGM) issued recommendations in 2022 to propose 100 methods of action.

Objective
To assess the acceptability to GPs of the recommendations set out by the CGM to improve the consideration of the social situation of patients in consultations.

Design
Quantitative, cross-sectional, descriptive study, using the Delphi method.

Setting
The data were collected through the administration of a questionnaire to GPs practising in France.

Participants
Participants were recruited by email from the academic network of Sorbonne University. The only criteria for inclusion were to be a GP from Sorbonne University and to complete the full questionnaire. 25 participants were included.

Interventions
Proposals were grouped into 24 themes. Participants had to rate the acceptability of these themes by rating their degree of relevance and degree of applicability on a Likert scale.

Primary outcome
The primary outcome was the acceptability by GPs of proposals to take into account the SDH. Acceptability was defined as relevance with a median greater than or equal to 7 and applicability with a median greater than or equal to 7, in the absence of disagreements.

Results
After 2 rounds, 12 themes were accepted: 5 addressed interventions at the individual level (eg, ‘understanding the context of patients’ lives and identifying social difficulties’), 4 addressed interventions at the organisational level (eg, ‘communication actions aimed at vulnerable patient populations’) and 3 addressed interventions at territorial level (municipality and national). Relevance was very good for all of them, with median responses ranging from 8 to 9 and with no disagreement. Applicability was more mixed, with 12 themes deemed applicable. Justifications were provided through participants’ comments. Proposals were made to improve the applicability.

Conclusion
This study explored how SDH could be taken into account through the perspective of GPs in the context of the CGM’s recommendations. While all proposals were deemed relevant, some were not applicable. The findings emphasise the need for adaptations in the organisation of the practice, of care pathways and more generally, in the organisation of the health system. Those actions require the commitment of professionals and political actors.

Esperto, sempre consigliata specie nei pazienti ‘difficili’

Introduction
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a disabling condition that can affect adolescents during a vulnerable period of development. The underlying biological mechanisms for ME/CFS remain unclear and have rarely been investigated in the adolescent population, despite this period representing an age peak in the overall incidence. The primary objective of this is to provide a foundational set of biological data on adolescent ME/CFS patients. Data generated will be compared with controls and over several time points within each patient to potentially develop a biomarker signature of the disease, identify subsets or clusters of patients, and to unveil the pathomechanisms of the disease.

Methods and analysis
This protocol paper outlines a comprehensive, multilevel, longitudinal, observational study in paediatric ME/CFS. ME/CFS patients aged 12–19 years and controls will donate biosamples of urine, blood, and peripheral blood mononuclear cells for an in-depth omics profiling analysis (whole-genome sequencing, metabolomics and quantitative proteomics) while being assessed by gold-standard clinical and neuropsychological measures. ME/CFS patients will then be provided with a take-home kit that enables them to collect urine and blood microsamples during an average day and during days when they are experiencing postexertional malaise. The longitudinal repeated-measures study design is optimal for studying heterogeneous chronic diseases like ME/CFS as it can detect subtle changes, control for individual differences, enhance precision and boost statistical power. The outcomes of this research have the potential to identify biomarker signatures, aid in understanding the underlying mechanisms, and ultimately, improve the lives of children with ME/CFS.

Ethics and dissemination
This project was approved by the Royal Children’s Hospital’s Human Research Ethics Committee (HREC 74175). Findings from this study will be disseminated through peer-reviewed journal publications and presentations at relevant conferences. All participants will be provided with a summary of the study’s findings once the project is completed.

The authors have retracted a JAMA Internal Medicine paper due to discrepancies in calculations.

Background
The global increase in caesarean sections (CS), currently at 21.1% of all deliveries, has led to a rise in uterine scar defects, or ‘niches’, at the hysterotomy site. These niches, detectable in 13%–84% of cases via transvaginal ultrasound (TVS) and 42%–84% through sonohysterography (SHG), may contribute to gynaecological complications, including abnormal uterine bleeding, chronic pain and secondary infertility. Niche-associated risks for in vitro fertilisation (IVF) outcomes remain underexplored, and this study aims to evaluate their impact on clinical pregnancy rates.

Methods and analysis
This multicentre, prospective, non-interventional study will involve 250 women with a history of CS and secondary infertility undergoing IVF in 14 reproductive units of French Hospital. Participants will be assessed using SHG and TVS to determine niche presence (measurements of the length, depth and width of the niche, and residual myometrial thickness (RMT)). A niche is diagnosed by an indentation of at least 2 mm at the site of the caesarean scar, with a large niche defined as RMT

New England Journal of Medicine, Volume 391, Issue 22, Page 2148-2157, December 5, 2024.

Objectives
This study investigates the relationship between flat rate pricing for unlimited alcohol consumption in restaurants and bar and problematic alcohol consumption patterns identified by the Alcohol Use Disorders Identification Test (AUDIT) during the COVID-19 pandemic.

Methods
A cross-sectional study was conducted using data from the Japan Society and New Tobacco Internet Survey in February 2022. A total of 19 585 current drinkers (55% of drinkers were men, and the mean age was 48.3 years) were categorised based on AUDIT scores; non-problem drinking (an AUDIT Score of 0–7), problem drinking (an AUDIT Score of 8 or over), hazardous alcohol use (an AUDIT Score of 8–14) and probable alcohol use disorders (an AUDIT Score of 15 or over). A score of 2 or higher in the third question of the AUDIT is identified as binge drinking. The explanatory variable was the presence of using flat rate pricing for unlimited alcohol consumption in the previous 12 months during the COVID-19 pandemic (February 2021 to February 2022). The associations of using the flat rate pricing with the problem or binge drinking, and with hazardous alcohol use or probable alcohol use disorders were analysed.

Results
People who used flat rate pricing during the COVID-19 pandemic were likely to be problem drinking and binge drinking compared with non-users of flat rate pricing; the respective adjusted ORs were 4.64 (95% CI: 4.24 to 5.07) and 3.65 (95% CI: 3.33 to 4.00) through multivariable binary logistic regression. The users of the flat rate pricing were associated with hazardous alcohol use and probable alcohol use disorder; the adjusted relative risk ratios were 3.40 (95% CI: 3.06 to 3.77) and 8.58 (95% CI: 7.51 to 9.80) through multinomial logistic regression.

Conclusions
Overall, using flat rate pricing for unlimited alcohol consumption was associated with both binge drinking and problem drinking, including hazardous alcohol use and probable alcohol use disorders.

Introduction
Recent decades have seen a growth in multisectoral and transdisciplinary approaches to improving global health, particularly across human, animal and environmental health-related sciences that advocate for participatory, systems-based perspectives to understanding and promoting health and well-being in the context of social and ecological interactions. For several issues, including human health, animal health and food security, researchers have highlighted the need for transdisciplinary One Health approaches to assess the sustainability of interventions. To understand the current thinking and conceptualisation of sustainability across One Health disciplines, we present a protocol paper for an umbrella systematic review study planned in 2024.

Methods and analysis
A search strategy based on Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines was developed. The Medline, Embase, Global Health and Web of Science Core Collection were the four databases interrogated through the search strategy and included all articles found in the English language up to 14 April 2024. Meta-analyses, systematic, structured literature reviews and narrative reviews on sustainability will be included and a full-text review of all articles will be undertaken. The articles will be quality appraised using the AMSTAR 2 tool. Data that cover proposed factors influencing and characterising sustainability will be extracted across One Health disciplines including similarities and differences, and a summative content analysis will be completed to identify any emerging themes and develop an analytical framework. The conceptualisation of sustainability in the context of One Health multisectoral approaches will be summarised, a definition of sustainability proposed and include an identification of tools for measuring and assessing sustainability.

Ethics and dissemination
No primary data will be collected; therefore, ethical approval will not be required. The results will be disseminated in peer-reviewed literature and conference presentations. The findings will also be directly disseminated to the Quadripartite agencies.

Prospero registration number
CRD42018094031

This crossover randomized clinical trial aims to determine the effect of different arm positions on blood pressure readings.

Introduction
Cerebral palsy (CP) presents a complex neurodevelopmental disorder with a spectrum of motor impairments stemming from early brain injury. Whereas CP is traditionally viewed as a non-progressive condition, emerging evidence suggests a progressive decline in mobility and function, particularly in adulthood. Despite the prevalence of self-reported age-related gait decline in adults with CP, objective evidence supporting this phenomenon remains limited. Moreover, mechanistic insights into these functional alterations and their comparison with typically developing (TD) peers are lacking. To address this gap, our study aims to objectively assess age-related changes in gait performance among individuals with CP while examining physiological differences compared with TD peers.

Methods and analysis
This protocol will compare the mobility of individuals with and without CP within two age groups (18–25 and 35–50 years old). Participants at Gross Motor Function Classification System levels I–II at age 18 will be invited to partake in the study. Every participant will be invited to complete four visits investigating a wide range of mobility related measures: walking performance, muscle strength, cardiopulmonary performance, fatigability, cost of walking and quantitative gait analysis. Through this comprehensive analysis encompassing gait performance metrics, self-reported outcomes, muscle strength, biomechanics and metabolical cost of walking, and fatigability, we seek to elucidate the underlying mechanisms driving age-related gait decline in adults with CP and inform targeted interventions to maintain function and quality of life.

Ethics and dissemination
The study has been approved by the French ethics board (#2022-A02510-43) and will be communicated through conferences, articles and to participants through layman terms.

Trial registration number
NCT06163950.

Objectives
The first COVID-19 lockdown raised concerns about reduced access to primary care, especially for people with chronic diseases particularly at risk in the absence of follow-up. However, the COVIQuest trial, evaluating the impact of a general practitioner (GP) phone call (intervention) to chronic patients with cardiovascular disease (CVD) or mental health disorder (MHD) concluded that the intervention had no effect at 1 month on the rate of self-reported hospitalisations in the CVD subtrial, whereas the intervention group in MHD subtrial might have a higher rate. This second part of the study aimed to describe the 6 month hospitalisation and specialised consultation rates, using the French health data system (Système National des Données de Santé). The secondary objective was to describe these rates during the same period in 2019.

Design
A cluster randomised controlled trial, with clusters being GPs.

Setting
Primary care, 149 GPs from eight French regions.

Participants
Patients ≥70 years old with chronic CVD or ≥18 years old with MHD.

Interventions
A standardised GP-initiated phone call aiming to evaluate patient’s need for urgent care (vs usual care for control groups).

Primary and secondary outcome measures
The occurrence of at least one hospitalisation at end point 31 October 2020 (randomisation 30 April 2020), excluding those starting on 30 April 2020, was measured as planned. Another main outcome was the occurrence of at least one specialised consultation during the same period. These 6 month effects were studied, using a logistic regression model within a generalised estimating equation framework, for each subtrial.

Results
4640 patients were included: 3274 cardiovascular (mean age 79.9±7.0 years; 57.8% male) and 1366 psychiatric (53.2±7.0; 36.5%). For both subtrials, the intervention patients were significantly more hospitalised than the control patients, respectively, 17.3% versus 14.9% of CVD patients (OR=1.26 (1.05 to 1.52)); 14.4% versus 10.7% of MHD patients (OR=1.40 (1.00 to 1.96)). During the same period in 2019, the hospitalisation rates were, respectively, 16.3%, 18.2%, 15.8% and 14.8%. The proportions of patients with at least one specialised consultation were not different between the intervention and control groups, respectively, 24.6% versus 24.3% for CVD patients (OR=1.06 (0.85 to 1.32)); 26.5% versus 24.4% for MHD patients (OR=1.15 (0.84 to 1.57)). During the same period in 2019, these rates were, respectively, 22.7%, 24.6%, 28.0% and 25.5%.

Conclusions
The intervention was associated with higher rates of hospitalisation at 6 months in patients with MHD or CVD. No intervention impact was found in outpatient care. These results are difficult to interpret because of a potential artefact induced by national campaigns promoting medical use during lockdown, overlapping the study inclusion period. This study showed that medico-administrative databases could represent a complementary cost-effective tool to clinical research for long-term and healthcare consumption outcomes.

Trial registration number
NCT04359875.

Background and objectives
Violence against women (VAW) is widespread and can have serious physical and mental health consequences, including post-traumatic stress disorder (PTSD) and sleep disorders. Victim-survivors often face barriers in accessing specialised care, highlighting the need for a multidisciplinary response, especially in healthcare settings. The Maison des Femmes (MdF) model provides holistic support to women experiencing VAW, including medical, psychological, social and legal support. The aim of this study is to examine whether the MdF’s comprehensive intervention programme offers advantages over standard care in improving mental health indicators, such as PTSD.

Method and analysis
Our pragmatic quasi-experimental study uses a non-randomised controlled cluster design. The intervention group comprises women enrolled in MdFs in five French cities, while the comparison group includes women receiving usual care in sociomedical structures located geographically close to MdF centres. Our study aims to recruit 360 women (180 per group), aged 18 years or older, who have experienced intimate partner violence or sexual violence and who seek care at the study centres. The primary analysis will compare the change in PTSD Checklist for DSM-5 (PCL-5) scores over 6 months in the two groups using multivariable linear regression with propensity score adjustment. Secondary outcomes include sleep disorders, quality of life, symptoms of anxiety and depression, self-esteem, sense of safety and well-being, initiation of legal and socioprofessional proceedings, and healthcare utilisation.

Ethics and dissemination
The study was approved by the ‘Comité de protection des personnes Ile de France III’ (CPP Committee for the Protection of Persons Ile de France III; institutional review board on 20 December 2023; Ref no. (Numéro SI): 23.04197.000491).
The results of the study will be communicated via academic publications; easily understandable briefs for a broader public; and proactive involvement with medical institutions, journalists and advocacy groups.

Trial registration number
NCT06226818. Version Number 1- february2024.

Circulation, Volume 150, Issue Suppl_1, Page A4134309-A4134309, November 12, 2024. Introduction:We report the case of a heart transplant patient on chronic immunosuppression diagnosed with cryptococcal meningitis. Up to 5% of solid organ transplant patients develop cryptococcosis, carrying a 50% mortality rate in central nervous system involvement.Case Presentation:This is a 57-year-old male with a past medical history of heart failure with reduced ejection fraction (HFrEF) status post orthotopic heart transplantation (on prednisone 7.5 mg daily, mycophenolate, tacrolimus and sirolimus), pulmonary sarcoid, and chronic hepatitis B (on tenofovir and entecavir) who presented with headache, nausea, vomiting and seizure-like activity. The patient’s heart rate was 129 beats per minute, blood pressure 188/92 mmHg, but was afebrile. He eventually underwent a lumbar puncture with the cerebrospinal fluid (CSF) positive for cryptococcal antigen (1:2560). The patient was started on liposomal amphotericin B and flucytosine. Mycophenolate and sirolimus were held in the setting of his infection. The patient’s hospital course was complicated by acute kidney injury likely secondary to elevated tacrolimus levels while on fluconazole. He was ultimately discharged with plans to repeat CSF studies as an outpatient.Discussion:Here we report a case of cryptococcal meningitis in a heart transplant patient in the context of pulmonary sarcoidosis, chronic hepatitis B and quadruple immunosuppression. Of note, as part of rejection surveillance, the patient undertook serial AlloSure and AlloMap testing. Sirolimus was added to his regimen due to persistently elevated AlloSure scores. Indeed, immunosuppressive agents are the leading risk factor for cryptococcosis in organ transplant patients. Our patient also has two important risk factors for cryptococcal infection. Firstly, sarcoidosis is associated with T-cell dysregulation, compromising cell-mediated immunity. Additionally, hepatitis B carriers have an increased predisposition for cryptococcal infections, notwithstanding that our patient had been on dual antiviral therapy.Conclusion:Quadruple immunosuppression in heart transplant patients, especially in the context of risk factors such as sarcoidosis and hepatitis B infection, can result in cryptococcal meningitis and should be considered in patients with suggestive symptoms. Effective prophylactic regimens for such higher risk patients may be a potential area for further investigation.

Circulation, Volume 150, Issue Suppl_1, Page A4141628-A4141628, November 12, 2024. Introduction:Atherosclerotic cardiovascular disease (ASCVD) remains the leading cause of mortality worldwide. Lipid-lowering therapies (LLTs) are a key element to reduce the risk of recurrence of ASCVD events. However, despite concordant guidelines, LLTs are often underused in real-life setting.Research questions:The aim of this study is to describe the use of LLTs and its impact on morbi-mortality in the year following a first ASCVD event.Methods:This retrospective study used the national health data system (SNDS), collecting health insurance claims and hospital discharge data from 99% of the French population. Incident cases in 2021 were identified, corresponding to all adults with a first ASCVD event, based on ICD-10 hospital coding. ASCVD includes coronary artery disease [myocardial infarction, unstable angina or coronary revascularization], cerebrovascular events [ischemic stroke, carotid revascularization] and peripheral artery disease (PAD) requiring artery revascularization. In patients discharged alive from the index event, longitudinal analyses were performed at 1-year from discharge to describe LLT use, occurrence of major ASCVD events and all-cause mortality.Results:In 2021, 195,211 newly diagnosed ASCVD cases were identified among 43,1M adults (mean age: 70.3 (±13.7) yo; 62% of male). The first ASCVD event was myocardial infarction (N=51,614) or ischemic stroke (N=52,865) in 53.5% of incident cases. The remaining 46.5% corresponded mostly to coronary revascularization procedures (N=83,910), followed by PAD (N=26,925). In-hospital mortality was 5.5% (N=10,673). In patients analyzed at 1 year (N=180,875), 16.9% did not receive any LLT. This value rose to 26.7% among patients who had no received LLT prior to the ASCVD event. After a myocardial infarction, patients were more likely to receive LLT (91.9%) compared to after an ischemic stroke (72.9%) or revascularization for PAD (68.0%). Finally, 1-year all-cause mortality was higher in non-LLT compared to LLT patients (20.9% vs 4.0%). Additional data on the recurrence of ASCVD events as a function of LLT use are currently being analyzed and will be presented at the congress.Conclusion:Contrary to recommendations, the underuse of LLTs after a first ASCVD event remains very high, particularly after a stroke. This is associated with a significantly higher mortality at 1 year, justifying the need to reinforce implementation of the guidelines in real life for a better management of residual lipid risk.

Circulation, Volume 150, Issue Suppl_1, Page A4122486-A4122486, November 12, 2024. Background:Fetal cardiomyopathy (FCM) affects 8 per 100,000 live births, often with unknown etiology. Progress in fetal cardiac screening, genetic testing and management may have impacted historically poor outcomes.Aims:We sought to investigate genetic associations and clinical outcomes of FCM in the current era.Methods:This was a retrospective Fetal Heart Society Research Collaborative cohort study of FCM cases diagnosed from January 2017-December 2021 in 39 centers. Cases of fetal myocardial disease attributable to maternal diabetes, structural heart disease, arrhythmia or extra-cardiac conditions were excluded. Data including outcomes to 1 year after birth were collected. Significance of genetic testing results and FCM subtype were classified by each center.Results:There were 138 FCM cases diagnosed at a median gestational age of 27+4weeks (range 13-39 weeks). Suspected fetal heart disease (41%, 56/138) was the most common referral indication. There was a known family history of CM in 19% (26/138). FCM phenotypes included 38% (52/138) dilated, 24% (33/138) hypertrophic, 17% (24/138) non-compacted, 10% (14/138) mixed, 5% (7/138) restrictive, 3% (4/138) ventricular aneurysm, 3% (4/138) unspecified. Hydrops was present at diagnosis in 15% (20/138) and by delivery or at fetal demise in 26% (36/138). Of 128 continued pregnancies, 7% (9/128) had a fetal demise, 92% (118/128) a live birth and one was lost to follow-up. Among live births, 10% (12/118) received only palliative care. Of 106 actively treated, 75% (80/106) survived to 1 year; 7% (7/106) required ECMO, and 22% (23/106) were listed for transplant with 18 of these successfully transplanted. Of the cohort, a total of 80% (110/138) had genetic testing (including 30 with invasive prenatal testing), with 38% (52/138) having a confirmed genetic etiology and 28% (38/138) with a variant of uncertain significance (VUS) (Figure 1). Transplant-free survival to 1 year was similar for those with and without a genetic diagnosis (40%,21/52 vs 47%,40/86, p=0.48).Conclusion:Outcomes remain poor in FCM, with