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1.
Pediatr Pulmonol ; 2021 Sep 13.
Artigo em Inglês | MEDLINE | ID: mdl-34516722

RESUMO

INTRODUCTION: Bronchiolitis is the leading cause of hospitalization for infants but its economic burden is not well documented. Our objective was to describe the clinical evolution and to assess the 1-month cost of a first episode of acute bronchiolitis presenting to the emergency department (ED). METHODS: Our study was an epidemiologic analysis and a cost study of the cohort drawn from the clinical trial GUERANDE, conducted in 24 French pediatric EDs. Infants of 6 weeks to 12 months of age presenting at pediatric EDs with a first episode of bronchiolitis were eligible. The costs considered were collected from a societal viewpoint, according to the recommendations of the French National Health Authority. RESULTS: A total of 777 infants were included with a median age of 4 months. A total of 57% were hospitalized during the month following the first consultation in the ED, including 28 (3.6%) in an intensive care unit. The mean length of stay was 4.2 days (SD = 3.7). The average time to relief of all symptoms was 13 days (SD = 7). Average total cost per patient was €1919 (95% confidence interval: 1756-2138) from a societal perspective, mostly due to hospitalization cost. The estimated annual cost of bronchiolitis in infants was evaluated to be between €160 and €273 million in France. DISCUSSION: Bronchiolitis represent a high cost for the health care system and broadly for society, with hospitalizations costs being the main cost driver. Thus significant investments should be made to develop innovative therapies, to reduce the number of hospitalizations and length of stay.

2.
Eur J Health Econ ; 2021 Aug 09.
Artigo em Inglês | MEDLINE | ID: mdl-34373958

RESUMO

BACKGROUND: Innovative provider payment methods that avoid adverse selection and reward performance require accurate prediction of healthcare costs based on individual risk adjustment. Our objective was to compare the performances of a simple neural network (NN) and random forest (RF) to a generalized linear model (GLM) for the prediction of medical cost at the individual level. METHODS: A 1/97 representative sample of the French National Health Data Information System was used. Predictors selected were: demographic information; pre-existing conditions, Charlson comorbidity index; healthcare service use and costs. Predictive performances of each model were compared through individual-level (adjusted R-squared (adj-R2), mean absolute error (MAE) and hit ratio (HiR)), and distribution-level metrics on different sets of covariates in the general population and by pre-existing morbid condition, using a quasi-Monte Carlo design. RESULTS: We included 510,182 subjects alive on 31st December, 2015. Mean annual costs were 1894€ (standard deviation 9326€) (median 393€, IQ range 95€; 1480€), including zero-claim subjects. All models performed similarly after adjustment on demographics. RF model had better performances on other sets of covariates (pre-existing conditions, resource counts and past year costs). On full model, RF reached an adj-R2 of 47.5%, a MAE of 1338€ and a HiR of 67%, while GLM and NN had an adj-R2 of 34.7% and 31.6%, a MAE of 1635€ and 1660€, and a HiR of 58% and 55 M, respectively. RF model outperformed GLM and NN for most conditions and for high-cost subjects. CONCLUSIONS: RF should be preferred when the objective is to best predict medical costs. When the objective is to understand the contribution of predictors, GLM was well suited with demographics, conditions and base year cost.

3.
BMJ Open ; 11(8): e048187, 2021 08 18.
Artigo em Inglês | MEDLINE | ID: mdl-34408046

RESUMO

INTRODUCTION: At the time of the worrying emergence and spread of bacterial resistance, reducing the selection pressure by reducing the exposure to antibiotics in patients with community-acquired pneumonia (CAP) is a public health issue. In this context, the combined use of molecular tests and biomarkers for guiding antibiotics discontinuation is attractive. Therefore, we have designed a trial comparing an integrated approach of diagnosis and treatment of severe CAP to usual care. METHODS AND ANALYSIS: The multiplex PCR and procalcitonin to reduce duration of antibiotics exposure in patients with severe-CAP (MULTI-CAP) trial is a multicentre (n=20), parallel-group, superiority, open-label, randomised trial. Patients are included if adult admitted to intensive care unit for a CAP. Diagnosis of pneumonia is based on clinical criteria and a newly appeared parenchymal infiltrate. Immunocompromised patients are excluded. Subjects are randomised (1:1 ratio) to either the intervention arm (experimental strategy) or the control arm (usual strategy). In the intervention arm, the microbiological diagnosis combines a respiratory multiplex PCR (mPCR) and conventional microbiological investigations. An algorithm of early antibiotic de-escalation or discontinuation is recommended, based on mPCR results and the procalcitonin value. In the control arm, only conventional microbiological investigations are performed and antibiotics de-escalation remains at the clinician's discretion. The primary endpoint is the number of days alive without any antibiotic from the randomisation to day 28. Based on our hypothesis of 2 days gain in the intervention arm, we aim to enrol a total of 450 patients over a 30-month period. ETHICS AND DISSEMINATION: The MULTI-CAP trial is conducted according to the principles of the Declaration of Helsinki, is registered in Clinical Trials and has been approved by the Committee for Protection of Persons and the National French Drug Safety Agency. Written informed consents are obtained from all the patients (or representatives). The results will be disseminated through educational institutions, submitted to peer-reviewed journals for publication and presented at medical congresses. TRIAL REGISTRATION NUMBER: NCT03452826; Pre-results.


Assuntos
COVID-19 , Pneumonia , Adulto , Antibacterianos/uso terapêutico , Humanos , Unidades de Terapia Intensiva , Reação em Cadeia da Polimerase Multiplex , Pneumonia/tratamento farmacológico , Pró-Calcitonina
4.
Diabetes Ther ; 12(9): 2311-2327, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34390477

RESUMO

Telemedicine in diabetes care has been evolving over several years, particularly since the advent of cloud-connected technologies for diabetes management, such as glucose monitoring devices, including continuous glucose monitoring (CGM) systems, that facilitate sharing of glucose data between people with diabetes and their healthcare professionals in near-real time. Extreme social distancing and shielding in place for vulnerable patients during the COVID-19 pandemic has created both the challenge and the opportunity to provide care at a distance on a large scale. Available evidence suggests that glucose control has in fact improved during this period for people with diabetes who are able to use CGM devices for remote glucose monitoring. The development of telemedicine as part of the standard of care in diabetes faces significant challenges in the European context, particularly in terms of providing consistent and effective care at a distance to large populations of patients while using robust systems that can be supported by large regional and national healthcare services. These challenges include a fragmented approach to healthcare technology assessment and reimbursement, lack of eHealth education and literacy, particularly amongst healthcare professionals, lack of data integration, as well as concerns about electronic health records, patient consent and privacy. Here we review the benefits of and challenges to wider application of telemedicine and telemonitoring in the post-pandemic future, with the aim to ensure that the value of these eHealth services is provided to patients, healthcare providers and health systems.

5.
Artigo em Inglês | MEDLINE | ID: mdl-34420366

RESUMO

Background: In patients with ST-elevation myocardial infarction (STEMI) and multivessel disease, percutaneous coronary intervention (PCI) for non-culprit lesions guided by FFR is superior to treatment of the culprit lesion alone. Whether deferring non-culprit PCI is safe in this specific context is questionable. We aimed to assess clinical outcomes at one-year in STEMI patients with multivessel coronary artery disease and an FFR-guided strategy for non-culprit lesions, according to whether or not ≥1 PCI was performed. Methods: Outcomes were analyzed in patients of the randomized FLOWER MI (Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction) trial in whom, after successful primary PCI, non-culprit lesions were assessed using FFR. The primary outcome was a composite of all-cause death, non-fatal MI, and unplanned hospitalization with urgent revascularization at one year. Results: Among 1,171 patients enrolled in this study, 586 were assigned to the FFR-guided group: 388 (66%) of them had ≥1 PCI and 198 (34%) had no PCI. Mean FFR before decision (i.e., PCI or not) of non-culprit lesions were 0.75±0.10 and 0.88±0.06, respectively. During follow-up, a primary outcome event occurred in 16 of 388 patients (4.1%) in patients with PCI and in 16 of 198 patients (8.1%) in patients without PCI (adjusted hazard ratio, 0.42; 95% confidence interval, 0.20 to 0.88; P = 0.02). Conclusions: In patients with STEMI undergoing complete revascularization guided by FFR measurement, those with ≥1 PCI had lower event rates at 1 year, compared with patients with deferred PCI, suggesting that deferring lesions judged relevant by visual estimation but with FFR >0.80 may not be optimal in this context. Future randomized studies are needed to confirm this data.

6.
Emergencias ; 33(4): 292-298, 2021 Aug.
Artigo em Espanhol, Inglês | MEDLINE | ID: mdl-34251142

RESUMO

OBJECTIVES: To determine the efficacy of emergency medical center physicians' use of a protocol to guide their management of telephone consultations for fever and gastroenteritis. MATERIAL AND METHODS: Cluster randomized controlled trial. Participating centers were randomized to use the telephone protocol or provide usual telephone assistance. Six emergency centers in France included calls from patients needing advice on fever or gastroenteritis. Centers assigned to the protocol followed specific guidelines on managing the call and giving advice on treatment. Primary endpoints were the number of in-person visits and hospital admissions required within 15 days of the call. Secondary endpoints were patient satisfaction and costs. RESULTS: A total of 2498 calls were included. Use of the assigned protocol while attending 1234 calls was associated with a relative risk for hospitalization or an unscheduled in-person visit for care of 0.70 (95% CI, 0.58-0.85) versus usual practice. Ambulance use, admission to an intensive care unit, mortality, morbidity, and symptom improvement did not differ significantly between centers using the protocol and those following usual practice. Ninety percent of the patients were satisfied. The cost of care was €91 in centers applying the protocol and €150 in the other centers (P .01). CONCLUSION: Use of the protocol was associated with fewer unscheduled in-person visits for care and fewer hospital admissions. The protocol is safe and less costly than the centers' usual approaches to giving telephone advice.

7.
Clin Ther ; 43(7): 1201-1212, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34059326

RESUMO

PURPOSE: The SARAH (Sorafenib Versus Radioembolization in Advanced Hepatocellular Carcinoma) trial (ClinicalTrials.gov Identifier NCT01482442) did not show a significant survival benefit for patients treated with transarterial radioembolization (TARE) compared with continuous oral sorafenib. The improved toxicity profile of patients treated with TARE in the trial, however, could result in a quality of life benefit in economic evaluations. Our objective was to perform a cost-utility analysis of TARE versus sorafenib for locally advanced and inoperable hepatocellular carcinoma. METHODS: This study used patient-level data of the SARAH trial regarding resource use, progression-free and overall survival, and quality of life for the within-trial period for the patients who received at least 1 dose of sorafenib or 1 treatment with TARE according to their randomization arm. Data were extrapolated by using a partitioned survival model that incorporated costs and health outcomes, measured in life-years and quality-adjusted life-years (QALYs). FINDINGS: The use of TARE resulted in an average loss of 0.036 life-year and a gain of 0.006 QALY compared with sorafenib. The aerage cost for the TARE arm was €17,179 (95% CI, 9,926-24,280) higher than the sorafenib arm, for an incremental cost-effectiveness ratio of €3,153,086/QALY. The probabilistic sensitivity analysis revealed a 50% risk that the TARE strategy was dominated. TARE was consistently dominated by sorafenib or had an incremental cost-effectiveness ratio more than €450,000/QALY in all sensitivity analyses. IMPLICATIONS: This economic evaluation of SARAH found that using radioembolization with yttrium-90 microspheres for the treatment of hepatocellular carcinoma was not a cost-effective option at the usually accepted willingness-to-pay thresholds.

8.
N Engl J Med ; 385(4): 297-308, 2021 07 22.
Artigo em Inglês | MEDLINE | ID: mdl-33999545

RESUMO

BACKGROUND: In patients with ST-elevation myocardial infarction (STEMI) who have multivessel disease, percutaneous coronary intervention (PCI) for nonculprit lesions (complete revascularization) is superior to treatment of the culprit lesion alone. However, whether complete revascularization that is guided by fractional flow reserve (FFR) is superior to an angiography-guided procedure is unclear. METHODS: In this multicenter trial, we randomly assigned patients with STEMI and multivessel disease who had undergone successful PCI of the infarct-related artery to receive complete revascularization guided by either FFR or angiography. The primary outcome was a composite of death from any cause, nonfatal myocardial infarction, or unplanned hospitalization leading to urgent revascularization at 1 year. RESULTS: The mean (±SD) number of stents that were placed per patient for nonculprit lesions was 1.01±0.99 in the FFR-guided group and 1.50±0.86 in the angiography-guided group. During follow-up, a primary outcome event occurred in 32 of 586 patients (5.5%) in the FFR-guided group and in 24 of 577 patients (4.2%) in the angiography-guided group (hazard ratio, 1.32; 95% confidence interval, 0.78 to 2.23; P = 0.31). Death occurred in 9 patients (1.5%) in the FFR-guided group and in 10 (1.7%) in the angiography-guided group; nonfatal myocardial infarction in 18 (3.1%) and 10 (1.7%), respectively; and unplanned hospitalization leading to urgent revascularization in 15 (2.6%) and 11 (1.9%), respectively. CONCLUSIONS: In patients with STEMI undergoing complete revascularization, an FFR-guided strategy did not have a significant benefit over an angiography-guided strategy with respect to the risk of death, myocardial infarction, or urgent revascularization at 1 year. However, given the wide confidence intervals for the estimate of effect, the findings do not allow for a conclusive interpretation. (Funded by the French Ministry of Health and Abbott; FLOWER-MI ClinicalTrials.gov number, NCT02943954.).


Assuntos
Angiografia Coronária , Reserva Fracionada de Fluxo Miocárdico , Intervenção Coronária Percutânea/métodos , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Idoso , Intervalos de Confiança , Estenose Coronária/cirurgia , Feminino , Seguimentos , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Revascularização Miocárdica/métodos , Modelos de Riscos Proporcionais , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Infarto do Miocárdio com Supradesnível do Segmento ST/fisiopatologia , Método Simples-Cego , Stents
10.
Health Econ Policy Law ; : 1-13, 2021 Mar 05.
Artigo em Inglês | MEDLINE | ID: mdl-33662232

RESUMO

France is one of the European countries hardest hit by the Covid-19 pandemic. The pandemic brought into light structural weaknesses of the health system, including its governance and decision-making process, but also provoked changes that helped to improve its resilience. We analyse the French experience of Covid-19 in 2020 by critically reviewing major policy measures implemented during the first two waves of the pandemic. France has struggled to find the right balance between the rock of economic and social damage caused by containment measures and the hard alternative of a rapidly spreading pandemic. The response to the first wave, including a full lock-down, was an emergency response that revealed the low level of preparedness for pandemics and the overly hospital-centred provision of health care in France. During the second wave, this response evolved into a more level strategy trying to reconcile health needs in a broader perspective integrating socio-economic considerations, but without fully managing to put in place an effective health strategy. We conclude that to achieve the right balance, France will have to strengthen health system capacity and improve the cooperation between actors at central and local levels with greater participatory decision-making that takes into account local-level realities and the diversity of needs.

11.
JAMA ; 325(6): 552-560, 2021 02 09.
Artigo em Inglês | MEDLINE | ID: mdl-33560322

RESUMO

Importance: The optimal transfusion strategy in patients with acute myocardial infarction and anemia is unclear. Objective: To determine whether a restrictive transfusion strategy would be clinically noninferior to a liberal strategy. Design, Setting, and Participants: Open-label, noninferiority, randomized trial conducted in 35 hospitals in France and Spain including 668 patients with myocardial infarction and hemoglobin level between 7 and 10 g/dL. Enrollment could be considered at any time during the index admission for myocardial infarction. The first participant was enrolled in March 2016 and the last was enrolled in September 2019. The final 30-day follow-up was accrued in November 2019. Interventions: Patients were randomly assigned to undergo a restrictive (transfusion triggered by hemoglobin ≤8; n = 342) or a liberal (transfusion triggered by hemoglobin ≤10 g/dL; n = 324) transfusion strategy. Main Outcomes and Measures: The primary clinical outcome was major adverse cardiovascular events (MACE; composite of all-cause death, stroke, recurrent myocardial infarction, or emergency revascularization prompted by ischemia) at 30 days. Noninferiority required that the upper bound of the 1-sided 97.5% CI for the relative risk of the primary outcome be less than 1.25. The secondary outcomes included the individual components of the primary outcome. Results: Among 668 patients who were randomized, 666 patients (median [interquartile range] age, 77 [69-84] years; 281 [42.2%] women) completed the 30-day follow-up, including 342 in the restrictive transfusion group (122 [35.7%] received transfusion; 342 total units of packed red blood cells transfused) and 324 in the liberal transfusion group (323 [99.7%] received transfusion; 758 total units transfused). At 30 days, MACE occurred in 36 patients (11.0% [95% CI, 7.5%-14.6%]) in the restrictive group and in 45 patients (14.0% [95% CI, 10.0%-17.9%]) in the liberal group (difference, -3.0% [95% CI, -8.4% to 2.4%]). The relative risk of the primary outcome was 0.79 (1-sided 97.5% CI, 0.00-1.19), meeting the prespecified noninferiority criterion. In the restrictive vs liberal group, all-cause death occurred in 5.6% vs 7.7% of patients, recurrent myocardial infarction occurred in 2.1% vs 3.1%, emergency revascularization prompted by ischemia occurred in 1.5% vs 1.9%, and nonfatal ischemic stroke occurred in 0.6% of patients in both groups. Conclusions and Relevance: Among patients with acute myocardial infarction and anemia, a restrictive compared with a liberal transfusion strategy resulted in a noninferior rate of MACE after 30 days. However, the CI included what may be a clinically important harm. Trial Registration: ClinicalTrials.gov Identifier: NCT02648113.


Assuntos
Anemia/terapia , Transfusão de Sangue , Infarto do Miocárdio/terapia , Idoso , Idoso de 80 Anos ou mais , Anemia/complicações , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/prevenção & controle , Feminino , Hemoglobinas/análise , Humanos , Masculino , Infarto do Miocárdio/sangue , Infarto do Miocárdio/complicações
12.
Clin Cardiol ; 44(2): 143-150, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33405291

RESUMO

BACKGROUND: Anemia is common in patients with acute myocardial infarction (AMI), and is an independent predictor of mortality. The optimal transfusion strategy in these patients is unclear. HYPOTHESIS: We hypothesized that a "restrictive" transfusion strategy (triggered by hemoglobin ≤8 g/dL) is clinically noninferior to a "liberal" transfusion strategy (triggered by hemoglobin ≤10 g/dL), but is less costly. METHODS: REALITY is an international, randomized, multicenter, open-label trial comparing a restrictive vs a liberal transfusion strategy in patients with AMI and anemia. The primary outcome is the incremental cost-effectiveness ratio (ICER) at 30 days, using the primary composite clinical outcome of major adverse cardiovascular events (MACE; comprising all-cause death, nonfatal stroke, nonfatal recurrent myocardial infarction, or emergency revascularization prompted by ischemia) as the effectiveness criterion. Secondary outcomes include the ICER at 1 year, and MACE (and its components) at 30 days and at 1 year. RESULTS: The trial aimed to enroll 630 patients. Based on estimated event rates of 11% in the restrictive group and 15% in the liberal group, this number will provide 80% power to demonstrate clinical noninferiority of the restrictive group, with a noninferiority margin corresponding to a relative risk equal to 1.25. The sample size will also provide 80% power to show the cost-effectiveness of the restrictive strategy at a threshold of €50 000 per quality-adjusted life year. CONCLUSIONS: REALITY will provide important guidance on the management of patients with AMI and anemia.


Assuntos
Anemia , Infarto do Miocárdio , Anemia/diagnóstico , Anemia/terapia , Transfusão de Sangue , Transfusão de Eritrócitos , Hemoglobinas , Humanos , Infarto do Miocárdio/complicações , Infarto do Miocárdio/terapia
13.
Cephalalgia ; 41(3): 279-293, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33472427

RESUMO

The Clinical Trials Subcommittee of the International Headache Society presents the first Health Technology Assessment for the Acute Treatment of Migraine Attacks and Prevention of Migraine. Health technology assessments are systematic evaluations of the properties, effects, and consequences of healthcare technologies; this position statement is designed to inform decision makers about access to and reimbursement for medications and devices for the acute and preventive treatment of migraine. This position statement extends beyond the already available guidelines on randomized controlled trials for migraine to incorporate real-world evidence and a synthetic approach for considering multiple data sources and modelling methods when assessing the value of migraine treatments.

14.
Neuromodulation ; 24(1): 86-101, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32865344

RESUMO

BACKGROUND: Recent studies have highlighted multicolumn spinal cord stimulation (SCS) efficacy, hypothesizing that optimized spatial neural targeting provided by new-generation SCS lead design or its multicolumn programming abilities could represent an opportunity to better address chronic back pain (BP). OBJECTIVE: To compare multicolumn vs. monocolumn programming on clinical outcomes of refractory postoperative chronic BP patients implanted with SCS using multicolumn surgical lead. MATERIALS AND METHODS: Twelve centers included 115 patients in a multicenter, randomized, double-blind, controlled trial. After randomization, leads were programmed using only one or several columns. The primary outcome was change in BP visual analogic scale (VAS) at six months. All patients were then programmed using the full potential of the lead up until 12-months follow-up. RESULTS: At six months, there was no significant difference in clinical outcomes whether the SCS was programmed using a mono or a multicolumn program. At 12 months, in all patients having been receiving multicolumn SCS for at least six months (n = 97), VAS decreases were significant for global pain (45.1%), leg pain (55.8%), and BP (41.5%) compared with baseline (p < 0.0001). CONCLUSION: The ESTIMET study confirms the significant benefit experienced on chronic BP by patients implanted with multicolumn SCS, independently from multicolumn lead programming. These good clinical outcomes might result from the specific architecture of the multicolumn lead, giving the opportunity to select initially the best column on a multicolumn grid and to optimize neural targeting with low-energy requirements. However, involving more columns than one does not appear necessary, once initial spatial targeting of the "sweet spot" has been achieved. Our findings suggest that this spatial concept could also be transposed to cylindrical leads, which have drastically improved their capability to shape the electrical field, and might be combined with temporal resolution using SCS new modalities.

15.
Artigo em Inglês | MEDLINE | ID: mdl-33276656

RESUMO

Spinal muscular atrophy (SMA) is one of the most common severe hereditary diseases of infancy and early childhood. The progression of this illness causes a high degree of disability; hence, a significant burden is experienced by individuals with this disease and their families. We analyzed the time taken to care for patients suffering from SMA in European countries and the burden on their informal caregivers. We designed a cross-sectional study recording data from France, Germany, Spain and the United Kingdom. The primary caregivers completed a self-administered questionnaire that included questions about the time of care, The Zarit Burden Interview, type of SMA and socio-demographic characteristics. Multivariate analyses were used to study the associations between the type of SMA, time of care and burden supported by informal caregivers. The caregivers provided 10.0 h (SD = 6.7) per day of care (the principal caregivers provided 6.9 h, SD = 4.6). The informal caregivers of patients with type I SMA had a 36.3 point higher likelihood (p < 0.05) of providing more than 10 h of care per day in comparison with caregivers of patients with type III SMA. The severity of the disease was associated with more time of care and a higher burden on the caregivers.


Assuntos
Cuidadores , Atrofia Muscular Espinal , Criança , Pré-Escolar , Efeitos Psicossociais da Doença , Estudos Transversais , Europa (Continente) , França , Alemanha , Humanos , Atrofia Muscular Espinal/epidemiologia , Espanha , Inquéritos e Questionários , Reino Unido
16.
Arch Cardiovasc Dis ; 113(10): 590-598, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-33011157

RESUMO

BACKGROUND: Cardiovascular diseases are a leading cause of mortality, but a substantial proportion are preventable. AIMS: The Mutuelle générale de l'éducation nationale (MGEN), a provider of private health insurance in France, has developed the VIVOPTIM programme, a novel digital approach to healthcare based on individualized, multiprofessional, ranked management of cardiovascular risk factors. METHODS: Between November 2015 and June 2016, eligible individuals (age 30-70 years) from two regions of France were invited to participate. Volunteers completed a questionnaire based on the Framingham Heart Study Risk Score and were assigned to one of three cardiovascular risk levels. VIVOPTIM comprises four components: cardiovascular risk assessment, instruction on cardiovascular diseases and associated risk factors, personalized coaching (telephone sessions with a specially trained healthcare professional to provide information on risk factors and disease management, set individual health targets, monitor progress and motivate participants), and e-Health monitoring. RESULTS: Data from 2240 participants were analysed. Significant benefits were observed on mean systolic blood pressure (-3.4mmHg), weight (-1.5kg), smoking (-2.2 cigarettes/day) and daily steps (+1726 steps/day (all P<0.0001)), though not on weekly duration of exercise (-0.2hours/week, P=0.619). CONCLUSION: As a result of the positive mid-to-long-term results of the pilot programme on weight, smoking, blood pressure, and uptake of physical activity, the VIVOPTIM programme was extend to the whole of France in 2018 and has the potential to have a genuine impact on patient care and organization of the healthcare system in France.


Assuntos
Doenças Cardiovasculares/prevenção & controle , Estilo de Vida Saudável , Educação de Pacientes como Assunto , Prevenção Primária , Telemedicina , Adulto , Idoso , Pressão Sanguínea , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/etiologia , Dieta Saudável , Exercício Físico , Feminino , França , Conhecimentos, Atitudes e Prática em Saúde , Nível de Saúde , Humanos , Masculino , Adesão à Medicação , Pessoa de Meia-Idade , Projetos Piloto , Avaliação de Programas e Projetos de Saúde , Medição de Risco , Fatores de Risco , Abandono do Hábito de Fumar , Perda de Peso
17.
BMC Cancer ; 20(1): 975, 2020 Oct 09.
Artigo em Inglês | MEDLINE | ID: mdl-33036567

RESUMO

BACKGROUND: Currently, oral targeted therapies are known to be effective and are frequently used to treat metastatic cancer patients, but fatigue is a frequently reported early side effect of these treatments. This fatigue may impact the patient's treatment adherence and result in a negative impact on quality of life. Physical exercise significantly improved the general well-being and quality of life of advanced cancer patients. However, there is no specific physical activity program adapted for patients with advanced disease. METHODS: QUALIOR is a two-part, randomized, open-label, and multicenter with two arms phase II/III trial. Patients (phase II: n = 120; phase III: n = 312) with metastatic cancer (breast cancer, kidney cancer, lung cancer, and other cancers [including but not limited to colon cancer, melanoma, sarcoma, or hepatocarcinoma]) treated with a first- or second-line oral targeted therapy without chemotherapy will be included. Patients will be randomized (2:1) to a 3-month supervised home-based standardized physical activity program or to a recommended adapted physical activity (via a booklet). The primary objective of the phase II is to evaluate the feasibility of the supervised program. The primary objective of the phase III is the evaluation of the benefit of the supervised home-based program compare to the recommended program in terms of fatigue and quality of life at 3 months. The secondary objectives aim to evaluate the impact of the supervised program on fatigue over time, pain, physical capacities, psychosocial and cognitive functions, general quality of life, frequency of dose reduction and patients' adherence to the targeted therapy, overall survival, and progression-free survival. This study will also evaluate the medico-economic impact of supervised program compared to the recommended adapted physical activity program. DISCUSSION: The aim of this study is to evaluate home-based physical exercise program for metastatic cancer patients treated with oral targeted therapies to help patients to cope with fatigue and improve quality of life. TRIAL REGISTRATION: This trial was registered in ClinicalTrials.gov since May 2017 ( NCT03169075 ).


Assuntos
Terapia por Exercício/métodos , Metástase Neoplásica/terapia , Administração Oral , Estudos de Viabilidade , Feminino , Humanos , Masculino
18.
Thromb Haemost ; 120(12): 1597-1628, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32920811

RESUMO

COVID-19 is also manifested with hypercoagulability, pulmonary intravascular coagulation, microangiopathy, and venous thromboembolism (VTE) or arterial thrombosis. Predisposing risk factors to severe COVID-19 are male sex, underlying cardiovascular disease, or cardiovascular risk factors including noncontrolled diabetes mellitus or arterial hypertension, obesity, and advanced age. The VAS-European Independent Foundation in Angiology/Vascular Medicine draws attention to patients with vascular disease (VD) and presents an integral strategy for the management of patients with VD or cardiovascular risk factors (VD-CVR) and COVID-19. VAS recommends (1) a COVID-19-oriented primary health care network for patients with VD-CVR for identification of patients with VD-CVR in the community and patients' education for disease symptoms, use of eHealth technology, adherence to the antithrombotic and vascular regulating treatments, and (2) close medical follow-up for efficacious control of VD progression and prompt application of physical and social distancing measures in case of new epidemic waves. For patients with VD-CVR who receive home treatment for COVID-19, VAS recommends assessment for (1) disease worsening risk and prioritized hospitalization of those at high risk and (2) VTE risk assessment and thromboprophylaxis with rivaroxaban, betrixaban, or low-molecular-weight heparin (LMWH) for those at high risk. For hospitalized patients with VD-CVR and COVID-19, VAS recommends (1) routine thromboprophylaxis with weight-adjusted intermediate doses of LMWH (unless contraindication); (2) LMWH as the drug of choice over unfractionated heparin or direct oral anticoagulants for the treatment of VTE or hypercoagulability; (3) careful evaluation of the risk for disease worsening and prompt application of targeted antiviral or convalescence treatments; (4) monitoring of D-dimer for optimization of the antithrombotic treatment; and (5) evaluation of the risk of VTE before hospital discharge using the IMPROVE-D-dimer score and prolonged post-discharge thromboprophylaxis with rivaroxaban, betrixaban, or LMWH.


Assuntos
COVID-19/diagnóstico , Cardiologia , Doenças Cardiovasculares/diagnóstico , SARS-CoV-2/fisiologia , Anticoagulantes/uso terapêutico , COVID-19/tratamento farmacológico , COVID-19/epidemiologia , Doenças Cardiovasculares/tratamento farmacológico , Doenças Cardiovasculares/epidemiologia , Europa (Continente) , Heparina de Baixo Peso Molecular/uso terapêutico , Humanos , Inflamação , Guias de Prática Clínica como Assunto , Fatores de Risco , Rivaroxabana/uso terapêutico , Sociedades Médicas , Trombofilia , Trombose
19.
J Card Fail ; 26(12): 1067-1074, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32942010

RESUMO

BACKGROUND: Coronary angiography (CA) is usually performed in patients with reduced left ventricular ejection fraction (LVEF) to search ischemic cardiomyopathy. Our aim was to examine the agreement between CA and cardiovascular magnetic resonance (CMR) imaging among a cohort of patients with unexplained reduced LVEF, and estimate what would have been the consequences of using CMR imaging as the first-line examination. METHODS: Three hundred five patients with unexplained reduced LVEF of ≤45% who underwent both CA and CMR imaging were retrospectively registered. Patients were classified as CMR+ or CMR- according to presence or absence of myocardial ischemic scar, and classified CA+ or CA- according to presence or absence of significant coronary artery disease. RESULTS: CMR+ (n = 89) included all 54 CA+ patients, except 2 with distal coronary artery disease in whom no revascularization was proposed. Among the 247 CA- patients, 15% were CMR+. CMR imaging had 96% sensitivity, 85% specificity, 99% negative predictive value, and 58% positive predictive value for detecting CA+ patients. Revascularization was performed in 6.5% of the patients (all CMR+). Performing CA only for CMR+ patients would have decreased the number of CAs by 71%. CONCLUSIONS: In reduced LVEF, performing CA only in CMR+ patients may significantly decrease the number of unnecessary CAs performed, without missing any patients requiring revascularization.

20.
Artigo em Inglês | MEDLINE | ID: mdl-32764338

RESUMO

Background: this study aimed to estimate the economic impact and health-related quality of life (HRQOL) of patients with spinal muscular atrophy (SMA) in three European countries. It was used a cross-sectional study carried out in France, Germany, and the United Kingdom. Data were collected from July 2015 to November 2015. Healthcare costs (hospitalizations, emergencies, medical tests, drugs used, visits to general practitioners (GPs) and specialists, medical material and healthcare transport), and non-healthcare costs (social services and informal care) were identified and valued. EuroQol instruments, the Zarit interview, and the Barthel Index were also used to reflect the burden and the social impact of the disease beyond the cost of healthcare. Results: we included 86 children with SMA, 26.7% of them had Type I, and 73.3% Type II or III. The annual average cost associated with SMA reaches €54,295 in the UK, €32,042 in France and €51,983 in Germany. The direct non-healthcare costs ranged between 79-86% of the total cost and the informal care costs were the main component of these costs. Additionally, people suffering from this disease have a very low health-related quality of life, and there are large differences between countries. Conclusions: SMA has a high socioeconomic impact in terms of healthcare and social costs. It was also observed that the HRQOL of affected children was extremely reduced. The figures shown in this study may help to design more efficient and equitable policies, with special emphasis on the support provided to the families or on non-healthcare aid.


Assuntos
Nível de Saúde , Atrofia Muscular Espinal , Qualidade de Vida , Cuidadores , Criança , Efeitos Psicossociais da Doença , Estudos Transversais , Europa (Continente) , Feminino , Alemanha/epidemiologia , Custos de Cuidados de Saúde , Humanos , Licença Médica , Perfil de Impacto da Doença , Inquéritos e Questionários , Reino Unido
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