RESUMEN
BACKGROUND: Children with autism spectrum disorder (ASD) and moderate to severe intellectual disability (ID) face many challenges. There is little evidence-based research into educational settings for children with ID and ASD and in France. Little is known about how this unserved population could benefit from intervention and education. This study assessed the feasibility and efficacy of a new intervention model using an individualized educational approach. METHODS: We conducted a randomized, single-blind controlled trial to assess a novel intervention: the "Developmental and Sequenced One-to-One Intervention (DS1-EI)". In DS1-EI, trained teachers worked one-to-one with each child in a small classroom setting, offering 10 h per week of the intervention. The focus was on encouraging spontaneous communication, promoting skills through play with peers, supporting positive interactions, and developmental and sequenced learning. We enrolled 5- to 9-year-old children with ASD and ID across 11 French child care institutions for children with co-occurring ASD and ID. Participants were matched in dyads by developmental quotient and randomized to the treatment-as-usual (TAU) group or the DS1-EI group. Independent raters blindly assessed the primary variables: The Childhood Autism Rating scale (CARS) and the Psychoeducational Profile, third edition (PEP-3). The secondary variables included the Vineland Adaptive Behavior Scale II (VABS-II) and the Clinical Global Assessment Scale (CGAS). Here we perform interim analyses at 24 months. RESULTS: At baseline, 72 participants were randomized. Nine patients (5 in the DS1-EI group and 4 in the TAU group) dropped out of the study. Using linear mixed models, both intent-to-treat (ITT) and per-protocol (PP) analyses at the 12-, 18- and 24-month outcomes showed no significant group nor group-by-time interaction effects. However, we found significant improvements in most primary and secondary variables over time in both groups. CONCLUSIONS: The study did not show that DS1-EI was superior to TAU in treating children with ASD and ID over 24 months. However, the low dropout rate shows that DS1-EI is feasible, and well accepted. As the study is still ongoing, we need to wait for data at 36 months to ensure whether DS1-EI could be recommended. TRIAL REGISTRATION: ANSM130282B-31 (April 16, 2013) and ACTRN12616000592448. Registered 6 May 2016, retrospectively registered, http://www.anzctr.org.au/.
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Trastorno del Espectro Autista , Discapacidad Intelectual , Trastorno del Espectro Autista/complicaciones , Trastorno del Espectro Autista/terapia , Niño , Preescolar , Comunicación , Francia , Humanos , Método Simple CiegoRESUMEN
OBJECTIVE: The aim was to evaluate the distribution of the diameter of the great saphenous vein (GSV) at mid-thigh level and to investigate its association with clinical class, symptoms, and proximal extent of reflux. METHODS: Vascular physicians, members of the French Society of Phlebology, were invited to participate in a consecutive observational study in patients presenting with symptoms and/or signs of uni- or bilateral chronic venous disorders (CVDs) in previously untreated limbs (clinical class of the CEAP classification C0s - C6). Patients were included between January and March 2015. They completed a specially designed venous symptoms questionnaire. Duplex ultrasound of the included limbs was performed with the patient standing to detect reflux in the GSV and to measure the GSV inner diameter at mid-thigh. RESULTS: Between January and March 2015, 35 physicians examined 1245 patients (2450 limbs after excluding 40 limbs): 77% were female, mean age 52 ± 14; 69% of the patients had venous symptoms in one or both legs. The most frequent symptoms were feeling of heaviness, feeling of swelling and aching. Predominant CEAP clinical classes were C2 (38% of limbs) and C1 (35%). In case of GSV reflux (40% of limbs), the average diameter was 5.6 ± 2 mm and the distribution was 62% < 6 mm, 30% between 6 and 8 mm, and 8% > 8 mm. The study showed a clear association between clinical class and GSV diameter (the higher the clinical class, the larger the diameter; p < .0001), between venous symptoms and diameter (the larger the diameter, the higher the intensity of symptoms, p < .0001 for overall discomfort) and between proximal extent of reflux and diameter (the more proximal the extent of reflux, the larger the diameter, p < .0001). CONCLUSION: The DIAGRAVES study demonstrated that in France for patients consulting with CVDs, more than half of the incompetent GSVs had a diameter < 6 mm, while large diameters were relatively infrequent. This should be kept in mind when considering management strategies in patients with CVDs.
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Vena Safena , Ultrasonografía Doppler Dúplex/métodos , Insuficiencia Venosa , Anatomía Regional , Enfermedad Crónica , Femenino , Francia/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Tamaño de los Órganos , Selección de Paciente , Vena Safena/diagnóstico por imagen , Vena Safena/patología , Vena Safena/fisiopatología , Índice de Severidad de la Enfermedad , Procedimientos Quirúrgicos Vasculares/métodos , Insuficiencia Venosa/diagnóstico , Insuficiencia Venosa/epidemiología , Insuficiencia Venosa/fisiopatología , Insuficiencia Venosa/cirugíaRESUMEN
OBJECTIVES: The purpose of the study was to compare the efficacy of a product containing cranberry and propolis (DUAB) to placebo for reducing frequency of cystitis in women with recurrent acute cystitis. METHOD: A multicenter, placebo-controlled, randomized study of women aged >18 years with at least 4 episodes of cystitis in the previous 12 months was performed. The number of cystitis episodes over a 6-month follow-up was the primary end point. RESULTS: Forty-two women were included in the cranberry + propolis group, and 43 women were in the placebo group. The mean age was 53 ± 18 years, with 6.2 ± 3.6 cystitis episodes in the previous year, with no differences between the 2 groups. The mean number of infections was lower in the propolis + cranberry group (respectively, 2.3 ± 1.8 vs. 3.1 ± 1.8). The total number of cystitis episodes in the first 3 months was lower in the propolis + cranberry group (0.7 ± 1.1 vs. 1.3 ± 1.1, p = 0.0257) after adjusting for water consumption. The mean time to onset of the first urinary tract infection (UTI) was also significantly longer in the propolis + cranberry group (69.9 ± 45.8 days vs. 43.3 ± 45.9, p = 0.0258). Tolerance to the treatments was good and comparable in both groups. CONCLUSIONS: We demonstrate for the first time that cranberry and propolis supplementation significantly reduces the incidence of UTIs during the first 3 months and delays the onset of an episode of cystitis.
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Cistitis/tratamiento farmacológico , Infecciones por Escherichia coli/prevención & control , Extractos Vegetales/administración & dosificación , Própolis/administración & dosificación , Infecciones Urinarias/prevención & control , Vaccinium macrocarpon/química , Adulto , Anciano , Femenino , Humanos , Incidencia , Persona de Mediana Edad , Recurrencia , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: The effects of the seaweed extract were evaluated on the animal model equivalent of depression compared with a control group treated with the carrier (spring water) and a reference group treated with Imipramine and showed significative effect. This clinical trial was intended to confirm in humans the potential efficacy identified in animals. The primary objective was to compare against a placebo the effect of Ulva L.L extract in healthy volunteers whose anhedonia was characterized by a component of depression. METHODS: Single-centre double-blind randomized placebo-controlled clinical trial on parallel arms of two groups of 45 subjects. The study could include men or women aged 18 to 65 years with anhedonia characterized by a Snaith Hamilton Pleasure Scale score (SHAPS) of ≥5 and feeling low morale for at least four weeks characterized by a component of depression evaluated on the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR). Evaluation criteria: QIDS-SR; Patient Global Improvement Impression (PGII) and Clinical Global Improvement Impression (CGII). RESULTS: 86 subjects were included in the trial: 42 in the placebo group and 44 Ulva group. At D84, QIDS-SR significantly decreased more in the Ulva.L.L. group than in the placebo group (p: 0.0389). This difference is essentially linked to an improvement of the sleep disorders (p: 0.0219), of the psychomotor consequences (p: 0.002) and of the nutrition behaviour (p: 0.0694). 90.1% have the feeling of being improved in the Ulva group vs 72.5% in the placebo group (p: 0.0114) and in parallel 90.9% of the practitioners have the feeling that the subject has improved vs 70.8% (p: 0.0214). CONCLUSION: This double-blind randomized placebo-controlled trial shows that daily intake for three months of a water-soluble extract of Ulva L.L. continues to significantly improve the component of depression of subjects presenting anhedonia compared with a placebo. TRIAL REGISTRATION: Trial retrospectively registred on ClinicalTrial.gov under ID: NCT03545399 Date: 05/22/2018.
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Anhedonia/efectos de los fármacos , Depresión/tratamiento farmacológico , Depresión/psicología , Extractos Vegetales/uso terapéutico , Ulva , Adolescente , Adulto , Anciano , Anhedonia/fisiología , Depresión/diagnóstico , Método Doble Ciego , Femenino , Voluntarios Sanos/psicología , Humanos , Masculino , Persona de Mediana Edad , Efecto Placebo , Extractos Vegetales/aislamiento & purificación , Extractos Vegetales/farmacología , Estudios Retrospectivos , Autoinforme , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: Over-the-counter medicines may be proposed by pharmacists for children with acute cough. Study objectives were to describe the sociodemographic profile of children who were proposed a cough syrup by a pharmacist, the nature of the cough and type(s) of cough syrup proposed and to assess the evolution of the cough, tolerance and satisfaction with treatment. METHODS: Observational, prospective, longitudinal, multicentre study with 157 pharmacies in France. Children who were proposed a cough syrup by a pharmacist were recruited. Questionnaires were completed by the pharmacists and/or parents at inclusion and by the parents after 5 days of treatment. RESULTS: Four hundred fourteen children were included (mean age: 6.0±2.9 years); 45.9% had a dry and 43.3% a productive cough. 30.4% were proposed an allopathic antitussive syrup, 28.3% an allopathic expectorant syrup and 23.7% a homeopathic syrup. Children with a dry cough were more likely to be given an allopathic antitussive (55.2%) or homeopathic (28.2%) syrup. Children with a productive cough or cough of several days duration were more likely to be given an allopathic expectorant syrup (70.1%). Cough disappearance was more frequent with homeopathic syrups compared to allopathic expectorants (P=0.002), or allopathic antitussives (P=0.042). Adverse events were most common with allopathic antitussive syrups (18.7%) (P<0.001). Two-thirds of parents were satisfied with the treatment their child received. CONCLUSIONS: Pharmacists play an important role in the management of acute cough in children. Homeopathic cough syrups may have an interest in terms of public health.
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Antitusígenos/administración & dosificación , Tos/tratamiento farmacológico , Expectorantes/administración & dosificación , Medicamentos sin Prescripción/administración & dosificación , Enfermedad Aguda , Niño , Preescolar , Servicios Comunitarios de Farmacia , Femenino , Francia , Humanos , Estudios Longitudinales , Masculino , Satisfacción del Paciente/estadística & datos numéricos , Farmacéuticos/estadística & datos numéricos , Estudios Prospectivos , Encuestas y CuestionariosRESUMEN
BACKGROUND: The market for Connected Health Devices (CHD) with healthcare applications is growing fast and should be worth several billion euros in turnover in the coming years. Their development will completely transform the organisation of our healthcare system, profoundly change the way patients are managed and revolutionizes disease prevention. MAIN BODY: The CHD with healthcare applications is a tidal wave that has societal impact calling into question the privacy of patients' personal and healthcare information and its protection in secure systems. Rather than trying to stop the use of CHD, we must channel the wave by clearly examining the advantages versus the risks and threats to the patients, and find counter-measures for implementation. The main difficulty is channeling the wave in a way that is acceptable to CHD developers who otherwise will bypass the rules, even if they can be sued for it. Therefore, it appears necessary to implement guidelines that can be used by all developers, defining the minimum requirement for assuring the security of patient privacy and healthcare management. CONCLUSION: In European Healthcare Systems, there is an imperative need for establishing security guidelines that CHD producers could use to ensure compliance, so that patient privacy and healthcare management is safeguarded. The aim would be to implement the guidelines a posteriori rather than a priori control so as not to hamper innovation.
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Confidencialidad/normas , Atención a la Salud/normas , Guías como Asunto/normas , Aplicaciones de la Informática Médica , Europa (Continente) , HumanosRESUMEN
BACKGROUND: Chronic lower limb oedema is one of the complications of superficial or deep chronic venous disorders. It is ranked as "C3"on the CEAP classification. In epidemiological studies, the recognition of oedema is mainly based on clinical signs, and oedema is more easily detected in the second part of the day when it becomes evident. We addressed the question whether oedema is already present in the morning in patients suffering of primary varicose veins without trophic changes. PATIENTS AND METHODS: In total, 101 patients with primary varicose veins (C2 and/or C3 stage of the CEAP classification) and 122 controls were enrolled as they appeared in our centre. The consultation time was no later than 6 hours after the patient had woken up. Oedema was detected by pitting test and ultrasound. RESULTS: The mean consultation time lapse was 3.7 ± 1.2 hours after waking-up. Oedema was more frequent in the group of primary varicose veins without trophic changes (36 % compared to 14 % in the control group; p < 0.01). Oedema was mainly detected by ultrasound and far less so by the pitting test. CONCLUSIONS: Patients with varicose veins have morning oedema more frequently than patients without varicosis and at a higher rate than in epidemiological studies.
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Ritmo Circadiano , Edema/etiología , Várices/complicaciones , Adulto , Anciano , Anciano de 80 o más Años , Estudios de Casos y Controles , Edema/diagnóstico por imagen , Edema/fisiopatología , Femenino , Francia , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Factores de Riesgo , Factores de Tiempo , Ultrasonografía , Várices/diagnóstico , Várices/fisiopatología , Adulto JovenRESUMEN
BACKGROUND: Pharmacists play a key role in primary healthcare, but the characteristics of patients who consult a pharmacist directly rather than going to their general practitioner (GP) are unknown. Our aim was to describe the socio-demographic and clinical characteristics of patients who seek direct therapeutic advice from a pharmacist for influenza-like illness (ILI) or ear, nose and throat (ENT) disorders, the types of medicines dispensed and patient satisfaction with the advice received. METHODS: This prospective, observational study was carried out on a random sample of French pharmacies between November 2010 and March 2011. Patients (≥12-years) with early symptoms of ILI or ENT disorders (<36 h duration) who received treatment were included. Socio-demographic data, symptom severity and disease impact on daily activities and sleep were recorded at inclusion. Symptom evolution and patient satisfaction were assessed after 3 days of treatment. RESULTS: 573 patients (mean age: 42.5 ± 16.2 years; 61.9% female) were recruited by 133 pharmacies. Two-thirds of patients (63.2%) visited the pharmacy early (<24 h) after symptom onset. The most common symptoms were runny nose (56.4%), sore throat (54.6%) and cough (49.0%). Patients were given 2.6 ± 1.2 medications; 98.4% of patients received allopathic (usually paracetamol, 33.5%) and 25.3% homeopathic (Oscillococcinum, 56.6%) treatment, usually combined with allopathy. Compliance was good and 77.2% of patients continued treatment for 3 days. Most symptoms improved significantly after 3 days and quality of life was enhanced. 85.9% of patients were satisfied with the advice received. CONCLUSIONS: Seeking a pharmacist's advice for the management of ILI and ENT disorders has several public health benefits. The clinical improvement and high patient satisfaction observed validate the role of the pharmacist as a health professional of first resort.
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Acetaminofén/uso terapéutico , Diagnóstico Precoz , Gripe Humana/diagnóstico , Gripe Humana/tratamiento farmacológico , Enfermedades Otorrinolaringológicas/diagnóstico , Enfermedades Otorrinolaringológicas/tratamiento farmacológico , Farmacéuticos , Adulto , Resfriado Común/tratamiento farmacológico , Tos/tratamiento farmacológico , Manejo de la Enfermedad , Femenino , Francia , Homeopatía , Humanos , Masculino , Persona de Mediana Edad , Medicamentos sin Prescripción/uso terapéutico , Satisfacción del Paciente , Atención Primaria de Salud/métodos , Estudios Prospectivos , Factores Socioeconómicos , Resultado del Tratamiento , Adulto JovenRESUMEN
Topical hyaluronic acid (HA) is routinely used in the local treatment of chronic wounds, but few data have been reported to date. A 60-day double-blind, randomised, controlled superiority trial was designed to investigate the efficacy and safety of a gauze pad containing HA in local treatment of venous leg ulcers, compared with its neutral vehicle. The primary endpoint was the percentage of wound size reduction after 45 days. Totally 89 patients were included. At day 45, the percentage of ulcer surface reduction was significantly greater in the HA group (73 ± 4·6%) versus neutral vehicle group (46 ± 9·6%) (P = 0·011). The number of healed ulcers was significantly higher in the HA group at day 45 (31·1% versus 9·3% respectively) and day 60 (37·8% versus 16·3% respectively; P < 0·05). At day 30, pain intensity based on visual analogue scale was significantly lower in the HA group (12·4 mm ± 2·6 versus 22·8 mm ± 3·8; P = 0·026). Tolerance of both treatments was comparable in the two groups. HA gauze pad, in local treatment of venous leg ulcers, was significantly more effective than the neutral vehicle on wound size reduction, healed ulcers rate and pain management with a good safety profile.
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Vendajes , Ácido Hialurónico/administración & dosificación , Úlcera Varicosa/terapia , Administración Tópica , Adolescente , Adulto , Método Doble Ciego , Femenino , Francia , Humanos , Masculino , Persona de Mediana Edad , Marruecos , Polonia , Estudios Prospectivos , Resultado del Tratamiento , Cicatrización de Heridas , Adulto JovenRESUMEN
The exponential increase in the number of electronic document exchanges in healthcare has considerably increased the risk of document drop-out or address errors. It may therefore be important to know to whom the information belongs and who produced it. This becomes a major concern when the document has been involved in processes leading to the choice of therapy and eventually in cases where patients seek damages for medical malpractice. Watermarking, which is the embedding of security elements, such as a digital signature, within a document, can help to ensure that a digital document is reliable. However, at the same time, questions arise about the validity of watermarking-based evidence. In this paper, beyond the technical aspects, we discuss the worldwide legal acceptability of watermarking and the need for its recognition as a standard according to technical characteristics that the CEN and ISO need to agree on.
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Seguridad Computacional/normas , Sistemas de Administración de Bases de Datos/normas , Registros Electrónicos de Salud/normas , Guías como Asunto , Registros de Salud Personal , Almacenamiento y Recuperación de la Información/normas , Francia , Estándares de ReferenciaRESUMEN
AIMS: To determine the efficacy in pain reduction of a topical 1% lidocaine compared to a placebo cream in patients with oral mucosal lesions due to trauma or minor oral aphthous ulcer. METHODS: The design was a double-blind, randomized, placebo-controlled, six-center trial on 59 patients. Pain intensity and relief were measured using a 100-mm visual analog scale (VAS). One-tailed Student t test and ANOVA analyses were used for statistical analyses. RESULTS: Independent of the pain origin (oral mucosal trauma or minor oral aphthous ulcer), the application of the 1% lidocaine cream led to a mean reduction in VAS pain intensity of 29.4 mm ± 17.0, which was significantly greater than the decrease obtained with the placebo cream. Analysis showed a statistically significant efficacy of the 1% lidocaine cream (P = .0003). Its efficacy was not related to the type of lesion, and no adverse drug reaction, either local or systemic, was reported by any of the patients. CONCLUSION: A significant reduction in pain intensity occurred after application of 1% lidocaine cream and was significantly greater than that with the placebo cream. Taking into account the study's limitations, this product seems safe to use.
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Anestésicos Locales/administración & dosificación , Lidocaína/administración & dosificación , Mucosa Bucal/lesiones , Estomatitis Aftosa/tratamiento farmacológico , Administración Tópica , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Mucosa Bucal/efectos de los fármacos , Pomadas , Dimensión del Dolor , Placebos , Adulto JovenRESUMEN
BACKGROUND: As patients often see the data of their medical histories scattered among various medical records hosted in several health-care establishments, the purpose of our multidisciplinary study was to define a pragmatic and secure on-demand based system able to gather this information, with no risk of breaching confidentiality, and to relay it to a medical professional who asked for the information via a specific search engine. METHODS: Scattered data are often heterogeneous, which makes the task of gathering information very hard. Two methods can be compared: trying to solve the problem by standardizing and centralizing all the information about every patient in a single Medical Record system or trying to use the data "as is" and find a way to obtain the most complete and the most accurate information. Given the failure of the first approach, due to the lack of standardization or privacy and security problems, for example, we propose an alternative that relies on the current state of affairs: an on-demand system, using a specific search engine that is able to retrieve information from the different medical records of a single patient. RESULTS: We describe the function of Medical Record Search Engines (MRSE), which are able to retrieve all the available information regarding a patient who has been hospitalized in different hospitals and to provide this information to health professionals upon request. MRSEs use pseudonymized patient identities and thus never have access to the patient's identity. However, though the system would be easy to implement as it by-passes many of the difficulties associated with a centralized architecture, the health professional would have to validate the information, i.e. read all of the information and create his own synthesis and possibly reject extra data, which could be a drawback. We thus propose various feasible improvements, based on the implementation of several tools in our on-demand based system. CONCLUSIONS: A system that gathers all of the currently available information regarding a patient on the request of health-care professionals could be of great interest. This low-cost pragmatic alternative to centralized medical records could be developed quickly and easily. It could also be designed to include extra features and should thus be considered by health authorities.
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Sistemas de Registros Médicos Computarizados , Seguridad Computacional , Confidencialidad , Humanos , Motor de BúsquedaRESUMEN
When dealing with medical data sharing, in particular within telemedicine applications, there is a need to ensure information security. Being able to verify that the information belongs to the right patient and is from the right source or that it has been rerouted or modified is a major concern. Watermarking, which is the embedding of security elements, such as a digital signature, within a document, can help to ensure that a digital document is reliable. However, at the same time, questions arise about the validity of watermarking-based proof. In this paper, beyond the technical aspects, we discuss the legal acceptability of watermarking in the context of telemedicine applications.
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Mala Praxis , Telemedicina/instrumentación , Telemedicina/métodos , Acceso a la Información , Seguridad Computacional , Confidencialidad , Documentación , Humanos , Internet , Imagen por Resonancia Magnética/métodos , Aplicaciones de la Informática Médica , Sistemas de Registros Médicos Computarizados , Sistemas de Identificación de Pacientes , Programas InformáticosRESUMEN
Through this article, we point out the unavoidable empowerment of patients with regard to their personal health record and propose the mixed management of patients' medical records. This mixed management implies sharing responsibilities between the patient and the Medical Practitioner (MP) by making patients responsible for the validation of their administrative information, and MPs responsible for the validation of their patients' medical information. We propose a solution to gather and update patients' administrative and medical data in order to reconstitute patients' medical histories accurately. This method is based on two processes. The aim of the first process is to provide patients administrative data, in order to know where and when they received care (name of the health structure or health practitioner, type of care: outpatient or inpatient). The aim of the second process is to provide patients' medical information and to validate it under the responsibility of the MP with the help of patients if needed. During these two processes, the patients' privacy will be ensured through cryptographic hash functions like the Secure Hash Algorithm, which allows the pseudonymization of patients' identities. The Medical Record Search Engine we propose will be able to retrieve and to provide upon a request formulated by the MP all the available information concerning a patient who has received care in different health structures without divulging the patient's true identity. Associated with strong traceability of all access, modifications or deletions, our method can lead to improved efficiency of personal medical record management while reinforcing the empowerment of patients over their medical records.
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Registros de Salud Personal , Participación del Paciente , Relaciones Médico-Paciente , Poder Psicológico , Responsabilidad Social , HumanosRESUMEN
The implementation of REGULATION (EC) No 1924/2006 has led to the formation of a list of health claims that can be used in food supplements (EU 432/2012). However, such supplements are often composed of plant preparations with claims omitted from this list. The peculiarity of plants is related to their long history of use, that could allow claims based on traditionally recognized health effects. In addition, the scientific literature has been enriched over the years through clinical studies that have assessed the bioavailability and efficacy of bioactive components, and investigated their mechanisms of action. Based on existing recognized models which aim to classify research according to the level of scientific evidence, Synadiet developed a three-grade model (A, B or C) for assessing plants health claims. In this paper, the applicability of the model is illustrated through an example for which a Grade B health claim attesting the possible contribution of red clover isoflavones to the improvement of blood lipid levels in postmenopausal women has been attributed. The model appears able to be easily extrapolated to claims pertaining to other plants. If adopted by consensus at European level, this model could initiate the implementation of a positive list of health claims on plant preparations.
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Suplementos Dietéticos/normas , Análisis de los Alimentos/métodos , Etiquetado de Alimentos/normas , Preparaciones de Plantas/normas , Plantas Comestibles , Adulto , Anciano , Suplementos Dietéticos/análisis , Femenino , Etiquetado de Alimentos/legislación & jurisprudencia , Humanos , Isoflavonas/análisis , Isoflavonas/normas , Legislación Alimentaria , Lípidos/sangre , Masculino , Persona de Mediana Edad , Valor Nutritivo , Preparaciones de Plantas/análisis , Posmenopausia/sangre , Trifolium/químicaRESUMEN
Several studies suggest that microbial alterations (dysbiosis) are intimately linked to chronic inflammation occurring upon aging. The aim of this study was to investigate the potential interest of a synbiotic approach (co-administration of a probiotic bacteria and a prebiotic dietary fibre) to improve gastrointestinal wellness and inflammatory markers in middle-aged people. Middle-aged subjects were randomized to take synbiotic (Bifidobacterium animalis lactis and fructo-oligosaccharides (FOS)) or placebo for 30 days. Stool frequency and consistency were improved in both placebo and synbiotic-treated volunteers while the synbiotic treatment significantly decreased the number of days with abdominal discomfort. Synbiotic treatment had no impact on mood dimensions, quality of life scores or the overall composition of the gut microbiota (16S rRNA gene sequencing of DNA extracted from stool). Importantly, plasma proinflammatory cytokines (interleukin (IL)-6, IL-8, IL-17a and interferon-gamma (IFNγ)) were significantly lower after 30 days of synbiotic supplementation. This effect appears to be independent of the gut barrier function. This study demonstrates that a combination of B. animalis lactis and the well-known prebiotic FOS could be a promising synbiotic strategy to decrease inflammatory status with improvement of gut disorders in middle-aged people.
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Microbioma Gastrointestinal/efectos de los fármacos , Simbióticos/administración & dosificación , Anciano , Envejecimiento , Bifidobacterium animalis/fisiología , Biomarcadores/metabolismo , Citocinas/metabolismo , Método Doble Ciego , Heces/microbiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Calidad de VidaRESUMEN
BACKGROUND: AIMS Short- and mid-term side effects of sclerotherapy, in particular with polidocanol (lauromacrogol 400), have been previously described in our registry of 12,173 sessions. The objective of this follow-up registry was to evaluate the long-term incidence of adverse events with polidocanol. METHODS: The physicians involved in the initial French registry were contacted and asked to partake in the follow-up survey. Initially included patients were controlled at the latest possible date to determine whether a complication had occurred after the end of the initial survey. RESULTS: Data on 1,605 patients included in the French registry were reviewed with a maximum follow-up of 60 months, covering 3,357 patient years. Five (0.4%) adverse events were observed in patients treated with liquid polidocanol and 46 (1.1%) in patients treated with polidocanol foam. The most frequent side effects were visual disturbances (n=14), and the most severe were muscular vein thrombosis (n=8). The onset of side effects was mostly observed directly after sclerotherapy or in the 6 months after (84% in the first year). One deep vein thrombosis recurrence occurred in a patient with heterozygote Factor V Leiden after stopping anticoagulant treatment (foam sclerotherapy). CONCLUSIONS: Foam sclerotherapy is a recognized reference method in the treatment of varicose veins of all types. This study demonstrates that polidocanol is a safe sclerosing agent in the short and long term.
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Polietilenglicoles/efectos adversos , Soluciones Esclerosantes/efectos adversos , Escleroterapia/efectos adversos , Telangiectasia/terapia , Várices/terapia , Sistemas de Registro de Reacción Adversa a Medicamentos , Femenino , Francia/epidemiología , Humanos , Incidencia , Estudios Longitudinales , Masculino , Polidocanol , Sistema de RegistrosRESUMEN
Giving patients power over their personal health record is an unavoidable evolution in all industrialized countries which will reflect their active participation in the management of their own health. This would lead to patients sharing management with health professionals, which would need traceability of the data provider to maintain trust and transparency. The systematic use of electronic signatures by medical practitioners will be essential to provide sufficient guarantees and to clearly determine who has added what in the PEHR.
Asunto(s)
Seguridad Computacional/normas , Registros de Salud Personal , Participación del Paciente/métodos , Humanos , Poder Psicológico , Relaciones Profesional-PacienteRESUMEN
Through this article, we propose a mixed management of patients' medical records, so as to share responsibilities between the patient and the Medical Practitioner by making Patients responsible for the validation of their administrative information, and MPs responsible for the validation of their Patients' medical information. Our proposal can be considered a solution to the main problem faced by patients, health practitioners and the authorities, namely the gathering and updating of administrative and medical data belonging to the patient in order to accurately reconstitute a patient's medical history. This method is based on two processes. The aim of the first process is to provide a patient's administrative data, in order to know where and when the patient received care (name of the health structure or health practitioner, type of care: out patient or inpatient). The aim of the second process is to provide a patient's medical information and to validate it under the accountability of the Medical Practitioner with the help of the patient if needed. During these two processes, the patient's privacy will be ensured through cryptographic hash functions like the Secure Hash Algorithm, which allows pseudonymisation of a patient's identity. The proposed Medical Record Search Engines will be able to retrieve and to provide upon a request formulated by the Medical Practitioner all the available information concerning a patient who has received care in different health structures without divulging the patient's identity. Our method can lead to improved efficiency of personal medical record management under the mixed responsibilities of the patient and the MP.