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1.
Brain Sci ; 14(3)2024 Feb 28.
Artigo em Inglês | MEDLINE | ID: mdl-38539616

RESUMO

Cannabis use disorder (CUD) is a growing public health concern, with rising prevalence and significant impact on individuals across age groups. This systematic review examines 24 studies investigating pharmacological and non-pharmacological interventions for CUD among adolescents (up to 17), young adults (18-24), and older adults (25-65). Database searches were conducted for randomized controlled trials of CUD interventions reporting outcomes such as cannabis use, abstinence, withdrawal symptoms, and treatment retention. For adolescents, interventions such as contingent rewards and family engagement have shown promise, while young adults benefit from technology-based platforms and peer support. In older adults, pharmacological adjuncts combined with counseling have shown promise in enhancing treatment outcomes. However, optimal treatment combinations remain uncertain, highlighting the need for further research. Addressing CUD requires tailored interventions that acknowledge developmental stages and challenges across the lifespan. Although promising interventions exist, further comparative effectiveness research is needed to delineate the most efficacious approaches.

2.
Mol Genet Metab ; 140(3): 107674, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-37542768

RESUMO

OBJECTIVES: Patients with PMM2-CDG develop acute events (stroke-like episodes (SLEs), thromboses, haemorrhages, seizures, migraines) associated with both clotting factors (factor XI) and coagulation inhibitors (antithrombin, protein C and protein S) deficiencies. The aim of the study was to correlate acute events to haemostasis and propose practical guidelines. METHODS: In this multicentric retrospective study, we evaluated clinical, radiological, haemostasis and electroencephalography data for PMM2-CDG patients hospitalized for acute events. Cerebral events were classified as thrombosis, haemorrhage, SLE, or "stroke mimic" (SM: normal brain imaging or evoking a migraine). RESULTS: Thirteen patients had a total of 31 acute episodes: 27 cerebral events with 7 SLEs, 4 venous thromboses, 4 haemorrhages (3 associated with thrombosis), 15 SMs at a mean age of 7.7 years; 4 non-cerebral thromboses, one of which included bleeding. A trigger was frequently involved (infection, head trauma). Although sometimes normal at baseline state, factor XI, antithrombin and protein C levels decreased during these episodes. No correlation between haemostasis anomalies and type of acute event was found. DISCUSSION: Acute events in PMM2-CDG are not negligible and are associated with haemostasis anomalies. An emergency protocol is proposed for their prevention and treatment (https://www.filiere-g2m.fr/urgences). For cerebral events, brain Magnetic Resonance Imaging with perfusion weight imaging and diffusion sequences, electroencephalogram and haemostasis protein levels guide the treatment: anticoagulation, antithrombin or fresh frozen plasma supplementation, antiepileptic therapy. Preventing bleeding and thrombosis is required in cases of surgery, prolonged immobilization, hormone replacement therapy. CONCLUSION: Acute events in PMM2-CDG are associated with abnormal haemostasis, requiring practical guidance.


Assuntos
Defeitos Congênitos da Glicosilação , Fosfotransferases (Fosfomutases) , Acidente Vascular Cerebral , Trombose , Humanos , Criança , Proteína C , Estudos Retrospectivos , Fator XI , Defeitos Congênitos da Glicosilação/patologia , Antitrombinas , Hemostasia , Hemorragia
3.
Fertil Steril ; 119(4): 626-633, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36592649

RESUMO

OBJECTIVE: To evaluate the prevalence on magnetic resonance imaging (MRI) of ovarian endometrioma (OMA) and deep infiltrating endometriosis (DIE) in adolescents presenting with severe dysmenorrhea. DESIGN: Prospective study. SETTING: Clinic. PATIENT(S): A total of 345 adolescents aged 12-20 years referred to the radiologic MRI department unit between September 2019 and June 2020. INTERVENTION(S): Multiplanar pelvic MRI with cine MRI was performed. Data on the medical history with systematic questioning were collected for each patient before the scan. MAIN OUTCOME MEASURE(S): Data on the endometriosis phenotypes (OMA and/or DIE), distribution of anatomical lesions, and adenomyosis were evaluated and recorded using a dedicated MRI spreadsheet. Myometrial contractions were systematically reported for each case. The data were correlated with the characteristics of the patients and severity of painful symptoms evaluated using a visual analog scale. RESULT(S): The prevalence rates of endometriosis and adenomyosis were 39.3% (121 patients) and 11.4% (35 patients), respectively. Among the adolescents with endometriosis, 25 (20.7%) presented with OMA, and 107 (88.4%) presented with DIE. The odds ratios (confidence intervals) for each pairwise comparison between the age distributions were 2.3 (1.4-3.8) for 15-18 vs. <15 years of age and 3.3 (1.2-8.5) for 18-20 vs. <15 years of age, highlighting a predominance of cases after 18 years of age. Uterine contractions were visualized in 34.4% of cases, with no particular association with endometriosis. No clinical risk factor was identified as being particularly associated with endometriosis. Notably, the visual analog scale score was the same for cases with and without endometriosis. CONCLUSION(S): Severe endometriosis phenotypes (OMA and/or DIE) can be observed in adolescents with intense dysmenorrhea, with a linear increase in prevalence over time resulting in a clear predominance after 18 years of age. Endometriosis in adolescents is a challenging clinical problem with a long delay in diagnosis. Imaging can help reduce this delay in young patients with suggestive symptoms. CLINICAL TRIAL REGISTRATION NUMBER: NCT05153512.


Assuntos
Adenomiose , Endometriose , Feminino , Humanos , Gravidez , Adenomiose/patologia , Dismenorreia/diagnóstico por imagem , Dismenorreia/epidemiologia , Dismenorreia/etiologia , Endometriose/diagnóstico por imagem , Endometriose/epidemiologia , Imageamento por Ressonância Magnética , Prevalência , Estudos Prospectivos
4.
EBioMedicine ; 84: 104246, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-36099812

RESUMO

BACKGROUND: Primary Ovarian Insufficiency (POI), a public health problem, affects 1-3.7% of women under 40 yielding infertility and a shorter lifespan. Most causes are unknown. Recently, genetic causes were identified, mostly in single families. We studied an unprecedented large cohort of POI to unravel its molecular pathophysiology. METHODS: 375 patients with 70 families were studied using targeted (88 genes) or whole exome sequencing with pathogenic/likely-pathogenic variant selection. Mitomycin-induced chromosome breakages were studied in patients' lymphocytes if necessary. FINDINGS: A high-yield of 29.3% supports a clinical genetic diagnosis of POI. In addition, we found strong evidence of pathogenicity for nine genes not previously related to a Mendelian phenotype or POI: ELAVL2, NLRP11, CENPE, SPATA33, CCDC150, CCDC185, including DNA repair genes: C17orf53(HROB), HELQ, SWI5 yielding high chromosomal fragility. We confirmed the causal role of BRCA2, FANCM, BNC1, ERCC6, MSH4, BMPR1A, BMPR1B, BMPR2, ESR2, CAV1, SPIDR, RCBTB1 and ATG7 previously reported in isolated patients/families. In 8.5% of cases, POI is the only symptom of a multi-organ genetic disease. New pathways were identified: NF-kB, post-translational regulation, and mitophagy (mitochondrial autophagy), providing future therapeutic targets. Three new genes have been shown to affect the age of natural menopause supporting a genetic link. INTERPRETATION: We have developed high-performance genetic diagnostic of POI, dissecting the molecular pathogenesis of POI and enabling personalized medicine to i) prevent/cure comorbidities for tumour/cancer susceptibility genes that could affect life-expectancy (37.4% of cases), or for genetically-revealed syndromic POI (8.5% of cases), ii) predict residual ovarian reserve (60.5% of cases). Genetic diagnosis could help to identify patients who may benefit from the promising in vitro activation-IVA technique in the near future, greatly improving its success in treating infertility. FUNDING: Université Paris Saclay, Agence Nationale de Biomédecine.


Assuntos
Infertilidade , Insuficiência Ovariana Primária , Feminino , Humanos , Infertilidade/complicações , Mitomicinas , NF-kappa B , Medicina de Precisão , Insuficiência Ovariana Primária/etiologia
5.
Am J Addict ; 31(6): 535-545, 2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-36062888

RESUMO

BACKGROUND AND OBJECTIVES: Substance use disorders (SUDs) are chronic relapsing diseases characterized by significant morbidity and mortality. Phenomenologically, patients with SUDs present with a repeating cycle of intoxication, withdrawal, and craving, significantly impacting their diagnosis and treatment. There is a need for better identification and monitoring of these disease states. Remote monitoring chronic illness with wearable devices offers a passive, unobtrusive, constant physiological data assessment. We evaluate the current evidence base for remote monitoring of nonalcohol, nonnicotine SUDs. METHODS: We performed a systematic, comprehensive literature review and screened 1942 papers. RESULTS: We found 15 studies that focused mainly on the intoxication stage of SUD. These studies used wearable sensors measuring several physiological parameters (ECG, HR, O2 , Accelerometer, EDA, temperature) and implemented study-specific algorithms to evaluate the data. DISCUSSION AND CONCLUSIONS: Studies were extracted, organized, and analyzed based on the three SUD disease states. The sample sizes were relatively small, focused primarily on the intoxication stage, had low monitoring compliance, and required significant computational power preventing "real-time" results. Cardiovascular data was the most consistently valuable data in the predictive algorithms. This review demonstrates that there is currently insufficient evidence to support remote monitoring of SUDs through wearable devices. SCIENTIFIC SIGNIFICANCE: This is the first systematic review to show the available data on wearable remote monitoring of SUD symptoms in each stage of the disease cycle. This clinically relevant approach demonstrates what we know and do not know about the remote monitoring of SUDs within disease states.


Assuntos
Transtornos Relacionados ao Uso de Substâncias , Dispositivos Eletrônicos Vestíveis , Humanos , Fissura , Atenção à Saúde , Transtornos Relacionados ao Uso de Substâncias/diagnóstico , Transtornos Relacionados ao Uso de Substâncias/terapia
7.
Orphanet J Rare Dis ; 17(Suppl 1): 261, 2022 07 12.
Artigo em Inglês | MEDLINE | ID: mdl-35821070

RESUMO

Turner syndrome (TS; ORPHA 881) is a rare condition in which all or part of one X chromosome is absent from some or all cells. It affects approximately one in every 1/2500 liveborn girls. The most frequently observed karyotypes are 45,X (40-50%) and the 45,X/46,XX mosaic karyotype (15-25%). Karyotypes with an X isochromosome (45,X/46,isoXq or 45,X/46,isoXp), a Y chromosome, X ring chromosome or deletions of the X chromosome are less frequent. The objective of the French National Diagnosis and Care Protocol (PNDS; Protocole National de Diagnostic et de Soins) is to provide health professionals with information about the optimal management and care for patients, based on a critical literature review and multidisciplinary expert consensus. The PNDS, written by members of the French National Reference Center for Rare Growth and Developmental Endocrine disorders, is available from the French Health Authority website. Turner Syndrome is associated with several phenotypic conditions and a higher risk of comorbidity. The most frequently reported features are growth retardation with short adult stature and gonadal dysgenesis. TS may be associated with various congenital (heart and kidney) or acquired diseases (autoimmune thyroid disease, celiac disease, hearing loss, overweight/obesity, glucose intolerance/type 2 diabetes, dyslipidemia, cardiovascular complications and liver dysfunction). Most of the clinical traits of TS are due to the haploinsufficiency of various genes on the X chromosome, particularly those in the pseudoautosomal regions (PAR 1 and PAR 2), which normally escape the physiological process of X inactivation, although other regions may also be implicated. The management of patients with TS requires collaboration between several healthcare providers. The attending physician, in collaboration with the national care network, will ensure that the patient receives optimal care through regular follow-up and screening. The various elements of this PNDS are designed to provide such support.


Assuntos
Diabetes Mellitus Tipo 2 , Síndrome de Turner , Adulto , Cromossomos Humanos X/genética , Feminino , Humanos , Cariótipo , Cariotipagem , Síndrome de Turner/diagnóstico , Síndrome de Turner/genética , Síndrome de Turner/terapia
8.
J Neurol Sci ; 440: 120332, 2022 09 15.
Artigo em Inglês | MEDLINE | ID: mdl-35841696

RESUMO

Existing pharmacological treatments for psychiatric disorders have demonstrated limited efficacy, delayed onset of action, and significant burden of side effects. Recent findings from human studies with psychedelics have shown promise, demonstrating rapid and sustained clinical benefits of these compounds for a variety of psychiatric disorders. Classical psychedelics have a rich history and some of these compounds have been used in shamanic and spiritual ceremonies for millennia. The psychoactive effects of these drugs, particularly on human consciousness, have generated great scientific curiosity, and early research on psychedelics suggested their clinical benefits for psychiatric conditions, including alcohol use disorders and anxiety and depressive symptoms in terminal illness and life-threatening conditions. Since the 1990s, after a period of dormancy that followed the criminalization of psychedelic drugs since the Controlled Substance Act of 1970, the continued interest in their unique psychoactive effects along with the pursuit for novel and more effective treatments in psychiatry have led to a renewed interest in research on these compounds. While preliminary findings on psychedelics are encouraging, current evidence is still insufficient to support extensive use of these drugs routinely. Long-term safety and efficacy of these compounds remain unclear, and several clinical trials are underway and may add clarity to these questions. Therefore, this article intends to provide an overview of the evidence to date on psychedelic drugs - particularly psilocybin, MDMA, and LSD - for the treatment of psychiatric disorders.


Assuntos
Alcoolismo , Alucinógenos , Transtornos Mentais , Alucinógenos/farmacologia , Alucinógenos/uso terapêutico , Humanos , Dietilamida do Ácido Lisérgico/farmacologia , Dietilamida do Ácido Lisérgico/uso terapêutico , Transtornos Mentais/tratamento farmacológico , Psilocibina/farmacologia , Psilocibina/uso terapêutico
9.
Psychiatry Res Neuroimaging ; 324: 111494, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35640450

RESUMO

Bipolar disorder (BD) is a highly variable and burdensome disease for patients and caregivers. A BD diagnosis almost triples the likelihood of developing dementia as the disease progresses. Neurocognitive reserve appears to be one of the most important influences on lifelong functional outcomes and quality of life in BD. Though several prior studies have assessed the effects of lithium on regional gray and white matter volumes in this population, representative cohorts are typically middle-aged, have a more severe pathology, and are not as commonly assessed in the depressive phase (which represents the majority of most patients' lifespans outside of remission). Here we have shown that positive adaptations with lithium can be observed throughout the brain after only six weeks of monotherapy at low-therapeutic serum levels. Importantly, these results remove some confounders seen in prior studies (patients were treatment free at time of enrollment and mostly treatment naïve). This cohort also includes underrepresented demographics in the literature (young adult patients, mostly bipolar II, and exclusively in the depressed phase). These findings bolster the extensive body of evidence in support of long-term lithium therapy in BD, furthering the possibility of its expanded use to wider demographics.


Assuntos
Transtorno Bipolar , Transtorno Bipolar/diagnóstico por imagem , Transtorno Bipolar/tratamento farmacológico , Humanos , Lítio/uso terapêutico , Compostos de Lítio/farmacologia , Compostos de Lítio/uso terapêutico , Imageamento por Ressonância Magnética/métodos , Pessoa de Meia-Idade , Qualidade de Vida , Adulto Jovem
10.
Rev Prat ; 69(4): 417-422, 2019 Apr.
Artigo em Francês | MEDLINE | ID: mdl-31626499

RESUMO

Menometrorrhagia is a frequent bleeding symptom in young women, and may be related to an inherited bleeding disorder. If there is no gynecological etiology, hemostasis tests are required. The early medical management of these teenage girls is important, especially when a bleeding disorder is known. The bleeding risk of the first periods may then be anticipated. Afterwards, the objective of the treatment is to keep the bleeding symptoms under control: anti-fibrinolytic treatment, specific replacement therapy for bleeding disorder and hormonal treatment. This management requires a multidisciplinary medical team, mainly hematologist and gynecologist, all along the genital lifespan, from the first periods to the desire for pregnancy.


MÉNOMÉTRORRAGIES DE L'ADOLESCENTE ET DE LA JEUNE FEMME AYANT UN TROUBLE HÉRÉDITAIRE DE L'HÉMOSTASE Les ménométrorragies constituent une symptomatologie hémorragique fréquente de la jeune femme. Elles peuvent être en lien avec un trouble de l'hémostase, qu'il faut savoir dépister en l'absence de cause gynéco-obstétricale. La prise en charge précoce des jeunes filles est essentielle, notamment quand le diagnostic d'anomalie de l'hémostase est établi. Il est important d'annoncer le risque hémorragique potentiel pour permettre d'anticiper les premières règles. Ensuite, la prise en charge consiste à maîtriser l'abondance des règles : traitement antifibrinolytique, traitement substitutif spécifique du trouble de l'hémostase et traitement hormonal. Cette prise en charge doit être multidisciplinaire, associant l'hématologue et le gynécologue, des premières règles de l'adolescente au désir de grossesse des jeunes femmes.


Assuntos
Transtornos Herdados da Coagulação Sanguínea , Menorragia , Adolescente , Transtornos Herdados da Coagulação Sanguínea/terapia , Feminino , Ginecologia/normas , Hematologia/normas , Humanos , Menorragia/terapia , Menstruação/fisiologia , Obstetrícia/normas , Gravidez
11.
Int J Geriatr Psychiatry ; 33(2): e323-e329, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29044798

RESUMO

OBJECTIVE: To examine associations among substance use disorder (SUD) and measures of length of stay (LOS) and non-psychiatric medical comorbidity (MEDCO) in older-adult inpatients with serious mental illness (SMI), hypothesizing SUD would be related to worse clinical outcomes. METHODS: A cross-sectional study analyzed medical records from 2010 to 2016 of 7258 inpatients with SMI ≥ age 50, obtained from a 274-bed psychiatric hospital. Descriptive analyses examined prevalence rates for SUD status (+/-), individual drug classes, and total number of SUDs (polysubstance use disorders). Regression models examined the influence of 2 independent variables of interest: (1) SUD status (+/-) and (2) type of SUD (ie, specific drug), controlling for demographic factors and additional (non-SUD) psychiatric disorders. Two dependent (outcome) variables were examined: LOS and MEDCO. RESULTS: The overall SUD rate was 26%; cocaine was the most common SUD (≈ 10%). SUD status and additional (non-SUD) psychiatric diagnoses were significantly associated with longer LOS (both P < 0.001). For individual SUDs, cocaine, marijuana, opiates, and alcohol were all significantly associated with LOS (all P < 0.01). SUD status, age, sex, admission status, and race were significantly associated with MEDCO (all P < 0.002). For individual SUDs, barbiturates, opiates, and alcohol were all significantly associated with MEDCO (P < 0.01). CONCLUSIONS: The prevalence of SUD in this sample underscores concerns related to treating older adults presenting providers with comorbid SUD and SMI. This combination may increase the burden and complexity of care, warranting further investigation into mechanisms and long-term consequences.


Assuntos
Hospitais Psiquiátricos/estatística & dados numéricos , Transtornos Mentais/complicações , Transtornos Relacionados ao Uso de Substâncias/epidemiologia , Idoso , Comorbidade , Estudos Transversais , Feminino , Humanos , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Prevalência , Análise de Regressão
12.
Bull Cancer ; 103(5): 444-54, 2016 May.
Artigo em Francês | MEDLINE | ID: mdl-26987841

RESUMO

Methotrexate represents the standard intrathecal treatment of breast cancer meningeal carcinomatosis. However, its optimal schedule remains undefined. The aim of the present study was to evaluate results obtained with the methotrexate schedule used in Saint-Louis hospital (Paris). Patients followed in Saint-Louis hospital for breast cancer and who received intrathecal methotrexate were included in this retrospective monocentric study. Intrathecal treatment received contained methotrexate 12 mg/day (days: 1-5) and then 15 mg/week until progression or toxicity. Between 2003 and 2015, 41 patients were included. Primitive tumours were RH+/HER2-, HER2+ and triple-negative in respectively 66%, 14%, 5% and 15% of patients, 22% of them had meningeal carcinomatosis as metastatic disease initial manifestation. Objective response rate was 54%, median overall survival was 4.0 mois [CI 95%: 3-7.3] and 1-year survival rate was 15.2% (11.4%, 50% et 0% in RH+/HER2-, HER2+ and triple-negative subgroups; HR=0.45 [0.21-0.97] between HER2+ and RH+/HER2-). In univariate analysis, prognostic factors were brain involvement (p=0.049), initial cerebrospinal fluid protein level (p=0.0002) and concomitant systemic treatment received (p=0.049). This intrathecal methotrexate schedule demonstrates a similar median overall survival as the one obtained with a dose-dense schedule and an improved quality of life. Nevertheless, as the objective response and 1-year survival rates are slightly inferior, a dose-dense schedule remains still preferred in HER2+ patients or in those harboring a mainly meningeal progression.


Assuntos
Antimetabólitos Antineoplásicos/administração & dosagem , Neoplasias da Mama/patologia , Carcinomatose Meníngea/tratamento farmacológico , Carcinomatose Meníngea/secundário , Metotrexato/administração & dosagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Antimetabólitos Antineoplásicos/efeitos adversos , Aracnoidite/induzido quimicamente , Neoplasias da Mama/química , Neoplasias da Mama/mortalidade , Protocolos Clínicos , Esquema de Medicação , Feminino , Humanos , Injeções Espinhais , Carcinomatose Meníngea/etiologia , Carcinomatose Meníngea/mortalidade , Metotrexato/efeitos adversos , Pessoa de Meia-Idade , Paris , Prognóstico , Estudos Retrospectivos , Taxa de Sobrevida , Fatores de Tempo , Neoplasias de Mama Triplo Negativas/química , Neoplasias de Mama Triplo Negativas/mortalidade , Neoplasias de Mama Triplo Negativas/patologia
13.
Artigo em Inglês | MEDLINE | ID: mdl-26368941

RESUMO

Immune activation and failure of physiologic compensatory mechanisms over time have been implicated in the pathophysiology of illness progression in bipolar disorder. Recent evidence suggests that such changes are important contributors to neuroprogression and may mediate the cross-sensitization of episode recurrence, trauma exposure and substance use. The present review aims to discuss the potential factors related to bipolar disorder refractoriness and neuroprogression. In addition, we will discuss the possible impacts of early therapeutic interventions as well as the alternative approaches in late stages of the disorder.


Assuntos
Transtorno Bipolar/fisiopatologia , Transtorno Bipolar/terapia , Animais , Progressão da Doença , Resistência a Medicamentos/fisiologia , Humanos
14.
Stud Health Technol Inform ; 216: 353-7, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26262070

RESUMO

Software medical devices must now comply with the "ergonomics" essential requirement of the Medical Device Directive. However, the usability standard aiming to guide the manufacturers is very difficult to understand and apply. Relying on a triangulation of methods, this study aims to highlight the need to combine various expertises to be able to grasp the standard. To identify the areas of expertise on which the usability standard relies, an analytical review of this document was performed as well as an analysis of a discussion forum dedicated to it and an analysis of a case study of its application for CE marking. The results show that the IEC 62366 is a usability standard structured as a risk management one. It obviously requires Human Factors/Ergonomics expertise to be able to correctly identify and prevent risks of use errors, but it also requires risk management expertise to be able to grasp the issues of the risk analysis and master the related methods.


Assuntos
Análise de Falha de Equipamento/normas , Segurança de Equipamentos/normas , Equipamentos e Provisões/normas , Guias de Prática Clínica como Assunto , Competência Profissional/normas , Software/normas , França , Fidelidade a Diretrizes/organização & administração , Fidelidade a Diretrizes/normas , Internacionalidade , Avaliação das Necessidades/normas , Revisão da Utilização de Recursos de Saúde/normas
15.
Stud Health Technol Inform ; 194: 54-60, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23941930

RESUMO

Increasingly, studies are being published on the potential negative effect of introducing poor designed Health Information Technology (HIT) into clinical settings, relating to technology-induced errors and adverse events. Academic research on HIT design and evaluation is an extremely important source of information in providing new insights into factors contributing to successful system (re)design efforts, system user-friendliness and usability issues and safety critical aspects of HIT design. However, these studies have been inconsistent and incomprehensive in their reporting, complicating the appraisal of outcomes, generalizability of study findings, meta-analysis and harmonization of the available evidence. To improve identification of type of use errors and safety related issues regarding design and implementation of HIT, consensus on issues to be reported on in scientific publications is a necessary step forward. This study presents the first approach to a framework providing a set of principles to follow for comprehensive and unambiguous reporting of HIT design and usability evaluation studies with the objective to reduce variation, improve on the publication reporting quality and proper indexation of these studies. This framework may be helpful in expanding the knowledge base not only concerning the application of Human Factors (HF)/Usability studies of HIT but also improve the knowledge base of how to (re)design and implement effective, efficient and safe HIT.


Assuntos
Documentação/métodos , Ergonomia/métodos , Gestão da Informação em Saúde/organização & administração , Sistemas de Informação em Saúde/organização & administração , Informática Médica/métodos , Gestão de Riscos/organização & administração , Interface Usuário-Computador , Comportamento do Consumidor , Europa (Continente) , Software , Design de Software
16.
Stud Health Technol Inform ; 194: 139-44, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23941945

RESUMO

The EU revised Medical Device Directive introduces a major change in the CE marking of medical devices (MD) aiming at improving their safety. Manufacturers must now comply with an "ergonomics" essential requirement to prevent risks of use errors. This requirement is characterized by the integration of a usability engineering process in the MD design cycle to be documented in a usability engineering file. This study focuses on the first step of the usability engineering process, i.e. the analysis of the intended context of use of the MD, and shows the benefits of this analysis when performed early in the MD design cycle. Usability experts have conducted an analysis of the intended contexts of use for the extension of an existing device (analgesia monitor) in order to support manufacturer's design choices. Observations and interviews were carried out in two neonatology units (Maternity and Neonatology Intensive Care units) with a particular focus on pain management activities performed by physicians and nursery nurses. The results highlight irreducible differences between the two environments which led to identify different risks of use errors and specific ergonomics requirements. The results provided the manufacturer enough information to make informed decision about the extension of the device.


Assuntos
Analgesia/instrumentação , Análise de Falha de Equipamento/métodos , Ergonomia/métodos , Gestão da Informação em Saúde/métodos , Monitorização Intraoperatória/instrumentação , Manejo da Dor/instrumentação , Vigilância de Produtos Comercializados/métodos , França , Inquéritos e Questionários
17.
Stud Health Technol Inform ; 183: 337-42, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23388310

RESUMO

The revised Medical Device Directive has been adopted by the EU in 2010. A major change is that software for certain purposes is now considered a medical device. This entails that a new view needs to be developed on the design, development, evaluation and post-market surveillance of medical software that meets the definition of a medical device. This paper identifies some issues at stake and discusses them.


Assuntos
Aprovação de Equipamentos/legislação & jurisprudência , Aprovação de Equipamentos/normas , Equipamentos e Provisões/normas , Regulamentação Governamental , Software/legislação & jurisprudência , Software/normas , Europa (Continente) , Guias como Assunto
18.
Bipolar Disord ; 9 Suppl 1: 128-35, 2007 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-17543031

RESUMO

BACKGROUND: There is evidence that vulnerability to depression and anxiety disorders is markedly increased by traumatic life events. While childhood abuse has been reported to be associated with poorer outcomes in bipolar disorder, little is known about the neurobiological basis underlying this association. The aim of this study was to ascertain whether bipolar patients who were exposed to a traumatic event or events (TE) have lower brain-derived neurotrophic factor (BDNF) levels and more severe psychopathology as indicated by increased comorbidity and other clinical features when compared to those who were not exposed to TE. METHODS: One-hundred and sixty-three consecutively recruited bipolar outpatients were assessed by Structured Clinical Interview for DSM-IV (SCID) and standard protocol in order to evaluation psychopathology and clinical features. The reported TE was assessed using DSM-IV stem criteria for trauma (as defined by A1 and A2 criteria for trauma for post-traumatic stress disorder). Subjects were divided into 2 groups according to presence or absence of lifetime TE. The levels of BDNF, comorbidity and other clinical features were compared between groups. RESULTS: After adjusting for confounders, results indicated that bipolar patients with a history of TE have alcohol abuse/dependence (p < 0.001), anxiety comorbidity, and lower levels of serum BDNF (p < 0.01) compared to those without a history of TE. There was no difference between the 2 groups in age of onset, presence of psychosis, other substance abuse and dependence, rapid cycling or suicide attempts. CONCLUSIONS: Our findings suggest that TE are associated with significantly increased prevalence of alcohol and anxiety comorbidity as well as lower BDNF levels in bipolar patients. It is possible that a decrease in BDNF levels may account for increased comorbidity, but further prospective studies are required to confirm this.


Assuntos
Transtorno Bipolar/complicações , Transtorno Bipolar/metabolismo , Fator Neurotrófico Derivado do Encéfalo/metabolismo , Acontecimentos que Mudam a Vida , Psicopatologia , Transtornos Psicóticos/etiologia , Adulto , Idoso , Transtorno Bipolar/epidemiologia , Transtorno Bipolar/etiologia , Manual Diagnóstico e Estatístico de Transtornos Mentais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Escalas de Graduação Psiquiátrica , Transtornos Psicóticos/epidemiologia , Estudos Retrospectivos , Transtornos de Estresse Traumático/complicações
19.
Psychiatry Res ; 153(1): 33-8, 2007 Sep 30.
Artigo em Inglês | MEDLINE | ID: mdl-17544154

RESUMO

This study evaluates the influence of manic symptoms on quality of life in a sample of adult bipolar disorder (BD) patients. This was a cross-sectional study including 125 BD outpatients from a university-based program. All patients were diagnosed using the Structured Clinical Interview for DSM-IV for BD. Manic symptoms and quality of life were assessed using the Young Mania Rating Scale (YMRS) and the World Health Organization Quality of Life Instrument-Short Version (WHOQOL-BREF), respectively. In the unadjusted analysis using linear regression, the score of manic symptoms was inversely associated with scores of quality of life within the social domain of the WHOQOL. In the adjusted analysis, the score of manic symptoms was inversely associated with the social, physical, and psychological domains of the WHOQOL. In a separate analysis at the YMRS items, items 4 (irritability) and 5 (sleep) were associated with lower quality of life.


Assuntos
Transtorno Bipolar/psicologia , Qualidade de Vida/psicologia , Atividades Cotidianas/psicologia , Adaptação Psicológica , Adulto , Assistência Ambulatorial , Atitude Frente a Saúde , Transtorno Bipolar/diagnóstico , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Escalas de Graduação Psiquiátrica , Comportamento Social , Meio Social
20.
Can J Psychiatry ; 52(3): 175-81, 2007 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-17479526

RESUMO

OBJECTIVE: To assess the impact of anxiety comorbidity on the quality of life of patients with bipolar disorder (BD). METHODS: We undertook a cross-Sectional survey of 162 BD outpatients interviewed with the Structured Clinical Interview for DSM-IV. The primary outcome measure was quality of life, assessed with the 26-item WHO Quality of Life Instrument (WHOQOL-BREF). RESULTS: Anxiety comorbidity in BD patients was associated with lower scores in all domains of quality of life. The impact of anxiety comorbidity on the psychological domain of the WHOQOL-BREF was kept, even when the current level of depression was added to the model as a confounding factor. Current anxiety comorbidity was also associated with lifetime alcohol abuse and dependence, rapid cycling, lifetime psychosis, number of suicide attempts, and a lower score in the Global Assessment of Functioning measure. CONCLUSION: Our findings suggest that anxiety comorbidity in BD patients is related to lower quality of life, particularly on the psychological domain. BD-anxiety comorbidity may be associated with such markers of illness severity as number of suicide attempts, rapid cycling, lifetime alcohol abuse, and psychosis. The recognition and treatment of anxiety comorbidity may help patients with BD to relieve their psychological pain and improve their overall quality of life.


Assuntos
Transtornos de Ansiedade/epidemiologia , Transtorno Bipolar/epidemiologia , Qualidade de Vida/psicologia , Adolescente , Adulto , Assistência Ambulatorial , Transtornos de Ansiedade/diagnóstico , Transtornos de Ansiedade/terapia , Transtorno Bipolar/diagnóstico , Transtorno Bipolar/terapia , Comorbidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença
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