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PURPOSE: The long-acting reversible contraception progestin subdermal implant (ENG implant) may be effective to improve endometriosis-related symptoms. Since adenomyosis is a histopathological form of endometriosis, we aimed to evaluate the effectiveness of ENG implant in adenomyosis management. MATERIALS AND METHODS: Electronic search in Medline, Scopus, Embase databases and Google Scholar using combinations of the following keywords: Progestin; subdermal implant; Implanon; Nexplanon; Adenomyosis; Endometriosis. RESULTS: Out of 889 articles in the initial database, 5 prospective observational studies were eligible for inclusion in our literature review. Our review involving 152 participants found a significant reduction in pelvic pain and dysmenorrhoea (baseline median VAS score ranged from 10 to 7.62 before implantation vs VAS score ranged from 1.81 to 0.1 after implantation) as well as an increase in the levels of haemoglobin after implantation of the device (from 86 g/L to 129 g/L after implantation). Moreover, the improvement may be sustained throughout the long-term follow-up visits (until 36 months). The most common adverse events were changes in bleeding patterns which were tolerable in most cases. CONCLUSION: ENG implant may be a relevant and promising medical option in the management of adenomyosis. Nevertheless, randomised controlled trials and prospective studies with larger cohorts are needed to confirm the potential role of ENG implant in the management of adenomyosis.
The etonogestrel-releasing subdermal contraceptive implant may be a relevant medical option in the management of adenomyosis.
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BACKGROUND: The association between the pattern of cortical thickness (CT) and executive dysfunction (ED) in mild cognitive impairment (MCI) and subjective cognitive complaints (SCC) is still poorly understood. We aimed to investigate the association between CT and ED in a large French cohort (MEMENTO) of 2323 participants with MCI or SCC. METHODS: All participants with available CT and executive function data (verbal fluency and Trail Making Test [TMT]) were selected (n=1924). Linear regressions were performed to determine relationships between executive performance and the brain parenchymal fraction (BPF) and CT using FreeSurfer. RESULTS: The global executive function score was related to the BPF (sß: 0.091, P<0.001) and CT in the right supramarginal (sß: 0.060, P=0.041) and right isthmus cingulate (sß: 0.062, P=0.011) regions. Literal verbal fluency was related to the BPF (sß: 0.125, P<0.001) and CT in the left parsorbitalis region (sß: 0.045, P=0.045). Semantic verbal fluency was related to the BPF (sß: 0.101, P<0.001) and CT in the right supramarginal region (sß: 0.061, P=0.042). The time difference between the TMT parts B and A was related to the BPF (sß: 0.048, P=0.045) and CT in the right precuneus (sß: 0.073, P=0.019) and right isthmus cingulate region (sß: 0.054, P=0.032). CONCLUSIONS: In a large clinically based cohort of participants presenting with either MCI or SCC (a potential early stage of Alzheimer's disease [AD]), ED was related to the BPF and CT in the left pars orbitalis, right precuneus, right supramarginal, and right isthmus cingulate regions. This pattern of lesions adds knowledge to the conventional anatomy of ED and could contribute to the early diagnosis of AD.
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INTRODUCTION AND HYPOTHESIS: We assessed 3-year anatomic and functional results using synthetic glue to fix mesh in laparoscopic sacrocolpopexy. METHODS: Prospective multicenter cohort study in three academic urogynecology departments. Seventy consecutive patients with stage ≥ 3 POP-Q (Pelvic Organ Prolapse Quantification) anterior and/or apical prolapse underwent laparoscopic sacrocolpopexy using synthetic surgical glue to fix anterior and posterior meshes to the vagina. Patients were followed up at 1, 2 and 3 years. Primary outcome was anterior and apical anatomic success (POP-Q stage ≤ 1) at 3 years. Secondary outcomes comprised functional results (international quality of life and sexuality scales), mesh-related morbidity and urinary incontinence at 3 years. RESULTS: Mean age was 56.7 ± 1.2 years. Mean follow-up was 43 months. Anterior compartment anatomic success rate was 87% at 2 years (Ba, -2.4 cm; p < 0.0001) and 86.5% at 3 years (Ba, -2.3 cm; p < 0.0001); apical success was 96.3% at 2 years (C, -6.8 cm; p < 0.0001) and 97.3% at 3 years (C, -6.5 cm; p < 0.0001). All quality-of-life scores improved significantly and lastingly at 3 years: PFDI-20, PFIQ-7 and PISQ-12, respectively, p < 0.0001, p < 0.0001 and p = 0.01. There was one case of vaginal mesh exposure at 3 years (2.8%) and five of mesh shrinkage at 1 year (7.8%), none at 2 years and two at 3 years (5.4%). Urinary incontinence rate was 29.7% at 1 year, 14.8% at 2 years and 11.1% at 3 years. CONCLUSION: Vaginal mesh adhesive in laparoscopic sacrocolpopexy remained effective at 3 years, with excellent tolerance and no specific complications. Anatomic and functional results were good and enduring in terms of both anterior and apical correction.
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Procedimientos Quirúrgicos Ginecológicos , Laparoscopía , Prolapso de Órgano Pélvico , Mallas Quirúrgicas , Incontinencia Urinaria , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Procedimientos Quirúrgicos Ginecológicos/efectos adversos , Procedimientos Quirúrgicos Ginecológicos/métodos , Humanos , Laparoscopía/efectos adversos , Persona de Mediana Edad , Prolapso de Órgano Pélvico/cirugía , Estudios Prospectivos , Calidad de Vida , Mallas Quirúrgicas/efectos adversos , Resultado del Tratamiento , Incontinencia Urinaria/cirugía , Vagina/cirugíaRESUMEN
PURPOSE: To evaluate the different techniques for Essure® microinserts removal and to assess the risk of fracture of the device and the intra- and post-operative complications in relation to surgical technique variants. METHODS: Electronic search in Medline, Scopus and Embase databases using the following keywords: Essure; Essure removal; Essure surgical technique. RESULTS: Out of 95 articles in the initial database, 17 studies were eligible for inclusion in our literature review. Several surgical techniques have been described in which the most frequent were laparoscopic salpingectomy (LS), laparoscopic cornuectomy (LC), laparoscopic or vaginal hysterectomy (LH, VH) with en-bloc salpingectomy. There were more fractures of the device with the LS procedure (6.25%) followed by the LC technique (2.77%), while there was no fracture with hysterectomy. However, peri-and post-operative complications were more severe and frequent with hysterectomy in comparison with the LC and LS procedures (respectively 8.1% Clavien Dindo grade 3 for the hysterectomy group, 1.11% for the LC procedure and 0.69% for the LS technique). CONCLUSION: Due to the lack of standardised surgical treatment guidelines, a system of care networks for symptomatic patients with adverse effects related to Essure® headed by specialised centres may offer a suitable and high-quality management with the appropriate removal techniques within two objectives: limiting the risk of fracture (with an en-bloc removal of the Essure® microinserts) and avoiding intra- and post-operative complications.
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Remoción de Dispositivos/métodos , Histerectomía/efectos adversos , Dispositivos Intrauterinos/efectos adversos , Laparoscopía/efectos adversos , Salpingectomía/efectos adversos , Esterilización Tubaria/efectos adversos , Femenino , Humanos , Histerectomía/métodos , Complicaciones Posoperatorias , Salpingectomía/métodos , Esterilización Tubaria/métodos , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
OBJECTIVES: Single nucleotide polymorphisms in the cytochrome P450 (CYP) 2B6 gene have been associated with high interindividual variation in efavirenz pharmacokinetics. However, clinical data on the relationship of CYP2B6 polymorphisms with the occurrence of efavirenz-induced central nervous system (CNS) symptoms are limited. METHODS: We analysed four polymorphisms in the CYP2B6 (516 G>T), CYP3A5 (6986 A>G) and ATP-binding cassette, sub-family B, member 1 (ABCB1) (2677 G>T/A and 3435 C>T) genes in HIV-infected adults virologically suppressed on a protease inhibitor-based regimen who switched to a regimen containing emtricitabine, didanosine and efavirenz in the setting of the ANRS ALIZE trial. Kaplan-Meier methods and Cox regression analysis were used to investigate their association with efavirenz plasma levels and CNS events up to 48 months after switching. RESULTS: In total, 191 patients with a median age of 41 years, who were 87% male and 85% Caucasian, were enrolled in the study. Variant allelic frequencies were 0.49, 0.93, 0.59 and 0.63 for CYP2B6 516, CYP3A5 392, ABCB1 2677 and ABCB1 3435, respectively. The median efavirenz plasma concentration (MEPC) was 2.2 mg/L [interquartile range (IQR) 1.7-2.8 mg/L] and was significantly higher in patients with the deficient CYP2B6 516T. Overall, 242 CNS events were reported in 104 individuals (54%). No correlation was found between MEPC and CNS events. The occurrence of a first CNS event was lower in patients with the CYP2B6 516 G/G genotype vs. CYP2B6 516 T genotypes [50% (IQR: 40-60%) vs. 66% (IQR: 56-75%), respectively; P = 0.02]. In an adjusted Cox regression model, there was a tendency towards a higher risk of a first CNS event among carriers of the variant CYP2B6 516 T allele (relative risk 1.4 [95% CI, 0.99-2.1]; P?=?.06), compared with noncarriers. CONCLUSIONS: The deficient CYP2B6 516 T allele is associated with higher efavirenz plasma drug levels and more frequent CNS-related symptoms.
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Fármacos Anti-VIH/inmunología , Benzoxazinas/efectos adversos , Enfermedades del Sistema Nervioso Central/inducido químicamente , Citocromo P-450 CYP2B6/genética , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/genética , Predisposición Genética a la Enfermedad , Infecciones por VIH/tratamiento farmacológico , Adulto , Alquinos , Fármacos Anti-VIH/administración & dosificación , Fármacos Anti-VIH/farmacocinética , Terapia Antirretroviral Altamente Activa/efectos adversos , Terapia Antirretroviral Altamente Activa/métodos , Benzoxazinas/administración & dosificación , Benzoxazinas/farmacocinética , Ciclopropanos , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Plasma/química , Polimorfismo de Nucleótido SimpleRESUMEN
OBJECTIVES: The aim of this work was to provide a reference for the CD4 T-cell count response in the early months after the initiation of combination antiretroviral therapy (cART) in HIV-1-infected patients. METHODS: All patients in the Collaboration of Observational HIV Epidemiological Research Europe (COHERE) cohort who were aged ≥ 18 years and started cART for the first time between 1 January 2005 and 1 January 2010 and who had at least one available measurement of CD4 count and a viral load ≤ 50 HIV-1 RNA copies/mL at 6 months (± 3 months) after cART initiation were included in the study. Unadjusted and adjusted references curves and predictions were obtained using quantile regressions. RESULTS: A total of 28 992 patients were included in the study. The median CD4 T-cell count at treatment initiation was 249 [interquartile range (IQR) 150, 336] cells/µL. The median observed CD4 counts at 6, 9 and 12 months were 382 (IQR 256, 515), 402 (IQR 274, 543) and 420 (IQR 293, 565) cells/µL. The two main factors explaining the variation of CD4 count at 6 months were AIDS stage and CD4 count at cART initiation. A CD4 count increase of ≥ 100 cells/mL is generally required in order that patients stay 'on track' (i.e. with a CD4 count at the same percentile as when they started), with slightly higher gains required for those starting with CD4 counts in the higher percentiles. Individual predictions adjusted for factors influencing CD4 count were more precise. CONCLUSIONS: Reference curves aid the evaluation of the immune response early after antiretroviral therapy initiation that leads to viral control.
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Antirretrovirales/uso terapéutico , Terapia Antirretroviral Altamente Activa/métodos , Linfocitos T CD4-Positivos/inmunología , Infecciones por VIH/tratamiento farmacológico , VIH-1/efectos de los fármacos , Adolescente , Adulto , Anciano , Recuento de Linfocito CD4 , Estudios de Cohortes , Monitoreo de Drogas , Europa (Continente) , Femenino , Infecciones por VIH/patología , Humanos , Masculino , Persona de Mediana Edad , Resultado del Tratamiento , Carga Viral , Adulto JovenRESUMEN
OBJECTIVES: The aim of the study was to determine the time to, and risk factors for, triple-class virological failure (TCVF) across age groups for children and adolescents with perinatally acquired HIV infection and older adolescents and adults with heterosexually acquired HIV infection. METHODS: We analysed individual patient data from cohorts in the Collaboration of Observational HIV Epidemiological Research Europe (COHERE). A total of 5972 participants starting antiretroviral therapy (ART) from 1998, aged < 20 years at the start of ART for those with perinatal infection and 15-29 years for those with heterosexual infection, with ART containing at least two nucleoside reverse transcriptase inhibitors (NRTIs) and a nonnucleoside reverse transcriptase inhibitor (NNRTI) or a boosted protease inhibitor (bPI), were followed from ART initiation until the most recent viral load (VL) measurement. Virological failure of a drug was defined as VL > 500 HIV-1 RNA copies/mL despite ≥ 4 months of use. TCVF was defined as cumulative failure of two NRTIs, an NNRTI and a bPI. RESULTS: The median number of weeks between diagnosis and the start of ART was higher in participants with perinatal HIV infection compared with participants with heterosexually acquired HIV infection overall [17 (interquartile range (IQR) 4-111) vs. 8 (IQR 2-38) weeks, respectively], and highest in perinatally infected participants aged 10-14 years [49 (IQR 9-267) weeks]. The cumulative proportion with TCVF 5 years after starting ART was 9.6% [95% confidence interval (CI) 7.0-12.3%] in participants with perinatally acquired infection and 4.7% (95% CI 3.9-5.5%) in participants with heterosexually acquired infection, and highest in perinatally infected participants aged 10-14 years when starting ART (27.7%; 95% CI 13.2-42.1%). Across all participants, significant predictors of TCVF were those with perinatal HIV aged 10-14 years, African origin, pre-ART AIDS, NNRTI-based initial regimens, higher pre-ART viral load and lower pre-ART CD4. CONCLUSIONS: The results suggest a beneficial effect of starting ART before adolescence, and starting young people on boosted PIs, to maximize treatment response during this transitional stage of development.
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Antirretrovirales/uso terapéutico , Farmacorresistencia Viral , Infecciones por VIH/tratamiento farmacológico , Grupos de Población , Adolescente , Adulto , Niño , Preescolar , Estudios de Cohortes , Europa (Continente) , Femenino , Humanos , Lactante , Masculino , Factores de Tiempo , Insuficiencia del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: Open studies have reported favourable results for sacral nerve stimulation in the treatment of refractory constipation. Here, its efficacy was assessed in a double-blind crossover RCT. METHODS: Patients with at least two of the following criteria were included: fewer than three bowel movements per week; straining to evacuate on more than 25 per cent of attempts; or sensation of incomplete evacuation on more than 25 per cent of occasions. Response to therapy was defined as at least three bowel movements per week and/or more than 50 per cent improvement in symptoms. Responders to an initial 3-week peripheral nerve evaluation were offered permanent implantation of a pulse generator and were assigned randomly in a crossover design to two 8-week intervals of active or sham stimulation. At the end of the two trial periods, the patients received active stimulation until the final evaluation at 1 year. RESULTS: Thirty-six patients (34 women; mean(s.d.) age 45(14) years) underwent peripheral nerve evaluation. Twenty responded and received a permanent stimulator. A positive response was observed in 12 of 20 and 11 of 20 patients after active and sham stimulation periods respectively (P = 0·746). Pain related to the device occurred in five patients and wound infection or haematoma in three, leading to definitive removal of the pulse generator in two patients. At 1 year, 11 of the 20 patients with an implanted device continued to respond. Stimulation had no significant effect on colonic transit time. CONCLUSION: These results do not support the recommendation of permanent implantation of a pulse generator in patients with refractory constipation who initially responded to temporary nerve stimulation. Registration number: NCT01629303 (http://www.clinicaltrials.gov).
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Estreñimiento/terapia , Terapia por Estimulación Eléctrica/métodos , Plexo Lumbosacro , Adolescente , Adulto , Anciano , Estudios Cruzados , Método Doble Ciego , Terapia por Estimulación Eléctrica/instrumentación , Femenino , Estudios de Seguimiento , Humanos , Neuroestimuladores Implantables , Masculino , Persona de Mediana Edad , Resultado del Tratamiento , Adulto JovenRESUMEN
Several genetic polymorphisms have been associated with Late Onset Alzheimer's Disease (LOAD), but there has been limited evidence on whether these polymorphisms predict intermediary stage outcomes such as cognitive changes in prospective community-based studies. Our aim was to evaluate whether polymorphisms previously established as predictors of LOAD also predict worse cognitive function and accelerated decline across multiple cognitive domains. We analyzed data from the 3C-Dijon study, in which 4931 respondents aged 65+ were examined up to 5 times over 10 years with a neuropsychological assessment. We evaluated the associations of polymorphisms in APOE, CR1, BIN1, CLU, PICALM, ABCA7, MS4A6A, CD33, MS4A4E and CD2AP with level and change in 5 neuropsychological tests, assuming a dominant effect model. To optimize measurement, we used a mixed regression model with a latent process for each cognitive domain: global cognition (Mini Mental State Examination); verbal fluency (Isaac's Set Test); visual memory (Benton Visual Retention Test); information processing (Trail Making Test B) and literacy (National Adult Reading Test). APOE was associated with accelerated decline in global cognition and verbal fluency. Only two non-APOE genetic polymorphisms were associated with cognitive decline: CR1 was associated with rate of change in verbal fluency and BIN1 was associated with rate of change in global cognition. In a large prospective population-based study of dementia-free individuals, only a few cognitive domains were associated with established LOAD risk alleles. The most consistent associations were for global cognition and verbal fluency.
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Enfermedad de Alzheimer/genética , Trastornos del Conocimiento/genética , Proteínas Adaptadoras Transductoras de Señales/genética , Anciano , Anciano de 80 o más Años , Enfermedad de Alzheimer/psicología , Apolipoproteínas E/genética , Apolipoproteínas E/metabolismo , Trastornos del Conocimiento/psicología , Estudios de Cohortes , Femenino , Estudios de Asociación Genética , Predisposición Genética a la Enfermedad , Humanos , Estudios Longitudinales , Masculino , Memoria , Proteínas Nucleares/genética , Polimorfismo Genético , Estudios Prospectivos , Receptores de Complemento 3b/genética , Factores de Riesgo , Proteínas Supresoras de Tumor/genéticaRESUMEN
OBJECTIVES: The aim of this study was to describe the proportion of liver-related diseases (LRDs) as a cause of death in HIV-infected patients in France and to compare the results with data from our five previous surveys. METHODS: In 2010, 24 clinical wards prospectively recorded all deaths occurring in around 26 000 HIV-infected patients who were regularly followed up. Results were compared with those of previous cross-sectional surveys conducted since 1995 using the same design. RESULTS: Among 230 reported deaths, 46 (20%) were related to AIDS and 30 (13%) to chronic liver diseases. Eighty per cent of patients who died from LRDs had chronic hepatitis C, 16.7% of them being coinfected with hepatitis B virus (HBV). Among patients who died from an LRD, excessive alcohol consumption was reported in 41%. At death, 80% of patients had undetectable HIV viral load and the median CD4 cell count was 349 cells/µL. The proportion of deaths and the mortality rate attributable to LRDs significantly increased between 1995 and 2005 from 1.5% to 16.7% and from 1.2 to 2.0, respectively, whereas they tended to decrease in 2010 to 13% and 1.1, respectively. Among liver-related causes of death, the proportion represented by hepatocellular carcinoma (HCC) dramatically increased from 5% in 1995 to 40% in 2010 (p = 0.019). CONCLUSIONS: The proportion of LRDs among causes of death in HIV-infected patients seems recently to have reached a plateau after a rapid increase during the decade 1995-2005. LRDs remain a leading cause of death in this population, mainly as a result of hepatitis C virus (HCV) coinfection, HCC representing almost half of liver-related causes of death.
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Consumo de Bebidas Alcohólicas/mortalidad , Carcinoma Hepatocelular/mortalidad , Infecciones por VIH/mortalidad , Hepatitis C Crónica/mortalidad , Cirrosis Hepática Alcohólica/mortalidad , Neoplasias Hepáticas/mortalidad , Adulto , Recuento de Linfocito CD4 , Carcinoma Hepatocelular/inmunología , Causas de Muerte/tendencias , Estudios Transversales , Femenino , Francia/epidemiología , Infecciones por VIH/complicaciones , Infecciones por VIH/inmunología , Hepatitis C Crónica/complicaciones , Hepatitis C Crónica/inmunología , Humanos , Cirrosis Hepática Alcohólica/complicaciones , Cirrosis Hepática Alcohólica/inmunología , Neoplasias Hepáticas/inmunología , Masculino , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
BACKGROUND: Few studies consider the incidence of individual AIDS-defining illnesses (ADIs) at higher CD4 counts, relevant on a population level for monitoring and resource allocation. METHODS: Individuals from the Collaboration of Observational HIV Epidemiological Research Europe (COHERE) aged ≥14 years with ≥1 CD4 count of ≥200 µL between 1998 and 2010 were included. Incidence rates (per 1000 person-years of follow-up [PYFU]) were calculated for each ADI within different CD4 strata; Poisson regression, using generalized estimating equations and robust standard errors, was used to model rates of ADIs with current CD4 ≥500/µL. RESULTS: A total of 12 135 ADIs occurred at a CD4 count of ≥200 cells/µL among 207 539 persons with 1 154 803 PYFU. Incidence rates declined from 20.5 per 1000 PYFU (95% confidence interval [CI], 20.0-21.1 per 1000 PYFU) with current CD4 200-349 cells/µL to 4.1 per 1000 PYFU (95% CI, 3.6-4.6 per 1000 PYFU) with current CD4 ≥ 1000 cells/µL. Persons with a current CD4 of 500-749 cells/µL had a significantly higher rate of ADIs (adjusted incidence rate ratio [aIRR], 1.20; 95% CI, 1.10-1.32), whereas those with a current CD4 of ≥1000 cells/µL had a similar rate (aIRR, 0.92; 95% CI, .79-1.07), compared to a current CD4 of 750-999 cells/µL. Results were consistent in persons with high or low viral load. Findings were stronger for malignant ADIs (aIRR, 1.52; 95% CI, 1.25-1.86) than for nonmalignant ADIs (aIRR, 1.12; 95% CI, 1.01-1.25), comparing persons with a current CD4 of 500-749 cells/µL to 750-999 cells/µL. DISCUSSION: The incidence of ADIs was higher in individuals with a current CD4 count of 500-749 cells/µL compared to those with a CD4 count of 750-999 cells/µL, but did not decrease further at higher CD4 counts. Results were similar in patients virologically suppressed on combination antiretroviral therapy, suggesting that immune reconstitution is not complete until the CD4 increases to >750 cells/µL.
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Antirretrovirales/administración & dosificación , Linfocitos T CD4-Positivos/inmunología , Infecciones por VIH/epidemiología , Infecciones por VIH/inmunología , Adulto , Recuento de Linfocito CD4/estadística & datos numéricos , Estudios de Cohortes , Europa (Continente)/epidemiología , Femenino , Infecciones por VIH/tratamiento farmacológico , Humanos , Incidencia , Masculino , Distribución de PoissonRESUMEN
BACKGROUND: The main source of key medical information consists in original articles published in peer-reviewed biomedical journals. Reported studies use increasingly sophisticated statistical and epidemiological approaches that first require a solid understanding of core methods. However, such understanding is not widely shared among physicians. Our aim was to assess whether the basic statistical and epidemiological methods used in original articles published in general biomedical journals are taught during the first years of the medical curriculum in France. METHODS: We selected original articles published in The New England Journal of Medicine, The Lancet, and The Journal of the American Medical Association, over a period of six months in 2007 and in 2008. A standardized statistical content checklist was used to extract the necessary information in the "Abstract", "Methods", "Results", footnotes of tables, and legends of figures. The methods used in the selected articles were compared to the national program and the public health program of biostatistics and epidemiology taught during the first six years of medical school. RESULTS: The 237 analyzed original articles all used at least one statistical or epidemiological method. Descriptive statistics, confidence interval and Chi(2) or Fisher tests, methods used in more than 50% of articles, were repeatedly taught throughout the medicine curriculum. Measures of association, sample size, fit and Kaplan-Meier method, used in 40 to 50% of articles, were specifically taught during training sessions on critical reading methods. Cox model (41% of articles) and logistic regression (24% of articles) were never taught. The most widely used illustrations, contingency tables (92%) and flowcharts (48%), were not included in the national program. CONCLUSION: More teaching of the core methods underlying the understanding of sophisticated methods and illustrations should be included in the early medical curriculum so that physicians can read the scientific literature critically for their medical education.
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Investigación Biomédica/educación , Investigación Biomédica/estadística & datos numéricos , Educación de Pregrado en Medicina , Proyectos de Investigación/estadística & datos numéricos , Lista de Verificación , Comprensión , Curriculum/normas , Métodos Epidemiológicos , Francia , Humanos , Revisión por Pares , Edición/estadística & datos numéricos , LecturaRESUMEN
BACKGROUND: Imatinib mesylate is a potent inhibitor of platelet-derived growth factor and transforming growth factor-ß signalling pathways which may play a role in systemic sclerosis (SSc)-associated skin changes. OBJECTIVES: We aimed primarily at assessing the efficacy of imatinib mesylate in scleroderma skin fibrosis. METHODS: We performed a phase II double-blinded trial on patients with scleroderma with either morphoea involving > 20% of body surface area or SSc with extensive skin involvement: modified Rodnan Skin Score (mRSS) ≥ 20/51. Each patient was randomized to receive either imatinib mesylate 400 mg or placebo daily for a total of 6 months, and then was followed up 6 months after therapy discontinuation. Skin fibrosis was assessed by mRSS and measurement of the dermal thickness using skin biopsies performed at inclusion and at 6 months of treatment. In addition, quality of life (Dermatology Life Quality Index and modified Health Assessment Questionnaire for Scleroderma) was recorded at each visit, and pulmonary function before and after intervention. RESULTS: Twenty-eight patients were included in the study with a mean age of 48·9 years (range 30-71): 25 had a diagnosis of a SSc and three of diffuse cutaneous scleroderma. Demographic data, frequency of organ involvement of SSc and mRSS were comparable between groups. At 6 months, the proportion of variation of mRSS from inclusion was not statistically significantly different between the two groups (median +0·10 in imatinib group vs. -0·16 in placebo group, P = 0·098). Similarly, changes in dermal thickness, quality of life and diffusion capacity for carbon monoxide were not significantly different between groups. CONCLUSIONS: This study failed to demonstrate the efficacy of imatinib 400 mg daily to improve skin fibrosis of diffuse scleroderma after 6 months of treatment based on validated outcome measurements.
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Piperazinas/uso terapéutico , Inhibidores de Proteínas Quinasas/uso terapéutico , Pirimidinas/uso terapéutico , Esclerodermia Difusa/tratamiento farmacológico , Piel/patología , Adulto , Anciano , Benzamidas , Método Doble Ciego , Femenino , Fibrosis/tratamiento farmacológico , Humanos , Mesilato de Imatinib , Masculino , Persona de Mediana Edad , Factor de Crecimiento Derivado de Plaquetas/metabolismo , Calidad de Vida , Esclerodermia Difusa/metabolismo , Factor de Crecimiento Transformador beta/metabolismo , Resultado del TratamientoRESUMEN
The aim of this study was to determine factors associated with complete satisfaction with the care provided (satisfaction with physicians and satisfaction with services and organization) among HIV-infected patients followed up in the French ANRS CO8 APROCO-COPILOTE cohort. Analyses focused on cross-sectional data collected during the ninth year of cohort follow-up. Satisfaction with care, sociodemographic characteristics, and behavioral data were collected using self-administered questionnaires, while clinical data were derived from medical records. Complete satisfaction with care was defined as being 100% satisfied. Two logistic regression models were used to identify predictors of (1) complete satisfaction with physicians (n=404) and (2) complete satisfaction with services and organization (n=396). Sixteen percent of patients were completely satisfied with physicians, while 15.9% were completely satisfied with services and organization. Being older and reporting fewer discomforting antiretroviral therapy (ART) side effects were factors independently associated with complete satisfaction with both physicians and services and organization. Strong support from friends and absence of hepatitis C (HCV) co-infection were independently associated with complete satisfaction with physicians, while strong support from one's family and comfortable housing conditions were independently associated with complete satisfaction with services and organization. Even after nine years of follow-up, social vulnerabilities still strongly influence HIV-infected patients' interactions with the health care system. Day-to-day experience with the disease, including perceived treatment side effects, appears to play a key role in the quality of these interactions. More attention should be given to patient satisfaction, especially for socially vulnerable patients, in order to avoid potentially detrimental consequences such as poor adherence to ART.
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Terapia Antirretroviral Altamente Activa , Atención a la Salud/normas , Infecciones por VIH , Prioridad del Paciente , Satisfacción del Paciente/estadística & datos numéricos , Adulto , Terapia Antirretroviral Altamente Activa/efectos adversos , Terapia Antirretroviral Altamente Activa/métodos , Terapia Antirretroviral Altamente Activa/psicología , Estudios de Cohortes , Coinfección , Manejo de la Enfermedad , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/psicología , Femenino , Infecciones por VIH/complicaciones , Infecciones por VIH/psicología , Infecciones por VIH/terapia , Hepatitis C/complicaciones , Humanos , Masculino , Registros Médicos Orientados a Problemas/estadística & datos numéricos , Cumplimiento de la Medicación/psicología , Persona de Mediana Edad , Prioridad del Paciente/psicología , Prioridad del Paciente/estadística & datos numéricos , Relaciones Profesional-Paciente , Mejoramiento de la Calidad , Calidad de Vida , Autoinforme , Apoyo SocialRESUMEN
OBJECTIVE: The exceptional health situation related to the Coronavirus 2019 (COVID-19) pandemic has required an in-depth and immediate reorganisation of gynaecological cancer care. The main objective was to assess the psychological impact of such treatment modifications during the lockdown period for gynaecological and breast cancer patients. PATIENTS AND METHODS: A multicentre prospective study was conducted in three university gynaecological cancer wards (Hospices Civils de Lyon, France) during the French first lockdown (16th March to 11th May 2020). All patients with non-metastatic breast cancer or gynaecological cancer were included. Data was collected regarding treatment modifications (delay, cancellation, change of therapeutic plan). The psychological impact of treatment modifications during and after the lockdown was assessed by validated questionnaires (SF-12, EORTC-QLQ-C30, HADS). RESULTS: A total of 205 consecutive patients were included, aged 60.5 ± 1.0 years. Seven patients (3.4%) presented a SARS-CoV-2 infection, and two patients died. Treatment was maintained for 122 (59.5%) patients, postponed for 72 (35.1%) and cancelled for 11 (5.4%). During the lockdown, 35/118 (29.7%) patients suffered from confirmed anxiety and the mean fatigue-EORTC score was 48.00 ± 2.51; it was 38.64 ± 2.33 (p = 0.02) after the lockdown. After the lockdown and compared to the lockdown period, the mental SF-12 score and overall health status EORTC score were significantly higher (45.03 ± 1.06 vs 41.71 ± 1.15, p = 0.02 and 64.58 ± 1.66 vs 57.44 ± 2.02, p = 0.0007, respectively). The number of confirmed-anxiety cases was significantly higher amongst patients for whom treatment was delayed or cancelled (40.5% vs 23.7%, p = 0.04). CONCLUSION: This study quantified the treatment modifications of gynaecological cancer patients during the COVID-19 lockdown and revealed a poorer psychological state and quality of life during this period, even for patients whose treatment plan was not actually modified. Anxiety was more significant in patients with a delayed or cancelled treatment.
Asunto(s)
Neoplasias de la Mama , COVID-19 , Neoplasias de la Mama/terapia , Control de Enfermedades Transmisibles , Femenino , Humanos , Persona de Mediana Edad , Estudios Prospectivos , Calidad de Vida , SARS-CoV-2RESUMEN
The closure of port-sites wounds, as the ultimate step of surgical laparoscopic procedures, can be allowed by threads, staples, surgical glue or adhesive sutures. We describe a simple and easy skin suturing technique which saves time and provides significant surgical ergonomics.
Asunto(s)
Laparoscopía/normas , Técnicas de Sutura/normas , Cicatrización de Heridas/fisiología , Humanos , Laparoscopía/métodos , Laparoscopía/estadística & datos numéricos , Técnicas de Sutura/instrumentación , Técnicas de Sutura/estadística & datos numéricosRESUMEN
Since elytrocele/enterocele may occur between 0.1% to 10% after hysterectomy, surgical techniques to repair elytrocele should be learnt to master. We propose the step-by-step description of the vaginal technique: dissection and resection of the peritoneal sac followed by a mini-invasive posterior transvaginal sacrospinous colpopexy.
Asunto(s)
Procedimientos Quirúrgicos Ginecológicos/métodos , Hernia/complicaciones , Histerectomía , Enfermedades Peritoneales/cirugía , Técnicas de Sutura , Femenino , Humanos , VaginaRESUMEN
Since the recent controversy about vaginal mesh implants, surgeons should use safe and effective devices and procedures to treat female stress urinary incontinence (SUI). We propose to describe the noninvasive and ambulatory technique of the urethral bulking procedure. Bulking agents are a simple, minimally invasive technique that can be offered in the treatment of female SUI.
Asunto(s)
Hidrogeles/uso terapéutico , Incontinencia Urinaria de Esfuerzo/cirugía , Procedimientos Quirúrgicos Urológicos/métodos , Femenino , Humanos , Hidrogeles/administración & dosificación , Inyecciones , Cabestrillo Suburetral/efectos adversos , Resultado del Tratamiento , UretraRESUMEN
The transvaginal natural orifice transluminal endoscopic surgery (vNOTES) is a new minimally invasive and emerging technique. Feasibility and safety profiles of peritoneal access via transvaginal routes have been demonstrated especially for the adnexal surgery. In order to be reproducible and replicable with a standardized procedure, we propose the step-by-step video description of the vNOTES salpingectomy. The advantages of the vNOTES (low postoperative pain, faster postoperative recovery, scarless surgery) could lead to a promising alternative to conventional laparoscopic salpingectomy/adnexectomy.