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1.
Pharmacoepidemiol Drug Saf ; 28(9): 1258-1266, 2019 09.
Artículo en Inglés | MEDLINE | ID: mdl-31338901

RESUMEN

PURPOSE: The effect of chronic use of low-dose aspirin (LDA) on overall cancer is still unclear owing to many controversial results and methodological limitations of studies. This study aimed to assess the effect of LDA use on overall cancer incidence among the French population. METHODS: We conducted a 10-year historical cohort study using the permanent sample of the French national health care databases: the Système National des Données de Santé (SNDS). We used data for 111 025 individuals aged 50 to 80 years at study entry (January 1, 2006) without prevalent cancer or LDA use. Individuals were followed until the earliest of cancer incidence, death from any cause, exit from the database, or end of the study on December 31, 2015. We estimated the effect of LDA on cancer incidence by using a dynamic model to account for the competing risk of death in the presence of time-dependent exposure and risk factors. RESULTS: LDA use was associated with reduced 10-year risk of cancer (subdistribution hazard ratio [SHR] 0.81 [95% CI 0.77-0.86]). The SHRs were 0.88 [0.82-0.94] for men and 0.93 [0.85-1.02] for women. Moreover, each additional year of LDA use was associated with reduced 10-year risk of cancer (SHR 0.93 [0.92-0.95]). LDA use was also associated with reduced 10-year risk of death (SHR 0.86 [0.82-0.91]). CONCLUSIONS: This is the first population-based study to demonstrate a protective effect of LDA on overall cancer incidence and to account for the main methodological issues of previous observational studies.


Asunto(s)
Aspirina/administración & dosificación , Neoplasias de la Mama/epidemiología , Neoplasias de la Próstata/epidemiología , Anciano , Anciano de 80 o más Años , Neoplasias de la Mama/prevención & control , Bases de Datos Factuales/estadística & datos numéricos , Relación Dosis-Respuesta a Droga , Femenino , Estudios de Seguimiento , Francia/epidemiología , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Neoplasias de la Próstata/prevención & control , Factores de Riesgo
2.
Artículo en Inglés | MEDLINE | ID: mdl-29133564

RESUMEN

Posaconazole is an antifungal drug used in both prophylaxis and treatment of invasive fungal infections. Its oral formulation requires therapeutic drug monitoring. To overcome gastric acidity, a gastro-resistant posaconazole tablet has recently been developed. POSANANTES was a prospective noninterventional study that aimed to monitor plasma concentration trough level (Cmin) of posaconazole tablets used prophylactically in patients with hematological malignancies. Fifty patients were included. Group A (n = 31) included patients receiving induction chemotherapy for myeloid malignancies, and group B (n = 19) included patients treated for graft-versus-host disease after allogeneic hematopoietic stem cells transplantation. In multivariate analysis, female sex, group B assignment, and evaluation of Cmin at day 8 (versus any other day planned by the analysis) were associated with a higher Cmin, while diarrhea was associated with a lower Cmin (P < 0.05). Thirty-four percent (n = 17) of all included patients had to prematurely stop treatment, mainly in group A. In conclusion, this real-life prospective study showed good absorption of posaconazole tablets used for prophylaxis in patients with hematological malignancies, even though this strategy was somewhat limited due to the high number of patients in group A who had to stop their treatment in an untimely fashion.


Asunto(s)
Antifúngicos/uso terapéutico , Hongos/efectos de los fármacos , Neoplasias Hematológicas/tratamiento farmacológico , Estómago/fisiología , Comprimidos/uso terapéutico , Triazoles/uso terapéutico , Adulto , Anciano , Profilaxis Antibiótica/métodos , Femenino , Enfermedad Injerto contra Huésped/microbiología , Neoplasias Hematológicas/microbiología , Trasplante de Células Madre Hematopoyéticas/métodos , Humanos , Infecciones Fúngicas Invasoras/tratamiento farmacológico , Infecciones Fúngicas Invasoras/microbiología , Masculino , Persona de Mediana Edad , Análisis Multivariante , Estudios Prospectivos , Adulto Joven
3.
Pharmacoepidemiol Drug Saf ; 27(7): 763-770, 2018 07.
Artículo en Inglés | MEDLINE | ID: mdl-29763992

RESUMEN

PURPOSE: Access to claims databases provides an opportunity to study medication use and safety during pregnancy. We developed an algorithm to identify pregnancy episodes in the French health care databases and applied it to study antiepileptic drug (AED) use during pregnancy between 2007 and 2014. METHODS: The algorithm searched the French health care databases for discharge diagnoses and medical procedures indicative of completion of a pregnancy. To differentiate claims associated with separate pregnancies, an interval of at least 28 weeks was required between 2 consecutive pregnancies resulting in a birth and 6 weeks for terminations of pregnancy. Pregnancy outcomes were categorized into live births, stillbirths, elective abortions, therapeutic abortions, spontaneous abortions, and ectopic pregnancies. Outcome dates and gestational ages were used to calculate pregnancy start dates. RESULTS: According to our algorithm, live birth was the most common pregnancy outcome (73.9%), followed by elective abortion (17.2%), spontaneous abortion (4.2%), ectopic pregnancy (1.1%), therapeutic abortion (1.0%), and stillbirth (0.4%). These results were globally consistent with French official data. Among 7 559 701 pregnancies starting between 2007 and 2014, corresponding to 4 900 139 women, 6.7 per 1000 pregnancies were exposed to an AED. The number of pregnancies exposed to older AEDs, comprising the most teratogenic AEDs, decreased throughout the study period (-69.4%), while the use of newer AEDs increased (+73.4%). CONCLUSIONS: We have developed an algorithm that allows identification of a large number of pregnancies and all types of pregnancy outcomes. Pregnancy outcome and start dates were accurately identified, and maternal data could be linked to neonatal data.


Asunto(s)
Anticonvulsivantes/efectos adversos , Anticonvulsivantes/uso terapéutico , Epilepsia/tratamiento farmacológico , Complicaciones del Embarazo/epidemiología , Resultado del Embarazo , Adolescente , Adulto , Algoritmos , Anticonvulsivantes/administración & dosificación , Bases de Datos Factuales , Epilepsia/epidemiología , Femenino , Francia , Humanos , Recién Nacido , Persona de Mediana Edad , Embarazo , Complicaciones del Embarazo/tratamiento farmacológico , Factores de Riesgo , Adulto Joven
4.
Ann Rheum Dis ; 72(4): 552-9, 2013 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-22563030

RESUMEN

OBJECTIVES: To develop a questionnaire assessing the expectations of patients regarding management of osteoarthritis (OA of the knee. METHODS: A detailed document reporting on a qualitative analysis of interviews of patients with knee OA was sent to experts and a Delphi procedure was adopted for item generation. Eighty physicians (64 general practitioners, 16 rheumatologists) recruited 566 patients with knee OA to test the provisional questionnaire. Items were reduced according to their metric properties and exploratory factor analysis. The reliability of the questionnaire was tested by the Cronbach α coefficient. Construct validity was tested by divergent validity and confirmatory factor analysis. Test-retest reliability was assessed by the intraclass correlation coefficient (ICC) and the Bland-Altman technique. RESULTS: Sixty items were extracted from analysis of the interview data. The experts needed three Delphi rounds to obtain consensus on a 33-item provisional questionnaire. The item reduction process resulted in an 18-item questionnaire. Exploratory factor analysis extracted three main factors: factor 1 represented expectations for education, factor 2 expectations for information on technical and human support, and factor 3 expectations for physician empathy. The Cronbach α coefficient was 0.91 (95% CI 0.89 to 0.92). Expected divergent validity was observed. Confirmation factor analyses confirmed higher intra-factor than inter-factor correlations. Test-retest reliability was good with an ICC of 0.79, and Bland-Altman analysis did not reveal a systematic trend. CONCLUSIONS: A new 18-item questionnaire assessing patient expectations of management of knee OA by their physicians is proposed. The questionnaire has good content and construct validity.


Asunto(s)
Médicos Generales/normas , Osteoartritis de la Rodilla/terapia , Relaciones Médico-Paciente , Reumatología/normas , Encuestas y Cuestionarios/normas , Técnica Delphi , Humanos , Educación del Paciente como Asunto/normas , Psicometría/normas , Reproducibilidad de los Resultados
5.
Clin Breast Cancer ; 23(1): 60-70, 2023 01.
Artículo en Inglés | MEDLINE | ID: mdl-36376237

RESUMEN

BACKGROUND: Complementary therapy in oncology aims to help patients better cope with the illness and side effects (SEs) of cancer treatments that affect their quality of life (QOL). This study aimed to assess the benefits of homeopathic treatment on the health-related QOL (HRQOL) of patients with non-metastatic breast cancer (BC) prescribed in postsurgical complementary therapy. PATIENTS AND METHODS: An extraction from the French nationwide healthcare database targeted all patients who underwent mastectomy for newly diagnosed BC between 2012 and 2013. HRQOL was proxied by the quantity of medication used to palliate the SEs of cancer treatments. RESULTS: A total of 98,009 patients were included (mean age: 61 ± 13 years). Homeopathy was used in 11%, 26%, and 22% of patients respectively during the 7 to 12 months before surgery, the 6 months before, and 6 months after. Thereafter, the use remained stable at 15% for 4 years. Six months after surgery, there was a significant overall decrease (RR = 0.88, confidence interval (CI)95 = 0.87-0.89) in the dispensing of medication associated with SEs in patients treated with ≥ 3 dispensing of homeopathy compared to none. The decrease appeared to be greater for immunostimulants (RR = 0.79, (CI)95 = 0.74-0.84), corticosteroids (RR = 0.82, (CI)95 = 0.79-0.85), and antidiarrheals (RR = 0.83, (CI)95 = 0.77-0.88). CONCLUSION: The study showed an increasing use of homeopathy in patients with BC following diagnosis. This use was maintained after surgery and seemed to play a role in helping patients to better tolerate the SEs of cancer treatments.


Asunto(s)
Neoplasias de la Mama , Homeopatía , Humanos , Persona de Mediana Edad , Anciano , Femenino , Homeopatía/efectos adversos , Neoplasias de la Mama/terapia , Neoplasias de la Mama/etiología , Calidad de Vida , Estudios Retrospectivos , Mastectomía/efectos adversos , Atención a la Salud
6.
Ann Rheum Dis ; 71(11): 1803-8, 2012 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-22563026

RESUMEN

OBJECTIVE: To assess the association of adherence to the 2007 recommendations of the European League Against Rheumatism (EULAR) for managing early arthritis and radiographic progression and disability in patients METHODS: The authors conducted a prospective population-based cohort study. The ESPOIR cohort was a French cohort of 813 patients with early arthritis not receiving disease-modifying antirheumatic drugs (DMARDs). Adherence to the 2007 EULAR recommendations was defined by measuring adherence to three of the recommendations concerning the initiation and early adjustment of DMARDs. The study endpoints were radiographic progression, defined as the presence of at least one new erosion between baseline and 1 year, and disability as a heath assessment questionnaire score ≥1 at 2 years. A propensity score of being treated according to the recommendations was developed. RESULTS: After adjustment for propensity score, treatment centre and the main confounding factors, patients without recommendation adherence were at increased risk of radiographic progression at 1 year, and of functional impairment at 2 years (OR 1.98, (95% CI: 1.08 to 3.62 and OR: 2.36, (95% CI: 1.17 to 4.67), respectively). CONCLUSIONS: Early arthritis patients whose treatment adhered to the 2007 EULAR recommendations seemed to benefit from such treatment in terms of risk of clinical and radiographic progression. Using a propensity score of being treated according to recommendations in observational studies may be useful in assessing the potential impact of these recommendations on outcome.


Asunto(s)
Antirreumáticos/uso terapéutico , Artritis/tratamiento farmacológico , Cooperación del Paciente , Guías de Práctica Clínica como Asunto , Artritis/diagnóstico , Artritis/diagnóstico por imagen , Artrografía , Progresión de la Enfermedad , Femenino , Humanos , Articulaciones/patología , Modelos Logísticos , Masculino , Persona de Mediana Edad , Pronóstico , Puntaje de Propensión , Estudios Prospectivos , Resultado del Tratamiento
7.
PLoS One ; 15(2): e0228660, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32053648

RESUMEN

Until 2018, cervical cancer screening in France was an unorganized individual screening, with the exception of some pilot programs in some territories. We aimed to assess, before the implementation of organized cervical cancer screening and human papillomavirus (HPV) nonavalent vaccine introduction in the vaccination schedule in 2018, (i) the individual cervical cancer screening coverage, (ii) the management of squamous intraepithelial lesions (SIL) and (iii) the related costs. We used the Système National des Données de Santé (SNDS) (Echantillon Généraliste de Bénéficiaires [EGB] and Programme de Médicalisation des systèmes d'information [PMSI]) to assess the cervical screening coverage rate in France between January 1st, 2012 and December 31st, 2014, and to describe diagnostic investigations and therapeutic management of SIL in 2013. After extrapolation to the general population, a total of 10,847,814 women underwent at least one smear test over the 3-year study period, corresponding to a coverage rate of 52.4% of the women aged 25 to 64 included. In 2013, 126,095 women underwent HPV test, 327,444 women underwent colposcopy, and 9,653 underwent endocervical curettage; 31,863 had conization and 12,162 had laser ablation. Besides, 34,067 women experienced hospital stays related to management of SIL; 25,368 (74.5%) had high-grade lesions (HSIL) and 7,388 (21.7%) low-grade lesions (LSIL). Conization was the most frequent in-hospital therapeutic procedure: 89.5% (22,704) of women with an in-hospital procedure for HSIL and 64.7% (4,781) for LSIL. Mean cost of smear test, colposcopy and HPV tests were around 50€. Total cost for hospital stays in 2013 was estimated at M41€, or a mean cost of 1,211€ per woman; 76% were due to stays with HSIL. This study highlights the low coverage rate of individual cervical cancer screening and a high burden related to SIL management.


Asunto(s)
Detección Precoz del Cáncer/métodos , Tamizaje Masivo/métodos , Lesiones Intraepiteliales Escamosas/diagnóstico , Lesiones Intraepiteliales Escamosas/terapia , Neoplasias del Cuello Uterino/diagnóstico , Adulto , Anciano , Cuello del Útero/patología , Cuello del Útero/virología , Colposcopía/economía , Conización , Estudios Transversales , Detección Precoz del Cáncer/economía , Femenino , Francia/epidemiología , Costos de la Atención en Salud , Humanos , Tamizaje Masivo/economía , Persona de Mediana Edad , Infecciones por Papillomavirus/virología , Lesiones Intraepiteliales Escamosas/economía , Lesiones Intraepiteliales Escamosas/epidemiología , Neoplasias del Cuello Uterino/economía , Neoplasias del Cuello Uterino/epidemiología , Frotis Vaginal/economía , Frotis Vaginal/métodos , Displasia del Cuello del Útero/diagnóstico , Displasia del Cuello del Útero/economía , Displasia del Cuello del Útero/epidemiología , Displasia del Cuello del Útero/virología
8.
J Neurol ; 264(6): 1185-1192, 2017 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-28516332

RESUMEN

Data on the prevalence of multiple sclerosis (MS) in France are scarce. National and regional updated estimates are needed to better plan health policies. In this nationwide study, we provided estimates of the prevalence of MS in France in 2012 and mortality rate in 2013. MS cases were identified in the French national health insurance database (SNIIRAM-PMSI) using reimbursement data for disease-modifying treatment, long-term disease status for MS, disability pension for MS, and hospitalisation for MS (MS ICD-10 code: G35). We identified 99,123 MS cases, corresponding to an overall crude prevalence rate of 151.2 per 100,000 inhabitants [95% confidence interval (CI) 150.3-152.2]: 210.0 per 100,000 in women (95% CI 208.4-211.5) and 88.7 per 100,000 in men (95% CI 87.6-89.7). The overall prevalence rate was 155.6 per 100,000 inhabitants (95% CI 154.7-156.6) after standardization on the 2013-European population. We observed a prevalence gradient with a higher prevalence (190-200 per 100,000) in North-Eastern France and a lower prevalence in Southern and Western France (126-140). The crude mortality rate in 2013 was 13.7 per 1,000 MS cases (11.4 in women and 20.3 in men). The standardized mortality ratio was 2.56 (95% CI 2.41-2.72). Our results revise upwards the estimation of MS prevalence in France and confirm the excess mortality of MS patients compared to the general population.


Asunto(s)
Esclerosis Múltiple/epidemiología , Esclerosis Múltiple/mortalidad , Adolescente , Adulto , Distribución por Edad , Anciano , Anciano de 80 o más Años , Algoritmos , Bases de Datos Factuales/estadística & datos numéricos , Femenino , Francia/epidemiología , Hospitalización/estadística & datos numéricos , Humanos , Seguro de Salud/estadística & datos numéricos , Clasificación Internacional de Enfermedades , Masculino , Persona de Mediana Edad , Prevalencia , Estudios Retrospectivos , Adulto Joven
9.
Neurology ; 89(15): 1612-1618, 2017 Oct 10.
Artículo en Inglés | MEDLINE | ID: mdl-28887374

RESUMEN

OBJECTIVE: To determine whether REM sleep behavior disorder (RBD) in Parkinson disease (PD) is associated with lesions and dysfunctions of the autonomic nervous system by evaluating enteric phosphorylated α-synuclein histopathology (PASH) and permeability. METHODS: A total of 45 patients with PD were included in this cross-sectional study. RBD was diagnosed on the basis of a standardized clinical interview and confirmed by polysomnography. For each patient, 5 biopsies were taken at the junction between the sigmoid and descending colon during the course of a rectosigmoidoscopy. For the detection of enteric PASH, 2 colonic biopsies were analyzed by immunohistochemistry with antibodies against phosphorylated α-synuclein and PGP9.5 in 43 patients (2 patients were excluded because only 1 biopsy was available). The paracellular permeability and transcellular permeability were evaluated by measuring sulfonic acid and horseradish peroxidase flux, respectively, in the 3 remaining biopsies mounted in Ussing chambers. RESULTS: Enteric PASH was more frequent in the subgroup of patients with PD with RBD compared to patients without RBD (18 of 28, 64.3%, vs 2 of 15, 13.3%, respectively, p < 0.01). No differences were observed in intestinal permeability between patients with PD with and without RBD. CONCLUSIONS: Patients with PD and RBD have a greater frequency of synuclein pathology in the enteric nervous system, suggesting that RBD is associated with widespread synuclein neuropathology.


Asunto(s)
Sistema Nervioso Entérico/patología , Enfermedad de Parkinson/complicaciones , Trastorno de la Conducta del Sueño REM/etiología , Anciano , Anciano de 80 o más Años , Permeabilidad de la Membrana Celular/fisiología , Colonoscopía , Estudios Transversales , Sistema Nervioso Entérico/metabolismo , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , alfa-Sinucleína/metabolismo
10.
Intensive Care Med ; 43(7): 957-970, 2017 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-28315940

RESUMEN

PURPOSE: We assessed outcomes in brain-injured patients after implementation of a multi-faceted approach to reduce respiratory complications in intensive care units. METHODS: Prospective nationwide before-after trial. Consecutive adults with acute brain injury requiring mechanical ventilation for ≥24 h in 20 French intensive care units (ICUs) were included. The management of invasive ventilation in brain-injured patients admitted between 1 July 2013 and 31 October 2013 (4 months) was monitored and analysed. After the baseline period (1 November 2013-31 December 2013), ventilator settings and decision to extubate were selected as targets to hasten weaning from invasive ventilation. During the intervention period, low tidal volume (≤7 ml/kg), moderate positive end-expiratory pressure (PEEP, 6-8 cm H2O) and an early extubation protocol were recommended. The primary endpoint was the number of days free of invasive ventilation at day 90. Comparisons were performed between the two periods and between the compliant and non-compliant groups. RESULTS: A total of 744 patients from 20 ICUs were included (391 pre-intervention; 353 intervention). No difference in the number of invasive ventilation-free days at day 90 was observed between the two periods [71 (0-80) vs. 67 (0-80) days; P = 0.746]. Compliance with the complete set of recommendations increased from 8 (2%) to 52 (15%) patients after the intervention (P < 0.001). At day 90, the number of invasive ventilation-free days was higher in the 60 (8%) patients whose care complied with recommendations than in the 684 (92%) patients whose care deviated from recommendations [77 (66-82) and 71 (0-80) days, respectively; P = 0.03]. The mortality rate was 10% in the compliant group and 26% in the non-compliant group (P = 0.023). Both multivariate analysis [hazard ratio (HR) 1.78, 95% confidence interval (95% CI) 1.41-2.26; P < 0.001] and propensity score-adjusted analysis (HR 2.25, 95% CI 1.56-3.26, P < 0.001) revealed that compliance was an independent factor associated with the reduction in the duration of mechanical ventilation. CONCLUSIONS: Adherence to recommendations for low tidal volume, moderate PEEP and early extubation seemed to increase the number of ventilator-free days in brain-injured patients, but inconsistent adoption limited their impact. Trail registration number: NCT01885507.


Asunto(s)
Lesiones Encefálicas/terapia , Respiración con Presión Positiva/métodos , Desconexión del Ventilador/métodos , Lesión Pulmonar Inducida por Ventilación Mecánica/prevención & control , Adulto , Anciano , Extubación Traqueal/efectos adversos , Extubación Traqueal/mortalidad , Lesiones Encefálicas/diagnóstico por imagen , Lesiones Encefálicas/mortalidad , Estudios Controlados Antes y Después , Femenino , Escala de Coma de Glasgow , Humanos , Unidades de Cuidados Intensivos , Masculino , Persona de Mediana Edad , Ensayos Clínicos Controlados no Aleatorios como Asunto , Respiración con Presión Positiva/efectos adversos , Respiración con Presión Positiva/mortalidad , Estudios Prospectivos , Mejoramiento de la Calidad , Estadísticas no Paramétricas , Volumen de Ventilación Pulmonar , Tomografía Computarizada por Rayos X , Lesión Pulmonar Inducida por Ventilación Mecánica/mortalidad
11.
Joint Bone Spine ; 83(2): 185-90, 2016 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-26677991

RESUMEN

OBJECTIVE: To evaluate the effect of physiotherapy on functional limitation in an observational cohort of early axial spondyloarthritis. DESIGN: prospective population-based cohort study. PATIENTS: 708 patients with early axial spondyloarthritis between 2007 and 2010 naive of TNF blockers. INTERVENTION: early physiotherapy defined by at least eight supervised sessions of physical therapy during the first six months. MEASUREMENTS: the primary outcome was functional improvement defined by a relative improvement of at least 20% in BASFI at six months. Secondary outcomes were improvement in BASFI at one and two years and ASAS20 response criteria at six months. STATISTICAL ANALYSIS: a propensity score of having physiotherapy was developed and multivariate analysis using propensity score weighting were used to assess the effect of physiotherapy on outcome. RESULTS: Overall, 166 (24%) patients had physiotherapy during the first six months. After using propensity score weighting, there was no functional improvement on the primary outcome in patients treated with early physical therapy (relative risk [IC95%]: 1.15 [0.91-1.45]). No differences were observed on secondary outcomes (relative risk [IC95%]: 0.94 [0.80-1.11]). CONCLUSIONS: It seems there is no functional benefit for patients with early spondyloarthritis to be treated early by physiotherapy in daily practice, even though the efficacy of physiotherapy has been shown in several randomized controlled studies.


Asunto(s)
Espondiloartritis/terapia , Adulto , Femenino , Humanos , Masculino , Modalidades de Fisioterapia , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto
12.
BMJ ; 353: i2002, 2016 05 10.
Artículo en Inglés | MEDLINE | ID: mdl-27164970

RESUMEN

OBJECTIVE: To assess the risk of pulmonary embolism, ischaemic stroke, and myocardial infarction associated with combined oral contraceptives according to dose of oestrogen (ethinylestradiol) and progestogen. DESIGN: Observational cohort study. SETTING: Data from the French national health insurance database linked with data from the French national hospital discharge database. PARTICIPANTS: 4 945 088 women aged 15-49 years, living in France, with at least one reimbursement for oral contraceptives and no previous hospital admission for cancer, pulmonary embolism, ischaemic stroke, or myocardial infarction, between July 2010 and September 2012. MAIN OUTCOME MEASURES: Relative and absolute risks of first pulmonary embolism, ischaemic stroke, and myocardial infarction. RESULTS: The cohort generated 5 443 916 women years of oral contraceptive use, and 3253 events were observed: 1800 pulmonary embolisms (33 per 100 000 women years), 1046 ischaemic strokes (19 per 100 000 women years), and 407 myocardial infarctions (7 per 100 000 women years). After adjustment for progestogen and risk factors, the relative risks for women using low dose oestrogen (20 µg v 30-40 µg) were 0.75 (95% confidence interval 0.67 to 0.85) for pulmonary embolism, 0.82 (0.70 to 0.96) for ischaemic stroke, and 0.56 (0.39 to 0.79) for myocardial infarction. After adjustment for oestrogen dose and risk factors, desogestrel and gestodene were associated with statistically significantly higher relative risks for pulmonary embolism (2.16, 1.93 to 2.41 and 1.63, 1.34 to 1.97, respectively) compared with levonorgestrel. Levonorgestrel combined with 20 µg oestrogen was associated with a statistically significantly lower risk than levonorgestrel with 30-40 µg oestrogen for each of the three serious adverse events. CONCLUSIONS: For the same dose of oestrogen, desogestrel and gestodene were associated with statistically significantly higher risks of pulmonary embolism but not arterial thromboembolism compared with levonorgestrel. For the same type of progestogen, an oestrogen dose of 20 µg versus 30-40 µg was associated with lower risks of pulmonary embolism, ischaemic stroke, and myocardial infarction.


Asunto(s)
Anticonceptivos Orales Combinados , Embolia Pulmonar/inducido químicamente , Estudios de Cohortes , Anticoncepción , Anticonceptivos Orales , Estrógenos , Femenino , Humanos , Infarto del Miocardio/inducido químicamente , Factores de Riesgo , Accidente Cerebrovascular/inducido químicamente
13.
JAMA Intern Med ; 174(1): 40-8, 2014 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-24126705

RESUMEN

IMPORTANCE: Lifestyle improvements after an acute coronary syndrome reduce cardiovascular risk but are difficult to achieve. OBJECTIVE: To determine whether a nurse-led or dietician-led cardiovascular risk factor education program would improve risk factor reduction over the long term after an acute coronary syndrome. DESIGN, SETTING, AND PARTICIPANTS: The Réseau Insuffisance Cardiaque (RESICARD) PREVENTION: study was a 2-arm, parallel-group, multicenter, randomized clinical trial at 6 tertiary care hospitals in France. Patients hospitalized in a cardiac intensive care unit for an acute coronary syndrome with at least 1 lifestyle risk factor (current smoking, sedentary lifestyle, or overweight or obesity) were randomized according to a computer-generated list with sequentially numbered, sealed envelopes. INTERVENTION: Patients underwent an education program in a unique non-hospital setting (a House of Education) or were treated according to physicians' usual standard of care. MAIN OUTCOMES AND MEASURES: The primary outcome was a composite that included at least 1 of the following: smoking cessation, at least 3 hours per week of physical activity, at least 5% reduction in weight, and at least 4% reduction in waist circumference. Patients were followed up for 1 year. An intent-to-treat analysis was performed. RESULTS From June 21, 2006, to July 30, 2008, a total of 251 patients were randomized to the House of Education and 251 to conventional care. The 2 groups did not differ significantly at 12 months in the primary composite outcome (51.8% vs 49.8% success rate; adjusted relative risk [aRR], 1.11; 95% CI, 0.90-1.37) or with correction of all risk factors (aRR, 1.22; 95% CI, 0.89-1.66). Similarly, the 2 groups did not differ by physical activity (aRR, 1.05; 95% CI, 0.92-1.21), smoking cessation (aRR, 0.99; 95% CI, 0.87-1.13), and weight or waist reduction (aRR, 1.07; 95% CI, 0.84-1.36). CONCLUSIONS AND RELEVANCE: Compared with conventional care, the House of Education did not result in superior improvement in lifestyle-related cardiovascular risk factors after an acute coronary syndrome. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00337480.


Asunto(s)
Síndrome Coronario Agudo/terapia , Educación del Paciente como Asunto/métodos , Conducta de Reducción del Riesgo , Adulto , Anciano , Anciano de 80 o más Años , Ejercicio Físico , Femenino , Conductas Relacionadas con la Salud , Humanos , Masculino , Persona de Mediana Edad , Obesidad/complicaciones , Obesidad/terapia , Sobrepeso/complicaciones , Sobrepeso/terapia , Factores de Riesgo , Conducta Sedentaria , Fumar/terapia , Cese del Hábito de Fumar/métodos , Resultado del Tratamiento , Circunferencia de la Cintura
14.
PLoS One ; 8(1): e53886, 2013.
Artículo en Inglés | MEDLINE | ID: mdl-23349757

RESUMEN

OBJECTIVE: We aimed to develop a questionnaire assessing fears and beliefs of patients with knee OA. DESIGN: We sent a detailed document reporting on a qualitative analysis of interviews of patients with knee OA to experts, and a Delphi procedure was adopted for item generation. Then, 80 physicians recruited 566 patients with knee OA to test the provisional questionnaire. Items were reduced according to their metric properties and exploratory factor analysis. Reliability was tested by the Cronbach α coefficient. Construct validity was tested by divergent validity and confirmatory factor analysis. Test-retest reliability was assessed by the intra-class correlation coefficient (ICC) and the Bland and Altman technique. RESULTS: 137 items were extracted from analysis of the interview data. Three Delphi rounds were needed to obtain consensus on a 25-item provisional questionnaire. The item-reduction process resulted in an 11-item questionnaire. Selected items represented fears and beliefs about daily living activities (3 items), fears and beliefs about physicians (4 items), fears and beliefs about the disease (2 items), and fears and beliefs about sports and leisure activities (2 items). The Cronbach α coefficient of global score was 0.85. We observed expected divergent validity. Confirmation factor analyses confirmed higher intra-factor than inter-factor correlations. Test-retest reliability was good, with an ICC of 0.81, and Bland and Altman analysis did not reveal a systematic trend. CONCLUSIONS: We propose an 11-item questionnaire assessing patients' fears and beliefs concerning knee OA with good content and construct validity.


Asunto(s)
Miedo , Osteoartritis de la Rodilla/psicología , Encuestas y Cuestionarios , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad
15.
PLoS One ; 8(9): e75486, 2013.
Artículo en Inglés | MEDLINE | ID: mdl-24098699

RESUMEN

We compared the performance of four rapid diagnostic tests (RDTs) for imported malaria, and particularly Plasmodium falciparum infection, using thick and thin blood smears as the gold standard. All the tests are designed to detect at least one protein specific to P. falciparum (Plasmodium histidine-rich protein 2 (PfHRP2) or Plasmodium LDH (PfLDH)) and one pan-Plasmodium protein (aldolase or Plasmodium LDH (pLDH)). 1,311 consecutive patients presenting to 9 French hospitals with suspected malaria were included in this prospective study between April 2006 and September 2008. Blood smears revealed malaria parasites in 374 cases (29%). For the diagnosis of P. falciparum infection, the three tests detecting PfHRP2 showed high and similar sensitivity (96%), positive predictive value (PPV) (90%) and negative predictive value (NPV) (98%). The PfLDH test showed lower sensitivity (83%) and NPV (80%), despite good PPV (98%). For the diagnosis of non-falciparum species, the PPV and NPV of tests targeting pLDH or aldolase were 94-99% and 52-64%, respectively. PfHRP2-based RDTs are thus an acceptable alternative to routine microscopy for diagnosing P. falciparum malaria. However, as malaria may be misdiagnosed with RDTs, all negative results must be confirmed by the reference diagnostic method when clinical, biological or other factors are highly suggestive of malaria.


Asunto(s)
Antígenos de Protozoos/aislamiento & purificación , Lactato Deshidrogenasas/aislamiento & purificación , Malaria Falciparum/diagnóstico , Malaria Falciparum/epidemiología , Proteínas Protozoarias/aislamiento & purificación , Francia/epidemiología , Humanos , Malaria Falciparum/sangre , Valor Predictivo de las Pruebas , Estudios Prospectivos , Tamaño de la Muestra , Sensibilidad y Especificidad
16.
PLoS One ; 7(9): e44994, 2012.
Artículo en Inglés | MEDLINE | ID: mdl-23024781

RESUMEN

BACKGROUND: Representative national data on disability are becoming increasingly important in helping policymakers decide on public health strategies. We assessed the respective contribution of chronic health conditions to disability for three age groups (18-40, 40-65, and >65 years old) using data from the 2008-2009 Disability-Health Survey in France. METHODS: Data on 12 chronic conditions and on disability for 24,682 adults living in households were extracted from the Disability-Health Survey results. A weighting factor was applied to obtain representative estimates for the French population. Disability was defined as at least one restriction in activities of daily living (ADL), severe disability as the inability to perform at least one ADL alone, and self-reported disability as a general feeling of being disabled. To account for co-morbidities, we assessed the contribution of each chronic disorder to disability by using the average attributable fraction (AAF). FINDINGS: We estimated that 38.8 million people in France (81.7% [95% CI 80.9;82.6]) had a chronic condition: 14.3% (14.0;14.6) considered themselves disabled, 4.6% (4.4;4.9) were restricted in ADL and 1.7% (1.5;1.8) were severely disabled. Musculoskeletal and sensorial impairments contributed the most to self-reported disability (AAF 15.4% and 12.3%). Neurological and musculoskeletal diseases had the largest impact on disability (AAF 17.4% and 16.4%, respectively). Neurological disorders contributed the most to severe disability (AAF 31.0%). Psychiatric diseases contributed the most to disability categories for patients 18-40 years old (AAFs 23.8%-40.3%). Cardiovascular conditions were also among the top four contributors to disability categories (AAFs 8.5%-11.1%). CONCLUSIONS: Neurological, musculoskeletal, and cardiovascular chronic disorders mainly contribute to disability in France. Psychiatric impairments have a heavy burden for people 18-40 years old. These findings should help policymakers define priorities for health-service delivery in France and perhaps other developed countries.


Asunto(s)
Enfermedad Crónica/epidemiología , Personas con Discapacidad/estadística & datos numéricos , Vigilancia en Salud Pública , Adulto , Anciano , Femenino , Francia/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Estudios Retrospectivos
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