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BACKGROUND: The European Union (EU) is a confederation of 27 member states, the institutions of which work according to negotiated decisions. The EU has implemented similar legislation and a common market, and has adopted the same currency in most of its member states. Although financing health systems is a responsibility of the national governments, the EU has enacted the Charter of Fundamental Rights to standardize public health policies. However, for historical reasons, health policy and health expenditure is not uniform across the 27 EU member states (EU-27). MATERIAL AND METHODS: We hypothesized that increased health expenditure would be associated with better cancer outcome and that this would be most apparent in breast cancer, because of the availability of effective screening methods and treatments. Using publically available data from the World Health Organization, the International Monetary Fund, and the World Bank, we assessed associations between cancer indicators and wealth and health indicators. To do so, we constructed scatter plots and used the Spearman's rank correlation coefficient. RESULTS: A marked difference in wealth and health expenditure indicators was observed between Eastern and Western European countries, with Western European being the higher. Higher wealth and higher health expenditures were associated both with increased cancer incidence and decreased cancer mortality. In breast cancer, the association with incidence was stronger. We created mortality/incidence ratios and observed that the more spent on health, the fewer the deaths after a cancer diagnosis. CONCLUSION: Despite the initiatives to standardize public health policies of the EU-27, health expenditure continues to be higher in Western European countries and this is associated with better cancer outcome in these countries.
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Gastos en Salud , Neoplasias/mortalidad , Unión Europea/economía , Humanos , Incidencia , Neoplasias/economía , Neoplasias/patología , Factores SocioeconómicosRESUMEN
BACKGROUND: We sought to compare the outcomes of endovenous laser ablation (EVLA) of the great saphenous vein (GSV) to EVLA of the GSV and calf incompetent perforator veins (IPVs) in management of venous stasis ulcers (VSUs). METHODS: A retrospective review of patients with active VSUs (clinical, etiology, anatomy, and pathophysiology [CEAP] classification C6) that received EVLA of the GSV or combined EVLA of the GSV and IPV between May 2005 and May 2010 was completed. Primary outcomes measured include ulcer healing and a change in the venous clinical severity score (VCSS). Secondary end points included complications, ulcer recurrence rate, and time to ulcer healing. RESULTS: Ninety-five patients (108 limbs) met inclusion criteria with active VSU (CEAP classification C6) before ablation. The average age was 58 years, with a male predominance (61%). Seventy-eight patients (91 limbs) were treated with EVLA of the GSV alone. Subgroup analysis revealed that 46 of 91 limbs (35 patients) had GSV reflux only (group 1) and 45 of 91 limbs (43 patients) had underlying IPV (group 2). Seventeen patients (17 limbs) underwent combined EVLA of the GSV and IPV (group 3). VSU healing (CEAP classification C5) occurred in 21 of 46 limbs (46%) in group 1, 15 of 45 limbs (33%) in group 2, and 12 of 17 limbs (71%) in group 3. A comparison of ulcer healing between groups 1 and 2 and between groups 1 and 3 revealed no significant difference (Fisher's exact test; P = 0.285 and P = 0.095, respectively). However, there was a significant difference in ulcer healing between groups 2 and 3 (P = 0.011). Group 1 ulcers healed in an average of 14.8 weeks, group 2 ulcers in 11.2 weeks, and group 3 in 13.2 weeks (analysis of variance; P = 0.918). Postoperative complications occurred in 7 limbs (15%) in group 1, 5 limbs (11%) in group 2, and 3 (18%) limbs in group 3. Recurrence of VSU occurred in 2 limbs (4%) in group 1, 5 limbs in group 2 (11%), and in no limbs in group 3 (Fisher's exact test; P = 0.676). Mean follow-up was 16.9 weeks for group 1, 19.2 weeks for group 2, and 14.0 weeks for group 3 (P = 0.69). CONCLUSIONS: Ulcer healing was accomplished to a significantly greater degree using EVLA of the GSV and IPV compared to GSV ablation alone for the treatment of active VSU in patients with combined reflux. This study suggests that limbs with VSU disease should be routinely examined for both superficial axial and perforator venous reflux and, when appropriate, combined ablation of the GSV and IPV should be considered in management of this disease.
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Procedimientos Endovasculares , Terapia por Láser , Vena Safena/cirugía , Várices/cirugía , Insuficiencia Venosa/cirugía , Cicatrización de Heridas , Adulto , Anciano , Anciano de 80 o más Años , Análisis de Varianza , Procedimientos Endovasculares/efectos adversos , Femenino , Humanos , Terapia por Láser/efectos adversos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento , Várices/diagnóstico , Insuficiencia Venosa/diagnósticoRESUMEN
The mean pulmonary artery pressure (P(pa)) achieved on mild-to-moderate exercise is age related and its haemodynamic correlates remain to be documented in patients free of pulmonary hypertension (PH). Our retrospective study involved patients free of PH investigated in our centre for possible pulmonary vascular disease between January 1, 2007 and October 31, 2009 who underwent right heart catheterisation at rest and during supine exercise up to 60 W. The 38 out of 99 patients aged <50 yrs were included and a P(pa) of 30 mmHg was considered the upper limit of normal on exercise. The 24 subjects who developed P(pa)>30 mmHg on exercise had higher resting P(pa) (19±3 versus 15±4 mmHg) and indexed pulmonary vascular resistance (PVRi; 3.4±1.5 versus 2.2±1.1 WU·m(2); p<0.05) than the remaining 14 subjects. Resting P(pa) >15 mmHg predicted exercise P(pa) >30 mmHg with 88% sensitivity and 57% specificity. The eight patients with resting P(pa) 22-24 mmHg all had exercise P(pa) >30 mmHg. In subjects aged <50 yrs investigated for possible pulmonary vascular disease and free of PH, patients with mild-to-moderate exercise P(pa) >30 mmHg had higher resting PVRi and higher resting P(pa), although there was no resting P(pa) threshold value that could predict normal response on mild-to-moderate exercise. The clinical relevance of such findings deserves further long-term follow-up studies.
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Gasto Cardíaco/fisiología , Ejercicio Físico/fisiología , Hipertensión Pulmonar/diagnóstico , Hipertensión Pulmonar/fisiopatología , Presión Esfenoidal Pulmonar/fisiología , Descanso/fisiología , Adulto , Cateterismo Cardíaco , Femenino , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Arteria Pulmonar/fisiología , Curva ROC , Estudios Retrospectivos , Sensibilidad y Especificidad , Posición SupinaRESUMEN
Pulmonary arterial hypertension (PAH) is a progressive, fatal disease. We studied 674 consecutive adult patients who were prospectively enrolled in the French PAH registry (121 incident and 553 prevalent cases). Two survival analyses were performed. First, the cohort of 674 patients was followed for 3 yrs after study entry and survival rates described. Then, we focused on the subset with incident idiopathic, familial and anorexigen-associated PAH (n = 56) combined with prevalent patients who were diagnosed <3 yrs prior to study entry (n = 134). In the cohort of 674 patients, 1-, 2-, and 3-yr survival rates were 87% (95% CI 84-90), 76% (95% CI 73-80), and 67% (95% CI 63-71), respectively. In prevalent idiopathic, familial and anorexigen-associated PAH, 1-, 2-, and 3-yr survival rates were higher than in incident patients (p = 0.037). In the combined cohort of patients with idiopathic, familial and anorexigen-associated PAH, multivariable analysis showed that survival could be estimated by means of a novel risk-prediction equation using patient sex, 6-min walk distance, and cardiac output at diagnosis. This study highlights survivor bias in prevalent cohorts of PAH patients. Survival of idiopathic, familial and anorexigen-associated PAH can be characterised by means of a novel risk-prediction equation using patients' characteristics at diagnosis.
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Hipertensión Pulmonar , Anciano , Estudios de Cohortes , Hipertensión Pulmonar Primaria Familiar , Femenino , Humanos , Hipertensión Pulmonar/epidemiología , Hipertensión Pulmonar/mortalidad , Masculino , Persona de Mediana Edad , Análisis Multivariante , Prevalencia , Neumología/métodos , Factores de Riesgo , Resultado del TratamientoRESUMEN
Non-melanoma skin cancers are the most prevalent form of cancer, with cutaneous squamous cell carcinoma (cscc) being the 2nd most common type. Patients presenting with high-risk lesions associated with locally advanced or metastatic cscc face high rates of recurrence and mortality. Accurate staging and risk stratification for patients can be challenging because no system is universally accepted, and no Canadian guidelines currently exist. Patients with advanced cscc are often deemed ineligible for either or both of curative surgery and radiation therapy (rt) and, until recently, were limited to off-label systemic cisplatin-fluorouracil or cetuximab therapy, which offers modest clinical benefits and potentially severe toxicity. A new systemic therapy, cemiplimab, has been approved for the treatment of locally advanced and metastatic cscc. In the present review, we provide recommendations for patient classification and staging based on current guidelines, direction for determining patient eligibility for surgery and rt, and an overview of the available systemic treatment options for advanced cscc and of the benefits of a multidisciplinary approach to patient management.
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Carcinoma de Células Escamosas/terapia , Neoplasias Cutáneas/terapia , Carcinoma de Células Escamosas/patología , Humanos , Metástasis de la Neoplasia , Neoplasias Cutáneas/patologíaRESUMEN
OBJECTIVE: Color duplex ultrasound (CDU) imaging is a noninvasive alternative to computed tomography (CT) for the detection of endoleak. This study compared CT and CDU imaging in the detection of endoleaks requiring intervention after endovascular aneurysm repair (EVAR). METHODS: All EVARs performed at our institution from 1996 to 2007 were retrospectively reviewed. CDU and CT scans < or =3 months were paired and the presence of an endoleak and its type were recorded. Clinical follow-up was reviewed and interventions for endoleak were recorded. Interventions were performed for type I, for type II with sac enlargement, and for type III endoleaks. The first analysis of clinical test outcomes used the findings of CT scan as a gold standard and the second used the findings at time of intervention as a gold standard. RESULTS: During the time period reviewed, 496 patients underwent EVAR, and 236 of these had CDU and CT follow-up studies paired < or =3 months of each other. Mean follow-up was 17 months (range, <1-111 months). We reviewed 944 studies or 472 pairs. Eighteen patients (7.6%) required intervention for 19 endoleaks: six type I, 11 type II, and two type III. Early endoleak (< or =1 month) requiring reintervention was detected in 1 vs late endoleak (mean, 28 months; range, 0.6-88 months) in 18. All type I and III endoleaks were treated with endovascular cuff or limb extension placement. Three type II endoleaks were treated with open ligation, and coil or glue embolization was used in eight. CDU imaging detected endoleaks requiring intervention in 89% of cases, whereas CT detected endoleak in 58% (P < .05). The ability to correctly identify the type of endoleak as confirmed at time of intervention was 74% with CDU imaging vs 42% by CT (P < .05). CDU, for the detection of endoleak requiring intervention, had a sensitivity of 90%, specificity of 81%, negative predictive value (NPV) of 99%, and positive predictive value (PPV) of 16%, while CT had a sensitivity of 58%, specificity of 87%, NPV of 98%, and PPV of 15%. CONCLUSIONS: CDU imaging has a high sensitivity in detecting endoleaks requiring intervention, is better at identifying the type of endoleak, and is an excellent test for graft surveillance after endovascular aneurysm repair. Compared with CT scan, CDU imaging in our experience is the preferred test on which to base an intervention for endoleak.
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Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aortografía/métodos , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Falla de Prótesis , Tomografía Computarizada por Rayos X , Ultrasonografía Doppler en Color , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Reoperación , Estudios Retrospectivos , Sensibilidad y Especificidad , Factores de Tiempo , Resultado del TratamientoRESUMEN
The aim of the present study was to describe a large cohort of fenfluramine-associated pulmonary arterial hypertension (fen-PAH) and its possible prognostic markers. The records of all patients with a diagnosis of fen-PAH evaluated at the present authors' centre from 1986-2004 were retrospectively studied. Baseline clinical and haemodynamic data were collected, as well as survival times. The median duration of fenfluramine exposure was 6 months, with a median of 4.5 yrs between exposure and onset of symptoms. Nine (22.5%) out of 40 patients evaluated resulted positive for the presence of germline bone morphogenetic protein receptor (BMPR) type 2 mutations. In these patients, the duration of exposure to fenfluramine was significantly lower than in patients without mutation. The median survival was 6.4 yrs, without significant difference between fen-PAH and a control group of idiopathic and familial pulmonary arterial hypertension patients referred to the present authors' centre during the same time frame and treated identically. Duration of fenfluramine exposure showed no relation to survival, while cardiac index was the only independent predictor of multivariate analysis. Fenfluramine-associated pulmonary arterial hypertension shares clinical, functional, haemodynamic and genetic features with idiopathic pulmonary arterial hypertension, as well as overall survival rates. Therefore, the present authors conclude that fenfluramine exposure characterises a potent trigger for pulmonary arterial hypertension without influencing its clinical course.
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Depresores del Apetito/efectos adversos , Fenfluramina/efectos adversos , Hipertensión Pulmonar/inducido químicamente , Hipertensión Pulmonar/epidemiología , Adulto , Distribución por Edad , Análisis de Varianza , Depresores del Apetito/administración & dosificación , Intervalos de Confianza , Femenino , Fenfluramina/administración & dosificación , Estudios de Seguimiento , Francia/epidemiología , Humanos , Hipertensión Pulmonar/fisiopatología , Incidencia , Masculino , Persona de Mediana Edad , Análisis Multivariante , Obesidad/tratamiento farmacológico , Modelos de Riesgos Proporcionales , Medición de Riesgo , Índice de Severidad de la Enfermedad , Distribución por Sexo , Tasa de SupervivenciaRESUMEN
This study reviewed a large national core laboratory database for the Ancure (Guidant, Menlo Park, California) phase I and II trial of overall aneurysm sac regression after endovascular aneurysm repair. Data were reviewed for aneurysm size and endoleak in follow-up. Endoleak was recorded as well as maximum major and minor axis aortic diameters. Included were patients with baseline assessment within 3 months of implantation and at least 24 months of follow-up, and 444 were available for review. The mean baseline aortic diameter was 56.6 mm; mean follow-up was 48.7 months. Of these patients, 129 (29.5%) had aneurysm regression to less than 40 mm, 42 (9.5%) regressed to less than 35 mm, and 12 (2.7%) had complete aneurysm sac obliteration. Multivariate analysis demonstrated that baseline aneurysm size was the only predictor of aneurysm size regression. Significant sac regression is common after Ancure aneurysm repair and appears to be related primarily to initial aneurysm size.
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Aneurisma de la Aorta/cirugía , Aneurisma de la Aorta/diagnóstico por imagen , Aortografía/métodos , Bases de Datos como Asunto , Humanos , Estudios Retrospectivos , Factores de Tiempo , Tomografía Computarizada por Rayos X , Resultado del TratamientoRESUMEN
BACKGROUND: After stopping a 3 to 6 months course of oral anticoagulation for a first episode of idiopathic venous thromboembolism (VTE), the risk of recurrent VTE is high (10% per year). In this setting, international guidelines recommend at least 6 months treatment. However, this recommendation is not satisfactory for the following reasons: (1) no randomized trial has compared 6 months to extended duration (2 years) anticoagulation; and (2), even though the frequency of recurrent VTE is similar after pulmonary embolism (PE) and deep vein thrombosis (DVT), the fatality rate of recurrent VTE after PE is higher than that after DVT. METHODS: A French multicentre double blind randomized trial. The main objective is to demonstrate, after a first episode of symptomatic idiopathic PE treated for 6 months using a vitamin K antagonist, that extended anticoagulation for 18 months (INR between 2 and 3) is associated with an increased benefit / risk ratio (recurrent VTE and severe anticoagulant-related bleeding) compared to placebo. The double blind evaluation is ensured using by active warfarin and placebo, and blinded INR. The protocol was approved by the ethics board of the Brest Hospital on the 7th of March 2006. For an alpha risk of 5% and a beta risk of 20%, the estimated sample size is 374 patients. EXPECTED RESULTS: This study has the potential to: (1) demonstrate that the benefit / risk ratio of extended anticoagulation for 18 months is higher than that observed with placebo in patients with a first episode of idiopathic PE initially treated for 6 months, during and after the treatment period; and (2) to validate or invalidate the contribution of isotope lung scans, lower limb Doppler ultrasound and D-Dimer at 6 months of treatment as predictors of recurrent VTE (medico-economic analysis included).
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Anticoagulantes/uso terapéutico , Embolia Pulmonar/tratamiento farmacológico , Tromboembolia Venosa/tratamiento farmacológico , Vitamina K/antagonistas & inhibidores , Warfarina/uso terapéutico , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Distribución de Chi-Cuadrado , Interpretación Estadística de Datos , Método Doble Ciego , Hemorragia/inducido químicamente , Humanos , Placebos , Guías de Práctica Clínica como Asunto , Pronóstico , Recurrencia , Medición de Riesgo , Factores de Tiempo , Warfarina/administración & dosificación , Warfarina/efectos adversosRESUMEN
The use of computerised tomography in the diagnosis of pulmonary embolism has been the subject of clinical research while, at the same time, technical progress has provided the current multidetector-row spiral equipment. Computerised tomography has been assessed both with respect to reference strategies as well as in extensive pragmatic trials. The preliminary evaluation of the clinical probability and the assay of d-dimers has progressively become imperative. The value of the venous doppler ultrasound of the legs, in particular in the elderly, is limited by the variable accessibility according to the centre. In rare cases, uncertainty persists, for example with a good quality negative multidetector-row spiral computerised tomography associated with a high clinical probability, leaving room for complementary explorations. The confrontation between clinicians and radiologists is then all the more pertinent.
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Embolia Pulmonar/diagnóstico , Tomografía Computarizada por Rayos X , Algoritmos , Productos de Degradación de Fibrina-Fibrinógeno/análisis , Humanos , Pulmón/diagnóstico por imagenRESUMEN
BACKGROUND: In view of recent substantial changes in the management of orthopedic surgery patients, a study was performed in order to update data on the epidemiology of venous thromboembolism (VTE) in patients undergoing lower limb arthroplasty according to contemporary practise. METHODS: We performed a prospective observational study of a cohort of consecutive patients hospitalized for total hip or knee replacement in June 2003. The primary study outcome was the incidence of symptomatic VTE at 3 months. All events were adjudicated by an independent critical event committee. RESULTS: Data from 1080 patients (mean age 68.0 years) were available; 63.2% were undergoing total hip replacement and 36.8% total knee replacement. Pharmacological thromboprophylaxis was administered for a mean time of 36 days. Injectable antithrombotics were used in more than 99% of patients, irrespective of the type of surgery. The incidence of the primary study outcome was 1.8% (20 events; 95% CI: 1.0-2.6%). The incidences were 1.3% and 2.8% in hip and knee surgery patients, respectively. There were two pulmonary embolisms, both in knee surgery patients; neither was fatal. Thirty-five per cent of VTEs occurred after hospital discharge. An age of at least 75 years and the absence of ambulation before hospital discharge were the only significant (P < 0.05) predictors of VTE. The rate of clinically significant bleeding was 1.0% and the rate of death was 0.9%. CONCLUSIONS: The incidence of symptomatic VTE after lower limb arthroplasty is low, even if there is still a need to improve thromboprophylaxis, notably in patients undergoing knee arthroplasty.
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Artroplastia de Reemplazo de Cadera/efectos adversos , Artroplastia de Reemplazo de Rodilla/efectos adversos , Embolia Pulmonar/epidemiología , Tromboembolia Venosa/epidemiología , Factores de Edad , Anciano , Artroplastia de Reemplazo de Cadera/estadística & datos numéricos , Artroplastia de Reemplazo de Rodilla/estadística & datos numéricos , Femenino , Fibrinolíticos/efectos adversos , Fibrinolíticos/uso terapéutico , Francia/epidemiología , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Vigilancia de la Población , Estudios Prospectivos , Embolia Pulmonar/etiología , Embolia Pulmonar/fisiopatología , Embolia Pulmonar/prevención & control , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Tromboembolia Venosa/etiología , Tromboembolia Venosa/fisiopatología , Tromboembolia Venosa/prevención & control , CaminataRESUMEN
INTRODUCTION: Pulmonary arterial hypertension (PAH) is rare in the presence of malignancy and tumour embolisation is one of several possible pathological mechanisms. CASE REPORTS: We report our experience of 5 clinical cases and undertake a literature revue of the pathophysiological mechanisms and of the possible diagnostic and therapeutic approaches. CONCLUSIONS: Neoplastic PAH due to tumour micro-emboli is rare and the diagnosis difficult to establish. Cytological examination of pulmonary arterial blood could allow early institution of appropriate chemotherapy and lead to an improvement in the grave prognosis of this condition.
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Hipertensión Pulmonar/etiología , Células Neoplásicas Circulantes , Adulto , Femenino , Humanos , Linitis Plástica/diagnóstico , Neoplasias Pulmonares/diagnóstico , Masculino , Persona de Mediana Edad , Neoplasias Gástricas/diagnósticoRESUMEN
INTRODUCTION: Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare disease characterized by the persistence of thromboemboli obstructing the pulmonary arteries as an organized tissue. The consequence is an increase in pulmonary vascular resistance resulting in pulmonary hypertension (PH) and progressive right heart failure. BACKGROUND: It is difficult to recognize the postembolic nature of PH because there is no known history of thromboembolic disease in more than 50% of cases. Diagnosis is based on the presence of mismatched segmental defects in the ventilation-perfusion scanning. When CTEPH is suspected, pulmonary angiography and high-resolution CT scan are required to establish the diagnosis and to assess the operability. Pulmonary angiography is always performed in conjunction with a diagnostic right heart catheterization, which is required to confirm the diagnosis of PH and to determine the degree of hemodynamic impairement. If there is a good correlation between the pulmonary vascular resistance and the anatomical obstruction, pulmonary endarterectomy (PEA) must be proposed. Otherwise, vasodilator and antiproliferative treatments and lung transplantation represent interesting alternatives. VIEWPOINT AND CONCLUSION: PEA remains the treatment of choice for eligible patients. Nevertheless, there is a need to conduct randomized trials to assess the efficacy of novel medical therapies in some situations: (1) in inoperable CTEPH due to distal lesions, (2) before PEA (therapeutic bridge) in patients who are considered "high risk" due to extremely poor hemodynamics, (3) in patients with persistent pulmonary hypertension after surgery.
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Hipertensión Pulmonar/etiología , Hipertensión Pulmonar/terapia , Embolia Pulmonar/complicaciones , Humanos , Hipertensión Pulmonar/diagnóstico , Hipertensión Pulmonar/fisiopatología , Pulmón/diagnóstico por imagen , Embolia Pulmonar/terapia , RadiografíaRESUMEN
Essentials The reproducibility of Clinical Events Committee (CEC) adjudications is almost unexplored. A random selection of events from a venous thromboembolism trial was blindly re-adjudicated. 'Unexplained sudden deaths' (possible fatal embolism) explained most discordant adjudications. A precise definition for CEC adjudication of this type of events is needed and proposed. SUMMARY: Background When clinical trials use clinical endpoints, establishing independent Clinical Events Committees (CECs) is recommended to homogenize the interpretation of investigators' data. However, the reproducibility of CEC adjudications is almost unexplored. Objectives To assess the reproducibility of CEC adjudications in a trial of venous thromboembolism (VTE) prevention. Methods The PREVENU trial, a multicenter trial of VTE prevention, included 15 351 hospitalized medical patients. The primary endpoint was the composite of symptomatic VTE, major bleeding or unexplained sudden death (interpreted as possible fatal pulmonary embolism [PE]) at 3 months. The CEC comprised a chairman and four pairs of adjudicators. Of 2970 adjudicated clinical events, a random selection of 179 events (121 deaths, 40 bleeding events, and 18 VTE events) was blindly resubmitted to the CEC. Kappa values and their 95% confidence intervals (CIs) were calculated to measure adjudication agreement. Results Overall, 18 of 179 (10.1%, 95% CI 6.5-15.3%) adjudications proved discordant. Agreement for the PREVENU composite primary endpoint was good (kappa = 0.73, 95% CI 0.61-0.85). When analyzed separately, agreements were very good for non-fatal VTE events (1, 95% CI not applicable), moderate for all (fatal and non-fatal) VTE events (0.58, 95% CI 0.34-0.82), good for fatal and non-fatal major bleeding events (0.71, 95% CI 0.55-0.88), and moderate for all fatal events (0.60, 95% CI 0.40-0.81). Unexplained sudden death interpreted as possible fatal PE was responsible for nine of 18 (50%) discordant adjudications. Conclusion The reproducibility of CEC adjudications was good or very good for non-fatal VTE and bleeding events, but insufficient for VTE-related deaths, for which more precise and widely accepted definitions are needed.
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Comités de Monitoreo de Datos de Ensayos Clínicos , Tromboembolia Venosa/prevención & control , Anticoagulantes/uso terapéutico , Muerte Súbita , Determinación de Punto Final , Hemorragia , Humanos , Embolia Pulmonar/sangre , Embolia Pulmonar/prevención & control , Embolia Pulmonar/terapia , Reproducibilidad de los Resultados , Proyectos de Investigación , Resultado del Tratamiento , Tromboembolia Venosa/sangre , Tromboembolia Venosa/terapiaRESUMEN
INTRODUCTION: Surgical treatment of spinal deformity is high risk in patients suffering from Parkinson's disease (PD). Several series have already reported a high rate of complications. However, none of these studies included more than 40 patients and none of the risk factors of complications were described. The aim of this study was to describe the rate and risk factors of revision surgery as well as the clinical outcome at the last visit in a large multicenter study of PD patients operated for spinal deformities. METHODS: A multicenter retrospective study included arthrodesis for spinal deformity in patients with PD. Clinical and surgical data including revision surgeries were collected. Assessment of functional outcomes at last follow-up was classified in 3 grades and spinal balance was assessed on anteroposterior and lateral plain X-rays of the entire spine. RESULTS: Forty-eight patients were included. Median age was 67 years old (range 41-80). Median follow-up was 27 months. The rate of surgical revision was 42%. Eighty per cent of revisions were performed for chronic mechanical complication. Global results were considered to be good in 17 patients (35%), doubtful in 17 patients (35%) and a failure in 14 patients (30%), for the whole series. CONCLUSIONS: The results of surgery for spinal deformities in patients with Parkinson disease vary with a high rate of complications and revisions. Nevertheless, these results should be seen in relation to the natural progression of these spinal deformities once spinal imbalance has developed. The association between preoperative clinical balance and final outcome suggests that early surgery can probably play a role in treatment. LEVEL OF EVIDENCE: Level IV (e.g. case series).
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Enfermedad de Parkinson , Enfermedades de la Columna Vertebral/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Progresión de la Enfermedad , Femenino , Francia , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Enfermedades de la Columna Vertebral/diagnóstico por imagen , Fusión Vertebral , Resultado del TratamientoRESUMEN
BACKGROUND: Tilt of the First Distal Uninstrumented Vertebra (FDUV) reflects changes in the main curve and compensatory lumbar curve after posterior fusion to treat thoracic Adolescent Idiopathic Scoliosis (AIS). HYPOTHESIS: FDUV tilt 5 years or more post-fusion depends chiefly on reduction of the main curve and on other factors such as selection of the last instrumented vertebra. MATERIAL AND METHOD: A multicenter retrospective cohort of 182 patients with Lenke 1 or 2 AIS treated with posterior instrumentation and followed up for a mean of 8 years and a minimum of 5 years was studied. The patients were divided into two groups based on whether tilt of the upper endplate of the FDUV was ≤5° or >5°at last follow-up. Variables associated with tilt were identified by multiple logistic regression. RESULTS: Six variables were significantly associated with FDUVtilt: percentage of correction at last follow-up, correction loss, lumbar modifier B, number of instrumented vertebrae, inclusion within the instrumentation of the distal neutral vertebra, and inclusion within the instrumentation of the lowest vertebra intersected by the central sacral vertical line. DISCUSSION AND CONCLUSION: The main variables associated with FDUVtilt ≤5° were a final correction percentage ≥60% and absence of correction loss between the postoperative period and last follow-up. Given the stable reduction provided by contemporary instrumentations, we recommend selective thoracic fusion of Lenke 1 or 2 AIS with lumbar modifiers A, B, and C. The lowest instrumented vertebra should be either the neutral vertebra or the vertebra intersected by the central sacral vertical line if it is distal to the neutral vertebra. LEVEL OF EVIDENCE IV: Retrospective multicenter study.
Asunto(s)
Escoliosis/cirugía , Fusión Vertebral , Vértebras Torácicas/fisiopatología , Vértebras Torácicas/cirugía , Adolescente , Femenino , Estudios de Seguimiento , Humanos , Región Lumbosacra/diagnóstico por imagen , Masculino , Periodo Posoperatorio , Radiografía , Estudios Retrospectivos , Escoliosis/diagnóstico por imagen , Fusión Vertebral/instrumentación , Fusión Vertebral/métodos , Vértebras Torácicas/diagnóstico por imagenRESUMEN
INTRODUCTION: Although the advent of multi-detector row computed tomography (CT) has enabled better visualization of subsegmental pulmonary (SSP) arteries, SSP embolism is of uncertain clinical significance. We aimed at answering the following questions: Is spiral CT an accurate method to detect SSP embolism? How are subsegmental perfusion defects managed in outcome studies including spiral CT? What are the main characteristics and outcomes of patients in whom CT detects isolated subsegmental defects? METHODS: We performed a Medline search on July 1, 2004, using the keywords 'pulmonary embolism' and 'computed tomography'. We limited our search to English language prospective studies comparing CT to pulmonary angiography, and to prospective outcome studies including CT in a diagnostic strategy, with at least a 3-month follow-up. RESULTS: Fourteen studies comparing CT to pulmonary angiography, and five prospective management studies using CT were retrieved. The sensitivity of single-detector CT for detecting subsegmental defects compared with pulmonary angiography was low (25%). The proportion of isolated SSP images was significantly higher in management studies using multi-detector CT (17 of 770 scans, 2.2%) compared with those using single-detector CT (22 of 2232, 1.0%; P = 0.01). No straightforward attitude regarding anticoagulation therapy for isolated subsegmental defects emerged from the available literature. Finally, important clinical differences were found between patients having subsegmental and segmental or more proximal defects. CONCLUSIONS: These findings underline the uncertainty regarding the clinical significance of SSP embolism, and the management of patients with such findings.
Asunto(s)
Embolia Pulmonar/diagnóstico , Embolia Pulmonar/terapia , Angiografía , Anticoagulantes/farmacología , Humanos , MEDLINE , Estudios Prospectivos , Reproducibilidad de los Resultados , Sensibilidad y Especificidad , Factores de Tiempo , Tomografía Computarizada Espiral/métodos , Resultado del TratamientoRESUMEN
This article describes the results of a participatory process aiming to design and develop a referential of competencies for nurses to be used in secondary professional training within the context of the global South, and more specifically in the Democratic Republic of Congo (DRC). Priority focus is given to the presentation of the final validated product. The competencies' referential is accompanied by a training referential as a pre-requisite guide, which outlines the course of study. Only the referential of competencies is described in this article. The result documents, in the first instance, the shape which this referential of competencies takes in reality, from which a school nurse can be brought to mobilise while practicing his/her profession. The referential's basis and presentation is founded on four key skill sets as a starting point. Each of the four key skills were further broken down and divided according to levels of competencies and minimal criteria for perfecting these skills per year of study. The presentation of the referential of competencies ends by regrouping "families of situations" for each year as well as with an adapted glossary. The discussion focuses on the results of the referential of competencies in its context but also on the use which should be made of this tool within the framework of the implementation of the education and training reform for nurses in DRC. Another point is the interest of this approach by skills for various types of professional training in the health sciences.