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Background: It is widely accepted that there is a stepwise increase in the risk of acute ischemic stroke with chronic kidney disease (CKD). However, whether the risk of specific ischemic stroke subtypes varies with CKD remains unclear. Objective: To assess the association between ischemic stroke subtypes (cardioembolic, arterial, lacunar, and other) classified using the Trial of ORG 10172 in Acute Stroke Treatment (TOAST) and CKD stage. Design: retrospective cohort study. Setting: Ontario, Canada. Patients: A total of 17 434 adults with an acute ischemic stroke in Ontario, Canada between April 1, 2002 and March 31, 2013, with an estimated glomerular filtration rate (eGFR) measurement or receipt of maintenance dialysis captured in a stroke registry were included. Measurements: Kidney function categorized as an eGFR of ≥60, 30-59, <30 mL/min/1.73 m2, or maintenance dialysis. Ischemic stroke classified by TOAST included arterial, cardioembolic, lacunar, and other (dissection, prothrombotic state, cortical vein/sinus thrombosis, and vasculitis) types of strokes. Methods: Adjusted regression models. Results: In our cohort, 58.9% had an eGFR of ≥60, 34.7% an eGFR of 30-59, 6.0% an eGFR of <30 and 0.5% were on maintenance dialysis (mean age of 73 years; 48% women). Cardioembolic stroke was more common in patients with non-dialysis-dependant CKD (eGFR 30-59: 50.4%, adjusted odds ratio [OR] 1.20, 95% confidence interval [CI]: 1.02, 1.44; eGFR<30: 50.6%, OR 1.21, 95% CI: 1.02, 1.44), whereas lacunar stroke was less common (eGFR 30-59: 22.7% OR 0.85, 95% CI: 0.77, 0.93; eGFR <30: 0.73, 95% CI: 0.61, 0.88) compared with those with an eGFR ≥60. In stratified analyses by age and CKD, lacunar strokes were more frequent in those aged less than 65 years, whereas cardioembolic was higher in those aged 65 years and above. Limitations: TOAST classification was not captured for all patients. Conclusion: Non-dialysis CKD was associated with a higher risk of cardioembolic stroke, whereas an eGFR ≥60 mL/min/1.73 m2 was associated with a higher risk of lacunar stroke. Detailed stroke subtyping in CKD may therefore provide mechanistic insights and refocus treatment strategies in this high-risk population.
Contexte: Il est largement admis qu'il y a une augmentation progressive du risque d'accident vasculaire cérébral ischémique aigu en contexte d'insuffisance rénale chronique (IRC). On ignore cependant si le risque de certains sous-types particuliers d'AVC ischémiques varie en présence d'IRC. Objectif: Évaluer le lien entre le stade d'IRC et certains sous-types d'AVC ischémiques (cardioembolique, artériel, lacunaire et autres) classés selon l'essai TOAST (Trial of ORG 10172 in Acute Stroke Treatment). Type d'étude: Étude de cohorte retrospective. Cadre: Ontario (Canada). Sujets: Ont été inclus 17 434 adultes ayant subi un AVC ischémique aigu en Ontario (Canada) entre le 1er avril 2002 et le 31 mars 2013, et pour lesquels le registre d'AVC comportait une mesure du débit de filtration glomérulaire estimé (DFGe) ou une dialyze chronique. Mesures: La fonction rénale a été classée selon le DFGe (≥ 60 ml/min/1,73 m2 entre 30 et 59 ml/min/1,73 m2 <30 ml/min/1.73 m2) ou une dialyze chronique. Les types d'AVC ischémiques classés par l'essai TOAST comprenaient les AVC artériels, cardioemboliques, lacunaires et autres (dissection, état prothrombotique, thrombose de la veine/sinus cortical, vascularite). Méthodologie: Modèles de régression ajustés. Résultats: Dans notre cohorte (âge moyen de 73 ans; 48% de femmes), 58,9 % des patients avaient un DFGe ≥ 60 ml/min/1,73 m2; 34,7% avaient un DFGe entre 30 et 59 ml/min/1,73 m2; 6,0 % avaient un DFGe < 30 ml/min/1,73 m2 et 0,5 % des patients étaient en dialyze chronique En comparaison des patients ayant un DFGe ≥ 60 ml/min/1,73 m2, les AVC cardioemboliques étaient plus fréquents chez les patients atteints d'IRC sans dialyze (DFGe entre 30 et 59 ml/min/1,73 m2: 50,4%; rapport de cote corrigé [RCc] = 1,20; IC 95 % = 1,02-1,44DFGe < 30 ml/min/1,73 m2: 50,6 %; RCc = 1,21; IC95% = 1,02-1,44) alors que les AVC lacunaires étaient moins fréquents [DFGe entre 30 et 59 ml/min/1,73 m2: 22,7%; RCc = 0,85; IC 95% = 0,77-0,93DFGe < 30 ml/min/1,73 m2: RCc = 0,73; IC 95% = 0,61-0,88]. Dans les analyses stratifiées en fonction de l'âge et de l'IRC, les AVC lacunaires étaient plus fréquents chez les moins de 65 ans tandis que les AVC cardioemboliques étaient plus fréquents chez les plus de 65 ans. Limites: La classification TOAST n'était pas enregistrée pour tous les patients. Conclusion: L'IRC sans dialyze a été associée à un risque plus élevé d'AVC cardioembolique alors qu'un DFGe ≥ 60 ml/min/1.73 m2 a été associé à un risque plus élevé d'AVC lacunaire. Le sous-typage détaillé des AVC en contexte d'IRC pourrait donc fournir des informations mécanistiques et recentrer les stratégies de traitement dans cette population à haut risque.
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Importance: There is conflicting evidence on the association between intrapartum epidural analgesia and risk of autism spectrum disorder (ASD) in offspring. Objective: To evaluate the association between intrapartum epidural analgesia and the risk of ASD in offspring. Design, Setting, and Participants: This population-based cohort study was conducted in Ontario, Canada, using the health and administrative records of singleton live births by vaginal delivery between April 1, 2006, and March 31, 2014. Neonates with less than 24 weeks' gestation or weighing less than 500 g were excluded. Offspring were followed up from 18 months of age until ASD diagnosis, loss to follow-up, or the end of the study (December 31, 2020), whichever occurred first. Exposure, covariate, and outcome data were obtained using provincial health administrative databases. Exposures: Any intrapartum exposure to epidural or combined spinal-epidural analgesia. Main Outcomes and Measures: The primary outcome was ASD diagnosis after 18 months of age. Inverse probability of treatment weighting (IPTW) of Cox proportional hazards regression models was used to estimate the hazard ratio (HR) of intrapartum epidural analgesia and ASD in offspring. Offspring head injury was used as a control outcome. Models were adjusted for maternal sociodemographic factors, health behaviors, and medical and obstetrical history as well as labor, delivery, and offspring characteristics. Post hoc analyses included restriction to term neonates, a conditional within-mother analysis, exclusion of records with concomitant intrapartum pain management exposures, a complete case analysis, use of an alternative ASD definition, and estimation of the average treatment effect in the treated group. Results: Among the 650â¯373 mother-offspring pairs included in the study, 418â¯761 (64.4%) were exposed to intrapartum epidural analgesia. The mean (SD) maternal age at delivery was 29.7 (5.5) years; the offspring had a mean (SD) gestational age at delivery of 39.1 (1.6) weeks and included 329 808 male newborns (50.7%). The exposed and unexposed groups were similar in all maternal and newborn characteristics after IPTW (standardized difference <0.10). Autism spectrum disorder was diagnosed in 7546 offspring (1.8%) of mothers who received intrapartum epidural analgesia (incidence rate, 18.8 [95% CI, 18.4-19.3] per 10â¯000 person-years) compared with 3234 offspring (1.4%) who were unexposed (incidence rate, 14.4 [95% CI, 13.9-14.9] per 10â¯000 person-years). The crude HR for ASD associated with intrapartum epidural analgesia was 1.30 (95% CI, 1.25-1.36), and the IPTW-adjusted HR was 1.14 (95% CI, 1.08-1.21). Results did not qualitatively differ in post hoc analyses. Conclusions and Relevance: Results of this study showed that intrapartum epidural analgesia was associated with a small increase in risk for ASD in offspring. The biological plausibility of this association, however, remains unclear, and the finding must be interpreted with caution.
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Analgesia Epidural , Trastorno del Espectro Autista , Trabajo de Parto , Analgesia Epidural/efectos adversos , Trastorno del Espectro Autista/epidemiología , Trastorno del Espectro Autista/etiología , Estudios de Cohortes , Femenino , Humanos , Recién Nacido , Masculino , Ontario/epidemiología , EmbarazoRESUMEN
Background: Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is implicated in elevating the risk for cardiovascular (CV) disease; whether the elevated risk applies to all types of CV diseases or specific types is unclear. This study examined the association of AAV and adverse CV outcomes compared with the non-AAV population. Methods: We conducted a population-based, retrospective cohort study of adults (mean age 61 years, 51% female) with a new diagnosis of AAV in Ontario, Canada from 2007 to 2017. Weighted models were used to examine the association of AAV (n = 1520) and CV events in a matched (1:4) control cohort (n = 5834). The main outcomes were major adverse CV events (MACE), defined as myocardial infarction (MI), stroke or CV death, its components, atrial fibrillation (AF) and congestive heart failure (CHF). Results: Over a mean follow-up of 3.8 years, AAV (compared with non-AAV) was associated with a higher risk of stroke: cumulative incidence 7.0% versus 5.2%, sub-distribution hazard ratio (sHR) 1.49 [(95% confidence interval (95% CI) 1.10-2.02]; AF: cumulative incidence 16.4% versus 11.5%, sHR 1.51, 95% CI 1.30-1.75; and CHF: cumulative incidence 20.8% versus 13.3%, sHR 1.41, 95% CI 1.22-1.62; but not for MACE, MI or CV death. The risks for all CV events, except CV death, were significantly elevated in the early period after AAV diagnosis, in particular AF (365-day sHR 2.06, 95% CI 1.71-2.48; 90-day sHR 3.33, 95% CI 2.66-4.18) and CHF (365-day sHR 1.75, 95% CI 1.48-2.07; 90-day sHR 2.65, 95% CI 2.15-3.26). Conclusion: AAV is associated with a high risk of certain types of CV events, particularly in the early period following diagnosis.
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BACKGROUND: In February 2018, Canada's National Advisory Committee on Immunization (NACI) recommended tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccination during pregnancy to protect newborns against pertussis infection. We sought to describe pre- and postrecommendation trends in Tdap vaccination coverage among pregnant Ontario residents. METHODS: Using linked health administrative databases, we conducted a population-based retrospective cohort study of all pregnant individuals who gave birth in Ontario hospitals between April 2012 and March 2020. We described Tdap vaccination patterns in pregnancy for the entire study period and before and after the NACI recommendation. We used log-binomial regression to identify characteristics associated with Tdap vaccination during pregnancy. RESULTS: Among the 991 850 deliveries included, 7.0% of pregnant individuals received the Tdap vaccination during pregnancy. Vaccine coverage increased from 0.4% in 2011/12 to 29.2% in 2019/20. Coverage was highest among individuals who were older, had no previous live births, had adequate prenatal care and received maternity care primarily from a family physician. After adjustment, characteristics associated with lower coverage included younger maternal age, having a multiple birth, residing in a rural location and higher area material deprivation. In 2019/20, 71.0% of vaccinated individuals received the Tdap vaccination during the recommended gestational window (27-32 wk). Stratified analyses of the pre- and postrecommendation cohorts yielded similar findings to the main analyses with a few gradient differences after adjustment. INTERPRETATION: During pregnancy, Tdap vaccination coverage increased substantially in Ontario between 2011/12 and 2019/20, most notably after recommendations for universal Tdap vaccination during pregnancy began in Canada. To further improve vaccine coverage in the obstetric setting, public health strategies should consider tailoring their programs to reach subpopulations with lower vaccine coverage.
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Vacunas contra Difteria, Tétanos y Tos Ferina Acelular , Servicios de Salud Materna , Tos Ferina , Femenino , Humanos , Embarazo , Recién Nacido , Toxoides , Tos Ferina/epidemiología , Tos Ferina/prevención & control , Estudios Retrospectivos , Ontario/epidemiología , VacunaciónRESUMEN
Importance: Thiazide diuretics are commonly prescribed for the treatment of hypertension, a disease highly prevalent among older individuals and in those with chronic kidney disease. How specific thiazide diuretics compare in regard to safety and clinical outcomes in these populations remains unknown. Objective: To compare safety and clinical outcomes associated with chlorthalidone or hydrochlorothiazide use among older adults with varying levels of kidney function. Design, Setting, and Participants: This population-based retrospective cohort study was conducted in Ontario, Canada, from 2007 to 2015. Participants included adults aged 66 years or older who initiated chlorthalidone or hydrochlorothiazide during this period. Data were analyzed from December 2019 through September 2020. Exposures: New chlorthalidone users were matched 1:4 with new hydrochlorothiazide users by a high-dimensional propensity score. Time-to-event models accounting for competing risks examined the associations between chlorthalidone vs hydrochlorothiazide use and the outcomes of interest overall and within estimated glomerular filtration rate (eGFR) categories (≥60, 45-59, and <45 mL/min/1.73 m2). Main Outcomes and Measures: The outcomes of interest were adverse kidney events (ie, eGFR decline ≥30%, dialysis, or kidney transplantation), cardiovascular events (composite of myocardial infarction, coronary revascularization, heart failure, or atrial fibrillation), all-cause mortality, and electrolyte anomalies (ie, sodium or potassium levels outside reference ranges). Results: After propensity score matching, the study cohort included 12â¯722 adults (mean [SD] age, 74 [7] years; 7063 [56%] women; 5659 [44%] men; mean [SD] eGFR, 69 [19] mL/min/1.73 m2), including 2936 who received chlorthalidone and 9786 who received hydrochlorothiazide. Chlorthalidone use was associated with a higher risk of eGFR decline of 30% or greater (hazard ratio [HR], 1.24 [95% CI, 1.13-1.36]) and cardiovascular events (HR, 1.12 [95% CI, 1.04-1.22]) across all eGFR categories compared with hydrochlorothiazide use. Chlorthalidone use was also associated with a higher risk of hypokalemia compared with hydrochlorothiazide use, which was more pronounced among those with higher eGFR (eGFR ≥60 mL/min/1.73 m2: HR, 1.86 [95% CI, 1.67-2.08]; eGFR 45-59 mL/min/1.73 m2: HR, 1.57 [95% CI, 1.25-1.96]; eGFR <45 mL/min/1.73 m2: HR, 1.10 [95% CI, 0.84-1.45]; P for interaction = .001). No significant differences were observed between chlorthalidone and hydrochlorothiazide for dialysis or kidney transplantation (HR, 1.44 [95% CI, 0.88-2.36]), all-cause mortality (HR, 1.10 [95% CI, 0.93-1.29]), hyperkalemia (HR, 1.05 [95% CI, 0.79-1.39]), or hyponatremia (HR, 1.14 [95% CI, CI 0.98-1.32]). Conclusions and Relevance: This cohort study found that among older adults, chlorthalidone use was associated with a higher risk of eGFR decline, cardiovascular events, and hypokalemia compared with hydrochlorothiazide use. The excess risk of hypokalemia with chlorthalidone was attenuated in participants with reduced kidney function. Placed in context with prior observational studies comparing the safety and clinical outcomes associated with thiazide diuretics, these results suggest that there is no evidence to prefer chlorthalidone over hydrochlorothiazide.
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Clortalidona/uso terapéutico , Hidroclorotiazida/uso terapéutico , Insuficiencia Renal Crónica , Inhibidores de los Simportadores del Cloruro de Sodio/uso terapéutico , Anciano , Clortalidona/administración & dosificación , Clortalidona/efectos adversos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Femenino , Tasa de Filtración Glomerular , Servicios de Salud para Ancianos , Humanos , Hidroclorotiazida/administración & dosificación , Hidroclorotiazida/efectos adversos , Hipopotasemia/inducido químicamente , Masculino , Ontario , Inhibidores de los Simportadores del Cloruro de Sodio/administración & dosificación , Inhibidores de los Simportadores del Cloruro de Sodio/efectos adversosRESUMEN
RATIONALE & OBJECTIVES: Alpha-blockers (ABs) are commonly prescribed for control of resistant or refractory hypertension in patients with and without chronic kidney disease (CKD). The association between AB use and kidney, cardiac, mortality, and safety-related outcomes in CKD remains unknown. STUDY DESIGN: Population-based retrospective cohort study. SETTINGS & PARTICIPANTS: Ontario (Canada) residents 66 years and older treated for hypertension in 2007 to 2015 without a prior prescription for an AB. EXPOSURES: New use of an AB versus new use of a non-AB blood pressure (BP)-lowering medication. OUTCOMES: 30% or greater estimated glomerular filtration rate (eGFR) decline; dialysis initiation or kidney transplantation (kidney replacement therapy); composite of acute myocardial infarction, coronary revascularization, congestive heart failure, or atrial fibrillation; safety (hypotension, syncope, falls, and fractures) events; and mortality. ANALYTICAL APPROACH: New users of ABs (doxazosin, terazosin, and prazosin) were matched to new users of non-ABs by a high dimensional propensity score. Cox proportional hazards and Fine and Gray models were used to examine the association of AB use with kidney, cardiac, mortality, and safety outcomes. Interactions by eGFR categories (≥90, 60-89, 30-59, and<30mL/min/1.73m2) were explored. RESULTS: Among 381,120 eligible individuals, 16,088 were dispensed ABs and matched 1:1 to non-AB users. AB use was associated with higher risk for≥30% eGFR decline (HR, 1.14; 95% CI, 1.08-1.21) and need for kidney replacement therapy (HR, 1.28; 95% CI, 1.13-1.44). eGFR level did not modify these associations, P interaction=0.3and 0.3, respectively. Conversely, AB use was associated with lower risk for cardiac events, which was also consistent across eGFR categories (HR, 0.92; 95% CI, 0.89-0.95; P interaction=0.1). AB use was also associated with lower mortality risk, but only among those with eGFR<60mL/min/1.73m2 (P interaction<0.001): HRs were 0.85 (95% CI, 0.78-0.93) and 0.71 (95% CI, 0.64-0.80) for eGFR of 30 to 59 and<30mL/min/1.73m2, respectively. LIMITATIONS: Observational design, BP measurement data unavailable. CONCLUSIONS: AB use in CKD is associated with higher risk for kidney disease progression but lower risk for cardiac events and mortality compared with alternative BP-lowering medications.
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Antagonistas Adrenérgicos alfa/uso terapéutico , Fibrilación Atrial/epidemiología , Insuficiencia Cardíaca/epidemiología , Hipertensión/tratamiento farmacológico , Fallo Renal Crónico/epidemiología , Infarto del Miocardio/epidemiología , Insuficiencia Renal Crónica/metabolismo , Terapia de Reemplazo Renal/estadística & datos numéricos , Accidentes por Caídas/estadística & datos numéricos , Anciano , Anciano de 80 o más Años , Antihipertensivos/uso terapéutico , Estudios de Cohortes , Progresión de la Enfermedad , Doxazosina/uso terapéutico , Femenino , Fracturas Óseas/epidemiología , Tasa de Filtración Glomerular , Humanos , Hipertensión/complicaciones , Hipotensión/inducido químicamente , Fallo Renal Crónico/terapia , Masculino , Mortalidad , Revascularización Miocárdica/estadística & datos numéricos , Ontario/epidemiología , Prazosina/análogos & derivados , Prazosina/uso terapéutico , Puntaje de Propensión , Modelos de Riesgos Proporcionales , Insuficiencia Renal Crónica/complicaciones , Estudios Retrospectivos , Síncope/inducido químicamenteRESUMEN
INTRODUCTION: Oncoplastic breast surgery (OBS) is increasingly used to decrease the deformity in breast conserving therapy (BCT) for breast cancer. We aimed to evaluate patient reported satisfaction following level II OBS and mastectomy utilizing the BREAST-Q questionnaire. METHODS: Patients who underwent level II OBS BCT and those who underwent mastectomies were distributed the BREAST-Q post-reduction/mammoplasty module. Clinicopathological data were collected from review of patient charts. Results were scored using the standardized scoring system (Q-score). Results of the OBS group were compared to those in the mastectomy group. RESULTS: A total of 88 patients who underwent level II OBS and 101 patients who underwent mastectomy completed the questionnaire. Mann-Whitney odds estimator demonstrated higher satisfaction with breasts (1.51, 95% CI [1.04-2.25], p = 0.026) and higher psychosocial well-being (1.51, 95% CI [1.04-2.15], p = 0.022) in those who underwent OBS compared to mastectomy. CONCLUSION: Results demonstrate a high satisfaction with breasts and improved psychosocial wellbeing in patients who underwent level II OBS compared to those undergoing mastectomy. These results demonstrate that OBS should be considered in patients where mastectomy otherwise would be necessary. Further larger multi-institutional studies are necessary to examine the effect of OBS on the quality of life of breast cancer patients.
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Neoplasias de la Mama/cirugía , Mamoplastia/métodos , Mastectomía Segmentaria/métodos , Mastectomía/métodos , Satisfacción del Paciente , Calidad de Vida , Neoplasias de la Mama/patología , Neoplasias de la Mama/psicología , Femenino , Estudios de Seguimiento , Humanos , Mamoplastia/psicología , Mastectomía/psicología , Mastectomía Segmentaria/psicología , Persona de Mediana Edad , Pronóstico , Estudios Prospectivos , Encuestas y CuestionariosRESUMEN
PURPOSE: Evidence regarding red blood cell (RBC) transfusion practices and their impact on hematopoietic cell transplantation (HCT) outcomes are poorly understood. PATIENTS AND METHODS: We performed a noninferiority randomized controlled trial in four different centers that evaluated patients with hematologic malignancies requiring HCT who were randomly assigned to either a restrictive (hemoglobin [Hb] threshold < 70 g/L) or liberal (Hb threshold < 90 g/L) RBC transfusion strategy between day 0 and day 100. The noninferiority margin corresponds to a 12% absolute difference between groups in Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) score relative to baseline. The primary outcome was health-related quality of life (HRQOL) measured by FACT-BMT score at day 100. Additional end points were collected: HRQOL by FACT-BMT score at baseline and at days 7, 14, 28, 60, and 100; transplantation-related mortality; length of hospital stay; intensive care unit admissions; acute graft-versus-host disease; Bearman toxicity score; sinusoidal obstruction syndrome; serious infections; WHO Bleeding Scale; transfusion requirements; and reactions to therapy. RESULTS: A total of 300 patients were randomly assigned to either restrictive-strategy or liberal-strategy treatment groups between 2011 and 2016 at four Canadian adult HCT centers. After HCT, mean pre-transfusion Hb levels were 70.9 g/L in the restrictive-strategy group and 84.6 g/L in the liberal-strategy group (P < .0001). The number of RBC units transfused was lower in the restrictive-strategy group than in the liberal-strategy group (mean, 2.73 units [standard deviation, 4.81 units] v 5.02 units [standard deviation, 6.13 units]; P = .0004). After adjusting for transfusion type and baseline FACT-BMT score, the restrictive-strategy group had a higher FACT-BMT score at day 100 (difference of 1.6 points; 95% CI, -2.5 to 5.6 points), which was noninferior compared with that of the liberal-strategy group. There were no significant differences in clinical outcomes between the transfusion strategies. CONCLUSION: In patients undergoing HCT, the use of a restrictive RBC transfusion strategy threshold of 70 g/L was as effective as a threshold of 90 g/L and resulted in similar HRQOL and HCT outcomes with fewer transfusions.
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Transfusión de Eritrocitos/métodos , Neoplasias Hematológicas/terapia , Trasplante de Células Madre Hematopoyéticas/métodos , Unidades de Cuidados Intensivos/estadística & datos numéricos , Adulto , Canadá , Transfusión de Eritrocitos/efectos adversos , Femenino , Enfermedad Injerto contra Huésped/diagnóstico , Enfermedad Injerto contra Huésped/etiología , Trasplante de Células Madre Hematopoyéticas/efectos adversos , Humanos , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Calidad de Vida , Resultado del TratamientoRESUMEN
BACKGROUND: Whether the survival benefit of ß-blockers in congestive heart failure (CHF) from randomized trials extends to patients with advanced chronic kidney disease (CKD) [estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 but not receiving dialysis] is uncertain. METHODS: This was a retrospective cohort study using administrative datasets. Older adults from Ontario, Canada, with incident CHF (median age 79 years) from April 2002 to March 2014 were included. We matched new users of ß-blockers to nonusers on age, sex, eGFR categories (>60, 30-60, <30), CHF diagnosis date and a high-dimensional propensity score. Using Cox proportional hazards models, we examined the association of ß-blocker use versus nonuse with all-cause mortality. RESULTS: We matched 5862 incident ß-blocker users (eGFR >60, n = 3136; eGFR 30-60, n = 2368; eGFR <30, n = 358). There were 2361 mortality events during follow-up. ß-Blocker use was associated with reduced all-cause mortality [adjusted hazard ratio (HR) 0.58, 95% confidence interval (CI) 0.54-0.64]. This result was consistent across all eGFR categories (>60: adjusted HR 0.55, 95% CI 0.49-0.62; 30-60: adjusted HR 0.63, 95% CI 0.55-0.71; <30: adjusted HR 0.55, 95% CI 0.41-0.73; interaction term, P = 0.30). The results were consistent in an intention-to-treat analysis and with ß-blocker use treated as a time-varying exposure. CONCLUSIONS: ß-Blocker use is associated with reduced all-cause mortality in elderly patients with CHF and CKD, including those with an eGFR <30. Randomized trials that examine ß-blockers in patients with CHF and advanced CKD are needed.
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Antagonistas Adrenérgicos beta/uso terapéutico , Tasa de Filtración Glomerular , Insuficiencia Cardíaca/mortalidad , Insuficiencia Renal Crónica/mortalidad , Anciano , Femenino , Insuficiencia Cardíaca/tratamiento farmacológico , Insuficiencia Cardíaca/patología , Humanos , Masculino , Pronóstico , Insuficiencia Renal Crónica/tratamiento farmacológico , Insuficiencia Renal Crónica/patología , Estudios Retrospectivos , Tasa de SupervivenciaRESUMEN
Alpha-blockers (ABs) are commonly prescribed as part of a multidrug regimen in the management of hypertension. We set out to assess the risk of hypotension and related adverse events with AB use compared with other blood pressure (BP) lowering drugs using a population-based, retrospective cohort study of women (≥66 years) between 1995 and 2015 in Ontario, Canada. Cox proportional hazards examined the association of AB use and hypotension and related events (syncope, fall, and fracture) compared with other BP lowering drugs matched via a high dimensional propensity score. The primary outcome was a composite of hospitalizations for hypotension and related events (syncope, fractures, and falls) within 1 year. From 734 907 eligible women, 14 106 were dispensed an AB (mean age, 75.7; standard deviation 6.9 years, median follow-up 1 year) and matched to 14 106 dispensed other BP lowering agents. The crude incidence rate of hypotension and related events was 95.7 (95% CI [confidence interval], 90.4-101.1, events 1214 [8.6%]) with AB and 79.8 (95% CI, 74.9-84.7 per 1000 person-years, events 1025 [7.3%]) with other BP lowering medications (incident rate ratio, 1.20; 95% CI, 1.10-1.30). The risk was higher for hypotension (hazard ratio, 1.71; 95% CI, 1.33-2.20) and syncope (hazard ratio, 1.44; 95% CI, 1.18-1.75) with no difference in falls, fractures, adverse cardiac events, or all-cause mortality. Treatment of hypertension in women with ABs is associated with a higher risk of hypotension and hypotension-related events compared with other BP lowering agents. Our findings suggest that ABs should be used with caution, even as add on therapy for hypertension.
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Antagonistas Adrenérgicos alfa/efectos adversos , Hipertensión/tratamiento farmacológico , Hipotensión/inducido químicamente , Hipotensión/epidemiología , Accidentes por Caídas/estadística & datos numéricos , Antagonistas Adrenérgicos alfa/uso terapéutico , Factores de Edad , Anciano , Anciano de 80 o más Años , Antihipertensivos/uso terapéutico , Canadá , Estudios de Cohortes , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Femenino , Fracturas Óseas/diagnóstico , Fracturas Óseas/epidemiología , Evaluación Geriátrica/métodos , Humanos , Hipertensión/diagnóstico , Hipotensión/fisiopatología , Incidencia , Pronóstico , Puntaje de Propensión , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Medición de Riesgo , Síncope/diagnóstico , Síncope/epidemiología , Resultado del TratamientoRESUMEN
Importance: Sodium polystyrene sulfonate is commonly prescribed for the treatment of hyperkalemia. Case reports of intestinal injury after administration of sodium polystyrene sulfonate with sorbitol resulted in a US Food and Drug Administration warning and discontinuation of combined 70% sorbitol-sodium polystyrene sulfonate formulations. There are ongoing concerns about the gastrointestinal (GI) safety of sodium polystyrene sulfonate use. Objective: To assess the risk of hospitalization for adverse GI events associated with sodium polystyrene sulfonate use in patients of advanced age. Design, Setting, and Participants: Population-based, retrospective matched cohort study of eligible adults of advanced age (≥66 years) dispensed sodium polystyrene sulfonate from April 1, 2003, to September 30, 2015, in Ontario, Canada, with maximum follow-up to March 31, 2016. Initial data analysis was conducted from August 1, 2018, to October 3, 2018; revision analysis was conducted from February 25, 2019, to April 2, 2019. Cox proportional hazards regression models were used to examine the association of sodium polystyrene sulfonate use with a composite of GI adverse events compared with nonuse that was matched via a high-dimensional propensity score. Additional analyses were limited to a subpopulation with baseline laboratory values of estimated glomerular filtration rate and serum potassium level. Exposure: Dispensed sodium polystyrene sulfonate in an outpatient setting. Main Outcomes and Measures: The primary outcome was a composite of adverse GI events (hospitalization or emergency department visit with intestinal ischemia/thrombosis, GI ulceration/perforation, or resection/ostomy) within 30 days of initial sodium polystyrene sulfonate prescription. Results: From a total of 1â¯853â¯866 eligible adults, 27â¯704 individuals were dispensed sodium polystyrene sulfonate (mean [SD] age, 78.5 [7.7] years; 54.7% male), and 20â¯020 sodium polystyrene sulfonate users were matched to 20â¯020 nonusers. Sodium polystyrene sulfonate use compared with nonuse was associated with a higher risk of an adverse GI event over the following 30 days (37 events [0.2%]; incidence rate, 22.97 per 1000 person-years vs 18 events [0.1%]; incidence rate, 11.01 per 1000 person-years) (hazard ratio, 1.94; 95% CI, 1.10-3.41). Results were consistent in additional analyses, including the subpopulation with baseline laboratory values (hazard ratio, 2.91; 95% CI, 1.38-6.12), and intestinal ischemia/thrombosis was the most common type of GI injury. Conclusions and Relevance: The use of sodium polystyrene sulfonate is associated with a higher risk of hospitalization for serious adverse GI events. These findings require confirmation and suggest caution with the ongoing use of sodium polystyrene sulfonate.
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Resinas de Intercambio de Catión/efectos adversos , Enfermedades Gastrointestinales/inducido químicamente , Hospitalización/estadística & datos numéricos , Hiperpotasemia/tratamiento farmacológico , Isquemia Mesentérica/inducido químicamente , Oclusión Vascular Mesentérica/inducido químicamente , Poliestirenos/efectos adversos , Trombosis/inducido químicamente , Anciano , Anciano de 80 o más Años , Enterostomía/estadística & datos numéricos , Femenino , Enfermedades Gastrointestinales/epidemiología , Humanos , Perforación Intestinal/inducido químicamente , Perforación Intestinal/epidemiología , Masculino , Isquemia Mesentérica/epidemiología , Oclusión Vascular Mesentérica/epidemiología , Ontario , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Trombosis/epidemiología , Úlcera/inducido químicamente , Úlcera/epidemiologíaRESUMEN
Background and Purpose- Early hematoma expansion after intracerebral hemorrhage is a potentially modifiable predictor of outcome and a promising therapeutic target. Radiological markers seen on noncontrast computed tomography can help predict hematoma expansion and risk stratify patients presenting with intracerebral hemorrhage. Our objective was to assess the interrater and intrarater reliability of 5 commonly reported noncontrast computed tomographic markers of hematoma expansion. Methods- Four readers independently reviewed images from 40 patients from 2 intracerebral hemorrhage imaging databases (PREDICT Collaboration [Predicting Haematoma Growth and Outcome in Intracerebral Haemorrhage Using Contrast Bolus CT] and Massachusetts General Hospital). Readers were blind to all demographic and outcome data and used accepted definitions to establish the presence or absence of intrahematoma hypodensities, blend sign, fluid level, irregular hematoma morphology, and heterogeneous hematoma density. We calculated interrater and intrarater agreement and stratified kappas for the 5 imaging markers. Results- Interrater agreement was excellent for all 5 markers, ranging from 94% to 98%. Interrater kappas ranged from 0.67 to 0.91 (the lowest for fluid level). Interrater agreement had a similar pattern, ranging from 89% to 93%, with Kappas ranging from 0.60 to 0.89. Conclusions- We show that 5 commonly used noncontrast computed tomographic imaging findings all have good-to-excellent interrater and intrarater reliabilities, with the best kappa for blend sign, hypodensities, and heterogeneity.
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Hemorragia Cerebral/diagnóstico por imagen , Progresión de la Enfermedad , Tomografía Computarizada por Rayos X/normas , Estudios de Cohortes , Humanos , Variaciones Dependientes del Observador , Valor Predictivo de las Pruebas , Distribución Aleatoria , Reproducibilidad de los Resultados , Método Simple CiegoRESUMEN
BACKGROUND: Epidemiological analyses demonstrate that pneumonia survivors have a higher risk of myocardial infarction than people with similar load of risk factors for atherosclerotic cardiovascular disease (ASCVD) but without pneumonia. This may be due to a higher baseline burden of ASCVD in patients with pneumonia that is not captured by the accounting of known ASCVD risk factors in epidemiological analyses or to unfavorable accelerating effects of pneumonia on atherosclerosis. METHODS: We analyzed data from the Multi-Ethnic Study of Atherosclerosis. We identified 54 participants that were hospitalized for pneumonia during study follow-up and that also had assessment of coronary artery calcium (CAC, an objective marker of coronary atherosclerotic burden) before and after this hospitalization. We matched them to 54 participants who were not hospitalized for pneumonia but that had CAC assessments at the same study visits as the pneumonia cases. We compared baseline CAC scores and their progression between groups. RESULTS: Baseline CAC scores were similar in both groups (median [IQR]; 6.3 [0-356.8] in pneumonia participants vs. 10.8 [0-178.3] in controls; p = 0.25). After a median of 4.8 years, the direction and magnitude of CAC score change, and the slope of CAC score progression between groups was also similar (median change [IQR], 21.8 [0 to 287.29] in participants with pneumonia versus 15.8 [0 to 140.94] in controls, p = 0.28; difference in slope, 7.7, 95% CI -9.0 to 24.6, p = 0.18). However, among participants with high baseline ASCVD risk (i.e. ACC/AHA 10-year risk estimate ≥7.5%), participants with pneumonia showed a larger increase in CAC scores (median change [IQR]; 159.10 [38.55-407.34] versus 48.72 [0.97-246.99] in controls; p = 0.02) and a trend towards a steeper slope of CAC score progression (difference in slope, 19.7, 95% CI -6.6 to 45.6, p = 0.07). CONCLUSION: Pneumonia may accelerate the progression of atherosclerosis in people with high baseline ASCVD risk.
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Calcio/metabolismo , Vasos Coronarios/metabolismo , Hospitalización , Neumonía/metabolismo , Anciano , Aterosclerosis/complicaciones , Aterosclerosis/epidemiología , Estudios de Casos y Controles , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neumonía/complicaciones , Factores de RiesgoRESUMEN
Purpose To evaluate whether journal-level variables (impact factor, cited half-life, and Standards for Reporting of Diagnostic Accuracy Studies [STARD] endorsement) and study-level variables (citation rate, timing of publication, and order of publication) are associated with the distance between primary study results and summary estimates from meta-analyses. Materials and Methods MEDLINE was searched for meta-analyses of imaging diagnostic accuracy studies, published from January 2005 to April 2016. Data on journal-level and primary-study variables were extracted for each meta-analysis. Primary studies were dichotomized by variable as first versus subsequent publication, publication before versus after STARD introduction, STARD endorsement, or by median split. The mean absolute deviation of primary study estimates from the corresponding summary estimates for sensitivity and specificity was compared between groups. Means and confidence intervals were obtained by using bootstrap resampling; P values were calculated by using a t test. Results Ninety-eight meta-analyses summarizing 1458 primary studies met the inclusion criteria. There was substantial variability, but no significant differences, in deviations from the summary estimate between paired groups (P > .0041 in all comparisons). The largest difference found was in mean deviation for sensitivity, which was observed for publication timing, where studies published first on a topic demonstrated a mean deviation that was 2.5 percentage points smaller than subsequently published studies (P = .005). For journal-level factors, the greatest difference found (1.8 percentage points; P = .088) was in mean deviation for sensitivity in journals with impact factors above the median compared with those below the median. Conclusion Journal- and study-level variables considered important when evaluating diagnostic accuracy information to guide clinical decisions are not systematically associated with distance from the truth; critical appraisal of individual articles is recommended. © RSNA, 2017 Online supplemental material is available for this article.
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Diagnóstico por Imagen/normas , Factor de Impacto de la Revista , Publicaciones Periódicas como Asunto/normas , Proyectos de Investigación , Diagnóstico por Imagen/estadística & datos numéricos , Humanos , Publicaciones Periódicas como Asunto/estadística & datos numéricos , Reproducibilidad de los ResultadosRESUMEN
OBJECTIVE: The purpose of this study was to compare the efficacy of gelatin sponge with that of coils for splenic artery embolization in the treatment of blunt splenic injury. MATERIALS AND METHODS: A single-center retrospective review was performed with the records of 63 patients (45 men, 18 women; mean age, 45.5 years; range, 16-84 years) with blunt splenic injury treated at a tertiary care trauma center by splenic artery embolization with gelatin sponge (n = 30 patients) or metallic coils (n = 33 patients) between 2005 and 2014. The two groups had comparable median American Association for the Surgery of Trauma grades of IV and comparable angiographic appearances regarding active extravasation and pseudoaneurysm formation at preembolization splenic arteriography (p = 0.32). Clinical outcomes and procedure-related outcomes were evaluated. RESULTS: The success rates were similar in the two groups: splenic artery embolization failed in 6.6% (2/30) of patients in the gelatin sponge group and 12.1% (4/33) in the coil embolization group (p = 0.45; 95% CI, -30.1% to 19.2%). Major complications occurred in six patients (20.0%) in the gelatin sponge group and in six patients (18.1%) in the coil group (p = 0.85; 95% CI, -23.0% to 26.6%). Minor complications occurred in three patients (10.0%) in the gelatin sponge group and seven patients (21.2%) in the coil group (p = 0.21; 95% CI, -35.4% to 14.0%). Procedure time was significantly shorter in the gelatin sponge group (median, 32 minutes; interquartile range, 18-48 minutes) than in the coil group (median, 53 minutes; interquartile range, 30-76 minutes) (p = 0.01). CONCLUSION: Splenic artery embolization with gelatin sponge appears to be as effective and as safe as coil embolization and can be completed in a shorter time.
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Embolización Terapéutica/métodos , Gelatina/uso terapéutico , Bazo/lesiones , Arteria Esplénica , Heridas no Penetrantes/terapia , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Embolización Terapéutica/instrumentación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Factores de Tiempo , Resultado del TratamientoRESUMEN
Purpose To evaluate the accuracy of computed tomography (CT) for diagnosis of internal hernia (IH) in patients who have undergone laparoscopic Roux-en-Y gastric bypass and to develop decision tree models to optimize diagnostic accuracy. Materials and Methods This was a retrospective, ethics-approved study of patients who had undergone laparoscopic Roux-en-Y gastric bypass with surgically confirmed IH (n = 76) and without IH (n = 78). Two radiologists independently reviewed each examination for the following previously established CT signs of IH: mesenteric swirl, small-bowel obstruction (SBO), mushroom sign, clustered loops, hurricane eye, small bowel behind the superior mesenteric artery, and right-sided anastomosis. Radiologists also evaluated images for two new signs, superior mesenteric vein (SMV) "beaking" and "criss-cross" of the mesenteric vessels. Overall impressions for diagnosis of IH were recorded. Diagnostic accuracy and interobserver agreement were calculated, and multivariate recursive partitioning was performed to evaluate various decision tree models by using the CT signs. Results Accuracy and interobserver agreement regarding the nine CT signs of IH showed considerable variation. The best signs were mesenteric swirl (sensitivity and specificity, 86%-89% and 86%-90%, respectively; κ = 0.74) and SMV beaking (sensitivity and specificity, 80%-88% and 94%-95%, respectively; κ = 0.83). Overall reader impression yielded the highest sensitivity and specificity (96%-99% and 90%-99%, respectively; κ = 0.79). The decision tree model with the highest overall accuracy and sensitivity included mesenteric swirl and SBO, with a diagnostic odds ratio of 154 (95% confidence interval [CI]: 146, 161), sensitivity of 96% (95% CI: 87%, 99%), and specificity of 87% (95% CI: 75%, 93%). The decision tree with the highest specificity included SMV beaking and SBO, with a diagnostic odds ratio of 105 (95% CI: 101, 109), sensitivity of 90% (95% CI: 79%, 95%), and specificity of 92% (95% CI: 83%, 97%). Conclusion The decision tree with the highest accuracy and sensitivity for diagnosis of IH included mesenteric swirl and SBO, the model with the highest specificity included SMV beaking and SBO, and the remaining signs showed lower accuracy and/or poor to fair interobserver agreement. Overall reader impression yielded the highest accuracy for diagnosis of IH, likely because alternate diagnoses not incorporated in the models were considered. © RSNA, 2016 Online supplemental material is available for this article.
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Derivación Gástrica , Hernia Abdominal/diagnóstico por imagen , Obesidad Mórbida/cirugía , Complicaciones Posoperatorias/diagnóstico por imagen , Tomografía Computarizada por Rayos X , Adulto , Toma de Decisiones Clínicas , Femenino , Humanos , Intestinos/diagnóstico por imagen , Laparoscopía , Masculino , Persona de Mediana Edad , Reproducibilidad de los Resultados , Estudios Retrospectivos , Sensibilidad y EspecificidadRESUMEN
OBJECTIVE: With the introduction of direct entry (0+5) residency programs in addition to the traditional (5+2) programs, the number of vascular surgery graduates across Canada is expected to increase significantly during the next 5 to 10 years. Society's need for these newly qualified surgeons is unclear. This study evaluated the predicted requirement for vascular surgeons across Canada to 2021. A program director survey was also performed to evaluate program directors' perceptions of the 0+5 residency program, the expected number of new trainees, and faculty recruitment and retirement. METHODS: The estimated and projected Canadian population numbers for each year between 2013 and 2021 were determined by the Canadian Socio-economic Information and Management System (CANSIM), Statistics Canada's key socioeconomic database. The number of vascular surgery procedures performed from 2008 to 2012 stratified by age, gender, and province was obtained from the Canadian Institute for Health Information Discharge Abstract Database. The future need for vascular surgeons was calculated by two validated methods: (1) population analysis and (2) workload analysis. In addition, a 12-question survey was sent to each vascular surgery program director in Canada. RESULTS: The estimated Canadian population in 2013 was 35.15 million, and there were 212 vascular surgeons performing a total of 98,339 procedures. The projected Canadian population by 2021 is expected to be 38.41 million, a 9.2% increase from 2013; however, the expected growth rate in the age group 60+ years, who are more likely to require vascular procedures, is expected to be 30% vs 3.4% in the age group <60 years. Using population analysis modeling, there will be a surplus of 10 vascular surgeons in Canada by 2021; however, using workload analysis modeling (which accounts for the more rapid growth and larger proportion of procedures performed in the 60+ age group), there will be a deficit of 11 vascular surgeons by 2021. Program directors in Canada have a positive outlook on graduating 0+5 residents' skill, and the majority of programs will be recruiting at least one new vascular surgeon during the next 5 years. CONCLUSIONS: Although population analysis projects a potential surplus of surgeons, workload analysis predicts a deficit of surgeons because it accounts for the rapid growth in the 60+ age group in which the majority of procedures are performed, thus more accurately modeling future need for vascular surgeons. This study suggests that there will be a need for newly graduating vascular surgeons in the next 5 years, which could have an impact on resource allocation across training programs in Canada.
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Necesidades y Demandas de Servicios de Salud/tendencias , Fuerza Laboral en Salud/tendencias , Evaluación de Necesidades/tendencias , Cirujanos/provisión & distribución , Cirujanos/tendencias , Procedimientos Quirúrgicos Vasculares/tendencias , Canadá , Bases de Datos Factuales , Educación de Postgrado en Medicina/tendencias , Predicción , Asignación de Recursos para la Atención de Salud/tendencias , Humanos , Internado y Residencia/tendencias , Perfil Laboral , Sistema de Registros , Cirujanos/educación , Factores de Tiempo , Procedimientos Quirúrgicos Vasculares/educación , Carga de TrabajoRESUMEN
OBJECTIVES: HIV prevalence among people who inject drugs (PWID) in Ottawa is estimated at about 10%. The successful integration of peers into outreach efforts and wider access to HIV point-of-care testing (POCT) create opportunities to explore the role of peers in providing HIV testing. The PROUD study, in partnership with Ottawa Public Health (OPH), sought to develop a model for community-based peer-administered HIV POCT. METHODS: PROUD draws on community-based participatory research methods to better understand the HIV risk environment of people who use drugs in Ottawa. From March-October 2013, 593 people who reported injecting drugs or smoking crack cocaine were enrolled through street-based recruitment. Trained peer or medical student researchers administered a quantitative survey and offered an HIV POCT (bioLytical INSTI test) to participants who did not self-report as HIV positive. RESULTS: 550 (92.7%) of the 593 participants were offered a POCT, of which 458 (83.3%) consented to testing. Of those participants, 74 (16.2%) had never been tested for HIV. There was no difference in uptake between testing offered by a peer versus a non-peer interviewer (OR = 1.05; 95% CI = 0.67-1.66). Despite testing those at high risk for HIV, only one new reactive test was identified. CONCLUSION: The findings from PROUD demonstrate high uptake of community-based HIV POCT. Peers were able to successfully provide HIV POCT and reach participants who had not previously been tested for HIV. Community-based and peer testing models provide important insights on ways to scale-up HIV prevention and testing among people who use drugs.
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Trastornos Relacionados con Cocaína/epidemiología , Infecciones por VIH/epidemiología , Trastornos Relacionados con Opioides/epidemiología , Sistemas de Atención de Punto , Adulto , Canadá/epidemiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Factores de Riesgo , Encuestas y CuestionariosRESUMEN
Purpose To determine if adherence to the Standards for Reporting of Diagnostic Accuracy (STARD) is associated with postpublication citation rates. Materials and Methods A comprehensive search of PubMed, EMBASE, and Cochrane Library databases was performed to identify published articles that have evaluated adherence of diagnostic accuracy studies to the STARD statement. These were included if the number of STARD items reported ("STARD result") could be obtained for each evaluated study. The date of publication, journal impact factor, and citation rate (citations per day) were extracted for the diagnostic accuracy studies. Univariate correlations were performed to identify any association between STARD result, impact factor, and citation rate. Multivariate regression analysis was performed to explore the effect of impact factor on postpublication citation rates. Results The authors were able to obtain the STARD results for 1002 "original" diagnostic accuracy studies from eight different "STARD evaluation" articles. The median impact factor was 3.97 (interquartile range [IQR]: 2.32-6.21), the median STARD result was 15 of 25 items (IQR: 12-18), and the median citation rate was 0.007 citations per day (IQR: 0.0032-0.017). The authors identified a weak positive correlation between STARD result and citation rate (r = 0.096; 95% confidence interval [CI]: 0.034, 0.157), a moderate positive correlation between impact factor and citation rate (r = 0.58; 95% CI: 0.535, 0.617), and a weak positive correlation between impact factor and STARD result (r = 0.13; 95% CI: 0.064, 0.186). Multivariate analysis accounting for journal clustering effects revealed that, when impact factor is partialed out, the positive correlation between citation rate and STARD result does not persist (r = 0.029; 95% CI: -0.033, 0.091). Conclusion There is a positive correlation between completeness of reporting, as evaluated with STARD, and citation rate as well as impact factor. When adjusted for impact factor, the positive correlation between completeness of reporting and citation rate does not persist. (©) RSNA, 2016 Online supplemental material is available for this article.
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Pruebas Diagnósticas de Rutina/normas , Adhesión a Directriz/normas , Factor de Impacto de la Revista , Control de Calidad , Reproducibilidad de los Resultados , Proyectos de Investigación/normas , Pruebas Diagnósticas de Rutina/métodos , HumanosRESUMEN
PURPOSE: A single-center randomized clinical trial was performed to compare postinterventional primary patency rates achieved by cutting balloon angioplasty and high-pressure balloon angioplasty in the treatment of de novo stenoses within autogenous arteriovenous (AV) fistulae for hemodialysis. MATERIALS AND METHODS: Forty-eight patients undergoing their first angioplasty were prospectively randomized to undergo angioplasty with a cutting balloon or high-pressure balloon 4-8 mm in diameter because cutting balloons larger than 8 mm are not available. Nine patients were excluded after angiography, with seven requiring balloons larger than 8 mm. In the remaining 39 patients, there were 42 stenoses in the following regions: juxtaanastomotic (38%), perianstomotic (38%), midcephalic (9%), and cephalic arch (14%). Patients in the cutting balloon group were younger (mean age difference, 9 y; P = .04), but other demographic variables were comparable (range, P = .08-.89). The mean follow-up period was 8.5 mo (range, 24 d to 32 mo). Kaplan-Meier analysis was used to compare duration of patency. Mann-Whitney rank-sum t test and χ2/Fisher exact tests were used to compare continuous and categoric variables, respectively. RESULTS: Technical success was achieved in all 39 patients. At 3, 6, and 12 months, the postinterventional primary patency rates for the cutting balloon group were 61.1% (95% confidence interval [CI], 35.75%-82.70%), 27.7% (95% CI, 9.69%-53.48%), and 11.1% (95% CI, 1.38%-34.71%), respectively, compared with 70.0% (95% CI, 45.72%-88.11%), 42.1% (95% CI, 20.25%-66.50%), and 26.3% (95% CI, 9.15%-51.20%), respectively, for the high-pressure balloon group (P < .3 at each interval). CONCLUSIONS: Compared with high-pressure balloon angioplasty, cutting balloon angioplasty does not improve postinterventional primary patency of de novo stenotic lesions in autogenous arteriovenous fistulae.