Narcolepsy and adjuvanted pandemic influenza A (H1N1) 2009 vaccines - Multi-country assessment.

Background: In 2010, a safety signal was detected for narcolepsy following vaccination with Pandemrix, an AS03-adjuvanted monovalent pandemic H1N1 influenza (pH1N1) vaccine. To further assess a possible association and inform policy on future use of adjuvants, we conducted a multi-country study of narcolepsy and adjuvanted pH1N1 vaccines.

Methods: We used electronic health databases to conduct a dynamic retrospective cohort study to assess narcolepsy incidence rates (IR) before and during pH1N1 virus circulation, and after pH1N1 vaccination campaigns in Canada, Denmark, Spain, Sweden, Taiwan, the Netherlands, and the United Kingdom.

Diabetes self-management education is not associated with a reduction in long-term diabetes complications: an effectiveness study in an elderly population.

Rationale, Aims And Objectives: The efficacy of diabetes self-management education on glycaemic control, self-care behaviour and knowledge has been established by short-term studies in experimental settings. The objective of this study was to assess its effectiveness to improve quality of care and reduce the risk of long-term diabetes complications in unselected older patients with recently diagnosed diabetes in routine clinical care.

Methods: Using population-level health care administrative databases and registries, all patients aged ≥66 years in Ontario, Canada with diabetes for <5 years were identified.

Diabetes education through group classes leads to better care and outcomes than individual counselling in adults: a population-based cohort study.

Objective: Self-management education, supported by multidisciplinary health care teams, is essential for optimal diabetes management. We sought to determine whether acute diabetes complications or quality of care differed for patients in routine clinical care when their self-management education was delivered through group diabetes education classes versus individual counselling.

Methods: With the use of population-level administrative and primary data, all diabetic patients in Ontario who attended a self-management education program in 2006 were identified and grouped according to whether they attended group classes (n=12,234), individual counselling (n=55,761) or a mixture of both (n=9,829).

Utilization of Diabetes Education Centres in Ontario by people without diabetes.

Objective: The aim of this study was to describe the utilization of diabetes education centres by people not diagnosed with diabetes mellitus in real-world clinical care in Ontario.

Methods: Using population-level health administrative databases and registries, all people in Ontario, Canada, who attended a diabetes self-management education centre in 2006 were identified. The proportion of attendees without diagnosed diabetes at the time of their visit was determined, they were stratified by centre and health region, and their utilization of diabetes education centres was characterized.

Disparities in attendance at diabetes self-management education programs after diagnosis in Ontario, Canada: a cohort study.

Background: Patients newly-diagnosed with diabetes require self-management education to help them understand and manage the disease. The goals of the study were to determine the frequency of diabetes self-management education program utilization by newly-diagnosed patients, and to evaluate whether there were any demographic or clinical disparities in utilization.

Methods: Using population-level health care data, all 46,553 adults who were diagnosed with any type of non-gestational diabetes in Ontario, Canada between January and June 2006 were identified.

Absence of disparities in the quality of primary diabetes care for South Asians and Chinese in an urban Canadian setting.

Objective: To examine whether quality of diabetes care is equitable for South Asian and Chinese patients in an urban Canadian setting.

Research Design And Methods: Process and intermediate measures of quality of care were compared between 246 South Asians, 170 Chinese, and 431 patients from the general population with type 2 diabetes selected from 45 family physicians' practices.

Results: A total of 61% of Chinese achieved A1C ≤7.

Diabetes prevalence and care in the Metis population of Ontario, Canada.

Objective: The Métis are a distinct Aboriginal people in Canada with a unique history, culture, and language. This study examined diabetes prevalence and care in the Métis of Ontario.

Research Design And Methods: The 14,480 people in the citizenship registry of the Métis Nation of Ontario were linked with provincial health care databases to determine diabetes prevalence and processes of care.

The impact of diabetes education on blood glucose self-monitoring among older adults.

Objectives: To determine whether attending diabetes education is associated with blood glucose self-monitoring among unselected older adults in routine clinical care.

Method: A cross-sectional population-based study was carried out on 15,190 people with diabetes aged 65-79 years. Subjects were identified using a registry of doctor-diagnosed diabetes derived from administrative data, and attendance at diabetes education centres (DECs) was determined from a separate registry of DEC utilization for 2006.

Comparison of primary care physician payment models in the management of hypertension.

Objective: To determine primary care physician screening, treatment, and control rates for hypertension and to examine whether type of physician payment model affected these rates.

Design: A cross-sectional chart abstraction study.

Setting: Community health centres (salary), primary care networks (capitation), or traditional fee-for-service practices in Ontario.

Validation of a health administrative data algorithm for assessing the epidemiology of diabetes in Canadian children.

Objective: To validate a case definition of pediatric diabetes using administrative health data and describe trends in incidence and prevalence over time in Ontario, Canada.

Methods: We sampled hospital records of 700 children from 1994 to 2003 with a prior history of at least one outpatient or hospital record for diabetes mellitus and 300 randomly selected children with no diabetes records. We defined patients as having diabetes based on diagnoses and drug utilization from chart abstraction and compared sensitivity and specificity of a number of combinations of overall health care use using administrative data to develop a highly specific definition.

Diabetes quality of care in academic endocrinology practice: a descriptive study.

Objective: To describe the quality of diabetes care delivered by academic endocrinologists practicing at 4 teaching hospitals affiliated with a single medical school.

Methods: Up to 30 patients who first saw an endocrinologist for an ambulatory consultation for diabetes between January 2004 and December 2005 were randomly selected for chart review. Process and intermediate measures of quality of care were abstracted.

Administrative data algorithms can describe ambulatory physician utilization.

Objective: To validate algorithms using administrative data that characterize ambulatory physician care for patients with a chronic disease.

Data Sources: Seven-hundred and eighty-one people with diabetes were recruited mostly from community pharmacies to complete a written questionnaire about their physician utilization in 2002. These data were linked with administrative databases detailing health service utilization.

Accuracy of administrative databases in identifying patients with hypertension.

Background: Traditionally, the determination of the occurrence of hypertension in patients has relied on costly and time-consuming survey methods that do not allow patients to be followed over time.

Objectives: To determine the accuracy of using administrative claims data to identify rates of hypertension in a large population living in a single-payer health care system.

Methods: Various definitions for hypertension using administrative claims databases were compared with 2 other reference standards: (1) data obtained from a random sample of primary care physician offices throughout the province, and (2) self-reported survey data from a national census.

Antimitochondrial antibody profiles: are they valid prognostic indicators in primary biliary cirrhosis?

Objective: Retrospective studies have reported that subtypes of antimitochondrial antibodies (AMAs) discriminate between a benign and a progressive course in patients with primary biliary cirrhosis (PBC). Four AMA profiles (A-D) were defined: profiles A and B associated with a benign course and C and D with a progressive course. We aimed to confirm whether AMA profiles predict prognosis in a large sample of North American patients with PBC.

Primary biliary cirrhosis with additional features of autoimmune hepatitis: response to therapy with ursodeoxycholic acid.

Patients with primary biliary cirrhosis (PBC) may have additional features of autoimmune hepatitis (AIH). Corticosteroids usually contraindicated in PBC have been advocated for these patients. Patients with antimitochondrial antibody (AMA)-positive PBC from two previous randomized, controlled trials were assessed for features of AIH.

Human leukocyte antigen Class II associations in serum antimitochondrial antibodies (AMA)-positive and AMA-negative primary biliary cirrhosis.

Background/aims: An association of Class II HLA-DR8 antigen is reported in patients with serum antimitochondrial antibodies (AMA)-positive primary biliary cirrhosis (PBC); no information exists as to an association with AMA-negative PBC. We compared the frequency of HLA Class II genes in AMA-positive and AMA-negative PBC patients and healthy controls.

Methods: Genomic DNA was extracted from the blood of 154 AMA-positive and 26 AMA-negative Caucasian PBC patients and from 216 healthy Caucasian controls and tested for the alleles at two HLA Class II loci, DRbeta1 and DQbeta1.

Prevalence of IgA antibodies to endomysium and tissue transglutaminase in primary biliary cirrhosis.

The association between celiac disease and primary biliary cirrhosis has been described in several case reports and small screening studies, with varying prevalence rates. Stored sera from 378 patients with primary biliary cirrhosis were tested for immunoglobulin (Ig) A endomysium and tissue transglutaminase antibodies. Ten patients were positive for both antibodies (2.

Are antibodies to carbonic anhydrase II specific for anti-mitochondrial antibody-negative primary biliary cirrhosis?

Antibodies to carbonic anhydrase II (CAII) have been reported to be specific to anti-mitochondrial antibody (AMA)-negative primary biliary cirrhosis (PBC). We examined whether antibodies to CAII are specific for AMA-negative PBC or a nonspecific response in autoimmune liver disease. Antibody assays to CAII, by western immunoblot (dilution 1:200), were performed on sera from 16 AMA-negative PBC patients, 21 AMA-positive PBC patients, 21 autoimmune hepatitis type 1 (AIH) patients, and 18 alcoholic liver disease (ALD) patients.

Vitamin D-receptor genotypes as independent genetic predictors of decreased bone mineral density in primary biliary cirrhosis.

Background & Aims: Hepatic osteodystrophy is a complication of primary biliary cirrhosis (PBC). Allelic polymorphisms of the vitamin D receptor (VDR) gene are related to bone mineral density (BMD) in normal cohorts and those with primary osteoporosis. We sought to establish the prevalence of reduced bone mass in PBC, correlate BMD with VDR gene polymorphisms, and identify risk factors for the development of hepatic osteodystrophy.

Effect of pretransplantation ursodeoxycholic acid therapy on the outcome of liver transplantation in patients with primary biliary cirrhosis.

As ursodeoxycholic acid (UDCA) delays the need for transplantation, this could result in patients with more comorbid disease, therefore more likely to have a worse outcome posttransplantation. The aim of this study is to compare posttransplantation outcome in patients who received UDCA versus placebo who subsequently required a liver transplant. Data on all trial patients referred for transplantation were retrospectively collected from three randomized controlled trials of UDCA in patients with primary biliary cirrhosis (PBC).

Asymptomatic primary biliary cirrhosis: a study of its natural history and prognosis.

Objective: To document the natural history of asymptomatic primary biliary cirrhosis and identify prognostic features that would predict the development of symptomatic disease.

Methods: A retrospective chart review of all patients with abnormal liver biochemical tests and antimitochondrial antibody-positive, liver biopsy-compatible primary biliary cirrhosis who were seen in a single tertiary care center between 1983 and 1994 was performed. Statistical analysis using Cox regression was employed to compare survival of the study population with an age- and gender-matched control population and to identify potential prognostic variables.

Cost-effectiveness of ursodeoxycholic acid therapy in primary biliary cirrhosis.

Ursodeoxycholic acid (UDCA) is a safe and effective treatment for patients with primary biliary cirrhosis (PBC), but the cost of this drug has raised concerns regarding cost-effectiveness. The aim of our study was to determine the cost-effectiveness of UDCA in PBC. We compared the costs and outcomes of managing PBC patients with and without UDCA.

Fatigue in primary biliary cirrhosis.

Background: Fatigue is a frequent and debilitating symptom in patients with primary biliary cirrhosis (PBC).

Aims: To study fatigue in relation to sleep, depression, and liver disease severity.

Methods: Patients with PBC completed validated self report questionnaires measuring fatigue, sleep quality, depression, and functional capacity.

Prevalence, kinetics, and therapeutic modulation of autoantibodies against Sp100 and promyelocytic leukemia protein in a large cohort of patients with primary biliary cirrhosis.

Antinuclear antibodies (ANA) staining nuclear dot structures predominantly occur in primary biliary cirrhosis (PBC) patients and recognize the Sp100 and promyelocytic leukemia protein (PML). From retrospective analysis of sera from a clinically well-defined Canadian series of 170 PBC patients included into a 24-month therapeutic trial of ursodeoxycholic acid (UDCA), we report the prevalence of these ANA and their dynamics in the course of the disease. Using an enzyme-linked immunosorbent assay (ELISA), anti-Sp100 autoantibodies were shown in 35 (21%) patients.

Combined analysis of randomized controlled trials of ursodeoxycholic acid in primary biliary cirrhosis.

Background & Aims: Long-term ursodeoxycholic acid (UDCA) therapy slows the progression of primary biliary cirrhosis. This study examined the effect of UDCA therapy on survival free of liver transplantation in a large group of patients.

Methods: Data from three clinical trials were combined in which patients with primary biliary cirrhosis were randomly assigned to receive UDCA (n = 273) or placebo (n = 275).