Rationale and design of a European epidemiological post-authorization safety study (PASS) program: rivaroxaban use in routine clinical practice.

Background: Rivaroxaban is a highly selective factor Xa inhibitor approved for use in Europe for multiple indications.

Study Design And Methods: The European rivaroxaban epidemiological post-authorization safety study (PASS) program consists of seven complementary observational studies. For four of the studies, data are obtained from health-care databases in the UK, the Netherlands, Germany, and Sweden.

Age and sex related self-reported symptoms in a general population across 30 years: Patterns of reporting and secular trend.

Objective: To study age and sex specific prevalence of 30 symptoms in random samples from the general population and to analyze possible secular trends across time.

Study Population: The study was based on data from eight on-going Swedish cohort studies, with baseline investigations performed between 1973 and 2003. Samples were drawn from the general population of the cities of Gothenburg and Eskilstuna, and of Uppsala County.

The reporting and diagnosis of uterine fibroids in the UK: an observational study.

Background: Uterine fibroids (UFs) are the most common benign tumour in women, and many undergo hysterectomy or uterus-preserving procedures (UPPs) to manage their symptoms. We aimed to validate the recording of UFs in a primary care database, The Health Improvement Network (THIN), and to determine the incidence of UFs in the UK.

Methods: In this observational study, women in THIN aged 15-54 years between January 2000 and December 2009 with no previous record of UFs, hysterectomy or UPPs were identified.

Prescribing patterns of combined hormonal products containing cyproterone acetate, levonorgestrel and drospirenone in the UK.

Background: There are limited data to show the levels of prescribing of combined oral contraceptives (COCs) and other hormonal products containing estrogen/progestogen combinations that may be outside the product licence.

Aims: To determine the diagnosis/indication recorded at the time of prescription of cyproterone acetate/ethinylestradiol (CPA/EE) and two COCs, levonorgestrel/EE (LNG/EE) and drospirenone/EE (DRSP/EE).

Design And Setting: Retrospective study using a primary care database, The Health Improvement Network (THIN).

The incidence of hysterectomy, uterus-preserving procedures and recurrent treatment in the management of uterine fibroids.

Objective: To determine the incidence of hysterectomy and uterus-preserving procedures (UPPs) among women with uterine fibroids (UFs) and the incidence of further procedures after a UPP.

Study Design: This was an observational study using a primary care database, The Health Improvement Network (THIN). Women in THIN with UFs aged 15-54 years between January 2000 and December 2009 were eligible for study.

The continuation rates of long-acting reversible contraceptives in UK general practice using data from The Health Improvement Network.

Purpose: The purpose of this study was to determine the continuation rates of new users of long-acting reversible contraceptive (LARC) methods in the UK, using data from general practice.

Methods: We conducted an observational study using a general practitioner (GP) database, The Health Improvement Network (THIN). The methods studied were copper intrauterine devices (Cu-IUDs), levonorgestrel-releasing intrauterine system (LNG-IUS), progestogen-only implants and progestogen-only injections.

Use of long-acting reversible contraceptives in the UK from 2004 to 2010: analysis using The Health Improvement Network Database.

Objectives: To determine the use of long-acting reversible contraceptives (LARCs) in the UK over the period 2004 to 2010, using the general practice database The Health Improvement Network (THIN).

Methods: Women in THIN, aged 18 to 44 years during 2004 to 2010, who had been registered with their general practitioner for at least five years, with a prescription history of at least one year were included. THIN was searched using the Read and MULTILEX codes for: copper intrauterine devices (Cu-IUDs), the levonorgestrel releasing-intrauterine system (LNG-IUS), progestogen-only implants, and progestogen-only injections.

Risk of acute liver injury associated with the use of moxifloxacin and other oral antimicrobials: a retrospective, population-based cohort study.

Study Objective: To estimate the incidence and relative risk of a hospitalization or emergency visit for noninfectious liver injury in users of eight oral antimicrobials-amoxicillin, amoxicillin-clavulanic acid, clarithromycin, cefuroxime, doxycycline, levofloxacin, moxifloxacin, telithromycin-compared with nonusers of these antimicrobials.

Design: Retrospective, observational cohort study with a nested case-control analysis.

Data Source: HealthCore Integrated Research Database.

Use of rivaroxaban in Germany: a database drug utilization study of a drug started in hospital.

Purpose: The purpose of this drug utilization study was to describe the use of rivaroxaban in Germany during a time period in which approval was limited to the prevention of venous thromboembolism following hip or knee replacement. Additionally, we explored the feasibility of reconstructing inpatient drug use of rivaroxaban in a database where with a few exceptions inpatient prescribing information is not available.

Methods: Source of data was one statutory health insurance providing data on about seven million insurants throughout Germany.

Study of long-acting reversible contraceptive use in a UK primary care database: validation of methodology.

OBJECTIVES To develop and validate algorithms to identify new users of long-acting reversible contraceptives (LARCs) in a primary care database, The Health Improvement Network (THIN). METHODS Women in THIN aged 12 to 49 years in 2005 were studied. THIN was searched using Read and MULTILEX codes to identify new users of copper intrauterine devices (Cu-IUDs), the levonorgestrel-releasing intrauterine system (LNG-IUS) and progestogen-only implants.

Validation of acute liver injury cases in a population-based cohort study of oral antimicrobial users.

We conducted a cohort study of acute, noninfectious liver injury among oral antimicrobial users. Potential cases were identified in the HealthCore Integrated Research Database (HIRD(SM)) population between July 1, 2001, and March 31, 2009, using ICD-9-CM codes primarily for acute and subacute necrosis of the liver, hepatic coma, and unspecified hepatitis. Liver test results were used to confirm case status according to published criteria.

Mortality after hemorrhagic stroke: data from general practice (The Health Improvement Network).

Objective: To investigate short-term case fatality and long-term mortality after intracerebral hemorrhage (ICH) and subarachnoid hemorrhage (SAH) using data from The Health Improvement Network database.

Methods: Thirty-day case fatality was stratified by age, sex, and calendar year after ICH and SAH using logistic regression. Cox proportional hazards regression analyses were used to estimate the risk of death during the first year of follow-up and survivors at 1 year.

Incidence of hemorrhagic stroke in the general population: validation of data from The Health Improvement Network.

Purpose: The Health Improvement Network (THIN) is a UK healthcare database composed of computerized information from primary care physicians (PCPs). We analyzed the validity of our method for identifying cases of intracerebral hemorrhage (ICH) and subarachnoid hemorrhage (SAH) within THIN and assessed the incidence of these events.

Methods: Patients aged 20-89 years were identified and followed until (i) ICH or SAH was detected, (ii) the patient reached 90 years old (iii) death, or (iv) the end of the study.

Epidemiology of meningioma in the United Kingdom.

Background: Data on the epidemiology and aetiology of meningioma are limited.

Methods: The Health Improvement Network UK primary care database was used to ascertain incident cases of meningioma between January 1996 and June 2008. Ten thousand controls analysis were frequency-matched by age, sex and year.

Hormonal therapies and meningioma: is there a link?

Background: The aetiology of meningiomas is largely unknown although hormones have been suggested to play a role.

Methods: A cohort study was performed to evaluate hormone-related factors associated with meningioma. Patients (12-89 years) with a first diagnosis of meningioma (January 1996-June 2008) were identified from The Health Improvement Network UK primary care database and age- and sex-matched to controls (n=10000) from the same cohort.

Treatment patterns in paediatric patients with a new diagnosis of gastroesophageal reflux disease.

Objective: Few data exist on the treatment of gastroesophageal reflux disease (GERD) in paediatrics. The objective of this study was to examine treatment patterns of GERD in paediatrics in the primary care.

Methods: Incident GERD cases among paediatric patients were identified using The Health Improvement Network UK primary care database.

A population-based survey of the epidemiology of symptom-defined gastroesophageal reflux disease: the Systematic Investigation of Gastrointestinal Diseases in China.

Background: The epidemiology of gastroesophageal reflux disease (GERD) has yet to be investigated using the symptomatic threshold criteria recommended by the Montreal Definition. This study aimed to determine the prevalence of symptom-defined GERD across five regions of China, and to investigate variables associated with GERD.

Methods: A representative sample of 18 000 adults (aged 18-80 years) were selected equally from rural and urban areas in each region (n = 1800).

Study of a cohort of patients newly diagnosed with depression in general practice: prevalence, incidence, comorbidity, and treatment patterns.

Objective: To estimate the prevalence and incidence of depression; investigate its association with risk factors including comorbidities and drug and health care use; and describe treatment patterns of depression in primary care using The Health Improvement Network database.

Method: In this cohort study, subjects with a first recorded diagnosis of depression (Read code) between January 1, 2002, and December 31, 2004 (n=47,170) were identified from a source population of 1,287,829 subjects aged 10-79 years. A comparison group was sampled from the same population and frequency matched to the depression cohort by age, sex, and calendar year (n=50,000).

Heart failure, myocardial infarction, lung cancer and death in COPD patients: a UK primary care study.

Background: The leading comorbidities and causes of death in patients with chronic obstructive pulmonary disease (COPD) are lung cancer and cardiovascular disease. The aim of this study was to establish the incidence of lung cancer, myocardial infarction and heart failure in patients with COPD in UK primary care.

Methods: The General Practice Research Database (GPRD) was used to identify a cohort of 1927 patients with a first recorded diagnosis of COPD.

Follow-up of a cohort of children and adolescents with gastro-esophageal reflux disease who were free of reflux esophagitis at initial diagnosis.

Objective: Few studies have examined the incidence of complications from gastro-esophageal reflux disease (GERD) in children and adolescents in primary care. Here we aimed to describe the natural history of GERD in a pediatric population with no reflux esophagitis at initial diagnosis, assessing diagnoses of new esophageal complications and extra-esophageal conditions.

Material And Methods: We used The Health Improvement Network UK primary care database (which includes data on more than 2 million patients) to identify individuals aged 1-17 years with a first diagnosis of gastro-esophageal reflux or heartburn in the period 2000-2005, via a computerized search followed by a manual review of the patient records.

Prospective drug safety monitoring using the UK primary-care General Practice Research Database: theoretical framework, feasibility analysis and extrapolation to future scenarios.

Background: Post-launch drug safety monitoring is essential for the detection of adverse drug signals that may be missed during preclinical trials. Traditional methods of postmarketing surveillance such as spontaneous reporting have intrinsic limitations, many of which can be overcome by the additional application of structured pharmacoepidemiological approaches. However, further improvement in drug safety monitoring requires a shift towards more proactive pharmacoepidemiological methods that can detect adverse drug signals as they occur in the population.

Gastroesophageal reflux disease in children and adolescents in primary care.

Objectives: To determine the prevalence and incidence of a diagnosis of gastroesophageal reflux disease (GERD) in children and adolescents in UK primary care, and to assess comorbidities that are associated with a diagnosis of GERD.

Material And Methods: Incident GERD cases during 2000-05 were identified from The Health Improvement Network (THIN) UK primary care database via a computer search for diagnostic codes for GERD, followed by manual review of the patient records.

Results: We identified 1700 children with a first diagnosis of GERD during 2000-05.

Stressful psychosocial factors and symptoms of gastroesophageal reflux disease: a population-based study in Norway.

Objective: Adverse psychosocial factors, including work-related stress, are, like gastroesophageal reflux disease (GERD), increasing health problems in industrialized countries. The importance of clarifying the relation between psychosocial factors and GERD has been stressed, but there are few population-based studies.

Material And Methods: This was a population-based, cross-sectional, case-control study based on two health surveys conducted in the Norwegian county Nord-Trondelag in 1984-86 and 1995-97.

Prevalence, incidence, morbidity and treatment patterns in a cohort of patients diagnosed with anxiety in UK primary care.

Background: Anxiety disorders are common and can cause substantial quality of life impairment.

Objective: The aim of this study was to investigate the frequency of anxiety in UK primary care. Treatment patterns and factors associated with an anxiety diagnosis were also assessed.

General symptom reporting in female fibromyalgia patients and referents: a population-based case-referent study.

Background: Fibromyalgia is characterized by widespread musculoskeletal pain and palpation tenderness. In addition to these classic symptoms, fibromyalgia patients tend to report a number of other complaints. What these other complaints are and how often they are reported as compared with related referents from the general population is not very well known.