The incidence of medically-attended norovirus gastro-enteritis in Japan: Modelling using a medical care insurance claims database.

Background: The burden of medically-attended acute gastro-enteritis (MA-AGE) that can be attributed to norovirus is not well established in Japan. Using a nationwide database of medical care insurance claims, we estimated the incidence of medically-attended norovirus-attributable gastroenteritis (MA-NGE) in Japan.

Methods: The incidences of MA-NGE outpatient consultations or hospitalization in Japan were modelled on seasonal patterns of MA-AGE for unspecified causes derived from the Japan Medical Data Center (JMDC) database for the period July 2007 to June 2015.

Assessing the Impact of a Focused Deterrence Strategy to Combat Intimate Partner Domestic Violence.

The Offender Focused Domestic Violence Initiative (OFDVI) represents for the first time anywhere the application of the evidence-based focused deterrence policing approach to combat intimate partner domestic violence (IPDV). Through holding offenders accountable, the strategy has resulted in 20% reductions each in IPDV-related calls for police service and arrests. Victim injuries have been significantly reduced and the 1-year IPDV offender recidivism rate is about 16-17%.

Modelling Estimates of Norovirus Disease in Patients with Chronic Medical Conditions.

Background: The burden of disease due to norovirus infection has been well described in the general United States population, but studies of norovirus occurrence among persons with chronic medical conditions have been limited mostly to the immunocompromised. We assessed the impact of norovirus gastroenteritis on health care utilization in US subjects with a range of chronic medical conditions.

Methods: We performed a retrospective cohort study using MarketScan data from July 2002 to December 2013, comparing the rates of emergency department visits, outpatient visits and hospitalizations among patients with chronic conditions (renal, cardiovascular, respiratory, immunocompromising, gastrointestinal, hepatic/pancreatic and neurological conditions and diabetes) with those in a healthy population.

The incidence of childhood and adolescent seizures in the UK from 1999 to 2011: A retrospective cohort study using the Clinical Practice Research Datalink.

Background: In postmarketing vaccine surveillance, adverse events observed in a vaccinated population are compared to the number expected based on a background incidence rate. The background rate should be accurate and obtained from a population comparable to the one vaccinated. Such rates are often not available.

Advantages and problems with pregnancy registries: observations and surprises throughout the life of the International Lamotrigine Pregnancy Registry.

Purpose: The International Lamotrigine Pregnancy Registry monitored for a signal of a substantial increase in the frequency of major congenital malformations associated with lamotrigine exposures in pregnancy over an 18-year period. Key methodological lessons are discussed.

Methods: The strengths and weaknesses of the Registry were assessed using quantifiable methodological and operational parameters including enrollment, completeness of exposure and outcome data reporting, and lost to follow-up.

Bridging differences in outcomes of pharmacoepidemiological studies: design and first results of the PROTECT project.

Background: Observational pharmacoepidemiological (PE) studies on drug safety have produced discrepant results that may be due to differences in design, conduct and analysis.

Purpose: The pharmacoepidemiology work-package (WP2) of the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium (PROTECT) project aims at developing, testing and disseminating methodological standards for design, conduct and analysis of pharmacoepidemiological studies applicable to different safety issues using different databases across European countries. This article describes the selection of the safety issues and the description of the databases to be systematically studied.

Safety of MF59-adjuvanted A/H1N1 influenza vaccine in pregnancy: a comparative cohort study.

Objective: The 2009-2010 A/H1N1 pandemic provided a unique setting to study the safety of MF59-adjuvanted vaccination in pregnancy.

Study Design: This was an observational cohort study of the safety of an MF59-adjuvanted A/H1N1 vaccine (Focetria) conducted among 4508 pregnant women (2295 vaccinated vs 2213 unvaccinated), with 3 month follow-up of neonates.

Results: No maternal deaths or abortions occurred among the vaccinated women.

Incidence of new-onset seizures in mild to moderate Alzheimer disease.

Objective: To estimate the incidence rate and predictors of seizures in patients with mild to moderate Alzheimer disease (AD).

Design: Cohort study of patients with mild to moderate AD in clinical trials. Risk factors for potential seizures were evaluated by stratified descriptive statistics and univariable and multivariable Cox proportional hazards regressions.

Comparing the General Practice Research Database and the UK Epilepsy and Pregnancy Register as tools for postmarketing teratogen surveillance: anticonvulsants and the risk of major congenital malformations.

Background: Use of pregnancy registries is a common method of postmarketing surveillance of pregnancy outcomes to identify potential teratogens. However, with the increase in electronic capture of healthcare data for administrative, audit and research purposes, data generated during routine clinical practice might be used to address questions similar to those explored using pregnancy registries.

Objectives: To establish how data from the UK General Practice Research Database (GPRD) compares with data from the UK Epilepsy and Pregnancy Register and to assess how it can contribute to postmarketing surveillance of pregnancy outcomes.

Identifying major congenital malformations in the UK General Practice Research Database (GPRD): a study reporting on the sensitivity and added value of photocopied medical records and free text in the GPRD.

Background: Postmarketing teratogen surveillance is essential and requires a data source that can reliably capture a wide range of congenital malformations. The UK General Practice Research Database (GPRD) may have the potential to be used for this kind of surveillance.

Objective: To assess the extent to which this database can be used to accurately identify major congenital malformations.

Background incidence of serum creatinine threshold rises in a predominantly female clinical trial population without underlying renal disease.

Objective: Serum creatinine (Cr) is used to monitor renal function during pre-marketing clinical trials. Standard thresholds for a serum creatinine (Cr) increase predictive of renal injury remain to be established in this setting.

Study Design And Setting: Aggregated clinical trial data were utilized to evaluate the background frequency of Cr increases of ≥ 0.

Exploring differential prescribing between anti-epileptic drugs in epilepsy patients with a history of mood disorders.

Purpose: To explore differential prescribing of anti-epileptic drugs (AEDs) to patients with epilepsy by history of mood disorder.

Methods: Epilepsy was defined as at least one diagnosis code and one AED prescription, and all patients must have been on the database 182 days before and after their first AED prescription. The Integrated HealthCare Information Services (IHCIS) insurance claims database included 44 557 patients with epilepsy between January 1997 and March 2007.

Predictors of placebo response in pooled lamotrigine neuropathic pain clinical trials.

Objectives: One limitation of neuropathic pain clinical trials is the often large and variable extent of response in the placebo group, possibly obscuring true medication effects. We pooled data from 252 individuals in the placebo arms of 3 clinical trials of lamotrigine in patients with neuropathic pain to examine the relationship of baseline patient and study site characteristics with 12-week change in the Pain Intensity Numerical Rating Scale score (DeltaPI-NRS). The 574 patients in the pooled lamotrigine treatment arms were used as a replication dataset.

Magnetic resonance in systems with equivalent spin-1/2 nuclides. Part 3: Ket analysis and spectral intensities.

In earlier papers (Parts 1 and 2), featuring group-theoretical analysis, it was shown that the isotropic EPR spectra of free radical (S=1/2) species XL(n), where the n equivalent nuclei also have spin 1/2, have a more complicated form than disclosed by the usual (first-order) oversimplified analysis. Explicit solutions for n=3 (analytic, as well as computational) of the spin-hamiltonian matrix H(s) for the energies and spin states were obtained and given in Part 2, but are amplified herein, and differences in several important representations of H(s) are discussed. In the present work, we focus also on details of relative spectral intensities, some of which are not straightforward.

Predictors of placebo group decline in the Alzheimer's disease Assessment Scale-cognitive subscale (ADAS-Cog) in 24 week clinical trials of Alzheimer's disease.

One limitation of several recent 24 week Alzheimer's disease (AD) clinical trials was the lack of cognitive decline detected by the AD Assessment Scale-cognitive subscale (ADAS-cog) in the placebo groups, possibly obscuring true medication effects. Data from 733 individuals in the placebo arms of six AD clinical trials performed 1996-1997 were pooled to examine the relationship of clinical, demographic, and genetic characteristics with the 24 week change in ADAS-cog. Baseline cognitive and functional status and the screening-to-baseline change in ADAS-cog were the strongest independent predictors of the 24 week change in ADAS-cog.

Background incidence of liver chemistry abnormalities in a clinical trial population without underlying liver disease.

Background: The FDA has recently proposed pre-marketing liver chemistry subject stopping criteria. The study was undertaken to determine the background rates of liver chemistry abnormalities in clinical trial populations without underlying liver disease.

Methods: Data from 28 Phase II-IV trials in diseases with normal risk of underlying liver abnormalities were included.

Risk of ischaemic cardiovascular events from selective cyclooxygenase-2 inhibitors in osteoarthritis.

Purpose: Most previous observational studies assessing cardiovascular risk associated with Cox-2 inhibitors (Cox-2is) used a case control approach, limiting the assessment of absolute risk by disease group and effect of duration of exposure. We conducted a retrospective cohort study in patients with osteoarthritis.

Methods: Using the Life-link US claims database, all subjects had at least five years history in the database.

Magnetic resonance in systems with equivalent spin-1/2 nuclides. Part 2: energy values and spin states.

In an earlier paper (Part 1), featuring group-theoretical analysis, it was shown that the isotropic EPR spectra of free radical (S=1/2) species XL(n), where the n equivalent nuclei also have spin 1/2, have a more complicated form than anticipated from the usual (first-order) oversimplified analysis. The nucleus of X is taken to be spin-less. The latter predicts n+1 lines with intensity ratios given by the coefficients of the binomial expansion; for systems with n=3, the EPR spectrum in fact consists of 6 lines.

Data resources for investigating drug exposure during pregnancy and associated outcomes: the General Practice Research Database (GPRD) as an alternative to pregnancy registries.

Pregnancy registries are the most commonly used data resource for the post-marketing surveillance of drug teratogenicity. However, the limited sample size and potential selection bias in these registries has led us to investigate the potential of the UK General Practice Research Database (GPRD) as an alternative data source for monitoring drug safety during pregnancy. In addition, a literature review identified further observational data sources that monitor pregnancy outcomes for future evaluation.