Improving Data Collection in Pregnancy Safety Studies: Towards Standardisation of Data Elements in Pregnancy Reports from Public and Private Partners, A Contribution from the ConcePTION Project.

Introduction And Objective: The ConcePTION project aims to improve the way medication use during pregnancy is studied. This includes exploring the possibility of developing a distributed data processing and analysis infrastructure using a common data model that could form a foundational platform for future surveillance and research. A prerequisite would be that data from various data access providers (DAPs) can be harmonised according to an agreed set of standard rules concerning the structure and content of the data.

Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project.

Introduction And Objective: The risks and benefits of medication use in pregnancy are typically established through post-marketing observational studies. As there is currently no standardised or systematic approach to the post-marketing assessment of medication safety in pregnancy, data generated through pregnancy pharmacovigilance (PregPV) research can be heterogenous and difficult to interpret. The aim of this article is to describe the development of a reference framework of core data elements (CDEs) for collection in primary source PregPV studies that can be used to standardise data collection procedures and, thereby, improve data harmonisation and evidence synthesis capabilities.

Evaluation of the Diagnostic Potential of Recombinant Com1 in an ELISA for the Diagnosis of Q Fever in Sheep, Goats and Cattle.

is the causative agent of Q fever, a zoonosis infecting domestic ruminants and humans. Currently used routine diagnostic tools offer limited sensitivity and specificity and symptomless infected animals may be missed. Therefore, diagnostic tools of higher sensitivity and specificity must be developed.

The Impact of Liraglutide on Diabetes-Related Foot Ulceration and Associated Complications in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events: Results From the LEADER Trial.

Objective: Diabetes-related foot ulcers (DFUs) and their sequelae result in large patient and societal burdens. Long-term data determining the efficacy of individual glucose-lowering agents on DFUs are lacking. Using existing data from the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial, we conducted post hoc analyses assessing the impact of liraglutide versus placebo in people with type 2 diabetes and at high risk of cardiovascular (CV) events on the incidence of DFUs and their sequelae.

The impact of pre-school booster vaccination of 4--6-year-old children on pertussis in 0--1-year-old children.

Pertussis in young children is severe and relatively prevalent in vaccinated populations. We estimated the impact of pre-school booster vaccination of 4-6-year-old children on pertussis in 0-1-year-old children. We conducted a population-based historical cohort study of all children born in Denmark, 1977-2001 (N=1,536,717) using information on place of residence to identify household members and vaccination history from nationwide registers.

Childhood vaccination and nontargeted infectious disease hospitalization.

Context: It has been hypothesized that multiple-antigen vaccines, such as measles-mumps-rubella vaccine, or aggregated vaccine exposure could lead to immune dysfunction, resulting in nontargeted infectious diseases as a result of an "overload" mechanism.

Objective: To evaluate the relationship between routinely administered childhood vaccines (Haemophilus influenzae type b; diphtheria-tetanus-inactivated poliovirus; diphtheria-tetanus-acellular pertussis-inactivated poliovirus; whole-cell pertussis; measles-mumps-rubella; oral poliovirus) and hospitalization for nontargeted infectious diseases.

Design, Setting, And Participants: Population-based cohort comprising all children born in Denmark from 1990 through 2001 (N = 805 206).

Spontaneously reported adverse reactions after diphtheria-tetanus revaccination at 4-6 years of age--a comparison of two vaccines with different amounts of diphtheria toxoid.

On 1 January 1996, diphtheria-tetanus revaccination at the age of 5 years was implemented in the Danish Childhood Vaccination Programme. Initially, a combined DT vaccine containing 25 Lf diphtheria toxoid was used. Due to a high frequency of spontaneously reported adverse reactions, however, concerns were raised that the diphtheria dose was too high, and it was reduced to 6.

Impact of routine vaccination with a pertussis toxoid vaccine in Denmark.

In many countries, acellular pertussis vaccines have replaced whole-cell vaccines. We evaluated the impact of a pertussis toxoid vaccine on pertussis in Denmark. We calculated incidence rates for pertussis before and after pertussis toxoid vaccine was introduced, and estimated vaccination effectiveness (VE).

Safety and immunogenicity of a booster dose of inactivated poliovirus vaccine produced in vero-cells.

Statens Serum Institut has developed a new vero-cell culturing technique for the manufacturing of inactivated poliovirus vaccine (IPV). This technique implies that the cultivation of cells and poliovirus is performed in a medium free of materials of animal origin and free of antibiotics. In a double-blind randomised clinical trial, IPV(vero) manufactured by this new technique was compared to conventionally produced IPV(mkc).

Childhood vaccination and type 1 diabetes.

Background: A link between childhood vaccinations and the development of type 1 diabetes has been proposed.

Methods: We evaluated a cohort comprising all children born in Denmark from January 1, 1990, through December 31, 2000, for whom detailed information on vaccinations and type 1 diabetes was available. Using Poisson regression models, we estimated rate ratios according to vaccination status, including the trend associated with the number of doses, among all children and in a subgroup of children who had siblings with type 1 diabetes.

Association between thimerosal-containing vaccine and autism.

Context: Mercuric compounds are nephrotoxic and neurotoxic at high doses. Thimerosal, a preservative used widely in vaccine formulations, contains ethylmercury. Thus it has been suggested that childhood vaccination with thimerosal-containing vaccine could be causally related to neurodevelopmental disorders such as autism.

Autism and thimerosal-containing vaccines: lack of consistent evidence for an association.

Background: In 1999, concerns were raised that vaccines containing the preservative Thimerosal might increase the risk of autism and/or other neurodevelopmental disorders.

Methods: Between the mid-1980s through the late-1990s, we compared the prevalence/incidence of autism in California, Sweden, and Denmark with average exposures to Thimerosal-containing vaccines. Graphic ecologic analyses were used to examine population-based data from the United States (national immunization coverage surveys and counts of children diagnosed with autism-like disorders seeking special education services in California); Sweden (national inpatient data on autism cases, national vaccination coverage levels, and information on use of all vaccines and vaccine-specific amounts of Thimerosal); and Denmark (national registry of inpatient/outpatient-diagnosed autism cases, national vaccination coverage levels, and information on use of all vaccines and vaccine-specific amounts of Thimerosal).

[Varicella disease and varicella vaccine. A literature review].

Varicella is an infectious childhood disease. A safe and effective vaccine is accessible. The varicella disease usually takes a mild course but studies performed outside Denmark reveal a considerable occurrence of complications.

Systemic absorption of metronidazole after application of a metronidazole 25% dental gel.

Systemic absorption of metronidazole was studied after one application of a metronidazole 25% dental gel into inflamed periodontal pockets. 14 patients with periodontal disease participated. Metronidazole gel was applied into the pockets of all teeth with probing depth > or = 5 mm, minimum 10 teeth/patient.

[Assessment of the diet of malnourished outpatients with chronic obstructive respiratory insufficiency].

We investigated the daily diets of malnourished patients with chronic obstructive ventilatory insufficiency. A total of 28 patients with body weights of less than 80% of ideal body weight were included. The patients were all ambulatory and in a stable phase of their illness.

[Diet and health. A survey of diet and health in women 40-50 years of age].

During the period 1980-1986, the Housekeeping Committees of the Danish Rural Institute carried out individual investigations of the diets of 513 women aged 23-50 years. Out of these, 124 were in the age group 40-50 years and this group was selected for health investigation. A Danish version of the Cornell Medical Index questionnaire with 138 enquiries about current and previous health conditions was sent to the 108 women who agreed to participate.

Nutritional repletion in malnourished patients with emphysema.

We examined the effect of nutritional supplementation for 13 wk on anthropometric, pulmonary function, and immunological status in malnourished ambulant patients with pulmonary emphysema (EP). The study was placebo controlled, randomized and double blind. Twenty-eight patients were included.

Benign mesenchymoma in the trachea of a patient with the nevoid basal cell carcinoma syndrome.

A case of benign mesenchymoma within the trachea of a patient with the nevoid basal cell carcinoma syndrome (NBS) is presented. The patient presented himself with stridor. After excision the tumour recurred twice, confirming that the treatment of choice is wide, local excision.