OBSERVE-5: observational postmarketing safety surveillance registry of etanercept for the treatment of psoriasis final 5-year results.

Background: OBSERVE-5 was a 5-year Food and Drug Administration-mandated surveillance registry of patients with psoriasis.

Objective: We sought to assess long-term etanercept safety and effectiveness.

Methods: Patients with moderate to severe psoriasis enrolled; a single baseline dose of etanercept was required.

Body size and risk of spontaneous abortion among danish pregnancy planners.

Background: Several studies indicate that female obesity increases the risk of spontaneous abortion (SAB). Central adiposity, height, and location of typical weight gain have not been examined as risk factors for SAB.

Methods: We examined the associations between selected anthropometric factors and risk of SAB among 5132 women enrolled in a Danish Internet-based prospective cohort study of pregnancy planners.

The influence of prevalent cohort bias in the association between periodontal disease progression and incident coronary heart disease.

Purpose: In longitudinal studies, the onset of the index condition (e.g. exposure) does not always coincide with the start of a study's observation period, leading to the possibility of bias in estimation that derives from studying prevalent exposure rather than new exposure.

Estimating the proportion of all observed birth defects occurring in pregnancies terminated by a second-trimester abortion.

Background: Prenatal termination of pregnancy may underestimate risks or cause bias in epidemiological studies of birth defects if such studies measure only defects diagnosed postnatally. We aimed to estimate the proportion of all fetuses with birth defects terminated in the second trimester of pregnancy-overall and for specific defects.

Methods: The study comprised all pregnancies ending in a singleton birth, miscarriage, or termination of pregnancy for which health care services were sought, as recorded in Danish medical registries between 1 January 2007 and 31 December 2011.

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.

Risk of birth defects associated with maternal pregestational diabetes.

Maternal diabetes preceding pregnancy may increase the risk of birth defects in the offspring, but not all studies confirm this association, which has shown considerable variation over time, and the effect of having type 1 versus type 2 diabetes is unclear. We conducted a population-based cohort study in the Northern Italy Emilia-Romagna region linking administrative databases with a Birth Defects Registry. From hospital discharge records we identified all diabetic pregnancies during 1997-2010, and a population of non-diabetic parturients matched for age, residence, year and delivery hospital.

Risk factors for venous thromboembolism in 1.3 million pregnancies: a nationwide prospective cohort.

Objective: To quantify risk factors for venous thromboembolism during pregnancy and the puerperal period.

Design: In a nationwide prospective cohort study we followed pregnant and puerperal women in Denmark from 1995 to 2009 for venous thromboembolism. Information on risk factors and confounders was retrieved from national registries.

Active and passive smoking and fecundability in Danish pregnancy planners.

Objective: To investigate the extent to which fecundability is associated with active smoking, time since smoking cessation, and passive smoking.

Design: Prospective cohort study.

Setting: Denmark, 2007-2011.

Weight at birth and subsequent fecundability: a prospective cohort study.

Objective: To examine the association between a woman's birth weight and her subsequent fecundability.

Method: In this prospective cohort study, we included 2,773 Danish pregnancy planners enrolled in the internet-based cohort study "Snart-Gravid", conducted during 2007-2012. Participants were 18-40 years old at study entry, attempting to conceive, and were not receiving fertility treatment.

Topiramate use in pregnancy and the birth prevalence of oral clefts.

Purpose: First marketed in the USA in 1996, topiramate (TPM) is an antiepileptic drug later approved for migraine prophylaxis, and in 2012 for weight loss in combination with phentermine. Some studies indicate an elevated prevalence of oral cleft (OC) in infants exposed to TPM in utero. We evaluated the association between TPM use in early pregnancy and the risk of OC.

Incidence of malignancy in patients with moderate-to-severe asthma treated with or without omalizumab.

Background: The Epidemiologic Study of Xolair (omalizumab): Evaluating Clinical Effectiveness and Long-term Safety in Patients with Moderate-to-Severe Asthma (EXCELS) assessed the long-term safety of omalizumab in a clinical practice setting as part of a phase IV US Food and Drug Administration postmarketing commitment.

Objective: We sought to evaluate long-term safety in omalizumab-treated and nonomalizumab-treated patients. Primary outcome measures focused on assessment of malignancies.

Strong association between smoking and the risk of revision in a cohort study of patients with metal-on-metal total hip arthroplasty.

Thus far the ability to predict who will develop early failure following the insertion of a metal-on-metal (MoM) bearing has been very limited. Our objective was to assess the effect of smoking on failure rates in patients with MoM bearing, compared with patients with ceramic-on-polyethylene (CoP) bearing. From a prospective hospital-based registry we included all primary THAs operated upon between 1/2001 and 12/2011 with MoM or CoP bearings of the same cup design and head size (28 mm).

Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: a global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation.

Background: Atrial fibrillation (AF) is the most common cardiac arrhythmia, affecting 1% to 2% of the population and raising the risk of stroke 5-fold. Until recently, the only treatment choices for stroke prevention in patients with AF have been vitamin K antagonists (VKA) or antiplatelet drugs. With approval of novel oral anticoagulants (NOACs) antithrombotic treatment, patterns are changing.

Six persistent research misconceptions.

Scientific knowledge changes rapidly, but the concepts and methods of the conduct of research change more slowly. To stimulate discussion of outmoded thinking regarding the conduct of research, I list six misconceptions about research that persist long after their flaws have become apparent. The misconceptions are: 1) There is a hierarchy of study designs; randomized trials provide the greatest validity, followed by cohort studies, with case-control studies being least reliable.

Challenges in designing a national surveillance program for inflammatory bowel disease in the United States.

This review describes the history of U.S. government funding for surveillance programs in inflammatory bowel diseases (IBD), provides current estimates of the incidence and prevalence of IBD in the United States, and enumerates a number of challenges faced by current and future IBD surveillance programs.

Incidence rates of malignancies and hospitalized infectious events in patients with psoriasis with or without treatment and a general population in the U.S.A.: 2005-09.

Background: Rates of malignancies and hospitalized infectious events (HIEs) among psoriasis patients are higher than in the general population, but it is unclear if higher rates are associated with the underlying inflammatory state, treatments or both.

Objectives: To assess the incidence of malignancies and HIEs in a healthy US population, a psoriasis population, and four treated psoriasis populations.

Methods: Using a US claims database, we identified a general population, a psoriasis cohort, and four treatment cohorts [non-biologic systemics, etanercept, other TNF blockers (adalimumab, infliximab) and phototherapy] to assess the incidence of lymphomas, nonmelanoma skin cancer (NMSC), all malignancies (excluding NMSC), and HIEs, standardized for age and sex.

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.

Correlates of menstrual cycle characteristics among nulliparous Danish women.

Objective: We examined the association between lifestyle factors and menstrual cycle characteristics among nulliparous Danish women aged 18-40 years who were participating in an Internet-based prospective cohort study of pregnancy planners.

Methods: We used cross-sectional data collected at baseline to assess the association of age, body mass index (BMI), physical activity, alcohol and caffeine consumption, and smoking with the prevalence of irregular cycles, short (≤25 days) and long (≥33 days) cycles, and duration and amount of menstrual flow. We used log-binomial and multinomial logistic regression to estimate prevalence ratios and 95% confidence intervals.

Re-using Mini-Sentinel data following rapid assessments of potential safety signals via modular analytic programs.

The U.S. Food and Drug Administration (FDA)'s Mini-Sentinel pilot has created a distributed data system with over 125 million lives and nearly 350 million person-years of observation time.

Safety of MF59-adjuvanted influenza vaccination in the elderly: results of a comparative study of MF59-adjuvanted vaccine versus nonadjuvanted influenza vaccine in northern Italy.

MF59-adjuvanted trivalent influenza vaccine (Novartis Vaccines and Diagnostics, Siena, Italy) has been shown to be more effective than nonadjuvanted vaccine in the elderly population. Here we present results from a large-scale, observational, noninterventional, prospective postlicensure study that evaluated the safety of MF59-adjuvanted vaccine in elderly subjects aged 65 years or more. The study was performed in 5 northern Italian health districts during the 2006-2007, 2007-2008, and 2008-2009 influenza seasons.