Circadian rhythm disruptions may have harmful impacts on health. Circadian rhythm disruptions caused by jet lag compromise the quality and amount of sleep and may lead to a variety of symptoms such as fatigue, headache, and loss of attention and alertness. Even a minor change in time schedule may cause considerable stress for the body. Transitions into and out of daylight saving time alter the social and environmental timing twice a year. According to earlier studies, this change in time-schedule leads to sleep disruption and fragmentation of the circadian rhythm. Since sleep deprivation decreases motivation, attention, and alertness, transitions into and out of daylight saving time may increase the amount of accidents during the following days after the transition. We studied the amount of road traffic accidents one week before and one week after transitions into and out of daylight saving time during years from 1981 to 2006. Our results demonstrated that transitions into and out of daylight saving time did not increase the number of traffic road accidents.

Incidence-based mortality modelling comparing the risk of breast cancer death in screened and unscreened women in nine Swedish counties has suggested a 39% risk reduction in women 40 to 69 years old after introduction of mammography screening in the 1980s and 1990s.

Daylight saving time is widely adopted. Little is known about its influence on the daily rest-activity cycles. We decided to explore the effects of transition into daylight saving time on the circadian rhythm of activity.

The summary of product characteristics (SmPCs) is an important information source that includes the adverse drug reactions (ADRs) associated with the drug. Drugs with the same mechanism of action are expected to have a similar ADR profile and thus a substantial overlap of the described ADRs in the SmPC. The objective of this study is to assess this overlap. We extracted all ADRs (excluding hypersensitivity and administration site reactions) that were described in the first and all subsequent versions of the SmPCs of all approved TNF-α inhibitors in the European Union. The Medical Dictionary for Regulatory Activities was used to characterize the ADRs. At the end of follow-up, 293 unique ADRs (at high level term level) were described in the SmPCs of the 5 TNF-α inhibitors. There was substantial variation in the number of ADRs described in the SmPC among the TNF-α inhibitors. Of the 293 ADRs, 133 (45%) were described in the SmPC of one TNF-α inhibitor and 39 (13%) in the SmPCs of all 5 TNF-α inhibitors. Serious ADRs and ADRs classified as important risks were described approximately four times more often in a second SmPC than ADRs not classified as such. In conclusion, the ADRs described in the SmPCs of the TNF-α inhibitors differ considerably in number and type. In order to adequately inform prescribers and patients, acquired knowledge of the safety profile of drugs with the same mechanism of action should increasingly be taken into account in the assessment of all drugs within the class.

Haemovigilance is an important element of blood regulation. It includes collecting and evaluating the information on adverse events resulting from the use of blood and blood components with the aim to improve donor and patient safety. We describe the results of the pilot of the integrated GBT+ Blood for the haemovigilance function in 10 sub-Saharan African countries.

Transitioning patients from an originator to a corresponding biosimilar has been extensively studied in both randomized controlled trials and observational studies. Although transitioning is considered well-tolerated, with no negative impacts on efficacy and/or safety, 2.6-25.8% of patients restart treatment with the originator (retransitioning). Retransitioning to the originator can be considered an indication of biosimilar treatment failure or dissatisfaction with biosimilar treatment. Increasing our knowledge of patients who retransition might help to reduce the number of patients retransitioning.

To evaluate the association between regulatory drug safety advisories and changes in drug utilisation.

The timing at which venous thromboembolism (VTE) occurs after major surgery has major implications for the optimal duration of thromboprophylaxis. The aim of this study was to perform a systematic review and meta-analysis of the timing of postoperative VTE up to 4 weeks after surgery.

Atrial fibrillation (AF) is a worldwide healthcare challenge owing to population ageing. In this study, we assessed the current trends in the incidence and prevalence of AF for the first time in an unselected, nationwide population.

Decentralised clinical trial activities-such as participant recruitment via social media, data collection through wearables and direct-to-participant investigational medicinal product (IMP) supply-have the potential to change the way clinical trials (CTs) are conducted and with that to reduce the participation burden and improve generalisability. In this study, we investigated the decentralised and on-site conduct of trial activities as reported in CT protocols with a trial start date in 2019 or 2020.

Background: Rural-urban disparities have been reported in the access, utilization, and quality of healthcare. We aimed to assess whether use of antiarrhythmic therapies (AATs) in patients with atrial fibrillation (AF) differs between those with rural and urban residence. Methods: The registry-based FinACAF cohort covers all patients with AF from all levels of care in Finland. Patients were divided into rural and urban categories and into urbanization degree tertiles based on their municipality of residence at the time of AF diagnosis. The primary outcome was the use of any AAT, including cardioversion, catheter ablation, and fulfilled antiarrhythmic drug (AAD) prescription. Results: We identified 177,529 patients (49.9% female, mean age 73.0 (SD13.0) years) with incident AF during 2010-2018. Except for AADs, the differences in AAT use were nonsignificant when patients were stratified according to the rural-urban classification system (urban vs. rural adjusted incidence rate ratios (aIRRs) with 95% CIs for any AAT 1.01 (0.99-1.03), AADs 1.11 (1.07-1.15), cardioversion 1.01 (0.98-1.03), catheter ablation 1.05 (0.98-1.12)). However, slightly higher use of all rhythm control modalities was observed in the highest urbanization degree tertile when compared to the lowest tertile (aIRRs with 95% Cis for any AAT 1.06 (1.03-1.08), AADs 1.18 (1.14-1.23), cardioversion 1.05 (1.02-1.08), catheter ablation 1.10 (1.02-1.19)). Conclusions: This nationwide retrospective cohort study observed that urban residence is associated with higher use of AADs in patients with incident AF. Otherwise, the observed disparities were only marginal, suggesting that in the use of rhythm control therapies, no large rural-urban inequity exists in Finland.

In studies evaluating the effectiveness of additional risk minimisation measures (aRMMs), the need for speed must be properly balanced with the quality of the study. We assessed the duration of aRMM effectiveness evaluations, using additional pharmacovigilance activities, for centrally authorised medicinal products in the European Union.

Insulin therapy in type 2 diabetes may increase mortality and cancer incidence, but the impact of different types of basal insulins on these endpoints is unclear. Compared to the traditional NPH insulin, the newer, longer-acting insulin analogues detemir and glargine have shown benefits in randomized controlled trials. Whether these advantages translate into lower mortality among users in real life is unknown.

Several studies have suggested that anti-diabetic insulin analogue treatment might increase cancer risk. The aim of this study was to review the postulated association between insulin and insulin analogue treatment and breast cancer development, and plausible mechanisms.

The case-crossover (CXO) and self-controlled case series (SCCS) designs are increasingly used in pharmacoepidemiology. In both, relative risk estimates are obtained within persons, implicitly controlling for time-fixed confounding variables.

To identify pharmacoepidemiological multi-database studies and to describe data management and data analysis techniques used for combining data.

Several studies have addressed cytokine gene polymorphisms and their possible associations with periodontitis. We examined the association between salivary anti- and pro-inflammatory mediator polymorphisms and initial periodontitis in Finnish adolescents, taking into account the effect of smoking. Salivary samples of 93 clinically examined adolescents from Eastern Finland were analyzed. Their oral health and smoking habits were recorded. Periodontal probing depth (PPD), and bleeding on probing (BOP) at four sites per tooth, root calculus (RC), and visible plaque index (VPI) were recorded from the index teeth. Salivary MMP-8 median values were assessed. The sites with ≥4 mm PD were categorized as follows: PPD1 = one or more ≥4 mm pocket, PPD2 = two or more ≥4 mm pockets, and PPD3 = three or more ≥4 mm pockets. Genomic DNA was extracted from 300 μl of the saliva samples by genomic QIAamp® DNA Blood Mini Kit and genotyped for polymorphisms. Genetic variants for genotyping were selected from the following genes of interest: S100A8, FCGR2A, FCGR2B, IL10, MMP8, MMP3, MMP13, VDR, TLR4, MMP2, MPO, ELANE, IL1A, IL1B, IL1RN, CD28, MMP9, DDX39B, NFKBIL1, LTA, TNF, SOD2, IL6, TLR4, TIMP1, and SYN1. After false discovery rate control (FDR), polymorphisms in MMP3 (rs679620, rs520540, rs639752), CD28 (rs3116496), and VDR (rs2228570) associated (FDR q < 0.05) with deepened periodontal pockets. Smoking did not affect the results. Genetic polymorphisms of pro-inflammatory mediators MMP3, CD28, and VDR seem to link to initial periodontitis.

Background Mental health conditions (MHCs) are associated with poor outcomes in patients with atrial fibrillation. However, persistence of oral anticoagulation therapy in patients with atrial fibrillation and MHCs is unknown. We aimed to evaluate the effect of MHCs on the persistence of direct oral anticoagulant (DOAC) use in patients with atrial fibrillation based on a nationwide cohort. Methods and Results The nationwide registry-based FinACAF (Finnish Anticoagulation in Atrial Fibrillation) cohort included 67 503 patients with incident atrial fibrillation and indication for permanent oral anticoagulation (CHA2DS2-VASc score >1 in men and >2 in women) starting DOAC therapy between 2011 and 2018. MHCs of interest were depression, bipolar disorder, anxiety disorder, schizophrenia, and composite of any MHC. The main outcome was nonpersistence of DOAC use, defined as the first 120-day period without DOAC purchases after drug initiation. The mean age of the patients was 75.3±8.9 years, 53.6% were women, and the prevalence of any MHC was 17.8%. Persistence after 1 year from DOAC initiation was 79.3% in patients without MHCs and 77.2% in patients with any MHC, and after 2 years were 64.4% and 60.6%, respectively (P<0.001). Higher incidence of nonpersistence to DOACs was observed in all MHC categories: adjusted subdistribution hazard ratios, 1.16 (95% CI, 1.11-1.21) for any MHC, 1.32 (95% CI, 1.22-1.42) for depression, 1.44 (95% CI, 1.15-1.80) for bipolar disorder, 1.25 (95% CI, 1.11-1.41) for anxiety disorder, and 1.30 (95% CI, 1.02-1.64) for schizophrenia. However, patients with only anxiety disorder without other MHCs were not at higher risk of nonpersistence. Conclusions MHCs are associated with nonpersistence of DOAC use. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04645537.

Little is known about rural-urban differences in the treatment and outcomes in patients with atrial fibrillation (AF). We aimed to assess whether the initiation of oral anticoagulant (OAC) therapy in patients with AF differs between those with rural and urban residence.

To provide procedure-specific estimates of symptomatic venous thromboembolism (VTE) and major bleeding after abdominal surgery.