Development of Real-Time Surveillance for Serious Adverse Events in a Pragmatic Clinical Trial Using National Registers in Finland.

Purpose: We developed a hybrid safety surveillance approach for a large, pragmatic clinical trial of a high-dose quadrivalent influenza vaccine (QIV-HD), using both active and passive data collection methods. Here, we present the methods and results for the passive register-based surveillance of serious adverse events (SAEs), which replaced conventional SAE reporting during the trial.

Patients And Methods: The trial recruited over 33,000 older adults of whom 50% received the QIV-HD while the rest received a standard-dose vaccine (QIV-SD) as a control vaccine.

Pre-pregnancy weight, the rate of gestational weight gain, and the risk of early gestational diabetes mellitus among women registered in a tertiary care hospital in India.

Background: The impact of pre-pregnancy weight and the rate of gestational weight gain (GWG) together on the risk of early GDM (< 24 weeks gestation; eGDM) has not been studied in the Indian context. We aimed to study the influence of (1) pre-pregnancy weight on the risk of eGDM diagnosed in two time intervals; and (2) in addition, the rate of GWG by 12 weeks on the risk of eGDM diagnosed in 19-24 weeks.

Method: Our study utilized real-world clinical data on pregnant women routinely collected at an antenatal care clinic at a private tertiary hospital, in Pune, India.

Underreporting of SARS-CoV-2 infections during the first wave of the 2020 COVID-19 epidemic in Finland-Bayesian inference based on a series of serological surveys.

In Finland, the first wave of the COVID-19 epidemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) took place from March to June 2020, with the majority of COVID-19 cases diagnosed in the Helsinki-Uusimaa region. The magnitude and trend in the incidence of COVID-19 is one way to monitor the course of the epidemic. The diagnosed COVID-19 cases are a subset of the infections and therefore the COVID-19 incidence underestimates the SARS-CoV-2 incidence.

Effects of technology-based interventions on dietary intake or anthropometrics among adolescents and adults in South Asia - A systematic review of intervention studies.

Introduction: Mobile technology has been increasingly used as part of dietary interventions, but the effects of such interventions have not been systematically evaluated in the South Asian context. The systematic review aimed to determine the effects of technology-based interventions on dietary intake or anthropometrics among adolescents and adults in South Asia.

Methods: Five electronic databases were searched (PubMed, Scopus, Web of Science, Global Health Library and Health Technology Assessment).

Analysing Subgroups and Treatment Discontinuation in a Finnish Cohort of Patients with Neovascular AMD.

Purpose: We aimed to study the regional detailed visual outcome and treatment discontinuation of neovascular age-related macular degeneration (nAMD).

Methods: Clinical records of 110 patients treated for nAMD at the sole referral centre in the Helsinki region were analysed retrospectively. The follow-up was up to the fourth year.

Birth cohort differences in height, weight and BMI among Indian women aged 15-30 years: analyses based on three cross-sectional surveys.

Objective: To explore long-term trends in height, weight and BMI across birth cohorts among Indian women aged 15-30 years.

Design: Nationally representative cross-sectional surveys.

Setting: Data from three National Family Health Surveys were conducted in 1998-1999, 2005-2006 and 2015-2016.

Spotlight influenza: Estimation of influenza vaccine effectiveness in elderly people with assessment of residual confounding by negative control outcomes, Finland, 2012/13 to 2019/20.

BackgroundCohort studies on vaccine effectiveness are prone to confounding bias if the distribution of risk factors is unbalanced between vaccinated and unvaccinated study subjects.AimWe aimed to estimate influenza vaccine effectiveness in the elderly population in Finland by controlling for a sufficient set of confounders based on routinely available register data.MethodsFor each of the eight consecutive influenza seasons from 2012/13 through 2019/20, we conducted a cohort study comparing the hazards of laboratory-confirmed influenza in vaccinated and unvaccinated people aged 65-100 years using individual-level medical and demographic data.

Exposure misclassification bias in the estimation of vaccine effectiveness.

In epidemiology, a typical measure of interest is the risk of disease conditional upon exposure. A common source of bias in the estimation of risks and risk ratios is misclassification. Exposure misclassification affects the measurement of exposure, i.

Mitigation of biases in estimating hazard ratios under non-sensitive and non-specific observation of outcomes-applications to influenza vaccine effectiveness.

Background: Non-sensitive and non-specific observation of outcomes in time-to-event data affects event counts as well as the risk sets, thus, biasing the estimation of hazard ratios. We investigate how imperfect observation of incident events affects the estimation of vaccine effectiveness based on hazard ratios.

Methods: Imperfect time-to-event data contain two classes of events: a portion of the true events of interest; and false-positive events mistakenly recorded as events of interest.

Effectiveness of 2 Influenza Vaccines in Nationwide Cohorts of Finnish 2-Year-Old Children in the Seasons 2015-2016 Through 2017-2018.

Background: From 2015-2016 through 2017-2018, injectable, trivalent inactivated influenza vaccines (IIV3) and a nasal spray, tetravalent live-attenuated influenza vaccine (LAIV4) were used in parallel in Finland. To understand how well vaccination with each vaccine type protected children against influenza under real-life conditions, vaccine effectiveness in 2-year-olds was estimated for all 3 seasons.

Methods: Each season, a nationwide register-based cohort study was conducted.

Mobile Helpline and Reversible Contraception: Lessons From a Controlled Before-and-After Study in Rural India.

Background: Researchers and activists have expressed concerns over the lack of availability and nonuse of reversible, modern, contraceptive methods in India for decades. New attempts to increase access, availability, and acceptance of reversible contraceptives need to be developed, instead of relying solely on female sterilization. Mobile health (mHealth) initiatives may offer one way to serve underprivileged populations who face challenges in sexual and reproductive health (SRH) in countries such as India.

Cohort study design for estimating the effectiveness of seasonal influenza vaccines in real time based on register data: The Finnish example.

This paper presents the principles of implementing register-based cohort studies as currently applied for real-time estimation of influenza vaccine effectiveness in Finland. All required information is retrieved from computerised national registers and deterministically linked via the unique personal identity code assigned to each Finnish resident. The study cohorts comprise large subpopulations eligible for a free seasonal influenza vaccination as part of the National Vaccination Programme.

Determinants of plasma phospholipid arachidonic and docosahexaenoic acids among adolescent girls in central Mozambique - possible roles of iron and zinc.

We explored if linoleic acid (LA) and alpha-linolenic acid (ALA) will be efficiently converted to arachidonic acid (AA) and docosahexaenoic acid (DHA) in the adolescent girls (aged 15-18 years, n=145) in Mozambique consuming habitually low fat diet and if low iron and/or zinc status predicts the conversion. Total fat, LA and ALA intakes were 15-19%, 1.2-3.

Mid-upper arm circumference is associated with biochemically determined nutritional status indicators among adolescent girls in Central Mozambique.

Biochemically determined nutritional status measurements in low-income countries are often too expensive. Therefore, we hypothesized that some anthropometrical or functional measurements (handgrip) could reflect nutritional status measured by specific biochemical indicators. We did a population-based study from 1 urban area and 2 rural districts in Zambézia Province of Mozambique.

Age at menarche and diet among adolescents in slums of Nashik, India.

Background And Aim: The role of dietary patterns in determining age at menarche is insufficiently understood in low-income countries. The relationship between dietary patterns, particularly the consumption of oil, and age at menarche in a slum-dwelling adolescent population in India is examined.

Methods: Data were derived from a cross-sectional baseline survey and anthropometric measurements among 10- to 19-year-old adolescents (n=545, female respondents 272, of whom 160 were post-menarcheal) and a household survey in two slums in the city of Nashik, Western India.

FERTILITY INTENTIONS AND EARLY LIFE HEALTH STRESS AMONG WOMEN IN EIGHT INDIAN CITIES: TESTING THE REPRODUCTIVE ACCELERATION HYPOTHESIS.

In life history theory, early life adversity is associated with an accelerated reproductive tempo. In harsh and unpredictable conditions in developing societies fertility is generally higher and the reproductive tempo faster than in more secure environments. This paper examines whether differences in female anthropometry, particularly adult height, are associated with fertility intentions of women in urban environments in India.

Optimal designs for epidemiologic longitudinal studies with binary outcomes.

Alternating presence and absence of a medical condition in human subjects is often modelled as an outcome of underlying process dynamics. Longitudinal studies provide important insights into research questions involving such dynamics. This article concerns optimal designs for studies in which the dynamics are modelled as a binary continuous-time Markov process.

Estimating haplotype frequencies by combining data from large DNA pools with database information.

We assume that allele frequency data have been extracted from several large DNA pools, each containing genetic material of up to hundreds of sampled individuals. Our goal is to estimate the haplotype frequencies among the sampled individuals by combining the pooled allele frequency data with prior knowledge about the set of possible haplotypes. Such prior information can be obtained, for example, from a database such as HapMap.

Process evaluation of a tobacco prevention program in Indian schools--methods, results and lessons learnt.

In India, 57% of men between 15 and 54 years and 10.8% of women between 15 and 49 years use tobacco. A wide variety of tobacco gets used and the poor and the underprivileged are the dominant victims of tobacco and its adverse consequences.

Anti-microbial resistance stratified by risk factor among Escherichia coli strains isolated from the urinary tract at a rural clinic in Central India.

Background: The failure of empirical therapy is frequently observed, even in community-acquired urinary tract infections. We, therefore, conducted a prospective, clinic-based study in 2004-2005 to document anti-microbial resistance rates and correlate them with possible risk factors to assist empirical decision-making.

Materials And Methods: Symptomatic patients with pyuria underwent urine culture.

Relative risks for stroke by age, sex, and population based on follow-up of 18 European populations in the MORGAM Project.

Background And Purpose: Within the framework of the MOnica Risk, Genetics, Archiving and Monograph (MORGAM) Project, the variations in impact of classical risk factors of stroke by population, sex, and age were analyzed.

Methods: Follow-up data were collected in 43 cohorts in 18 populations in 8 European countries surveyed for cardiovascular risk factors. In 93 695 persons aged 19 to 77 years and free of major cardiovascular disease at baseline, total observation years were 1 234 252 and the number of stroke events analyzed was 3142.

Joint analysis of prevalence and incidence data using conditional likelihood.

Disease prevalence is the combined result of duration, disease incidence, case fatality, and other mortality. If information is available on all these factors, and on fixed covariates such as genotypes, prevalence information can be utilized in the estimation of the effects of the covariates on disease incidence. Study cohorts that are recruited as cross-sectional samples and subsequently followed up for disease events of interest produce both prevalence and incidence information.

Estimating population haplotype frequencies from pooled DNA samples using PHASE algorithm.

Recent studies show that the PHASE algorithm is a state-of-the-art method for population-based haplotyping from individually genotyped data. We present a modified version of PHASE for estimating population haplotype frequencies from pooled DNA data. The algorithm is compared with (i) a maximum likelihood estimation under the multinomial model and (ii) a deterministic greedy algorithm, on both simulated and real data sets (HapMap data).

Gender differences in genetic risk profiles for cardiovascular disease.

Background: Cardiovascular disease (CVD) incidence, complications and burden differ markedly between women and men. Although there is variation in the distribution of lifestyle factors between the genders, they do not fully explain the differences in CVD incidence and suggest the existence of gender-specific genetic risk factors. We aimed to estimate whether the genetic risk profiles of coronary heart disease (CHD), ischemic stroke and the composite end-point of CVD differ between the genders.

Nested case-control data utilized for multiple outcomes: a likelihood approach and alternatives.

Suppose a nested case-control design has been applied for collecting covariate data when studying a specific disease. With possible new outcomes of interest it would be sensible to utilize the previously selected control group instead of (or in addition to) a new control selection, given that the same covariate data were relevant and available, and that their measurements had adequate stability and quality. We formulate this problem in the framework of the competing risks survival model.