Analyzing Adherence to Prenatal Supplement: Does Pill Count Measure Up?

Objective. To determine if adherence as measured by pill count would show a significant association with serum-based measures of adherence. Methods. Data were obtained from a prenatal vitamin D supplementation trial where subjects were stratified by race and randomized into three dosing groups: 400 (control), 2000, or 4000 IU vitamin D3/day. One measurement of adherence was obtained via pill counts remaining compared to a novel definition for adherence using serum 25-hydroxy-vitamin D (25-OH-D) levels (absolute change in 25(OH)D over the study period and the subject's steady-state variation in their 25(OH)D levels). A multivariate logistic regression model examined whether mean percent adherence by pill count was significantly associated with the adherence measure by serum metabolite levels. Results. Subjects' mean percentage of adherence by pill count was not a significant predictor of adherence by serum metabolite levels. This finding was robust across a series of sensitivity analyses. Conclusions. Based on our novel definition of adherence, pill count was not a reliable predictor of adherence to protocol, and calls into question how adherence is measured in clinical research. Our findings have implications regarding the determination of efficacy of medications under study and offer an alternative approach to measuring adherence of long half-life supplements/medications

Vaccino antinfluenzale stagionale in Italia: misurare l’efficacia sul campo e la sicurezza : Stagione 2015-2016

In Italia, nella stagione influenzale 2015-2016 sono stati condotti dall\u2019Istituto Superiore di Sanit\ue0 (ISS), con il supporto dell\u2019Agenzia Italiana del Farmaco (AIFA), due studi al fine di stimare l\u2019efficacia sul campo (I-MOVE, Influenza - Monitoring Vaccine Effectiveness) e valutare la sicurezza (SVEVA, Studio sulla Valutazione degli Eventi dopo Vaccinazione Antinfluenzale) del vaccino antinfluenzale. Nel complesso hanno aderito 8 Regioni che corrispondono a oltre met\ue0 della popolazione italiana nel 2015 (non tutte le Regioni hanno aderito a entrambi gli obiettivi di studio). Nello studio I-MOVE sono stati reclutati 1.094 casi di ILI (Influenza-Like Illness), dai 64 medici di medicina generale e pediatri di libera scelta partecipanti (506 casi e 498 controlli). I risultati suggeriscono che il vaccino ha conferito una protezione moderata nei confronti del tipo virale A(H1N1)pdm09 e molto bassa per A(H3N2) e B a causa del sostanziale grado di mismatch antigenico osservato, rispetto al ceppo vaccinale. Nello studio SVEVA sono stati monitorati 3.213 soggetti vaccinati e rilevati 854 (26%) eventi dopo 7 giorni dalla vaccinazione, la maggior parte dei quali di lieve entit\ue0. Al fine di ottenere stime di efficacia pi\uf9 solide e descrivere eventi avversi rari, \ue8 necessario tuttavia raggiungere una numerosit\ue0 campionaria maggiore.In Italy, during the 2015/2016 flu season, the National Institute of Health (ISS), with the support of the Italian Drug Agency (AIFA), conducted two studies to estimate vaccine effectiveness (I-MOVE) and evaluate safety (SVEVA) of the flu vaccine. A total of 8 regions, among 21, participated to the study which can correspond to more than 50% of the Italian population in 2015 (not all regions participated to both objectives of the study). For the I-MOVE study, 1094 cases of ILI (506 cases and 498 controls) were recruited by 64 general practitioners and pediatricians. The results indicate that the vaccine gave moderate protection against the virus type A (H1N1) pdm09 and very low protection for A (H3N2) and B due to the antigenic mismatch that was observed, compared to the vaccine strain. For SVEVA study, 3213 vaccinated cases were monitored and 854 (26%) side effects were notified after 7 days of vaccination, the major part were mild. In order to obtain more solid data regarding vaccine effectiveness, and to describe rare adverse events, it is necessary to increase the sample size of both studies

Mandatory and recommended vaccination in the EU, Iceland and Norway: results of the VENICE 2010 survey on the ways of implementing national vaccination programmes

This report provides an updated overview of recommended and mandatory vaccinations in the European Union (EU), Iceland and Norway, considering the differences in vaccine programme implementation between countries. In 2010, the Vaccine European New Integrated Collaboration Effort (VENICE) network, conducted a survey among the VENICE project gatekeepers to learn more about how national vaccination programmes are implemented, whether recommended or mandatory. Information was collected from all 27 EU Member States, Iceland and Norway. In total 15 countries do not have any mandatory vaccinations; the remaining 14 have at least one mandatory vaccination included in their programme. Vaccination against polio is mandatory for both children and adults in 12 countries; diphtheria and tetanus vaccination in 11 countries and hepatitis B vaccination in 10 countries. For eight of the 15 vaccines considered, some countries have a mixed strategy of recommended and mandatory vaccinations. Mandatory vaccination may be considered as a way of improving compliance to vaccination programmes. However, compliance with many programmes in Europe is high, using only recommendations. More information about the diversity in vaccine offer at European level may help countries to adapt vaccination strategies based on the experience of other countries. However, any proposal on vaccine strategies should be developed taking into consideration the local context habits

Impact of Feedback on Three Phases of Performance Monitoring

We investigated if certain phases of performance monitoring show differential sensitivity to external feedback and thus rely on distinct mechanisms. The phases of interest were: the error phase (FE), the phase of the correct response after errors (FEC), and the phase of correct responses following corrects (FCC). We tested accuracy and reaction time (RT) on 12 conditions of a continuous-choice-response task; the 2-back task. External feedback was either presented or not in FE and FEC, and delivered on 0%, 20%, or 100% of FCC trials. The FCC20 was matched to FE and FEC in the number of sounds received so that we could investigate when external feedback was most valuable to the participants. We found that external feedback led to a reduction in accuracy when presented on all the correct responses. Moreover, RT was significantly reduced for FCC100, which in turn correlated with the accuracy reduction. Interestingly, the correct response after an error was particularly sensitive to external feedback since accuracy was reduced when external feedback was presented during this phase but not for FCC20. Notably, error-monitoring was not influenced by feedback-type. The results are in line with models suggesting that the internal error-monitoring system is sufficient in cognitively demanding tasks where performance is ∼ 80%, as well as theories stipulating that external feedback directs attention away from the task. Our data highlight the first correct response after an error as particularly sensitive to external feedback, suggesting that important consolidation of response strategy takes place here

Mandatory and recommended vaccination in the EU, Iceland and Norway: results of the VENICE 2010 survey on the ways of implementing national vaccination programmes

This report provides an updated overview of recommended and mandatory vaccinations in the European Union (EU), Iceland and Norway, considering the differences in vaccine programme implementation between countries. In 2010, the Vaccine European New Integrated Collaboration Effort (VENICE) network, conducted a survey among the VENICE project gatekeepers to learn more about how national vaccination programmes are implemented, whether recommended or mandatory. Information was collected from all 27 EU Member States, Iceland and Norway. In total 15 countries do not have any mandatory vaccinations; the remaining 14 have at least one mandatory vaccination included in their programme. Vaccination against polio is mandatory for both children and adults in 12 countries; diphtheria and tetanus vaccination in 11 countries and hepatitis B vaccination in 10 countries. For eight of the 15 vaccines considered, some countries have a mixed strategy of recommended and mandatory vaccinations. Mandatory vaccination may be considered as a way of improving compliance to vaccination programmes. However, compliance with many programmes in Europe is high, using only recommendations. More information about the diversity in vaccine offer at European level may help countries to adapt vaccination strategies based on the experience of other countries. However, any proposal on vaccine strategies should be developed taking into consideration the local context habits

Health technology assessments on human papillomavirus vaccinations in Europe: A survey from VENICE network

Background: VENICE II is a project funded in 2008 by the European Centre for Disease Prevention and Control to collect information on the national vaccination programmes, to increase their knowledge and to know the impact of new vaccines introduced in member states (MS). In 2006-2007, two vaccines against human papillomavirus (HPV) were authorized in Europe. Methods: An online survey was carried out to investigate the decision-making process undertaken regarding the potential introduction of the HPV vaccinations into MS national immunization programmes as well as to investigate the modalities of implementation of the vaccination programmes. There were specific questions about health technology assessment and reports of the countries that had carried them out were reviewed. Results: In 21 of the 29 MS, the national advisory body recommended to introduce HPV vaccination in their national immunization schedule and in 18 countries introduced it. Only 6 countries have realized a health technology assessments (HTA) report, each one with different methodology, but in all of them both vaccines show positive evaluations. Conclusion: From the available HTA, HPV vaccination is cost-effective under the assumption of a lifelong protection. Screening programme for cervical cancer and HPV vaccination programme should be always complementary. Organizational aspects need to be taken into account to improve the vaccination. HPV vaccination should target girls before the debut of their sexual life. Instead HPV vaccination of boys has not been demonstrated as bringing significant epidemiological benefits and has not been shown as being cost-effective

Seasonal influenza immunisation in Europe. Overview of recommendations and vaccination coverage for three seasons: pre-pandemic (2008/09), pandemic (2009/10) and post-pandemic (2010/11)

Since 2008, annual surveys of influenza vaccination policies, practices and coverage have been undertaken in 29 European Union (EU)/ European Economic Area (EEA) countries. After 2009, this monitored the impact of European Council recommendation to increase vaccination coverage to 75% among risk groups. This paper summarises the results of three seasonal influenza seasons: 2008/09, 2009/10 and 2010/11. In 2008/09, 27/29 countries completed the survey; in 2009/10 and 2010/11, 28/29 completed it. All or almost all countries recommended vaccination of older people (defined as those aged ≥50, ≥55, ≥59, ≥60 or ≥65 years), and people aged ≥6 months with clinical risk and healthcare workers. A total of 23 countries provided vaccination coverage data for older people, but only 7 and 10 had data for the clinical risk groups and healthcare workers, respectively. The number of countries recommending vaccination for some or all pregnant women increased from 10 in 2008/09 to 22 in 2010/11. Only three countries could report coverage among pregnant women. Seasonal influenza vaccination coverage during and after the pandemic season in older people and clinical groups remained unchanged in countries with higher coverage. However, small decreases were seen in most countries during this period. The results of the surveys indicate that most EU/EEA countries recommend influenza vaccination for the main target groups; however, only a few countries have achieved the target of 75% coverage among risk groups. Coverage among healthcare workers remained low

Active surveillance for safety monitoring of seasonal influenza vaccines in Italy, 2015/2016 season

Background: Surveillance for adverse events following immunization is an important component of any national immunization programme because it is critical to assessing the safety of vaccines and to detecting potentially rare and severe adverse events and responding in a timely manner. We conducted an enhanced active surveillance aimed at assessing the safety of flu vaccines in the 2015-2016 season in Italy. The study was targeted to the population groups for which the seasonal vaccine is recommended in Italy. Methods: During the study period, a total of 3213 individuals receiving seasonal influenza vaccination were registered on the web-based platform. Any adverse events experienced after 7 days from vaccination by individuals aged six months or more were collected through a telephone interview or by a web-based self-administered questionnaire. All individuals experiencing at least one event during the 7 days of follow-up were contacted for follow-up to 60 days. Results: Overall, 854 events were reported: 845 events (26%) after administration of the first dose and 9 (12%) after the second dose. The majority of adverse events reported after 7 days from the first dose were of little clinical importance, and most involved local symptoms. Conclusion: Our data, even though the number of vaccinated individuals was smaller than expected, is consistent with the safety of influenza vaccines in Italy during the 2015-2016 season regarding the most common adverse events. Further efforts are needed to obtain sufficient power to study rarer adverse events. Active monitoring and systematic studies to test generated signals and hypotheses are crucial to intensify awareness among the public and professionals with regard to the safety of vaccines