Healthcare professionals' self-reported experiences and preferences related to direct healthcare professional communications:a survey conducted in the Netherlands

Background: In Europe, Direct Healthcare Professional Communications (DHPCs) are important tools to inform healthcare professionals of serious, new drug safety issues. However, this tool has not always been successful in effectively communicating the desired actions to healthcare professionals. Objective: The aim of this study was to explore healthcare providers' experiences and their preferences for improvement of risk communication, comparing views of general practitioners (GPs), internists, community pharmacists and hospital pharmacists. Methods: A questionnaire was developed and pilot tested to assess experiences and preferences of Dutch healthcare professionals with DHPCs. The questionnaire and two reminders were sent to a random sample of 3488 GPs, internists and community and hospital pharmacists in the Netherlands. Descriptive statistics were used to describe demographic characteristics of the respondents. Chi squares, ANOVAs and the Wilcoxon signed rank test were used, when appropriate, to compare healthcare professional groups. Results: The overall response rate was 34% (N=1141, ranging from 24% for internists to 46% for community pharmacists). Healthcare providers trusted safety information more when provided by the Dutch Medicines Evaluation Board (MEB) than by the pharmaceutical industry. This was more the case for GPs than for the other healthcare professionals. Respondents preferred safety information to be issued by the MEB, the Dutch Pharmacovigilance Center or their own professional associations. The preferred alternative channels of drug safety information were e-mail, medical journals and electronic prescribing systems. Conclusions: Safety information of drugs does not always reach healthcare professionals through DHPCs. To improve current risk communication of drug safety issues, alternative and/or additional methods of risk communication should be developed using electronic methods and medical journals. Moreover, (additional) risk communication coming from an independent source such as the MEB should be considered. Special effort is needed to reach GPs

The complete mitochondrial genome of the rodent intra-arterial nematodes Angiostrongylus cantonensis and Angiostrongylus costaricensis

The two rodent intra-arterial nematodes, Angiostrongylus cantonensis and Angiostrongylus costaricensis, can cause human ill-health. The present study aimed to characterize and compare the mitochondrial (mt) genomes of these two species, and clarify their phylogenetic relationship and the position in the phylum Nematoda. The complete mt genomes of A. cantonensis and A. costaricensis are 13,497 and 13,585bp in length, respectively. Hence, they are the smallest in the class of Chromadorea characterized thus far. Like many nematode species in the class of Chromadorea, they encode 12 proteins, 22 transfer RNAs, and two ribosomal RNAs. All genes are located on the same strand. Nucleotide identity of the two mt genomes is 81.6%, ranging from 77.7% to 87.1% in individual gene pairs. Our mt genome-wide analysis identified three major gene arrangement patterns (II-1, II-2, and II-3) from 48 nematode mt genomes. Both patterns II-1 and II-2 are distinct from pattern II-3, which covers the Spirurida, supporting a closer relationship between Ascaridida and Strongylida rather than Spirurida. Thymine (T) was highly concentrated on coding strands in Chromadorea, but balanced between the two strands in Enoplea, probably due to the gene arrangement pattern. Interestingly, the gene arrangement pattern of mt genomes and phylogenetic analysis based on concatenated amino acids indicated a closer relationship between the order Ascaridida and Rhabditida rather than Spirurida as indicated in previous studies. These discrepancies call for new research, reassessing the position of the order of Ascaridida in the phylogenetic tree. Once consolidated, the findings are important for population genetic studies and target identificatio

Digital Data, Administrative Data, and Survey Compared: Updating the Classical Toolbox for Assessing Data Quality of Big Data, Exemplified by the Generation of Corruption Data

In the digital age, new data types have become available that can, potentially, be used in social science research. Besides data that were originally created for scientific purposes (research-elicited data), administrative mass data (traditional-type big data) and data from digital devices (new-type big data) have become more and more relevant for research processes. Both data types can be subsumed under the term “big data.” In this paper, we scrutinize the quality of administrative mass data on corruption in contrast to research-elicited data (e.g., survey data). Since data quality is crucial for the measurement of a social phenomenon such as corruption, we pose the question of how a social phenomenon can be measured by means of data from these different sources. As a first step, we refer to the so-called Bick-Mueller-Model. It was developed in the 1980s for observing the special features and particularities of administrative mass data (traditional-type big data). We contrast this model with the so-called Error-Approach that is typically applied in survey research. In order to account for new trends in data generation and application, we show the progress that has been made since Bick and Mueller introduced their model and discuss new features of digitalism and new technologies. We conclude that the features of the so-called Bick-Mueller are useful for tackling the particularities of administrative data and also – to some degree – new-type big data. The “error” perspective that is inherent both in the classical survey research and in the so-called Bick-Mueller model also applies to new-type big data when it comes to assessing their quality. Moreover, it is possible that the data from these different sources can complement each other. For this, researchers must be aware of the fact that neither data source actually measures corruption directly. For answering specific research questions, it is crucial to consider the advantages and disadvantages of using specific data types

Additional safety risk to exceptionally approved drugs in Europe?

AIMS Regulatory requirements for new drugs have increased. Special approval procedures with priority assessment are possible for drugs with clear 'unmet medical need'. We question whether these Exceptional Circumstances (EC) or Conditional Approval (CA) procedures have led to a higher probability of serious safety issues. METHODS A retrospective cohort study was performed of new drugs approved in Europe between 1999 and 2009. The determinant was EC/CA vs. standard procedure approval. Outcome variables were frequency and timing of a first Direct Healthcare Professional Communication (DHPC). An association between approval procedure and the time from market approval to DHPC was assessed using Kaplan-Meyer survival analysis and Cox-regression to correct for covariates. RESULTS In total 289 new drugs were approved. Forty-six (16.4%) were approved under EC or CA, of which seven received a DHPC (15%). This was similar to the standard approval drugs (243), of which 33 received one or more DHPC (14%, P = 0.77). The probability of acquiring a DHPC for standard approval drugs vs. EC/CA drugs during 11-year follow-up is 22% (95% CI 14%, 29%) and 26% (95% CI 8%, 44%), respectively (log-rank P = 0.726). This difference remained not significant in the Cox-regression model: hazard ratio 0.94 (95% CI 0.40, 2.20). Only drug type was identified as a confounding covariate. CONCLUSION The EC/CA procedure is not associated with a higher probability of DHPCs despite limited clinical development data. These data do not support the view that early drug approval increases the risk of serious safety issues emerging after market approval

Positive und negative ethische Aspekte von Korruption

'Korruption ist nicht deswegen ethisch negativ oder gesellschaftlich schädlich zu bewerten, weil sie gegen geltende Gesetze verstößt. Die Auswirkungen von Normen und Gesetzen können gesellschaftlich und wirtschaftlich ambivalent sein und sich auch im Zeitverlauf ändern. Für die Bewertung von Korruption muss daher ein nichtnormativer Ansatz gewählt werden. Für die Bewertung der Konsequenzen von Korruption lassen sich eine Reihe von empirischen und theoretischen Befunden und Meinungen heranziehen, die sich weitgehend auf quantifizierbare Effekte beziehen. Zu den schädlichen Wirkungen gehören beispielsweise, dass der Preis auf Märkten steigt, weil der Wettbewerb verzerrt wird, oder dass Qualitätsmängel bei Gütern oder Dienstleistungen auftreten. Zwar werden in der wissenschaftlichen Literatur überwiegend die schädlichen Wirkungen von Korruption betont, es werden aber auch positive Konsequenzen genannt wie etwa die Beschleunigung administrativer Leistungen beim so genannten Speed Money. Es lässt sich sogar zeigen, dass Korruption nicht automatisch eine pareto-ineffiziente Allokation nach sich ziehen muss. Der Beitrag verschiedener soziologischer Richtungen zur Korruptionstheorie kann insbesondere darin bestehen, die nicht-quantifizierbaren Effekte von Korruption aufzuzeigen. Fasst man Korruption i.S.d. Handlungstheorie als eine Interaktionssequenz zwischen einem Prinzipal, einem Agenten (der für ihn arbeitet) und einem Klienten, der den Agenten besticht, dann lassen sich die schädlichen Auswirkungen von Korruption in einem größeren Rahmen deutlich machen. Korruption kann dann als gesellschaftlich negatives Sozialkapital definiert werden, das destabilisierend wirkt, weil es der Gesellschaft die Vertrauensgrundlage entzieht, die für ihre Existenz lebensnotwendig ist. Fehlendes Vertrauen kann nicht quantifiziert und nicht substituiert werden. Die Un-Ethik von Korruption wird auf diese Weise besser approximiert als über die juristische Tatsache, dass Akteure gegen geltendes Recht verstoßen haben.' (Autorenreferat

The Quality of Big Data: Development, Problems, and Possibilities of Use of Process-Generated Data in the Digital Age

The paper introduces the HSR Forum on digital data by discussing what big data are. The authors show that big data are not a new type of social science data but actually one of the oldest forms of social science data. In addition, big data are not necessarily digital data. Regardless, current methodological debates often assume that “big data” are “digital data.” The authors thus also show that digital data have a big drawback concerning data quality because they do not cover the whole population – due to so-called digital divides, not everybody is on the internet, and who is on the internet, is socially structured. The result is a selection bias. Based on this analysis, the paper concludes that big data and digital data are data like any other type of data – they have both advantages and specific blind spots. So rather than glorifying or demonising them, it seems much more sensible to discuss which specific advantages and drawbacks they have as well as when and how they are better suited for answering specific research questions and when and how other types of data are better suited – these are the questions that are addressed in this HSR Forum

Explaining the emergence of social trust:Denmark and Germany

How does social trust emerge in a country? By comparing the cases of Denmark and Germany through six historical phases, we suggest that a plausible explanation is long run political stability. In Denmark, social trust was arguably allowed to accumulate slowly over time and was probably not destroyed up till the universal welfare state of the 20th century. In Germany, however, political instability since the first German state building hampered the emergence and maintenance of social trust, which is why social trust was never allowed to grow in this country.How does social trust emerge in a country? By comparing thecases of Denmark and Germany through six historical phases, we suggest thata plausible explanation is long run political stability. In Denmark, social trustwas arguably allowed to accumulate slowly over time and was probably notdestroyed up till the universal welfare state of the 20th century. In Germany,however, political instability since the first German state building hamperedthe emergence and maintenance of social trust, which is why social trust wasnever allowed to grow in this country

Explaining the emergence of social trust:Denmark and Germany

How does social trust emerge in a country? By comparing the cases of Denmark and Germany through six historical phases, we suggest that a plausible explanation is long run political stability. In Denmark, social trust was arguably allowed to accumulate slowly over time and was probably not destroyed up till the universal welfare state of the 20th century. In Germany, however, political instability since the first German state building hampered the emergence and maintenance of social trust, which is why social trust was never allowed to grow in this country.How does social trust emerge in a country? By comparing thecases of Denmark and Germany through six historical phases, we suggest thata plausible explanation is long run political stability. In Denmark, social trustwas arguably allowed to accumulate slowly over time and was probably notdestroyed up till the universal welfare state of the 20th century. In Germany,however, political instability since the first German state building hamperedthe emergence and maintenance of social trust, which is why social trust wasnever allowed to grow in this country

Explaining the emergence of social trust: Denmark and Germany

"How does social trust emerge in a country? By comparing the cases of Denmark and Germany through six historical phases, the authors suggest that a plausible explanation is long run political stability. In Denmark, social trust was arguably allowed to accumulate slowly over time and was probably not destroyed up till the universal welfare state of the 20th century. In Germany, however, political instability since the first German state building hampered the emergence and maintenance of social trust, which is why social trust was never allowed to grow in this country." (author's abstract

Mord, Selbstmord und Anomie: ein neuer Ansatz zur Operationalisierung und empirischen Anwendung des Anomiekonstruktes von Emile Durkheim

Die Studie stützt sich auf Durkheims Anomietheorie, in der Mord- und Selbstmordraten als soziale Phänomene begriffen werden, die wiederum nur mit anderen sozialen Tatsachen zu erklären sind. Unter dieser soziologischen Perspektive interessiert also nicht das letztliche Motiv des Selbstmörders bzw. Mörders, sondern der Einfluss gesellschaftlicher Verhältnisse. Im Fokus dieser Analyse stehen variierende Mord- und Selbstmordraten zwischen Gesellschaften und über die Zeit hinweg. Verzichtet wird damit auf biologische und psychologische Erklärungen. Im ersten Abschnitt werden aus der Theorie Durkheims zwei zentrale Aussagen abgeleitet, die dann empirisch überprüft werden. Ziel ist dabei, die Inkongruenzen der bisherigen empirischen Anomieforschung aufzudecken und mit einem neuen Ansatz zu überwinden. Weiterhin wird eine neue Art der empirischen Operationalisierung präsentiert, die es erlaubt, den von Durkheim postulierten Zusammenhang zwischen Mord bzw. Selbstmord und Anomie zu untersuchen. Im dritten Teil werden dann empirische Befunde dargestellt, die Durkheims Thesen zur Anomie stützen. (ICA2