Comparative efficacy and safety of biosimilar infliximab and other biological treatments in ankylosing spondylitis: systematic literature review and meta-analysis.

OBJECTIVES: To compare the efficacy and safety of infliximab-biosimilar with other biological drugs for the treatment of active ankylosing spondylitis (AS). METHODS: Systematic literature review for randomized controlled trials (RCTs) with adalimumab, etanercept, golimumab, infliximab and infliximab-biosimilar in AS was performed and indirect meta-analysis (Bayesian mixed treatment comparison) was carried out. The proportion of patients reaching 20 % improvement by the assessment of Spondyloarthritis International Society response criteria (ASAS20) at weeks 12 and 24 was used as efficacy endpoints, and the occurrence of serious adverse events at week 24 was applied to compare the safety of the biologicals. RESULTS: Altogether, 13 RCTs, identified by the systematic literature search, were included in the analysis. Results on the ASAS20 efficacy endpoint were reported for week 12 in 12 RCTs involving 2,395 patients, and for week 24 in 5 RCTs comprising 1,337 patients. All the five biological agents proved to be significantly superior to placebo. Infliximab showed the highest odds ratio (OR) of 7.2 (95 % CI 3.68-13.19) compared to placebo, followed by infliximab-biosimilar with OR 6.25 (95 % CI 2.55-13.14), both assessed at week 24. No significant difference was found between infliximab-biosimilar and other biological treatments regarding their efficacy and safety. CONCLUSIONS: This is the first study which includes a biosimilar drug in the meta-analysis of biological treatments in AS. The results have proven the similar efficacy and safety profile of infliximab-biosimilar treatment compared to other biologicals.

Systemic country differences in the European innovation performance - Does institutional context matter?

The so-called "High Performance Working System" (HPWS) and the lean production are representing the theoretical and methodological foundations of this paper. In this relation it is worth making distinction between various theoretical streams of the HPWS. The first theoretical stream in the literature is focusing on the diffusion of the Japanese-style management and organizational practices both in the US and in the Europe. The second theoretical strand comprises the approach of sociology of work and dealing with the learning/innovation capabilities of the new forms of work organization. Finally, the third theoretical approach is addressing on the types of knowledge and learning process and their relations with the innovation capabilities of the firm. The authors’ analysis is based on the international comparison, both in regional and in cross country comparison. For regional comparison the share of ICT clusters in Europe, USA and the rest of the world was assessed. For the purpose of the cross-country comparison in the EU, the innovation performance measured by the index Innovation Union Scoreboard (IUS) was used in both the before and after the financial crisis.

The role of overseas Chinese investment in the emerging countries of Southeast and East Asia: A Confucian model of the foreign direct investment decision-making process using factors unconsidered in the West

The purpose of this study was to gain a better understanding of the foreign direct investment location decision making process through the examination of non-Western investors and their investment strategies in non-traditional markets. This was accomplished through in-depth personal interviews with 50 Overseas Chinese business owners and executives in several different industries from Hong Kong, Singapore, Taiwan, Malaysia, and Thailand about 97 separate investment projects in Southeast and East Asia, including The Philippines, Malaysia, Hong Kong, Singapore, Vietnam, India, Pakistan, South Korea, Australia, Indonesia, Cambodia, Thailand, Burma, Taiwan, and Mainland China.^ Traditional factors utilized in Western models of the foreign direct investment decision making process are reviewed, as well as literature on Asian management systems and the current state of business practices in emerging countries of Southeast and East Asia. Because of the lack of institutionalization in these markets and the strong influences of Confucian and patriarchal value systems on the Overseas Chinese, it was suspected that while some aspects of Western rational economic models of foreign direct investment are utilized, these models are insufficient in this context, and thus are not fully generalizable to the unique conditions of the Overseas Chinese business network in the region without further modification.^ Thus, other factors based on a Confucian value system need to be integrated into these models. Results from the analysis of structured interviews suggest Overseas Chinese businesses rely more heavily on their network and traditional Confucian values than rational economic factors when making their foreign direct investment location decisions in emerging countries in Asia. This effect is moderated by the firm's industry and the age of the firm's owners. ^

Atlantic Ais in the Sixteenth and Seventeenth Centuries: Maritime Adaptation, Indigenous Wrecking, and Buccaneer Raids on Florida’s Central East Coast

The Ais were a Native American group who lived along the Atlantic shoreline of Florida south of Cape Canaveral. This coastal population’s position adjacent to a major shipping route afforded them numerous encounters with the Atlantic world that linked Europe, Africa, the Caribbean, and the Americas. Through their exploitation of the goods and peoples from the European shipwrecks thrown ashore, coupled with their careful manipulation of other Atlantic contacts, the Ais polity established an influential domain in central east Florida during the sixteenth and seventeenth centuries. The pre-contact peoples of Florida’s east coast, including the ancestors of the Ais, practiced a maritime adaptation concentrated on the exploitation of their bountiful riverine, estuarine, and marine environments. The Ais then modified their maritime skills to cope with the opportunities and challenges that accompanied European contact. Using their existing aquatic abilities, they ably salvaged goods and castaways from the Spanish, French, English, and Dutch vessels dashed on the rocks and reefs of Florida’s coast. The Ais’ strategic redistribution of these materials and peoples to other Florida Native Americans, the Spaniards of St. Augustine, and other passing Europeans gained them greater influence. This process, which I call indigenous wrecking, enabled the Ais to expand their domain on the peninsula. Coastal Florida Native Americans’ maritime abilities also attracted the attention of Europeans. In the late seventeenth century, English buccaneers and salvagers raided Florida’s east coast to capture indigenous divers, whom they sent to work the wreck of a sunken Spanish treasure ship located in the Bahamas. The English subsequently sold the surviving Native American captives to other Caribbean slave markets. Despite population losses to such raids, the Ais and other peoples of the east coast thrived on Atlantic exchange and used their existing maritime adaptation to resist colonial intrusions until the start of the eighteenth century. This dissertation thus offers a narrative about Native Americans and the Atlantic that is unlike most Southeastern Indian stories. The Ais used their maritime adaptation and the process of indigenous wrecking to engage and exploit the arriving Atlantic world. In the contact era, the Ais truly became Atlantic Ais.

Compilation of maximum ingestion and maximum clearance rate data for marine pelagic organisms

The metabolic rate of organisms may either be viewed as a basic property from which other vital rates and many ecological patterns emerge and that follows a universal allometric mass scaling law; or it may be considered a property of the organism that emerges as a result of the organism's adaptation to the environment, with consequently less universal mass scaling properties. Data on body mass, maximum ingestion and clearance rates, respiration rates and maximum growth rates of animals living in the ocean epipelagic were compiled from the literature, mainly from original papers but also from previous compilations by other authors. Data were read from tables or digitized from graphs. Only measurements made on individuals of know size, or groups of individuals of similar and known size were included. We show that clearance and respiration rates have life-form-dependent allometries that have similar scaling but different elevations, such that the mass-specific rates converge on a rather narrow size-independent range. In contrast, ingestion and growth rates follow a near-universal taxa-independent ~3/4 mass scaling power law. We argue that the declining mass-specific clearance rates with size within taxa is related to the inherent decrease in feeding efficiency of any particular feeding mode. The transitions between feeding mode and simultaneous transitions in clearance and respiration rates may then represent adaptations to the food environment and be the result of the optimization of tradeoffs that allow sufficient feeding and growth rates to balance mortality.

Compilation of respiration rate data for marine pelagic organisms

The metabolic rate of organisms may either be viewed as a basic property from which other vital rates and many ecological patterns emerge and that follows a universal allometric mass scaling law; or it may be considered a property of the organism that emerges as a result of the organism's adaptation to the environment, with consequently less universal mass scaling properties. Data on body mass, maximum ingestion and clearance rates, respiration rates and maximum growth rates of animals living in the ocean epipelagic were compiled from the literature, mainly from original papers but also from previous compilations by other authors. Data were read from tables or digitized from graphs. Only measurements made on individuals of know size, or groups of individuals of similar and known size were included. We show that clearance and respiration rates have life-form-dependent allometries that have similar scaling but different elevations, such that the mass-specific rates converge on a rather narrow size-independent range. In contrast, ingestion and growth rates follow a near-universal taxa-independent ~3/4 mass scaling power law. We argue that the declining mass-specific clearance rates with size within taxa is related to the inherent decrease in feeding efficiency of any particular feeding mode. The transitions between feeding mode and simultaneous transitions in clearance and respiration rates may then represent adaptations to the food environment and be the result of the optimization of tradeoffs that allow sufficient feeding and growth rates to balance mortality.

Data compilation on the biological response to ocean acidification: environmental and experimental context of data sets and related literature

The exponential growth of studies on the biological response to ocean acidification over the last few decades has generated a large amount of data. To facilitate data comparison, a data compilation hosted at the data publisher PANGAEA was initiated in 2008 and is updated on a regular basis (doi:10.1594/PANGAEA.149999). By January 2015, a total of 581 data sets (over 4 000 000 data points) from 539 papers had been archived. Here we present the developments of this data compilation five years since its first description by Nisumaa et al. (2010). Most of study sites from which data archived are still in the Northern Hemisphere and the number of archived data from studies from the Southern Hemisphere and polar oceans are still relatively low. Data from 60 studies that investigated the response of a mix of organisms or natural communities were all added after 2010, indicating a welcomed shift from the study of individual organisms to communities and ecosystems. The initial imbalance of considerably more data archived on calcification and primary production than on other processes has improved. There is also a clear tendency towards more data archived from multifactorial studies after 2010. For easier and more effective access to ocean acidification data, the ocean acidification community is strongly encouraged to contribute to the data archiving effort, and help develop standard vocabularies describing the variables and define best practices for archiving ocean acidification data.

Data compilation of dinoflagellates growth rate, grazing rate and gross gowth efficiency from field and labratory experiments

The present data compilation includes dinoflagellates growth rate, grazing rate and gross growth efficiency determined either in the field or in laboratory experiments. From the existing literature, we synthesized all data that we could find on dinoflagellates. Some sources might be missing but none were purposefully ignored. We did not include autotrophic dinoflagellates in the database, but mixotrophic organisms may have been included. This is due to the large uncertainty about which taxa are mixotrophic, heterotrophic or symbiont bearing. Field data on microzooplankton grazing are mostly comprised of grazing rate using the dilution technique with a 24h incubation period. Laboratory grazing and growth data are focused on pelagic ciliates and heterotrophic dinoflagellates. The experiment measured grazing or growth as a function of prey concentration or at saturating prey concentration (maximal grazing rate). When considering every single data point available (each measured rate for a defined predator-prey pair and a certain prey concentration) there is a total of 801 data points for the dinoflagellates, counting experiments that measured growth and grazing simultaneously as 1 data point.

Compilation of growth rate data for marine pelagic organisms

The metabolic rate of organisms may either be viewed as a basic property from which other vital rates and many ecological patterns emerge and that follows a universal allometric mass scaling law; or it may be considered a property of the organism that emerges as a result of the organism's adaptation to the environment, with consequently less universal mass scaling properties. Data on body mass, maximum ingestion and clearance rates, respiration rates and maximum growth rates of animals living in the ocean epipelagic were compiled from the literature, mainly from original papers but also from previous compilations by other authors. Data were read from tables or digitized from graphs. Only measurements made on individuals of know size, or groups of individuals of similar and known size were included. We show that clearance and respiration rates have life-form-dependent allometries that have similar scaling but different elevations, such that the mass-specific rates converge on a rather narrow size-independent range. In contrast, ingestion and growth rates follow a near-universal taxa-independent ~3/4 mass scaling power law. We argue that the declining mass-specific clearance rates with size within taxa is related to the inherent decrease in feeding efficiency of any particular feeding mode. The transitions between feeding mode and simultaneous transitions in clearance and respiration rates may then represent adaptations to the food environment and be the result of the optimization of tradeoffs that allow sufficient feeding and growth rates to balance mortality.

Data compilation of ciliates growth rate, grazing rate and gross gowth efficiency from field and labratory experiments

The present data compilation includes ciliates growth rate, grazing rate and gross growth efficiency determined either in the field or in laboratory experiments. From the existing literature, we synthesized all data that we could find on cilliate. Some sources might be missing but none were purposefully ignored. Field data on microzooplankton grazing are mostly comprised of grazing rate using the dilution technique with a 24h incubation period. Laboratory grazing and growth data are focused on pelagic ciliates and heterotrophic dinoflagellates. The experiment measured grazing or growth as a function of prey concentration or at saturating prey concentration (maximal grazing rate). When considering every single data point available (each measured rate for a defined predator-prey pair and a certain prey concentration) there is a total of 1485 data points for the ciliates, counting experiments that measured growth and grazing simultaneously as 1 data point.

Registry of selected samples from the Tara Oceans Expedition (2009-2013)

The present data set is a registry of samples from the Tara Oceans Expedition (2009-2013) that were selected for publication in a special issue of the SCIENCE journal (see related references below). The registry provides details about the sampling location and methodology of each sample. Uniform resource locators (URLs) offer direct links to additional contextual environmental data and to the corresponding sequence runs used for analysis in the related literature publications in the SCIENCE journal.

Study protocol of European Fans in Training (EuroFIT) : a four-country randomised controlled trial of a lifestyle program for men delivered in elite football clubs

Funding The EuroFIT study is funded by the European Union’s Seventh Framework Program for research technological development and demonstration under Grant Agreement no: 602170. The Health Services Research Unit, University of Aberdeen, is core funded by the Chief Scientist Office of the Scottish Government Health Directorates.

Costs and effects of new professional roles : Evidence from a literature review

“The authors wish to thank the European Commission for funding this research programme ‘Health Care Reform: The iMpact on practice, oUtcomes and cost of New ROles for health profeSsionals (MUNROS), under the European Community’s Seventh Framework Programme (FP7 HEALTH-2012-INNOVATION-1) grant agreement number HEALTH-F3-2012-305467EC. The authors also wish to thank all those who supported and guided this work both within the MUNROS research project team and as external associates. In particular we would like to thank Mathijs Kelder for his valuable contribution in the review process. The authors also wish to thank all the MUNROS research and project partners for their continuing collaboration in this research”.

Costs and effects of new professional roles : Evidence from a literature review

“The authors wish to thank the European Commission for funding this research programme ‘Health Care Reform: The iMpact on practice, oUtcomes and cost of New ROles for health profeSsionals (MUNROS), under the European Community’s Seventh Framework Programme (FP7 HEALTH-2012-INNOVATION-1) grant agreement number HEALTH-F3-2012-305467EC. The authors also wish to thank all those who supported and guided this work both within the MUNROS research project team and as external associates. In particular we would like to thank Mathijs Kelder for his valuable contribution in the review process. The authors also wish to thank all the MUNROS research and project partners for their continuing collaboration in this research”.

Costs and effects of new professional roles : Evidence from a literature review

“The authors wish to thank the European Commission for funding this research programme ‘Health Care Reform: The iMpact on practice, oUtcomes and cost of New ROles for health profeSsionals (MUNROS), under the European Community’s Seventh Framework Programme (FP7 HEALTH-2012-INNOVATION-1) grant agreement number HEALTH-F3-2012-305467EC. The authors also wish to thank all those who supported and guided this work both within the MUNROS research project team and as external associates. In particular we would like to thank Mathijs Kelder for his valuable contribution in the review process. The authors also wish to thank all the MUNROS research and project partners for their continuing collaboration in this research”.