Missing steps in a staircase: a qualitative study of the perspectives of key stakeholders on the use of adaptive designs in confirmatory trials

Background Despite the promising benefits of adaptive designs (ADs), their routine use, especially in confirmatory trials, is lagging behind the prominence given to them in the statistical literature. Much of the previous research to understand barriers and potential facilitators to the use of ADs has been driven from a pharmaceutical drug development perspective, with little focus on trials in the public sector. In this paper, we explore key stakeholders’ experiences, perceptions and views on barriers and facilitators to the use of ADs in publicly funded confirmatory trials. Methods Semi-structured, in-depth interviews of key stakeholders in clinical trials research (CTU directors, funding board and panel members, statisticians, regulators, chief investigators, data monitoring committee members and health economists) were conducted through telephone or face-to-face sessions, predominantly in the UK. We purposively selected participants sequentially to optimise maximum variation in views and experiences. We employed the framework approach to analyse the qualitative data. Results We interviewed 27 participants. We found some of the perceived barriers to be: lack of knowledge and experience coupled with paucity of case studies, lack of applied training, degree of reluctance to use ADs, lack of bridge funding and time to support design work, lack of statistical expertise, some anxiety about the impact of early trial stopping on researchers’ employment contracts, lack of understanding of acceptable scope of ADs and when ADs are appropriate, and statistical and practical complexities. Reluctance to use ADs seemed to be influenced by: therapeutic area, unfamiliarity, concerns about their robustness in decision-making and acceptability of findings to change practice, perceived complexities and proposed type of AD, among others. Conclusions There are still considerable multifaceted, individual and organisational obstacles to be addressed to improve uptake, and successful implementation of ADs when appropriate. Nevertheless, inferred positive change in attitudes and receptiveness towards the appropriate use of ADs by public funders are supportive and are a stepping stone for the future utilisation of ADs by researchers.

A comparison of greenhouse gas emissions in the residential sector of major Canadian cities

One of the most significant sources of greenhouse gas (GHG) emissions in Canada is the buildings sector, with over 30% of national energy end-use occurring in buildings. Energy use must be addressed to reduce emissions from the buildings sector, as nearly 70% of all Canada’s energy used in the residential sector comes from fossil sources. An analysis of GHG emissions from the existing residential building stock for the year 2010 has been conducted for six Canadian cities with different climates and development histories: Vancouver, Edmonton, Winnipeg, Toronto, Montreal, and Halifax. Variation across these cities is seen in their 2010 GHG emissions, due to climate, characteristics of the building stock, and energy conversion technologies, with Halifax having the highest per capita emissions at 5.55 tCO2e/capita and Montreal having the lowest at 0.32 tCO2e/capita. The importance of the provincial electricity grid’s carbon intensity is emphasized, along with era of construction, occupancy, floor area, and climate. Approaches to achieving deep emissions reductions include innovative retrofit financing and city level residential energy conservation by-laws; each region should seek location-appropriate measures to reduce energy demand within its residential housing stock, as well as associated GHG emissions.

Vox Populi, Vox Dei? A closer look at the ‘public opinion’ argument for retention

The Japanese government’s justification for retaining the death penalty is that abolition would erode the legitimacy of and public trust in the criminal justice system, leading to victims’ families taking justice into their own hands. This justification is based on the results of a regularly administered public opinion survey, which is said to show strong public support for the death penalty. However, a close analysis of the results of the 2014 survey fails to validate this claim. Just over a third of respondents were committed to retaining the death penalty at all costs, while the rest accepted the possibility of future abolition, with some of them seeing this as contingent on the introduction of life imprisonment without parole as an alternative sentence. These findings hardly describe a society that expects the strict application of the death penalty and whose trust in justice depends on the government’s commitment to retaining it. My reading of the 2014 survey is that the Japanese public is ready to embrace abolition. Japan, after all, is a signatory to the International Covenant on Civil and Political Rights, which calls on states not to delay or prevent abolition, so this should be welcome news for the Japanese government!

Public–private partnerships in Russia: dynamics contributing to an emerging policy paradigm

Public–private partnerships (PPPs) are new in Russia and represent project implementation in progress. The government is actively pursuing PPP deployment in sectors such as transportation and urban infrastructure, and at all levels including federal, regional and especially local. Despite the lack of pertinent laws and regulations, the PPP public policy quickly transforms into a policy paradigm that provides simplified concepts and solutions and intensifies partnership development. The article delineates an emerging model of Russia’s PPP policy paradigm, whose structure includes the shared understanding of the need for long-term collaboration between the public sector and business, a changing set of government responsibilities that imply an increasing private provision of public services, and new institutional capacities. This article critically appraises the principal dynamics that contribute to an emerging PPP policy paradigm, namely the broad government treatment of the meaning of a partnership and of a contractual PPP; a liberal PPP approval process that lacks clear guidelines and consistency across regions; excessive emphasis on positive PPP externalities and neglect of drawbacks; and unjustifiably extensive government financial support to PPPs. Whilst a paradigm appears to be useful specifically for the policy purpose of PPP expansion, it may also mask inefficiencies such as higher prices of public services and greater government risks.

A potential vorticity signature for the cold sector of winter extratropical cyclones

The cold sector of a midlatitude storm is characterized by distinctive features such as strong surface heat fluxes, shallow convection, convective precipitation and synoptic subsidence. In order to evaluate the contribution of processes occurring in the cold sector to the mean climate, an appropriate indicator is needed. This study describes the systematic presence of negative potential vorticity (PV) behind the cold front of extratropical storms in winter. The origin of this negative PV is analyzed using ERA-Interim data, and PV tendencies averaged over the depth of the boundary layer are evaluated. It is found that negative PV is generated by diabatic processes in the cold sector and by Ekman pumping at the low centre, whereas positive PV is generated by Ekman advection of potential temperature in the warm sector. We suggest here that negative PV at low levels can be used to identify the cold sector. A PV-based indicator is applied to estimate the respective contributions of the cold sector and the remainder of the storm to upward motion and large-scale and convective precipitation. We compare the PV-based indicator with other distinctive features that could be used as markers of the cold sector and find that potential vorticity is the best criterion when taken alone and the best when combined with any other.

Kazakhstan: long-term economic growth and the role of the oil sector

This study combines a narrative and modelling framework to analyse the development of Kazakhstan’s oil sector since its takeoff following separation from the USSR. As in the case of other emerging or transitional countries with large natural resource endowments, a key question is whether the exploitation of the natural resource is a benefit to longer term economic development: is it a curse, a blessing – or neither? Narrative evidence suggests that the establishment of good governance, in terms of institutions and policies, provides a background to sound long-term development, especially if combined with the development of sectors outside the natural resource sector, for example diversification into manufacturing and services, often through attracting FDI. The narrative is supported by econometric modelling of the relationship between domestic output, overseas output and exports of oil, which finds in favour of a sustained positive effect of oil exports on GDP. The model then provides a basis for projection of the growth in GDP given a consensus view of likely developments in the oil price.

Il/legitimate risks? Occupational health and safety and the public in Britain, c. 1960-2015

The last 20 years have seen the emergence of a popular climate of antipathy towards occupational health and safety regulation within the UK, particularly within the mainstream British media. The governance of health and safety has thus in recent years become an increasingly visible and contested public and political issue. The extent of this contestation, and its impact on the State’s governance of health and safety in the workplace and beyond, is explained and historicized within this chapter. Why has public rhetoric about health and safety apparently become so important in framing the ways in which the State could legitimately act in recent years? The chapter demonstrates how since 1960 the State remained a significant player – one among many, admittedly – and that while its roles in managing health and safety had long been bounded by a number of factors, a variable that emerged with particular saliency over the last 20 years has been a mediated notion of ‘public opinion’. This focus serves to remind us of the ways in which State action has at certain moments been pushed in particular directions by factors beyond formal mechanisms of rule.

Vasectomy within the public health services in Campinas, Sao Paulo, Brazil

Objective: To describe some of the characteristics of men who underwent a vasectomy in the public health network of Campinas, Sao Paulo, Brazil. Methods: A descriptive study including 202 men randomly selected from a list of all the men vasectomized between 1998 and 2004 in the public health network. Results: Most of the men were 30 years of age or older when vasectomized, had completed elementary school and had two or more children of both sexes. Most of the men came from the lowest income segment of the population: 47.6% in 1998-1999 and 61.3% in 2003-2004. Although the men knew various contraceptive methods, 51.2% reported that their partners were using combined oral contraceptives at the time of surgery. Most men initially sought information on vasectomy at health-care clinics where care was provided by a multidisciplinary team; most received counselling, however, 47.9% of the men waited more than 4 months for the vasectomy. Conclusions: The profile of the vasectomized men in this study appears to indicate that the low-income population from Campinas, Sao Paulo, Brazil has access to vasectomy; however, the waiting time for vasectomy reveals that difficulties exist in obtaining this contraceptive method in the public health service.

VISTA Variables in the Via Lactea (VVV): The public ESO near-IR variability survey of the Milky Way

We describe the public ESO near-IR variability survey (VVV) scanning the Milky Way bulge and an adjacent section of the mid-plane where star formation activity is high. The survey will take 1929 h of observations with the 4-m VISTA telescope during 5 years (2010-2014), covering similar to 10(9) point sources across an area of 520 deg(2), including 33 known globular clusters and similar to 350 open clusters. The final product will be a deep near-IR atlas in five passbands (0.9-2.5 mu m) and a catalogue of more than 106 variable point sources. Unlike single-epoch surveys that, in most cases, only produce 2-D maps, the VVV variable star survey will enable the construction of a 3-D map of the surveyed region using well-understood distance indicators such as RR Lyrae stars, and Cepheids. It will yield important information on the ages of the populations. The observations will be combined with data from MACHO, OGLE, EROS, VST, Spitzer, HST, Chandra, INTEGRAL, WISE, Fermi LAT, XMM-Newton, GAIA and ALMA for a complete understanding of the variable sources in the inner Milky Way. This public survey will provide data available to the whole community and therefore will enable further studies of the history of the Milky Way, its globular cluster evolution, and the population census of the Galactic Bulge and center, as well as the investigations of the star forming regions in the disk. The combined variable star catalogues will have important implications for theoretical investigations of pulsation properties of stars. (C) 2009 Elsevier B.V. All rights reserved.

Persuading the Public : A Linguistic Analysis of Barack Obama’s Speech on “Super Tuesday” 2008

This essay examines the persuasive side of language in a speech given by Senator Barack Obama on Super Tuesday in February 2008. It studies how Senator Obama utilizes language to convince and persuade his audience. This is done from an Aristotelian point of view, meaning that the study focuses foremost on how the senator’s word choices relate to Aristotle’s three means of persuasion, ethos, pathos and logos. Those basic guiding principles are relevant to use since Aristotle’s work on the subject of rhetoric is still today one of the most relevant works in that field. The analysis is basically performed through personal observations guided by previous studies, within the frame of Aristotelian rhetoric. The results show how Senator Obama enforces the three means of persuasion through language and how it can be considered persuasive. The study might add to rhetoric studies from a linguistic perspective since it reaches a better understanding of language used in the field of politics, where rhetoric is a prominent component.

Immigration, security and the public debate on US language policy : a critical discourse analysis of language attitudes in the United States of America

The narrative of the United States is of a "nation of immigrants" in which the language shift patterns of earlier ethnolinguistic groups have tended towards linguistic assimilation through English. In recent years, however, changes in the demographic landscape and language maintenance by non-English speaking immigrants, particularly Hispanics, have been perceived as threats and have led to calls for an official English language policy.This thesis aims to contribute to the study of language policy making from a societal security perspective as expressed in attitudes regarding language and identity originating in the daily interaction between language groups. The focus is on the role of language and American identity in relation to immigration. The study takes an interdisciplinary approach combining language policy studies, security theory, and critical discourse analysis. The material consists of articles collected from four newspapers, namely USA Today, The New York Times, Los Angeles Times, and San Francisco Chronicle between April 2006 and December 2007.Two discourse types are evident from the analysis namely Loyalty and Efficiency. The former is mainly marked by concerns of national identity and contains speech acts of security related to language shift, choice and English for unity. Immigrants are represented as dehumanised, and harmful. Immigration is given as sovereignty-related, racial, and as war. The discourse type of Efficiency is mainly instrumental and contains speech acts of security related to cost, provision of services, health and safety, and social mobility. Immigrants are further represented as a labour resource. These discourse types reflect how the construction of the linguistic 'we' is expected to be maintained. Loyalty is triggered by arguments that the collective identity is threatened and is itself used in reproducing the collective 'we' through hegemonic expressions of monolingualism in the public space and semi-public space. The denigration of immigrants is used as a tool for enhancing societal security through solidarity and as a possible justification for the denial of minority rights. Also, although language acquisition patterns still follow the historical trend of language shift, factors indicating cultural separateness such as the appearance of speech communities or the use of minority languages in the public space and semi-public space have led to manifestations of intolerance. Examples of discrimination and prejudice towards minority groups indicate that the perception of worth of a shared language differs from the actual worth of dominant language acquisition for integration purposes. The study further indicates that the efficient working of the free market by using minority languages to sell services or buy labour is perceived as conflicting with nation-building notions since it may create separately functioning sub-communities with a new cultural capital recognised as legitimate competence. The discourse types mainly represent securitising moves constructing existential threats. The perception of threat and ideas of national belonging are primarily based on a zero-sum notion favouring monolingualism. Further, the identity of the immigrant individual is seen as dynamic and adaptable to assimilationist measures whereas the identity of the state and its members are perceived as static. Also, the study shows that debates concerning language status are linked to extra-linguistic matters. To conclude, policy makers in the US need to consider the relationship between four factors, namely societal security based on collective identity, individual/human security, human rights, and a changing linguistic demography, for proposed language intervention measures to be successful.