Cross-sector surveys assessing perceptions of key stakeholders towards barriers, concerns and facilitators to the appropriate use of adaptive designs in confirmatory trials

Background Appropriately conducted adaptive designs (ADs) offer many potential advantages over conventional trials. They make better use of accruing data, potentially saving time, trial participants, and limited resources compared to conventional, fixed sample size designs. However, one can argue that ADs are not implemented as often as they should be, particularly in publicly funded confirmatory trials. This study explored barriers, concerns, and potential facilitators to the appropriate use of ADs in confirmatory trials among key stakeholders. Methods We conducted three cross-sectional, online parallel surveys between November 2014 and January 2015. The surveys were based upon findings drawn from in-depth interviews of key research stakeholders, predominantly in the UK, and targeted Clinical Trials Units (CTUs), public funders, and private sector organisations. Response rates were as follows: 30(55 %) UK CTUs, 17(68 %) private sector, and 86(41 %) public funders. A Rating Scale Model was used to rank barriers and concerns in order of perceived importance for prioritisation. Results Top-ranked barriers included the lack of bridge funding accessible to UK CTUs to support the design of ADs, limited practical implementation knowledge, preference for traditional mainstream designs, difficulties in marketing ADs to key stakeholders, time constraints to support ADs relative to competing priorities, lack of applied training, and insufficient access to case studies of undertaken ADs to facilitate practical learning and successful implementation. Associated practical complexities and inadequate data management infrastructure to support ADs were reported as more pronounced in the private sector. For funders of public research, the inadequate description of the rationale, scope, and decision-making criteria to guide the planned AD in grant proposals by researchers were all viewed as major obstacles. Conclusions There are still persistent and important perceptions of individual and organisational obstacles hampering the use of ADs in confirmatory trials research. Stakeholder perceptions about barriers are largely consistent across sectors, with a few exceptions that reflect differences in organisations’ funding structures, experiences and characterisation of study interventions. Most barriers appear connected to a lack of practical implementation knowledge and applied training, and limited access to case studies to facilitate practical learning. Keywords: Adaptive designs; flexible designs; barriers; surveys; confirmatory trials; Phase 3; clinical trials; early stopping; interim analyses

How do people perceive, understand, and anticipate responding to flash flood risks and warnings? Results from a public survey in Boulder, Colorado, USA

This study investigates flash flood forecast and warning communication, interpretation, and decision making, using data from a survey of 418 members of the public in Boulder, Colorado, USA. Respondents to the public survey varied in their perceptions and understandings of flash flood risks in Boulder, and some had misconceptions about flash flood risks, such as the safety of crossing fast-flowing water. About 6% of respondents indicated consistent reversals of US watch-warning alert terminology. However, more in-depth analysis illustrates the multi-dimensional, situationally dependent meanings of flash flood alerts, as well as the importance of evaluating interpretation and use of warning information along with alert terminology. Some public respondents estimated low likelihoods of flash flooding given a flash flood warning; these were associated with lower anticipated likelihood of taking protective action given a warning. Protective action intentions were also lower among respondents who had less trust in flash flood warnings, those who had not made prior preparations for flash flooding, and those who believed themselves to be safer from flash flooding. Additional analysis, using open-ended survey questions about responses to warnings, elucidates the complex, contextual nature of protective decision making during flash flood threats. These findings suggest that warnings can play an important role not only by notifying people that there is a threat and helping motivate people to take protective action, but also by helping people evaluate what actions to take given their situation.

What are the limitations on the wider therapeutic use of phage?

Bacterial resistance to antibiotics poses a serious health threat. Since research into new antibiotics is not progressing at the same rate as the development of bacterial resistance, widespread calls for alternatives to antibiotics have been made. Phage therapy is an ideal alternative candidate to be investigated. However the success of phage therapy may be hampered by a lack of investment support from large pharmaceutical companies, due to their narrow spectrum of activity in antibiotics, very large costs associated with clinical trials of the variety of phages needed, and regulatory requirements remaining unclear. Intellectual property is difficult to secure for therapeutic phage products for a variety of reasons, and patenting procedures vary widely between the US and the EU. Consequently, companies are more likely to invest in phage products for decontamination or veterinary use, rather than clinical use in humans. Some still raise questions as to the safety of phage therapy overall, suggesting the possibility of cytotoxicity and immunogenicity, depending on the phage preparation and route. On the other hand, with patients dying because of infections untreatable with conventional antibiotics, the question arises as to whether it is ethical not to pursue phage therapy more diligently. A paradigm shift about how phage therapy is perceived is required, as well as more rigorous proof of efficacy in the form of clinical trials of existing medicinal phage products. Phage therapy potential may be fulfilled in the meantime by allowing individual preparations to be used on a named-patient basis, with extensive monitoring and multidisciplinary team input. The National Health Service and academia have a role in carrying out clinical phage research, which would be beneficial to public health, but not necessarily financially rewarding.

Health surveys and use of maternal and child health care services in three municipalities within the Sao Paulo metropolitan area

Objectives. To describe the changes in the use of maternal and child health care services by residents of three municipalities-Embu, Itapecerica da Serra, and Taboao da Serra-in the Sao Paulo metropolitan area, 12 years after the implementation of the Unified Health System (SUS) in Brazil, and to analyze the potential of population-based health care surveys as sources of data to evaluate these changes. Methods. Two population-based, cross-sectional surveys were carried out in 1990 and 2002 in municipalities located within the Sao Paulo metropolitan area. For children under 1 year of age, the two periods were compared in terms of outpatient services utilization and hospital admission; for the mothers, the periods were compared in terms of prenatal care and deliveries. In both surveys, stratified and multiple-stage conglomerate sampling was employed, with standardization of interview questions. Results. The most important changes observed were regarding the location of services used for prenatal care, deliveries, and hospitalization of children less than 1 year of age. There was a significant increase in the use of services in the surrounding region or hometown, and decrease in the utilization of services in the city of Sao Paulo (in 1990, 80% of deliveries and almost all admissions for children less than 1 year versus 32% and 46%, respectively, in 2002). The use of primary care units and 24-hour walk-in clinics also increased. All these changes reflect care provided by public resources. In the private sector, there was a decrease in direct payments and payments through company-paid health insurance and an increase in payments through self-paid health insurance. Conclusions. The major changes observed in the second survey occurred simultaneous to the changes that resulted from the implementation of the SUS. Population-based health surveys are adequate for analyzing and comparing the utilization of health care services at different times.

Use of a predictive model for food insecurity estimates in Brazil

In 2004 the National Household Survey (Pesquisa Nacional par Amostras de Domicilios - PNAD) estimated the prevalence of food and nutrition insecurity in Brazil. However, PNAD data cannot be disaggregated at the municipal level. The objective of this study was to build a statistical model to predict severe food insecurity for Brazilian municipalities based on the PNAD dataset. Exclusion criteria were: incomplete food security data (19.30%); informants younger than 18 years old (0.07%); collective households (0.05%); households headed by indigenous persons (0.19%). The modeling was carried out in three stages, beginning with the selection of variables related to food insecurity using univariate logistic regression. The variables chosen to construct the municipal estimates were selected from those included in PNAD as well as the 2000 Census. Multivariate logistic regression was then initiated, removing the non-significant variables with odds ratios adjusted by multiple logistic regression. The Wald Test was applied to check the significance of the coefficients in the logistic equation. The final model included the variables: per capita income; years of schooling; race and gender of the household head; urban or rural residence; access to public water supply; presence of children; total number of household inhabitants and state of residence. The adequacy of the model was tested using the Hosmer-Lemeshow test (p=0.561) and ROC curve (area=0.823). Tests indicated that the model has strong predictive power and can be used to determine household food insecurity in Brazilian municipalities, suggesting that similar predictive models may be useful tools in other Latin American countries.

Demographic characteristics and prevalence of serologic markers among blood donors who use confidential unit exclusion (CUE) in Sao Paulo, Brazil: implications for modification of CUE polices in Brazil

BACKGROUND: This study evaluated demographic profiles and prevalence of serologic markers among donors who used confidential unit exclusion (CUE) to assess the effectiveness of CUE and guide public policies regarding the use of CUE for enhancing safety versus jeopardizing the blood supply by dropping CUE. STUDY DESIGN AND METHODS: We conducted a cross-sectional analysis of whole blood donations at a large public blood center in Sao Paulo from July 2007 through June 2009, compared demographic data, and confirmed serologic results among donors who used and who have never used CUE (CUE never). RESULTS: There were 265,550 whole blood units collected from 181,418 donors from July 2007 through June 2009. A total of 9658 (3.6%) units were discarded, 2973 (1.1%) because CUE was used at the current donation (CUE now) and 6685 (2.5%) because CUE was used in the past (CUE past). The CUE rate was highest among donors with less than 8 years of education (odds ratio [OR], 2.78; 95% confidence interval [CI], 2.51-3.08). CUE now donations were associated with higher positive infectious disease marker rates than CUE never donations (OR, 1.41; CI, 1.13-1.77), whereas CUE past donations were not (OR, 1.04; CI, 0.75-1.45). CONCLUSION: The CUE process results in a high rate of unit discard. CUE use on an individual donation appears predictive of a high-risk marker-positive donation and, thus, appears to contribute modestly to blood safety. The policy of discarding units from donors who have previously CUE-positive donations does not improve safety and should be discontinued.

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.

Maternal health care professionals perspective on the provision and use of antenatal and delivery care : a qualitative descriptive study in rural Vietnam

Background. High quality maternal health care is an important tool to reduce maternal and neonatal mortality. Services offered should be evidence based and adapted to the local setting. This qualitative descriptive study explored the perspectives and experiences of midwives, assistant physicians and medical doctors on the content and quality of maternal health care in rural Vietnam. Method. The study was performed in a rural district in northern Vietnam. Four focus group discussions with health care professionals at primary health care level were conducted. The data was analysed using qualitative manifest and latent content analysis. Result. Two main themes emerged: "Contextual conditions for maternal health care" and "Balancing between possibilities and constraints". Contextual conditions influenced both pregnant women's use of maternal health care and health care professionals' performance. The study participants stated that women's uses of maternal health care were influenced by economical constraints and cultural norms that impeded their autonomy in relation to childbearing. Structural constraints within the health care system included inadequate financing of the primary health care, resulting in lack of human resources, professional re-training and adequate equipment. Conclusion. Contextual conditions strongly influenced the performance and interaction between pregnant women and health care professionals within antenatal care and delivery care in a rural district of Vietnam. Although Vietnam is performing comparatively well in terms of low maternal and child mortality figures, this study revealed midwives' and other health care professionals' perceived difficulties in their daily work. It seemed maternal health care was under-resourced in terms of staff, equipment and continuing education activities. The cultural setting in Vietnam constituting a strong patriarchal society and prevailing Confucian norms limits women's autonomy and reduce their possibility to make independent decisions about their own reproductive health. This issue should be further addressed by policy-makers. Strategies to reduce inequities in maternal health care for pregnant women are needed. The quality of client-provider interaction and management of pregnancy may be strengthened by education, human resources, re-training and provision of essential equipment.

Medical students’ knowledge, attitudes, and perceptions on contraceptive use and counselling : a cross-sectional survey in Maharashtra, India

Objectives. This study aimed to investigate the knowledge, attitudes and perceptionstowards contraceptive use and counselling among medical students in Maharashtra, India. Setting. Considerable global maternal mortality and morbidity could be avoided through theuse of effective contraception. In India, contraception services are frequently unavailable or there are obstacles to obtaining modern, reversible contraceptives. Participants. A cross-sectional descriptive study using a self-administered questionnaire was conducted among 1996 medical students in their fifth year of study at 27 medical colleges in the state of Maharashtra, India. Descriptive and analytical statistics interpreted the survey instrument and significant results were presented with 95% CI. Results. Respondents expressed a desire to provide contraceptive services. A few studentshad experienced training in abortion care. There were misconceptions about moderncontraceptive methods and the impact of sex education. Attitudes towards contraceptionwere mainly positive, premarital counselling was supported and the influence of traditional values and negative provider attitudes on services was recognised. Gender, area of upbringing and type of medical college did not change the results. Conclusions. Despite mostly positive attitudes towards modern contraceptives, sex education and family planning counselling, medical students in Maharashtra have misconceptions about modern methods of contraception. Preservice and in-service training in contraceptive counselling should be implemented in order to increase women's access to evidence-based maternal healthcare services.

Draft Proposed Public Transportation Routes for Waterville, ME

Currently, there is a public bus transportation route in Waterville, Maine. However, this system could be improved. Our goal was to use GIS to find optimal public transportation routes throughout the city based on given points of interest and high population density areas. Three different groups of points of interest were created in the North, West, and South sections of Waterville. Using the Network Analyst tool, which calculates optimal routes, using existing street data, based on the input of stops, barriers, and impedance, we ran an analysis of what we thought would be the routes that best served the greatest number of people. Two different sets of routes were found: one with length as the impedance (the shortest length between the selected stops was favored), and one with population density as the impedance (the roads with the highest population density were favored). Finally, the times of the resulting routes (given a constant speed limit of 25 mph) were calculated and evaluated.

On the limits of cheap talk for public good provision

This article studies a model where, as a consequence of private information, agents do not have incentive to invest in a desired joint project, or a public good, when they are unable to have prior discussion with their partners. As a result, the joint project is never undertaken and inefficiency is observed. Agastya, Menezes and Sengupta (2007) prove that with a prior stage of communication, with a binary message space, it is possible to have some efficiency gain since "all ex-ante and interim efficient equilibria exhibit a simple structure". We show that any finite message space does not provide efficiency gain on the simple structure discussed in that article. We use laboratory experiments to test these results. We find that people do contribute, even without communication, and that any kind of communication increases the probability of project implementation. We also observed that communication reduces the unproductive contribution, and that a large message space cannot provide efficiency gain relative to the binary one.

Private or public? a taxonomy of optimal ownership and management regimes

We develop a theory of public versus private ownership based on value diversion by managers. Government is assumed to face stronger institutional constraints than has been assumed in previous literature. The model which emerges from these assumptions is fexible and has wide application. We provide amapping between the qualitative characteristics of an asset, its main use - including public goods characteristics, and spillovers toother assets values - and the optimal ownership and management regime. The model is applied to single and multiple related assets. We address questions such as; when is it optimal to have one of a pair ofr elated assets public and the other private; when is joint management desirable; and when should a public asset be managed by the owner of a related private asset? We show that while private ownership can be judged optimal in some cases solely on the basis of qualitative information, the optimality of any other ownership and management regimes relies on quantitative analysis. Our results reveal the situations in which policy makers will have difficulty in determining the opimal regime.

Discrete public goods with incomplete information

We analyze simultaneous discrete public good games wi.th incomplete information and continuous contributions. To use the terminology of Admati and Perry (1991). we consider comribution and subscription games. In the former. comrioutions are :1ot rcfunded if the project is not completed. while in thp. iatter they are. For the special case whp.re provision by a single player is possible we show the existence of an equilibrium in Doth cootribution and subscription games where a player decides to provide the good by himself. For the case where is not feasible for a single player to provide the good by himself, we show that any equilibriwn of both games is inefficient. WE also provide a sufficient condition for "contributing zero" to be the unique equilibrium of the contribution garoe with n players and characterize e

Discrete public goods with incomplete information

We analyze simultaneous discrete public good games with incomplete information and continuous contributions. To use the tenninology of Admati and Perry (1991), we consider contribution and subscription games. In the former, contributions are not refunded ifthe project is not completed, while in the latter they are. For the special case where provision by a single player is possible we show the existence of an equihbrium in both contnbution and subscription games where a player decides to provide the good by himself. For the case where is not feasible for a single player to provide the good by himself: we show that there exist equilibria of the subscription game where each participant pays the same amount. Moreover, using the technical apparatus from Myerson (1981) we show that neither the subscription nor the contribution games admit ex-post eÁ cient equibbria. hl addition. we provide a suÁ cient condition for êontributing zero 'to be the unique equihbrium of the contnbution game with n players.