Proposed best practice for statisticians in the reporting and publication of pharmaceutical industry-sponsored clinical trials

In this paper we set out what we consider to be a set of best practices for statisticians in the reporting of pharmaceutical industry-sponsored clinical trials. We make eight recommendations covering: author responsibilities and recognition; publication timing; conflicts of interest; freedom to act; full author access to data; trial registration and independent review. These recommendations are made in the context of the prominent role played by statisticians in the design, conduct, analysis and reporting of pharmaceutical sponsored trials and the perception of the reporting of these trials in the wider community.

D. H. Lawrence and the publication of Look! We Have Come Through!

In 1917 D.H. Lawrence's whole outlook on the social and cultural environment of his country was embodied in his attitude towards the literary marketplace. The suppression of The Rainbow in 1915 and his opposition to the war contributed to his feeling of detachment from what he called ‘the bourgeois world, the world which controls press, publication and all’. Presenting new archival evidence, this article examines the publishing history of the poetry volume Look! We Have Come Through, issued by Chatto & Windus in 1917. Closer examination of the motives of the individual editors involved in the production of the volume reveals why Lawrence was required to make changes to his text but also why the firm were eager to publish a volume that was to have little commercial impact. Issued at a critical moment in Lawrence's relationship with the marketplace, and in the history of literary modernism, the episode shows how, in spite of general hostility to his work, there were forces in the mainstream publishing market that were keen to embrace modern literary forms and take risks with the work of authors whose subject-matter was challenging and potentially dangerous.

Tree species’ tolerance to water stress, salinity and fire

According to climate change predictions, water availability might change dramatically in Europe and adjacent regions. This change will undoubtedly have an adverse effect on existing tree species and affect their ability to cope with a lack or an excess of water, changes in annual precipitation patterns, soil salinity and fire disturbance. The following chapter will describe tree species and proven-ances used in European forestry practice which are the most suitable to deal with water stress, salinity and fire. Each subchapter starts with a brief description of each of the stress factors and discusses the predictions of the likelihood of their occurrence in the near future according to the climate change scenarios. Tree spe-cies and their genotypes able to cope with particular stress factor, together with indication of their use by forest managers are then introduced in greater detail.

The publication of Catherine Carswell's novels

This article draws on new documentary evidence to discuss in detail the publishing history of the novels of the Scottish writer Catherine Carswell.

The design of probiotic studies to substantiate health claims

The EC Regulation No. 1924/2006 on Nutrition and Health claims made on foods has generated considerable debate and concern among scientists and industry. At the time of writing, the European Food Safety Authority (EFSA) has not approved any probiotic claims despite numerous human trials and meta-analyses showing evidence of beneficial effects. On 29th and 30th September 2010, ten independent, academic scientists with a documented record in probiotic research, met to discuss designs for future probiotic studies to demonstrate health benefits for gut and immune function. The expert panel recommended the following: (i) always formulate a precise and concrete hypothesis, and appropriate goals and parameters before starting a trial; (ii) ensure trials have sufficient sample size, such that they are adequately powered to reach statistically significant conclusions, either supporting or rejecting the a priori hypothesis, taking into account adjustment for multiple testing (this might necessitate more than one recruitment site); (iii) ensure trials are of appropriate duration; (iv) focus on a single, primary objective and only evaluate multiple parameters when they are hypothesis-driven. The panel agreed that there was an urgent need to better define which biomarkers are considered valuable for substantiation of a health claim. As a first step, the panel welcomed the publication on the day of the meeting of EFSA's draft guidance document on immune and gut health, although it came too late for study designs and dossiers to be adjusted accordingly. New validated biomarkers need to be identified in order to properly determine the range of physiological functions influenced by probiotics. In addition, validated biomarkers reflecting risk factors for disease, are required for article 14 claims (EC Regulation No. 1924/2006). Finally, the panel concluded that consensus among scientists is needed to decide appropriate clinical endpoints for trials.

Citation and peer review of data: moving towards formal data publication

This paper discusses many of the issues associated with formally publishing data in academia, focusing primarily on the structures that need to be put in place for peer review and formal citation of datasets. Data publication is becoming increasingly important to the scientific community, as it will provide a mechanism for those who create data to receive academic credit for their work and will allow the conclusions arising from an analysis to be more readily verifiable, thus promoting transparency in the scientific process. Peer review of data will also provide a mechanism for ensuring the quality of datasets, and we provide suggestions on the types of activities one expects to see in the peer review of data. A simple taxonomy of data publication methodologies is presented and evaluated, and the paper concludes with a discussion of dataset granularity, transience and semantics, along with a recommended human-readable citation syntax.

Explaining history to children: Otto and Marie Neurath’s work on the ‘Visual history of mankind’

This essay traces the development of Otto Neurath’s ideas that led to the publication of one of the first series of children’s books produced by the Isotype Institute in the late 1940s, the Visual History of Mankind. Described in its publicity material as ‘new in content’ and ‘new in method’, it embodied much of Otto Neurath’s thinking about visual education, and also coincided with other educational ideas in the UK in the 1930s and 1940s. It exemplified the Isotype Institute’s approach: teamwork, thinking about the needs of younger readers, clear explanation, and accessible content. Further, drawing on correspondence, notes and drawings from the Otto and Marie Neurath Isotype Collection at the University of Reading, the essay presents insights to the making of the books and the people involved, the costs of production and the influence of this on design decisions, and how the books were received by teachers and children.

From hieroglyphics to Isotype: a visual autobiography (Otto Neurath)

Otto Neurath (1882–1945) wrote From hieroglyphics to Isotype during the last two years of his life and this is the first publication of the text in full, carefully edited from the original manuscripts. He called it a 'visual autobiography', in which he documents the importance of visual material to him from his earliest years to his professional activity with the picture language of Isotype. Neurath draws clear links between the stimulus he received as a boy from illustrated books, toys and exhibitions to the considered work in visual education that occupied him for the last two decades of his life. This engaging and informal account gives a rich picture of Central European culture around the turn of the twentieth century, seen through the eyes of Neurath's insatiable intelligence, as well as a detailed exposition of the technique of Isotype, a milestone of modern graphic design. This edition includes the numerous illustrations intended by Neurath to accompany his text, and is completed by an extensive appendix showing examples from the rich variety of graphic material that he collected.

Evaluating the likelihood of the adoption of an animal welfare assessment system in European agri-food supply chains

Purpose – The purpose of this paper is to analyse the likelihood of adoption of a recently designed Welfare Assessment System in agri-food supply chains and the factors affecting the adoption decision. The application is carried out for pig and poultry chains. Design/methodology/approach – This research consisted of two main components: interviews with retailers in pig and poultry supply chains in eight different EU countries to explore their perceptions towards the adoption possibilities of the welfare assessment system; and a conjoint analysis designed to evaluate the perceived adoption likelihood of the assessment system by different Standards Formulating Organisations (SFOs). Findings – Stakeholders were found to be especially concerned about the costs of implementation of the system and how it could, or should, be merged with existing assurance schemes. Another conclusion of the study is that the presence of a strong third independent party supporting the implementation of the welfare assessment system would be the most important influence on the decision whether, or not, to adopt it. Originality/value – This research evaluates the adoption possibilities of a novel Welfare Assessment System and presents the views of different supply chain stakeholders on an adoption of such a system. The main factors affecting the adoption decision are identified and analysed. Contrary to expectations, the costs of adoption of a new welfare assessment system were not considered to be the most important factor affecting the decision of supply chain stakeholders about the adoption of this new welfare system.

Likelihood-free estimation of model evidence

Statistical methods of inference typically require the likelihood function to be computable in a reasonable amount of time. The class of “likelihood-free” methods termed Approximate Bayesian Computation (ABC) is able to eliminate this requirement, replacing the evaluation of the likelihood with simulation from it. Likelihood-free methods have gained in efficiency and popularity in the past few years, following their integration with Markov Chain Monte Carlo (MCMC) and Sequential Monte Carlo (SMC) in order to better explore the parameter space. They have been applied primarily to estimating the parameters of a given model, but can also be used to compare models. Here we present novel likelihood-free approaches to model comparison, based upon the independent estimation of the evidence of each model under study. Key advantages of these approaches over previous techniques are that they allow the exploitation of MCMC or SMC algorithms for exploring the parameter space, and that they do not require a sampler able to mix between models. We validate the proposed methods using a simple exponential family problem before providing a realistic problem from human population genetics: the comparison of different demographic models based upon genetic data from the Y chromosome.

Developing consensus on hospital prescribing indicators of potential harms amenable to decision support

Aim: To develop a list of prescribing indicators specific for the hospital setting that would facilitate the prospective collection of high severity and/or high frequency prescribing errors, which are also amenable to electronic clinical decision support (CDS). Method: A three-stage consensus technique (electronic Delphi) was carried out with 20 expert pharmacists and physicians across England. Participants were asked to score prescribing errors using a 5-point Likert scale for their likelihood of occurrence and the severity of the most likely outcome. These were combined to produce risk scores, from which median scores were calculated for each indicator across the participants in the study. The degree of consensus between the participants was defined as the proportion that gave a risk score in the same category as the median. Indicators were included if a consensus of 80% or more was achieved. Results: A total of 80 prescribing errors were identified by consensus as being high or extreme risk. The most common drug classes named within the indicators were antibiotics (n=13), antidepressants (n=8), nonsteroidal anti-inflammatory drugs (n=6), and opioid analgesics (n=6).The most frequent error type identified as high or extreme risk were those classified as clinical contraindications (n=29/80). Conclusion: 80 high risk prescribing errors in the hospital setting have been identified by an expert panel. These indicators can serve as the basis for a standardised, validated tool for the collection of data in both paperbased and electronic prescribing processes, as well as to assess the impact of electronic decision support implementation or development.

Farmers’ attitudes to disease risk management in England: a comparative analysis of sheep and pig farmers

The UK Department for Environment, Food and Rural Affairs (Defra) identified practices to reduce the risk of animal disease outbreaks. We report on the response of sheep and pig farmers in England to promotion of these practices. A conceptual framework was established from research on factors influencing adoption of animal health practices, linking knowledge, attitudes, social influences and perceived constraints to the implementation of specific practices. Qualitative data were collected from nine sheep and six pig enterprises in 2011. Thematic analysis explored attitudes and responses to the proposed practices, and factors influencing the likelihood of implementation. Most feel they are doing all they can reasonably do to minimise disease risk and that practices not being implemented are either not relevant or ineffective. There is little awareness and concern about risk from unseen threats. Pig farmers place more emphasis than sheep farmers on controlling wildlife, staff and visitor management and staff training. The main factors that influence livestock farmers’ decision on whether or not to implement a specific disease risk measure are: attitudes to, and perceptions of, disease risk; attitudes towards the specific measure and its efficacy; characteristics of the enterprise which they perceive as making a measure impractical; previous experience of a disease or of the measure; and the credibility of information and advice. Great importance is placed on access to authoritative information with most seeing vets as the prime source to interpret generic advice from national bodies in the local context. Uptake of disease risk measures could be increased by: improved risk communication through the farming press and vets to encourage farmers to recognise hidden threats; dissemination of credible early warning information to sharpen farmers’ assessment of risk; and targeted information through training events, farming press, vets and other advisers, and farmer groups, tailored to the different categories of livestock farmer.

Opening up climate research: A linked data approach to publishing data provenance

Traditionally, the formal scientific output in most fields of natural science has been limited to peer- reviewed academic journal publications, with less attention paid to the chain of intermediate data results and their associated metadata, including provenance. In effect, this has constrained the representation and verification of the data provenance to the confines of the related publications. Detailed knowledge of a dataset’s provenance is essential to establish the pedigree of the data for its effective re-use, and to avoid redundant re-enactment of the experiment or computation involved. It is increasingly important for open-access data to determine their authenticity and quality, especially considering the growing volumes of datasets appearing in the public domain. To address these issues, we present an approach that combines the Digital Object Identifier (DOI) – a widely adopted citation technique – with existing, widely adopted climate science data standards to formally publish detailed provenance of a climate research dataset as an associated scientific workflow. This is integrated with linked-data compliant data re-use standards (e.g. OAI-ORE) to enable a seamless link between a publication and the complete trail of lineage of the corresponding dataset, including the dataset itself.

Participatory scenarios as a tool to link science and policy on food security under climate change in East Africa

How effective are multi-stakeholder scenarios building processes to bring diverse actors together and create a policy-making tool to support sustainable development and promote food security in the developing world under climate change? The effectiveness of a participatory scenario development process highlights the importance of ‘boundary work’ that links actors and organizations involved in generating knowledge on the one hand, and practitioners and policymakers who take actions based on that knowledge on the other. This study reports on the application of criteria for effective boundary work to a multi-stakeholder scenarios process in East Africa that brought together a range of regional agriculture and food systems actors. This analysis has enabled us to evaluate the extent to which these scenarios were seen by the different actors as credible, legitimate and salient, and thus more likely to be useful. The analysis has shown gaps and opportunities for improvement on these criteria, such as the quantification of scenarios, attention to translating and communicating the results through various channels and new approaches to enable a more inclusive and diverse group of participants. We conclude that applying boundary work criteria to multi-stakeholder scenarios processes can do much to increase the likelihood of developing sustainable development and food security policies that are more appropriate.