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.

Attitudes to reading in English primary schools

This article reports on a two-year research project investigating attitudes to reading held by teachers and pupils in a sample of English primary schools. The project draws on international and national surveys of reading engagement and the findings of previous research, but seeks to provide more detailed data relating to the attitudes of individual children and the strategies used by individual schools and teachers whose pupils demonstrate positive attitudes to reading. Written questionnaires for teachers and pupils and oral interviews with teachers are used, generating both quantitative and qualitative data. Results are related to previous research literature in this area which shows a link between reading motivation and attainment, and to motivational theory. In conclusion, it is argued that teaching strategies which promote positive attitudes to reading need to be used alongside the teaching of reading skills in any effort to raise attainment.

The role of agronomic research in climate change and food security policy

Societal concern is growing about the consequences of climate change for food systems and, in a number of regions, for food security. There is also concern that meeting the rising demand for food is leading to environmental degradation thereby exacerbating factors in part responsible for climate change, and further undermining the food systems upon which food security is based. A major emphasis of climate change/food security research over recent years has addressed the agronomic aspects of climate change, and particularly crop yield. This has provided an excellent foundation for assessments of how climate change may affect crop productivity, but the connectivity between these results and the broader issues of food security at large are relatively poorly explored; too often discussions of food security policy appear to be based on a relatively narrow agronomic perspective. To overcome the limitation of current agronomic research outputs there are several scientific challenges where further agronomic effort is necessary, and where agronomic research results can effectively contribute to the broader issues underlying food security. First is the need to better understand how climate change will affect cropping systems including both direct effects on the crops themselves and indirect effects as a result of changed pest and weed dynamics and altered soil and water conditions. Second is the need to assess technical and policy options for either reducing the deleterious impacts or enhancing the benefits of climate change on cropping systems while minimising further environmental degradation. Third is the need to understand how best to address the information needs of policy makers and report and communicate agronomic research results in a manner that will assist the development of food systems adapted to climate change. There are, however, two important considerations regarding these agronomic research contributions to the food security/climate change debate. The first concerns scale. Agronomic research has traditionally been conducted at plot scale over a growing season or perhaps a few years, but many of the issues related to food security operate at larger spatial and temporal scales. Over the last decade, agronomists have begun to establish trials at landscape scale, but there are a number of methodological challenges to be overcome at such scales. The second concerns the position of crop production (which is a primary focus of agronomic research) in the broader context of food security. Production is clearly important, but food distribution and exchange also determine food availability while access to food and food utilisation are other important components of food security. Therefore, while agronomic research alone cannot address all food security/climate change issues (and hence the balance of investment in research and development for crop production vis à vis other aspects of food security needs to be assessed), it will nevertheless continue to have an important role to play: it both improves understanding of the impacts of climate change on crop production and helps to develop adaptation options; and also – and crucially – it improves understanding of the consequences of different adaptation options on further climate forcing. This role can further be strengthened if agronomists work alongside other scientists to develop adaptation options that are not only effective in terms of crop production, but are also environmentally and economically robust, at landscape and regional scales. Furthermore, such integrated approaches to adaptation research are much more likely to address the information need of policy makers. The potential for stronger linkages between the results of agronomic research in the context of climate change and the policy environment will thus be enhanced.

Characterizing intuition in information systems research

The study of intuition is an emerging area of research in psychology, social sciences, and business studies. It is increasingly of interest to the study of management, for example in decision-making as a counterpoint to structured approaches. Recently work has been undertaken to conceptualize a construct for the intuitive nature of technology. However to-date there is no common under-standing of the term intuition in information systems (IS) research. This paper extends the study of intuition in IS research by using exploratory research to cate-gorize the use of the word “intuition” and related terms in papers published in two prominent IS journals over a ten year period. The entire text of MIS Quarterly and Information Systems Research was reviewed for the years 1999 through 2008 using searchable PDF versions of these publications. As far as could be deter-mined, this is the first application of this approach in the analysis of the text of IS academic journals. The use of the word “intuition” and related terms was catego-rized using coding consistent with Grounded Theory. The focus of this research was on the first two stages of Grounded Theory analysis - the development of codes and constructs. Saturation of coding was not reached: an extended review of these publications would be required to enable theory development. Over 400 incidents of the use of “intuition”, and related terms were found in the articles reviewed. The most prominent use of the term of “intuition” was coded as “Intui-tion as Authority” in which intuition was used to validate a research objective or finding; representing approximately 37 per cent of codes assigned. The second most common coding occurred in research articles with mathematical analysis, representing about 19 per cent of the codes assigned, for example where a ma-thematical formulation or result was “intuitive”. The possibly most impactful use of the term “intuition” was “Intuition as Outcome”, representing approximately 7 per cent of all coding, which characterized research results as adding to the intui-tive understanding of a research topic or phenomena. This research contributes to a greater theoretical understanding of intuition enabling insight into the use of intuition, and the eventual development of a theory on the use of intuition in academic IS research publications. It also provides potential benefits to practi-tioners by providing insight into and validation of the use of intuition in IS man-agement. Research directions include the creation of reflective and/or formative constructs for intuition in information systems research.

Addressing rural social exclusion through African social purpose ventures

Objectives. The overarching aim of this paper is to consider the relationship between social entrepreneurship and rural development, and as a mechanism to address social exclusion in the Global South, with specific reference to Sub-Saharan Africa. Drawing upon a number of case examples of social purpose ventures in Kenya, Mozambique and Zambia the objectives of this paper are: - To provide a synthesis of existing literature on the interaction between social purpose ventures and rural BoP communities in the developing world; - To explore extant social exclusion literature including economic, political and international development dimensions; and - To analyse the case study examples to consider the channels through which social purpose ventures contribute to tackling social exclusion amongst the rural BoP. Prior Work. There is growing interest in the role that social enterprises and wider social purpose ventures can play in sustainable development in the Global South. In many developing countries the majority of the population still reside in rural areas with these areas often particularly marginalised and underdeveloped. Previous studies have provided anecdotal examples where social purpose ventures have the potential to provide innovative solutions to the development challenges faced by rural households and communities. Yet research in this area remains relatively nascent and fragmented. In depth empirical studies examining social purpose ventures and rural development in the Global South are furthermore limited. Approach. Data was collected during in-depth case study research with social purpose ventures in Zambia, Kenya and Mozambique. Cases were selected through a purposive sample with access negotiated to rural BoP communities through gatekeeper partners. Qualitative research methods were primarily employed including interviews, stakeholder focus groups and observational research. Results Six channels through which social purpose ventures contribute to tackling social exclusion amongst rural BoP communities are identified. These include ventures with the BoP as employees, producers, consumers, entrepreneurs, service users and shareholders. A number of shared characteristics for successful social purpose ventures are also outlined. Finally implications for policy, practice and research are discussed. Implications. Despite the increasing attention being given to social purpose ventures as a mechanism for global sustainable development many questions remain unanswered. Limited empirical work has been undertaken on such ventures operating in rural settings in the developing world, particularly Africa. The paper will add to academic and practitioner knowledge in this area especially in relation to up-scaling impact, the long term sustainability and viability of social purpose enterprise ventures, and effective supporting interventions. This paper adds to knowledge in the field of social purpose venturing in the developing world. It identifies various channels through which such ventures help tackle rural social exclusion and also factors influencing their success. The paper provides insights for practitioners and policy makers, particularly in relation to facilitating successful social purpose venturing. Value This paper will provide insights relevant to both academic and practitioner audiences. It addresses a subject area and geographical region that has received limited research attention to date. The paper adds to knowledge on social purpose ventures and social entrepreneurship in Africa and wider developing world environments, and contributes to debates on its potential and present limitations as a vehicle for development and societal transformation

Institutional framing of CSR and social entrepreneurship interactions in South Africa

Objectives. This paper considers the intersection of Corporate Social Responsibility (CSR) and social entrepreneurship in South Africa through the lens of institutional theories and draws upon a number of illustrative case study examples. In particular it: (1) charts the historically evolving relationship between CSR and social entrepreneurship in South Africa, and how this relationship has been informed by institutional changes since the end of apartheid, particularly over the last few years; (2) identifies different interactional relationship forms between social enterprises and corporates engaging in CSR, with an emphasis on new innovative multi-stakeholder partnerships; and (3) considers internal engagements with social responsibility by SME social enterprises in South Africa. Prior Work. Reflecting South Africa’s history of division, the controversial role of business during apartheid, and the ongoing legacies of that period, the South African government has been particularly pro-active in encouraging companies to contribute to development and societal transformation through CSR and Black Economic Empowerment (BEE). Accordingly a substantial body of work now exists examining and critically reflecting upon CSR and BEE across a range of sectors. In response to perceived problems with BEE, efforts have recently been made to foster broader-based economic empowerment. However the implications of these transitions for the relationship between CSR and social entrepreneurship in South Africa have received scant academic attention. Approach. Analysis is undertaken of legislative and policy changes in South Africa with a bearing on CSR and social entrepreneurship. Data collected during fieldwork in South Africa working with 6 social enterprise case studies is utilised including qualitative data from key informant interviews, focus groups with stakeholders and observational research. Results. The paper considers the historically evolving relationship between CSR and social entrepreneurship in South Africa informed by institutional change. Five different relationship forms are identified and illustrated with reference to case examples. Finally internal engagement with social responsibility concerns by small and medium social enterprises are critically discussed. Implications. This paper sheds light on some of the innovative partnerships emerging between corporates and social enterprises in South Africa. It reflects on some of the strengths and weaknesses of South Africa’s policy and legislative approaches. Value. The paper provides insights useful for academic and practitioner audiences. It also has policy relevance, in particularly for other African countries potentially looking to follow South Africa’s example, in the development of legislative and policy frameworks to promote corporate responsibility, empowerment and transformation.

A gestalt generated from grounded theory concerning intuition in IS research

Intuition is an important and under-researched concept in information systems. Prior exploratory research has shown that that there is potential to characterize the use of intuition in academic information systems research. This paper extends this research to all of the available issues of two leading IS journals with the aim of reaching an approximation of theoretical saturation. Specifically, the entire text of MISQ and ISR was reviewed for the years 1990 through 2009 using searchable PDF versions of these publications. All references to intuition were coded on a basis consistent with Grounded Theory, interpreted as a gestalt and represented as a mind-map. In the period 1990-2009, 681 incidents of the use of "intuition", and related terms were found in the articles reviewed, representing a greater range of codes than prior research. In addition, codes were assigned to all issues of MIS Quarterly from commencement of publication to the end of the 2012 publication year to support the conjecture that coding saturation has been approximated. The most prominent use of the term of "intuition" was coded as "Intuition as Authority" in which intuition was used to validate a statement, research objective or a finding; representing approximately 34 per cent of codes assigned. In research articles where mathematical analysis was presented, researchers not infrequently commented on the degree to which a mathematical formulation was "intuitive"; this was the second most common coding representing approximately 16 per cent of the codes. The possibly most impactful use of the term "intuition" was "Intuition as Outcome", representing approximately 7 per cent of all coding, which characterized research results as adding to the intuitive understanding of a research topic or phenomena.This research aims to contribute to a greater theoretical understanding of the use of intuition in academic IS research publications. It provides potential benefits to practitioners by providing insight into the use of intuition in IS management, for example, emphasizing the emerging importance of "intuitive technology". Research directions include the creation of reflective and/or formative constructs for intuition in information systems research and the expansion of this novel research method to additional IS academic publications and topics.

Intersections and differentiations: a corpus-assisted discourse study of gender representations in the British press before, during and after the London Olympics 2012

This study examines the impact of a global sports event on gender representations in media reporting. Whereas previous research on gender, sport and media has been mainly concerned with sports events in the North American or Australian context, this study investigates the British media reporting before, during and after the London Olympics 2012. Our study follows the approach of Corpus-Assisted Discourse Studies (CADS) and uses both quantitative and qualitative research procedures. The results reveal more balanced gender representations during the London Olympics in that the ‘regular’ biased associations were supressed in favour of positive references to female achievements. However, little carry-though of the ‘gains’ was noted. Also, this study shows that the positive associations intersected with national sentiments and were used to celebrate the nation-state. At the same time, some subtle resistance was observed to accepting as ‘truly’ British the non-white athletes and those not born in Britain.