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.

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

The determinants of online loan applications from small businesses

Purpose – The purpose of this paper is to examine both the characteristics of the business customers and the types of venture which make use of online loan applications. Despite the growth in the use of technology in banking and the advent of online banking, little research has been conducted on the factors underlying online loan application behaviour amongst business banking customers. Design/methodology/approach – A multivariate analysis is conducted on a USA dataset to empirically test the hypotheses derived in this paper. The empirical evidence is drawn from the US Survey of Small Business Finances, which contains 3,561 sample ventures, representing 5.3 million small businesses in the USA. Findings – The paper finds that online loan behaviour is largely determined by the characteristics of the entrepreneur, rather than that of the venture. It is also found that factors that trust, evident in the length of the relationship between the applicants and their primary lender, is important. Moderating these effects is further evidence that suggests the number of lenders and distance between lenders and applicants has a marked effect on online loan behaviour. Originality/value – This paper identifies the factors determining small business online loan application behaviour. This is important because the nature of online loan behaviour is changing the existing relationships between banks and customers. Whilst online loan applications afford banks the opportunity to substantially reduce costs, the danger is that long term relationships with customers are harder to cement.

The use of information technology by the quantity surveying professionals in Hong Kong

This paper introduces the findings of a recent study on the use of information technology (IT) among the quantity surveying (QS) organisations in Hong Kong. The study was conducted through a structured questionnaire survey among 18 QS organisations registered in Hong Kong, representing around 53% of the total number of organisations in the profession. The data set generated from this study provided rich information about what information technology the QS profession used, what the perceived benefits and barriers experienced by the users in the industry were. The survey concluded that although IT had been widely used in QS organisations in Hong Kong, it is mainly used to support various individual tasks of the QS services at a basic level, rather than to streamline the production of QS services as a whole through automation. Most of the respondents agreed that IT plays an important role in the QS profession but they had not fully taken advantage of IT to improve their competitive edge in the market. They usually adopted a more passive “wait and see” approach. In addition, very few QS organisations in Hong Kong have a comprehensive policy in promoting the use of IT within the organisations. It is recommended that the QS profession must recognise the importance of IT and take appropriate actions to meet the challenges of ever-changing and competitive market place.

Educational value of different types of exhibits in an interactive science and technology center

This study analyzes the short-term consequences of visitors' use of different types of exhibits (i.e., "exemplars of phenomena" and "analogy based") together with the factors affecting visitors' understanding of and their evaluation of the use of such exhibits. One hundred and twenty five visitors (either alone or in groups) were observed during their interaction and interviewed immediately afterwards. Findings suggest that the type of exhibit constrains the nature of the understanding achieved. The use of analogical reasoning may lead to an intended causal explanation of an exhibit that is an exemplar of a phenomenon, but visitors often express misconceptions as a consequence of using this type of exhibit. Analogy-based exhibits are often not used as intended by the designer. This may be because visitors do not access the source domain intended; are unaware of the use of analogy per se (in particular, when the exhibit is of the subtype "only showing similarities between relationships"); only acquire fragmentary knowledge about the target; or fail to use analogical reasoning of which they were capable. Furthermore, exhibits related to everyday world situations are recognized to have an immediate educative value for visitors. Suggestions for enhancing the educative value of exhibits are proposed.

iTrench: a study of user reactions to the use of information technology in field archaeology

This article describes work undertaken by the VERA project to investigate how archaeologists work with information technology (IT) on excavation sites. We used a diary study to research the usual patterns of behaviour of archaeologists digging the Silchester Roman town site during the summer of 2007. Although recording had previously been undertaken using pen and paper, during the 2007 season a part of the dig was dedicated to trials of IT and archaeologists used digital pens and paper and Nokia N800 handheld PDAs to record their work. The goal of the trial was to see whether it was possible to record data from the dig whilst still on site, rather than waiting until after the excavation to enter it into the Integrated Archaeological Database (IADB) and to determine whether the archaeologists found the new technology helpful. The digital pens were a success, however, the N800s were not successful given the extreme conditions on site. Our findings confirmed that it was important that technology should fit in well with the work being undertaken rather than being used for its own sake, and should respect established work flows. We also found that the quality of data being entered was a recurrent concern as was the reliability of the infrastructure and equipment.

Coping with linguistic challenges in UK higher education: the use of strategies by Chinese research students

The present study sets out to examine the strategies used by Chinese learners in a predominantly naturalistic environment and how such learner strategy use relates to their proficiency in the second language. Data were collected from four Chinese research students in the UK using semi-structured interviews. Their proficiency in English was assessed with an oral interview and a listening test. The main findings from this study are that the learners used a wide range of strategies overall, including metacognitive, cognitive, social/affective and compensation strategies. The majority of the commonly reported strategies were metacognitive strategies, suggesting that the learners were self-directed and attempting to manage their own learning in an informal context. They also showed idiosyncrasies in their use of learner strategies. Attempts to explain the learners’ strategy use in relation to their levels of proficiency in English and contextual factors, as well as several other factors, are offered. Implications for target-country institutions in terms of the provision of support to Chinese students are discussed.

The role of efficacy and well-being in guiding the use of education and training services by young homeless mothers

This paper builds on previous work applying the concept of well-being to the field of housing. It uses the concepts of self-esteem, efficacy and social identity to explore the situations of a group of young homeless mothers. In particular, it focuses on the impact of well-being factors, among others, in understanding the uptake of education and training services. The paper concludes by arguing that well-being issues are crucial for housing agencies and others who want to engage with young homeless people.

RedGloo: Experiences of developing and using an emerging technology in higher education

Student life has change a lot since 2005 when the idea to create a Social Network Service (SNS) for students in the School of Systems Engineering at the University of Reading was conceived and went live in 2006, called RedGloo.