Qualitative research within trials: developing a standard operating procedure for a clinical trials unit

<p>BACKGROUND: Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design.</p> <p>METHODS: Health services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP).</p> <p>RESULTS: The qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component.</p> <p>CONCLUSIONS: We recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials.</p&gt

Using mixed methods in monitoring and evaluation : experiences from international development

This paper provides an overview of the various ways in which mixing qualitative and quantitative methods could add value to monitoring and evaluating development projects. In particular it examines how qualitative methods could address some of the limitations of randomized trials and other quantitative impact evaluation methods; it also explores the importance of examining"process"in addition to"impact", distinguishing design from implementation failures, and the value of mixed methods in the real-time monitoring of projects. It concludes by suggesting topics for future research -- including the use of mixed methods in constructing counterfactuals, and in conducting reasonable evaluations within severe time and budget constraints.Poverty Monitoring&Analysis,Scientific Research&Science Parks,Science Education,Poverty Impact Evaluation,Statistical&Mathematical Sciences

Developing Morally Sensitive Policy in the NICU: Donation after Circulatory Determination of Death

Policy development is an important activity for the practice of healthcare. Policies, after all, may cultivate common practices and ensure that best available evidence is employed in clinical decision making. Qualitative research and individuals with expertise in qualitative research methods have much to offer policy makers. We were confronted with the situation of developing policy for donation after circulatory death (DCD) for our newborn intensive care program. Due the moral-ethical complexities surrounding DCD, and the limited experience with DCD in this context, we approached policy development from an iterative design perspective employing qualitative methods. We describe our experience in employing this approach and the methodological implications of design as a method for policy development

Designing Refillable Packaging: A Qualitative Approach

In recognition of the fact that current packaging design fails to address the resource reductions needed to support the sustainability agenda (INCPEN, 2001; Environmental Services Association, 2004), a 2 year collaborative research project between Loughborough University and The Boots Company, funded by DEFRA, was set up to investigate the feasibility of developing refillable packaging systems which appeal to the consumer whilst reducing the overall sustainability impact. The overall aim of the project – ‘Refillable Packaging Systems’, reported on in this paper was to develop a refillable packaging system for a ‘body wash’ product and to investigate its feasibility with respect to consumer acceptance (female customers, aged 21-40) and sustainability improvements. In order to achieve the project aim a broad range of qualitative methods were used. This paper details the methods used to collate background understanding, develop design concepts and test the viability of the design solutions. It reflects on why they were used, how effective they were and on the benefits of combining these different methods at different stages. The paper concludes that combining together an array of design related qualitative methods, of the nature described, can produce rich and valuable outcomes. The project demonstrates that this approach can lead to the development of a more detailed understanding of the topic under investigation and open up discussion by creating demonstrator products which can be handled, critiqued and examined. Keywords: Packaging; Design Methods; Questionnaire; Visual Templates; Prototyping; Consumer Workshops</p

An Exploratory Sequential Mixed Methods Approach to Understanding Researchers’ Data Management Practices at UVM: Findings from the Qualitative Phase

The objective of this article is to report on the first qualitative phase of an exploratory sequential mixed methods research design focused on researcher data management practices and related institutional research data services. The aim of this study is to understand data management behaviors of faculty at the University of Vermont (UVM), a higher-research activity Research University, in order to guide the development of campus research data management services. The population of study was all faculty who received National Science Foundation (NSF) grants between 2011 and 2014 who were required to submit a data management plan (DMP); qualitative data was collected in two forms: (1) semi-structured interviews and (2) document analysis of data management plans. From a population of 47 researchers, six were included in the interview sample, representing a broad range of disciplines and NSF Directorates, and 35 data management plans were analyzed. Three major themes were identified through triangulation of qualitative data sources: data management activities, including data dissemination and data sharing; institutional research support and infrastructure barriers; and perceptions of data management plans and attitudes towards data management planning. The themes articulated in this article will be used to design a survey for the second quantitative phase of the study, which will aim to more broadly generalize data management activities at UVM across all disciplines

Practice-based research methods for new media design in museums and interpretive interactive environments : what practice-based research methods allow the design and development of an interactive touch screen interface for children between the age of 6-13 years, which is informative, engaging and exploratory within the Powerhouse Museum Sydney?

University of Technology, Sydney.Faculty of Design, Building and Architecture.Design and research methods specifically for the development of interactive touch screen interfaces in a museum contexts was limited to and relied on summative evaluation to determine the effectiveness of the design. Further more, curators were relied upon to determine content and structure narratives within the exhibitions. This resulted in a subjective narrative and a design that doesn't necessarily engage or appeal to the audience. The objective of the research was to develop an interactive table touch screen interface about the Moon for children between the ages of 6-13 years within the Powerhouse Museum in Sydney. The interface was developed using a practice-based design and research approach to discover the necessary methods for effective design. Therefore the interactive touch screen interface was developed from a user-centered/participatory iterative design approach, which included a diverse range of methods. The methods of research required for the design development were structured within a reconfigured framework in which multiple methods of research and design were practiced to inform and justify design decisions. The methods of research operated within an iterative cyclic process in which a mixed-fidelity prototype was utilised. The reconfigured framework not only provided a struct ure in wh ich the design was justified by data, it also allowed for basic design practices to be incorporated into t he structure, these included critical reflection and intervention to interpret and inform the design . The reconfigured framework allowed qualitative and quantitative methods to feed into design decisions. As a result of the hybrid approach a series of statistical data analysis, observation and interpretation were necessary to decipher testing results and raw data from cultural probe, low-fidelity and high-fidelity prototype testing and evaluations. As well as these methods observation, unstructured interviews and cultural probe testing were carried out informed by literature and formative research methods. These methods were broken down into phases and roles in which the structure and relationship between each practice is visually represented and directed. The framework was visualised to allow future designers to utilise this structure. The study revealed that the combination of qualitative and quantitative methods and usercentered design was essential and unavoidable for the design and development of the interactive touch interface. This was represented by the successful design and development of a high-fidelity prototype that proved to engage, inform and allowed an exploratory experience for the target audience. This development was a direct result of the reconfigured framework and the focus on user participation as a key component in which data, reflection and interventions were utilised to inform the design

First make something – principled, creative design as a tool for multi-disciplinary research in clinical engineering

Design provides a set of tools for exploring our world and these can give very different insights from the tools of the natural scientist or social scientist. The Art and Design Research Centre at Sheffield Hallam University is developing the use of creative practice at the centre of multi-disciplinary research and has demonstrated that this approach can bring significant results in areas of research which are more usually thought of thought of as science or engineering. This paper describes a 3-year project which has provided completely new ideas for the design of artificial limbs based on close analogies with human anatomy. The project was intended to look at very long-term developments but has also resulted in ideas for today's products and has changed the thinking of both clinicians and manufacturers. Investigative methods included iterative cycles of creative development and reflection; work with users including the production of video material to stimulate their thinking beyond the state of the art; and both qualitative and quantitative evaluation of design outcomes with scientific and clinical specialists.</p

Evaluation of the Community Child Health Research Network (CCHN) Community-Academic Partnership

Background: The Community Child Health Network (CCHN) is a research collaborative network of five communities in the U.S. formed to study maternal and child health disparities, via a community-based participatory research study design. CCHN studies how community, family, and individual level influences interact with biological processes to affect maternal stress, resilience, and allostatic load; ultimately, the study evaluates whether such factors result in health disparities in pregnancy outcomes and infant and early childhood mortality and morbidity. The purpose of this paper is to assess the community-based participatory research (CBPR) process that governs the CCHN and offer lessons from our experiences. Methods: This study employs a qualitative approach to evaluate the CBPR process among CCHN community and academic partners. Qualitative interviews (n=17) were completed by both community and academic CCHN partners. Results: Content analysis of qualitative data revealed six major themes (1) lack of necessary resources; (2) collaborative learning; (3) perceived benefits; (4) communication and education; (5) trust and expectations; and (6) sustainability. Discussion: The benefits and challenges of implementing productive, community-academic partnerships were present both at the local site-level and the network-level. Ultimately, the inclusion of community-based participatory research principles and methods enhanced the study development, implementation, analysis, and dissemination of findings. Conclusion: Lessons learned from a multi-site CBPR project, including strategies for managing learning and communication across different geographic sites, may be useful to other CBPR and multi-site community-based research endeavors

Study behaviours in an increasingly digital world: Learning habits, top tips and 'study hacks' questionnaire survey

In response to recent changes in the higher education market, student performance and competitor activity, The Open University has developed strategic objectives around a shift to developing ‘digital by design’ modules and the development of new digital tools to improve student success rates. In order to design effective tools, this initial piece of research was designed to understand more about students’ current study behaviours. The survey was built on a framework with student success at the centre, and generated a great deal of rich, qualitative data about how current distance learning students approach their study. The data was analysed using a thematic analysis, and produced a number of interesting themes. These included a variety of digital personas; priorities when organising study sessions; note-taking methods and reasons for making notes; and boundaries. The practical applications of these findings are some embryonic concepts for new tools and digital spaces for students that encourage the development of successful study behaviours. These concepts are being developed in conjunction with a rigorous research plan

Design and sustainable development: what is the contribution that design can make? A case study of the Welsh Woollen Industry

This paper reports on ongoing research examining the contribution that design can make to sustainable development, that is: '… development that meets the needs of the present without compromising the ability of future generations to meet their own needs' (WCED, 1987, p. 43) It outlines the need for global sustainable development and its adoption into global and governmental policies. Both of the key concepts of design and sustainable development are discussed, as is the relationship between them (Spangenberg 2001, Walker 2006). The contradictions between design as a stimulator of consumption and its potential contribution to sustainable development are examined. The context of the research is Wales, one of the few nations to have a legal commitment to sustainable development (Welsh Assembly Government 2004a), and a selected part of the textile industry there. The policy background and the measurement of sustainable development in Wales are discussed. A background is given to the selected part of the textile industry, that is the Welsh Woollen Industry and a classification of it into ‘old’ and ‘new’ sectors is proposed. The methodology of the study is outlined, having a social constructionist philosophy, informed by feminism and interpretivism. The methods developed to explore this relationship are principally qualitative (Rossman and Rallis 1998) within which a case study approach is taken (Langrish 1993, Yin 2003). Analysis of data collected indicate that the use of design as a recognised activity is uneven, some producers using design strategically to give their work unique appeal and others not using it in a conscious way. In other contexts a design input does not contribute to economic sustainability as might be expected (Lorenz 1986). Further work is outlined including concepts and tools to be used. More data will be collected from producers in urban areas in order to gain further insights and from key people working in both design and sustainable development at an institutional level. Keywords: Design; Sustainable Development; Wales; Welsh textile industry; rural producers</p