Qualitative and mixed methods research in trials

This BMC Special Issue on qualitative and mixed methods research in clinical trials marks an important stage in both methodological development and collaborative relationships between researchers from different academic and clinical fields. It is indicative of the level of interest in the work of a now-substantial community of researchers, and a measure of the extent of integration of that work into the methodological component of trials. It highlights the ability to explore, explain and work through important questions for trials, as well as to provide trialists with evidence-based tools which they can use to improve and refine their own research practice. It is a sign of the growth in comfort and familiarity within the trials community with the aims, perspectives and techniques of qualitative and mixed methods research. Key aims of this series are to showcasethe range of qualitative and mixed methods research in this field and the ways in which they can be utilised to support the methodological growth of clinical trials. The range of qualitative and mixed methods studies published in Trials in recent years is indicative of the growing importance of these approaches. Now endorsed by funders [3] and embraced by trialists [16], qualitative studies are moving beyond being an adjunct to a trial or an opportunist form of study. They are becoming an integral activity for trial teams and clinical trials units [19, 2]. This is a long way to have come in the relatively short history of this particular field. In the late 1980s and 1990s, early work on views of trials and their processes was often hypothetical and adopted simple thematic approaches, commonly collecting data with simple questionnaires. It often focused on a small number of key logistical and ethical issues: recruitment, standards of consent and challenges of integrating research and clinical obligations. From this has grown a complex field with expanding interests and objectives using a range of methodological approaches. If we look at the field now, those core concerns are still important with research around recruitment still forming a large part of the qualitative and mixed methods portfolio. This strand of work continues because, as with the trials we study, it is rarely the case that there can be one definitive piece of research which fully answers our questions. Many studies seek to better understand the challenges involved in different settings (see for example work by Donovan and colleagues [6]) and are doing so with increasing sophistication. Some studies, for instance, involve direct intervention in an ongoing trial as the knowledge gained in pilot or integrated qualitative research is fed into the recruitment process to improve practice [7, 13]. Such studies provide a depth analysis of one trial, seeking to understand the particular circumstances in which it is set and the conditions under which it operates, in order to implement change, but these studies almost always have lessons for upcoming trials. New trials bring with them new challenges, and we push on with recruitment-related research as the questions as well as the settings keep on changing. We now have, for instance, the opportunity to recruit hard-to-reach research populations via social media [24]. We have legislation in Europe which permits trial enrolment in emergency settings without prior consent. Qualitative research helps us to understand how such approaches to recruitment in these novel settings are viewed [21, 25–27]. Studies of decision-making, consent and recruitment are part of an ongoing endeavour to chip away at important questions and improve understanding of the multifaceted and dynamic nature of this key area of trials practice. The body of qualitative research on recruitment is now sufficiently large for reviews [10] and metaanalyses to be a reality [9, 11], and given the importance of these approaches, we are working with our sister journal Systematic Reviews for this Special Issue (see Systematic Reviews Special Issue editorial by David Gough). Ethical aspects of trial conduct also continue to be an important area for qualitative and mixed methods research. Exploration of the impact of policies such as feedback of results, a policy driven by development of fair and transparent trial processes, demonstrates Correspondence: [email protected] London School of Hygiene and Tropical Medicine, London, UK