The contribution of qualitative research in designing a complex intervention for secondary prevention of coronary heart disease in two different healthcare systems

Background: Developing complex interventions for testing in randomised controlled trials is of increasing importance in healthcare planning. There is a need for careful design of interventions for secondary prevention of coronary heart disease (CHD). It has been suggested that integrating qualitative research in the development of a complex intervention may contribute to optimising its design but there is limited evidence of this in practice. This study aims to examine the contribution of qualitative research in developing a complex intervention to improve the provision and uptake of secondary prevention of CHD within primary care in two different healthcare systems.

Methods: In four general practices, one rural and one urban, in Northern Ireland and the Republic of Ireland, patients with CHD were purposively selected. Four focus groups with patients (N = 23) and four with staff (N = 29) informed the development of the intervention by exploring how it could be tailored and integrated with current secondary prevention activities for CHD in the two healthcare settings. Following an exploratory trial the acceptability and feasibility of the intervention were discussed in four focus groups (17 patients) and 10 interviews (staff). The data were analysed using thematic analysis.

Results: Integrating qualitative research into the development of the intervention provided depth of information about the varying impact, between the two healthcare systems, of different funding and administrative arrangements, on their provision of secondary prevention and identified similar barriers of time constraints, training needs and poor patient motivation. The findings also highlighted the importance to patients of stress management, the need for which had been underestimated by the researchers. The qualitative evaluation provided depth of detail not found in evaluation questionnaires. It highlighted how the intervention needed to be more practical by minimising administration, integrating role plays into behaviour change training, providing more practical information about stress management and removing self-monitoring of lifestyle change.

Conclusion: Qualitative research is integral to developing the design detail of a complex intervention and tailoring its components to address individuals' needs in different healthcare systems. The findings highlight how qualitative research may be a valuable component of the preparation for complex interventions and their evaluation.

Methodological issues for qualitative research with learning disabled children

This paper discusses key methodological issues for qualitative research with learning disabled children, based on the author's experience of involving learning disabled children in her doctoral study. The study was founded on the social model of disability and a sociological understanding of childhood that recognizes the abilities of disabled children as competent research participants. Issues that arose throughout the research process, from the early stages of gaining access to children, to communication challenges for interviewing learning disabled children, and the analysis and dissemination of data, are discussed. Within this context, this paper explores key methodological issues for researchers with regard to interviewing learning disabled children and actively involving them in qualitative research.

Validity, trustworthiness and rigour:reasserting realism in qualitative research

Aim The aim of this paper is to challenge recent sceptical approaches to the possibility of validating qualitative research and to underline the benefits of adopting a realist approach to validity. Background In recent discussion about the methodological bases for qualitative research it has been argued that, because different methodologies take different approaches to validity, attempts to develop a common set of validation criteria are futile. On the basis of this sceptical view, a number of strategies for judging qualitative research have been proposed. These include suggestions that: it should be judged according to aesthetic or rhetorical criteria, rather than epistemological validity; responsibility for appraisal should move from researchers to readers; each methodology should be assessed individually according to its own merits. Discussion None of these suggestions provide a viable alternative to validity, defined as the extent to which research reflects accurately that to which it refers. Because the form of research does not determine its content, replacement of epistemology by aesthetics is unsustainable. Because research reports mediate between writer and reader, a one-sided approach to this relationship constitutes a false dichotomy. If we accept the criterion of practitioner confidence as a means of judging methodological approaches, this involves rejection of judgement according to a methodology�s own merits. Conclusion If qualitative research is actually about something, and if it is required to provide beneficial information, then a realist approach to validity holds out greatest promise.

On the Problems of Mixing RCTs with Qualitative Research: The Case of the MRC Framework for the Evaluation of Complex Healthcare Interventions

In the perceived hierarchy of research designs, the results from randomized controlled trials are considered to provide the highest level of evidence. Indeed these trials have been upheld as the gold standard in research. The benefits and limitations of the randomized controlled trial as a method of evaluating the effectiveness of healthcare interventions are presented. The article then examines the different levels of complexity within healthcare interventions and the problems this poses in determining effectiveness. In an effort to provide a solution to this problem, the Medical Research Council produced a framework to assist investigators to develop and evaluate complex healthcare interventions. The framework is described with reference to an example of implementing and evaluating protocols for weaning patients in the intensive care unit. The framework is critiqued on the basis that it involves an ambiguous or contradictory ontology, which fails to articulate the relationship between the positivism of randomized controlled trials with the relativism of qualitative approaches. It is concluded that the use of realist strategies in combination with randomized controlled trials provides the most coherent solution to this quandary