title: The contribution of qualitative research in designing a complex intervention for secondary prevention of coronary heart disease in two different healthcare systems.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Medical Education, Queen's University Belfast, Northern Ireland, UK. m.corrigan@qub.ac.uk
authors.forename: Mairead
authors.initials: M
authors.lastname: Corrrigan
authors.forename: Margaret E
authors.initials: ME
authors.lastname: Cupples
authors.forename: Susan M
authors.initials: SM
authors.lastname: Smith
authors.forename: Molly
authors.initials: M
authors.lastname: Byrne
authors.forename: Claire S
authors.initials: CS
authors.lastname: Leathem
authors.forename: Pauline
authors.initials: P
authors.lastname: Clerkin
authors.forename: Andrew W
authors.initials: AW
authors.lastname: Murphy
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001291:Attitude of Health Personnel; D001294:Attitude to Health; D003327:Coronary Disease / Q000517:prevention & control*; D003695:Delivery of Health Care; D005240:Feasibility Studies; D005260:Female; D017144:Focus Groups; D006801:Humans; D007494:Ireland; D008297:Male; D008875:Middle Aged; D009660:Northern Ireland; D011320:Primary Health Care / Q000458:organization & administration / Q000592:standards*; D036301:Qualitative Research; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D055502:Secondary Prevention; D013222:State Medicine; D011795:Surveys and Questionnaires