title: Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study.
abstract: BACKGROUND
  Qualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice.
  
  
  METHODS
  A telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research.
  
  
  RESULTS
  Interviewees described the added value of qualitative research for the trial, explaining how it solved problems at the pretrial stage, explained findings, and helped to increase the utility of the evidence generated by the trial. From the interviews, we identified three models of relationship of the qualitative research to the trial. In 'the peripheral' model, the trial was an opportunity to undertake qualitative research, with no intention that it would add value to the trial. In 'the add-on' model, the qualitative researcher understood the potential value of the qualitative research but it was viewed as a separate and complementary endeavour by the trial lead investigator and wider team. Interviewees described how this could limit the value of the qualitative research to the trial. Finally 'the integral' model played out in two ways. In 'integral-in-theory' studies, the lead investigator viewed the qualitative research as essential to the trial. However, in practice the qualitative research was under-resourced relative to the trial, potentially limiting its ability to add value to the trial. In 'integral-in-practice' studies, interviewees described how the qualitative research was planned from the beginning of the study, senior qualitative expertise was on the team from beginning to end, and staff and time were dedicated to the qualitative research. In these studies interviewees described the qualitative research adding value to the trial although this value was not necessarily visible beyond the original research team due to the challenges of publishing this research.
  
  
  CONCLUSIONS
  Health researchers combining qualitative research and trials viewed this practice as strengthening evaluative research. Teams viewing the qualitative research as essential to the trial, and resourcing it in practice, may have a better chance of delivering its added value to the trial.
authors.affiliation: Health Services Research, Medical Care Research Unit, School of Health and Related Research (ScHARR), University of Sheffield, Regent Street, Sheffield S1 4DA, UK. a.ocathain@sheffield.ac.uk.
authors.forename: Alicia
authors.initials: A
authors.lastname: O'Cathain
authors.forename: Jackie
authors.initials: J
authors.lastname: Goode
authors.forename: Sarah J
authors.initials: SJ
authors.lastname: Drabble
authors.forename: Kate J
authors.initials: KJ
authors.lastname: Thomas
authors.forename: Anne
authors.initials: A
authors.lastname: Rudolph
authors.forename: Jenny
authors.initials: J
authors.lastname: Hewison
mesh_terms: D003142:Communication; D006801:Humans; D007407:Interviews as Topic / Q000379:methods*; D036301:Qualitative Research; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D012109:Research Support as Topic; D035844:Researcher-Subject Relations; D006113:United Kingdom