title: Qualitative research within trials: developing a standard operating procedure for a clinical trials unit.
abstract: 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.
  
  
  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).
  
  
  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.
  
  
  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.
authors: College of Medicine, Swansea University, Singleton Park, Swansea SA2 8PP,UK. f.l.rapport@swansea.ac.uk
authors: Frances
authors: F
authors: Rapport
authors: Mel
authors: M
authors: Storey
authors: Alison
authors: A
authors: Porter
authors: Helen
authors: H
authors: Snooks
authors: Kerina
authors: K
authors: Jones
authors: Julie
authors: J
authors: Peconi
authors: Antonio
authors: A
authors: Sánchez
authors: Stefan
authors: S
authors: Siebert
authors: Kym
authors: K
authors: Thorne
authors: Clare
authors: C
authors: Clement
authors: Ian
authors: I
authors: Russell
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D003299:Cooperative Behavior; D006302:Health Services Research / Q000592:standards*; D006801:Humans; D033183:Interdisciplinary Communication; D017410:Practice Guidelines as Topic; D036301:Qualitative Research; D012107:Research Design / Q000592:standards*; D012108:Research Personnel