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Table 3 SPARE trial qualitative recruitment investigation - mapping findings and changes

From: Key issues in recruitment to randomised controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (CRUK/07/011)

Key issues Findings Changes/recommendations Aspect of trial changed/recommendation for Implementation
   Simplified flowchart PIS and protocol a Amended and ethical approval obtained
  Difficulty in explaining the trial    
   Easy explanation of trial Recruiter-patient interaction b Training session
  Randomisation period confusion Opened up randomisation period Protocol a Amended and ethical approval obtained
Aspects of trial design and conduct Information overload Two-stage information provision (chemo and post-chemo) Recruitment and pre-recruitment interactions (also linked to streamlining of pathway) b Training session
b Recruitment appointment tips document
  Complex recruitment pathway Streamlining of recruitment pathway and information provision Recruitment pathway b Streamlining recommendations document
    PIS a Amended and ethical approval obtained
  Loaded terminology and unbalanced information Use of neutral terms and equivalent information on both arms   
    Recruiter-patient interaction b Training session
b Recruitment appointment tips document
  Patients' strong treatment preferences Eliciting and addressing concerns/preferences Recruiter-patient interaction b Training session
b Recruitment appointment tips document
Preferences Patient preferences influenced by recruiter, and number of people in recruitment pathway Acknowledging and reflecting on own preferences; Recruiter-patient interaction b Training session
   Streamlining and limiting number of people involved in recruitment pathway Recruitment pathway b Streamlining recommendations document
  1. a these changes of the PIS and protocol were done together
  2. b these aspects were done at various points in the study, but it was not possible to monitor their implementation because of the closure of the trial
  3. The major findings and the subsequent changes and methods of implementation of the qualitative recruitment investigation are shown in Table 3.