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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.