Table 3.
SPARE trial qualitative recruitment investigation - mapping findings and changes
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 |
a these changes of the PIS and protocol were done together
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
The major findings and the subsequent changes and methods of implementation of the qualitative recruitment investigation are shown in Table 3.