Conclusion
pain
Qualitative research is a suitable method to be integrated into clinical trials, providing more in-depth information to the tolerability and acceptability of a procedure. The pharmacokinetic data from SCIP support the infusion of high-dose BPG as a possible alternative to monthly IM SP, a finding that would likely be redundant should it prove to be more painful or less tolerable than the current therapy. Our qualitative data demonstrated that the procedure under investigation was acceptable to participants with tolerable discomfort for most. It also identified a subset of participants with more extreme pain, and potential approaches that could be explored to alleviate this. Furthermore, findings from this sub-study have allowed for the development of more detailed participant information sheets for the SCIP-II trial–with suggestions provided by participants of SCIP-I to be incorporated for paediatric and adult cohorts.