Table 1 Summary of amendments to the HAND-1 feasibility study protocol
Protocol | Date | Summary of changes prior to start of recruitment |
|---|---|---|
v 1.1 | 27 Aug 2015 | • Minor administrative and typographical changes • Clarification that if a participant requires treatment on more than one finger, then both/all fingers will be treated in the same manner (i.e. both/all with limited fasciectomy or both/all with needle fasciotomy). For any study outcomes that require reference to a single finger, the one which the patient reports pre-operatively as causing the most trouble will be selected |
Protocol | Date | Summary of changes after start of recruitment |
v 2.0 | 21 Jun 2016 | • Modification to 6-month follow-up so that participants who are unable to have a 6-month visit within the study follow-up period, because of the waiting time from randomisation to surgery, will be followed up via postal questionnaire only • Clarification that the qualitative research is carried out by researchers from the University of Bristol, and that participants may pause or stop audio-recordings or discussions with the qualitative researcher at any time • Clarification of serious adverse event (SAE) reporting timelines and process |