Table 1 Timepoints for collection of outcome measures
Outcome | Outcome Measures | Ideal timepoint of evaluation | Maximum timepoint of evaluation |
|---|---|---|---|
Participant preference | Participant preference for control or intervention prosthesis captured on CRFs | 4Â weeks after delivery of the second prosthesis | 8Â weeks following delivery of the second prosthesis |
Condition specific quality of life | TOMCP-27 | Baseline | Prior to delivery of either prosthesis |
4Â weeks after delivery of each prosthesis | 8Â weeks after delivery of each prosthesis | ||
Generic health-related quality of life | SF-12v2 and EQ-5D-5L | Baseline | Prior to delivery of either prosthesis |
4Â weeks after delivery of each prosthesis | 8Â weeks after delivery of each prosthesis | ||
Costs from the healthcare perspective | Resource use questionnaire | Timing and consumable data collected at each clinical visit or laboratory stage | 1Â week after each clinical visit or laboratory stage |
Participants’ perception, lived-experience and preference of the two methods of making facial prostheses | Semi-structured interviews (qualitative sub-study) | Sampled across the IMPRESSeD study visits or within 12 months of study completion | Broad time frame helpful to identify what is important to patients whilst going through the manufacturing process and when reflecting on processes in retrospect |