Table 1 The main feasibility progression criteria
Feasibility criteria | Interpretation | Progress information to potential full-scale trial |
|---|---|---|
Specific breathing protocol | Add-on breathing technique | Acceptable participants adherence of breathing protocol during clinic visits |
Outcome measures | Diary data | Acceptable participants adherence of home exercises |
Patient-reported outcome measures | Clinically relevant outcomes measure differences between groups | |
Patient-reported outcome measures | Clinically relevant outcome measures responsiveness in order to choose primary and secondary outcome measures for larger scale study | |
Eligibility criteria | Inclusive or restrictive recruitment criteria | Successful recruitment in acceptable time frame |
Randomization | Simple randomization | Balance study groups in numbers and demographics |