Table 1 Methods of aggregation for feasibility outcome measures
Proportion | Method |
|---|---|
Eligible participants consenting to participate | \(\frac{\#\;\text{meeting}\;\text{eligibility}\;\text{criteria}\;-\;\#\;\text{in}\;\text{whom}\;\text{consent}\;\text{not}\;\text{obtained}}{\#\;\text{meeting}\;\text{eligibility}\;\text{criteria}}\)Â Â |
Consenting participants receiving the allocated treatment | \(\frac{\#\;\text{consenting\;to\;treatment}\;-\;\#\;\text{not\;administered\;allocated\;treatment}}{\#\;\text{consenting\;to\;treatment}}\) |
Treated participants completing 4- and 12-week laboratory tests | \(\frac{\#\;\text{completing}\;100\%\;\text{of\;weeks}\;4\;\text{and}\;12\;\text{lab\;tests}}{\#\;\text{consenting\;to\;treatment}}\) |
Treated participants completing 4-, 8-, and 12-week side effect questionnaire | \(\frac{\#\;\text{completing}\;100\%\;\text{of\;weeks}\;4,\;8,\;\text{and}\;12\;\text{side-effect\;questionnaire}}{\#\;\text{consenting\;to\;treatment}}\) |
Treated participants completing 4-, 8-, and 12-week FACIT-fatigue scale | \(\frac{\#\;\text{completing}\;100\%\;\text{of\;weeks}\;4,\;8,\;\text{and}\;12\;\text{FACIT-fatigue\;scale}}{\#\;\text{consenting\;to\;treatment}}\) |
Treatment doses taken as per protocol based on pill count | \(\frac{\text{Total}\;\#\;\text{of\;doses}\;-\;\#\;\text{of\;missed\;doses}}{\text{Total}\;\#\;\text{of\;doses}}\) |
Treated participants taking at least 90% of their prescribed doses | \(\frac{\#\;\text{of\;participants\;taking\;at\;least}\;90\%\;\text{of\;prescribed\;doses}}{\text{Total}\;\#\;\text{of\;treated\;participants}}\) |
Treated participants requiring a step down in therapy | \(\frac{\#\;\text{of\;participants\;requiring\;a\;step\;down\;in\;therapy}}{\text{Total}\;\#\;\text{of\;treated\;participants}}\) |