Table II.
Assessment of the quality of evidence for intervention.
| GRADE factors | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Author, year (ref.) | Study design | Limitations in study design and/or executiona | Inconsistency | Indirectness | Imprecision | Publication bias | Moderate/large effect size | Dose effect | Overall quality |
| Moroney et al, 2011 (27) | Phase 1, non-randomized | P | N | N | N | N | Not present | Not present | ++ |
| Piha-Paul et al, 2014 (28) | Phase 1, non-randomized | P | N | N | P (very few patients were included) | N | Not present | Not present | + |
| Tinker et al, 2013 (29) | Phase 2, non-randomized | P | N | N | N | N | Not present | Not present | ++ |
a
None of the included clinical trials had control groups, all lacked blinding and all were non-randomized. For GRADE factors (19): N, no serious limitations; P, presence of serious limitation. For overall quality (of evidence): +, very low; ++, low; +++, moderate; ++++, high.