Table 1.
Randomized Controlled Trial | ||||
---|---|---|---|---|
Item | Bottoni4 (2006) | Fabbriciani16 (2004) | Sperber30 (2001) | Jorgensen51 (1999) |
A. Was the treatment allocation randomized and concealed? | + | + | + | − |
B. Was the outcome assessor blinded to the intervention? | + | − | − | + |
C. Were the groups similar at baseline? | + | + | + | + |
D. If not, were adjustments made in the analysis for differences of prognostic indicators at baseline and/or for confounding variables? | NA | NA | NA | NA |
E. Was a sufficient proportion (≥80%) of included patients available for the full length of follow-up? | + | + | + | + |
F. If not, was selective loss to follow-up excluded? | NA | NA | NA | NA |
G. Was an intention-to-treat analysis included? | − | − | − | − |
H. Were the interventions clearly defined? | + | + | + | + |
I. Were the inclusion and exclusion criteria for study entry clearly defined? | + | + | + | + |
J. Were the outcome measures suitable to measure clinically relevant differences in treatment effects? | + | + | + | + |
K. Was the follow-up duration adequate to measure clinical differences between treatment modalities (≥1 year)? | + | + | + | + |
Quality score (%)b | 8 (88) | 7 (77) | 7 (77) | 7 (77) |
+, positive or yes; −, negative or no; NA, not applicable.
Minimum, 0; maximum, 9.