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. 2012 Jun 23;470(10):2785–2799. doi: 10.1007/s11999-012-2404-6

Table 5.

GRADE evidence profile of RCTs for effect of vertebroplasty for osteoporotic vertebral fractures

Outcome Summary of findings Quality assessment
Time (months) Number (treated/control) WMD (95% CI, g/cm2) Risk of bias* Inconsistency Indirectness Imprecision Others§ Quality
Pain score 1–29 8 (449/285) −2.06 (−3.39, −0.74) No serious Not serious Not serious Not serious None High
90 8 463/289) −1.47 (−2.20, −0.75) Not serious Not serious Not serious Not serious None High
Greater than 180 6 (379/237) −1.25 (−1.64, −0.86) Not serious Not serious Not serious Not serious None High
RDQ score 30 4 (191/161) −1.75 (−2.71, −0.78) Not serious Not serious Not serious Serious None Moderate
90 3 (173/145) −1.44 (−2.45, −0.44) Not serious Not serious Not serious Serious None Moderate
EQ-5D score 30–90 3 (103/85) −0.11 (−0.13, −0.08) Not serious Not serious Not serious Serious None Moderate
QUALEFFO 1–29 3 (139/129) −5.68 (−9.10, −2.26) Not serious Not serious Not serious Serious None Moderate
Refracture 7 (81/45) −1.44 (−2.45, −0.44) Not serious Not serious Not serious Not serious None High

GRADE = Grading of Recommendations Assessment, Development and Evaluation; WMD = weighted mean difference; RDQ = Roland-Morris Disability Questionnaire; EQ-5D = European Quality of Life–5 Dimensions; QUALEFFO = Quality of Life Questionnaire of the European Foundation for Osteoporosis; * inadequate blinding, lack of allocation concealed in some trials may increase risk of bias; inconsistent report of outcomes and significant heterogeneity existed across the trials, but all were well explained by the subgroup analysis; if a study has a wide confidence interval around the estimate of the effect, or included patients less than 400, it may cause imprecision; §“Other” consisted of publication bias and upgraded quality of evidence (large effect, plausible residual confounding and dose-response gradient).