Table 3.
GRADE assessments for ferric carboxymaltose compared to iron sucrose complex (ISC) for anemia in Indians.
| FCM compared to ISC for anemia in Indians | |||||
|
Patient or population: Anaemic Indians Setting: Hospital Settings Intervention: FCM Comparison: ISC | |||||
| Outcomes |
No of participants
(studies) Follow-up |
Certainty of the evidence
(GRADE) |
Relative effect
(95% CI) |
Anticipated absolute effects | |
| Risk with ISC | Risk difference with FCM | ||||
| Hb (g/dL) (Post-scores) – 4 Weeks | 187 (1 RCT) |
⨁⨁◯◯ Lowb,c |
– | – | SMD2.48 higher (2.09 higher to 2.86 higher) |
| Hb (g/dL) (Post-scores) – 6 Weeks | 422 (4 RCTs) |
⨁⨁◯◯ Lowb,d |
– | – | SMD1.04 higher (0.71 higher to 1.37 higher) |
| Hb (g/dL)(Post-scores) – 12 Weeks | 258 (3 RCTs) |
⨁◯◯◯ Very lowb,e,f |
– | – | SMD0.95 higher (0.29 higher to 1.6 higher) |
| Serum Ferritin (μg/dL) (Post scores) – 4 Weeks | 187 (1 RCT) |
⨁⨁◯◯ Lowa,b |
– | – | SMD14.33 higher (12.84 higher to 15.83 higher) |
| Serum Ferritin (μg/dL) (Post scores) – 6 Weeks | 264 (2 RCTs) |
⨁◯◯◯ Very lowb,g,h |
– | – | SMD1.21 higher (0.25 higher to 2.17 higher) |
| Serum Ferritin (μg/dL) (Post scores) – 12 Weeks | 100 (1 RCT) |
⨁⨁◯◯ Lowa,b |
– | – | SMD2.43 higher (1.91 higher to 2.95 higher) |
| Adverse reaction | 869 (8 RCTs) |
⨁⨁⨁◯ Moderateg |
not estimable | 142 per 1,000 |
142 fewer per 1,000 (142 fewer to 142 fewer) |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and therelative effect of the intervention (and its 95% CI). CI: confidence interval;SMD: standardised mean difference | |||||
|
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | |||||
|
Explanations a. Downgraded by one for limitation in study design (high RoB) b. Downgraded by one as sample size not optimal c. Downgraded by one for limitation in study design (high RoB in D2 domain of RoB 2) d. Downgraded by one for limitation in study design (high RoB) in three out of four studies e. Downgraded by one for limitation in study design (high RoB) in two out of three studies f. Downgraded by one for inconsistency (heterogeneity) I2=84% g. Downgraded by one for limitation in study design (high RoB) in all studies h. Downgraded by one for inconsistency (heterogeneity) I2=92% | |||||