Table 8.
Certainty assessment | № of patients | Effect | Certainty | Importance | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
№ of studies |
Study design | Risk of bias |
Inconsistency | Indirectness | Imprecision | Other considerations |
sEMR | fEMR+RFA | Relative (95% CI) |
Absolute (95% CI) |
||
EAC at 1-2 yrs (only 3 studies had follow up of more than 3 yrs); single arm comparison: sEMR (11 observational studies) vs. fEMR + RFA (9 observational studies) | ||||||||||||
20a | observational studies | seriousb | not serious | not serious | very seriousc | publication bias strongly suspectedd | 10/701 (1.4%) | 12/702 (1.7%) |
RR 0.83 (0.36 to 1.92) |
3 fewer per 1,000 (from 11 fewer to 16 more) |
⨁◯◯◯ Very low |
CRITICAL |
Complete eradication of neoplasia at 1-2 yrs (only 3 studies had follow up of more than 3 yrs) indirect comparison: sEMR (11 observational studies) vs. fEMR + RFA (9 observational studies) | ||||||||||||
20a | observational studies | seriousb | not serious | seriouse | not serious | publication bias strongly suspectedd | 717/774 (92.6%) | 699/747 (93.6%) |
OR 1.33 (0.56 to 3.15) |
15 more per 1,000 (from 45 fewer to 43 more) |
⨁◯◯◯ Very low |
CRITICAL |
Stricture | ||||||||||||
52f | observational studies | seriousg | not serioush | not serious | not serious | none | 269/840 (32.0%) | 585/13882 (4.2%) |
RR 7.33 (6.46 to 8.31) |
267 more per 1,000 (from 230 more to 308 more) |
⨁◯◯◯ Very low |
CRITICAL |
Bleeding | ||||||||||||
32i | observational studies | seriousb | not serioush | not serious | seriousj | none | 59/840 (7.0%) | 53/5902 (0.9%) |
RR 7.82 (5.44 to 11.25) |
61 more per 1,000 (from 40 more to 92 more) |
⨁◯◯◯ Very low |
CRITICAL |
Perforation | ||||||||||||
40k | observational studies | seriousb | not serious | not serious | seriousj | none | 13/840 (1.5%) | 16/5799 (0.3%) |
RR 5.62 (2.72 to 11.65) |
13 more per 1,000 (from 5 more to 29 more) |
⨁◯◯◯ Very low |
CRITICAL |
sEMR (11 observational studies) vs. fEMR + RFA (9 observational studies)
Comparison of independent single arm studies with no time concurrent controls
Very small event number in both treatment groups
Publication bias was noted by Desai et al using Eggers regression test for the sEMR studies
Indirectness suspected since the outcome is eradication of dysplasia and not recurrence of cancer or mortality from cancer
sEMR (12 observational studies) vs. fEMR + RFA (40 observational studies)
Comparison of independent single arm studies with no time concurrent controls. Additionally the sEMR intervention was not standardized and differed between studies; some studies had less resections per procedure and used steroid, while other studies had more resections per procedure.
Cannot assess for inconsistency because 2 treatment interventions are pooled from a single arm studies, but there was heterogeneity observed when the pooled estimate was calculate for each intervention separately.
sEMR (12 observational studies) vs. fEMR + RFA (20 observational studies)
low event number
sEMR (12 observational studies) vs. fEMR + RFA (28 observational studies)