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. Author manuscript; available in PMC: 2024 Aug 26.
Published in final edited form as: Gastroenterology. 2024 Jun;166(6):1020–1055. doi: 10.1053/j.gastro.2024.03.019

Table 8.

Grading of Recommendations Assessment, Development and Evaluation Evidence Profile for PICO Question 4: Comparing resection of visible lesions followed by ablation of the remaining BE segment with resection of the entire BE segment.

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
a.

sEMR (11 observational studies) vs. fEMR + RFA (9 observational studies)

b.

Comparison of independent single arm studies with no time concurrent controls

c.

Very small event number in both treatment groups

d.

Publication bias was noted by Desai et al using Eggers regression test for the sEMR studies

e.

Indirectness suspected since the outcome is eradication of dysplasia and not recurrence of cancer or mortality from cancer

f.

sEMR (12 observational studies) vs. fEMR + RFA (40 observational studies)

g.

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.

h.

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.

i.

sEMR (12 observational studies) vs. fEMR + RFA (20 observational studies)

j.

low event number

k.

sEMR (12 observational studies) vs. fEMR + RFA (28 observational studies)