Table 7.
Grading of Recommendations Assessment, Development and Evaluation Evidence Profile for PICO Question 3: Comparing EET with surveillance in individuals with NDBE
| Certainty assessment | № of patients | Effect | Certainty | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| № of studies | Study design |
Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations |
EET | no treatment |
Relative (95% CI) |
Absolute (95% CI) |
||
| Disease progression and mortality | ||||||||||||
| 6 | non-randomized studies | seriousa | not serious | not serious | seriousb | none | No comparative evidence from RCT or cohort studies. Population-based studies and single-arm cohort studies with consecutive patients: Progression to EAC (incidence): - The US RFA Patient Registry [Wolf 2015]: incidence of EAC in patients with NDBE was 0.47 per 1000PY; - USA large database -TriNetX [Smith 2023]: incidence of EAC was 3.34 per 1000 PY (95% CI: 0.75, 7.04); Progression to LGD and HGD (incidence): - US RFA Registry [Pasricha 2014] in cadence of LGD and HGD was 1.2 per 1000PY and 3.12 per 1000PY respectively. - Small cohort study [Corbett 2022]: 53 patients followed for 11.5 years post RFA of NDBE for incidence of LGD of 1.64 pre 1000PY. - Single arm cohort study [Wang 2022]: 123 patients followed for 7 years, incidence of LGD and HGD 3.48 and 1.16 per 1000 PY respectively - Single-arm cohort study [Wani 2020]: 61 patients 3.3 years of follow up no progression to progress to HGD or adenocarcinoma. |
⨁◯◯◯ Very low | CRITICAL | |||
| Stricture | ||||||||||||
| 10 | non-randomized studies | not serious | not serious | not serious | seriousc | strong association | 75/1489 (5.0%) | 1/10000 (0.0%) | not estimable |
38 more per 1,000 (from 28 more to 48 more)d |
⨁⨁◯◯ Low |
CRITICAL |
| Bleeding | ||||||||||||
| 9 | non-randomized studies | not serious | not serious | not serious | very seriousb | none | 12/1439 (0.8%) | 1/10000 (0.0%) | not estimable |
9 more per 1,000 (from 4 more to 14 more)e |
⨁◯◯◯ Very low |
CRITICAL |
| Pein | ||||||||||||
| 8 | non-randomized studies | not serious | not serious | not serious | very seriousb | none | 11/370 (3.0%) | 1/10000 (0.0%) | not estimable |
21 more per 1,000 (from 1 more to 42 more)f |
⨁◯◯◯ Very low |
IMPORTANT |
a.
No comparison group, poorly defined intervention (mostly combining 2 different endoscopic methods). Also some studies limited the cohort to responders to endoscopic treatment only. Furthermore, major confounders such as PPI use and smoking were not adjusted for in most of the studies.
b.
Very low event numbers
c.
low events were observed
d.
Stricture events in Surveillance group with esophageal biopsy is very low
e.
Major bleeding events in Surveillance group with esophageal biopsy is very low
f.
Severe pain post upper endoscopy with biopsy is very rare