Table 3.
Summary of findings (GRADE, pending completion)
| Outcomes | No. of participants (studies) | Certainty of the evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects | |
|---|---|---|---|---|---|
| Risk with plastic stents | Risk difference with LAMS/ BFMS* | ||||
| Clinical improvement | 1007 (8 observational studies, 1 RCT) | ⨁⨁◯◯ LOW | OR 2.58 (1.81, 3.68) | 741 per 1000 | 140 more per 1000 (97 more to 172 more) |
| Clinical improvement assessed with: CT scan and resolution of symptoms | 60 (1 RCT) | ⨁⨁◯◯ LOW | OR 0.52 (0.04, 6.04) | 966 per 1000 | 30 fewer per 1000 (437 fewer to 29 more) |
| Number of endoscopic sessions | 513 (5 observational studies) | ⨁◯◯◯ VERY LOW | MD −0.43 (−0.84 to −0.02) | — | — |
| Percutaneous drainage placement | 443 (4 observational studies) | ⨁◯◯◯ VERY LOW | OR 0.68 (0.37, 1.24) | 134 per 1000 | 39 fewer per 1000 (80 fewer to 27 more) |
| Mortality | 507 (7 observational studies) | ⨁◯◯◯ VERY LOW | OR 0.60 (0.22, 1.62) | 39 per 1000 | 15 fewer per 1000 (30 fewer to 23 more) |
| Any adverse event | 891 (9 observational studies) | ⨁◯◯◯ VERY LOW | OR 1.22 (0.61, 2.46) | 198 per 1000 | 34 more per 1000 (67 fewer to 180 more) |
| Complication: bleeding | 818 (8 observational studies) | ⨁◯◯◯ VERY LOW | OR 1.31 (0.46, 3.73) | 44 per 1000 | 13 more per 1000 (24 fewer to 103 more) |
| Stent obstruction | 694 (5 observational studies) | ⨁◯◯◯ VERY LOW | OR 1.11 (0.26, 4.64) | 102 per 1000 | 10 more per 1000 (73 fewer to 243 more) |
| Stent migration | 838 (7 observational studies) | ⨁◯◯◯ VERY LOW | OR 0.47 (0.22, 1.01) | 52 per 1000 | 27 fewer per 1000 (40 fewer to 0 fewer) |
| Perforation/peritonitis | 506 (5 observational studies) | ⨁◯◯◯ VERY LOW | OR 2.12 (0.65, 6.90) | 22 per 1000 | 23 more per 1000 (8 fewer to 112 more) |
| Technical failure | 888 (8 observational studies) | ⨁◯◯◯ VERY LOW | OR 1.06 (0.19, 6.00) | 4 per 1000 | 0 fewer per 1000 (4 fewer to 22 more) |
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; and 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.
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).