Table 2.
Confounding adjustment method & data-sharing approach | Effectiveness outcome, change in body mass indexb | Safety outcomec | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
<5% | ≥5% | ≥10% | ≥20% | ≥30% | Re-hospitalization | Re-intervention | ||||||||
OR | 95% CI | OR | 95% CI | OR | 95% CI | OR | 95% CI | OR | 95% CI | OR | 95% CI | OR | 95% CI | |
Stratification | ||||||||||||||
Pooled individual-level | 3.74 | 3.08, 4.54 | 0.13 | 0.08, 0.22 | 0.12 | 0.10, 0.16 | 0.09 | 0.07, 0.11 | 0.08 | 0.05, 0.11 | 0.85 | 0.62, 1.15 | 0.82 | 0.59, 1.11 |
Risk-set | 3.74 | 3.08, 4.54 | 0.13 | 0.08, 0.22 | 0.12 | 0.10, 0.16 | 0.09 | 0.07, 0.11 | 0.08 | 0.05, 0.11 | 0.85 | 0.62, 1.15 | 0.82 | 0.59, 1.11 |
Summary-table | 3.74 | 3.08, 4.54 | 0.13 | 0.08, 0.22 | 0.12 | 0.10, 0.16 | 0.09 | 0.07, 0.11 | 0.08 | 0.05, 0.11 | 0.85 | 0.62, 1.15 | 0.82 | 0.59, 1.11 |
Effect-estimate, fixed-effect | 3.73 | 3.08, 4.52 | 0.13 | 0.08, 0.20 | 0.12 | 0.09, 0.16 | 0.09 | 0.07, 0.11 | 0.09 | 0.06, 0.12 | 0.94 | 0.69, 1.28 | 0.85 | 0.62, 1.15 |
Effect-estimate, random-effects | 3.59 | 1.52, 8.48 | 0.15 | 0.06, 0.33 | 0.12 | 0.06, 0.23 | 0.07 | 0.04, 0.12 | 0.05 | 0.01, 0.16 | 0.85 | 0.29, 2.46 | 0.74 | 0.41, 1.32 |
Measure of heterogeneity, Qd | 22.59 | <.0001 | 2.41 | 0.2983 | 4.67 | 0.0962 | 7.23 | 0.0269 | 7.79 | 0.0203 | 12.79 | 0.0017 | 4.31 | 0.1156 |
Matching | ||||||||||||||
Pooled individual-level | 3.66 | 2.85, 4.73 | 0.15 | 0.05, 0.37 | 0.17 | 0.11, 0.26 | 0.10 | 0.07, 0.13 | 0.08 | 0.06, 0.12 | 0.87 | 0.58, 1.30 | 0.78 | 0.52, 1.17 |
Risk-set | 3.66 | 2.85, 4.73 | 0.15 | 0.05, 0.37 | 0.17 | 0.11, 0.26 | 0.10 | 0.07, 0.13 | 0.08 | 0.06, 0.12 | 0.87 | 0.58, 1.30 | 0.78 | 0.52, 1.17 |
Summary-table | 3.66 | 2.85, 4.73 | 0.15 | 0.05, 0.37 | 0.17 | 0.11, 0.26 | 0.10 | 0.07, 0.13 | 0.08 | 0.06, 0.12 | 0.87 | 0.58, 1.30 | 0.78 | 0.52, 1.17 |
Effect-estimate, fixed-effect | 3.63 | 2.84, 4.66 | 0.16 | 0.07, 0.40 | 0.19 | 0.12, 0.29 | 0.10 | 0.07, 0.13 | 0.09 | 0.06, 0.13 | 0.93 | 0.62, 1.38 | 0.81 | 0.55, 1.21 |
Effect-estimate, random-effects | 2.93 | 1.08, 7.94 | 0.16 | 0.07, 0.40 | 0.19 | 0.12, 0.29 | 0.10 | 0.07, 0.13 | 0.06 | 0.02, 0.20 | 0.73 | 0.25, 2.11 | 0.64 | 0.24, 1.72 |
Measure of heterogeneity, Qd | 16.27 | 0.0003 | 1.72 | 0.4217 | 1.64 | 0.4385 | 1.71 | 0.4234 | 7.05 | 0.0294 | 7.91 | 0.0191 | 7.71 | 0.0211 |
Inverse probability weighting | ||||||||||||||
Pooled individual-level | 3.16 | 2.67, 3.75 | 0.14 | 0.09, 0.20 | 0.11 | 0.08, 0.13 | 0.10 | 0.09, 0.12 | 0.09 | 0.06, 0.11 | 0.85 | 0.65, 1.12 | 0.86 | 0.65, 1.14 |
Risk-set | 3.16 | 2.67, 3.75 | 0.14 | 0.10, 0.21 | 0.11 | 0.09, 0.13 | 0.10 | 0.09, 0.12 | 0.09 | 0.06, 0.12 | 0.85 | 0.65, 1.12 | 0.86 | 0.65, 1.14 |
Effect-estimate, fixed-effect | 3.15 | 2.65, 3.74 | 0.11 | 0.08, 0.17 | 0.11 | 0.09, 0.13 | 0.10 | 0.09, 0.12 | 0.12 | 0.09, 0.17 | 1.16 | 0.86, 1.55 | 1.09 | 0.81, 1.45 |
Effect-estimate, random-effects | 3.11 | 2.55, 3.80 | 0.14 | 0.03, 0.60 | 0.09 | 0.05, 0.16 | 0.10 | 0.04, 0.29 | 0.02 | 0.00, 0.37 | 0.78 | 0.16, 3.71 | 0.43 | 0.09, 1.93 |
Measure of heterogeneity, Qd | 2.27 | 0.3208 | 4.10 | 0.1281 | 6.42 | 0.0403 | 41.94 | <.0001 | 12.10 | 0.0024 | 31.41 | <.0001 | 16.87 | 0.0002 |
Matching weighting | ||||||||||||||
Pooled individual-level | 3.74 | 2.92, 4.80 | 0.15 | 0.06, 0.36 | 0.12 | 0.07, 0.19 | 0.09 | 0.07, 0.12 | 0.08 | 0.06, 0.12 | 0.80 | 0.54, 1.17 | 0.82 | 0.56, 1.22 |
Risk-set | 3.74 | 2.92, 4.80 | 0.15 | 0.06, 0.35 | 0.12 | 0.07, 0.19 | 0.09 | 0.07, 0.12 | 0.08 | 0.06, 0.12 | 0.80 | 0.54, 1.17 | 0.82 | 0.56, 1.22 |
Effect-estimate, fixed-effect | 3.73 | 2.90, 4.80 | 0.15 | 0.06, 0.37 | 0.12 | 0.08, 0.20 | 0.09 | 0.07, 0.12 | 0.09 | 0.06, 0.13 | 0.82 | 0.55, 1.23 | 0.83 | 0.56, 1.24 |
Effect-estimate, random-effects | 3.53 | 1.42, 8.77 | 0.15 | 0.06, 0.37 | 0.12 | 0.08, 0.20 | 0.08 | 0.05, 0.13 | 0.05 | 0.01, 0.17 | 0.78 | 0.24, 2.50 | 0.79 | 0.49, 1.29 |
Measure of heterogeneity, Qd | 11.59 | 0.0030 | 0.38 | 0.8233 | 0.88 | 0.6426 | 2.89 | 0.2352 | 6.52 | 0.0384 | 8.50 | 0.0142 | 2.38 | 0.3040 |
Note: AGB= Adjusted gastric banding; RYGB= Roux-en-Y gastric bypass; OR= odds ratio; CI= confidence interval
There were 584 (6.2%) patients who underwent AGB and 8,777 (93.8%) patients who underwent RYGB.
The incidences for <5%, ≥5%, ≥10%, ≥20%, and ≥30% change in body mass index were 68.0%, 93.7%, 76.5%, 31.2%, and 6.8%, respectively, for the AGB users; 32.9%, 99.1%, 96.8%, 83.8%, and 47.7%, respectively, for the RYGB users. These effectiveness outcomes were defined as the occurrence of the outcomes of interest closet to the end of the first post-procedure year so the incidences for <5% change in body mass index and ≥5% change in body mass index do not sum up to 100%.
The incidences for re-hospitalization and re-intervention were 9.9% and 9.3%, respectively, for the AGB users, and 11.7% and 11.6%, respectively, for the RYGB users.
Q is a measure of heterogeneity among the three data-contributing sites. The summary statistic and p-value from Cochran’s Q test are shown here.