Table 4.
Effectiveness outcome, change in body mass indexc | Safety outcomed | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
<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 | 3.95 | 3.26, 4.79 | 0.15 | 0.10, 0.23 | 0.12 | 0.09, 0.15 | 0.08 | 0.07, 0.10 | 0.07 | 0.05, 0.10 | 0.86 | 0.63, 1.15 | 0.81 | 0.58, 1.09 |
Risk-set | 3.95 | 3.26, 4.79 | 0.15 | 0.10, 0.23 | 0.12 | 0.09, 0.15 | 0.08 | 0.07, 0.10 | 0.07 | 0.05, 0.10 | 0.86 | 0.63, 1.15 | 0.81 | 0.58, 1.09 |
Summary-table | 3.95 | 3.26, 4.79 | 0.15 | 0.10, 0.23 | 0.12 | 0.09, 0.15 | 0.08 | 0.07, 0.10 | 0.07 | 0.05, 0.10 | 0.86 | 0.63, 1.15 | 0.81 | 0.58, 1.09 |
Effect-estimate, fixed-effect | 3.93 | 3.25, 4.76 | 0.14 | 0.09, 0.21 | 0.11 | 0.09, 0.14 | 0.08 | 0.07, 0.10 | 0.09 | 0.06, 0.12 | 0.95 | 0.70, 1.28 | 0.83 | 0.62, 1.12 |
Effect-estimate, random-effects | 3.73 | 1.52, 9.12 | 0.16 | 0.08, 0.34 | 0.11 | 0.04, 0.28 | 0.07 | 0.03, 0.12 | 0.04 | 0.01, 0.16 | 0.85 | 0.30, 2.36 | 0.75 | 0.46, 1.21 |
Measure of heterogeneity, Qe | 25.49 | <.0001 | 2.46 | 0.2922 | 11.25 | 0.0036 | 10.50 | 0.0052 | 8.27 | 0.0159 | 12.04 | 0.0024 | 3.29 | 0.1930 |
Matching | ||||||||||||||
Pooled individual-level | 3.99 | 3.10, 5.15 | 0.08 | 0.02, 0.24 | 0.11 | 0.06, 0.18 | 0.08 | 0.06, 0.10 | 0.08 | 0.06, 0.12 | 0.86 | 0.57, 1.30 | 0.93 | 0.61, 1.42 |
Risk-set | 3.99 | 3.10, 5.15 | 0.08 | 0.02, 0.24 | 0.11 | 0.06, 0.18 | 0.08 | 0.06, 0.10 | 0.08 | 0.06, 0.12 | 0.86 | 0.57, 1.30 | 0.93 | 0.61, 1.42 |
Summary-table | 3.99 | 3.10, 5.15 | 0.08 | 0.02, 0.24 | 0.11 | 0.06, 0.18 | 0.08 | 0.06, 0.10 | 0.08 | 0.06, 0.12 | 0.86 | 0.57, 1.30 | 0.93 | 0.61, 1.42 |
Effect-estimate, fixed-effect | 3.93 | 3.06, 5.05 | 0.08 | 0.02, 0.26 | 0.11 | 0.06, 0.18 | 0.08 | 0.06, 0.10 | 0.09 | 0.06, 0.13 | 0.89 | 0.61, 1.27 | 0.95 | 0.63, 1.44 |
Effect-estimate, random-effects | 3.42 | 1.06, 10.98 | 0.08 | 0.02, 0.26 | 0.11 | 0.06, 0.18 | 0.06 | 0.04, 0.11 | 0.05 | 0.01, 0.16 | 0.79 | 0.38, 1.67 | 0.79 | 0.34, 1.83 |
Measure of heterogeneity, Qe | 20.91 | <.0001 | 0.00 | 0.9985 | 0.21 | 0.8981 | 3.32 | 0.1898 | 7.47 | 0.0239 | 4.11 | 0.1275 | 5.51 | 0.0633 |
HR | 95% CI | HR | 95% CI | HR | 95% CI | HR | 95% CI | HR | 95% CI | HR | 95% CI | HR | 95% CI | |
Stratification | ||||||||||||||
Pooled individual-level | 2.23 | 2.01, 2.48 | 0.51 | 0.47, 0.56 | 0.34 | 0.31, 0.38 | 0.17 | 0.14, 0.19 | 0.09 | 0.07, 0.13 | 0.83 | 0.63, 1.08 | 0.79 | 0.59, 1.05 |
Risk-set | 2.23 | 2.00, 2.47 | 0.51 | 0.47, 0.56 | 0.34 | 0.31, 0.38 | 0.17 | 0.14, 0.19 | 0.09 | 0.07, 0.13 | 0.82 | 0.63, 1.08 | 0.79 | 0.59, 1.05 |
Summary-table | 3.35 | 2.98, 3.79 | 0.41 | 0.38, 0.46 | 0.36 | 0.33, 0.39 | 0.22 | 0.19, 0.25 | 0.12 | 0.08, 0.17 | 0.81 | 0.61, 1.07 | 0.78 | 0.56, 1.03 |
Effect-estimate, fixed-effect | 2.31 | 2.08, 2.57 | 0.52 | 0.47, 0.57 | 0.34 | 0.31, 0.38 | 0.17 | 0.15, 0.20 | 0.11 | 0.08, 0.14 | 0.94 | 0.72, 1.23 | 0.81 | 0.61, 1.08 |
Effect-estimate, random-effects | 2.28 | 1.17, 4.42 | 0.54 | 0.38, 0.75 | 0.34 | 0.26, 0.45 | 0.14 | 0.09, 0.22 | 0.06 | 0.02, 0.18 | 0.81 | 0.34, 1.96 | 0.75 | 0.49, 1.14 |
Measure of heterogeneity, Qe | 28.81 | <.0001 | 14.65 | 0.0007 | 8.62 | 0.0134 | 7.96 | 0.0186 | 7.06 | 0.0292 | 12.00 | 0.0025 | 2.99 | 0.2232 |
Matching | ||||||||||||||
Pooled individual-level | 2.41 | 2.03, 2.85 | 0.49 | 0.43, 0.55 | 0.34 | 0.30, 0.39 | 0.16 | 0.14, 0.19 | 0.10 | 0.07, 0.13 | 0.85 | 0.59, 1.22 | 0.90 | 0.61, 1.32 |
Risk-set | 2.41 | 2.03, 2.85 | 0.49 | 0.43, 0.56 | 0.34 | 0.30, 0.39 | 0.16 | 0.14, 0.19 | 0.10 | 0.07, 0.13 | 0.85 | 0.59, 1.22 | 0.90 | 0.61, 1.32 |
Summary-table | 3.75 | 3.16, 4.46 | 0.39 | 0.35, 0.44 | 0.37 | 0.32, 0.42 | 0.22 | 0.18, 0.26 | 0.12 | 0.08, 0.17 | 0.85 | 0.58, 1.24 | 0.89 | 0.59, 1.32 |
Effect-estimate, fixed-effect | 2.36 | 1.99, 2.80 | 0.49 | 0.43, 0.55 | 0.34 | 0.30, 0.39 | 0.16 | 0.14, 0.20 | 0.11 | 0.08, 0.15 | 0.88 | 0.61, 1.27 | 0.92 | 0.62, 1.36 |
Effect-estimate, random-effects | 2.22 | 0.88, 5.59 | 0.52 | 0.36, 0.74 | 0.35 | 0.24, 0.50 | 0.13 | 0.08, 0.21 | 0.05 | 0.01, 0.20 | 0.79 | 0.40, 1.55 | 0.79 | 0.37, 1.67 |
Measure of heterogeneity, Qe | 21.66 | <.0001 | 9.16 | 0.0102 | 7.95 | 0.0187 | 6.67 | 0.0356 | 6.90 | 0.0317 | 4.17 | 0.1242 | 5.07 | 0.0792 |
Note: AGB= Adjusted gastric banding; RYGB= Roux-en-Y gastric bypass; OR= odds ratio; CI= confidence interval; HR= hazard ratio
The disease risk score was estimated using Cox proportional hazards regression on patients receiving Roux-en-Y gastric bypass procedure.
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.