Table 3.
Confounding adjustment method & data-sharing approach | Effectiveness outcome, change in body mass indexb | Safety outcomec | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
<5% | ≥5% | ≥10% | ≥20% | ≥30% | Re-hospitalization | Re-intervention | ||||||||
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 | 2.20 | 1.97, 2.46 | 0.53 | 0.49, 0.58 | 0.36 | 0.32, 0.40 | 0.17 | 0.15, 0.20 | 0.10 | 0.07, 0.13 | 0.84 | 0.64, 1.12 | 0.82 | 0.61, 1.09 |
Risk-set | 2.20 | 1.97, 2.46 | 0.53 | 0.49, 0.58 | 0.36 | 0.32, 0.40 | 0.17 | 0.15, 0.20 | 0.10 | 0.07, 0.13 | 0.84 | 0.64, 1.12 | 0.82 | 0.61, 1.09 |
Summary-table | 3.48 | 3.11, 3.89 | 0.42 | 0.39, 0.46d | 0.37 | 0.34, 0.41d | 0.22 | 0.19, 0.26d | 0.12 | 0.08, 0.17 | 0.84 | 0.62, 1.11 | 0.81 | 0.60, 1.09 |
Effect-estimate, fixed-effect | 2.26 | 2.02, 2.52 | 0.54 | 0.49, 0.59 | 0.36 | 0.33, 0.40 | 0.17 | 0.15, 0.20 | 0.11 | 0.08, 0.15 | 0.97 | 0.73, 1.28 | 0.85 | 0.64, 1.14 |
Effect-estimate, random-effects | 2.35 | 1.21, 4.56 | 0.58 | 0.41, 0.81 | 0.36 | 0.27, 0.47 | 0.15 | 0.10, 0.22 | 0.06 | 0.02, 0.19 | 0.85 | 0.32, 2.22 | 0.76 | 0.45, 1.28 |
Measure of heterogeneity, Qe | 25.29 | <.0001 | 15.08 | 0.0005 | 7.80 | 0.0202 | 6.55 | 0.0377 | 6.66 | 0.0357 | 13.50 | 0.0012 | 3.97 | 0.1371 |
Matching | ||||||||||||||
Pooled individual-level | 2.25 | 1.91, 2.66 | 0.50 | 0.44, 0.57 | 0.35 | 0.31, 0.40 | 0.17 | 0.15, 0.21 | 0.10 | 0.07, 0.14 | 0.85 | 0.60, 1.22 | 0.78 | 0.54, 1.11 |
Risk-set | 2.25 | 1.91, 2.66 | 0.50 | 0.44, 0.57 | 0.35 | 0.31, 0.40 | 0.17 | 0.15, 0.21 | 0.10 | 0.07, 0.14 | 0.85 | 0.60, 1.22 | 0.78 | 0.54, 1.11 |
Summary-table | 3.49 | 2.95, 4.13 | 0.40 | 0.36, 0.45 | 0.38 | 0.33, 0.43 | 0.23 | 0.19, 0.27 | 0.12 | 0.09, 0.17 | 0.85 | 0.58, 1.23 | 0.77 | 0.52, 1.12 |
Effect-estimate, fixed-effect | 2.23 | 1.89, 2.63 | 0.50 | 0.45, 0.57 | 0.35 | 0.31, 0.40 | 0.17 | 0.15, 0.21 | 0.11 | 0.08, 0.15 | 0.91 | 0.63, 1.32 | 0.81 | 0.56, 1.18 |
Effect-estimate, random-effects | 1.95 | 0.92, 4.16 | 0.56 | 0.32, 0.99 | 0.36 | 0.27, 0.47 | 0.17 | 0.12, 0.23 | 0.07 | 0.02, 0.23 | 0.73 | 0.29, 1.87 | 0.64 | 0.24, 1.72 |
Measure of heterogeneity, Qe | 15.58 | 0.0004 | 22.17 | <.0001 | 4.79 | 0.0911 | 3.24 | 0.1976 | 5.58 | 0.0612 | 7.65 | 0.0218 | 7.71 | 0.0211 |
Inverse probability weighting | ||||||||||||||
Pooled individual-level | 1.92 | 1.73, 2.13 | 0.49 | 0.45, 0.54 | 0.32 | 0.29, 0.35 | 0.19 | 0.17, 0.22 | 0.10 | 0.08, 0.14 | 0.84 | 0.65, 1.08 | 0.85 | 0.65, 1.12 |
Risk-set | 1.93 | 1.51, 2.47 | 0.49 | 0.40, 0.59 | 0.32 | 0.26, 0.38 | 0.19 | 0.14, 0.27 | 0.10 | 0.06, 0.17 | 0.84 | 0.46, 1.53 | 0.80 | 0.60, 1.07 |
Effect-estimate, fixed-effect | 1.92 | 1.73, 2.13 | 0.50 | 0.46, 0.54 | 0.32 | 0.29, 0.35 | 0.20 | 0.18, 0.23 | 0.15 | 0.11, 0.20 | 1.16 | 0.89, 1.51 | 1.07 | 0.81, 1.40 |
Effect-estimate, random-effects | 1.85 | 1.55, 2.21 | 0.54 | 0.43, 0.68 | 0.32 | 0.25, 0.41 | 0.19 | 0.11, 0.33 | 0.02 | 0.00, 0.42 | 0.74 | 0.22, 2.51 | 0.45 | 0.11, 1.80 |
Measure of heterogeneity, Qe | 3.31 | 0.1905 | 9.67 | 0.0079 | 9.24 | 0.0098 | 22.16 | <.0001 | 10.49 | 0.0053 | 27.68 | <.0001 | 15.27 | 0.0005 |
Matching weighting | ||||||||||||||
Pooled individual-level | 2.29 | 1.94, 2.71 | 0.53 | 0.46, 0.59 | 0.34 | 0.30, 0.39 | 0.17 | 0.14, 0.20 | 0.10 | 0.07, 0.14 | 0.80 | 0.56, 1.15 | 0.83 | 0.57, 1.20 |
Risk-set | 2.33 | 2.08, 2.62 | 0.52 | 0.47, 0.57 | 0.34 | 0.31, 0.38 | 0.17 | 0.14, 0.20 | 0.10 | 0.07, 0.13 | 0.80 | 0.60, 1.07 | 0.85 | 0.57, 1.28 |
Effect-estimate, fixed-effect | 2.26 | 1.91, 2.67 | 0.52 | 0.46, 0.59 | 0.34 | 0.30, 0.39 | 0.17 | 0.14, 0.20 | 0.11 | 0.08, 0.15 | 0.83 | 0.57, 1.20 | 0.83 | 0.57, 1.22 |
Effect-estimate, random-effects | 2.23 | 1.11, 4.49 | 0.56 | 0.40, 0.78 | 0.34 | 0.26, 0.44 | 0.14 | 0.09, 0.23 | 0.06 | 0.02, 0.20 | 0.77 | 0.27, 2.24 | 0.81 | 0.53, 1.25 |
Measure of heterogeneity, Qe | 10.84 | 0.0044 | 7.90 | 0.0192 | 4.05 | 0.1316 | 6.28 | <.0431 | 6.20 | 0.0450 | 8.35 | 0.0154 | 2.22 | 0.3285 |
Note: AGB= Adjusted gastric banding; RYGB= Roux-en-Y gastric bypass; HR= hazard 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.
These were calculated using the Mantel-Haenszel approach, because the exact confidence intervals for the regression-based analysis could not be obtained.
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.