Table 7.
Confounding Adjustment Method and Data-Sharing Approach | Effectiveness Outcome (Treatment Switching)c | Safety Outcome (Serious Infections)d | ||
---|---|---|---|---|
OR | 95% CI | OR | 95% CI | |
Stratification | ||||
Pooled individual-level | 0.53 | 0.35, 0.78 | 0.88 | 0.42, 1.64 |
Risk-set | 0.53 | 0.36, 0.78 | 0.88 | 0.42, 1.64 |
Summary-table | 0.53 | 0.35, 0.78 | 0.88 | 0.42, 1.64 |
Effect-estimate, fixed-effect | 0.56 | 0.38, 0.82 | 0.97 | 0.52, 1.82 |
Effect-estimate, random-effects | 0.51 | 0.28, 0.96 | 0.97 | 0.52, 1.82 |
Heterogeneity (Qe) and P value | 2.67 | 0.2624 | 0.24 | 0.8832 |
Matching | ||||
Pooled individual-level | 0.41 | 0.26, 0.63 | 0.86 | 0.37, 1.93 |
Risk-set | 0.41 | 0.26, 0.63 | 0.86 | 0.37, 1.93 |
Summary-table | 0.41 | 0.26, 0.63 | 0.86 | 0.37, 1.93 |
Effect-estimate, fixed-effect | 0.41 | 0.27, 0.63 | 0.89 | 0.40, 1.98 |
Effect-estimate, random-effects | 0.41 | 0.27, 0.63 | 0.89 | 0.40, 1.98 |
Heterogeneity (Q) and P value | 1.77 | 0.4115 | 0.00 | 0.9961 |
HR | 95% CI | HR | 95% CI | |
Stratification | ||||
Pooled individual-level | 0.59 | 0.41, 0.84 | 0.86 | 0.47, 1.57 |
Risk-set | 0.59 | 0.41, 0.84 | 0.86 | 0.47, 1.57 |
Summary-table | 0.58 | 0.39, 0.83 | 0.86 | 0.42, 1.57 |
Effect-estimate, fixed-effect | 0.63 | 0.44, 0.91 | 0.95 | 0.52, 1.75 |
Effect-estimate, random-effects | 0.59 | 0.26, 1.32 | 0.95 | 0.52, 1.75 |
Heterogeneity (Q) and P value | 3.83 | 0.1466 | 0.21 | 0.8989 |
Matching | ||||
Pooled individual-level | 0.46 | 0.31, 0.68 | 0.89 | 0.42, 1.86 |
Risk-set | 0.46 | 0.31, 0.68 | 0.89 | 0.42, 1.86 |
Summary-table | 0.45 | 0.30, 0.68 | 0.88 | 0.38, 1.95 |
Effect-estimate, fixed-effect | 0.47 | 0.32, 0.70 | 0.91 | 0.42, 2.00 |
Effect-estimate, random-effects | 0.52 | 0.22, 1.25 | 0.91 | 0.42, 2.00 |
Heterogeneity (Q) and P value | 4.01 | 0.1345 | 0.00 | 1.0000 |
Abbreviations: CI, confidence interval; HR, hazard ratio; OR, odds ratio; TNFi, tumor necrosis factor α inhibitor.
a The disease risk score was estimated using Cox proportional hazards regression in patients receiving tumor necrosis factor-α inhibitor biologicals.
b There were 407 (5.2%) patients who initiated use of non-TNFi biologicals and 7,419 (94.8%) patients who initiated use of TNFi biologicals.
c The incidence of treatment switching was 7.6% in new users of non-TNFi biologicals and 11.2% in new users of TNFi biologicals.
d The incidence of serious infection was 2.9% in new users of non-TNFi biologicals and 3.1% in new users of TNFi biologicals.
eQ is a measure of heterogeneity among the 3 data-contributing sites. The summary statistic and P value from Cochran’s Q test are shown.