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. 2017 Aug 8;14(6):584–596. doi: 10.1177/1740774517724165

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© The Author(s) 2017

This article is distributed under the terms of the Creative Commons Attribution 4.0 License (http://www.creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (http://www.uk.sagepub.com/aboutus/openaccess.htm).

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Figure 2. — Monitoring effect on the primary endpoint. Figure 2 shows the forest plot of a random-effect meta-analysis of within-trial monitoring effects. The overall estimate of the random-effect meta-analysis closely agrees with the model-based estimate of −0.04 with two-sided 95% confidence interval (−0.40; 0.33). There is no significant heterogeneity between trials. Note that trial #05 is non-informative because there were major findings in all but one patient. Trials are grouped by risk class. The intervention effect does not differ by risk class. The black vertical line at 0.6 shows the pre-specified tolerance margin for claiming non-inferiority. Overall and in both subgroups, the non-inferiority margin is outside the meta-analysis confidence interval (CI).