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Lowering the P Value Threshold.

In Reply This systematic review and meta-analysis1 addressed 1 of 6 research questions that comprised a larger project funded by the Agency for Healthcare Research and Quality in partnership with the National Heart, Lung, and Blood Institute. The protocol was registered with PROSPERO (CRD42016047985) and the final report is publicly available.2 Prior to publication, the draft report was posted for public comment and underwent peer review. This project was designed and conducted by a team without related conflicts of interest and no biases toward a particular result. As such, to our knowledge, no unpublished data were intentionally removed from any of the analyses. Regarding the analysis comparing SMART with a higher dose of inhaled corticosteroids and LABA controller therapy with an end point of exacerbation risk, the 2 studies in question were excluded from the pooled estimate for valid reasons. First, the study by Ställberg et al3 included patients with both the same and higher inhaled corticosteroid doses in the comparator group; therefore, it was not pooled with studies that examined solely higher dosing. Second, the study by Pavord et al4 did not specifically provide the number of study participants in each group who experienced a severe exacerbation; rather, they reported the time to first exacerbation or mean rate of severe exacerbations per patient-year. Therefore, the results shown in Figure 3 represented the best available evidence at the time for the outcome of exacerbation risk.