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When vaccine safety studies use an historical comparator, the increased diagnostic code density over time may generate low expected rates (based on historical data) and high observed rates (based on current data), suggesting a false positive association between a vaccine and AEFI.
Design Prospective cohort study with historical comparator.
Estimating cost effectiveness from an observational cohort study with a historical comparator dataset has inherent problems that would be avoided in a randomised controlled trial.
However, the improved outcome observed in the GIMEMA study is likely related to the use of ATRA in consolidation as the historical comparator received chemotherapy without ATRA.
The GI-REASONS had proportionally fewer upper GI ulcer complications than historical comparator studies (6, 8, 9), and changes in hemoglobin and/or hematocrit had a greater influence on the primary composite GI endpoint.
The benchmark set by temozolomide was chosen as the historical comparator for our study rather than the outcome reported on previous bevacizumab studies because the latter had not been validated in a multi-institutional setting when this study was designed.
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We used historical comparators from ADHERE, selecting patients who met eligibility requirements for CRT-D.
Thus, the proportions of patients with treatment success in the respective groups defined by drug resistance status can be used as historical comparators to assess the effectiveness of treatment in cohorts on the short regimen or the bedaquiline-containing regimen.
The two year results highlight many of the methodological difficulties of such an approach, including the inherent difficulty with historical comparators, and the major uncertainties around the interpretation of the current results.
We excluded Gärden 2013 because it was not a RCT; it used an historical control group as comparator (Gärden 2013).
19 The study was limited methodologically by the open-label design and use of historical data as the comparator instead of a placebo-control group and the lack of imaging especially for the ERA group.
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