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Characteristics of the tegaserod initiators and their matched comparators did not differ substantially for any of the characteristics that were part of the propensity score (demographics, pre-existing diagnoses or medical conditions, procedures, prior drug use, and baseline healthcare utilization).
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Finally, there was left one individual with CD whose matched comparators had been excluded for any of the above reasons.
An additional strength of the study was the availability of a matched comparator group of obese patients who did not undergo surgical weight loss intervention.
An adjusted indirect comparison (frequentist approach) was conducted in all four indications and declined by IQWiG as the chosen comparators did not correspond to the appropriate comparators chosen by the G-BA.
Furthermore, a matched comparator cohort (5:1 ratio) was extracted from the Swedish population register.
When a person died before his or her matched comparator, we continued to follow the comparator to record his or her utilization until death or the end of the Medicare claims data, whichever came first.
Exclusion of trials with pharmacologically active comparators did not alter our findings to a significant effect.
Moreover, in case of malfunctions, such comparators do not distinguish between comparison errors and comparator errors.
In case transforms are applied in signal domain comparators do not need to be adapted.
Other study design approaches include a new user cohort design, which uses an active comparator as a referent and estimates event rates during the time following initiation of treatment, and the case control design, which compares exposure rates during the time before outcome incidence and compares with exposure rates among matched patients who did not experience the outcome.
With this approach, the comparator doesn't need to match the test product.
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Since I tried Ludwig back in 2017, I have been constantly using it in both editing and translation. Ever since, I suggest it to my translators at ProSciEditing.

Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com