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which were developed to assess relatively better responses, as could be expected to occur in efficient drugs such as biological drugs.
As a possible limitation of our analysis is that the time period of two years after the publication as a cut-off point between the two groups of trials, is an arbitrary choice and may not be sufficient to assess the implementation properly. Indeed we have found that there is a further increase in implementation over the years. A strength of this study is that a primary and very comprehensive search of the entire literature was conducted specifically aiming at the population of interest.
All domains and instruments that have been used in the trials should be reported. Interestingly we have found that sometimes domains and instruments were used but not reported separately. For example, the domain ‘fatigue’, which is included in the ‘BASDAI’, as well as specific instruments included in the BASMI, were not always reported separately. There might be several explanations for this. A trivial one is space constraint, but online appendices may resolve this problem. Another possibility is that authors only report positive results. Most likely, however, authors may not understand the purpose of core sets: Reporting outcomes of a trial in a homogeneous manner, with the aim to avoid publication bias and the possibility to compare measures across trials.
In conclusion, this study provides evidence for the utilization of the ASAS/OMERACT core-set in RCTs of both DC-ART and SMARD, especially to the use of the domains and to a lesser extent to the use of specific instruments. However, there is room for improvement, aiming at reporting the complete core-set and their instruments.
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