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The 2012 agreement involved a shift in the improvement coach role, from supporting the mere use of registries towards facilitating improvement efforts based on registries and indicators.
Data collection for disease outcomes in our trial was mainly based on registries, and new and changing regulations meant extra negotiations and time delays.
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Because the study was based on registry and survey data, no ethical approval was required.
No ethical approval was required according to Danish legislation and the National Committee on Health Research Ethics in the Central Denmark Region as the study was based on registry and survey data (j. no. 181/2011).
However, these rates may not accurately reflect the incidence of the disease throughout the country because these data were only based on registries of Manila (National Capital Region or NCR) and Rizal [2], [6].
Further, assessment of survival and health economics will be based on registry data and hence, blinded to intervention.
Recent studies based on registry data and direct clinical observations have resolved the issue of dose response to Imig by showing incremental improvements in clinical parameters based on increasing doses of Imig [18], [46].
In the UK, asthma in adults has been studied more thoroughly.[22], [23] A review concluded that the prevalence plateaued during the 1990s after increasing since the 1970s ,[12] aconclusion, however, in part based on registry studies and studies of selected populations.[22] The present study corroborates these findings despite the higher asthma prevalence in the UK.
They are both observational, based on registry data, and therefore not randomized.
Furthermore, it was an observational study based on registry data and the median follow-up time was short (3.4 years estimated with the "reverse Kaplan-Meier" method (Schemper and Smith 1996)).
The study was based on registry data only, and study persons were not contacted by the researchers.
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