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These external criteria may be clinical endpoints, patient-rated global improvement measures, or other PROs with established responsiveness.
These criteria, or anchors, may be clinical endpoints (i.e., laboratory measures, physiological measures, clinician ratings), patient-rated global improvement or other PROs with established responsiveness, or some combination of clinical and patient-based outcomes.
Therefore, we investigated IL-1Rrp2 mRNA expression by hSFs and hACs, because IL-1RAcP expression in these cells has already been reported [ 25] and is further demonstrated by their well established responsiveness to IL-1β.
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To establish responsiveness, several estimates (like effect sizes or standardized response means) can be calculated which permits comparison of the sensitivity to change between several instruments.
Longitudinal studies to establish responsiveness and predictive validity should also be undertaken.
In this paper, we describe a study to establish responsiveness in a new disease-specific quality of life (QoL) measure for EDs that taps these broader outcomes.
A recent visual analogue scale for IBS (VAS-IBS) has been developed [ 25], however this tool was validated on a sample of women only and requires further testing in clinical practice to establish responsiveness.
Once additional studies are completed to further validate this measure and establish responsiveness, it may potentially be considered for inclusion in future studies for treatment of mCRPC designed to obtain US labeling claims focused on PC symptom improvement, provided all FDA PRO guidance criteria beyond content validity are also sufficiently met in this population.
Content validity has been established and responsiveness to change has been shown for intrathecal baclofen treatment with children with severe CP [ 82].
Having established the responsiveness of these cells to NF-κB pathway activation, the effects of four drugs currently in clinical use, 5-FU (10 μM), CPT (1 μm), oxaliplatin (10 μM), and erlotinib (20 μM), as well as phleomycin (100 μg/ml), a radiomimetic compound, were determined.
In addition, targeting MLCP-dependent Ca2+ sensitisation could be particularly effective in re-establishing local responsiveness to TxA2 and membrane depolarisation, thereby restoring regulation of regional perfusion [18].
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