Whatever the outcomes, they should be validated as well as developmentally-appropriate.
To our knowledge, IGA has not been validated as an outcome measure [7].
However, no organ failure scoring system has been validated as an outcome measure at 28 days or more.
Both these trials, introducing clinical benefit as an outcome of palliative chemotherapy, were severely questioned [ 20- 24] for the following methodological reasons: - Clinical benefit has never been validated as an outcome of a palliative treatment in pancreatic cancer.
Although a variety of pulmonary function test (PFT) measures have long been used to study ILD in SSc, only the forced vital capacity (FVC) has been validated as an outcome measure in randomized controlled trials [ 5].
The psychometric properties of the anaemia (FACT-An) and fatigue (FACT-F) subscales with cancer patients have been assessed (Yellen et al, 1997), and the FACT-An has been validated as an outcome measure for cancer related anaemia (Cella and Bonomi, 1996; Cella, 1997, 1998; Cella and Webster, 1997; Yellen et al, 1997).
Lastly, the DAS28 results were based on CRP, which may yield higher responses than the DAS28 (erythrocyte sedimentation rate); however, CRP has been well validated as an outcome measure to assess disease activity 21 and is increasingly used in clinical trials.
Although no biomarker has been validated as a surrogate outcome for regulatory purposes, these biomarkers represent plausible candidate surrogate outcomes being pursued by AD trialists.
This has now been validated as a discriminative outcome measure in PsA [ 15].
Center of pressure (COP) displacements are commonly used to evaluate balance performance in the elderly, 20 and COP path length was validated as a performance outcome measure in a large group study.
