When asked for documentation of the validity of the CA tests, the CA Department of Education failed to make such documentation public.
Phase I addressed the content and structure of the measure, and the documentation of content validity through qualitative research methods.
–In the event of an appeal, the collector must reply with documentation supporting the validity of the claim.
However, as results in both sub-samples are very similar, there is no indication that language, duration or method of Life-Chart documentation affects the validity of the ratings.
There is extensive documentation on its construct validity, reliability, and responsiveness for both general and disease-specific populations.
Documentation of the content validity of a measure is specific to its context of use, including but not limited to the population of interest, and is typically established through the generation of evidence from qualitative research comprising patients whose clinical and demographic characteristics are similar to those of the patients enrolled in the respective clinical trials.
Both steps of documentation will be validated by the members of the focus group to ensure internal validity.
Furthermore, the FDA has emphasized the critical value of patient input in supporting content validity, noting that "documentation of patient input in item generation as well as evaluation of patient understanding through cognitive interviewing can contribute to evidence of content validity" [ 5].
Patient-reported outcomes, such as HRQOL, functional status, and fatigue measures, are increasingly used to examine the effectiveness of new therapies for AS [ 19, 23, 39- 42], but there is little documentation as to the reliability, validity, and responsiveness of these measures in patients with AS.
Limitations of the validity of the present documentation which must be highlighted include the finding that responses were not collected from all of the medical schools addressed.
The scientific value of a disease-specific PRO is dependent on the following criteria: Rationale for choosing selected endpoints, documentation of psychometric characteristics (content and construct validity, reliability and responsiveness) and interpretation guidelines including minimal important difference [ 18].
