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We propose that clinicians consider 5 elements when reading a study using PROs: study design and PRO assessment strategy, PRO measure performance, validity of results, context of the findings, and generalizability to their own patient population.
This chapter traces the history of PRO inclusion in clinical trials, highlights selected PRO assessment tools, and outlines the important study design issues to consider when measuring, analyzing, and reporting PROs in early-phase clinical trials.
The known-groups validity, or the ability of a PRO to distinguish between groups known to differ on characteristics which are expected to impact the PRO assessment, was evaluated by assessing the following a priori hypotheses.
The overall objective of PRO assessment in this study was to compare PROs between the two treatment arms.
On average, protocols addressed less than 1/3 of recommended PRO items, with most trials offering only basic information, such as the PRO assessment schedule and questionnaires used [25].
PRO assessment in pressure ulcers is in its infancy, with few studies including PROs as study outcomes.
For the PRO analyses, 207 (90%) panitumumab patients and 184 (79%) BSC patients had at least one post-baseline PRO assessment and comprised the PRO All Enrolled analysis set (Table 2).
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But I'm concerned about the bias of this article, and the way that coming round to support conservative, pro-privatization, anti-union, pro-assessment policies is presented as a conversion experience.
Further details and results of the PRO-assessment are described elsewhere [ 17].
While waiting for their appointment, patients completed the PRO-assessment of adherence (self-report questionnaire) and Quality of Life (QOL).
Obviously, the usefulness of a proxy-approach to PRO-assessment depends strongly on the reliability of the rating in terms of agreement with the patient's self-rating.
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