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Two studies have applied a design allowing three-way analyses of variance between subjects, trials and instruments [ 11, 14].
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Concept selection and confirmation were guided by expert opinion (one US and one Australian gastroenterologist) and a review of published GERD studies, including observational studies, clinical trials, and instrument development and validation studies.
The first consisted of a review of the literature in order to identify the outcome measures adopted in FM clinical trials and the instruments used to assess them.
Since a cost analysis will be undertaken for the main trial and the instruments and methods will be piloted in this study, the rationale and methods are therefore described below.
For the feasibility study (phase 1) 12 patients with colorectal cancer will be recruited to assess the feasibility and acceptability of the intervention, recruitment processes for the trial and study instruments.
Quality of life (QoL) is increasingly required as an outcome measure in clinical trials and an appropriate instrument is necessary.
Both platforms will trial innovative components, sensors and instruments that their producers hope can go on to win future business.
At the same time as instruments were being developed, we had opportunities to pilot draft instruments in two clinical trials and chose to do so with instruments developed up to that point.
In addition, as clinicians will act as assessors for the most part in this trial, the battery of measures and instruments has to be kept relatively simple and manageable in scope.
It is not surprising then, that the use of generic HRQoL evaluation instruments, such as the Euroqol-5D (EQ-5D), have become increasingly popular as a primary outcome measure in clinical trials and as a primary instrument for economic evaluation through cost-utility analysis[ 4].
Work aiming at standardizing core outcome measures and instruments for randomized clinical trials is ongoing.
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