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In most trials Quality of Life is collected only up to progression.
In the three nalmefene clinical trials, quality of life was measured using EQ-5D at baseline, 3 and 6 months, and additionally at 12 months for SENSE.
In chemotherapy trials quality of life (QOL) is assessed mostly at the days of chemotherapy administration (i.e. event-driven) during treatment and follows fixed time intervals in the aftercare phase (i.e. time-driven).
Cognitive function Changes in global disease severity Activities of daily living Clinical global impression Behaviour Death Mood Safety as measured by incidence and severity of adverse effects Dependency (such as institutionalisation) Acceptability of treatment as measured by withdrawal from trials Quality of life Costs.
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Since we documented strong therapy-related impairment of quality of life upon treatment initiation, in future trials, quality-of-life analyses should be documented over extended periods of time (i.e., up to 1 year) to potentially demonstrate treatment-related effects in relation to time, to patient tolerance, and to cumulated toxicity.
We next assessed the effect of trial quality on outcome as it is often hypothesized trials of lower methodological quality tend to yield more positive clinical signals for the therapy being tested when compared to trials of higher methodological quality.
We also assessed the effect of trial quality on outcome, as it is often hypothesized that, compared with trials of higher methodological quality, trials of lower methodological quality tend to yield more positive clinical signals for the therapy being tested.
Clinical trial quality of psychopharmacological studies has changed significantly in most of the aspects we analyzed.
As a result, clinical trial quality of psychopharmacological studies has changed significantly during the past 60 years in several aspects such as study design, sampling, randomization, allocation, statistical methods, ethical aspects and reporting.
Two reviewers extracted data and assessed trial quality of each study independently.
In the HERS Trial, quality of life and depressive symptoms were measured at a three-year follow-up [ 13].
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