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Retention in treatment, reduction in illicit drug use and craving, and patient and staff ratings of improvements were the most frequently used outcome indicators in these trials.
Patient ratings of improvements or outcomes of treatment have commonly been obtained by eliciting patients' perceptions as part of an investigation of satisfaction with hospital care.
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Subjective ratings of improvement were also requested from the patients.
These were defined as pain intensity, physical functioning, emotional functioning, participant ratings of improvement and satisfaction with treatment, symptoms and adverse events and participant disposition [ 29].
Also, it has been demonstrated that parent and teacher ratings of improvement with MPH correlate only modestly [ 50] and differ in their magnitude [ 33].
Relevant anchors may be clinical endpoints, global clinician or patient ratings of improvement in symptom or health status, or other measures.
Wilcoxin two-sample tests, t-tests and general linear modeling compared BII scores of subjects with global ratings of improvement versus no improvement, and subjects taking tadalafil versus placebo.
Our literature review confirmed that the two most commonly used approaches to elicit patient reports on the outcomes of treatments were measures of patient satisfaction and measures which employed global ratings of improvement.
The initiative on methods, measurement, and pain assessment in clinical trials defined the following outcome domains as important for chronic pain trials: pain, physical functioning, emotional functioning, participants' ratings of improvement and satisfaction, symptoms and adverse events, and participants' disposition.
These 6 core outcome domains are i) pain, ii) physical functioning, iii) emotional functioning, iv) participant ratings of improvement and satisfaction with treatment, v) symptoms and adverse events, and vi) participant disposition [ 14].
To demonstrate known-groups validity and test for differences between groups expected to be different after treatment, Wilcoxin two-sample tests and t-tests were used to compare BII scores at the End-of-Study Visit between subjects with global ratings of improvement versus no improvement on the GAQ, and between subjects taking tadalafil versus subjects taking placebo.
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