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Many clinical trials of cholinesterase inhibitors (ChE-Is) and memantine have included behavioral measures as primary or secondary outcomes, and most have observed behavioral benefits in conjunction with treatment.
In comparison, among 450 patients on PAH therapies at our institution between 2003 and 2013, clinical assessments regularly incorporated serial echocardiography and 6-minute walk distance tests (92%and95%5% of patients, respectively) and repeat measurement of invasive hemodynamics (46% of patients).The majority of PAH trials have utilized surrogate measures as primary endpoints.
Power calculations used the neurocognitive measures as primary outcome measures.
Articles were reviewed that included PRO measures as primary or secondary endpoints in clinical trial settings.
Two studies [ 24, 36] used composite measures as primary outcomes and significant benefits were found in individual components.
It can be due to insufficient power, since most economic evaluations alongside trials have clinical measures as primary endpoints.
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These authorities recommend, for the purpose of drug licensing and marketing authorisation, that risks and benefits of preventative therapies for children with asthma are assessed in clinical trials that measure, as primary outcomes, physiological tests of pulmonary function and clinical measures such as symptom scores.
The pharmaceutical industry funded 80% of the RCTS we identified, and so it is not surprising that the frequency with which outcomes in the disease activity domain have been measured as primary or secondary outcomes reflects, to some extent, the requirements of the FDA [22], [23] and EMEA [24] [27].
Although PROs are often measured as primary outcomes in clinical trials, challenges remain in their application.
Abdominal fat area and body fat percent were measured as primary outcomes.
Fifty four trials designated at least one outcome measure as primary in the protocol (n=49) or publication (43).
More suggestions(15)
evaluate as primary
measures as leading
measures as prudent
measures as dependent
measures as many
measures as benignly
measures as required
measures as disruptive
measures as essential
measures as equivalent
measures as unfair
measures as simple
measures as imperfect
measures as unconstitutional
measures as insufficient
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