Source:http://linkedlifedata.com/resource/pubmed/id/19798060
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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
1
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pubmed:dateCreated |
2010-1-13
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pubmed:abstractText |
Defining the minimal clinically meaningful improvement (MCMI) is crucial to understanding the treatment effects on health-status measures. We estimated the MCMI on the quality of erection questionnaire (QEQ), a validated measure specific to assess erectile quality during sexual intercourse. Data were from two controlled trials of an investigational phosphodiesterase type 5 inhibitor. Improvement on the Erectile Function domain of the International Index of Erectile Function was used as the anchor. For men who improved by exactly 1 erectile dysfunction severity category (anchor group (n=95)), clinically meaningful improvement (CMI, estimated with mean QEQ total change score from baseline to end of treatment) and MCMI (estimated with the lower limit of the 95% confidence interval of the mean) were 22.4 (s.d., 2.2) and 18.0 points, respectively. For the difference between the anchor group and men with no change in severity category (n=116), CMI and MCMI were 17.7 (s.d., 2.9) and 12 points, respectively. Distribution-based analyses (baseline s.e. of measurement (s.e.m.)=7.99, end-of-treatment s.e.m.=8.22 and s.e. of difference=11.46) supported a proposed MCMI of 12 points. Convergence of anchor-based and distribution-based criteria supports at least a 12-point difference in QEQ scores between treatments as clinically important.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical | |
pubmed:status |
MEDLINE
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pubmed:issn |
1476-5489
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pubmed:author | |
pubmed:issnType |
Electronic
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pubmed:volume |
22
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
45-50
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pubmed:dateRevised |
2010-11-18
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pubmed:meshHeading |
pubmed-meshheading:19798060-Adult,
pubmed-meshheading:19798060-Aged,
pubmed-meshheading:19798060-Algorithms,
pubmed-meshheading:19798060-Data Interpretation, Statistical,
pubmed-meshheading:19798060-Double-Blind Method,
pubmed-meshheading:19798060-Erectile Dysfunction,
pubmed-meshheading:19798060-Humans,
pubmed-meshheading:19798060-Male,
pubmed-meshheading:19798060-Middle Aged,
pubmed-meshheading:19798060-Patient Satisfaction,
pubmed-meshheading:19798060-Penile Erection,
pubmed-meshheading:19798060-Phosphodiesterase 5 Inhibitors,
pubmed-meshheading:19798060-Phosphodiesterase Inhibitors,
pubmed-meshheading:19798060-Questionnaires,
pubmed-meshheading:19798060-Treatment Outcome,
pubmed-meshheading:19798060-Young Adult
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pubmed:articleTitle |
Clinically meaningful improvement on the quality of erection questionnaire in men with erectile dysfunction.
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pubmed:affiliation |
Pfizer, New York, NY, USA.
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pubmed:publicationType |
Journal Article,
Randomized Controlled Trial,
Research Support, Non-U.S. Gov't
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