PMID- 21855209
OWN - NLM
STAT- MEDLINE
DCOM- 20120203
LR  - 20240109
IS  - 1873-7560 (Electronic)
IS  - 0302-2838 (Linking)
VI  - 60
IP  - 5
DP  - 2011 Nov
TI  - Minimal clinically important differences in the erectile function domain of the 
      International Index of Erectile Function scale.
PG  - 1010-6
LID - 10.1016/j.eururo.2011.07.053 [doi]
AB  - BACKGROUND: Despite widespread adoption of the six-item erectile function (EF) 
      domain of the International Index of Erectile Function (IIEF) as a clinical trial 
      end point, there are currently no objective data on what constitutes a minimal 
      clinically important difference (MCID) in the EF domain. OBJECTIVE: Estimate the 
      MCID for the IIEF EF domain. DESIGN, SETTING, AND PARTICIPANTS: Anchor-based 
      MCIDs were estimated using data from 17 randomized, double-blind, 
      placebo-controlled, parallel-group clinical trials of the phosphodiesterase type 
      5 inhibitor (PDE5-I) tadalafil for 3345 patients treated for 12 wk. MEASUREMENTS: 
      The anchor for the MCID is the minimal improvement measure calculated using 
      change from baseline to 12 wk on IIEF question 7: "Over the past 4 weeks, when 
      you attempted sexual intercourse how often was it satisfactory for you?" MCIDs 
      were developed using analysis of variance (ANOVA)- and receiver operating 
      characteristic (ROC)-based methods in a subset of studies (n=11) by comparing 
      patients with and without minimal improvement (n=863). MCIDs were validated in 
      the remaining six studies (n=377). RESULTS AND LIMITATIONS: The ROC-based MCID 
      for the EF domain was 4, with estimated sensitivity and specificity of 0.74 and 
      0.73, respectively. MCIDs varied significantly (p<0.0001) according to baseline 
      ED severity (mild: 2; moderate: 5; severe: 7). MCIDs consistently distinguished 
      between patients in the validation sample classified as no change or minimally 
      improved overall and by geographic region, ED etiology, and age group. MCIDs did 
      not differ by age group, geographic region, or ED etiology. Current analyses were 
      based on 17 clinical trials of tadalafil. Results need to be replicated in 
      studies using other PDE5-Is or in nonpharmacologic intervention studies. 
      CONCLUSIONS: The contextualization of treatment-related changes in terms of 
      clinically relevant improvement is essential to understanding treatment efficacy, 
      to interpreting results across studies, and to managing patients effectively. 
      This analysis provides, for the first time, anchor-based estimates of MCIDs in 
      the EF domain score of the IIEF.
CI  - Copyright (c) 2011 European Association of Urology. Published by Elsevier B.V. All 
      rights reserved.
FAU - Rosen, Raymond C
AU  - Rosen RC
AD  - New England Research Institutes, Inc., Watertown, MA 02472, USA. 
      rrosen@neriscience.com
FAU - Allen, Kerstin R
AU  - Allen KR
FAU - Ni, Xiao
AU  - Ni X
FAU - Araujo, Andre B
AU  - Araujo AB
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20110730
PL  - Switzerland
TA  - Eur Urol
JT  - European urology
JID - 7512719
RN  - 0 (Carbolines)
RN  - 0 (Phosphodiesterase 5 Inhibitors)
RN  - 742SXX0ICT (Tadalafil)
RN  - EC 3.1.4.35 (Cyclic Nucleotide Phosphodiesterases, Type 5)
SB  - IM
CIN - Eur Urol. 2011 Nov;60(5):1017-9. PMID: 21906865
CIN - J Urol. 2012 Aug;188(2):547-8. PMID: 22784747
MH  - Aged
MH  - Analysis of Variance
MH  - Asia
MH  - Australia
MH  - Carbolines/therapeutic use
MH  - Cyclic Nucleotide Phosphodiesterases, Type 5/metabolism
MH  - Double-Blind Method
MH  - Erectile Dysfunction/*diagnosis/*drug therapy/enzymology/physiopathology
MH  - Europe
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Multicenter Studies as Topic
MH  - North America
MH  - Patient Satisfaction
MH  - *Penile Erection/drug effects
MH  - Phosphodiesterase 5 Inhibitors/therapeutic use
MH  - Predictive Value of Tests
MH  - ROC Curve
MH  - Randomized Controlled Trials as Topic
MH  - Recovery of Function
MH  - Reproducibility of Results
MH  - Severity of Illness Index
MH  - South America
MH  - *Surveys and Questionnaires
MH  - Tadalafil
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2011/08/23 06:00
MHDA- 2012/02/04 06:00
CRDT- 2011/08/23 06:00
PHST- 2011/05/19 00:00 [received]
PHST- 2011/07/21 00:00 [accepted]
PHST- 2011/08/23 06:00 [entrez]
PHST- 2011/08/23 06:00 [pubmed]
PHST- 2012/02/04 06:00 [medline]
AID - S0302-2838(11)00791-3 [pii]
AID - 10.1016/j.eururo.2011.07.053 [doi]
PST - ppublish
SO  - Eur Urol. 2011 Nov;60(5):1010-6. doi: 10.1016/j.eururo.2011.07.053. Epub 2011 Jul 
      30.