PMID- 24125113
OWN - NLM
STAT- MEDLINE
DCOM- 20140729
LR  - 20191210
IS  - 1743-6109 (Electronic)
IS  - 1743-6095 (Linking)
VI  - 10
IP  - 12
DP  - 2013 Dec
TI  - Nonresponders, partial responders, and complete responders to PDE5 inhibitors 
      therapy according to IIEF criteria: validation of an anchor-based treatment 
      responder classification.
PG  - 3029-37
LID - 10.1111/jsm.12335 [doi]
AB  - INTRODUCTION: Despite widespread use of the International Index of Erectile 
      Function (IIEF) in erectile dysfunction (ED) research, there are no published 
      criteria for classifying ED treatment responders in clinical trials or patient 
      management settings. A new classification for treatment response in men with ED 
      has been developed and validated in a large clinical trial database. AIM: The 
      study aims to test discriminant and convergent validity of the responder 
      classification and examine the role of covariates. METHOD: Treatment assignment 
      was used to test discriminant validity. The diary-based Sexual Encounter Profile 
      (SEP) question ("Did your erection last long enough for you to have successful 
      intercourse?") and Global Assessment Question (GAQ) ("Has the treatment you have 
      been taking over the past study interval improved your erections?") were used to 
      evaluate convergent validity. Chi-square and Cochran-Armitage trend tests were 
      used to examine outcome associations. Logistic regression was used to further 
      assess the relationship of outcomes controlling for covariates. MAIN OUTCOME 
      MEASURE: The classification measure was developed and validated in a database 
      from 17 clinical trials in 3,252 men with ED randomized to placebo or tadalafil. 
      The treatment responder is defined as complete (erectile function [EF] >/= 26); 
      partial (EF < 26; met minimal clinically important difference [MCID] criteria); 
      or nonresponder following treatment (EF < 26; did not meet MCID). RESULTS: The 
      new responder definition performed consistently well in all prespecified tests of 
      validity. Eighty-nine percent of subjects classified as complete responders were 
      in the treatment group, and the responder definition was associated with changes 
      on the SEP and GAQ measures, respectively (SEP odds ratio [OR] = 14, 95% 
      confidence intervals [CI] 11-17; GAQ OR = 50, 95% CI 39-88; complete vs. 
      nonresponders). CONCLUSIONS: We developed and validated a novel method of 
      defining an ED treatment responder based on multiple IIEF criteria and using 
      other measures (SEP, GAQ) for validation. The results have implications for 
      understanding results of clinical trials in ED, and in monitoring response to 
      treatment in the clinic.
CI  - (c) 2013 International Society for Sexual Medicine.
FAU - Yang, May
AU  - Yang M
AD  - New England Research Institutes, Inc., Watertown, MA, USA.
FAU - Ni, Xiao
AU  - Ni X
FAU - Sontag, Angelina
AU  - Sontag A
FAU - Litman, Heather J
AU  - Litman HJ
FAU - Rosen, Raymond C
AU  - Rosen RC
LA  - eng
PT  - Journal Article
PT  - Validation Study
DEP - 20131011
PL  - Netherlands
TA  - J Sex Med
JT  - The journal of sexual medicine
JID - 101230693
RN  - 0 (Carbolines)
RN  - 0 (Phosphodiesterase 5 Inhibitors)
RN  - 742SXX0ICT (Tadalafil)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Carbolines/therapeutic use
MH  - Classification
MH  - Coitus
MH  - Double-Blind Method
MH  - Erectile Dysfunction/*classification/*drug therapy/physiopathology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Penile Erection/drug effects
MH  - Phosphodiesterase 5 Inhibitors/*therapeutic use
MH  - Tadalafil
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Convergent Validity
OT  - Discriminant Validity
OT  - Minimal Clinically Important Difference
EDAT- 2013/10/16 06:00
MHDA- 2014/07/30 06:00
CRDT- 2013/10/16 06:00
PHST- 2013/10/16 06:00 [entrez]
PHST- 2013/10/16 06:00 [pubmed]
PHST- 2014/07/30 06:00 [medline]
AID - S1743-6095(15)30203-4 [pii]
AID - 10.1111/jsm.12335 [doi]
PST - ppublish
SO  - J Sex Med. 2013 Dec;10(12):3029-37. doi: 10.1111/jsm.12335. Epub 2013 Oct 11.