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Cited by 460Sexual function and dysfunction studiesStatistical Methods in Clinical TrialsHealth Systems, Economic Evaluations, Quality of Life

Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale

Rosen, Raymond C., Allen, Kerstin R., Ni, Xiao, Araujo, Andre B.·2011·European Urology
DOI 10.1016/j.eururo.2011.07.053
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Abstract

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.

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  • Rosen and colleagues noted that clinically significant changes in IIEF scores varied by baseline erectile function status: men with mild erectile dysfunction reported a clinically relevant improvement with a two-point IIEF increase, while those with severe erectile dysfunction required a seven-point improvement.

    “As an example, Rosen and colleagues noted that clinically significant changes in IIEF scores varied depending on baseline erectile function status.141 Men with mild ED would report a clinically relevant improvement if the IIEF score increased by two points, while those with severe ED required a seven point improvement to note equally significant changes.”

    From Challenges in Testosterone Measurement, Data Interpretation, and Methodological Appraisal of Interventional Trials (2016) · cites this paper as [141]

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Authors
Rosen, R. C., Allen, K. R., Ni, X., & Araujo, A. B.
Affiliations
  • New England Research Institutes (US)
  • Eli Lilly (United States) (US)
Corresponding author
Rosen, Raymond C.
ORCID
Allen, Kerstin R.
Venue
European Urology
Publisher
Elsevier BV
Published
2011-11
Volume
60
Issue
5
Pages
1010-1016
ISSN
0302-2838 (ISSN-L)
DOI
10.1016/j.eururo.2011.07.053
OpenAlex
W2154659002
Cited by
460
References
20
Citations by year
2026: 48 · 2025: 39 · 2024: 31 · 2023: 29 · 2022: 49 · 2021: 41 · 2020: 32 · 2019: 31 · 2018: 32 · 2017: 33 · 2016: 29 · 2015: 14 · 2014: 14 · 2013: 20 · 2012: 13
FWCI
11.23
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • European Urology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Sexual function and dysfunction studies
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
Keywords
minimal clinically important difference, erectile function, International Index of Erectile Function, erectile dysfunction, tadalafil, phosphodiesterase-5 inhibitors, anchor-based MCID, receiver operating characteristic, clinical trial endpoints
MeSH terms
Tadalafil, Aged, Analysis of Variance, Asia, Australia, Carbolines, Double-Blind Method, Europe, Humans, Erectile Dysfunction, Male, Middle Aged, North America, Penile Erection, Predictive Value of Tests, Surveys and Questionnaires, ROC Curve, Severity of Illness Index, South America, Time Factors, Reproducibility of Results, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Treatment Outcome, Patient Satisfaction, Recovery of Function, Cyclic Nucleotide Phosphodiesterases, Type 5, Phosphodiesterase 5 Inhibitors

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