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Wiley InterScience

Journal of Sexual Medicine

Journal of Sexual Medicine

Volume 4 Issue 6, Pages 1626 - 1634

Published Online: 21 Sep 2007

© 2010 International Society for Sexual Medicine



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ORIGINAL RESEARCH—OUTCOMES ASSESSMENT
Validation of the Erection Hardness Score
John P. Mulhall, MD,* Irwin Goldstein, MD, Andrew G. Bushmakin, MS, Joseph C. Cappelleri, PhD, MPH, and Kyle Hvidsten, MPH §
  *Weill Medical College of Cornell University and Memorial Sloan Kettering Cancer Center, New York, NY, USA;   Sexual Medicine, Alvarado Hospital, San Diego, CA, USA;   Pfizer Inc, Global Research & Development, Groton, CT, USA;   § Pfizer Inc, New York, NY, USA
Correspondence to  John P. Mulhall, MD, Department of Urology, Weill Medical College of Cornell University, New York Presbyterian Hospital & Memorial Sloane Kettering Cancer Center, 525 East 68th Street, New York, NY 10021, USA. Tel: 212-746-5653; Fax: 212-746-0403; E-mail: jpm2005@med.cornell.edu
Copyright 2007 International Society for Sexual Medicine
KEYWORDS
Erectile Dysfunction • Erection Hardness • Patient-reported Outcome

ABSTRACT

AbstractIntroductionMethodsResultsDiscussionReferences

Introduction. Erection hardness is a fundamental component of erectile function, and is a very specific and easily monitored outcome. The Erection Hardness Score (EHS) is a single-item, patient-reported outcome (PRO) for scoring erection hardness.

Aims. The aim of this article is to report the psychometric validation of the EHS.

Methods. The dataset (N = 307) was from a multinational sildenafil trial (efficacy in the treatment of erectile dysfunction [ED]) with a 2-week screening phase, a 6-week double-blind, placebo-controlled treatment phase, and a 6-week open-label extension.

Main Outcome Measures. Test–retest reliability (intraclass correlation coefficient), quality and distribution of responses, known-groups validity (ability to differentiate between ED severity groups defined by the International Index of Erectile Function [IIEF] questionnaire), convergent validity (Pearson correlation coefficients with domain scores of the IIEF and the Quality of Erection Questionnaire [QEQ]), treatment responsiveness, and clinically important difference.

Results. The EHS demonstrated good test–retest reliability, acceptable quality and distribution of responses, known-groups validity against the IIEF (including clear differentiation between normal and impaired erectile function), moderate-to-strong convergent validity against the prespecified domains of the IIEF and QEQ, and high treatment responsiveness.

Conclusion. The EHS has desirable measurement properties, including being highly responsive to treatment. This one-item PRO is robust and easy to use for evaluating erection hardness. Psychometric analysis supports the use of the EHS as a simple, reliable, and valid tool for the assessment of erection hardness in clinical trials research. Mulhall JP, Goldstein I, Bushmakin AG, Cappelleri JC, and Hvidsten K. Validation of the Erection Hardness Score. J Sex Med 2007;4:1626–1634.


DIGITAL OBJECT IDENTIFIER (DOI)
10.1111/j.1743-6109.2007.00600.x About DOI

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