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Validation of the erection hardness score.

Mulhall JP, Goldstein I, Bushmakin AG, Cappelleri JC, Hvidsten K

Weill Medical College of Cornell University and Memorial Sloan Kettering Cancer Center, New York, NY 10021, USA. jpm2005@med.cornell.edu

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.

Published 31 October 2007 in J Sex Med, 4(6): 1626-34.
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