Some Developments on the International Index of Erectile Function (IIEF)

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Copyright 0 1999 Drug Information Association Inc.

SOME DEVELOPMENTS ON THE INTERNATIONAL INDEX OF ERECTILE FUNCTION (IIEF) JOSEPHC. CAPPELLERI, PHD, MPH Associate Director, Biometrics. Department of Clinical Research, Pfizer Central Research, Groton, Connecticut

RAYMOND C. ROSEN,PHD Professor of Psychiatry, Center for Sex and Marital Health, University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, Piscataway, New Jersey

MICHAELD. SMITH,PHD Lead Statistician, Biometrics. Pfizer Central Research, Sandwich, United Kingdom

FRANCES QUIRK,PHD Local Clinical Team Leader, Clinical Development, Pfizer Central Research, Sandwich, United Kingdom

MURRAYC. MAYTOM,MD Clinical Project Manager, Pfizer Central Research, Sandwich, United Kingdom

AVANISHMISHRA,PHD Senior Manager, Outcomes Research, Pfizer Pharmaceuticals Group, New York, New York

IANH. OSTERLOH, MD Global Candidate Team Leader, Viagra, Pfizer Cennal Research, Sandwich, United Kingdom

This manuscript covers two complementary topics. For both topics, data from clinical studies and control samples were used. The first topic provides an overview of the development and validation of the International Index of Erectile Function (IIEF), a 15item questionnaire, for male erectile and sexual function. A principal components analysis revealed five factors (erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF demonstrated reliability, validity, and sensitivity and specificity with regard to treatment effect. The second topic presents, among men who reported having had sexual intercourse, the methodology and results on the evaluation of the erectile function (EF) domain of the IIEF; which has a range of scores from 6-30 for these men, as a diagnostic tool to help discriminate between men with and without erectile dysfunction (ED). For a prevalence rate of ED equal to 0.5 in a clinical population, the Classification and Regression Trees program gave a cutoff score of 25: men with EF scores of 25 or less were retrospectively classified as having ED, while those with scores above 25 were classified as not having ED (sensitivity = 0.97, specificity = 0.88). The IIEF has been developed and validated as a scale that is

Presented at the DIA Workshop “Global Statistical Challenges and Strategies in the Pharmaceutical Industry,” March 15-17. 1998, Hilton Head Island, South Carolina. Reprint address: Joseph C. Cappelleri, PhD, MPH, Pfizer Central Research, Department of Clinical Research, Eastern Point Road, Groton, CT 06340. E-mail: joseph-c-cappelleri @groton.pfizer.com

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Cappelleri, Rosen, Smith, Quirk, Maytom, Mishra, and Osterloh

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reliable, brieg self-administered, and psychometrically sound. Its EF domain showed desirable diagnostic properties. More research is encouraged in this area. Key Words: Diagnostic tests; Erectile dysfunction; Impotence; Penile erection; Question-

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