PSYCHOLOGICAL IMPACT OF ERECTILE DYSFUNCTION: VALIDATION OF A NEW HEALTH RELATED QUALITY OF LIFE MEASURE FOR PATIENTS WITH ERECTILE DYSFUNCTION DAVID M. LATINI,* DAVID F. PENSON,† HILARY H. COLWELL, DEBORAH P. LUBECK,* SHILPA S. MEHTA,* JAMES M. HENNING* AND TOM F. LUE‡ From the Department of Urology and Urology Outcomes Research Group, University of California, San Francisco, San Francisco, California, Departments of Urology, Veterans Affairs Puget Sound Health Care System and University of Washington, Seattle, Washington, and TAP Pharmaceutical Products, Lake Forest, Illinois ABSTRACT Purpose: Male erectile dysfunction has a substantial impact on health related quality of life. We examined the psychometric properties of 2 new scales created to measure the psychological impact of erectile dysfunction. Materials and Methods: Patients enrolled in a long-term study of men with erectile dysfunction completed clinical and health related quality of life information at baseline and at 3 followup points. The questionnaire incorporated a number of standard scales of psychosocial characteris- tics as well as questions developed from comments made during focus groups of men with erectile dysfunction and of their female partners. Principal components analysis was used to identify underlying constructs in response to the new questions. Results: A total of 168 men completed the baseline quality of life questionnaire. The principal components analysis of the psychological impact of erectile dysfunction questions resulted in 2 new scales. Reliability was good with an internal consistency reliability of 0.91 for scale 1 and 0.72 for scale 2. Test-retest reliability was 0.76 and 0.66, respectively. Men reporting a greater psychological impact of erectile dysfunction also reported greater impairment in functional status, lower sexual self-efficacy, greater depression and anxiety at the last intercourse. Each new scale significantly differentiated men with mild/moderate versus severe erectile dysfunction. Conclusions: We developed 2 new scales to measure the psychological impact of erectile dysfunction and they showed good reliability and validity. These new scales, named the Psychological Impact of Erectile Dysfunction instrument, comprehensively capture the psychological effect of erectile dysfunction on health related quality of life, which is not adequately assessed by existing patient centered measures of erectile function. KEY WORDS: penis; impotence; questionnaires; quality of life; psychology, medical Erectile dysfunction has substantial impact on male qual- ity of life. In addition to the impact on the sexual experience, in many men erectile dysfunction creates psychological dis- tress that affects their relationships with family and friends. 1 In a study of a general measure of health related quality of life men with erectile dysfunction reported significantly worse results than normal respondents on measures of social function, role limitations due to emotional problems and emotional well-being. 2 In another study men with erectile dysfunction reported significantly lower physical and emo- tional satisfaction, and lower general happiness than men in the study without the condition. 3 Unfortunately few available validated and reliable instru- ments specifically measure the effect of erectile dysfunction on health related quality of life. Most patient administered questionnaires used for erectile dysfunction are measures of symptoms and functional status or general psychological functioning. 4 While these types of measures provide useful information, they do not capture the wide impact of erectile dysfunction on health related quality of life. Qualitative re- search in men with the disease showed that an array of emotional consequences of erectile dysfunction are not as- sessed by current measures. Men with erectile dysfunction have substantial damage to their self-image as males and as sexual beings. They also report that erectile dysfunction im- pacts not only the emotional intimacy of their primary rela- tionship, but also daily interactions with women or other potential partners. 5, 6 To date only 2 instruments have specifically attempted to assess the psychological effect of erectile dysfunction on health related quality of life, namely the Quality of Life-Male Erectile Dysfunction and Erectile Dysfunction Effect on Quality of Life. 7 Each has similar limitations. The most im- portant limitation is that they provide a single score rather than separate scores for subscales that measure the different types of psychological impact of erectile dysfunction. In ad- dition, 2 instruments word questions in the negative, which assumes that erectile dysfunction is a problem in the respon- dent and may bias results. We developed a quality of life instrument that adequately assesses the impact of erectile dysfunction on health related quality of life, including subscales that measure different facets of the psychological consequences of the condition. This instrument, called the Psychological Impact of Erectile Accepted for publication June 7, 2002. Supported in part by TAP Pharmaceutical Products and Veterans Affairs Puget Sound Health Care System, Seattle, Washington. * Financial interest and/or other relationship with TAP Pharmaceutical Products. † Financial interest and/or other relationship with Pfizer, Boehr- inger Ingelheim, Astra Zeneca and TAP Pharmaceutical Products. ‡ Financial interest and/or other relationship with Bayer, Lilly, ICOS, Pfizer, Pharmacia, TAP Pharmaceutical Products and Upjohn. 0022-5347/02/1685-2086/0 Vol. 168, 2086 –2091, November 2002 THE JOURNAL OF UROLOGY ® Printed in U.S.A. Copyright © 2002 by AMERICAN UROLOGICAL ASSOCIATION,INC. ® DOI: 10.1097/01.ju.0000034365.57110.b7 2086