Female Assessment of Male Erectile Dysfunction Detection Scale (FAME): Development and Validation

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Female Assessment of Male Erectile Dysfunction Detection Scale (FAME): Development and Validation jsm_1348

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Eusebio Rubio-Aurioles, MD, PhD,* Michael Sand, PhD, MPH,† Nadine Terrein-Roccatti, PhD,* John Dean, MBBS, FRCGP,‡ Jan Longworth, BMedSci, BMBS, DOccMed,§ Ian Eardley, MA, MChir, FRCS (Urol), FEBU,¶ Gerald Brock, MD,** Jay Lee, MD,†† Iván Arango de Montis, MD,* and Claudia Rampazzo-Bonaldo, MD* *Asociación Mexicana para la Salud Sexual, A.C. (AMSSAC), Mexico City, Mexico; †Boehringer-Ingelheim Inc., Ridgefield, CT, USA; ‡St. Peter’s Sexual Medicine, The London Clinic, London, UK; §ITTC, Tamar Science Park, Plymouth, UK; ¶St. James’s University Hospital, Leeds, UK; **St. Joseph’s Health Care/Lawson Research Institute, London, ON, Canada; ††Urology Research, Prostate Cancer Institute, Calgary, AB, Canada DOI: 10.1111/j.1743-6109.2009.01348.x

ABSTRACT

Introduction. Although erectile dysfunction (ED) affects both members of the couple, no tools exist for the detection of ED by the female partner. Aim. The aim of this study was to develop a scale for the detection of ED, as assessed by the female partner. Methods. Development and validation of the Female Assessment of Male Erectile dysfunction detection scale (FAME) consisted of five stages: (i) two focus group discussions conducted among female partners of ED sufferers; (ii) item construction; (iii) initial content validation to document face validity and reduce number of items; (iv) final selection of items and investigation of concurrent validity and reliability, sensitivity and specificity of the scale in 83 Spanish-speaking couples; and (v) multicenter study conducted in a group of 106 English-speaking couples. Concurrent validity was assessed using Spearman’s rho correlation coefficients between FAME and clinical diagnosis, the Sexual Health Inventory for Men (SHIM), and the erectile function domain of the International Index of Erectile Function (IIEF-EF). Reliability was tested using Cronbach’s alpha, and sensitivity and specificity was investigated using clinical diagnosis as the gold standard criterion. Main Outcome Measures. Validity, reliability, specificity, and sensitivity of the FAME scale when correlated with SHIM, IIEF-EF, and clinical diagnosis. Results. Qualitative analysis yielded 44 clues; 21 items demonstrated statistical significance as the best discriminating items using a t-test for independent samples. A final scale of six items was tested for validity, reliability, specificity, and sensitivity. FAME correlated significantly with clinical diagnosis (0.791, P < 0.001), the SHIM (0.788, P < 0.001), and the IIEF-EF (0.777, P < 0.001). Additional support for discriminant validity was obtained with receiver operating characteristics analysis. Cronbach’s alpha was 0.941. Sensitivity was 96.1% and specificity 86.0%. Conclusions. Accurate detection of ED in men by the female partner is possible. In this study, FAME demonstrated concurrent validity and very good reliability, as well as excellent sensitivity and specificity. Rubio-Aurioles E, Sand M, Terrein-Roccatti N, Dean J, Longworth J, Eardley I, Brock G, Lee J, Arango de Montis I, and Rampazzo-Bonaldo C. Female assessment of male erectile dysfunction detection scale (FAME): Development and validation. J Sex Med 2009;6:2255–2270. Key Words. Erectile Dysfunction Detection; Female Partner; Female Partner Experience of Erectile Dysfunction

Introduction

D Funding Support: This project was sponsored by Bayer Healthcare/Bayer Schering Pharma, Germany and carried out in Mexico, Canada and the UK.

© 2009 International Society for Sexual Medicine

etection of erectile dysfunction (ED) using questionnaires and scales has been made possible through the development of instruments such as the International Index of Erectile Function (IIEF) [1]. The original IIEF questions were J Sex Med 2009;6:2255–2270

2256 developed to measure the treatment effects of sildenafil, which was under evaluation for the treatment of ED at that time. Since then, the IIEF has received almost universal acceptance due to its favorable psychometric characteristics, and has been widely used in clinical trials for ED [2]. A shorter version of the IIEF was subsequently developed. This is a five-item scale that demonstrated sufficient sensitivity and specificity to be used as a detection tool, and is known as the IIEF-5 or the SHIM (Sexual Health Inventory for Men) [3]. The sensitivity and efficacy of the SHIM for the detection of ED was validated in a general clinical population that included patients with underlying conditions such as diabetes or hypertension [4]. Recognizing that the IIEF does not capture descriptive data for all of the important consequences of ED, several other questionnaires have been developed. Most of the newer instruments have focused on treatment-related aspects of ED. For example, the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire [5] and the Treatment Satisfaction Scale (TSS) [6,7] were both developed to assess treatment satisfaction. Several questionnaires have been developed to capture the quality of life dimensions of ED, and the impact that treatment might have on the man and his female partner. The Self Esteem And Relationship questionnaire (SEAR) was designed to capture quality of life issues relating to the sexual relationship, self-esteem and overall relationship aspects of ED patients [8]. The Psychological and Interpersonal Relationship Scales questionnaire was developed to assess differences in perception of treatment in relation to the pharmacokinetic properties of medication [9]. Other instruments, such as the Erection Hardness Score, have looked into specific aspects of erection failure [10]. Attempts to capture broader aspects of the male experience of ED have also been conducted. For example, the Sexual Experience Questionnaire was developed to capture in a single scale the function and health-related quality of life in men with ED [11]. Similarly, the Sexual Quality of Life Questionnaire, for use in men with premature ejaculation or ED, independently assessed the impact of these two particular male sexual dysfunctions on quality of life [12]. In recent years, there has been considerable interest in the impact of ED and its treatment on the female partner [13,14]. The Female Experience of Men’s Attitudes to Life Events and Sexuality (FEMALES) study [13] was conducted in J Sex Med 2009;6:2255–2270

Rubio-Aurioles et al. partners of men who had previously participated in the Men’s Attitudes to Life Events and Sexuality study, an international study exploring men’s life events in relation to ED and overall health [15]. The FEMALES study showed that female partners of men with ED had sexual activity less frequently and experienced lower levels of sexual desire, arousal, orgasm, and satisfaction with their sexual relationship, when compared with a time prior to the onset of the man’s ED. Decreases in female sexual satisfaction and frequency of orgasm were directly related to the male partner’s self-reported severity of ED. FEMALES also demonstrated that the treatment of ED led to improvements in the female partner’s sexual quality of life. The proportion of women who experienced sexual desire, arousal, and orgasm “almost always” or “most times” was significantly higher in the group whose male partners were currently using a phosphodiesterase type 5 inhibitor. Several questionnaires exist to assess the experience of ED from the perspective of the female partner. One example, the Index of Sexual Life, was developed in France by Chevret and collaborators, and was tested in a French-speaking population [16]. In addition, both the previouslymentioned EDITS [5] and TSS [6,7] have corresponding partner versions to assess treatment satisfaction from the perspective of the female partner. Women are significant influencers of the treatment-seeking behavior of the male partner [17]. Because the female partner may be able to contribute important information on the history of the man’s ED and describe changes in patterns of erectile function [18], there have been recommendations to include the female partner in the management of ED [19]. Although the prevalence of ED has been estimated at approximately 20% in the general male population, less than 30% of men with ED seek treatment [20]. Furthermore, men are typically more reluctant than women to seek treatment for most ailments [21]. It has been suggested that men’s uptake and adherence to therapy is affected by the female partner’s attitudes, and that successful long-term ED therapy is more likely with the involvement and support of the female partner. Furthermore, published recommendations indicate that partner preferences for different treatment options should always be considered carefully, and any ED therapy should be chosen and accepted by both the patient and his partner to maximize treatment effectiveness [19].

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FAME Scale: Development and Validation A questionnaire completed by the female partner may encourage men to consult a physician about their ED, providing a valuable opportunity to screen for any associated underlying conditions such as metabolic syndrome, type 2 diabetes mellitus, hypogonadism, and cardiovascular disease [22,23]. Aims

The aim of this study was to investigate whether the perceptions of the female partner of a man with ED could be used as a means of accurately detecting his ED. The objectives of the current project were to develop a short questionnaire for completion by the female partner, and subsequently to assess the psychometric properties (i.e., validity and reliability, sensitivity, and specificity) of this questionnaire, the Female Assessment of Male Erectile dysfunction detection scale (FAME). Methods

Participants A total of 422 individuals (211 heterosexual couples) participated in the various stages of development and validation of the questionnaire. Men were interviewed by a clinical expert in ED to verify their ED status. The appropriate Ethics Review Board approved the relevant procedures prior to conducting each stage of the study. All participants (female and male) in each stage provided signed informed consent. Stage I: Qualitative Research To investigate how women experienced the onset and subsequent progression of ED in their partners, two focus groups consisting of 10 and 9 women, respectively, were assembled. Focus group participants were selected from the database of the AMSSAC research center, where a large number of ED patients participating in clinical trials are registered. Patients were contacted and asked to invite their partners to participate in the study. In addition, during a radio interview, the first author requested the participation of female volunteers who would be willing to present their male partners for a clinical examination. Limited efforts were made to include participants from a variety of socioeconomic backgrounds; all women were living in Mexico City and spoke Spanish. The inclusion criteria for this stage were: 1. women ⱖ18 years of age whose partner had documented ED based on at least one of the

2. 3. 4. 5.

following: a score of ⱕ21 in the SHIM questionnaire, an IIEF-erectile function domain (IIEF-EF) score of ⱕ25, or a documented clinical diagnosis by a certified expert in ED. Additionally, the duration of the man’s ED had to be at least 3 months, but no longer than 3 years, so that clues for its onset had not been forgotten; a stable relationship of at least 2 years’ duration; awareness of the man’s ED being present before the selection interview (regardless of the specific label given to the condition); onset of the man’s ED at least 1 year after the couple began sexual relations; and ability to read and understand the informed consent form.

Exclusion criteria were: (i) the presence of any medical or psychiatric diagnosis in any of the two members of the couple that, in the opinion of the investigator, could interfere with the quality of the information obtained; and (ii) the presence of conflict in the relationship not directly attributable to ED, such as active infidelity, threats for separation or divorce, violence or alcohol abuse. Each group held a 2-hour discussion session, during which participants identified those themes/clues which may have indicated that their partner was suffering from ED. Both sessions were transcribed verbatim, and a subsequent analysis of the contents of these transcripts was performed, following the principles of grounded theory [24]. In short, grounded theory requires that the content analysis of qualitative data be derived from the actual data, and not from preconceived theories or assumptions. Each theme/clue identified by participants during the group discussions was classified, with similar themes grouped together into the same class, until a list of distinct clues indicating the development of ED in the partner was developed. This process resulted in the identification of 44 clues.

Stage II: Item Development The clues identified in stage I of the study were transformed into items. Some of the original clues were eliminated because they resulted from communication between the man and his partner about his ED, and not from the partner’s own assessment of his condition. Other items were eliminated because they reflected conflict between the couple that may have arisen as a direct consequence of the development of the man’s ED. This process resulted in a questionnaire with 42 items, each with five response options, rated 1 to 5 (where 5 represented better erectile function). J Sex Med 2009;6:2255–2270

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Stage III: Initial Content (Face) Validation, and Initial Item Reduction with Panel of Judges Two panels of judges were formed, one consisting of three clinical experts in ED (two women and one man), and the other of three women whose partners had confirmed ED, but who had not attended any of the focus group discussions. The judges rated each of the 42 items according to clarity and ability to detect ED.

conducted by identifying the best-performing items on the t-test. The following activities were conducted in order to determine the final number of items in the scale: receiver operating characteristics (ROC) analysis, and a comparison of different alpha reliability scores for a number of scales containing four to seven items, using the internal consistency coefficient, Cronbach’s alpha. This led to the final selection of a six-item scale.

Stage IV: Final Item Selection, Initial Concurrent Validity, and Reliability From the ratings of the judging panels, a final list of 23 items was constructed. These 23 items were tested in two groups of couples: one containing men with ED and their partners (37 couples) and the other, men without ED and their partners (45 couples). Participants for this phase of the study were recruited from two sources: the database of ED patients of the AMSSAC research center in Mexico City, and open invitations made via newspaper advertisement and radio interview. Couples were invited to the study through a “talk with the expert” meeting, where general issues regarding the sexual life of the couple were addressed. Participants in the non-ED group came primarily from this open invitation in the mass media. No attempt was made to gather a representative sample of the population of Mexico City. Participants were offered a small reimbursement for traveling expenses. Men were required to be >18 years of age and have untreated ED for ⱖ6 months (for inclusion in the ED subgroup), or normal erectile function (non-ED subgroup), as assessed by a clinician who was an expert in ED. To be eligible for participation, women had to be >18 years of age and in a stable relationship for >6 months with a participating man. Both sexes had to have a level of literacy that enabled the understanding of informed consent and of the questionnaire itself. Participants were excluded if they were unable to read the questionnaire in Spanish. It was not possible to age-match these groups, as ED prevalence tends to increase with age [15]. All individuals in this phase of the study had not participated in any of the previous stages. Men were interviewed by a clinician to verify their ED status, and both sexes were interviewed to identify other sexual dysfunctions and/or medical conditions. A t-test for independent samples was used to investigate the discriminating ability of each item. A total of 21 items demonstrated statistical significance in differentiating between the ED and non-ED populations. A final reduction of items was then

Stage V: English Translation, Confirmation of Concurrent Validity, Discriminant Validity, Reliability and Investigation of Sensitivity, and Specificity of the Final FAME Scale The initial development of the FAME scale described in stages I–IV took place in a Spanishspeaking population within Mexico City, Mexico. It was therefore also necessary to determine the validity and reliability of the scale in an Englishspeaking population, and assess the optimal cut-off point, sensitivity, and specificity of the scale in this population. The original Spanish scale was translated and back-translated by professional translators until the linguistic equivalency of both versions was satisfactory. The concurrent validity, reliability, sensitivity, and specificity of the FAME scale was then evaluated in a multicenter study population of 108 couples: one group of women with male partners who had untreated ED (N = 51) and a comparison group of women whose partners had no ED (N = 57). Three centers in the United Kingdom and two in Canada recruited couples for this stage of the study. The UK centers were located in Plymouth and Leeds, and the Canadian centers were in London, Ontario, and Calgary, Alberta. The presence or absence of ED in men was verified by clinician interview. As in stage IV, study groups were not matched for age. Men were required to be >18 years of age and have had untreated ED for ⱖ6 months (for inclusion in the ED subgroup), or normal erectile function (non-ED subgroup) as assessed by a clinician who was an expert in ED. To be eligible for participation, women had to be >18 years of age and in a stable relationship for >6 months with a participating man. Both sexes had to have a level of literacy that enabled the understanding of informed consent and of the questionnaire itself. Participants were excluded if they were unable to read the questionnaire in English. The FAME scale was evaluated to confirm concurrent validity against clinical diagnosis, and the SHIM and IIEF-EF scores using Spearman’s rho correlation coefficient.

J Sex Med 2009;6:2255–2270

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FAME Scale: Development and Validation Discriminant validity (to assess the ability of the scale to discriminate between ED and non-ED subgroups) was measured by ROC analysis, using clinical diagnosis as the gold standard criterion, in combination with the reported sensitivity and specificity of the test after determination of the best-fit cut point. Reliability was tested using Cronbach’s alpha. Sensitivity and specificity were investigated using clinical diagnosis as the gold standard criteria. This analysis was performed using several different cut-off points, in order to determine the optimal point. ROC curves were calculated for FAME (answered by the female partner), and the SHIM and IIEF-EF (answered by the male partner), to compare the three scales in terms of sensitivity and specificity.

Main Outcome Measures Clinical Diagnosis The presence or absence of ED in male participants was determined by clinical interview using the following definition “the consistent or recurrent inability of a man to attain and or maintain penile erection sufficient for satisfactory sexual activity” [25]. SHIM This shorter version of the IIEF is a five-item scale that has shown sufficient sensitivity and specificity for use as a detection tool when tested in clinical populations not participating in ED trials [3,4]. IIEF-EF [1] This is a widely used measure of erectile function that has received almost universal acceptance due to its favorable psychometric characteristics [2]. The IIEF-EF has excellent diagnostic properties: based upon a classification-tree analysis, the optimal cut-off score was found to be 25, with men scoring ⱕ25 classified as having ED and those scoring > 25 as having normal function (sensitivity = 0.97; specificity = 0.88). Subsequently, among men in a stable relationship who attempted sexual activity and intercourse, the severity of ED was classified into five diagnostic categories: no ED (IIEF-EF score 26–30), mild (IIEF-EF score 22–25), mild to moderate (IIEF-EF score 17–21), moderate (IIEF-EF score 11–16), and severe (IIEF-EF score 6–10) [2]. All statistical calculations were made using the SPSS package version 15.0.1 (SPSS Inc., 1989– 2006).

Results

Demographics of Participants Table 1 presents participants’ demographics for stages I (qualitative research), IV (final item selection), and V (final confirmation of concurrent validity and psychometric characteristics). The relationship duration range was 13–26 years. In general, participants in the non-ED subgroup were significantly younger and were in relationships of shorter duration than those in the ED subgroup. In the English-speaking population, the education level of female partners in both the ED and non-ED subgroups was similar. However, in the Spanish-speaking population, women whose partners had ED tended to be educated to a lower level than those in the non-ED subgroup. The income level of stage V participants was assessed with a single question; most participants rated their income level as medium, and the difference between self-reported levels of income of the ED and non-ED subgroups was non-significant. Qualitative Research Content analysis of the focus group sessions yielded 44 different categories of clues that women reported as indicative that their partners were developing ED (Table 2). These categories were organized into six main classes, including physical signs of ED, behavioral themes/clues, psychological impact of ED in the man, psychological impact of ED on the woman, the impact of ED on the relationship, and the impact of ED on the sexual satisfaction of the woman. Although most of the reported clues were not included in the final detection scale, the complete findings from this qualitative investigation are included in Appendix I, as these may prove valuable for assessing female perspectives of ED in future research. Item Development, Initial Content (Face) Validation, and Initial Item Reduction with a Panel of Judges After the content analysis in stage I, a list of 42 items was developed (Appendix I). The final decision of whether to include or exclude each item was taken based on the following criteria: items that reflected aspects of a conflictive relationship were rejected, items with a combined score (clarity and ability to detect ED) >9.5 were selected, and items that represented the female adaptation of SHIM items were selected. A few additional items were also chosen because the Mexican investigator team (Rubio-Aurioles, Terrein-Roccatti, Arango de Montis, and Rampazzo-Bonaldo) were J Sex Med 2009;6:2255–2270

J Sex Med 2009;6:2255–2270 SD 8.300 7.926 10.180 3.192 3.660

SE 1.45 1.55 2.02 2.01 0.755 0.679

SE 1.81 1.72 2.221 0.697 0.799 Non-ED group (N = 45 couples) Mean SD 40.84 9.82 37.69 8.92 13.62 10.23 13.57 10.15 15.00 3.867 14.53 3.757 SE 1.46 1.33 1.52 1.51 0.576 0.560

t* 5.25 4.83 2.28 2.33 -1.064 -1.674

*t-value test for independent samples (unequal variance assumed). **P value (two-tailed). ***P value (asymptotic bilateral significance estimation). c2 = Chi-square; df = degrees of freedom; ED = erectile dysfunction; FAME = Female Assessment of Male Erectile dysfunction detection scale; SD = standard deviation; SE = standard error.

Stage V: English translation, confirmation of concurrent validity, reliability, and investigation of sensitivity and specificity of the final FAME scale (N = 108 couples) ED group (N = 51 couples) Non-ED group (N = 57 couples) Mean SD SE Mean SD SE t* Age of man (years) 61.63 9.681 1.350 43.11 13.501 1.788 8.254 Age of woman (years) 58.49 10.100 1.414 40.60 14.007 1.855 7.670 Years in relationship according to man 26.14 15.827 2.216 16.61 13.409 1.776 3.353 Years in relationship according to woman 26.59 15.826 2.216 16.61 13.485 1.786 3.504 Years of education of man 12.53 2.525 0.354 13.15 3.495 0.463 -1.064 Years of education of woman 12.06 2.034 0.285 12.96 3.474 0.460 -1.674 df N % N % c2 Level of self-reported income Male participants Low 14 27.5 9 15.8 Medium 34 66.7 41 71.9 3.016 2 High 3 5.9 7 12.3 Female participants Low 11 21.6 10 17.5 Medium 39 76.5 42 73.2 2.500 2 High 1 2.0 5 8.8

Stage IV: Final item selection, initial concurrent validity, and reliability (N = 82 couples) ED group (N = 37 couples) Mean SD Age of man (years) 51.70 8.85 Age of woman (years) 47.59 9.47 Years in relationship according to man 19.38 12.28 Years in relationship according to woman 19.44 12.25 Years of education of man 11.94 4.529 Years of education of woman 10.78 4.131

Age of man (years) Age of woman (years) Years in relationship Years of education of man Years of education of woman

Mean 50.24 45.29 21.67 10.10 8.71

Demographics of participants in stages I, IV, and V of the process

Stage I: Qualitative research (N = 21 couples)

Table 1

0.287

0.221

P** <0.001 <0.001 0.001 0.001 0.290 0.097 P***

P** <0.001 <0.001 0.025 0.023 0.002 <0.001

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FAME Scale: Development and Validation Table 2 List of themes/clues identified after content analysis of focus group discussions Physical signs 1. Failure to obtain erection 2. Diminished rigidity 3. Failure to maintain erection 4. Failure of erectogenic interventions 5. Changes in ejaculation pattern 6. Penis looks smaller 7. Rapid intercourse 8. Failure to penetrate 9. Use of hand to help penetration 10. Man masturbates to get an erection 11. Inability to perform sexual coital positions 12. Erectile capacity varies 13. Man sweats during sexual intercourse Behavioral themes/clues 14. Increase in use of alternatives for sexual stimulation and satisfaction 15. Less time devoted to sexual foreplay and intercourse 16. Diminished frequency of sexual activity 17. Diminished variety of sexual interaction 18. Man avoids sexual interaction 19. Man makes efforts to obtain or maintain erection 20. Man seeks help for erection problem 21. Man recognises inability to perform sexually 22. Increase in self observation in the man 23. Increase in demand of female partner assurances of satisfaction 24. Non-specific behavioral change Psychological impact on the man 25. Anger 26. Anxiety over sexual performance 27. Denial of erectile failure 28. Depressive mood 29. Loss of confidence in obtaining erections Psychological impact on the woman 30. Increase of female somatic complaints 31. Anger in the woman Impact on the relationship 32. Preoccupation with unfaithfulness of the woman 33. Fear of unfaithfulness of the man 34. Woman feels rejection 35. Man becomes aggressive 36. Man blames woman for erectile failure 37. Man seeks reassurance of his male identity 38. Man concedes failure in his male duties 39. Man compensates for failure with other behaviors 40. Communication about erectile failure becomes difficult 41. Woman becomes concerned with man’s health Sexual satisfaction of the woman 42. Erection feels less satisfying 43. Sexual desire diminishes in the woman 44. Foreplay produces less arousal in the woman

curious to investigate if these could work as differentiators of ED vs. non-ED from a female perspective (items 18, 20, 21, 23, 26, 28, 31, and 39).

Final Item Selection, Initial Concurrent Validity, and Reliability An initial field test was performed in the stage IV population described in Table 1, using 23 items selected from the previous stage. Table 3 presents

2261 the list of items tested, and the result of an independent sample t-test for equality of means, with degrees of freedom and two-tailed P values. A total of 21 out of 23 items had significantly different mean values (P ⱕ 0.05), indicating that they differentiated between the ED and non-ED groups. To arrive at a selection of items for inclusion in the final FAME scale, ROC curves were calculated for various scales, constructed with the first four to seven items presented in Table 3. The ROC curve analysis also included the SHIM questionnaire answered by the corresponding male partners of the female participants. The area under the curve increased as the number of items increased. The sensitivity and specificity of all of the constructed FAME scales compared favorably with SHIM, demonstrating their potential and validity as detection tools (Figure 1). Additionally, a preliminary reliability analysis was performed to decide the optimal number of items for the FAME scale. Table 4 presents a comparison of reliability coefficients (Cronbach’s alpha) for consecutive increases in the number of items. Optimal reliability was achieved with a sixitem scale, and for this reason, the first six items shown in Table 3 were selected for the final stages of the study. The final FAME questionnaire, including possible answers and instructions to calculate the final score, is shown in Appendix II.

English Validation and Investigation of the Psychometric Properties of the Final FAME Scale The final six-item scale was subjected to a back translation process by independent professional translators. The rest of the items were translated by the lead author (Rubio-Aurioles). This final scale was tested in a population of Englishspeaking couples. The demographics of the participants in this stage of the process are presented in Table 1. Concurrent Validity To investigate the concurrent validity of the English-language version of the FAME scale, the Spearman’s rho correlation coefficient between total FAME score and the diagnosis obtained after clinical interview with the male participant was assessed. FAME scores correlated significantly (rho = 0.791, P < 0.001) with clinical diagnosis. Moreover, both the SHIM and IIEF-EF scores compared favorably with coefficients for the FAME scale (SHIM: rho = 0.809, P < 0.001; IIEFEF: rho = 0.813, P < 0.001), as all three scales correlated strongly with clinical diagnosis (Table 5). J Sex Med 2009;6:2255–2270

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Table 3 Independent sample t-test* of individual items (N = 83 women: partner with clinical diagnosis of ED, N = 38; partner with negative screening in clinical interview for ED, N = 45) t-test for equality of means Item

t value

df

P (two-tailed)

1. When your partner had erections during sexual stimulation, how frequently were erections firm enough for penetration? 2. During sexual intercourse, how frequently was your partner capable of maintaining erections after penetration? 3. During sexual intercourse, how difficult was it for your partner to maintain an erection until completion of sexual intercourse? 4. How would you rate your partner’s confidence to obtain and maintain an erection? 5. How frequently does your partner look sad or depressed because of his sexual performance? 6. When you and your partner had sexual intercourse, how frequently was this satisfactory for him? 7. During sexual intercourse, how frequently does your partner use his hand to assist with penetration? 8. How frequently have you noticed that your partner’s penis looks smaller than it was? 9. How frequently does your partner’s erection make you feel less sexual satisfaction? 10. During sexual intercourse, how frequently does your partner need to make an effort to obtain or maintain his erection? 11. How frequently does your partner tell you that he feels that he is not fulfilling his responsibilities because he has not had a good erection? 12. During sexual intercourse, how frequently was your partner’s erection less rigid? 13. How much has the frequency of your sexual intercourse (how frequently you have sex) diminished? 14. During sexual intercourse, how frequently have the medications or remedies used to improve erections failed? 15. How frequently do you experience anger or rage because of the erectile failures of your partner? 16. During sexual intercourse, how frequently does your partner focus on himself and his erection rather than on you or your sexual relationship? 17. During sexual activity, how much has the time devoted to preliminary sexual play (sexual foreplay before penetration) diminished? 18. How frequently is sexual intercourse much more rapid than it used to be? 19. How frequently does your partner show himself extremely obliging with other things, as if he was compensating for the lack of a good erection? 20. How difficult is it to talk with your partner about erection failures? 21. When there is a chance to have sexual activity, how frequently do you experience sexual desire or wish to have sexual intercourse with your partner? 22. During sexual intercourse, how frequently is your partner not able to obtain an erection? 23. During sexual intercourse, how frequently are caresses and foreplay before penetration less exciting for you than before?

-10.78

51.34

<0.0001

-8.16

70.18

<0.0001

-8.07

62.39

<0.0001

-7.55

75.03

<0.0001

-6.75

61.24

<0.0001

-6.69

47.79

<0.0001

-6.53

71.57

<0.0001

-6.24

44.49

<0.0001

-5.75

65.24

<0.0001

-5.62

80.99

<0.0001

-5.42

51.81

<0.0001

-4.25 -4.15

63.70 79.74

0.0001 0.0001

-3.69

42.32

0.0006

-3.58

61.85

0.0007

-3.46

57.23

0.0010

-3.43

74.82

0.0010

-3.28 -3.27

68.58 69.08

0.0016 0.0017

-2.64 -2.39

61.39 73.64

0.0105 0.0196

-1.65

80.95

0.1019

-1.54

77.93

0.1287

Items in bold are the final items of the scale. *t-value test for independent samples (unequal variance assumed). df = degrees of freedom; ED = erectile dysfunction.

Additional confirmation was provided by calculating the Spearman’s rho correlation coefficient between the total score of FAME and either the SHIM or IIEF-EF scores (SHIM rho = 0.788, P < 0.001; IIEF-EF rho = 0.777, P < 0.001). Both measures supported the concurrent validity of the FAME scale. As the couples’ age, number of years in the relationship, and the woman’s number of years of education were different for each subgroup (see Table 1), the scale may have been detecting these differences and not the characteristics relating to presence or absence of ED. Therefore, it was J Sex Med 2009;6:2255–2270

decided upon to perform a fourth order partial correlation test, controlling for age of the man or woman, years of relationship according to the man, and years of education of the woman. Table 5 shows the results of these partial correlation coefficients as well as the corresponding Pearson correlation coefficients between clinical diagnosis and FAME, SHIM, and IIEF-EF. The partial correlation coefficients remained very strong and highly comparable to the bivariate Pearson correlation coefficients. Therefore, the correlations between clinical diagnosis and the three scales were not due to the differences in age of the man or woman,

0.2

0.4

0.6

0.8

1.0

1 - Specificity Scale

FAME 6 items SHIM FAME 4 items FAME 5 items FAME 7 items

Area under the curve 0.930 0.974 0.926 0.930 0.935

Figure 1 Receiver operating characteristics (ROC) curves for the preliminary versions of the Spanish-language FAME scale, including specific numbers of items, and the SHIM scale (answered by the male partner). FAME = Female Assessment of Male Erectile dysfunction detection scale; SHIM = Sexual Health Inventory for Men.

time in relationship of the man, or years of education of the woman, further demonstrating that the FAME scale is actually measuring characteristics relating to ED and not other factors.

Discriminant Validity ROC analysis was performed for FAME, SHIM, and IIEF-EF (Figure 2). As indicated, all three scales resulted in curves covering >90% of the area (a perfect test covers 100% of the ROC curve area). These results, together with the specificity and sensitivity reported in Table 7, indicate that Table 4 Comparison of reliability coefficients (Cronbach’s alpha) of consecutive increases in the number of items of the FAME scale after the independent sample t-test of individual items Number of items considered

Cronbach’s alpha

4 5 6 7

0.932 0.935 0.941 0.937

The items selected for this analysis were the most discriminating items according to Table 3. FAME = Female Assessment of Male Erectile dysfunction detection scale.

Fourth order partial correlations of clinical diagnosis vs. FAME, SHIM, and IIEF-EF, controlling for age of the man or woman, years in relationship according to man, and years of education of the woman Partial r df P (two-tailed) FAME 0.735 101 <0.001 SHIM 0.766 101 <0.001 IIEF-EF 0.713 101 <0.001

0

P (two-tailed) <0.001 <0.001

0

N 108 107

0.2

P (two-tailed) <0.001 <0.001 <0.001

FAME 6 items SHIM FAME 4 items FAME 5 items FAME 7 items

N 108 108 107

0.4

Pearson r 0.819 0.839 0.818

0.6

Clinical diagnosis vs. FAME, SHIM, and IIEF-EF Spearman’s rho FAME 0.791 SHIM 0.809 IIEF-EF 0.813 FAME vs. reference scales Spearman’s rho SHIM 0.788 IIEF-EF 0.777

Sensitivity

0.8

Table 5 Spearman’s rho and Pearson correlation coefficients of the FAME, SHIM, and IIEF-EF scales with clinical diagnosis, and between FAME and the reference scales, and partial correlations of the FAME, SHIM, and IIEF-EF scales with clinical diagnosis, controlling for age of the man or woman, years in relationship according to the man or woman, and years of education of the woman

1.0

df = degrees of freedom; FAME = Female Assessment of Male Erectile dysfunction detection scale; IIEF-EF = erectile function domain of the International Index of Erectile Function; SHIM = Sexual Health Inventory for Men.

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J Sex Med 2009;6:2255–2270

2264

Rubio-Aurioles et al. Table 6 Cronbach’s alpha coefficients of FAME, SHIM, and IIEF-EF scales

1.0

Sensitivity

0.8 0.6 0.4

FAME SHIM IIEF-EF

0.2 0

0

0.2

0.4

0.6

0.8

1.0

1 - Specificity Scale

FAME SHIM IIEF-EF

Cronbach’s alpha

N

FAME SHIM IIEF-EF

0.941 0.964 0.973

108 108 107

FAME = Female Assessment of Male Erectile dysfunction detection scale; IIEF-EF = erectile function domain of the International Index of Erectile Function; SHIM = Sexual Health Inventory for Men.

(FAME, SHIM, and IIEF-EF) is shown in Table 7. The FAME scale had identical sensitivity to, and a higher specificity than, the SHIM in the study population.

Area under the curve 0.970 0.981 0.966

Figure 2 ROC curves for the FAME, SHIM, and IIEF-EF scales. FAME = Female Assessment of Male Erectile dysfunction detection scale; IIEF-EF = erectile function domain of the International Index of Erectile Function; ROC = receiver operating characteristics; SHIM = Sexual Health Inventory for Men.

the FAME scale performs in a very similar way to the validated SHIM and IIEF-EF scales.

Reliability To investigate the reliability of the Englishlanguage FAME scale, internal consistency was calculated using Cronbach’s alpha, resulting in a score of 0.941 (Table 6). By comparison, a score of 0.942 was obtained when standardized items were used. Therefore, the FAME scale was considered to have very good internal consistency. Cronbach’s alpha values for FAME, SHIM, and IIEF-EF are shown in Table 6. Remarkably, the reliability coefficient of the FAME scale in this English-speaking population was identical to that found in the initial Spanish-speaking population (see Table 4). Sensitivity and Specificity The sensitivity and specificity of the Englishlanguage version of the FAME scale were calculated for cut-off points from 21 to 27, in order to find out the optimal point for the study population (Table 7). As a detection scale needs the highest possible sensitivity with reasonable specificity, a cut-off point of 24 was selected. A comparison of the sensitivity and specificity measures for each of the scales used in the study J Sex Med 2009;6:2255–2270

Criteria

Discussion

The research question that guided this project was whether the perceptions of the female partner of a man with ED could be used as a means of detecting the man’s ED. These results confirm that this is possible. The FAME scale demonstrated concurrent validity (using clinical diagnosis, SHIM, and IIEF-EF scores answered by the male partner) and good reliability, sensitivity, and specificity, equivalent to previously validated measures for the assessment and detection of ED (i.e., SHIM and IIEF-EF). The women participating in this study accurately perceived the development of ED in their partners. This demonstrates that a relatively brief questionnaire answered by the female partner Table 7 Sensitivity and specificity analysis of the FAME scale at various cut-off points and the FAME, SHIM, and IIEF-EF scales FAME scale Cut-off point (ED = scale score ⱕ specified value) 21 22 23 24* 25 26 27

Sensitivity (%) 90.2 90.2 94.1 96.1 96.1 96.1 98.0

Specificity (%) 91.2 89.5 86.0 86.0 80.7 77.2 77.2

FAME, SHIM, and IIEF-EF scales Cut-off point (ED = scale score ⱕ specified value) FAME 24 SHIM 21 IIEF-EF 25

Sensitivity (%) 96.1 96.1 98.0

Specificity (%) 86.0 78.9 78.9

*Ideal cut-off point for the study population. FAME = Female Assessment of Male Erectile dysfunction detection scale; IIEF-EF = erectile function domain of the International Index of Erectile Function; SHIM = Sexual Health Inventory for Men.

2265

FAME Scale: Development and Validation could be used with confidence to detect ED in the male partner—if the FAME score was ⱕ24, the male partner was highly likely to have ED. An additional benefit of the present study was the richness of the findings from the qualitative phase. Most of these findings were omitted from the final scale because the objective was to obtain a brief, user-friendly scale for detection. However, the wide variety of clues identified in the focus group discussions clearly demonstrates the female partner’s perception not only of changes in erectile function, but also of the psychological impact of ED on both members of the couple and its subsequent effect on the quality of their relationship. Some of the clues identified in the qualitative phase of the study were eliminated because they represented areas of conflict for the couple. Unfortunately, this prevented the answering of a critical question: “Were those expressions of conflict a direct result of the man’s ED or a manifestation of a dysfunctional couple?” Another aspect of the study worth mentioning is the judges’ assumption that items addressing the male experience of ED were not going to be good discriminators. This preconception can be seen clearly in the results presented in Appendix I, where items referring to the female perception of male emotions or experiences were not rated highly (i.e., items 23, 36, 38), and may reflect prejudices on the part of both the study population and health-care professionals in the study. However, after the initial field test and corroboration in the English-speaking population, these items showed enough discriminatory power to be included in the final detection scale. In fact, the final scale obtained after rigorous quantitative analysis contained three items that addressed the physical signs of ED (firmness of erection, ability to complete intercourse, and ability to maintain erections), while the remaining three items enquired about the partner’s emotions (confidence in obtaining and maintaining erections, sadness or depression because of sexual performance, and satisfaction in the male partner). This supports the notion that ED is a condition affecting both members of the couple, with the female partner directly experiencing both the changes and consequences of the decline in erectile function. The limitations to this study should be acknowledged. The FAME scale was developed originally in a Spanish-speaking convenience population in Mexico, and subsequently tested in a limited convenience sample of couples from two English-speaking countries. Although the

FAME questionnaire demonstrated validity, reliability, and appropriate psychometric characteristics in Mexican Spanish-speaking couples and English-speaking couples from Canada and the United Kingdom, it is possible that the questionnaire may perform differently in other populations. Further research is needed to evaluate whether the scale remains valid and reliable in couples of different cultural and linguistic backgrounds to those of the present study. Throughout the development and testing process, convenience samples, rather than representative populations, were used. Future research should address this limitation by including more representative samples. The correlations between the FAME score and the widely used SHIM and IIEF-EF scales are robust (SHIM rho = 0.788, P < 0.001; IIEF-EF rho = 0.777, P < 0.001). However, when the mean of these correlations is squared to obtain the coefficient of determination, approximately 61% of the FAME variance is shared by the SHIM and IIEF-EF scales. What contributes to the remaining 39% is open to conjecture; it may be a result of the complexity of the perceptions involved in men with ED and their partners, or might be due to other unknown factors. Further research should clarify these subtle issues. The ED and non-ED subgroups utilized in stages IV and V were not age matched and differed in other characteristics, such as the years of relationship and years of education of the woman, suggesting another potential limitation of the study. However, a partial correlation analysis subsequently confirmed that the correlations between FAME and clinical diagnosis remain strong after this statistical control. For the future, it is desirable that age-matched subgroups be used. Conclusions

Accurate detection of ED in men by the female partner is possible. In this study, FAME (completed by the woman) compared favorably with the SHIM (completed by the man). In populations of Spanish-speaking couples in Mexico and Englishspeaking couples in Canada and the United Kingdom, the FAME scale showed very good concurrent validity, using clinical diagnosis as the gold standard. FAME also demonstrated good reliability, sensitivity, and specificity in this multinational sample of women with partners with and without ED. Further research is needed to assess the validity of this tool in other populations. J Sex Med 2009;6:2255–2270

2266 These results also illustrate that ED is an interactive condition, which is clearly identifiable by the female partner. These findings support the integration of the female partner into the process of ED diagnosis and treatment.

Rubio-Aurioles et al.

Category 3 (a) Final Approval of the Completed Manuscript Eusebio Rubio-Aurioles; Michael Sand; Nadine Terrein-Roccatti; John Dean; Jan Longworth; Ian Eardley; Gerald Brock; Jay Lee; Iván Arango de Montis; Claudia Rampazzo-Bonaldo

Acknowledgment

The authors would like to express their gratitude to Lorenzo Ruiz-Martínez, Product Manager of Men’s Health/Marketing at GSK Mexico who, at the initiation of this project, asked the lead author the critical question: “Would it be possible to detect ED by asking the female partner?” The authors are also indebted to Carlos Carreño of Bayer Mexico and to Patricia Stenger, RN, CDE who was Director, Scientific Affairs Genito-Urinary Team, Global Strategic Marketing at Bayer Healthcare at the time of this project. Corresponding Author: Eusebio Rubio-Aurioles, MD, PhD, Asociacion Mexicana para la Salud Sexual AC, Tezoquipa 26, Colonia L Joya, Tlalpan C.P. 14000 Mexico D.F. Tel: 52-55-5573-3460; Fax: 52-55-55131065; E-mail: [email protected] Conflict of Interest: Dr. Rubio-Aurioles, Dr. Dean, Dr. Lee, Dr. Eardley, Dr. Arango de Montis, and Dr. Rampazzo-Bonaldo have acted as paid consultants and clinical trial investigators for Bayer Schering. Dr. Sand was an employee of Bayer Schering at the initial time of the study. Statement of Authorship

Category 1 (a) Conception and Design Eusebio Rubio-Aurioles; Michael Sand; Nadine Terrein-Roccatti (b) Acquisition of Data Eusebio Rubio-Aurioles; Nadine Terrein-Roccatti; John Dean; Jan Longworth; Ian Eardley; Gerald Brock; Jay Lee; Iván Arango de Montis; Claudia Rampazzo-Bonaldo (c) Analysis and Interpretation of Data Eusebio Rubio-Aurioles; Michael Sand; Nadine Terrein-Roccatti; John Dean; Jan Longworth; Ian Eardley; Gerald Brock; Jay Lee; Iván Arango de Montis; Claudia Rampazzo-Bonaldo

Category 2 (a) Drafting the Manuscript Eusebio Rubio-Aurioles (b) Revising It for Intellectual Content Michael Sand; Nadine Terrein-Roccatti; John Dean; Jan Longworth; Ian Eardley; Gerald Brock; Jay Lee; Iván Arango de Montis; Claudia Rampazzo-Bonaldo J Sex Med 2009;6:2255–2270

References

1 Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The International Index of Erectile Function (IIEF): A multidimensional scale for assessment of erectile dysfunction. Urology 1997;49:822–30. 2 Rosen RC, Cappelleri JC, Gendrano N 3rd. The International Index of Erectile Function (IIEF): A state-of-the-science review. Int J Impot Res 2002; 14:226–44. 3 Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Pena BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res 1999;11:319– 26. 4 Heruti RJ, Yossef M, Shochat T. Screening for erectile dysfunction as part of periodic examination programs-concept and implementation. Int J Impot Res 2004;16:341–5. 5 Althof SE, Corty EW, Levine SB, Levine F, Burnett AL, McVary K, Stecher V, Seftel AD. EDITS: Development of questionnaires for evaluating satisfaction with treatments for erectile dysfunction. Urology 1999;53:793–9. 6 Kubin M, Trudeau E, Gondek K, Seignobos E, Fugl-Meyer AR. Early conceptual and linguistic development of a patient and partner Treatment Satisfaction Scale (TSS) for erectile dysfunction. Eur Urol 2004;46:768–74; discussion 774–5. 7 Rosen R, Goldstein I, Huang XY, Bangerter K, Taylor T. The Treatment Satisfaction Scale (TSS) is a sensitive measure of treatment effectiveness for both patients and partners: Results of a randomized controlled trial with vardenafil. J Sex Med 2007; 4:1009–21. 8 Cappelleri JC, Althof SE, Siegel RL, Shpilsky A, Bell SS, Duttagupta S. Development and validation of the Self-Esteem And Relationship (SEAR) questionnaire in erectile dysfunction. Int J Impot Res 2004;16:30–8. 9 Swindle RW, Cameron AE, Lockhart DC, Rosen RC. The Psychological and Interpersonal Relationship Scales: Assessing psychological and relationship outcomes associated with erectile dysfunction and its treatment. Arch Sex Behav 2004; 33:19–30. 10 Mulhall JP, Goldstein I, Bushmakin AG, Cappelleri JC, Hvidsten K. Validation of the erection hardness score. J Sex Med 2007;4:1626–34.

FAME Scale: Development and Validation 11 Mulhall JP, King R, Kirby M, Hvidsten K, Symonds T, Bushmakin AG, Cappelleri JC. Evaluating the sexual experience in men: Validation of the Sexual Experience Questionnaire. J Sex Med 2008;5:365– 76. 12 Abraham L, Symonds T, Morris MF. Psychometric validation of a Sexual Quality of Life Questionnaire for use in men with premature ejaculation or erectile dysfunction. J Sex Med 2008;5:595– 601. 13 Fisher WA, Rosen RC, Eardley I, Sand M, Goldstein I. Sexual experience of female partners of men with erectile dysfunction: The Female Experience of Men’s Attitudes to Life Events and Sexuality (FEMALES) study. J Sex Med 2005; 2:675–84. 14 Fisher WA, Rosen RC, Mollen M, Brock G, Karlin G, Pommerville P, Goldstein I, Bangerter K, Bandel T-J, Derogatis LR, Sand M, for the Vardenafil Study Group. Improving the sexual quality of life of couples affected by erectile dysfunction: A double-blind, randomized, placebocontrolled trial of vardenafil. J Sex Med 2005; 2:699–708. 15 Rosen RC, Fisher WA, Eardley I, Niederberger C, Nadel A, Sand M. The multinational Men’s Attitudes to Life Events and Sexuality (MALES) study: I. Prevalence of erectile dysfunction and related health concerns in the general population. Curr Med Res Opin 2004;20:607– 17. 16 Chevret M, Jaudinot E, Sullivan K, Marrel A, De Gendre AS. Impact of erectile dysfunction (ED) on sexual life of female partners: Assessment with the Index of Sexual Life (ISL) questionnaire. J Sex Marital Ther 2004;30:157–72.

2267 17 Rosen RC, Fisher WA, Eardley I, Sand M. Influence of female partners and others on continuation of PDE-5 inhibitor therapy. International Society for the Study of Women’s Sexual Health (ISSWSH) Annual Meeting 2006. Lisbon, Portugal, 2006. 18 Althof SE, Seftel AD. The evaluation and management of erectile dysfunction. Psychiatr Clin North Am 1995;18:171–92. 19 Dean J, Rubio-Aurioles E, McCabe M, Eardley I, Speakman M, Buvat J, de Tejada IS, Fisher W. Integrating partners into erectile dysfunction treatment: Improving the sexual experience for the couple. Int J Clin Pract 2008;62:127–33. 20 Kubin M, Wagner G, Fugl-Meyer AR. Epidemiology of erectile dysfunction. Int J Impot Res 2003;15:63–71. 21 Galdas PM, Cheater F, Marshall P. Men and health help-seeking behaviour: Literature review. J Adv Nurs 2005;49:616–23. 22 Guay A, Jacobson J. The relationship between testosterone levels, the metabolic syndrome (by two criteria), and insulin resistance in a population of men with organic erectile dysfunction. J Sex Med 2007;4:1046–55. 23 Kupelian V, Shabsigh R, Araujo AB, O’Donnell AB, McKinley JB. Erectile dysfunction as a predictor of the metabolic syndrome in aging men: Results from the Massachusetts Male Aging Study. J Urol 2006;176:222–6. 24 Glaser BG, Strauss AL. The discovery of grounded theory: Strategies for qualitative research. Chicago, IL: Aldine Publishing Company; 1967:271. 25 NIH Consensus Conference. Impotence. NIH consensus development panel on impotence. JAMA 1993;270:83–90.

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Appendix I

List of Items Developed after the Content Analysis of Focus Group Discussions and Judges’ Ratings (0–10) of Each Item’s Clarity and Ability to Detect Erectile Dysfunction

Item 1. During sexual intercourse, how frequently does your partner need to make an effort to obtain or maintain his erection? 2. During sexual intercourse, how difficult is it for your partner to maintain an erection until completion of sexual intercourse? 3. How difficult is it to talk with your partner about erection failures? 4. During sexual intercourse, how frequently have the medications or remedies used to improve erections failed? 5. During sexual intercourse, how frequently is your partner unable to obtain an erection? 6. How would you rate your partner’s confidence to obtain and maintain an erection? 7. During sexual intercourse, how often is your partner capable of maintaining erections after penetration? 8. How frequently does your partner tell you that he feels that he is not fulfilling his responsibilities because he has not had a good erection? 9. How frequently do you experience anger or rage because of the erectile failures of your partner? 10. How frequently does your partner’s erection make you feel less sexual satisfaction? 11. During sexual intercourse, how frequently does your partner blame you for not having a good erection? 12. How frequently does your partner show himself extremely obliging with other things, as if he is compensating for the lack of a good erection? 13. During sexual intercourse, how frequently does your partner focus on himself and his erection rather than on you or your sexual relationship? 14. During sexual intercourse, how frequently is your partner’s erection less rigid? 15. How frequently does your partner show anxiety because of his sexual performance? 16. During sexual activity, how much has the use of sexual activities other than intercourse increased? 17. How frequently does your partner deny having sexual problems? 18. During sexual intercourse, how frequently does your partner use his hand to assist with penetration? 19. How afraid is your partner that you will be unfaithful? 20. How much has the frequency of your sexual intercourse (how frequently you have sex) diminished? 21. During sexual activity, how much has the time devoted to preliminary sexual play (sexual foreplay before penetration) diminished?

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Mean clarity of item (score A)

Standard deviation clarity score

Mean ability of item to detect ED (score B)

Standard deviation ability to detect ED score

Total score: mean A + B/2

Standard deviation total score

Selected or rejected for final scale

10.00

0.00

10.00

0.00

10.00

0.0000

Selected

9.83

0.41

10.00

0.00

9.92

0.2041

Selected

10.00

0.00

9.83

0.41

9.92

0.2041

Selected

10.00

0.00

9.83

0.41

9.92

0.2041

Selected

10.00

0.00

9.83

0.41

9.92

0.2041

Selected

9.83

0.41

9.83

0.41

9.83

0.4082

Selected

9.67

0.82

10.00

0.00

9.83

0.4082

Selected

10.00

0.00

9.50

0.84

9.75

0.4183

Selected

9.50

0.84

9.83

0.41

9.67

0.6055

Selected

10.00

0.00

9.33

1.03

9.67

0.5164

Selected

9.50

1.22

9.67

0.82

9.58

0.6646

Rejected

10.00

0.00

9.17

1.17

9.58

0.5845

Selected

9.67

0.82

9.50

1.22

9.58

0.6646

Selected

9.17

1.60

9.83

0.41

9.50

1.0000

Selected

10.00

0.00

8.83

0.98

9.42

0.4916

Rejected

9.83

0.41

8.83

1.47

9.33

0.8756

Rejected

10.00

0.00

8.67

1.37

9.33

0.6831

Rejected

9.50

0.84

9.17

0.98

9.33

0.7528

Selected

10.00

0.00

8.50

1.52

9.25

0.7583

Rejected

9.83

0.41

8.50

1.76

9.17

0.9309

Selected

9.83

0.41

8.50

1.64

9.17

0.9309

Selected

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FAME Scale: Development and Validation Appendix I Continued

Item 22. When there is a chance to have sexual intercourse, how frequently do you feel rejection from your partner? 23. How frequently does your partner look sad or depressed because of his sexual performance? 24. When there is a chance to have sexual intercourse, how often does your partner avoid it? 25. During sexual intercourse, how frequently has your partner masturbated (stimulated himself with the hand) to achieve an erection? 26. When there is a chance to have sexual activity, how frequently do you experience sexual desire or wish to have sexual intercourse with your partner? 27. How afraid are you that your partner will be unfaithful due to his erection problems? 28. How frequently have you noticed that your partner’s penis looks smaller than it was? 29. How frequently do you worry about the physical health of your partner? 30. During sexual intercourse, how much does your partner’s ability to have an erection vary? 31. During sexual intercourse, how frequently are caresses and foreplay before penetration less exciting for you than before? 32. During sexual intercourse, how frequently does your partner seek assurances that he is a complete man? 33. How frequently have you noticed that your partner ejaculates in lower quantities or with less strength? 34. When there is a chance to have sexual intercourse, how often do you feel your partner becomes aggressive? 35. How much has the variety of things you do when you have sexual intercourse with your partner diminished? 36. When your partner has erections during sexual stimulation, how frequently are they firm enough for penetration? 37. During sexual intercourse, how would you rate the variety of sexual positions that you and your partner have? 38. When you and your partner have sexual intercourse, how often is this satisfactory for him? 39. How frequently is sexual intercourse much more rapid than it used to be? 40. How frequently does your partner show anger because of his sexual performance? 41. How frequently do you experience physical discomfort during sexual intercourse? 42. During sexual intercourse, how frequently do you notice that your partner sweats more than before?

Standard deviation clarity score

Mean ability of item to detect ED (score B)

Standard deviation ability to detect ED score

Total score: mean A + B/2

Standard deviation total score

Selected or rejected for final scale

9.67

0.82

8.67

1.03

9.17

0.7528

Rejected

9.83

0.41

8.33

1.21

9.08

0.6646

Selected

10.00

0.00

8.17

1.94

9.08

0.9704

Rejected

9.33

1.63

8.67

0.82

9.00

0.8367

Rejected

9.83

0.41

8.17

1.72

9.00

0.9487

Selected

10.00

0.00

7.83

1.33

8.92

0.6646

Rejected

9.50

1.22

8.17

1.47

8.83

0.8165

Selected

10.00

0.00

7.50

2.26

8.75

1.1292

Rejected

8.83

1.47

8.67

1.63

8.75

1.5083

Rejected

9.83

0.41

7.67

2.07

8.75

1.1726

Selected

8.83

1.47

8.50

1.38

8.67

1.2517

Rejected

9.33

1.63

8.00

2.19

8.67

1.3663

Rejected

9.67

0.82

7.67

1.37

8.67

0.8756

Rejected

9.50

0.84

7.83

1.72

8.67

1.1690

Rejected

7.67

3.39

9.67

0.82

8.67

2.0897

Selected

9.50

1.22

7.67

1.86

8.58

1.4289

Rejected

8.50

2.51

8.50

1.97

8.50

1.7321

Selected

9.50

0.84

7.00

3.74

8.25

2.1852

Selected

8.17

2.86

8.17

1.60

8.17

2.0166

Rejected

10.00

0.00

4.83

3.43

7.42

1.7151

Rejected

8.67

2.42

5.50

3.62

7.08

2.8181

Rejected

Mean clarity of item (score A)

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Appendix II

Fame Questionnaire The following questions refer to the past 6 months. Please check the appropriate box and select ONLY ONE option 1. When your partner had erections during sexual stimulation, how often were erections firm enough for penetration? • Almost never/never • A few times (much less than half the time) • Sometimes (about half the time) • Most times (much more than half the time) • Almost always/always 2. During sexual intercourse, how often was your partner capable of maintaining erections after penetration? • Almost never/never • A few times (much less than half the time) • Sometimes (about half the time) • Most times (much more than half the time) • Almost always/always 3. During sexual intercourse, how difficult was it for your partner to maintain an erection until completion of sexual intercourse? • Extremely difficult • Very difficult • Difficult • Slightly difficult • Not difficult 4. How would you rate your partner’s confidence to obtain and maintain an erection? • Very low • Low • Moderate • High • Very high 5. How often does your partner look sad or depressed because of his sexual performance? • Almost never/never • A few times (much less than half the time) • Sometimes (about half the time) • Most times (much more than half the time) • Almost always/always 6. When you and your partner had sexual intercourse, how often was this satisfactory for him? • Almost never/never • A few times (much less than half the time) • Sometimes (about half the time) • Most times (much more than half the time) • Almost always/always Scoring instructions for the scale: rate each answer 1, 2, 3, 4 or 5 depending on the selected option: 1 for the first category and 5 for the last one, except for question 5 which should be rated in the reverse order: 5 for the first category and 1 for the last one. ADD UP all the items. If the total score is 24 or less, the partner to whom the responses refer might have erectile dysfunction. A consultation with a health professional experienced in erectile dysfunction is recommended who will suggest appropriate treatment.

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