Development and Validation of the Polish Version of the Female Sexual Function Index in the Polish Population of Femalesjsm_

1 Development and Validation of the Polish Version of the Female Sexual Function Index in the Polish Population of Femalesjsm_12012 1..10 Krzysztof Nowosielski, MD, PhD,* Beata Wróbel, MD, PhD, Urszula Sioma-Markowska, MSc, PhD, and Ryszard Poręba, MD* *Department of Gynecology and Obstetrics, Specialist Teaching Hospital in Tychy, Tychy, Poland; Department of Health Science, Medical Collage in Sosnowiec, Sosnowiec, Poland; Center for Sexual Medicine, Da browa Górnicza, Poland; Department of Gynecology and Obstetrics, The School of Health Care, Medical University of Silesia, Katowice, Tychy, Poland DOI: 10.1111/jsm.12012 ABSTRACT Introduction. Unlike male sexual function, which is relatively easy to assess, female sexual function is still a diagnostic challenge. Although numerous new measurements for female sexual dysfunction (FSD) have recently been developed, the Female Sexual Function Index (FSFI) remains the gold standard for screening. It has been validated in more than 30 countries. The FSFI has been used in several studies conducted in Poland, but it has never been standardized for Polish women. Aim. The aim of this study was to develop a Polish version of the FSFI (PL-FSFI). Materials and Methods. In total, 189 women aged 18 55 years were included in the study. Eighty-five were diagnosed with FSD as per the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM IV-TR) criteria; 104 women did not have FSD. All subjects completed the PL-FSFI at baseline (day 0), day 7, and day 28. Main Outcome Measures. Test retest reliability was determined by Pearson s product moment correlations. Reliability was tested using Cronbach s a coefficient. Construct validity was evaluated by principal component analysis using varimax rotation and factor analysis. Discriminant validity was assessed with between-groups analysis of variance. Results. All domains of the PL-FSFI demonstrated satisfactory internal consistencies, with Cronbach s a value of >0.70 for the entire sample. The test retest reliability demonstrated good-to-excellent agreement between the assessment points. Based on principal component analysis, a 5-factor model was established that explained 83.62% of the total variance. Domain intercorrelations of the PL-FSFI ranged from 0.37 0.77. The optimal PL-FSFI cutoff score was 27.50, with 87.1% sensitivity and 83.1% specificity. Conclusion. The PL-FSFI is a reliable questionnaire with good psychometric and discriminative validity. Therefore, it can be used as a tool for preliminary screening for FSD among Polish women. Nowosielski K, Wróbel B, Sioma-Markowska U, and Poręba R. Development and validation of the Polish version of the Female Sexual Function Index in the Polish Population of Females.. Key Words. Female Sexual Function Index; Polish Version; Validation; Development Introduction Female sexuality is a complex and multidimensional phenomenon. Many factors, including culture, social context, age, mental health, and interpersonal relations, may influence the sexual function of women. Thus, the prevalence of female sexual dysfunction (FSD) varies worldwide between 8 75% [1 6]. The few studies on FSD in Poland have shown that FSD may affect up to 17% of healthy women and up to 42% of the women with diabetes mellitus [7 9]. Unlike male sexual function, which is relatively easy to assess, female sexual function is still a diagnostic challenge [10,11]. The current concept of women s sexual function emphasizes the responsive 2012 International Society for Sexual Medicine

2 Nowosielski et al. component of women s sexuality. Based on the circular model of the sexual response research confirmed that women provide a variety of reasons and incentives for engaging in sexual activity [11]. Thus, many components associated with sexuality, which are integral to a sexual response, must be assessed when counseling women with sexual problems [11]. As observed in other countries, a number of sexual problems are highly prevalent in Poland. However, sexual health here is still unmentionable, and few women seek medical help for FSD. Although numerous new measurements for FSD have recently been developed, the Female Sexual Function Index (FSFI) remains the gold standard for screening [10]. It has been translated and validated in more than 30 countries and is used to assess FSD in women with different medical conditions, including vulvodynia, vulvar intraepithelial neoplasia, hemodialysis, diabetes, breast cancer, obesity, urinary incontinence, depression, and human immunodeficiency virus infection [11 19]. The most recent studies from Japan, Korea, Iran, Taiwan, Malaysia, China, United Kingdom, or the Netherlands have proved its reliability and psychometric validity in the assessment of dimensions of female sexual functioning in clinical and nonclinical samples [12,15 20]. Moreover, the applicability of the FSFI has been confirmed for women in various stages of life, such as pregnancy, postpartum, postmenopausal periods [21,22]. The FSFI has been used in a few studies conducted in Poland [7 9,23 25], but it has never been validated or standardized for Polish women. Such a validation would help medical professionals screen women for FSD and refer selected individuals for further counseling. Aim The aim of this study was to develop a Polish version of the FSFI (PL-FSFI) and to examine its psychometric reliability and validity. Main Outcome Measures Internal consistencies in the PL-FSFI were evaluated by Cronbach s a coefficient. Intraclass correlation coefficient was used to assess the test retest reliability. Principal component analysis using varimax rotation was used to evaluate the factor structure and construct validity. Discriminant validity was assessed with a between-groups analysis of variances (anova). The degree of association between the PL-FSFI scores and marital satisfaction (assessed on a 5-point Likert scale) was calculated by the Pearson product moment correlation. A receiver operating characteristic analysis was performed to determine the optimal cutoff values of the PL-FSFI. Methods Study Population A total of 300 women between the ages of 18 55 years were eligible for this cross-sectional study conducted between June 2011 and February 2012; 150 women had sexual problems and 150 did not. The healthy women were recruited from three gynecological offices in Dąbrowa Górnicza, Sosnowiec, and Tychy in Poland when they visited the offices for a yearly routine gynecological check-up. The women with sexual problems were recruited from the Center for Sexual Medicine in Dąbrowa Górnicza, Poland. Thirty-five women with sexual problems and 20 healthy women declined to participate in the study, with refusal rates of 23% and 13%, respectively. During the screening phase of the study, the authors conducted the medical interviews. The following exclusion criteria were used: history of depression or other mental disorders, severe somatic diseases, thyroid dysfunction, diabetes mellitus, liver dysfunctions, unstable coronary heart disease, extreme kidney failure, addiction to psychoactive substances, consumption of >150 ml of alcohol daily, body mass index >30 kg/m 2, history of major gynecological operations (hysterectomy, oophorectomy, or mastectomy), use of medications affecting sexual function (antipsychotics, antihypertensives, antidepressants, antihistamines, benzodiazepines, or oral contraceptives), pregnancy or within 3 months postpartum, and no sexual initiation. The Beck Depression Inventory (BDI) was used as a screening tool for the presence of depressive symptoms. All patients who scored 12 in the BDI were excluded from the study, as depressive symptoms may influence sexual function in female patients [26]. Finally, 189 women were included in the study 85 women diagnosed with FSD on the basis of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM IV-TR) [8] criteria and 104 healthy women. The clinical study was approved by the Bioethical Committee of the Medical University of Silesia. Study Design Recruitment During the screening phase of the study, all women who agreed to participate were explained

Development of the Polish Version of the FSFI 3 the project in brief, then they read and signed an informed consent form. A standard medical evaluation form was used to assess participants for the project, and the DSM IV-TR criteria [27] were used for diagnosing FSD. Of the 115 women seen at the Center for Sexual Medicine, 85 met the inclusion criteria for the study and the DSM IV-TR criteria for FSD; these women were included in the FSD group. Of the 130 healthy women, 24 did not pass the inclusion or exclusion criteria, and 2 were diagnosed with FSD based on DSM-IV-TR criteria. The control group comprised 104 healthy women. Linguistic Validation The Polish translation of the original FSFI was obtained from the Mapi Research Trust and is available at: http://www.proqolid.org/instruments/ female_sexual_function_index_fsfi. To test for clarity, intelligibility, and appropriateness of the PL-FSFI, the questionnaire was administered to a group of 25 female students. A face-to-face interview was conducted with these women to check for any difficulties in understanding and interpreting the individual questions; no major difficulties were noted. Subsequently, the PL-FSFI was administered to all 189 individuals participating in the study. Validation of the PL-FSFI On the first day (day 0) all participants were asked to fill out a 139-item self-prepared questionnaire assessing socioepidemiological parameters and sexual behavior including: age at first sexual intercourse, total number of sexual partners, whether having a regular partner, whether sexually active during the previous 4 weeks, sexual orientation, frequency of sexual intercourse, frequency of masturbation, marital satisfaction, and overall satisfaction with sex life assessed on 5-point Likert scale (where a higher score represented a better satisfaction), incidents of sexual harassment in the past (answer yes or no). The PL-FSFI was completed with a 30-day recall at the baseline (day 0), and then again on day 7 and day 28, but with a 7-day recall on these occasions. Measurements FSFI The FSFI is a self-administered questionnaire consisting of 19 items grouped in 6 subscales: sexual desire (2 items), arousal (4 items), lubrication (4 items), orgasm (3 items), satisfaction (3 items), and pain (3 items). The questionnaire was developed by Rosen et al. to assess sexual function in women over the prior 4 weeks [11]. The subscale scores ranged from 0 6, with higher scores indicating better sexual function. The questionnaire showed a high degree of internal consistency (Cronbach s a values 0.82) and high test retest reliability for each domain (r = 0.79 0.86). It has been successfully cross-validated, and a diagnostic cutoff score of 26.55 has been determined for classification of total FSD [5,28]. However, according to DSM-IV-TR and the American Urology Association Foundation (AUAF; formerly the American Foundation of Urologic Disease) both an FSFI score 26.55 points and the presence of personal distress are required for FSD diagnosis [10]. Demographic and Sexual Activity Measurements Body mass index (kg/m 2 ) was calculated as body mass/height 2. Waist-to-hip ratio (WHR) was calculated as the ratio of the circumference of the waist to the circumference of the hips. Sexual activity was defined as any of the following: caressing, foreplay, masturbation, vaginal or anal intercourse, or oral sex. The marital satisfaction and overall satisfaction with sex life was evaluated on a 5-point Likert scale. Statistical Analysis The Statistica 9.0 Pl computer software (StatSoft, Kraków, Poland) was used for statistical analysis. The distribution of data was assessed with the Shapiro-Wilk W-test. Because of the non-normal distribution of the sample population and the lack of variance homogeneity, the nonparametric Mann-Whitney U-test was used for analysis of quantitative variables. The chi-square test, chisquare test with Yates correction, and Fisher s exact test (for sample sizes less 20) were used for analyzing qualitative variables. Although a number of possible sample-based criteria could be used to establish a PL-FSFI cutoff score, we used the score that minimized the sum of false-positive and false-negative error rates. This is an independent and more objective criterion for determining the optimal cutoff values based on a receiver operating characteristic (ROC) analysis. The area under the curve (AUC) was also calculated. P values less than 0.05 were considered statistically significant. Reliability Reliability was assessed by internal consistencies and the test retest reliability. Internal consistencies were evaluated by Cronbach s a coefficient.

4 Nowosielski et al. An a coefficient of 0.70 was considered to indicate adequate to excellent reliability [12]. The intraclass correlation coefficient (ICC) was used to assess the test retest reliability, with ICC values of 0.40 representing poor to fair agreement, 0.41 0.60 representing moderate agreement, 0.61 0.80 representing good agreement, and >0.80 representing excellent agreement between the two assessments [12]. Validity To evaluate the factor structure and construct validity of the PL-FSFI, principal component analysis using varimax rotation was conducted for all 19 questionnaire items. The data from the entire sample group (N = 189) at day 0 were analyzed. Intercorrelations between the total and individual domain scores were calculated using Pearson s r coefficient. Discriminant validity was assessed by comparing the mean scores of the FSD group and control group in a between-groups anova. To measure concurrent validity, correlations between PL-FSFI total score and overall sexual satisfaction assessed on 5-point Likert scale were calculated using Pearson s r. Divergent Validity The degree of association between the PL-FSFI scores (domains and full scale) and marital satisfaction assessed on 5-point Likert scale were calculated by the Pearson product-moment correlation. Results The mean age of the studied population was 39.20 6.78 years. The FSD and control groups did not differ significantly in regard with any socioeconomic parameters except: (i) the marital satisfaction, which was better among the control group than that among the FSD group (4.33 vs. 3.57, respectively); (ii) the overall sexual satisfaction with a current partner, which was better among the control group than that among the FSD group (3.69 vs. 2.63, respectively); and (iii) residency FSD group women were more likely than control group women to live in urban areas (62.7% vs. 44.9%) (Table 1). The evaluation of sexual function by the PL- FSFI revealed that the mean total score in the FSD group was 21.59, while it was 27.95 in the control group. The largest differences between the groups were observed in the satisfaction domain and the smallest, in the desire domain (Table 2). In the FSD group, based on DSM-IV-TR criteria, the prevalence of desire, arousal, orgasm, and pain disorders were 76.5% (65/85), 56.5% (48/85), 56.5% (48/85), and 24.7% (21/85), respectively. Forty-two women were found to have only one dysfunction (49.4%). The rest reported at least two; combined arousal and desire disorder was the most prevalent at 60.5% (26/43). Reliability All domains of the PL-FSFI demonstrated satisfactory internal consistencies (Table 3), with a value of >0.70 for all subjects (FSD patients and the controls). The test retest reliability was examined in all 189 women, in FSD group and controls after 7 and 28 days (Table 4). All domains demonstrated good-to-excellent agreement between the questions. However, the test retest reliability of the total score between days 0 and 7 had higher ICC than between days 7 and 28 or days 0 and 28 for all groups. Validity All authors of this study agreed that the PL-FSFI had adequate content to evaluate female sexual function and that it could be used for assessing Polish women. To evaluate the factor structure of the PL-FSFI, principal component analysis using varimax rotation was performed. Based on this analysis, a 5-factor model was established with desire/ arousal, lubrication, orgasm, satisfaction, and pain domains (Table 5). This model explained 83.62% of the total variance of the PL-FSFI items. All items clustered in a predicted fashion and had relatively high factor loadings, supporting the factoral validity of the PL-FSFI. Domain intercorrelations of the PL-FSFI were significantly high, ranging from 0.37 0.77 (Table 6). The highest positive correlation was observed between the desire and arousal domains (r = 0.77), which is consistent with the factor analysis results described in the previous section. The discriminant validity of the PL-FSFI was calculated using the between-groups anova analysis. It revealed significant differences in mean scores for all domains as well as in the total scores (Table 7). Thus, the PL-FSFI demonstrated good discriminant validity. The concurrent validity of the PL-FSFI as measured by the Pearson s correlation coefficient between the overall sexual satisfaction assessed on 5-point Likert scale and the PL-FSFI was significant for all domains, ranging from r = 0.27 to 0.72 (Table 7).

Development of the Polish Version of the FSFI 5 Table 1 The general characteristic of the study population Variable FSD (N = 85) No FSD (N = 104) Total (N = 189) P * (FSD vs. no FSD) Age years (mean, SD, range) 38.14 7.39 50.06 6.17 39.20 6.78 0.10 (22.31 51.91) (26.62 51.34) (22.32 51.91) BMI (kg/m 2 ) 23.60 4.48 24.85 3.83 24.29 4.17 0.06 WHR 0.79 0.06 0.80 0.08 0.80 0.07 0.71 Age of the first intercourse years (mean, SD) 20.15 2.89 19.51 2.23 19.80 2.56 0.24 Nr of lifetime sexual partners (median, upper/lower quartile) 2.0 (1.0 3.0) 1.0 (1.0 3.0) 2.0 (1.0 3.0) 0.28 Marital satisfaction (5-point Likert scale) (mean, SD) 3.41 0.73 4.713 0.41 3.73 0.82 0.00001 Overall sexual satisfaction with a current partner (5-point 2.63 0.96 3.69 0.95 3.21 1.09 0.00001 Likert scale) (mean, SD) Duration of marriage/relationship years (mean, SD) 14.28 8.00 17.27 7.40 15.96 7.79 0.07 Education (N, %) Primary 2 (2.38) 2 (1.92) 4 (2.13) 0.30 Secondary 57 (67.86) 80 (76.92) 137 (72.87) Tertiary 25 (29.75) 22 (21.15) 47 (25.00) Regular participation in religious practices Yes 50 (47.62) 54 (51.92) 104 (55.32) 0.66 No 44 (52.38) 50 (48.08) 84 (44.68) Marital state N (%) Married/Partnership 74 (87.06) 95 (92.23) 168 (89.37) 0.36 Single 11 (12.94) 8 (7.77) 20 (10.63) Residency (N, %) Rural 28 (37.33) 54 (55.10) 82 (47.40) 0.02 City (urban area) 47 (62.67) 44 (44.90) 91 (52.60) Monthly incomes per one family member (N, %) Unemployed 3 (3.57) 3 (2.94) 6 (3.23) 0.33 Up to 400 50 (59.52) 71 (69.61) 121 (65.05) Up to 1,200 30 (35.71) 25 (24.51) 55 (29.57) Over 1,200 1 (1.19) 3 (2.94) 4 (2.15) Having a regular sexual partner (N, %) Yes 80 (94.12) 102 (98.08) 182 (96.30) 0.14 No 5 (5.88) 2 (1.92) 7 (3.70) Having children Yes 66 (98.51) 89 (94.68) 155 (96.27) 0.32 No 1 (1.49) 5 (5.32) 6 (3.73) Sexually active during last 4 weeks (N, %) Yes 73 (86.90) 97 (93.27) 170 (90.43) 0.11 No 11 (13.10) 7 (6.73) 18 (9.57) Menstrual status (N, %) Regular 72 (84.71) 95 (91.35) 167 (88.36) 0.36 Irregular 9 (10.59) 6 (5.77) 15 (7.94) Postmenopausal 4 (4.71) 3 (2.88) 7 (3.70) *ch2 test/fisher s exact test for the qualitative variables; Mann-Whitney U-test for the quantitative variables Sexual activity defined as any of the following: caressing, foreplay, masturbation and vaginal intercourse FSD = female sexual dysfunction; BMI = Body Mass Index; WHR = waist-to-hip ratio; SD = standard deviation The degree of association between the PL-FSFI scores and marital satisfaction assessed on 5-point Likert scale was calculated by Pearson product moment correlation (Table 8). These correlations were performed on the sample of 168 individuals who were in stable relationships, 74 of whom were in the FSD group and 95 of whom were controls. The analysis demonstrated that the correlations Table 2 The general characteristic of the studied population sexual health Domain Full sample FSD No FSD (N = 189) (N = 85) (N = 104) Mean, SD Mean, SD Mean, SD Desire 3.39 1.16 2.76 0.97 3.92 1.04 1.16 Arousal 4.04 1.36 3.17 1.28 4.75 0.95 1.52 Lubrication 4.87 1.39 4.20 1.59 5.47 0.88 1.27 Orgasm 4.34 1.52 3.39 1.49 5.12 1.02 1.73 Satisfaction 4.67 1.34 3.61 1.24 5.53 0.61 1.92 Pain 5.10 1.52 4.26 1.83 5.79 0.66 1.53 Full score 26.62 6.73 21.59 6.58 27.95 2.12 6.36 Mean difference between FSD and No FSD

6 Nowosielski et al. Table 3 Internal consistency (Cronbach s alpha) of the Polish version of the Female Sexual Function Index (PL-FSFI) Domain Internal consistency (Cronbach s alpha) Full sample (N = 189) FSD (N = 85) No FSD (N = 104) Desire (Items 1 2) 0.88 0.87 0.82 Arousal (Items 3 6) 0.92 0.90 0.87 Lubrication (Items 7 10) 0.92 0.92 0.86 Orgasm (Items 11 13) 0.88 0.84 0.82 Satisfaction (Items 15 16) 0.91 0.85 0.71 Pain (Items 17 19) 0.96 0.95 0.90 Total (Items 1 19) 0.96 0.95 0.87 Table 4 Test retest reliability (intraclass correlation coefficient [ICC]) of the Polish version of the Female Sexual Function Index (PL-FSFI) Domain Day 0 7 Day 0 28 Day 7 28 Intraclass Correlation Coefficients for full sample Desire (Items 1 2) 0.83 0.80 0.85 Arousal (Items 3 6) 0.89 0.86 0.86 Lubrication (Items 7 10) 0.85 0.80 0.80 Orgasm (Items 11 13) 0.88 0.81 0.85 Satisfaction (Items 15 16) 0.87 0.78 0.81 Pain (Items 17 19) 0.80 0.73 0.81 Total (Items 1 19) 0.83 0.75 0.82 Intraclass Correlation Coefficients for FSD Desire (Items 1 2) 0.71 0.72 0.73 Arousal (Items 3 6) 0.74 0.65 0.74 Lubrication (Items 7 10) 0.78 0.74 0.80 Orgasm (Items 11 13) 0.72 0.70 0.70 Satisfaction (Items 15 16) 0.81 0.63 0.77 Pain (Items 17 19) 0.72 0.70 0.75 Total (Items 1 19) 0.69 0.67 0.67 Intraclass Correlation Coefficients for no FSD Desire (Items 1 2) 0.85 0.86 0.76 Arousal (Items 3 6) 0.93 0.87 0.72 Lubrication (Items 7 10) 0.95 0.88 0.74 Orgasm (Items 11 13) 0.94 0.85 0.66 Satisfaction (Items 15 16) 0.94 0.90 0.75 Pain (Items 17 19) 0.96 0.89 0.71 Total (Items 1 19) 0.93 0.77 0.73 were statistically significant, though generally modest in magnitude (low-moderate to very-lowmoderate). In both groups, the strongest overlap with marital satisfaction was observed for the satisfaction domain of the PL-FSFI. ROC analysis of the PL-FSFI total score showed that the AUC was 0.93 (CI: 0.89 0.97) on day 0 (Figure 1). The optimal PL-FSFI cutoff score was found to be 27.50, yielding a 87.1% sensitivity, a 83.1% specificity, and a positive predictive value (PPV) of 86.3%. The suggested cutoff scores for individual domains are presented in Table 9. Discussion This study illustrated that the PL-FSFI has sufficient reliability and validity for use in screening for sexual problems in Polish women. To the authors knowledge, this study is the first to evaluate the psychometric validity of PL-FSFI in a population of Polish women. It should be emphasized that owing to the personal nature of the questionnaire, the present study was difficult to perform. In Poland, similar to other conservative countries like Iran, Taiwan, Malaysia, and Japan, sexuality is rarely a subject of scientific debate [12,15 17]. Most people consider sexual topics to be extremely private and are not willing to discuss them, neither with general practitioners nor with sexual health care professionals. Because studies on sexual function in Polish individuals are lacking, the authors research is of great importance, shedding new light on the sexual issues of Polish women [29,30]. The PL-FSFI showed only modest correlations with a measure of marital satisfaction that was Table 5 Principal component analysis with varimax rotation of the Polish version of the Female Sexual Function Index Factors Items F1 F2 F3 F4 F5 Desire: frequency 0.84* 0.12 0.24 0.03 0.09 Desire: level 0.85* 0.10 0.22 0.04 0.20 Arousal: frequency 0.67* 0.14 0.23 0.36 0.23 Arousal: level 0.71* 0.23 0.24 0.26 0.36 Arousal: confidence 0.64* 0.34 0.20 0.26 0.38 Arousal: satisfaction 0.64* 0.22 0.31 0.37 0.32 Lubrication: frequency 0.39 0.30 0.15 0.35 0.62* Lubrication: difficulty 0.26 0.30 0.12 0.20 0.82* Lubrication: frequency of 0.41 0.29 0.16 0.33 0.59* maintaining Lubrication: difficulty in 0.24 0.36 0.25 0.12 0.78* maintaining Orgasm: frequency 0.23 0.22 0.22 0.83* 0.26 Orgasm: difficulty 0.16 0.37 0.37 0.51* 0.45 Orgasm: satisfaction 0.34 0.18 0.50 0.51* 0.38 Satisfaction: with amount of 0.34 0.35 0.61* 0.21 0.36 closeness with partner Satisfaction: with sexual 0.29 0.28 0.81* 0.15 0.10 relationship Satisfaction: with overall 0.37 0.14 0.81* 0.19 0.15 sex life Pain: frequency during 0.20 0.83* 0.22 0.15 0.29 vaginal penetration Pain: frequency following 0.19 0.89* 0.15 0.13 0.24 vaginal penetration Pain: level during or 0.14 0.85* 0.24 0.19 0.27 following vaginal penetration Eigenvalue 11.69 1.72 1.05 0.90 0.51 % of explained variance 61.57 9.07 5.53 4.75 2.71 The highest factor loading in each principal component is shown with asterisk and shadings. F1 = desire/arousal; F2 = pain; F3 = satisfaction; F4 = orgasm; F5 = lubrication

Development of the Polish Version of the FSFI 7 Table 6 Domain intercorrelation (Pearson s r) Full sample Desire Arousal Lubrication Orgasm Satisfaction Pain Desire 1.00 Arousal 0.77* 1.00 Lubrication 0.51* 0.75* 1.00 Orgasm 0.48* 0.71* 0.74* 1.00 Satisfaction 0.59* 0.75* 0.65* 0.73* 1.,00 Pain 0.37* 0.59* 0.70* 0.62* 0.61* 1.00 No FSD Desire 1.00 Arousal 0.56* 1.00 Lubrication 0.29* 0.48* 1.00 Orgasm 0.24* 0.42* 0.52* 1.00 Satisfaction 0.35* 0.52* 0.33* 0.32* 1.00 Pain 0.21 0.10 0.29* 0.23* 0.11 1.00 FSD Desire 1.00 Arousal 0.75* 1.00 Lubrication 0.47* 0.71* 1.00 Orgasm 0.31* 0.63* 0.71* 1.00 Satisfaction 0.46* 0.62* 0.56* 0.65* 1.00 Pain 0.024* 0.49* 0.67* 0.52* 0.43* 1.00 *P < 0.05 assessed by a single question. Divergence of the PL-FSFI from the marital satisfaction scores was greater for the FSD group than for the control group, for whom a moderately high correlation was noted between marital satisfaction and the global sexual satisfaction domain. Thus, for women with FSD, PL-FSFI scores seem to be independent of the influence of marital satisfaction and adjustment. Similar results were presented in the original validation of the FSFI [11]. Similarly to papers by Takahashi et al. and Fakhri et al. [12,17], the results of the authors research showed the strong correlations between the PL-FSFI domain scores and the overall sexual Table 7 PL-FSFI Discriminant validity FSD (N = 85) No FSD(N = 104) Items and domains Mean, SD Mean, SD P * Desire 2.76 0.97 3.92 1.04 <0.0001 1. Desire: frequency 2.20 0.85 3.25 1.07 2. Desire: level 2.40 0.87 3.29 0.80 Arousal 3.17 1.28 4.75 0.95 <0.0001 3. Arousal: frequency 2.75 1.23 4.12 1.11 4. Arousal: level 2.67 1.05 3.72 0.85 5. Arousal: confidence 2.60 1.13 3.82 0.77 6. Arousal: satisfaction 2.56 1.43 4.12 0.96 Lubrication 4.20 1.59 5.47 0.88 <0.0001 7. Lubrication: frequency 3.36 1.56 4.50 0.91 8. Lubrication: difficulty 3.67 1.41 4.55 0.75 9. Lubrication: frequency of maintaining 3.27 1.59 4.47 1.03 10. Lubrication: difficulty in maintaining 3.70 1.38 4.58 0.73 Orgasm 3.39 1.49 5.12 1.02 <0.0001 11. Orgasm: frequency 2.69 1.51 4.18 1.18 12. Orgasm: difficulty 3.15 1.40 4.38 0.77 13. Orgasm: satisfaction 2.65 1.35 4.27 0.98 Satisfaction 3.61 1.24 5.53 0.61 <0.0001 14. Satisfaction: with amount of closeness with partner 3.09 1.37 4.63 0.80 15. Satisfaction: with sexual relationship 3.09 1.05 4.62 0.61 16. Satisfaction: with overall sex life 2.81 1.13 4.52 0.68 Pain 4.26 1.83 5.79 0.66 <0.0001 17. Pain: frequency during vaginal penetration 3.53 1.62 4.86 0.57 18. Pain: frequency following vaginal penetration 3.68 1.65 4.86 0.57 19. Pain: level during or following vaginal penetration 2.44 1.52 4.74 0.65 Full score 21.59 6.58 27.95 2.12 <0.0001 *P values for domain scores and full score were assessed by using between-group analysis of variances.

8 Nowosielski et al. Table 8 PL-FSFI domain characteristics: divergent and concurrent validity Full sample FSD No FSD Domain Pearson r P value Pearson r P value Pearson r P value Divergent validity with marital satisfaction Desire 0.39 0.0001 0.35 0.001 0.13 0.19 Arousal 0.41 0.0001 0.34 0.002 0.04 0.69 Lubrication 0.32 0.0001 0.24 0.03 0.02 0.84 Orgasm 0.37 0.0001 0.27 0.01 0.03 0.75 Satisfaction 0.51 0.0001 0.41 0.001 0.22 0.02 Pain 0.27 0.0001 0.10 0.43 0.01 0.95 Full scale 0.45 0.0001 0.33 0.002 0.11 0.29 Concurrent validity with overall sexual satisfaction Desire 0.39 0.0001 0.35 0.01 0.16 0.16 Arousal 0.41 0.0001 0.34 0.001 0.22 0.06 Lubrication 0.32 0.0001 0.24 0.01 0.29 0.009 Orgasm 0.37 0.0001 0.27 0.02 0.33 0.02 Satisfaction 0.72 0.0001 0.51 0.01 0.49 0.01 Pain 0.27 0.0001 0.26 0.01 0.26 0.25 Full scale 0.45 0.0001 0.09 0.21 0.37 0.001 Table 9 Suggested cutoff scores for individual domains of the Polish version of Female Sexual Function Index Domain Cutoff Sensitivity (%) Specificity (%) PPV (%) AUC Desire 3.6 75.8 68.4 74.0 0.79 (0.73 0.85) Arousal 3.9 86.5 67.1 76.3 0.85 (0.79 0.90) Lubrication 5.1 80.8 63.5 75.8 0.76 (0.69 0.83) Orgasm 3.6 95.1 64.7 71.8 0.85 (0.79 0.92) Satisfaction 4.4 97.1 65.5 75.2 0.93 (0.89 0.96) Pain 5.6 89.4 64.3 75.6 0.82 (0.76 0.88) satisfaction assessed on 5-point Likert scale indicating a sufficient concurrent validity of the PL-FSFI. The results demonstrated satisfactory internal consistencies of the PL-FSFI for all domains, with all Cronbach s a values over the threshold of 0.70, which is considered to be adequate-to-excellent reliability. The test retest reliability showed goodto-excellent ICC values, with the highest value between days 0 and 7 with a 30-day recall period. Similar results have been presented in recent studies on the FSFI validation in other countries [15 18] and in the original validation of the FSFI [11]. The strongest correlation value in the study sample was seen between the desire and arousal domains, consistent with the factor analysis results. Similar correlations were shown in the validation of the Malayan version of the FSFI and in the original validation of the FSFI for women with arousal disorders [10,16]. In contrast, Takahasi et al. in Japan and Fakhri et al. in Iran showed that in those countries the strongest correlations were between the lubrication and desire domains [12,17]. The PL-FSFI demonstrated the ability to discriminate between FSD subjects and healthy subjects. This indicates the satisfactory discriminant validity of the questionnaire, consistent with those of other publications [10,15 18]. The analysis of construct validity enabled the authors to establish a 5-factor model that incor- Sensitivity 1,0 0,8 0,6 0,4 0,2 0,0 0,0 0,2 0,4 0,6 0,8 1,0 1-Specificity Figure 1 ROC curve for total score of the PL-FSFI. PL-FSFI = Polish version of the Female Sexual Function Index; ROC = receiver operating characteristic

Development of the Polish Version of the FSFI 9 porates desire/arousal, lubrication, orgasm, satisfaction, and pain domains. The model explained 83.62% of the total variance in the PL-FSFI items. The described model is not in accordance with the clinical classification of FSD, which includes desire, arousal, lubrication, orgasm, pain, and satisfaction. However, the results do support the original 5-factor model proposed by Rosen et al. in their initial validation study [10]. A literature review reveals inconsistencies regarding models of factorial FSFI. Two recent validation studies conducted in Japan and the United Kingdom proposed best-fitting 5-factor models for the FSFI [17,31], whereas a Chinese study proposed a 6-factor model [18] and a Taiwanese study proposed a 3-factor model [15]. The nature of these discrepancies remains unknown. A possible explanation may be the influence of cultural differences in the perception of desire or arousal problems. Further studies are needed to investigate this issue. Based on the AUC analysis, the authors established a cutoff score for the PL-FSFI (27.50) that has a sensitivity of 87.1%, a specificity of 83.1%, and a PPV of 86.3%. Previous studies have suggested different cutoff values. Wiegel et al. [8] proposed a total score of 26.55 to differentiate between FSD and healthy women. Safarinejad et al. suggested that scores <65% of the maximum achievable scores in each domain (scores below 3.9) and full-scale scores (scores below 23.4) were indicative of FSD [7], whereas the cutoff proposed in an Iranian study was 24.75. In the authors opinion, these differences might be caused by a low level of knowledge regarding sexual function as well as the mentality of Polish women. Because sexual knowledge in Poland is poor, many women do not consider some sexual problems to be bothersome, and they might even perceive these problems to be part of normal sexual function. Additionally, sexuality is still unmentionable in Poland and most people are not willing to either discuss it or admit to having sexual problems [29,30]. Concerning single-domain cutoff values, a study by Sidi et al. in Malaysia [16] described different values, but they did not use the original scoring system published by Rosen et al. [10]. On the other hand, Gerstenberger et al. suggested a 5-point scale for women with hypoactive sexual desire disorders [20]. The authors did propose cutoff values for single domains of the FSFI, however, the small sample size of the study group did recommend these for use in Polish women. Further studies on a larger group are needed to cross-validate these cutoff values for single domains of the FSFI. Finally, this study had the following limitations. Firstly, the study sample was homogenous; only healthy women not taking any medications, including antihypertensive drugs or oral contraceptives (OCs), were included. Therefore, we should be cautious while applying the PL-FSFI to women with diseases or those taking OCs. Second, the study sample was too small to recommend the calculated cutoff values for single domains of the PL-FSFI in screening for FSD in Polish women. Thirdly, although the authors verified the degree of association between the PL-FSFI scores and marital adjustment (divergent validity), marital satisfaction was assessed using 5-point Likert scale but not with a validated questionnaire. Despite these limitations, the findings are in agreement with numerous previous validation studies on the FSFI. However, the authors suggest that further cross-validation studies of the PL-FSFI be conducted in women of different backgrounds and health conditions. Conclusions The PL-FSFI is a reliable questionnaire with good psychometric and discriminative validity. Therefore, it can be used as a tool for preliminary screening for FSD among Polish women. Funding None. Acknowledgments None. Corresponding Author: Krzysztof Nowosielski, MD, PhD, Department of Gynecology and Obstetrics, Specialist Teaching Hospital in Tychy, ul. Edukacji 102, 43-100 Tychy, Poland. Tel: +48-502-027-943; Fax: +48 3221934 04; E-mail: krzysnowosilcow@yahoo.com Disclosure of Interests: None. Statement of Authorship Category 1 (a) Conception and Design Krzysztof Nowosielski; Beata Wróbel; Urszula Sioma-Markowska; Ryszard Poręba (b) Acquisition of Data Krzysztof Nowosielski; Beata Wróbel; Urszula Sioma-Markowska; Ryszard Poręba

10 Nowosielski et al. (c) Analysis and Interpretation of Data Krzysztof Nowosielski; Beata Wróbel; Urszula Sioma-Markowska; Ryszard Poręba Category 2 (a) Drafting the Article Krzysztof Nowosielski; Beata Wróbel; Urszula Sioma-Markowska; Ryszard Poręba (b) Revising It for Intellectual Content Krzysztof Nowosielski; Ryszard Poręba Category 3 (a) Final Approval of the Completed Article Krzysztof Nowosielski; Beata Wróbel; Urszula Sioma-Markowska; Ryszard Poręba References 1 Laumann EO, Nicolosi A, Glasser DB, Paik A, Gingell C, Moreira E, Wang T; GSSAB Investigators Group. Sexual problems among women and men aged 40 80 y: Prevalence and correlates identified in the Global Study of Sexual Attitudes and Behaviors. Int J Impot Res 2005;17:39 57. 2 Laumann EO, Glasser DB, Neves RC, Moreira ED Jr; GSSAB Investigators Group. A population-based survey of sexual activity, sexual problems and associated help-seeking behavior patterns in mature adults in the United States of America. 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