2232
The Premature Ejaculation Diagnostic Tool (PEDT): Linguistic Validity of the Chinese Version Yan-Ping Huang, MD, PhD, Bin Chen, MD, PhD, Ping Ping, MD, PhD, Hong-Xiang Wang, MM, Kai Hu, MB, Tao Zhang, MM, Hao Yang, MB, Yan Jin, MB, Qi Yang, MD, and Yi-Ran Huang, MD, PhD Department of Urology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Andrology, Shanghai, China DOI: 10.1111/jsm.12612
ABSTRACT
Introduction. The premature ejaculation diagnostic tool (PEDT) was developed to standardize the diagnosis of PE and has been applied in many countries. However, a linguistic validation of the Chinese version of PEDT does not exist. Aims. This study aims to undertake the Chinese validation of the PEDT and to evaluate its association with self-estimated intravaginal ejaculatory latency time (IELT) and clinical expert diagnosis of PE. Methods. A Chinese version of PEDT was confirmed by andrologist and bilingual linguist. Participants were recruited among seven different communities of Shanghai from 2011 to 2012, and their information regarding self-reported PE, self-estimated IELT, expert diagnosis of PE, and PEDT scores were collected. Main Outcome Measures. Validity of the PEDT and its association with clinical expert diagnosis of PE and self-estimated IELT were analyzed. Results. A total of 143 patients without PE (mean age 55.11 ± 7.65 years) and 100 men with PE (mean age 53.07 ± 8.08 years) were enrolled for validation. Of the patients in PE group, the number of men reporting self-estimated IELTs of ≤1, 1–2, and >2 minutes were 34 (34.0%), 22 (22.0%), and 44 (44.0%), respectively. The Cronbach’s alpha score (α = 0.77) showed adequate internal consistency, and the test–retest correlation coefficients of each item (r ≥ 0.70, P < 0.001) indicated excellent stability over time. The frequency of agreement showed that there was excellent concordance between PEDT diagnosis and clinician diagnosis when the PEDT scores ≥11. An adequate correlation was found between total PEDT score and self-estimated IELT (ρ = −0.396, P < 0.001), and sensitivity and specificity analyses suggested a score of ≤8 indicated no time-defined PE (self-estimated IELT ≤1 minute). Conclusions. The Chinese version of PEDT is valid in screening the presence of PE among Chinese men. The PEDT showed an adequate negative correlation with self-estimated IELT and an excellent concordance with clinician diagnosis of PE. Huang Y-P, Chen B, Ping P, Wang H-X, Hu K, Zhang T, Yang H, Jin Y, Yang Q, and Huang Y-R. The premature ejaculation diagnostic tool (PEDT): Linguistic validity of the Chinese version. J Sex Med 2014;11:2232–2238. Key Words. Premature Ejaculation; Premature Ejaculation Diagnostic Tool; Validity and Reliability; Intra-Vaginal Ejaculatory Latency Time; Ejaculatory Disorder
Introduction
P
remature ejaculation (PE) is the most common ejaculatory disorder, and it has been reported that PE has an estimated prevalence of
J Sex Med 2014;11:2232–2238
approximately 16–38% in male population [1–5]. However, the controversy in the definition of PE and lack of specific criteria in the diagnosis of PE are serious limitations to research, which implies that the prevalence rate of PE is likely to be © 2014 International Society for Sexual Medicine
Chinese PEDT Validation inaccurate. Although the definition from the American Psychiatric Association’s Diagnostic and Statistical Manual, revised version 4 (DSMIV-TR) has been accepted widely [6,7], it is still hard to apply systematically for diagnosing this condition, as the definition is vague and open to interpretation [8]. The intravaginal ejaculatory latency time (IELT) [9] and self-report outcome [10] are considered as two important diagnosis elements for PE and overcome some limitations of DSM-IV-TR, but they cannot be used to diagnose PE separately. The premature ejaculation diagnostic tool (PEDT), involving the elements of diagnosis of PE such as control, frequency, minimal sexual stimulation, distress, and interpersonal difficulty, was developed and validated by Symonds et al. [11] to standardize the diagnosis of PE in clinical trials. As a brief self-administered questionnaire, the PEDT is considered to be an easily administered tool to facilitate the diagnosis of PE and has shown good validity and reliability in many European countries [12]. However, a test of the PEDT’s appropriateness and validity of scoring system across different cultures is necessary before its use outside the non-English speaking country. Studies have examined the reliability and validity of Korean and Turkish versions of the PEDT [13,14]. Although several Chinese epidemiological studies reported the incidence of PE diagnosed by the translated PEDT [15], there was no linguistic validation test to the Chinese PEDT before it was widely used. Furthermore, there is still an underlying suspicion that subjective answers to questions about the dimensions of ejaculation might not reflect the measures of IELT and true PE status. Thus, the purpose of this study was to carry out the Chinese validation of the PEDT and to evaluate its association with self-estimated IELT and clinical expert diagnosis of PE. Material and Methods
Linguistic Validation Two andrologists individually translated the original English version of the PEDT into Chinese, and one bilingual linguist performed backward translation. The other authors reviewed and confirmed a preliminary Chinese version of PEDT. Cognitive debriefing interviews with 20 males with self-reported PE in andrology outpatient were conducted to test the interpretation of the translation. A final Chinese version was developed
2233 according to the preliminary version and summary of all feedbacks from the 20 men’s interviews.
Study Population This validation study was conducted in seven different communities of Shanghai from 2011 to 2012, and men were recruited by posted flyers. Subjects were excluded from the study if they had severe diseases (such as unstable angina, congestive heart failure, significant renal or hepatic dysfunction, and severe psychological disorders) and/or clinically noteworthy penile deformities. All participants were asked to complete the question “Do you have the feeling of uncontrolled rapid ejaculation during the intra-vaginal sexual intercourse?,” and men were screened as PE positive if they answered “yes” to the question. The participants were also requested to self-estimate IELT, which was defined as the time that intercourse lasted from initiation of vaginal penetration to ejaculation on the majority of their attempts. After completing the foregoing self-reported data, each participant was asked to answer the Chinese PEDT questionnaire. Men in the “self-reported PE” group must be currently sexually active in a stable, heterosexual relationship of at least 6 months duration. The men were also screened to ensure they did not have erectile dysfunction (International Index of Erectile Function-5 [IIEF-5] ≥22) nor were taking any medications for sexual function or for psychiatric illness. Those men screened with “self-reported non-PE” problem were free of any sexual dysfunction, and were currently sexually active, in a heterosexual relationship of at least 6 months duration. Study Procedure The study was approved by the ethical committee of our institution before commencement of the study, and all participants gave their written informed consent. Men who got through the above screening and who agreed to participate in the next phase completed the PEDT a second time for test–retest calculations. Subsequently, they were scheduled for an appointment for a diagnostic interview with an expert clinician. There are three clinical experts in all and each of them had several years experience in diagnosing and treating men with PE, and they were blinded to the subjects’ self-report regarding PE status and also to their PEDT score. The clinical experts made detailed records on the process of assessment and checked the self-estimate IELT again and elucidated how they made their diagnosis. The PE J Sex Med 2014;11:2232–2238
2234
Huang et al.
diagnosis includes three elements: (i) feeling of uncontrolled rapid ejaculation; (ii) dissatisfaction with short ejaculatory latency; and (iii) distress and interpersonal difficulty related to early ejaculation. At the end of each interview, the expert recorded a diagnosis: “does have PE” or “does not have PE.” Participants who self-reported PE and met expert diagnosis of PE simultaneously were diagnosed as clinical PE, and clinical non-PE was confirmed according to self-report and expert estimate. The uncertain diagnosis of PE, such as discrepancy between self-report and clinician diagnosis, premature-like ejaculatory dysfunction and natural variable PE [8,16], were excluded from the study.
Statistical Analyses All analyses were conducted using SPSS 13.0 (SPSS Inc., Chicago, IL, USA). The primary analysis was conducted between the clinical diagnoses and PEDT diagnoses. Each diagnostic method stated PE or non-PE. Psychometric analyses were used to check the internal consistency, test–retest reliability, and validity. Internal consistency was evaluated with Cronbach’s alpha, and α ≥ 0.70 was considered to be a good level of internal consistency. Test–retest reliability was also evaluated with Pearson correlation coefficient, and the minimal acceptable level was defined as 0.70. The self-estimated IELT was calculated as geometric mean. The correlation between selfestimated IELT and PEDT score were evaluated with Spearman correlation analyses. Sensitivity and specificity was evaluated with receiver operating characteristic (ROC) analysis. Table 1
Results
Demographics A total of 380 eligible participants completed all the questionnaires and self-reported data at the first interview and agreed to participate in the second interview. Twenty-seven participants dropped out in the second interview, and 110 participants were excluded as the uncertain diagnosis of PE. At last, 143 participants without PE and 100 men with PE were enrolled for validation. The mean ages of the PE group and the non-PE group were 53.07 ± 8.08 (27–68) years and 55.11 ± 7.65 (28–69) years, respectively. Of the patients in PE group, the number of men reporting selfestimated IELTs of ≤1, 1–2, and >2 minutes were 34 (34.0%), 22 (22.0%), and 44 (44.0%), respectively. The number of men with self-estimated IELTs of 2–5, 5–10, and >10 minutes in non-PE group were 39 (27.2%), 57 (39.9%), and 47 (32.9%), respectively. There were no statistically significant differences between the two groups with regard to age, sex frequency, marital status, education, and fertility status. The detailed demographics are shown in Table 1. The Validation of PEDT in Chinese The Cronbach’s alpha score was calculated as 0.77, showing adequate internal consistency. The test– retest correlation coefficients of each item were ≥0.70, and the correlation coefficients of the total score was 0.82, indicating excellent stability over time (P < 0.001) (Table 2). Table 3 shows the frequency of agreement between the PEDT diagnosis and clinical diagnosis. If using a cut-score of PE ≥9 and no-PE ≤8, there was a 17.6% (13 men)
Demographics for the PE and no-PE cohorts No-PE (n = 143)
Age (years) Mean (SD) Range Sex frequency (times per month) Median Range Marital status Married/living as married Single/windowed/separated/divorced Education level Primary school or lower Middle school High school University Postgraduate or higher Fertility status Fathered children No child
J Sex Med 2014;11:2232–2238
PE (n = 100)
P 0.059
53.07 (8.08) 27–68
55.11 (7.65) 28–69 0.524
3.00 1–13
3.00 1–9 0.387
98.6% (141) 1.4% (2)
97.0% (157) 3.0% (3)
0.7% (1) 7.7% (11) 37.8% (54) 33.6% (48) 20.3% (29)
0.0% (0) 18.0% (18) 38.0% (38) 33.0% (33) 11.0% (11)
93.7% (134) 6.3% (9)
91.0% (91) 9.0% (9)
0.061
0.428
2235
Chinese PEDT Validation Table 2 Test–retest correlation coefficients (R) and P values of each five-item PEDT Question 1 R P
2
3
4
5
Total scores
0.72 0.74 0.77 0.71 0.70 0.82
The Premature Ejaculation Diagnostic Tool (PEDT): Linguistic Validity of the Chinese Version Yan-Ping Huang, MD, PhD, Bin Chen, MD, PhD, Ping Ping, MD, PhD, Hong-Xiang Wang, MM, Kai Hu, MB, Tao Zhang, MM, Hao Yang, MB, Yan Jin, MB, Qi Yang, MD, and Yi-Ran Huang, MD, PhD Department of Urology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Andrology, Shanghai, China DOI: 10.1111/jsm.12612
ABSTRACT
Introduction. The premature ejaculation diagnostic tool (PEDT) was developed to standardize the diagnosis of PE and has been applied in many countries. However, a linguistic validation of the Chinese version of PEDT does not exist. Aims. This study aims to undertake the Chinese validation of the PEDT and to evaluate its association with self-estimated intravaginal ejaculatory latency time (IELT) and clinical expert diagnosis of PE. Methods. A Chinese version of PEDT was confirmed by andrologist and bilingual linguist. Participants were recruited among seven different communities of Shanghai from 2011 to 2012, and their information regarding self-reported PE, self-estimated IELT, expert diagnosis of PE, and PEDT scores were collected. Main Outcome Measures. Validity of the PEDT and its association with clinical expert diagnosis of PE and self-estimated IELT were analyzed. Results. A total of 143 patients without PE (mean age 55.11 ± 7.65 years) and 100 men with PE (mean age 53.07 ± 8.08 years) were enrolled for validation. Of the patients in PE group, the number of men reporting self-estimated IELTs of ≤1, 1–2, and >2 minutes were 34 (34.0%), 22 (22.0%), and 44 (44.0%), respectively. The Cronbach’s alpha score (α = 0.77) showed adequate internal consistency, and the test–retest correlation coefficients of each item (r ≥ 0.70, P < 0.001) indicated excellent stability over time. The frequency of agreement showed that there was excellent concordance between PEDT diagnosis and clinician diagnosis when the PEDT scores ≥11. An adequate correlation was found between total PEDT score and self-estimated IELT (ρ = −0.396, P < 0.001), and sensitivity and specificity analyses suggested a score of ≤8 indicated no time-defined PE (self-estimated IELT ≤1 minute). Conclusions. The Chinese version of PEDT is valid in screening the presence of PE among Chinese men. The PEDT showed an adequate negative correlation with self-estimated IELT and an excellent concordance with clinician diagnosis of PE. Huang Y-P, Chen B, Ping P, Wang H-X, Hu K, Zhang T, Yang H, Jin Y, Yang Q, and Huang Y-R. The premature ejaculation diagnostic tool (PEDT): Linguistic validity of the Chinese version. J Sex Med 2014;11:2232–2238. Key Words. Premature Ejaculation; Premature Ejaculation Diagnostic Tool; Validity and Reliability; Intra-Vaginal Ejaculatory Latency Time; Ejaculatory Disorder
Introduction
P
remature ejaculation (PE) is the most common ejaculatory disorder, and it has been reported that PE has an estimated prevalence of
J Sex Med 2014;11:2232–2238
approximately 16–38% in male population [1–5]. However, the controversy in the definition of PE and lack of specific criteria in the diagnosis of PE are serious limitations to research, which implies that the prevalence rate of PE is likely to be © 2014 International Society for Sexual Medicine
Chinese PEDT Validation inaccurate. Although the definition from the American Psychiatric Association’s Diagnostic and Statistical Manual, revised version 4 (DSMIV-TR) has been accepted widely [6,7], it is still hard to apply systematically for diagnosing this condition, as the definition is vague and open to interpretation [8]. The intravaginal ejaculatory latency time (IELT) [9] and self-report outcome [10] are considered as two important diagnosis elements for PE and overcome some limitations of DSM-IV-TR, but they cannot be used to diagnose PE separately. The premature ejaculation diagnostic tool (PEDT), involving the elements of diagnosis of PE such as control, frequency, minimal sexual stimulation, distress, and interpersonal difficulty, was developed and validated by Symonds et al. [11] to standardize the diagnosis of PE in clinical trials. As a brief self-administered questionnaire, the PEDT is considered to be an easily administered tool to facilitate the diagnosis of PE and has shown good validity and reliability in many European countries [12]. However, a test of the PEDT’s appropriateness and validity of scoring system across different cultures is necessary before its use outside the non-English speaking country. Studies have examined the reliability and validity of Korean and Turkish versions of the PEDT [13,14]. Although several Chinese epidemiological studies reported the incidence of PE diagnosed by the translated PEDT [15], there was no linguistic validation test to the Chinese PEDT before it was widely used. Furthermore, there is still an underlying suspicion that subjective answers to questions about the dimensions of ejaculation might not reflect the measures of IELT and true PE status. Thus, the purpose of this study was to carry out the Chinese validation of the PEDT and to evaluate its association with self-estimated IELT and clinical expert diagnosis of PE. Material and Methods
Linguistic Validation Two andrologists individually translated the original English version of the PEDT into Chinese, and one bilingual linguist performed backward translation. The other authors reviewed and confirmed a preliminary Chinese version of PEDT. Cognitive debriefing interviews with 20 males with self-reported PE in andrology outpatient were conducted to test the interpretation of the translation. A final Chinese version was developed
2233 according to the preliminary version and summary of all feedbacks from the 20 men’s interviews.
Study Population This validation study was conducted in seven different communities of Shanghai from 2011 to 2012, and men were recruited by posted flyers. Subjects were excluded from the study if they had severe diseases (such as unstable angina, congestive heart failure, significant renal or hepatic dysfunction, and severe psychological disorders) and/or clinically noteworthy penile deformities. All participants were asked to complete the question “Do you have the feeling of uncontrolled rapid ejaculation during the intra-vaginal sexual intercourse?,” and men were screened as PE positive if they answered “yes” to the question. The participants were also requested to self-estimate IELT, which was defined as the time that intercourse lasted from initiation of vaginal penetration to ejaculation on the majority of their attempts. After completing the foregoing self-reported data, each participant was asked to answer the Chinese PEDT questionnaire. Men in the “self-reported PE” group must be currently sexually active in a stable, heterosexual relationship of at least 6 months duration. The men were also screened to ensure they did not have erectile dysfunction (International Index of Erectile Function-5 [IIEF-5] ≥22) nor were taking any medications for sexual function or for psychiatric illness. Those men screened with “self-reported non-PE” problem were free of any sexual dysfunction, and were currently sexually active, in a heterosexual relationship of at least 6 months duration. Study Procedure The study was approved by the ethical committee of our institution before commencement of the study, and all participants gave their written informed consent. Men who got through the above screening and who agreed to participate in the next phase completed the PEDT a second time for test–retest calculations. Subsequently, they were scheduled for an appointment for a diagnostic interview with an expert clinician. There are three clinical experts in all and each of them had several years experience in diagnosing and treating men with PE, and they were blinded to the subjects’ self-report regarding PE status and also to their PEDT score. The clinical experts made detailed records on the process of assessment and checked the self-estimate IELT again and elucidated how they made their diagnosis. The PE J Sex Med 2014;11:2232–2238
2234
Huang et al.
diagnosis includes three elements: (i) feeling of uncontrolled rapid ejaculation; (ii) dissatisfaction with short ejaculatory latency; and (iii) distress and interpersonal difficulty related to early ejaculation. At the end of each interview, the expert recorded a diagnosis: “does have PE” or “does not have PE.” Participants who self-reported PE and met expert diagnosis of PE simultaneously were diagnosed as clinical PE, and clinical non-PE was confirmed according to self-report and expert estimate. The uncertain diagnosis of PE, such as discrepancy between self-report and clinician diagnosis, premature-like ejaculatory dysfunction and natural variable PE [8,16], were excluded from the study.
Statistical Analyses All analyses were conducted using SPSS 13.0 (SPSS Inc., Chicago, IL, USA). The primary analysis was conducted between the clinical diagnoses and PEDT diagnoses. Each diagnostic method stated PE or non-PE. Psychometric analyses were used to check the internal consistency, test–retest reliability, and validity. Internal consistency was evaluated with Cronbach’s alpha, and α ≥ 0.70 was considered to be a good level of internal consistency. Test–retest reliability was also evaluated with Pearson correlation coefficient, and the minimal acceptable level was defined as 0.70. The self-estimated IELT was calculated as geometric mean. The correlation between selfestimated IELT and PEDT score were evaluated with Spearman correlation analyses. Sensitivity and specificity was evaluated with receiver operating characteristic (ROC) analysis. Table 1
Results
Demographics A total of 380 eligible participants completed all the questionnaires and self-reported data at the first interview and agreed to participate in the second interview. Twenty-seven participants dropped out in the second interview, and 110 participants were excluded as the uncertain diagnosis of PE. At last, 143 participants without PE and 100 men with PE were enrolled for validation. The mean ages of the PE group and the non-PE group were 53.07 ± 8.08 (27–68) years and 55.11 ± 7.65 (28–69) years, respectively. Of the patients in PE group, the number of men reporting selfestimated IELTs of ≤1, 1–2, and >2 minutes were 34 (34.0%), 22 (22.0%), and 44 (44.0%), respectively. The number of men with self-estimated IELTs of 2–5, 5–10, and >10 minutes in non-PE group were 39 (27.2%), 57 (39.9%), and 47 (32.9%), respectively. There were no statistically significant differences between the two groups with regard to age, sex frequency, marital status, education, and fertility status. The detailed demographics are shown in Table 1. The Validation of PEDT in Chinese The Cronbach’s alpha score was calculated as 0.77, showing adequate internal consistency. The test– retest correlation coefficients of each item were ≥0.70, and the correlation coefficients of the total score was 0.82, indicating excellent stability over time (P < 0.001) (Table 2). Table 3 shows the frequency of agreement between the PEDT diagnosis and clinical diagnosis. If using a cut-score of PE ≥9 and no-PE ≤8, there was a 17.6% (13 men)
Demographics for the PE and no-PE cohorts No-PE (n = 143)
Age (years) Mean (SD) Range Sex frequency (times per month) Median Range Marital status Married/living as married Single/windowed/separated/divorced Education level Primary school or lower Middle school High school University Postgraduate or higher Fertility status Fathered children No child
J Sex Med 2014;11:2232–2238
PE (n = 100)
P 0.059
53.07 (8.08) 27–68
55.11 (7.65) 28–69 0.524
3.00 1–13
3.00 1–9 0.387
98.6% (141) 1.4% (2)
97.0% (157) 3.0% (3)
0.7% (1) 7.7% (11) 37.8% (54) 33.6% (48) 20.3% (29)
0.0% (0) 18.0% (18) 38.0% (38) 33.0% (33) 11.0% (11)
93.7% (134) 6.3% (9)
91.0% (91) 9.0% (9)
0.061
0.428
2235
Chinese PEDT Validation Table 2 Test–retest correlation coefficients (R) and P values of each five-item PEDT Question 1 R P
2
3
4
5
Total scores
0.72 0.74 0.77 0.71 0.70 0.82
