Translation, Cross‐Cultural Adaptation, and Psychometric Validation of the 5‐Item International Index of Erectile Function (IIEF‐5) into Urdu

Translation, Cross‐Cultural Adaptation, and Psychometric Validation of the 5‐Item International Index of Erectile Function (IIEF‐5) into Urdu

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Translation, Cross-Cultural Adaptation, and Psychometric Validation of the 5-Item International Index of Erectile Function (IIEF-5) into Urdu jsm_2714

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Muhammad Asif Mahmood, MCPS,* Khaleeq Ur Rehman, MS (Urol),† M. Amanullah Khan, PhD,‡ and Tipu Sultan, BSc‡ *Department of Medicine, KhairunNisa Hospital, Lahore, Pakistan; †Department of Urology/Andrology, Fatima Memorial Hospital and FMH College of Medicine and Dentistry, Lahore, Pakistan; ‡Department of Community Medicine, FMH College of Medicine and Dentistry, Lahore, Pakistan DOI: 10.1111/j.1743-6109.2012.02714.x

ABSTRACT

Introduction. Patients suffering from erectile dysfunction (ED) feel shy to discuss this issue with their physician. Self-report questionnaires are a key instrument to break this barrier. Most of these questionnaires are in English, and their validated translations in Urdu, the official language of Pakistan, are not available. Aim. The aim of our study is to translate, cross-culturally adapt, and perform psychometric validation of an Urdu translation of the 5-item International Index of Erectile Function (IIEF-5). Methods. The translation of IIEF-5 was done in Urdu and was refined through reverse translation and expert committee reviews. It was then pretested on 20 bilingual men and reviewed again to develop a final Urdu version of the questionnaire. We selected 47 patients who had been in a stable sexual relationship over the past 6 months and asked them to fill out the IIEF-5 questionnaire in both languages (Urdu and English), followed by evaluation of ED by a clinician, who was blinded to the responses of the patient to the questionnaire. Main Outcome Measures. The self-report to questionnaire and independent clinical assessment were compared. Patients refilled out the questionnaire again at the end of the interview to assess test–retest consistency. These data were now analyzed statistically using descriptive statistics, Cohen’s kappa, and Cronbach’s alpha analysis. Results. The Cohen’s kappa showed a very high degree of agreement between the two versions (P < 0.0001), and a high degree of internal consistency was demonstrated on Cronbach’s alpha analysis ([0.882] with 95% confidence interval [0.839–0.916]). The clinical assessment of the presence and severity of ED also matched with the self-report questionnaire. Conclusion. We can safely conclude that this Urdu version of IIEF-5 is a valid instrument for use in the literate population of Pakistan. Mahmood MA, Rehman KU, Khan MA, and Sultan T. Translation, cross-cultural adaptation, and psychometric validation of the 5-item International Index of Erectile Function (IIEF-5) into Urdu. J Sex Med **;**:**–**. Key Words. Erectile Dysfunction; Translation; Questionnaire; Self-Report Validated Instrument

Introduction

E

rectile dysfunction (ED) is a fairly common disorder but poorly acknowledged and misunderstood in many ways. Its initial diagnosis is based on self-report questionnaires. Rosen et al. published a self-report questionnaire by the name of International index of Erectile Function (IIEF) in 1997, which was a composite scale for the

© 2012 International Society for Sexual Medicine

assessment of multiple aspects of erectile function (EF). IIEF was extensively used as an instrument for diagnostic as well as prognostic assessment in majority of the studies. Later, an abridged 5-item version of the instrument was also developed by the same author [1,2]. This abridged version became popular in clinical practice as well as in research for the assessment of responsiveness to various medications for sexual dysfunction. Both J Sex Med **;**:**–**

2 IIEF and IIEF-5 have been translated and validated in some languages [3–8]. ED is fairly common in Pakistan, as construed by clinical impressions of the medical practitioners and also by the growing off-label sales of phosphodiestrase type 5 inhibitors. Epidemiologic studies however have not been conducted to test this anecdotal impression. With a rapid growth and development of the discipline of erectile medicine over the past decade, awareness is growing and an ever-increasing number of physicians are motivated to offer medical help to their patients with various grades of ED. That necessitates the availability of an appropriate, validated diagnostic and prognostic instrument, which can be used for assessment of EF in various clinical settings. Urdu is the national language of Pakistan, and there are no validated translations of IIEF-5 in Urdu language. We have translated, cross-culturally adapted, and validated IIEF-5 into Urdu language for use in Pakistan. Materials and Methods

This qualitative study was conducted after approval from the ethical review board. The research was completed in two consecutive phases of “translation-adaptation” and “validation for cross cultural equivalence.”

Phase 1: Translation and Adaptation The IIEF-5 questionnaire was translated by a translator who had proficiency both in English and Urdu languages and had an extensive experience of translating literary, social, official, and scientific text into Urdu (the official and educational language of Pakistan). This translation was then reverse translated into English by two independent translators who had documented evidence of high proficiency and fluency in Urdu as well as English languages, although the mother tongue of both these persons was not English. They had not seen the original English version of IIEF-5 and were blinded to each other. The Urdu and the reverse translated English versions were both reviewed for face validity and cross-cultural equivalence, by a panel of experts. This panel of experts comprised of three medical and three nonmedical experts with documented proficiency in both languages. This panel proposed a final baseline Urdu translation. This baseline Urdu translation was then tested on 20 consenting men presenting with ED to the outpatients and had good command over both J Sex Med **;**:**–**

Mahmood et al. Urdu as well as English. They filled out the questionnaire in both languages and were then interviewed by the physician who was blinded to their previously filled out questionnaires. The physician hence made an independent clinical assessment of their EF. The subjects refilled out the questionnaire at the end of the interview. The responses were now judged for inconsistency of response to the same question in two versions, which were discussed with the subjects if required, and compared with the clinical assessment of the physician. These subjects were finally asked to comment on the adequacy of the translation, and also to give any suggestions if they had. This input was later used to develop a final Urdu version of the questionnaire, which was again reviewed by the panel of experts.

Phase 2: Validation for Cross-Cultural Equivalence A total of 47 men were recruited over a period of 2 months and included 37 people with ED of a diverse etiology ranging through diabetes mellitus, hypertension, atherosclerotic vascular disease, pelvic and urological disorders, Peyronie’s disease, and psychological ED, while 10 had presented with complaints other than ED and were used as controls. These 47 patients were able to speak and understand both languages. All were now administered the IIEF-5 both in English as well as Urdu languages. The physician as in field test then assessed the subjects for ED, and the patients refilled out the questionnaire at the end of the interview. The results were then processed through SPSS version 16 (SPSS Inc., Chicago, IL, USA). The psychometric properties of the Urdu version of IIEF-5 were evaluated on the following parameters. The severity of ED was classified into the following five categories based on IIEF-5 scores (Severe ED [5–7], Moderate ED [8–11], Moderate to Mild ED [12–16], Mild ED [17–20], No ED [21–25]) [2], and the descriptive data of the scores for each domain were compared. 1. The means of the scores of these domains ⫾ standard deviations were compared by t-test to calculate the P values for each domain. 2. Cohen’s kappa was calculated to evaluate the magnitude of agreement between the English and the Urdu versions of the questionnaires. 3. The intraclass correlation coefficient was calculated through Cronbach’s alpha for internal consistency between the Urdu and the English versions of the questionnaires.

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Translation & Validation of IIEF-5 in Urdu Table 1 A comparison of the mean and standard deviations of scores obtained by the questionnaire in both languages Language Urdu ED severity category N (%)

English N (%)

P value Total (Fisher’s N (%) Exact test)

Severe ED 2 (4.3) Moderate ED 4 (8.5) Mild to moderate ED 15 (31.9) Mild ED 16 (34.0) No ED 10 (21.3) 47 (100.0)

4 5 13 15 10 47

6 9 28 31 20 94

(8.5) (10.6) (27.7) (31.9) (21.3) (100.0)

0.67 1.0 0.65 0.82 1.0

Results

Pretesting Urdu Version in the Field The testing of baseline Urdu translation on 20 bilingual consenting men in a stable sexual relationship over the past 6 months demonstrated that 90% of them had no difficulty in comprehension of the questions. Only two suggestions for alternate phrases were offered by these subjects when they were objectively inquired. Both were considered more appropriate than the original translation, and were incorporated in the revised Urdu version of IIEF-5. Clinical assessment made by the physician was found to correspond with self-report responses in more than 95% men. The test–retest consistency was also found to be 95%. Validation for Cross-Cultural Equivalence The scores obtained from English and Urdu versions were stratified into five grades as mentioned in the Methods section [2], and Fisher’s exact test was applied (Table 1). A comparison of the score obtained from English and the Urdu versions is shown in Table 2. The degree of agreement between Urdu and the original U.S. English versions was evaluated by Cohen’s kappa statistics, and a high degree of agreement was demonstrated (0.714), P < 0.0001. Finally, the internal consistency of the questionnaire was assessed by Cronbach’s alpha, which demonstrated a very high degree of internal consistency (0.882) with 95% confidence interval (0.839–0.916). Discussion

Translation and Adaptation of the English Version of IIEF-5 into Urdu Translation and adaptation of the English version of IIEF-5 into Urdu for cross-cultural and psychometric equivalence posed a unique set of problems. Most

of the difficulties in translation were in finding easily comprehensible terms and phrases for the population of a country which has more than five mother tongues in different provinces (Punjabi, Pashto, Sindhi, Balochi, Brahvi, Urdu, Balti, and Kohistani) but one national language (Urdu), which is not the mother tongue of any of these provinces. This language is also the official medium of instruction and is an extremely formal language with most of its technical vocabulary originating outside national territory, in Arabia, Iran, and Turkey, although well adopted over time. Sexual activity is an extremely private interaction with physical as well as psychosocial components that can be realized, experienced, and expressed only in cultural context and, hence, ideally in the mother tongue of the subject. Urdu however is the official medium of instruction in most of the country and for a person with average level of literacy; it is the only language with a potential for nationwide use for a self-report questionnaire. We understand that the real challenge in this task was to find a corresponding terminology of Urdu which was as close to the native languages as possible. Our results and the subsequent statistical Table 2 Comparison of scores obtained by the questionnaire in both languages Language

N How do you rate your confidence that you could get and keep an erection? When you had erection with sexual stimulation, how often were your erections hard enough for penetration? During sexual intercourse, how often were you able to maintain your erection after you had penetrated (entered) your partner? During sexual intercourse, how difficult was it to maintain your erection to completion of intercourse? When you attempted sexual intercourse, how often was it satisfactory for you?

Urdu Mean ⫾ SD 47

English Mean ⫾ SD 47

P value

3.23 ⫾ 1.28

3.26 ⫾ 1.310

0.937

3.53 ⫾ 1.08

3.40 ⫾ 1.11

0.575

3.34 ⫾ 1.16

3.32 ⫾ 1.18

0.930

3.53 ⫾ 1.15

3.15 ⫾ 1.30

0.135

3.26 ⫾ 1.20

3.09 ⫾ 1.34

0.521

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analyses have shown that our translation– adaptation produced satisfactory results.

Statement of Authorship

Validation of the Urdu Version of IIEF-5 The Urdu version of IIEF-5 has been found to be a reliable and cross-culturally equivalent instrument to the original English version in the population which has been studied. A high degree of effectiveness in diagnosis and discrimination among various grades and severity of ED has also been demonstrated with a high degree of internal consistency. There are, however, some areas that need consideration and further evaluation. This study has been conducted only in those subjects who had a good command on both languages, which implies a fairly high grade of literacy. It may however be noted here that the subjects included in this study represented 75% of the people reporting to our ED clinics, and the sample can be considered a fair if not perfect representation of the average literate man in Pakistani community. We believe nonetheless that the effectiveness of this Urdu version of IIEF-5 needs to be further evaluated in less educated individuals as well. This study has proven the psychometric validity of the Urdu version only in bilingually literate men reporting to the OPD with complaints regarding their sexual performance, and the high degree of agreement between the Urdu and the original U.S. English versions evaluated by Cohen’s kappa statistics (P value P < 0.0001) suggests that this Urdu version shall be effective in most situations, although its validity may be further enhanced by subsequent studies in less educated subjects.

(a) Conception and Design Muhammad Asif Mahmood; Khaleeq Ur Rehman; M. Amanullah Khan (b) Acquisition of Data Muhammad Asif Mahmood; Khaleeq Ur Rehman (c) Analysis and Interpretation of Data Muhammad Asif Mahmood; Khaleeq Ur Rehman; M. Amanullah Khan; Tipu Sultan

Conclusion

This Urdu version of IIEF-5 is a useful instrument for the diagnosis of ED. There is some possibility that the instrument may not be as useful in the less educated, but this is a presumption, which needs to be evaluated in a subsequent study. We can safely conclude that this Urdu version of IIEF-5 is a useful instrument for the literate population in Pakistan. Corresponding Author: Khaleeq Ur Rehman, MS (Urol), Department of Urology/Andrology, Fatima Memorial Hospital and FMH College of Medicine and Dentistry, Lahore 54700, Pakistan. Tel: 00923008492949; Fax: 04237570586; E-mail: [email protected] Conflict of Interest: None.

J Sex Med **;**:**–**

Category 1

Category 2 (a) Drafting the Article Muhammad Asif Mahmood; Khaleeq Ur Rehman; M. Amanullah Khan (b) Revising It for Intellectual Content Muhammad Asif Mahmood; Khaleeq Ur Rehman; M. Amanullah Khan; Tipu Sultan

Category 3 (a) Final Approval of the Completed Article Muhammad Asif Mahmood; Khaleeq Ur Rehman; M. Amanullah Khan; Tipu Sultan

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