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Obstetrics & Gynecology 2003;102:1000-1005
© 2003 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

Validation of a Spanish Version of the Pelvic Organ Prolapse Incontinence Sexual Questionnaire

Audrey A. Romero, MD, Anne Hardart, MD, William Kobak, MD, Clifford Qualls, PhD and Rebecca Rogers, MD

From the Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina; Department of Obstetrics and Gynecology, St. Luke’s Roosevelt Hospital Center, New York, New York; Department of Obstetrics and Gynecology, Advocate Christ Medical Center, Oak Lawn, Illinois; and Departments of Mathematics and Statistics and Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Albuquerque, New Mexico.

Address reprint requests to: Audrey A Romero, MD, Duke University Medical Center, Department of Obstetrics and Gynecology, Box3192, Durham, NC27710; E-mail:romer005{at} mc.duke.edu.


   ABSTRACT
TOP
ABSTRACT
MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 APPENDIX A
 REFERENCES
 
OBJECTIVE: To develop a validated Spanish version of the Pelvic Organ Prolapse Incontinence Sexual Questionnaire (PISQ).

METHODS: The PISQ is a previously described validated and reliable questionnaire. We used a back-translation method to develop a Spanish-language version. Twenty-six bilingual patients with pelvic organ prolapse and/or urinary incontinence were randomized to complete either the original English version or the final Spanish version of the PISQ first, followed by the other questionnaire. Scores of the two versions were compared. Paired t test for total PISQ and its three domain scores and Wilcoxon signed rank test for each item assessed the bias between the two equivalent versions. Agreement between the two versions was assessed by weighted {kappa} statistics, with 95% confidence intervals for each item. P values of .05 or less were considered significant, and {kappa} values of .75 or greater were considered to indicate good agreement.

RESULTS: English and Spanish versions demonstrated no differences for each of the factors and total scores (P = .15, .83, .28, and .56, respectively). Wilcoxon signed rank test demonstrated that one item was answered differently in the English and Spanish versions. Good agreement between Spanish and English versions in 30 of the 31 items was demonstrated by weighted {kappa} statistics. Overall, 72% of women scored both versions of the questionnaire equivalently.

CONCLUSIONS: We have developed a validated and reliable Spanish questionnaire to evaluate sexual functioning in Spanish-speaking patients with pelvic organ prolapse and/or urinary incontinence.

Quality-of-life instruments are important in the assessment of women with pelvic floor disorders. They help one to understand and quantify symptomatology as well as the effects of incontinence and pelvic organ prolapse on patients’ lives. They are also essential in research, because improving quality of life is the major goal of treatment for women with these disorders. Condition-specific questionnaires should be validated and proven reliable to ensure that they are applicable to the population in question and that the information obtained from them is consistent and applicable to the subject of study. As the population of ethnic minorities grows in the United States, validated language-specific questionnaires are needed to ensure that it is possible to assess the quality of life of non–English-speaking patients. Hispanics constitute one of the fastest growing minorities in the United States. The US Census Bureau estimates that as of 2000, 32.8 million Hispanics reside in the United States,1 representing 12% of the total US population. Of the Hispanic population, 66.1% are of Mexican origin, 14.5% Central or South American, 9% Puerto Rican, 4% Cuban, and the remaining 6.4% are of other Hispanic origins. Although many Hispanic patients are bilingual, Spanish often remains the language of choice, and for many patients it is their only language. Without validated and reliable questionnaires in Spanish, a large proportion of the population is excluded from receiving adequate care.

Questionnaires that are merely translated from English to Spanish by someone fluent in both languages will not necessarily reflect the content and meaning of the original questionnaire, nor is it certain that the translated version will have the same validity as the original. A reliable, validated, condition-specific, self-administered questionnaire evaluating sexual function in women with pelvic organ prolapse and urinary incontinence has recently been developed.2 In this study, the previously validated English version of the Pelvic Organ Prolapse Incontinence Sexual Questionnaire (PISQ) was translated into Spanish and then validated among a cohort of bilingual women.


   MATERIALS AND METHODS
TOP
ABSTRACT
 MATERIALS AND METHODS
RESULTS
 DISCUSSION
 APPENDIX A
 REFERENCES
 
The validated and reliable English version of the Pelvic Organ Prolapse Incontinence Sexual Questionnaire (PISQ) has been described previously. The questionnaire consists of 31 items, divided into three domains: behavioral–emotive, physical, and partner-related. The English version of the PISQ was translated into Spanish with the use of a back-translation method,3–5 and the translation and validation process was undertaken in collaboration with the University of Southern California. Two separate sites were used so that the population of Spanish-speaking patients would be diverse. The translation was performed independently by two researchers fluent in Spanish, English, and medical terminology. Two other translators then translated these Spanish versions back into English. Those back-translated versions were then compared with the original English version to ensure that no meaning or concepts were lost during the translation process, and a single preliminary combined Spanish version was prepared. The preliminary Spanish translation was then distributed to five final translators to identify problems in the comprehension of items, and minor corrections were made to produce the final Spanish version (see Appendix A).

To validate the translated questionnaire, patients who could read and speak both English and Spanish were recruited from the gynecology and urogynecology clinics at the University of New Mexico Health Sciences Center and the Los Angeles County University of Southern California Medical Center, from August 2001 to February 2002. To screen for symptoms of urinary incontinence and/or pelvic organ prolapse, patients were asked the following question: "Do you have symptoms of urine leaking, pressure in your vagina or feeling that things are falling out?" Of those subjects who qualified (stated ability to read and speak both English and Spanish and having positive symptoms), 50 patients were approached, and 34 agreed to participate (17 from the University of New Mexico and 17 from the University of Southern California). Institutional review board approval was obtained at both sites, and the women provided informed consent before participation in the study. Participants filled out the final Spanish and English versions of the PISQ. They also completed questionnaires collecting demographic information. An independent research coordinator used a random number table to assign patients to complete either the English or the Spanish version of the PISQ first. After completing the English or the Spanish version, the patients completed the alternate-language version of the PISQ.

Validation of the Spanish version was undertaken by comparison of the scores obtained by the patients on the two versions; each patient acted as her own control. Any bias between the alternate-language versions was assessed by a paired t test for total PISQ scores and its three factors, and Wilcoxon signed rank test was used to evaluate agreement between Spanish and English versions of each item. The degree of agreement above chance between the two versions was assessed by weighted {kappa} statistics with 95% confidence intervals for each item. Demographic variables were presented by descriptive statistics. P values of .05 or less were considered significant, and {kappa} values of .75 or greater were considered to indicate good agreement.

Our sample size of 34 bilingual subjects taking both the English and Spanish versions of the PISQ was adequate to detect a two-point difference with 80% power and {alpha} = .05. The standard deviation (SD) used for this power analysis was obtained from the preliminary test–retest PISQ data.


   RESULTS
TOP
ABSTRACT
 MATERIALS AND METHODS
 RESULTS
DISCUSSION
 APPENDIX A
 REFERENCES
 
A total of 34 subjects were randomized for the study. Four of these subjects withdrew before completing any of the questionnaires. One patient felt the questions were too personal, and three patients reported that they were not having sexual relations frequently enough to answer the questions. Four subjects only partially completed the questionnaires. Of the patients who did not complete the questionnaire, one patient answered only one or two of the questions on the English questionnaire, whereas three patients failed to answer questions on the Spanish version. Because this study was undertaken to compare the English and Spanish versions of the questionnaire, the data from these patients was not included in the final analysis, leaving 26 patients. Subjects were multiparous, mean (± SD) age was 50 ± 9 (range 33–69) and mean body mass index was 29 ± 4.9 (range 22–41). The majority of the subjects identified themselves as Hispanic (96%). Most of the subjects were menopausal (77%), and 40% used some form of hormone replacement therapy. There were no significant differences in ethnicity, age, body mass index, gravidity, parity or hormonal status between subjects who did and subjects who did not complete the questionnaires (P > .05).

The means, SDs, and P values for each of the factors and total factors of the English and Spanish questionnaires are shown in Table 1Go. There were no significant differences in behavioral–emotive, physical, and partner-related scores for both the English and Spanish questionnaires (paired t test, P = .15, .83, and .28, respectively). Overall there were no significant differences between the two versions for total factor scores (P = .56). Six subjects (24%) scored the Spanish version of the questionnaire one point higher than the English version, whereas one subject scored the Spanish version 4 points higher than the English version. Seventy-two percent of the women answered both the English and Spanish versions equivalently. Analysis by Wilcoxon signed rank test demonstrated one item within the behavioral–emotive domain that had good agreement ({kappa} = .77 ± .10) but bias (P = .02). This item concerned the patient’s ability to achieve orgasm.


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  		Table 1. Factors and Total Factors
 
Analysis of the agreement between the two versions by weighted {kappa} statistics demonstrated agreement between 30 of the 31 items. Of the 31 items, 23 had {kappa} >= .70 and all P >= .27. Items 3, 5, 14, 23, and 25 had good agreement ({kappa} ranged from .64 to .67, and all P >= .31). Items 13, 16, and 31 had moderate agreement ({kappa} ranged from .51 to .56, with all P >= .06). Item 19 scored poorly in the partner-related domain and concerned the patient’s fear about fecal incontinence during sexual relations. The item had a {kappa} of .37 ±.31 but no bias (P = 1.0).

Because this study was undertaken to compare the English and Spanish versions of the questionnaire, a post hoc power analysis was undertaken with the 26 subjects who had completed both the English and Spanish versions of the PISQ. Our sample size of 26 bilingual patients was adequate to detect a 2.4 point difference between the Spanish and English versions of the PISQ, with 80% power and {alpha} = .05. This post hoc power analysis was based on the SD of the differences (4.1) between the total factors for the English version and the total factors for the Spanish version. The detectable difference of 2.4 is 2% of the possible total 125 points, for PISQ total scores.


   DISCUSSION
TOP
ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
APPENDIX A
 REFERENCES
 
Little is known regarding the sexual functioning of women with pelvic floor disorders. Even less is known regarding Spanish-speaking women with these disorders or whether their issues are different from those of English-speaking women with prolapse and/or incontinence. With the help of the PISQ, we might better study the effects of pelvic floor disorders and of pelvic floor surgery on sexual functioning. Because the percentage of women whose primary language is Spanish is increasing throughout the United States, it is important to include them in any efforts to describe and to address quality-of-life issues. In addition, women who have immigrated to the United States might have pelvic floor disorders that result from different obstetric practices in their countries of origin, or they might have different quality-of-life issues based on cultural differences. It will be important to understand how these cultural and geographic differences affect sexual functioning and to not assume that problems of this population will be identical to those of women who are able to complete questionnaires that require fluency in English.

By using the back-translation method, we have developed a Spanish version of the PISQ. Because more than 70% of the patients answered the questionnaires identically, and because 30 of the 31 items showed agreement, we can be reasonably assured that the questions in Spanish convey the same meaning as those in English. The one item that scored poorly was in the partner-related domain and was in regard to fear of fecal incontinence during sexual relations. Although we should be cautious about specifically comparing responses to the poorly scoring items, the global scores, the scores for each domain, and the scores for the rest of the items should be comparable for English and Spanish versions.

Each subject completed the questionnaires in English and in Spanish, and therefore the demographics of the English and Spanish groups are identical. On the other hand, because all subjects needed to be bilingual to participate in the study, we have inevitable selection and recall biases. The possibility exists that these biases contribute to a falsely higher level of agreement between the two versions, despite randomization to complete either the final Spanish or English version first. Having participants complete questionnaires at different times might minimize the amount of recall bias. We attempted to diversify the population by validating and completing the questionnaire at two different sites. However, the questionnaire has not been validated in all ethnic and cultural settings where Spanish is spoken, and this too might be a limitation to the study. We are aware that there might be differences in different subcultures that might not be addressed in this questionnaire.

The Spanish version of the PISQ is a reliable and valid instrument for assessing sexual function in Spanish-speaking women with pelvic floor disorders. As we continue to study the quality-of-life issues in women with pelvic floor disorders, having access to a broader segment of our population will potentially improve our ability to positively affect quality of life when we treat women with these disorders.


   APPENDIX A
TOP
ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 APPENDIX A
REFERENCES
 
Cuestionario de Prolapso Pélvico Órgano/Incontinencia de Orina/Función Sexual (PISQ)

Instrucciones
Abajo se encuentra una lista de preguntas sobre su vida sexual. Toda la información es confidencial. Los doctores usaran las repuestas para entender loque es importante en la vida sexual de nuestros pacientes. Cuando está leyendo las preguntas, piense en su sexualidad durante los seis meses pasados. Por favor marque en el cuadro la mejor repuesta. Gracias por su ayuda.

  1. ¿Con que frequencia tiene usted y su pareja relaciones sexules?
  2. ¿Qué tan frequente le gustaria tener relaciones o actividad sexual?
  3. ¿Tiene su pareja problemas con erecciones que afecta su actividad sexual?
  4. ¿Tiene su pareja problemas con eyaculaciòn prematura que afecta su actividad sexual?
  5. ¿Tiene usted clímax (orgasmo) cuando se masturba?
  6. No me masturbo
  7. ¿Tiene usted clímax (orgasmo) cuando tiene relaciones sexuales con su pareja?
  8. ¿Tiene usted clímax (orgasmo) cuando es acariciada por su pareja?
  9. ¿Nota lo siguiente cuando tiene sexo con su pareja: su respiración y pulso sé pone rápido, su vagina se moja, sensaciones de placer en sus senos o parte genital?
  10. ¿Se siente excitada (prendida) sexualmente cuando tiene actividades sexuales con su pareja?
  11. ¿Con que frequencia tiene deseo de tener relaciones sexuales? Los sentimientos pueden incluir ganas de tener relaciones sexuales, planeando para tener relaciones sexuales y sentimientos de frustracion porque no tiene relaciones sexuales?
  12. ¿Se siente dolor durante relaciones sexuales?
  13. ¿Se siente que la vagina está seca y que no puede tener relaciones sexuales?
  14. ¿Se abstiene de relaciones sexuales porque la vagina es muy corta?
  15. ¿Se abstiene de relaciones sexuales porque la vagina se le sale hacia fuera? (Puede ser prolapse o salidade la vagina solamente o junto con la vejiga o el recto).
  16. ¿Tiene sexo oral o por el ano porque es incómodo tener relaciones sexuales por la vagina?
  17. ¿Sufre de la perdida de orina durante relaciones sexuales?
  18. ¿Sufre de la perdida de excremento durante relaciones sexuales?
  19. ¿El temor de perder (excremento o orina) affecta su vida sexual?
  20. ¿La vergüenza de perder excremento o orina affecta su vida sexual?
  21. ¿Que tan satisfecha está con su relación sexual con su pareja?
  22. ¿Generalmente piensa que su pareja esta satisfecho con sus relaciones sexuales?
  23. ¿Esta satisfecha con la variedad de las actividades sexuales en su vida sexual?
  24. ¿Cuando tiene relaciones sexuales con su pareja, tiene reaciones emocionales negativas como miedo, asco vergüenza o culpa?
  25. ¿Con que frequencia se siente satisfecha despues de relaciones sexuales?
  26. ¿Con que frequencia tiene orgasmos durante relaciones sexuales?
  27. ¿Comparado con orgasmos en el pasado, que tan intensos son sus orgasmos que ha tenido durante los ultimos seis meses?
  28. ¿Favor de completar la frase: Cuando tenemos relaciones sexuales, yo inicio las actividades par tener relaciones sexuales. . . .
  29. ¿Evita usted relaciones sexuales por que tiene vergüenza?
  30. ¿Piensa que su pareja no quiere tener relaciones sexuales por sus problemas con incontinencia o prolapso?


   Footnotes
 
doi:10.1016/S0029-7844(03)00694-X

Received March 28, 2003. Received in revised form May 22, 2003. Accepted June 12, 2003.


   REFERENCES
TOP
ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 APPENDIX A
 REFERENCES
 
1. Therrien M, Ramirez RR. The Hispanic population in the United States: March 2000, current population reports, P20-535. Washington: US Census Bureau.

2. Rogers R, Kammerer-Doak D, Villarreal A, Coates K, Qualls C. A new instrument to measure sexual function in women with urinary Incontinence and/or pelvic organ prolapse. Am J Obstet Gynecol 2001;184:552–8.[Medline]

3. Berry JW. Introduction to methodology. In: Triandis H, Berry JW, eds. Handbook of cross-cultural psychology, vol 2. Boston: Allyn and Bacon, 1980:1–28.

4. Brislin RW. Translation and content analysis of oral and written material. In: Triandis H, Berry JW, eds. Handbook of cross-cultural psychology, vol 2. Boston: Allyn and Bacon, 1980:389–444.

5. Lamas X, Farre M, Llorente M, Cami J. Spanish version of the 49-item short form of the Addiction Research Center Inventory. Drug Alcohol Depend 1994;35:203–9.[Medline]





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