Adaptation to Spanish Language and Validation of the Fecal Incontinence Quality of Life Scale

Transcription

1 Adaptation to Spanish Language and Validation of the Fecal Incontinence Quality of Life Scale Miguel Minguez, M.D., 1 Vicente Garrigues, M.D., 2 Maria Jose Soria, M.D., 3 Montserrat Andreu, M.D., 4 Fermin Mearin, M.D., 5 Pere Clave, M.D. 6 1 Department of Gastroenterology, Hospital Clinico Universitario, Valencia, Spain 2 Department of Gastroenterology, Hospital La Fe, Valencia, Spain 3 Department of Gastroenterology, Hospital Universitario Puerta del Mar, Cadiz, Spain 4 Department of Gastroenterology, Hospital del Mar, Barcelona, Spain 5 Department of Gastroenterology, Centro Medico Teknon, Barcelona, Spain 6 Department of Gastroenterology, Institut Guttmann, Barcelona, Spain PURPOSE: The aim of this study was to perform a psychometric evaluation of the Fecal Incontinence Quality of Life Scale in the Spanish language. METHODS: Eleven hospitals in Spain participated in the study, which included 118 patients with active fecal incontinence. All the patients filled out a questionnaire on the severity of their incontinence, a general questionnaire of health (Medical Outcomes Survey Short Form), and a Spanish translation of the Fecal Incontinence Quality of Life Scale (Cuestionario de Calidad de Vida de Incontinencia Anal), which consists of 29 items in four domains: lifestyle, behavior, depression, and embarrassment. On a second visit, patients repeated the Fecal Incontinence Quality of Life Scale. For each domain, an evaluation was made of temporal reliability, internal reliability, the convergent validity with the generic questionnaire of health, and the discriminant validity correlating the domains of Cuestionario de Calidad de Vida de Incontinencia Anal with the severity of fecal incontinence. RESULTS: For cultural adaptation, the answer alternatives for 14 items were modified. A total of 111 patients (94 percent) completed the study adequately. Temporal reliability (test Supported in part by a grant from the Instituto de Salud Carlos III (Grant 03/02). Presented at the meeting of the Asociación Española de Gastroenterología, Madrid, Spain, March 1 to 2, Correspondence to: Miguel Minguez, M.D., Department of Gastroentology, Hospital Clínico, Valencia, Av Blasco Ibañez 17, Valencia 46010, Spain, mminguez@uv.es Dis Colon Rectum 2006; 49: DOI: /s * The American Society of Colon and Rectal Surgeons Published online: 08 March 2006 retest) was good for all domains except for embarrassment, which showed significant differences (P < 0.02). Internal reliability was good/excellent for all domains (Cronbach alpha >0.80, between 0.84 and 0.96). The four domains of Cuestionario de Calidad de Vida de Incontinencia Anal significantly correlated with the domains of the generic questionnaire on health (P < 0.01) and with the scale of severity of fecal incontinence (P < 0.001). All domains of Cuestionario de Calidad de Vida de Incontinencia Anal correlated negatively with the need to wear pads (P < 0.01) and with the presence of complete fecal incontinence. CONCLUSIONS: The Cuestionario de Calidad de Vida de Incontinencia Anal incorporates sufficient requirements of reliability and validity to be applied to patients with fecal incontinence. [Key words: Fecal incontinence; Quality-oflife scale; Cultural adaptation] F ecal incontinence (FI) produces, according to doctors and patients, important alterations in the general dynamics of life from the moment it occurs. Its effect on the quality of life must be evaluated following standard forms of measurement. Generic scales that are useful for assessing the perception of the general state of health, such as the SF-36 which fundamentally evaluates the functional state and emotional well-being, may be used, or specific questionnaires that attempt to evaluate the impact that a determined illness has on the quality of life, in this case the presence of fecal incontinence (FI), can also be administered. 490

2 Vol. 49, No. 4 SPANISH FECAL INCONTINENCE QUESTIONNAIRE 491 In 2000, Rockwood et al. 1 first published a survey on the quality of life specifically for patients with FI, which was validated in English: the Fecal Incontinence Quality of Life Scale (FIQL). This questionnaire, developed after meticulous screening, consists of 29 items that evaluate four scales (lifestyle, behavior, depression, and embarrassment) and was psychometrically assessed, complying with the criteria of reliability and validation sufficiently to evaluate the quality of life specifically in patients with FI. The reception of the mailed questionnaire was very low; only 9 of 55 patients completed the test retest. Therefore, it was necessary to repeat the study by means of telephone interviews with 61 patients, of which only 47 (77 percent) finished. The convergent validation was performed using the generic questionnaire SF-36. This questionnaire has been widely used to evaluate the changes in quality of life in patients subjected to different types of treatment: lateral internal sphincterotmy, 2 treatment with heat controlled by radiofrequency, 3,4 injection of substances to increase the volume (microspheres) in the internal anal sphincter, 5 artificial anal sphincter, 6,7 overlapping anal sphincter repair, 8 and neurostimulation. 9 However, the correlation between the severity of the incontinence and the information obtained by the FIQL has not been evaluated. Furthermore, validations in other languages have not been performed either. The aim of this study was to translate and adapt the FIQL to Spanish culture and to validate it following usual psychometric tools. Also, the discriminant validity of the questionnaire according to the severity of FI was evaluated. PATIENTS AND METHODS The study population was made up of 118 patients over 18 years old. All suffered FI of diverse etiology and were recruited between June and November 2001 in eleven hospitals in Spain. All patients presented active symptoms at the moment of inclusion and had the intellectual capacity to understand and fill in the questionnaire. Participation was voluntary. Permission was obtained for the use of the original questionnaire (Fecal Incontinence Quality of Life Scale (FIQL)) from the authors of the English validation. 1 This questionnaire comprises of 29 items that cover four dimensions of perceived health: lifestyle (10 items), behavior (9 items), depression/ self-perception (7 items), and embarrassment (3 items). Each item has a range of 1 to 4, with 1 being the lowest value for the state of quality of life. The score for each scale is the average of all the items. Cultural Adaptation The translation to Spanish was performed by four gastroenterologists accustomed to evaluating functional digestive pathology and a psychologist who specializes in surveys on the quality of life, all with sufficient knowledge of the English language. Once translated and some expressions modified to adapt them to the Spanish language and culture, the questionnaire was back-translated from Spanish into English by two native bilingual doctors, one from the United States and the other from the United Kingdom. After consensus of the researchers, the translated version was administered to 14 subjects (12 women and 2 men, age = 56 T 12 years), 10 of them patients with FI, to determine the difficulty and degree of comprehension of the questionnaire (pilot test of the adaptation). The final version, which was called Cuestionario de Calidad de Vida de Incontinencia Anal (CCVIA), was approved by consensus in a meeting of the Grupo Español de Motilidad Digestiva (GEMD) (Appendix 1). Study Design All surveys were performed in each of the participating hospitals (Appendix 2). The patients themselves filled in the FI-specific quality-of-life questionnaire (CCVIA), together with the Spanish version of the generic questionnaire SF Also, a questionnaire to measure the severity of the incontinence (Wexner scale) 11 was completed. Between seven and ten days afterward, the patients again completed the FI-specific questionnaire (CCVIA). Patients were helped by medical personnel if they had any questions when filling in the questionnaires. Psychometric Properties Internal Reliability. The internal consistency of each scale was analyzed by means of the Cronbach alpha coefficient, the result being considered acceptable (> ), good (> ), and excellent (>0.9). 12 Test Retest Reliability. The temporal stability of the questionnaire, repeated in an interval of seven to ten days during which no change was expected to occur, was evaluated by calculating the interclass cor-

3 492 MINGUEZ ET AL Dis Colon Rectum, April 2006 relation coefficient (ICC) for each scale with the corresponding 95 percent confidence interval (95 CI). Traditionally, it is accepted that the ICC is adequate when the value is higher than Validity. The convergent validity of the questionnaire was analyzed by evaluating the correlation between the four scales of the CCVIA and the appropriate dimensions of the SF-36 (Pearson correlation coefficient). To analyze the divergent validity, the four scales of the CCVIA were correlated to the Wexner scale of incontinence severity (measuring it globally and establishing a subgroup in which the score that depended on lifestyle was excluded), severity of incontinence depending on the use of pads, and severity of incontinence depending on the existence of total (gases, liquids, and solids) or partial incontinence (only gases and liquids). Statistical Analysis The descriptive analysis of each of the quantitative variables of the questionnaire (specific and generic) and of the Wexner scale was performed by means of analysis of average values and standard deviation. The analysis of internal validity was performed by Cronbach alpha coefficients, whereas the test-retest analysis was performed using the ICC. The analysis of the validity of CCVIA with respect to SF-36 was made using Pearson correlation coefficients. A P value of less than 0.05 was considered significant. RESULTS Translation and Back-Translation In the back-translation there were only minor inconsistencies in two items. Because of the cultural adaptation, the answers in section Q3 of the original questionnaire were modified after the pilot test and discussion between the researchers about the best possibilities. The original answers strongly agree, somewhat agree, somewhat disagree, and strongly disagree were replaced by most of the time, some of the time, a little of the time, and none of the time. These answers were perfectly understood by the pilot population; in contrast, those literally translated from the original English were not completely understood by the patients and help from hospital staff was frequently needed to answer the questionnaire. In the answers about having episodes of incontinence, agree or disagree was changed to frequency. Patients Of the 118 patients recruited in the study period, 111 (94 percent) completed all the questionnaires (92 women and 19 men; average age = 60 T 12 years). With respect to education, 36 percent had less than high school, 32 percent had finished high school, 19 percent had some college, and 10 percent had a B.S., B.A., or graduate degree. The average severity of incontinence, according to the Wexner scale, was 12 T 4.8; 78 percent of the patients on some occasion had used protective pads to avoid soiling undergarments; and 82 percent had complete incontinence (gases, liquids, and solids). Psychometric Analysis Reliability. Table 1 gives the evaluation of temporal stability, which was optimal (ICC > 0.80) for the scales related to lifestyle, behavior, and depression/ self-perception. However, the values were more inferior than desired for the scale of embarrassment (ICC = 0.74). The questions that constitute the four scales of the CCVIA showed an acceptable internal reliability (consistency), with alpha values over 0.70 in all cases (Table 1). Convergent Validity. The correlation that exists between the four scales of the CCVIA questionnaire and the corresponding scales of the SF-36 was examined, making a total of ten comparisons (Table 2). All were statistically significant, confirming that the questionnaire analyzed possesses an adequate validity when compared with an instrument of proven sensitivity such as the quality-of-life questionnaire SF-36. Divergent Validity. The correlation between the severity of the incontinence and CCVIA was very good, when taking into account the global results of the score of the questionnaire of Wexner or the partial results, excluding the score that corresponds to the change in lifestyle (Table 3). The existence of an inverse correlation is observed (the higher the score in the Wexner scale, the lower it is in each domain of CCVIA), i.e., the more severe the incontinence, the higher the repercussion on the perception of health for each of the domains. With a cutoff point of 9 on the Wexner scale, significant differences between patients were observed (Table 4). The use of protective pads was related to a worse perception of health in each domain of CCVIA

4 Vol. 49, No. 4 SPANISH FECAL INCONTINENCE QUESTIONNAIRE 493 Table 1. Values Obtained by Means of Two Administrations for Each Scale of the Questionnaire on the Quality of Life for Fecal Incontinence Scale Test Retest ICC Alpha Lifestyle 2.86 (0.99) 2.87 (1.04) 0.92 ( ) 0.96 Behavior 2.31 (0.84) 2.36 (0.91) 0.90 ( ) 0.95 Depression self-perception 3.12 (0.78) 3.20 (0.77) 0.85 ( ) 0.92 Embarrassment 2.37 (0.93) 2.53 (0.95) 0.74 ( ) 0.85 The values of test and retest are expressed as means (standard deviation) and the interclass correlation coefficient (ICC) as coefficients and 95% confidence intervals. Table 2. Correlation of Scales of the Questionaire on the Quality of Life for Fecal Incontinence with the Scales Considered in the Generic Questionnaire SF-36 Physical Role General Health Vitality Social Functioning Emotional Role Mental Health Lifestyle 0.43* 0.54* 0.38* Behavior 0.47* Depression self-perception 0.64* 0.63* 0.62* Embarrassment 0.23** 0.37* 0.25** *P < 0.001; **P < Table 3. Pearson s Correlation Coefficient Between Scores of Wexner Scale and Domains of CCVIA without Score of Change in Lifestyle Global Lifestyle 0.49* 0.62* Behavior 0.50* 0.82* Depression 0.47* 0.89* Embarrassment 0.45* 0.58* CCVIA = Cuestionario de Calidad de Vida de Incontinencia Anal. *P < Table 4. Comparison Between Different Groups of Patients with Fecal Incontinence (FI) According to the Score of Severity of Wexner Above or Below 9 and the Perception of the Quality of Life by the Domains of CCVIA Wexner <9 (29%) Wexner Q9 (70%) Lifestyle 3.5 ± 0.7* 2.6 ± 0.9 Behavior 2.9 ± 0.8* 2.0 ± 0.7 Depression 3.5 ± 0.8* 2.6 ± 0.9 Embarrassment 2.8 ± 0.8* 2.1 ± 0.9 CCCIA = Cuestionario de Calidad de Vida de Incontinencia Anal. *P < (Table 5). Moreover, there were significant differences in behavior, lifestyle, and embarrassment between patients who suffer total FI and those who present incontinence of liquid stool or gas (Table 6). DISCUSSION This study presents the results of the transcultural adaptation and the validation of the Fecal Incontinence Quality of Life questionnaire (FIQL) for its use in the Spanish population. CCVIA is the first specific questionnaire that evaluates the quality of life of patients with FI to be validated in the Spanish language. There is a need for measurements of quality of life in Spanish given the large Spanish-speaking population that exists in the world (i.e., 400 million people; 40 million in the United States). Historically, all study groups have recognized that FI has a great impact on the quality of life of patients and it has been empirically observed that the more serious the incontinence, the higher the repercussion on different social and personal events. However, it has been only recently that objective forms of measurement, by means of generic or specific questionnaires, have begun to evaluate the effect that FI (different types and degrees of severity) has on the quality of life and the changes that patients undergo after treatment. The form of measurement has been different depending on the questionnaire used. The simplest form asks about the influence that FI had on the quality of life of a patient (none, some, much) and/or frequency (from never to always). This type of question is not capable of discriminating between concrete aspects of life changed by the illness, so clinical or specific studies on the repercussion of FI

5 494 MINGUEZ ET AL Dis Colon Rectum, April 2006 Table 5. Comparison Between Different Groups of Patients with Fecal Incontinence (FI) with Respect to the Use of Pads and the Perception of Quality of Life by Domains of CCVIA Use of Pads (78%) No Pads (22%) Lifestyle 2.7 ± ± 0.8 Behavior 2.2 ± ± 0.8 Depression 2.7 ± ± 0.8 Embarrassment 2.1 ± ± 0.8 CCVIA = Cuestionario de Calidad de Vida de Incontinencia Anal. P < for all values. Table 6. Comparison Between Different Groups of Patients with Fecal Incontinence (FI) with Respect to the Presence of Incontinence of Gas and/or Liquid or Total Incontinence (Gas, Liquid, and Solid) and the Perception of Quality of Life by Domains of CCVIA Incontinence of Gas and/or Liquid (18%) Total Incontinence (82%) Lifestyle 3.3 ± ± 0.9 Behavoir 2.7 ± 0.9* 2.2 ± 0.8 Depression 3.2 ± ± 0.9 Embarrassment 2.8 ± 0.8* 2.2 ± 0.9 CCVIA = Cuestionario de Calidad de Vida de Incontinencia Anal. *P < have used questionnaires, validated or not, that measure the state of health and the quality of life in different domains (activity, social and physical function). The ideal questionnaire should comply with several requisites: simplicity; capacity to evaluate different aspects of the direct impact of FI on the patient; differentiation between suffering FI or not; discrimination according to the severity or type; and sensitivity to any change after treatment. In 1993, Jorge and Wexner 10 proposed a system of scoring (0 20) to evaluate the severity of FI. It included a question about how the frequency of episodes of FI changed lifestyle. This questionnaire, generally known as the Wexner scale, has been widely used because of its simplicity 13 and has been used to evaluate the cutoff score that indicates changes in the quality of life. A score equal to or greater than 9 is associated with a low score of the gastrointestinal quality-of-life index (<105), 14 i.e., confined at home and little social activity. In 2000, Rockwood et al. 1 validated the first specific questionnaire on the quality of life of patients with FI, the Fecal Incontinence Quality of Life Scale (FIQL), which consists of 29 questions that evaluate four domains of health (lifestyle, behavior, depression/self-perception, and embarrassment). Because this questionnaire is recommended by the American Society of Colon and Rectal Surgeons, it was chosen by the GEMD to be validated in Spanish. The transcultural adaptation of FIQL was performed by means of translation/back-translation, which is the most widely used method to ensure the semantic and conceptual equivalence of a questionnaire written in another language. 15 Our objective was to maintain a close correspondence between the original version in United States English and the version in the Spanish spoken in Spain. To this end, several processes were performed: semantic translation of the original English to Spanish, revision of the translation by consensus, and back-translation by two bilingual natives. The last step was the administration of the questionnaire to a group of subjects to evaluate the level of comprehension of the questions. In the final version, the original answers strongly agree, somewhat agree, somewhat disagree, and strongly disagree were replaced by most of the time, some of the time, a little of the time, and none of the time, because these answers were completely understood by the pilot population. The original English questions were not completely understood by the patients and help from hospital staff was needed to answer them. In the answers about having episodes of incontinence, the answer agree or disagree was changed. In this study, the patients completed the questionnaire by themselves during a hospital visit, with personnel on hand to help with any possible questions. We believe that this method is preferable to that used by the authors of the original questionnaire (mail or telephone interview) because it permits a greater degree of intimacy, there is more collaboration to resolve questions, there is no time limit to answer the questions, and consequently there is a higher degree of participation. In this respect, 111 out of 118 patients (94 percent) completed the study adequately, which is a much better response compared with that obtained by mail (16 percent) or by telephone (77 percent), the two methods used in the validation of the original version. The interval between the two administrations of the questionnaire seven to ten days was similar although slightly shorter than in the original publication by Rockwood et al. 1 (10 14 days). This shorter interval could overstimate the test retest reliability, but it minimizes

6 Vol. 49, No. 4 SPANISH FECAL INCONTINENCE QUESTIONNAIRE 495 the risk of a change in the clinical status of the patient (i.e., the severity of incontinence), which could also modify the quality of life. Our study has allowed the validation of the questionnaire using 111 patients, which is better than the original number (47 patients), and using the face-toface self-administration method, which we consider to be more adequate than a telephone interview. The results of internal reliability of our study demonstrate that the questionnaire possesses good psychometric properties in the four domains, with Cronbach alpha values similar or greater than those obtained by Rockwood et al. 1 : lifestyle (0.96 vs. 0.96), behavior (0.94 vs. 0.96), depression (0.92 vs. 0.88), and embarrassment (0.84 vs.0.80). However, in temporal stability, significant differences exist with the domain embarrassment. We believe that a change in the severity of incontinence should not be the cause of the change, because the other domains were stable. We do not know if cultural differences could account for instability of the domain. A possible reason could be that this domain is constituted by only three questions and changes in time in any of them have greater impact on the whole domain. Further studies should investigate this issue. The convergent validation of this questionnaire, when compared with the corresponding domains of SF-36, demonstrates a significant correlation in all of them, with similar results to those obtained in the English version. We have demonstrated that this questionnaire significantly correlates, for all its domains, with the scale of severity of FI most used in the literature (Wexner scale) in such a way that a high score on this scale correlates to a worse quality of life in any of the domains. Furthermore, we have demonstrated that a score of 9 or more on the Wexner scale significantly implies a worse quality of life with respect to a score lower than 9. These data, previously reported by Eypasch et al. 14 using a generic questionnaire on quality of life for gastrointestinal symptoms, are important given the specific characteristics of CCVIA. The analysis of the discriminant capacity depending on the use of protective pads manifests that their use is associated with a worse quality of life. However, only the domains of behavior and embarrassment showed significant differences between patients suffering incontinence of gas or liquid stool and those with total FI (gases, liquids, and solids). In conclusion, we consider that the questionnaire on the quality of life of those suffering from fecal incontinence in its Spanish version (CCVIA) presents sufficient psychometric requirements to be used as a measure of health in patients with FI. APPENDIX 1: FECAL INCONTINENCE QUALITY OF LIFE SCALE Cuestionario de Calidad de Vida de Incontinencia Anal Instructions The next questions refer to what you think about your health and the limitations in your daily habitual activities in the last month due to accidental bowel leakage. Answer every question as it is indicated. Please do not hesitate to ask if you are not sure of what to answer. Instrucciones Las preguntas que siguen se refieren a lo que usted piensa sobre su salud, y las limitaciones que le produce su forma de contener las heces o gases en sus actividades habituales en el último mes. Conteste cada pregunta tal como se le indica. Si no está seguro/a de cómo responder a una pregunta, por favor no dude en preguntar. Clarification ANAL INCONTINENCE is the loss of capacity to control voluntarily the expulsion of flatus or stools by your anus. Aclaraciones: INCONTINENCIA ANAL es la perdida de la capacidad de controlar voluntariamente la expulsión de gases o heces por el ano. Es decir que a una persona cuando se le escapan (sin poder evitarlo) los gases o las heces por el ano se considera que tiene una incontinencia anal. Please Do Not Leave a Question without an Answer. Mark Only One Answer Make a cross in the answer that it is next to your situation No Deje Ninguna Pregunta Sin Responder Marque Una Sola Respuesta Tache con una cruz la respuesta que considere adecuada a su situación

7 496 MINGUEZ ET AL Dis Colon Rectum, April 2006 Q1: In general, would you say your health is: En general, usted diría que su salud es: 1 Ì Excellent (Excelente) 2 Ì Very good (Muy Buena) 3 Ì Good (Bien) 4 Ì Fair (Regular) 5 Ì Poor (Mal) Q2 Q3: In the following text you will find a list of situations and behaviors that can be related to an anal incontinence episode. Please indicate how much of the time the issue is a concern for you due to accidental bowel leakage. If it is a concern for you for reasons other than accidental bowel leakage then mark a cross in no proceed. Q2 Q3: A continuación encontrará un listado de situaciones y de comportamientos que se pueden relacionar con un episodio de incontinencia anal. Por favor indique con qué frecuencia le ocurren en relación a la posibilidad de que usted tenga un episodio de incontinencia anal. En el supuesto de que esta situación se produzca por motivos diferentes a la incontinencia, marque como respuesta válida no procede. DUE TO ACCIDENTAL EPISODES OF ANAL INCONTINENCE DEBIDO A LOS EPISODIOS DE INCONTINENCIA ANAL Q2: Most of the time Muchas veces Some of the time Bastantes veces Alittle of the time Alguna vez None of the time Nunca No proceed No procede a) I am afraid to leave home Tengo miedo (temor) a salir fuera de casa b) I avoid visiting friends Evito hacer visitas a mis amigos c) I avoid staying overnight away from home Evito pasar la noche fuera de casa d) It s difficult for me to leave home and do things like going to a movie or to church Me resulta difícil salir de casa para ir a algunos sitios, como el cine o la iglesia e) I eat less (reduce the quantity of my meals) before leaving home Si tengo que salir de casa reduzco la cantidad de comida f) Whenever I am away from home, I try to stay near a restroom as much as possible Cuando estoy fuera de casa intento estar siempre lo mas cerca posible de un retrete público g) It is fundamental for me to organize my daily activities according to when and how often I need to go to the toilet Para mi es fundamental organizar las actividades diarias en función de cuándo y cuantas veces necesite ir al retrete h) I avoid travelling Evito viajar i) It worries me not be able to reach a toilet in time Me preocupa no ser capaz de llegar al retrete a tiempo j) I feel I have no control over my bowels Me parece que no soy capaz de controlar mi defecación k) I can t hold my bowel movement long enough to get to the bathroom Soy incapaz de aguantar las heces hasta llegar al retrete l) I leak stool without even knowing it Se me escapan las heces sin darme cuenta

8 Vol. 49, No. 4 SPANISH FECAL INCONTINENCE QUESTIONNAIRE 497 m) I try to prevent bowel accidents by staying very near a bathroom Intento prevenir los episodios de incontinencia situándome cerca de un cuarto de baño. Q3: Most of the time Muchas veces Some of the time Bastantes veces Alittleof the time Alguna vez None of the time Nunca No proceed No procede a) I feel ashamed Me siento avergonzada/o b) I can not do many of things I want to do No hago muchas de las cosas que me gustaria hacer c) I worry about bowel accidents Estoypreocupadoporquesemeescapanlasheces d) I feel depressed Me siento deprimido e) I worry about others smelling stool on me Me preocupa que otras personas puedan oler mis heces f) I feel like I am not a healthy person Siento que no soy una persona sana g) I enjoy life less Disfruto menos de la vida h) I have sex less often than I would like to Tengo menos relaciones sexuales de las que desearía i) I feel different from other people Me siento diferente del resto de la gente j) The possibility of bowel accidents is always on my mind En mi cabeza esta siempre presente la posibilidad de tener un episodio de incontinencia k) I am afraid to have sex Tengo miedo al acto sexual l) I avoid traveling on public transport (trains, planes, buses, subway, etc.) Evito hacer viajes en transportes públicos (tren, avión, autobús, metro etc.) m) I avoid eating out Evito comer fuera de casa n) When I go to a new place, I always try to know where the toilet is Cuando voy a un lugar nuevo intento siempre saber dónde está el retrete Q4: During the last month, have you felt sad, discouraged, hopeless, or had many problems that you wondered if anything was worthwhile? Durante el mes pasado, se ha sentido usted tan triste, desanimado, desesperanzado que le parecía que la vida no tenia sentido? 1 Ì Extremely So To the point that I have just about given up (siempre hasta el punto de abandonarlo todo) 2 Ì Very Much So (muchas veces) 3 Ì Quite a Bit (pocas veces) 4 Ì Some Enough to bother me (alguna vez, pero suficiente para sentirme molesto) 5 Ì A Little Bit (muy poco) 6 Ì Not At All (nunca) The Fecal Incontinence Quality of Life Scale is composed of 29 items; these items form four scales: 1. Lifestyle (10 items) 2. Coping/Behavior (9 items)

9 498 MINGUEZ ET AL Dis Colon Rectum, April Depression/Self-Perception (7 items) 4. Embarrassment (3 items) El cuestionario de calidad de vida de incontinencia anal tiene 29 preguntas que evaluan cuatro dominios: 1. Estilo de vida (10 preguntas) 2. Conducta (9 preguntas) 3. Depresión/Percepción de uno mismo (7 preguntas) 4. Verguenza (3 preguntas) Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. Scale scores are the mean to all items in the scale. No proceed is coded as missing value in the analysis for all questions. Se establece un rango del 1 al 5 para cada item. El 1 indica un estado funcional bajo de calidad de vida. La puntuación para cada apartado se calcula como la media de los items que conforman cada apartado (suma de todos los puntos de cada item dividido por el número de items). La respuesta No procede se considera como valor perdido. 1) Lifestile, ten items: Q2a, Q2b, Q2c, Q2d, Q2e, Q2g, Q2h, Q3b, Q3l, Q3m 2) Coping/Behavior, nine items: Q2f, Q2i, Q2j, Q2k, Q2m, Q3d, Q3h, Q3j, Q3n 3) Depression/Self-Perception, seven items: Q1 (is reverse code), Q3d, Q3f, Q3g, Q3i, Q3k, Q4 4) Embarrassment, 3 items: Q2l, Q3a, Q3e 1) Estilo de vida: Lo configuran los items: Q2a, Q2b, Q2c, Q2d, Q2e, Q2g, Q2h, Q3b, Q3l, Q3m APPENDIX 2: COLLABORATING INVESTIGATORS AND CENTERS Institution Hospital Universitario N.S. de la Candelaria, Santa Cruz de Tenerife, Tenerife, Spain Hospital Clinic, IDIBAPS, Barcelona, Spain Hospital Universitario Vall d Hebrón, Barcelona, Spain Hospital General de Albacete, Albacete, Spain Hospital Clínico San Carlos, Madrid, Spain Hospital Clinico Universitario, Valencia, Spain Centro Medico Teknon, Barcelona, Spain Investigator Juan Salvador Baudet, M.D. Gloria Lacima, M.D. Jose Luis Fernández-Fraga, M.D. Pedro Cascales, M.D. Antonio Ruiz de Leon, M.D. Adolfo Benages, MD. Cristina Puigdellivol, MD. 2) Conducta: Los items: Q2: Q2f, Q2i, Q2j, Q2k, Q2m, Q3d, Q3h, Q3j, Q3n 3) Depresión, autopercepción: Q1 (se codifica al revés), Q3d, Q3f, Q3g, Q3i, Q3k, Q4 4) Verguenza: Q2l, Q3a, Q3e REFERENCES 1. Rockwood TH, Church JM, Fleshman JW, et al. Fecal Incontinence Quality of Life Scale, Quality of life instrument for patients with fecal incontinence. Dis Colon Rectum 2000;43: Hyman N. Incontinence after lateral internal sphincterotomy: a prospective study and quality of life assessment. Dis Colon Rectum 2004;1: Efron JE, Corman ML, Fleshman J, et al. Safety and effectiveness of temperature-controlled radio-frequency energy delivery to the anal canal (Secca procedure) for the treatment of fecal incontinence. Dis Colon Rectum 2003;12: Takahashi T, Garcia-Osogobio S, Valdovinos MA, Belmonte C, Barreto C, Velasco L. Extended two-year results of radio-frequency energy delivery for the treatment of fecal incontinence (the Secca procedure). Dis Colon Rectum 2003;6: Davis K, Kumar D, Poloniecki J. Preliminary evaluation of an injectable anal sphincter bulking agent (Durasphere) in the management of faecal incontinence. Aliment Pharmacol Ther 2003;18: Devesa JM, Rey A, Hervas PL, et al. Artificial anal sphincter: complications and functional results of a large personal series. Dis Colon Rectum 2002;9: Wong WD, Congliosi SM, Spencer MP, et al. The safety and efficacy of the artificial bowel sphincter for fecal incontinence: results from a multicenter cohort study. Dis Colon Rectum 2002;9: Halverson AL, Hull TL. Long term outcome of overlapping anal sphincter repair. Dis Colon Rectum 2000;6: Matzel KE, Stadelmaier U, Bittorf B, Hohenfellner M, Hohenberger W. Bilateral sacral spinal nerve stimulation for fecal incontinence after low anterior rectum resection. Int J Colorectal Dis 2002;17: Badia X, Salamero M, Alonso J. La Medición de la Salud. Guia de escalas de medición en español. Cuestionario de Salud SF-36. Barcelona: Edimac edit, Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum 1993;36: Fayes PM, Machin D. Quality of Life: assessment, analysis and interpretation. Chichester: John Wiley & Sons, 2000.

10 Vol. 49, No. 4 SPANISH FECAL INCONTINENCE QUESTIONNAIRE Rockwood TH. Incontinence severity and QOL scales for fecal incontinence. Gastroenterology 2004;126(Suppl 1): S Eypasch E, Williams JI, Wood-Dauphinee S, et al. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br J Surg 1995;82: Sperber AD. Translation and validation of study instruments for cross-cultural research. Gastroenterology 2004;126(Suppl 1):S124 8.