Cross cultural adaptation and validation of The Bowel Function in the Community toll to Brazil

Abstracts

Estudos sobre hábito intestinal, considerando cultura, hábitos alimentares e de vida entre outros, não existem no Brasil. O objetivo deste artigo é apresentar o The Bowel Function in the Community, ferramenta específica para avaliação do hábito intestinal das populações, adaptado e validado para o Brasil. O processo de adaptação cultural incluiu tradução, retrotradução e avaliação por comitê de especialistas, obtendo-se uma versão traduzida do instrumento, posteriormente submetida a análises que atestaram a validade de conteúdo do mesmo. A confiabilidade inter-observadores e estabilidade (teste-reteste) foram confirmadas por níveis de concordância de boa a excelente e de moderada a excelente para a maioria das questões e agrupamentos do instrumento. Concluiu-se que a versão adaptada do instrumento pode ser aplicada em nosso meio para dar continuidade ao processo de validação, bem como para ampliar o conhecimento do hábito intestinal na população brasileira.

Defecação; Comparação transcultural; Enfermagem; Estudos de validação

ORIGINAL ARTICLE

Cross Cultural Adaptation and validation of The Bowel function in the community tool to Brazil

Adaptación cultural y validacion deel instrumento The Bowel Function in the Community para Brazil

Rita de Cássia Domansky^I; Vera Lúcia Conceição de Gouveia Santos^II

^IStomal Therapy Nurse. PhD. in Nursing. University Hospital of State University of Londrina. Professor of the Nursing Course at UniFil - University Center Filadélfia. Londrina, PR, Brazil. [e-mail]

IIStomal Therapy Nurse. Associated Professor of the Departament of Medical Surgical Nursing, School of Nursing of the University of São Paulo.São Paulo, SP, Brazil. [e-mail]

^{Correspondence addressed to}

ABSTRACT

Studies about bowel habit, considering culture, dietary and life patterns, do not exist in Brazil. The aim of this article is to present The Bowel Function in the Community, as a specific tool to assess the bowel function in populations, adapted and validated in Brazil. The process of cultural adaptation and validation included translation, back translation and evaluation by a committee of specialists. The obtained version was submitted to analysis which confirmed its content validity. Inter rater reliability and stability were ratified through good to excellent and moderate to excellent levels of agreement respectively for almost all of instrument´s questions and groups. In conclusion, the adapted and validated version of The Bowel Function in the Community tool may be applied in our country to continue the validation process and to obtain more information about the bowel habits in Brazilian population.

Key words: Defecation. Cross-cultural comparison. Nursing. Validation studies.

RESUMEN

Estudios sobre el hábito intestinal, considerando la cultura, los estándares de alimentación y de vida, no existen en Brasil. El objetivo del artículo es presentar The bowel function in the community, como una herramienta para evaluar el habito intestinal de las poblaciones, ya adaptado y validado en Brazil. El proceso de adaptación cultural ha incluido la traducción, traducción inversa y evaluación por comité de expertos. La versión traducida fue sometida a análisis que han confirmado su validez de contenido. La fiabilidad entre observadores y estabilidad fueron confirmadas a través de los niveles buenos a excelentes y moderados a excelentes, respectivamente, para la mayoría de las preguntas y de los grupos del instrumento. En conclusión, la versión adaptada del instrumento puede ser usada en nuestro país, permitiendo continuar su proceso de validación como obtener más datos a cerca del hábito intestinal de la población brasileña.

Descriptores: Defecación. Comparación transcultural. Enfermería. Estudios de validación.

INTRODUCTION

Bowel habits vary from person to person, and it is difficult to establish standards of normalcy. This variation does not happen only from one individual to the next, but also in the same individual and in different moments of life. It can be affected by diet, stress, drugs, diseases and co morbidities, even by social and cultural standards, among others⁽¹⁾.

In the 1960s, the studies were concerned with distinguishing the frequency of the bowel habits in healthy individuals, with mentions such as once a day⁽²⁾ or 3 to 11 evacuations a week⁽³⁾. In the 1980s, two other aspects were included, which are still considered fundamental in bowel habit assessment, such as the consistency and easy exoneration of the fecal contents instead of the frequency of evacuation⁽⁴⁾. Therefore, the limit between normalcy and abnormality for bowel habits is still undefined, and, even in wide-ranging, careful studies with samples that were apparently healthy^(5-6), the authors could not achieve a consensus.

Still, studies indicate that between 94 and 100% of the healthy population have between three evacuations a day and three evacuations a week, and the frequency of evacuation, fecal consistency, absence of pain or effort to evacuate, feeling of full evacuation and feelings of pleasure make up the definition of normal bowel habits^(7-8).

In Brazil, there are no studies about bowel habits that cover aspects such as culture, lifestyle and dietary habits, as well as others, as mentioned in American studies. Likewise, there are no epidemiological studies about bowel constipation (BC) and fecal incontinence (FI) or other gastrointestinal functional disorders. Although international publications are useful, they do not reflect the Brazilian population.

The inexistence of Brazilian publications covering this topic encouraged the cultural adaptation and the validation of the only instrument found in literature about the topic, The Bowel Function in the Community Tool, an objective tool for assessing the intestinal patterns in the community.

The purpose of this article is to present The Bowel Function in the Community Tool, as an objective tool to assess the intestinal patterns in the community, adapted for Brazil.

THE BOWEL FUNCTION IN THE COMMUNITY TOOL

The The Bowel Function in the Community Tool was developed by Reilly and co-workers, in the gastroenterology research unit of Mayo Clinic, Minnesota⁽⁹⁾. It consists of 70 questions, grouped by specificity: general bowel habits (16 questions); fecal incontinence (13 questions); urinary symptoms (13 questions); anal-rectal diseases and surgical history (12 questions); medical care utilization (4 questions) and potential contributing medical disorders (5 questions). In the original study, six questions were not included in these groups, and their respective results were not presented. The instrument was originally developed to be self-applicable and does not allow for the calculation of scores, either partial in the groups or total in the scale. Therefore, the interpretation is executed from the analysis of the responses in each group, aiming to characterize the bowel pattern or patterns according to international criteria.

In order to validate the instrument, the authors applied it to 94 patients who received care in gastroenterology and coloproctology outpatient services, with 75 of them being re-tested within six weeks through mail (34) and telephone (41) by a specialist physician and considered the gold standard. The Kappa index (k) was used both for the verification of intra rater reliability - comparing the answers of the self-applied instrument with those received by mail - and for the concurrent validity, obtained by comparing the answers of the self-applied instrument with those obtained by telephone. The results obtained by the authors indicate that the instrument was understood and accepted well, with k values between 0.03 and 1 for the test-retest reliability and between 0.27 and 1 for the concurrent validity. Both tests considered a confidence interval of 95%.

PROCEDURES OF CULTURAL ADAPTATION AND VALIDATION FOR BRAZIL

The authors of The Bowel Function in the Community Tool authorized the Brazilian researchers to adapt the instrument for the local reality, and the Ethical Committee in Research of the Nursing School of the University of São Paulo (File # no 370/2004/CEP/EEUSP) and the hospital where it was applied allowed its execution.

The cultural adaptation was based in methods proposed by Brazilian⁽¹¹⁾ and international⁽¹²⁾ authors. Initially, the original instrument was translated by a professional translator of English who was also fluent in Portuguese and aware of the research goals. The back-translation of the Portuguese version in English was done by another professional of English who was also fluent in Portuguese, but not aware of the research goals. A board of five bilingual specialists in coloproctology proofread and compared the original, the translated and the back-translated versions, focusing on the semantic, idiomatic, cultural and conceptual equivalence of all three versions.

The resulting version was submitted to 26 individuals of the general population, split in three sequential groups: pre-test 1 (PT1), with 10 individuals undergoing interview and self-application; focal group (FG), with 6 individuals; and pre-test 2 (PT2), with 10 individuals, undergoing interview and self-application as well. All the subjects were randomly selected and had characteristics that were similar to the general population. At the end of this stage - after each group received the product of the previous group with updated suggestions - the version considered adequate for the next stage of the project (analysis of the measurement properties of the instrument) was obtained.

The measurement properties of the adapted version were tested in a sample of the general population, where the inter rater reliability and the stability or test-retest reliability were analyzed. It should be noted that content validity - also proposed as a measurement property to be assessed - was verified in the first stage, according to the analysis of the adequacy of the items of the instrument to represent the hypothetical universe of the content, in correct proportions⁽¹³⁾ by the board of specialists. Even though it is possible to calculate the content validity index - which indicates the range of agreement between the specialists, it should be considered that the subjective judgments should be relied upon⁽¹³⁾.

The clinical application to a consecutive sample of 356 active workers of administrative sectors in a public school hospital, was done from June 28 to July 16, 2004. The eligibility criteria were: being physically and mentally able to take part in the study by answering the interview; holding a position in an administrative department; and agreeing in taking part in the study.

Data collection was done by the researchers and six undergraduate Nursing students at Londrina State University, submitted to qualification to obtain the standardization of the collection procedures through interviews. Therefore, after a simultaneous and independent application of the adapted version of the instrument, the students who obtained at least 80% of agreement with researcher were considered capable of performing data collection.

After the study subjects were selected, the interviews were scheduled and happened individually, in a private place, during their working shift and at their workplace. If the individual could not be found at the appointed time and place, the interviewers would retry to meet this person three more times, before excluding the person from the sample.

In order to evaluate the inter rater reliability, the first 120 interviews were held by the interviewers and the researcher, with the questionnaires being filled out simultaneously and independently. For the evaluation of the test-retest reliability, 120 individuals were drawn from the 356 interviewees, with the purpose of having the same interviewers reapply the questionnaires one week after the first interview.

The descriptive analysis used average values, standard deviations and variation amplitude (minimum - maximum). For the evaluation of the level of agreement among the answers, both for the inter rater reliability and for the test-retest, the Kappa index was used (k). The k values varied from -1 (total disagreement) to +1 (full agreement) and, in this study, the following parameters were adopted: k < 0.00 = inexistent agreement; k between 0.00 and 0.19 = weak agreement; k between 0.20 and 0.39 = regular agreement; k between 0.40 and 0.59 = moderate agreement; k between 0.60 and 0.79 = good agreement; k between 0.80 and 1.00 = excellent agreement⁽¹⁴⁾. The level of statistical significance was set at 5%.

RESULTS AND DISCUSSION

After the translation and back-translation of the instrument were finished, the analysis of the original and translated versions by the members of the board of specialists yielded levels of agreement of 100% for 36 (52%) of 69 questions of the instrument and 80% for the other 33 (48%). The suggestions were considered and included in the instrument.

Question #69 - which deals with the educational level of the subjects - was changed since the beginning of the translation process in order to conform with the parameters set by the Ministry of Education and Culture in Brazil. Some of the drugs mentioned in question #17 are not marketed in Brazil, which caused them to be adapted to the drugs that are available in the national market, including lukewarm water with cornstarch - a homemade remedy that is widely used in the country.

During the pre-testing stage - split into pre-test 1, focal group and pre-test 2 - all the participants were randomly selected, with characteristics that were similar to the target population of this study. In pre-test 1 (PT1), with an average duration of 20 minutes for the interview, the individuals had no difficulties to answer the questionnaire, making few semantic and linguistic suggestions to improve the understanding of the questions, which were incorporated. Six individuals who had not been part of PT1 took part in the focal group (FG) stage, with 90-minute meetings. They only suggested the inclusion of the expression Cross the answer in the header of questions 31, 32 and 33, which was then done. In pre-test 2 (PT2), which had 10 individuals who had not taken part in either PT1 or GF, the interview also lasted around 20 minutes. There were no suggestions for changes in the instrument at this stage.

After the first stage of the study was finished, it yielded the adapted version of the instrument, used on the clinical application stage for the validation of its properties of measurement.

Among the 356 individuals of the sample, 44% were male and 56% were female; age varied from 24 to 70 years; 76% were Caucasians; 69% were married. Regarding the level of education, 37% had full high school education and 22% had incomplete elementary education. Of the respondents, 44% earned from four to six times the minimum wage and 36% earned up to three times the minimum wage.

For the verification of the inter rater reliability, the sub-sample consisted of 120 individuals, of which 65% were women, aged 20 to 68 years; 74% were Caucasians and 67% were married; 38% had high-school level education and 43% had elementary education; 41% of them earned from one to three times the minimum wage. Of the 63 questions considered for this analysis, 77.7% had an excellent level of agreement between the observers, i.e., between the interviewers and the researchers. The k indexes per group, the confidence interval of 95% and the p value for the interrater reliability are shown in Table 1.

For the analysis of the test-retest reliability with the 120 subjects submitted to the second interview after one week, 53% were female, aged between 29 and 67 years old; 71% were Caucasians and 70% were married; 46% had high-school education and 23 had incomplete elementary education; 44% of the respondents earned between four and six times the minimum wage and 32%, up to three times the minimum wage. The agreement levels obtained (k) show that 33% of the 63 questions had k between 0.40 and 0.60 (moderate agreement) and, when added to the good and excellent levels of concordance (k between .061 and 1.00), the result is 27% of the questions (Table 1).

For the questions that were not inserted in the groups, the obtained k indexes were k = 0.000 for question #29; k = 0.3424 to 0.4568 for question #31; k = 0.6033 to 0.7245 for question #32; k = 0.7070 to 0.8355 for question #33 and 0.3865 for question #68, all of them with p < 0.0001.

The adapted version of the instrument (^Appendix) was well-accepted and understood by the subjects of the investigation, made easy by the interview technique, which minimized the problems due to lack of knowledge about the content and the interpretations of the questions or answers. Kappa indexes lower than 0.40 are probably related to the low prevalence of the event in the studied population or the presence of answers that can be considered inadequate or even absent, due to embarrassment caused by the question. It should be considered that the topic dealt with in the questionnaire - bowel habits - can embarrass the respondents, especially if they have to face younger interviewers - even though these have been previously trained - in addition to cross-section aspects of the study, i.e., involves a single meeting between interviewer and interviewee. Such occurrences may result in limitations for the study, and should be investigated in the future. On the other hand, when life events are assessed at two different times, stability may suffer some sort of alteration and interfere in the measurement, especially if the coverage corresponds to the twelve previous months⁽¹³⁾, such as in this case.

In addition to these considerations, there are no studies that can be considered the gold standard in the topic in Brazil, which would not only allow for the expansion of the results obtained herein as the number of tested measurement properties, resulting in a more accurate assessment of the instrument in its adapted version. Certainly, changes must be considered for future applications, whose considerations were also mentioned by the authors⁽⁹⁾.

FINAL CONSIDERATIONS

The process of cultural adaptation and validation of The Bowel Function in the Community Tool was the first step in the development of a project whose purpose is to asses the bowel habits in communities of the Brazilian population, allowing for the identification of the bowel habits and the establishment of a gold standard.

The restricted number of measurement properties tested, related mainly to reliability, could lead the critics to disregard the validation of the adapted version of the instrument for Brazilians. It should be noted, however, that the results obtained here are added to those that were obtained and demonstrated in the original study⁽⁹⁾.

In Brazil, the group fecal incontinence in the instrument has already been used in a study⁽¹⁵⁾ about the prevalence of urinary, anal and combined incontinence, in a sample stratified per population group in the city of Pouso Alegre, in the state of Minas Gerais; and the whole instrument was used in a study⁽¹⁶⁾ that assessed the bowel habits of the urban population in Londrina (PR).

It is worth noting that the process of validation is continuous, i.e., the more evidence can be gathered about an instrument that measures what it should, the more reliable it will be considered by the researchers in its validity and usage⁽¹³⁾.

REFERENCES

Received: 13/07/2009

Approved: 24/08/2009

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• 15. Santos CRS. Prevalência das incontinências urinária e anal na população urbana de Pouso Alegre MG [dissertação na Internet] São Paulo: Escola de Enfermagem, Universidade de São Paulo; 2008. [citado 2009 maio 15]. Disponível em: http://www.teses.usp.br/teses/disponiveis/7/7139/tde-07052009-104824/
• 16. Domansky RC. Avaliação do hábito intestinal e fatores de risco para a incontinência anal na população geral [tese na Internet]. São Paulo: Escola de Enfermagem, Universidade de São Paulo; 2009. [citado 2009 jul. 2]. Disponível em: http://www.teses.usp.br/teses/disponiveis/7/7139/tde-23062009-094830/

Appendix

Correspondence addressed to:

Vera Lucia CG Santos

Av. Dr. Enéas de Carvalho Aguiar, 419 - Cerqueira César

CEP 05403-000 - São Paulo, SP, Brazil

Publication Dates

• Publication in this collection
  16 Dec 2009
• Date of issue
  Dec 2009

History

• Received
  13 July 2009
• Accepted
  24 Aug 2009