Cross-cultural Adaptation and Validation of the Stoma Quality of Life Questionnaire for Patients With a Colostomy or Ileostomy in Brazil: A Cross-sectional Study
Many studies examining the quality of life of stoma patients utilize questionnaires that have not been validated specifically for these patients in their native language. Owing to the large and increasing prevalence of intestinal stomas, a cross-sectional study was conducted among patients of a stoma patient health care service in Juiz de Fora, Brazil between September 2014 and August 2015 to validate the Stoma Quality of Life (Stoma-QoL) questionnaire in Portuguese (Brazilian variant).
In addition, the effect of sociodemographic, clinical, and eating habit variables on the quality of life of people with a colostomy or ileostomy was assessed. Eating habit variables included eating comfort in the postoperative period, excluding foods for a period of time, fear of eating, and excluding foods that may cause odor, gas, diarrhea, and/or constipation. All patients with a colostomy or ileostomy served by 1 ostomy care center were invited to participate. Patients who were at least 18 years of age, provided signed informed consent, and had the physical and mental capacity to complete the questionnaire were eligible to participate. The sociodemographic, clinical history, eating behavior, and Stoma-QoL questionnaires were administered by trained researchers as part of patient nutritional care. A sample of 11 (10% of all study participants) also completed the 12-item Short Form Health Survey (SF-12), which includes a Mental Component Summary (MCS) and a Physical Component Summary (PCS), to establish convergent validity. All participant response data were collected using a standardized form developed for this study and stored in electronic files. The identities of patients were kept anonymous, and patients had the option to refuse to participate during the assessment. Data were analyzed descriptively; the Mann-Whitney and Kruskal-Wallis tests were used to analyze associations among the variables collected. Normal distribution of the Stoma-QoL total scores was assessed using the Kolmogorov-Smirnov test. Internal consistency was assessed as a whole using Cronbach’s alpha, and agreement and reproducibility were determined using the intraclass correlation coefficient. Relationships between the Stoma-QoL and the SF-12 items were examined using the Pearson correlation coefficient. The majority of the 111 participants were men (57, 51.4%), most (94, 84.7%) were 50 years of age or older, 70 (63.1%) had a colostomy, and 41 (36.9%) had an ileostomy. Most stomas (79, 71.2%) were created to treat cancer of the colon and rectum. The mean overall Stoma-QoL score for study participants was 58.7 ± SD 12.0 (range 32.0–78.0). The internal consistency of the translated Stoma-QoL was .87, demonstrating a high degree of reliability. The convergent validity of the Stoma-QoL with the SF-12 confirmed higher correlation among the items regarding emotional aspects, mental health, social aspects, and vitality, with a higher correlation with the MCS (r = .52; P = .02) and lower correlation between the PCS and the items that assess general health, functional capacity, physical aspects, and pain (r = .38; P = .04), although both were significant. A moderate and significant association was noted between the questionnaires. Women (P = .02) and patients who deprived themselves of food for a certain period of time had a lower quality of life (P = .05). Persons who excluded foods out of fear of repercussions also had significantly lower QoL scores (P <.001). Colostomy and ileostomy patients had a similar quality of life. This study confirms the Stoma-QoL is a valid research tool for colostomy and ileostomy patients in Brazil. Further studies are recommended in the field of food and nutrition to verify observed concerns related to the eating behavior of intestinal stoma patients and the relationship to their quality of life.
Extended life expectancy has increased the prevalence of chronic disorders. Improved living conditions, better prevention of chronic diseases, infectious disease management, medical technological improvements, and overall aging of the population have resulted in more people living with chronic diseases that can negatively affect their quality of life. As a result, quality of life has become an important area for research in health care.1 Chronic diseases are usually slow in progression, long in duration, and require medical treatment. Most chronic diseases can worsen patients’ overall health by limiting their capacity to live well and compromising functional status, productivity, and quality of life; they are also major contributors to health care costs.2
Instruments used to assess physical, social, and emotional aspects related to quality of life can be categorized as generic or specific. Generic instruments are used to measure overall quality of life; specific instruments are used for related groups of people who have a disease or are undergoing treatment3 and tend to be more sensitive to a particular population.4
With the increase in the number of quality-of-life assessment instruments, interest arose in translating them for other cultures. However, little research has been conducted on the problem of cultural impact on meaning and scaling of constructs; additionally, cross-cultural comparisons and evaluations of core quality-of-life domains and indicators are lacking.5
The creation of an intestinal stoma (ostomy) has a strong emotional impact on patients; the stoma changes body image, self-image, and self-esteem and can be accompanied by associated disorders. Body alterations such as stomas can cause various adjustments known to impair quality of life.6 The creation of a stoma also interrupts the absorptive process at the point where it is constructed, affecting both the nature of bodily elimination and the individual’s ability to absorb nutrients.7 The number of cases and conditions that lead to the use of intestinal stomas such as colon and rectum cancer, inflammatory bowel diseases, sigmoid volvulus, diverticulitis, and accidents has increased. In Western countries, ~0.3% of the adult population live with a stoma.8 To date, there are no official published data on the number of ostomates in Brazil.
Most studies on the quality of life of stoma patients use generic questionnaires or those related to cancer. However, quality-of-life questionnaires specific to people with ostomies may better detect differences and changes in quality of life in these patients.9,10
European nurses sought to create a quality-of-life questionnaire specifically for patients with a colostomy or ileostomy. The 37-question Stoma Quality of Life (Stoma-QoL) survey, developed in English, was translated initially into French, German, Spanish, and Danish, and repeatedly administered to 182 patients. The validity and reliability of the final version of the questionnaire subsequently were tested, and 20 items were selected. The final Stoma-QoL questionnaire was based on 4 domains: sleep, sexual activity, relations to family and close friends, and social relations outside family and close friends. Each of the 20 items uses a 4-response Likert scale from 1 (always) to 4 (not at all). The total score ranges from 20 to 80 (the higher the score, the better the quality of life). In a study11 involving the development and validation of Stoma-QoL, the questionnaire was self-administered to 182 colostomy and ileostomy patients; the authors confirmed the suitability of the instrument in clinical practice and research. Internal consistency reliability calculated as Cronbach’s alpha was 0.92. Spearman’s correlation coefficients of scores across times of administration indicated a high test-retest reliability. Item calibrations by country confirmed cross-cultural comparability across the European countries included in the study.
The aim of this study was to validate a Portuguese (Brazilian variant) version of the Stoma-QoL. In addition, the authors assessed how sociodemographic, clinical, and eating habit variables can affect the quality of life of stoma patients.
Methods and Procedures
Cross-cultural validation. The first phase of the study was the cross-cultural validation of the Stoma-QoL. In the second phase, the cross-sectional study was conducted to analyze variables associated with the questionnaire point scoring. The study was conducted between September 2014 and August 2015.
Cross-cultural validation is a complex process that requires high methodological rigor; there is no consensus in the literature about the how it should be performed.12 For the cross-cultural adaptation of this questionnaire to the Brazilian variant of Portuguese, the following steps were carried out: validation, instrument translation to the new language, assessment by experts, and back-translation by a native English speaker.12,13 Initially, the questionnaire in its original English version was translated into Portuguese independently by a nutritionist and a nurse with at least 5 years of experience in their fields. They translated and analyzed each item selected to compose the instrument until they agreed to ensure the instrument’s applicability and whether all the aspects to be studied were accurately represented. This validation is not statistically determined and is not expressed by any correlation coefficient. The final consolidated version of this independent translation was submitted to a native English language translator, together with the original in English, to evaluate the adaptation of the items to the new language. The translator must be proficient in both languages of interest and familiar with the cultures associated with the language of the different groups. This characteristic allows for the translation process to consider the nuances of the language for which the instrument is targeted, facilitating a more culturally appropriate adaptation process.14
Participants. After translation, the Stoma-QoL was administered to patients served by the Stoma Patient Health Care Service in Juiz de Fora, a Brazilian city located in the Southeast region of the country with approximately 500 000 inhabitants and a health care hub for ~2 million people. This service provided care for 428 patients monthly; all were contacted by telephone and invited to participate in the survey. Study inclusion criteria stipulated participants should be at least 18 years of age, have an intestinal stoma (ileostomy or colostomy), and be physically and mentally capable of completing the Stoma-QoL along with a sociodemographic, clinical, and eating behavior questionnaire. Eating habit variables included eating comfort in the postoperative period, excluding foods for a period of time, fear of eating, and excluding foods for different reasons. Participation was voluntary. Researchers completed the paper-and-pencil questionnaires: Table 1, Table 2, and Table 3 show the questions and scoring.
The questionnaires were administered by trained researchers as part of their nutritional clinical care. All volunteers gave their written informed consent after being provided oral and written information about the aims and protocol of the study. The Stoma-QoL questionnaire takes 5 to 10 minutes to complete. The questionnaire with sociodemographic, clinical, and eating behavior characteristics takes 15 to 20 minutes to complete.
The present study was approved by the Ethical Committee in Human Research from Federal University of Juiz de Fora (protocol number 516.306).
Data collection. The first author trained a team of graduates in nutrition to participate in the patient assessment on the selected measurement day. All data were collected using a standardized form developed for the study and stored electronically. The identities of patients were kept anonymous, and patients had the option to refuse to participate during the assessment.
Statistical analysis. The reliability and accuracy of the Stoma-QoL were assessed through their internal consistency using Cronbach’s alpha coefficient. Internal consistency was assessed for the questionnaire as a whole, with a minimum value of 0.70 adopted as a satisfactory level.15 Agreement and reproducibility were assessed using the intraclass correlation coefficient (ICC). An ICC of 0.75 indicates excellent study reproducibility.16
Convergent validity. The last step of the study was establishing convergent validity, defined as the significant relationship between 2 or more measures of a single construct or of theoretically related constructs using different methods or evaluation instruments.17 This step of the validation process involved the Stoma-QoL questionnaire translated into Brazilian Portuguese and the 12-item version of the Short-Form Health Survey (SF-12) previously validated in Brazil.18 The SF-12 questionnaire evaluates 8 dimensions that influence quality of life and considers the individual’s perception of aspects of health over the previous 4 weeks. Each item has a group of responses distributed on a graduated Likert scale and evaluates the following dimensions: physical functioning, role-physical, pain, general health, vitality, social functioning, role-emotional, and mental health. Through an algorithm specific to the instrument, 2 scores are obtained: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). In both, the total score ranges from 0 to 100, with higher scores associated with better quality of life.19-21 A sample of 11 (10%) of all study participants was randomly selected to respond to the SF-12 questionnaire. The Pearson correlation coefficient was determined between each item of the questionnaires and the final scores for the PCS and MCS components. In interpreting the Pearson correlation coefficient, a value (both positive and negative) >0.6 is considered a strong correlation, 0.35 to 0.6 indicates moderate correlation, and 0 to 0.35 indicates a weak correlation.22
Results from the Stoma-QoL and the sociodemographic/clinical/eating behavior questionnaire were entered, processed, and analyzed using SPSS software, version 15 (SPSS Inc, Chicago, IL). Sociodemographic, clinical, and eating behavior variables were descriptively analyzed. The normal distribution of Stoma-QoL total scores was assessed using the Kolmogorov-Smirnov test, the normality of the scores was rejected, and nonparametric tests (Mann-Whitney and Kruskal-Wallis) were used to analyze the associations among independent sociodemographic, clinical, and eating behavior variables. A 5% significance level was considered for analysis.
Among the 428 intestinal ostomy patients in the care of the stoma health care service, 111 of both genders met the inclusion/exclusion criteria and/or were permitted to participate. The majority (57, 51.4%) were men, most (94, 84.7%) were in the 50 years of age or older age group, 65 (58.6%) were married, and 14 (12.6%) had a college education (see Table 1).
Among all participants, 70 (63.1%) had a colostomy and 41 (36.9%) had a ileostomy; 66 (59.5%) had a permanent stoma, 72 (64.9%) had the stoma for more than 1 year, and 79 (71.2%) had the ostomy due to cancer of the colon and rectum (see Table 2).
Regarding eating behavior, 69 (62.2%) had felt comfortable with their normal eating habits within 1 day to 3 months of surgery, 52 (46.8%) were afraid to eat some type of food, and 52 (46.8%) excluded foods from their eating routine for fear of causing gas (see Table 3).
The internal consistency of the translated Stoma-QoL had a Cronbach’s alpha of 0.87, indicating the instrument is sufficiently reliable as a research tool. The reproducibility over time was estimated by an ICC of 0.85 (95% confidence interval [CI] 0.69–0.95), demonstrating good reproducibility. The convergent validity between the Stoma-QoL and the SF-12 using the Pearson coefficient confirmed a higher correlation among the emotional, mental health, social aspect, and vitality items, of the MCS (r = 0.52; P =.02) and lower values for correlations between the PCS and the questions that assess general health, functional capacity, physical aspects, and pain (r = 0.38; P = .04), although both were significant. A moderate and significant association was found between the questionnaires.
The mean overall Stoma-QoL scale score for study participants was 58.7 ± SD 12.0 (range 32.0–78.0). Scores were mostly comparable among the characteristics, and statistically significant differences were observed for gender and eating behavior (see Table 4). Women had lower quality of life than men (P = .02), as well as stoma patients who fasted (P =.05) and those who excluded foods from their eating routine for fear of repercussions (P <.001). Colostomy and ileostomy patients had a similar quality of life, as well as persons whose stoma was created due to colon or rectal cancer and other diseases.
Studies about quality of life have become increasingly common in recent decades.23 This fact supports the growing need to build, validate, and translate generic and specific quality-of-life instruments.
The results of this study showed the questionnaire translated into Brazilian Portuguese has reliability for research with individuals having ostomy by intestinal bypass (colostomy and ileostomy). A high internal consistency within the Stoma-QoL was found, with a Cronbach’s alpha of 0.87, a value that remained close to the original validation study of the Stoma QoL9 with a Cronbach’s alpha of 0.92 and also of the validation done with the same questionnaire by Canova et al,24 which found an alpha value of 0.90.
Results of convergent construct analysis indicate the Stoma-QoL instrument, compared to the SF-12, is capable of measuring quality of life with positive and statistically significant correlations with MCS (r = 0.52; P = .02) and PCS (r = 0.38; P = .04), even though the evaluated questionnaires deal with a specific and a generic instrument, respectively. The SF-12 instrument was chosen owing to its quick application, its ability to access the full range of levels of quality of life,25,26 and inclusion of domains similar to those of the Stoma-QoL.
Sociodemographic variables. No significant differences were found among the sociodemographic variables in the quality of life of stoma patients except with respect to gender (P = .02). According to an observational study,27 frustrations due to unmet expectations, past experiences, and lack of social support are factors that should be considered as potential determinants of health-related, quality-of-life differences observed between men and women. Women have been shown in descriptive epidemiological studies28 to be more easily psychologically affected by environmental stressors than men. It is possible women with a stoma experience more stress because they have to maintain traditionally female roles such as family obligations, taking care of the home, and working. In addition, the change in body image associated with the stoma may decrease self-esteem, which can lead to a decrease in quality of life. An exploratory, descriptive, qualitative study29 showed that stoma patients may change their outlook on life, mainly due a negative body image and changes in elimination patterns, eating habits, and hygiene; they need to adapt to the use of the equipment, resulting in diminished self-esteem, impaired sexuality, and social isolation.
Ostomy type. Patients with a colostomy or ileostomy reported similar quality of life. In a cross-sectional multicenter Stoma-QoL application and validation survey24 performed in Italy among 251 stoma patients, quality-of-life scores for colostomy and ileostomy patients were similar. An observational study30 in Europe showed the structure of the health care system may further support a similar quality of life between colostomy and ileostomy patients. Interestingly, the present study was performed among a sample of Latin American (Brazilian) stoma patients and a quality of life similar to the European population was observed. In Brazil, the National Guidelines for Health Care of Persons with a Stoma,31 under the National Health System, ensure the comprehensive health care of stoma patients, which includes supplying materials that promote self-care. The Stoma Therapy Services help the person with a stoma achieve autonomy by utilizing educational workshops and experience exchange groups, among others methods.32 Although Brazil is a developing nation and has economic and social problems, having that social support can lead to a similar quality of life among colostomy and ileostomy patients.
Cause for ostomy. Patients whose ostomy was due to cancer of the colon and rectum had a quality of life similar to persons with other stoma indications, which also was observed in the validation study by Canova et al.24 In contrast, a review by Breukink and Donovan33 reported patients with inflammatory intestinal diseases had a lower quality of life than those with colon and rectal cancer due to anxiety and depression. Having the social support of a stoma patients group and a multidisciplinary team can improve the quality of life in stoma patients with cancer and those who have other diseases.
Eating habits. With regard to eating behavior, patients who fasted had a significantly lower quality of life than those who did not (P = .05). An important, frequently observed consideration in the context of care for a person with a stoma is that eating habits are associated with myths of various types. Some beliefs about food have no scientific basis and can be harmless; some can have serious implications for health and the well-being.34 A qualitative, descriptive, exploratory Brazilian study35 performed among 25 intestinal stoma patients revealed some extreme changes in eating habits are due to fear of being singled out by others who are part of their social life, including family and friends. The study also revealed changes in bowel habits can lead to embarrassing situations for stoma patients, especially when they are still adapting to this new life situation.
It also was found that stoma patients who were afraid to eat some type of food had a significantly lower quality of life (P <.001) than those without such fears. Dietary advice for patients after stoma construction surgery is essential for their rehabilitation. However, this is often overlooked or patients receive conflicting advice, which generates the fear of eating. According to a review by Cronin,36 dietary advice and nutritional care offered to all new stoma patients pre- and post surgery in a clear and concise manner will facilitate a better quality of life for the patient. Adequate and individualized nutritional counseling is an important component in managing individuals who will have a stoma. Consuming a balanced diet is essential to good health. The objectives of nutritional care for stoma patients are to prevent obstruction of the stoma, promote healing from the surgery, and prevent or minimize gastrointestinal disorders such as flatulence, diarrhea, constipation, and unpleasant odors.6,37,38
Most participants in this study were older than 50 years; therefore, it is unknown how a younger population would have scored. Also, 74% of those invited did not participate in the study, so selection bias is possible. Additional studies in different regions of Brazil and using larger samples are needed.
This study confirms the Portuguese (Brazilian variant) translated Stoma-QoL is a valid tool for research on the quality of life of Brazilian patients with an intestinal stoma. This tool also may be used to evaluate patient adjustment to the ostomy and quality of life to supplement clinical consultation. Further longitudinal studies should explore how patients adjust to life with an ostomy over time and how they adapt their living and eating habits. This would facilitate development of individualized clinical and nutritional follow-up plans to provide better quality of life. The translated Stoma-QoL is available at: www.ufjf.br/nutricao/informacoes/downloads/.
The authors thank the nurse responsible for the service (Alfeu Gomes de Oliveira Júnior) and his entire team, which provided all the technical assistance with the data collection. The study was supported by Brazilian government organization (FAPEMIG; APQ 03502/13).
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Potential Conflicts of Interest: The study was supported by Brazilian government organization (FAPEMIG; APQ 03502/13).
Ms. Oliveira is an Assistant Professor; Dr. Mendes is an Adjunct Professor; Dr. Netto is an Adjunct Professor, Department of Nutrition; and Dr. Leite is a CNPq Productivity Sponsorship; and an Associate Professor, School of Medicine, Department of Public Health, Federal University of Juiz de Fora. Please address correspondence to: Prof. Ana Lívia de Oliveira, Department of Nutrition, Federal University of Juiz de Fora – UFJF, José Lourenço Kelmer, sn Campus Universitário, Juiz de Fora, Minas Gerais, Brazil; email: email@example.com.