Design and ethics approval. This methodological study sought to adapt and validate the OAI-23 for use with Brazilian individuals living with an ostomy. The researchers obtained authorization from the authors of the original instrument as well as from the health centers where the questionnaire was previously applied. In addition, the experimental design was approved by the Research Ethics Committee at the University of São Paulo School of Nursing (process no. 829/2009). The research protocol was also approved by the directors of Specialized Outpatient Centres from Santa Maria city, in Rio Grande do Sul; Campo Grande city, in Mato Grosso do Sul; and Cabo Frio city, in Rio de Janeiro, in addition to the Director of São Paulo Ostomy Association, in São Paulo.
All participants were informed about the research’s aim and steps; they then gave their verbal consent and also signed an informed consent form. The data collection period was from 2011 to 2012.
Sociodemographic and clinical characteristics. The researchers developed a paper-and-pencil questionnaire for the collection of sociodemographic data as well as clinical features. Sociodemographic data such as sex, age, marital status, religion, education level, and work status were collected. The authors also collected clinical data (including amount of time since stoma surgery, follow-up time, cause of the ostomy, and comorbidities).
OAI-23. The OAI-23 is intended to measure the social and psychological adaptation of individuals who underwent ostomy surgery as well as the adjustment necessary for accepting the stoma and improving coping-related behaviors.16 The original English version of the OAI-23 is based on items from the English-adapted version of the OSAS.16
In the factorial analysis of the OAI-23, 4 factors account for the total variance of the phenomenon. These factors include acceptance, which refers to the adaptation of the patient to the stoma (factor 1: items 1, 3, 4, 6, 9, 14, 15, 19, and 23); anxiety/preoccupation, which refers to constant thought and worry about the stoma (factor 2: items 12, 13, 17, 20, and 21); social engagement, which refers to the reintegration of patients into their family, social, and work environments (factor 3: items 5, 7, 8, and 11); and anger, which refers to the degree of irritation/frustration expressed by the patient that is caused by the stoma (factor 4: items 2 and 10). Items 16, 18, and 22 had factor loads greater than 0.40 in 2 or more factors; for this reason, they were considered independent and not included in any of the instrument factors.16
Each item was graded on a 5-point Likert scale (0 to 4). Twelve (12) items (2, 5, 7, 8, 10, 11, 12, 13, 16, 17, 18, and 21) were negatively described and scored inversely. The total score ranged from 0 to 92, with higher scores being indicative of better psychosocial adaptation. A cutoff point has yet to be established.16
Janis and Field Self-Esteem Scale. The Janis and Field Self-Esteem Scale assesses the level of self-esteem and feelings of social adequacy.21,22 Developed by Janis and Field21 and translated and adapted by Ulhôa for Brazil,22 this scale is composed of 23 items with graded answers ranging from 1 to 5: always (1), frequently (2), sometimes (3), rarely (4), and never (5). Answers are not classified as correct or incorrect. The answers to questions 3, 7, 8, 9, and 10 have inverse values. There is no cutoff grade or rating for the self-esteem level. The total scores are obtained by summing the values from all the items and can range from 23 to 115.22
Cultural adaptation. The cultural adaptation of the OAI-23 for Brazilians was conducted according to the standards published and revised by Beaton et al,23 and included some modifications as proposed by the Institut Hospital del Mar d’Investigacions Mèdiques (IMIM).24
The translation of the original instrument was performed by 2 independent and qualified translators. One translator’s native language was English, and they were also fluent in Portuguese. The other translator was an expert in English. Both were aware of the objectives of the translation. For this phase, the translations were evaluated using a standardized instrument that contained, in addition to the column for recording the translation, columns for difficulty scores (0 to 10, less to more difficult); comments about these difficulties were also provided.
The committee of expert evaluators consisted of 2 enterostomal therapy nurses, a nurse specializing in quality of life, and a coloproctologist. All evaluators were fluent in English and communicated via telephone and/or e-mail. Their evaluations were aimed at analyzing and comparing the semantic, idiomatic, cultural, and conceptual equivalences of the original and translated versions of this instrument. A minimum level of agreement of 80% was adopted for determining equivalence among the evaluators.25
Following this first phase of translation and evaluation, a pretest was applied to a heterogeneous focus group (n = 11). Inclusion criteria included being 18 years of age or older, having a temporary or permanent stoma of any type and for any reason, and having sufficient physical and mental conditions to be interviewed (eg, no pain, cognitively able to understand the questions). This step, which may also be denoted as cognitive debriefing, was performed with a small sample size according to recommendations found in the literature.26 Patients who met these criteria were called by the president of the Ostomy Association of the State of São Paulo (AOESP) and asked to participate in the study.
The version of the instrument administered during the pretest was then back-translated into English by a different set of translators, both fluent in English and Portuguese and unaware of the study objectives. After completing the translation and pretest phases, and prior to clinical application, back-translations were sent to Dr. Kingsley Simmons, one of the authors of the original instrument, for analysis.
Evaluation of measurement properties of the adapted version. The Brazilian Portuguese adapted version of the OAI-23, resulting from the first phase of the present study, was applied to patients who had undergone ostomy surgery at 3 outpatient hospitals in Cabo Frio, Rio de Janeiro (RJ); Campo Grande, Mato Grosso do Sul (MS); and Santa Maria (RS), Rio Grande do Sul (RS) as well as patients registered at the AOESP in São Paulo (SP).
For the quantitative composition of the sample, a minimum of 8 participants was considered for each instrument item,27 totaling 184 people. The same inclusion criteria applied during the focus group phase were also considered in the next phase of the experimental approach.
A convenience sample of patients was invited to participate prior to their outpatient appointment. After signing the informed consent form, data collection occurred through individual interviews in a private office or restricted area of the health care center or location. The researcher recorded the interviews in a paper-and-pencil instrument. To evaluate the stability of the adapted version, all patients were invited to return within 15 days and complete the OAI-23 questionnaire again.
In addition to the data collected from the adapted version of the OAI-23, an instrument to obtain sociodemographic and clinical data as well as the Janis and Field Self-Esteem Scale15 were also applied.
Data management and analysis. The data were organized and analyzed using the software Statistical Package for the Social Sciences, SPSS1 version 20.0 Descriptive analyses were performed for all variables. For all statistical tests, a significance level of 5% was considered.
The reliability of the OAI-23 was assessed by evaluating internal consistency and stability using Cronbach’s alpha coefficient and the ICC, respectively. It has been reported previously that Cronbach’s alpha coefficients ≥ 0.70 are indicative of satisfactory internal consistency.28 Although a sample corresponding to 15% of the total was established to analyze the reliability and stability of the test/retest, 81 patients with ostomy (42.4%) responded to the retest. The magnitude of the test/retest agreement level was standardized as follows: < 0.40 (weak), 0.41 to 0.60 (moderate), 0.61 to 0.80 (good), and 0.81 to 1.022 (excellent), with higher coefficients being associated with greater instrument stability. Confirmatory factor analysis (CFA) was performed to determine whether the adapted version of the OAI-23, presented herein, exhibited the factorial structure of the original version when only including the factors of the instrument. For the CFA, the following model fit indices and parameters were considered: goodness of fit index (GFI) < 0.80; root mean square error approximation (RMSEA) ≤ 0.08; adjusted goodness of fit index (AGIF) ≤ 0.90; and chi-square measure < 0.05.27.
The convergent validity of the adapted version of the OAI-23 was assessed by correlating the total scores on the OAI-23, as well as the scores of each factor with the Janis and Field Self-Esteem Scale scores. This was accomplished by applying the Kolmogorov-Smirnov (normality) and Spearman tests. To visualize and analyze the magnitude of these correlations, the following classification was adopted: < 0.30 (weak), 0.30 to 0.50 (moderate), 0.50 to 0.99 (strong), and 1.00 (perfect).29
The discriminant validity was assessed using backward logistic regression after comparisons were made between the scores on the adapted version of the OAI-23 and age, sex, ostomy time, type/anatomical origin, cause of the stoma, and character of the stoma (temporary vs. permanent).