Cross-cultural adaptation and assessment of the reliability and validity of the Core Outcome Measures Index (COMI) for the Brazilian-Portuguese language

The use of patient-orientated questionnaires is of utmost importance in assessing the outcome of spine surgery. Standardisation, using a common set of outcome measures, is essential to aid comparisons across studies/in registries. The Core Outcome Measures Index (COMI) is a short, multidimensional outcome instrument validated for patients with spinal disorders. This study aimed to produce a Brazilian-Portuguese version of the COMI. A cross-cultural adaptation of the COMI into Brazilian-Portuguese was carried out using established guidelines. 104 outpatients with chronic LBP (> 3 months) were recruited from a Public Health Spine Medical Care Centre. They completed a questionnaire booklet containing the newly translated COMI, and other validated symptom-specific questionnaires: Oswestry Disability Index (ODI) and Roland Morris disability scale (RM), and a pain visual analogue scale. All patients completed a second questionnaire within 7-10 days to assess reproducibility. The COMI summary score displayed minimal floor and ceiling effects. On re-test, the responses for each individual domain of the COMI were within 1 category in 98% patients for the domain 'function', 96% for 'symptom-specific well-being', 97% for 'general quality of life', 99% for 'social disability' and 100% for 'work disability'. The intraclass correlation coefficients (ICC2,1) for COMI pain and COMI summary scores were 0.91-0.96, which compared favourably with the corresponding values for the RM (ICC, 0.99) and ODI (ICC, 0.98). The standard error of measurement for the COMI was 0.6, giving a "minimum detectable change" (MDC95%) of approximately 1.7 points i.e., the minimum change to be considered "real change" beyond measurement error. The COMI scores correlated as hypothesised (Rho, 0.4-0.8) with the other symptom-specific questionnaires. The reproducibility of the Brazilian-Portuguese version of the COMI was comparable to that of other language versions. The COMI scores correlated in the expected manner with existing but longer symptom-specific questionnaires suggesting good convergent validity for the COMI. The Brazilian-Portuguese COMI represents a valuable tool for Brazilian study-centres in future multicentre clinical studies and surgical registries.

12 item Allodynia Symptom Checklist/Brasil: cross-cultural adaptation, internal consistency and reproducibility

Since there was no Portuguese questionnaire to evaluate cutaneous allodynia, which has been pointed out as a risk factor of migraine, we aimed to perform the cross-cultural adaptation of the 12 item Allodynia Symptom Checklist for the Brazilian population and to test its measurement properties. It consisted in six stages: translation, synthesis, back translation, revision by a specialist committee, pretest and submission the documents to the committee. In the pretest stage, the questionnaire was applied to 30 migraineurs of both sexes, who had some difficulty in understanding it. Thus, a second version was applied to 30 additional subjects, with no difficulties being reported. The mean filling out time was 3'36", and the internal consistency was 0.76. To test reproducibility, 15 other subjects filled out the questionnaire at two different times, it was classified as moderate (weighted kappa=0.58). We made available to Brazilian population an easy, quick and reliable questionnaire.

Cross-cultural adaptation of the Work Disability Diagnosis Interview (WoDDI) for the Brazilian context

The Work Disability Diagnosis Interview (WoDDI) is a structured interview guide developed by the University of Sherbrooke, Canada to help clinicians detect the most important work-related disability predictors and to identify one or more causes of prolonged absenteeism. This methodological study aims for the cross-cultural adaptation of the WoDDI for the Brazilian context. The method followed international guidelines for studies of this kind, including the following steps: initial translation, synthesis of translations, back translation, evaluation by an expert committee and testing of the penultimate version. These steps allowed obtaining conceptual, semantic, idiomatic, experiential and operational equivalences, in addition to content validity. The results showed that the translated WoDDI is adapted to the Brazilian context and can be used after training.

Translation and Cross-cultural Adaptation of the Lower Extremity Functional Scale Into a Brazilian Portuguese Version and Validation on Patients With Knee Injuries

STUDY DESIGN: Clinical measurement. OBJECTIVE: To translate and culturally adapt the Lower Extremity Functional Scale (LEFS) into a Brazilian Portuguese version, and to test the construct and content validity and reliability of this version in patients with knee injuries. BACKGROUND: There is no Brazilian Portuguese version of an instrument to assess the function of the lower extremity after orthopaedic injury. METHODS: The translation of the original English version of the LEFS into a Brazilian Portuguese version was accomplished using standard guidelines and tested in 31 patients with knee injuries. Subsequently, 87 patients with a variety of knee disorders completed the Brazilian Portuguese LEES, the Medical Outcomes Study 36-Item Short-Form Health Survey, the Western Ontario and McMaster Universities Osteoarthritis Index, and the International Knee Documentation Committee Subjective Knee Evaluation Form and a visual analog scale for pain. All patients were retested within 2 days to determine reliability of these measures. Validation was assessed by determining the level of association between the Brazilian Portuguese LEFS and the other outcome measures. Reliability was documented by calculating internal consistency, test-retest reliability, and standard error of measurement. RESULTS: The Brazilian Portuguese LEES had a high level of association with the physical component of the Medical Outcomes Study 36-Item Short-Form Health Survey (r = 0.82), the Western Ontario and McMaster Universities Osteoarthritis Index (r = 0.87), the International Knee Documentation Committee Subjective Knee Evaluation Form (r = 0.82), and the pain visual analog scale (r = -0.60) (all, P<.05). The Brazilian Portuguese LEES had a low level of association with the mental component of the Medical Outcomes Study 36-Item Short-Form Health Survey (r = 0.38, P<.05). The internal consistency (Cronbach alpha = .952) and test-retest reliability (intraclass correlation coefficient = 0.957) of the Brazilian Portuguese version of the LEES were high. The standard error of measurement was low (3.6) and the agreement was considered high, demonstrated by the small differences between test and retest and the narrow limit of agreement, as observed in Bland-Altman and survival-agreement plots. CONCLUSION: The translation of the LEFS into a Brazilian Portuguese version was successful in preserving the semantic and measurement properties of the original version and was shown to be valid and reliable in a Brazilian population with knee injuries. J Ort hop Sports Phys Ther 2012;42(11):932-939, Epub 9 October 2012. doi:10.2519/jospt.2012.4101

Cross-cultural adaptation and psychometric properties of the Brazilian-Portuguese version of the Duke Anticoagulation Satisfaction Scale

Aim. The aim of this study was to evaluate the internal reliability and validity of the BrazilianPortuguese version of Duke Anticoagulation Satisfaction Scale (DASS) among cardiovascular patients. Background. Oral anticoagulation is widely used to prevent and treat thromboembolic events in several conditions, especially in cardiovascular diseases; however, this therapy can induce dissatisfaction and reduce the quality of life. Design. Methodological and cross-sectional research design. Methods. The cultural adaptation of the DASS included the translation and back-translation, discussions with healthcare professionals and patients to ensure conceptual equivalence, semantic evaluation and instrument pretest. The BrazilianPortuguese version of the DASS was tested among subjects followed in a university hospital anticoagulation outpatient clinic. The psychometric properties were assessed by construct validity (convergent, known groups and dimensionality) and internal consistency/reliability (Cronbachs alpha). Results. A total of 180 subjects under oral anticoagulation formed the baseline validation population. DASS total score and SF-36 domain correlations were moderate for General health (r = -0.47, p < 0.01), Vitality (r = -0.44, p < 0.01) and Mental health (r = -0.42, p < 0.01) (convergent). Age and length on oral anticoagulation therapy (in years) were weakly correlated with total DASS score and most of the subscales, except Limitation (r = -0.375, p < 0.01) (Known groups). The Cronbachs alpha coefficient was 0.79 for the total scale, and it ranged from 0.76 (hassles and burdens)0.46 (psychological impact) among the domains, confirming the internal consistency reliability. Conclusions. The BrazilianPortuguese version of the DASS has shown levels of reliability and validity comparable with the original English version. Relevance to clinical practice. Healthcare practitioners and researchers need internationally validated measurement tools to compare outcomes of interventions in clinical management and research tools in oral anticoagulation therapy.

Cross-cultural adaptation and psychometric properties of the Brazilian version of the scale of oral health outcomes for 5-year-old children (SOHO-5)

Abstract Background Most of the instruments available to measure the oral health-related quality of life (OHRQoL) in paediatric populations focus on older children, whereas parental reports are used for very young children. The scale of oral health outcomes for 5-year-old children (SOHO-5) assesses the OHRQoL of very young children through self-reports and parental proxy reports. We aimed to cross-culturally adapt the SOHO-5 to the Brazilian Portuguese language and to assess its reliability and validity. Findings We tested the quality of the cross-cultural adaptation in 2 pilot studies with 40 children aged 5–6 years and their parents. The measurement was tested for reliability and validity on 193 children that attended the paediatric dental screening program at the University of São Paulo. The children were also clinically examined for dental caries. The internal consistency was demonstrated by a Cronbach's alpha coefficient of 0.90 for the children’s self-reports and 0.77 for the parental proxy reports. The test-retest reliability results, which were based on repeated administrations on 159 children, were excellent; the intraclass correlation coefficient was 0.98 for parental and 0.92 for child reports. In general, the construct validity was satisfactory and demonstrated consistent and strong associations between the SOHO-5 and different subjective global ratings of oral health, perceived dental treatment need and overall well-being in both the parental and children’s versions (p < 0.001). The SOHO-5 was also able to clearly discriminate between children with and without a history of dental caries (mean scores: 5.8 and 1.1, respectively; p < 0.001). Conclusion The present study demonstrated that the SOHO-5 exhibits satisfactory psychometric properties and is applicable to 5- to 6-year-old children in Brazil.

Personal and Social Performance (PSP) scale for patients with schizophrenia: translation to Portuguese, cross-cultural adaptation and interrater reliability

INTRODUCTION: Schizophrenia is a chronic mental disorder associated with impairment in social functioning. The most widely used scale to measure social functioning is the GAF (Global Assessment of Functioning), but it has the disadvantage of measuring at the same time symptoms and functioning, as described in its anchors. OBJECTIVES:Translation and cultural adaptation of the PSP, proposing a final version in Portuguese for use in Brazil. METHODS: We performed five steps: 1) translation; 2) back translation; 3) formal assessment of semantic equivalence; 4) debriefing; 5) analysis by experts. Interrater reliability (Intraclass correlation, ICC) between two raters was also measured. RESULTS: The final version was applied by two independent investigators in 18 adults with schizophrenia (DSM-IV-TR). The interrater reliability (ICC) was 0.812 (p < 0.001). CONCLUSION: The translation and adaptation of the PSP had an adequate level of semantic equivalence between the Portuguese version and the original English version. There were no difficulties related to understanding the content expressed in the translated texts and terms. Its application was easy and it showed a good interrater reliability. The PSP is a valid instrument for the measurement of personal and social functioning in schizophrenia.

Cross-cultural adaptation of the Safety Attitudes Questionnaire - Short Form 2006 for Brazil

The objective of this study was to perform a cross-cultural adaptation of the Safety Attitudes Questionnaire - Short Form 2006 for Brazil. The instrument was applied in six hospitals in three regions of Brazil. Content, face, and construct validity was performed. Analysis of the instrument's reliability was performed by verifying the items' internal consistency through Cronbach's alpha. The sample was composed of 1301 professionals working in clinical and surgical wards of six hospitals. Confirmatory analysis showed that the model including 41 items was satisfactory. The Portuguese version presented an alpha of 0.89. The item-total correlations among the domains were moderate to strong, except for the domain Stress Recognition. We concluded that the instrument's version adapted to Portuguese and applied in our sample is valid and reliable.

TRANSLATION AND CULTURAL ADAPTATION OF THE GLOBAL APPRAISAL OF INDIVIDUAL NEEDS - INITIAL

The objective of this study was to perform the translation on and cultural adaptation of the Global Appraisal of Individual Needs - Initial instrument, and calculate its content validity index. This is a methodological study designed for the cultural adaptation of the instrument. The instrument was translated into Portuguese in two versions that originated the synthesis of the translations, which were then submitted to the evaluation of four judges, experts in the field of alcohol and other drugs. After the suggested changes were made, the instrument was back-translated and resubmitted to the judges and authors of the original instrument, resulting in the final version of the instrument, Avaliacao Global das Necessidades Individuais - Inicial. The content validity index of the instrument was 0.91, considered valid according to the literature. The instrument Avaliacao Global das Necessidades Individuais - Inicial was culturally adapted to the Portuguese language spoken in Brazil; however, it was not submitted to tests with the target population, which suggests further studies should be performed to test its reliability and validity.

Adaptação cultural cruzada e validação da versão do Índice Funcional de Espondilite Anquilosante de Bath (BASFI) para o português do Brasil

OBJETIVO: Conduzir uma adaptação cultural cruzada do Índice Funcional de Espondilite Anquilosante de Bath (BASFI, Bath Ankylosing Spondylitis Functional Index) para o português do Brasil e avaliar suas propriedades de medição. MéTODOS: O BASFI foi traduzido por quatro reumatologistas e três professores de língua inglesa. O questionário traduzido foi aplicado a pacientes com espondilite anquilosante por observadores treinados e autoaplicado em três momentos, dias 1, 2 e 14. A validade foi estimada analisando-se a associação do BASFI e as medidas de capacidade funcional (rotação cervical, distância intermaleolar, teste de Schober e distância occipito-parede). A consistência interna foi testada pelo coeficiente α de Cronbach, e a confiabilidade pelo teste-reteste (coeficiente de correlação intraclasse [CCI]). RESULTADOS: Foram incluídos 60 pacientes com espondilite anquilosante: 85% do gênero masculino, com idade média de 47 ± 12 anos e duração média da doença de 20 ± 11 anos. A confiabilidade intraobservador no teste-reteste (intervalo de duas semanas) revelou alto ICC (0,999; 95% IC: 0,997-0,999), além de alta consistência interna (coeficiente α de Cronbach: 0,86; 95% IC: 0,80-0,90). Considerando-se a validade, os índices do BASFI foram correlacionados com a rotação cervical (0,53; P < 0,001) e a distância intermaleolar (0,50; P < 0,001). CONCLUSÃO: A versão do BASFI para o português do Brasil é confiável e válida para avaliação de pacientes com espondilite anquilosante.

Quality of life assessment septoplasty in patients with nasal obstruction

Naasal obstruction is a common complaint in the population. When caused by a deviated nasal septum, septoplasty is the procedure of choice for treating these patients. NOSE is a tool for assessing the disease-specific quality of life related to nasal obstruction. Aim: To assess the impact of septoplasty on patients with nasal obstruction secondary to deviated nasal septum based on the disease-specific quality-of-life questionnaire. Design: Prospective. Methods: Patients undergoing septoplasty with/without turbinectomy after no clinical improvement with medical treatment were assessed by the NOSE questionnaire before and 3 months after surgery. We evaluated the surgical improvement based on total score, the magnitude of the surgery in the disease-specific quality of life and the correlation between the preoperative score and postoperatively improvement. Results: Fourty-six patients were included in the study. There was a statistically significant improvement in the preoperative NOSE score (md = 75, IQR = 26) and after three months (md = 10, IQR = 20) (p < 0.001.T-Wilcoxon). The standardized response mean was 3.07. We found a strong correlation between the preoperative score in the NOSE questionnaire and improvements in the postoperative period (r = -0.789, p < 0.001, Spearman). No difference was found in improvement scores by gender. (p = 0.668, U-Mann-Whitney). Conclusion: Septoplasty resulted in a statistically significant improvement in the disease-specific QOL questionnaire.

Semantic Equivalence of the Brazilian Portuguese version of the "Body Change Inventory"

With the increase in research on the components of Body Image, validated instruments are needed to evaluate its dimensions. The Body Change Inventory (BCI) assesses strategies used to alter body size among adolescents. The scope of this study was to describe the translation and evaluation for semantic equivalence of the BCI in the Portuguese language. The process involved the steps of (1) translation of the questionnaire to the Portuguese language; (2) back-translation to English; (3) evaluation of semantic equivalence; and (4) assessment of comprehension by professional experts and the target population. The six subscales of the instrument were translated into the Portuguese language. Language adaptations were made to render the instrument suitable for the Brazilian reality. The questions were interpreted as easily understandable by both experts and young people. The Body Change Inventory has been translated and adapted into Portuguese. Evaluation of the operational, measurement and functional equivalence are still needed.

Validation of the Subjective Handicap of Epilepsy (SHE) in Brazilian patients with epilepsy

The objectives of the study were to translate and adapt the Subjective Handicap of Epilepsy (SHE) instrument to Brazilian Portuguese and to determine its psychometric properties for the evaluation of quality of life in patients with epilepsy. A sample of 448 adult patients with epilepsy with different clinical profiles (investigation, preoperative period, postoperative period, and drug treatment follow-up) was evaluated with the SHE and the Epilepsy Surgery Inventory (ESI-55). Exploratory factorial analysis demonstrated that four factors explained 60.47% of the variance and were sensitive to discriminate the different clinical groups, with the preoperative group having the poorest quality of life. Internal consistency ranged from 0.92 to 0.96, and concurrent validity with the ESI-55 was moderate/strong (0.32-0.70). Test-retest reliability was confirmed, with an ICC value of 0.54 (2 days), 0.91 (7 days), and 0.97 (30 days). The SHE had satisfactory psychometric qualities for use in the Brazilian population, similar to those of the original version. The instrument seems to be more adequate in psychometric terms for the postoperative and drug treatment follow-up groups, and its use should be encouraged. (c) 2012 Elsevier Inc. All rights reserved.

Questionário Atitudes de Segurança: adaptação transcultural do Safety Attitudes Questionnaire - Short Form 2006 para o Brasil

O objetivo deste estudo foi realizar a adaptação transcultural do Safety Attitudes Questionnaire - Short Form 2006 para o Brasil. O instrumento foi aplicado em seis hospitais de três Regiões do Brasil. Foi realizada a validade de conteúdo, face e de construto. A análise da confiabilidade do instrumento foi realizada por meio da análise da consistência interna dos itens por meio do alfa de Cronbach. A amostra do estudo foi composta por 1.301 profissionais das enfermarias clínicas e cirúrgicas de seis hospitais. A análise confirmatória mostrou que o ajuste do modelo final dos 41 itens foi considerado satisfatório. Aversão do instrumento em Português apresentou alfa de 0,89. As correlações item/total entre os domínios foram consideradas de moderada a forte, com exceção do domínio percepção do estresse. Conclui-se, portanto, que a versão do instrumento adaptada para o Português é considerada válida e confiável nesta amostra.

Adaptação transcultural do Vulnerable Elders Survey-13 (VES-13): contribuindo para a identificação de idosos vulneráveis

Para a utilização do VES-13 instrumento que identifica idosos vulneráveis foi realizada sua adaptação transcultural, processo que visa à equivalência entre o instrumento original e sua versão em outra cultura. A avaliação da equivalência semântica, idiomática cultural e conceitual obteve uma média geral de concordância de 78%, 78%, 97% e 94%, respectivamente. Para verificar a concordância no teste-reteste, utilizou-se o coeficiente Kappa de Cohen, onde a maioria das variáveis foram significantes. A análise de sua consistência interna foi verificada pelo uso do coeficiente alpha de Cronbach, onde 70% do fenômeno em estudo estão representados no instrumento. O VES-13, traduzido e adaptado, mostrou-se um instrumento confiável no que diz respeito à estabilidade e consistência interna de suas medidas. Sua estrutura simples e de fácil aplicabilidade pode, portanto, favorecer a identificação das pessoas idosas vulneráveis, contribuindo, assim, para a priorização do acompanhamento pelos serviços de saúde.