Translation, adaptation and practicability of Nurses’ knowledge of high alert medications to the Brazilian culture

This is a methodological study with the aim to translate, adapt and assess the practicability of parts A and B of the instrument Nurses’ knowledge of high-alert medications to the Brazilian culture. The translation and cultural adaptation followed the steps recommended by the international literature. The appointed judges assessed the semantic, idiomatic, conceptual and cultural equivalences; the degree of agreement among the judges was quantified by the Content Validity Index. The translation and back-translation stages were successfully performed and the assessment of the synthesized version by the committee resulted in changes of questions, ensuring the equivalence between the original and the translated versions. The specialists suggested three new questions for the instrument. Some questions were reformulated in the pre-testing stage to improve understanding. The Brazilian version of the instrument obtained satisfactory outcomes in terms of translation, cultural adaptation and practicability, being considered as easily applicable and viable for clinical practice. Descriptors: Validation Studies; Translating; Questionnaires; Medication Errors; Patient Safety. RESUMO Estudo metodológico com o objetivo de traduzir, adaptar e avaliar a praticabilidade das partes A e B do Nurses’ knowledge of high-alert medications para a cultura brasileira. A tradução e adaptação cultural seguiram as etapas recomendadas pela literatura internacional. Os juízes avaliaram as equivalências semântica, idiomática, conceitual e cultural; a concordância entre os juízes foi quantificada pelo Índice de Validade de Conteúdo. As etapas de tradução e retrotradução foram realizadas com sucesso e a avaliação da versão síntese pelo Comitê resultou em alterações de questões, assegurando as equivalências entre a versão original e a traduzida. Os especialistas sugeriram três novas questões ao instrumento. Foram realizadas reformulações em algumas questões no pré-teste, a fim de melhorar a compreensão. A versão brasileira do instrumento Nurses’ knowledge of high-alert medications mostrou resultados satisfatórios quanto à tradução, adaptação cultural e praticabilidade, sendo considerado um instrumento de fácil aplicação e viável para a prática clínica. Descritores: Estudos de Validação; Tradução; Questionários; Erros de Medicação; Segurança do Paciente. Apolinario PP, Rodrigues RCM, Silva JB, Secoli SR, Lima MHM. Rev. Eletr. Enf. [Internet]. 2015 jul/set;17(3). Available from: http://dx.doi.org/10.5216/ree.v17i3.30299. 2 INTRODUCTION High-alert medications are described in the international literature as potentially dangerous, since they present greater risks of significant damage to patients when misused. This definition does not indicate that mistakes associated with these drugs are the most frequent, but rather that the consequences of a mistake related to such drugs are generally more severe . In this sense, incidents of serious damage and/or death are often related to inadequate use of high-alert medications, although medication errors usually occur in health services, and in most cases, patients are not injured. A previous study, which analyzed data from the the American platform MedMarx for reporting medication errors, showed that the five major drugs mentioned in the reports of all incidents with medication (whether damaging or not) were high-alert medications. Such data make it evident that medication errors related to high-alert medications represent a potential risk for non-fatal errors as well as for harmful incidents. Errors and undesirable complications related to the treatment of patients currently represent one of the major challenges for the improvement of quality and safety of patients. Medication errors associated with high-alert medications, as a result of severe consequences for patients, have become part of recommendations and priority strategies of health agencies and organizations specialized in the improvement of patient safety. It is known that approximately 60% of medication errors occur in the drug administration process, which is one of the main responsibilities of the nursing staff and requires deep knowledge from nurses in terms of mode of action, adverse reactions and interaction of drugs. Throughout their professional training, nurses gain specific knowledge and skills that qualify them for the administration of drugs. However, the lack of knowledge of nursing professionals has been pointed out as one of the main reasons for the occurrence of errors in the administration of drugs. Previous studies have pointed out to the need for improving training of nurses by focusing on pharmacological knowledge, with the aim to improve safety in drug administration, among which, high-alert medications. However, the development of educational strategies that aim to reduce errors involving high-alert medications presupposes knowing the complexity of the drug use system, considering the multiprofessional feature of this process, in such a way that all health care professionals be involved in the outline of interventions that seek patients' safety. In the international literature, there are reports of the importance of the objective assessment of the knowledge of nurses regarding high-alert medications, by means of reliable and valid instruments of measurement. The Nurses’ knowledge of high-alert medications (NKHAM), developed by researchers from Taiwan in 2006, has proven to be reliable and valid for the assessment of the knowledge of nurses regarding high-alert medications. The instrument was applied to a sample of 305 nurses selected by the snowball method, in order to evaluate the reliability and validity of content and construct by means of the contrasting groups method. The reliability of questions, in a true or false design, was estimated through internal consistency by means of the Kuder-Richardson Formula 20 (KR-20), where α= 0.74 was found for the total sample of the 305 nurses studied. The validity of the construct showed that the set of 20 questions was able to distinguish the difference of knowledge scores between two groups of nursing students: one group had the Registered Nurse – RN license (n=30) and the other was made up of undergraduate students of the last semester, who had no RN license (n=30) (students with RN vs. students without RN: 63.8 (12.9) vs. 53.0 (14.5), t=3.01; p=0.004). In the Brazilian culture, the literature shows a significant gap in the use of reliable and valid instruments Apolinario PP, Rodrigues RCM, Silva JB, Secoli SR, Lima MHM. Rev. Eletr. Enf. [Internet]. 2015 jul/set;17(3). Available from: http://dx.doi.org/10.5216/ree.v17i3.30299. 3 that enable the measurement of knowledge of nurses regarding high-alert medications. Considering the importance of an objective assessment of this knowledge among Brazilian nurses and the recommendations of the literature to use the process of cultural adaptation in the absence of a valid instrument for the desired context , the objective of this study was to translate and adapt parts A and B of the Nurses’ knowledge of high-alert medications – NKHAM into Brazilian Portuguese and assess its practicability. METHOD This is a methodological study, which consists of the investigation of the method of production, organization and analysis of data, with the purpose of creating and validating research instruments and techniques. The questionnaire that was submitted to the adaptation to the Brazilian Portuguese language was created by Hsaio et al. and aims to assess the knowledge of nurses about high-alert medications. It consists of two sections: Section 1, which assess nurses' knowledge of high-alert medications, and Section 2, which aims to analyze errors related to drug administration. Section 1, which assesses the nurses’ knowledge, is composed of the following parts: Part A Drug administration, composed of 10 true or false questions which assess knowledge of route and dose of drug administration; Part B Regulations of drugs, composed of 10 true or false questions, subsequent to Part A, which determine how high-alert medications must be stored, provided and prescribed; Part C Contributing factors, which consider personal details and those related to respondents' work experience (age, education, time worked) and training programs that contributed to nurses' knowledge of high-alert medications; and Part D Self-assessment, which enables a subjective selfevaluation by respondents about three factors related to high-alert medications 1. Barriers encountered (composed of 14 barriers presented as multiple-choice questions; 2. Degree of knowledge (consisting of five levels that range from "sufficient" to "completely insufficient"; and 3. Need for training (consisting of three options "necessary", "no comments", and "unnecessary") In Section 2, named Error Events, respondents are required to describe a common error of drug administration, with information about the nature of the error and its consequences for the patient, if any. Anonymity is ensured to both respondents and their institutions. The 20 true or false questions that compose parts A and B of section 1 were developed on the basis of a broad review of the literature and of consultation of specialists . It is a short instrument, designed to be responded individually by means of dichotomous questions, for which respondents answer true or false for each statement, generating arbitrary scores. Each correct answer receives five points, which results in a possible total of 100 points. High scores indicate a high degree of knowledge and low scores indicate a low degree of knowledge of high-alert medications. The cultural adaptation process that was used followed the recommendations proposed by Beaton et al., which are broadly used in the international literature. It consists of the initial translation, the synthesis of translations, back-translation, an expert committee review and pre-testing. After obtaining the author's consent, parts A and B were independently translated from the original version of the instrument by two bilingual translators, whose native language was Brazilian Portuguese. Only one of the translators was informed about the objectives of the study. There was no exchange of information between translators, so two independent translations of the NKHAM 20 questions were produced: translation 1 (T1) and translation 2 (T2). In order to synthesize the translations, versions T1 and T2 were analyzed and compared jointly by researchers and an English language specialist. The differences between translations T1 and T2 were Apolinario PP, Rodrigues RCM, Silva JB, Secoli SR, Lima MHM. Rev. Eletr. Enf. [Internet]. 2015 jul/set;17(3). Available from: http://dx.doi.org/10.5216/ree.v17i3.30299. 4 analyzed until a consensus was reached between researchers, after which a final version was produced (T12). The translated synthesis (T12) was back-translated into English by two other translators, whose native language was English and who did not participate in the first translation stage. These translators were not informed about the concepts and objectives of the instrument and did not have a degree in life sciences. At the end of this stage, two versions were produced: backtranslation 1 (BT1) and back-translation 2 (BT2). The backtranslation of the instrument aims to review data; it is a conference process of the version produced that has the purpose of checking whether the translated instrument reflects the original one, thus ensuring the quality of cultural adaptation. Subsequently, a specialist committee was formed to assess the validity of the synthesized version content of the NKHAM questions so as to obtain the version for pretesting application. This committee was composed of seven bilingual specialists, namely: two PhD professors in Linguistics, one PhD professor in nursing with experience in research methodology, one PhD professor in nursing with experience in teaching, support and research in high-alert medications and health care of ICU patients, one PhD professor in pharmacy with experience in HAM studies, one Master in nursing with experience in high-alert medications and care of ICU patients, and one nurse with experience in high-alert medications and care of ICU patients. The assessment of the instrument items was performed in order to obtain the semantic, idiomatic, cultural and conceptual equivalences. The percentage of agreement among specialists as to the instrument assessment and its items was obtained by means of the calculation of the content validity index CVI. The judges' analysis was grounded by the translated versions (T1 and T2), the translation synthesis, the backtranslations (BT1 and BT2), the NKHAM original version, as well as by the recommendations of the literature regarding semantic, idiomatic, cultural and conceptual equivalences. Such process aims to ensure that the final translated version respects the meaning of the original English version, to make sure that the situations referred to in the items actually assess the nurses' knowledge of high-alert medications and analyze whether these items are culturally relevant to the target population. After the content validity step, a pre-test was performed, with the application of the NKHAM adapted version to 40 nurses, from both genders, with experience in ICU or semi-intensive unit, from a teaching hospital in a countryside city of the state of São Paulo. Nurses with less than 12 months of professional experience were excluded, so as to ensure a minimum experience from participants in the administration of high-alert medications. After responding to the questionnaire, participants were interviewed with the purpose of investigating the practicability of the instrument, that is, problems encountered by them regarding the understanding of each sentence as well as the detection of difficult terms. Pre-testing data were submitted to a descriptive analysis by means of the Statistical Package for the Social Sciences (SPSS), version 17.0. The CVI was used to assess the degree of agreement among judges who participated in this stage of the content validity. This index allows for the analysis of each item individually, and subsequently, the instrument as a whole. The agreement among reviewers regarding each item of the instrument was measured by means of a Likert scale, with scores ranging from 1 to 4 (1 = not equivalent; 2 = impossible to assess equivalence without reviewing the item; 3 = equivalent, but needs minor changes; and 4 = totally equivalent). Items that obtained scores of 1 or 2 were reviewed or eliminated. The calculation of the CVI for each item consisted of the division between the number of answers with scores 3 or 4 by the total number of answers. The literature Apolinario PP, Rodrigues RCM, Silva JB, Secoli SR, Lima MHM. Rev. Eletr. Enf. [Internet]. 2015 jul/set;17(3). Available from: http://dx.doi.org/10.5216/ree.v17i3.30299. 5 recommends a CVI > 0.78 for analyses of committees composed of six or more judges. The practicability of the Brazilian version of NKHAM parts A and B was investigated by means of the application of a valid questionnaire, for which the ease to understand, interpret and answer the questions of the adapted instrument was considered. The study proposal was approved by the university's Research Ethics Committee under number 442.552/2013. All nurses enrolled signed a Free and Informed Consent Form. RESULTS The translation, synthesis and back-translation steps were satisfactorily performed. In the initial stage of the translation process of the NKHAM 20 questions, the following considerations stood out: • the terms "Push fast", "Fast IV infusion" and "Fast IV push" were considered as synonymous and were translated as "infunda rapidamente", according to the author's recommendation in the original instrument; • the concentration of the KCl electrolyte at 15% was changed to 19.1% so as to obtain a cultural equivalence, since the 19.1% concentration is the most common in the Brazilian context; • considering the cultural and idiomatic equivalences, the terms "drug", "expression" and "port A route" were translated as "medicamento", "medida" and "port-a-Cath",