Texto & Contexto Enfermagem

Objective: to translate and culturally adapt the Patient Measure of Safety questionnaire to Brazilian Portuguese. Method: a transcultural adaptation study conducted in six stages: translation, synthesis, back-translation, review by experts committee, pre-test, and presentation of the documentation of the entire process to the authors of the instrument. Results: in the initial translation and cultural adaptation stage, two versions of the questionnaire were generated. The divergences between both versions and other suggestions were discussed, and the decisions were made by consensus, thus creating a single version. In the back-translation stage, there were no significant differences between the versions and the original instrument. The assessment of the semantic, idiomatic, cultural and conceptual equivalences of the Patient Measure of Safety items was performed by a committee of experts from different Brazilian regions. The results of the content validity index were above 0.9 for most of the items. The pre-test was conducted with 30 patients. The mean time for the application of the questionnaire was 31.9 minutes. In relation to the understanding of the items by the patients, a regular or poor interpretation was identified only for 6 of the 44 items, which were modified. Conclusion: the “Questionário de Avaliação da Segurança pelo Paciente”, name given to the translated and transculturally adapted version, resulted from a thoughtful process, presenting consistency in the equivalence of the translation and constituting an applicable instrument understood by the target population. DESCRIPTORS: Translation. Patient safety. Patient-centered care. Hospital care. Nursing.


ederal de San
a Catarina
Programa de Pós-Graduação em Enfermagem. Florianópolis
Santa CatarinaBrasil


Janeide Freitas de Mello


TRANSLATION AND TRANSCULTURAL ADAPTATION OF THE PATIENT MEASURE OF SAFETY ( PMOS ) QUESTIONNAIRE TO BRAZILIAN PORTUGUESE
1980-265X2/1693C7BE4FCE6F6EDC60A6AA4D71EAB0ED10.1590/1980-265X-TCE-2018-0322Received: December 3, 2018. Approved: June 10, 2019.DESCRIPTORS: TranslationPatient safetyPatient-centered careHospital careNursing
Objective: to translate and culturally adapt the Patient Measure of Safety questionnaire to Brazilian Portuguese.Method: a transcultural adaptation study conducted in six stages: translation, synthesis, back-translation, review by experts committee, pre-test, and presentation of the documentation of the entire process to the authors of the instrument.Results: in the initial translation and cultural adaptation stage, two versions of the questionnaire were generated.The divergences between both versions and other suggestions were discussed, and the decisions were made by consensus, thus creating a single version.In the back-translation stage, there were no significant differences between the versions and the original instrument.The assessment of the semantic, idiomatic, cultural and conceptual equivalences of the Patient Measure of Safety items was performed by a committee of experts from different Brazilian regions.The results of the content validity index were above 0.9 for most of the items.The pre-test was conducted with 30 patients.The mean time for the application of the questionnaire was 31.9 minutes.In relation to the understanding of the items by the patients, a regular or poor interpretation was identified only for 6 of the 44 items, which were modified.Conclusion: the "Questionário de Avaliação da Segurança pelo Paciente", name given to the translated and transculturally adapted version, resulted from a thoughtful process, presenting consistency in the equivalence of the translation and constituting an applicable instrument understood by the target population.

INTRODUCTION

In the last decades, it became evident that hospitals are not safe places for the patients.A number of studies point to a high incidence of adverse events related to health care, affecting one out of seven hospitalized patients. 1In view of this, health organizations have sought to implement safe practices in the sense of avoiding the occurrence of adverse events. 2 Among the various strategies for the promotion of patient safety, patient-centered care has been advocated as an intervention capable of reducing the occurrence of adverse events, [3][4][5] being included as an essential element in the reforms of the health systems in some countries. 68] This philosophy values the patient's experience by adopting an individualized and integrated care approach, based on the physical and emotional needs of the patient.][13][14] The acquisition of information by the patient to improve the quality of health care has been a practice with an upward trend in some countries.] However, most of these instruments require that the patients inform on the outcomes of their care (safety incidents, for example), instead of the factors that could represent failures in the care structures and processes or care environment that would result in safety incidents, in the case of this example. 17Thus, due to the absence of an instrument that can provide patient information on the safety of their care or of the care environment, to be used in improving safety at the very level of the unit, the Patient Measure of Safety (PMOS) questionnaire emerged, developed in England by researchers of the Yorkshire Quality and Safety Research Group (YQSR Group) since 2011. 15,18he PMOS was created to be used in the hospitalization unit as a diagnostic tool, aiming to identify strong and weak areas based on the information provided by the patients and allowing intervening and preventing the errors from occurring. 15This is a measurement instrument devised for the future, providing a proactive assessment of the local and organizational factors that can generate safety incidents in hospitalized patients. 17 number of studies using the PMOS obtained high participation of the patients (86%), showing that they are willing to provide information on the safety of their care.][21] Currently, although we identify various ways of promoting patient participation in the health care processes and tools like the PMOS that can contribute to patient safety, in Brazil it is a topic still little explored. 6


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In this context, the PMOS would be a useful tool to be incorporated into the Brazilian context, in the sense of promoting patient-centered care and to improve quality and safety in health care.] Considering that the development of instruments is a time consuming process and involves certain costs, the transcultural adaptation of an already developed and validated instrument can be a good alternative.In addition to that, using an alre

y valid
ted instrument enables the conduction of studies in different populations and the comparison of characteristics of individuals belonging to different cultural contexts. 22hus, acknowledging the qualities of the PMOS and the need to include patient-centered initiatives and patient safety in health care in Brazil, this study had the objective of translating and transculturally adapting the PMOS to Brazili n Portuguese.


METHOD

This is a translation and transcultural adaptation study with the objective of creating the Brazilian Portuguese version of the PMOS questionnaire.This study was approved by the Research Ethics Committee of the Federal University of Sant

Catarina and was conducted in the period from A
ril to November 2017.The authors of the instrument authorized the conduction of the study by email in February 2016.

To conduct the study, the ethical precepts of research with human beings set forth in Resolution No. 466/2012 of the National Health Council were followed.The principles of bioethics, autonomy, non-maleficence, beneficence, justice and equality were observed.


Patient Measure of Safety (PMOS) Questionnaire

The original version of the PMOS consists in 44 items that assess 9 domains considered as critical for contributing to safety incidents in hospitalized patients, namely: communication and teamwork (9 items); organization and care planning (5 items); access to resources (4 items); ward type and layout (11 items); information flow (3 items); staff roles and responsibilities (4 items); staff training (2 items); equipment (design and functioning) (2 items); and delays (2 items).Item 1 (I was always treated with dignity and respect), not included in none of the domains, and item 25 (Others -Please specify), although included in the "ward type and layout" domain, do not add up to the total of the items in this domain. 15,17,23he questionnaire items are presented as statements with which the patients are asked to agree or disagree in a five-point Likert scale: "strongly disagree" (1); "disagree" (2); "neither agree or disagree" (3); "agree" (4); and "strongly ag

e" (5).] Although the original instrument does not conta
n sociodemographic data, the following information was included in the study: age, gender, schooling, profession, origin (city), hospitalization time, hospital, hospitalization unit, reason for hospitalization and number of previous hospitalizations.


Procedures for Translation and Transcultural Adaptation

The method for the translation and transcultural adaptation of the PMOS questionnaire to Brazilian Portuguese followed these internationally recommended sta

s for translation and
transcultural adaptation of instruments (Figure 1): translation, synthesis, back-translation, review by experts committee, pre-test, and presentation of the documentation of the entire process to the authors of the instrument.Each stage was recorded by means of a writte

report.


Stage I -T
anslation

In this stage, two bilingual translators, both with Brazilian Portuguese as their mother tongue (one being a health professional with knowledge on patient safety and the other with lay knowledge on the theme), independently produced two translated versions (T1 and T2).


Stage

I -Synthesis

In stage II, t
e participants were the researcher, the translator who created version T1 (health professional with knowledge on patient safety) and a professional translator.In this stage, the results of translations T1 and T2 were synthesized, producing a consensual translation: T1-2.


Stage III -Back-translation

In this stage, the participants were two bilingual wome

tors, English native speaker
and fluent in Brazilian Portuguese.They back-translated the instrument (version T1-2) to its original language, independently and totally blinded to the original version and to the concepts of the construct, generating two back-translated versions (BT1 and BT2).


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Stage IV -Experts Committee

The synthesis version of the PMOS translation (T1-2) was submitted to an experts committee to identify its content validity by assessing the semantic, idiom tic, cultural and conceptual equivalences of each item of the questionnaire.This committee was comprised by ten specialists from different Brazilian regions (South, Southwest, and Midwest) with a PhD, mastery of the Portuguese language, development of research studies, and publications in the area.

The specialists evaluated the semantic, idiomatic, cultural and conceptual equivalences for all the items of the original and translated versions of the questionnaire by accessing the SurveyMonkey® platform.6] For the items that scored - or 0, the specialists were asked to describe their suggestions or comments.

Consensus among the specialists was established by calculating the Content Validity Index (CVI), obtained by the calculation of the number of +1 answers divided

y the total number
of answers, adopting as acceptable a value above 0.9. 27


Stage V -Pre-Test

With the objective of verifying the understanding of the instrument by the target population and its applicability, a pre-test was conducted with 30 patients, according to the recommendation, 24 hospitalized in surgical, medical and mat rnity hospitalization units of a university hospital in the South of Brazil.

The participants of the pre-test were patients aged over 18 years old, Brazilian, fluent in Brazilian Portuguese, and with a minimum hospitalization time of 24 hours (inclusion criteria).The patients excluded were those without the ability to accept participating in the research (for example: due to neurological or psychiatric alterations, advanced disease, or in sedation) or those who were too weak or anguished (for exam le: due to respiratory impairment, pain or immediate postoperative period).

During the pre-test, the time to answer the questions and their comprehension by the patients were observed.This stage did not provide information on the psychometric properties of the questionnaire, whi h can be modified by the translation and transcultural adaptation process.

After signing the Free and Informed Consent Form, the patients answered the pre-final version of the questionnaire and the question referring to the evaluation of their comprehension, classifying it as good, regular or poor.T

items with poor and regular interpretations were reviewed and modified.


Stage VI -Submission and ap
raisal of all the written reports to and by the authors of the instrument

In this stage, all the reports and forms were sent to the authors of the instrument to verify if the recommended

tages we
e followed and if the reports positively reflected the process.


RESULTS

The original instrument and the translated and transculturally adapted version to Brazilian Portuguese of the PMOS questionnaire are presented in Chart 1.In the initial (I) stage of the translation and transcultural adaptation process of the PMOS, two versions of the questionnaire (T1 and T2) were created.The divergences between T1 and T2 and other suggestions were discussed, and the decisions were made by consensus, t

s ori
inating the synthesis version: T1-T2 (Stage II).


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Chart 1 -Cont.


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In this stage (II) the topics discussed and their solutions were the following: for the title, instead of "Medida de Segurança do Paciente", it was decided to use "Medida da Segurança pelo Paciente"; for "drugs" (item 3), it was decided to use "medicamentos" (T1) and not "drogas" (T2), for being the term most frequently used; "shift change" (item 7), was translated as "mudança de plantão" (T2) and not as "passagem de plantão", although this is a frequently used expression; "to deal" (item 15), despite the indication for "lidar" (T1 and T2), was translated as "atender", considered more appropriate for the item; "poor" (item 23) was translated as "inadequada" (T1) instead of "pobre" (T2); for "poor" (item 26), the word "insatisfatória" (T1) was chosen instead of "pobre" (T2); "on time", instead of "em tempo" (T1), was translated as "na hora certa", for considering that it is better understood; "hoists" (item 39) was translated as "elevadores" (T1) instead of "guindastes" (T2); and the expressions "drug charts" and "medical notes" were translated as "prescrição de medicamentos" and "anot ções médicas" instead of "gráficos de drogas" and "notas médicas" (T1 and T2).

In relation to the back-translations (BT1 and BT2), produced from version T1-2 (Stage III), there were no significant differences between them and the original instrument.Although some items did not use the s me wording of the original instrument, they showed similar content and ideas.

In the Experts Committee stage (IV), the assessments of the semantic, idiomatic, cultural and conceptual equivalences of the instrument's domains and items were performed.

Most of the CVI results of the PMOS items (mean of the semantic, idiomatic, conceptual and cultural equivalences of each of the items) was above 0.9, according to what is presented in Chart 2. CVI results of 0.9 or below were found for the following items: title of the PMOS (0.78), items 3 (0.90), 5 (0.90), 6 (0.88), 7 (0.83), 9 (0.90), 13 (0.85), 15 (0.90), 18 (0.80), 26 (0.85), 32 (0.85) and the statements in items 20 to 25 (0.88).The CVI means by equivalences resulted in values above 0.9, with the following results: 0.93 for semantic equivalence; 0.96 for idiomatic and conceptual equivalences, and 0.92 for cultur l equivalence.Although most of the items evaluated received, in general (by item or equivalence), CVI scores above 0.9, which would indicate an acceptable level of agreement among the specialists, in the second evaluation round the need was identified for grammatical changes, word order inversion 10/16 in phrases, and substitution of some terms by synonyms, some suggested by the specialists in the first evaluation round.

Accordingly, the following changes were made in the search for better semantic, idiomatic, conceptual and cultural adequacy: the title was changed to "Questionário de Avaliação da Segurança pelo Paciente (PMOS)", maintaining the acronym in English for ease of identification in the databases; regarding the questionnaire items, the word "prescritos" (item 3) was substituted by "receitados", more easily understood by the target population of the questionnaire; "meu plano de cuidados" and "a outra equipe" (item 6) were respectively changed to "meu tratamento" and "outros profissionais", for ease of understanding; "mudança" (item 7) was changed to "troca", more adequate from the conceptual point of view; the expression "não foi capaz" (item 9) was substituted by "não sabia"; "na hora certa" (item 10) was changed to "na hora marcada"; "posição" (item 11) was changed to "localização"; the expression "de materiais e equipamentos" was added to item 13 for ease of understanding; "equipe" (item 16) was substituted by "funcionários", for considering that the people who answer to the bell is not the entire team, but the employees who make up the team; "era claro" (item 17) was changed to "eu sabia"; "lidar com aspectos" (item 18) was changed to "realizar"; "não foi capaz" (item 19) was changed to "não sabia"; the word "ruído" (item 20) was changed to "barulho"; the word "maqueiros" (item 31) was substituted by the expression "transporte em maca", for the existence of professionals (stretcher bearers) exclusively for the transportation of patients not being common to most of the institutions and for this task being performed, most of the times, by Nursing professionals; the word "elevadores" (items 33 and 39) was removed, since these pieces of equipment, used for moving or *removing* patients, are still little used in most of the Brazilian hospital ; "ficou aguardando" (item 35) was changed to "tinha que esperar", for being closer to the purpose of the item, which is assessing the information flow; "funcionários" (item 36) was substituted by "profissionais"; "enfermeira" (item 38) was substituted by "enfermeiro/enfermeira", considering the gender issue; and "equipe" (items 40 and 43) was changed to "profissionais" to avoid generalizatio s and to ease understanding.

According to the results of the pre-test (Stage V), the mean time for its application was 31.9 minutes.In relation to the respondents, 53.3% were male and 46.7% female, most with high school (63.3%) and the rest with elementary school (30%) and higher education (6.7%), hospitalized in the surgical (50%), medical (40%) and maternity (10%) units, with a mean hospitalization time of 9.16 days.

Regarding the comprehension of the questionnaire items, a regular or poor interpretation was identified for 6 items, which were modified as follows: in item 17, the word "enfermagem" was added, since some respondents were doubtful whether the question referred to Nursing or to Medicine; in item 27, the word "profissional" was changed to "médico", because the term "profissional" was unclear to the patient, and also considering that the meaning of "consultant" (British English) is physician; in item 31, due to difficulty in understanding, the word "maca" was removed because, if maintained, it would not consider other types of transportation such as wheelchair or ambulance, for example; in item 32, the expression "em conjunto" was substituted by "juntos" for ease of understanding; in item 38, "enfermeiro/enfermeira" was changed to "profissional de enfermagem", c

the differ
nt Nursing categories existing in Brazil; and, in item 42, the expression "se esforçar" was changed to "dificuldade" since, in the previous version, the meaning is contrary to what the question intends to evaluate.

Finally, all the reports and versions of the instrument referring to the translation and cultural adaptation process of the PMOS were forwarded to the authors of the original instrument.


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DISCUSSION

The transcultural adaptation of the PMOS questionnaire to Brazilian Portuguese rigorously followed the stages proposed by Beaton et al., 24 a process that has been followed in Brazil 28 and internationally i most of the transcultural adaptation studies. 29n the initial stage of the transcultural adaptation process, there were no discrepancies between the T1 and T2 translations, since many of the differences between both translations were related to the use of synonyms and to the structure of the items (syntax).The words and phrase structuring considered more adequate by the evaluators of the synthesis stage were chosen.

Synthesizing the versions of an instrument consists in comparing them and evaluating their differences with the objective of obtaining a single version.In this process, inappropriate choices are identified nd solved by means of a discussion among the evaluators, together with the researchers responsible for the translation. 22he back-translations of the PMOS synthesis version showed similitude when compared to each other and to the original instrument, as well as the consistency quality of the PMOS synthesis version.Thus, the first translated version of the PMOS was created to be submitted to the experts committee.

Back-translation is a process to verify the accuracy of a translation.In this stage of the transcultural adaptation process, the translated instrument (synthesis version) is back-translated to its original language and then compared to the original version, 30 seeking to assess if the synthesis version reflects the contents of the original version in order to ensure the consistency of the translation. 31or an adequate translation, semantic, idiomatic, conceptual and cultural equivalences are also relevant.Should these equivalences not be found, changes must be implemented with the objective to attain them. 24In this study, the recommendations to obtain these equivalences were followed, thus ensuring an instrument adapted to the Brazilian culture.The evaluators' suggestions were considered and changes were implemented in most of the PMOS items, as well as in those with CVI values considered inadequate.It is also worth considering that the selection of evaluators from different regions of the country and with the cited qualifications was fundamental for an adequate and appropriate transcultural adaptation to the Brazilian context as a whole.

The Brazilian version of the PMOS was subjected to the pre-test, which aims at maintaining the meaning of the original version, improving comprehension, and finding errors or problems in the application of the instrument in the adaptation process. 24It represents an important phase, as it allows identifying if it is possible to apply the translated version and if the terms used were adequate for the population. 32erforming the pre-test of the PMOS translated version showed good acceptance and ease of understanding, res lting in few changes.Its application to a sample with different profiles verified the results of the assessment of the understanding of the instrument.In this way, the Brazilian version of the PMOS was translated and transculturally adapted, revealing to be a tool that can be used in our environment for the evaluation, by the patients, of aspects that can endanger their safety in the hospital setting.

Seeking to identify other experiences of application of the PMOS similar to this one, no studies dealing with the transcultural adaptation of the PMOS to other languages were found.However, a study was indeed found in which the PMOS was adapted so that it could be used for older adult patients

ith st
oke, acute myocardial infarction, and hip fracture in Australian hospitals.In this study, in addition to the change in health terms less common in the Australian context, the key change to the PMOS consisted in the reduction in the number of items negatively worded from 56% to 28% (from 24 to 12 items), with the intention to reduce the possibility of confusion or inducing unreliable an wers.


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This choice was justified based on previous studies with adult, older adult and acute hospitalized patients, in which it was found that simple questions would be more effective. 33In the transcultural adaptation process of the PMOS to Brazilian Portuguese, no difficulties were found related to the negatively worded items; therefore, they were maintained as in the original instrument.

In another study, the PMOS was the base for the elaboration of an instrument that allowed the patients to provide feedback on contributing factors for possible safety incidents in primary care, called Primary Care Patient Measure of Safety (PC PMOS).The final PC PMOS consisted of a tool with 50 items and 15 domains which was well received by patients and professionals during the face validity test.In this study, the contributing factors for safety incidents focused mainly on communication, access to care, factors related to the patient, planning and care organization, execution of the tasks, and information flow. 34onsequent y, even if small changes were made due to differences between Brazil and England, the translation and cultural adaptation process of the PMOS for its use in Brazil was successful, being conducted in a systematic manner and complying with all t

recommende
stages.No items were removed from the original questionnaire, and the instrument presented satisfactory values regarding content validity.

As a limitation of the research, the fact that the scale has not undergone the translation and transcultural adaptation process for other countries in its original version is emphasized, which hinders discussion and comparison of the results.


CONCL SION

The Questionário de Avaliação da Segurança pelo Paciente (PMOS) was the result of a thoughtful transcultural adaptation process.This study showed the importance of following the recommended steps for this process, resulting in an applicable instrument understood by the target population, presenting consistency in the translation and cultural adapta ion equivalence for its use in Brazil.

Today, considering the worldwide focus on patient safety, acknowledging the role of the patient in the health care processes and the nonexistence in Brazil of an instrument for evaluation by the patients of aspects that can endanger their safety, it is verified that the instrument, transculturally adapted by means of this study, ca be useful in Brazil.

In the fields of teaching and research, the contribution of the transcultural adaptation process of the PMOS lies in the detailed description of each of its stages.Thus, the methodological process of this study can be reproduced in the transcultural adaptation of other instruments, or even the adapted version of the PMOS itself can also motivate other research s