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whose purpose is to evaluate the stressful experiences in the parents&#44; rather than their satisfaction with their children&#39;s care&#46;<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">5</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">The Dutch questionnaire EMPATHIC-N was developed from an initial list of 92 parental satisfaction indicators with neonatal intensive care&#44; generated from a literature review and expert opinion obtained using the Delphi method in two stages&#46; These items were evaluated by parents and caregivers&#44; selecting 67 items&#44; divided into five domains&#58; information&#44; care &#38; treatment&#44; organization&#44; parental participation&#44; and professional attitude&#46; Each item is answered using a scale from one &#40;1&#41;&#44; &#8220;certainly not&#8221; to six &#40;6&#41;&#44; &#8220;certainly yes&#8221;&#44; in addition to the alternative &#8220;does not apply&#8221;&#46; Four open questions were also added for overall satisfaction assessment&#44; 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cross-cultural adaptation&#44; and validation of EMPATHIC-N content was carried out from March 2013 to December 2014&#44; in the NICU of Instituto de Medicina Integral Prof&#46; Fernando Figueira &#40;IMIP&#41;&#46; IMIP is a tertiary hospital in the city of Recife&#44; state of Pernambuco&#44; Brazil&#44; which has a multi-professional team&#44; providing assistance exclusively to users of the Brazilian Public Health System &#40;SUS&#41;&#46; In IMIP&#44; in 2014&#44; there were 5846 live births and 29&#46;3&#37; of them were preterm newborns&#46;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">8</span></a> The NICU has 50 beds&#44; with a mean daily occupancy of 86&#46;9&#37;&#44; mean number of admissions of 139 patients&#47;month&#44; and mean length of stay of 9&#46;3 days&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">The translation and cultural adaptation was carried out according to the method proposed by the Translation and Cross-Cultural Adaptation Group of the International Society for Pharmacoeconomics and Outcomes Research &#40;ISPOR&#41; in 2005&#46;<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">9</span></a> This method was suggested by the author of the EMPATHIC-N questionnaire&#44; after authorizing the translation and cultural adaptation&#46; The ISPOR proposes the following steps&#58; Preparation&#44; Translation&#44; Reconciliation&#44; Back-translation&#44; Review of Back-translation&#44; Harmonization&#44; Comprehension Test&#44; Review after Comprehension Test&#44; and Final Review &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41;&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0040" class="elsevierStylePara elsevierViewall">The translation consists of the creation of two translated versions&#44; one by a Brazilian individual with knowledge of the English language &#40;V1&#41; and the other by a British individual &#40;V2&#41;&#46; V1 and V2 were analyzed by the translators&#44; and a single version in Portuguese &#40;V3&#41; was created in the Reconciliation stage&#46; In the Back-translation step&#44; V3 was translated back into English &#40;V4&#41; by two translators&#44; one Brazilian and one whose native language was English&#46; The Review of Back-translation step was carried out by comparing the V4 with the EMPATHIC-N questionnaire&#46; The differences were discussed in the Harmonization step&#44; which resulted in the Portuguese version V5&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">In the Comprehension Test step&#44; V5 was applied to parents whose children had stayed for more than 48<span class="elsevierStyleHsp" style=""></span>h in the NICU&#46; The questionnaire was answered during hospitalization in the NICU and the parents were selected by consecutive sampling&#46; Parents were excluded when they declared to be illiterate or had children who had died&#46; The parents signed the Free and Informed Consent &#40;FIC&#41; form and were asked to read&#44; answer&#44; and interpret the questions&#46; The analysis of all answers was carried out by the same researcher&#46; An item was considered not understood when more than 15&#37; of parents reported not understanding the question or mistakenly interpreted its meaning&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">The items that were not understood were adjusted at the Review step&#44; after the Comprehension Test&#44; and the adjustments resulted in the final Portuguese version V6&#46; In the Final Review&#44; adjustments related to typos&#44; grammatical&#44; and layout errors of the questionnaire were carried out&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">The Content Validation of the final version was performed by expert consensus&#46; The sample consisted of all college&#47;university level employees of the NICU-IMIP who were working during the study period&#46; Employees were excluded if they were on vacation or leave&#44; or attending a residency program&#46; The members of the multidisciplinary team of NICU-IMIP were considered experts&#44; consisting of 41 neonatologist physicians&#44; nine nurses&#44; two psychologists&#44; one speech therapist&#44; and 12 physical therapists&#44; totaling 65 professionals&#46; This number of professionals is higher than the number reported in other studies &#40;ten to 20 professionals&#41; to constitute the panel of experts&#46;<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">10</span></a></p><p id="par0060" class="elsevierStylePara elsevierViewall">After reading and signing the informed consent form&#44; the experts answered a questionnaire evaluating the relevance of each of the 57 items of the final version &#40;V6&#41; included in a parental satisfaction assessment questionnaire in the NICU&#46; A Likert scale with five points was used for the answers&#44; with 5 being &#8220;very relevant&#8221; and 1 &#8220;very irrelevant&#8221;&#46; Space was also provided for qualitative observations&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">The data in this step were entered in duplicate using Excel 7 software &#40;Microsoft&#44; WA&#44; USA&#41; and validated in EpiInfo 3&#46;5&#46;3 &#40;Centers for Disease Control and Prevention&#44; USA&#41;&#46; STATA software &#40;StataCorp&#46; 2011&#46; <span class="elsevierStyleItalic">Stata Statistical Software&#58; Release 12</span>&#46; College Station&#44; TX&#44; USA&#41; was used for data analysis&#44; providing frequency distribution&#44; mean&#44; and standard deviation per item&#44; whereas the internal consistency analysis of the items was analyzed by calculating Cronbach&#39;s alpha coefficient for each domain&#46; The items with mean responses higher than or equal to 3&#46;5 were maintained in the final version of the parental satisfaction assessment tool&#46;<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">11</span></a></p><p id="par0070" class="elsevierStylePara elsevierViewall">The study met all ethical aspects according to Resolution No&#46; 466&#47;12 of the National Health Council<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">12</span></a> and was approved by the Research Ethics Committee of the IMIP&#44; CAE&#58; 18419913&#46;8&#46;0000&#46;5201&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Results</span><p id="par0075" class="elsevierStylePara elsevierViewall">The translation of EMPATHIC-N was carried out as proposed&#46; During the preparation of V3&#44; the order of a few sentences was inverted according to the syntax of Brazilian Portuguese and the verb tense was changed to the third person singular&#44; using the past continuous tense equivalent in Portuguese&#44; which is more common in informal speech&#46; The most common term was chosen for those that had synonyms&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">During the Review of the Back-translation of V4&#44; the EMPATHIC-N was jointly compared by the researchers and translators regarding the semantic equivalence&#46; Most statements retained the correct meaning after the back-translation&#44; with differences being attributed to the use of synonyms by the two translators&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">The statement &#8220;We received sympathy from the doctors and nurses&#8221; was modified after comparison with the back-translation&#46; Considering that &#8220;Sympathy&#8221; could be translated as &#8220;compassion&#8221;&#44; &#8220;solidarity&#8221;&#44; or &#8220;understanding&#8221;&#44; it was considered more appropriate to translate the phrase to &#8220;The doctors and nurses showed solidarity&#8221;&#46; At the final evaluation&#44; &#8220;How would you rate our performance in general&#63;&#8221; was translated to &#8220;How would you rate the overall performance of our unit&#63;&#8221; to make it clear to the respondent that the question was related to the work of the professionals in the NICU&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">The layout&#44; order&#44; and division of items by topic of the EMPATHIC-N were maintained in the Portuguese version V5&#44; which was submitted to two comprehension tests&#46; The interviewees were mothers with a mean age of 28 years&#44; all of mixed-race ethnicity and with more than eight years of schooling&#44; but none had a college&#47;university degree&#46; After interviewing eight mothers&#44; their interest was observed regarding the assessment of the service&#44; with verbalization of their complaints and compliments&#46; Most had difficulty differentiating nurses from nurse technicians&#44; which could modify the assessment&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">There was a predominance of extreme responses &#40;1 or 6&#41;&#44; which was attributed to the mothers&#8217; difficulty in using the Likert scale&#46; Thus&#44; it was decided to add characters to the scale&#44; with faces expressing satisfaction or dissatisfaction&#44; which was reported to and accepted by the author of the original questionnaire&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">It was observed that questions 41 and 55 were not answered coherently&#46; Question 41 addressed the fact of receiving an explanatory leaflet&#44; but the assessed NICU does not have this material&#44; making it impossible to review this item&#46; As for question 55&#44; it addressed the &#8220;cultural background&#8221;&#44; which was not understood by the interviewees&#44; as it is not compatible with this context&#46;</p><p id="par0105" class="elsevierStylePara elsevierViewall">The difficulty in understanding some items led to the substitution of words or expressions by equivalents that were easier to understand&#44; or to changes in the order of sentences&#46; Examples were added to some items &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>&#41;&#46; The term NICU was replaced by intensive care unit &#40;ICU&#41;&#44; as this is the term most often used in Brazil&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0110" class="elsevierStylePara elsevierViewall">After the changes were carried out in the questionnaire&#44; this version was submitted to a second Comprehension Test with five mothers&#46; At this step&#44; before the questionnaire was handed to them&#44; the difference regarding the function between the professionals was clarified and the explanation of the Likert scale was reinforced&#46; This test showed complete understanding of items and more varied responses in the Likert scale&#46;</p><p id="par0115" class="elsevierStylePara elsevierViewall">At the Content Validation step&#44; of the 65 professionals&#44; ten were excluded because they were residents&#44; and 55 questionnaires were handed out&#44; of which 40 &#40;72&#46;7&#37;&#41; were returned&#44; consisting of 20 neonatologist physicians&#44; 11 nurses&#44; one psychologist&#44; one speech therapist&#44; and seven physical therapists&#46; In the group of experts&#44; 95&#37; had a postgraduate degree in the area and a mean of 10&#46;6 years of experience in neonatology&#46; Only one professional filled out the space intended for qualitative observations&#46;</p><p id="par0120" class="elsevierStylePara elsevierViewall">The mean and standard deviation of responses were calculated&#44; as shown in <a class="elsevierStyleCrossRef" href="#fig0015">Fig&#46; 3</a>&#46; Items 32 &#8220;Even during invasive procedures&#44; we could always stay close to our child&#8221; and 40 &#8220;It was easy to talk to the ICU by telephone&#8221; were excluded&#44; as they obtained a mean lower than 3&#46;5&#46; The reliability of the data collection instrument was assessed using the internal consistency of items by calculating Cronbach&#39;s alpha coefficient&#46; All domains obtained values &#62;0&#46;7 &#40;<a class="elsevierStyleCrossRef" href="#fig0020">Fig&#46; 4</a>&#41;&#46; After excluding items 32 and 40&#44; Cronbach&#39;s alpha was recalculated&#44; remaining &#62;0&#46;7 in all of them&#46;</p><elsevierMultimedia ident="fig0015"></elsevierMultimedia><elsevierMultimedia ident="fig0020"></elsevierMultimedia><p id="par0125" class="elsevierStylePara elsevierViewall">After these steps&#44; the adapted&#44; translated&#44; and validated parent satisfaction assessment tool for the NICU in Brazil was obtained&#44; consisting of 53 items plus four open questions&#44; keeping the layout and the division by sub-items of the original questionnaire&#44; but with characters representing the Likert scale&#46;</p><p id="par0130" class="elsevierStylePara elsevierViewall">However&#44; at the review step&#44; it was decided to reintroduce the items that had been excluded during the process of cultural adaptation&#44; with a total of 57 items in the final questionnaire&#44; in addition to the four open questions for overall assessment of satisfaction&#44; a section for demographic information&#44; and a space for parents to freely express their experiences&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Discussion</span><p id="par0135" class="elsevierStylePara elsevierViewall">The study carried out the translation into Brazilian Portuguese&#44; cross-cultural adaptation&#44; and validation of the content of the EMPATHIC-N questionnaire&#46;</p><p id="par0140" class="elsevierStylePara elsevierViewall">The Comprehension Test was performed with mothers to make it accessible to the assessed population&#44; as the EMPATHIC-N is self-applied and was developed in the Netherlands&#44; which has a different socioeconomic and cultural profile&#44; with low social inequality and easy access to health services&#46;<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">13</span></a></p><p id="par0145" class="elsevierStylePara elsevierViewall">When assessing the profile of pregnant Brazilian women&#44; as shown in the &#8220;Nascer no Brasil&#8221; study carried out from 2011 to 2012&#44; it identified women with a mean age of 25&#46;7 years&#44; of whom 18&#46;2&#37; were adolescents and 10&#46;5&#37; were 35 years or older&#46; Of the respondents&#44; 73&#46;5&#37; had at least eight years of schooling and only 8&#46;9&#37; of them had a college&#47;university degree&#46;<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">14</span></a> The 2014 IMIP epidemiological data show a similar profile&#44; with 22&#46;6&#37; adolescent mothers and 90&#46;5&#37; with more than eight years of schooling&#46;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">8</span></a></p><p id="par0150" class="elsevierStylePara elsevierViewall">In the Netherlands&#44; the presence of immigrant populations&#44; with cultural diversity and language barriers in the NICU environment&#44; can lead to increased maternal stress if the situations are not well managed&#46;<a class="elsevierStyleCrossRef" href="#bib0185"><span class="elsevierStyleSup">15</span></a> In spite of the proven importance of this issue&#44; the pilot test demonstrated that the question &#8220;Our cultural background was taken into account&#8221; was not understood by the interviewees&#44; and thus was excluded&#46; This was likely due to the fact that there are no major internal cultural differences in the Northeast of Brazil&#44; but it may possibly occur in other Brazilian regions&#44; such as the North&#44; where there are indigenous populations of different ethnic groups&#44; or in the Southeast&#44; where there are more immigrants&#46;</p><p id="par0155" class="elsevierStylePara elsevierViewall">The reliability of the data collection tool used for content validation by the expert panel was measured by analyzing the internal consistency of items through Cronbach&#39;s alpha coefficient&#46; Values &#62;0&#46;7 for all domains demonstrate its reliability in assessing the relevance of the items maintained in the tool final version&#46;<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">13</span></a> The statistical analysis of this phase resulted in the exclusion of two items&#46;<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">13</span></a></p><p id="par0160" class="elsevierStylePara elsevierViewall">One of the items addresses the permanence of parents during invasive procedures&#46; Although the presence of parents is supported by the literature&#44; the experts did not consider the presence of this item to be relevant in the assessment of parental satisfaction&#44; which may reflect a habitual custom of some neonatal units&#46;<a class="elsevierStyleCrossRefs" href="#bib0190"><span class="elsevierStyleSup">16&#44;17</span></a> The American Heart Association&#44; however&#44; recommends that it should be a family decision regarding whether or not to be present at the time of cardiac resuscitation&#46;<a class="elsevierStyleCrossRef" href="#bib0200"><span class="elsevierStyleSup">18</span></a></p><p id="par0165" class="elsevierStylePara elsevierViewall">The other item &#8220;It was easy to talk to the ICU by telephone&#8221; received a negative assessment&#44; probably due to the fact that it is not customary to give information by phone in the NICU-IMIP&#44; in order to encourage the participation of parents and prevent inadequate understanding of information&#46; However&#44; this practice may be present in other health services to facilitate communication&#44; which is often unsatisfactorily conducted in several situations&#46;<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">7</span></a> A study carried out in a Danish NICU in 2007 included interviews with 780 parents and identified the fact that it requires time to be able to talk with a doctor or nurse as the main communication complaint&#46;<a class="elsevierStyleCrossRef" href="#bib0205"><span class="elsevierStyleSup">19</span></a></p><p id="par0170" class="elsevierStylePara elsevierViewall">In the present study&#44; the step consisting of the evaluation by the expert panel identified the importance of communication&#44; as all the items from the group &#8220;Information&#8221; were assessed as relevant and maintained in the study&#46;</p><p id="par0175" class="elsevierStylePara elsevierViewall">The statement that addressed the presence of an explanatory leaflet was initially excluded&#44; because there is no such practice in the assessed unit&#46; This is a method used that allows a first contact of parents with the ICU&#44; used in many countries&#44; providing important information regarding their stay at the unit&#46; A European study carried out in 125 neonatal units observed that 43&#37; of parents reported not having received information about the unit and 46&#37; did not receive clear information about the machines&#44; monitors&#44; and alarms used there&#46; Therefore&#44; this practice&#44; although promising&#44; does not yet show adequate coverage in most units&#46;<a class="elsevierStyleCrossRef" href="#bib0210"><span class="elsevierStyleSup">20</span></a></p><p id="par0180" class="elsevierStylePara elsevierViewall">Importantly&#44; the item &#8220;We actively participated in the decision-making about the care and treatment of our child&#8221; showed only 50&#37; &#8220;relevant&#8221; and &#8220;very relevant&#8221; answers&#46; A systematic review assessing the needs of parents of newborns admitted to the NICU highlighted six primary needs&#44; among them the adequate information and inclusion in care and decision-making related to the child&#46;<a class="elsevierStyleCrossRef" href="#bib0215"><span class="elsevierStyleSup">21</span></a> Therefore&#44; it is clear that there are still flaws regarding the acknowledgment of basic concepts of patient- and family-oriented medicine by NICU professionals&#46;</p><p id="par0185" class="elsevierStylePara elsevierViewall">Four health team behaviors are suggested to meet the parents&#8217; needs&#58; emotional support&#44; parental empowerment&#44; welcoming environment&#44; and unit support policies and education of parents in practicing new skills through guided participation&#46;<a class="elsevierStyleCrossRef" href="#bib0215"><span class="elsevierStyleSup">21</span></a> All these issues are addressed in the EMPATHIC-N in the domains of information&#44; care and treatment&#44; parental participation&#44; and organization&#46;</p><p id="par0190" class="elsevierStylePara elsevierViewall">The method proposed in this study would result in the exclusion of these four items of the questionnaire&#46; However&#44; the importance of these items&#44; according to literature evidence&#44; resulted in the re-evaluation of their exclusion&#46; Considering the opinion of the original questionnaire&#39;s author&#44; who was against the exclusion of items&#44; it was decided to keep them&#46;</p><p id="par0195" class="elsevierStylePara elsevierViewall">The indication for the exclusion of these items by the proposed method does not seem to be related to methodological error&#44; but to the incipiency of the concepts of family and patient-oriented medicine in the assessed service&#46; Routines such as telephone contact&#44; presence of parents during invasive procedures&#44; and the presence of explanatory leaflets are supported by the literature and should be encouraged&#46; Therefore&#44; the items were reintroduced in the final questionnaire&#44; considering that the questionnaire can&#44; in the future&#44; be applied at different locations and that if these items cannot be applied&#44; the alternative &#8220;does not apply&#8221; can be used&#46;</p><p id="par0200" class="elsevierStylePara elsevierViewall">After all the proposed steps&#44; the EMPATHIC-N&#44; of Dutch origin&#44; is available in its Brazilian version&#44; filling this gap in the literature&#46; The importance of such a tool for its capacity to assess satisfaction is emphasized&#44; which is considered one of the attributes of quality in healthcare<a class="elsevierStyleCrossRef" href="#bib0220"><span class="elsevierStyleSup">22</span></a> and stimulate questioning about routines within the NICU&#44; aiming at excellence in the offered service&#46;</p><p id="par0205" class="elsevierStylePara elsevierViewall">Further studies should evaluate the psychometric properties of the translated and adapted questionnaire&#46; Regional characteristics that may influence the cross-cultural adaptation should be taken into consideration&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Conflicts of interest</span><p id="par0210" class="elsevierStylePara elsevierViewall">The authors declare no conflicts of interest&#46;</p></span></span>"
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        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Objectives</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Considering the lack of questionnaires that propose to evaluate parental satisfaction with the Neonatal Intensive Care Unit &#40;NICU&#41; in Brazil&#44; this study aimed to carry out the translation of the EMPATHIC-N questionnaire into Brazilian Portuguese&#44; the cross-cultural adaptation and validation of its contents&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Method</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">The translation and cultural adaptation of the questionnaire was carried out according to the protocol established by the Translation and Cross-Cultural Adaptation Group of the International Society for Pharmacoeconomics and Outcomes Research &#40;ISPOR&#41; in 2005&#46; The validation of the content was carried out by a panel of experts&#44; who evaluated each item from &#8220;very irrelevant&#8221; to &#8220;very relevant&#8221;&#46; Items with a mean Likert scale value &#60;3&#46;5 were excluded&#46; Cronbach&#39;s alpha of the domains was calculated&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">The questionnaire was submitted to two pilot tests with mothers of newborns admitted to the NICU of the study&#44; after which some terms were modified to achieve global understanding&#46; Cronbach&#39;s alpha remained above 0&#46;7 in all items&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusion</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">The tool resulting from the translation&#44; cultural adaptation&#44; and validation of the EMPATHIC-N questionnaire showed to be adequate to assess satisfaction of parents of newborns admitted to the NICU in Brazil&#46;</p></span>"
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Original article
Brazilian adaptation and validation of the Empowerment of Parents in the Intensive Care-Neonatology (EMPATHIC-N) questionnaire
Adaptação brasileira e validação do questionário Empowerment of Parents in the Intensive Care-Neonatology (EMPATHIC-N)
Dafne B.C.A. Gomeza,
Corresponding author
dafnebarcala@hotmail.com

Corresponding author.
, Suely A. Vidala,b, Luciana C.S. Limac
a Instituto de Medicina Integral Prof. Fernando Figueira (IMIP), Recife, PE, Brazil
b Instituto de Medicina Integral Prof. Fernando Figueira (IMIP), Grupo de Estudos em Gestão e Avaliação em Saúde (GEAS), Recife, PE, Brazil
c Instituto de Medicina Integral Prof. Fernando Figueira (IMIP), Programa de Residência Médica, Recife, PE, Brazil
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          "en" => "<p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">Demonstration of the modified terms after the first pilot test by each item of version 5&#46;</p>"
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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">From the perspective of family- and patient-oriented Medicine&#44; the parents&#8217; perception and satisfaction about their children&#39;s care of are considered quality measures for the evaluation of care&#46;<a class="elsevierStyleCrossRefs" href="#bib0115"><span class="elsevierStyleSup">1&#44;2</span></a> A literature review found four tools in the English language related to parents&#8217; satisfaction with the neonatal intensive care unit &#40;NICU&#41;&#58; the Neonatal Index of Parent Satisfaction &#40;NIPS&#41; scale&#44; the Neonatal Intensive Care Unit&#8211;Parent Satisfaction Form &#40;NICU&#8211;PSF&#41; questionnaire&#44; the Parental Stress Scale&#58; Neonatal Intensive Care Unit &#40;PSS&#58;NICU&#41; scale&#44; and the EMpowerment of PArent in THe Intensive Care-Neonatology &#40;EMPATHIC-N&#41; questionnaire&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">3</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">The NIPS is a 27-item questionnaire&#44; divided into three areas&#58; quality of care&#44; communication&#44; and attitudes in care&#47;personality&#46; However&#44; this scale most often focuses on the frequency of events in the NICU rather than the parents&#8217; opinion regarding care&#46;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">4</span></a> The NICU&#8211;PSF addresses the concepts of overall satisfaction&#44; continuous communication&#44; information&#44; preparation&#44; participation in care&#44; support for decision-making&#44; spiritual needs and closeness in care&#44; and monitoring&#46; Its validity was established by content validity and internal consistency analysis in five of its nine evaluated scales&#44; but there are questions about the quality of the sample used for validation&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">3</span></a> The PSS&#58;NICO is a questionnaire adapted from experience in pediatric units&#44; whose purpose is to evaluate the stressful experiences in the parents&#44; rather than their satisfaction with their children&#39;s care&#46;<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">5</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">The Dutch questionnaire EMPATHIC-N was developed from an initial list of 92 parental satisfaction indicators with neonatal intensive care&#44; generated from a literature review and expert opinion obtained using the Delphi method in two stages&#46; These items were evaluated by parents and caregivers&#44; selecting 67 items&#44; divided into five domains&#58; information&#44; care &#38; treatment&#44; organization&#44; parental participation&#44; and professional attitude&#46; Each item is answered using a scale from one &#40;1&#41;&#44; &#8220;certainly not&#8221; to six &#40;6&#41;&#44; &#8220;certainly yes&#8221;&#44; in addition to the alternative &#8220;does not apply&#8221;&#46; Four open questions were also added for overall satisfaction assessment&#44; a section for demographic information and a free space for parents to express their experiences&#46;<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">6</span></a> Among the satisfaction indicators regarding the provided care&#44; communication between the NICU professionals and parents is highly valued&#44; as it is one of the pillars of family- and patient-oriented medicine&#44; supporting the sharing of information honestly and completely&#44; to stimulate the participation of parents in decision-making&#46;<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">7</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">The evaluation of the EMPATHIC-N psychometric tests was carried out in two cohorts of parents of patients in a Dutch NICU&#59; during this process&#44; 10 items were excluded&#44; resulting in 57 items&#46; The internal consistency was evaluated&#44; which showed an adequate level of reliability in all domains&#44; with Cronbach&#39;s <span class="elsevierStyleItalic">&#945;</span> test &#62;0&#46;8&#46; Spearman&#39;s correlation test evaluated the congruent validity between the domain level and overall satisfaction&#44; which showed to be satisfactory&#46; Moreover&#44; a non-differential effect was verified between the demographic variables and domains&#46;<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">6</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">Despite the importance of assessing parental satisfaction with neonatal care in any population&#44; there are no validated instruments published in Portuguese with this purpose&#46; This study translated the EMPATHIC-N questionnaire content into Brazilian Portuguese&#44; and performed its cross-cultural adaptation and validation&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Method</span><p id="par0030" class="elsevierStylePara elsevierViewall">The methodological work of translation&#44; cross-cultural adaptation&#44; and validation of EMPATHIC-N content was carried out from March 2013 to December 2014&#44; in the NICU of Instituto de Medicina Integral Prof&#46; Fernando Figueira &#40;IMIP&#41;&#46; IMIP is a tertiary hospital in the city of Recife&#44; state of Pernambuco&#44; Brazil&#44; which has a multi-professional team&#44; providing assistance exclusively to users of the Brazilian Public Health System &#40;SUS&#41;&#46; In IMIP&#44; in 2014&#44; there were 5846 live births and 29&#46;3&#37; of them were preterm newborns&#46;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">8</span></a> The NICU has 50 beds&#44; with a mean daily occupancy of 86&#46;9&#37;&#44; mean number of admissions of 139 patients&#47;month&#44; and mean length of stay of 9&#46;3 days&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">The translation and cultural adaptation was carried out according to the method proposed by the Translation and Cross-Cultural Adaptation Group of the International Society for Pharmacoeconomics and Outcomes Research &#40;ISPOR&#41; in 2005&#46;<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">9</span></a> This method was suggested by the author of the EMPATHIC-N questionnaire&#44; after authorizing the translation and cultural adaptation&#46; The ISPOR proposes the following steps&#58; Preparation&#44; Translation&#44; Reconciliation&#44; Back-translation&#44; Review of Back-translation&#44; Harmonization&#44; Comprehension Test&#44; Review after Comprehension Test&#44; and Final Review &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41;&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0040" class="elsevierStylePara elsevierViewall">The translation consists of the creation of two translated versions&#44; one by a Brazilian individual with knowledge of the English language &#40;V1&#41; and the other by a British individual &#40;V2&#41;&#46; V1 and V2 were analyzed by the translators&#44; and a single version in Portuguese &#40;V3&#41; was created in the Reconciliation stage&#46; In the Back-translation step&#44; V3 was translated back into English &#40;V4&#41; by two translators&#44; one Brazilian and one whose native language was English&#46; The Review of Back-translation step was carried out by comparing the V4 with the EMPATHIC-N questionnaire&#46; The differences were discussed in the Harmonization step&#44; which resulted in the Portuguese version V5&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">In the Comprehension Test step&#44; V5 was applied to parents whose children had stayed for more than 48<span class="elsevierStyleHsp" style=""></span>h in the NICU&#46; The questionnaire was answered during hospitalization in the NICU and the parents were selected by consecutive sampling&#46; Parents were excluded when they declared to be illiterate or had children who had died&#46; The parents signed the Free and Informed Consent &#40;FIC&#41; form and were asked to read&#44; answer&#44; and interpret the questions&#46; The analysis of all answers was carried out by the same researcher&#46; An item was considered not understood when more than 15&#37; of parents reported not understanding the question or mistakenly interpreted its meaning&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">The items that were not understood were adjusted at the Review step&#44; after the Comprehension Test&#44; and the adjustments resulted in the final Portuguese version V6&#46; In the Final Review&#44; adjustments related to typos&#44; grammatical&#44; and layout errors of the questionnaire were carried out&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">The Content Validation of the final version was performed by expert consensus&#46; The sample consisted of all college&#47;university level employees of the NICU-IMIP who were working during the study period&#46; Employees were excluded if they were on vacation or leave&#44; or attending a residency program&#46; The members of the multidisciplinary team of NICU-IMIP were considered experts&#44; consisting of 41 neonatologist physicians&#44; nine nurses&#44; two psychologists&#44; one speech therapist&#44; and 12 physical therapists&#44; totaling 65 professionals&#46; This number of professionals is higher than the number reported in other studies &#40;ten to 20 professionals&#41; to constitute the panel of experts&#46;<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">10</span></a></p><p id="par0060" class="elsevierStylePara elsevierViewall">After reading and signing the informed consent form&#44; the experts answered a questionnaire evaluating the relevance of each of the 57 items of the final version &#40;V6&#41; included in a parental satisfaction assessment questionnaire in the NICU&#46; A Likert scale with five points was used for the answers&#44; with 5 being &#8220;very relevant&#8221; and 1 &#8220;very irrelevant&#8221;&#46; Space was also provided for qualitative observations&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">The data in this step were entered in duplicate using Excel 7 software &#40;Microsoft&#44; WA&#44; USA&#41; and validated in EpiInfo 3&#46;5&#46;3 &#40;Centers for Disease Control and Prevention&#44; USA&#41;&#46; STATA software &#40;StataCorp&#46; 2011&#46; <span class="elsevierStyleItalic">Stata Statistical Software&#58; Release 12</span>&#46; College Station&#44; TX&#44; USA&#41; was used for data analysis&#44; providing frequency distribution&#44; mean&#44; and standard deviation per item&#44; whereas the internal consistency analysis of the items was analyzed by calculating Cronbach&#39;s alpha coefficient for each domain&#46; The items with mean responses higher than or equal to 3&#46;5 were maintained in the final version of the parental satisfaction assessment tool&#46;<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">11</span></a></p><p id="par0070" class="elsevierStylePara elsevierViewall">The study met all ethical aspects according to Resolution No&#46; 466&#47;12 of the National Health Council<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">12</span></a> and was approved by the Research Ethics Committee of the IMIP&#44; CAE&#58; 18419913&#46;8&#46;0000&#46;5201&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Results</span><p id="par0075" class="elsevierStylePara elsevierViewall">The translation of EMPATHIC-N was carried out as proposed&#46; During the preparation of V3&#44; the order of a few sentences was inverted according to the syntax of Brazilian Portuguese and the verb tense was changed to the third person singular&#44; using the past continuous tense equivalent in Portuguese&#44; which is more common in informal speech&#46; The most common term was chosen for those that had synonyms&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">During the Review of the Back-translation of V4&#44; the EMPATHIC-N was jointly compared by the researchers and translators regarding the semantic equivalence&#46; Most statements retained the correct meaning after the back-translation&#44; with differences being attributed to the use of synonyms by the two translators&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">The statement &#8220;We received sympathy from the doctors and nurses&#8221; was modified after comparison with the back-translation&#46; Considering that &#8220;Sympathy&#8221; could be translated as &#8220;compassion&#8221;&#44; &#8220;solidarity&#8221;&#44; or &#8220;understanding&#8221;&#44; it was considered more appropriate to translate the phrase to &#8220;The doctors and nurses showed solidarity&#8221;&#46; At the final evaluation&#44; &#8220;How would you rate our performance in general&#63;&#8221; was translated to &#8220;How would you rate the overall performance of our unit&#63;&#8221; to make it clear to the respondent that the question was related to the work of the professionals in the NICU&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">The layout&#44; order&#44; and division of items by topic of the EMPATHIC-N were maintained in the Portuguese version V5&#44; which was submitted to two comprehension tests&#46; The interviewees were mothers with a mean age of 28 years&#44; all of mixed-race ethnicity and with more than eight years of schooling&#44; but none had a college&#47;university degree&#46; After interviewing eight mothers&#44; their interest was observed regarding the assessment of the service&#44; with verbalization of their complaints and compliments&#46; Most had difficulty differentiating nurses from nurse technicians&#44; which could modify the assessment&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">There was a predominance of extreme responses &#40;1 or 6&#41;&#44; which was attributed to the mothers&#8217; difficulty in using the Likert scale&#46; Thus&#44; it was decided to add characters to the scale&#44; with faces expressing satisfaction or dissatisfaction&#44; which was reported to and accepted by the author of the original questionnaire&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">It was observed that questions 41 and 55 were not answered coherently&#46; Question 41 addressed the fact of receiving an explanatory leaflet&#44; but the assessed NICU does not have this material&#44; making it impossible to review this item&#46; As for question 55&#44; it addressed the &#8220;cultural background&#8221;&#44; which was not understood by the interviewees&#44; as it is not compatible with this context&#46;</p><p id="par0105" class="elsevierStylePara elsevierViewall">The difficulty in understanding some items led to the substitution of words or expressions by equivalents that were easier to understand&#44; or to changes in the order of sentences&#46; Examples were added to some items &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>&#41;&#46; The term NICU was replaced by intensive care unit &#40;ICU&#41;&#44; as this is the term most often used in Brazil&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0110" class="elsevierStylePara elsevierViewall">After the changes were carried out in the questionnaire&#44; this version was submitted to a second Comprehension Test with five mothers&#46; At this step&#44; before the questionnaire was handed to them&#44; the difference regarding the function between the professionals was clarified and the explanation of the Likert scale was reinforced&#46; This test showed complete understanding of items and more varied responses in the Likert scale&#46;</p><p id="par0115" class="elsevierStylePara elsevierViewall">At the Content Validation step&#44; of the 65 professionals&#44; ten were excluded because they were residents&#44; and 55 questionnaires were handed out&#44; of which 40 &#40;72&#46;7&#37;&#41; were returned&#44; consisting of 20 neonatologist physicians&#44; 11 nurses&#44; one psychologist&#44; one speech therapist&#44; and seven physical therapists&#46; In the group of experts&#44; 95&#37; had a postgraduate degree in the area and a mean of 10&#46;6 years of experience in neonatology&#46; Only one professional filled out the space intended for qualitative observations&#46;</p><p id="par0120" class="elsevierStylePara elsevierViewall">The mean and standard deviation of responses were calculated&#44; as shown in <a class="elsevierStyleCrossRef" href="#fig0015">Fig&#46; 3</a>&#46; Items 32 &#8220;Even during invasive procedures&#44; we could always stay close to our child&#8221; and 40 &#8220;It was easy to talk to the ICU by telephone&#8221; were excluded&#44; as they obtained a mean lower than 3&#46;5&#46; The reliability of the data collection instrument was assessed using the internal consistency of items by calculating Cronbach&#39;s alpha coefficient&#46; All domains obtained values &#62;0&#46;7 &#40;<a class="elsevierStyleCrossRef" href="#fig0020">Fig&#46; 4</a>&#41;&#46; After excluding items 32 and 40&#44; Cronbach&#39;s alpha was recalculated&#44; remaining &#62;0&#46;7 in all of them&#46;</p><elsevierMultimedia ident="fig0015"></elsevierMultimedia><elsevierMultimedia ident="fig0020"></elsevierMultimedia><p id="par0125" class="elsevierStylePara elsevierViewall">After these steps&#44; the adapted&#44; translated&#44; and validated parent satisfaction assessment tool for the NICU in Brazil was obtained&#44; consisting of 53 items plus four open questions&#44; keeping the layout and the division by sub-items of the original questionnaire&#44; but with characters representing the Likert scale&#46;</p><p id="par0130" class="elsevierStylePara elsevierViewall">However&#44; at the review step&#44; it was decided to reintroduce the items that had been excluded during the process of cultural adaptation&#44; with a total of 57 items in the final questionnaire&#44; in addition to the four open questions for overall assessment of satisfaction&#44; a section for demographic information&#44; and a space for parents to freely express their experiences&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Discussion</span><p id="par0135" class="elsevierStylePara elsevierViewall">The study carried out the translation into Brazilian Portuguese&#44; cross-cultural adaptation&#44; and validation of the content of the EMPATHIC-N questionnaire&#46;</p><p id="par0140" class="elsevierStylePara elsevierViewall">The Comprehension Test was performed with mothers to make it accessible to the assessed population&#44; as the EMPATHIC-N is self-applied and was developed in the Netherlands&#44; which has a different socioeconomic and cultural profile&#44; with low social inequality and easy access to health services&#46;<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">13</span></a></p><p id="par0145" class="elsevierStylePara elsevierViewall">When assessing the profile of pregnant Brazilian women&#44; as shown in the &#8220;Nascer no Brasil&#8221; study carried out from 2011 to 2012&#44; it identified women with a mean age of 25&#46;7 years&#44; of whom 18&#46;2&#37; were adolescents and 10&#46;5&#37; were 35 years or older&#46; Of the respondents&#44; 73&#46;5&#37; had at least eight years of schooling and only 8&#46;9&#37; of them had a college&#47;university degree&#46;<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">14</span></a> The 2014 IMIP epidemiological data show a similar profile&#44; with 22&#46;6&#37; adolescent mothers and 90&#46;5&#37; with more than eight years of schooling&#46;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">8</span></a></p><p id="par0150" class="elsevierStylePara elsevierViewall">In the Netherlands&#44; the presence of immigrant populations&#44; with cultural diversity and language barriers in the NICU environment&#44; can lead to increased maternal stress if the situations are not well managed&#46;<a class="elsevierStyleCrossRef" href="#bib0185"><span class="elsevierStyleSup">15</span></a> In spite of the proven importance of this issue&#44; the pilot test demonstrated that the question &#8220;Our cultural background was taken into account&#8221; was not understood by the interviewees&#44; and thus was excluded&#46; This was likely due to the fact that there are no major internal cultural differences in the Northeast of Brazil&#44; but it may possibly occur in other Brazilian regions&#44; such as the North&#44; where there are indigenous populations of different ethnic groups&#44; or in the Southeast&#44; where there are more immigrants&#46;</p><p id="par0155" class="elsevierStylePara elsevierViewall">The reliability of the data collection tool used for content validation by the expert panel was measured by analyzing the internal consistency of items through Cronbach&#39;s alpha coefficient&#46; Values &#62;0&#46;7 for all domains demonstrate its reliability in assessing the relevance of the items maintained in the tool final version&#46;<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">13</span></a> The statistical analysis of this phase resulted in the exclusion of two items&#46;<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">13</span></a></p><p id="par0160" class="elsevierStylePara elsevierViewall">One of the items addresses the permanence of parents during invasive procedures&#46; Although the presence of parents is supported by the literature&#44; the experts did not consider the presence of this item to be relevant in the assessment of parental satisfaction&#44; which may reflect a habitual custom of some neonatal units&#46;<a class="elsevierStyleCrossRefs" href="#bib0190"><span class="elsevierStyleSup">16&#44;17</span></a> The American Heart Association&#44; however&#44; recommends that it should be a family decision regarding whether or not to be present at the time of cardiac resuscitation&#46;<a class="elsevierStyleCrossRef" href="#bib0200"><span class="elsevierStyleSup">18</span></a></p><p id="par0165" class="elsevierStylePara elsevierViewall">The other item &#8220;It was easy to talk to the ICU by telephone&#8221; received a negative assessment&#44; probably due to the fact that it is not customary to give information by phone in the NICU-IMIP&#44; in order to encourage the participation of parents and prevent inadequate understanding of information&#46; However&#44; this practice may be present in other health services to facilitate communication&#44; which is often unsatisfactorily conducted in several situations&#46;<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">7</span></a> A study carried out in a Danish NICU in 2007 included interviews with 780 parents and identified the fact that it requires time to be able to talk with a doctor or nurse as the main communication complaint&#46;<a class="elsevierStyleCrossRef" href="#bib0205"><span class="elsevierStyleSup">19</span></a></p><p id="par0170" class="elsevierStylePara elsevierViewall">In the present study&#44; the step consisting of the evaluation by the expert panel identified the importance of communication&#44; as all the items from the group &#8220;Information&#8221; were assessed as relevant and maintained in the study&#46;</p><p id="par0175" class="elsevierStylePara elsevierViewall">The statement that addressed the presence of an explanatory leaflet was initially excluded&#44; because there is no such practice in the assessed unit&#46; This is a method used that allows a first contact of parents with the ICU&#44; used in many countries&#44; providing important information regarding their stay at the unit&#46; A European study carried out in 125 neonatal units observed that 43&#37; of parents reported not having received information about the unit and 46&#37; did not receive clear information about the machines&#44; monitors&#44; and alarms used there&#46; Therefore&#44; this practice&#44; although promising&#44; does not yet show adequate coverage in most units&#46;<a class="elsevierStyleCrossRef" href="#bib0210"><span class="elsevierStyleSup">20</span></a></p><p id="par0180" class="elsevierStylePara elsevierViewall">Importantly&#44; the item &#8220;We actively participated in the decision-making about the care and treatment of our child&#8221; showed only 50&#37; &#8220;relevant&#8221; and &#8220;very relevant&#8221; answers&#46; A systematic review assessing the needs of parents of newborns admitted to the NICU highlighted six primary needs&#44; among them the adequate information and inclusion in care and decision-making related to the child&#46;<a class="elsevierStyleCrossRef" href="#bib0215"><span class="elsevierStyleSup">21</span></a> Therefore&#44; it is clear that there are still flaws regarding the acknowledgment of basic concepts of patient- and family-oriented medicine by NICU professionals&#46;</p><p id="par0185" class="elsevierStylePara elsevierViewall">Four health team behaviors are suggested to meet the parents&#8217; needs&#58; emotional support&#44; parental empowerment&#44; welcoming environment&#44; and unit support policies and education of parents in practicing new skills through guided participation&#46;<a class="elsevierStyleCrossRef" href="#bib0215"><span class="elsevierStyleSup">21</span></a> All these issues are addressed in the EMPATHIC-N in the domains of information&#44; care and treatment&#44; parental participation&#44; and organization&#46;</p><p id="par0190" class="elsevierStylePara elsevierViewall">The method proposed in this study would result in the exclusion of these four items of the questionnaire&#46; However&#44; the importance of these items&#44; according to literature evidence&#44; resulted in the re-evaluation of their exclusion&#46; Considering the opinion of the original questionnaire&#39;s author&#44; who was against the exclusion of items&#44; it was decided to keep them&#46;</p><p id="par0195" class="elsevierStylePara elsevierViewall">The indication for the exclusion of these items by the proposed method does not seem to be related to methodological error&#44; but to the incipiency of the concepts of family and patient-oriented medicine in the assessed service&#46; Routines such as telephone contact&#44; presence of parents during invasive procedures&#44; and the presence of explanatory leaflets are supported by the literature and should be encouraged&#46; Therefore&#44; the items were reintroduced in the final questionnaire&#44; considering that the questionnaire can&#44; in the future&#44; be applied at different locations and that if these items cannot be applied&#44; the alternative &#8220;does not apply&#8221; can be used&#46;</p><p id="par0200" class="elsevierStylePara elsevierViewall">After all the proposed steps&#44; the EMPATHIC-N&#44; of Dutch origin&#44; is available in its Brazilian version&#44; filling this gap in the literature&#46; The importance of such a tool for its capacity to assess satisfaction is emphasized&#44; which is considered one of the attributes of quality in healthcare<a class="elsevierStyleCrossRef" href="#bib0220"><span class="elsevierStyleSup">22</span></a> and stimulate questioning about routines within the NICU&#44; aiming at excellence in the offered service&#46;</p><p id="par0205" class="elsevierStylePara elsevierViewall">Further studies should evaluate the psychometric properties of the translated and adapted questionnaire&#46; Regional characteristics that may influence the cross-cultural adaptation should be taken into consideration&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Conflicts of interest</span><p id="par0210" class="elsevierStylePara elsevierViewall">The authors declare no conflicts of interest&#46;</p></span></span>"
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          "clase" => "keyword"
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            0 => "Neonatal intensive care"
            1 => "Quality of health care"
            2 => "Patient satisfaction"
            3 => "Parents"
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            0 => "Terapia intensiva neonatal"
            1 => "Qualidade da assist&#234;ncia &#224; sa&#250;de"
            2 => "Satisfa&#231;&#227;o do paciente"
            3 => "Pais"
            4 => "Tradu&#231;&#227;o &#40;produto&#41;"
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        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Objectives</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Considering the lack of questionnaires that propose to evaluate parental satisfaction with the Neonatal Intensive Care Unit &#40;NICU&#41; in Brazil&#44; this study aimed to carry out the translation of the EMPATHIC-N questionnaire into Brazilian Portuguese&#44; the cross-cultural adaptation and validation of its contents&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Method</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">The translation and cultural adaptation of the questionnaire was carried out according to the protocol established by the Translation and Cross-Cultural Adaptation Group of the International Society for Pharmacoeconomics and Outcomes Research &#40;ISPOR&#41; in 2005&#46; The validation of the content was carried out by a panel of experts&#44; who evaluated each item from &#8220;very irrelevant&#8221; to &#8220;very relevant&#8221;&#46; Items with a mean Likert scale value &#60;3&#46;5 were excluded&#46; Cronbach&#39;s alpha of the domains was calculated&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">The questionnaire was submitted to two pilot tests with mothers of newborns admitted to the NICU of the study&#44; after which some terms were modified to achieve global understanding&#46; Cronbach&#39;s alpha remained above 0&#46;7 in all items&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusion</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">The tool resulting from the translation&#44; cultural adaptation&#44; and validation of the EMPATHIC-N questionnaire showed to be adequate to assess satisfaction of parents of newborns admitted to the NICU in Brazil&#46;</p></span>"
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        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Objetivos</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Considerando a aus&#234;ncia de question&#225;rios que se proponham a avaliar satisfa&#231;&#227;o de pais em Unidade de Cuidados Intensivos Neonatal &#40;UCIN&#41; no Brasil&#44; o presente estudo teve o objetivo de realizar a tradu&#231;&#227;o do question&#225;rio EMpowerment of PArents in THe Intensive Care- Neonatology para o portugu&#234;s brasileiro&#44; adapta&#231;&#227;o transcultural e valida&#231;&#227;o de seu conte&#250;do&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">M&#233;todo</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Foi realizada tradu&#231;&#227;o e adapta&#231;&#227;o transcultural do question&#225;rio&#44; segundo protocolo estabelecido pelo Grupo da Tradu&#231;&#227;o e Adapta&#231;&#227;o Transcultural da Sociedade Internacional para Pesquisas Farmacoecon&#244;micas - ISPOR em 2005&#46; A valida&#231;&#227;o do conte&#250;do foi realizada atrav&#233;s de um comit&#234; de especialistas&#44; avaliando cada item de &#8220;muito irrelevante&#8221; a &#8220;muito relevante&#8221;&#46; Foram exclu&#237;dos os itens com m&#233;dia da Escala Likert menor que 3&#44;5&#46; Foi calculado alfa de Cronbach dos dom&#237;nios&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Na tradu&#231;&#227;o foi invertida a ordem de algumas frases de acordo com a sintaxe do portugu&#234;s brasileiro e alterado o tempo verbal para terceira pessoa do pret&#233;rito imperfeito&#46; A maior parte das afirmativas manteve o sentido com a retradu&#231;&#227;o&#44; sendo as diferen&#231;as atribu&#237;das a utiliza&#231;&#227;o de sin&#244;nimos pelos dois tradutores&#46; Foi submetido a dois testes piloto com m&#227;es de rec&#233;m nascidos internados na UCIN do estudo&#44; modificando-se alguns termos at&#233; atingir compreens&#227;o global&#46; O alfa de Cronbach permaneceu acima de 0&#44;7 em todos os itens&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclus&#227;o</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">O instrumento resultante da tradu&#231;&#227;o&#44; adapta&#231;&#227;o transcultural e valida&#231;&#227;o do EMPATHIC-N mostra-se adequado para avaliar satisfa&#231;&#227;o dos pais de rec&#233;m-nascidos internados em UCIN no Brasil&#46;</p></span>"
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        "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as&#58; Gomez DB&#44; Vidal SA&#44; Lima LC&#46; Brazilian adaptation and validation of the Empowerment of Parents in the Intensive Care-Neonatology &#40;EMPATHIC-N&#41; questionnaire&#46; J Pediatr &#40;Rio J&#41;&#46; 2017&#59;93&#58;156&#8211;64&#46;</p>"
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