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which can be divided into direct and indirect approaches&#46;<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">7</span></a> Direct methods&#44; such as directly observed therapy or measurement of drug metabolites in plasma or urine samples&#44; are cumbersome or technically complex&#44;<a class="elsevierStyleCrossRefs" href="#bib0145"><span class="elsevierStyleSup">8&#44;9</span></a> and are thus unavailable in daily practice&#46; Indirect methods include electronic medication monitors&#44; which are expensive and also largely unavailable outside the research environment&#44;<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">10</span></a> and questionnaires&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">Adherence questionnaires have been developed&#44; validated and used in patients with several chronic diseases&#46;<a class="elsevierStyleCrossRefs" href="#bib0160"><span class="elsevierStyleSup">11&#44;12</span></a> In hypertension&#44; the most widely used questionnaire is the Morisky Medication Adherence Scale<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">13</span></a> but its Portuguese version is not free to use without a license from the author&#46; Another commonly used questionnaire is the Hill-Bone Compliance to High Blood Pressure Therapy Scale&#44; which has been developed and validated in a low literacy setting&#44; and its psychometric characteristics described&#46;<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">14</span></a> A Portuguese version of this questionnaire does not exist&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Given the need to assess adherence to therapy with a simple and readily available instrument in daily practice&#44; it was our aim to perform a translation and cultural adaptation of the Hill-Bone Compliance Scale from the original English to Portuguese&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Methods</span><p id="par0030" class="elsevierStylePara elsevierViewall">A formal translation and cultural adaptation process was performed&#44; as recommended in the Principles of Good Practice of the International Society for Pharmacoeconomics and Outcomes Research regarding patient-reported outcomes &#40;PRO&#41; measures&#46;<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">15</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">As preparation&#44; the authors of the original scale were contacted and provided authorization for the process&#59; moreover&#44; a member &#40;CDH&#41; of the team that developed and tested the original instrument was involved in the preparation of this manuscript&#46; A working group was assembled&#44; including physicians with experience in the care of hypertensive patients and physicians who have been responsible for the production&#44; as well as translation and cultural adaptation&#44; of questionnaires&#46;<a class="elsevierStyleCrossRefs" href="#bib0185"><span class="elsevierStyleSup">16&#8211;18</span></a> Forward translation from English to European Portuguese was performed by two independent native Portuguese speakers who are fluent in English&#46; Discrepancies were then discussed and resolved by consensus&#44; involving the whole study group&#44; producing a final forward translation version&#46; Back translation was then performed by someone fluent in both languages who was neither involved in the previous steps nor familiar with the original scale&#46; A more conceptual&#44; rather than literal&#44; style was employed in this step&#46; The working group then compared the back translation against the original questionnaire in order to identify discrepancies in the concepts&#59; if significant discrepancies were identified&#44; the process of forward translation would be restarted&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">Once no conceptual discrepancies were found between the original questionnaire and the Portuguese version&#44; it was then presented to Portuguese-speaking hypertensive patients&#46; Patients were recruited in the hypertension clinic of a University Hospital in Porto&#44; Portugal&#46; An effort was made to include patients with a variety of educational and cultural backgrounds&#46; They were asked to fill the questionnaire paying particular attention to the construction and phrasing of the sentences&#44; insuring that the concepts were interpreted appropriately&#46; All patients&#8217; difficulties or misunderstandings&#44; as well as their opinions on the questionnaire&#44; were analyzed and used as a basis for changes in the wording&#46; This process was repeated until the questionnaire was understood correctly by the patients&#46; The final version was reviewed by the working group and this report was prepared&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Results</span><p id="par0045" class="elsevierStylePara elsevierViewall">The original version of the Hill-Bone Compliance Scale was obtained from the original authors &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Figure 1</a>&#41;&#44; as well as authorization to perform the translation process&#46; Several discrepancies occurred&#44; namely in the translation of the expression &#8220;shake salt on your food&#8221; in question 4&#44; and the verbs &#8220;skip&#8221; and &#8220;miss taking&#8221; from questions 10 and 12&#8211;14&#46; All differences were discussed and resolved&#44; and a final forward translation version was produced by consensus &#40;Supplement 1&#41;&#46; The back translation was performed and&#44; despite some wording differences&#44; the resulting version showed no conceptual discrepancies with the original scale&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0050" class="elsevierStylePara elsevierViewall">The Portuguese version was then presented to nine patients from the hypertension clinic&#46; Numerous problems were identified&#44; such as the expression &#8216;fast food&#8217;&#44; which had been kept from the original and was not understood by most of the patients&#46; The most important source of misunderstanding was the phrasing of questions 10&#44; 11&#44; 12 and 14 &#8211; patients tended to answer &#8216;All of the time&#8217; &#40;because they always took their medication&#41; but the correct answer for that idea was &#8216;None of the time&#8217;&#46; The translation into Portuguese of these questions implies a negative phrase and the desired answer &#8216;None of the time&#8217; creates a double negative which was difficult for the patients&#46; In addition&#44; most patients had difficulties marking questions with a number that corresponds to a response option&#46; In view of these findings&#44; questions 10&#44; 11 and 12 were changed to a positive phrasing&#44; so that good adherence will produce a positive answer&#46; Consequently&#44; the score attributed to the response options for question 10 had to be changed&#44; in order to preserve comparability with the scoring of the original scale&#46; Furthermore&#44; we changed the format of the questionnaire so that the response options are presented after the question &#40;rather than a space to mark a number&#41;&#46; This new version was presented to six other patients from the hypertension clinic&#46; With the new version&#44; no crucial difficulties or misunderstandings were detected&#46; One patient had difficulty with question 2 &#40;which also has a negative phrasing&#41;&#59; we decided to maintain this phrasing and the capital letters for the negative particle&#44; as in the original scale&#46; Question 5 addresses the intake of food rich in salt&#59; the available evidence shows that&#44; in Portugal&#44; most salt intake comes from salt-rich food&#44; such as bread&#44; cheese and sausages&#47;cold meat&#46;<a class="elsevierStyleCrossRef" href="#bib0200"><span class="elsevierStyleSup">19</span></a> We therefore changed question 5 in order to include these examples&#46; The final Portuguese version of the questionnaire &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Figure 2</a>&#41; was reviewed and accepted by the working group&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Discussion</span><p id="par0055" class="elsevierStylePara elsevierViewall">We propose a Portuguese version of the Hill-Bone Compliance Scale&#44; resulting from a formal translation and cultural adaptation process&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">The development of PRO measures is crucial for the assessment of chronic diseases such as hypertension&#46; Poor adherence to therapy is a major issue in hypertension care&#44; but instruments that assess it are scarce&#46; Despite multiple limitations&#44; questionnaires are the most accessible instruments to assess adherence in daily clinical practice&#46; PRO measures must be developed or translated to the language of the population that will use them&#46; To our knowledge&#44; no original European Portuguese adherence questionnaire or European Portuguese translations have been described in the literature&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">The forward-backward translation process that we used is the most widely accepted method&#46;<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">15</span></a> Similar methods have been used for the translation of this questionnaire into other languages&#46;<a class="elsevierStyleCrossRefs" href="#bib0205"><span class="elsevierStyleSup">20&#44;21</span></a></p><p id="par0070" class="elsevierStylePara elsevierViewall">Several difficulties were identified after the first version was presented to patients&#46; It was clear that the phrasing obtained by translation from the original English was too complex in the Portuguese language&#44; especially for a questionnaire that is meant to be used by an elderly population with low literacy&#46; The changes were clearly necessary for cultural adaptation&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">The main strength of this study is the use of a formal methodology&#44; which ensures that the version obtained maintains the same concepts as the original scale&#46; Other concepts or domains that might be useful in the evaluation of adherence could not be included when following the standardized international recommendations for a translation and cultural adaptation process&#46;<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">15</span></a> The use of other questionnaires that analyze different dimensions may provide a broader assessment of adherence&#44; namely of the reasons for non-adherence&#46; A minor limitation is the fact that the study was conducted in a hospital clinic&#44; while the questionnaire is intended also to be used in a primary care setting&#46; However&#44; the patients involved were of similar age&#44; literacy level and socioeconomic background to most hypertensive patients in primary care&#44; had mostly essential&#44; not resistant&#44; hypertension&#44; and were originally referred to the hospital by primary care physicians&#46; Furthermore&#44; we do not describe a validation process&#44; and the psychometric characteristics of the Portuguese Hill-Bone Compliance Scale should be evaluated in the future&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Conclusion</span><p id="par0080" class="elsevierStylePara elsevierViewall">We describe the translation and cultural adaptation of the Hill-Bone Compliance Scale and propose a European Portuguese version to be used with hypertensive patients in a primary or hospital setting&#46; Further studies are necessary for the validation of this new version&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Ethical disclosures</span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Protection of human and animal subjects</span><p id="par0085" class="elsevierStylePara elsevierViewall">The authors declare that no experiments were performed on humans or animals for this investigation&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Confidentiality of data</span><p id="par0090" class="elsevierStylePara elsevierViewall">The authors declare that no patient data appears in this article&#46;</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Right to privacy and informed consent</span><p id="par0095" class="elsevierStylePara elsevierViewall">The authors declare that no patient data appears in this article&#46;</p></span></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Conflicts of interest</span><p id="par0100" class="elsevierStylePara elsevierViewall">The authors have no conflicts of interest to declare&#46;</p></span></span>"
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        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Introduction</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Hypertension is an extremely prevalent disease worldwide and hypertension control rates remain low&#46; Lack of adherence contributes to poor control and to cardiovascular events&#46; No questionnaire in Portuguese is readily available for the assessment of adherence to antihypertensive drugs&#46; We aimed to perform a translation and cultural adaptation to Portuguese of the Hill-Bone Compliance to High Blood Pressure Therapy Scale&#44; a validated instrument to measure adherence in hypertensive patients&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">A formal process was employed&#44; consisting of a forward translation by two independent translators and a back translation by a third translator&#46; Discrepancies were resolved after each step&#46; Hypertensive patients were involved to identify and resolve phrasing and wording difficulties and misunderstandings&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">The forward and back translation did not produce significant discrepancies&#46; However&#44; important issues were identified when the questionnaire was presented to patients&#44; which led to changes in the wording of the questions and in the format of the questionnaire&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusion</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Questionnaires are important instruments to assess adherence to therapy&#44; particularly in hypertension&#46; A formal translation and cultural adaptation process ensures that the new version maintains the same concepts as the original&#46; After translation&#44; several changes were necessary to ensure that the questionnaire was understandable by elderly&#44; low literacy patients&#44; such as the majority of hypertensive patients&#46; We propose a Portuguese version of the Hill-Bone Compliance Scale&#44; which will require validation in further studies&#46;</p></span>"
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        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Introdu&#231;&#227;o</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">A hipertens&#227;o arterial &#40;HTA&#41; &#233; extremamente prevalente em todo o mundo e a propor&#231;&#227;o de doentes controlados permanece baixa&#46; A m&#225; ades&#227;o &#224; terap&#234;utica dificulta o controlo da doen&#231;a e contribui para a ocorr&#234;ncia de eventos cardiovasculares&#46; N&#227;o existe nenhum question&#225;rio em portugu&#234;s imediatamente dispon&#237;vel para avaliar a ades&#227;o a f&#225;rmacos anti-hipertensores&#46; O nosso objetivo &#233; realizar a tradu&#231;&#227;o e adapta&#231;&#227;o cultural do question&#225;rio de ades&#227;o <span class="elsevierStyleItalic">Hill-Bone</span>&#44; um instrumento validado em doentes com HTA&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">M&#233;todos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Foi utilizado um processo formal&#44; consistindo numa tradu&#231;&#227;o para portugu&#234;s por dois tradutores&#44; seguida de uma retrovers&#227;o para ingl&#234;s por um terceiro tradutor&#46; As discrep&#226;ncias foram discutidas e resolvidas ap&#243;s cada passo&#46; Doentes com HTA foram envolvidos&#44; de forma a identificar e corrigir constru&#231;&#245;es de frases e escolhas de palavras que provocaram problemas de compreens&#227;o&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">A tradu&#231;&#227;o e retrovers&#227;o n&#227;o produziram discrep&#226;ncias relevantes&#46; Foram identificados problemas de compreens&#227;o importantes quando o question&#225;rio foi apresentado aos doentes&#44; motivando altera&#231;&#245;es na elabora&#231;&#227;o das perguntas e no formato do question&#225;rio&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclus&#227;o</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Os question&#225;rios s&#227;o instrumentos importantes na avalia&#231;&#227;o da ades&#227;o &#224; terap&#234;utica&#44; em particular na HTA&#46; O processo formal de tradu&#231;&#227;o e adapta&#231;&#227;o cultural visa garantir que a nova vers&#227;o mant&#233;m os mesmos conceitos que o original&#46; V&#225;rias altera&#231;&#245;es foram necess&#225;rias para garantir que o question&#225;rio &#233; corretamente interpretado por indiv&#237;duos idosos e com baixa literacia&#44; caracter&#237;sticas de grande parte dos doentes hipertensos&#46; Propomos a vers&#227;o portuguesa do question&#225;rio <span class="elsevierStyleItalic">Hill-Bone</span> de ades&#227;o &#224; terap&#234;utica anti-hipertensora&#44; que dever&#225; ser validada em estudos futuros&#46;</p></span>"
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                      "titulo" => "Prevalence&#44; awareness&#44; treatment and control of hypertension and salt intake in Portugal&#58; changes over a decade&#46; The PHYSA study"
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Original Article
Translation and cultural adaptation of the Hill-Bone Compliance to High Blood Pressure Therapy Scale to Portuguese
Tradução e adaptação cultural do Questionário Hill-Bone de Adesão à Terapêutica Antihipertensora para Português
Luís Nogueira-Silvaa,b,
Autor para correspondência
luisnogueirasilva@gmail.com

Corresponding author.
, Ana Sá-Sousab, Maria João Limaa, Agostinho Monteiroc, Cheryl Dennison-Himmelfarbd, João A. Fonsecab,e
a Serviço de Medicina Interna, Centro Hospitalar S. João, Porto, Portugal
b CINTESIS – Centro de Investigação em Tecnologias e Sistemas de Informação em Saúde, Universidade do Porto, Portugal
c Faculdade de Medicina, Universidade do Porto, Portugal
d Johns Hopkins University School of Nursing, Baltimore, USA
e Unidade de Alergologia, Instituto CUF Porto e Hospital CUF Porto, Porto, Portugal
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        "titulo" => "Tradu&#231;&#227;o e adapta&#231;&#227;o cultural do Question&#225;rio <span class="elsevierStyleItalic">Hill-Bone</span> de Ades&#227;o &#224; Terap&#234;utica Antihipertensora para Portugu&#234;s"
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          "en" => "<p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">Original Hill-Bone Compliance to High Blood Pressure Therapy Scale&#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">Hypertension is a highly prevalent disease worldwide and is estimated to affect around 42&#37; of Portuguese adults&#44;<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">1</span></a> a prevalence that is predicted to grow in the future&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">2</span></a> Over the last decade&#44; considerable improvements have been achieved in the care of hypertensive patients in Portugal&#44; with the proportion of those receiving treatment increasing from less than 40&#37;<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">3</span></a> to almost 75&#37;&#59; however&#44; the proportion of controlled patients remains at an unsatisfactory 42&#46;5&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">1</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Poor adherence to therapy is an issue in all chronic diseases and even more important in a largely asymptomatic disease like hypertension&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">4</span></a> It leads to lack of control<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">5</span></a> and to a higher risk of cardiovascular events&#46;<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">6</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Several methods exist to assess adherence&#44; which can be divided into direct and indirect approaches&#46;<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">7</span></a> Direct methods&#44; such as directly observed therapy or measurement of drug metabolites in plasma or urine samples&#44; are cumbersome or technically complex&#44;<a class="elsevierStyleCrossRefs" href="#bib0145"><span class="elsevierStyleSup">8&#44;9</span></a> and are thus unavailable in daily practice&#46; Indirect methods include electronic medication monitors&#44; which are expensive and also largely unavailable outside the research environment&#44;<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">10</span></a> and questionnaires&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">Adherence questionnaires have been developed&#44; validated and used in patients with several chronic diseases&#46;<a class="elsevierStyleCrossRefs" href="#bib0160"><span class="elsevierStyleSup">11&#44;12</span></a> In hypertension&#44; the most widely used questionnaire is the Morisky Medication Adherence Scale<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">13</span></a> but its Portuguese version is not free to use without a license from the author&#46; Another commonly used questionnaire is the Hill-Bone Compliance to High Blood Pressure Therapy Scale&#44; which has been developed and validated in a low literacy setting&#44; and its psychometric characteristics described&#46;<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">14</span></a> A Portuguese version of this questionnaire does not exist&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Given the need to assess adherence to therapy with a simple and readily available instrument in daily practice&#44; it was our aim to perform a translation and cultural adaptation of the Hill-Bone Compliance Scale from the original English to Portuguese&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Methods</span><p id="par0030" class="elsevierStylePara elsevierViewall">A formal translation and cultural adaptation process was performed&#44; as recommended in the Principles of Good Practice of the International Society for Pharmacoeconomics and Outcomes Research regarding patient-reported outcomes &#40;PRO&#41; measures&#46;<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">15</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">As preparation&#44; the authors of the original scale were contacted and provided authorization for the process&#59; moreover&#44; a member &#40;CDH&#41; of the team that developed and tested the original instrument was involved in the preparation of this manuscript&#46; A working group was assembled&#44; including physicians with experience in the care of hypertensive patients and physicians who have been responsible for the production&#44; as well as translation and cultural adaptation&#44; of questionnaires&#46;<a class="elsevierStyleCrossRefs" href="#bib0185"><span class="elsevierStyleSup">16&#8211;18</span></a> Forward translation from English to European Portuguese was performed by two independent native Portuguese speakers who are fluent in English&#46; Discrepancies were then discussed and resolved by consensus&#44; involving the whole study group&#44; producing a final forward translation version&#46; Back translation was then performed by someone fluent in both languages who was neither involved in the previous steps nor familiar with the original scale&#46; A more conceptual&#44; rather than literal&#44; style was employed in this step&#46; The working group then compared the back translation against the original questionnaire in order to identify discrepancies in the concepts&#59; if significant discrepancies were identified&#44; the process of forward translation would be restarted&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">Once no conceptual discrepancies were found between the original questionnaire and the Portuguese version&#44; it was then presented to Portuguese-speaking hypertensive patients&#46; Patients were recruited in the hypertension clinic of a University Hospital in Porto&#44; Portugal&#46; An effort was made to include patients with a variety of educational and cultural backgrounds&#46; They were asked to fill the questionnaire paying particular attention to the construction and phrasing of the sentences&#44; insuring that the concepts were interpreted appropriately&#46; All patients&#8217; difficulties or misunderstandings&#44; as well as their opinions on the questionnaire&#44; were analyzed and used as a basis for changes in the wording&#46; This process was repeated until the questionnaire was understood correctly by the patients&#46; The final version was reviewed by the working group and this report was prepared&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Results</span><p id="par0045" class="elsevierStylePara elsevierViewall">The original version of the Hill-Bone Compliance Scale was obtained from the original authors &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Figure 1</a>&#41;&#44; as well as authorization to perform the translation process&#46; Several discrepancies occurred&#44; namely in the translation of the expression &#8220;shake salt on your food&#8221; in question 4&#44; and the verbs &#8220;skip&#8221; and &#8220;miss taking&#8221; from questions 10 and 12&#8211;14&#46; All differences were discussed and resolved&#44; and a final forward translation version was produced by consensus &#40;Supplement 1&#41;&#46; The back translation was performed and&#44; despite some wording differences&#44; the resulting version showed no conceptual discrepancies with the original scale&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0050" class="elsevierStylePara elsevierViewall">The Portuguese version was then presented to nine patients from the hypertension clinic&#46; Numerous problems were identified&#44; such as the expression &#8216;fast food&#8217;&#44; which had been kept from the original and was not understood by most of the patients&#46; The most important source of misunderstanding was the phrasing of questions 10&#44; 11&#44; 12 and 14 &#8211; patients tended to answer &#8216;All of the time&#8217; &#40;because they always took their medication&#41; but the correct answer for that idea was &#8216;None of the time&#8217;&#46; The translation into Portuguese of these questions implies a negative phrase and the desired answer &#8216;None of the time&#8217; creates a double negative which was difficult for the patients&#46; In addition&#44; most patients had difficulties marking questions with a number that corresponds to a response option&#46; In view of these findings&#44; questions 10&#44; 11 and 12 were changed to a positive phrasing&#44; so that good adherence will produce a positive answer&#46; Consequently&#44; the score attributed to the response options for question 10 had to be changed&#44; in order to preserve comparability with the scoring of the original scale&#46; Furthermore&#44; we changed the format of the questionnaire so that the response options are presented after the question &#40;rather than a space to mark a number&#41;&#46; This new version was presented to six other patients from the hypertension clinic&#46; With the new version&#44; no crucial difficulties or misunderstandings were detected&#46; One patient had difficulty with question 2 &#40;which also has a negative phrasing&#41;&#59; we decided to maintain this phrasing and the capital letters for the negative particle&#44; as in the original scale&#46; Question 5 addresses the intake of food rich in salt&#59; the available evidence shows that&#44; in Portugal&#44; most salt intake comes from salt-rich food&#44; such as bread&#44; cheese and sausages&#47;cold meat&#46;<a class="elsevierStyleCrossRef" href="#bib0200"><span class="elsevierStyleSup">19</span></a> We therefore changed question 5 in order to include these examples&#46; The final Portuguese version of the questionnaire &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Figure 2</a>&#41; was reviewed and accepted by the working group&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Discussion</span><p id="par0055" class="elsevierStylePara elsevierViewall">We propose a Portuguese version of the Hill-Bone Compliance Scale&#44; resulting from a formal translation and cultural adaptation process&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">The development of PRO measures is crucial for the assessment of chronic diseases such as hypertension&#46; Poor adherence to therapy is a major issue in hypertension care&#44; but instruments that assess it are scarce&#46; Despite multiple limitations&#44; questionnaires are the most accessible instruments to assess adherence in daily clinical practice&#46; PRO measures must be developed or translated to the language of the population that will use them&#46; To our knowledge&#44; no original European Portuguese adherence questionnaire or European Portuguese translations have been described in the literature&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">The forward-backward translation process that we used is the most widely accepted method&#46;<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">15</span></a> Similar methods have been used for the translation of this questionnaire into other languages&#46;<a class="elsevierStyleCrossRefs" href="#bib0205"><span class="elsevierStyleSup">20&#44;21</span></a></p><p id="par0070" class="elsevierStylePara elsevierViewall">Several difficulties were identified after the first version was presented to patients&#46; It was clear that the phrasing obtained by translation from the original English was too complex in the Portuguese language&#44; especially for a questionnaire that is meant to be used by an elderly population with low literacy&#46; The changes were clearly necessary for cultural adaptation&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">The main strength of this study is the use of a formal methodology&#44; which ensures that the version obtained maintains the same concepts as the original scale&#46; Other concepts or domains that might be useful in the evaluation of adherence could not be included when following the standardized international recommendations for a translation and cultural adaptation process&#46;<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">15</span></a> The use of other questionnaires that analyze different dimensions may provide a broader assessment of adherence&#44; namely of the reasons for non-adherence&#46; A minor limitation is the fact that the study was conducted in a hospital clinic&#44; while the questionnaire is intended also to be used in a primary care setting&#46; However&#44; the patients involved were of similar age&#44; literacy level and socioeconomic background to most hypertensive patients in primary care&#44; had mostly essential&#44; not resistant&#44; hypertension&#44; and were originally referred to the hospital by primary care physicians&#46; Furthermore&#44; we do not describe a validation process&#44; and the psychometric characteristics of the Portuguese Hill-Bone Compliance Scale should be evaluated in the future&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Conclusion</span><p id="par0080" class="elsevierStylePara elsevierViewall">We describe the translation and cultural adaptation of the Hill-Bone Compliance Scale and propose a European Portuguese version to be used with hypertensive patients in a primary or hospital setting&#46; Further studies are necessary for the validation of this new version&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Ethical disclosures</span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Protection of human and animal subjects</span><p id="par0085" class="elsevierStylePara elsevierViewall">The authors declare that no experiments were performed on humans or animals for this investigation&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Confidentiality of data</span><p id="par0090" class="elsevierStylePara elsevierViewall">The authors declare that no patient data appears in this article&#46;</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Right to privacy and informed consent</span><p id="par0095" class="elsevierStylePara elsevierViewall">The authors declare that no patient data appears in this article&#46;</p></span></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Conflicts of interest</span><p id="par0100" class="elsevierStylePara elsevierViewall">The authors have no conflicts of interest to declare&#46;</p></span></span>"
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        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Introduction</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Hypertension is an extremely prevalent disease worldwide and hypertension control rates remain low&#46; Lack of adherence contributes to poor control and to cardiovascular events&#46; No questionnaire in Portuguese is readily available for the assessment of adherence to antihypertensive drugs&#46; We aimed to perform a translation and cultural adaptation to Portuguese of the Hill-Bone Compliance to High Blood Pressure Therapy Scale&#44; a validated instrument to measure adherence in hypertensive patients&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">A formal process was employed&#44; consisting of a forward translation by two independent translators and a back translation by a third translator&#46; Discrepancies were resolved after each step&#46; Hypertensive patients were involved to identify and resolve phrasing and wording difficulties and misunderstandings&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">The forward and back translation did not produce significant discrepancies&#46; However&#44; important issues were identified when the questionnaire was presented to patients&#44; which led to changes in the wording of the questions and in the format of the questionnaire&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusion</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Questionnaires are important instruments to assess adherence to therapy&#44; particularly in hypertension&#46; A formal translation and cultural adaptation process ensures that the new version maintains the same concepts as the original&#46; After translation&#44; several changes were necessary to ensure that the questionnaire was understandable by elderly&#44; low literacy patients&#44; such as the majority of hypertensive patients&#46; We propose a Portuguese version of the Hill-Bone Compliance Scale&#44; which will require validation in further studies&#46;</p></span>"
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        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Introdu&#231;&#227;o</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">A hipertens&#227;o arterial &#40;HTA&#41; &#233; extremamente prevalente em todo o mundo e a propor&#231;&#227;o de doentes controlados permanece baixa&#46; A m&#225; ades&#227;o &#224; terap&#234;utica dificulta o controlo da doen&#231;a e contribui para a ocorr&#234;ncia de eventos cardiovasculares&#46; N&#227;o existe nenhum question&#225;rio em portugu&#234;s imediatamente dispon&#237;vel para avaliar a ades&#227;o a f&#225;rmacos anti-hipertensores&#46; O nosso objetivo &#233; realizar a tradu&#231;&#227;o e adapta&#231;&#227;o cultural do question&#225;rio de ades&#227;o <span class="elsevierStyleItalic">Hill-Bone</span>&#44; um instrumento validado em doentes com HTA&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">M&#233;todos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Foi utilizado um processo formal&#44; consistindo numa tradu&#231;&#227;o para portugu&#234;s por dois tradutores&#44; seguida de uma retrovers&#227;o para ingl&#234;s por um terceiro tradutor&#46; As discrep&#226;ncias foram discutidas e resolvidas ap&#243;s cada passo&#46; Doentes com HTA foram envolvidos&#44; de forma a identificar e corrigir constru&#231;&#245;es de frases e escolhas de palavras que provocaram problemas de compreens&#227;o&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">A tradu&#231;&#227;o e retrovers&#227;o n&#227;o produziram discrep&#226;ncias relevantes&#46; Foram identificados problemas de compreens&#227;o importantes quando o question&#225;rio foi apresentado aos doentes&#44; motivando altera&#231;&#245;es na elabora&#231;&#227;o das perguntas e no formato do question&#225;rio&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclus&#227;o</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Os question&#225;rios s&#227;o instrumentos importantes na avalia&#231;&#227;o da ades&#227;o &#224; terap&#234;utica&#44; em particular na HTA&#46; O processo formal de tradu&#231;&#227;o e adapta&#231;&#227;o cultural visa garantir que a nova vers&#227;o mant&#233;m os mesmos conceitos que o original&#46; V&#225;rias altera&#231;&#245;es foram necess&#225;rias para garantir que o question&#225;rio &#233; corretamente interpretado por indiv&#237;duos idosos e com baixa literacia&#44; caracter&#237;sticas de grande parte dos doentes hipertensos&#46; Propomos a vers&#227;o portuguesa do question&#225;rio <span class="elsevierStyleItalic">Hill-Bone</span> de ades&#227;o &#224; terap&#234;utica anti-hipertensora&#44; que dever&#225; ser validada em estudos futuros&#46;</p></span>"
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Informação do artigo
ISSN: 08702551
Idioma original: Inglês
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