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in a primary care setting&#44; by a general practitioner &#40;GP&#41;&#44; generally the patient&#39;s own &#40;routine medical care&#41;&#59; &#40;3&#41; in a private laboratory with experience in the area&#59; &#40;4&#41; by the patients themselves using point-of-care devices &#40;self-testing&#41;&#44; either self-monitoring&#44; in which patients perform the test at home and then contact their center for dose adjustment&#44; or self-management&#44; in which patients perform the test at home and adjust the dose themselves if necessary&#46;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">9</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">Primary or routine care monitoring was first implemented in Portugal 14 years ago&#44; and in 2010&#44; a protocol was established between Centro Hospitalar de Vila Nova de Gaia&#47;Espinho &#40;CHVNGE&#41; and the Espinho-Gaia and Gaia health center groups providing for the monitoring of AF patients with INR within the therapeutic range for at least three months&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">Anticoagulation consultations were first decentralized in the Espinho-Gaia group in the Al&#233;m Douro FHU and progressively extended to 17 units by 2014&#46; Decentralization began in 10 units of the Gaia group in 2013&#44; and remained at this number in 2014&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">The guidelines of the Regional Health Authority of the North region stipulate that a coordinator and a team consisting of two GPs and two family practice nurses should be responsible for managing the program&#44; under the supervision of a specialist in hemotherapy from the reference hospital&#44; together with a procedure manual based on principles of good practice&#46; There should also be a computerized database with patients&#8217; history&#44; print-outs of diagnoses&#44; INR values and ranges&#44; drugs prescribed &#40;proposed treatment&#41;&#44; next scheduled appointment&#44; and an algorithm to guide prescription and scheduling of appointments&#44; which are subject to validation or change by the physician responsible&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">In the Regional Health Authority of the North region&#44; initial anticoagulation monitoring is performed by practice nurses&#44; who determine INR using CoaguChek XS Plus or XS Pro<span class="elsevierStyleSup">&#174;</span> meters&#46; The patient then sees his or her GP&#44; who adjusts the dosage if necessary and schedules the next visit&#46; The data are entered in the TAONet<span class="elsevierStyleSup">&#174;</span> system&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">At the same time&#44; six-monthly laboratory quality control is performed at the CHVNGE&#44; which can be consulted on a day-to-basis&#46; A fast track system for patients under anticoagulant therapy has also been established&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">The quality of a center&#39;s anticoagulation control can be assessed by calculating the percentage TTR of the patients monitored there&#44; low values being associated with adverse events&#46; TTR in a given center can be determined in various ways&#44; most commonly by one of three methods&#58; &#40;1&#41; as the fraction of INR values that are within therapeutic range&#59; &#40;2&#41; by analysis of a cross-section of patient records to determine the percentage of patients whose INR is within the therapeutic range at a given point in time compared to the total number of patients with measured INR at that point in time&#59; or &#40;3&#41; by applying the Rosendaal linear interpolation method&#44; which assumes that there is a linear relationship between two consecutive INR values and allocates a specific INR value to each day between tests&#44; thus enabling the number of days within the therapeutic range to be calculated&#46;<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">10</span></a></p><p id="par0070" class="elsevierStylePara elsevierViewall">Each approach has its advantages and disadvantages&#44; and various factors can affect the variability of results&#46; Several studies have compared the different methods but were unable to recommend one over another due to methodological issues&#46;<a class="elsevierStyleCrossRefs" href="#bib0160"><span class="elsevierStyleSup">11&#8211;13</span></a> Nevertheless&#44; the NICE guideline of August 2014 recommends the Rosendaal method to monitor anticoagulant therapy in AF patients&#46;<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">14</span></a></p><p id="par0075" class="elsevierStylePara elsevierViewall">The aim of this study was to assess the quality of monitoring anticoagulant therapy with VKAs in patients with non-valvular AF in healthcare units of the Espinho-Gaia and Gaia health center groups&#44; using the Rosendaal method&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Methods</span><p id="par0080" class="elsevierStylePara elsevierViewall">This was a retrospective observational analytical study of patients under VKA therapy registered at healthcare units in the Espinho-Gaia and Gaia health center groups&#44; of which the following 27 out of the total of 37 &#40;73&#37;&#41; provide anticoagulation monitoring&#58; the Primary Health Care Units &#40;PHCUs&#41; of Madalena&#44; Marinha&#44; Crestuma&#44; Lever&#44; Perosinho&#44; Silvalde and Viver Sa&#250;de&#44; and the FHUs of Aguda&#44; Al&#233;m D&#8217;Ouro&#44; Anta&#44; Espinho&#44; Caminho Novo&#44; Canelas&#44; Grij&#243;&#44; Monte Murado&#44; Nova Via and S&#227;o F&#233;lix da Marinha in the Espinho-Gaia group&#59; and the following in the Gaia group&#58; the FHUs of Arco do Prado&#44; Gaya&#44; Nova Salus&#44; Sa&#250;de no Futuro&#44; Cam&#233;lias and Abel Salazar&#44; and the PHCUs of Bar&#227;o do Corvo&#44; Soares dos Reis&#44; Oliveira do Douro and Avintes&#46; In order to protect data confidentiality&#44; the units fulfilling the inclusion criteria were allocated a letter of the alphabet from A to Z in descending order of number of patients&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">The variables studied were sociodemographic characteristics&#44; INR values&#44; TTR and current therapy&#46; Patients were considered to be monitored at a healthcare unit if they had a minimum of six visits with INR measurements in 2014&#46;<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">15</span></a> INR values were classified as subtherapeutic &#40;&#60;2&#41;&#44; therapeutic &#40;2-3&#41; or supratherapeutic &#40;&#62;3&#41;&#46; Records were searched for patients with a therapeutic range of 2-3&#44; any with different ranges being excluded&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">The Rosendaal method<a class="elsevierStyleCrossRef" href="#bib0185"><span class="elsevierStyleSup">16</span></a> allocates a person-time for different levels of anticoagulation assuming a linear relationship between consecutive measurements&#46; The person-time within the target therapeutic range is calculated as a proportion of the total person-time of follow-up&#46; The percentage of days within the target range is expressed as the ratio between the difference between two consecutive INR values in range divided by the total INR difference&#44; as expressed in the formula<a class="elsevierStyleCrossRef" href="#bib0190"><span class="elsevierStyleSup">17</span></a>&#58;<elsevierMultimedia ident="eq0005"></elsevierMultimedia></p><p id="par0095" class="elsevierStylePara elsevierViewall">We opted for this method as it enables comparison with the results of other Portuguese and international studies&#46;<a class="elsevierStyleCrossRefs" href="#bib0180"><span class="elsevierStyleSup">15&#44;18&#8211;20</span></a></p><p id="par0100" class="elsevierStylePara elsevierViewall">Poor control was defined as TTR &#60;60&#37;&#44;<a class="elsevierStyleCrossRefs" href="#bib0135"><span class="elsevierStyleSup">6&#44;14&#44;15</span></a> moderate control as 60-75&#37;&#44; and good control as &#62;75&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">6</span></a></p><p id="par0105" class="elsevierStylePara elsevierViewall">All records for 2014 were collected using TAONet<span class="elsevierStyleSup">&#174;</span> software&#46; The data were recorded and analyzed using Microsoft Excel<span class="elsevierStyleSup">&#174;</span> 2010 and SPSS<span class="elsevierStyleSup">&#174;</span> version 21&#44; with no information capable of identifying patients&#46; A descriptive analysis was performed&#44; calculating prevalences and standard deviations&#46; The chi-square test with a 95&#37; confidence interval was used to analyze the association between variables&#59; a value of p&#60;0&#46;05 was considered statistically significant&#46;</p><p id="par0110" class="elsevierStylePara elsevierViewall">Informed consent was considered unnecessary since no data identifying patients were collected or included in the database&#46; Approval for the study was obtained from the ethics committee of the Regional Health Authority of the North region&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Results</span><p id="par0115" class="elsevierStylePara elsevierViewall">Of the 8249 INR records&#44; 1601 were excluded because either there was no diagnosis of non-valvular AF &#40;359&#41; or there was no diagnostic code &#40;1242&#41;&#59; the remaining 6648 records corresponded to 596 patients with non-valvular AF&#46;</p><p id="par0120" class="elsevierStylePara elsevierViewall">In addition&#44; 259 records were excluded as repeats&#44; 76 for showing different values on the same date and 430 of patients with less than six visits recorded&#46; The final number of records was thus 5883&#46; One unit only had patients with less than six visits&#44; and so the number of units analyzed was 26 rather than 27&#46; The records corresponded to 479 patients&#44; of whom 301 &#40;62&#46;8&#37;&#41; were followed in the Espinho-Gaia group and 178 &#40;37&#46;2&#37;&#41; in the Gaia group&#46; Loss to follow-up was 19&#46;6&#37;&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">Mean age was 75&#46;6&#177;8&#46;2 years&#44; range 41-96 years&#46; The most prevalent age-group was 75-84 years&#44; accounting for 52&#46;2&#37; of the sample&#44; and 89&#46;8&#37; of patients were aged 65 or over &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Figure 1</a>&#41;&#46; There was a higher prevalence of women &#40;51&#46;6&#37;&#41;&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0130" class="elsevierStylePara elsevierViewall">The most commonly used anticoagulant was warfarin &#40;86&#37; of cases&#41;&#44; the other 14&#37; being prescribed acenocoumarol&#46;</p><p id="par0135" class="elsevierStylePara elsevierViewall">As seen in <a class="elsevierStyleCrossRef" href="#fig0010">Figure 2</a>&#44; 60&#46;3&#37; of the sample were within the target therapeutic range &#40;INR 2-3 inclusive&#41;&#44; while 39&#46;8&#37; had values outside the range - 18&#46;8&#37; with subtherapeutic INR &#40;&#60;2&#41; and 21&#37; with supratherapeutic INR &#40;&#62;3&#41;&#46; High bleeding risk &#40;INR &#62;4&#46;5&#41; was identified in 1&#46;8&#37; of the sample and 5&#37; presented high thrombotic risk &#40;INR &#60;1&#46;5&#41;&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0140" class="elsevierStylePara elsevierViewall">The 26 units were allocated a letter of the alphabet from A to Z in descending order of number of patients &#40;<a class="elsevierStyleCrossRef" href="#fig0015">Figure 3</a>&#41;&#46; The mean number of patients followed per unit was 18&#177;14 &#40;range 2-62&#41;&#46;</p><elsevierMultimedia ident="fig0015"></elsevierMultimedia><p id="par0145" class="elsevierStylePara elsevierViewall">The mean number of visits was 12&#46;9&#177;3&#46;2&#46; Unit E showed the lowest mean&#44; with 6&#46;6 visits for 30 patients&#44; while unit W had the highest mean&#44; with 21&#46;7 visits for three patients&#44; as shown in <a class="elsevierStyleCrossRef" href="#fig0020">Figure 4</a>&#46;</p><elsevierMultimedia ident="fig0020"></elsevierMultimedia><p id="par0150" class="elsevierStylePara elsevierViewall"><a class="elsevierStyleCrossRef" href="#fig0025">Figure 5</a> shows that 35&#46;3&#37; of patients presented poor control&#44; 29&#46;2&#37; moderate control&#44; and 35&#46;5&#37; good control&#46;</p><elsevierMultimedia ident="fig0025"></elsevierMultimedia><p id="par0155" class="elsevierStylePara elsevierViewall">Mean TTR was 67&#46;4&#177;6&#46;5&#37;&#44; with 66&#46;6&#177;6&#46;2&#37; in the Espinho-Gaia group and 68&#46;9&#177;7&#46;2&#37; in the Gaia group&#44; a difference that was statistically significant &#40;p&#61;0&#46;03&#41;&#46; As seen in <a class="elsevierStyleCrossRef" href="#fig0030">Figure 6</a>&#44; TTR varied between 55&#46;6&#37; and 79&#46;5&#37;&#44; with three units presenting values below 60&#37; and four units achieving rates above 75&#37;&#46;</p><elsevierMultimedia ident="fig0030"></elsevierMultimedia><p id="par0160" class="elsevierStylePara elsevierViewall">A finding of poor control did not appear to be related to the number of patients followed by a particular center &#40;p&#61;0&#46;17&#41;&#46; No statistically significant association was found between INR control and gender &#40;p&#61;0&#46;35&#41; or with the anticoagulant drug used &#40;p&#61;0&#46;079&#41;&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Discussion</span><p id="par0165" class="elsevierStylePara elsevierViewall">The mean TTR in the Espinho-Gaia and Gaia health center groups was 67&#46;4&#177;6&#46;5&#37;&#44; which indicates moderate control according to the established cut-offs&#46;</p><p id="par0170" class="elsevierStylePara elsevierViewall">Recent large-scale clinical trials comparing NOACs with warfarin in non-valvular AF provided important data on the quality of oral anticoagulant therapy with VKAs&#44; using the Rosendaal method&#46; Mean TTR in our study was higher than reported in international studies&#46; The ROCKET-AF clinical trial comparing rivaroxaban with warfarin&#44; which included patients from 45 countries&#44; found a mean TTR at the individual patient level of 55&#46;2&#177;21&#46;3&#37;&#46; The data for Western Europe &#40;16&#37; of the sample&#41; showed a mean TTR of 66&#46;6&#177;17&#46;7&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0195"><span class="elsevierStyleSup">18</span></a> In the ARISTOTLE trial comparing apixaban with warfarin&#44; median TTR was 66&#37;&#44;<a class="elsevierStyleCrossRef" href="#bib0200"><span class="elsevierStyleSup">19</span></a> and in the RE-LY trial comparing dabigatran with warfarin&#44; in patients from 44 countries including Portugal&#44;<a class="elsevierStyleCrossRef" href="#bib0205"><span class="elsevierStyleSup">20</span></a> mean TTR was 67&#46;2&#37; overall and 61&#37; for the Portuguese population&#46;<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">14</span></a> In a study of outpatients attending the anticoagulation clinic of a Portuguese hospital&#44; mean TTR in patients with non-valvular AF was 59&#46;3&#177;19&#46;8&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">15</span></a></p><p id="par0175" class="elsevierStylePara elsevierViewall">The higher the percentage of TTR&#44; the lower the risk of adverse events&#46; Outcome data from the SPORTIF III and IV trials revealed that 43&#37; of events occurred in AF patients taking warfarin with poor control of TTR &#40;&#60;60&#37;&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">6</span></a> Our study showed poor control in 35&#46;3&#37; of patients&#44; meaning that a significant proportion were at risk&#46; Of these&#44; 10&#46;8&#37; presented INR &#60;1&#46;8&#44; representing a higher risk for ischemic stroke&#44; and 9&#46;5&#37; had INR &#62;3&#46;5&#44; associated with a higher risk of intracranial hemorrhage&#46;<a class="elsevierStyleCrossRef" href="#bib0195"><span class="elsevierStyleSup">18</span></a></p><p id="par0180" class="elsevierStylePara elsevierViewall">There was considerable variation in the number of patients followed in each unit&#44; but this was not reflected in statistically significant differences in TTR values&#46; There were a mean of 12 visits over one-year follow-up&#44; about one visit per month&#44; which may be excessive&#46; Although there is disagreement concerning testing frequency&#44; some authors suggest up to 12 weeks for patients with stable INRs without increased bleeding or thromboembolic risk&#46;<a class="elsevierStyleCrossRef" href="#bib0210"><span class="elsevierStyleSup">21</span></a></p><p id="par0185" class="elsevierStylePara elsevierViewall">The strong points of our study are an inclusion criterion of a minimum of six INR measurements&#44; since INR tends to vary more at the beginning of therapy&#44;<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">15</span></a> defining TTR levels to determine quality of anticoagulation control&#44;<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">6</span></a> and the use of Rosendaal&#39;s linear interpolation method to calculate TTR at the individual patient level&#46;<a class="elsevierStyleCrossRef" href="#bib0185"><span class="elsevierStyleSup">16</span></a> It is also a pioneering study that reflects the situation regarding primary care monitoring of oral anticoagulation with VKAs in the municipality of Vila Nova de Gaia in north Portugal&#44; and is reproducible&#46;</p><p id="par0190" class="elsevierStylePara elsevierViewall">The study also has certain limitations&#44; including information bias from the use of INR records and because 11&#46;5&#37; of records were excluded&#46; A further limitation is that it was unknown whether patients were under initial or chronic anticoagulant therapy&#44; whether invasive procedures may have prompted suspension of therapy&#44; and whether environmental and&#47;or genetic factors influenced the results&#59; the method of dose adjustment &#40;automatic TAONet<span class="elsevierStyleSup">&#174;</span> protocol or unit protocols&#41; was also unknown&#46; In addition&#44; the overall loss of patients to follow-up &#40;19&#46;6&#37;&#41;&#44; the loss of records and lack of diagnostic coding &#40;15&#46;1&#37; of cases&#41; may have given rise to selection bias&#46;</p><p id="par0195" class="elsevierStylePara elsevierViewall">It is worth considering extending the study to other health center groups in the future using the same methodology&#44; in order to assess the situation for the country as a whole&#46; The TAONet<span class="elsevierStyleSup">&#174;</span> platform should be modified to include mandatory fields and more sociodemographic data&#46; Accurate recording of diagnoses&#44; dosages and visit outcomes should also be encouraged&#46; Further training of health professionals who manage anticoagulant therapy in primary care may be necessary&#46;</p><p id="par0200" class="elsevierStylePara elsevierViewall">In addition&#44; we should stress the importance of adherence to treatment and compliance with dietary recommendations &#40;to avoid day-to-day variations in intake of vitamin K-rich foods&#41; in order to improve control&#44; as well as the need for systematic investigation of signs of supratherapeutic INR levels&#44; such as bleeding gums or ecchymosis&#46;</p><p id="par0205" class="elsevierStylePara elsevierViewall">In conclusion&#44; our study showed moderate control of coagulation parameters&#44; but better than in other studies&#46; Nevertheless&#44; there is still room for improvement in anticoagulation monitoring in primary health care&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Ethical disclosures</span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Protection of human and animal subjects</span><p id="par0210" class="elsevierStylePara elsevierViewall">The authors declare that no experiments were performed in humans and&#47;or animals for this research&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Confidentiality of data</span><p id="par0215" class="elsevierStylePara elsevierViewall">The authors declare that they have followed the protocols of their work center on the publication of patient data&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Right to privacy and informed consent</span><p id="par0220" class="elsevierStylePara elsevierViewall">The authors declare that no patient data appear in this article&#46;</p></span></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Conflicts of interest</span><p id="par0225" 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">Anticoagulant therapy is an effective measure in preventing thromboembolic adverse events&#46; Of the diseases in which this treatment is indicated&#44; atrial fibrillation &#40;AF&#41; has the highest incidence worldwide&#44; with a prevalence of 1&#46;5-2&#37;&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Objectives</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">To assess the quality of monitoring of patients with non-valvular AF under oral anticoagulation with vitamin K antagonists in Vila Nova de Gaia healthcare units&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Methods</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">This was a retrospective observational analytical study of the population registered at the 37 healthcare units of the Vila Nova de Gaia and Espinho health center area under oral anticoagulation with vitamin K antagonists during 2014&#46; The data were collected using TAONet<span class="elsevierStyleSup">&#174;</span> software&#46; The variables studied were health units&#44; age&#44; gender&#44; INR value&#44; time in therapeutic range &#40;TTR&#41; and medication&#46; TTR was calculated for each patient using the Rosendaal linear interpolation method&#46; It was stipulated that each patient should have undergone at least six INR measurements&#46; Data were analyzed using Microsoft Excel<span class="elsevierStyleSup">&#174;</span> 2010 and SPSS<span class="elsevierStyleSup">&#174;</span> version 21&#44; using descriptive and inferential statistical techniques&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Results</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">A total of 479 patients with non-valvular AF were studied&#44; corresponding to 5883 INR tests&#46; Mean TTR was 67&#46;4&#177;6&#46;5&#37;&#44; and 35&#46;3&#37; of patients exhibited poor control &#40;TTR &#60;60&#37;&#41;&#46;</p></span> <span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Discussion</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Our study showed moderate control of coagulation parameters&#44; but better than in many international clinical trials and in another Portuguese observational study&#46; Nevertheless&#44; there is still room for improvement in anticoagulation monitoring in primary health care&#46;</p></span>"
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        "resumen" => "<span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Introdu&#231;&#227;o</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">A terap&#234;utica com anticoagulantes &#233; uma medida eficaz na preven&#231;&#227;o de eventos tromboemb&#243;licos&#46; Das patologias que requerem este tratamento&#44; a fibrilha&#231;&#227;o auricular &#40;FA&#41; &#233; das que tem maior express&#227;o a n&#237;vel mundial&#44; com uma preval&#234;ncia de 1&#44;5-2&#37;&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Objetivos</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Aferir a qualidade da monitoriza&#231;&#227;o de doentes com FA n&#227;o valvular sob anticoagulantes dicumar&#237;nicos&#44; nas unidades funcionais &#40;UF&#41; do concelho de Gaia&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Material e m&#233;todos</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Estudo observacional retrospetivo anal&#237;tico&#46; Popula&#231;&#227;o&#58; doentes inscritos nas 37 UF dos ACeS Gaia e Espinho-Gaia sob hipocoagula&#231;&#227;o com dicumar&#237;nicos&#44; durante o ano de 2014&#46; Fonte dos dados&#58; TAOnet&#174;&#46; Vari&#225;veis estudadas&#58; ACeS&#44; UF&#44; idade&#44; g&#233;nero&#44; INR&#44; tempo em intervalo terap&#234;utico &#40;TTR&#41; e terap&#234;utica&#46; O TTR foi calculado pelo m&#233;todo de interpola&#231;&#227;o linear de Rosendaal&#46; Foram consideradas no m&#237;nimo seis visitas por doente&#46; Tratamento estat&#237;stico&#58; Microsoft Excel&#174; 2010 e <span class="elsevierStyleItalic">SPSS</span>&#174;21&#46;</p></span> <span id="abst0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Resultados</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Foram estudados 479 doentes com FA n&#227;o valvular&#44; o que correspondeu a 5883 registos&#46; O TTR m&#233;dio foi de 67&#44;4&#37; &#40;&#177;<span class="elsevierStyleHsp" style=""></span>6&#44;5&#41;&#46; Apresentaram mau controlo da hipocoagula&#231;&#227;o &#40;TTR<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>60&#37;&#41; 35&#44;3&#37; dos doentes&#46;</p></span> <span id="abst0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">Discuss&#227;o</span><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">O nosso estudo revela um padr&#227;o de controlo de hipocoagula&#231;&#227;o moderado&#44; mas superior ao encontrado noutros estudos&#46; No entanto&#44; consideramos que ainda h&#225; um grande potencial de melhoria nos cuidados de hipocoagula&#231;&#227;o prestados nos cuidados de sa&#250;de prim&#225;rios&#46;</p></span>"
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Original Article
The HIPOGAIA study: Monitoring of oral anticoagulation with vitamin K antagonists in the municipality of Gaia
Estudo HIPOGAIA: monitorização da hipocoagulação oral com dicumarínicos no concelho de Gaia
Marta Guedes
Corresponding author
martasguedes@gmail.com

Corresponding author.
, Catarina Rego
Unidade de Saúde Familiar Nova Via, ACeS Grande Porto VIII, Espinho/Gaia, Portugal
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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Anticoagulant therapy is an effective measure in preventing thromboembolic adverse events&#46; Of the diseases in which this treatment is indicated&#44; atrial fibrillation &#40;AF&#41; has the highest incidence worldwide&#44; with a prevalence of 1&#46;5-2&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">1</span></a> According to the FATA study&#44; overall AF prevalence in eight Vila Nova de Gaia family health units &#40;FHUs&#41; was 1&#46;29&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">2</span></a> AF can cause major hemodynamic changes but prognosis is mainly determined by associated thromboembolic phenomena&#44; which have a significant impact on morbidity and mortality&#46; Stroke&#44; the leading cause of death and disability in Portugal&#44; is five times more common in AF patients&#46;<a class="elsevierStyleCrossRefs" href="#bib0120"><span class="elsevierStyleSup">3&#44;4</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">There are two types of anticoagulant drugs&#44; vitamin K antagonists &#40;VKAs&#41; &#40;warfarin and acenocoumarol&#41; and the new oral anticoagulants &#40;NOACs&#41; &#40;notably dabigatran&#44; rivaroxaban and apixaban&#41;&#46; Only the first type require monitoring of international normalized ratio &#40;INR&#41;&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">VKAs inhibit the production of vitamin K epoxide reductase&#44; thus preventing reconversion to an active form and reducing gamma-carboxylation of glutamic acid residues at sites near the end-terminal of coagulation factors II &#40;prothrombin&#41;&#44; VII&#44; IX and X&#46; They also inhibit vitamin-K dependent carboxylation of protein C and its cofactor protein S&#46;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">5</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">VKAs have been used for 70 years and were until recently considered the gold standard treatment&#46; They are inexpensive and there is solid evidence that they prevent thromboembolic events in AF patients&#44; one study showing that warfarin reduced ischemic and hemorrhagic stroke by 62&#37; compared to placebo&#46;<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">6</span></a> They are also effective in deep vein thrombosis&#44; pulmonary embolism&#44; acute coronary disease requiring stenting&#44; rheumatic valve disease &#40;in the presence of AF or a history of embolism&#41;&#44; antiphospholipid syndrome &#40;with history of arterial or venous thrombosis&#41;&#44; and valve disease in patients with mechanical or biological prostheses&#46;<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">7</span></a> They are also used to prevent thromboembolism following orthopedic surgery&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Nevertheless&#44; there are certain difficulties with the use of VKAs&#44; including a narrow therapeutic window&#44; genetic factors causing interindividual differences in elimination kinetics&#44; and environmental factors such as adherence to therapy&#44; drug interactions and vitamin K dietary intake that can affect their absorption&#44; pharmacokinetics and pharmacodynamics&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Monitoring the effect of these drugs is therefore essential to achieve and maintain adequate levels to prevent thrombotic events while minimizing the risk of bleeding complications&#46; This is done by measuring prothrombin time as expressed by the INR&#46;<a class="elsevierStyleCrossRefs" href="#bib0145"><span class="elsevierStyleSup">8&#44;9</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">There are various ways to monitor oral anticoagulant therapy&#58; &#40;1&#41; in a hospital environment &#40;anticoagulation clinics&#41; by a physician&#44; generally a specialist in hematology or hemotherapy or with experience in the area&#59; &#40;2&#41; in a primary care setting&#44; by a general practitioner &#40;GP&#41;&#44; generally the patient&#39;s own &#40;routine medical care&#41;&#59; &#40;3&#41; in a private laboratory with experience in the area&#59; &#40;4&#41; by the patients themselves using point-of-care devices &#40;self-testing&#41;&#44; either self-monitoring&#44; in which patients perform the test at home and then contact their center for dose adjustment&#44; or self-management&#44; in which patients perform the test at home and adjust the dose themselves if necessary&#46;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">9</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">Primary or routine care monitoring was first implemented in Portugal 14 years ago&#44; and in 2010&#44; a protocol was established between Centro Hospitalar de Vila Nova de Gaia&#47;Espinho &#40;CHVNGE&#41; and the Espinho-Gaia and Gaia health center groups providing for the monitoring of AF patients with INR within the therapeutic range for at least three months&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">Anticoagulation consultations were first decentralized in the Espinho-Gaia group in the Al&#233;m Douro FHU and progressively extended to 17 units by 2014&#46; Decentralization began in 10 units of the Gaia group in 2013&#44; and remained at this number in 2014&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">The guidelines of the Regional Health Authority of the North region stipulate that a coordinator and a team consisting of two GPs and two family practice nurses should be responsible for managing the program&#44; under the supervision of a specialist in hemotherapy from the reference hospital&#44; together with a procedure manual based on principles of good practice&#46; There should also be a computerized database with patients&#8217; history&#44; print-outs of diagnoses&#44; INR values and ranges&#44; drugs prescribed &#40;proposed treatment&#41;&#44; next scheduled appointment&#44; and an algorithm to guide prescription and scheduling of appointments&#44; which are subject to validation or change by the physician responsible&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">In the Regional Health Authority of the North region&#44; initial anticoagulation monitoring is performed by practice nurses&#44; who determine INR using CoaguChek XS Plus or XS Pro<span class="elsevierStyleSup">&#174;</span> meters&#46; The patient then sees his or her GP&#44; who adjusts the dosage if necessary and schedules the next visit&#46; The data are entered in the TAONet<span class="elsevierStyleSup">&#174;</span> system&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">At the same time&#44; six-monthly laboratory quality control is performed at the CHVNGE&#44; which can be consulted on a day-to-basis&#46; A fast track system for patients under anticoagulant therapy has also been established&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">The quality of a center&#39;s anticoagulation control can be assessed by calculating the percentage TTR of the patients monitored there&#44; low values being associated with adverse events&#46; TTR in a given center can be determined in various ways&#44; most commonly by one of three methods&#58; &#40;1&#41; as the fraction of INR values that are within therapeutic range&#59; &#40;2&#41; by analysis of a cross-section of patient records to determine the percentage of patients whose INR is within the therapeutic range at a given point in time compared to the total number of patients with measured INR at that point in time&#59; or &#40;3&#41; by applying the Rosendaal linear interpolation method&#44; which assumes that there is a linear relationship between two consecutive INR values and allocates a specific INR value to each day between tests&#44; thus enabling the number of days within the therapeutic range to be calculated&#46;<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">10</span></a></p><p id="par0070" class="elsevierStylePara elsevierViewall">Each approach has its advantages and disadvantages&#44; and various factors can affect the variability of results&#46; Several studies have compared the different methods but were unable to recommend one over another due to methodological issues&#46;<a class="elsevierStyleCrossRefs" href="#bib0160"><span class="elsevierStyleSup">11&#8211;13</span></a> Nevertheless&#44; the NICE guideline of August 2014 recommends the Rosendaal method to monitor anticoagulant therapy in AF patients&#46;<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">14</span></a></p><p id="par0075" class="elsevierStylePara elsevierViewall">The aim of this study was to assess the quality of monitoring anticoagulant therapy with VKAs in patients with non-valvular AF in healthcare units of the Espinho-Gaia and Gaia health center groups&#44; using the Rosendaal method&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Methods</span><p id="par0080" class="elsevierStylePara elsevierViewall">This was a retrospective observational analytical study of patients under VKA therapy registered at healthcare units in the Espinho-Gaia and Gaia health center groups&#44; of which the following 27 out of the total of 37 &#40;73&#37;&#41; provide anticoagulation monitoring&#58; the Primary Health Care Units &#40;PHCUs&#41; of Madalena&#44; Marinha&#44; Crestuma&#44; Lever&#44; Perosinho&#44; Silvalde and Viver Sa&#250;de&#44; and the FHUs of Aguda&#44; Al&#233;m D&#8217;Ouro&#44; Anta&#44; Espinho&#44; Caminho Novo&#44; Canelas&#44; Grij&#243;&#44; Monte Murado&#44; Nova Via and S&#227;o F&#233;lix da Marinha in the Espinho-Gaia group&#59; and the following in the Gaia group&#58; the FHUs of Arco do Prado&#44; Gaya&#44; Nova Salus&#44; Sa&#250;de no Futuro&#44; Cam&#233;lias and Abel Salazar&#44; and the PHCUs of Bar&#227;o do Corvo&#44; Soares dos Reis&#44; Oliveira do Douro and Avintes&#46; In order to protect data confidentiality&#44; the units fulfilling the inclusion criteria were allocated a letter of the alphabet from A to Z in descending order of number of patients&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">The variables studied were sociodemographic characteristics&#44; INR values&#44; TTR and current therapy&#46; Patients were considered to be monitored at a healthcare unit if they had a minimum of six visits with INR measurements in 2014&#46;<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">15</span></a> INR values were classified as subtherapeutic &#40;&#60;2&#41;&#44; therapeutic &#40;2-3&#41; or supratherapeutic &#40;&#62;3&#41;&#46; Records were searched for patients with a therapeutic range of 2-3&#44; any with different ranges being excluded&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">The Rosendaal method<a class="elsevierStyleCrossRef" href="#bib0185"><span class="elsevierStyleSup">16</span></a> allocates a person-time for different levels of anticoagulation assuming a linear relationship between consecutive measurements&#46; The person-time within the target therapeutic range is calculated as a proportion of the total person-time of follow-up&#46; The percentage of days within the target range is expressed as the ratio between the difference between two consecutive INR values in range divided by the total INR difference&#44; as expressed in the formula<a class="elsevierStyleCrossRef" href="#bib0190"><span class="elsevierStyleSup">17</span></a>&#58;<elsevierMultimedia ident="eq0005"></elsevierMultimedia></p><p id="par0095" class="elsevierStylePara elsevierViewall">We opted for this method as it enables comparison with the results of other Portuguese and international studies&#46;<a class="elsevierStyleCrossRefs" href="#bib0180"><span class="elsevierStyleSup">15&#44;18&#8211;20</span></a></p><p id="par0100" class="elsevierStylePara elsevierViewall">Poor control was defined as TTR &#60;60&#37;&#44;<a class="elsevierStyleCrossRefs" href="#bib0135"><span class="elsevierStyleSup">6&#44;14&#44;15</span></a> moderate control as 60-75&#37;&#44; and good control as &#62;75&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">6</span></a></p><p id="par0105" class="elsevierStylePara elsevierViewall">All records for 2014 were collected using TAONet<span class="elsevierStyleSup">&#174;</span> software&#46; The data were recorded and analyzed using Microsoft Excel<span class="elsevierStyleSup">&#174;</span> 2010 and SPSS<span class="elsevierStyleSup">&#174;</span> version 21&#44; with no information capable of identifying patients&#46; A descriptive analysis was performed&#44; calculating prevalences and standard deviations&#46; The chi-square test with a 95&#37; confidence interval was used to analyze the association between variables&#59; a value of p&#60;0&#46;05 was considered statistically significant&#46;</p><p id="par0110" class="elsevierStylePara elsevierViewall">Informed consent was considered unnecessary since no data identifying patients were collected or included in the database&#46; Approval for the study was obtained from the ethics committee of the Regional Health Authority of the North region&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Results</span><p id="par0115" class="elsevierStylePara elsevierViewall">Of the 8249 INR records&#44; 1601 were excluded because either there was no diagnosis of non-valvular AF &#40;359&#41; or there was no diagnostic code &#40;1242&#41;&#59; the remaining 6648 records corresponded to 596 patients with non-valvular AF&#46;</p><p id="par0120" class="elsevierStylePara elsevierViewall">In addition&#44; 259 records were excluded as repeats&#44; 76 for showing different values on the same date and 430 of patients with less than six visits recorded&#46; The final number of records was thus 5883&#46; One unit only had patients with less than six visits&#44; and so the number of units analyzed was 26 rather than 27&#46; The records corresponded to 479 patients&#44; of whom 301 &#40;62&#46;8&#37;&#41; were followed in the Espinho-Gaia group and 178 &#40;37&#46;2&#37;&#41; in the Gaia group&#46; Loss to follow-up was 19&#46;6&#37;&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">Mean age was 75&#46;6&#177;8&#46;2 years&#44; range 41-96 years&#46; The most prevalent age-group was 75-84 years&#44; accounting for 52&#46;2&#37; of the sample&#44; and 89&#46;8&#37; of patients were aged 65 or over &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Figure 1</a>&#41;&#46; There was a higher prevalence of women &#40;51&#46;6&#37;&#41;&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0130" class="elsevierStylePara elsevierViewall">The most commonly used anticoagulant was warfarin &#40;86&#37; of cases&#41;&#44; the other 14&#37; being prescribed acenocoumarol&#46;</p><p id="par0135" class="elsevierStylePara elsevierViewall">As seen in <a class="elsevierStyleCrossRef" href="#fig0010">Figure 2</a>&#44; 60&#46;3&#37; of the sample were within the target therapeutic range &#40;INR 2-3 inclusive&#41;&#44; while 39&#46;8&#37; had values outside the range - 18&#46;8&#37; with subtherapeutic INR &#40;&#60;2&#41; and 21&#37; with supratherapeutic INR &#40;&#62;3&#41;&#46; High bleeding risk &#40;INR &#62;4&#46;5&#41; was identified in 1&#46;8&#37; of the sample and 5&#37; presented high thrombotic risk &#40;INR &#60;1&#46;5&#41;&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0140" class="elsevierStylePara elsevierViewall">The 26 units were allocated a letter of the alphabet from A to Z in descending order of number of patients &#40;<a class="elsevierStyleCrossRef" href="#fig0015">Figure 3</a>&#41;&#46; The mean number of patients followed per unit was 18&#177;14 &#40;range 2-62&#41;&#46;</p><elsevierMultimedia ident="fig0015"></elsevierMultimedia><p id="par0145" class="elsevierStylePara elsevierViewall">The mean number of visits was 12&#46;9&#177;3&#46;2&#46; Unit E showed the lowest mean&#44; with 6&#46;6 visits for 30 patients&#44; while unit W had the highest mean&#44; with 21&#46;7 visits for three patients&#44; as shown in <a class="elsevierStyleCrossRef" href="#fig0020">Figure 4</a>&#46;</p><elsevierMultimedia ident="fig0020"></elsevierMultimedia><p id="par0150" class="elsevierStylePara elsevierViewall"><a class="elsevierStyleCrossRef" href="#fig0025">Figure 5</a> shows that 35&#46;3&#37; of patients presented poor control&#44; 29&#46;2&#37; moderate control&#44; and 35&#46;5&#37; good control&#46;</p><elsevierMultimedia ident="fig0025"></elsevierMultimedia><p id="par0155" class="elsevierStylePara elsevierViewall">Mean TTR was 67&#46;4&#177;6&#46;5&#37;&#44; with 66&#46;6&#177;6&#46;2&#37; in the Espinho-Gaia group and 68&#46;9&#177;7&#46;2&#37; in the Gaia group&#44; a difference that was statistically significant &#40;p&#61;0&#46;03&#41;&#46; As seen in <a class="elsevierStyleCrossRef" href="#fig0030">Figure 6</a>&#44; TTR varied between 55&#46;6&#37; and 79&#46;5&#37;&#44; with three units presenting values below 60&#37; and four units achieving rates above 75&#37;&#46;</p><elsevierMultimedia ident="fig0030"></elsevierMultimedia><p id="par0160" class="elsevierStylePara elsevierViewall">A finding of poor control did not appear to be related to the number of patients followed by a particular center &#40;p&#61;0&#46;17&#41;&#46; No statistically significant association was found between INR control and gender &#40;p&#61;0&#46;35&#41; or with the anticoagulant drug used &#40;p&#61;0&#46;079&#41;&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Discussion</span><p id="par0165" class="elsevierStylePara elsevierViewall">The mean TTR in the Espinho-Gaia and Gaia health center groups was 67&#46;4&#177;6&#46;5&#37;&#44; which indicates moderate control according to the established cut-offs&#46;</p><p id="par0170" class="elsevierStylePara elsevierViewall">Recent large-scale clinical trials comparing NOACs with warfarin in non-valvular AF provided important data on the quality of oral anticoagulant therapy with VKAs&#44; using the Rosendaal method&#46; Mean TTR in our study was higher than reported in international studies&#46; The ROCKET-AF clinical trial comparing rivaroxaban with warfarin&#44; which included patients from 45 countries&#44; found a mean TTR at the individual patient level of 55&#46;2&#177;21&#46;3&#37;&#46; The data for Western Europe &#40;16&#37; of the sample&#41; showed a mean TTR of 66&#46;6&#177;17&#46;7&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0195"><span class="elsevierStyleSup">18</span></a> In the ARISTOTLE trial comparing apixaban with warfarin&#44; median TTR was 66&#37;&#44;<a class="elsevierStyleCrossRef" href="#bib0200"><span class="elsevierStyleSup">19</span></a> and in the RE-LY trial comparing dabigatran with warfarin&#44; in patients from 44 countries including Portugal&#44;<a class="elsevierStyleCrossRef" href="#bib0205"><span class="elsevierStyleSup">20</span></a> mean TTR was 67&#46;2&#37; overall and 61&#37; for the Portuguese population&#46;<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">14</span></a> In a study of outpatients attending the anticoagulation clinic of a Portuguese hospital&#44; mean TTR in patients with non-valvular AF was 59&#46;3&#177;19&#46;8&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">15</span></a></p><p id="par0175" class="elsevierStylePara elsevierViewall">The higher the percentage of TTR&#44; the lower the risk of adverse events&#46; Outcome data from the SPORTIF III and IV trials revealed that 43&#37; of events occurred in AF patients taking warfarin with poor control of TTR &#40;&#60;60&#37;&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">6</span></a> Our study showed poor control in 35&#46;3&#37; of patients&#44; meaning that a significant proportion were at risk&#46; Of these&#44; 10&#46;8&#37; presented INR &#60;1&#46;8&#44; representing a higher risk for ischemic stroke&#44; and 9&#46;5&#37; had INR &#62;3&#46;5&#44; associated with a higher risk of intracranial hemorrhage&#46;<a class="elsevierStyleCrossRef" href="#bib0195"><span class="elsevierStyleSup">18</span></a></p><p id="par0180" class="elsevierStylePara elsevierViewall">There was considerable variation in the number of patients followed in each unit&#44; but this was not reflected in statistically significant differences in TTR values&#46; There were a mean of 12 visits over one-year follow-up&#44; about one visit per month&#44; which may be excessive&#46; Although there is disagreement concerning testing frequency&#44; some authors suggest up to 12 weeks for patients with stable INRs without increased bleeding or thromboembolic risk&#46;<a class="elsevierStyleCrossRef" href="#bib0210"><span class="elsevierStyleSup">21</span></a></p><p id="par0185" class="elsevierStylePara elsevierViewall">The strong points of our study are an inclusion criterion of a minimum of six INR measurements&#44; since INR tends to vary more at the beginning of therapy&#44;<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">15</span></a> defining TTR levels to determine quality of anticoagulation control&#44;<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">6</span></a> and the use of Rosendaal&#39;s linear interpolation method to calculate TTR at the individual patient level&#46;<a class="elsevierStyleCrossRef" href="#bib0185"><span class="elsevierStyleSup">16</span></a> It is also a pioneering study that reflects the situation regarding primary care monitoring of oral anticoagulation with VKAs in the municipality of Vila Nova de Gaia in north Portugal&#44; and is reproducible&#46;</p><p id="par0190" class="elsevierStylePara elsevierViewall">The study also has certain limitations&#44; including information bias from the use of INR records and because 11&#46;5&#37; of records were excluded&#46; A further limitation is that it was unknown whether patients were under initial or chronic anticoagulant therapy&#44; whether invasive procedures may have prompted suspension of therapy&#44; and whether environmental and&#47;or genetic factors influenced the results&#59; the method of dose adjustment &#40;automatic TAONet<span class="elsevierStyleSup">&#174;</span> protocol or unit protocols&#41; was also unknown&#46; In addition&#44; the overall loss of patients to follow-up &#40;19&#46;6&#37;&#41;&#44; the loss of records and lack of diagnostic coding &#40;15&#46;1&#37; of cases&#41; may have given rise to selection bias&#46;</p><p id="par0195" class="elsevierStylePara elsevierViewall">It is worth considering extending the study to other health center groups in the future using the same methodology&#44; in order to assess the situation for the country as a whole&#46; The TAONet<span class="elsevierStyleSup">&#174;</span> platform should be modified to include mandatory fields and more sociodemographic data&#46; Accurate recording of diagnoses&#44; dosages and visit outcomes should also be encouraged&#46; Further training of health professionals who manage anticoagulant therapy in primary care may be necessary&#46;</p><p id="par0200" class="elsevierStylePara elsevierViewall">In addition&#44; we should stress the importance of adherence to treatment and compliance with dietary recommendations &#40;to avoid day-to-day variations in intake of vitamin K-rich foods&#41; in order to improve control&#44; as well as the need for systematic investigation of signs of supratherapeutic INR levels&#44; such as bleeding gums or ecchymosis&#46;</p><p id="par0205" class="elsevierStylePara elsevierViewall">In conclusion&#44; our study showed moderate control of coagulation parameters&#44; but better than in other studies&#46; Nevertheless&#44; there is still room for improvement in anticoagulation monitoring in primary health care&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Ethical disclosures</span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Protection of human and animal subjects</span><p id="par0210" class="elsevierStylePara elsevierViewall">The authors declare that no experiments were performed in humans and&#47;or animals for this research&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Confidentiality of data</span><p id="par0215" class="elsevierStylePara elsevierViewall">The authors declare that they have followed the protocols of their work center on the publication of patient data&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Right to privacy and informed consent</span><p id="par0220" class="elsevierStylePara elsevierViewall">The authors declare that no patient data appear in this article&#46;</p></span></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Conflicts of interest</span><p id="par0225" class="elsevierStylePara elsevierViewall">The authors have no conflicts of interest to declare&#46;</p></span></span>"
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            0 => "Cuidados de sa&#250;de prim&#225;rios"
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            2 => "Fibrilha&#231;&#227;o auricular n&#227;o valvular"
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        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Introduction</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Anticoagulant therapy is an effective measure in preventing thromboembolic adverse events&#46; Of the diseases in which this treatment is indicated&#44; atrial fibrillation &#40;AF&#41; has the highest incidence worldwide&#44; with a prevalence of 1&#46;5-2&#37;&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Objectives</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">To assess the quality of monitoring of patients with non-valvular AF under oral anticoagulation with vitamin K antagonists in Vila Nova de Gaia healthcare units&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Methods</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">This was a retrospective observational analytical study of the population registered at the 37 healthcare units of the Vila Nova de Gaia and Espinho health center area under oral anticoagulation with vitamin K antagonists during 2014&#46; The data were collected using TAONet<span class="elsevierStyleSup">&#174;</span> software&#46; The variables studied were health units&#44; age&#44; gender&#44; INR value&#44; time in therapeutic range &#40;TTR&#41; and medication&#46; TTR was calculated for each patient using the Rosendaal linear interpolation method&#46; It was stipulated that each patient should have undergone at least six INR measurements&#46; Data were analyzed using Microsoft Excel<span class="elsevierStyleSup">&#174;</span> 2010 and SPSS<span class="elsevierStyleSup">&#174;</span> version 21&#44; using descriptive and inferential statistical techniques&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Results</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">A total of 479 patients with non-valvular AF were studied&#44; corresponding to 5883 INR tests&#46; Mean TTR was 67&#46;4&#177;6&#46;5&#37;&#44; and 35&#46;3&#37; of patients exhibited poor control &#40;TTR &#60;60&#37;&#41;&#46;</p></span> <span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Discussion</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Our study showed moderate control of coagulation parameters&#44; but better than in many international clinical trials and in another Portuguese observational study&#46; Nevertheless&#44; there is still room for improvement in anticoagulation monitoring in primary health care&#46;</p></span>"
        "secciones" => array:5 [
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            "titulo" => "Introduction"
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          2 => array:2 [
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        "resumen" => "<span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Introdu&#231;&#227;o</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">A terap&#234;utica com anticoagulantes &#233; uma medida eficaz na preven&#231;&#227;o de eventos tromboemb&#243;licos&#46; Das patologias que requerem este tratamento&#44; a fibrilha&#231;&#227;o auricular &#40;FA&#41; &#233; das que tem maior express&#227;o a n&#237;vel mundial&#44; com uma preval&#234;ncia de 1&#44;5-2&#37;&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Objetivos</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Aferir a qualidade da monitoriza&#231;&#227;o de doentes com FA n&#227;o valvular sob anticoagulantes dicumar&#237;nicos&#44; nas unidades funcionais &#40;UF&#41; do concelho de Gaia&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Material e m&#233;todos</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Estudo observacional retrospetivo anal&#237;tico&#46; Popula&#231;&#227;o&#58; doentes inscritos nas 37 UF dos ACeS Gaia e Espinho-Gaia sob hipocoagula&#231;&#227;o com dicumar&#237;nicos&#44; durante o ano de 2014&#46; Fonte dos dados&#58; TAOnet&#174;&#46; Vari&#225;veis estudadas&#58; ACeS&#44; UF&#44; idade&#44; g&#233;nero&#44; INR&#44; tempo em intervalo terap&#234;utico &#40;TTR&#41; e terap&#234;utica&#46; O TTR foi calculado pelo m&#233;todo de interpola&#231;&#227;o linear de Rosendaal&#46; Foram consideradas no m&#237;nimo seis visitas por doente&#46; Tratamento estat&#237;stico&#58; Microsoft Excel&#174; 2010 e <span class="elsevierStyleItalic">SPSS</span>&#174;21&#46;</p></span> <span id="abst0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Resultados</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Foram estudados 479 doentes com FA n&#227;o valvular&#44; o que correspondeu a 5883 registos&#46; O TTR m&#233;dio foi de 67&#44;4&#37; &#40;&#177;<span class="elsevierStyleHsp" style=""></span>6&#44;5&#41;&#46; Apresentaram mau controlo da hipocoagula&#231;&#227;o &#40;TTR<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>60&#37;&#41; 35&#44;3&#37; dos doentes&#46;</p></span> <span id="abst0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">Discuss&#227;o</span><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">O nosso estudo revela um padr&#227;o de controlo de hipocoagula&#231;&#227;o moderado&#44; mas superior ao encontrado noutros estudos&#46; No entanto&#44; consideramos que ainda h&#225; um grande potencial de melhoria nos cuidados de hipocoagula&#231;&#227;o prestados nos cuidados de sa&#250;de prim&#225;rios&#46;</p></span>"
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ISSN: 21742049
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