Electronic medical record in clinical trials of effectiveness of drugs integrated in clinical practice

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"apellidos" => "Carcas" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "a" "identificador" => "aff0005" ] ] ] 1 => array:3 [ "nombre" => "Francisco" "apellidos" => "Abad Santos" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "b" "identificador" => "aff0010" ] ] ] 2 => array:3 [ "nombre" => "Luis" "apellidos" => "Sánchez Perruca" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "c" "identificador" => "aff0015" ] ] ] 3 => array:4 [ "nombre" => "Rafael" "apellidos" => "Dal-Ré" "email" => array:1 [ 0 => "rafael.dalre@fuam.uam.es" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "d" "identificador" => "aff0020" ] 1 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] ] "afiliaciones" => array:4 [ 0 => array:3 [ "entidad" => "Servicio de Farmacología Clínica, Hospital Universitario La Paz, Facultad de Medicina, Universidad Autónoma de Madrid, Madrid, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Servicio de Farmacología Clínica, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria Hospital Universitario de La Princesa (IP), Madrid, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Dirección Técnica de Sistemas de Información Sanitaria, Gerencia Adjunta de Planificación y Calidad, Gerencia de Atención Primaria, Consejería de Salud de la Comunidad Autónoma de Madrid, Madrid, Spain" "etiqueta" => "c" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "Investigación Clínica, Programa BUC (Biociencias UAM + CSIC), Centro de Excelencia Internacional, Universidad Autónoma de Madrid, Madrid, Spain" "etiqueta" => "d" "identificador" => "aff0020" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Historia clínica electrónica en los ensayos clínicos de efectividad con medicamentos integrados en la práctica clínica" ] ] "textoCompleto" => "Over the past 2 decades, the need for health interventions reaching the market to be put into context with those already in use has been consistently stressed. When considering drugs, it is not only important that the new drug demonstrates its safety and efficacy against a placebo, something often required by the Regulatory Agencies, but also against the standard treatment already in routine clinical use, i.e., comparative effectiveness. Comparative effectiveness research is “the generation and synthesis of scientific evidence comparing benefits and harms of interventions to prevent, diagnose, cure, treat or monitor a disease or clinical condition or to improve healthcare in clinical practice“.<a class="elsevierStyleCrossRef" href="#bib0255">1</a> Depending on the objective (and the available budget) a particular design should be chosen. <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a> shows various types of comparative effectiveness studies and their estimated cost. Pragmatic clinical trials (PCTs) are among the most interesting ones.<a class="elsevierStyleCrossRefs" href="#bib0265">3,4</a><elsevierMultimedia ident="tbl0005"></elsevierMultimedia>In PCTs, patients are randomized to two or more interventions used in clinical practice, introducing the least number of changes to it: they intend to retain the advantages of randomization<a class="elsevierStyleCrossRef" href="#bib0275">5</a> ensuring the representativeness (external validity) of clinical practice. Taken to its most genuine expression, comparative effectiveness studies should be carried out in a way that integrate and are indissoluble with the healthcare activity itself.<a class="elsevierStyleCrossRef" href="#bib0280">6</a> In this context, the important development of information and communication technology within health systems has meant that the use of electronic medical records (EMR) is now widespread, something that implies servitudes that few had anticipated.<a class="elsevierStyleCrossRef" href="#bib0285">7</a>The EMR incorporates all relevant health events that occur to patients, both from a healthcare as well as from a social welfare point of view: reasons for consultation, diagnosis, clinical events, diagnostic tests (imaging, pathological, genetic, biochemical), surgical interventions or otherwise, prescriptions drugs and so on. This information, properly collected, can provide an invaluable tool for assessing the comparative effectiveness. With the EMR, in which data are collected and are likely to be analyzed at any time, could it be the case that the best treatment available to the patient could be prescribed and, simultaneously, collect data which contributes to better treat future patients? Is it possible to propose a care and research scenario simultaneously? The PCTs through the EMR (EMRPCTs), does it meet this double objective? And if so, would it require the approval of a clinical research ethics committee (CREC) and the informed consent (IC) from all the participants? As a clinical trial, should the Regulatory Agency intervene?Electronic medical records, a key tool for integrating medical care and effectiveness researchThe last reason to use the EMR is to obtain better health outcomes that derive from making decisions based on better access to information.<a class="elsevierStyleCrossRef" href="#bib0290">8</a> In principle, the decision should be based on the results of studies of comparative effectiveness of interventions available; without a doubt, the best methodological tool for this is the randomized clinical trial. However, when results can be obtained directly from the EMR, can the border between healthcare and clinical research be defined? <a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a> describes the commonly accepted differences between clinical research and medical care. The border does not seem to be very clear. But, what can it be said about the essential difference between the two activities, their objectives? One seeks knowledge for future patients, the other seeks to cure or alleviate the patient in the present moment.<elsevierMultimedia ident="tbl0010"></elsevierMultimedia>Proposals at international level and pragmatic clinical trials with EMR already underwayRetrospective observational studies of effectiveness (and safety) have been conducted for decades, using databases linked to EMR data (anonymised) of primary care doctors. The best known in Europe is the UK's Clinical Practice Research Datalink (CPRD), which has taken over from the General Practice Research Database (GPRD).<a class="elsevierStyleCrossRef" href="#bib0340">18</a> The British government is making a firm commitment to facilitate all types of observational studies and clinical trials, having data on 52 million Britons from the CPRD.<a class="elsevierStyleCrossRef" href="#bib0340">18</a> From the CPRD 2 pilot EMRPCTs were conducted: one comparing 2 statins in patients with familial hypercholesterolemia and high risk of cardiovascular disease, and another comparing 2 antibiotics in the treatment of COPD exacerbations.<a class="elsevierStyleCrossRef" href="#bib0345">19</a> In addition, 2 other cluster randomized clinical trials have been recently published.<a class="elsevierStyleCrossRefs" href="#bib0350">20,21</a>The theoretical advantages of EMRPCTs are important: do not require additional time or effort from the doctor, the healthcare system or the patient.<a class="elsevierStyleCrossRef" href="#bib0360">22</a> In the PCTs, the patient comes to the doctor's office, who collects in the EMR clinical and laboratory tests data relevant to his/her illness. If the doctor is participating in a EMRPCTs, the selection criteria of the same discriminate which of his/her patients meet them; having to decide whether they want to participate. Each participant is randomized to one of the treatments under study. Researchers will be checking the progress of each case (anonymous) and collect the results of the variables of interest that are transferred from the EMR to the PCTs database. The great advantage of this type of trials is that treatments are compared to the real conditions of clinical use; the disadvantage is that the study is open-label (the patient knows which treatment receives) something that is not modifiable, as the objective is to minimize changes to routine clinical practice. Performing such studies should be compared to the alternative: that doctors treat their patients without generating useful knowledge for future cases. Therefore, in the EMRPCTs, doctors treat their patients with standard treatments commonly used in their clinical practice (seeking to cure, relieve or control the disease), while researchers seek to generate knowledge about what treatment is most effective, and hence able to know which is more efficient. Despite these theoretical advantages, the reality in the development of the studies mentioned in the UK is complex. The EMRPCTs encountered major difficulties in their development, from the ethical and administrative phase to the participation of interested doctors and patient selection<a class="elsevierStyleCrossRef" href="#bib0345">19</a>; by contrast, cluster trials appear to have had an efficient implementation.It should be mentioned that two very particular EMRPCTs are being carried out in the UK, in 7000 patients with asthma and COPD, where an experimental drug is being compared (unauthorized; it is therefore a phase 3 open-label clinical trial) to standard treatments in primary care, following the usual consultation process, prescribing and dispensing of medicines.<a class="elsevierStyleCrossRef" href="#bib0365">23</a> The sponsor, therefore, seeks to obtain comparative effectiveness (and safety) data, but encounters 2 very noticeable distortions in the PCTs: obtaining the IC, using a patient information leaflet for the participant which probably contains several pages with information, and dispensing a drug possibly packaged as “sample for clinical research”. These two facts significantly alter the usual conditions of medical care and therefore move away from a true PCT. In any case, these pre-authorization EMRPCTs explore a way to develop in the future.Another approach comes from the USA, the so-called The Learning Healthcare System, which seeks to integrate research, education and care in a new framework, a new paradigm.<a class="elsevierStyleCrossRef" href="#bib0370">24</a> One method is called point-of-care clinical trial, which aims to integrate comparative effectiveness studies in the health care system.<a class="elsevierStyleCrossRef" href="#bib0375">25</a> Thus, obtaining the results of the effectiveness of interventions is performed in “unity of act” with health care, rather than being separate activities, as it usually happens. There is currently a pilot EMRPCTs underway and, according to its sponsors, the strategy seems to be working well.<a class="elsevierStyleCrossRef" href="#bib0380">26</a>Ethical and regulating aspects to consider in a pragmatic clinical trial (PCT) with electronic medical records (EMR)The methodological development that comparative effectiveness studies have experienced<a class="elsevierStyleCrossRef" href="#bib0280">6</a> has not been accompanied by a similar development in their ethical and regulatory aspects.Ethical aspectsIt seems logical to assume that the basic principles of research bioethics in humans (non-maleficence, beneficence, autonomy and justice) should always be considered, regardless of whether interventions are experimental or are already accepted in clinical practice; this, however, does not mean that, at times, the way to implement them will produce serious conflicts.Undoubtedly the most important ethical problem affects the IC. Obtaining the IC complies with the principle of autonomy, which requires to respect the decision of each person to participate or not in a trial.<a class="elsevierStyleCrossRef" href="#bib0300">10</a> This principle is mandatory.<a class="elsevierStyleCrossRefs" href="#bib0385">27,28</a> Although there are situations where failure to obtain an IC from the participant is ethically and legally permissible, they are the exception and not the rule. Moreover, the experience of the 2 EMRPCTs in the UK shows that the CREC did not accept a short patient information leaflet for the participant, just one page long, as they understood that many information elements were missing.<a class="elsevierStyleCrossRefs" href="#bib0345">19,22</a> Researchers thought, not without reason, that the most relevant information to be included in the patient information leaflet for the participant is that the uncertainty of the doctor about which drug is best for the patient is replaced by randomization.<a class="elsevierStyleCrossRef" href="#bib0360">22</a>In the context of the PCTs integrated into clinical practice, obtaining or not the IC is of paramount importance. Thus, some argue that in PCTs, obtaining an IC is not always ethically necessary.<a class="elsevierStyleCrossRefs" href="#bib0395">29–31</a> In the PCTs with minimal risk, studying drugs widely used and where it is not expected that patients will have preferences for one or another, it would be acceptable not even informing them about the randomization of treatment, although they should know that they are invited to participate in a study in which, of course, have the option not to participate. Also, a PCT aims to be conducted in a way that the patient/doctor consultation is practically unaltered. This is not possible if the process of obtaining the IC carries the same method currently used in clinical trials, where the information for the participant covers 20 items required by the standards of good clinical practice,<a class="elsevierStyleCrossRefs" href="#bib0390">28,32</a> occupying several pages of information not easily understandable.<a class="elsevierStyleCrossRefs" href="#bib0415">33,34</a>Kim and Miller,<a class="elsevierStyleCrossRef" href="#bib0425">35</a> on the contrary, do not accept PCTs without obtaining the IC of the participants, believing that not informing them about the randomization is deceiving. Furthermore, they argue the fact that assuming that patients do not have a preference for any of the treatments under study is a patronizing attitude. As they understand that the IC in use in clinical trials of another kind is not acceptable in the PCTs, they propose a simple process, whereby the patient is informed orally of the objective of the study and the method of treatment randomization; the doctor would make a note regarding obtaining the verbal IC given by the patient in the medical history, while the variables of interest would be sent to the PCTs database.<a class="elsevierStyleCrossRef" href="#bib0425">35</a> From an ethical point of view, you can take one of the two positions mentioned, but in Spain (and Europe), unless there is a change of legislation, we must obtain the IC following a process that seems out of proportion in a EMRPCTs context, besides that, as shown by multiple studies, it is of little help when it comes to adequately informing participants.<a class="elsevierStyleCrossRefs" href="#bib0430">36,37</a>A special case is the EMRPCTs comparing a newly marketed drug with other commonly used: first, the new drug will possibly have some characteristic (e.g., efficacy, safety, ease of administration) which can make it more attractive to the patients; second, it will probably be more expensive than the comparator. In the event that the physician could prescribe both drugs with full freedom, only the patients who show no preference for any drugs can be included in the EMRPCTs.<a class="elsevierStyleCrossRef" href="#bib0440">38</a>Regulatory aspectsAs it is well known, the conduct of clinical trials with drugs is a highly regulated activity. Until now, regulation is identical for trials in early stages of development (phases 1 and 2) and for comparing drugs marketed in authorized conditions of use (phase 4). For some time, there is the conviction that administrative intervention is excessive for Phase 4 trials. The new Regulations, which will come into force in the European Union in 2016, introduce the term “low intervention” in clinical trials, in which participants will be treated with authorized medicinal products and in accordance with the terms of the SmPC, the additional diagnostic or monitoring procedures do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice; these tests shall be authorized by the relevant CREC and the Regulatory Agency, but will be exempt from contracting an insurance policy.<a class="elsevierStyleCrossRef" href="#bib0445">39</a> It would seem logical that EMRPCTs become part of such trials; indeed, many of them will present a null additional risk regarding clinical practice: the only difference would be randomization of authorized and conventional medicinal products, which does not involve any increased risk. Contrary to what is advocated by the current legislation<a class="elsevierStyleCrossRef" href="#bib0390">28</a> and the future Regulation,<a class="elsevierStyleCrossRef" href="#bib0445">39</a> we believe that the EMRPCTs with no additional risk should not be subject to review by the Regulatory Agency. In any case, the EMRPCTs protocols should be evaluated by the CREC for the reasons set out in <a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>.<elsevierMultimedia ident="tbl0015"></elsevierMultimedia>An additional aspect to solve is how to ensure the quality control of EMRPCTs data, which, of course, cannot be based on the monitoring visits to participating centres required by the good clinical practice guidelines.<a class="elsevierStyleCrossRefs" href="#bib0345">19,28,32</a> The visit to the centres would be limited to cases of suspected fraud.<a class="elsevierStyleCrossRef" href="#bib0345">19</a> The fact that the EMRPCTs are based on the information that doctors include in the EMR of each patient requires that such information is accepted as valid. From the trial's database, the researchers can check the suitability of certain data (“central monitoring”), but ultimately the reliability of the same depends on the accuracy with which the doctors have recorded the information.The situation in Spain. Prospects for conducting pragmatic clinical trials with electronic medical recordsThe development of EMR in the autonomous regions has been accelerated significantly in recent years. Automation and communication of the different clinical data systems, including the incorporation of clinical parameters, laboratory tests, imaging, electronic prescriptions, etc., is today widespread in the EMR. This is a fundamental qualitative leap in the quality of information available.However, the implementation of the EMR and its contents appear to differ significantly. While in some Autonomous Regions EMR is already implemented in both primary care and hospitals, in other regions the implementation is uneven. A survey conducted among doctors analyzed the extent of EMR implementation in the care of patients with diabetes, and a high variability became evident between Autonomous Regions regarding the adequacy of their health information systems in the care of these patients.<a class="elsevierStyleCrossRef" href="#bib0460">42</a> This suggests a similar variability in other chronic diseases, and probably much more in acute conditions.Without wishing to describe exhaustively the EMR and the clinical information systems in place or under development in the different Autonomous Regions and their potential, <a class="elsevierStyleCrossRef" href="#tbl0020">Table 4</a> summarizes the characteristics of clinical information best referenced in the medical literature in our country. BIFAP, created in the image of the British GPRD has been developed in order to make retrospective observational studies.<a class="elsevierStyleCrossRefs" href="#bib0465">43,44</a> Meanwhile, SIDIAP<a class="elsevierStyleCrossRef" href="#bib0475">45</a> and AP-Madrid have the advantage of being routine care use EMR systems and therefore its use for EMRPCTs would be much more natural. However, with the information publicly available, it is difficult to know to what extent they are workable for conducting EMRPCTs. There are a number of observational epidemiological studies that have revealed the validity of the variables recorded in these EMR systems.<a class="elsevierStyleCrossRefs" href="#bib0480">46–49</a> It is unknown to what extent EMRPCTs could be conducted integrally with clinical care. It is also unclear the degree of validity of the most relevant health variables, although probably, the validation needed for observational studies would be acceptable to perform EMRPCTs. As far as we know, no EMRPCTs are being carried out in Spain. However, the opportunity is clear and the management behind these clinical information systems should be open to their use.<elsevierMultimedia ident="tbl0020"></elsevierMultimedia>ConclusionThe development and integration of the EMR in healthcare make it an undeniable future tool for incorporating PCTs to clinical practice, and opens a door of great interest for the study of the effectiveness of drugs. For their full development, the current regulation of clinical trials should adapt to the characteristics of this type of trials. Regulatory authorities, researchers and the CREC should consider that such tests are able to provide the best evidence for the best (and ultimately, more efficient) treatment of patients in clinical practice. The entry into force of the new regulation of clinical trials in Europe<a class="elsevierStyleCrossRef" href="#bib0445">39</a> should serve to address, after the relevant discussion, the necessary legislative changes that would allow to carry out the EMRPCTs with minimal intrusion into routine clinical practice, which requires a consensual solution on the best way to obtain the IC from the participants in these trials. In this sense, obtaining a simplified IC, which the Regulation allows for cluster trials,<a class="elsevierStyleCrossRef" href="#bib0500">50</a> could be a useful starting point which, in any case, should not be a cause for bias in the selection of EMRPCTs participants.FinancingThis work did not require any funding.AuthorshipAntonio J. Carcas and Rafael Dal-Ré have contributed similarly in development of this paper.Conflict of interestsThe authors declare that they have no conflict of interest." "textoCompletoSecciones" => array:1 [ "secciones" => array:8 [ 0 => array:3 [ "identificador" => "sec0005" "titulo" => "Electronic medical records, a key tool for integrating medical care and effectiveness research" "secciones" => array:1 [ 0 => array:2 [ "identificador" => "sec0010" "titulo" => "Proposals at international level and pragmatic clinical trials with EMR already underway" ] ] ] 1 => array:3 [ "identificador" => "sec0015" "titulo" => "Ethical and regulating aspects to consider in a pragmatic clinical trial (PCT) with electronic medical records (EMR)" "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0020" "titulo" => "Ethical aspects" ] 1 => array:2 [ "identificador" => "sec0025" "titulo" => "Regulatory aspects" ] ] ] 2 => array:2 [ "identificador" => "sec0030" "titulo" => "The situation in Spain. Prospects for conducting pragmatic clinical trials with electronic medical records" ] 3 => array:2 [ "identificador" => "sec0035" "titulo" => "Conclusion" ] 4 => array:2 [ "identificador" => "sec0040" "titulo" => "Financing" ] 5 => array:2 [ "identificador" => "sec0045" "titulo" => "Authorship" ] 6 => array:2 [ "identificador" => "sec0050" "titulo" => "Conflict of interests" ] 7 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2015-01-20" "fechaAceptado" => "2015-01-29" "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "Please cite this article as: Carcas AJ, Abad Santos F, Sánchez Perruca L, Dal-Ré R. Historia clínica electrónica en los ensayos clínicos de efectividad con medicamentos integrados en la práctica clínica. Med Clin (Barc). 2015;145:452–457." ] ] "multimedia" => array:4 [ 0 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at1" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "leyenda" => "Modified from Institute of Medicine.<a class="elsevierStyleCrossRef" href="#bib0260">2</a>" "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Type of study \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Estimated cost (US dollars million. \t\t\t\t\t\t\n \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="table-entry " colspan="2" align="left" valign="top">Randomized clinical trial</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Small sample \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">2.5–5.0 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Large sample \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">15–20 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="2" align="left" valign="top"></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Records \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">2.0–4.0 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Large cohort studies \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">0.8–6 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Small retrospective studies (databases) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">0.1–0.25 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Simulation/modelling studies \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">0.1–0.2 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Systematic reviews \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">0.2–0.35 \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab1034943.png" ] ] ] ] "descripcion" => array:1 [ "en" => "(Some) types and cost estimates of comparative effectiveness studies." ] ] 1 => array:8 [ "identificador" => "tbl0010" "etiqueta" => "Table 2" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at2" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "leyenda" => "Modified from Kass et al.<a class="elsevierStyleCrossRef" href="#bib0295">9</a>" "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Characteristics of clinical research (clinical trials) \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Current situation of medical care \t\t\t\t\t\t\n \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Objective: to obtain generalizable knowledge.<a class="elsevierStyleCrossRef" href="#bib0300">10</a> Utility for future patients, but not necessarily for participants \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Objective: to cure, relieve or control the patient's disease process \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Systematic research. Data collection according to the study protocol \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Data collection is ubiquitous. Many medical centres collect data of all kinds as part of their quality control systems \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Clinical trials have less benefits and more risks, discomforts and burdens than medical care \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Only about 50% of patients receive recommended treatments.<a class="elsevierStyleCrossRef" href="#bib0260">2</a> The wrong drug prescription is associated with a higher frequency of adverse events.<a class="elsevierStyleCrossRef" href="#bib0305">11</a> About 40–45% of hospitalizations due to adverse drug events are preventable.<a class="elsevierStyleCrossRefs" href="#bib0310">12,13</a> Routine diagnostic procedures and treatment in health care may carry risks and drawbacks, often by overuse of medical services that are not accompanied by clear clinical benefits.<a class="elsevierStyleCrossRef" href="#bib0320">14</a> Thus, we have identified more than 250 tests and procedures overused or improperly used.<a class="elsevierStyleCrossRef" href="#bib0325">15</a> Low value procedures affect a significant number of patients<a class="elsevierStyleCrossRef" href="#bib0330">16</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">The trial protocol will dictate which treatment each participant receives. However, there are effectiveness clinical trials of enormous flexibility: patients randomly receive one of the marketed drugs, but they can change, for whatever reason, to another drug at any time, without having to leave the trial<a class="elsevierStyleCrossRef" href="#bib0335">17</a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">In a growing number of health systems free choice of treatment by the physician is clearly restricted to the drugs included in the forms and therapeutic protocols \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab1034942.png" ] ] ] ] "descripcion" => array:1 [ "en" => "Comparison between the characteristics of clinical research and medical care." ] ] 2 => array:8 [ "identificador" => "tbl0015" "etiqueta" => "Table 3" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at3" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">(a) To assess that its objective is relevant in the environment in which it is intended to be conducted \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">(b) To verify that the treatments under study are common in the healthcare environment and be prescribed under the authorized conditions of use \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">(c) To verify that the drugs under study have clinical equivalence,<a class="elsevierStyleCrossRef" href="#tblfn0005">a</a> essential condition for the ethical approach of the trial \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">(d) To ensure that there are no additional procedures or inconveniences for the doctor or the participant apart from those expected in clinical practice related to the disease under study. If any (for example, some additional visit, obtaining an additional blood sample or completion of any form), they do not involve exceeding the minimal risk<a class="elsevierStyleCrossRef" href="#tblfn0010">b</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab1034941.png" ] ] ] "notaPie" => array:2 [ 0 => array:3 [ "identificador" => "tblfn0005" "etiqueta" => "a" "nota" => "Clinical equivalence is the genuine uncertainty by the experts of the medical community so that they are not in a position to prefer any of the treatments under study.<a class="elsevierStyleCrossRef" href="#bib0450">40</a>" ] 1 => array:3 [ "identificador" => "tblfn0010" "etiqueta" => "b" "nota" => "Minimal risk is the probability and magnitude of physical or psychological harm that is normally found in usual daily activities or routine medical, dental or psychological examinations in a healthy person.<a class="elsevierStyleCrossRef" href="#bib0455">41</a>" ] ] ] "descripcion" => array:1 [ "en" => "Reasons why pragmatic clinical trials must be reviewed and approved by a clinical research ethics committee." ] ] 3 => array:8 [ "identificador" => "tbl0020" "etiqueta" => "Table 4" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at4" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "leyenda" => "AEMPS: Spanish Agency of Medicines and Medical Devices; PC: primary care; BIFAP: database for pharmacoepidemiological research in primary care; ICPC: International Classification of Primary Care; e-CAP: electronic medical records for primary care of the Catalan Institute of Health; EMR: electronic medical records; HCEUC: centralized single electronic medical record; ICS: Catalan Institute of Health; IDIAP: Institute for Research in Primary Care; SIDIAP: Information System for Research Development in Primary Care." "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head " align="" valign="top" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">BIFAP (<a class="elsevierStyleInterRef" id="intr0005" href="http://www.bifap.org/">http://www.bifap.org/</a>) \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">SIDIAP (<a class="elsevierStyleInterRef" id="intr0010" href="http://www.sidiap.org/">http://www.sidiap.org/</a>) \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">AP-Madrid \t\t\t\t\t\t\n \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">General description \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Computerized database of PC medical records to conduct pharmacoepidemiological studies. Owned by the AEMPS (Spanish Agency of Medicines and Medical Devices), it has the support of several autonomous regions and scientific societies \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Promoted by the ICS (Catalan Institute of Health) and the IDIAP (Jordi Gol Primary Care Research Institute). Its aim is to generate reliable databases for research from the e-CAP records and other complementary databases \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">HCEUC is the system for PC of the Autonomous Region of Madrid. It has a high degree of information standardization. Its implementation was completed in October 2012 and allows access to HCEUC from any centre \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="4" align="left" valign="top"></td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="4" align="left" valign="top">Characteristics</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Population included \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">4,800,207 (number of existing medical records) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">5,835,000 (80% of the Catalan population) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">6,387,500 (all the active medical records; universal coverage) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Preferential area \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">PC \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">PC \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">PC, 262 health centres and 163 clinics \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Number of doctors \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">2692 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">274 PC teams (does not report on the number of doctors) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">4406 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="4" align="left" valign="top"></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">EMR content \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">General patient data, health problems, medication and vaccination records \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Demographics, clinical, pharmaceutical dispensing, laboratory, hospital admissions, death \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Organized by episodes of care ICPC. Health problems, demographics, data logging in clinical protocols, general patient data, vaccination records, prescriptions and diagnostic tests \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Pathologies in which epidemiological studies have been conducted with outcome variables \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Osteoporosis; acute liver damage; acute myocardial infarction; acute gastrointestinal bleeding \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Diabetes; hip fracture; osteoporosis; osteoarthritis, vascular diseases \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Diabetes; oral anticoagulation; renal failure \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab1034944.png" ] ] ] ] "descripcion" => array:1 [ "en" => "Characteristics and type of variables contained in selected electronic medical records and databases." ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:50 [ 0 => array:3 [ "identificador" => "bib0255" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Initial national priorities for comparative effectiveness research" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "Institute of Medicine, Committee on Comparative Effectiveness Research Prioritization" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Libro" => array:3 [ "fecha" => "2009" "editorial" => "The National Academies Press" "editorialLocalizacion" => "Washington, DC" ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib0260" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Learning what works: infrastructure required for comparative effectiveness research. 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Electronic medical record in clinical trials of effectiveness of drugs integrated in clinical practice

Historia clínica electrónica en los ensayos clínicos de efectividad con medicamentos integrados en la práctica clínica

Antonio J. Carcasa, Francisco Abad Santosb, Luis Sánchez Perrucac, Rafael Dal-Réd,

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rafael.dalre@fuam.uam.es

Corresponding author.

a Servicio de Farmacología Clínica, Hospital Universitario La Paz, Facultad de Medicina, Universidad Autónoma de Madrid, Madrid, Spain

b Servicio de Farmacología Clínica, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria Hospital Universitario de La Princesa (IP), Madrid, Spain

c Dirección Técnica de Sistemas de Información Sanitaria, Gerencia Adjunta de Planificación y Calidad, Gerencia de Atención Primaria, Consejería de Salud de la Comunidad Autónoma de Madrid, Madrid, Spain

d Investigación Clínica, Programa BUC (Biociencias UAM + CSIC), Centro de Excelencia Internacional, Universidad Autónoma de Madrid, Madrid, Spain

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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Over the past 2 decades&#44; the need for health interventions reaching the market to be put into context with those already in use has been consistently stressed&#46; When considering drugs&#44; it is not only important that the new drug demonstrates its safety and efficacy against a placebo&#44; something often required by the Regulatory Agencies&#44; but also against the standard treatment already in routine clinical use&#44; i&#46;e&#46;&#44; comparative effectiveness&#46; Comparative effectiveness research is &#8220;the generation and synthesis of scientific evidence comparing benefits and harms of interventions to prevent&#44; diagnose&#44; cure&#44; treat or monitor a disease or clinical condition or to improve healthcare in clinical practice&#8220;&#46;<a class="elsevierStyleCrossRef" href="#bib0255"><span class="elsevierStyleSup">1</span></a> Depending on the objective &#40;and the available budget&#41; a particular design should be chosen&#46; <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a> shows various types of comparative effectiveness studies and their estimated cost&#46; Pragmatic clinical trials &#40;PCTs&#41; are among the most interesting ones&#46;<a class="elsevierStyleCrossRefs" href="#bib0265"><span class="elsevierStyleSup">3&#44;4</span></a></p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0010" class="elsevierStylePara elsevierViewall">In PCTs&#44; patients are randomized to two or more interventions used in clinical practice&#44; introducing the least number of changes to it&#58; they intend to retain the advantages of randomization<a class="elsevierStyleCrossRef" href="#bib0275"><span class="elsevierStyleSup">5</span></a> ensuring the representativeness &#40;external validity&#41; of clinical practice&#46; Taken to its most genuine expression&#44; comparative effectiveness studies should be carried out in a way that integrate and are indissoluble with the healthcare activity itself&#46;<a class="elsevierStyleCrossRef" href="#bib0280"><span class="elsevierStyleSup">6</span></a> In this context&#44; the important development of information and communication technology within health systems has meant that the use of electronic medical records &#40;EMR&#41; is now widespread&#44; something that implies servitudes that few had anticipated&#46;<a class="elsevierStyleCrossRef" href="#bib0285"><span class="elsevierStyleSup">7</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">The EMR incorporates all relevant health events that occur to patients&#44; both from a healthcare as well as from a social welfare point of view&#58; reasons for consultation&#44; diagnosis&#44; clinical events&#44; diagnostic tests &#40;imaging&#44; pathological&#44; genetic&#44; biochemical&#41;&#44; surgical interventions or otherwise&#44; prescriptions drugs and so on&#46; This information&#44; properly collected&#44; can provide an invaluable tool for assessing the comparative effectiveness&#46; With the EMR&#44; in which data are collected and are likely to be analyzed at any time&#44; could it be the case that the best treatment available to the patient could be prescribed and&#44; simultaneously&#44; collect data which contributes to better treat future patients&#63; Is it possible to propose a care and research scenario simultaneously&#63; The PCTs through the EMR &#40;EMRPCTs&#41;&#44; does it meet this double objective&#63; And if so&#44; would it require the approval of a clinical research ethics committee &#40;CREC&#41; and the informed consent &#40;IC&#41; from all the participants&#63; As a clinical trial&#44; should the Regulatory Agency intervene&#63;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Electronic medical records&#44; a key tool for integrating medical care and effectiveness research</span><p id="par0020" class="elsevierStylePara elsevierViewall">The last reason to use the EMR is to obtain better health outcomes that derive from making decisions based on better access to information&#46;<a class="elsevierStyleCrossRef" href="#bib0290"><span class="elsevierStyleSup">8</span></a> In principle&#44; the decision should be based on the results of studies of comparative effectiveness of interventions available&#59; without a doubt&#44; the best methodological tool for this is the randomized clinical trial&#46; However&#44; when results can be obtained directly from the EMR&#44; can the border between healthcare and clinical research be defined&#63; <a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a> describes the commonly accepted differences between clinical research and medical care&#46; The border does not seem to be very clear&#46; But&#44; what can it be said about the essential difference between the two activities&#44; their objectives&#63; One seeks knowledge for future patients&#44; the other seeks to cure or alleviate the patient in the present moment&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Proposals at international level and pragmatic clinical trials with EMR already underway</span><p id="par0025" class="elsevierStylePara elsevierViewall">Retrospective observational studies of effectiveness &#40;and safety&#41; have been conducted for decades&#44; using databases linked to EMR data &#40;anonymised&#41; of primary care doctors&#46; The best known in Europe is the UK&#39;s <span class="elsevierStyleItalic">Clinical Practice Research Datalink</span> &#40;CPRD&#41;&#44; which has taken over from the <span class="elsevierStyleItalic">General Practice Research Database</span> &#40;GPRD&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0340"><span class="elsevierStyleSup">18</span></a> The British government is making a firm commitment to facilitate all types of observational studies and clinical trials&#44; having data on 52 million Britons from the CPRD&#46;<a class="elsevierStyleCrossRef" href="#bib0340"><span class="elsevierStyleSup">18</span></a> From the CPRD 2 pilot EMRPCTs were conducted&#58; one comparing 2 statins in patients with familial hypercholesterolemia and high risk of cardiovascular disease&#44; and another comparing 2 antibiotics in the treatment of COPD exacerbations&#46;<a class="elsevierStyleCrossRef" href="#bib0345"><span class="elsevierStyleSup">19</span></a> In addition&#44; 2 other cluster randomized clinical trials have been recently published&#46;<a class="elsevierStyleCrossRefs" href="#bib0350"><span class="elsevierStyleSup">20&#44;21</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">The theoretical advantages of EMRPCTs are important&#58; do not require additional time or effort from the doctor&#44; the healthcare system or the patient&#46;<a class="elsevierStyleCrossRef" href="#bib0360"><span class="elsevierStyleSup">22</span></a> In the PCTs&#44; the patient comes to the doctor&#39;s office&#44; who collects in the EMR clinical and laboratory tests data relevant to his&#47;her illness&#46; If the doctor is participating in a EMRPCTs&#44; the selection criteria of the same discriminate which of his&#47;her patients meet them&#59; having to decide whether they want to participate&#46; Each participant is randomized to one of the treatments under study&#46; Researchers will be checking the progress of each case &#40;anonymous&#41; and collect the results of the variables of interest that are transferred from the EMR to the PCTs database&#46; The great advantage of this type of trials is that treatments are compared to the real conditions of clinical use&#59; the disadvantage is that the study is open-label &#40;the patient knows which treatment receives&#41; something that is not modifiable&#44; as the objective is to minimize changes to routine clinical practice&#46; Performing such studies should be compared to the alternative&#58; that doctors treat their patients without generating useful knowledge for future cases&#46; Therefore&#44; in the EMRPCTs&#44; doctors treat their patients with standard treatments commonly used in their clinical practice &#40;seeking to cure&#44; relieve or control the disease&#41;&#44; while researchers seek to generate knowledge about what treatment is most effective&#44; and hence able to know which is more efficient&#46; Despite these theoretical advantages&#44; the reality in the development of the studies mentioned in the UK is complex&#46; The EMRPCTs encountered major difficulties in their development&#44; from the ethical and administrative phase to the participation of interested doctors and patient selection<a class="elsevierStyleCrossRef" href="#bib0345"><span class="elsevierStyleSup">19</span></a>&#59; by contrast&#44; cluster trials appear to have had an efficient implementation&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">It should be mentioned that two very particular EMRPCTs are being carried out in the UK&#44; in 7000 patients with asthma and COPD&#44; where an experimental drug is being compared &#40;unauthorized&#59; it is therefore a phase 3 open-label clinical trial&#41; to standard treatments in primary care&#44; following the usual consultation process&#44; prescribing and dispensing of medicines&#46;<a class="elsevierStyleCrossRef" href="#bib0365"><span class="elsevierStyleSup">23</span></a> The sponsor&#44; therefore&#44; seeks to obtain comparative effectiveness &#40;and safety&#41; data&#44; but encounters 2 very noticeable distortions in the PCTs&#58; obtaining the IC&#44; using a patient information leaflet for the participant which probably contains several pages with information&#44; and dispensing a drug possibly packaged as &#8220;sample for clinical research&#8221;&#46; These two facts significantly alter the usual conditions of medical care and therefore move away from a true PCT&#46; In any case&#44; these pre-authorization EMRPCTs explore a way to develop in the future&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">Another approach comes from the USA&#44; the so-called <span class="elsevierStyleItalic">The Learning Healthcare System</span>&#44; which seeks to integrate research&#44; education and care in a new framework&#44; a new paradigm&#46;<a class="elsevierStyleCrossRef" href="#bib0370"><span class="elsevierStyleSup">24</span></a> One method is called <span class="elsevierStyleItalic">point-of-care clinical trial</span>&#44; which aims to integrate comparative effectiveness studies in the health care system&#46;<a class="elsevierStyleCrossRef" href="#bib0375"><span class="elsevierStyleSup">25</span></a> Thus&#44; obtaining the results of the effectiveness of interventions is performed in &#8220;unity of act&#8221; with health care&#44; rather than being separate activities&#44; as it usually happens&#46; There is currently a pilot EMRPCTs underway and&#44; according to its sponsors&#44; the strategy seems to be working well&#46;<a class="elsevierStyleCrossRef" href="#bib0380"><span class="elsevierStyleSup">26</span></a></p></span></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Ethical and regulating aspects to consider in a pragmatic clinical trial &#40;PCT&#41; with electronic medical records &#40;EMR&#41;</span><p id="par0045" class="elsevierStylePara elsevierViewall">The methodological development that comparative effectiveness studies have experienced<a class="elsevierStyleCrossRef" href="#bib0280"><span class="elsevierStyleSup">6</span></a> has not been accompanied by a similar development in their ethical and regulatory aspects&#46;</p><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Ethical aspects</span><p id="par0050" class="elsevierStylePara elsevierViewall">It seems logical to assume that the basic principles of research bioethics in humans &#40;non-maleficence&#44; beneficence&#44; autonomy and justice&#41; should always be considered&#44; regardless of whether interventions are experimental or are already accepted in clinical practice&#59; this&#44; however&#44; does not mean that&#44; at times&#44; the way to implement them will produce serious conflicts&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">Undoubtedly the most important ethical problem affects the IC&#46; Obtaining the IC complies with the principle of autonomy&#44; which requires to respect the decision of each person to participate or not in a trial&#46;<a class="elsevierStyleCrossRef" href="#bib0300"><span class="elsevierStyleSup">10</span></a> This principle is mandatory&#46;<a class="elsevierStyleCrossRefs" href="#bib0385"><span class="elsevierStyleSup">27&#44;28</span></a> Although there are situations where failure to obtain an IC from the participant is ethically and legally permissible&#44; they are the exception and not the rule&#46; Moreover&#44; the experience of the 2 EMRPCTs in the UK shows that the CREC did not accept a short patient information leaflet for the participant&#44; just one page long&#44; as they understood that many information elements were missing&#46;<a class="elsevierStyleCrossRefs" href="#bib0345"><span class="elsevierStyleSup">19&#44;22</span></a> Researchers thought&#44; not without reason&#44; that the most relevant information to be included in the patient information leaflet for the participant is that the uncertainty of the doctor about which drug is best for the patient is replaced by randomization&#46;<a class="elsevierStyleCrossRef" href="#bib0360"><span class="elsevierStyleSup">22</span></a></p><p id="par0060" class="elsevierStylePara elsevierViewall">In the context of the PCTs integrated into clinical practice&#44; obtaining or not the IC is of paramount importance&#46; Thus&#44; some argue that in PCTs&#44; obtaining an IC <span class="elsevierStyleItalic">is not</span> always ethically necessary&#46;<a class="elsevierStyleCrossRefs" href="#bib0395"><span class="elsevierStyleSup">29&#8211;31</span></a> In the PCTs with minimal risk&#44; studying drugs widely used and where it is not expected that patients will have preferences for one or another&#44; it would be acceptable not even informing them about the randomization of treatment&#44; although they should know that they are invited to participate in a study in which&#44; of course&#44; have the option not to participate&#46; Also&#44; a PCT aims to be conducted in a way that the patient&#47;doctor consultation is practically unaltered&#46; This is not possible if the process of obtaining the IC carries the same method currently used in clinical trials&#44; where the information for the participant covers 20 items required by the standards of good clinical practice&#44;<a class="elsevierStyleCrossRefs" href="#bib0390"><span class="elsevierStyleSup">28&#44;32</span></a> occupying several pages of information not easily understandable&#46;<a class="elsevierStyleCrossRefs" href="#bib0415"><span class="elsevierStyleSup">33&#44;34</span></a></p><p id="par0065" class="elsevierStylePara elsevierViewall">Kim and Miller&#44;<a class="elsevierStyleCrossRef" href="#bib0425"><span class="elsevierStyleSup">35</span></a> on the contrary&#44; do not accept PCTs without obtaining the IC of the participants&#44; believing that not informing them about the randomization is deceiving&#46; Furthermore&#44; they argue the fact that assuming that patients do not have a preference for any of the treatments under study is a patronizing attitude&#46; As they understand that the IC in use in clinical trials of another kind is not acceptable in the PCTs&#44; they propose a simple process&#44; whereby the patient is informed orally of the objective of the study and the method of treatment randomization&#59; the doctor would make a note regarding obtaining the verbal IC given by the patient in the medical history&#44; while the variables of interest would be sent to the PCTs database&#46;<a class="elsevierStyleCrossRef" href="#bib0425"><span class="elsevierStyleSup">35</span></a> From an ethical point of view&#44; you can take one of the two positions mentioned&#44; but in Spain &#40;and Europe&#41;&#44; unless there is a change of legislation&#44; we must obtain the IC following a process that seems out of proportion in a EMRPCTs context&#44; besides that&#44; as shown by multiple studies&#44; it is of little help when it comes to adequately informing participants&#46;<a class="elsevierStyleCrossRefs" href="#bib0430"><span class="elsevierStyleSup">36&#44;37</span></a></p><p id="par0070" class="elsevierStylePara elsevierViewall">A special case is the EMRPCTs comparing a newly marketed drug with other commonly used&#58; first&#44; the new drug will possibly have some characteristic &#40;e&#46;g&#46;&#44; efficacy&#44; safety&#44; ease of administration&#41; which can make it more attractive to the patients&#59; second&#44; it will probably be more expensive than the comparator&#46; In the event that the physician could prescribe both drugs with full freedom&#44; only the patients who show no preference for any drugs can be included in the EMRPCTs&#46;<a class="elsevierStyleCrossRef" href="#bib0440"><span class="elsevierStyleSup">38</span></a></p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Regulatory aspects</span><p id="par0075" class="elsevierStylePara elsevierViewall">As it is well known&#44; the conduct of clinical trials with drugs is a highly regulated activity&#46; Until now&#44; regulation is identical for trials in early stages of development &#40;phases 1 and 2&#41; and for comparing drugs marketed in authorized conditions of use &#40;phase 4&#41;&#46; For some time&#44; there is the conviction that administrative intervention is excessive for Phase 4 trials&#46; The new Regulations&#44; which will come into force in the European Union in 2016&#44; introduce the term &#8220;low intervention&#8221; in clinical trials&#44; in which participants will be treated with authorized medicinal products and in accordance with the terms of the SmPC&#44; the additional diagnostic or monitoring procedures do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice&#59; these tests shall be authorized by the relevant CREC and the Regulatory Agency&#44; but will be exempt from contracting an insurance policy&#46;<a class="elsevierStyleCrossRef" href="#bib0445"><span class="elsevierStyleSup">39</span></a> It would seem logical that EMRPCTs become part of such trials&#59; indeed&#44; many of them will present a <span class="elsevierStyleItalic">null</span> additional risk regarding clinical practice&#58; the only difference would be randomization of authorized and conventional medicinal products&#44; which does not involve any increased risk&#46; Contrary to what is advocated by the current legislation<a class="elsevierStyleCrossRef" href="#bib0390"><span class="elsevierStyleSup">28</span></a> and the future Regulation&#44;<a class="elsevierStyleCrossRef" href="#bib0445"><span class="elsevierStyleSup">39</span></a> we believe that the EMRPCTs with no additional risk should not be subject to review by the Regulatory Agency&#46; In any case&#44; the EMRPCTs protocols should be evaluated by the CREC for the reasons set out in <a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>&#46;</p><elsevierMultimedia ident="tbl0015"></elsevierMultimedia><p id="par0080" class="elsevierStylePara elsevierViewall">An additional aspect to solve is how to ensure the quality control of EMRPCTs data&#44; which&#44; of course&#44; cannot be based on the monitoring visits to participating centres required by the good clinical practice guidelines&#46;<a class="elsevierStyleCrossRefs" href="#bib0345"><span class="elsevierStyleSup">19&#44;28&#44;32</span></a> The visit to the centres would be limited to cases of suspected fraud&#46;<a class="elsevierStyleCrossRef" href="#bib0345"><span class="elsevierStyleSup">19</span></a> The fact that the EMRPCTs are based on the information that doctors include in the EMR of each patient requires that such information is accepted as valid&#46; From the trial&#39;s database&#44; the researchers can check the suitability of certain data &#40;&#8220;central monitoring&#8221;&#41;&#44; but ultimately the reliability of the same depends on the accuracy with which the doctors have recorded the information&#46;</p></span></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">The situation in Spain&#46; Prospects for conducting pragmatic clinical trials with electronic medical records</span><p id="par0085" class="elsevierStylePara elsevierViewall">The development of EMR in the autonomous regions has been accelerated significantly in recent years&#46; Automation and communication of the different clinical data systems&#44; including the incorporation of clinical parameters&#44; laboratory tests&#44; imaging&#44; electronic prescriptions&#44; etc&#46;&#44; is today widespread in the EMR&#46; This is a fundamental qualitative leap in the quality of information available&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">However&#44; the implementation of the EMR and its contents appear to differ significantly&#46; While in some Autonomous Regions EMR is already implemented in both primary care and hospitals&#44; in other regions the implementation is uneven&#46; A survey conducted among doctors analyzed the extent of EMR implementation in the care of patients with diabetes&#44; and a high variability became evident between Autonomous Regions regarding the adequacy of their health information systems in the care of these patients&#46;<a class="elsevierStyleCrossRef" href="#bib0460"><span class="elsevierStyleSup">42</span></a> This suggests a similar variability in other chronic diseases&#44; and probably much more in acute conditions&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">Without wishing to describe exhaustively the EMR and the clinical information systems in place or under development in the different Autonomous Regions and their potential&#44; <a class="elsevierStyleCrossRef" href="#tbl0020">Table 4</a> summarizes the characteristics of clinical information best referenced in the medical literature in our country&#46; BIFAP&#44; created in the image of the British GPRD has been developed in order to make retrospective observational studies&#46;<a class="elsevierStyleCrossRefs" href="#bib0465"><span class="elsevierStyleSup">43&#44;44</span></a> Meanwhile&#44; SIDIAP<a class="elsevierStyleCrossRef" href="#bib0475"><span class="elsevierStyleSup">45</span></a> and AP-Madrid have the advantage of being routine care use EMR systems and therefore its use for EMRPCTs would be much more natural&#46; However&#44; with the information publicly available&#44; it is difficult to know to what extent they are workable for conducting EMRPCTs&#46; There are a number of observational epidemiological studies that have revealed the validity of the variables recorded in these EMR systems&#46;<a class="elsevierStyleCrossRefs" href="#bib0480"><span class="elsevierStyleSup">46&#8211;49</span></a> It is unknown to what extent EMRPCTs could be conducted integrally with clinical care&#46; It is also unclear the degree of validity of the most relevant health variables&#44; although probably&#44; the validation needed for observational studies would be acceptable to perform EMRPCTs&#46; As far as we know&#44; no EMRPCTs are being carried out in Spain&#46; However&#44; the opportunity is clear and the management behind these clinical information systems should be open to their use&#46;</p><elsevierMultimedia ident="tbl0020"></elsevierMultimedia></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Conclusion</span><p id="par0100" class="elsevierStylePara elsevierViewall">The development and integration of the EMR in healthcare make it an undeniable future tool for incorporating PCTs to clinical practice&#44; and opens a door of great interest for the study of the effectiveness of drugs&#46; For their full development&#44; the current regulation of clinical trials should adapt to the characteristics of this type of trials&#46; Regulatory authorities&#44; researchers and the CREC should consider that such tests are able to provide the best evidence for the best &#40;and ultimately&#44; more efficient&#41; treatment of patients in clinical practice&#46; The entry into force of the new regulation of clinical trials in Europe<a class="elsevierStyleCrossRef" href="#bib0445"><span class="elsevierStyleSup">39</span></a> should serve to address&#44; after the relevant discussion&#44; the necessary legislative changes that would allow to carry out the EMRPCTs with minimal intrusion into routine clinical practice&#44; which requires a consensual solution on the best way to obtain the IC from the participants in these trials&#46; In this sense&#44; obtaining a simplified IC&#44; which the Regulation allows for cluster trials&#44;<a class="elsevierStyleCrossRef" href="#bib0500"><span class="elsevierStyleSup">50</span></a> could be a useful starting point which&#44; in any case&#44; should not be a cause for bias in the selection of EMRPCTs participants&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Financing</span><p id="par0105" class="elsevierStylePara elsevierViewall">This work did not require any funding&#46;</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Authorship</span><p id="par0110" class="elsevierStylePara elsevierViewall">Antonio J&#46; Carcas and Rafael Dal-R&#233; have contributed similarly in development of this paper&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conflict of interests</span><p id="par0115" class="elsevierStylePara elsevierViewall">The authors declare that they have no conflict of interest&#46;</p></span></span>"
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          "identificador" => "sec0005"
          "titulo" => "Electronic medical records&#44; a key tool for integrating medical care and effectiveness research"
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              "identificador" => "sec0010"
              "titulo" => "Proposals at international level and pragmatic clinical trials with EMR already underway"
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          "identificador" => "sec0015"
          "titulo" => "Ethical and regulating aspects to consider in a pragmatic clinical trial &#40;PCT&#41; with electronic medical records &#40;EMR&#41;"
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              "identificador" => "sec0020"
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          "titulo" => "The situation in Spain&#46; Prospects for conducting pragmatic clinical trials with electronic medical records"
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          "titulo" => "Conclusion"
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        "nota" => "<p class="elsevierStyleNotepara" id="npar0015">Please cite this article as&#58; Carcas AJ&#44; Abad Santos F&#44; S&#225;nchez Perruca L&#44; Dal-R&#233; R&#46; Historia cl&#237;nica electr&#243;nica en los ensayos cl&#237;nicos de efectividad con medicamentos integrados en la pr&#225;ctica cl&#237;nica&#46; Med Clin &#40;Barc&#41;&#46; 2015&#59;145&#58;452&#8211;457&#46;</p>"
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          "leyenda" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Modified from Institute of Medicine&#46;<a class="elsevierStyleCrossRef" href="#bib0260"><span class="elsevierStyleSup">2</span></a></p>"
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                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Estimated cost &#40;US dollars million&#46;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="table-entry  " colspan="2" align="left" valign="top"><span class="elsevierStyleItalic">Randomized clinical trial</span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Small sample&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">15&#8211;20&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">Large cohort studies</span>&nbsp;\t\t\t\t\t\t\n
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          "leyenda" => "<p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Modified from Kass et al&#46;<a class="elsevierStyleCrossRef" href="#bib0295"><span class="elsevierStyleSup">9</span></a></p>"
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                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Characteristics of clinical research &#40;clinical trials&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Current situation of medical care&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Objective&#58; to obtain generalizable knowledge&#46;<a class="elsevierStyleCrossRef" href="#bib0300"><span class="elsevierStyleSup">10</span></a> Utility for future patients&#44; but not necessarily for participants&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Objective&#58; to cure&#44; relieve or control the patient&#39;s disease process&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Systematic research&#46; Data collection according to the study protocol&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Data collection is ubiquitous&#46; Many medical centres collect data of all kinds as part of their quality control systems&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Clinical trials have less benefits and more risks&#44; discomforts and burdens than medical care&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Only about 50&#37; of patients receive recommended treatments&#46;<a class="elsevierStyleCrossRef" href="#bib0260"><span class="elsevierStyleSup">2</span></a> The wrong drug prescription is associated with a higher frequency of adverse events&#46;<a class="elsevierStyleCrossRef" href="#bib0305"><span class="elsevierStyleSup">11</span></a> About 40&#8211;45&#37; of hospitalizations due to adverse drug events are preventable&#46;<a class="elsevierStyleCrossRefs" href="#bib0310"><span class="elsevierStyleSup">12&#44;13</span></a> Routine diagnostic procedures and treatment in health care may carry risks and drawbacks&#44; often by overuse of medical services that are not accompanied by clear clinical benefits&#46;<a class="elsevierStyleCrossRef" href="#bib0320"><span class="elsevierStyleSup">14</span></a> Thus&#44; we have identified more than 250 tests and procedures overused or improperly used&#46;<a class="elsevierStyleCrossRef" href="#bib0325"><span class="elsevierStyleSup">15</span></a> Low value procedures affect a significant number of patients<a class="elsevierStyleCrossRef" href="#bib0330"><span class="elsevierStyleSup">16</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">The trial protocol will dictate which treatment each participant receives&#46; However&#44; there are effectiveness clinical trials of enormous flexibility&#58; patients randomly receive one of the marketed drugs&#44; but they can change&#44; for whatever reason&#44; to another drug at any time&#44; without having to leave the trial<a class="elsevierStyleCrossRef" href="#bib0335"><span class="elsevierStyleSup">17</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">In a growing number of health systems free choice of treatment by the physician is clearly restricted to the drugs included in the forms and therapeutic protocols&nbsp;\t\t\t\t\t\t\n
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          "en" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Comparison between the characteristics of clinical research and medical care&#46;</p>"
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                  \t\t\t\t" class=""><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">&#40;a&#41; To assess that its objective is relevant in the environment in which it is intended to be conducted&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">&#40;b&#41; To verify that the treatments under study are common in the healthcare environment and be prescribed under the authorized conditions of use&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">&#40;c&#41; To verify that the drugs under study have clinical equivalence&#44;<a class="elsevierStyleCrossRef" href="#tblfn0005"><span class="elsevierStyleSup">a</span></a> essential condition for the ethical approach of the trial&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">&#40;d&#41; To ensure that there are no additional procedures or inconveniences for the doctor or the participant apart from those expected in clinical practice related to the disease under study&#46; If any &#40;for example&#44; some additional visit&#44; obtaining an additional blood sample or completion of any form&#41;&#44; they do not involve exceeding the minimal risk<a class="elsevierStyleCrossRef" href="#tblfn0010"><span class="elsevierStyleSup">b</span></a>&nbsp;\t\t\t\t\t\t\n
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              "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Clinical equivalence is the genuine uncertainty by the experts of the medical community so that they are not in a position to prefer any of the treatments under study&#46;<a class="elsevierStyleCrossRef" href="#bib0450"><span class="elsevierStyleSup">40</span></a></p>"
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              "nota" => "<p class="elsevierStyleNotepara" id="npar0010">Minimal risk is the probability and magnitude of physical or psychological harm that is normally found in usual daily activities or routine medical&#44; dental or psychological examinations in a healthy person&#46;<a class="elsevierStyleCrossRef" href="#bib0455"><span class="elsevierStyleSup">41</span></a></p>"
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          "leyenda" => "<p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">AEMPS&#58; Spanish Agency of Medicines and Medical Devices&#59; PC&#58; primary care&#59; BIFAP&#58; database for pharmacoepidemiological research in primary care&#59; ICPC&#58; International Classification of Primary Care&#59; e-CAP&#58; electronic medical records for primary care of the Catalan Institute of Health&#59; EMR&#58; electronic medical records&#59; HCEUC&#58; centralized single electronic medical record&#59; ICS&#58; Catalan Institute of Health&#59; IDIAP&#58; Institute for Research in Primary Care&#59; SIDIAP&#58; Information System for Research Development in Primary Care&#46;</p>"
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                  <table border="0" frame="\n
                  \t\t\t\t\tvoid\n
                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head  " align="" valign="top" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">BIFAP &#40;<a class="elsevierStyleInterRef" id="intr0005" href="http://www.bifap.org/">http&#58;&#47;&#47;www&#46;bifap&#46;org&#47;</a>&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">SIDIAP &#40;<a class="elsevierStyleInterRef" id="intr0010" href="http://www.sidiap.org/">http&#58;&#47;&#47;www&#46;sidiap&#46;org&#47;</a>&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">AP-Madrid&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">General description</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Computerized database of PC medical records to conduct pharmacoepidemiological studies&#46; Owned by the AEMPS &#40;Spanish Agency of Medicines and Medical Devices&#41;&#44; it has the support of several autonomous regions and scientific societies&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Promoted by the ICS &#40;Catalan Institute of Health&#41; and the IDIAP &#40;Jordi Gol Primary Care Research Institute&#41;&#46; Its aim is to generate reliable databases for research from the e-CAP records and other complementary databases&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">HCEUC is the system for PC of the Autonomous Region of Madrid&#46; It has a high degree of information standardization&#46; Its implementation was completed in October 2012 and allows access to HCEUC from any centre&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="4" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="4" align="left" valign="top"><span class="elsevierStyleItalic">Characteristics</span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Population included&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">4&#44;800&#44;207 &#40;number of existing medical records&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">5&#44;835&#44;000 &#40;80&#37; of the Catalan population&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">6&#44;387&#44;500 &#40;all the active medical records&#59; universal coverage&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Preferential area&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">PC&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">PC&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">PC&#44; 262 health centres and 163 clinics&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Number of doctors&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">2692&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">274 PC teams &#40;does not report on the number of doctors&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">4406&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="4" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">EMR content</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">General patient data&#44; health problems&#44; medication and vaccination records&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Demographics&#44; clinical&#44; pharmaceutical dispensing&#44; laboratory&#44; hospital admissions&#44; death&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Organized by episodes of care ICPC&#46; Health problems&#44; demographics&#44; data logging in clinical protocols&#44; general patient data&#44; vaccination records&#44; prescriptions and diagnostic tests&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">Pathologies in which epidemiological studies have been conducted with outcome variables</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Osteoporosis&#59; acute liver damage&#59; acute myocardial infarction&#59; acute gastrointestinal bleeding&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Diabetes&#59; hip fracture&#59; osteoporosis&#59; osteoarthritis&#44; vascular diseases&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Diabetes&#59; oral anticoagulation&#59; renal failure&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
                  """
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          "en" => "<p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Characteristics and type of variables contained in selected electronic medical records and databases&#46;</p>"
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Article information

ISSN: 23870206
Original language: English

DOI:10.1016/j.medcle.2016.03.024

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