Letter to the Editor
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The goal of our work was, at all times, to analyse the factors associated with mortality in a number of very elderly patients admitted with ischaemic stroke, but not to describe the activities developed at each health care area involved. Thus, the methods applied were in line with the goal of the study.</p><p id="par0010" class="elsevierStylePara elsevierViewall">We believe, however, that having the opportunity to discuss about obtaining an informed consent for a retrospective study is far more interesting. We appreciate and share the ethical concerns of our colleges, since obtaining the informed consent in this type of situation might be highly complicated and usually infeasible due to, for instance, deaths or transfers. Although the current regulation in force, SAS/3470/2009,<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">1</span></a> governs the exception to the informed consent for post authorisation studies, Spain does not have a specific regulation for observational studies other than the Organic Law on the Protection of Personal Data (Ley Orgánica de Protección de Datos, LOPD), from 1999.<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">2</span></a> Our study<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">3</span></a> was outlined in 2008, prior to regulation SAS/3470/2009, when the legal framework was flexible for retrospective and non-experimental studies. Even to date, clinical research ethics committees exempt the need for informed consent in retrospective studies whenever it cannot be obtained for a significant number of patients, or when the scientific question is deemed relevant for the society, or when ethics regulations concerning professional secrecy, from the Declaration both of Oviedo and Helsinki are firmly observed, and when the information is codified in an anonymous database. It goes without saying that retrospective studies with a wide range of subjects and necessary mortality data abundant in medical literature would be, otherwise, infeasible.</p><p id="par0015" class="elsevierStylePara elsevierViewall">We have had the honour of accessing data obtained thanks to the work carried out by numerous and excellent professionals. However, we are concerned about the vision of those colleagues who state that the result of their labour as medical practitioners might be enough condition to become the author of a scientific research, though we do agree on their comments regarding the role of data collection which it should not suppose authorship on its own. The physicians who participated in this study assisted in every health care area involved, including the Stroke Care Unit and the Neurology Department they belong to, thus contributing to generating data. Furthermore, every author participated in the creation, design, collection and interpretation of data, and in the writing or critical revision of the manuscript, in accordance with authorship criteria well defined by the International Committee of Medical Journal Editors (ICMJE).<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">4</span></a> We thank the significant number of health care professionals involved in the medical care received by these patients.</p></span>" "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Serrano Villar S, Porta-Etessam J. Respuesta. Med Clin (Barc). 2015;144:238.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:4 [ 0 => array:3 [ "identificador" => "bib0025" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Orden SAS/3470/2009, por la que se publican las directrices sobre estudios posautorización de tipo observacional para medicamentos de uso humano. Available from: <a href="http://www.aemps.gob.es/">www.aemps.gob.es</a> [accessed 25.04.14]." ] ] ] 1 => array:3 [ "identificador" => "bib0030" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Ley orgánica 15/1999, de 13 de diciembre, de protección de datos de carácter personal. Available from: <a href="http://www.boe.es/boe/dias/1999/12/14/pdfs/A43088-43099.pdf">http://www.boe.es/boe/dias/1999/12/14/pdfs/A43088-43099.pdf</a> [accessed 15.05.14]." ] ] ] 2 => array:3 [ "identificador" => "bib0035" "etiqueta" => "3" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "El ictus en pacientes muy ancianos: mitos y realidades" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "S. Serrano-Villar" 1 => "G. Fresco" 2 => "P. Ruiz-Artacho" 3 => "A. Bravo" 4 => "C. Valencia" 5 => "M. Fuentes-Ferrer" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:5 [ "tituloSerie" => "Med Clin (Barc)" "fecha" => "2013" "volumen" => "140" "paginaInicial" => "53" "paginaFinal" => "58" ] ] ] ] ] ] 3 => array:3 [ "identificador" => "bib0040" "etiqueta" => "4" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Uniform requirements for manuscripts submitted to biomedical journals. Available from: <a href="http://www.icmje.org/">www.icmje.org</a> [accessed 15.05.14]." ] ] ] ] ] ] ] ] "idiomaDefecto" => "en" "url" => "/23870206/0000014400000005/v1_201511080018/S238702061500087X/v1_201511080018/en/main.assets" "Apartado" => array:4 [ "identificador" => "43309" "tipo" => "SECCION" "en" => array:2 [ "titulo" => "Letters to the Editor" "idiomaDefecto" => true ] "idiomaDefecto" => "en" ] "PDF" => "https://static.elsevier.es/multimedia/23870206/0000014400000005/v1_201511080018/S238702061500087X/v1_201511080018/en/main.pdf?idApp=UINPBA00004N&text.app=https://www.elsevier.es/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S238702061500087X?idApp=UINPBA00004N" ]
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