Stroke in very old patients and ethics in clinical research

Egido, Jose A.; Garcia, Ana M.

doi:10.1016/j.medcle.2015.05.039

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Egido, Ana M. Garcia" "autores" => array:2 [ 0 => array:4 [ "nombre" => "Jose A." "apellidos" => "Egido" "email" => array:1 [ 0 => "jegidoh@yahoo.com" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "Ana M." "apellidos" => "Garcia" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "b" "identificador" => "aff0010" ] ] ] ] "afiliaciones" => array:2 [ 0 => array:3 [ "entidad" => "Unidad de Ictus, Hospital Clínico San Carlos, Madrid, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Acute Stroke Unit, Worcestershire Royal Hospital, Worcester, United Kingdom" "etiqueta" => "b" "identificador" => "aff0010" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "El ictus en pacientes muy ancianos y deontología en la investigación clínica" ] ] "textoCompleto" => "We have carefully and in amazement read the article published in your magazine, “Strokes in elderly patients: myth and reality” (“El ictus en pacientes muy ancianos: mitos y realidades”), signed by Serrano-Villar et al.<a class="elsevierStyleCrossRef" href="#bib0035">1</a>As members of the Stroke Unit at Hospital Clínico San Carlos during the period of the study, we would like to hereby state that this work has been carried out without the knowledge or participation of the members of the Stroke Unit mentioned in the study, which, according to the table included therein, accounts for 59% of the sample.Some aspects of what is mentioned in the work have raised deep concerns and are in detriment to the credibility of the study: the study includes 274 patients “from 2009 to 2010” admitted into the Stroke Unit, 22 of which were older than 85 years. This piece of information is, without a doubt, uncertain: in 2009 there were 567 admissions, and in 2010, there were 600, that is to say, a total of 1167 admissions, 1052 excluding TIA, a figure significantly higher to the abovementioned figure. These data are taken from the hospital's coding service, which is the same source cited by the authors.The authors do not specify if there were losses in the analysis or their causes. We were surprised to read that they state that no patient over 85 years old received intravenous thrombolysis, therefore omitting 15 patients within this age group who received fibrinolytic treatment during that period, data available in the European thrombolysis register (SITS),<a class="elsevierStyleCrossRef" href="#bib0040">2</a> which we use with the applicable informed consent and approval by the Research Ethics Committee, and as quoted by the authors of the work, enables us to participate in the international study of thrombolysis in elderly patients.<a class="elsevierStyleCrossRef" href="#bib0045">3</a>It is obvious that this modification of overall figures practically nullifies the rest of the analysis and provides a biased interpretation that we consider detrimental to our professional reputation. Our activity as a Stroke Unit is four times what is reflected in the article. In our Stroke Unit, the operation criteria are standardised regardless of age, which is not an exclusion criteria for admission. Further, we noticed that one can see absolute figures regarding the use of resources: it is easy to understand that some explorations in this group of patients are not stated in the actual clinical situation; for instance, extremely severe stroke, with a clear diagnosis of cardioembolism, do not require a carotid duplex, which does not change the therapeutic approach in very old patients.We understand that the signing authors are solely responsible of the veracity of the data because the magazine cannot do much to confirm such data, but we are forced to make a statement in the same publication where the study was released.Consequently, we can introduce ethical considerations regarding this study.Both the medical code of ethics<a class="elsevierStyleCrossRef" href="#bib0050">4</a> and the Data Protection Organic Act (Ley Orgánica de Protección de Datos)<a class="elsevierStyleCrossRef" href="#bib0055">5</a> specifically require the informed consent to include personal and health data in records. Being a physician does not grant the authority to know a patient's confidential information if there is no professional relationship with that patient. Access to patients’ health data by third parties not related to their health care for investigation purposes requires informed consent from the interested party and his or her physician.Said data belong to the patient, and this is established both under the law and medical ethics rules. The physician acts as a guarantor of those rights, which are assigned by the patient to the physician in charge for the exclusive purpose of the care provided.<a class="elsevierStyleCrossRef" href="#bib0060">6</a> In the section “Material and methods”, the authors fail to make any references to the informed consent.Lastly, international criteria of authorship identify the author as any person making a “relevant intellectual contribution” to the design of the study, the interpretation of data or the manuscript, stating clearly that merely introducing data is not ground for authorship. However, if the clinical work is the basis of a study, it is hard to accept that the authors had no role whatsoever in the gathering of data for the clinical history, or the intellectual construction of each diagnosis, or therapeutic decision-making. Nothing is further away from our intention than to claim recognition as authors of this work; our intention is to defend the importance of clinical work when it is the basis of scientific communication, careful use of data obtained retrospectively and respect for patients’ rights." "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "Please cite this article as: Egido JA, Garcia AM. El ictus en pacientes muy ancianos y deontología en la investigación clínica. Med Clin (Barc). 2015;144:237–238." ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:6 [ 0 => array:3 [ "identificador" => "bib0035" "etiqueta" => "1" "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" ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib0040" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "SITS: Safe Implementation of Treatments in Stroke. Available from: <a href="http://www.sitsinternational.org/">www.sitsinternational.org</a> [accessed 24.03.14]." ] ] ] 2 => array:3 [ "identificador" => "bib0045" "etiqueta" => "3" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Thrombolysis in very elderly people: controlled comparison of SITS International Stroke Thrombolysis Registry and Virtual International Stroke Trials Archive" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "N.K. Mishra" 1 => "N. Ahmed" 2 => "G. Andersen" 3 => "J.A. Egido" 4 => "P.J. Lindsberg" 5 => "P.A. Ringleb" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1136/bmj.c6046" "Revista" => array:4 [ "tituloSerie" => "Br Med J" "fecha" => "2010" "volumen" => "341" "paginaInicial" => "c6046" ] ] ] ] ] ] 3 => array:3 [ "identificador" => "bib0050" "etiqueta" => "4" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Consejo General de Colegios Oficiales de Médicos. Código de Deontología Médica: Guía de Ética Médica. Julio" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "Organización Médica Colegial de España" ] ] ] ] ] "host" => array:2 [ 0 => array:1 [ "Libro" => array:1 [ "fecha" => "2011" ] ] 1 => array:1 [ "WWW" => array:1 [ "link" => "www.cgcom.es" ] ] ] ] ] ] 4 => array:3 [ "identificador" => "bib0055" "etiqueta" => "5" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Ley Orgánica 15/1999, de 13 de diciembre, de Protección de Datos de Carácter Personal. BOE núm. 298, de 14 de diciembre de 1999. pp. 43088–99." ] ] ] 5 => array:3 [ "identificador" => "bib0060" "etiqueta" => "6" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Ley 41/2002, de 14 de noviembre, básica reguladora de la autonomía del paciente y de derechos y obligaciones en materia de información y documentación clínica. BOE núm. 274, de 15 de noviembre de 2002. pp. 40126–32." ] ] ] ] ] ] ] ] "idiomaDefecto" => "en" "url" => "/23870206/0000014400000005/v1_201511080018/S2387020615000868/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/S2387020615000868/v1_201511080018/en/main.pdf?idApp=UINPBA00004N&text.app=https://www.elsevier.es/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2387020615000868?idApp=UINPBA00004N"]

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Vol. 144. Issue 5.

Pages 237-238 (March 2015)

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