Editorial article
Publication in the Spanish Journal of Anesthesiology and Reanimation of study protocols
Publicación en la Revista Española de Anestesiología y Reanimación de protocolos de estudios
a Servicio de Anestesiología, Reanimación y Terapéutica del Dolor, Consorcio Hospital General Universitario de Valencia, Valencia, Spain
b Departmento de Anestesiología y Cuidados críticos, Institut d'Investigació Pi i Sunyer (IDIBAPS), Hospital Clínic i Provincial, Barcelona, Spain
c CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain
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Errando, C. Ferrando" "autores" => array:2 [ 0 => array:4 [ "nombre" => "C.L." "apellidos" => "Errando" "email" => array:1 [ 0 => "errando013@gmail.com" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "C." "apellidos" => "Ferrando" "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] ] ] "afiliaciones" => array:3 [ 0 => array:3 [ "entidad" => "Servicio de Anestesiología, Reanimación y Terapéutica del Dolor, Consorcio Hospital General Universitario de Valencia, Valencia, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Departmento de Anestesiología y Cuidados críticos, Institut d'Investigació Pi i Sunyer (IDIBAPS), Hospital Clínic i Provincial, Barcelona, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain" "etiqueta" => "c" "identificador" => "aff0015" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Publicación en la <span class="elsevierStyleItalic">Revista Espa</span><span class="elsevierStyleItalic">ñ</span><span class="elsevierStyleItalic">ola de Anestesiolog</span><span class="elsevierStyleItalic">í</span><span class="elsevierStyleItalic">a y Reanimaci</span><span class="elsevierStyleItalic">ó</span><span class="elsevierStyleItalic">n</span> de protocolos de estudios" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">In the March issue of the SPANISH JOURNAL OF ANAESTHESIOLOGY (REDAR), Abad-Motos et al.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> published an article describing and presenting to the scientific community a protocol for a study with unknown (unpublished) results. This, together with a similar article by Campos et al.,<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> are the first of its kind to appear in our journal.</p><p id="par0010" class="elsevierStylePara elsevierViewall">Why publish this type of article? Do readers need to know certain aspects of a study–specifically, the approach used, a detailed description of the background and the methods to be used, and the authors’ own critique of their methodology-before publication and even before the start of data collection? What is this “relatively new” fashion or trend?</p><p id="par0015" class="elsevierStylePara elsevierViewall">Scientific publications have grown exponentially, and continue to do so year after year. We will not go into all the reasons for this-suffice to say that the existence of large numbers of scientists working on many different aspects of science is not as positive as it would first appear. In the field of science, and therefore of medicine, evidence has shown that much of the scientific literature, perhaps even half, is untrue!<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a>. Richard Horton, one of the editors of <span class="elsevierStyleItalic">The Lancet</span>, gives several reasons for this, including but not limited to studies with small sample sizes, tiny effects - albeit with differences, invalid exploratory analyses, flagrant conflicts of interest, and an obsession for pursuing fashionable trends (intensive care and pain therapy appear frequently in the field of anaesthesiology), etc.<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">Seen from the authors’ perspective, this could be the main, but not the only, cause. We also have to consider the review that every article must undergo once the authors have submitted it to a journal or scientific channel for publication. This step that should, as it was originally conceived, border on excellence, has its own limitations. Whatever the method used (blind, single blind, open, etc.), peer review has its drawbacks and is resistant to study. Some have called it a secretive process in which reports only accessible to a chosen few are issued and then discussed and debated by the editors of the journal “behind closed doors” before taking the final decision to publish.<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">Returning the our first argument. The weaknesses of the studies published cause two major problems: incorrect results, as mentioned above, and a waste of resource.<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">5,6</span></a> Let us not forget that considerable resources from various sources have gone towards much of the research carried out worldwide.</p><p id="par0030" class="elsevierStylePara elsevierViewall">There are also other problems, such as assessing the replicability, reproducibility and the aforementioned "fragility" of the study results.<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">7,8</span></a> Not to mention the ever-present scourge of scientific fraud.<a class="elsevierStyleCrossRefs" href="#bib0045"><span class="elsevierStyleSup">9–11</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">How can these problems be resolved or avoided? Some experts have put forward a variety of solutions.<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> For example, performing systematic reviews using previously registered and published protocols for that describe the research schedule and allow third parties to identify discrepancies between the protocol and the final published study. This, in 2011, prompted the creation of PROSPERO, an international, open access, prospective register of systematic reviews. These open access registers will help prevent publication bias, unnecessary duplication, and will improve transparency. In fact, some public health institution, for example in the UK and Canada, demand protocol registry,<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> and some experts have drawn up guidelines on recommended (or required) statistical analysis plans for different types of data.<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">Such is the importance of this issue that for some years several indexed scientific medical journals, for example <span class="elsevierStyleItalic">Systematic Reviews</span>,<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a><span class="elsevierStyleItalic">Trials</span><a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a> or <span class="elsevierStyleItalic">British Medical Journal Open</span>,<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a> have accepted articles that describe research and work protocols. The aim is not only to make them publicly accessible, but also, in some cases, to improve the quality of clinical trials or accept innovative designs, and to facilitate discussion on the problems found in previous studies or in the research presented.<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a></p><p id="par0045" class="elsevierStylePara elsevierViewall">The recommendation to publish study protocols is now being extended to almost all types of scientific study: observational,<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a> randomized studies with data extracted from large databases ("big data" from electronic medical records or administrative databases),<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a> or pragmatic clinical trials.<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a></p><p id="par0050" class="elsevierStylePara elsevierViewall">One of the drawbacks of publishing study protocols is the absence of a formal structure. In their instructions to authors, specialised journals request that such manuscripts be submitted as if they were an original study (randomized, observational, etc.) but obviously without the "Results" section; introduction, material and methods (or methods, including statistics), discussion and bibliography (with or without tables or figures). New structured publication standards specific to this type of study are being developed. Some, for example, combine certain international recommendations (Standard Protocol Items: Recommendations for Interventional Trials [SPIRIT] plus the specific details of each protocol, or Preferred reporting items for systematic review and meta-analysis protocols [PRISMA-P]).<a class="elsevierStyleCrossRefs" href="#bib0080"><span class="elsevierStyleSup">16,17</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">In our specialty, (apart from general medical journals that publish studies in various specialties) one of the pioneers in this respect has been <span class="elsevierStyleItalic">Acta Anaesthesiologica Scandinavica</span>, which published 27 study protocols between January 2019 and March 2020.<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">18</span></a></p><p id="par0060" class="elsevierStylePara elsevierViewall">The publication of protocols for any type of scientific study has, like all innovations, its pros and cons.<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a> In addition, the systematic inclusion of these articles in specific publications or in a new section involves making changes, for example: should they be published <span class="elsevierStyleItalic">on-line</span> only or in print format? Do they require an electronic platform to speed up comments? What is the ideal exposure time? Should modified protocols be replaced and justified without removing the previous versions?<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a></p><p id="par0065" class="elsevierStylePara elsevierViewall">It must be emphasized that for study protocols to be valid, they must not only be detailed, correctly formatted, and published prior to the start of the field research (so that any changes suggested can be introduced), but also peer-reviewed, published before the start of recruitment (in prospective studies), before data collection (in retrospective studies), or before searching the literature (in systematic reviews).<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a> REDAR, like other leading journals, has started publishing articles on study protocols. We thank all authors who continue to entrust their manuscripts to REDAR and help improve both the journal and its circulation by submitting study protocols for publication.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Funding</span><p id="par0070" class="elsevierStylePara elsevierViewall">No funding.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Conflicts of interest</span><p id="par0075" class="elsevierStylePara elsevierViewall">CF is editor in chief of REDAR and CLE is associate editor of REDAR.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:3 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Funding" ] 1 => array:2 [ "identificador" => "sec0010" "titulo" => "Conflicts of interest" ] 2 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Errando CL, Ferrando C. Publicación en la <span class="elsevierStyleItalic">Revista Espa</span><span class="elsevierStyleItalic">ñ</span><span class="elsevierStyleItalic">ola de Anestesiolog</span><span class="elsevierStyleItalic">í</span><span class="elsevierStyleItalic">a y Reanimaci</span><span class="elsevierStyleItalic">ó</span><span class="elsevierStyleItalic">n</span> de protocolos de estudios. Rev Esp Anestesiol Reanim. 2020;67:361–363.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:18 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Auditoría nacional de complicaciones después de la cirugía gástrica por cáncer dentro o no de un protocolo de recuperación intensificada (POWER.4): protocolo de un estudio prospectivo, multicéntrico, observacional de cohortes" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "A. Abad-Motos" 1 => "J. Ripollés-Melchor" 2 => "M. Bruna-Esteban" 3 => "C. Ferrando-Ortolá" 4 => "G. Paseiro-Crespo" 5 => "A. 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