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"documento" => "article" "crossmark" => 1 "subdocumento" => "sco" "cita" => "Med Clin. 2016;146:273-7" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:2 [ "total" => 76 "formatos" => array:2 [ "HTML" => 43 "PDF" => 33 ] ] "es" => array:11 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Artículo especial</span>" "titulo" => "Lista de comprobación del proceso de elaboración de guías de práctica clínica" "tienePdf" => "es" "tieneTextoCompleto" => "es" "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "273" "paginaFinal" => "277" ] ] "titulosAlternativos" => array:1 [ "en" => array:1 [ "titulo" => "Guideline development process checklist" ] ] "contieneTextoCompleto" => array:1 [ "es" => true ] "contienePdf" => array:1 [ "es" => true ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figura 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 2030 "Ancho" => 3007 "Tamanyo" => 490274 ] ] "descripcion" => array:1 [ "es" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Esquema del proceso de desarrollo de guías de práctica clínica.Los diferentes pasos y la participación de los miembros del grupo elaborador de la guía (GEG) están interrelacionados y no son necesariamente secuenciales. El panel de la guía de práctica clínica (GPC) y los grupos de apoyo (como, por ejemplo, metodólogos, economistas de la salud, equipo de revisión sistemática y la secretaría de apoyo administrativo) trabajan en colaboración, informados por usuarios y grupos de interés, habitualmente supervisados por un comité de vigilancia. Por ejemplo, mientras se decide cómo incorporar tempranamente a los grupos de interés para el establecimiento de prioridades y selección de temas, el GEG debe también considerar que el desarrollo de relaciones formales con los grupos de interés permitirá una difusión e implementación efectiva y apoyo para la actualización de la GPC. Además, las consideraciones de organización, planificación y capacitación abarcan la totalidad del proyecto de elaboración de una GPC, y medidas tales como la documentación de la metodología utilizada y las decisiones adoptadas, así como la consideración del conflicto de intereses, se deben considerar a lo largo de todo el proceso. (Traducido con permiso de Schünemann et al.<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">1</span></a>).</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Itziar Etxeandia-Ikobaltzeta, Romina Brignardello-Petersen, Alonso Carrasco-Labra, Pablo Alonso-Coello" "autores" => array:4 [ 0 => array:2 [ "nombre" => "Itziar" "apellidos" => "Etxeandia-Ikobaltzeta" ] 1 => array:2 [ "nombre" => "Romina" "apellidos" => "Brignardello-Petersen" ] 2 => array:2 [ "nombre" => "Alonso" "apellidos" => "Carrasco-Labra" ] 3 => array:2 [ "nombre" => "Pablo" "apellidos" => "Alonso-Coello" ] ] ] ] ] "idiomaDefecto" => "es" "Traduccion" => array:1 [ "en" => array:9 [ "pii" => "S2387020616301930" "doi" => "10.1016/j.medcle.2016.05.007" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2387020616301930?idApp=UINPBA00004N" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S002577531500593X?idApp=UINPBA00004N" "url" => "/00257753/0000014600000006/v2_201606250036/S002577531500593X/v2_201606250036/es/main.assets" ] ] "itemSiguiente" => array:19 [ "pii" => "S2387020616301942" "issn" => "23870206" "doi" => "10.1016/j.medcle.2016.05.008" "estado" => "S300" "fechaPublicacion" => "2016-03-18" "aid" => "3498" "copyright" => "Elsevier España, S.L.U." "documento" => "article" "crossmark" => 1 "subdocumento" => "pgl" "cita" => "Med Clin. 2016;146:278.e1-7" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:1 [ "total" => 0 ] "en" => array:13 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Consensus statement</span>" "titulo" => "Spanish consensus statement for diagnosis and treatment of paroxysmal nocturnal haemoglobinuria" "tienePdf" => "en" "tieneTextoCompleto" => "en" "tieneResumen" => array:2 [ 0 => "en" 1 => "es" ] "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "278.e1" "paginaFinal" => "278.e7" ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Consenso español para el diagnóstico y tratamiento de la hemoglobinuria paroxística nocturna" ] ] "contieneResumen" => array:2 [ "en" => true "es" => true ] "contieneTextoCompleto" => array:1 [ "en" => true ] "contienePdf" => array:1 [ "en" => true ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 3596 "Ancho" => 2500 "Tamanyo" => 675375 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Algorithm diagnosis, monitoring and treatment of PNH. <span class="elsevierStyleSup">a</span>Full, reticulocyte blood count, <span class="elsevierStyleItalic">lactate dehydrogenase</span> (LDH), indirect bilirubin, haptoglobin, plasma haemoglobin, haemoglobinuria, haemosidenuria, vitamin B12, serum erythropoietin, iron, folic acid, direct Coombs, creatinine, estimated glomerular filtration rate (eGFR), proteinuria. <span class="elsevierStyleSup">b</span>Abdominal and cardiac ecodoppler, cranial MRI or angiography through helical computed tomography (annual or clinical changes). <span class="elsevierStyleSup">c</span>Assess each case individually. BNP: B-type natriuretic peptide; Hb: haemoglobin; HLA: <span class="elsevierStyleItalic">Human Leucocyte Antigen</span>; PNH: paroxysmal nocturnal haemoglobinuria; PH: pulmonary hypertension; PI: pulmonary insufficiency; RF: renal failure; CRF: chronic renal failure; NYHA: New York Heart Association; NMR: nuclear magnetic resonance; MDS: myelodysplastic syndrome.</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Ana Villegas, Beatriz Arrizabalaga, Santiago Bonanad, Enrique Colado, Anna Gaya, Ataúlfo González, Isidro Jarque, Ramiro Núñez, Emilio Ojeda, Alberto Orfao, José-María Ribera, Vicente Vicente, Álvaro Urbano-Ispizua" "autores" => array:14 [ 0 => array:2 [ "nombre" => "Ana" "apellidos" => "Villegas" ] 1 => array:2 [ "nombre" => "Beatriz" "apellidos" => "Arrizabalaga" ] 2 => array:2 [ "nombre" => "Santiago" "apellidos" => "Bonanad" ] 3 => array:2 [ "nombre" => "Enrique" "apellidos" => "Colado" ] 4 => array:2 [ "nombre" => "Anna" "apellidos" => "Gaya" ] 5 => array:2 [ "nombre" => "Ataúlfo" "apellidos" => "González" ] 6 => array:2 [ "nombre" => "Isidro" "apellidos" => "Jarque" ] 7 => array:2 [ "nombre" => "Ramiro" "apellidos" => "Núñez" ] 8 => array:2 [ "nombre" => "Emilio" "apellidos" => "Ojeda" ] 9 => array:2 [ "nombre" => "Alberto" "apellidos" => "Orfao" ] 10 => array:2 [ "nombre" => "José-María" "apellidos" => "Ribera" ] 11 => array:2 [ "nombre" => "Vicente" "apellidos" => "Vicente" ] 12 => array:2 [ "nombre" => "Álvaro" "apellidos" => "Urbano-Ispizua" ] 13 => array:1 [ "colaborador" => "Grupo de Trabajo de HPN de la Sociedad Española de Hematología y Hemoterapia" ] ] ] ] ] "idiomaDefecto" => "en" "Traduccion" => array:1 [ "es" => array:9 [ "pii" => "S0025775316000099" "doi" => "10.1016/j.medcli.2015.12.012" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0025775316000099?idApp=UINPBA00004N" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2387020616301942?idApp=UINPBA00004N" "url" => "/23870206/0000014600000006/v3_201704140441/S2387020616301942/v3_201704140441/en/main.assets" ] "itemAnterior" => array:19 [ "pii" => "S2387020616301929" "issn" => "23870206" "doi" => "10.1016/j.medcle.2016.05.006" "estado" => "S300" "fechaPublicacion" => "2016-03-18" "aid" => "3427" "copyright" => "Elsevier España, S.L.U." "documento" => "article" "crossmark" => 1 "subdocumento" => "rev" "cita" => "Med Clin. 2016;146:267-72" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:2 [ "total" => 1 "HTML" => 1 ] "en" => array:13 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Review</span>" "titulo" => "Appropriate prescription, adherence and safety of non-steroidal anti-inflammatory drugs" "tienePdf" => "en" "tieneTextoCompleto" => "en" "tieneResumen" => array:2 [ 0 => "en" 1 => "es" ] "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "267" "paginaFinal" => "272" ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Prescripción apropiada, adherencia y seguridad de los antiinflamatorios no esteroideos" ] ] "contieneResumen" => array:2 [ "en" => true "es" => true ] "contieneTextoCompleto" => array:1 [ "en" => true ] "contienePdf" => array:1 [ "en" => true ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0010" "etiqueta" => "Fig. 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 1530 "Ancho" => 2951 "Tamanyo" => 185938 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Summary of the most important secondary effects of the nonsteroidal anti-inflammatory drugs that are most commonly used in clinical practice. ASA: acetylsalicylic acid; OAC: oral anticoagulants. <span class="elsevierStyleItalic">Source</span>: Modified from Lanas et al.<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">4</span></a></p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Carlos Sostres, Ángel Lanas" "autores" => array:2 [ 0 => array:2 [ "nombre" => "Carlos" "apellidos" => "Sostres" ] 1 => array:2 [ "nombre" => "Ángel" "apellidos" => "Lanas" ] ] ] ] ] "idiomaDefecto" => "en" "Traduccion" => array:1 [ "es" => array:9 [ "pii" => "S0025775315005928" "doi" => "10.1016/j.medcli.2015.09.022" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0025775315005928?idApp=UINPBA00004N" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2387020616301929?idApp=UINPBA00004N" "url" => "/23870206/0000014600000006/v3_201704140441/S2387020616301929/v3_201704140441/en/main.assets" ] "en" => array:19 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Special article</span>" "titulo" => "Guideline development process checklist" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "273" "paginaFinal" => "277" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "Itziar Etxeandia-Ikobaltzeta, Romina Brignardello-Petersen, Alonso Carrasco-Labra, Pablo Alonso-Coello" "autores" => array:4 [ 0 => array:4 [ "nombre" => "Itziar" "apellidos" => "Etxeandia-Ikobaltzeta" "email" => array:1 [ 0 => "itzi.etxe@gmail.com" ] "referencia" => array:3 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span 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"etiqueta" => "<span class="elsevierStyleSup">e</span>" "identificador" => "aff0025" ] ] ] ] "afiliaciones" => array:5 [ 0 => array:3 [ "entidad" => "Servicio de Evaluación de Tecnologías Sanitarias del País Vasco (Osteba), Dirección de Investigación e Innovación Sanitaria, Departamento de Salud, Gobierno Vasco-Eusko Jaurlaritza, Vitoria-Gasteiz, ÿlava-Araba, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Unidad de Odontología Basada en Evidencia, Facultad de Odontología, Universidad de Chile, Santiago, Chile" "etiqueta" => "c" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada" "etiqueta" => "d" "identificador" => "aff0020" ] 4 => array:3 [ "entidad" => "Centro Cochrane Iberoamericano, Instituto de Investigación Biomédica Sant Pau (IIB Sant Pau)-Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain" "etiqueta" => "e" "identificador" => "aff0025" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⿿" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Lista de comprobación del proceso de elaboracio¿n de guías de práctica clínica" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 2030 "Ancho" => 3007 "Tamanyo" => 462403 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Outline of the clinical practice guidelines development process.The different steps and the participation of the guideline development group members (GDG) are interrelated and are not necessarily sequential. The clinical practice guideline (CPG) panel and support groups (such as, for example, methodologists, health economists, the systematic review team and the administrative support secretariat) work collaboratively and are informed by users and interest groups, usually supervised by a monitoring committee. For example, while deciding how to incorporate interest groups early during the process to select and prioritise the subjects, the GDG also needed to consider that the development of formal relations with interest groups will facilitate effective dissemination and implementation and provide support for updating the CPG. In addition, considerations for the organisation, planning and training cover the entire CPG development project, and measures such as documentation of the methodology used and the decisions taken as well as the consideration of conflicts of interest, need to be present throughout the process. (Translated with permission from Schünemann et al.<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">1</span></a>).</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">The clinical practice guideline (CPG) development process checklist has been translated with permission. The Canadian Medical Association owns the rights to this article, Guidelines 2.0: Systematic development of a comprehensive checklist for a successful guideline enterprise,<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">1</span></a> originally published in CMAJ. The limited authorisation to translate the checklist into Spanish does not extend to any other organisation or person. The Canadian Medical Association and the authors of the original publication are not responsible for the translation and do not necessarily endorse the accuracy or quality of the translation.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Clinical practice guideline development process checklist</span><p id="par0010" class="elsevierStylePara elsevierViewall">The CPG is defined as a set of recommendations based on a systematic review of the evidence and an assessment of the risks and benefits of different alternatives, whose purpose is to optimise health care for patients.<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">2</span></a> The implementation of a CPG aims to reduce the variability of clinical practice, improve quality and safety and offer patients the best possible care. However, its success depends, among other factors, on the rigour of its development and the strategies defined for its dissemination, implementation and continuous updating. Aware of this, since the early nineties programmes for the development and implementation of CPG began to be established internationally, and many actors have become increasingly interested in CPG, including national organisations, scientific and professional societies, health care services, policy makers, patients and caregivers. During this time numerous methodological manuals on CPG development, implementation and evaluation processes have been published as well as tools to assess the credibility of the CPG.<a class="elsevierStyleCrossRefs" href="#bib0160"><span class="elsevierStyleSup">3,5</span></a> However, there is still a current need for practical guidelines to facilitate CPG development and implementation.</p><p id="par0015" class="elsevierStylePara elsevierViewall">In order to respond to this need, an international group of researchers led by academics at McMaster University and in partnership with the Guidelines International Network have developed a comprehensive guideline development checklist, using a systematic methodology.<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">1</span></a> Likewise, they have also created a website with resources<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">6</span></a> which includes, in addition to this checklist, links to tools and relevant support resources that facilitate the implementation of the different stages of a CPG development, from planning and formulation of recommendations to its implementation, evaluation and continuous updating.</p><p id="par0020" class="elsevierStylePara elsevierViewall">This checklist was carried out systematically from a thorough review of relevant sources on the subject, with the following inclusion criteria, and with no restrictions on the publication date: documents described as ⿿guides for guidelines⿿, methodological reports or manuals available from organisations that produce guidelines such as professional and international agencies and associations, as well as documents that describe the process of developing guidelines for clinical care, public health and health systems worldwide with a geographical perspective. Sources<a class="elsevierStyleCrossRefs" href="#bib0160"><span class="elsevierStyleSup">3⿿5,7⿿29</span></a> were reviewed in duplicate, items for the checklist were extracted and classified into subjects (<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>). Through an iterative process the duplication and omission of the items was analysed, and finally, for the final review, experts in methodology related to the field of CPG were engaged. These professionals are experts for different stages of CPG development, for example, the selection, quality assessment or synthesis of evidence stages.</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0025" class="elsevierStylePara elsevierViewall">The objective was to establish this checklist as a resource available to the public, offering learning tools and training materials for individuals and organisations interested in starting, improving or assessing their CPG development process.</p><p id="par0030" class="elsevierStylePara elsevierViewall">The final checklist consists of 18 subjects and 146 items, which include links to training materials and other support resources for the implementation of the various CPG development process tasks, represented in these items. The list, along with the accompanying glossary is presented on a resource website on the Internet created to facilitate its use to groups who want to develop CPG (<a href="http://cebgrade.mcmaster.ca/guidecheck.html">http://cebgrade.mcmaster.ca/guidecheck.html</a>). The subjects and items that are included cover the stages of each activity related to the guidelines, from the planning and formulation of recommendations to their implementation, evaluation and continuous updating (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>). Given the growing interest in the development and implementation of CPG and the many Spanish-speaking countries with national CPG programmes, we believe that the availability of this tool in Spanish can be especially relevant and useful in our environment. Therefore, with this publication we aim to disseminate the Spanish version of this checklist.<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">1</span></a></p><elsevierMultimedia ident="fig0005"></elsevierMultimedia></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Translation process</span><p id="par0035" class="elsevierStylePara elsevierViewall">The people from the translation group (IEI, RBP, ACL, PAC) ⿿ two from Chile (RBP, ACL) and two from Spain (IEI, PAC) ⿿ belong to the group of authors who created the list in English, they are Spanish speakers who speak English. First, one of these people (IEI) translated the complete checklist, it was then later reviewed by the others (RBP, ACL, PAC) with the assistance of a translator (ACA). The glossary was translated by three people (RBP, ACL, PAC), and reviewed and standardised by the other (IEI). Following that processes, the list was reviewed by four Spanish-speaking, bilingual CPG experts, two persons who work in Argentina and Chile (MEE, GR) and two who work in Spain (NIR, FS). The translation group resolved disagreements by consensus. The inclusion of both Latin America and Spanish authors and reviewers aimed to promote the use of a Spanish that was as neutral and understandable as possible for Spanish speaking countries.</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">The checklist in Spanish</span><p id="par0040" class="elsevierStylePara elsevierViewall"><a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a> shows the description of the 18 subjects that make up the checklist. The complete list, with its 146 items covering the different stages of the CPG development (planning, formulation of recommendations, dissemination, implementation, evaluation and updates), is available as supplementary material in <a class="elsevierStyleCrossRef" href="#sec0025">Annex 1</a>. The checklist will also be available on the website<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">6</span></a> and will include links to training materials (for example, tutorials, readings and recommended references) as well as related resources (for example, a conflict of interest declaration form, links to tools for rating the strength of recommendations, adaptation of guidelines and resources available for the dissemination of CPG). In supplementary material, <a class="elsevierStyleCrossRef" href="#sec0025">Annex 2</a> contains the glossary accompanying the checklist.</p><p id="par0045" class="elsevierStylePara elsevierViewall">The CPG development process checklist in Spanish is aimed at Spanish-speaking CPG developers, its purpose is to ensure that key steps in the planning and implementation of their CPGs are not omitted. Its greatest strength is its systematic development that stems from a thorough review of relevant sources on the subject, and perhaps its biggest limitation is its extension. However, it is not intended that all CPGs address each of the sections or items described in the checklist. Professionals who produce their own guidelines can omit items that are not applicable to their CPG or specific organisation. However, it is important to note that following the steps outlined in the list will ensure that the key elements for the proper development of a CPG are taken into account. Moreover, we should also mention that the different items are often interrelated and are not necessarily sequential. It is therefore important that the checklist user groups become familiar with the subjects and items included before applying them (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>).</p><p id="par0050" class="elsevierStylePara elsevierViewall">This list is more generic, it very broadly covers the subjects and elements that must be considered in the development of guidelines, and for this reason it has the advantage of being usable and applicable to a variety of users and guidelines, for clinical practice and public and private health systems.</p><p id="par0055" class="elsevierStylePara elsevierViewall">Making the checklist available on the aforementioned interactive web platform, ensures that feedback from the community of developers and users is provided to users through crowdsourcing and the open collaboration processes which will facilitate the continuous updating of the list. It also has the advantage of serving as an updated archive and single entry point to offer easy and integrated access to a number of practical resources for professionals involved in implementation and assessment of CPGs.</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Conflict of interest</span><p id="par0060" class="elsevierStylePara elsevierViewall">The authors declare no conflict of interest.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:6 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Clinical practice guideline development process checklist" ] 1 => array:2 [ "identificador" => "sec0010" "titulo" => "Translation process" ] 2 => array:2 [ "identificador" => "sec0015" "titulo" => "The checklist in Spanish" ] 3 => array:2 [ "identificador" => "sec0020" "titulo" => "Conflict of interest" ] 4 => array:2 [ "identificador" => "xack278017" "titulo" => "Acknowledgements" ] 5 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2015-04-22" "fechaAceptado" => "2015-09-03" "NotaPie" => array:2 [ 0 => array:2 [ "etiqueta" => "⿿" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Etxeandia-Ikobaltzeta I, Brignardello-Petersen R, Carrasco-Labra A, Alonso-Coello P. Lista de comprobación del proceso de elaboracio¿n de guías de práctica clínica. Med Clin (Barc). 2016;146:273⿿277.</p>" ] 1 => array:2 [ "etiqueta" => "⿿⿿" "nota" => "<p class="elsevierStyleNotepara" id="npar0010">Adapted and translated from Schünemann HJ, Wiercioch W, Etxeandia I, Falavigna M, Santesso N, Mustafa R, et al. Guidelines 2.0: Systematic development of a comprehensive checklist for a successful guideline enterprise. CMAJ. 2014;186:E123-42.</p>" ] ] "apendice" => array:1 [ 0 => array:1 [ "seccion" => array:1 [ 0 => array:4 [ "apendice" => "<p id="par0075" class="elsevierStylePara elsevierViewall"><elsevierMultimedia ident="upi0005"></elsevierMultimedia></p>" "etiqueta" => "Appendix A" "titulo" => "Supplementary data" "identificador" => "sec0030" ] ] ] ] "multimedia" => array:3 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 2030 "Ancho" => 3007 "Tamanyo" => 462403 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Outline of the clinical practice guidelines development process.The different steps and the participation of the guideline development group members (GDG) are interrelated and are not necessarily sequential. The clinical practice guideline (CPG) panel and support groups (such as, for example, methodologists, health economists, the systematic review team and the administrative support secretariat) work collaboratively and are informed by users and interest groups, usually supervised by a monitoring committee. For example, while deciding how to incorporate interest groups early during the process to select and prioritise the subjects, the GDG also needed to consider that the development of formal relations with interest groups will facilitate effective dissemination and implementation and provide support for updating the CPG. In addition, considerations for the organisation, planning and training cover the entire CPG development project, and measures such as documentation of the methodology used and the decisions taken as well as the consideration of conflicts of interest, need to be present throughout the process. (Translated with permission from Schünemann et al.<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">1</span></a>).</p>" ] ] 1 => 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" => "<p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">GDG: guide development group.</p><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">We recommend reading the entire checklist, available as <a class="elsevierStyleCrossRef" href="#sec0025">Annex 1</a> in the online supplementary materials, along with the glossary available as <a class="elsevierStyleCrossRef" href="#sec0025">Annex 2</a>, to clarify important questions about all the items.</p>" "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">Subjects \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">Description \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">1. Organisation, budget, planning and training \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Involves drawing a general, but detailed, plan including a description of what is feasible, how it will be achieved and what resources are needed to produce and use the guidelines. The plan must refer to a specific period which should be expressed in formal units of measurement \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">2. Priority setting \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Refers to interest groups⿿ identification, balance and classification of priorities. Priority setting ensures that resources and attention are focused on general areas (for example, chronic obstructive pulmonary disease, diabetes, cardiovascular disease, cancer, prevention), where health care recommendations can provide the greatest benefit to the population, a jurisdiction or country. A focus on priority setting should contribute to future plans while responding to existing potentially difficult circumstances \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">3. Guideline group membership \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Defines who is involved, in what capacity and how members of the guideline development group are chosen as well as other stages of the guideline development work \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">4. Establishing guideline group processes \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Defines the steps to follow, how those people involved will interact and how decisions will be made \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">5. Identifying target audience and topic selection \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Includes the description of possible guideline recipients or users and definitions of the subjects to be discussed therein (for example, diagnosis of chronic obstructive pulmonary disease) \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">6. Consumer and interest group involvement \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Describes how those people or groups who are not necessarily members of the GDG, but are affected by the guidelines (for example target audience or recipients) will participate \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">7. Conflict of interest considerations \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Focuses on the definition and management of any divergence between the interests of the individual and their professional obligations, which may lead to questioning whether actions or decisions are motivated by any other benefit, such as financial, academic, income for their clinic or position in the community. This includes, in turn, financial, intellectual or other relations that might affect the ability of an individual or organisation to address a scientific issue with an open mind \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">8. Question generation (PICO format) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Focuses on defining the key issues to be submitted using the PICO format - patient/problem, intervention, comparison, result/<span class="elsevierStyleItalic">outcome</span> - including a detailed population, intervention (including tests and diagnostic strategies) and outcomes that will be relevant to decision-making (for example, should test A be used, or should treatments B, C, D or E be used in chronic obstructive pulmonary disease?) \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">9. Considering values and preferences \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Includes incorporating, into the developing recommendations process, how those people who are affected by this process evaluate the possible consequences. This includes the patients, caregivers and doctors⿿ knowledge, attitudes, expectations, moral and ethical values and beliefs; the patient's goals for life and health; previous experience with intervention and the condition; experience with symptoms (such as difficulty breathing, pain, dyspnoea, weight loss); preferences and importance of desired and undesired outcomes; perceived impact of the condition or interventions in their quality of life, well-being or satisfaction, and interactions between the burden of carrying out the intervention, the intervention itself, and other contexts that the patient may experience; preferences for alternative courses of action; and preferences for content and communication styles, information and participation in decision-making and care-giving. This may be related to what in economic literature is considered <span class="elsevierStyleItalic">utilities</span>. An intervention itself may be considered as a result of a recommendation (for example, the burden of taking medication or undergoing surgery) and the level of importance or value associated with it \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">10. Deciding what evidence to include and searching for evidence \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Focuses on determining the criteria for inclusion and exclusion based on the type of evidence (for example, rigorous research, collecting research informally), the study design, characteristics of the population, interventions and comparators, and decide how evidence will be identified and obtained. Also includes, but is not limited to, evidence on the values and preferences, data and local resources \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">11. Summarising evidence and considering additional information \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Focuses on the presentation of evidence in a synthetic format (for example, tables or short stories) to facilitate the development and comprehension of recommendations. Also involves identifying and considering additional relevant information to the matter under consideration \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">12. Judgement of the quality, strength or completeness of all the evidence \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Includes assessing the confidence levels that someone may have for the obtained evidence, through transparent assessment of the research processes (individual studies and of all the studies) and other evidence using structured approaches. This may include, but is not limited to, evidence on the baseline risk or burden of disease, the importance of the results and interventions, values, preferences and utilities, use of resource (costs), estimates of effects and the accuracy of 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">13. Developing recommendations and determining their strength \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Developing recommendations implies the use of a structured analytical strategy and a transparent process and systematic approach to integrating factors that influence a recommendation. Determining the strength of recommendations refers to making judgements about the degree of confidence the GDG has that the implementation of a recommendation will have more desirable than undesirable consequences \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">14. Wording of recommendations and of considerations of implementation, feasibility and equity \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Refers to the choice of syntax and formulations that facilitate the understanding and implementation of recommendations. Such wording is connected to considerations of the implementation, feasibility and equity, that refer to GDG considerations about how the recommendation will be used and the impact it may have on the described factors \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">15. Reporting and peer review \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Reporting refers to how to publish guidelines (for example, print, online). Peer review refers to how the guideline document should be reviewed before publication and how it can be assessed (for example, for errors), both internally and externally, by interest groups who were not guideline development group members \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">16. Dissemination and implementation \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Focuses on strategies to raise awareness of the guidelines for the relevant groups and improve its acceptance (for example, publications and tools such as mobile applications) \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">17. Evaluation and use \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Refers to formal and informal strategies that facilitate making judgements about: assessment of the guidelines as a process and a product; evaluation of its use or updating, or both; its impact assessment and whether the guidelines lead to an improvement in the health of patients or population, or other consequences \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">18. Updating \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Refers to how and when the guidelines should be revised because there have been changes in the evidence or other factors that influence the recommendations \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab1393883.png" ] ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Subjects included in the Clinical Practice Guideline development process checklist.</p>" ] ] 2 => array:5 [ "identificador" => "upi0005" "tipo" => "MULTIMEDIAECOMPONENTE" "mostrarFloat" => false "mostrarDisplay" => true "Ecomponente" => array:2 [ "fichero" => "mmc1.pdf" "ficheroTamanyo" => 749478 ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:29 [ 0 => array:3 [ "identificador" => "bib0150" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "H.J. 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Guideline development process checklist
Lista de comprobación del proceso de elaboracio¿n de guías de práctica clínica
Itziar Etxeandia-Ikobaltzetaa,b,
, Romina Brignardello-Petersenc,d, Alonso Carrasco-Labrab,c, Pablo Alonso-Coellob,e
Corresponding author
a Servicio de Evaluación de Tecnologías Sanitarias del País Vasco (Osteba), Dirección de Investigación e Innovación Sanitaria, Departamento de Salud, Gobierno Vasco-Eusko Jaurlaritza, Vitoria-Gasteiz, ÿlava-Araba, Spain
b Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
c Unidad de Odontología Basada en Evidencia, Facultad de Odontología, Universidad de Chile, Santiago, Chile
d Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
e Centro Cochrane Iberoamericano, Instituto de Investigación Biomédica Sant Pau (IIB Sant Pau)-Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain