Recommended article of the month
Comment on “Expanding Disease Definitions in Guidelines and Expert Panel Ties to Industry: A Cross-sectional Study of Common Conditions in the United States”
Luís M. Moura
Membro do Corpo Redatorial da Revista Portuguesa de Cardiologia
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Moura" "autores" => array:1 [ 0 => array:2 [ "nombre" => "Luís M." "apellidos" => "Moura" ] ] ] ] ] "idiomaDefecto" => "pt" "Traduccion" => array:1 [ "en" => array:9 [ "pii" => "S2174204914000051" "doi" => "10.1016/j.repce.2013.09.007" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => true "ES2" => true "LATM" => true ] "gratuito" => true "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2174204914000051?idApp=UINPBA00004E" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0870255113002515?idApp=UINPBA00004E" "url" => "/08702551/0000003200000012/v1_201312121234/S0870255113002515/v1_201312121234/pt/main.assets" ] ] "itemAnterior" => array:20 [ "pii" => "S2174204914000087" "issn" => "21742049" "doi" => "10.1016/j.repce.2013.06.028" "estado" => "S300" "fechaPublicacion" => "2013-12-01" "aid" => "375" "copyright" => "Sociedade Portuguesa de Cardiologia" "documento" => "article" "crossmark" => 0 "licencia" => "http://creativecommons.org/licenses/by-nc-nd/4.0/" "subdocumento" => "sco" "cita" => "Rev Port Cardiol. 2013;32:1051-2" "abierto" => array:3 [ "ES" => true "ES2" => true "LATM" => true ] "gratuito" => true "lecturas" => array:2 [ "total" => 2371 "formatos" => array:3 [ "EPUB" => 163 "HTML" => 1721 "PDF" => 487 ] ] "en" => array:11 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Image in Cardiology</span>" "titulo" => "Cardiac magnetic resonance imaging: A non-invasive tool for the diagnosis of eosinophilic myocarditis" "tienePdf" => "en" "tieneTextoCompleto" => "en" "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "1051" "paginaFinal" => "1052" ] ] "titulosAlternativos" => array:1 [ "pt" => array:1 [ "titulo" => "Ressonância magnética cardíaca: a ferramenta não invasiva, para o diagnóstico de miocardite eosinofílica" ] ] "contieneTextoCompleto" => array:1 [ "en" => true ] "contienePdf" => array:1 [ "en" => true ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1671 "Ancho" => 1669 "Tamanyo" => 280173 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">A) 2D echocardiogram showing slight increased of the apical wall thickness (arrow). B) 2D echocardiogram after treatment showing a decreased in the apical wall thickness (arrow). Cardiac MRI showing an elevated T2 signal intensity in the septo apical and apical segments corresponding to tissue edema (C) with delayed subendocardial enhancement in the same segments (D).</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "María Martín, Ana García-Campos, Cecilia Corros, José Rozado, Santiago Colunga, María Luisa Rodríguez, Jesús de la Hera, José Sergio Hevia, Elena Santamarta" "autores" => array:9 [ 0 => array:2 [ "nombre" => "María" "apellidos" => "Martín" ] 1 => array:2 [ "nombre" => "Ana" "apellidos" => "García-Campos" ] 2 => array:2 [ "nombre" => "Cecilia" "apellidos" => "Corros" ] 3 => array:2 [ "nombre" => "José" "apellidos" => "Rozado" ] 4 => array:2 [ "nombre" => "Santiago" "apellidos" => "Colunga" ] 5 => array:2 [ "nombre" => "María Luisa" "apellidos" => "Rodríguez" ] 6 => array:2 [ "nombre" => "Jesús" "apellidos" => "de la Hera" ] 7 => array:2 [ "nombre" => "José" "apellidos" => "Sergio Hevia" ] 8 => array:2 [ "nombre" => "Elena" "apellidos" => "Santamarta" ] ] ] ] ] "idiomaDefecto" => "en" "Traduccion" => array:1 [ "en" => array:9 [ "pii" => "S0870255113002540" "doi" => "10.1016/j.repc.2013.06.012" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => true "ES2" => true "LATM" => true ] "gratuito" => true "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0870255113002540?idApp=UINPBA00004E" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2174204914000087?idApp=UINPBA00004E" "url" => "/21742049/0000003200000012/v1_201401310146/S2174204914000087/v1_201401310146/en/main.assets" ] "en" => array:14 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Recommended article of the month</span>" "titulo" => "Comment on “Expanding Disease Definitions in Guidelines and Expert Panel Ties to Industry: A Cross-sectional Study of Common Conditions in the United States”" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "1053" "paginaFinal" => "1054" ] ] "autores" => array:1 [ 0 => array:3 [ "autoresLista" => "Luís M. Moura" "autores" => array:1 [ 0 => array:3 [ "nombre" => "Luís M." "apellidos" => "Moura" "email" => array:1 [ 0 => "luismoura@med.up.pt" ] ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Membro do Corpo Redatorial da Revista Portuguesa de Cardiologia" "identificador" => "aff0005" ] ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall"><elsevierMultimedia ident="tb0005"></elsevierMultimedia></p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Abstract</span><p id="par0020" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Background:</span> Financial ties between health professionals and industry may unduly influence professional judgments and some researchers have suggested that widening disease definitions may be one driver of over-diagnosis, bringing potentially unnecessary labeling and harm. We aimed to identify guidelines in which disease definitions were changed, to assess whether any proposed changes would increase the numbers of individuals considered to have the disease, whether potential harms of expanding disease definitions were investigated, and the extent of members’ industry ties<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a>.</p><p id="par0025" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Methods and Findings:</span> We undertook a cross-sectional study of the most recent publication between 2000 and 2013 from national and international guideline panels making decisions about definitions or diagnostic criteria for common conditions in the United States. We assessed whether proposed changes widened or narrowed disease definitions, rationales offered, mention of potential harms of those changes, and the nature and extent of disclosed ties between members and pharmaceutical or device companies. Of 16 publications on 14 common conditions, ten proposed changes widening and one narrowing definitions. For five, impact was unclear. Widening fell into three categories: creating “pre-disease”; lowering diagnostic thresholds; and proposing earlier or different diagnostic methods. Rationales included standardizing diagnostic criteria and new evidence about risks for people previously considered to not have the disease. No publication included rigorous assessment of potential harms of proposed changes. Among 14 panels with disclosures, the average proportion of members with industry ties was 75%. Twelve were chaired by people with ties. For members with ties, the median number of companies to which they had ties was seven. Companies with ties to the highest proportions of members were active in the relevant therapeutic area. Limitations arise from reliance on only disclosed ties, and exclusion of conditions too broad to enable analysis of single panel publications.</p><p id="par0030" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Conclusions:</span> For the common conditions studied, a majority of panels proposed changes to disease definitions that increased the number of individuals considered to have the disease, none reported rigorous assessment of potential harms of that widening, and most had a majority of members disclosing financial ties to pharmaceutical companies.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Comentário</span><p id="par0035" class="elsevierStylePara elsevierViewall">A maioria dos médicos nos Estados Unidos que participam nos comités das <span class="elsevierStyleItalic">guidelines</span> e que contribuem para as decisões acerca de definições ou critérios diagnósticos de patologias comuns têm ligações à indústria farmacêutica e às companhias de dispositivos médicos, de acordo com este estudo recentemente publicado.</p><p id="par0040" class="elsevierStylePara elsevierViewall">Os investigadores utilizaram para a realização do estudo 16 publicações de comités de <span class="elsevierStyleItalic">guidelines</span> nacionais e internacionais, publicadas entre 2000-2013, sobre o diagnóstico de 14 patologias frequentes. Destas, dez propuseram o alargamento de algumas definições diagnósticas, uma delas o estreitamento das definições e o impacto das restantes não era claro<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a>.</p><p id="par0045" class="elsevierStylePara elsevierViewall">As patologias cujas definições foram alteradas incluíram a hipertensão arterial, doença de Alzheimer e a artrite reumatoide. Os comités dessas recomendações alargaram alguns conceitos através da criação das chamadas condições pré-doença, diminuição do limiar diagnóstico ou através de propostas de metodologias diagnósticas precoces diferentes das anteriormente estabelecidas. O <span class="elsevierStyleItalic">rationale</span> utilizado para justificar as alterações efetuadas incluíram a estandardização de critérios diagnósticos e as evidências recentes acerca do risco da população previamente considerada não doente.</p><p id="par0050" class="elsevierStylePara elsevierViewall">Cerca de 75% dos membros de 14 dos comités das <span class="elsevierStyleItalic">guidelines</span> com conflito de interesses relatados admitiram ligações à indústria, habitualmente como consultores, membros de conselhos consultivos <span class="elsevierStyleItalic">(advisory boards)</span>, palestrantes ou que receberam apoios para a investigação<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a>.</p><p id="par0055" class="elsevierStylePara elsevierViewall">O estudo publicado na <span class="elsevierStyleItalic">PLoS Medicine</span> não fez a comparação de resultados entre as <span class="elsevierStyleItalic">guidelines</span>, com e sem alteração das definições da doença, para determinar se as ligações à indústria eram mais frequentes entre os grupos de membros dos comités que alteraram as <span class="elsevierStyleItalic">guidelines</span> quando comparados com os grupos que não alteraram.</p><p id="par0060" class="elsevierStylePara elsevierViewall">Finalmente, os autores do artigo afirmam que «existem conflitos financeiros, mas também não financeiros ou intelectuais (tais como a progressão académica) e não deverá haver a presunção de que ter um conflito significa ser antiético ou que um qualquer profissional tem necessariamente benefícios financeiros através da influência das suas opções».</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:3 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Abstract" ] 1 => array:2 [ "identificador" => "sec0010" "titulo" => "Comentário" ] 2 => array:1 [ "titulo" => "Bibliografia" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2013-09-26" "fechaAceptado" => "2013-09-26" "multimedia" => array:1 [ 0 => array:5 [ "identificador" => "tb0005" "tipo" => "MULTIMEDIATEXTO" "mostrarFloat" => false "mostrarDisplay" => true "texto" => array:1 [ "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0015" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Comentário a «Definições da doença nas recomendações clínicas (</span><span class="elsevierStyleItalic"><span class="elsevierStyleBold">guidelines</span></span><span class="elsevierStyleBold">) e relação dos seus autores com a indústria: um estudo de prevalência de patologias frequentes nos Estados Unidos»</span></p><p id="par1005" class="elsevierStylePara elsevierViewall">Moynihan RN, Cooke GP, Doust JA, et al. PLoS Medicine; 10(8):e1001500</p></span>" ] ] ] "bibliografia" => array:2 [ "titulo" => "Bibliografia" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:1 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Expanding disease definitions in guidelines and expert panel ties to industry: A cross-sectional study of common conditions in the United States" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "R.N. Moynihan" 1 => "G.P. Cooke" 2 => "J.A. Doust" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1371/journal.pmed.1001500" "Revista" => array:5 [ "tituloSerie" => "PLoS medicine" "fecha" => "2013" "volumen" => "10" "paginaInicial" => "e1001500" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/23966841" "web" => "Medline" ] ] ] ] ] ] ] ] ] ] ] ] ] "idiomaDefecto" => "en" "url" => "/21742049/0000003200000012/v1_201401310146/S2174204914000051/v1_201401310146/en/main.assets" "Apartado" => array:4 [ "identificador" => "9913" "tipo" => "SECCION" "en" => array:2 [ "titulo" => "Recommended article of the month" "idiomaDefecto" => true ] "idiomaDefecto" => "en" ] "PDF" => "https://static.elsevier.es/multimedia/21742049/0000003200000012/v1_201401310146/S2174204914000051/v1_201401310146/en/main.pdf?idApp=UINPBA00004E&text.app=https://revportcardiol.org/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2174204914000051?idApp=UINPBA00004E" ]
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