{"id":5688,"date":"2019-03-28T09:23:39","date_gmt":"2019-03-28T09:23:39","guid":{"rendered":"https:\/\/thepublicationplan.com\/?p=5688"},"modified":"2019-03-28T09:28:14","modified_gmt":"2019-03-28T09:28:14","slug":"disparities-claimed-between-stance-and-action-on-clinical-trial-outcome-reporting-by-top-medical-journals","status":"publish","type":"post","link":"https:\/\/thepublicationplan.com\/2019\/03\/28\/disparities-claimed-between-stance-and-action-on-clinical-trial-outcome-reporting-by-top-medical-journals\/","title":{"rendered":"Disparities claimed between stance and action on clinical trial outcome reporting by top medical journals"},"content":{"rendered":"<p><img data-recalc-dims=\"1\" loading=\"lazy\" decoding=\"async\" data-attachment-id=\"5689\" data-permalink=\"https:\/\/thepublicationplan.com\/2019\/03\/28\/disparities-claimed-between-stance-and-action-on-clinical-trial-outcome-reporting-by-top-medical-journals\/legs-in-multi-colored-running-shoes\/\" data-orig-file=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2019\/03\/COMPare.jpg?fit=1254%2C836&amp;ssl=1\" data-orig-size=\"1254,836\" data-comments-opened=\"1\" data-image-meta=\"{&quot;aperture&quot;:&quot;4.5&quot;,&quot;credit&quot;:&quot;Getty Images\/iStockphoto&quot;,&quot;camera&quot;:&quot;Canon EOS 5D Mark II&quot;,&quot;caption&quot;:&quot;Which one should I choose? Legs in multi-colored running shoes.&quot;,&quot;created_timestamp&quot;:&quot;1512130055&quot;,&quot;copyright&quot;:&quot;Panchenko Dmytro (Panchenko Dmytro (Photographer) - [None]&quot;,&quot;focal_length&quot;:&quot;70&quot;,&quot;iso&quot;:&quot;400&quot;,&quot;shutter_speed&quot;:&quot;0.003125&quot;,&quot;title&quot;:&quot;Legs in multi-colored running shoes.&quot;,&quot;orientation&quot;:&quot;1&quot;}\" data-image-title=\"Legs in multi-colored running shoes.\" data-image-description=\"\" data-image-caption=\"&lt;p&gt;Which one should I choose? Legs in multi-colored running shoes.&lt;\/p&gt;\n\" data-medium-file=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2019\/03\/COMPare.jpg?fit=300%2C200&amp;ssl=1\" data-large-file=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2019\/03\/COMPare.jpg?fit=1024%2C683&amp;ssl=1\" class=\"alignnone size-full wp-image-5689\" src=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2019\/03\/COMPare.jpg?resize=1254%2C836&#038;ssl=1\" alt=\"Legs in multi-colored running shoes.\" width=\"1254\" height=\"836\" srcset=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2019\/03\/COMPare.jpg?w=1254&amp;ssl=1 1254w, https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2019\/03\/COMPare.jpg?resize=300%2C200&amp;ssl=1 300w, https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2019\/03\/COMPare.jpg?resize=768%2C512&amp;ssl=1 768w, https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2019\/03\/COMPare.jpg?resize=1024%2C683&amp;ssl=1 1024w\" sizes=\"auto, (max-width: 1254px) 100vw, 1254px\" \/><\/p>\n<p>Guidance from the <a href=\"http:\/\/www.equator-network.org\/\" target=\"_blank\" rel=\"noopener noreferrer\">EQUATOR network<\/a> and the <a href=\"http:\/\/www.icmje.org\/recommendations\/browse\/publishing-and-editorial-issues\/clinical-trial-registration.html\" target=\"_blank\" rel=\"noopener noreferrer\">ICMJE<\/a> stipulates that clinical trials must be publicly registered at inception in order for results to be considered for publication. This practice was intended to reduce selective reporting of trial outcomes; however, discrepancies between pre-specified and published outcomes of clinical trials <a href=\"https:\/\/bmcmedicine.biomedcentral.com\/articles\/10.1186\/s12916-015-0520-3\" target=\"_blank\" rel=\"noopener noreferrer\">persist<\/a>. A recent <a href=\"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-019-3173-2\" target=\"_blank\" rel=\"noopener noreferrer\">article<\/a> published in <em><a href=\"https:\/\/trialsjournal.biomedcentral.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">Trials<\/a><\/em> by Dr Ben Goldacre (<a href=\"http:\/\/www.alltrials.net\/\" target=\"_blank\" rel=\"noopener noreferrer\">AllTrials<\/a>-founder) and colleagues reported high levels of outcome misreporting in journals listed as endorsing the <a href=\"http:\/\/www.consort-statement.org\/\" target=\"_blank\" rel=\"noopener noreferrer\">CONSORT statement<\/a> on the correct reporting of clinical trials. What\u2019s more, the group reported that most correction letters they sent to address such misreporting were rejected.<\/p>\n<p>This prospective study (<a href=\"http:\/\/compare-trials.org\/\" target=\"_blank\" rel=\"noopener noreferrer\">COMPare<\/a>) tracked outcome switching in 67 randomised controlled trials (RCTs) published over a six-week period (19 Oct\u201330 Nov 2015) in the five top CONSORT-endorsing medical journals (<em><a href=\"https:\/\/www.nejm.org\/\" target=\"_blank\" rel=\"noopener noreferrer\">The New Engl J Med<\/a><\/em>, <em><a href=\"https:\/\/www.thelancet.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">The Lancet<\/a><\/em>, <em><a href=\"https:\/\/jamanetwork.com\/journals\/jama\" target=\"_blank\" rel=\"noopener noreferrer\">JAMA<\/a><\/em>, <em><a href=\"https:\/\/www.bmj.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">The BMJ<\/a><\/em> and <em><a href=\"https:\/\/annals.org\/aim\" target=\"_blank\" rel=\"noopener noreferrer\">Annals of Internal Medicine<\/a><\/em>). Overall, outcome reporting was deemed to be poor; 58\/67 (87%) manuscripts analysed contained CONSORT-breaching discrepancies judged to require a correction letter. Of these letters, only 40% were published, with a median delay of 99 days. <a href=\"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-019-3172-3\" target=\"_blank\" rel=\"noopener noreferrer\">Qualitative analysis<\/a> was thought to suggest misunderstanding among journal editors surrounding correct outcome reporting and CONSORT, a finding that may explain why some journals did not cooperate when presented with evidence of misreporting.<\/p>\n<p>The authors warn that readers of a journal with a CONSORT-supporting stance may assume that trial results are reported in line with pre-specified outcomes. To ensure this is the case, Goldacre and his colleagues suggest a number of strategies: 1) Changes to journals\u2019 correspondence processes; 2) Indexed post-publication peer review; 3) Changes to CONSORT\u2019s enforcement mechanisms; 4) Changes to practices in methodology research to increase sharing of misreporting with the broader academic community.<\/p>\n<div data-opinionstage-embed-url=\"https:\/\/www.opinionstage.com\/api\/v1\/polls\/2544229\/code.json?width=\" style=\"display: none; visibility: hidden;\"><\/div>\n<p>\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2013<\/p>\n<p>Summary by\u00a0<a href=\"http:\/\/www.aspire-scientific.com\/#team_\">Emma Prest PhD<\/a>\u00a0from\u00a0<a href=\"http:\/\/www.aspire-scientific.com\/\">Aspire Scientific<\/a><\/p>\n<p>\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2013<\/p>\n<p>With thanks to our sponsors, <a href=\"http:\/\/www.aspire-scientific.com\/\">Aspire Scientific Ltd<\/a> and <a href=\"http:\/\/www.networkpharma.com\/\">NetworkPharma Ltd<\/a><\/p>\n<hr \/>\n","protected":false},"excerpt":{"rendered":"<p>Selective reporting of clinical trial outcomes may be widespread. This study reports instances occurring in CONSORT-endorsing medical journals.<\/p>\n","protected":false},"author":4,"featured_media":5689,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"advanced_seo_description":"","jetpack_seo_html_title":"","jetpack_seo_noindex":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_publicize_connection_overrides":[],"_wpas_customize_per_network":false},"categories":[231660481,9631846,322948647,16950752],"tags":[343162440,343162404,343162406],"class_list":["post-5688","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-clinical-trial-registries","category-reporting-guidelines","category-selective-publication","category-data-transparency","tag-academic-publishing","tag-consort","tag-randomised-controlled-trial-rct","post-has-thumbnail"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2019\/03\/COMPare.jpg?fit=1254%2C836&ssl=1","jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p5Yk5l-1tK","jetpack_likes_enabled":true,"jetpack-related-posts":[],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/thepublicationplan.com\/wp-json\/wp\/v2\/posts\/5688","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thepublicationplan.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thepublicationplan.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thepublicationplan.com\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/thepublicationplan.com\/wp-json\/wp\/v2\/comments?post=5688"}],"version-history":[{"count":2,"href":"https:\/\/thepublicationplan.com\/wp-json\/wp\/v2\/posts\/5688\/revisions"}],"predecessor-version":[{"id":5691,"href":"https:\/\/thepublicationplan.com\/wp-json\/wp\/v2\/posts\/5688\/revisions\/5691"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/thepublicationplan.com\/wp-json\/wp\/v2\/media\/5689"}],"wp:attachment":[{"href":"https:\/\/thepublicationplan.com\/wp-json\/wp\/v2\/media?parent=5688"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thepublicationplan.com\/wp-json\/wp\/v2\/categories?post=5688"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thepublicationplan.com\/wp-json\/wp\/v2\/tags?post=5688"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}