{"id":375,"date":"2013-01-18T16:26:09","date_gmt":"2013-01-18T16:26:09","guid":{"rendered":"http:\/\/stg-blogs.bmj.com\/bmjopen\/?p=375"},"modified":"2013-02-27T13:46:18","modified_gmt":"2013-02-27T13:46:18","slug":"using-the-spirit-statement-to-improve-trial-protocols","status":"publish","type":"post","link":"https:\/\/stg-blogs.bmj.com\/bmjopen\/2013\/01\/18\/using-the-spirit-statement-to-improve-trial-protocols\/","title":{"rendered":"Using the SPIRIT statement to improve trial protocols"},"content":{"rendered":"<p><span style=\"font-family: Calibri\"><span style=\"color: #000000\"><br \/>\nWe have updated our <a href=\"http:\/\/bmjopen.bmj.com\/site\/about\/guidelines.xhtml#studyprotocols\" target=\"_blank\">instructions for authors <\/a>to show that we now encourage the use of the <a href=\"http:\/\/www.spirit-statement.org\/\" target=\"_blank\">SPIRIT statement<\/a>.<\/span><\/span><\/p>\n<p><span style=\"font-family: Calibri\"><span style=\"color: #000000\">SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) is \u2018an international initiative that aims to improve the quality of clinical trial protocols by defining an evidence-based set of items to address in a protocol\u2019. Its creation was funded by four Canadian health research institutions. <\/span><\/span><\/p>\n<p><span style=\"font-family: Calibri\">The <a href=\"http:\/\/annals.org\/article.aspx?articleid=1556168\" target=\"_blank\">full statement <\/a>has been published in the Annals of Internal Medicine, and the <a href=\"http:\/\/www.bmj.com\/content\/346\/bmj.e7586?\" target=\"_blank\">explanation and elaboration<\/a> in the BMJ. BMJ Open\u2019s editor-in-chief, Dr Trish Groves, is a member of the SPIRIT group. <\/span><\/p>\n<p><span style=\"font-family: Calibri\">BMJ Open published 17 protocols in 2011 and 79 in 2012, though not all were for interventional trials. We require ethics approval and registration in an ICMJE-approved registry for trial protocols, and encourage registration of systematic review protocols in <a href=\"http:\/\/www.crd.york.ac.uk\/PROSPERO\/\" target=\"_blank\">PROSPERO<\/a>, led by BMJ Open editorial board member Prof Lesley Stewart.<\/span><\/p>\n<p><span style=\"font-family: Calibri\">Publishing protocols provides a valuable service by allowing researchers to publicise ongoing work and hopefully facilitating cooperation and reducing duplicated efforts. By making the intended methods fully available the chances of a study\u2019s replication may be enhanced. Protocol publication should also ensure that any changes to methods adopted during a trial are reported as such in results papers. <\/span><\/p>\n<p><span style=\"font-family: Calibri\">As the SPIRIT authors <a href=\"http:\/\/www.bmj.com\/content\/346\/bmj.e7586?\" target=\"_blank\">write<\/a>, &#8216;High quality protocols facilitate proper conduct, reporting, and external review of clinical trials.&#8217;\u00a0We will be encouraging authors to use SPIRIT to help meet these goals. <\/span><!--TrendMD v2.4.8--><\/p>\n","protected":false},"excerpt":{"rendered":"<p>We have updated our instructions for authors to show that we now encourage the use of the SPIRIT statement. SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) is \u2018an international initiative that aims to improve the quality of clinical trial protocols by defining an evidence-based set of items to address in a protocol\u2019. Its creation [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/stg-blogs.bmj.com\/bmjopen\/2013\/01\/18\/using-the-spirit-statement-to-improve-trial-protocols\/\">Read More&#8230;<\/a><\/p>\n","protected":false},"author":143,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1750,2470,344],"tags":[],"class_list":["post-375","post","type-post","status-publish","format-standard","hentry","category-about-the-journal","category-content","category-journalology"],"jetpack_featured_media_url":"","_links":{"self":[{"href":"https:\/\/stg-blogs.bmj.com\/bmjopen\/wp-json\/wp\/v2\/posts\/375","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stg-blogs.bmj.com\/bmjopen\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stg-blogs.bmj.com\/bmjopen\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stg-blogs.bmj.com\/bmjopen\/wp-json\/wp\/v2\/users\/143"}],"replies":[{"embeddable":true,"href":"https:\/\/stg-blogs.bmj.com\/bmjopen\/wp-json\/wp\/v2\/comments?post=375"}],"version-history":[{"count":0,"href":"https:\/\/stg-blogs.bmj.com\/bmjopen\/wp-json\/wp\/v2\/posts\/375\/revisions"}],"wp:attachment":[{"href":"https:\/\/stg-blogs.bmj.com\/bmjopen\/wp-json\/wp\/v2\/media?parent=375"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stg-blogs.bmj.com\/bmjopen\/wp-json\/wp\/v2\/categories?post=375"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stg-blogs.bmj.com\/bmjopen\/wp-json\/wp\/v2\/tags?post=375"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}