{"id":9795,"date":"2021-08-24T09:04:04","date_gmt":"2021-08-24T09:04:04","guid":{"rendered":"https:\/\/thepublicationplan.com\/?p=9795"},"modified":"2021-09-15T14:03:54","modified_gmt":"2021-09-15T14:03:54","slug":"new-consort-extension-for-trials-using-cohorts-and-routinely-collected-data-consort-routine","status":"publish","type":"post","link":"https:\/\/thepublicationplan.com\/2021\/08\/24\/new-consort-extension-for-trials-using-cohorts-and-routinely-collected-data-consort-routine\/","title":{"rendered":"New CONSORT extension for trials using cohorts and routinely collected data: CONSORT-ROUTINE"},"content":{"rendered":"<img data-recalc-dims=\"1\" loading=\"lazy\" decoding=\"async\" data-attachment-id=\"9806\" data-permalink=\"https:\/\/thepublicationplan.com\/2021\/08\/24\/new-consort-extension-for-trials-using-cohorts-and-routinely-collected-data-consort-routine\/checklist-with-tick-marks-in-a-flat-style-questionnaire-on-a-clipboard-paper-successful-completion-of-business-tasks-checklist-tasks-to-do-list-survey-exam-concepts-vector-illustration\/\" data-orig-file=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/CONSORT-ROUTINE.jpg?fit=591%2C591&amp;ssl=1\" data-orig-size=\"591,591\" data-comments-opened=\"1\" data-image-meta=\"{&quot;aperture&quot;:&quot;0&quot;,&quot;credit&quot;:&quot;Getty Images\/iStockphoto&quot;,&quot;camera&quot;:&quot;&quot;,&quot;caption&quot;:&quot;Checklist with tick marks in a flat style. Questionnaire on a clipboard paper. Successful completion of business tasks. Checklist, tasks, to-do list, survey, exam concepts. Vector illustration.&quot;,&quot;created_timestamp&quot;:&quot;0&quot;,&quot;copyright&quot;:&quot;&quot;,&quot;focal_length&quot;:&quot;0&quot;,&quot;iso&quot;:&quot;0&quot;,&quot;shutter_speed&quot;:&quot;0&quot;,&quot;title&quot;:&quot;Checklist with tick marks in a flat style. Questionnaire on a clipboard paper. Successful completion of business tasks. Checklist, tasks, to-do list, survey, exam concepts. Vector illustration&quot;,&quot;orientation&quot;:&quot;1&quot;}\" data-image-title=\"\" data-image-description=\"\" data-image-caption=\"\" data-medium-file=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/CONSORT-ROUTINE.jpg?fit=300%2C300&amp;ssl=1\" data-large-file=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/CONSORT-ROUTINE.jpg?fit=591%2C591&amp;ssl=1\" class=\"size-full wp-image-9806 aligncenter\" src=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/CONSORT-ROUTINE.jpg?resize=591%2C591&#038;ssl=1\" alt=\"\" width=\"591\" height=\"591\" srcset=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/CONSORT-ROUTINE.jpg?w=591&amp;ssl=1 591w, https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/CONSORT-ROUTINE.jpg?resize=300%2C300&amp;ssl=1 300w, https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/CONSORT-ROUTINE.jpg?resize=150%2C150&amp;ssl=1 150w, https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/CONSORT-ROUTINE.jpg?resize=250%2C250&amp;ssl=1 250w, https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/CONSORT-ROUTINE.jpg?resize=50%2C50&amp;ssl=1 50w\" sizes=\"auto, (max-width: 591px) 100vw, 591px\" \/>Cohort and <a href=\"https:\/\/thepublicationplan.com\/2019\/03\/12\/patient-reported-outcomes-are-they-an-essential-element-of-publication-planning\/\" target=\"_blank\" rel=\"noopener\">routinely collected data<\/a> are being <a href=\"https:\/\/f1000research.com\/articles\/9-323\/v3\" target=\"_blank\" rel=\"noopener\">increasingly used<\/a> in randomised controlled trials (RCTs) to identify eligible participants, collect patient or outcome data, or implement interventions. The original Consolidated Standards of Reporting Trials (<a href=\"http:\/\/www.consort-statement.org\/consort-2010\" target=\"_blank\" rel=\"noopener\">CONSORT<\/a>) 2010 statement helps improve reporting of RCTs through <a href=\"https:\/\/thepublicationplan.com\/2021\/04\/15\/key-principles-for-better-evidence-communication\/\" target=\"_blank\" rel=\"noopener\">transparency and completeness.<\/a> Details of an extension to CONSORT for RCTs conducted using cohorts or routinely collected data, <a href=\"https:\/\/www.bmj.com\/content\/373\/bmj.n857\" target=\"_blank\" rel=\"noopener\">CONSORT-ROUTINE<\/a>, have been recently published in the <em><a href=\"https:\/\/www.bmj.com\/\" target=\"_blank\" rel=\"noopener\">British Medical Journal<\/a><\/em>.\n\nRoutinely collected data are data that are not initially collected with research purposes in mind, and include registries, databases (such as private health insurance databases) and electronic health records. Cohorts are groups of individuals from whom data are collected for research purposes. Although cohort and routinely collected data can make RCTs more efficient (eg, by reducing time and money spent on recruitment) and more representative of real world patient populations, current reporting guidelines do not cover their unique methodology in a standardised way.\n<blockquote>\n<p style=\"text-align: center;\">Although cohort and routinely collected data can make RCTs more efficient and more representative of real world patient populations, current reporting guidelines do not cover their unique methodology in a standardised way.<\/p>\n<\/blockquote>\nAlong with several modifications to the original checklist, the CONSORT-ROUTINE extension includes 5 new items specific to RCTs conducted using cohorts or routinely collected data:\n<ul>\n \t<li>ROUTINE-1 on the description of the cohort or routinely collected database(s)<\/li>\n \t<li>ROUTINE-2 on the eligibility criteria for participants in the cohort or routinely collected database(s)<\/li>\n \t<li>ROUTINE-3 on data linkage across 2 or more databases<\/li>\n \t<li>ROUTINE-4 on consent for use of cohort or routinely collected data and trial participation<\/li>\n \t<li>ROUTINE-5 on codes and algorithms used to define or derive the outcomes from the cohort or routinely collected database(s).<\/li>\n<\/ul>\nIt is hoped that this new extension will improve the transparency and reporting of RCTs using cohort and routinely collected data, thereby helping to reduce wastage in research.\n\n<a href=\"https:\/\/www.bmj.com\/content\/bmj\/373\/bmj.n857.full.pdf\"><img data-recalc-dims=\"1\" loading=\"lazy\" decoding=\"async\" data-attachment-id=\"8637\" data-permalink=\"https:\/\/thepublicationplan.com\/2021\/01\/06\/new-artificial-intelligence-specific-extension-to-the-spirit-guidelines-published\/cmpp-reading-banner\/\" data-orig-file=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/01\/CMPP-reading-banner.png?fit=618%2C75&amp;ssl=1\" data-orig-size=\"618,75\" data-comments-opened=\"1\" data-image-meta=\"{&quot;aperture&quot;:&quot;0&quot;,&quot;credit&quot;:&quot;&quot;,&quot;camera&quot;:&quot;&quot;,&quot;caption&quot;:&quot;&quot;,&quot;created_timestamp&quot;:&quot;0&quot;,&quot;copyright&quot;:&quot;&quot;,&quot;focal_length&quot;:&quot;0&quot;,&quot;iso&quot;:&quot;0&quot;,&quot;shutter_speed&quot;:&quot;0&quot;,&quot;title&quot;:&quot;&quot;,&quot;orientation&quot;:&quot;0&quot;}\" data-image-title=\"CMPP reading banner\" data-image-description=\"\" data-image-caption=\"\" data-medium-file=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/01\/CMPP-reading-banner.png?fit=300%2C36&amp;ssl=1\" data-large-file=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/01\/CMPP-reading-banner.png?fit=618%2C75&amp;ssl=1\" class=\"alignnone wp-image-8637 size-full\" src=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/01\/CMPP-reading-banner.png?resize=618%2C75&#038;ssl=1\" alt=\"\" width=\"618\" height=\"75\" srcset=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/01\/CMPP-reading-banner.png?w=618&amp;ssl=1 618w, https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/01\/CMPP-reading-banner.png?resize=300%2C36&amp;ssl=1 300w\" sizes=\"auto, (max-width: 618px) 100vw, 618px\" \/><\/a>\n\nAfter reading the article,\u00a0<a href=\"https:\/\/www.surveymonkey.com\/r\/2D52GLG\">click here<\/a>\u00a0for a brief survey and to receive your authorization code for your Credit Tracker. This serves as documentation for the activity.\n\n\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2013\n\n<div id=\"totalpoll\" class=\"totalpoll-wrapper totalpoll-uid-2e21fe0b6d537996d47c3d4b16d0e3cc is-ltr is-screen-vote\" totalpoll=\"9792\" totalpoll-uid=\"2e21fe0b6d537996d47c3d4b16d0e3cc\" totalpoll-screen=\"vote\" totalpoll-ajax-url=\"https:\/\/thepublicationplan.com\/wp-admin\/admin-ajax.php?action=totalpoll&totalpoll%5BpollId%5D=9792&totalpoll%5Baction%5D=view&totalpoll%5Bscreen%5D=vote\"><script type=\"text\/totalpoll-config\" totalpoll-config=\"9792\">{\"ajaxEndpoint\":\"https:\\\/\\\/thepublicationplan.com\\\/wp-admin\\\/admin-ajax.php?action=totalpoll\",\"behaviours\":{\"ajax\":true,\"scrollUp\":true,\"async\":false},\"effects\":{\"transition\":\"fade\",\"duration\":\"500\"},\"i18n\":{\"Previous\":\"Previous\",\"Next\":\"Next\",\"of\":\"of\",\"Something went wrong! Please try again.\":\"Something went wrong! Please try again.\"}}<\/script><link rel=\"stylesheet\" id=\"totalpoll-poll-2e21fe0b6d537996d47c3d4b16d0e3cc-css\"  href=\"https:\/\/thepublicationplan.com\/wp-content\/cache\/totalpoll\/css\/2e21fe0b6d537996d47c3d4b16d0e3cc.css\" type=\"text\/css\" media=\"all\" \/><div id=\"totalpoll-poll-9792\" class=\"totalpoll-container\"><form action=\"\" enctype=\"multipart\/form-data\" class=\"totalpoll-form\" method=\"POST\" novalidate=\"novalidate\"><div style=\"visibility: hidden; position: absolute; width: 0px; height: 0px;\">\r\n    <svg id=\"totalpoll-check-icon\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewBox=\"0 0 24 24\">\r\n        <path d=\"M0,0H24V24H0Z\" fill=\"none\"\/>\r\n        <path d=\"M9,15.1999l-4.2-4.2L2.3999,13.4,9,20.0001,22.0001,7,19.6,4.5999Z\"\/>\r\n    <\/svg>\r\n<\/div>\r\n    <div class=\"totalpoll-questions\">\r\n\t\t<div class=\"totalpoll-question\"\r\n     totalpoll-min-selection=\"1\"\r\n     totalpoll-max-selection=\"1\" >\r\n    <div class=\"totalpoll-question-container\">\r\n        <div class=\"totalpoll-question-content\" >\r\n\t\t\t<p>How often do you think you will use the CONSORT-ROUTINE extension?<\/p>\n        <\/div>\r\n\r\n        <div class=\"totalpoll-question-choices\">\r\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"choice-1417cb13-0b05-45a6-b5b7-5723c0798a9f-selector\" tabindex=\"0\"\r\n       class=\"totalpoll-question-choices-item totalpoll-question-choices-item-type-text \" >\r\n    <div class=\"totalpoll-question-choices-item-container\">\r\n        \r\n\t\t        \r\n        <div class=\"totalpoll-question-choices-item-control\">\r\n            <div class=\"totalpoll-question-choices-item-selector totalpoll-question-choices-item-selector-single\">\r\n\t\t\t\t<input type=\"radio\" id=\"choice-1417cb13-0b05-45a6-b5b7-5723c0798a9f-selector\" name=\"totalpoll[choices][1d125e14-caa2-4a90-95d7-b751504a589c][]\" value=\"1417cb13-0b05-45a6-b5b7-5723c0798a9f\">                <div class=\"totalpoll-question-choices-item-selector-box\">\r\n                    <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewBox=\"0 0 24 24\">\r\n                        <use xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"#totalpoll-check-icon\"><\/use>\r\n                    <\/svg>\r\n                <\/div>\r\n            <\/div>\r\n            <div class=\"totalpoll-question-choices-item-label\">\r\n                <span >Often<\/span>\r\n            <\/div>\r\n        <\/div>\r\n    <\/div>\r\n<\/label>\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"choice-ca1a270e-c703-47fd-add2-9c074715cee3-selector\" tabindex=\"0\"\r\n       class=\"totalpoll-question-choices-item totalpoll-question-choices-item-type-text \" >\r\n    <div class=\"totalpoll-question-choices-item-container\">\r\n        \r\n\t\t        \r\n        <div class=\"totalpoll-question-choices-item-control\">\r\n            <div class=\"totalpoll-question-choices-item-selector totalpoll-question-choices-item-selector-single\">\r\n\t\t\t\t<input type=\"radio\" id=\"choice-ca1a270e-c703-47fd-add2-9c074715cee3-selector\" name=\"totalpoll[choices][1d125e14-caa2-4a90-95d7-b751504a589c][]\" value=\"ca1a270e-c703-47fd-add2-9c074715cee3\">                <div class=\"totalpoll-question-choices-item-selector-box\">\r\n                    <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewBox=\"0 0 24 24\">\r\n                        <use xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"#totalpoll-check-icon\"><\/use>\r\n                    <\/svg>\r\n                <\/div>\r\n            <\/div>\r\n            <div class=\"totalpoll-question-choices-item-label\">\r\n                <span >Occasionally<\/span>\r\n            <\/div>\r\n        <\/div>\r\n    <\/div>\r\n<\/label>\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"choice-e5bd9d07-8335-4c28-b34a-4709437ea587-selector\" tabindex=\"0\"\r\n       class=\"totalpoll-question-choices-item totalpoll-question-choices-item-type-text \" >\r\n    <div class=\"totalpoll-question-choices-item-container\">\r\n        \r\n\t\t        \r\n        <div class=\"totalpoll-question-choices-item-control\">\r\n            <div class=\"totalpoll-question-choices-item-selector totalpoll-question-choices-item-selector-single\">\r\n\t\t\t\t<input type=\"radio\" id=\"choice-e5bd9d07-8335-4c28-b34a-4709437ea587-selector\" name=\"totalpoll[choices][1d125e14-caa2-4a90-95d7-b751504a589c][]\" value=\"e5bd9d07-8335-4c28-b34a-4709437ea587\">                <div class=\"totalpoll-question-choices-item-selector-box\">\r\n                    <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewBox=\"0 0 24 24\">\r\n                        <use xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"#totalpoll-check-icon\"><\/use>\r\n                    <\/svg>\r\n                <\/div>\r\n            <\/div>\r\n            <div class=\"totalpoll-question-choices-item-label\">\r\n                <span >Not very often<\/span>\r\n            <\/div>\r\n        <\/div>\r\n    <\/div>\r\n<\/label>\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"choice-ac63ca37-ce3a-4550-8023-82e13d72d3be-selector\" tabindex=\"0\"\r\n       class=\"totalpoll-question-choices-item totalpoll-question-choices-item-type-text \" >\r\n    <div class=\"totalpoll-question-choices-item-container\">\r\n        \r\n\t\t        \r\n        <div class=\"totalpoll-question-choices-item-control\">\r\n            <div class=\"totalpoll-question-choices-item-selector totalpoll-question-choices-item-selector-single\">\r\n\t\t\t\t<input type=\"radio\" id=\"choice-ac63ca37-ce3a-4550-8023-82e13d72d3be-selector\" name=\"totalpoll[choices][1d125e14-caa2-4a90-95d7-b751504a589c][]\" value=\"ac63ca37-ce3a-4550-8023-82e13d72d3be\">                <div class=\"totalpoll-question-choices-item-selector-box\">\r\n                    <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewBox=\"0 0 24 24\">\r\n                        <use xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"#totalpoll-check-icon\"><\/use>\r\n                    <\/svg>\r\n                <\/div>\r\n            <\/div>\r\n            <div class=\"totalpoll-question-choices-item-label\">\r\n                <span >Never<\/span>\r\n            <\/div>\r\n        <\/div>\r\n    <\/div>\r\n<\/label>\r\n\t\t\t\t\t\t\t            \r\n\t\t\t            \r\n        <\/div>\r\n    <\/div>\r\n<\/div>\r\n    <\/div>\r\n<div class=\"totalpoll-form-hidden-fields\">\r\n\t<div class=\"totalpoll-form-page\"><div class=\"totalpoll-form-field-hidden\"><div class=\"totalpoll-form-field totalpoll-form-field-type-hidden totalpoll-column-full\"><div class=\"totalpoll-form-field-wrapper\"><input type=\"hidden\" name=\"totalpoll[screen]\" value=\"vote\" class=\"totalpoll-form-field-input\"><div class=\"totalpoll-form-field-errors\"><\/div><\/div><\/div><\/div><div class=\"totalpoll-form-field-hidden\"><div class=\"totalpoll-form-field totalpoll-form-field-type-hidden totalpoll-column-full\"><div class=\"totalpoll-form-field-wrapper\"><input type=\"hidden\" name=\"totalpoll[pollId]\" value=\"9792\" class=\"totalpoll-form-field-input\"><div class=\"totalpoll-form-field-errors\"><\/div><\/div><\/div><\/div><div class=\"totalpoll-form-field-hidden\"><div class=\"totalpoll-form-field totalpoll-form-field-type-hidden totalpoll-column-full\"><div class=\"totalpoll-form-field-wrapper\"><input type=\"hidden\" name=\"totalpoll[action]\" value=\"\" class=\"totalpoll-form-field-input\"><div class=\"totalpoll-form-field-errors\"><\/div><\/div><\/div><\/div><\/div><\/div>\r\n<div class=\"totalpoll-buttons\">\r\n\t<button type=\"submit\" name=\"totalpoll[action]\" value=\"results\" class=\"totalpoll-button totalpoll-buttons-results\">Results<\/button><button type=\"submit\" name=\"totalpoll[action]\" value=\"vote\" class=\"totalpoll-button totalpoll-button-primary totalpoll-buttons-vote\">Vote<\/button><\/div>\r\n<\/form><\/div><\/div>\n\n\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2013<a style=\"font-size: 1rem;\" href=\"https:\/\/www.aspire-scientific.com\/\" target=\"_blank\" rel=\"noopener\"><img data-recalc-dims=\"1\" loading=\"lazy\" decoding=\"async\" class=\"alignnone\" src=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/Byline_Rachel-Hubbard.png?resize=618%2C75&#038;ssl=1\" alt=\"\" width=\"618\" height=\"75\" \/><\/a>\n\n<hr \/>\n\n<div class=\"wp-block-jetpack-subscriptions wp-block-jetpack-subscriptions__supports-newline\"><\/div>\n<!-- \/wp:post-content -->","protected":false},"excerpt":{"rendered":"<p>Find out what\u2019s in the new CONSORT-ROUTINE checklist for randomised controlled trials using cohorts and routinely collected data.<\/p>\n","protected":false},"author":1,"featured_media":9806,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"advanced_seo_description":"Find out what\u2019s in the new CONSORT-ROUTINE checklist for randomised controlled trials using cohorts and routinely collected data.","jetpack_seo_html_title":"","jetpack_seo_noindex":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"New CONSORT extension for trials using cohorts and routinely collected data: CONSORT-ROUTINE @bmj_latest @CONSORTing #PubPlan #medcomms #ISMPP 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