{"id":14104,"date":"2023-06-28T09:35:31","date_gmt":"2023-06-28T09:35:31","guid":{"rendered":"https:\/\/thepublicationplan.com\/?p=14104"},"modified":"2023-06-28T09:35:33","modified_gmt":"2023-06-28T09:35:33","slug":"spirit-outcomes-2022-extension-guidelines-for-transparent-inclusion-of-clinical-trial-outcomes-in-trial-protocols","status":"publish","type":"post","link":"https:\/\/thepublicationplan.com\/2023\/06\/28\/spirit-outcomes-2022-extension-guidelines-for-transparent-inclusion-of-clinical-trial-outcomes-in-trial-protocols\/","title":{"rendered":"SPIRIT-Outcomes 2022 Extension: guidelines for transparent inclusion of clinical trial outcomes in trial protocols"},"content":{"rendered":"<hr \/>\n<p><strong>KEY TAKEAWAYS<\/strong><\/p>\n<ul>\n<li>The SPIRIT-Outcomes 2022 Extension addresses the need for better guidance in describing outcomes in clinical trial protocols.<\/li>\n<li>The new extension should be used in conjunction with the original SPIRIT 2013 Statement to improve transparency and integrity of clinical trial reporting.<\/li>\n<\/ul>\n<hr \/>\n<p><img data-recalc-dims=\"1\" loading=\"lazy\" decoding=\"async\" data-attachment-id=\"14107\" data-permalink=\"https:\/\/thepublicationplan.com\/2023\/06\/28\/spirit-outcomes-2022-extension-guidelines-for-transparent-inclusion-of-clinical-trial-outcomes-in-trial-protocols\/business-women-work-on-computers-and-write-on-notepad-with-pen-t\/\" data-orig-file=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2023\/06\/Checking-the-list.jpeg?fit=6000%2C4000&amp;ssl=1\" data-orig-size=\"6000,4000\" data-comments-opened=\"1\" data-image-meta=\"{&quot;aperture&quot;:&quot;2.8&quot;,&quot;credit&quot;:&quot;PaeGAG - stock.adobe.com&quot;,&quot;camera&quot;:&quot;ILCE-6300&quot;,&quot;caption&quot;:&quot;Business women work on computers and write on notepad with pen to calculate financial statements within the office.&quot;,&quot;created_timestamp&quot;:&quot;1614956043&quot;,&quot;copyright&quot;:&quot;&quot;,&quot;focal_length&quot;:&quot;50&quot;,&quot;iso&quot;:&quot;100&quot;,&quot;shutter_speed&quot;:&quot;0.00625&quot;,&quot;title&quot;:&quot;Business women work on computers and write on notepad with pen t&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\/2023\/06\/Checking-the-list.jpeg?fit=300%2C200&amp;ssl=1\" data-large-file=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2023\/06\/Checking-the-list.jpeg?fit=1024%2C683&amp;ssl=1\" class=\"aligncenter size-full wp-image-14107\" src=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2023\/06\/Checking-the-list.jpeg?resize=1360%2C907&#038;ssl=1\" alt=\"\" width=\"1360\" height=\"907\" srcset=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2023\/06\/Checking-the-list.jpeg?w=6000&amp;ssl=1 6000w, https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2023\/06\/Checking-the-list.jpeg?resize=300%2C200&amp;ssl=1 300w, https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2023\/06\/Checking-the-list.jpeg?resize=1024%2C683&amp;ssl=1 1024w, https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2023\/06\/Checking-the-list.jpeg?resize=768%2C512&amp;ssl=1 768w, https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2023\/06\/Checking-the-list.jpeg?resize=1536%2C1024&amp;ssl=1 1536w, https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2023\/06\/Checking-the-list.jpeg?resize=2048%2C1365&amp;ssl=1 2048w, https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2023\/06\/Checking-the-list.jpeg?resize=1800%2C1200&amp;ssl=1 1800w, https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2023\/06\/Checking-the-list.jpeg?resize=1320%2C880&amp;ssl=1 1320w, https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2023\/06\/Checking-the-list.jpeg?w=2720&amp;ssl=1 2720w, https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2023\/06\/Checking-the-list.jpeg?w=4080&amp;ssl=1 4080w\" sizes=\"auto, (max-width: 1360px) 100vw, 1360px\" \/><\/p>\n<p>The Standard Protocol Items: Recommendations for Interventional Trials <a href=\"https:\/\/www.equator-network.org\/reporting-guidelines\/guidelines-for-reporting-outcomes-in-trial-protocols-the-spirit-outcomes-2022-extension\/\" target=\"_blank\" rel=\"noopener\">(SPIRIT)-Outcomes 2022 Extension<\/a> aims to provide harmonised, evidence- and consensus-based outcome reporting standards for clinical trial protocols. An addition to the <a href=\"https:\/\/www.equator-network.org\/reporting-guidelines\/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials\/\" target=\"_blank\" rel=\"noopener\">existing suite of extensions<\/a> supporting the <a href=\"https:\/\/www.spirit-statement.org\/\" target=\"_blank\" rel=\"noopener\">original SPIRIT 2013 Statement<\/a>, the latest extension was recently published in <em><a href=\"https:\/\/jamanetwork.com\/journals\/jama\/fullarticle\/2799547\" target=\"_blank\" rel=\"noopener\">JAMA<\/a><\/em> by Dr Nancy Butcher and colleagues.<\/p>\n<p>The SPIRIT-Outcomes 2022 Extension recommends nine items that should be included in trial protocols, regardless of trial design and population, to define and justify the chosen primary, secondary and other outcomes of the trial. The nine items cover:<\/p>\n<ul>\n<li>defining and justifying the chosen study outcomes, including the timing of their measurement and what constitutes a minimal important difference for use in sample size calculations<\/li>\n<li>describing who will assess the outcome, and the responsiveness of the chosen outcome assessment tools in the target population<\/li>\n<li>describing any statistical methods to account for multiplicity in the analysis or interpretation of the primary and secondary outcomes.<\/li>\n<\/ul>\n<p>Developed using the <a href=\"https:\/\/journals.plos.org\/plosmedicine\/article?id=10.1371\/journal.pmed.1000217\" target=\"_blank\" rel=\"noopener\">EQUATOR<\/a> methodology for developing reporting guidelines, the authors highlight that these nine checklist items define the minimally required outcome-specific information that should be included in a trial protocol in addition to the items included in the SPIRIT 2013 Statement. The SPIRIT-Outcomes 2022 Extension was developed in parallel with the associated <a href=\"https:\/\/thepublicationplan.com\/2023\/04\/18\/consort-outcomes-2022-extension-guidelines-for-complete-reporting-of-clinical-trial-outcomes\/\" target=\"_blank\" rel=\"noopener\">CONSORT-Outcomes 2022 Extension<\/a> and the authors noted how the two should be used together to maximise their utility in improving the transparency of clinical trial reporting and addressing selective nonreporting of trial results.<\/p>\n<blockquote>\n<p style=\"text-align: center;\">The SPIRIT-Outcomes 2022 Extension should be used in conjunction with the CONSORT-Outcomes 2022 Extension to improve the transparency of clinical trial reporting and address selective nonreporting of trial results.<\/p>\n<\/blockquote>\n<p>An important aspect in the development of both extensions was representation from patient and public partners on the expert panels. The authors call for such <a href=\"https:\/\/www.futuremedicine.com\/doi\/10.2217\/frd-2022-0003\" target=\"_blank\" rel=\"noopener\">patient and public partnerships<\/a> when developing future guidelines to bring in a broader range of perspectives, which will ultimately <a href=\"https:\/\/implementationscience.biomedcentral.com\/articles\/10.1186\/s13012-018-0745-6\" target=\"_blank\" rel=\"noopener\">benefit patient-centricity<\/a>.<\/p>\n<p>The SPIRIT-Outcomes 2022 Extension guidelines are hoped to be particularly useful to trial protocol authors, ethics review boards and journal editors. The authors urge the use of these guidelines for transparency and integrity in trial reporting, and welcome feedback from users of the extension to inform future updates.<\/p>\n<p>\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2013<\/p>\n<p><img data-recalc-dims=\"1\" loading=\"lazy\" decoding=\"async\" data-attachment-id=\"14110\" data-permalink=\"https:\/\/thepublicationplan.com\/2023\/06\/28\/spirit-outcomes-2022-extension-guidelines-for-transparent-inclusion-of-clinical-trial-outcomes-in-trial-protocols\/byline_sreerekha-pillai-2\/\" data-orig-file=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2023\/06\/Byline_Sreerekha-Pillai.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=\"\" data-image-description=\"\" data-image-caption=\"\" data-medium-file=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2023\/06\/Byline_Sreerekha-Pillai.png?fit=300%2C36&amp;ssl=1\" data-large-file=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2023\/06\/Byline_Sreerekha-Pillai.png?fit=618%2C75&amp;ssl=1\" class=\"aligncenter size-full wp-image-14110\" src=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2023\/06\/Byline_Sreerekha-Pillai.png?resize=618%2C75&#038;ssl=1\" alt=\"\" width=\"618\" height=\"75\" srcset=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2023\/06\/Byline_Sreerekha-Pillai.png?w=618&amp;ssl=1 618w, https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2023\/06\/Byline_Sreerekha-Pillai.png?resize=300%2C36&amp;ssl=1 300w\" sizes=\"auto, (max-width: 618px) 100vw, 618px\" \/><\/p>\n<div id=\"totalpoll\" class=\"totalpoll-wrapper totalpoll-uid-2e21fe0b6d537996d47c3d4b16d0e3cc is-ltr is-screen-vote\" totalpoll=\"14102\" totalpoll-uid=\"2e21fe0b6d537996d47c3d4b16d0e3cc\" totalpoll-screen=\"vote\" totalpoll-ajax-url=\"https:\/\/thepublicationplan.com\/wp-admin\/admin-ajax.php?action=totalpoll&totalpoll%5BpollId%5D=14102&totalpoll%5Baction%5D=view&totalpoll%5Bscreen%5D=vote\"><script type=\"text\/totalpoll-config\" totalpoll-config=\"14102\">{\"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-14102\" 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>Do you think the new SPIRIT-Outcomes 2022 Extension will improve the quality of clinical trial protocol reporting?<\/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-1e21b097-8628-4bd9-bd19-1e974e069c54-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-1e21b097-8628-4bd9-bd19-1e974e069c54-selector\" name=\"totalpoll[choices][649e333d-580f-4f0c-aaac-38749796b9f0][]\" value=\"1e21b097-8628-4bd9-bd19-1e974e069c54\">                <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 >Yes<\/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-08997402-255e-4bbd-9ae6-d16badf8cee2-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-08997402-255e-4bbd-9ae6-d16badf8cee2-selector\" name=\"totalpoll[choices][649e333d-580f-4f0c-aaac-38749796b9f0][]\" value=\"08997402-255e-4bbd-9ae6-d16badf8cee2\">                <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 >No<\/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-e4a552d4-6265-4bcd-9a97-591f54c5e79d-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-e4a552d4-6265-4bcd-9a97-591f54c5e79d-selector\" name=\"totalpoll[choices][649e333d-580f-4f0c-aaac-38749796b9f0][]\" value=\"e4a552d4-6265-4bcd-9a97-591f54c5e79d\">                <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 sure<\/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=\"14102\" 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","protected":false},"excerpt":{"rendered":"<p>How to improve outcome reporting in clinical trial protocols: read more about the SPIRIT-Outcomes 2022 Extension.<\/p>\n","protected":false},"author":2,"featured_media":14107,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"advanced_seo_description":"How to improve outcome reporting in clinical trial protocols: read more about the SPIRIT-Outcomes 2022 Extension.","jetpack_seo_html_title":"SPIRIT-Outcomes 2022 Extension: guidelines for transparent inclusion of clinical trial outcomes in trial protocols","jetpack_seo_noindex":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"SPIRIT-Outcomes 2022 Extension: guidelines for transparent inclusion of clinical trial outcomes in trial protocols @JAMA_current #MedComms 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