{"id":19411,"date":"2017-03-29T12:09:21","date_gmt":"2017-03-29T16:09:21","guid":{"rendered":"http:\/\/pmedicine.org\/epatients\/?p=19411"},"modified":"2017-03-29T12:27:28","modified_gmt":"2017-03-29T16:27:28","slug":"prepare-for-nejms-live-web-event-on-data-sharing-next-week","status":"publish","type":"post","link":"https:\/\/participatorymedicine.org\/epatients\/2017\/03\/prepare-for-nejms-live-web-event-on-data-sharing-next-week.html","title":{"rendered":"Prepare for NEJM&#8217;s major web event on sharing research data next week"},"content":{"rendered":"<p>In November we posted about an extraordinary development:\u00a0<a title=\"Permanent Link to NEJM Data Analysis Challenge: can others create value by seeing researchers\u2019 data?\" href=\"https:\/\/participatorymedicine.org\/epatients\/archives\/2016\/11\/nejm-data-analysis-challenge-can-others-create-value-by-seeing-researchers-data.html\" target=\"_blank\" rel=\"bookmark\">NEJM Data Analysis Challenge: can others create value by seeing researchers\u2019 data?<\/a>\u00a0The project has come to fruition, and the big event (free) is next Monday-Tuesday. The question for us: What&#8217;s the impact on patients?<\/p>\n<blockquote class=\"twitter-tweet\" data-lang=\"en\">\n<p dir=\"ltr\" lang=\"en\">Join us along with <a href=\"https:\/\/twitter.com\/zakkohane\">@zakkohane<\/a> for <a href=\"https:\/\/twitter.com\/hashtag\/NEJMDataSummit?src=hash\">#NEJMDataSummit<\/a>, a free web event on April 3\u20134, 2017. Learn more and register: <a href=\"https:\/\/t.co\/nWSP2xa5tp\">https:\/\/t.co\/nWSP2xa5tp<\/a> <a href=\"https:\/\/t.co\/6CeZizGSir\">pic.twitter.com\/6CeZizGSir<\/a><\/p>\n<p>\u2014 NEJM (@NEJM) <a href=\"https:\/\/twitter.com\/NEJM\/status\/844176049445453828\">March 21, 2017<\/a><\/p><\/blockquote>\n<p><script async src=\"\/\/platform.twitter.com\/widgets.js\" charset=\"utf-8\"><\/script><br \/>\n<!--more--><\/p>\n<p><a href=\"https:\/\/participatorymedicine.org\/epatients\/archives\/2016\/11\/nejm-data-analysis-challenge-can-others-create-value-by-seeing-researchers-data.html\" target=\"_blank\"><img loading=\"lazy\" decoding=\"async\" class=\"alignright wp-image-19136 size-medium\" src=\"https:\/\/participatorymedicine.org\/epatients\/wp-content\/uploads\/sites\/3\/2016\/11\/NEJM-data-challenge-flyer-capture-232x300.jpg\" alt=\"\" width=\"232\" height=\"300\" srcset=\"https:\/\/participatorymedicine.org\/epatients\/wp-content\/uploads\/sites\/3\/2016\/11\/NEJM-data-challenge-flyer-capture-232x300.jpg 232w, https:\/\/participatorymedicine.org\/epatients\/wp-content\/uploads\/sites\/3\/2016\/11\/NEJM-data-challenge-flyer-capture.jpg 500w\" sizes=\"auto, (max-width: 232px) 100vw, 232px\" \/><\/a>If you&#8217;re at\u00a0<em>all\u00a0<\/em>interested in issues of research, open data, and the collaborative future of health and care, you don&#8217;t want to miss this. Something&#8217;s happening that I believe is unprecedented, and the results so far are pretty mind-bending.<\/p>\n<p>Register (free) at <a href=\"http:\/\/events.nejm.org\" target=\"_blank\">events.nejm.org<\/a>, and follow the hashtag <a href=\"https:\/\/twitter.com\/search?f=tweets&amp;vertical=default&amp;q=%23nejmdatasummit\" target=\"_blank\">#NEJMDataSummit<\/a>. I&#8217;ll be in the audience live at the event, and you can fully participate online.<\/p>\n<p>This post gives a little background and my own prep notes, with links to the winning submissions and more.<\/p>\n<h2>Background<\/h2>\n<p>Our November post opened:<\/p>\n<blockquote><p>You may have heard that back in January the\u00a0<em>New England Journal of Medicine\u00a0<\/em>created a firestorm by <a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMe1516564\" target=\"_blank\">noting that some said \u201cparasites\u201d<\/a>\u00a0about people who want to see a researcher\u2019s original data.\u00a0Many (including Vice President Biden, at Health Datapalooza (<a href=\"http:\/\/www.epatientdave.com\/2016\/05\/10\/vice-president-bidens-potent-speech-about-the-importance-of-data-in-cancer\/\" target=\"_blank\">video<\/a>)) have objected strongly, saying that data from one project might be useful to other researchers, which could accelerate cures (as in his son Beau\u2019s brain cancer death) and improve payback from public research funding (aka government grants).<\/p>\n<p>In what I think is an amazing development, NEJM has responded by saying \u201cGame on: we will release the entire dataset from a well known study (\u201cSPRINT\u201d) \u2013 let\u2019s see if anyone else\u00a0<em>can\u00a0<\/em>find new value.\u201d<\/p><\/blockquote>\n<p>What&#8217;s extraordinary is that while academic medicine and its journals are often said to live behind castle walls, this journal &#8211; the highest ranked in the world &#8211; has listened. The results are in, and they&#8217;re pretty astounding.<\/p>\n<p>Equally great, to me, is that the big two-day event next week is 100% free, open to the public. That means\u00a0<em>you<\/em>.<\/p>\n<h2>Links and prep notes<\/h2>\n<ul>\n<li>Home page: <a href=\"https:\/\/challenge.nejm.org\/pages\/home\">https:\/\/challenge.nejm.org<\/a><\/li>\n<li>About: <a href=\"https:\/\/challenge.nejm.org\/pages\/about\">https:\/\/challenge.nejm.org\/pages\/about<\/a>. \u00a0Note:\n<ul>\n<li>\u201cThoughtful, transparent systems for the responsible sharing of data are important in maximizing the contribution of the patients who put themselves at risk by participating in clinical trials.\u201d\n<ul>\n<li>Note in particular the acknowledgement of patients&#8217; role in research. So often this is overlooked in discussions of trials and their data.<\/li>\n<\/ul>\n<\/li>\n<li>The SPRINT trial whose data is used in this project: \u201c<a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa1511939\">A Randomized Trial of Intensive versus Standard Blood-Pressure Control<\/a> (N Engl J Med 373: 2103-2116). Conclusion from the abstract:\u00a0<em>(edited for lay-friendliness;\u00a0<\/em><em>emphasis added)<\/em>\n<ul>\n<li><b>Among patients at high risk<\/b> for cardiovascular events<br \/>\n[heart attack, stroke, and more]<br \/>\n(but without diabetes),<br \/>\ntreating to keep blood pressure under\u00a0<b>120 instead of 140<\/b><br \/>\nresulted in<b> lower rates<\/b><strong> of<\/strong> <b>major cardiovascular events<\/b> and <b>death.<\/b><br \/>\n(But there were significantly higher rates of some adverse events.)<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>So, that was the original study, based on following 9,361 patients for several years. <em>Lots\u00a0<\/em>of data.\u00a0The question was, could\u00a0<em>other\u00a0<\/em>researchers look at all that data and find additional valuable, high quality conclusions?<\/p>\n<p>This speaks directly to the issue raised by Biden and others. Is there real value to be had, or are people who ask to see that data (as some have suggested) merely &#8220;parasites&#8221;?<\/p>\n<h2>Results:<\/h2>\n<p>They received\u00a0<a href=\"https:\/\/challenge.nejm.org\/challenges\/the-sprint-data-analysis-challenge-challenge-round\">143 submissions<\/a>.\u00a0Each has a comment page for crowdsourced feedback. Look at\u00a0<a href=\"https:\/\/challenge.nejm.org\/pages\/winners\">the winners<\/a>\u00a0&#8211; seems to <em>me\u00a0<\/em>some new value was derived from that data:<\/p>\n<ul>\n<li><b><a href=\"https:\/\/challenge.nejm.org\/posts\/5826\">To Treat Intensively or Not \u2014 Individualized Decision Making Support Tool<\/a><\/b>\n<ul>\n<li>&#8220;In the era of personalized medicine, population-based treatment efficacy measures are not sufficient. Treatment decisions should be personalized by considering the individual&#8217;s specific characteristics, taking multiple outcomes into account, and not overlooking adverse events. We created a personalized tool to support clinicians when deciding on intensive hypertension treatment. This tool considers predicted benefits and harms, weighted by the perceived severity of the events they represent, thus allowing for an efficient, personalized, and evidence-based decision.&#8221;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li><b><a href=\"https:\/\/challenge.nejm.org\/posts\/5837\">Assessing the Impact of Intensive Blood Pressure Management in Chronic Kidney Disease Patients<\/a> <\/b>\u00a0<i>(note that this provides a new, focused warning about one of the study\u2019s main findings!)<\/i><\/li>\n<\/ul>\n<ul>\n<ul>\n<li>We analyzed findings from the largest trial of intensive blood pressure management in patients with chronic kidney disease [CKD].\n<ul>\n<li>&#8220;First, BP is harder to manage intensively in this population.<\/li>\n<li>&#8220;Second, primary outcomes are not improved by intensive as compared with standard BP management in CKD patients.<\/li>\n<li>&#8220;Third, in CKD patients, intensive management is associated with a higher risk of therapy-related adverse events.<\/li>\n<li>&#8220;Therefore, our study cautions physicians <b>against<\/b> applying the SPRINT-recommended intensive systolic BP target of &lt;120 mm Hg <b>to CKD patients.&#8221;<\/b><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/ul>\n<ul>\n<li><b><a href=\"https:\/\/challenge.nejm.org\/posts\/5815\">Development and Validation of a Clinical Decision Score to Maximize Benefit and Minimize Harm from Intensive Blood Pressure Treatment<\/a><\/b><\/li>\n<\/ul>\n<ul>\n<ul>\n<li>&#8220;Intensive blood pressure treatment can reduce the chance of having a heart attack, stroke, or other major cardiovascular illness, but it may increase the risk of a serious adverse event, such as kidney failure. We <b>developed and validated a clinical decision score<\/b> to i<b>dentify patients likely to experience benefits and unlikely to experience harms<\/b> when undergoing intensive treatment. The score was developed from SPRINT trial data and tested using both SPRINT and ACCORD-BP trial data.&#8221;<\/li>\n<\/ul>\n<\/ul>\n<h2>Is there real patient value in this? Are the findings useful?<\/h2>\n<p>A huge question in our era is increasingly, what&#8217;s the impact on patients? Clearly, new knowledge came out of this extraordinary project. Is it useful to patients &#8211; the people who have the problem? Let&#8217;s bring that thinking to this event. Comment, and let&#8217;s get as many of us to participate real-time as we can:<\/p>\n<ul>\n<li>Register (free) at <a href=\"http:\/\/events.nejm.org\" target=\"_blank\">events.nejm.org<\/a><\/li>\n<li>Plan to be online live, if you can. <a href=\"http:\/\/events.nejm.org\/webcast.php?cid=7000\">Test your system<\/a>.<\/li>\n<li>Look through the submissions, not just the winners.\u00a0Do you see anything else important that&#8217;s not in the top three?<\/li>\n<li>Follow the hashtag <a href=\"https:\/\/twitter.com\/search?f=tweets&amp;vertical=default&amp;q=%23nejmdatasummit\" target=\"_blank\">#NEJMDataSummit<\/a><\/li>\n<\/ul>\n<p>There will also be live discussion room during the event.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In November we posted about an extraordinary development:\u00a0NEJM Data Analysis Challenge: can others create value by seeing researchers\u2019 data?\u00a0The project has come to fruition, and the big event (free) is [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"give_campaign_id":0,"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","_price":"","_stock":"","_tribe_ticket_header":"","_tribe_default_ticket_provider":"","_tribe_ticket_capacity":"0","_ticket_start_date":"","_ticket_end_date":"","_tribe_ticket_show_description":"","_tribe_ticket_show_not_going":false,"_tribe_ticket_use_global_stock":"","_tribe_ticket_global_stock_level":"","_global_stock_mode":"","_global_stock_cap":"","_tribe_rsvp_for_event":"","_tribe_ticket_going_count":"","_tribe_ticket_not_going_count":"","_tribe_tickets_list":"[]","_tribe_ticket_has_attendee_info_fields":false,"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[59,7,3586],"tags":[4328,4402,7522,3994,5702,5194,7958,7931],"coauthors":[],"class_list":["post-19411","post","type-post","status-publish","format-standard","hentry","category-policy-issues","category-positive-patterns","category-research-issues","tag-brain-cancer","tag-game","tag-health-datapalooza","tag-open-data","tag-register","tag-research","tag-sprint","tag-vice-president-biden"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - 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