{"id":1771,"date":"2018-08-03T12:11:17","date_gmt":"2018-08-03T12:11:17","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmjebmspotlight\/?p=1771"},"modified":"2018-08-10T13:05:11","modified_gmt":"2018-08-10T13:05:11","slug":"david-sacketts-four-reasons-required-to-assess-treatment-effects-with-randomization","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmjebmspotlight\/2018\/08\/03\/david-sacketts-four-reasons-required-to-assess-treatment-effects-with-randomization\/","title":{"rendered":"David Sackett\u2019s four worries about observational evidence"},"content":{"rendered":"<p>&nbsp;<\/p>\n<p><em>EBM students, if you haven&#8217;t already seen this paper then it&#8217;s a must-read: <a href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S1098301515019099\">Why Did the Randomized Clinical Trial Become the Primary Focus of My Career<\/a>?\u00a0<\/em><\/p>\n<p style=\"text-align: right\">Carl Heneghan<\/p>\n<hr \/>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-thumbnail wp-image-1324 alignleft\" src=\"https:\/\/blogs.bmj.com\/bmjebmspotlight\/files\/2017\/06\/Carl-Heneghan-150x150.png\" alt=\"\" width=\"150\" height=\"150\" \/><\/p>\n<p>The late David Sackett, the first Director of CEBM, undertook, wrote about and researched the methods of randomized controlled trials for most of his career. Why? Largely because at the start of his career he was so \u2018worried\u2019 about the overuse of clinical observations to inform treatment effects that were causing substantial harms.<\/p>\n<p>This paper, published in <a href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S1098301515019099\">Value in Health<\/a>, sets out four concerns about observational evidence that requires randomised trials to negate them. His worries were:<\/p>\n<p>Worry 1: I Became Worried That Clinicians Might Preferentially Give New Treatments to Patients with Better Prognoses<\/p>\n<p>Worry 2: I Became Worried That Compliant Patients Might Have Better Prognoses, Regardless of Their Treatment<\/p>\n<p>Worry 3: I Became Worried That Patients Who Liked Their Rx Might Report Better Outcomes Unrelated to the True Efficacy of Their Treatments<\/p>\n<p>Worry 4: I Was Worried That Clinicians Who Liked Their Rx Might Report Spuriously Better Outcomes Among Patients Who Received Them<\/p>\n<p>In his conclusions,\u00a0Dave points out that \u2018the proponents of observational studies of efficacy have developed strategies and tactics for avoiding and\/or overcoming these four worries that have forced me into hard RCT labor for the past 48 years. Indeed, I am curious as to how they will (and could) tell whether they have avoided or solved them.\u2019<\/p>\n<p>Given the current epidemic of published observational studies for informing treatment effects, I think it\u2019s about time to revisit David Sackett\u2019s four worries and whether current research addresses them.<\/p>\n<hr \/>\n<p>References<\/p>\n<p><a href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S1098301515019099\">Why Did the Randomized Clinical Trial Become the Primary Focus of My Career<\/a>? Sackett, David L. Value in Health , Volume 18 , Issue 5 , 550 &#8211; 552<\/p>\n<hr \/>\n<p>BMJ\u00a0<a href=\"http:\/\/ebm.bmj.com\/\">Evidence-Based Medicine<\/a>\u00a0\u2013\u00a0original evidence-based research, insights and opinion<\/p>\n<p>Read more in the\u00a0<a href=\"http:\/\/ebm.bmj.com\/content\/early\/2018\/01\/24\/bmjebm-2018-110906\">Welcome to BMJ Evidence-Based Medicine Editorial<\/a>.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\" wp-image-1618 alignright\" src=\"https:\/\/blogs.bmj.com\/bmjebmspotlight\/files\/2018\/01\/Picture1-2-1.png\" alt=\"\" width=\"280\" height=\"145\" \/><\/p>\n<hr \/>\n<p><b>Competing interests<\/b><\/p>\n<p>Carl has received expenses and fees for his media work including BBC Inside Health. He holds grant funding from the NIHR, the NIHR School of Primary Care Research, The NIHR Oxford BRC\u00a0 and the WHO. He has also received income from the publication of a series of toolkit books. CEBM jointly runs the\u00a0<a title=\"\" href=\"http:\/\/evidencelive.org\/\">EvidenceLive<\/a>\u00a0Conference with the BMJ and the\u00a0<a title=\"\" href=\"http:\/\/www.preventingoverdiagnosis.net\/\">Overdiagnosis Conference<\/a>\u00a0with some international partners which are based on a\u00a0 non-profit model.<!--TrendMD v2.4.8--><\/p>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; EBM students, if you haven&#8217;t already seen this paper then it&#8217;s a must-read: Why Did the Randomized Clinical Trial Become the Primary Focus of My Career?\u00a0 Carl Heneghan The late David Sackett, the first Director of CEBM, undertook, wrote about and researched the methods of randomized controlled trials for most of his career. Why? [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/blogs.bmj.com\/bmjebmspotlight\/2018\/08\/03\/david-sacketts-four-reasons-required-to-assess-treatment-effects-with-randomization\/\">Read More&#8230;<\/a><\/p>\n","protected":false},"author":1,"featured_media":1772,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[14374,14378],"tags":[],"class_list":["post-1771","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-carl-heneghan","category-ebm-library"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>David Sackett\u2019s four worries about observational evidence - BMJ EBM Spotlight<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/blogs.bmj.com\/bmjebmspotlight\/2018\/08\/03\/david-sacketts-four-reasons-required-to-assess-treatment-effects-with-randomization\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"David Sackett\u2019s four worries about observational evidence - BMJ EBM Spotlight\" \/>\n<meta property=\"og:description\" content=\"&nbsp; EBM students, if you haven&#8217;t already seen this paper then it&#8217;s a must-read: Why Did the Randomized Clinical Trial Become the Primary Focus of My Career?\u00a0 Carl Heneghan The late David Sackett, the first Director of CEBM, undertook, wrote about and researched the methods of randomized controlled trials for most of his career. 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