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Faith Healing and Subtraction Anxiety - Rajkumar - Circ CQO 2018

'Faith

'Faith Healing' and 'Subtraction Anxiety' in Unblinded Trials of Procedures: Lessons from DEFER and FAME-2 for End Points in the ISCHEMIA Trial Christopher A. Rajkumar, Sukhjinder S. Nijjer, Graham D. Cole, Rasha Al-Lamee and Darrel P. Francis Downloaded from http://circoutcomes.ahajournals.org/ by guest on April 2, 2018 Circ Cardiovasc Qual Outcomes. 2018;11: doi: 10.1161/CIRCOUTCOMES.118.004665 Circulation: Cardiovascular Quality and Outcomes is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231 Copyright © 2018 American Heart Association, Inc. All rights reserved. Print ISSN: 1941-7705. Online ISSN: 1941-7713 The online version of this article, along with updated information and services, is located on the World Wide Web at: http://circoutcomes.ahajournals.org/content/11/3/e004665 An erratum has been published regarding this article. Please see the attached page for: /content/11/4/e000038.full.pdf Permissions: Requests for permissions to reproduce figures, tables, or portions of articles originally published in Circulation: Cardiovascular Quality and Outcomes can be obtained via RightsLink, a service of the Copyright Clearance Center, not the Editorial Office. Once the online version of the published article for which permission is being requested is located, click Request Permissions in the middle column of the Web page under Services. Further information about this process is available in the Permissions and Rights Question and Answer document. Reprints: Information about reprints can be found online at: http://www.lww.com/reprints Subscriptions: Information about subscribing to Circulation: Cardiovascular Quality and Outcomes is online at: http://circoutcomes.ahajournals.org//subscriptions/

Circulation: Cardiovascular Quality and Outcomes CORRECTION Correction to: Moving the Goalposts Into Unblinded Territory: The Larger Lessons of DEFER and FAME 2 and Their Implications for Shifting End Points in ISCHEMIA [‘Faith HealingandSubtraction Anxiety’ in Unblinded Trials of Procedures: Lessons from DEFER and FAME-2 for End Points in the ISCHEMIA Trial] In the article by Rajkumar et al, “Moving the Goalposts Into Unblinded Territory: The Larger Lessons of DEFER and FAME 2 and Their Implications for Shifting End Points in ISCHEMIA”, which published online on March 12, 2018 and appeared in the March issue of the journal (Circ Cardiovasc Qual Outcomes 2018;11:e004665. DOI: 10.1161/CIRCOUTCOMES.118.004665), we are making corrections in light of information provided by the ISCHEMIA trialists after the article was accepted. “It was on this basis that $84 million of United States National Heart, Lung, and Blood Institute (US NHLBI) funding was awarded…” should read “Eighty-four million dollars of United States National Heart, Lung, and Blood Institute (US NHLBI) funding was awarded…”. “However, on January 17, 2018, over 99% of the way through the recruitment period, an amendment was made to the clinicaltrials.gov website…” should be extended. It should read: “However, on January 17, 2018, over 99% of the way through the recruitment period, 2 an amendment was made to the clinicaltrials.gov website. 3 This amendment indicated that the primary endpoint for ISCHEMIA had been altered to cardiovascular death, nonfatal MI, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure. The ISCHEMIA investigators have now detailed the steps involved in the change, which began in June 2017 after a recommendation from an NHLBI-appointed Independent Advisory Panel.” 1 “… the primary end point that was pre-specified and not one that was postspecified” should read “…the primary end point of cardiovascular death or nonfatal MI. 3 ” “The trial closed to recruitment on January 31, 2018, and is expected to report within the next few months. 2” should read “The trial closed to recruitment on January 31, 2018. 2 ” “When the trial reports, we suggest that readers focus on the primary end point pre-specified not any versions edited near trial end when the great majority of events will have already accumulated.” should read “When the trial reports, we suggest that readers focus on the primary end point of cardiovascular death and nonfatal MI that was originally pre-specified (which the ISCHEMIA trial will now report as a secondary endpoint).” “…we must reflect on whether there is any meaning to the term primary end point if these goalposts can be moved at will after a trial has begun recruiting— and especially if a very prominent trial does so shortly before reporting its result…” should read “…we must reflect on whether there is any meaning to the term primary end point when goalposts are moved after a trial has begun recruiting despite the best intentions of investigators.” © 2018 American Heart Association, Inc. http://circoutcomes.ahajournals.org Circ Cardiovasc Qual Outcomes. 2018;11:e000038. DOI: 10.1161/HCQ.0000000000000038 April 2018 1

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