Faith Healing and Subtraction Anxiety - Rajkumar - Circ CQO 2018

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 Healing’ and
‘Subtraction 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