Elsevier

The Lancet

Volume 384, Issue 9957, 22–28 November 2014, Pages 1826-1827
The Lancet

Comment
HEAT-PPCI sheds light on consent in pragmatic trials

https://doi.org/10.1016/S0140-6736(14)61040-0Get rights and content

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    HEAT-PPCI: heparin bests bivalirudin in STEMI, amid heated debate

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    This trial used a delayed consent process, in which patients were treated randomly with heparin or bivalirudin and consented afterward for data use; only 4 of 1820 patients declined enrollment in HEAT-PPCI.45 Supporters of this approach argue that upfront consent would have been unethical, delayed consent was an appropriate ethical design, and the trial importantly demonstrated efficacy of a more cost-effective treatment strategy.46 Although this approach seems feasible and acceptable to patients and regulators, an invasive intervention such as Impella or TandemHeart may not be as acceptable in the absence of informed consent.

  • Confronting Ethical and Regulatory Challenges of Emergency Care Research with Conscious Patients

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    Although many emergency care trials clearly pose more than minimal risks, there has been much discussion about whether comparative effectiveness trials of standard therapies specifically should be considered minimal risk.35 The debate over the Unfractionated Heparin Versus Bivalirudin in Primary Percutaneous Coronary Intervention study, for example, has centered around the claim that this trial comparing 2 approved anticoagulants for STEMI posed no risks over standard care.36 It is true that, in aggregate, such trials do not expose patients to different risks from standard care; however, applying the minimal risk designation in emergency care research is challenging.

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