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WASHINGTON – The delayed consent approach that investigators used to run the HEAT-PPCI trial generated almost as much controversy as the surprising finding that unfractionated heparin was safer than bivalirudin for anticoagulating ST-segment elevation myocardial infarction patients undergoing primary coronary stenting.
"I’m extremely bothered by the fact that you entered patients into the study without getting their permission," said Dr. William W. O’Neill, who spoke from the stage following the HEAT-PPCI (How Effective are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention) report as a member of the discussion panel for the session at the annual meeting of the American College of Cardiology.
"There have been people who say that no one [experiencing an acute myocardial infarction] remembers their informed consent, but most of us have a very strong ethical concern. There is a social contract we make with our patients to make sure they are not subject to research without their permission. That’s in the Declaration of Helsinki," said Dr. O’Neill, medical director of the Center for Structural Heart Disease at Henry Ford Hospital in Detroit.
But Dr. Adeel Shahzad, who presented the study’s findings, and Dr. Rod Stables, the study’s principal investigator, unequivocally defended the ethics of their approach, and stressed that the design had been approved by three separate national bodies charged with ethical oversight of U.K. medical studies.
"We’re not advocating the use of delayed consent for all trials. Every trial has different circumstances. We compared two drugs that were in routine use throughout the world and that were used for licensed indications," Dr. Shahzad, an interventional cardiologist at Liverpool (England) Heart and Chest Hospital, said in reply to Dr. O’Neill’s criticism. "In the primary PCI [percutaneous coronary intervention] setting the patient is in pain and possibly under the influence of drugs. In this setting and with an average door-to-balloon time of 29 minutes we don’t believe that informed consent is possible."
"In HEAT-PPCI, 75% of patients were randomized within 9 minutes or arrival. It’s a debatable point whether it is possible to obtain any meaningful consent on that time schedule," said Dr. Stables, director of the cardiac catheterization laboratory at Liverpool Heart and Chest Hospital.
The study’s design called for the informed consent process to occur following intervention, once patients had stabilized. Of the 1,829 patients treated in Liverpool who met the study’s entry criteria, 1,812 (99%) subsequently gave their consent to be included in the trial. Dr. Stables also noted that in addition to the formal approval obtained from three U.K. medical ethics groups, the study’s design also won approval from a panel composed of patients, and the trial also employed a full-time patient advocate.
The ethics of the approach used in HEAT-PPCI were endorsed by both Dr. Spencer B. King III, an interventional cardiologist at St. Joseph’s Health System in Atlanta, and by Dr. David R. Holmes Jr., an interventional cardiologist and professor of medicine at the Mayo Clinic in Rochester, Minn.
Dr. Holmes recalled his own experience when hospitalized on an emergency basis for "massive" gastrointestinal bleeding. A few weeks later he was contacted about a study that he had agreed to participate in while in a very debilitated state before he received treatment; he had absolutely no recollection of ever agreeing to be in the study.
Dr. O’Neill, Dr. Shahzad, Dr. Stables, Dr. King, and Dr. Holmes had no relevant disclosures.
On Twitter @mitchelzoler
WASHINGTON – The delayed consent approach that investigators used to run the HEAT-PPCI trial generated almost as much controversy as the surprising finding that unfractionated heparin was safer than bivalirudin for anticoagulating ST-segment elevation myocardial infarction patients undergoing primary coronary stenting.
"I’m extremely bothered by the fact that you entered patients into the study without getting their permission," said Dr. William W. O’Neill, who spoke from the stage following the HEAT-PPCI (How Effective are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention) report as a member of the discussion panel for the session at the annual meeting of the American College of Cardiology.
"There have been people who say that no one [experiencing an acute myocardial infarction] remembers their informed consent, but most of us have a very strong ethical concern. There is a social contract we make with our patients to make sure they are not subject to research without their permission. That’s in the Declaration of Helsinki," said Dr. O’Neill, medical director of the Center for Structural Heart Disease at Henry Ford Hospital in Detroit.
But Dr. Adeel Shahzad, who presented the study’s findings, and Dr. Rod Stables, the study’s principal investigator, unequivocally defended the ethics of their approach, and stressed that the design had been approved by three separate national bodies charged with ethical oversight of U.K. medical studies.
"We’re not advocating the use of delayed consent for all trials. Every trial has different circumstances. We compared two drugs that were in routine use throughout the world and that were used for licensed indications," Dr. Shahzad, an interventional cardiologist at Liverpool (England) Heart and Chest Hospital, said in reply to Dr. O’Neill’s criticism. "In the primary PCI [percutaneous coronary intervention] setting the patient is in pain and possibly under the influence of drugs. In this setting and with an average door-to-balloon time of 29 minutes we don’t believe that informed consent is possible."
"In HEAT-PPCI, 75% of patients were randomized within 9 minutes or arrival. It’s a debatable point whether it is possible to obtain any meaningful consent on that time schedule," said Dr. Stables, director of the cardiac catheterization laboratory at Liverpool Heart and Chest Hospital.
The study’s design called for the informed consent process to occur following intervention, once patients had stabilized. Of the 1,829 patients treated in Liverpool who met the study’s entry criteria, 1,812 (99%) subsequently gave their consent to be included in the trial. Dr. Stables also noted that in addition to the formal approval obtained from three U.K. medical ethics groups, the study’s design also won approval from a panel composed of patients, and the trial also employed a full-time patient advocate.
The ethics of the approach used in HEAT-PPCI were endorsed by both Dr. Spencer B. King III, an interventional cardiologist at St. Joseph’s Health System in Atlanta, and by Dr. David R. Holmes Jr., an interventional cardiologist and professor of medicine at the Mayo Clinic in Rochester, Minn.
Dr. Holmes recalled his own experience when hospitalized on an emergency basis for "massive" gastrointestinal bleeding. A few weeks later he was contacted about a study that he had agreed to participate in while in a very debilitated state before he received treatment; he had absolutely no recollection of ever agreeing to be in the study.
Dr. O’Neill, Dr. Shahzad, Dr. Stables, Dr. King, and Dr. Holmes had no relevant disclosures.
On Twitter @mitchelzoler
WASHINGTON – The delayed consent approach that investigators used to run the HEAT-PPCI trial generated almost as much controversy as the surprising finding that unfractionated heparin was safer than bivalirudin for anticoagulating ST-segment elevation myocardial infarction patients undergoing primary coronary stenting.
"I’m extremely bothered by the fact that you entered patients into the study without getting their permission," said Dr. William W. O’Neill, who spoke from the stage following the HEAT-PPCI (How Effective are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention) report as a member of the discussion panel for the session at the annual meeting of the American College of Cardiology.
"There have been people who say that no one [experiencing an acute myocardial infarction] remembers their informed consent, but most of us have a very strong ethical concern. There is a social contract we make with our patients to make sure they are not subject to research without their permission. That’s in the Declaration of Helsinki," said Dr. O’Neill, medical director of the Center for Structural Heart Disease at Henry Ford Hospital in Detroit.
But Dr. Adeel Shahzad, who presented the study’s findings, and Dr. Rod Stables, the study’s principal investigator, unequivocally defended the ethics of their approach, and stressed that the design had been approved by three separate national bodies charged with ethical oversight of U.K. medical studies.
"We’re not advocating the use of delayed consent for all trials. Every trial has different circumstances. We compared two drugs that were in routine use throughout the world and that were used for licensed indications," Dr. Shahzad, an interventional cardiologist at Liverpool (England) Heart and Chest Hospital, said in reply to Dr. O’Neill’s criticism. "In the primary PCI [percutaneous coronary intervention] setting the patient is in pain and possibly under the influence of drugs. In this setting and with an average door-to-balloon time of 29 minutes we don’t believe that informed consent is possible."
"In HEAT-PPCI, 75% of patients were randomized within 9 minutes or arrival. It’s a debatable point whether it is possible to obtain any meaningful consent on that time schedule," said Dr. Stables, director of the cardiac catheterization laboratory at Liverpool Heart and Chest Hospital.
The study’s design called for the informed consent process to occur following intervention, once patients had stabilized. Of the 1,829 patients treated in Liverpool who met the study’s entry criteria, 1,812 (99%) subsequently gave their consent to be included in the trial. Dr. Stables also noted that in addition to the formal approval obtained from three U.K. medical ethics groups, the study’s design also won approval from a panel composed of patients, and the trial also employed a full-time patient advocate.
The ethics of the approach used in HEAT-PPCI were endorsed by both Dr. Spencer B. King III, an interventional cardiologist at St. Joseph’s Health System in Atlanta, and by Dr. David R. Holmes Jr., an interventional cardiologist and professor of medicine at the Mayo Clinic in Rochester, Minn.
Dr. Holmes recalled his own experience when hospitalized on an emergency basis for "massive" gastrointestinal bleeding. A few weeks later he was contacted about a study that he had agreed to participate in while in a very debilitated state before he received treatment; he had absolutely no recollection of ever agreeing to be in the study.
Dr. O’Neill, Dr. Shahzad, Dr. Stables, Dr. King, and Dr. Holmes had no relevant disclosures.
On Twitter @mitchelzoler
EXPERT OPINION AT ACC 2014