OHRP Allows ICU Checklist Study to Resume
SHM and a coalition of medical organizations successfully challenged the Office of Human Research Protections (OHRP), leading the federal agency on Feb. 15 to overturn its ban on collecting data from a checklist program in use at more than 100 Michigan intensive-care units (ICU).
Quality improvement (QI) researchers were shocked when the OHRP froze a multicenter project investigating the use of checklists to reduce catheter-related infections.
Even though this simple intervention had been shown to dramatically cut ICU infection rates, the OHRP opted to halt the study because Johns Hopkins researchers hadn't run their protocols by the institutional review boards (IRBs) of the 100-plus hospitals participating in the study.
Fearing this ruling might have a chilling effect on QI studies nationwide, SHM immediately forged an alliance with several other medical organizations to challenge the OHRP's decision.
On Feb. 5, these organizations jointly sent a letter to Health and Human Services (HHS) Secretary Mike Leavitt, asking him to lift the OHRP's ban on data collection. The letter was co-signed by the Society of Critical Care Medicine, the American Thoracic Society, the American Association of Critical Care Nurses, and the American College of Chest Physicians.
In addition, SHM posted a letter on its Legislative Action Center Web page (at www.hospitalmedicine.org/beheard) so members could add their voices to the protest.
"I couldn't be more pleased with the way that SHM and hospitalists more generally identified the OHRP ruling as a threat to patient safety and quality, and mobilized resources to change the policy," says Robert Wachter, MD, who spotlighted the OHRP's ban on his blog, "Wachter's World" (www.wachtersÂworld.org). "Our success in this case proves that we will advocate for our patients, will enlist key partners, and will not be easily deterred. This is a proud moment for our field."
What shocked many was the breadth of the OHRP's ruling—and the rationale behind it. The OHRP's problem with the Hopkins study wasn't that the intervention was harmful—or even risky. The problem was that researchers Pronovost, et al., had published their results in the New England Journal of Medicine in 2006 and hadn't treated this study as "human subjects research".
In general, the OHRP's goals were laudable, says Dr. Wachter, professor and chief of the division of hospital medicine and a professor at the University of California at San Francisco and a former president of the SHM. They wanted to protect patients.
"I'm not clamoring to get rid of IRBs or to subject unwitting patients to potentially harmful therapies," Dr. Wachter says. "But it's crucial to find the right balance between protections built into the research world and allowing people to do quality improvement. This ruling is wrong."
Strategies to improve the quality of care—and measurements of the effect of those strategies—are a constant goal of hospital medicine, Dr. Wachter says. "This is the kind of thing that hospitalists should be doing as soon as they wake up in the morning," he asserts.
The checklist at the center of the controversy included five easily implemented procedures that the Centers for Disease Control and Prevention had previously identified as effective in reducing the rate of infections that could result when a central line catheter was inserted. Among the procedures on the checklist were such seemingly commonsense measures as hand washing, cleaning the patient's skin with chlorhexidine, and using barrier precautions during catheter insertions.
The Hopkins researchers suspected that in the busy ICU environment, these procedures were not routinely followed. Physicians might benefit from a reminder—a checklist.
To determine whether something as simple as a checklist could have an effect on infection rates, researchers from the Johns Hopkins Center for Innovation in Quality Patient Care partnered with 103 hospitals in Michigan that agreed to implement the checklists and keep track of infection rates.
When the researchers compared infection rates before and after the checklists were implemented, they found infections had dropped by two-thirds within the first three months. That's pretty significant when you consider that each year in ICUs across the nation, there are 80,000 catheter-related bloodstream infections that result in an estimated 28,000 patient deaths.
The Hopkins researchers figured they wouldn't have problems with OHRP because they weren't studying a new, unproven intervention. They were simply trying to discover the impact of providing a checklist of proven procedures.
Just to be on the safe side, though, the researchers presented their plans to the Hopkins IRB, which determined that the study was exempt from review.
So it surprised everyone when the OHRP, acting on an anonymous complaint, weighed in and shut down data collection after ruling that IRBs from each of the 103 hospitals participating in the study would need to separately evaluate and approve the study.
"Most people read about this and their jaws dropped," Dr. Wachter says. "They couldn't believe that the federal government would restrict research on the use of a checklist. It's wacky."
It was a perfect example of regulatory overreach, Dr. Wachter says.
"It can be challenging to draw the line," he adds. "But, to me, it defies common sense to say that a program in which we are going to implement a checklist and then collect data to see if it works constitutes research and therefore requires the same amount of patient protection as a study of a new device or a potentially toxic medication."
What made the OHRP ruling seem even more odd was the fact that another division of the HHS, the Agency for Healthcare Research and Quality, had added Dr. Pronovost's study to its list of "classic" papers shortly after the research was published.
Making matters worse in many researchers' minds was the fact the OHRP didn't stop with this study. An official letter to officials at Johns Hopkins extended the agency's reach to all Hopkins "quality assurance/quality improvement proposals for which federal funding is being sought."
The OHRP ordered that these proposals be "examined to determine if IRB review was conducted or if exempt status was not granted inappropriately. If these are not the case, the [principal investigators] for the proposals will be contacted and informed that prospective data collection requires IRB review and that an application for exempt status will not be accepted for these projects."
And the OHRP went even further. The November letter suggested that even quality assurance/quality improvement studies that included retrospective reviews might be construed as "human subjects research."
In essence, that means any attempt to evaluate the impact of any type of change in procedures meant to improve quality of care would require IRB scrutiny and—quite likely—patient consents, says Mary Ann Baily, PhD, an associate for ethics and health policy at the Hastings Center in Garrison, N.Y.
"I think it's very maddening," Dr. Baily says. "The OHRP has created an impossible situation. Why in heavens name would the OHRP want to tie QI researchers up in knots?"
Despite multiple requests from The Hospitalist, officials at the OHRP declined to comment.
Some QI researchers see the need for regulation. There should be some oversight, even when it comes to QI, says Lakshmi Halasyamani, MD, vice chair for the department of medicine at St. Joseph Mercy Hospital in Ann Arbor, Mich., and a member of SHM's Board of Directors. While the intervention involved in the Johns Hopkins case seems relatively benign, this isn't always the case with QI.
It comes down to evaluating the level of risk to patients, says Dr. Halasyamani. And there needs to be someone, somewhere in the process evaluating the risks to patients of each intervention, Dr. Halasyamani says.
"We shouldn't be creating a whole new level of bureaucracy that will slow down low-risk interventions that could have a huge impact," she adds. "But, you want someone looking at whether the interventions could have a downside."
When it's a low-risk intervention—like the one initiated by the Johns Hopkins researchers—the forms filled out by patients giving consent for treatment should be enough, Dr. Halasyamani says.
Before the OHRP's reversal, Dr. Wachter explained the urgency of the campaign to overturn the research ban.
"What about the next time I want to do a quality improvement study, or when one of my residents on a six-month rotation wants to do one?" he asked. "I'm going to say I don't think you should. It's going to take a month to get IRB approval and then, potentially, every patient, physician, nurse—basically everyone who comes into contact with the intervention—will need to be consented. The ruling will shut down innovation."™
SHM and a coalition of medical organizations successfully challenged the Office of Human Research Protections (OHRP), leading the federal agency on Feb. 15 to overturn its ban on collecting data from a checklist program in use at more than 100 Michigan intensive-care units (ICU).
Quality improvement (QI) researchers were shocked when the OHRP froze a multicenter project investigating the use of checklists to reduce catheter-related infections.
Even though this simple intervention had been shown to dramatically cut ICU infection rates, the OHRP opted to halt the study because Johns Hopkins researchers hadn't run their protocols by the institutional review boards (IRBs) of the 100-plus hospitals participating in the study.
Fearing this ruling might have a chilling effect on QI studies nationwide, SHM immediately forged an alliance with several other medical organizations to challenge the OHRP's decision.
On Feb. 5, these organizations jointly sent a letter to Health and Human Services (HHS) Secretary Mike Leavitt, asking him to lift the OHRP's ban on data collection. The letter was co-signed by the Society of Critical Care Medicine, the American Thoracic Society, the American Association of Critical Care Nurses, and the American College of Chest Physicians.
In addition, SHM posted a letter on its Legislative Action Center Web page (at www.hospitalmedicine.org/beheard) so members could add their voices to the protest.
"I couldn't be more pleased with the way that SHM and hospitalists more generally identified the OHRP ruling as a threat to patient safety and quality, and mobilized resources to change the policy," says Robert Wachter, MD, who spotlighted the OHRP's ban on his blog, "Wachter's World" (www.wachtersÂworld.org). "Our success in this case proves that we will advocate for our patients, will enlist key partners, and will not be easily deterred. This is a proud moment for our field."
What shocked many was the breadth of the OHRP's ruling—and the rationale behind it. The OHRP's problem with the Hopkins study wasn't that the intervention was harmful—or even risky. The problem was that researchers Pronovost, et al., had published their results in the New England Journal of Medicine in 2006 and hadn't treated this study as "human subjects research".
In general, the OHRP's goals were laudable, says Dr. Wachter, professor and chief of the division of hospital medicine and a professor at the University of California at San Francisco and a former president of the SHM. They wanted to protect patients.
"I'm not clamoring to get rid of IRBs or to subject unwitting patients to potentially harmful therapies," Dr. Wachter says. "But it's crucial to find the right balance between protections built into the research world and allowing people to do quality improvement. This ruling is wrong."
Strategies to improve the quality of care—and measurements of the effect of those strategies—are a constant goal of hospital medicine, Dr. Wachter says. "This is the kind of thing that hospitalists should be doing as soon as they wake up in the morning," he asserts.
The checklist at the center of the controversy included five easily implemented procedures that the Centers for Disease Control and Prevention had previously identified as effective in reducing the rate of infections that could result when a central line catheter was inserted. Among the procedures on the checklist were such seemingly commonsense measures as hand washing, cleaning the patient's skin with chlorhexidine, and using barrier precautions during catheter insertions.
The Hopkins researchers suspected that in the busy ICU environment, these procedures were not routinely followed. Physicians might benefit from a reminder—a checklist.
To determine whether something as simple as a checklist could have an effect on infection rates, researchers from the Johns Hopkins Center for Innovation in Quality Patient Care partnered with 103 hospitals in Michigan that agreed to implement the checklists and keep track of infection rates.
When the researchers compared infection rates before and after the checklists were implemented, they found infections had dropped by two-thirds within the first three months. That's pretty significant when you consider that each year in ICUs across the nation, there are 80,000 catheter-related bloodstream infections that result in an estimated 28,000 patient deaths.
The Hopkins researchers figured they wouldn't have problems with OHRP because they weren't studying a new, unproven intervention. They were simply trying to discover the impact of providing a checklist of proven procedures.
Just to be on the safe side, though, the researchers presented their plans to the Hopkins IRB, which determined that the study was exempt from review.
So it surprised everyone when the OHRP, acting on an anonymous complaint, weighed in and shut down data collection after ruling that IRBs from each of the 103 hospitals participating in the study would need to separately evaluate and approve the study.
"Most people read about this and their jaws dropped," Dr. Wachter says. "They couldn't believe that the federal government would restrict research on the use of a checklist. It's wacky."
It was a perfect example of regulatory overreach, Dr. Wachter says.
"It can be challenging to draw the line," he adds. "But, to me, it defies common sense to say that a program in which we are going to implement a checklist and then collect data to see if it works constitutes research and therefore requires the same amount of patient protection as a study of a new device or a potentially toxic medication."
What made the OHRP ruling seem even more odd was the fact that another division of the HHS, the Agency for Healthcare Research and Quality, had added Dr. Pronovost's study to its list of "classic" papers shortly after the research was published.
Making matters worse in many researchers' minds was the fact the OHRP didn't stop with this study. An official letter to officials at Johns Hopkins extended the agency's reach to all Hopkins "quality assurance/quality improvement proposals for which federal funding is being sought."
The OHRP ordered that these proposals be "examined to determine if IRB review was conducted or if exempt status was not granted inappropriately. If these are not the case, the [principal investigators] for the proposals will be contacted and informed that prospective data collection requires IRB review and that an application for exempt status will not be accepted for these projects."
And the OHRP went even further. The November letter suggested that even quality assurance/quality improvement studies that included retrospective reviews might be construed as "human subjects research."
In essence, that means any attempt to evaluate the impact of any type of change in procedures meant to improve quality of care would require IRB scrutiny and—quite likely—patient consents, says Mary Ann Baily, PhD, an associate for ethics and health policy at the Hastings Center in Garrison, N.Y.
"I think it's very maddening," Dr. Baily says. "The OHRP has created an impossible situation. Why in heavens name would the OHRP want to tie QI researchers up in knots?"
Despite multiple requests from The Hospitalist, officials at the OHRP declined to comment.
Some QI researchers see the need for regulation. There should be some oversight, even when it comes to QI, says Lakshmi Halasyamani, MD, vice chair for the department of medicine at St. Joseph Mercy Hospital in Ann Arbor, Mich., and a member of SHM's Board of Directors. While the intervention involved in the Johns Hopkins case seems relatively benign, this isn't always the case with QI.
It comes down to evaluating the level of risk to patients, says Dr. Halasyamani. And there needs to be someone, somewhere in the process evaluating the risks to patients of each intervention, Dr. Halasyamani says.
"We shouldn't be creating a whole new level of bureaucracy that will slow down low-risk interventions that could have a huge impact," she adds. "But, you want someone looking at whether the interventions could have a downside."
When it's a low-risk intervention—like the one initiated by the Johns Hopkins researchers—the forms filled out by patients giving consent for treatment should be enough, Dr. Halasyamani says.
Before the OHRP's reversal, Dr. Wachter explained the urgency of the campaign to overturn the research ban.
"What about the next time I want to do a quality improvement study, or when one of my residents on a six-month rotation wants to do one?" he asked. "I'm going to say I don't think you should. It's going to take a month to get IRB approval and then, potentially, every patient, physician, nurse—basically everyone who comes into contact with the intervention—will need to be consented. The ruling will shut down innovation."™