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Quality Improvement Initiatives Raise Ethics Questions

 |  By jsimmons@healthleadersmedia.com  
   August 26, 2010

This summer, my family took a sidetrip to Weston, WV—home to what is now called the Trans-Allegheny Lunatic Asylum. This huge, now-empty stone building with the majestic clock tower was closed (as Weston State Hospital) in 1994—and opened for tours several years ago. But the stories it leaves behind can trigger a new perspective on a very modern issue: quality improvement initiatives and ethics.

Construction of the facility—which has been classified as the second largest hand-carved stone masonry building in the world (next to the Kremlin)—started in 1858. The design called for long and rambling wings that could provide therapeutic sunlight and air, in the midst of a bucolic environment for its patients—those identified with varying mental conditions or recuperating from illnesses such as tuberculosis.

But laced into that history of the hospital are stories of early 20th century treatments such as "hydrotherapy" with patients wrapped in sheets and suspended in ice water baths for hours or even days. Or, even darker yet, of transorbital lobotomies performed by medical professionals with ice pick-like instruments in the 1940s and 1950s.

These "treatments" are considered cruel and even barbaric by today's standards. But at the time, they were seen as providing "acceptable" outcomes—at least in the view of various medical professionals—that could improve the life of the patient.

While decades have passed since these treatments appeared and disappeared, an interesting question, though, continues to hover: are all medical organizations making sure that their quality initiatives are meeting ethical standards?

This issue is addressed in a brief "to advance the policy debate" compiled by the Commonwealth Fund. The authors note that over the last two decades, quality improvement initiatives have flourished among hospitals and healthcare systems. But, while enhancing the quality of healthcare is important—and often required by accrediting organizations and others—the process of improvement can raise ethical issues.

They note, for example, questions that were raised in 2001 about a project on end-stage renal disease that was funded by the Centers for Medicaid & Medicare Services. While CMS considered the project to be a quality improvement initiative, the Office for Human Research Protection (OHRP) determined it was human subject research and that it should have been reviewed by an institutional review boards (IRB) prior to implementation.

And, in 2007, an anonymous whistleblower accused the leaders of a project in Michigan (funded by the Agency for Healthcare Research and Quality) to reduce life?threatening infections in intensive care units—through the use of checklists—of not having received proper ethical review. Questions were raised about whether the project constituted research and if informed consent should have been obtained from all patients who were involved.

The authors found that "despite myriad proposals" regarding the ethical oversight of quality improvement, "surprisingly little empirical research" has been reported on the review and oversight of quality improvement initiatives.

To get a better understanding of where this issue is now, they carried out two surveys. One was conducted in collaboration with the Institute for Healthcare Improvement (IHI) in April 2009 of quality improvement practitioners that had participated in IHI's "100.000 Lives Campaign."

The majority of IHI respondents in the study self-identified as managers either in a quality improvement/safety department or other hospital department. Most of the respondents (83%) indicated that quality improvement initiatives conducted by their faculty and staff were subject to some type of review prior to implementation; most of those (85%) reported that the review is conducted most of the time or always.

A majority of respondents said that they also agreed that assessing established practices (67%), scientifically sound design (62%), transparency (62%), and the identification and minimization of potential conflicts (57%) were ethical considerations for quality improvement initiatives conducted at their institution.

The authors also sought out the opinions of hospital CEOs through a survey conducted last November. About 71% of the CEO respondents indicated that quality improvement initiatives conducted by faculty and staff affiliated with their organization always were reviewed by some entity within their organization prior to implementation; 26% said that quality improvement initiatives sometimes were reviewed prior to implementation.

A larger proportion of hospital CEO respondents (56%) reported that an oversight mechanism pays attention to ethical issues "well"—compared with the IHI group at 45%. And, nearly twice as many hospital CEOs (70%) as IHI quality improvement professionals (40%) indicated that QI initiatives at their institution are funded by internal sources.

Overall, this means that according to the authors' data, quality improvement initiatives are being routinely reviewed by a variety of internal mechanisms prior to implementation—although rarely through the institutional review board or any other independent body charged specifically with ethical oversight.

This is turn raises more questions about whether an independent review board could provide a more independent assessment of quality initiatives? Or, whether activities that pose little if any risks or burdens even require such a review?

As the authors note, those answers still aren't easy, and in fact, require more research—particularly on how existing review mechanisms for quality improvement initiatives are structured: This includes who reviews these activities, how they are reviewed, and whether such processes include an ethical assessment of the proposed QI intervention?

This research, they said, is essential to ensuring that quality of care is improved and patients' rights and interests protected. The long-lost voices of the residents former Weston State Hospital would probably agree.

Janice Simmons is a senior editor and Washington, DC, correspondent for HealthLeaders Media Online. She can be reached at jsimmons@healthleadersmedia.com.

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