Moral distress, the inability to do what's right, plagues health-care workers in pandemic; first step to fight it may be talking about it

By Abigail Latimer

Since last spring, news-media headlines have been inundated with stories describing the scary circumstances facing medical workers in hospitals and facilities across the nation. Medical workers have been praised as heroes and regarded as the backbone of fighting this pandemic. We have heard stories of 80-hour-plus work weeks, with physical and mental exhaustion, and many of them contracting Covid-19, sometimes fatally.

The long-term consequences of their work in the pandemic is not yet known. Recently, as another Covid-19 surge overwhelmed some hospitals in other states and triggered restrictions again, we heard cries of burnout and hypothetical phrases like, “You think Covid is bad, wait till you don’t have an ICU nurse.” And they’re not wrong.

Some may be familiar with the concept of burnout — the point at which a helping professional has reached maximum capacity to be able to care compassionately while still preserving some trace amounts of sanity and emotional reserve. But what we’re not talking about is the devastating consequences that something called “moral distress” is causing and will likely cause long-term. 

Moral distress is the immediate and lingering reaction that health-care professionals have when they cannot do what they feel is ethically and morally right to do. Moral distress can cause psychological, emotional, and physical pain and consistently contributes to why professionals quit their professions.

Moral distress is not a new concept in health care, but is likely exacerbated by the pandemic. Examples of moral distress could be when there is not enough personal protective equipment or staff to care for a patient, or a medical worker cannot alleviate suffering at the end of life. Feelings like powerlessness, anger, worry, and guilt wreak havoc as so many helping professionals tie their identity to their professional identity; it’s who they are: "If I cannot do my job as I am professionally obligated to do, what does that say about me?" These reactions occur despite many of the situations being out of their control.

We do not yet know how to alleviate moral distress without addressing the sociopolitical and environmental factors that contribute to its presence in the first place. For some, talking with other people and naming their distress has been helpful. For others, distraction and avoidance to get through it seem like the best thing to do.

Treatment for moral injury, a similar concept rooted in military service, tells us that acceptance and forgiveness may help lessen the impacts of accumulating moral distress. But accepting difficult and distressing thoughts and feelings, and then forgiving ourselves or others, are not easy tasks. They are especially challenging when so many of these circumstances could be avoided by the actions of others. But latching on to blame and anger has typically only worsened distressing feelings, as natural and expected as these feelings may be.

Although there are no easy answers or quick fixes to a complicated problem, talking about it may be a start.

Abigail Latimer is a licensed clinical social worker and a Ph.D. candidate in the University of Kentucky College of Social Work, researching moral distress in health-care professionals and advanced illnesses in older adults. This was first published in the Lexington Herald-Leader.

Health chief goes another round with legislators, pushing back on data questions and answering queries on schools, other topics

By Al Cross
Kentucky Health News

FRANKFORT, Ky. – Republican legislators kept up their questioning of the state's coronavirus data Thursday, and the state health commissioner and Democratic lawmakers pushed back.

Sen. Danny Carroll

Sen. Danny Carroll of Paducah, co-chair of the Program Review and Investigations Committee, was the leading questioner and most outspoken legislator, just as he was at the panel's Aug. 13 meeting, when the committee heard from Dr. Steven Stack, commissioner of the Department for Public Health, and Doug Thoroughman, the state's acting chief epidemiologist.

Carroll kept relying Thursday on Thoroughman's tacit acknowledgement, in response to a Carroll question last month, that the positive-test rate that the state reports daily is not accurate, because of imperfect state and federal reporting systems. Thoroughman also said that the rate is useful for comparison over time because its method of calculation remains the same.

Thursday, Carroll noted that some test results have been delayed for weeks, and asked, "How can we have faith in daily numbers?" He said Democratic Gov. Andy Beshear never includes a disclaimer when giving the figure.

Dr. Steven Stack

Stack replied that while the data is "imperfect," it is "incredibly valuable. He noted that the state's daily report has an asterisk leading to a long footnote explaining how the rate is calculated.

He noted that the rate is an average over the previous seven days, and “I believe it becomes a very useful and accurate measure” for seeing trends. He said his department has undertaken "an unprecedented process" to get enough data for rates for about 80 counties.

Carroll replied, "The public sees the governor on TV talking about cases and positive rate" that changes from day to day . . . There is a stress that is put on our people as a result of these numbers." He quoted Thoroughman as saying that the numbers are not accurate, and said. "From an ethical standpoint, I struggle with the comfort level of putting this information out on a daily basis."

Stack replied, "I’m sorry you have such low confidence . . . " and Carroll interjected, "It’s not me. I hear it from my constituents daily. They’re mad about this."

Stack said he hears from others who are grateful for the information, and "It's possible for people to reach different conclusions from same information."

He added, "I don’t feel my ethics are compromised or challenged. . . . The metrics we use and the way we create them are consistent with the state of the art as best as public-health professionals can do it." He said President Trump uses weekly data on positive tests, and told Carroll, "Your concern might be that the president of the United States is misleading the public."

At another point, Carroll noted that the committee had also asked to hear again from Thoroughman, and asked why he wasn't present. Stack replied, "I’ve got him doing a lot of other work and I’m the commissioner," the person ultimately responsible for answering questions about the department.

Carroll said that was "disappointing . . . were it not for Dr. Thoroughman, I’m not sure we would know now that our positivity rates were off."

Toward the end of the meeting, after he and Stack went back and forth about a medical waiver to exempt a special-needs student from the mask mandate, Carroll boiled over.

He said of the state's reporting, "It’s being used to manipulate our people, to make our people scared, to control our people. It’s not accurate and its portrayed as being accurate."

Essentially repeating what he said at the last meeting, Carroll said, "Half of this state does not believe a word that you all say when it comes to the data." He said "All of this could have been avoided had the administration reached out" to leaders of the legislature's Republican majority about pandemic matters.

Sen. Karen Berg, M.D.

Earlier, Democratic Sen. Karen Berg of Louisville, a physician, complimented state health officials' work and said, “They need us to understand it and trust it” so legislators can tell constituents “We have got our best minds working on it . . . It will never be perfect. . . . My constituents have different reactions from Senator Carroll’s. . . . Our responsibility is to get on board and let’s do the best we can.”

Apparently addressing her colleagues, Berg said health-care providers are scared of the virus, and “You all need to understand . . . this is not the flu, this is not a hoax, this has nothing to do with politics or how you want it to be.”

Rep. Adam Koenig

A moderate voice: Rep. Adam Koenig, R-Erlanger, said health-care providers “deserve more thanks than they’re getting,” but “There’s nothing wrong with asking difficult questions.” He told Stack, “It’s been a wonderful opportunity for you to dispel misinformation. . . . No one up here thinks this is a hoax; this is not a political witch hunt; these are questions we get; there’s a lot of frustration.”

Earlier, Carroll had asked Stack, "Why do we not react the same way to these other diseases that we do to covid-19?"

Stack replied, "It's much more dangerous, everybody’s susceptible, and the sheer numbers . . . It's killing a lot more people," and there is no treatment that works on most patients. "There’s over 190,000 Americans who have died in six months. That way outstrips influenza." 

He said that the ultimate mortality rate for covid-19 will probably be about 1 percent, and if only one-third of Kentuckians got infected in a year's time, and 1% died, "That’s 15,000 Kentuckians. . . . That’s why it’s getting so much attention."

Death data: Rep. Lynn Bechler, R-Marion, the other co-chair, asked Stack about the recent notice from the Centers for Disease Control and Prevention that only 6 percent of covid-19 fatalities had no other health conditions that could have contributed to their deaths.

"I didn’t think it was newsworthy, quite frankly," Stack said, "because what we have said all along is that the most vulnerable population is people over 60 or 65 and with chronic medical conditions."

Bechler asked if it was "reasonable to suspect that 94 percent of deaths in Kentucky have underlying conditions." Stack said, "It could be even higher," since Kentucky ranks very high in chronic medical conditions.

Sen. Steve West, R-Paris, told Stack that "a lot of Kentuckians are wondering" about the death rate.

Stack replied, "The question is, how do we assign the immediate cause of death?" He said it's possible that people who have died of covid-19 "would have died in six months anyway" from another condition, but the state "follows the long-established norms we use for any other disease case."

In one of his written responses to questions asked at the last meeting, Stack said, "For death certificates for which the cause of death is not clear as to the contribution of covid-19, or appears to incorrectly include or exclude covid-19 as contributory to the cause of death, the committee reviews patient medical records, discusses the information available, and reaches consensus opinion on whether covid-19 is appropriate for inclusion or exclusion." 

He said the committee had reviewed 41 deaths through Sept. 8 and found that 17 had been removed from the covid-19 list. Through that date, the state had reported just under 1,000 covid-19 deaths.

Sen. Whitney Westerfield

In another written response, to a question posed by Sen. Whitney Westerfield, R-Hopkinsville, Stack said the positive-test rate "is more challenging to make precise due to variable timing of sample collection vs. test-result reporting and due to longstanding limitations in test-reporting policies, processes, and technologies. However, when these limiting variables stay constant, and data are averaged over a period of time, this metric is very helpful for trending purposes."

Asked how long health officials keep contact-tracing data, and whether it is being used for any purpose other than to trace contacts, Stack said, "Basic information is gathered; name, address, phone number, e-mail, etc. Local health departments and Department for Public Health epidemiologists, disease investigators and limited supervisory personnel have access to this. This data is not used for any other purpose other than to trace contacts. Privacy and data security standards are well established and maintained."

Schools: Westerfield asked Stack if he had "any information indicating a return to in-person schooling" before Sept. 28, the date Beshear has recommended.

Stack said they are sticking to that date, and wanted the extra time to learn from the experience of other states. He said he and Beshear are "working on number of things to announce Monday." They have indicated that will include county-level data to guide local decisions.

He said fans are being allowed in stadiums, with strict limits, because "the public demands to be in those stadiums. . ..  Going into a stadium in the middle of an epidemic is not a good idea." He said one stadium wanted 18,000 fans, "which means 600 infected people, shouting and screaming," and people in VIP suites. He estimated that could result in nine to 20 hospitalizations per game, and two deaths.

“We certainly can’t live in fear and not get back to some activities, but we can’t be reckless and careless about it, Stack said. “You could just turbocharge an epidemic,” especially in a major city like Louisville.

In a written question from the last meeting, Westerfield asked if "school data related to abuse/dependency/neglect referrals, substance use [and] behavioral health referrals [is] weighed against covid data when making the recommendations and orders related to schools."

Stack replied in writing, "These are all public-health issues. Social-emotional status of students, food insecurity, drug overdoses, child abuse, etc. all weigh on the minds of public health. Balancing these issues with the effects of a deadly virus that spreads so rapidly presents challenges. However, death or long-term health impacts on individuals from this virus cannot be reversed. Currently, these unintended consequences of managing covid-19 are not contemporaneously measureable as [are] individuals diagnosed with covid and any associated deaths. Data is being collected on abuse/neglect as well as for overdose deaths and other behavioral health impacts. The use of medication-assisted therapy, telehealth and other tele-visitation put in place since the very early stages of covid-19’s entrance into Kentucky has been very helpful. The assessment of the full consequences of covid-19 and impact of the measures taken to minimize the impact on individuals and the economy will be measured and studied for years to come."

A video of the committee meeting is on the KET website.

Widely noted U of L paralysis researcher loses federal funding over concerns about validity of data and oversight of her work

Dr. Susan Harkema

Dr. Susan Harkema stepped into the stoplight as a premier medical researcher at the University of Louisville the moment one of her paralyzed patients wiggled his toe.

News of the accomplishment spread quickly. She was featured in Time magazine and interviewed on "Good Morning America" and CNN. The publicity attracted more funding and patients to U of L.

But in March, a federal agency revoked funding from one of her studies, citing concerns about oversight and data validity. Meanwhile, the U.S. Office for Human Research Protections has its own review underway, a spokeswoman told Kate Howard of the Kentucky Center for Investigative Reporting. The scrutiny could have lasting consequences on future research.

In discontinuing the $914,000 study it funded, the National Institute on Disability, Independent Living and Rehabilitation Research cited an internal U of L audit and "numerous instances of non-compliance" of rules that must be followed. Elizabeth Woeckner, president of Citizens for Responsible Care and Research, a nonprofit watchdog group, told Howard she’s rarely seen a federal agency pull funding.

"In my experience, it’s a cold day in hell," Woeckner said.

A U of L review board found multiple problems with the study, which measured the effect of a muscle relaxer, Baclofen, on paralyzed patients using treadmills. Among the problems: U of L investigators found evidence of more than 150 possible "adverse events" that researchers failed to report, including a participant who reported severe pain in a knee pain that was discovered to be fractured. Some participants signed the wrong consent forms. In addition, research records had no follow-up data and no information about patients' medication compliance, Howard notes.

Inconsistencies led some patients to pay for therapy when insurance stopped covering part of the treatment, even though the study consent form never mentioned additional costs. Harkema maintained in an interview with Howard last month that staffers explained the potential for extra costs both orally and in a separate handout.

Despite the findings, the board decided that Harkema’s study should continue.

Harkema began recruiting patients for the Baclofen study in 2012. The study's goal was to measure the success of the drug in patients who perform locomotor training, which uses harnesses to help paralyzed patients stand and step on a treadmill.

Researchers sought to determine if patients using the drug saw different outcomes during 80 sessions of treadmill training over a span of four months.

Problems arose when two doctors involved with the study sent complaints to federal and university regulators. Steve Williams, a doctor who worked with Harkema on the study, alleged problems with Harkema’s ethics and research.

Last fall, Williams sent letters to U of L’s Institutional Review Board, a university-level organization that oversees all research studies, and to the National Institute on Disability, Independent Living and Rehabilitation Research about four of Harkema’s studies. Only the Baclofen study used federal funds.

Williams, who has since left U of L for a position at the University of Washington, told Howard that university officials weren’t willing to admit Harkema’s studies were sloppy. He alleges that Harkema's studies take advantage of a "vulnerable population."

"The research enterprise did not do their job protecting human subjects, and they let their concerns about other research funding … bias what they knew they should do, to do the right thing to protect people," Williams said.

Harkema rejects Williams's assertions. She told Howard that no patients were put at risk. She downplayed the effect of the federal action and said she voluntarily put the study on hold.

Harkema said concerns about her study were overblown, and the scrutiny arose after a few disgruntled ex-colleagues blitzed regulators with exaggerated accusations.

"I think that these are very disgruntled, unhappy individuals, who are making some incredibly bad choices out of their own selfishness," she said.

Harkema insisted that her data was not compromised. She admitted that follow-up records were merely disorganized. "Every allegation related to patient safety or risk was unfounded," she said.

Harkema said she voluntarily stopped enrolling patients in all four of her studies after Williams and another researcher complained. Enrollment in two of them has since resumed after Harkema said the university auditors and private funders found no reason to stop them.

In its letter to U of L, National Institute on Disability, Independent Living and Rehabilitation Research Director John Tschida cited problems outlined in the U of L review. They raised questions about the researchers' ability to reliably measure the potential benefits of Baclofen in that context.

"This is pretty egregious,” Milton Corn, deputy director for research and education at the National Library of Medicine, told Howard. Corn declined to comment on U of L’s research -- he’s not connected to the study’s funding agency -- but he called discontinuing any study "draconian."

"It’s much more common to try to work with the investigators and help them repair something that’s flawed and probably can be fixed," he said. "I think to say we want to discontinue this implies they really were very upset."

For now, Harkema is awaiting clearance from the federal Office For Human Research Protections. If she gets it, Harkema said she’ll resume the study, albeit without federal money.

KentuckyOne Health turns down ethics panel's request to remove or change cancer treatment banner advertisement

A Louisville cancer center features a giant banner that says: "FIGHT CANCER WITH 5 or FEWER TREATMENTS." The treatment, called CyberKnife and performed at the James Graham Brown Cancer Center, is a procedure that directs large doses of radiation accurately to tumors, but it only works for small, isolated tumors, Andrew Wolfson reports for The Courier-Journal.

Dr. Anthony Zietman, associate director of the Harvard Radiation Oncology residence program at Boston's Massachusetts General Hospital, agreed the banner is accurate but said it is misleading, falsely implying CyberKnife can cure cancer. "For the right person, it is a great treatment, but the banner implies it is for everyone," he told Wolfson, adding that fewer than 20 percent of cancer patients at his hospital are eligible for stereostatic radiosurgery treatment.

The University of Louisville Hospital's ethics committee voted unanimously on May 20 to request that KentuckyOne Health remove the banner or change it to give more context. "It is false and misleading advertising," said Dr. Larry Florman, a plastic and reconstructive surgeon who sits on the committee, which includes doctors, nurses and clergy. "It's almost like a scam."

The committee said in an email to KentuckyOne that cancer patients receiving traditional therapy were asking why their treatment included more than five sessions and why they couldn't receive CyberKnife treatments instead. KentuckyOne spokesman David McArthur said after talking with the chairman of the U of L Department of Radiation Oncology and examining clinical results, "We decided that keeping the banner in place is appropriate."

McArthur also noted that CyberKnife can fight cancer after just five or fewer treatments and that in almost three years, "all patients treated with it at the cancer center have received one to five treatments," Wolfson writes. "More than half were treated for metastatic cancer—cancer that had spread." McArthur added, "In the spirit of collaboration, we are looking for additional ways to ensure potential patients have the appropriate information to understand if CyberKnife is the right treatment for them."

Accuray is the Sunnyvale, Calif., company that makes CyberKnife. The company says the therapy is non-invasive and painless. In 2001, the U.S. Food and Drug Administration approved the system for use in any organ, including the prostate, lung, brain, spine, liver, pancreas and kidney.

Kentucky and online audiences hear discussion of proposed system for patients to report medical errors; comments due July 8

By Molly Burchett
Kentucky Health News

The Obama administration is creating a new system for patients to report medical mistakes because existing systems fail to do so, and if all goes as planned, the pilot program will launch this fall, a federal official told a Health Watch USA meeting in Kentucky and online Wednesday night.

Research suggests that many adverse medical events go unreported in current systems that don't allow patients to provide input about their care, said James Battles, Ph.D., of the Agency for Healthcare Research and Quality. To fix this problem, AHRQ has funded the development of a prototype patient reporting system through a contract with RAND Corp.

Called the Consumer Reporting System for Patient Safety, the project is designed to collect information from patients "about medical errors that resulted or nearly resulted in harm or injury” and can also secure reports from family members, said Battles. The data will be available for use by providers and health systems that wish to create or enhance their own local reporting systems.

Here's how the system will work: When a patient recognizes a medical error, an intake form will ask what happened, including questions about the details of the event and the health care provider(s). Providers and patient safety officers are expected to follow up with the patient, which AHRQ estimates would add 28 hours to the provider's annual work load. The collected data will be analyzed to produce estimates about the patient safety events, which will be shared with health institutions.

There is concern about how the project findings will be used and that "frivolous" patient reports may lead to increased medical malpractice liability for providers. Despite apprehension that findings could possibly be linked to financial or legal penalties for poor performance, hospitals say they are receptive to the idea, Robert Pear of the New York Times reported last fall when project was first posted in the Federal Register.

"The question then would become, frivolous to whom?" Battles said when asked what he would say to concerned providers. Patient input is critical to gaining a full understanding of an adverse event, he said, and the overall project will include public awareness campaigns to let patients know their care experience is valued: "The purpose of the system is to improve patient safety, develop ways to prevent future harm and inform policy."

Patients, physicians, hospitals and other health care providers have until July 8 to comment on revisions to the government proposal, says the notice published in the Federal Register. (Click here for more information.) Battles said AHRQ has made substantial changes to the proposed reporting system's data collection tools, based on comments received last fall when the project was originally outlined.

After approval from the federal Office of Management and Budget, Battles said, a pilot program will be launched this fall near Philadelphia, then the system will be tested on a regional basis while considering reports from providers and patients.

Health Watch USA, based in Somerset, was founded by Dr. Kevin Kavanagh to promote health care transparency and patient advocacy, says its website. The organization's next meeting will be held July 31 at 5 p.m. and will feature Dr. Patrick Conway, chief medical officer for the federal Center for Medicare and Medicaid Services.

Painkiller epidemic was driven in part by drug makers' financial relationships with researchers who discounted the risks

For almost a decade, medical officials and experts claimed OxyContin rarely posed problems of addiction for patients. The drug's label, which was approved by the Food and Drug Administration, said addiction risks were small. Research published in the New England Journal of Medicine also said OxyContin wasn't addictive; so did a study in another journal, which OxyContin manufacturer Purdue Pharma reprinted 10,000 times. Since the drug first hit the market, it has fueled a large-scale swath of prescription pain killer addiction, beginning in Central Appalachia, that has grown into a national epidemic, especially in rural areas.

The epidemic was driven in no small part by doctors' lack of knowledge about OxyContin, which was perpetuated by the drug's manufacturer through false claims that became scientific consensus. But now, "Many in the medical profession have rediscovered the destructive power of opiates," and are calling that consensus into question, Peter Whoriskey of The Washington Post reports. "A closer look at the opioid painkiller binge, in which retail prescriptions have roughly tripled in the past 20 years, shows that the rising sales and addictions were catalyzed by a massive effort by pharmaceutical companies to shape medical opinion and practice."

Doctors were wary of prescribing painkillers to any patient except those with cancer for years. But manufacturers and some pain specialists "helped create a body of scientific research assuaging the long-standing worries about opioids and pushed to expand the use of the drugs in people with chronic pain: bad backs, arthritis, sore knees," Whoriskey reports.

Through an examination of key scientific papers, court documents and FDA records, the Post found that many of the studies claiming OxyContin wasn't addictive were supported by Purdue Pharma. The conclusions those studies reached were sometimes not supported by data, and when the FDA needed to develop an opioid policy, it turned to a panel of doctors who had financial relationships with Purdue Pharma and other drug makers. (Read more)