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David Glenn

Patient Safety in the Apocalypse

October 4, 2013 by David Glenn

A year from now (or maybe five), my hospital (or maybe yours) will suddenly be filled with far more patients than it can cope with. Some damned thing — a viral pandemic, an earthquake, a dirty bomb — will send 700 people into a facility with 300 beds. The building’s electricity and oxygen supply may or may not be intact. Awful triage decisions will need to be made.

In the first hours of a crisis, hospitals can perform brilliantly. Think of the way nurses ferried NICU babies down the stairs at NYU Langone in last October’s storm. But if an emergency wears on for days, sleep-deprived, dehydrated, overwhelmed clinicians will inevitably start to lose their powers of attention and compassion. If the hospital doesn’t have a robust safety culture that can counteract that cognitive decay, physicians and nurses are likely to commit follies that needlessly cost lives.

FDAM coverSheri Fink’s extraordinary Five Days at Memorial revisits the aftermath of Hurricane Katrina at Memorial Medical Center in New Orleans. Forty-five patients died at Memorial in the week after the storm — far more than at any other hospital in the city, though most other facilities faced equally brutal conditions.

There is good reason to believe that at least one physician and at least two nurses injected high doses of morphine and Versed into at least a dozen Memorial patients, deliberately speeding their deaths. Many of those patients were frail and elderly. One was a paralyzed 61-year-old who was fully alert and oriented throughout the week. “So are we ready to rock and roll?” he reportedly asked a staff member on the morning of September 1, 2005, when he expected finally to be evacuated. A few hours later, he was injected with morphine — and, according to one account, smothered with a towel.

What happened here?

The morphine-wielding clinicians seem to have believed that many of the patients had already decompensated so badly that their deaths were imminent. Why should they suffer through a final 24 hours of pain, heat, and respiratory distress? But in most cases, the patients were barely known to the staff members who injected them; there’s no evidence that they received adequate physical assessments, much less that they were asked whether they wanted to be hastened into death.

In the least charitable reading, the clinicians simply wanted to get the hell out of the building. They had worked through three days with little electricity or air conditioning. They believed, wrongly, that too few helicopters were available to complete an evacuation in a reasonable time frame. They were exhausted, disheartened, and desperately worried about their family members, their houses, their pets. They’d heard lurid rumors of post-hurricane violence. They thought the crippled hospital might be overrun by looters at any moment. They wanted out. But of course they didn’t want to leave behind anyone alive. That would be cruel, and might open them up to charges of criminal abandonment. Easier to persuade themselves that the remaining patients were all miserable and on the brink of death. We’ll just give them a few injections to “ease their suffering.”

Or maybe that’s a badly unfair way of telling the story. As Fink makes clear, the physician and nurses who gave the injections had decades-long track records of dedication and skill. A grand jury reviewed the episode and declined to hand down any indictments. (That jury never heard from crucial witnesses, however, including Memorial physicians who had contacted prosecutors about what they had seen and heard.)

Throughout the book, Fink is meticulous about conveying the limits of what is actually known about the events. She never lapses into polemic, and she never tries to force the available facts into a tidy box. (For more on Fink’s “non-narrative narrative,” see this appreciation by Jeff Sharlet.)

Five Days at Memorial is so complex that it feels like a violation to boil it down into a clean set of lessons. But I’m going to try anyway. Here are three principles that might be drawn from the book about how to preserve patient safety in an extreme emergency. (Think of this as an IHI Open School course for the apocalypse.)

1. For God’s Sake, Know Each Other’s Names, and Talk to Each Other.

Even when Memorial had been largely evacuated and was down to a skeleton staff, not all the nurses and physicians in the building knew each other’s names or roles. I lost track of the number of times Fink mentioned one professional vaguely recognizing another in the hallway without actually knowing them. (“Thiele didn’t know Pou by name, but she looked like the physician in charge on the second floor.”)

This was partly because patients and staff members from a long-term-care facility had taken shelter at Memorial before the storm hit. But even so, it’s astonishing to read how little effort was made to share information and to build a sense of camaraderie inside the building. That atmosphere of semi-anonymity seems to have made it easier for rumors to spread and for drastic, ill-conceived plans to hatch. As Atul Gawande and his colleagues have demonstrated in their surgical-safety projects, medical staff members are much more likely to share information and to point out potential mistakes when they know one another’s names.

Across town at Charity Hospital, physical conditions were at least as bad as those at Memorial, and twice as many patients were present, but only three died. As Fink notes, this may have been partly because the staff there actively built themselves into teams. They held open meetings every four hours and worked to suppress false rumors (“you can only say it if you’ve seen it”).

2. DNR Means ‘Do Not Resuscitate’ — Not ‘I’m on the Cusp of Death, So Please Send Me to the Back of the Triage Line.’

The staff at Memorial (like those at some other New Orleans hospitals) decided that the most able-bodied patients should be evacuated first, with the sickest patients held back for the final wave. That kind of triage structure has been extensively debated, but it’s not what concerns me here. What concerns me is the criteria the hospital used to decide which patients were sickest. Rather than carefully assessing each patient’s medical history and physical status, the staff sometimes used DNR/DNI orders as a crude proxy: If a patient had a DNR/DNI order on file, she was presumed to be in the sickest category.

That makes little sense. I know a few far-sighted, able-bodied fifty-somethings who have prepared advance directives asking not to be intubated or resuscitated if they ever become severely ill. I’m pretty sure they don’t want to be abandoned or euthanized after a natural disaster.

In a 2010 report on disaster planning, a panel of the National Academy of Sciences made the same point: “DNR orders reflect individual preferences and foresight to establish advance directives more than an accurate estimate of survival. Accordingly, DNR orders are not useful parameters for considering the allocation of scarce resources.”

3. Be prepared.

Of course, the most important lesson is simply to be ready. Memorial, which was originally known as Southern Baptist Hospital, suffered severe floods in 1926 and 1927. But the memory of those floods faded, and the building’s emergency plans in 2005 turned out to be badly inadequate.

No reason to belabor this point here. Know your hospital’s disaster plan. Do some drills. If your building’s backup generators are still located in the basement, that’s a problem.

4. Be creative.

Don’t be too quick to give anyone up for dead. Fink ends her book with the story of Aarti Kinikar, a physician who worked in an overwhelmed Indian hospital during the H1N1 epidemic of 2010. When her facility ran out of ventilators, she had the inspiration to use modified CPAP machines on hundreds of small children. “Triaging better was not enough for her,” Fink writes.

Similarly, staff members at Charity Hospital refused to believe that their sickest patients couldn’t be saved or evacuated, and came up with ingenious plans to get them to safety.

I was at work last month on the day of the Navy Yard shootings. For an hour or so I was distracted, worrying about my sister, who at the time lived a couple of blocks from the base. I had to keep nudging my attention back to the tasks at hand: checking tacrolimus levels, preparing care plans. God only knows how my cognition might deteriorate during a severe disaster in my own building. But I hope I’ll be a little wiser for having read Five Days at Memorial.

 

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Why Nursing Associations Should Endorse the #alltrials Campaign

September 17, 2013 by David Glenn

Suleika Jaouad, a young leukemia survivor in New York, has been writing essays about her experience of illness. In her most recent post, she described the terror she felt in 2011 when she was considering whether to enroll in a clinical trial:

My doctors recommended a Phase 2 trial, meaning it was not yet known whether the new chemotherapy combination was even effective, let alone better than the standard of care. At a time when everything seemed so uncertain, I craved hard facts, statistics and proof that my cancer treatments were worth the havoc they wreaked on my mental and physical health. The last thing I wanted was to become one of those guinea pigs. I wanted a cure, not a trial.

Jaouad took a deep breath and signed on. Her gamble paid off: She responded well to the investigational chemo and her disease went into remission. Two years and one bone-marrow transplant later, she’s healthy.

If things hadn’t gone so well — if Jaouad had died during the trial — her loved ones might have consoled themselves by saying: At least her final weeks gave something to science. She took part in a trial that will contribute to the sum total of medical knowledge. Cancer patients twenty years from now will be better off because people like Suleika were willing to volunteer.

That’s how we all hope and assume science operates. But too often, those hopes and assumptions are wrong.

Bad PharmaAs Ben Goldacre explains in enormous detail in Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients, many clinical trials contribute nothing whatsoever to the well-being of future patients — because their results are never published or shared with the medical community.

In some cases, pharmaceutical companies stash the trials’ data in their filing cabinets because their results weren’t to their liking.

In other cases, academic researchers who’ve completed an undramatic trial — say, an investigational drug that turned out to be neither better nor worse than the status-quo therapy — can’t find a journal willing to publish such an unsexy result.

The end result of all this missing data is that clinicians are operating in the dark, with grossly incomplete knowledge of drugs’ efficacy and side effects.

One of Goldacre’s many examples concerns the cancer drug Avastin. In 2010, two Greek researchers noted that 14 of 26 large-scale Phase 3 trials of Avastin had never been published, or even presented at medical conferences. If regulators had had a fuller picture of Avastin’s efficacy (or lack thereof) and its risks, they might have moved more quickly to revoke its approval for breast cancer therapy (which finally happened at the end of 2011).

Several efforts have been made during the last decade to keep clinical-trial data from vanishing. Some agencies, for example, now require clinical trials to be listed in public registries before they begin.

But those efforts have had fitful success at best. Just last week, a paper in BMJ reported that many medical journals don’t insist that their authors use the public trial registries. If journal editors refuse to enforce that norm, many clinical trials will continue to be quietly buried.

Goldacre and his allies (including the Dartmouth Institute for Health Policy and Clinical Practice) have put together a simple petition, less than a hundred words long:

Thousands of clinical trials have not reported their results; some have not even been registered.

Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated.

All trials past and present should be registered, and the full methods and the results reported.

We call on governments, regulators and research bodies to implement measures to achieve this.

The petition doesn’t lay out any enforcement mechanisms. But it sets out a simple principle: No clinical trial should be buried or forgotten, period.

So far, the “all trials” petition has been endorsed by a wide variety of organizations (mostly in the U.K.) representing physicians, pharmacists, patients, and academic researchers. But, as of this writing, no professional nursing organizations have signed on.

That seems like a shame. We have as much at stake in this debate as any other profession.

We’re the people who actually place drugs in the mouths and veins of patients. When I look patients in the eye and tell them about the potential side effects of new medications, I don’t want my answers to be distorted because crucial trial data somehow never made it into the public realm.

Some of my nursing colleagues have an even more direct interest: Many nurse practitioners, of course, have prescribing authority. And research nurses often have the responsibility of walking potential clinical-trial participants through the informed-consent process. (As Goldacre notes, informed-consent forms sometimes mislead participants into believing that a trial’s results will definitely be shared with the scientific community, even in cases where the funder reserves the right not to publish.)

I hope the two nursing organizations I belong to — the American Nurses Association and the Oncology Nursing Society — will endorse the all-trials campaign.

We owe it to patients like Suleika Jaouad. If a person is brave enough to sign up for a clinical trial, she should be guaranteed that the results of that trial won’t be lost, buried, or forgotten.

 

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