Should You Stay or Should You Go?

family presence during resuscitation2Picture this familiar scene. A critically injured person is wheeled into the emergency room by paramedics. Concerned, shocked and occasionally hysterical family members rush to the patient’s side. An army of doctors, nurses and techs begin emergency resuscitation efforts, inserting breathing tubes, CPR, starting IV’s, drawing blood, administering drugs and other fluids.  One of these health care professionals, nodding toward the family and screaming “Get them out of here!”

We’ve all see it… either in real life or on TV.

Cutting to the next scene, the family is escorted into a stark family crisis room. While healthcare staff work desperately to resuscitate the patient, a social worker updates the family on their progress. If the patient dies, staff  make him as presentable as possible, and then invite the family in to say good-byes. The social worker supports the family during this difficult time, and the code team return to their care of other patients.

For decades, this approach seemed to work well. The common wisdom was that if we did let the family in during the code, they’d either get in the way or become so distraught that we’d have more patients on our hands. Furthermore, we felt we were doing the family a greater service by letting them see their loved one only after we’d removed tubes and lines, even though the calm scene we produced was in total contradiction to actual events.

But recently, this traditional approach has been questioned. It turns out that many family members want to be present during resuscitation efforts, rather than hidden away in a side room.

family presence during resuscitationAnd even though health care professionals are still divided on whether families should be present, most agree the issue must be addressed.

Now, research is starting to question whether family members be allowed to remain in the room as these potentially lifesaving efforts begin?

A two-year study led by a researcher Jane Leske PhD, has shown that family members – parents, spouses, fiancées and adult children – of trauma patients, can benefit by being present during critical moments of care.

Those who do choose to do it really want to be there,” says Leske, professor of nursing at the University of Wisconsin-Milwaukee. “They want to watch everything and get information. It lowers their anxiety and stress to see that everything possible is being done. Seeing is believing.”

However, family presence during resuscitation is controversial and underutilized. Indeed, many health care professionals and hospitals argue against it, concerned that the procedures may be too traumatic for family witnesses, or that family members may become emotionally out of control and interfere with care.

Leske conducted this study in collaboration with medical staff at a facility where families have the option of staying and observing resuscitation efforts. It compared outcomes for family members of patients, ages 18-93, with critical injuries from gunshot wounds or motor vehicle accidents at a Southeast Wisconsin Level 1 trauma center.  The center had offered family presence during resuscitation for more than two years by the time Leske’s study began.

cpr_pr.299225225_stdThe study focused on 140 family members over age 18, divided in two roughly equal groups – those who opted to remain with the victim during resuscitation; and those who chose not to, or were not able to reach the emergency department in time. Researchers interviewed family members within 72 hours after admission to the surgical intensive care unit, to discuss the family’s coping resources, communication and anxiety levels.

She and her research team found a number of benefits to having family members present, and no drawbacks.

They concluded that while families can benefit from being present during resuscitation, it’s also important that the hospital have policies and procedures in place on when and how to allow the option. For example, family presence during resuscitation should not be permitted when family members are intoxicated, extremely agitated or emotionally unstable.

Other researchers agree. A large French study published last month in the New England Journal of Medicine concluded that relatives who did not witness CPR had post-traumatic stress disorder (PTSD)–related symptoms of anxiety and depression more frequently than those who did witness CPR. Family-witnessed CPR did not affect resuscitation characteristics, patient survival, or the level of emotional stress in the medical team and did not result in medico-legal claims.

What are your thoughts on this?  Would you want to stay…or walk away.  Let us know.

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Reckless Research Race, Results in Rising Retractions. Reform Required?

As our regular readers know, SRxA’s Word on Health loves nothing more than a good alliteration to start the day!  Although the blog post title may rank as one of our more classic tongue twisters, there is nothing amusing about the content.  As involved as we are in medical communications and peer-reviewed, scientific publishing, we are saddened to report on the rise of a recent trend of falsified research. An unsettling pattern is emerging. The rate at which articles are retracted (meaning the study was published, only to later be dubbed unfit for print — typically due to either deliberate misconduct or an honest scientific mistake) is increasing. To our knowledge, at least three scientific journals have published articles over the past two years warning of the rise in retractions and misconduct by researchers who have fudged results.

Last year Nature reported a tenfold increase in retractions over the past decade even though the number of published papers only increased by 44%. Before that, the Journal of Medical Ethics published a study in 2010 that said a rise in recent retractions was the fault of misconduct and “honest scientific mistakes.” It calculated that the number of retractions had more than tripled from 50 in 2005 to 180 in 2009.

The latest publication to highlight this issue is Infection and Immunity. In the fall of 2010, Dr. Ferric C. Fang, editor in chief of the journal made an unsettling discovery – one of his authors had doctored several papers. The journal wound up retracting six of the papers from the author, Naoki Mori of the University of the Ryukyus. It soon became clear that Infection and Immunity was hardly the only victim of Dr. Mori’s misconduct. Since then, according to the blog Retraction Watch, other scientific journals, including the International Journal of Cancer  have retracted another 24 of his papers. This was a new experience for Fang. Prior to this incident Infection and Immunity had only retracted nine articles over a 40-year period. “Nobody had noticed the whole thing was rotten,” said Fang, a professor at the University of Washington School of Medicine. Dr. Fang became curious how far the rot extended. To find out, he teamed up with a fellow editor at the journal, and before long they reached a troubling conclusion: not only that retractions were rising at an alarming rate, but that retractions were just a manifestation of a much more profound problem.

Dr. Fang’s colleague, Dr. Arturo Casadevall, said he feared that science had turned into a winner-take-all game with perverse incentives that led scientists to cut corners and, in some cases, commit acts of misconduct. Last month, in a pair of editorials in Infection and Immunity, the two editors issued a plea for fundamental reforms. While no one claims that science was ever free of misconduct or bad research, the new raft of retractions appears to be a mix of misconduct and honest scientific mistakes. Several factors are at play here, scientists say. One may be that because journals are now online, bad papers are simply reaching a wider audience, making it more likely that errors will be spotted. But other forces are more pernicious. To survive professionally, scientists feel the need to publish as many papers as possible, and to get them into high-profile journals. And sometimes they cut corners or even commit misconduct to get there. To measure this claim, Drs. Fang and Casadevall looked at the rate of retractions in 17 journals from 2001 to 2010 and compared it with the journals’ “impact factor,”  – a score based on how often their papers are cited by scientists. The higher a journal’s impact factor, the higher its retraction rate. The highest “retraction index” in the study went to one of the world’s leading medical journals, The New England Journal of Medicine.

The scramble to publish in high-impact journals may be leading to more and more errors. Each year, every laboratory produces a new crop of Ph.D.s, who must compete for a small number of jobs, and the competition is getting fiercer. In 1973, more than half of biologists had a tenure-track job within six years of getting a Ph.D. By 2006 the figure was down to 15 percent. In such an environment, a high-profile paper can mean the difference between a career in science or leaving the field. The scramble isn’t over once young scientists get a job. “What people do is they count papers, and they look at the prestige of the journal in which the research is published, and they see how many grant dollars scientists have, and if they don’t have funding, they don’t get promoted,” Dr. Fang said. “It’s not about the quality of the research.”

With all this pressure on scientists, they may lack the extra time to check their own research. Instead, they have to be concerned about publishing papers before someone else publishes the same results. Adding to the pressure, thousands of new Ph.D. scientists are coming out of China and India, countries that offer cash rewards to scientists who get papers into high-profile journals. Dr. Fang worries that the situation could be become much worse if nothing happens soon. To change the system, Fang and Casadevall say graduate students need a better understanding of science’s ground rules. They would also move away from the winner-take-all system, in which grants are concentrated among a small fraction of scientists by putting a cap on the grants any one lab can receive. A little bit of old fashioned honesty wouldn’t hurt either!

Rogue Reporting

According to an article just published in the Journal of General Internal Medicine, results of drug studies published in medical journals may be misleading.

The UCLA-Harvard study says that the drug trials published in the most influential medical journals including the New England Journal of Medicine, the Journal of the American Medical AssociationThe Lancet, the Annals of Internal Medicine, the British Medical Journal and the Archives of Internal Medicine are frequently designed in a way that yields misleading or confusing results.

Investigators analyzed all the randomized drug trials published in the above journals between June 1, 2008, and Sept. 30, 2010, to determine the prevalence of outcome measures that make data interpretation difficult.  In addition, they reviewed each study’s abstract to determine the percentage that reported results using relative rather than absolute numbers, which can also be misleading.

They specifically looked at three outcome measures that have received increasing criticism from scientific experts: surrogate outcomes, composite outcomes and disease-specific mortality and found that :

  • 37% of the studies analyzed used surrogate outcomes – intermediate markers, such as a heart medication’s ability to lower blood pressure, but which may not be a good indicator of the medication’s impact on more important clinical outcomes, like heart attacks
  • 34% used composite outcomes which consist of multiple individual outcomes of unequal importance lumped together, such as hospitalizations and mortality, making it difficult to understand the effects on each outcome individually
  • 27% used disease-specific mortality, which measures deaths from a specific cause rather than from any cause. This may be a misleading measure because, even if a given treatment reduces one type of death, it could increase the risk of dying from another cause, to an equal or greater extent

Patients and doctors care less about whether a medication lowers blood pressure than they do about whether it prevents heart attacks and strokes or decreases the risk of premature death,” said the study’s lead author, Dr. Michael Hochman, a fellow in the Robert Wood Johnson Foundation Clinical Scholars Program at the David Geffen School of Medicine at UCLA’s division of general internal medicine and health services research, and at the U.S. Department of Veterans Affairs’ Los Angeles Medical Center.

Dr. Danny McCormick, the study’s senior author and a physician at the Cambridge Health Alliance and Harvard Medical School, added: “Patients also want to know, in as much detail as possible, what the effects of a treatment are, and this can be difficult when multiple outcomes of unequal importance are lumped together.”

The authors also found that 45% of exclusively commercially funded trials used surrogate endpoints, whereas only 29% of trials receiving non-commercial funding did. Furthermore, while 39% of exclusively commercially funded trials used disease-specific mortality, only 16% of trials receiving non-commercial funding did.

The study also showed that 44% of abstracts reported results in relative rather than absolute numbers, which can be misleading.  “The way in which study results are presented is critical,” McCormick said. “It’s one thing to say a medication lowers your risk of heart attacks from two-in-a-million to one-in-a-million, and something completely different to say a medication lowers your risk of heart attacks by 50 percent. Both ways of presenting the data are technically correct, but the second way, using relative numbers, could be misleading.”

To remedy the problems identified by their analysis, Hochman and McCormick believe that studies should report results in absolute numbers, either instead of, or in addition to, relative numbers, and that committees overseeing research studies should closely scrutinize study outcomes to ensure that lower-quality outcomes, like surrogate makers, are only used in appropriate circumstances.

So who’s to blame?  The pharma companies for using outcomes that are most likely to indicate favorable results for their products, the study authors for writing them up that way or the journals for accepting the manuscripts?  Let us know what you think.

To Give or Not to Give? – That is the question!

Few people in the respiratory community will have missed the study published last week in the New England Journal of Medicine (NEJM) that demonstrated Spiriva is comparable to Serevent in adults with uncontrolled asthma.

For those of you who did, SRxA’s Word on Health is pleased to provide you with a quick recap:

210 people with uncontrolled asthma were enrolled in a three-way, double-blind, triple dummy study.

All patients were treated with a beclamethasone inhaler (Qvar) to which was added Spiriva (tiotropium bromide), Serevent (salmeterol xinafoate) or a double dose of Qvar.

Results showed that Boehringer Ingelheim’s Spiriva, which is not currently FDA approved for asthma,  worked better than doubling the dosage of Teva’s Qvar and was just as effective as GlaxoSmithKline’s Serevent.

Interesting stuff, but in our opinion that was not the real news!

In an accompanying editorial, editors of the NEJM, chastised GSK for failing to provide free study drug to investigators from the National Heart, Lung, and Blood Institute. Apparently manufacturers were approached to supply both active drug and placebo inhalers, and while Boehringer Ingelheim (the manufacturer of tiotropium) and Teva (the manufacturer of Qvar) agreed to provide the materials, GlaxoSmithKline (the manufacturer of Salmeterol) refused.

The net result of this, say the editors was that investigators had to spend $900,000 from the National Institutes of Health (NIH) – and therefore they say, from taxpayers – to repackage the active drug and to create a visually identical placebo for use in the trial.

In a passionate conclusion to the editorial, Curfman, Morrissey and Drazen say:

The most precious commodity that drug manufacturers possess is the trust of their research subjects, and to maintain this trust they need to be willing to put their products at risk. When they refuse to provide their drugs to legitimate investigators, the researchers will get their studies done without company help. It will take more time and cost more money, but in the end, the research will be done and the company will be perceived as having acted in its own self-interest rather than having worked to enhance the health of the community.”

This story was picked up by various news media who continued the vilification of GSK.

Here at Word on Health we’re not so sure that this criticism is justified.

First, pharmaceutical companies are not required to donate products for third party studies.

Second, Serevent is already licensed for the treatment of asthma. The company has previously performed numerous trials to demonstrate its efficacy and safety, including four studies on its effects in patients with asthma on concomitant inhaled corticosteroids.  In other words GSK did not need this study.

Boehringer, on the other hand did.

Two years ago, safety concerns were raised with Spiriva inhalers. Although the FDA has since said that recent data do not show a connection between the inhaler and previously reported risks of stroke, heart attack and death, doubts continued to linger in the market.  Additionally, as Spririva is not yet approved for use in asthma, any data that could show efficacy in this indication would potentially be an important step in gaining an additional licensed indication.

It is also worth noting that the total cost of the study was > $5.3 million. Tax payers money was being spent regardless.

And finally, it’s not as if Glaxo don’t pay their dues.  They are a member of the Partnership for Quality Medical Donations (PQMD), an alliance of pharmaceutical companies and humanitarian agencies that works to encourage the donation and timely delivery of appropriate medicines to people in need. They were one of the biggest donors of drugs and emergency medical relief following the monsoon floods that hit Pakistan in August; they have provided in excess of $1 million dollars of drugs to Haiti since the earthquake, more than $2 million to South East Asia. They also helped out following floods in El Salvador, wild fires in California, cyclones in Myanmar and the 2009 earthquake in China.

Should companies be forced to donate product to studies that are of no interest to themselves, or should they be free to spend the money and donate their product where they wish?

Should highly respected medical journals be allowed to single out companies for exercising their right to chose how they allocate their product?

Word on Health would love to know what you think.

In the interests of full disclosure we’d like to point out that none of the companies mentioned in this story are current clients of SRxA.