美国国家公共电台 NPR Critics Trying To Stop A Big Study Of Sepsis Say The Research Puts Patients At Risk

 

DAVID GREENE, HOST:

Today, a consumer advocacy organization is asking federal health officials to halt a large medical study that's being conducted at major universities nationwide. Public Citizen says this study involving treatment for sepsis puts patients at risk and will at best produce confusing results. NPR's Richard Harris has the story.

RICHARD HARRIS, BYLINE¹: First, it's important to note that sepsis is a huge problem. It arises when the body tries to fight back infection and overreacts. Sepsis is a leading cause of death, killing² more than a quarter of a million Americans a year, and doctors don't agree about the best way to treat it. A large new study addresses one open question, which is, what's the right combination of IV fluids and drugs to maintain a safe blood pressure?

CRAIG COOPERSMITH: So trying to find the sweet spot, or the Goldilocks place, is important.

HARRIS: Dr. Craig Coopersmith, a sepsis expert at Emory University, says the CLOVERS trial is an attempt to do that. He's not involved in the study, but he reviewed a complaint about the trial lodged³ by the Public Citizen Health Research Group. Dr. Michael Carome, who heads that group, says his main concern is that the study is comparing two treatments - either using a little fluid or a lot - without comparing that to usual care.

MICHAEL CAROME: The problem is both of those experimental ways of treating sepsis may do worse. There may be higher mortality rate for both groups compared to usual care.

HARRIS: That might not be obvious. And if one turns out to be better than the other, that doesn't mean it would be better than usual care, he says. The study won't answer that question. He's also alarmed that in certain unusual circumstances, the protocol⁴ calls for holding off on treating dangerously low blood pressure for several hours.

CAROME: And no one caring for a sepsis patient would normally do that as part of usual care.

HARRIS: The study, designed at Harvard and funded by the National Institutes of Health, went through multiple reviews to conclude that it didn't pose an undue⁵ risk to patients.

CAROME: But the fact that it got through these layers of review with these serious design flaws signals that our system for protecting human subjects is broken.

HARRIS: Craig Coopersmith at Emory doesn't share that sense of alarm. Yes, studies are typically supposed to compare an experimental practice with standard of care, but in the case of fluids for sepsis...

COOPERSMITH: There's no clear standard of care for the first 24 hours.

HARRIS: So that direct comparison is not possible. He agrees with Carome that the study won't clearly show that one of these experimental treatments is better than a more middle-of-the-road approach to fluids and blood pressure medications, but at least the findings might help nudge doctors in one direction or another. As for the concerns about how to deal with a patient with very low blood pressure...

COOPERSMITH: In a very narrow patient population for a narrow period of time, there is a theoretical chance that somebody could have what I would consider to be too low of blood pressure.

HARRIS: And if he were a doctor involved in this trial, he would deviate⁶ from the protocol and treat that patient, as he expects his colleagues would as well. The study isn't designed the way he would have done it, Coopersmith says, but...

COOPERSMITH: I would be comfortable enrolling⁷ patients in this trial.

HARRIS: One of the scientists at Harvard who developed the study declined an interview request, but defended its design in a written statement. A spokesperson for the federal Office for Human Research Protection (ph) says it has not seen the complaint but expects to review the allegations. Richard Harris, NPR News.

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1 byline   

n.署名；v.署名

参考例句：

• His byline was absent as well.他的署名也不见了。
• We wish to thank the author of this article which carries no byline.我们要感谢这篇文章的那位没有署名的作者。

2 killing   

n.巨额利润；突然赚大钱，发大财

参考例句：

• Investors are set to make a killing from the sell-off.投资者准备清仓以便大赚一笔。
• Last week my brother made a killing on Wall Street.上个周我兄弟在华尔街赚了一大笔。

3 lodged   

v.存放( lodge的过去式和过去分词 )；暂住；埋入；（权利、权威等）归属

参考例句：

• The certificate will have to be lodged at the registry. 证书必须存放在登记处。 来自《简明英汉词典》
• Our neighbours lodged a complaint against us with the police. 我们的邻居向警方控告我们。 来自《简明英汉词典》

4 protocol   

n.议定书，草约，会谈记录，外交礼节

参考例句：

• We must observe the correct protocol.我们必须遵守应有的礼仪。
• The statesmen signed a protocol.那些政治家签了议定书。

5 undue   

adj.过分的；不适当的；未到期的

参考例句：

• Don't treat the matter with undue haste.不要过急地处理此事。
• It would be wise not to give undue importance to his criticisms.最好不要过分看重他的批评。

6 deviate   

v.(from)背离，偏离

参考例句：

• Don't deviate from major issues.不要偏离主要问题。
• I will never deviate from what I believe to be right.我绝不背离我自信正确的道路。

7 enrolling   

v.招收( enrol的现在分词 )；吸收；入学；加入；[亦作enrol]( enroll的现在分词 )；登记，招收，使入伍（或入会、入学等），参加，成为成员；记入名册；卷起，包起

参考例句：

• They lashed out at the university enrolling system. 他们猛烈抨击大学的招生制度。 来自辞典例句
• You're enrolling in a country club, Billy. 你是注册加入乡村俱乐部了，比利。 来自辞典例句