Thursday, July 7, 2011

Hip Protector Study Fiasco

There's an interesting story developing that I want to bring to GeriPal reader's attention.  Several researchers are under investigation for not reporting potential adverse effects of a hip-protector study.  There is a great deal of background reading for this study for those who are interested - I've just read the following three web-pages: this article in the Boston Globe, this Department of Health and Human Services (HHS) letter, and this press release from HipSaver.

Here are the outlines of the issue, as I understand it:
  • In 2004, Dr. Douglas Kiel, a researcher from Hebrew Senior Life - a terrific nursing home and research institution affiliated with Harvard (also not so shabby a place) - were conducting a study of hip protectors.  At the time, evidence that hip-protectors prevented hip fractures was unclear.  Previous studies were vulnerable to confounding - those in the group who wore hip protectors may have been different in important ways from those who did not wear hip protectors. Those differences, rather than the hip protectors, may have led to findings that hip proctors protect against fracture.  Dr. Kiel and colleagues came up with the novel idea of allowing patients (nursing home residents) to serve as their own controls: they would put a hip protector on only one hip, and the other hip would serve as the "control."  There would be no differences between study subjects because each subject experienced both the intervention and control at the same time!  The NIH funded the study at a cost of 8.5 million dollars.
  • As the study progressed, internal documents (emails) show that researchers began to worry that something unexpected was happening.  More study subjects were falling toward the side of the hip protector than the other side.  They were more likely to experience fractures on the side with the hip protector.  These findings were not disclosed to study subjects.
  • Fortunately, because this was an intervention trial that posed potential serious risks to human subjects (hip fracture), a Data Safety Monitoring Board  was established to review the study data and protect the health of study subjects. 
  • Unfortunately, researchers decided not to disclose the extent of the problem to the Data Safety Monitoring Board.  They made a conscious effort not to draw attention to it, because they feared the study would be shut down.
  • The results of the trail were published in JAMA in 2007.  The study demonstrated that hip protectors did not protect against hip fractures.  The accompanying editorial picked up on the finding that more patients experienced hip fracture on the side with the protector (13 fractures) than the side without (7 fractures), and concluded that either hip protectors are ineffective and cause fractures, or, "the use of a 1-sided hip protector modified the individual’s standing and walking, such that it increased the risk of hazardous fall onto the protected hip."
  • Post-hoc review of pilot data used to establish the feasibility of this large trial subsequently revealed that there was clear evidence that hip protectors worn on one side of the body led to falls toward that side.  Here is the data:
       Fell to left
Fell to right
Pad on left
21
9
Pad on right
15
37

  • In 2008, HipSaver's Inc sued Dr. Kiel for unfairly disparaging hip protectors.  The law suit led to uncovering the internal documents described above, and subsequent investigations by the Federal Government (HHS), JAMA, and Hebrew Senior Life.
  • HHS asked the institutions involved in the study to contact study participants and disclose the risks to which they had been exposed.
Investigations are ongoing, so it may be that information comes to light that is less damning to the study investigators.  But from what I've read, it seems they failed to provide information about known risks of their intervention to participants, and hid this information from the Data Safety Monitoring Board and JAMA.

What's fascinating to me about this study is the disregard for the welfare of human subjects by the investigators involved.  In previous posts I've spoken out against the dangers of industry sponsorship of trails.  This fiasco demonstrates the dangers of being wedded to science, without sufficient concern for the dangers posed to study participants - people. 

This fiasco will undoubtedly have fall out for other researchers, in terms of increased scrutiny of research protocols, red tape, IRB oversight, etc.  As it should.  Ethical violations of this sort are a serious matter.  It's a shame, though, because in the end all those extra hoops to jump through will protect some patients, but also create barriers that may prevent other great studies from being conducted.  And ultimately that's not in everyone's best interest either.

by: Alex Smith

7 comments:

Seth Landefeld said...

This story is humbling for all of us who conduct research, especially research as complicated and cumbersome as research that tests an intervention designed to improve patient care and outcomes - like this research on hip protectors. It seems very unlikely that the transgressions in this case harmed patients, but they do provide a cautionary tale for researchers.
For me, the major lessons to date are: (1) Always disclose relevant information completely to a DSMB and IRB, and when there is a question about what is relevant, use a broader interpretation rather than a loose one. (2) Look for surprising findings, and accept them before explaining them away with something comfortable, which is often a form of group think.

Catherine DuBeau said...

People who dont have all of the facts should be very careful about making highly judgemental statements such as "the disregard for the welfare of human subjects by the investigators involved;" "[not having] sufficient concern for the dangers posed to study participants." Not all of the facts have been established, and rushing to judgement does no one good, can inflict much harm, and is poor science to boot. There is huge potential financial gain for HipSavers (whose product was not in the study) in bringing up new concerns to regulators. Let's wait until the investigation is complete before disparaging others.

Eric Widera said...

I may have read it wrong by I thought the Office of Human Research Protection (OHRP) investigation is complete and they did determined that the research study on hip failed to comply with Department of Health and Human Services regulations for protecting human subjects in government-funded research. The lawsuit by HipSaver was also thrown out on Tuesday as HipSavers was not going to present evidence that contested the study's conclusion or that Kiel was acting maliciously.

Does any know of any other significant investigations that are pending?

Dan Matlock said...

Another lesson is to be very careful with what you write in e-mails:

The quotes from the e-mail exchange in the HHS memo that Alex references are amazing!

"Based on these results, we should question whether it is ethical to continue with this study design. I am very uncomfortable going to the DSMB at this point (I have not circulated any of these data to them – only the results of the biomechanical testing). I would almost rather cancel the call, giving them some reason or another, than try to come up with an explanation between now and Monday morning and potentially shoot ourselves in our collective feet. . . . . I will try to put a good face forward for the DSMB, but I am very uncomfortable at this point"

Even if there is an ongoing investigation, there were problems here. Thank you for posting this Alex!!

Another potential explanation: If you felt yourself going down, wouldn't you turn to the side with the pad...

Mary Poole said...

I do not understand why they would only use one sided Hip Protectors, when I am sure the participants had two hips. I worked in a community that promotes hip protectors, In 4 years we had no hip fractures in any of the residents who wore the double sided protectors and all of the residents had dementia, therefore a higher risk group.

Alex Smith said...

Thanks for the feedback everyone. I did go too far in sounding like I condemned the people involved, rather than their actions.

Francisco said...

I heard a discussion about an article based on this study. I was stunned: how the idea of a one-sided hip protector passed through an IRB? I compared it to an study using a one sided bull-proof vest.